Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits. (b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency. (d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. (e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency. (f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program. (g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect. (h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product. (i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103. (j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Merger Agreement (Warner Chilcott LTD), Merger Agreement (Allergan Inc), Merger Agreement (Actavis PLC)
Regulatory Matters. (a) Except as The Company has not had and would not reasonably be expected all Permits required by the FDA to have, individually or in conduct the aggregate, a Parent Material Adverse Effect, Business (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations “FDA Permits”). All of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity Permits held by or Notified Body that issued to the Company are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent , the Company is in compliance in all material respects with, and is not in default in any material respect 30 under (and to the Knowledge of the Company, no event which with the terms giving of notice or lapse of time, or both, would become a default under), each such Permit, and none of such Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transaction contemplated by this Agreement. The Company is the sole and exclusive owner of the FDA Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and holds all Parent right, title and interest in and to all Company Regulatory PermitsFilings free and clear of any Encumbrance (other than Permitted Encumbrances). The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as would notset forth on Section 4.13(b) of the Company Disclosure Schedule, individually since January 1, 2007, there has not been any voluntarily or in involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Company or product candidate of the businesses of each of Parent and each Parent Subsidiary are being conducted Company.
(c) The Company is in compliance in all material respects with all applicable LawsLaws and any other letters, including (i) notices or guidances issued by the FDCA; (ii) FDA or any Governmental Authority which regulates the PHSA; (iii) federal Medicare and Medicaid statutes and related state sale of pharmaceutical products or local statutes; (iv) biological, device or regenerative medicine products in any comparable foreign Laws for any jurisdiction. There are no pending or, to the Knowledge of the foregoing applicable in jurisdictions in which Company, threatened regulatory Actions (other than non-material quantities of any routine or periodic inspections or reviews) against the Company, and to the Knowledge of the Parent Products Company, there are no pending or Parent Product threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) pertaining to the products or product candidates are manufactured of the Company against any Person that manufactures any component, ingredient, or sold; material used in manufacturing the products or the product candidates of the Company pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (v“Collaborative Partners”) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH ActFDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, and device or regenerative medicine products in any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”)jurisdiction. Since January 1, 20122007 there have been no written notices, neither Parent nor reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any applicable Law relating to the Company or the products or product candidates of the Parent Subsidiaries has received Company or any subpoenas or investigative demands or other written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability inquiries that would not reasonably be expected interpreted as raising a compliance concern sent or delivered by any Governmental Authority with regard to have, individually or in any product of the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid Company or any other government healthcare program. None product candidate of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory AgencyCompany.
(d) All pre-clinical and clinical investigations in respect The manufacture of a Parent Product or Parent Product candidate conducted or sponsored by each the products of Parent and the Parent Subsidiaries are Company is being conducted in compliance in all material respects with all applicable Laws administered or issued current “good manufacturing practices,” as defined by the applicable Parent Regulatory AgenciesFDA, including (i) FDA standards for including, as applicable, the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained FDA’s “Quality System Regulation” set forth in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse EffectC.F.R. Part 820.
(e) Since January 1, 2012, neither Parent nor any The Company is and has been in compliance in all material respects with all Laws requiring the maintenance or submission of the Parent Subsidiaries has received any written notice from reports or records under requirements administered by the FDA or the EMA any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDRs (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling near-incidents and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyproduct malfunctions.
(f) Since January 1None of the Company or, 2012to the Knowledge of the Company, all reportsany of its Collaborative Partners, documents, claims, permits and notices required to be filed, maintained agents or furnished to subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Parent Regulatory Agency by Parent Governmental Authority, and there are no proceedings pending or, to the Parent Subsidiaries have been so filedKnowledge of the Company, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not threatened that reasonably might be expected to have, individually result in criminal or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (civil liability or were corrected in debarment or supplemented disqualification by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Authority. None of the Company or, failed to disclose a material fact required to be disclosed to the FDA or Knowledge of the Company, any other Parent Regulatory Agency, or of its Collaborative Partners has committed an any act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ” or for the FDA or any other Parent Regulatory Agency Governmental Authority to invoke any similar policy.
(g) There have been no Serious Adverse Events, except Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of the products of the Company or product candidates of the Company that have not been reported to the FDA in accordance with applicable Law.
(h) To the Knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the Knowledge of the Company, on behalf of the Company by any of its Collaborative Partners, are being, and at all times have been, conducted in compliance in all material respects with all applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Laws of any act other Governmental Authority. No clinical trial conducted by the Company or, to the Knowledge of the Company, on behalf of the Company has been terminated or statement suspended prior to completion for safety or failure to make a statement thatnon- compliance reasons, individually or in and neither the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the Knowledge of the Parent SubsidiariesCompany, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or entity involved in any such clinical trial.
(i) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge Knowledge of Parentthe Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Federal Health Care Program Laws.
(j) Neither the Company nor any officer, employeedirector, agent or distributor of Parent or any managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent SubsidiariesCompany, nor, to the knowledge Knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent or any (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Parent Subsidiaries, Company: (i) has been debarred, excluded or suspended or excluded from participation in any government health care program Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program her under Section 1128 1128A of the Social Security Act of 1935, as amendedcodified at Title 42, Chapter 7, of the United States Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the Knowledge of the Company, is the target or subject of any similar Parent Healthcare Law current investigation by a Governmental Authority relating to any Federal Health Care Program-related offense; or program(v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program
(k) The Company reasonably believes that it has the requisite know-how and processes to, subject to any required regulatory approvals, manufacture and market Dermagraft based on a new cell line in the event that the current cell line is no longer viable.
(gl) As to each Parent Product or Parent Product candidate subject to To the FDCA and the regulations Knowledge of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of ParentCompany, there are no facts which are reasonably likely pending or threatened filings against the Company of an action relating to causethe Company under any federal or state whistleblower statute, and Parent has not received any written notice from including under the FDA or any other Parent Regulatory Agency regarding False Claims Act of 1863 (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole31 U.S.C. § 3729 et seq.), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(im) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any To the Knowledge of the Parent Subsidiaries has experienced Company, the Company is not under investigation by any security breach Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or other incident resulting the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the unauthorized access, use or disclosure United States Department of data or information that is linked Health and Human Services Office of Civil Rights relating to any reasonably identifiable person such violations, or any other data protected under applicable Lawcomparable state or local Laws. Parent or Merger Sub The Company is not a business associate, “covered entity” as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103HIPAA. The Company has been in compliance in all material respects with federal and state data breach Laws.
(jn) Notwithstanding anything contained To the extent the Company provides reimbursement coding or billing advice regarding products offered for sale by the Company and procedures related thereto, such advice is and has been true and complete in this Section 4.13, no representation or warranty shall be deemed to be made all material respects and in this Section 4.13 compliance in respect all material respects with the payment requirements of environmental, Tax, employee benefits or labor Law mattersMedicare and other Federal Health Care Program Laws.
Appears in 3 contracts
Sources: Acquisition Agreement, Acquisition Agreement, Acquisition Agreement
Regulatory Matters. (a) Except (x) as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse EffectEffect or (y) that, individually or in the aggregate, as of the date of this Agreement, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent the Company and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the U.S. Food, Drug, and Cosmetic Act of 1938 (the “FDCA”), the U.S. Public Health Service Act (the “PHSA”), and the regulations of the FDA U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Company Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Company Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent the Company or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); (ii) all such Parent Company Regulatory Permits are valid and in full force and effect; and (iii) Parent is the Company and its Subsidiaries are in compliance with the terms of all Parent Company Regulatory Permits.
(b) Except as would not, individually or . All Company Regulatory Permits are in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent full force and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawseffect, except where such noncompliance or liability the failure to be in full force and effect (A) has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
Effect or (cB) Except as would notof the date of this Agreement, individually or in the aggregate, would not reasonably be expected to have a Parent Material Adverse Effectprevent, Parent and materially delay or materially impair the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None ability of the Parent Company to perform its obligations under this Agreement or to consummate the Mergers.
(b) Neither the Company nor any Parent Subsidiary of its Subsidiaries are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(dc) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Product candidate conducted or sponsored by each the Company or any of Parent and the Parent its Subsidiaries are being being, and since January 1, 2019 have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(ed) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, during the period beginning on January 1, 20122019 and ending on the date of this Agreement, neither Parent the Company nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which the Company Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(fe) Since January 1, 20122019, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent the Company and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 20122019, neither Parent the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent the Company or any of the Parent its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Company Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect. Neither Parent Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, (i) neither the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Parent Company to be sold. Since January 1, 2011, ; and (ii) neither Parent the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare Applicable Law or program.
(gf) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, as to each Parent Company Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Company or any of its Subsidiaries to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent the Company or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Company Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Company Product or Parent Product candidate by Parent the Company or any of the Parent its Subsidiaries of any Applicable Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect.
(hg) Except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, since (i) during the period beginning on January 1, 20122019 and ending on the date of this Agreement, neither Parent the Company nor any of the Parent its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To Company Product and (ii) to the knowledge of Parentthe Company, there are no facts which are reasonably likely to causeneither the Company nor any of its Subsidiaries has received, and Parent has not received any written notice from the FDA or any other Parent Company Regulatory Agency during the period beginning on January 1, 2019 and ending on the date of this Agreement regarding (iA) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent the Company or a Parent Subsidiary its Subsidiaries (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Company and its Subsidiaries, taken as a whole), (iiB) a material change in the marketing classification or a material change in the labeling of any such Parent Company Products, (iiiC) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Company Products, or (ivD) a material negative change in reimbursement status of a Parent Company Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Merger Agreement (Astrazeneca PLC), Merger Agreement (Alexion Pharmaceuticals, Inc.), Merger Agreement (Alexion Pharmaceuticals, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected material to havethe Company Group, individually or in the aggregate, taken as a Parent Material Adverse Effect, whole: (i) each of Parent and the Parent Subsidiaries holds (x) Company Products are in compliance with all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any current applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Device Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”)Laws; (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent each member of the Company Group is in compliance with all applicable Device Regulatory Laws relating to the terms sourcing, procurement, and the import of raw materials for the Company Products and the methods and materials used in, and the facilities and controls used for, the design, manufacture, processing, packaging, labeling, storage, distribution, export, and import, if applicable, of the Company Products; (iii) each member of the Company Group has received confirmation from the Notified Body that a formal application for conformity assessment of the Company Products has been accepted and that the Company Products may continue to be placed on the market of the European Union countries until December 31, 2028; and (iv) since January 1, 2021, all Parent such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled, distributed, exported, and imported, if applicable, by the Company Group in compliance with all applicable Device Regulatory PermitsLaws.
(b) Except as would notnot be material to the Company Group, individually taken as a whole: (i) all preclinical and clinical investigations sponsored by or in on behalf of a member of the aggregateCompany Group with respect to any Company Product are being, reasonably be expected to and since January 1, 2021, have a Parent Material Adverse Effectbeen, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Device Regulatory Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare Good Clinical Practices and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287Good Laboratory Practices requirements, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, federal and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information information; and personal information(ii) each member of the Company Group complies with, exceptand since January 1, in each case2021, for such noncompliance thathas complied with, individually all requirements under the Laws relating to monitoring and reporting of adverse events during clinical trials.
(c) No action has been taken by any Governmental Authority or is in the aggregateprocess of being taken that would slow, has not had and halt or enjoin the development, manufacturing, or marketing of the Company Products or the operation of the business of the Company Group or subject the development, manufacturing, or marketing of the Company Products or a member of the Company to regulatory enforcement action.
(d) Except as would not reasonably be expected material to the Company Group, taken as a whole, since January 1, 2021, the members of the Company Group have maintained records relating to the development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or export of the Company Products in material compliance with all applicable Device Regulatory Laws. Except as would not be material to the Company Group, taken as a Parent Material Adverse Effectwhole, each member of the Company Group and each of their respective contractors and agents have submitted to FDA, Notified Bodies and all other applicable regulatory authorities, institutional review boards, or accreditation bodies, all required supplemental applications, 510(k) premarket notifications, CE Mark applications, pre-market approval applications and de novo classification requests, as applicable, notices, filings and annual or other reports and information.
(e) Since Except as would not be material to the Company Group, taken as a whole, since January 1, 20122021, neither Parent nor any all manufacturing operations for the Company Products conducted by or on behalf of a member of the Parent Subsidiaries has received Company Group have been and are being conducted in compliance with the QSR and any written notice from similar requirements of the FDA or FDA, Notified Bodies and any other Company Product regulatory authority, and the EMA or any foreign agency with jurisdiction over Company Products are not adulterated within the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.meaning of
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to Except as would not be filed, maintained or furnished material to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filedCompany Group, maintained or furnishedtaken as a whole, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any no member of the Parent Subsidiaries, norCompany Group or, to the knowledge Knowledge of Parentthe Company, any director, officer, employee, contractor or agent or distributor of Parent or any a member of the Parent SubsidiariesCompany Group is the subject of any pending Action or, to the Knowledge of the Company, any ongoing investigation or inquiry, or has made an untrue statement received any notice of any actual investigation, inquiry, for-cause inspection or audit or other Action by a Governmental Authority regarding a violation of a material fact or a fraudulent statement Device Regulatory Law, including FDA pursuant to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in ” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or for the FDA or by any other Parent Regulatory Agency similar Governmental Authority pursuant to invoke any similar policy, except for or concerning allegations of a violation by a member of the Company Group or any act director, officers, employees, contractors or agents of a member of the Company Group of any Device Regulatory Laws, nor has a member of the Company Group or, to the Knowledge of the Company, any director, officer, employee, contractor or agent of a member of the Company Group committed any act, or made any statement or failure failed to make a any statement that, individually or in the aggregate, has not had and that would not reasonably be expected to have provide a Parent Material Adverse Effectbasis for FDA to invoke the FDA Application Integrity Policy or other similar Governmental Authority to invoke a similar policy or a violation of a Device Regulatory Law. Neither Parent nor any Except as would not be material to the Company Group, taken as a whole, no member of the Parent SubsidiariesCompany Group and no director, nor, to the knowledge of Parent, any officer, employee, contractor or agent or distributor of Parent or any a member of the Parent SubsidiariesCompany Group has violated any Device Regulatory Law nor knowingly made any false statements on, or omissions from, any notifications, applications, approvals, reports and other submissions to a Governmental Authority relating to any Company Product or has voluntarily disclosed any violations of Device Regulatory Laws related to any Company Product. Except as would not be material to the Company Group, taken as a whole, no member of the Company Group, nor any director, officer, employee, contractor or agent of a member of the Company Group, has been debarred or convicted of any crime or engaged in any other conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law Law, or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programLaw.
(g) As to each Parent Product or Parent Product candidate subject Except as would not be material to the FDCA Company Group, taken as a whole, (i) each member of the Company Group, and each Company Product being manufactured, marketed, or distributed, is in compliance in all respects with the regulations for medical device reporting set forth in 21 C.F.R. Part 803, and reports of corrections and removal under 21 C.F.R. Part 806, and any similar Law; (ii) since January 1, 2021, each member of the FDA promulgated thereunder Company Group has promoted, marketed, and continues to promote and market Company Products only for uses cleared or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent approved for such Company Product candidates are sold or intended by the FDA or other Governmental Authority; and (iii) no litigation or Governmental Authority enforcement action or investigation is pending or threatened with respect to the Company to be sold that is Group or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in its members’ compliance with all applicable the requirements under Device Regulatory Laws, including those relating to investigational use, marketing approval, current good manufacturing or the Company Group or its members’ promotional practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except To the Knowledge of the Company, no member of the Company Group and no director, officer, employee, contractor or agent of a member of the Company Group, has been investigated for, charged with or convicted of a Federal Health Care Program-related offense, or convicted of, charged with or investigated for a violation of federal or state Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation of controlled substances, or has been debarred, excluded or suspended from participation in a Federal Health Care Program (nor is any such debarment, exclusion or suspension pending), or been subject to any Order or consent decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority except, in each case of this Section 3.22(h), as would not, individually or in the aggregate, reasonably not be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent SubsidiariesCompany Group, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Merger Agreement (Nordson Corp), Merger Agreement (Nordson Corp), Merger Agreement (Nordson Corp)
Regulatory Matters. (a) Except The Product has been researched, developed, tested, manufactured, supplied, promoted, distributed, marketed, commercialized, stored and sold, as applicable, by Seller and, to Seller’s Knowledge, by each other Person on behalf of Seller, in compliance in all material respects with (i) all applicable Laws and (ii) all Permits. The Product is not adulterated or misbranded within the meaning of the FDA Act or any similar governmental act or Law of any jurisdiction.
(b) Seller has not had made available to Purchaser complete and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, correct copies of (i) each NDA submitted by or on behalf of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of Seller to the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with respect to the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”)Product; (ii) all such Parent other material document, correspondence, filing or other communication submitted to a Governmental or Regulatory Permits are valid Authority or the Department of Justice by or on behalf of Seller or received from a Governmental or Regulatory Authority or the Department of Justice by or on behalf of Seller, in each case, with respect to the Product or the Acquired Assets; (iii) all material scientific, clinical and in full force and effectsafety data of Seller with respect to the Product; and (iiiiv) Parent is in all audit reports performed by Seller or on its behalf to assess Seller’s compliance with the terms of all Parent Regulatory Permitsapplicable Health Laws.
(bc) Except as would notSeller has not received, individually nor with respect to the Product is there any pending or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including outstanding: (i) the FDCAForm 483 observations, FDA warning letters or post-sale warnings or other regulatory warning letters or sanctions; (ii) the PHSAinspectional observations or establishment inspection reports reciting penalties for corrective or remedial action or requiring corrective action plans; (iii) federal Medicare and Medicaid statutes and related state field notifications or local statutesalerts; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products import alerts, holds or Parent Product candidates are manufactured detentions; or sold; (v) federalother documents that, state in the case of each of the preceding clauses (i) through (iv), have been received by Seller from the FDA or provincial criminal any other Governmental or civil healthcare Regulatory Authority relating to the Product, or to Seller’s Knowledge, any facility in which the Product is manufactured, packaged or stored, and that assert ongoing material lack of compliance with any such Laws by Seller.
(including d) Seller is not in violation of, and, to Seller’s Knowledge, Seller is not the federal subject of, any pending investigation by a Governmental or Regulatory Authority regarding activities prohibited under, the U.S. Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h1320a-7b(b), et seq.), the exclusion laws U.S. ▇▇▇▇▇ Law (42 U.S.C. § 1320a-71395nn), the civil monetary penalties law U.S. False Claims Act (42 31 U.S.C. § 1320a-7a)3729, all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3aet seq.), the Public Health Service Trade Agreements Act (42 19 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126§§2501-2581) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the other Laws governing participation in United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance byhealthcare programs, or liability of Parent any comparable state or the Parent Subsidiaries underforeign Laws. There are no lawsuits, any Parent Healthcare and Data Protection Lawsactions or proceedings pending or, except where such noncompliance or liability to Seller’s Knowledge, threatened in writing against Seller that would not reasonably be expected to have, individually or result in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or exclusion of Seller from any third party payment program in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectthey participate.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries Seller has not received any written notice from the FDA or any other Governmental or Regulatory Authority that it has commenced, and to Seller’s Knowledge neither the EMA FDA nor any other Governmental or Regulatory Authority has threatened to commence, any foreign agency with jurisdiction over action to withdraw its approval or request the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityrecall of the Product, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocationcommenced, or rescission of to Seller’s Knowledge threatened to commence, any Parent Regulatory Permits or of action to enjoin production at any application for marketing approval already granted or currently pending before facility at which the FDA or such other Parent Regulatory AgencyProduct is manufactured.
(f) Since January 1Seller has not, 2012and to Seller’s Knowledge, all reportsno director, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employeeemployee or agent of Seller has, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, that would reasonably be expected to provide a basis for any Governmental or Regulatory Authority to invoke the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act in each case as related to the Product or statement or failure to make a statement thatthe Acquired Assets. Seller, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, norand, to the knowledge of ParentSeller’s Knowledge, any no director, officer, employee, employee or agent or distributor of Parent or any of the Parent SubsidiariesSeller, has been debarred or convicted of any crime or engaged in any conduct for which debarment or similar punishment is mandated or permitted by 21 U.S.C. § 335a(a) or any similar Law Laws or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldLaws. Since January 1Seller has not, 2011, neither Parent nor any of the Parent Subsidiaries, norand, to the knowledge of ParentSeller’s Knowledge, any no director, officer, employeeemployee or agent of Seller has been, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal the Federal health care program programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programLaws.
(g) As to each Parent The annual Prescription Drug User Fees for the Product or Parent Product candidate subject due for all time periods prior to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable Closing have been timely paid by Seller in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectfull when due.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Asset Purchase Agreement (Midatech Pharma PLC), Asset Purchase Agreement (Galena Biopharma, Inc.), Asset Purchase Agreement (Galena Biopharma, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each Each of Parent the Company and the Parent Company Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the United States Food, Drug and Cosmetic Act of 1938 (the “FDCA”), the Public Health Service Act (the “PHSA”), and the regulations of the FDA United States Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the qualitydevelopment, identitytesting, packaging, labeling, storage, import, export, marketing, sale, pricing, use, handling and control, strength, purity, quality, safety, efficacy, labelingreliability, manufacturing, marketing, promotion, distribution, sale, pricing, import distribution or export manufacturing of any of the Parent Company Products (any such Governmental Entity or Notified BodyEntity, a “Parent Company Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent or any the Company and each of the Parent Company Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); (ii) all such Parent Company Regulatory Permits are valid and in full force and effecteffect and will continue to be in full force and effect immediately following the Closing; and (iii) Parent is the Company and the Company Subsidiaries are in compliance in all material respects with the terms of all Parent Company Regulatory Permits. There are no material Proceedings pending or, to the knowledge of the Company, threatened against the Company or any Company Subsidiary that could reasonably be expected to result in, the revocation, cancellation, suspension or any other adverse modification of any Company Regulatory Permit held by the Company or any Company Subsidiary.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (iSection 4.9(b) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable Company Disclosure Letter sets forth, as of the date hereof, licenses or other registrations, marketing authorizations or other permits held by the Company issued by or pending with any Governmental Entity or other Company Regulatory Agency, as applicable, in jurisdictions in which material quantities connection with the clinical and other development, manufacture, marketing, promotion, distribution, sale or other use of any Company Product by or on behalf of the Parent Products Company or Parent any Company Subsidiary or any other Person in any jurisdiction (the “Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection LawsRegistrations”). Since January 1, 2012, neither Parent nor The Company and/or any Company Subsidiary are the sole and exclusive owners of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory AgencyProduct Registrations. All Company Products sold under the Product Registrations are manufactured, including promoted, and marketed in accordance with the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health specifications and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where standards contained in such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectProduct Registrations.
(c) Except as would not, individually or in Neither the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or Company nor any other government healthcare program. None of the Parent or any Parent Subsidiary are a Company Subsidiaries is party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, Orders or similar agreements with or imposed by any Parent Governmental Entity or Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Product candidate conducted or sponsored by each or on behalf of Parent and the Parent Company or any of the Company Subsidiaries are being being, and since January 1, 2017 have been, conducted in compliance in all material respects with (i) all applicable Laws administered or issued by the applicable Parent any Company Regulatory AgenciesAgency, including (iA) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and Regulations, (iiB) any applicable federal, state and provincial applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal informationPersonal Information and (C) applicable Healthcare Laws, exceptand (ii) experimental protocols, in each caseprocedures and controls pursuant to Healthcare Laws and, for where applicable, accepted professional and scientific standards. No pre-clinical or clinical testing conducted by or on behalf of the Company or any Company Subsidiary has been terminated or suspended due to safety or other non-business reasons, and, to the knowledge of the Company, there are no facts that could give rise to such noncompliance thata determination. No Company Regulatory Agency, individually clinical investigator, institutional review board or in independent monitoring committee has provided notice that it has initiated or, to the aggregateknowledge of the Company, has not had and threatened to initiate any action to place a hold order on, or otherwise terminate, delay, suspend or modify any such ongoing testing, and, to the knowledge of the Company, there are no facts that would not reasonably be expected to have give rise to such a Parent Material Adverse Effectdetermination.
(e) Since January 1, 20122017, neither Parent the Company nor any of the Parent Company Subsidiaries has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, reliability or manufacturing of drugs the Company Products which would reasonably be expected to lead to the denial, limitation, revocation, revocation or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(f) Since January 1, 20122017, all reports, documents, claims, permits Permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent the Company and the Parent Company Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits Permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 20122017, neither Parent the Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Company Regulatory Agency, or committed an act, made a statement, statement or failed to make a statement, in each such case, related to the business of Parent the Company or any of the Parent Company Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Company Regulatory Agency to invoke any similar policy. Since January 1, except for any act or statement or failure to make a statement that2017, individually or in (i) neither the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Parent Company to be sold. Since January 1, 2011, and (ii) neither Parent the Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare applicable Law or program.
(g) As to each Parent Company Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Company or any of the Company Subsidiaries to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent the Company or any of the Parent Company Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Company Product or Parent Product candidate is being or has been developed, manufactured, processed, stored, distributed and distributed, labeled, tested, sold or marketed in compliance in all material respects with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingreporting and security (and further including the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h)). Neither the Company nor any of the Company Subsidiaries have received any written notice from any Governmental Entity (including any Company Regulatory Agency) threatening any, and security. There there is no action or proceeding pending orpending, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case Proceeding alleging any material violation applicable to any Parent Company Product or Parent Product candidate by Parent the Company or any of the Parent Company Subsidiaries of any applicable Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectincluding any Healthcare Law.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122017, neither Parent the Company nor any of the Parent Company Subsidiaries have has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, notice or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Company Product. To the knowledge of Parentthe Company, there are no facts as of the date hereof which are reasonably likely to cause, and Parent neither the Company nor any of the Company Subsidiaries has not received any written notice from the FDA or any other Parent Company Regulatory Agency regarding since January 1, 2017 regarding: (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent the Company or the Parent Company Subsidiaries, taken as a whole), ; (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Company Products, ; (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Company Products, ; or (iv) a material negative change in reimbursement status of a Parent Company Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Agreement and Plan of Merger (Progenics Pharmaceuticals Inc), Agreement and Plan of Merger (Lantheus Holdings, Inc.), Merger Agreement (Lantheus Holdings, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectEffect or that, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is and its Subsidiaries are in compliance with the terms of all Parent Regulatory Permits.
. All Parent Regulatory Permits are in full force and effect, except where the failure to be in full force and effect (bA) Except as has not had, and would notnot reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or (B) individually or in the aggregate, would not reasonably be expected to have a Parent Material Adverse Effectprevent, materially delay or materially impair the businesses of each ability of Parent and each Parent Subsidiary are being conducted to perform its obligations under this Agreement or to consummate the Mergers (in compliance with all applicable Lawsthe case of this clause (B), including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any as of the foregoing applicable in jurisdictions in which material quantities date of any of the Parent Products or Parent Product candidates are manufactured or sold; this Agreement).
(vb) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Neither Parent nor any of the Parent its Subsidiaries has received are party to any written notification material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or communication from similar agreements with or imposed by any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, Agency that have had or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each Parent or any of Parent and the Parent its Subsidiaries are being being, and since January 1, 2019 have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect.
(ed) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on January 1, 20122019 and ending on the date of this Agreement, neither Parent nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which the Parent Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(fe) Since January 1, 20122019, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither , since January 1, 2019, (i) neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Subsidiaries has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, ; and (ii) neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Subsidiaries has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare Applicable Law or program.
(gf) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, as to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Applicable Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 3 contracts
Sources: Merger Agreement (Astrazeneca PLC), Merger Agreement (Alexion Pharmaceuticals, Inc.), Merger Agreement (Alexion Pharmaceuticals, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Neither Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor Merger Subs nor any of the Parent Subsidiaries Parent’s or Merger Subs’ personnel, Representatives or controlled Affiliates has received committed any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA FDA, the EMA or any other Governmental Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” or any such similar policies set forth in 56 Fedany applicable Laws. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any None of the Parent Subsidiaries, noror Merger Subs or, to the knowledge Parent’s or Merger Subs’ Knowledge, any of their officers, directors, Representatives or other of Parent, any officer, employee, agent ’s or distributor of Parent or any of the Parent SubsidiariesMerger Subs’ personnel, has been debarred or convicted of any crime or engaged in any conduct for which that has resulted, or would reasonably be expected to result, in debarment is mandated by or exclusion under applicable Laws, including, without limitation, 21 U.S.C. § 335a(a) Section 335a and 42 U.S.C. Section 1320a-7. To Parent’s and Merger Subs’ Knowledge, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion of Parent or Merger Subs are pending or threatened, against Parent or Merger Subs or any similar Law of their officers, directors, Representatives or authorized by 21 U.S.C. § 335a(bother personnel.
(b) Parent’s product candidates for human use or any similar Law applicable in other jurisdictions in which material quantities of any of anticipated to be for human use (the Parent Products or “Parent Product candidates Candidates”) are sold or intended being, and at all times have been, developed, tested, labeled, manufactured, stored, imported, exported and distributed, as applicable, in compliance in all material respects with the FDCA and applicable implementing regulations issued by the Parent FDA and applicable Laws and applicable implementing regulation issued by the EM and any other applicable Governmental Authorities, including, as applicable, those Laws relating to be sold. Since January 1the FDA’s current good manufacturing practices, 2011good laboratory practices, neither Parent nor any of the Parent Subsidiariesgood clinical practices, norinvestigational use and applications to market a new pharmaceutical product and, to the knowledge of Parent, any officer, employee, agent or distributor Knowledge of Parent or any of the Parent Subsidiarieswithout investigation, has been debarred, suspended or excluded from participation all Laws referred to in any government health care program or convicted of any crime or engaged in any conduct EudraLex Volume 10 (Guidelines for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programClinical Trials).
(gc) As to each Parent Product or Parent Product candidate subject to To the FDCA extent required by applicable Laws, all clinical studies, preclinical studies and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed tests conducted by or on behalf of Parent have been, and if still pending are being, conducted in material compliance with the research protocols submitted to the FDA or other Governmental Authority, good laboratory practices, good clinical practices, and all applicable Laws, including, but not limited to, the FDCA and the Laws of the EMA and, to Parent’s Knowledge, all clinical studies and preclinical studies and tests conducted by or on behalf of Parent have been or, if pending, are being conducted in material compliance, to the extent applicable with such practices and Laws. No clinical study conducted by or on behalf of Parent has been terminated or suspended prior to completion. None of the FDA, EMA or any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical study conducted by or on behalf of Parent has commenced, or, to Parent’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend or refuse to commence, any proposed or ongoing investigation or study conducted or proposed to be conducted by or on behalf of Parent.
(d) Parent is not subject to any investigation that is pending and of which Parent has been notified in writing or, to Parent’s Knowledge, which has been threatened, in each case by (i) the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal False Claims Act (31 U.S.C. §3729.
(e) Parent has not submitted any claim for payment to any government healthcare program in connection with any referrals related to any of the Parent SubsidiariesProduct Candidates that violated in any material respect any applicable self-referral law, except as would notincluding the Federal Ethics in Patient Referrals Act, individually 42 U.S.C. §1395nn, or in any applicable state self-referral law.
(f) All manufacturing operations conducted by or for the aggregate, reasonably be expected benefit of Parent with respect to have a Parent Material Adverse Effect, each such the Parent Product or Parent Product candidate is Candidates have been and are being or has been developed, manufactured, stored, distributed and marketed conducted in material compliance with all applicable Laws, including those relating including, to investigational usethe extent applicable, marketing approval, the provisions of the FDA’s current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingpractice regulations, and securitythe respective counterparts thereof promulgated by the EMA and other Governmental Authorities in countries outside the United States. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to Parent has not recalled any Parent Product Candidates and no Governmental Authority has suspended or Parent Product candidate by Parent or otherwise restricted the manufacture of any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent ProductProduct Candidates. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from that the FDA FDA, EMA or any other Parent Regulatory Agency regarding (i) the recallGovernmental Authority, market withdrawal any relevant institutional review board, independent ethics committee or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketingsimilar body has initiated, or distribution threatened to initiate, any action to suspend or otherwise restrict the manufacture of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Product Candidates.
(jg) Notwithstanding anything contained Parent has not submitted any claim for payment to any government healthcare program related to any of the Parent Product Candidates in this Section 4.13material violation of any laws relating to false claims or fraud, no representation including the Federal False Claim Act, 31 U.S.C. § 3729, or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits any applicable state false claim or labor Law mattersfraud law.
Appears in 3 contracts
Sources: Merger Agreement (Cyclo Therapeutics, Inc.), Merger Agreement (Cyclo Therapeutics, Inc.), Merger Agreement (Rafael Holdings, Inc.)
Regulatory Matters. (ai) Except (A) Each of the Company and its Subsidiaries holds all material authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, the Food and Drugs Act, the CDSA, and the regulations of Health Canada promulgated thereunder, the requirements of the European Medicines Agency and any other Governmental Entity that regulates the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Company Products (any such Governmental Entity, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any of its Subsidiaries as currently conducted and the testing, manufacturing, sale or distribution, as applicable, of each of the Company Products (the “Company Regulatory Permits”) and (B) all such Company Regulatory Permits are valid and in full force and effect. Since January 1, 2011, there has not occurred any violation of, default under, or event giving any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Regulatory Permit, that would prohibit or impede the sale of any Company Product currently manufactured and/or sold by the Company or any of its Subsidiaries into any market. Since January 1, 2011, no event has occurred that, to the knowledge of the Company, would reasonably be expected to result in a penalty under or the revocation, cancellation, non-renewal or adverse modification of, any Company Regulatory Permit, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(cii) Except as would notSince January 1, individually or in 2011, to the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None knowledge of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreementsCompany, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All all pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Company or any of its Subsidiaries have been and, if still pending, are being conducted in compliance in all material respects with all applicable Laws administered or issued by the applicable Parent Company Regulatory AgenciesAgency, including (iA) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (B) FDA regulations for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (C) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (iiD) any applicable federal, state and provincial material Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(eiii) Since January 1, 20122011, neither Parent nor none of the Company or any of the Parent its Subsidiaries has received any material written notice information from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs other Company Regulatory Agency which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or denial of any application for marketing approval already granted or currently pending before the FDA or such any other Parent Company Regulatory Agency.
(fiv) Since January 1, 2012, all All material reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent and the Parent Company or any of its Subsidiaries have been so filed, maintained or furnished. To the knowledge of the Company, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All all such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor None of the Company or any of the Parent Subsidiaries, norits Subsidiaries or, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of its Subsidiaries is the Parent Subsidiariessubject of any pending, has made an untrue statement or, to the knowledge of a material fact the Company, threatened investigation in respect of the Company or a fraudulent statement to the Company Products by the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed Agency pursuant to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its FDA’s policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which that could result in a material debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities Law. None of the Company or any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, norits Subsidiaries or, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Subsidiaries, its Subsidiaries has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person that could be excluded result in a material exclusion from participating in any the federal health care program programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gv) As to To the knowledge of the Company, the development, manufacture, testing, distribution, and marketing of each Parent Company Product or Parent or, as applicable, Company Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or since January 1, 2011 has been developed, manufactured, tested, distributed or marketed by or on behalf is being, and since January 1, 2011 has been, conducted in compliance in all material respects with the FDCA and the regulations of Parent the FDA promulgated thereunder, the Food and Drugs Act, the CDSA and the regulations of Health Canada promulgated thereunder, or any of the Parent Subsidiaries, except as would not, individually or similar Law in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, any foreign jurisdiction including those relating to investigational use, premarket clearance or marketing approval, current good manufacturing practices, packaginggood clinical practices, good laboratory practices, labeling, advertising, record keeping, reporting, keeping and securityfiling of reports. There is no action or proceeding pending or, to the knowledge of Parentthe Company, threatenedthreatened by any Company Regulatory Agency, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Company Product or Parent Company Product candidate by Parent the Company or any of the Parent its Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectbe material to the Company or any of its Subsidiaries.
(hvi) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122011, neither Parent nor any each of the Parent Company and its Subsidiaries have neither voluntarily or nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Company Product. To the knowledge of Parentthe Company, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding cause (iA) the recall, market withdrawal or replacement of any Company Product sold by the Company or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent any of its Subsidiaries, taken as a whole), (iiB) a material change in the marketing classification or a material change in the labeling of any such Parent Company Products, or (iiiC) a termination or suspension of the manufacturingmarketing of such Company Products.
(vii) Since January 1, marketing2011, neither the Company nor any of its Subsidiaries has received any written notice that the FDA, Health Canada or any other Company Regulatory Agency has commenced, or threatened to initiate, any action to enjoin manufacture or distribution of such Parent Productsany Company Product sold by the Company or any of its Subsidiaries.
(viii) Since January 1, 2011, none of the Company or (iv) any of its Subsidiaries has received any written notice from the FDA, Health Canada or any other Company Regulatory Agency alleging material violations of advertising or marketing Laws with respect to a Company Product or a material negative change in reimbursement status of a Parent Company Product.
(iix) Except as would not not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, neither Parent nor to the knowledge of the Company, no Company Product manufactured or distributed by the Company or any of its Subsidiaries is (A) adulterated within the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure meaning of data or information that is linked to any reasonably identifiable person 21 U.S.C. § 351 (or any other data protected under applicable similar Law. Parent ) or Merger Sub is not a business associate, as that term is defined in (B) misbranded within the HIPAA regulations at 45 C.F.R. meaning of 21 U.S.C. § 160.103352 (or any similar Law).
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Medicis Pharmaceutical Corp), Merger Agreement (Valeant Pharmaceuticals International, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in Each of the aggregate, a Parent Material Adverse Effect, (i) each of Parent Company and the Parent Company Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrationsholds, and authorizations under the FDCAis operating in material compliance with, the PHSA, the regulations such Company Permits of the FDA promulgated thereunder, data protection laws United States Food and Drug Administration (y“FDA”) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of or any other applicable Governmental Entity U.S. or Notified Body that are concerned foreign drug regulatory authority (collectively with the qualityFDA, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory AgencyAuthorities”) necessary required for the lawful operating conduct of the businesses of Parent or any of the Parent Subsidiaries its business as currently conducted or as planned to be conducted (collectively, the “Parent Regulatory Permits”); (ii. Each of the Company and the Company Subsidiaries has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and no event has occurred which would allow, with or without notice or lapse of time, revocation or termination thereof or would result in any other material impairment of the rights of the holder of any Regulatory Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not have a Company Material Adverse Effect. Except to the extent disclosed on Section 3.28(a) all such Parent Regulatory Permits are valid of the Company Disclosure Schedule, each of the Company and in full force the Company Subsidiaries has operated and effect; and (iii) Parent currently is in compliance in all material respects with applicable statutes and implementing regulations administered or enforced by the terms of all Parent FDA or any other Regulatory PermitsAuthority, except where the failure to so comply would not have a Company Material Adverse Effect.
(b) Except as would notSince January 1, individually 2005, all of Company’s and the Company Subsidiaries’ Pharmaceutical Products that are subject to the jurisdiction of the FDA or other Regulatory Authorities in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or, to the knowledge of the Company, on behalf of the Company or the Company Subsidiaries in compliance in all material respects with all applicable requirements under any Regulatory Permit or Laws, including applicable statutes and implementing regulations administered or enforced by the FDA or other Regulatory Authority, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new Pharmaceutical Product. Since January 1, 2005, all material applications, submissions, information and data utilized by the Company or the Company’s Subsidiaries as the basis for, or submitted by or, to the knowledge of the Company, on behalf of the Company or the Company’s Subsidiaries in connection with, any and all requests for a Regulatory Permit relating to the Company or any Company Subsidiary, and its respective business and Pharmaceutical Products, when submitted to the FDA or other Regulatory Authority, were true and correct in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Regulatory Authority.
(c) Since January 1, 2005, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary have been, and if still pending are being, conducted in material compliance with all applicable Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except to the extent disclosed on Section 3.28(c) of the Company Disclosure Schedule, since January 1, 2005, no clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical investigation conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary.
(d) Except as set forth in Section 3.28(d) of the Company Disclosure Schedule, since January 1, 2005, neither the Company nor any Company Subsidiary has had any Pharmaceutical Product or manufacturing site (whether Company-owned or that of a contract manufacturer for Pharmaceutical Products) subject to a Regulatory Authority (including (iFDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Regulatory Authority written notice of material inspectional observations, “warning letters,” “untitled letters” or written requests to make material changes, in each case as it applies to the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state Pharmaceutical Products or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable Company’s manufacturing processes or procedures that if not complied with would have a Company Material Adverse Effect.
(e) To the knowledge of the Company, Section 3.28(e) of the Company Disclosure Schedule sets forth a list of all recalls, field notifications, market withdrawals or replacements, written warnings, “dear doctor” letters, investigator notices, safety alerts, post-approval “serious adverse event” reports or other material written notice of action relating to an alleged lack of safety or regulatory compliance of the Pharmaceutical Products issued by the Company and/or any Company Subsidiary since January 1, 2005 (“Safety Notices”). To the Company’s knowledge, and except as disclosed in jurisdictions any item reference in which Section 3.28(e) of the Company Disclosure Schedule, there are no facts that would be reasonably likely to result in (A) a material quantities Safety Notice with respect to the Pharmaceutical Products, or (B) a material change in the labeling of any of the Parent Pharmaceutical Products.
(f) Since January 1, 2005, all manufacturing operations conducted by or, to the knowledge of the Company, for the benefit of the Company or any Company Subsidiary have been conducted in material compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 for Pharmaceutical Products sold in the United States, and the respective counterparts thereof promulgated by Regulatory Authorities in countries outside the United States, except where the failure to so comply would not have a Company Material Adverse Effect.
(g) Since January 1, 2005, neither the Company, nor any Company Subsidiary, has committed any act, made any statement or Parent Product candidates failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any applicable Laws. Since January 1, 2005, none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective officers or key employees has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment are manufactured pending, and the Company has not received written notice that any such claims, actions, proceedings or sold; investigations are threatened against the Company, the Company Subsidiaries, or any of their respective officers or key employees.
(vh) federalEach of the Company and the Company Subsidiaries, state and to the knowledge of the Company its respective directors, officers, employees, and agents (while acting in such capacity) is, and at all times has been, in material compliance with all health care Laws applicable to the Company or provincial criminal any Company Subsidiary or civil healthcare Laws (including by which any or their respective properties, businesses, products or other assets is bound or affected, including, to the extent applicable, the federal Anti-Kickback kickback Statute (42 U.S.C. §1320a-7(b§ 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. §§ 1320a-7b(a)), Physician Payment Sunshine the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law Food Drug and Cosmetic Act (42 21 U.S.C. §§ 1320a-7a301 et seq.), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any Medicare Program (Title XVIII of the Parent Products or Parent Product candidates are manufactures or soldSocial Security Act); , the Medicaid Program (vi) all applicable foreignTitle XIX of the Social Security Act), federalthe regulations promulgated pursuant to such Laws, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing requirements of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules programs and regulations promulgated pursuant to all under such applicable Laws, each as amended from time to time Laws (collectively, “Parent Healthcare and Data Protection Health Care Laws”). Since January 1, 20122005, neither Parent nor any none of the Parent Subsidiaries Company or any Company Subsidiary has received any written notification notification, correspondence or any other written or communication from any Parent Regulatory AgencyGovernmental Authority, including including, without limitation, the FDA, the Drug Enforcement AdministrationCenters for Medicare and Medicaid Services, and the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human ServicesGeneral, of noncompliance potential or actual material non-compliance by, or liability of Parent of, the Company or the Parent Subsidiaries underany Company Subsidiary, under any Parent Healthcare and Data Protection Health Care Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(ci) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent Company or any Parent Company Subsidiary are is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or other similar agreements written agreements, in each case, entered into with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product Authority, other than any such agreement, decree or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, order that has been debarred or convicted of any crime or engaged previously disclosed in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programOther Filing.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Lilly Eli & Co), Merger Agreement (Imclone Systems Inc)
Regulatory Matters. (a) Except Neither the Company nor any of its Affiliates nor any predecessor thereof has received any oral or written communication (including any Warning Letter, Courtesy Letter, untitled letter conveying adverse inspectional observations, Form 483 or similar notices) from any Governmental Authority, including but not limited to the FDA or FTC, or from any counterpart regulatory authorities in the European Union, or any other country, regarding the Company’s currently marketed products, or regarding claims that are currently being made for the Company’s currently marketed products, and to the Knowledge of the Company and its Affiliates, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries or Affiliates is not currently in compliance with any and all applicable Laws implemented by the FDA or FTC, or any counterpart regulatory authorities in the European Union or any other country, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. There are no pending voluntary or involuntary market withdrawals, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws field corrective actions (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)recalls), False Claims Act (42 U.S.C. §1320a-7b(a))destruction orders, Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating seizures or other regulatory enforcement actions related to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial product that have had or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(cb) Except as would notThe Company has, individually prior to the execution of this Agreement, made available to Parent copies of any and all documents in its or in its Subsidiaries’ possession that are material to assessing the aggregateCompany’s or any of its Subsidiaries’ material compliance with the Federal Food, reasonably be expected to have a Parent Material Adverse EffectDrug, Parent and Cosmetic Act, Federal Trade Commission Act, or the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid International Standards Organization and their respective implementing regulations or any other government healthcare programsimilar regulations in any applicable jurisdiction. None The Company and its Subsidiaries are in compliance in all material respects with all applicable requirements of the Parent or any Parent Subsidiary are a party to any Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act and the regulations promulgated thereunder (collectively, the “FDA Requirements”).
(c) To the extent currently required, all manufacturing, including testing, by the Company and its Subsidiaries have been conducted in all material corporate integrity agreementsrespects in compliance with applicable good manufacturing practices, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed and good laboratory practices as set forth by any Parent Regulatory Agencythe FDA.
(d) All pre-clinical The Company and clinical investigations in respect of a Parent Product its Subsidiaries have not filed any biologics license applications, new drug applications, medical device premarket notifications or Parent Product candidate conducted applications and neither the Company nor its Subsidiaries market any biologic, drug or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 medical device products. None of the Code of Federal Regulations and (ii) any applicable federalCompany, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, of their respective officers or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, noremployees or, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any Knowledge of the Parent SubsidiariesCompany, agents has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, the Office of the Inspector General of the Department of Health and Human Services or failed to disclose a material fact required to be disclosed to the FDA FDA, FTC or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any Office of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programInspector General.
(ge) As to each Parent Product or Parent Product candidate subject to To the FDCA and the regulations Company’s Knowledge, as of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parentdate hereof, there are no facts which are reasonably likely to cause, or circumstances that would render unlikely the Company’s compliance with the Dietary Supplement and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding Nonprescription Drug Consumer Protection Act (i) the recall, market withdrawal or replacement of any Company Product sold or intended due to be sold by Parent or a Parent Subsidiary (other than recallseffective on December 22, withdrawals or replacements 2007), in the form in which that are not material to Parent Act currently exists, or the Parent Subsidiariesregulations for Current Good Manufacturing Practice in Manufacturing, taken as a wholePackaging, Labeling, or Holding Operations for Dietary Supplements (21 C.F.R. Part 111), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Productsas to which compliance is required by June 25, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product2009.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Plethico Pharmaceuticals Ltd.), Merger Agreement (Nutra Acquisition CO Inc.)
Regulatory Matters. (ai) Neither the Company nor any of its Subsidiaries, all or part of whose rates or services are regulated by a Governmental Entity, (A) has rates which have been or are being collected subject to refund, pending final resolution of any suit, action or proceeding pending before a Governmental Entity or on appeal in a court of competent jurisdiction, or (B) is a party to any suit, action or proceeding before a Governmental Entity or on appeal from orders of a Governmental Entity, in each case, which have had or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect or would reasonably be expected to prevent, materially delay or impair the ability of the Company to consummate the Merger or comply with its obligations under this Agreement.
(ii) With respect to the FCC Private Licenses, (A) neither the Company nor any of its Subsidiaries is in “red light” status under the rules and policies of the FCC, (B) none of the FCC Private Licenses is used to provide commercial interconnected voice or data service and (C) none of the FCC Private Licenses was acquired by competitive bidding. Neither the Company nor any of its Subsidiaries holds any FCC-issued authorizations other than the FCC Private Licenses. Except as has would not had have and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each none of Parent the FCC Private Licenses will be terminated, impaired or become terminable, in whole or in part, solely as a result of the Merger and the Parent Subsidiaries holds (x) all permitsother transactions contemplated by this Agreement, licensesso long as the FCC has, franchisesprior to the Closing, approvals, clearances, registrations, and authorizations under approved the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity FCC Form 603 application or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws applications pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date FCC Private Licenses filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed and Ultimate Parent in connection with the Merger and the other transactions contemplated by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectthis Agreement.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Transcanada Corp), Merger Agreement (Columbia Pipeline Group, Inc.)
Regulatory Matters. Except as set forth in Section 3.15 of the Disclosure Schedule:
(a) Except as has not had and would not reasonably be expected As to haveeach product subject to the FDCA or similar Law in any foreign jurisdiction that is developed, individually or in manufactured, tested, distributed and/or marketed by the aggregate, a Parent Material Adverse Effect, Business (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory PermitsMedical Device”); (ii) all , each such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent Medical Device is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would notbeing developed, individually or in the aggregatemanufactured, reasonably be expected to have a Parent Material Adverse Effecttested, the businesses of each of Parent and each Parent Subsidiary are being conducted distributed and/or marketed in compliance with all applicable requirements under the FDCA and similar Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws those relating to health care fraud investigational use, premarket clearance or marketing approval to market a Medical Device, good manufacturing practices, labeling, advertising, record keeping, filing of reports and abuse, including but not limited to 18 U.S.C. Sections 286 and 287security, and in compliance with the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities Advanced Medical Technology Association Code of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Ethics on Interactions with Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC Professionals and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsAmerican Medical Association’s guidelines on gifts to physicians, except where such noncompliance or liability would not reasonably be expected to have, for failures that individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to aggregate have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. None of Guidant or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any violation applicable to any Medical Device of any Law, in the case of (i) and (ii), that individually or in the aggregate have not had and would reasonably be expected to have a Material Adverse Effect.
(b) No Medical Device is under consideration by senior management of Guidant or its Affiliates for recall, withdrawal, suspension, seizure or discontinuance, or has been recalled, withdrawn, suspended, seized or discontinued (other than for commercial or other business reasons) by, Guidant, a Transferred Subsidiary or an Asset Seller in the United States or outside the United States (whether voluntarily or otherwise), in each case since January 1, 2002. No proceedings in the United States or outside of the United States of which Guidant has Knowledge (whether completed or pending) seeking the recall, withdrawal, suspension, seizure or discontinuance of any Medical Device are pending against Guidant, a Transferred Subsidiary or an Asset Seller or any licensee of any Medical Device that individually or in the aggregate have had or would reasonably be expected to have a Material Adverse Effect.
(c) As to each Medical Device for which a premarket approval application, premarket notification, investigational device exemption or similar state or foreign regulatory application has been approved, the Business and the Transferred Subsidiaries are in compliance with 21 U.S.C. §§ 360 and 360e or 21 C.F.R. Parts 812 or 814, respectively, and all similar Laws and all terms and conditions of such licenses or applications, except for any such failure or failures to be in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. In addition, with respect to the Business and the Transferred Subsidiaries, Guidant and its Affiliates are in substantial compliance with all applicable registration and listing requirements set forth in 21 U.S.C. § 360 and 21 C.F.R. Part 807 and all similar Laws, except for any such failures to be in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect.
(d) No article of any Medical Device is (i) adulterated within the meaning of 21 U.S.C. § 351 (or similar Law), (ii) misbranded within the meaning of 21 U.S.C. § 352 (or similar Law), or (iii) a product that is in violation of 21 U.S.C. § 360 or § 360e (or similar Law), except for failures to be in compliance with the foregoing that would not reasonably be expected to have a Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead With respect to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent Business and the Parent Subsidiaries have been so filedTransferred Subsidiaries, maintained none of Guidant or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge Knowledge of ParentGuidant, any officer, employee, employee or agent or distributor of Parent Guidant or any of the Parent Subsidiariesits Affiliates, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Authority, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would could reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy.
(f) With respect to the Business and the Transferred Subsidiaries, except for any act none of Guidant or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge Knowledge of ParentGuidant, any officer, employee, employee or agent or distributor of Parent Guidant or any of the Parent Subsidiariesits Affiliates, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities Law. With respect to the Business and the Transferred Subsidiaries, none of any of the Parent Products Guidant or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge Knowledge of ParentGuidant, any officer, employee, employee or agent of Guidant or distributor of Parent or any of the Parent Subsidiaries, its Affiliates has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in any the federal health care program programs under Section 1128 of the Social Security Act of 1935, as amended, amended (the “Social Security Act”) or any similar Parent Healthcare Law or programLaw.
(g) As to each Parent Product or Parent Product candidate subject With respect to the FDCA Business and the regulations Transferred Subsidiaries, since January 1, 2002, none of Guidant or its Affiliates has received any written notice that the FDA promulgated thereunder or any similar Law applicable in other Governmental Authority has (i) commenced, or threatened to initiate, any foreign jurisdiction in which material quantities action to withdraw its approval or request the recall of any Medical Device, (ii) commenced, or threatened to initiate, any action to enjoin production of any Medical Device, or (iii) commenced, or threatened to initiate, any action to enjoin the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that production of any medical device produced at any facility where any Medical Device is or has been developed, manufactured, tested, distributed tested or marketed by or on behalf of Parent or any of the Parent Subsidiariespackaged, except as would not, for any such action that individually or in the aggregate, aggregate have not had and would not reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as To the Knowledge of Guidant, there are no facts, circumstances or conditions that would notreasonably be expected to form the basis for any investigation, suit, claim, action or proceeding against or affecting the Business relating to or arising under (i) the FDCA, or (ii) the Social Security Act or regulations of the Office of the Inspector General of the Department of Health and Human Services, in each case individually or in the aggregate, aggregate that has had or would reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Purchase Agreement (Boston Scientific Corp), Purchase Agreement (Abbott Laboratories)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to haveAt all times since January 1, individually or in the aggregate, a Parent Material Adverse Effect2016, (i) the Company has developed, tested, manufactured, labeled, marketed, promoted and stored, as applicable, each of Parent and the Parent Subsidiaries holds (x) all permitsCompany Products, licensesand, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) to the Company’s Knowledge, all such Parent Regulatory Permits are valid Company vendors have marketed and in full force and effect; and (iii) Parent is promoted each of the Company Products, in compliance with the terms of all Parent Regulatory Permits.
Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations enforced by the U.S. Food and Drug Administration (b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)“FDA”), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act of 1944, as amended (42 U.S.C. § 256b“PHSA”), and, to the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any Knowledge of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory AgencyCompany, comparable applicable Laws outside of the United States, including the FDAthose requirements relating to current good manufacturing practices, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health good laboratory practices and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which aregood clinical practices, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect. During the three (3) years prior to the date of this Agreement, each neither the Company nor any of its Subsidiaries has received any written notice or other communication from the FDA or any other Governmental Authority alleging any violation of any Law with respect to such Parent activities or any FDA “warning letters” with respect to any Company Product or Parent Product candidate is being or has been developedany manufacturing, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational usepromotional, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and securityor distribution processes or procedures. There is are no action existing conditions at the Company or proceeding pending any of its Subsidiaries or, to the knowledge Knowledge of Parentthe Company as of the date of this Agreement, threatened, including at any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable contract manufacturer with respect to any Parent Company Product, that would result in a Governmental Authority shutdown or import or export prohibition, Form FDA 483 or other written notice of material inspectional observations, “warning letters,” “untitled letters” or written requests to make material changes with respect to any Company Product including the design, manufacture or Parent Product candidate by Parent distribution of Company Products, or any of the Parent Subsidiaries of any Lawway in which the Company Products are marketed or promoted, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect. All deficiencies and non-conformities discovered during internal and external audits and inspections have been corrected and resolved in all material respects.
(hb) Except Since January 1, 2016, the Company does not and has not marketed Company Products using verbiage prohibited by Law, outside of the scope of indications, or for indications other than those permitted by the Law or by policy or guidance of any Governmental Authority, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect. During the three (3) years prior to the date of this Agreement, since January 1, 2012, neither Parent none of the Company nor any of its Subsidiaries or, to the Parent Subsidiaries have voluntarily Knowledge of the Company as of the date of this Agreement, any contract manufacturer with respect to any Company Product, has received any notices, information request letters, correspondence, orders or involuntarily initiatedother communications from the FDA or any other Governmental Authority issuing, conducted requiring or issued, or caused to be initiated, conducted or issued, causing any recall, field correctionsseizure, detention, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, notice or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, safety or efficacy of or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement manufacturing deficiencies of any Company Product sold Product, except as would not, individually or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Productsaggregate, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent . None of the Company nor any of its Subsidiaries or, to the Parent Subsidiaries has experienced Knowledge of the Company as of the date of this Agreement, any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked contract manufacturer with respect to any reasonably identifiable person Company Product, has taken any such action voluntarily. To the Company’s Knowledge, there have been no Serious Injuries or MDR Reportable Events associated with the use (including in clinical trials) of any Company Product that have not been reported to the FDA or any other data protected applicable Governmental Authority in accordance with an applicable Law.
(c) All preclinical studies and clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been conducted in material compliance with all applicable material Laws, including submission of all required applications (e.g., Investigational New Drug Application). As of the date of this Agreement, no clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons. As of the date of this Agreement, neither the FDA nor any other applicable Governmental Authority, clinical investigator who has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has commenced, or, to the Knowledge of the Company as of the date of this Agreement, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of the Company or any of its Subsidiaries. There are no pending or, to the Knowledge of the Company as of the date of this Agreement, threatened actions or proceedings by the FDA or any other Governmental Authority seeking to (or that would reasonably be expected to) prohibit or impede the sale of any Company Product into any market. The Company has made available to Parent accurate and complete copies of the material reports and material correspondence with Governmental Authorities with respect to preclinical and clinical trials, studies or tests conducted by or on behalf of the Company or any of its Subsidiaries, or with respect to any Company Product, that are listed in Section 4.18(c) of the Company Disclosure Letter and as of the date of this Agreement, there are no other such reports or correspondence with Governmental Authorities that would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d) To the Knowledge of the Company as of the date of this Agreement, none of the Company nor any of its Subsidiaries or any contract manufacturer with respect to any Company Product, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any Laws. None of the Company nor any of its Subsidiaries or, to the Knowledge of the Company as of the date of this Agreement, any of their respective officers or key employees, or any contract manufacturer with respect to any Company Product, has been convicted of any crime that has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. § 335a or any similar applicable Law. Parent There is no pending legal proceeding (or Merger Sub is not to the Knowledge of the Company as of the date of this Agreement, threatened legal proceeding) against the Company or any of its Subsidiaries, or any of their respective officers or key employees, or, to the Knowledge of the Company as of the date of this Agreement, any contract manufacturer with respect to any Company Product, that would reasonably be expected to result in such a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103material debarment.
(je) Notwithstanding anything contained None of the Company nor any of its Subsidiaries is a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Authority, and, to the Knowledge of the Company as of the date of this Section 4.13Agreement, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matterssuch action is pending.
Appears in 2 contracts
Sources: Merger Agreement (Smith & Nephew PLC), Merger Agreement (Osiris Therapeutics, Inc.)
Regulatory Matters. Each Company shall cause (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, )
(i) each of Parent Broker-Dealers to take all reasonable action to maintain all rights, privileges, broker-dealer licenses and the Parent Subsidiaries holds (x) all permitsmemberships, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity broker-dealer registrations necessary or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or desirable in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses normal conduct of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal informationits business, except, in each case, for such noncompliance that, individually or in to the aggregate, has not had and extent that failure to do so would not reasonably be expected to have result in a Parent Material Adverse Effect.
, (eii) Since January 1, 2012, neither Parent nor any each Broker-Dealer to comply with all material rules and regulations of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency SEC and FINRA applicable to it (including such rules and regulations dealing with jurisdiction over the developmentnet capital requirements) and, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of extent applicable to any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012Broker-Dealer, all reportssimilar, documentsequivalent or comparable foreign statutes, claimsrules, permits regulations and notices required to be filedother regulatory requirements, maintained or furnished to except, in each case, where the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices so comply would not reasonably be expected to haveresult in a Material Adverse Effect , individually (iii) all Broker-Dealers to deliver after the end of each fiscal quarter of each fiscal year of the Borrower or in promptly after the aggregatedate such information is filed with the SEC, a Parent Material Adverse Effect. All copy of each Broker-Dealer's Financial and Operational Combined Uniform Single Report filed with the SEC for such reports, documents, claims, permits fiscal quarter and notices were complete and accurate in (iv) all material respects on Broker-Dealers to promptly deliver copies of each notice or other correspondence received from the date filed SEC (or were corrected comparable agency in any applicable non-U.S. jurisdiction) concerning any investigation by such agency regarding financial or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor other operational results of any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statementCompany, in each such case, related case which are reasonably likely to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was madebe determined adversely and which if determined adversely, would reasonably be expected to provide result in a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, BriberyAdverse Effect , and Illegal Gratuities”(b) (i) all of its Investment Adviser Companies to take all reasonable action to maintain all rights, set forth privileges and investment adviser registrations necessary or desirable in 56 Fed. Reg. 46191 (September 10the normal conduct of its business, 1991) or for except, in each case, to the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or extent that failure to make a statement that, individually or in the aggregate, has not had and do so would not reasonably be expected to have result in a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole)Effect , (ii) a all of its Investment Adviser Companies to comply with all material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension rules and regulations of the manufacturingSEC applicable to it and, marketingto the extent applicable to any Investment Adviser Company, all similar, equivalent or distribution of such Parent Productscomparable foreign statutes, or (iv) a material negative change rules, regulations, and other regulatory requirements, except, in reimbursement status of a Parent Product.
(i) Except as each case, where the failure to so comply would not reasonably be expected to have result in a Parent Material Adverse Effect, neither Parent nor any and (iii) unless previously delivered, all of the Parent Subsidiaries has experienced any security breach its Investment Adviser Companies to promptly deliver copies of each notice or other incident resulting correspondence received from the SEC (or comparable agency in the unauthorized accessany applicable non-U.S. jurisdiction) concerning any investigation by such agency regarding financial or other operational results of any Investment Adviser Company, use or disclosure of data or information that is linked to any in each case which are reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed likely to be made determined adversely and which if determined adversely, would reasonably be expected to result in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersa Material Adverse Effect.
Appears in 2 contracts
Sources: First Lien Term Loan Agreement, First Lien Term Loan Agreement
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds all Parent Permits and clearances, including (x) all permits, licenses, franchises, approvals, clearances, registrations, authorizations and authorizations clearances under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, data protection laws thereunder and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified BodyEntity, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits. All Parent Regulatory Permits are in full force and effect, except where the failure to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured sold or intended by Parent to be sold; (vvi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), ▇▇▇▇▇ Law (42 U.S.C. §1395nn), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud Health Insurance Portability and abuse, including but not limited to 18 Accountability Act of 1996 (42 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA§1320d et. seq.), as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or soldLaws); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collectionlicensing, disclosure and reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsrequirements; and (viiviii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20122011, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United Stated States Department of Justice (including any United States Attorney’s Office), the United States Office of Inspector General of the Department of Health and Human Services Office of Inspector General and Office for Civil RightsServices, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have are not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries Subsidiaries, not to include investigator initiated studies, are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 58, 312, 314 314, 320, and 320 812 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 20122011, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs or medical devices which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 20122011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 20122011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122011, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product, other than notices or actions that are not material to Parent or the Parent Subsidiaries, taken as a whole. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material adverse change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Questcor Pharmaceuticals Inc), Merger Agreement (Mallinckrodt PLC)
Regulatory Matters. (a) Except as All activities of Issuer and its Subsidiaries that are subject to the jurisdiction of the FDA or any comparable Governmental Authority, or subject to Health Care Laws, have been conducted in compliance in all material respects with all applicable requirements under all such Health Care Laws.
(b) Neither Issuer, any of its Subsidiaries nor, to Issuer’s Knowledge, any Third Party, has not had and received notice or other communication alleging a possible material violation by Issuer or its Subsidiaries of any Health Care Law.
(c) There are no Actions pending or, to Issuer’s Knowledge, threatened, with respect to an actual or alleged violation by Issuer, any of its Subsidiaries, or to Issuer’s Knowledge, any Third Party, of any Health Care Law applicable to Issuer or any of its Subsidiaries.
(d) To Issuer’s Knowledge, there is no information, condition, event, occurrence or circumstance that would not reasonably be expected to haveadversely affect, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCAany material respect, the PHSAacceptance, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations obtaining or maintaining of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary Product Registration for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned Products.
(e) Issuer owns all Product Registrations with respect to be conducted (the “Parent Regulatory Permits”); (ii) all Products, and each of such Parent Regulatory Permits are valid and Product Registrations is in full force and effect; . All of the Products are being, and (iii) Parent is at all times have been, Exploited in compliance with the terms of all Parent Regulatory Permitsrequirements for the applicable Product Registrations.
(bf) Except as would notIssuer has made available to Purchaser true, individually correct and complete copies of (A) all material filings with the FDA or in the aggregate, reasonably be expected equivalent Governmental Authority relating to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which Products, (B) all material quantities of correspondence and communications with the FDA or equivalent Governmental Authority relating to any of the Parent Products or Parent Product candidates are manufactured or sold; and (vC) federalall material data, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b))information, False Claims Act (42 U.S.C. §1320a-7b(a))results, Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h)analyses, the exclusion laws (42 U.S.C. § 1320a-7)trial protocols, the civil monetary penalties law (42 U.S.C. § 1320a-7a)publications, all criminal laws and reports relating to health care fraud the safety and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any efficacy of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectProducts.
(cg) Except as would notIssuer has made available to Purchaser its current plan for development of all Products, individually or in including Issuer’s current plan for obtaining Product Registrations necessary to ultimately commercialize the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory AgencyProducts.
(dh) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agenciesapplications, including (i) FDA standards for the designnotifications, conductsubmissions, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, exceptclaims, in each casereports and statistics and other data, for such noncompliance that, individually or in utilized as the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilitybasis for, or manufacturing of drugs which would reasonably be expected submitted in connection with, any Product Registration for any Product, when submitted to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1applicable Governmental Authority were true, 2012correct and complete in all material respects as of the date of submission and any necessary or required updates, all reportschanges, documentscorrections or modification to such applications, claimssubmissions, permits information and notices required to be filed, maintained or furnished data have been submitted to the FDA or such other applicable Governmental Authority. None of the filings made by or on behalf of Issuer or any other Parent Regulatory Agency by Parent and of its Subsidiaries with the Parent Subsidiaries have been so filed, maintained FDA or furnished, except where failure an equivalent Governmental Authority relating to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, Products contained any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement or omitted any material fact necessary to make the FDA statements therein not misleading.
(i) Neither Issuer, any of its Subsidiaries or any other Parent Regulatory Agencyofficer, failed director, employee or, to disclose a material fact required to be disclosed to the FDA Issuer’s Knowledge, agent of Issuer or any other Parent Regulatory Agencyof its Subsidiaries, or any Third Party, (A) has committed an any act, or made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would that could reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its FDA’s policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policypolicy with respect to Issuer, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent its Subsidiaries or any of the Parent Subsidiariestheir respective officers, directors or employees; (B) has been debarred charged with or convicted of any crime criminal offense relating to the delivery of an item or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) service under Medicare, Medicaid, TRICARE or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warningcollectively, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a wholeFederal Health Care Programs”), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.;
Appears in 2 contracts
Sources: Stock Purchase Agreement (ONCOSEC MEDICAL Inc), Stock Purchase Agreement (ONCOSEC MEDICAL Inc)
Regulatory Matters. (a) Except as has not had The Borrower and would not reasonably be expected its Subsidiaries have conducted and currently conduct their business in compliance with all applicable U.S. federal, state, local or foreign laws, statutes, ordinances, rules, regulations, judgments, orders, injunctions, decrees, arbitration awards and Key Permits issued by any Governmental Authority (collectively, “Laws”), except where the failure to havedo so, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, could not reasonably be expected to have result in a Parent Material Adverse Effect.
(i) Borrower LDTs were researched, developed, designed, and validated in compliance with all applicable Laws, including the businesses of each of Parent FDCA, CLIA, Privacy Laws and each Parent Subsidiary are being state laws, and have been and continue to be performed, marketed, and conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH FTC Act, CLIA, Privacy Laws and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agencylaws, including the FDA, the Drug Enforcement Administration, the United States Department laws of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsNew York, except where such noncompliance or liability would not reasonably be expected the failure to havedo so, individually or in the aggregate, could not reasonably be expected to result in a Parent Material Adverse Effect.
(ii) Borrower Medical Devices have been and are being researched, developed, designed, investigated, manufactured, marketed, and distributed in compliance with all applicable Laws, including the FDCA, the FTC Act, Privacy Laws and state laws, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(iii) The cord blood collection and storage activities of the Borrower and its Subsidiaries have been and are being marketed, performed, and otherwise offered in compliance in all respects with all applicable Laws, including the FDCA and applicable FDA regulations (including 21 C.F.R. 1271), and constitute private storage (storage by and on behalf of a donor or a donor’s family members), except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect. The Borrower and its Subsidiaries do not engage in public cord blood storage.
(b) Except as set forth on Schedule 6.18(b) or as otherwise disclosed to the Lender, (i) to the Borrower’s knowledge, no investigation by any Governmental Authority with respect to the Borrower is pending or threatened, and (ii) the Borrower has not received any written communication from any Person (including any Governmental Authority) alleging any noncompliance with any applicable laws or any written communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products, in each case, to the extent such investigation or noncompliance could reasonably be expected to result in a Material Adverse Effect.
(c) Except as would notAll manufacturing facilities owned or operated by the Borrower or any of its Subsidiaries, individually or to Borrower’s knowledge used in the aggregateproduction of any Product (other than Products in development), reasonably be expected are and have been operated in material compliance with cGMPs and all other applicable laws. The FDA has not issued to have a Parent Material Adverse EffectBorrower, Parent and or to Borrower’s knowledge any other Person, any Form 483, Warning Letter, or untitled letter with respect to any such facility, or otherwise alleged of Borrower, or to Borrower’s knowledge of any other Person, any material non-compliance with cGMPs. All manufacturing facilities owned or operated by the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid Borrower or any of its Subsidiaries are operated in material compliance with other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreementsapplicable federal, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencystate and local laws.
(d) All pre-clinical and clinical investigations in respect of a Parent Product Except as set forth on Schedule 6.18(d) or Parent Product candidate conducted or sponsored by each of Parent and as otherwise disclosed to the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesLender, including (i) FDA standards for the designBorrower has made available to Lender lists and copies, conductif requested, performanceof all Key Permits and written correspondence submitted to or received from FDA, monitoringCMS, auditingor other Governmental Authority (including minutes and official contact reports relating to any written communications with any Governmental Authority) in the Borrower’s possession or control, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federalto the Borrower’s knowledge, state there has been no untrue statement of fact and provincial Laws restricting no fraudulent statement made by the collectionBorrower, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, of their respective agents or manufacturing of drugs which would reasonably be expected to lead representatives to the denialFDA, limitationCMS, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency Governmental Authority, and there has been no failure by Parent and the Parent Borrower or its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material any fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statementGovernmental Authority, in each such case, related to except where the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement thatdo so, individually or in the aggregate, has not had and would could not reasonably be expected to have result in a Parent Material Adverse Effect. Neither Parent nor any .
(e) Except as set forth in Schedule 6.18(e) or as otherwise disclosed to the Lender, no right of the Parent SubsidiariesBorrower to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise materially adversely affected as a result of any investigation or enforcement action, norwhether by any Governmental Authority or other Third Party, and to the Borrower’s knowledge, the Borrower has not been subject of any inspection, investigation, or audit, by any Governmental Authority in connection with any alleged improper activity.
(f) To Borrower’s knowledge, there is no arrangement relating to the Borrower providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. To the Borrower’s knowledge, all ▇▇▇▇▇▇▇▇ by the Borrower for its services have been true and correct (other than any inadvertent errors corrected in the ordinary course of business) and, to the Borrower’s knowledge, are in compliance with all applicable laws, including the Federal False Claims Act or any applicable state false claim or fraud law except where such failure, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(g) Except as set forth on Schedule 6.18(g), or as otherwise disclosed to the Lender, the Borrower has not, and to the knowledge of Parentthe Borrower, any no officer, employeedirector, employee or agent of the Borrower has, (i) been convicted of, charged with, or distributor of Parent to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any of other offense related to healthcare or been excluded or suspended from participation in any such program; or within the Parent Subsidiariespast five (5) years, has been debarred convicted of, charged with or, to the Borrower’s knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances; (ii) been convicted of any crime or engaged in any conduct for which that has resulted or would reasonably be expected to result in debarment is mandated by or exclusion under 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1335a, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law applicable law, and no such debarment or program.
(g) As to each Parent Product exclusion proceedings or Parent Product candidate subject investigations are pending or to the FDCA and Borrower’s knowledge, threatened against the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Borrower or any of the Parent Subsidiariesits officers, except as would notdirectors, individually managers, employees or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectagents.
(h) Except as would notset forth on Schedule 6.18(h), individually all studies, tests and preclinical and clinical trials conducted relating to the Products, by or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any on behalf of the Parent Borrower and the Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and Third Party services providers and consultants, have voluntarily or involuntarily initiatedbeen conducted, conducted or issuedand are currently being conducted, or caused in all material respects, in accordance with all applicable Laws, procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules and regulations. All results of such studies, tests and trials, and all other material information related to be initiatedsuch studies, conducted or issuedtests and trials, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action have been made available to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Productthe Lender as requested by it. To the knowledge of Parentextent required by applicable law, there are no facts which are reasonably likely to cause, and Parent the Borrower has not received any written notice from the FDA or any other Parent obtained all necessary Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not Authorizations material to Parent or the Parent Subsidiariesconduct of its business, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or business and distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productis currently being carried out.
(i) Except as would The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor impair the Borrower’s or any of its Subsidiaries’ ownership of or rights under (or the Parent Subsidiaries has experienced any security breach license or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked right to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associateuse, as that term is defined the case may be) any Regulatory Authorizations relating to the Products in the HIPAA regulations at 45 C.F.R. § 160.103any material manner.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.)
Regulatory Matters. (a) Except as To the Company’s knowledge, the Company and its subsidiaries are in compliance in all material respects with all applicable statutes, rules and regulations of the U.S. Food and Drug Administration and similar federal, state or local Governmental Entities (collectively, the “FDA”) and similar foreign Governmental Entities (“Foreign Authorities”) with respect to the sale, labeling, storing, testing, development, manufacture, packaging, distribution, or marketing of the products being distributed or developed by or on behalf of the Company and its subsidiaries. The Company has not had previously made available to Parent true and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each complete copies of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchisesapplications, approvals, clearances, registrations, and authorizations under registrations or licenses obtained by the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of its subsidiaries from the Parent Subsidiaries FDA or Foreign Authorities, or required in connection with the conduct of the business of the Company and its subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) and has made all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permitsinformation available to Parent.
(b) Except as would notThe Company has made available to Parent true and correct copies of all material written communications, individually or in and material oral communications to the aggregateextent reduced to written form, reasonably be expected to have a Parent Material Adverse Effectbetween the Company and its subsidiaries, on the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287one hand, and the health care fraud criminal provisions under HIPAAFDA or Foreign Authorities, on the other hand, in each case since January 1, 2002, with respect to the products being distributed or developed by or on behalf of the Company and its subsidiaries (collectively, the “Regulatory Correspondence”). The Company shall promptly deliver to Parent copies of all Regulatory Correspondence received or reduced to written form from the date hereof through the Closing. Neither the Company nor any of its subsidiaries is in receipt of written notice of, or, to the Company’s knowledge, is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action, in each case relating to any products being distributed or developed by or on behalf of the Company or any of its subsidiaries or to the facilities in which any such products are manufactured, collected or handled, by the FDA or Foreign Authorities.
(c) To the Company’s knowledge, there are no pending or threatened actions, proceedings or enforcement actions by the FDA or Foreign Authorities which would prohibit or materially adversely impact the conduct of the business of the Company and its subsidiaries as currently conducted.
(d) Neither the Company nor any of its subsidiaries has made any material false statements on, or omissions from, the applications, approvals, reports and other submissions to the FDA or Foreign Authorities prepared or maintained to comply with the requirements of the FDA or Foreign Authorities relating to the Company, its subsidiaries or any product being distributed or developed by or on behalf of the Company or any of its subsidiaries.
(e) Neither the Company nor any of its subsidiaries has received any notification, written or oral, that remains unresolved, from FDA or Foreign Authorities indicating that any product of the Company or any of its subsidiaries is misbranded or adulterated as defined in the U.S. Food, Drug & Cosmetic Act, 21 U.S.C. § 321, et seq., as amended amended, and the rules and regulations promulgated thereunder, or has violated in any similar respect the laws, rules or regulations of any Foreign Authority.
(f) No product of the Company or any of its subsidiaries has been recalled or withdrawn from the market as a result of any action by the HITECH ActFDA or any Foreign Authority against the Company or any of its subsidiaries or, and to the Company’s knowledge, any comparable federallicensee, statedistributor or marketer of any product of the Company or any of its subsidiaries, provincial or local healthcare Laws whether in the United States or in jurisdictions in which material quantities of any of elsewhere.
(g) To the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012Company’s knowledge, neither Parent the Company nor any of the Parent Subsidiaries its subsidiaries has received committed any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or and any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectamendments thereto. Neither Parent nor any None of the Parent SubsidiariesCompany, norits subsidiaries and, to the knowledge of ParentCompany’s knowledge, any manager, officer, employee, employee or agent or distributor of Parent the Company or any of the Parent Subsidiaries, its subsidiaries has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed result in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent (i) debarment under 21 U.S.C. § 335a or any of the Parent Subsidiaries of similar Legal Requirement or (ii) exclusion under 42 U.S.C. § 1320a-7 or any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectsimilar Legal Requirement.
(h) Except as would notThe FDA complaint handling system of the Company and its subsidiaries has been made available for review by Parent and contains complete and correct information about all product defect claims and all products returned to the Company or any of its subsidiaries because of warranty or other problems. The records of the Company and its subsidiaries relating to credits and allowances made with respect to any product have been made available to Parent and, individually or to the Company’s knowledge, are true and correct in all material respects. Neither the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent Company nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, its subsidiaries maintains any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, records of warranty or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (product defect claims other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductCompany’s FDA complaint handling system.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Agreement and Plan of Reorganization (Hemosense Inc), Agreement and Plan of Reorganization (Inverness Medical Innovations Inc)
Regulatory Matters. (a) Except All existing Registrations held by Seller as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws date of this Agreement are set forth in Schedule 1.1(k) and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; . Seller is the sole and (iii) Parent is exclusive owner of the Registrations. To the Knowledge of Seller, the Applicable Permits included in compliance with the terms Purchased Assets constitute all of all Parent Regulatory Permitsthe permits, approvals, licenses, franchises or authorizations from any applicable Governmental Authority held by Seller, that are used exclusively for the Product or the Business in the Territory.
(b) Except as would notTo Seller's Knowledge, individually or the Distribution of the Product by Seller in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being Territory has been conducted in material compliance with the Registrations and all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectPDMA.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent Seller has not received any written notice or, to Seller's Knowledge, other notice of proceedings from any applicable Governmental Authority alleging that the Product or any of the Purchased Assets or the ownership, Manufacturing or Distribution is in violation of any applicable Law during the period between June 7, 2002 and the Execution Date, or at any time prior to the Execution Date to the extent still active or pending, including (i) any FDA Form 483's with respect to the Product that would have a Material Adverse Effect; (ii) any FDA Notices of Adverse Findings with respect to the Product; or (iii) any warning letters from the FDA or any other Parent Regulatory Agency regarding applicable Governmental Authority with respect to the Product.
(id) Except as could not have a Material Adverse Effect on the Business, there has not been any occurrence of any product recall, market withdrawal or lot replacement conducted by or on behalf of Seller concerning the Product in the United States or any product recall, market withdrawal or lot replacement conducted by or on behalf of any Company entity as a result of any alleged defect in the Product sold in the United States during the period between [***] and the Execution Date, or intended at any time prior to be sold the Execution Date to the extent still active or pending. The Product is approved for commercialization in the United States pursuant to 21 CFR 314 subpart H. To Seller's Knowledge, Seller has made available to Purchaser every complaint and notice of alleged defect or adverse reaction with respect to the Product in the Territory that has been received in writing by Parent Seller and its Affiliates or a Parent Subsidiary (that has been orally transmitted to and recorded by Seller and its Affiliates, other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productlitigation set forth on Schedule 4.6.
(ie) Except The NDA included in the Purchased Assets is the only regulatory approval necessary from the FDA for Seller to Distribute the Product and conduct the Business as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any conducted as of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Execution Date.
(jf) Notwithstanding anything contained Seller has completed and filed all annual or other reports required by the FDA in this Section 4.13order to maintain the Registrations, no representation except for the most recent filing not yet due.
(g) Schedule 4.10(g) of the Seller Disclosure Schedule sets forth a complete list of all post-marketing commitments as may be necessary or warranty shall be deemed required by any applicable Governmental Authority to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersmaintain the NDA and any other Registrations relating to the Product.
Appears in 2 contracts
Sources: Asset Purchase and Sale Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each of Parent the Company and the Parent Company Subsidiaries holds all Company Permits, including (x) all permits, licenses, franchises, approvals, clearances, registrations, authorizations and authorizations clearances under the United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act, as amended (the “PHSA”), and the regulations of the FDA United States Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Company Products (any such Governmental Entity or Notified BodyEntity, a “Parent Company Regulatory Agency”) necessary for the lawful operating of the businesses of Parent the Company or any of the Parent Subsidiaries as currently conducted or as planned to be conducted Company Subsidiary (the “Parent Company Regulatory Permits”); (ii) all such Parent Company Regulatory Permits are valid and in full force and effect; and (iii) Parent the Company is in compliance with the terms of all Parent Company Regulatory Permits. All Company Regulatory Permits are in full force and effect, except where the failure to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, the businesses of each of Parent the Company and each Parent Company Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Company Products or Parent Company Product candidates are manufactured sold or intended by the Company to be sold; (vvi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), ▇▇▇▇▇ Law (42 U.S.C. §1395nn), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud Health Insurance Portability and abuse, including but not limited to 18 Accountability Act of 1996 (42 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA§1320d et seq.), as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or soldLaws); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collectionlicensing, disclosure and reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsrequirements; and (viiviii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Company Healthcare and Data Protection Laws”). Since January 1, 20122011, neither Parent the Company nor any of the Parent Subsidiaries Company Subsidiary has received any written notification or communication from any Parent Company Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Office of Inspector General of the Department of Health and Human Services Office of Inspector General and Office for Civil RightsServices, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent Company or the Parent Company Subsidiaries under, any Parent Company Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent The Company and the Parent Company Subsidiaries have are not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Company Product candidate conducted or sponsored by each of Parent the Company and the Parent Subsidiaries Company Subsidiaries, not to include investigator initiated studies, are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 58, 312, 314 320, and 320 812 of the Code of Federal Regulations and Regulations, (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect.
(e) Since January 1, 20122011, neither Parent the Company nor any of the Parent Subsidiaries Company Subsidiary has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs or medical devices which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(f) Since January 1, 20122011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent the Company and the Parent Company Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, 2011 neither Parent the Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent the Company or any of the Parent Company Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Company Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect. Neither Parent the Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Company Products or Parent Company Product candidates are sold or intended by the Parent Company to be sold. Since January 1, 2011, neither Parent the Company nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent Company Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Company Healthcare Law or program.
(g) As to each Parent Company Product or Parent Company Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Company Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent the Company or any of the Parent Company Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, each such Parent Company Product or Parent Company Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Company Product or Parent Company Product candidate by Parent the Company or any of the Parent Company Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122011, neither Parent the Company nor any of the Parent Company Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Company Product, other than notices or actions that are not material to the Company or the Company Subsidiaries, taken as a whole. To the knowledge of Parentthe Company, there are no facts which are reasonably likely to cause, and Parent the Company has not received any written notice from the FDA or any other Parent Company Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent the Company or a Parent Company Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent the Company or the Parent Company Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material adverse change in the labeling of any such Parent Company Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Company Products, or (iv) a material negative change in reimbursement status of a Parent Company Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.133.13, no representation or warranty shall be deemed to be made in this Section 4.13 3.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Questcor Pharmaceuticals Inc), Merger Agreement (Mallinckrodt PLC)
Regulatory Matters. (a) Except The Company and the Company Subsidiaries hold all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as has not had amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”) and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Government Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s current or under-development products (any such Government Authority, a “Company Regulatory Agency”) required for the lawful operation of the businesses of the Company and the Company Subsidiaries (the “Company Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any . All such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Company Permits are valid and in full force and effect; . None of such Company Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement. The Company and (iii) Parent is in compliance the Company Subsidiaries are the sole and exclusive owner of the Company Permits and the associated filings and applications with the terms FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company and the Company Subsidiaries (collectively, the “Company Regulatory Filings”) and hold all right, title and interest in and to all Company Regulatory Filings free and clear of all Parent any encumbrance. The Company and the Company Subsidiaries have not granted any third party any right or license to use, access or reference any of the Company Regulatory PermitsFilings, including, without limitation, any of the know-how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20122008, neither Parent nor there has not occurred any breach or violation of, default (with or without notice or lapse of the Parent Subsidiaries has received time or both) under or event giving rise to any written notification right of termination, amendment or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department cancellation of Justice (including any United States Attorney’s Officewith or without notice or lapse of time or both), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsCompany Permit, except where such noncompliance or liability as would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. The Company and the Company Subsidiaries are in compliance in all material respects with the terms of all Company Permits, and no event has occurred and no facts or circumstances exist that, to the knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit.
(c) Except Since January 1, 2008, all material applications, submissions, information and data utilized by the Company or the Company Subsidiaries as would notthe basis for, individually or in submitted by or, to the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None knowledge of the Parent Company, on behalf of the Company or the Company Subsidiaries in connection with, any Parent Subsidiary are a party and all requests for Company Permits when submitted to the FDA or other Company Regulatory Agency, were, to the Company’s knowledge, accurate and complete in all material respects as of the date of submission, and any material corporate integrity agreementsupdates, deferred prosecution agreementschanges, monitoring agreementscorrections or modifications to such applications, consent decreessubmissions, settlement orders, information and data required under Applicable Law have been submitted to the FDA or similar agreements with or imposed by any Parent other Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 20122008, neither Parent the Company nor any of the Parent Company Subsidiaries has received committed any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ” or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectpolicies under Applicable Law. Neither Parent the Company’s nor any of the Parent Company Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent ’ agents or distributor of Parent or any of the Parent Subsidiaries, subcontractors has been debarred or convicted of any crime or engaged in any conduct for which has resulted or could result in debarment is mandated or disqualification by 21 U.S.C. § 335a(a) the FDA or any similar Law other Government Authority, and there are no proceedings pending or authorized threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by 21 U.S.C. § 335a(b) the FDA or any similar Law applicable in other jurisdictions in which material quantities of any of Government Authority.
(e) Neither the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent Company nor any of the Parent Subsidiaries, Company Subsidiaries nor, to the knowledge of Parentthe Company, any director, officer, employeeagent, agent employee or distributor other Person associated with or acting on behalf of Parent the Company or any of the Parent SubsidiariesCompany Subsidiaries has: (i) used any corporate funds for any unlawful contribution, has been debarredgift, suspended entertainment or excluded other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from participation corporate funds; (iii) violated or is in any government health care program or convicted violation of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 provision of the Social Security Foreign Corrupt Practices Act of 19351977, as amendedamended (the “FCPA”), or any similar Parent Healthcare Law Applicable Law; or program(iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment.
(gf) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122008, neither Parent nor there has not been any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issuedconducted, or caused to be initiated, conducted or issued, any issued recall, field corrections, market withdrawal or replacementwithdrawal, safety alert, warning, “dear doctor” letter, investigator noticemarket correction, or other investigator notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged material lack of safety, safety or efficacy or regulatory compliance of any Parent Productproduct of the Company or product candidate of the Company.
(g) The Company and its Subsidiaries are in compliance in all material respects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the sale of pharmaceutical products or biological, or device products in any jurisdiction. To There are no pending or, to the knowledge of Parentthe Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company or its Subsidiaries. Since January 1, 2008 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to the Company or any Company Subsidiary or the products or product candidates of the Company or any Company Subsidiary or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to any product or any product candidate of the Company or any Company Subsidiary.
(h) The manufacture of the products of the Company or any Company Subsidiary is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA.
(i) The Company and its Subsidiaries are no facts which are reasonably likely to cause, and Parent has not received any written notice from have been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Parent Regulatory Agency regarding Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. There have been no Serious Adverse Events or Serious Injuries associated with the use (including in clinical trials) of the products or product candidates of the Company or any Company Subsidiary that have not been reported to the FDA in accordance with Applicable Law.
(j) To the knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company and Company Subsidiaries, and to the knowledge of the Company, on behalf of the Company and Company Subsidiaries, are being, and at all times have been, conducted incompliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by the Company or any Company Subsidiary or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial.
(k) Neither the Company nor any Company Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company or Company Subsidiary, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company or any Company Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing Federal Health Care Programs.
(l) Neither the Company nor any Company Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company or any Company Subsidiary, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company or any Company Subsidiary: (i) the recallhas been debarred, market withdrawal excluded or replacement of suspended from participation in any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), Federal Health Care Program; (ii) has had a material change in civil monetary penalty assessed against it, him or her under Section 1128A of the marketing classification or a material change in Social Security Act of 1935,codified at Title ▇▇, ▇▇▇▇▇▇▇ ▇, ▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Code (the labeling of any such Parent Products, “Social Security Act”); (iii) a termination or suspension is currently listed on the General Services Administration published list of the manufacturing, marketing, or distribution of such Parent Products, or parties excluded from federal procurement programs and non-procurement programs; (iv) to the knowledge of the Company, is the target or subject of any current investigation by a material negative change in reimbursement status Government Authority relating to any Federal Health Care Program related offense; or (v) is currently charged with or convicted of a Parent Productany criminal offense relating to the delivery of an item or service under any Federal Health Care Program.
(im) Except as would not reasonably be expected To the knowledge of the Company, there are no pending or threatened filings against the Company or any Company Subsidiary of an action relating to have a Parent Material Adverse Effectthe Company or any Company Subsidiary under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(n) To the knowledge of the Company, neither Parent the Company nor any Company Subsidiary is under investigation by any Government Authority for a violation of the Parent Subsidiaries has experienced Health Insurance Portability and Accountability Act of 1995, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any security breach or other incident resulting in notices from the unauthorized access, use or disclosure United States Department of data or information that is linked Health and Human Services Office of Civil Rights relating to any reasonably identifiable person such violations, or any other data protected under applicable Lawcomparable state or local laws. Parent or Merger Sub is not a business associate, Neither the Company nor any Company Subsidiaries are “covered entities” as that term is defined in HIPAA. The Company and the HIPAA regulations at 45 C.F.R. § 160.103Company Subsidiaries have been in compliance in all material respects with federal and state data breach laws.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Synageva Biopharma Corp.), Merger Agreement (Trimeris Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent PubCo Material Adverse Effect, (i) the businesses of each of Parent PubCo Entities and each Parent Subsidiary are being their respective Subsidiaries currently conduct, and have at all times since January 1, 2023, conducted their respective business in compliance in compliance with all Laws applicable Lawsto their respective operations, activities or services and any Orders to which they are a party or are subject, including (i) the FDCA; any settlement agreements or corporate integrity agreements, (ii) except for routine matters arising in the PHSA; (iii) federal Medicare and Medicaid statutes and related state ordinary course of business, none of any PubCo Entity or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent its Subsidiaries has received any written notification or communication from any Parent Regulatory Agencynotice, including the FDAcitation, the Drug Enforcement Administrationsuspension, the United States Department of Justice (including any United States Attorney’s Office)revocation, the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rightslimitation, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance bywarning, or liability request for repayment or refund issued by a Governmental Authority which alleges or asserts that any PubCo Entity or any of Parent its Subsidiaries has violated any Laws or which requires or seeks to adjust, modify or alter PubCo’s or any of its Subsidiary’s operations, activities, services or financial condition that has not been fully and finally resolved to the Parent Governmental Authority’s satisfaction without further Liability to the PubCo Entities and their respective Subsidiaries, and (iii) there are no restrictions imposed by any Governmental Authority upon PubCo’s or any of its Subsidiaries’ business, activities or services which would restrict or prevent any PubCo Entity or any of its Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effectfrom operating as it currently operates.
(cb) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None As of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical date of this agreement and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent PubCo Material Adverse Effect, PubCo and each such Parent Product or Parent Product candidate is being or has been developedof its Subsidiaries, manufacturedand to the Knowledge of PubCo, storedall of their respective directors, distributed officers, agents and marketed employees, are in compliance with in all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingmaterial respects with, and security. There is no action or proceeding pending orthe PubCo and each of its Subsidiaries have compliance programs including policies and procedures reasonably designed to cause the PubCo Entities and their respective Subsidiaries and their respective directors, officers, agents and employees to be in compliance in all material respects with, to the knowledge of Parentextent applicable, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectall Laws.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Agreement and Plan of Merger (Avalon GloboCare Corp.), Agreement and Plan of Merger (Avalon GloboCare Corp.)
Regulatory Matters. (ai) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent an Actavis Material Adverse Effect, (i) each of Parent Actavis and the Parent Actavis Subsidiaries holds all Actavis Permits and Clearances, including (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Relevant Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Actavis Products (any such Governmental Entity or Notified BodyRelevant Authority, a “Parent Actavis Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Actavis or any of the Parent Actavis Subsidiaries as currently conducted or as planned to be conducted (the “Parent Actavis Regulatory Permits”); (ii) all such Parent Actavis Regulatory Permits are valid and in full force and effect; and (iii) Parent Actavis is in compliance with the terms of all Parent Actavis Regulatory Permits. All Actavis Regulatory Permits are in full force and effect, except where the failure to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, an Actavis Material Adverse Effect.
(bii) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent an Actavis Material Adverse Effect, the businesses of each of Parent Actavis and each Parent Subsidiary the Actavis Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or soldforegoing; (vvi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), Stark Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h§1320d et. seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or soldLaws); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collectionlicensing, disclosure and reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsrequirements; and (viiviii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Actavis Healthcare and Data Protection Laws”). Since January 1, 20122011, neither Parent Actavis nor any of the Parent Actavis Subsidiaries has received any written notification or communication from any Parent Actavis Regulatory Agency, including without limitation the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent Actavis or the Parent Actavis Subsidiaries under, any Parent Actavis Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent an Actavis Material Adverse Effect.
(ciii) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent Actavis and the Parent Actavis Subsidiaries have are not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Actavis Regulatory Agency.
(div) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent Actavis and the Parent Actavis Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Warner Chilcott Regulatory Agencies, including without limitation (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and Regulations, (iiiii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent an Actavis Material Adverse Effect.
(ev) Since January 1, 20122011, neither Parent Actavis nor any of the Parent Actavis Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or denial of any application for marketing approval already granted or currently pending before the FDA or such other Parent Actavis Regulatory Agency.
(fvi) Since January 1, 20122011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Actavis Regulatory Agency by Parent Actavis and the Parent Actavis Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or and notices would not reasonably be expected to have, individually or in the aggregate, a Parent an Actavis Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Neither Actavis nor any of the Parent Actavis Subsidiaries, nor, to the knowledge Knowledge of ParentActavis, any officer, employee, agent or distributor of Parent Actavis or any of the Parent Actavis Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Actavis Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Actavis Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent Actavis or any of the Parent Actavis Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Actavis Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Actavis nor any of the Parent Actavis Subsidiaries, nor, to the knowledge Knowledge of ParentActavis, any officer, employee, agent or distributor of Parent Actavis or any of the Parent Actavis Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldLaw. Since January 1, 2011, neither Parent Neither Actavis nor any of the Parent Actavis Subsidiaries, nor, to the knowledge Knowledge of ParentActavis, any officer, employee, agent or distributor of Parent Actavis or any of the Parent Actavis Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gvii) As to each Parent Actavis Product or Parent Actavis Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Actavis or any of the Parent Actavis Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent an Actavis Material Adverse Effect, each such Parent Actavis Product or Parent Actavis Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge Knowledge of ParentActavis, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Actavis Product or Parent Actavis Product candidate by Parent Actavis or any of the Parent Actavis Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent an Actavis Material Adverse Effect.
(hviii) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122011, neither Parent nor any each of Actavis and the Parent Actavis Subsidiaries have neither voluntarily or nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Actavis Product. To the knowledge Knowledge of ParentActavis, there are no facts which are reasonably likely to cause, and Parent Actavis has not received any written notice from the FDA or any other Parent Actavis Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Warner Chilcott Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent Actavis or the Parent Actavis Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Actavis Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Actavis Products, or (iv) a material negative change in reimbursement status of a Parent an Actavis Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(jix) Notwithstanding anything contained in this Section 4.13Clause 6.2(m), no representation or warranty shall be deemed to be made in this Section 4.13 Clause 6.2(m) in respect of environmental, Tax, employee benefits or labor labour Law matters.
Appears in 2 contracts
Sources: Transaction Agreement (Actavis, Inc.), Transaction Agreement (Warner Chilcott PLC)
Regulatory Matters. (a) Except (i) With respect to each product that is, directly or indirectly, being distributed for commercial sale by the Company or any of the Company Subsidiaries (the "Products"): (1) the Company and the Company Subsidiaries have obtained all applicable approvals, clearances, authorizations, licenses and registrations required by Governmental Entities to permit the manufacture, distribution, sale (including reimbursement and pricing), marketing or human research and development of such Product (collectively, "Approvals"); (2) the Company and the Company Subsidiaries are in compliance in all material respects with all terms and conditions of each Approval in each country in which such Product is marketed; (3) the Company and the Company Subsidiaries are in compliance in all material respects with all applicable requirements (as set forth in relevant statutes and regulations) regarding registration, licensure or notification for each site (in any country) at which such Product is manufactured, processed, packed, held for distribution or from which it is distributed; (4) to the extent such Product is intended for export from the United States, the Company and the Company Subsidiaries are in compliance in all material respects with either all United States Food and Drug Administration ("FDA") requirements for marketing or 21 U.S.C. §381(e) or 382; and (5) none of the Company, the Company Subsidiaries or any officer or employee of the Company or the Company Subsidiaries is under investigation or has been debarred pursuant to 21 U.S.C. §335a; (ii) all manufacturing operations performed by or for the Company and the Company Subsidiaries are being, and to the Knowledge of the Company have been, conducted in full compliance with current good manufacturing practices, including, but not had limited to, the good manufacturing practice regulations and would not reasonably be expected guidance issued by the FDA and counterpart requirements in the European Union and other countries;
(iii) all nonclinical laboratory studies, as described in 21 C.F.R. §58.3(d), conducted or sponsored by the Company or the Company Subsidiaries are being, and to havethe Knowledge of the Company have been, conducted in full compliance with the good laboratory practice regulations set forth in 21 C.F.R. Part 58 and counterpart requirements in the European Union and other countries; (iv) all clinical studies of Products, as described in 21 C.F.R. §50.3(c), sponsored by the Company or the Company Subsidiaries are being, and to the Knowledge of the Company have been, conducted in full compliance with 21 C.F.R. §§812,50, 54 and 56; and (v) the Company and the Company Subsidiaries are in full compliance with the adverse event reporting requirements for devices in 21 C.F.R. Parts 812 and 803; except, in the case of subsections (i) through (iv) above, for any such failures to obtain or instances of noncompliance which, individually or in the aggregate, would not have a Parent Company Material Adverse Effect. Without limiting the generality of the foregoing definition of "Approvals", (i) each such definition shall specifically include, with respect to the United States, product license applications, premarket approval applications under Section 515 of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations premarket notifications under Section 510(k) of the FDA promulgated thereunderFDCA, data protection laws investigational device exemptions, and (y) all permitsproduct export applications issued by the FDA, licenses, franchises, approvals, clearances, registrations, certificates and authorizations as well as registrations issued by the Department of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory PermitsJustice.
(b) Except as would not, individually or in To the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any Knowledge of the foregoing applicable in jurisdictions in which material quantities of any Company, none of the Parent Products Company or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent Company Subsidiaries nor any of the Parent Subsidiaries has received any written notification their officers, employees or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, agents has made an any untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agencyforeign equivalent, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agencyforeign equivalent, or committed an any act, made a any statement, or failed to make a any statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, that would reasonably be expected to provide a basis for the FDA and any foreign equivalent to invoke its policy respecting “respecting, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ," set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program).
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (I Stat Corporation /De/), Merger Agreement (I Stat Corporation /De/)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to havenot, individually or in the aggregate, a Parent have an ETP Material Adverse Effect, (i) each none of Parent ETP and the Parent its Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations is subject to regulation as a common carrier under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws ICA and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and none of ETP or its Subsidiaries is, or has been in full force and effect; and (iii) Parent is the past three years a holding company or a public-utility company as defined in compliance with the terms of all Parent Regulatory PermitsPUHCA.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent an ETP Material Adverse Effect, the businesses of Effect each of Parent ETP’s Subsidiaries and each Parent Subsidiary are being conducted of ETP in compliance with all applicable Lawsthe past three years that is or was a public utility under the FPA engaged in the sale of electricity at wholesale and has been authorized by the FERC, pursuant to the FPA, to make such sales at market-based rates, and has been granted such waivers and blanket authorizations (including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare blanket authorization to issue securities and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any to assume liabilities under Section 204 of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates FPA and 18 C.F.R. Pt. 34) as are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anticustomarily granted to entities with market-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, based rate authority. Except as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to havenot, individually or in the aggregate, a Parent have an ETP Material Adverse Effect, to the knowledge of ETP, there are no facts that are reasonably likely to cause any such Subsidiary to lose or be ineligible for its market-based rate authorization or such customary waivers and blanket authorizations.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent an ETP Material Adverse Effect, Parent and all filings required to be made by ETP or any of its Subsidiaries during the Parent Subsidiaries have not engaged in activities which arethree years preceding the date hereof, with the FERC under the NGA, NGPA, the ICA, the FPA, the PUHCA, the Department of Energy, the FCC, or any applicable state public utility commission or department, as applicablethe case may be, cause for false claims liabilityhave been made, civil penalties including all forms, statements, reports, notices, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings complied, as of their respective dates, and, as amended or mandatory or permissive exclusion from Medicaresupplemented, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the requirements of applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent statutes and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits rules and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programregulations promulgated thereunder.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Energy Transfer Partners, L.P.), Merger Agreement (Sunoco Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to be material to the business of the Acquired Companies, taken as a whole: (i) the Acquired Companies own, possess or validly have a Parent Material Adverse Effectthe right to use all permits required to research, develop, manufacture, market, commercialize, distribute and sell its products; (ii) all products of the businesses of each of Parent Acquired Companies are and, since January 1, 2019, have been researched, developed, manufactured and each Parent Subsidiary are being conducted marketed in compliance accordance with all applicable specifications, Permits and applicable Laws, including (i) the FDCA; (ii) the PHSAGMPs, GLPs, GCPs, GDPs and GVPs; (iii) federal Medicare and Medicaid statutes and related state since January 1, 2019, (A) no product of the Acquired Companies or local statutes; (iv) manufacturing site has shut down, been subject to any comparable foreign Laws import or export prohibition, received any FDA Form 483 or other Governmental Body notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to any product of the Acquired Companies or any manufacturing operations for any product of the foregoing applicable in jurisdictions in which material quantities Acquired Companies and (B) there have been no recalls, field notifications, field corrections, warnings, “dear doctor” letters, investigator notices, safety alerts or other written notices of action issued by a Governmental Body or the Acquired Companies relating to an alleged lack of safety, efficacy, or regulatory compliance of any product of the Parent Products Acquired Companies (collectively, “Safety Notices”). Each Acquired Company has complied in all material respects with its obligations to make filings, declarations, listings, registrations, reports or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws submissions with the applicable regulatory authorities (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), FDA and the exclusion laws (42 U.S.C. § 1320a-7), DEA or any other Governmental Body performing functions similar to those performed by the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws FDA and the DEA) relating to health care fraud and abuseAcquired Company drug products, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, adverse event reports. Except as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to haveexpected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a Parent Material Adverse Effectwhole, no written deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions.
(cb) Except as would notnot reasonably be expected, individually or in the aggregate, reasonably to be expected material to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None business of the Parent or any Parent Subsidiary are Acquired Companies, taken as a party to any material corporate integrity agreementswhole, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including no Acquired Company has (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the Agreement Date, set forth in 56 Fed. Reg. 46191 (September 10the Company is not the subject of any pending or, 1991) or for to the Knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any officers, directors, employees, agents or clinical investigators of any other Parent Regulatory Agency of the Acquired Companies or, to invoke the Acquired Companies’ Knowledge, anyone acting on behalf of the Acquired Companies, is, has been, or is threatened in writing to be: (i) excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. § 1320a- 7b(f)) (“Excluded”); (ii) convicted of a crime for which a Person or entity can be debarred or Excluded; (iii) listed on the General Services Administrative published list of parties excluded from federal procurement programs and non-procurement programs or (iv) party to a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services or otherwise has any similar policycontinuing reporting obligations pursuant to any deferred prosecution or settlement with any Governmental Authority. To the Acquired Companies’ Knowledge, except for any act there are no facts or statement circumstances reasonably likely to result in such a debarment or failure exclusion with respect to make a statement thatits business.
(c) Except as would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with all Healthcare Laws applicable to the operation of its business as currently conducted. As of the Agreement Date, to the Knowledge of the Company no enforcement, regulatory or administrative proceeding is pending, and no such enforcement, regulatory or administrative proceeding has not had and been threatened in writing, against the Company under the Healthcare Laws, other than any such proceeding that would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would notexpected, individually or in the aggregate, reasonably to be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, material to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any business of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent SubsidiariesAcquired Companies, taken as a whole). None of the Acquired Companies has received any written notice, warning letter, or similar written communication that (iiA) alleges a material change in the marketing classification violation of, or asserts a material change in the labeling of failure to comply with, any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Productsapplicable Healthcare Law, or (ivB) imposes a material negative change in reimbursement status written obligation to undertake, or to bear all or any portion of a Parent Productthe cost of, any remedial action of any nature.
(id) Except as would not reasonably be expected Since January 1, 2019 , the Company and its Subsidiaries have performed periodic audits of all manufacturing sites that supply regulatory starting materials, drug substances, drug product intermediates, drug products or finished products to have a Parent Material Adverse Effect, neither Parent nor the Company or the Subsidiaries to the extent permitted by any Contract relating to such manufacturing site or required by applicable Healthcare Law. To the Knowledge of the Company, there are no written findings deemed critical by the auditor or inspector resulting from such audits or inspections since January 1, 2019 that have not been remediated in all material respects. To the Knowledge of the Company, any such manufacturing site has performed in all material respects all tasks required by such written remediation plans. The Company has made available to Parent complete and accurate copies of all reports from all regulatory audits or inspections conducted since January 1, 2019 by the Company and its Subsidiaries has experienced any security breach or other incident resulting or, to the extent in the unauthorized accesspossession or control of the Company and its Subsidiaries, use or disclosure of data or information that is linked to any reasonably identifiable person by their Representatives or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Governmental Bodies.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Biodelivery Sciences International Inc), Merger Agreement (Collegium Pharmaceutical, Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Seller Material Adverse EffectEffect or be material to the MRT Program, taken as a whole, and in each case solely with respect to the MRT Program:
(ia) Seller Parent and each of Parent and the Parent its Subsidiaries holds (x) all permitsis developing, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacytesting, labeling, packaging, manufacturing, marketing, promotiondistributing, distributionand storing, saleand at all times has developed, pricingtested, import or export labeled, packaged, manufactured, marketed, distributed, and stored the product(s) and product candidate(s) relating to the MRT Program in compliance in all material respects with (i) the FDC Act, (ii) the medicinal products laws of the Parent Products European Union and applicable implementing regulations and guidelines issued by applicable Governmental Entities in the European Union, including the EMA, and (iii) any such other applicable Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Entities in any other country where Seller Parent or any of the Parent its Subsidiaries as currently conducted has developed, tested, labeled, packaged, manufactured, distributed or as planned to be conducted (the “Parent Regulatory Permits”stored any such product(s) and product candidate(s); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of . Seller Parent and each Parent Subsidiary are being conducted of its Subsidiaries has complied in compliance all material respects with all applicable Laws, including security and privacy standards regarding protected health information under (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state privacy Laws with respect to the product(s) and provincial Laws restricting product candidate(s) relating to the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse EffectMRT Program.
(eb) Since January 1, 2012, neither Parent nor any All preclinical studies and other studies and tests of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling product(s) and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead product candidate(s) relating to the denialMRT Program conducted by or on behalf of the Seller have been, limitationand if still pending are being, revocationconducted in material compliance, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before to the FDA or such other Parent Regulatory Agencyextent applicable, with good laboratory practices, good clinical practices and all applicable Laws, including the FDC Act and the respective counterparts thereof outside the United States.
(fc) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained All documents filed by Seller Parent or furnished to any of its Subsidiaries with the FDA or any other Parent Regulatory Agency by Parent Governmental Entity with respect to the product(s) and product candidate(s) relating to the Parent Subsidiaries have been so filedMRT Program, maintained or furnishedthe manufacturing, except where failure to filehandling, maintain storage or furnish shipment of such reportsproduct(s) or product candidate(s), documentswere, claimsat the time of filing, permits or notices would not reasonably be expected to havetrue, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on respects.
(d) With respect to the date product(s) or product candidate(s) relating to the MRT Program, the Seller has not received any written notice of FDA regulatory actions against Seller Parent or any of its Subsidiaries, including notice of adverse findings, regulatory, untitled or warning letters or mandatory recalls, or any other notice from any governmental entity alleging or asserting material noncompliance with any Law. Neither Seller Parent, its Subsidiaries nor their respective suppliers or contract manufacturers have received an FDA Form 483 or any other written notice from a Governmental Entity of inspectional observations related to or affecting the product(s) and product candidate(s) relating to the MRT Program, which has not been closed out by the FDA or the relevant Governmental Entity.
(e) The Seller and each of the Selling Subsidiaries has filed with the FDA and any other applicable Governmental Entity all notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports, that are required by Law and material to the continued development or handling of the product(s) and product candidate(s) relating to the MRT Program.
(or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither f) Neither Seller Parent nor any of the Parent Subsidiariesits Subsidiaries have received written notice of any pending or threatened claim, norsuit, proceeding, hearing, enforcement, audit or, to the knowledge of ParentSeller’s Knowledge, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to investigation from the FDA or any other Governmental Entity alleging that any operation or activity of Seller Parent Regulatory Agencyor any of its Subsidiaries in connection with the MRT Program is in material violation of the FDC Act or the respective counterparts thereof promulgated by applicable state Governmental Entities or Governmental Entities outside the United States, failed to disclose a material fact required to be disclosed including, as applicable, the medicinal products and medical device Laws of the European Union. No civil, criminal or administrative action, suit, demand, claim, complaint, hearing, proceeding or, to the FDA Seller’s Knowledge, investigation for which the Seller has received written notice is pending or, to the Seller’s Knowledge, threatened against Seller Parent or any other of its Subsidiaries in connection with the MRT Program. To the Seller’s Knowledge, there has not been any material violation of any laws by Seller Parent Regulatory Agencyor any of its Subsidiaries in its product development efforts, submissions or reports to any Governmental Entity in connection with the MRT Program that could reasonably be expected to require investigation, corrective action or enforcement action.
(g) With respect to the MRT Program, (i) neither Seller Parent nor any of its Subsidiaries have committed an any act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” or any such similar policies set forth in 56 Fed. Reg. 46191 any applicable Laws and (September 10ii) neither the Seller nor, 1991) to the Seller’s Knowledge, any of its officers, employees or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregateagents, has not had and been convicted of any crime or engaged in any conduct that has resulted, or would not reasonably be expected to have result, in debarment or exclusion under applicable Law, including 21 U.S.C. Section 335a. To the Seller’s Knowledge, no claims, actions, proceedings or investigations with respect to the MRT Program that would reasonably be expected to result in such a Parent Material Adverse Effect. Neither Parent nor material debarment or exclusion of the Seller or any of the Parent Selling Subsidiaries are pending or threatened against the Seller or any of the Selling Subsidiaries or any of their respective officers, employees or agents.
(h) Neither the Seller nor or any of the Selling Subsidiaries, nor, to the knowledge of ParentSeller’s Knowledge, any officer, employee, agent officer or distributor employee of Parent the Seller or any of the Parent Selling Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law Laws or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of Laws with respect to the MRT Program. Neither the Seller nor, or any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Selling Subsidiaries, nor, to the knowledge of ParentSeller’s Knowledge, any officer, employee, agent officer or distributor employee of Parent the Seller or any of the Parent Selling Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct with respect to the MRT Program for which such Person or entity could be excluded from participating in any federal health care program the Federal healthcare programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to Laws. Neither the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent Seller nor any of the Parent Selling Subsidiaries have voluntarily or involuntarily initiatedis a party to any corporate integrity agreement, conducted or issuedmonitoring agreement, consent decree, settlement order, or caused similar agreement with respect to be initiated, conducted the MRT Program with or issued, imposed by any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductGovernmental Entity.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Neither Seller Parent nor any of its Subsidiaries is subject to any investigation related to any MRT Product or the MRT Program that is pending and of which Seller Parent or any of its Subsidiaries has experienced any security breach been notified in writing or, to the Seller’s Knowledge, which has been threatened in writing, in each case by (i) the FDA or other incident resulting in (ii) the unauthorized access, use Department of Health and Human Services Office of Inspector General or disclosure Department of data Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) (known as the “Anti-Kickback Statute”) or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Federal False Claims Act (31 U.S.C. §3729).
(j) Notwithstanding anything contained herein to the contrary, the representations and warranties set forth in this Section 4.13, no representation or warranty shall be deemed 2.9 are the only representations and warranties of the Seller and the Selling Subsidiaries with respect to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law regulatory matters.
Appears in 2 contracts
Sources: Asset Purchase Agreement (Translate Bio, Inc.), Asset Purchase Agreement (Translate Bio, Inc.)
Regulatory Matters. (a) Except All of Borrowers’ and their Subsidiaries’ material Products and material Regulatory Required Permits are listed on Schedule 4.17 on the Closing Date. With respect to each Product, (i) the Borrowers and their Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as has currently being conducted by or on behalf of Borrower, in each case except where the failure to obtain such Regulatory Required Permits could not had reasonably be expected to have a Material Adverse Effect and (ii) such Product is being tested, manufactured, marketed or sold, as the case may be, by Borrowers (or to the Borrowers’ knowledge, by any applicable third parties) in compliance with all applicable Laws and Regulatory Required Permits in each case except where the failure to do so could not reasonably be expected to have a Material Adverse Effect.
(b) None of the Borrowers or any Subsidiary thereof are in violation of any Healthcare Law, except where any such violation would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually No Borrower or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion any Subsidiary thereof receives any material payments directly (including through any third party payment processor) from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement ordersMedicaid, or similar agreements with or imposed by any Parent Regulatory AgencyTRICARE.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and To the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesBorrowers’ knowledge (after reasonable inquiry), including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 none of the Code of Federal Regulations and (ii) any applicable federalBorrowers or their Subsidiaries’ officers, state and provincial Laws restricting the collectiondirectors, use and disclosure of individually identifiable health information and personal informationemployees, exceptshareholders, in each case, for such noncompliance that, individually their agents or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, affiliates has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyFDA, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. Regulation 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program).
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ie) Except as would not reasonably be expected to have result in a Parent Material Adverse Effect, neither Parent each Product (i) has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws, and (ii) has been and/or shall be manufactured in accordance with Good Manufacturing Practices.
(f) No Borrower, nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized accessSubsidiary thereof, use or disclosure of data or information that is linked subject to any reasonably identifiable person proceeding, suit or, to any Borrower’s knowledge, investigation by any federal, state, local or foreign government or quasi-governmental body, agency, board or authority or any other data protected under applicable Law. Parent administrative or Merger Sub is not a business associate, as that term is defined investigative body (including the Office of the Inspector General of the United States Department of Health and Human Services),which could reasonably be expected to result in the HIPAA regulations at 45 C.F.R. § 160.103revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary thereof or otherwise be expected to result in a Material Adverse Effect.
(jg) Notwithstanding anything contained in this Section 4.13As of the Closing Date, there have been no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersmaterial Regulatory Reporting Events.
Appears in 2 contracts
Sources: Credit and Security Agreement (Treace Medical Concepts, Inc.), Credit and Security Agreement (Term Loan) (Treace Medical Concepts, Inc.)
Regulatory Matters. (ai) Except Each of the Company and its Subsidiaries has all Licenses necessary to conduct its business as has presently conducted, including all such Licenses of the United States Food and Drug Administration (the “FDA”) or any other applicable U.S. or foreign drug regulatory authority (collectively with the FDA, the “Regulatory Authorities”) necessary to conduct its business as presently conducted (collectively, the “Regulatory Licenses”), except those Licenses the absence of which, individually or in the aggregate with other such absences, would not had reasonably be expected to have a Company Material Adverse Effect and would not reasonably be expected to haveprevent, materially delay or materially impair the consummation of the transactions contemplated hereby. There has not occurred any revocation or termination of any Regulatory License, or any material impairment of the rights of the Company or its Subsidiaries under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the aggregateaggregate with other such revocations, a Parent Material Adverse Effectterminations and impairments, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, not reasonably be expected to have a Parent Company Material Adverse Effect, . Each of the businesses of each of Parent Company and each Parent Subsidiary are being conducted its Subsidiaries has operated in compliance in all material respects with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state Laws administered or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended enforced by the HITECH Act, and FDA or any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent other Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsAuthority, except where the failure so to comply, individually or in the aggregate with other such noncompliance or liability failures, would not reasonably be expected to have, individually or in the aggregate, have a Parent Company Material Adverse Effect.
(cii) Except as would notSince January 1, individually 2009, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the Knowledge of the Company, on behalf of the Company or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent its Subsidiaries have not engaged in activities which arebeen and, as applicableif still pending, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, (including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis those pertaining to Good Laboratory Practice and reporting of clinical trials Good Clinical Practice contained in Title 21 parts C.F.R. Part 58 and Part 312 and all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 5454 and 56), 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, except for such noncompliance noncompliances that, individually or in the aggregateaggregate with other such noncompliances, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy2009, except for any act or statement or failure to make a statement such exceptions that, individually or in the aggregateaggregate with other such exceptions, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, norno clinical trial conducted by or, to the knowledge of Parentthe executive officers of the Company, on behalf of the Company or its Subsidiaries has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries has commenced, or, to the Knowledge of the Company, threatened to initiate, any officeraction to place a clinical hold order on, employeeor otherwise terminate, agent materially delay or distributor suspend, any ongoing clinical investigation conducted by or, to the Knowledge of Parent the Company, on behalf of the Company or its Subsidiaries.
(iii) Since January 1, 2009, (A) neither the Company nor any of its Subsidiaries nor, to the Parent SubsidiariesKnowledge of the Company, any of their officers, directors, employees or agents has been debarred or convicted of any crime or engaged in any conduct for which that in any such case has resulted, or is reasonably likely to result, in debarment is mandated by under 21 U.S.C. § 335a(aSection 335a and (B) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of neither the Company nor any of its Subsidiaries has hired any employee under debarment or used a vendor that, to the Knowledge of the Company, employed any person under debarment.
(iv) The Company has made available to Parent Products complete and correct copies of each Investigational New Drug Application, each similar state or Parent Product candidates are sold foreign regulatory filing made on behalf of the Company or intended by its Subsidiaries, including all related supplements, amendments and annual reports, and all correspondence between the Parent to be sold. Company and any of its Affiliates on one hand and any Regulatory Authority on the other hand.
(v) Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, 2009 to the knowledge date of Parentthis Agreement, any officer, employee, agent each medicinal or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold pharmaceutical product that is or has been researched, developed, manufactured, testedlabeled, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiariessupplied, except as would notpromoted, individually or in the aggregateco-promoted, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been co-developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.co-marketed,
Appears in 2 contracts
Sources: Merger Agreement (Shire PLC), Merger Agreement (Dyax Corp)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect:
(a) Since January 1, 2023, the Company and all of its Subsidiaries are and have been in compliance with applicable requirements under: (i) each of Parent and the Parent Subsidiaries holds (x) all permitsFederal Food, licenses, franchises, approvals, clearances, registrationsDrug, and authorizations under Cosmetic Act, 21 U.S.C. § 301 et seq., and all regulations promulgated by the FDCAU.S. Food and Drug Administration (“FDA”) thereunder (collectively, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory PermitsFDCA”); (ii) the Federal Trade Commission Act, 15 U.S.C. § 41 et seq., and all such Parent regulations promulgated by the U.S. Federal Trade Commission (“FTC”) thereunder (collectively, the “FTC Act”); (iii) the Controlled Substances Act, 21 U.S.C. § 801 et seq., and all regulations promulgated by the Drug Enforcement Administration (“DEA”) thereunder (collectively, the “CSA”); (iv) all Laws, statutes and regulations administered by the United States Department of Agriculture (“USDA”) applicable to activities of the Company; and, (v) all federal, national, state, and local Laws applicable to the activities of the Company and its Subsidiaries with respect to foods, dietary supplements, cosmetics, drugs, medical devices, controlled substances, and other products or practices regulated by FDA, DEA, FTC, and USDA (subsections (i)-(v), collectively, the “Regulatory Laws”).
(b) The Company and all of its Subsidiaries hold all Permits necessary for the Company and its Subsidiaries to own, lease and operate their properties and assets, and to carry on and operate their businesses as currently conducted in material compliance with applicable requirements under Regulatory Laws (collectively, the “Regulatory Permits”).
(c) All Regulatory Permits are valid and valid, in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencyunencumbered.
(d) All pre-clinical Neither the Company nor any of its Subsidiaries have written notice of, and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and to the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 Knowledge of the Code of Federal Regulations and (ii) any applicable federalCompany, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and no circumstances exist that would not reasonably be expected to have a Parent Material Adverse Effectresult in, the actual or threatened withdrawal, revocation, suspension, encumbrance, or failure to renew any Regulatory Permit.
(e) Since January 1, 2012, neither Parent nor any To the Knowledge of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the developmentCompany, marketingall applications, labelingnotifications, salesubmissions, use handling information, claims, reports, and controldata submitted to FDA, safetyDEA, efficacy, reliabilityUSDA, or manufacturing other Governmental Authorities, were true, complete and correct in all material respects as of drugs which would reasonably be expected to lead to the denialdate of submission, limitationexcept as revised by any necessary or required material updates, revocationchanges, corrections or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencymodifications.
(f) Since January 1, 20122023, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to (i) neither the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Company nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field correctionsalert, field correction, product correction, product removal, public notification, market withdrawal withdrawal, suspension, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to for an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parentcompliance, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding reason (icollectively, “Recall”) relating to any product manufactured or labeled by or on behalf of the recall, market withdrawal Company or replacement any of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent its Subsidiaries, taken as a whole); and, (ii) a material change in no products manufactured or labeled by or on behalf of the marketing classification Company or a material change in any of its Subsidiaries have been adulterated or misbranded or subject to any Recall, detention, import alert or detention, seizure, injunction, or similar action.
(g) Since January 1, 2023, neither the labeling Company nor any of its Subsidiaries have received written notice of, and to the Knowledge of the Company, no circumstances exist that would reasonably be expected to result in, any such Parent Products(i) FDA Form 483, (ii) warning letter, (iii) a termination untitled letter, (iv) it has come to our attention (IHCTOA) letter, (v) civil or suspension of the manufacturingcriminal penalties, marketing(vi) injunction, (vii) seizure, (viii) requests or requirements from FDA, FTC, DEA, USDA, or distribution any other federal, national, state, or local Governmental Authority to modify any products, manufacturing processes, or procedures pursuant to any Regulatory Laws, (ix) letter of such Parent Productsadmonition, (x) notice of inspection findings, including a notice of noncompliance, (xi) order to show cause, (xii) immediate suspension order, (xiii) suspension, revocation, withdrawal, modification, or limitation of Permits or inspections, or (ivxiv) a material negative change other similar written correspondence or written notice from FDA, FTC, DEA, USDA, or any other Governmental Authority alleging or asserting noncompliance with any applicable Regulatory Laws or with the terms or requirements of any Regulatory Permits.
(h) There is no civil, criminal or administrative legal proceeding or request for information that is pending or threatened in reimbursement status writing (or, to the Knowledge of a Parent Productthe Company, orally) against the Company or any of its Subsidiaries or, to the Knowledge of the Company, any person engaged by the Company or its Subsidiaries to manufacture, supply materials for, label, or distribute its products (with respect to its business or its products), under any applicable Regulatory Laws.
(i) Except as Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any of their respective officers, directors, employees, or agents have committed any act, made any statement or failed to make any statement that would not reasonably be expected to have provide a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person basis for FDA or any other data protected under applicable LawGovernmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” 56 Fed. Parent Reg. 46191 (Sept. 10, 1991), or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103other similar Laws.
(j) Notwithstanding anything contained Neither the Company nor, to the Knowledge of the Company, any of its officers, directors, employees, or agents, have been subject to a consent decree, individual integrity agreement, deferred prosecution agreement, or other similar form of agreement with any Governmental Authority or convicted of any crime that has resulted, or would reasonably be expected to result, in this Section 4.13debarment under 21 U.S.C. § 335a or any other similar Laws and there are no claims, no representation actions, proceedings or warranty shall investigations that would reasonably be deemed expected to be made result in this Section 4.13 in respect such debarment are pending or, to the Knowledge of environmentalthe Company, Taxthreatened against the Company, employee benefits its Subsidiaries, or labor Law mattersany of their respective officers, directors, employees, or agents.
Appears in 2 contracts
Sources: Merger Agreement (SpartanNash Co), Merger Agreement (SpartanNash Co)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each of Parent the Company and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act, as amended (the “PHSA”), and the regulations of the FDA United States Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Company Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Company Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any the Company and each of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); (ii) all such Parent Company Regulatory Permits are valid and in full force and effect; and (iii) Parent is the Company and its Subsidiaries are in compliance with the terms of all Parent Company Regulatory Permits.
(b) Except as would not, individually or . All Company Regulatory Permits are in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent full force and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawseffect, except where such noncompliance or liability the failure to be in full force and effect has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(cb) Except as would not, individually or in Neither the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Company nor any of its Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(dc) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Company Product candidate conducted or sponsored by each the Company or any of Parent and the Parent its Subsidiaries are being and, since January 1, 2017 have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations Regulations, and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(ed) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, during the period beginning on January 1, 20122017 and ending on the date hereof, neither Parent the Company nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs the Company Products which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(fe) Since During the period beginning on January 1, 20122017 and ending on the date hereof, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent the Company and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 20122017, neither Parent the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent the Company or any of the Parent its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Company Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect. Neither Parent Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2017, (i) neither the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Company Products or Parent Company Product candidates are sold or intended by the Parent Company to be sold. Since January 1, 2011, ; and (ii) neither Parent the Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent the Company or any of the Parent its Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Applicable Law or program.
(gf) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, as to each Parent Company Product or Parent Company Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Company Product candidates are sold or intended by the Company or any of its Subsidiaries to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent the Company or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Company Product or Parent Company Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Company Product or Parent Company Product candidate by Parent the Company or any of the Parent its Subsidiaries of any Applicable Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect.
(hg) Except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, since during the period beginning on January 1, 20122017 and ending on the date hereof, neither Parent the Company nor any of the Parent its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Company Product. To the knowledge of Parentthe Company, there are no facts as of the date hereof which are reasonably likely to cause, and Parent neither the Company nor any of its Subsidiaries has not received any written notice from the FDA or any other Parent Company Regulatory Agency regarding during the period beginning on January 1, 2017 and ending on the date hereof regarding, (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent the Company or a Parent Subsidiary its Subsidiaries (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Company and its Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Company Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Company Products, or (iv) a material negative change in reimbursement status of a Parent Company Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Celgene Corp /De/), Merger Agreement (Bristol Myers Squibb Co)
Regulatory Matters. The Business Combination is subject to the requirements of the HSR Act, which prevents Novus and Energy Vault from completing the Business Combination until required information and materials are furnished to the Antitrust Division of the Department of Justice (a“DOJ”) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds Federal Trade Commission (x“FTC”) all permitsand specified waiting period requirements have been satisfied. For more information, licenses, franchises, approvals, clearances, registrations, and authorizations under see the FDCA, section titled “The Business Combination — Regulatory Approvals Required for the PHSA, Business Combination.” The Business Combination Agreement is subject to termination prior to the regulations Effective Time of the FDA promulgated thereunderBusiness Combination as follows: • by the mutual written consent of Novus and Energy Vault; • by Novus or Energy Vault, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including if (i) the FDCA; (ii) Effective Time will not have occurred prior to the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any date that is 180 days after the date of the foregoing applicable in jurisdictions in which material quantities of any of Business Combination Agreement (the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold“Outside Date”); (vi) all applicable foreignprovided, federalhowever, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding that the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated Business Combination Agreement may not be terminated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed this provision by or on behalf of Parent any party that either directly or indirectly through its affiliates is in breach or violation of any representation, warranty, covenant, agreement or obligation contained in the Business Combination Agreement and such breach or violation is the principal cause of the Parent Subsidiariesfailure of a condition to the Merger on or prior to the Outside Date, except as would notand, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate event that any law is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to enacted after the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any execution of the Parent Subsidiaries Business Combination Agreement extending the applicable waiting period under the HSR Act, the Outside Date will be automatically extended by the length of any Law, except as would not, individually such extension; or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change any governmental authority in the marketing classification United States has enacted, issued, promulgated, enforced or a material change in entered any injunction, order, decree or ruling (whether temporary, preliminary or permanent) which has become final and non-appealable and has the labeling effect of any such Parent Products, (iii) a termination or suspension making consummation of the manufacturingBusiness Combination transactions, marketingincluding the Merger, illegal or distribution of such Parent Products, otherwise preventing or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any prohibiting consummation of the Parent Subsidiaries has experienced any security breach or other incident resulting in Business Combination transactions, including the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.Merger; or
Appears in 2 contracts
Sources: Business Combination Agreement, Business Combination Agreement
Regulatory Matters. (a) Except as has not had All approved ANDAs and would not reasonably be expected NDAs relating to havethe Products and each such approved ANDA and NDA is valid, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid effective and in full force and effect; effect and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary there are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance byno proceedings pending, or liability to the knowledge of Parent or the Parent Subsidiaries underSeller, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs threatened which would reasonably be expected to lead to result in the denial, limitation, revocation, cancellation or rescission suspension thereof. None of the approved ANDAs or NDAs for the Products requires any Parent Regulatory Permits or further approval of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Government Agency for the purpose for which they currently are being manufactured or sold by or on behalf of Seller. This Section 5.1(g)(a) does not apply to the deregistration and related activities commenced in the United Kingdom.
(b) The Products now being distributed meet the requirements of applicable Regulatory Agency by Parent Authority laws and regulations. With respect to the Parent Subsidiaries Products, Seller has made available to Purchaser copies of (i) all material regulatory filings and Product Approvals, including applications for Product Approvals, and (ii) all serious adverse event reports and periodic adverse event reports that have been so filedfiled with the FDA since January 1, maintained 2005, including any material correspondence or furnishedother material documents. Seller shall maintain and file with the FDA any customer complaints that are directed to the Seller for any Product sold prior to the Closing Date.
(c) All regulatory materials submitted or filed by Seller with the FDA was, except where failure to fileat the time of submission or filing, maintain or furnish such reportstrue, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on respects, and no serious adverse event information has come to the date attention of Seller or its Affiliates that is materially different with respect to the incidence, severity or nature of such serious adverse events than the information that was filed as safety updates to any such regulatory submissions.
(or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent d) Neither Seller nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or nor any of the Parent Subsidiariesits or their respective officers, employees, or agents has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agencywith respect to the development of Products, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agencywith respect to the development of the Products, or committed an act, made a statement, or failed to make a statement, in each such case, related statement with respect to the business development of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would Products that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or and any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programamendments thereto.
(ge) As There are no known or pending, actions with respect to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recallwithdrawals, field corrections, market withdrawal actions or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Asset Sale and Purchase Agreement, Asset Sale and Purchase Agreement (Akorn Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a Parent Material Adverse Effectwhole, (i) to the knowledge of the Company, each of Parent the Company and the Parent Subsidiaries holds its subsidiaries (xor their respective agents) has all licenses, permits, licenses, franchises, approvals, clearancesvariances, registrations, exemptions, orders and authorizations under the FDCAother governmental authorizations, the PHSAconsents, the regulations of the FDA promulgated thereunder, data protection laws approvals and (y) all permits, licenses, franchises, approvals, clearances, registrationsand has submitted notices to, certificates and authorizations of any applicable all Governmental Entity or Notified Body Authorities that are concerned with the quality, identity, strength, purity, safety, efficacy, labelinguse, manufacturing, marketingadvertising, promotion, distribution, sale, pricing, import or export distribution and sale of the Parent Company Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Company Regulatory Agency”), including, but not limited to, all authorizations and registrations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, the Federal Controlled Substances Act of 1970 and the regulations of the U.S. Drug Enforcement Administration (the “DEA”) promulgated thereunder and all state controlled substance Laws and regulations, in each case to the extent necessary for the lawful operating of the businesses of Parent Company or any of the Parent Subsidiaries such subsidiary to own, lease and operate its properties or other assets and to carry on and operate its respective businesses as currently conducted or as planned to be conducted (the “Parent Regulatory Company Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) . Except as would not, individually or in the aggregate, reasonably be expected to have be materially adverse to the Company and its subsidiaries, taken as a Parent Material Adverse Effectwhole, all such Company Permits are valid and in full force and effect. Since January 1, 2012, there has occurred no violation by the Company or its subsidiaries of, default (with or without notice or lapse of time or both) by the Company or its subsidiaries under, or, to the knowledge of the Company, event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. Except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, the businesses of Company and each of Parent its subsidiaries are in compliance with the terms of all Company Permits and each Parent Subsidiary the consummation of the Merger, in and of itself, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit.
(b) Since January 1, 2012, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, all of the Company Products that are subject to the jurisdiction of the FDA, DEA or any other Company Regulatory Agency are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, advertised, promoted, detailed and distributed by or, to the knowledge of the Company, on behalf of the Company or its subsidiaries in compliance with all applicable requirements under any Company Permit or Laws administered or enforced by the FDA, DEA or other Company Regulatory Agency, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new Company Product.
(c) Since January 1, 2012, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries have been, and if still pending are being, conducted in compliance with all applicable Laws, including including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, except for such noncompliance as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. Since January 1, 2012, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole, no clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Company Regulatory Agency, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any ongoing clinical investigation conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries.
(id) Since January 1, 2012 through the FDCA; (ii) date hereof, neither the PHSA; (iii) federal Medicare and Medicaid statutes and related state Company nor any of its subsidiaries has received any FDA “warning letters” with respect to the Company Products or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable Company’s manufacturing or distribution processes or procedures.
(e) As of the date hereof, none of the Company or any of its subsidiaries, nor to the knowledge of the Company any contract manufacturer with respect to the Company Products, is subject to an unresolved Company Regulatory Agency shutdown or import or export prohibition, FDA Form 483 or other Company Regulatory Agency written notice of material inspectional observations, “warning letters,” “untitled letters” or written requests to make material changes, in jurisdictions in which material quantities of each case as it applies to the Company Products or any of the Parent Company’s manufacturing or distribution processes or procedures, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole.
(f) The current manufacturing operations conducted by or, to the knowledge of the Company, on behalf of the Company or any of its subsidiaries is conducted in compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 and 820 for Company Products sold in the United States, and the respective counterparts thereof promulgated by Company Regulatory Agencies in countries outside the United States, except where the failure to so comply would not, individually or Parent in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. As of the date hereof, there are no pending or, to the knowledge of the Company, threatened actions or proceedings by the FDA, DEA or any applicable foreign equivalent which would reasonably be expected to prohibit or materially impede the sale of any Company Product candidates currently manufactured and/or sold by the Company or any of its subsidiaries into any market except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole.
(g) Since January 1, 2012, to the knowledge of the Company, neither the Company, nor any of its subsidiaries, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any applicable Laws, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. Since January 1, 2012, none of the Company, its subsidiaries or, to the knowledge of the Company, any of their respective officers or key employees has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. Section 335a or any similar applicable Law except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. As of the date hereof, no Actions against the Company, its subsidiaries, or, to the knowledge of the Company, any of their respective officers or key employees that would reasonably be expected to result in such a material debarment are manufactured pending, and as of the date hereof the Company has not received written notice that any such Actions are threatened except as would not, individually or sold; in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole.
(vh) federalTo the knowledge of the Company, state each of the Company and its subsidiaries, and each of their respective directors, officers, employees and authorized agents (while acting in such capacity) is, and since January 1, 2012 has been, in compliance with all Health Care Laws applicable to the Company or provincial criminal or civil healthcare Laws (including any of its subsidiaries, including, to the extent applicable, the federal Anti-Kickback kickback Statute (42 U.S.C. §1320a-7(b§ 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. §§ 1320a-7b(a)), Physician Payment Sunshine the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h1320d et seq.), the exclusion laws Laws (42 U.S.C. § 1320a-7), the civil monetary penalties law Food Drug and Cosmetic Act (42 21 U.S.C. §§ 1320a-7a301 et seq.), all criminal laws relating to health care fraud and abusethe Controlled Substances Act (21 U.S.C. §§ 801 et seq), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any Medicare Program (Title XVIII of the Parent Products or Parent Product candidates are manufactures or soldSocial Security Act); , the Medicaid Program (vi) all applicable foreignTitle XIX of the Social Security Act), federalthe regulations promulgated pursuant to such Laws, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing requirements of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any ), state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules programs and regulations promulgated pursuant to all under such applicable Laws, each as amended from time to time Laws (collectively, “Parent Healthcare and Data Protection Health Care Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as for non-compliance that would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead materially adverse to the denialCompany and its subsidiaries, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, taken as a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing)whole. Since January 1, 2012, neither Parent nor any of 2012 through the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiariesdate hereof, except as would not, individually or in the aggregate, reasonably be expected to have be materially adverse to the Company and its subsidiaries, taken as a Parent Material Adverse Effectwhole, each such Parent Product none of the Company or Parent Product candidate is being any of its subsidiaries has received any written notification, written correspondence or has been developedany other written communication from any Governmental Authority, manufacturedincluding, storedwithout limitation, distributed the FDA, the DEA, the Centers for Medicare and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingMedicaid Services, and security. There the Department of Health and Human Services Office of Inspector General, specifically alleging non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws.
(i) As of the date hereof, none of the Company or any of its subsidiaries is no action a party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recallother similar written agreements, in each case alleging case, entered into with or imposed by any violation applicable to Company Regulatory Agency, other than any Parent Product such agreement, decree or Parent Product candidate by Parent order that has been previously disclosed in any filing with a Company Regulatory Agency.
(j) As of the date hereof, neither the Company nor any of its subsidiaries has received any written notice from the FDA, DEA or any of other Governmental Authority that it has commenced, or threatened to initiate, any action to withdraw approval, place sales, pricing or marketing restrictions on or request the Parent Subsidiaries recall of any LawCompany Product, or that it has commenced, or threatened to initiate, any action to enjoin or place restrictions on the production of any Company Products except as would not, individually or in the aggregate, reasonably be expected to have be materially adverse to the Company and its subsidiaries, taken as a Parent Material Adverse Effectwhole.
(hk) Except As to the Company Products for which a biological license application, new drug application, abbreviated new drug application, investigational new drug application, 510(k) clearance, premarket approval application, investigational device exemption, or similar state or foreign regulatory application has been approved, the Company and its subsidiaries are in compliance with 21 U.S.C. §§ 355, 360, 360e, Section 351 of the PHSA or 21 C.F.R. Parts 312, 314, 600, 601, 812 or 814 et seq., respectively, and all applicable similar state and foreign regulatory requirements of any Governmental Authority, and all terms and conditions of such licenses or applications, except for any such failure or failures to be in compliance that would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Company and its subsidiaries, taken as a whole. As to each drug for which the Company has sales, the Company and any relevant subsidiary of the Company, and the officers, employees or agents of the Company and any subsidiary of the Company, have included in the application for such drug, where required, the certification described in 21 U.S.C. § 335a(k)(1) and the list described in 21 U.S.C. § 335a(k)(2) and each such certification and list was true and complete when made except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of be materially adverse to the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, Company and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiariesits subsidiaries, taken as a whole). In addition, (ii) a material change the Company and each of its subsidiaries is in compliance with all applicable registration and listing requirements set forth in 21 U.S.C. § 360 and 21 C.F.R. Parts 207 and 807, except for failures to so comply that have not had, and would not, individually or in the marketing classification or a material change in the labeling of any such Parent Productsaggregate, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have be materially adverse to the Company and its subsidiaries, taken as a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103whole.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Hospira Inc), Merger Agreement (Pfizer Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each the Company and its Subsidiaries have obtained all Permits (including, for the avoidance of Parent and the Parent Subsidiaries holds (x) doubt, all permits, licenses, franchises, approvals, clearances, establishment registrations, device listings and authorizations under 510(k) clearances (or their foreign equivalents)) required by any Health Authority to permit the FDCA, the PHSA, the regulations conduct of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the their respective businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); conducted, (ii) all of such Parent Regulatory Permits are valid and in full force and effect; and , (iii) Parent the Company is in compliance with with, and is not in default under, each such Permit and (iv) none of such Permits shall be terminated or impaired or become terminable, in whole or in part, as a result of the terms of all Parent Regulatory Permitstransactions contemplated by this Agreement or the other Transaction Documents.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20122011, neither Parent nor none of the Company, any of the Parent its Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, noror, to the knowledge of Parentthe Company, any officerof their respective directors, employeeofficers, agent employees or distributor of Parent or any of Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Parent Company and its Subsidiaries, has ) have (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyHealth Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyHealth Authority, or (iii) committed an any other act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its the policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Fraud Policy”) or for the FDA or any other Parent Regulatory Agency Health Authority to invoke any a similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably policy that may be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, applicable to the knowledge of Parent, any officer, employee, agent or distributor of Parent Company or any of its Subsidiaries in another jurisdiction. None of the Parent SubsidiariesCompany, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending its Subsidiaries or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Parent Subsidiaries Company and its Subsidiaries) are the subject of any Lawpending or, except as would notto the Company’s knowledge, individually threatened investigation by the FDA under the FDA Fraud Policy, or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectsubject of any similar investigation by any other Health Authority.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ic) Except as would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect, neither Parent nor since January 1, 2011, the Company and each of its Subsidiaries and, to the knowledge of the Company, each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries), has been in compliance in all material respects with all Health Laws, including those relating to laboratory developed tests. None of the Company, any of its Subsidiaries or, to the Parent Subsidiaries has experienced knowledge of the Company, any security breach Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries) (i) have received any written notice or other incident resulting in written communication from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any failure to maintain systems and programs adequate to ensure compliance with any such Health Laws, or contesting the unauthorized accesspremarket clearance or approval of, use the uses of or disclosure the labeling and promotion of data or information that is linked any product subject to any reasonably identifiable person Health Law, or (ii) are subject to any enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(d) The Company and its Subsidiaries have filed with the applicable Health Authority all required and material Filings, including adverse event reports. All such Filings were in material compliance with Applicable Law when filed, and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any such Filings.
(e) None of the Company or any of its Subsidiaries, any of their respective officers, directors or managing employees (as such terms are defined in 42 C.F.R. § 1001.1001) or, to the knowledge of the Company, any other data protected under applicable Law. Parent Company Service Provider or Merger Sub is not a business associate, agent (as that such term is defined in the HIPAA regulations at 45 42 C.F.R. § 160.1031001.1001) of the Company or any of its Subsidiaries has been disqualified, debarred or deregistered by any Governmental Authority.
(jf) Notwithstanding anything contained in this Section 4.13As of the date hereof, no representation neither the Company nor any of its Subsidiaries have received any written coverage or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits reimbursement decision from any commercial third-party payor or labor Law mattersgovernment payor.
Appears in 2 contracts
Sources: Transaction Agreement, Transaction Agreement (Foundation Medicine, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each of Parent the Company and the Parent its Subsidiaries holds or is in the process of acquiring (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the U.S. Food, Drug, and Cosmetic Act of 1938 (the “FDCA”), and the PHSA, the applicable regulations of the FDA U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws (B) all authorizations under the U.S. Federal Insecticide, Fungicide and Rodenticide Act of 1910 (the “FIFRA”), the U.S. Food Quality Protection Act of 1996 (the “FQPA”) and the applicable regulations of the U.S. Environmental Protection Agency (the “EPA”) promulgated thereunder and (yC) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of the FDA, U.S. Department of Agriculture (“USDA”) and any other applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Company Products (any such Governmental Entity or Notified BodyEntity, a “Parent Company Regulatory Agency”) ), in each case, that is necessary for the lawful operating operation of the businesses of Parent the Company or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) . Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, all such Company Regulatory Permits are valid and in full force and effect and the Company and its Subsidiaries are in compliance with the terms of all Company Regulatory Permits.
(cb) Except as would notnot reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries is in compliance with all regulations and requirements of the FDA, USDA, EPA and other Company Regulatory Agencies, including any applicable Good Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or repackaging requirements, laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect, Parent since January 1, 2019, all Company Products have been produced, distributed, labeled, marketed and sold, and all raw materials and ingredients in such products have been procured, in compliance in all material respects with all Applicable Laws governing the Parent Subsidiaries procurement, production, distribution, labeling and sale of such products, raw materials or ingredients. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, there have not engaged in activities which arebeen no recalls, as applicablewithdrawals or suspensions with respect to any Company Products produced, cause for false claims liabilitydistributed, civil penalties labeled, marketed or mandatory or permissive exclusion from Medicare, Medicaid sold by the Company or any of its Subsidiaries. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries has received any written notice of or otherwise is aware of, any Company Regulatory Agency untitled letters, warning letters, notices of warning or withholding, suspension or withdrawal of inspection, seizure, criminal referral or other government healthcare programsimilar federal, state or private enforcement actions with respect to such Company Products. None Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries is subject (or has been subject) to any adverse inspection finding, recall, investigation, penalty assessment, audit or other compliance or enforcement action by the Parent or FDA, USDA, EPA and other Company Regulatory Agencies.
(c) Neither the Company nor any Parent Subsidiary are a of its Subsidiaries is party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Bioceres Crop Solutions Corp.), Merger Agreement (Marrone Bio Innovations Inc)
Regulatory Matters. (a) Except as All products and services of the Company or its Subsidiaries that are currently marketed or sold by or for the Company or its Subsidiaries or are currently under development or with respect to which the Company or any of its Subsidiaries has not had provided any indemnity or a warranty (collectively, the “Company Products”) have been in material compliance with all applicable Contract commitments, applicable Law, all applicable safety standards and all express and implied warranties, and no Litigations are pending (and, to the Knowledge of the Company, there is no reasonable basis for any present or future Litigation against the Company or any of its Subsidiaries giving rise to any such liability). Since January 1, 2012, neither the Company nor any of its Subsidiaries has been notified in writing of any claims for (and, to the Knowledge of the Company, there are no threatened claims for) any extraordinary product returns, warranty obligations or product services relating to any Company Products. As of the date hereof, since January 1, 2011, there have been no FDA (or similar foreign Governmental Authority) ordered Recalls, or any seizures or adverse regulatory actions taken (or, to the Knowledge of the Company, threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any Company Products are produced, processed, packaged or stored, and since January 1, 2012, the Company has not, either voluntarily or at the request of any Governmental Authority, initiated or participated in any Recalls of any Company Product. There are no facts, circumstances or conditions that would not reasonably be expected to haveform the basis for an enforcement action by the FDA or other Governmental Authority with respect to any action to withdraw or delay approval of, individually place restrictions on the production, clinical use or in testing or sales or marketing of, or request the aggregateRecall of, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations any product of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permitsthat would have a Company Material Adverse Effect if successful.
(b) Except as would notWithout limiting Section 3.13(a) or other provisions of this Section 3.13, individually each of the Company and its Subsidiaries is, and since January 1, 2012, has been, in compliance in all material respects with all health care Laws applicable to the Company and its Subsidiaries, or in by which any property, product or other asset of the aggregateCompany and its Subsidiaries is bound or affected, reasonably be expected to have a Parent Material Adverse Effectincluding, but not limited to, the businesses of each of Parent Federal Food, Drug and each Parent Subsidiary are being conducted in compliance with all applicable LawsCosmetic Act (21 U.S.C. §§ 301 et seq.), including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback kickback Statute (42 U.S.C. §1320a-7(b§ 1320a-7b(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-71320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil monetary penalties law penalty laws (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”), all criminal laws Laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under HIPAA, the exclusion laws, Social Security Act § 1128 (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the Patient Protection and Affordable Care Act of 2010, as amended by the HITECH ActHealth Care and Education Affordability Reconciliation Act of 2010, and in each case the regulations promulgated thereunder, all other Laws relating to the development, billing, labeling, storage, testing, distribution or marketing of pharmaceutical products, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities and foreign equivalents of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time foregoing (collectively, “Parent Healthcare and Data Protection Health Care Laws”). Neither the Company nor any Subsidiary of the Company has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation or arbitration from any Governmental Authority alleging potential or actual material non-compliance by, or material liability of, the Company or any Subsidiary of the Company under any Health Care Laws.
(c) Each of the Company and its Subsidiaries holds all Permits from the FDA and any similar foreign Governmental Authorities required for the conduct of its business as currently conducted (collectively, the “Regulatory Permits”) and all such Regulatory Permits are valid and in full force and effect. Each of the Company and its Subsidiaries has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory Permit. Each of the Company and its Subsidiaries has filed with the FDA and any similar foreign Governmental Authorities all material reports, documents, forms, notices, applications, records, claims, submissions, and supplements or amendments thereto, including adverse event reports and all other submitted data relating to the Company’s and its Subsidiaries’ products, as required by any Health Care Law or Regulatory Permit, and all such reports, documents, forms, notices, applications, records, claims, submissions, and supplements or amendments were in all material respects complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), and no written notice (or, to the Knowledge of the Company, any oral notice) of deficiencies which are material, individually or in the aggregate, has been issued or asserted by any applicable Governmental Authority with respect to any such reports, documents, forms, notices, applications, records, claims, submissions, or any supplements or amendments thereto.
(d) The Company and its Subsidiaries and their contract manufacturers are, and since January 1, 2012 have been, in material compliance with, and each Company Product regulated as a medical device or drug in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced and processed in material compliance with, a recognized quality management system, including the Quality System Regulation set forth in 21 C.F.R. Part 820, the current Good Manufacturing Practice (GMP) regulation set forth in 21 C.F.R. Part 211, as applicable, and the provisions of any similar non-U.S. requirements, such as the EU Medical Device Directives, the EU Drug Directives and ISO 13485 and ISO 9000 series, as applicable.
(e) The Company and its Subsidiaries have obtained and currently hold in good standing all material approvals, registrations and authorizations from, and have maintained or procured all records, studies and other documentation needed to reasonably satisfy and demonstrate compliance with the requirements of, the FDA (and any similar foreign Governmental Authority) for the conduct of their business activities relating to the Company Products and for the sale and/or provision of the Company Products (as applicable).
(f) Neither the Company nor any of its Subsidiaries has made any material false statement in, or material omission from, the applications, approvals, reports or other submissions to the FDA or to any similar foreign Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of the FDA or any similar foreign Governmental Authority; provided that no representation or warranty is made by the Company herein to the extent that any such statement or omission was made by or in reliance on data or information provided by any third Person, including any contractor, investigator or researcher, engaged or retained by, or otherwise acting on behalf of, the Company or any of its Subsidiaries (any such Person, a “Section 3.13 Third Person”).
(g) To the Knowledge of the Company, no Section 3.13 Third Person has made any material false statement in, or material omission from, any report, study or other documentation prepared in conjunction with the applications, approvals, reports or records submitted to or prepared for the FDA or any similar foreign Governmental Authority.
(h) Neither the Company nor any of its Subsidiaries has received any written notice of any investigation by any Governmental Authority in respect of the promotion of “off-label” or similar use of the Company Products and there is no pending or, to the Knowledge of the Company, threatened Litigation by any Governmental Authority with respect to the promotion of “off-label” or similar use of such products. To the Knowledge of the Company, no facts or circumstances exist that could reasonably support a material claim that the Company or any of its Subsidiaries has engaged in promotional activities that are in violation of any Law concerning “off-label” promotional activities, including any Health Care Law.
(i) Notwithstanding anything in this Agreement to the contrary, this Section 3.13 contains the sole and exclusive representations and warranties of the Company in any way relating to any FDA- or any similar foreign Governmental Authority-related safety, compliance or health matter, including compliance with Health Care Laws.
(j) To the Knowledge of the Company, the Company and its Subsidiaries have not used in any capacity the services of any individual or entity debarred or excluded, or which has engaged in any conduct that has resulted or would reasonably be expected to result in debarment or exclusion, under 21 U.S.C. § 335a(a), 42 U.S.C. § 1320a-7 or any equivalent or similar Laws.
(k) The clinical and pre-clinical studies conducted by or on behalf of or sponsored by the Company or a Subsidiary of the Company were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable Health Care Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act, its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and any foreign equivalents. Since January 1, 2012, neither Parent the Company nor any Subsidiary of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries Company has received any written notice or other correspondence from the FDA or any similar foreign Governmental Authority requiring the EMA termination, suspension or material modification of any ongoing clinical or pre-clinical study. There are no pending or, to the Knowledge of the Company, threatened actions or proceedings by the FDA or any similar foreign agency Governmental Authority which would prohibit or impede the potential future commercial sale of any of the Company’s or its Subsidiaries’ products. To the Knowledge of the Company, there are no contracts, including settlements with jurisdiction over the developmentGovernmental Authorities, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead impose obligations for independent review and oversight of marketing and sales practices or limit in any material respect the ability of the Company or any of its Subsidiaries to develop, manufacture, market or sell any of the denial, limitation, revocation, Company’s or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyits Subsidiaries’ products.
(fl) Since January 1The Company has made available to Purchaser prior to the date hereof true, 2012, correct and complete copies of (i) all reports, documents, claims, permits and notices required to be filed, maintained material filings made by the Company or furnished to any of its Subsidiaries with the FDA or any other Parent Regulatory Agency by Parent similar foreign Governmental Authority in its possession or control and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in (ii) all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to correspondence with the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA similar foreign Governmental Authority in its possession or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recallcontrol, in each case alleging any violation applicable with regard to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse EffectCompany’s and its Subsidiaries’ products.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Stock Purchase Agreement, Stock Purchase Agreement (Mallinckrodt PLC)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Utah Material Adverse EffectEffect and except with respect to Permits required under applicable Environmental Laws (which are addressed exclusively in Section 7.20), (i) each of Parent Utah and the Parent Utah Subsidiaries holds have obtained all of the Permits necessary under applicable Laws for Utah and the Utah Subsidiaries to own, lease and operate their assets in the manner in which they are now owned, leased and operated and to conduct their businesses as now conducted, including (xA) all permits, licenses, franchises, approvals, clearances, registrations, authorizations and authorizations approvals under the FDCAFDCA (including Sections 505, 510(k) and 515 thereof), the PHSA, PHSA and the regulations of the FDA promulgated thereunder, data protection laws thereunder and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labelingtesting, manufacturing, marketing, promotion, distribution, sale, storage, pricing, import or export of the Parent Utah Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Utah Regulatory Agency”) ), in each case necessary for the lawful operating operation of the businesses of Parent or any of the Parent Utah and its Subsidiaries as currently conducted or as planned to be conducted in each jurisdiction in which such Person operates (the “Parent Utah Regulatory Permits”); (ii) all such Parent Utah Regulatory Permits are valid and in full force and effect; and (iii) Parent Utah is in compliance with the terms of all Parent Utah Regulatory Permits.
(b) Except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Utah Material Adverse Effect, the businesses of each of Parent Utah and each Parent Utah Subsidiary are being conducted in compliance with with, and such Persons have appropriate internal controls that are reasonably designed to ensure compliance with, all applicable Laws, including (i) the FDCAFDCA (including all applicable registration and listing requirements set forth in Sections 505 and 510 of the FDCA and 21 C.F.R. Parts 207 and 807); (ii) the PHSA; (iii) the Prescription Drug Marketing Act, as amended; (iv) federal Medicare and Medicaid statutes and related state or local statutes; (ivv) the Patient Protection and Affordable Care Act, as amended (including the Biologics Price Competition and Innovation Act); (vi) the Veterans Health Care Act; (vii) the Physician Payments Sunshine Act; (viii) the Federal Trade Commission Act, as applicable; (ix) provincial formulary and drug pricing statutes; (x) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or soldforegoing; (vxi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute Statute, as amended (42 U.S.C. § 1320a-7(b)), ▇▇▇▇▇ Law (42 U.S.C. §1320a-7(b)1395nn), False Claims Act Act, as amended (42 U.S.C. §§ 1320a-7b(a)), Physician Payment Sunshine Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, state prescription drug marketing laws, and any comparable federal, state, provincial or local healthcare Laws; (xii) state or provincial licensing, disclosure and reporting requirements; (xiii) Laws with respect to the protection of personally identifiable information collected or maintained by or on behalf of Utah or the Utah Subsidiaries; (xiv) all applicable Laws analogous to the foregoing in the United States or in states and all other jurisdictions in which material quantities of Utah or any of the Parent Products Utah Subsidiary operates or Parent sells or distributes a Utah Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsUtah Product candidate; and (viixv) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Utah Healthcare and Data Protection Laws”). Since January 1, 20122017, neither Parent Utah nor any of the Parent Subsidiaries Utah Subsidiary has received any written notification or communication from any Parent Utah Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human ServicesServices or any other “notified body” or corresponding Governmental Authority in any jurisdiction, of noncompliance by, or liability of Parent Utah or the Parent any Utah Subsidiaries under, any Parent Utah Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Utah Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or Neither Utah nor any other government healthcare program. None of the Parent or any Parent Subsidiary are a party Utah Subsidiaries is subject to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, agreements or consent decrees, settlement orders, or similar agreements decrees with or imposed by any Parent Utah Regulatory AgencyAgency and, to the knowledge of Utah, (i) the imposition of any such agreement or decree is not currently pending and (ii) no Utah Entity has received written notice that the imposition of any such agreement or decree is currently contemplated or proposed.
(d) All Except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect, all pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent Utah and the Parent Utah Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesUtah Healthcare Laws, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the designCode of Federal Regulations, conduct(ii) FDA standards for good clinical practice requirements (GCPs) and clinical study submissions, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained including as set forth in Title 21 parts 50, 54, 56, 312, 314 314, 320, 812 and 320 814 of the Code of Federal Regulations Regulations, (iii) 42 U.S.C. 282(j), (iv) any comparable foreign Laws for any of the foregoing or other Laws regulating the conduct of pre-clinical and clinical investigations and (iiv) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except. Except, in each case, for such noncompliance thatmatters that would not reasonably be expected to have, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Utah Material Adverse Effect, since January 1, 2017: (i) no clinical trial conducted by or on behalf of Utah or any Utah Subsidiary has been terminated, materially delayed or suspended prior to completion; and (ii) neither the FDA nor any other applicable Governmental Authority or institutional review board that has or has had jurisdiction over a clinical trial conducted by or on behalf of Utah or any Utah Subsidiary has commenced, or, to the knowledge of Utah, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Utah or any Utah Subsidiary.
(e) Since January 1, 20122017, neither Parent Utah nor any of the Parent Subsidiaries Utah Subsidiary has received any written notice from the FDA (including any inspection reports on Form 483, FDA warning letters or FDA untitled letters) or the EMA or any foreign agency other Utah Regulatory Agency with jurisdiction over the development, marketing, labelinglabelling, sale, use use, handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, suspension or rescission of any Parent Regulatory Permits or revocation of any application or grant for marketing approval already granted or clearance with respect to any Utah Product currently pending before or previously approved or cleared by the FDA FDA, the EMA or such other Parent Utah Regulatory Agency, except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect.
(f) Since January 1, 20122017, all reports, documents, claims, permits permits, adverse event reports, notices and notices biological license, device or drug applications required to be filed, maintained or furnished to the FDA or any other Parent Utah Regulatory Agency by Parent Utah and the Parent Utah Subsidiaries have been so filed, maintained or furnishedfurnished in a timely manner, except where failure to file, maintain or furnish such reports, documents, claims, permits permits, notices or notices applications would not reasonably be expected to have, individually or in the aggregate, a Parent Utah Material Adverse Effect. All such reports, documents, claims, permits permits, notices and notices applications were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Neither Utah nor any of the Parent SubsidiariesUtah Subsidiary, nor, to the knowledge of ParentUtah, any officer, employee, agent or distributor of Parent Utah or any of the Parent SubsidiariesUtah Subsidiary, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Utah Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Utah Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Utah and its Subsidiaries, that, at the time of such disclosure was madedisclosure, act or failure, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Utah Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. .
(g) Neither Parent Utah nor any of the Parent SubsidiariesUtah Subsidiary, nor, to the knowledge of ParentUtah, any officer, employee, agent or distributor of Parent Utah or any of the Parent SubsidiariesUtah Subsidiary, has been (i) disqualified, suspended or debarred for any purpose, or received written notice of action or threat of action with respect to debarment under the provisions of 21 U.S.C. § 335a or any equivalent provisions in any other jurisdiction; (ii) excluded under 42 U.S.C. Section 1320a-7 or otherwise from participation in the Medicare program, any state Medicaid program or any other federal healthcare program; or (iii) formally charged with or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable Law, except in other jurisdictions each case as would not reasonably be expected to have, individually or in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldaggregate, a Utah Material Adverse Effect. Since January 1, 2011, neither Parent Neither Utah nor any of the Parent SubsidiariesUtah Subsidiary, nor, to the knowledge of ParentUtah, any officer, employee, agent or distributor of Parent Utah or any of the Parent SubsidiariesUtah Subsidiary, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gh) As to each Parent Utah Product or Parent Utah Product candidate subject to the FDCA and FDCA, the PHSA, the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Utah or any of the Parent Utah Subsidiaries, except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Utah Material Adverse Effect, each such Parent Utah Product or Parent Utah Product candidate is being or has been developed, manufactured, storedtested, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelinglabelling, advertising, storing, promotion, import/export, distribution, provision of samples (PDMA), record keeping, reporting, reporting and security. There is no investigation, action or proceeding pending or, to the knowledge of ParentUtah, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation of any Law applicable to any Parent Utah Product or Parent Utah Product candidate by Parent Utah or any of the Parent Subsidiaries of any LawUtah Subsidiaries, except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Utah Material Adverse Effect.
(hi) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122017, neither Parent nor any of the Parent Subsidiaries have no Utah Entity has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, recall or any field correctionscorrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Utah Product, in each case which has not been publicly disclosed by the applicable Utah Regulatory Agency, or is currently considering initiating, conducting or issuing any recall of any Utah Product, in each case except as would not reasonably be expected to have, individually or in the aggregate, a Utah Material Adverse Effect. To the knowledge of ParentUtah, there are no facts which are would reasonably likely be expected to cause, and Parent no Utah Entity has not received since January 1, 2017 any written notice from the FDA or any other Parent Utah Regulatory Agency regarding regarding, (i) the recall, market withdrawal or replacement of any Company Utah Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent Utah or the Parent Utah Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling labelling of any such Parent Utah Products, (iii) a termination termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Parent Utah Products, or (iv) a material negative change in reimbursement status of a Parent Utah Product.
(i) Except as , that in each case, would not reasonably be expected to have have, individually or in the aggregate, a Parent Utah Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Business Combination Agreement (Pfizer Inc), Business Combination Agreement (Mylan N.V.)
Regulatory Matters. (a) Except Company and each of its Subsidiaries hold (i) all material approvals, authorizations, certificates and licenses issued by the State Regulators that are required for Company and each of its Subsidiaries to conduct its business as presently conducted and (ii) all other material regulatory permits, approvals, licenses and other authorizations, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to Company or any of its Subsidiaries by a Governmental Entity that are required for Company and each of its Subsidiaries to conduct its business, as presently conducted (clause (i) and (ii) collectively, the “Company Licenses”).
(b) Each Company License is valid and in full force and effect and has not had been suspended, revoked, canceled or adversely modified, except where the failure to be in full force and effect, or the suspension, revocation, cancellation or modification of which would not reasonably be expected to haveresult in, individually or in the aggregate, a Parent Company Material Adverse Effect, . No Company License is subject to (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity conditions or Notified Body requirements that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or have not been imposed generally upon licenses in the aggregatesame service, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state unless such conditions or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability requirements would not reasonably be expected to haveresult in, individually or in the aggregate, a Parent Company Material Adverse Effect, or (ii) any pending regulatory proceeding or judicial review before a Governmental Entity, unless such pending regulatory proceeding or judicial review would not reasonably be expected to result in, individually or in the aggregate, a Company Material Adverse Effect. To the Knowledge of Company, there has been no event, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such Company License is renewable by its terms), except where the failure to be renewed would not reasonably be expected to result in, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None The licensee of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted Company License is in compliance with each Company License and has fulfilled and performed all applicable Laws administered or issued of its obligations with respect thereto, including all reports, notifications and applications required by the applicable Parent Regulatory Agenciesrules, including regulations, policies, instructions and orders of the State Regulators, and the payment of all regulatory fees and contributions, except (i) FDA standards for the designexemptions, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations waivers or similar concessions or allowances and (ii) any applicable federalwhere such failure to be in compliance, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for fulfill or perform its obligations or pay such noncompliance that, individually fees or in the aggregate, has not had and contributions would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to haveresult in, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Glowpoint, Inc.), Merger Agreement (Glowpoint, Inc.)
Regulatory Matters. (a) Except as has not had All activities of the Company, the Company Subsidiary are now, and since January 1, 2020, have been, in compliance in all respects with all applicable Health Care Laws except where such non-compliance would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. Since January 1, (i) each of Parent and 2020, neither the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under Company nor the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations Company Subsidiary has received any written notice or other written communication alleging any violation of any applicable Governmental Entity Health Care Laws with respect to such activities or Notified Body that are concerned with has received any warning letters or untitled letters, except where such non-compliance would not reasonably be expected to have, individually or in the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, aggregate a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory PermitsCompany Material Adverse Effect.
(b) Except as would notTo the knowledge of the Company, individually since January 1, 2020, each Company Product is being or in has been developed, manufactured, tested, distributed or marketed by or on behalf of the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Company or the businesses of each of Parent and each Parent Company Subsidiary are being conducted in compliance with all applicable Health Care Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws requirements relating to health care fraud and abuseresearch, including but not limited to 18 U.S.C. Sections 286 and 287investigational use, development, security, manufacture, sale, packaging, labeling, storing, testing, distribution, record-keeping, reporting, import, export, marketing, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawspromotion, except where such noncompliance or liability non-compliance would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. Since January 1, 2020, neither the Company nor the Company Subsidiary has received any unresolved (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to any Company Product or any manufacturing processes or procedures related to any Company Product due to allegations of material noncompliance with applicable Laws or Company Permits, or (v) other similar written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Health Care Laws or Company Permits with respect to any Company Product.
(c) Except All animal studies or other preclinical tests performed in connection with or as would notthe basis for any Company Permit required by applicable Health Care Laws for the Company Products have been conducted in all material respects in accordance with applicable Good Laboratory Practice requirements contained in 21 CFR Part 58. Neither the Company nor the Company Subsidiary has received any written notice or, individually or in to the aggregateknowledge of the Company, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None written communication from a Governmental Entity requiring the termination or suspension or material modification of the Parent or any Parent Subsidiary are a party preclinical study with respect to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory AgencyCompany Product.
(d) All pre-Accurate and complete copies of all material reports with respect to material human clinical and clinical investigations in respect of a trials that relate to the Company Products have been provided or made available to Parent. The Company has heretofore provided or made available to Parent Product all material correspondence between the Company or Parent Product candidate conducted or sponsored by each of Parent the Company Subsidiaries, on the one hand, and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by FDA and other Governmental Entities, on the applicable Parent Regulatory Agenciesother hand, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of regarding such clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effecttrials.
(e) All clinical trials conducted by or on behalf of the Company or the Company Subsidiary have been, and are being, conducted in material compliance with the Health Care Laws. Since January 1, 20122020, neither Parent the Company nor any of the Parent Subsidiaries Company Subsidiary has received any written notice from the FDA or the EMA FDA, any institutional review board, or any domestic or foreign agency with jurisdiction over Governmental Entity that the developmentFDA, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityany Institutional Review Board, or manufacturing of drugs which would reasonably be expected to lead Governmental Entity, has initiated, or, to the denialknowledge of the Company, limitationthreatened to initiate, revocationany clinical hold or other similar action to suspend any ongoing clinical trial sponsored by or on behalf of Company, or rescission any action to suspend or terminate any active Investigational New Drug Application (“IND”) sponsored by or on behalf of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory AgencyCompany.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required As it relates to be filed, maintained any clinical trial conducted by or furnished on behalf of the Company or the Company Subsidiary (with respect to the applicable Company Products) in connection with or as the basis for any submission to the FDA or any other Parent Regulatory Agency by Parent and comparable Governmental Entity, filed under an IND, or other foreign equivalent or that the Parent Subsidiaries Company anticipates will be submitted to the FDA or other comparable Governmental Entity, (i) all such clinical trials have been so filed, maintained or furnishedproperly registered in compliance with all applicable Health Care Laws, except where such failure to file, maintain or furnish such reports, documents, claims, permits or notices comply would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. All Effect and (ii) the results of all such reports, documents, claims, permits and notices were complete and accurate clinical trials have been disclosed in all material respects on in accordance with all applicable Health Care Laws, in each case including section 402 of the date filed PHSA, except where such failure to comply would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(g) There is not and since January 1, 2020, there has not been, and to the Company’s knowledge, there is no threat by any Governmental Entity or were corrected clinical investigators of, any return or defect of any Company Product proposed to be used during a clinical investigation, nor has the Company issued any replacements, safety alerts or any other written notice to an investigator or Governmental Entity asserting a lack of safety or regulatory compliance with respect to any Company Product used in or supplemented to be used during a clinical investigation, and to the Company’s knowledge, there are no facts that would be reasonably likely to result in the foregoing, except where such failure to comply would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(h) Neither the Company nor the Company Subsidiary is, or has been since January 1, 2020, a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order or similar agreement with or imposed by a subsequent filing). any Governmental Entity.
(i) Since January 1, 20122020, neither Parent the Company nor any of the Parent SubsidiariesCompany Subsidiary, nor, to the knowledge of Parent, or any officer, employeedirector, agent managing employee or distributor of Parent or any agents of the Parent Subsidiaries, Company or the Company Subsidiary (as those terms are defined in 42 C.F.R. § 1001.1001): (i) has (A) been placed under or otherwise made an untrue statement of a material fact subject to or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or (B) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, ; (ii) has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any been convicted of the Parent Subsidiaries, noror, to the knowledge Company’s knowledge, is under investigation for any offense related to any Bribery Legislation or Sanctions Laws; (iii) has been charged with or convicted of Parentany criminal offense relating to the delivery of an item or service under Medicare, any officerMedicaid, employee, agent or distributor of Parent TRICARE or any similar government health care program (collectively, “Federal Health Care Programs”) (in the case of the Parent SubsidiariesCompany’s managing employees and agents, the representation and warranty in this clause (iii) is only being made to the Company’s knowledge); (iv) has been debarred excluded from participation in any Federal Health Care Program or is currently listed on the U.S. Department of Health Office of Inspector General’s List of Excluded Individuals/Entities; (v) has been subject to, or convicted of any crime that would reasonably be expected to result in, debarment, exclusion, or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded suspension from participation in any government health care program Federal Health Care Program, or convicted of otherwise under 21 U.S.C. Section 335a or any crime similar Law; (vi) has had a civil monetary penalty assessed against it, him or engaged in any conduct for which such Person could be excluded from participating in any federal health care program her under Section 1128 1128A of the Social Security Act Act, codified at Title 42, Chapter 7, of 1935the United States Code; (vii) has been excluded, as amendedsuspended, debarred, or is otherwise ineligible to participate federal procurement or non-procurement programs, or is currently listed on the United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (viii) has been or are currently the subject of a proceeding that could lead to their becoming a debarred individual or debarred entity under Section 306 of the FDCA; (ix) is on any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder Clinical Investigator enforcement lists (including without limitation, the Disqualified/Totally Restricted List, the Restricted List, the Adequate Assurance List) or any similar Law applicable in any foreign jurisdiction in which material quantities is subject to an ongoing disqualification proceeding as defined by the FDA; or (x) is the target or subject of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those current investigation relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse EffectFederal Health Care Program-related offense.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Merger Agreement (Indivior PLC), Merger Agreement (Indivior PLC)
Regulatory Matters. (a) Each of the products currently marketed by ANI or any of its Subsidiaries and each of the products under development by ANI or any of its Subsidiaries is identified in Section 3.16(a) of the ANI Disclosure Schedule (the “ANI Products”). Except as has not had set forth in Section 3.16(a) of the ANI Disclosure Schedule, ANI and the ANI Subsidiaries hold all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”) and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the ANI Products (any such Government Authority, an “ANI Regulatory Agency”) required for the lawful operation of the businesses of ANI and the ANI Subsidiaries (the “ANI Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (iEffect on ANI. Except as set forth in Section 3.16(a) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) ANI Disclosure Schedule all such Parent Regulatory ANI Permits are valid and in full force and effect; . Except as set forth in Section 3.16(a) of the ANI Disclosure Schedule, none of such ANI Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement. ANI and (iii) Parent is in compliance the ANI Subsidiaries are the sole and exclusive owner of the ANI Permits and the associated filings and applications with the terms FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to ANI and the ANI Subsidiaries (collectively, the “ANI Regulatory Filings”) and hold all right, title and interest in and to all ANI Regulatory Filings free and clear of all Parent any Lien. ANI and the ANI Subsidiaries have not granted any third party any right or license to use, access or reference any of the ANI Regulatory PermitsFilings, including any of the know-how contained in any of the ANI Regulatory Filings or rights (including any regulatory exclusivities) associated with each such ANI Regulatory Filing.
(b) Except as set forth in Section 3.16(b) of the ANI Disclosure Schedule, since January 1, 2010, there has not occurred any breach or violation of, default (with or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any ANI Permit. Except as set forth in Section 3.16(b) of the ANI Disclosure Schedule, ANI and the ANI Subsidiaries are in compliance in all material respects with the terms of all ANI Permits, and no event has occurred and no facts or circumstances exist that, to the knowledge of ANI, would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectresult in the revocation, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Lawscancellation, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state non-renewal or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities adverse modification of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectANI Permit.
(c) Except as would not, individually or set forth in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None Section 3.16(c) of the Parent ANI Disclosure Schedule, since January 1, 2010, all material applications, submissions, information and data used by ANI or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement ordersthe ANI Subsidiaries as the basis for, or similar agreements with submitted by or, to the knowledge of ANI, on behalf of ANI or imposed by the ANI Subsidiaries in connection with, any Parent and all requests for ANI Permits when submitted to the FDA or other ANI Regulatory Agency, were, to ANI’s knowledge, accurate and complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to such applications, submissions, information and data required under Applicable Law have been submitted to the FDA or other ANI Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 20122010, neither Parent ANI nor any of the Parent ANI Subsidiaries has received committed any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA or any other ANI Regulatory Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” or similar policies under Applicable Law. Except as set forth in 56 Fed. Reg. 46191 (September 10Section 3.16(d) of the ANI Disclosure Schedule, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent neither ANI nor any of the Parent Subsidiaries, its ANI Subsidiaries nor, to the knowledge of ParentANI, any agent, subcontractor, director, officer, employee, agent employee or distributor other Person associated with or acting on behalf of Parent or any of the Parent Subsidiaries, ANI has been debarred or convicted of any crime or engaged in any conduct for which has resulted or could result in debarment is mandated or disqualification by 21 U.S.C. § 335a(a) the FDA or any similar Law other Government Authority, and there are no proceedings pending or authorized threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by 21 U.S.C. § 335a(b) the FDA or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent Government Authority.
(e) Neither ANI nor any of the Parent Subsidiaries, ANI Subsidiaries nor, to the knowledge of ParentANI, any director, officer, employeeagent, agent employee or distributor other Person associated with or acting on behalf of Parent ANI or any of the Parent SubsidiariesANI Subsidiaries has: (i) used any corporate funds for any unlawful contribution, has been debarredgift, suspended entertainment or excluded other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from participation corporate funds; (iii) violated or is in any government health care program or convicted violation of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 provision of the Social Security Foreign Corrupt Practices Act of 19351977, as amendedamended (the “FCPA”), or any similar Parent Healthcare Law Applicable Law; or program.
(giv) As to each Parent Product made any bribe, rebate, payoff, influence payment, kickback or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and securityother unlawful payment. There is are no action or proceeding pending or, to the knowledge of ParentANI, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent threatened filings against ANI or any ANI Subsidiary of an action relating to the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectfederal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)).
(hf) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122010, neither Parent nor there has not been any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issuedconducted, or caused to be initiated, conducted or issued, any issued recall, field correctionsnotification, field correction, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator noticemarket correction, or other investigator notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged material lack of safety, safety or efficacy or regulatory compliance of any Parent ANI Product.
(g) Except as set forth in Section 3.16(g) of the ANI Disclosure Schedule, ANI and its Subsidiaries are in compliance in all material respects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the clinical investigation, manufacture, sale, promotion, sampling and distribution of pharmaceutical products or biological, or device products in any jurisdiction. To ANI has at all times and is currently distributing, marketing, promoting, labeling and selling its products in accordance with the FDCA and Prescription Drug Marketing Act of 1987. There are no pending or, to the knowledge of ParentANI, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against ANI or its Subsidiaries. Since January 1, 2010 there have been no written notices, reports, FDA Form 483 observations that have not been disclosed by ANI, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to ANI or any ANI Subsidiary or any ANI Product or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to any ANI Product.
(h) The manufacture of the ANI Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA. ANI has been in material compliance with FDA’s registration and listing requirements to the extent required by FDA.
(i) ANI and its Subsidiaries are no facts which are reasonably likely to cause, and Parent has not received any written notice from have been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Parent Regulatory Agency regarding Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. Except as set forth in Section 3.16(i) of the ANI Disclosure Schedule, there have been no Serious Adverse Events or Serious Injuries associated with the use (iincluding in clinical trials) the recall, market withdrawal or replacement of any Company Product sold or intended ANI Products that have not been reported to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change FDA in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable accordance with Applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained To the knowledge of ANI, all studies, tests, and preclinical and clinical research being conducted by ANI and ANI Subsidiaries, and to the knowledge of ANI, on behalf of ANI and ANI Subsidiaries, are being, and at all times have been, conducted in this Section 4.13compliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by ANI or any ANI Subsidiary or, to the knowledge of ANI, on behalf of ANI or any ANI Subsidiary has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of ANI, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial.
(k) Neither ANI nor any ANI Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of ANI or any ANI Subsidiary, nor, to the knowledge of ANI, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of ANI or any ANI Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing any “Federal Health Care Program” (which means Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act) and any other state or federal health care program). ANI meets all the requirements of participation and payment of Medicare, Medicaid, and any other governmental health care programs and third party payment programs to the extent in which it participates (collectively, “Programs”). There is no representation action pending, received or, to ANI’s knowledge, threatened against ANI which relates in any way to a violation of any health care laws or warranty shall be deemed which could result in the imposition penalties against or the exclusion of ANI from participation in any Programs. Neither ANI nor any ANI Subsidiary nor officer, director, managing employee have engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from any Program. To ANI’s knowledge, there is no pending, proposed or final Medicare national or local coverage determination that, if finalized, would restrict coverage for ANI’s Products. ANI has not established any reimbursement support program, such that payment for ANI product is contingent upon a purchaser’s receipt of payment from a third party payer. ANI does not furnish any coverage, coding or billing advice to be made in this Section 4.13 in respect any health care professionals regarding off-label indications of environmental, Tax, employee benefits or labor Law mattersANI products.
Appears in 2 contracts
Sources: Agreement and Plan of Merger (Biosante Pharmaceuticals Inc), Merger Agreement (Biosante Pharmaceuticals Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent its Subsidiaries holds (xA) all permitsauthorizations and certifications applicable to its activities, licensesproducts and functions, franchisesincluding, approvalswhere applicable, clearances, registrations, and authorizations those under the FDCA, the PHSA, and the regulations and requirements of the FDA promulgated thereunder, including good laboratory, clinical, and manufacturing practices regulations, as well as ISO certifications and standards for healthcare and related data protection laws including ISO31000, ISO14155, ISO13485, ISO9001 and ISO 27001, and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, functionality, identity, strength, purity, safety, efficacy, labeling, manufacturing, testing, processing, research, packaging, labelling, storage, transport, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Products Drug Product Candidates (any such Governmental Entity or Notified BodyAuthority, a an “Parent Regulatory Agency”) ), necessary for the lawful operating activities and operations of the businesses of Parent or any of the Parent its Subsidiaries as currently conducted or as planned to be previously conducted during the period beginning on the Reference Date and ending on the date of this Agreement (collectively all such authorizations in (A) and (B) are referred hereafter as, the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are in each case valid and in full force and effecteffect (subject to the Bankruptcy and Equity Exceptions to the extent applicable thereto); and (iii) Parent is and its Subsidiaries are in compliance with the terms of all such Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any As of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012date hereof, neither Parent nor any of the Parent its Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(ci) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, reduced or special licensing measures, warnings notices, enhanced monitoring or audits, deficiency notices or similar agreements agreements, notices or measures with or imposed by any Parent Regulatory AgencyAgency or (ii) has knowledge (including as a result of any communication from the FDA) that a material Parent Regulatory Permit or application for a material Parent Regulatory Permit is invalid or will be or has been suspended, rejected, cancelled, terminated or granted in a scope narrower than applied for.
(dc) All pre-clinical and clinical investigations in respect of a Parent Drug Product or Parent Product candidate Candidate conducted or sponsored by each Parent or any of Parent and the Parent its Subsidiaries are being being, and since the Reference Date have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials promogulated by the FDA, and as contained in Title 21 parts 50, 54, 56, 310, 312, 314 314, 320, and 320 600 of the Code of Federal Regulations Regulations, applicable research protocols, institutional review board or other ethics committee requirements, and federal and state legal requirements, and (ii) any applicable federalApplicable Laws governing, state and provincial Laws relating to, or restricting the collection, processing, use and disclosure of individually identifiable information, health information information, human biological samples and genetic information, and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communication from the FDA or any other similar Governmental Authority or any ethics committee recommending or requiring the termination, suspension, clinical hold, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, Parent.
(ed) Since January 1Except as has not had and would not reasonably be expected to have, 2012individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on the Reference Date and ending on the date of this Agreement, neither Parent nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the design, development, testing, marketing, labeling, sale, use handling and control, functionality, safety, efficacy, reliability, distribution, storage, transport, packaging, processing, or manufacturing of drugs which Parent Drug Product Candidates that would reasonably be expected to lead to the denial, suspension, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any self-certification or application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(e) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, Parent and its respective directors, officers, employees and, to the knowledge of Parent, its other agents (while acting in such capacity) are, and since the Reference Date have been, in compliance with all Applicable Laws relating to controlled substances or the manufacturing, testing, processing, supplying, distributing, transporting, labeling, packaging, dispensing, using, reporting, storing, disposing, importing, exporting, controlling, wholesaling, brokering or trading of controlled substances, including the federal Controlled Substances Act (21 U.S.C. §§ 801 et seq.), and the regulations promulgated pursuant thereto, and any other similar local, state, or foreign laws, including all necessary registration, recordkeeping, reporting, security and storage requirements. Since the Reference Date to the date hereof, Parent has not received any correspondence or any other written communication from any Governmental Authority, including the Drug Enforcement Administration and local, state or foreign regulatory and law enforcement authorities, of potential or actual non-compliance by, or liability of, Parent under any Applicable Law relating to controlled substances.
(f) Since January 1, 2012the Reference Date, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true, accurate and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012the Reference Date, neither Parent nor any of the Parent its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor contractor of Parent or any of the Parent its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since the Reference Date, (i) neither Parent nor any of the Parent its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor contractor of Parent or any of the Parent its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Products Drug Product Candidates are tested, manufactured, marketed, distributed, or Parent Product candidates are sold or intended by the where Parent has publicly announced an intention to be sold. Since January 1, 2011, sell an Parent Drug Product Candidate; and (ii) neither Parent nor any of the Parent its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor contractor of Parent or any of the Parent its Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program program, health or buying procurement program, pricing or reimbursement scheme under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare Law program, including any conduct that would constitute non-compliance with the Federal Anti-Kickback Statute, Federal False Claims Act, or programtheir respective state equivalents.
(g) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, as to each Parent Drug Product or Parent Product candidate Candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectapplicable jurisdiction, each such Parent Drug Product or Parent Product candidate Candidate is being or has been designed, developed, manufactured, stored, distributed and marketed in compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good clinical practices and good manufacturing practices, packaging, labelingfunctionality, labeling and product claims, advertising, record keeping, reporting, and security. There is are no action or proceeding Proceedings pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product Platform or Parent Drug Product candidate Candidate by Parent or any of the Parent its Subsidiaries of any Applicable Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012(i) during the period beginning on the Reference Date and ending on the date of this Agreement, neither Parent nor any of the Parent its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market suspension, withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, functionality, efficacy or regulatory compliance of any Parent Product. To Drug Product Candidate and (ii) to the knowledge of Parent, there are no facts which are reasonably likely to causeneither Parent nor any of its Subsidiaries has received, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency during the period beginning on the Reference Date and ending on the date of this Agreement regarding (iA) the recall, market withdrawal or replacement of any Company Parent Drug Product sold or intended to be sold by Parent or a Parent Subsidiary Candidate (other than recalls, withdrawals or replacements that are not material to Parent or the Parent and its Subsidiaries, taken as a whole), (iiB) a material change in the marketing classification or a material change in the labeling of any such Parent ProductsDrug Product Candidates, (iiiC) a termination or suspension of the manufacturing, marketing, testing, or distribution of such Parent ProductsDrug Product Candidates, or (ivD) a material negative change in reimbursement status of a an Parent ProductDrug Product Candidate.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 2 contracts
Sources: Transaction Agreement (Recursion Pharmaceuticals, Inc.), Transaction Agreement (Exscientia PLC)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or set forth in the aggregate, a Parent Material Adverse EffectDisclosed Matters on Schedule 3.25(a), (i) each Loan Party and each of Parent its Subsidiaries are in compliance in all material respects with all applicable FDA Laws and the Parent Subsidiaries holds (x) applicable DEA Laws, including all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under applicable requirements of the FDCA, the PHSACSA, or any implementing regulations thereof, all laws and regulations administered or enforced by the regulations U.S. Drug Enforcement Administration, and all applicable statutes, rules, regulations, standards, policies and orders administered or issued by any foreign Governmental Authority, relating to any Product or any aspect of the FDA promulgated thereunderdevelopment, data protection laws and (y) all permitsManufacture, licensesproduction or Commercialization thereof or otherwise, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits none of the Products are valid and in full force and effect; and articles which may not be introduced into interstate commerce pursuant to the requirements of the FDCA, the CSA or foreign equivalents, as applicable, (iii) Parent is each Product has been developed, Manufactured or produced in compliance all material respects in accordance with FDA Good Manufacturing Practices (or any foreign equivalent, as applicable) and FDA Registration and Listing Requirements (or foreign equivalent, as applicable) and (iv) each of the terms of all Parent Regulatory PermitsProducts required to be approved or cleared by the FDA pursuant to the FDCA (or any foreign equivalent, as applicable) has been so approved or cleared.
(b) Except as would notNone of the Loan Parties or their respective Subsidiaries nor any officer, individually affiliate, employee or in the aggregateany of its Subsidiaries, reasonably be expected to have a Parent Material Adverse Effectagent, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Lawsany Loan Party or its Subsidiaries, including has (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a any material fact or a fraudulent statement to any Governmental Authority (including the FDA or any other Parent Regulatory AgencyFDA), (ii) failed to disclose a any material fact required to be disclosed to any Governmental Authority (including the FDA or any other Parent Regulatory AgencyFDA), or (iii) except as otherwise disclosed on Schedule 3.25(a), committed an any act, made a any statement, or failed to make a statementany statement that, in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would could reasonably be expected to provide constitute a material violation of any FDA Law.
(c) Except as provided on Schedule 3.25(c), there are no facts, circumstances or conditions that could reasonably be expected to form the basis for the FDA to invoke its policy respecting “Fraudany material investigation, Untrue Statements of Material Factssuit, Briberyclaim, and Illegal Gratuities”audit, set forth in 56 Fed. Reg. 46191 action (September 10, 1991legal or regulatory) or for proceeding (legal or regulatory) by a Governmental Authority (other than any routine GMP Regulation or compliance audits required by the FDA or any other Parent Regulatory Agency routine audits conducted by notified bodies with respect to invoke any similar policy, except for foreign good manufacturing practices requirements) pending or threatened in writing against any act Loan Party or statement or failure any of its Subsidiaries relating to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent FDA Laws or any applicable statutes, rules, regulations, standards, policies or orders administered or issued by any foreign Governmental Authority.
(d) Schedule 3.25(d) contains a list of all Products that have been Commercialized. Each Loan Party and its Subsidiaries, noras applicable, has all Regulatory Authorizations necessary to conduct its business in the manner in which such business is currently conducted. Borrower has previously made available to Lender all Regulatory Authorizations, all material correspondence with Regulatory Agencies (including the FDA and any foreign equivalent, as applicable) with respect to such Regulatory Authorization and all adverse event reports with respect to the Products that have been Commercialized and all requested documents related to the Products that have been Commercialized, in each case, in the possession and control of Holdings or any of its Subsidiaries. Borrower has not withheld any document or information with respect to the Products that have been Commercialized that would reasonably be considered to be material to Lender’s decision to provide the financing contemplated by this Agreement.
(e) Except as set forth in the Disclosed Matters on Schedule 3.25(e), (i) each Loan Party and its Subsidiaries, and, to the knowledge of Parent, any officer, employee, agent or distributor of Parent each Loan Party or any of the Parent its Subsidiaries, has been debarred each licensee of a Loan Party or convicted any of its Subsidiaries of any crime intellectual property, are in compliance with, and have complied with, all applicable federal, state, provincial, municipal, local and foreign laws, rules and regulations, governing its business, including all regulations promulgated by each applicable Regulatory Agency, the failure of compliance with which could reasonably be expected to result in a Material Adverse Effect and (ii) no Loan Party or engaged in its Subsidiaries has received any conduct for which debarment is mandated written notice from any Regulatory Agency citing action or inaction by 21 U.S.C. § 335a(a) any Loan Party or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of its Subsidiaries that would constitute a violation of any applicable federal, state, provincial, municipal, local and foreign laws, rules, regulations or standards, which could reasonably be expected to result in a Material Adverse Effect.
(f) Without limiting the generality of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, norclause (e) above, to the knowledge of Parent, any officer, employee, agent or distributor of Parent each Loan Party or any of the Parent its Subsidiaries, any and all studies, tests and preclinical and clinical trials and investigations conducted by or on behalf of the Loan Parties relating to any Product have been, and are being, conducted in all material respects in accordance with all applicable Requirements of Law, including good clinical practices (including under FDA (and foreign equivalent, as applicable) regulations (including the requirements set forth in 21 C.F.R. Part 11, Part 50, Part 54, Part 56, Part 312 and Part 314, as applicable)), good laboratory practices, and investigational new drug exemption requirements; Borrower has been debarredpreviously made available to Lender descriptions of the results of such studies, suspended tests, trials and investigations, which descriptions are accurate in all material respects; and no Loan Party or excluded any of its Subsidiaries has received any notices or correspondence from participation in any government health care program applicable Regulatory Agency or convicted comparable authority requiring the termination, suspension, material modification or clinical hold of any crime such studies, tests, trials or engaged investigations conducted by or on behalf of a Loan Party or its Subsidiaries, which termination, suspension, material modification or clinical hold could reasonably be expected to result in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programa Material Adverse Effect.
(g) As to To the knowledge of each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Loan Party or any of the Parent its Subsidiaries, except as would notthe development, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Manufacturing and production of each such Parent Product or Parent Product candidate is being or has at all times been developed, manufactured, stored, distributed and marketed (i) in compliance in all material respects with the final release quality specifications in effect for such Product and (ii) in compliance in all material respects with all applicable LawsRequirements of Law, including those relating to investigational usethe FDCA, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingthe CSA, and securityany foreign equivalents thereto. There is Except as set forth on Schedule 3.25(g), no action or proceeding pending orPerson currently Manufacturing Product and currently party to a Manufacturing Agreement and, to the actual knowledge of Parenteach Loan Party or any of its Subsidiaries, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recallno other Person Manufacturing Product, in each case alleging has received in the past five (5) years an FDA Form 483 or is currently subject to a Form 483 impacting any violation applicable Product with respect to any Parent facility Manufacturing Product and that, with respect to each such Form 483, all scientific and technical violations or Parent Product candidate by Parent other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or any of the Parent Subsidiaries of any Lawissues, except as would not, individually have been corrected or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectotherwise resolved.
(h) Except as would notset forth on Schedule 3.25(h), individually (i) no Product has been recalled, suspended, subject to a market withdrawal or field correction, or discontinued as a result of any action by the FDA or any other Governmental Authority (or any foreign equivalent, as applicable), by any Loan Party or any of its Subsidiaries or by any licensee, distributor or marketer of such Product and (ii) where required by Applicable Law, the Loan Parties and their Subsidiaries have maintained global post-marketing surveillance programs and procedures specifically designed to comprehensively monitor, collect and timely report any adverse event reports required to be reported in the aggregate, reasonably be expected relation to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, Products in accordance with any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack Requirements of safety, efficacy or regulatory compliance of any Parent ProductLaw. To the knowledge of Parenteach Loan Party or any of its Subsidiaries, there are no facts which are facts, circumstances, or conditions that could reasonably likely be expected to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the result in a recall, suspension, market withdrawal withdrawal, field correction or replacement discontinuance of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Schedule 3.25(i) contains a true, correct and complete list of all manufacturing and supply Contracts entered into by any Loan Party or any of its Subsidiaries with third parties and in effect for the supply of Product (the “Manufacturing Agreements”) as of the Effective Date. Borrower has previously made available to Lender true, correct and complete copies of each Manufacturing Agreement, and each such Manufacturing Agreement contains, or is accompanied by an adequate quality agreement. After giving effect to consummation of the transactions contemplated by this Agreement and the other Loan Documents, except as described on Schedule 3.25(i), each Manufacturing Agreement and quality agreement is a valid and binding obligation of the applicable Loan Party or Subsidiary and is in full force and effect, and to the knowledge of each Loan Party or any of its Subsidiaries, is a valid and binding obligation of any other party thereto, and neither the applicable Loan Party or its Subsidiaries or, to the knowledge of each Loan Party or any of its Subsidiaries, any other party thereto is in breach thereof or default thereunder. Except as would not reasonably be expected to have a Parent Material Adverse Effectdescribed on Schedule 3.25(i), neither Parent nor no Loan Party or any of the Parent its Subsidiaries has experienced received any security breach notice from any party thereto, oral or other incident resulting in written, regarding (i) the unauthorized accesscancellation, use termination or disclosure invalidation of data any Manufacturing Agreement or information that is linked (ii) any indication by or intent or threat of, such party, oral or written, to any reasonably identifiable person reduce or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in cease the HIPAA regulations at 45 C.F.R. § 160.103supply of Product through calendar year 2022.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, be material to the Company and the Company Subsidiaries, taken as a whole: (a) since June 30, 2022, neither the Company nor any Company Subsidiary has made any false, misleading, or untrue statement of material fact, or failed to disclose a material fact required to be disclosed, to any Regulatory Authority, nor committed any act, made any statement, or failed to make any statement that would reasonably be expected likely to have provide a Parent basis for the U.S. Food and Drug Administration (the “FDA”) to invoke its policy with respect to “Fraud, Untrue Statements of Material Adverse EffectFacts, Bribery and Illegal Gratuities,” or for any other Regulatory Authority to invoke any similar policy; (b) since June 30, 2022, neither the businesses Company nor any Company Subsidiary has experienced a theft or significant loss of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Lawscontrolled substances or listed chemicals that would require reporting to any Regulatory Authority, including the U.S. Drug Enforcement Administration (the “DEA”) or any similar foreign Regulatory Authority, or experienced any material diversion of controlled substances or listed chemicals or any material breach of the security systems and procedures required under any applicable Law governing the Company and the Company Subsidiaries’ development, testing, investigation, manufacture, storage, distribution, marketing, or sale of products; (c) since June 30, 2022, no product distributed or sold to any customer, consumer, pharmacy, or other medicine dispenser by the Company or any Company Subsidiary has been adulterated, misbranded, seized, withdrawn, recalled, or detained and, to the knowledge of the Company, there has occurred no fact or circumstance reasonably likely to cause (i) a change in the FDCA; manufacture of any such product outside the ordinary course of business, (ii) the PHSA; a seizure, denial, withdrawal, recall, detention, material field notification, material field correction, or safety alert relating to any such product, (iii) federal Medicare and Medicaid statutes and related state a termination, seizure, or local statutes; suspension of marketing of any such product, (iv) any comparable foreign Laws for any a product to become adulterated or misbranded; (d) since June 30, 2022, the Company and the Company Subsidiaries and their respective employees, officers, and directors have not been, and, to the knowledge of the foregoing applicable in jurisdictions in which material quantities of any Company, no agent, contractor, or supplier acting on behalf of, or providing products or services to, the Company and the Company Subsidiaries has been, (i) debarred (under the provisions of the Parent Products Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a) and (b) or Parent Product candidates are manufactured any similar Law), (ii) excluded from participation in United States federal health care programs (under the provisions of 42 U.S.C. § 1320a-7 or sold; any similar Law), (iii) convicted of a crime for which a Person can be debarred or excluded, (iv) threatened to be debarred or excluded, or (v) federalsubject to any equivalent sanction described in this Section 3.15 in any foreign jurisdiction; (e) since June 30, state 2022, neither the Company nor any Company Subsidiary has (i) received from the FDA any warning letter or provincial criminal untitled letter, or civil healthcare Laws (including ii) been the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities subject of any Legal Proceeding commenced by or on behalf of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agencya Governmental Authority, including the FDA, the Drug Enforcement AdministrationDEA, the United States Department of Justice (including any United States Attorney’s Office)DOJ, the United States Department of Health and Human Services Office of the Inspector General and Office for Civil Rights, of the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by(“OIG”), or liability of Parent or any similar foreign Regulatory Authority; (f) since June 30, 2022, neither the Parent Subsidiaries underCompany nor any Company Subsidiary has become, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably continued to be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to, or been requested to enter into any material corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreementsagreement, consent decreesdecree, settlement ordersorder, or other similar agreements written agreement, in each case, with or imposed by any Parent Regulatory Agency.
Governmental Authority, including the FDA, the DEA, the DOJ, the OIG, or any similar foreign Governmental Authority; (dg) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent since June 30, 2022, the Company and the Parent Company Subsidiaries are being conducted have been in compliance with all applicable Laws administered or issued by regarding the applicable Parent Regulatory Agenciesretention and integrity of records and documents; (h) since June 30, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 20122022, all reports, documents, claims, permits permits, submissions, filings, and notices required to be filedfiled with, maintained in connection with, or furnished to a Governmental Authority by the FDA or any other Parent Regulatory Agency by Parent Company and the Parent Company Subsidiaries have been so filed, maintained maintained, or furnished, except where failure to file, maintain or furnish and all such reports, documents, claims, permits or notices would not reasonably be expected to havepermits, individually or in the aggregatesubmissions, a Parent Material Adverse Effect. All such reportsfilings, documents, claims, permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing); (i) the Company and the Company Subsidiaries currently hold, in good standing (to the extent applicable), all regulatory authorizations and Governmental Authorizations required to engage in their respective operations including, as applicable, the research, investigation, development, design, manufacturing, packaging, labeling, marketing, advertising, promotion, import, export, testing, sale, sampling, distribution, use, and commercialization of health care products; and (j) the Company and the Company Subsidiaries are not authorized to bill, nor have they directly claimed or received reimbursement from, any Governmental Program or from any other Third-Party Payor Program for services reimbursable under such programs. Since January 1June 30, 20122022, neither Parent nor any of the Parent SubsidiariesCompany and its Company Subsidiaries have been in compliance with all Healthcare Laws applicable to their respective businesses and products, nor, to except where the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required failure to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as compliance would not, individually or in the aggregate, reasonably be expected likely to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Catalent, Inc.)
Regulatory Matters. (a) The Company and each of its Subsidiaries possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Bodies necessary for the Company’s and each of its Subsidiaries’ development activities for its products and product candidates (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrationssuch Regulatory Authorizations are, and authorizations under the FDCAsince January 10, the PHSA2022 have been, the regulations of the FDA promulgated thereunder, data protection laws and (yA) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; , (B) validly registered and on file with applicable Governmental Bodies and (iiiC) Parent is in compliance with all formal filing and maintenance requirements and (ii) the terms Company and each of its Subsidiaries has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no action has been taken or failed to be taken by the Company or its Subsidiaries or, to the knowledge of the Company, no other event has occurred, in each case, which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, (1) the Company and each of its Subsidiaries has filed, maintained or furnished to FDA or other applicable Governmental Bodies all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports), (2) all such submissions were complete and accurate and in compliance with applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing), and (3) the Company has made available to Parent true, complete, and accurate copies of all Parent Regulatory Permitssuch submissions and material correspondence with Governmental Bodies relating to such submissions.
(b) Except as would notnot reasonably be expected to be, individually or in the aggregate, reasonably be expected material to have the Company and its Subsidiaries taken as a Parent Material Adverse Effectwhole, all preclinical and clinical investigations for the businesses Company Products sponsored by the Company or any of each of Parent and each Parent Subsidiary its Subsidiaries or Collaboration Partners are being conducted in material compliance with all applicable LawsLegal Requirements, rules, regulations and guidance, including (i) Good Clinical Practices. Neither the FDCA; (ii) FDA nor any other Governmental Body performing functions similar to those performed by the PHSA; (iii) federal Medicare and Medicaid statutes and related state FDA has sent any written notices or local statutes; (iv) any comparable foreign Laws for other correspondence to the Company or any of its Subsidiaries and, to the foregoing applicable in jurisdictions in which material quantities of any knowledge of the Parent Company, any Collaboration Partners, with respect to any ongoing clinical or pre-clinical studies or tests for the Company Products requiring the termination, suspension or Parent Product candidates are manufactured material modification of such studies or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including tests. Neither the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent Company nor any of its Subsidiaries and, to the Parent Subsidiaries knowledge of the Company, any Collaboration Partners, has received any written notification or communication notifications from any Parent Regulatory Agencyinstitutional review board, including ethics committee or safety monitoring committee raising any material issues that require or would require the FDAtermination, the Drug Enforcement Administrationsuspension or investigation of, the United States Department of Justice (including any United States Attorney’s Office)or seeking to place a clinical hold order on or otherwise delay or materially restrict any, the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance clinical studies proposed or currently conducted by, or liability on behalf of, the Company or any of its Subsidiaries or Collaboration Partners, with respect to the Company Products, and, to knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent or the Parent Subsidiaries undercomplete and accurate copies of all material clinical and preclinical data, any Parent Healthcare including material information about adverse events, safety, efficacy, potency, and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or manufacturing in the aggregatepossession of and reasonably available to the Company or any of its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies, a Parent Material Adverse Effectin each case with respect to any clinical studies proposed or currently conducted by, or on behalf of, the Company or any of its Subsidiaries for the Company Products, and such data has not been falsified or otherwise materially manipulated by or on behalf of the Company or any of its Subsidiaries.
(c) Except as would not, individually or in Neither the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent Company nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent its Subsidiaries, nor, nor to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent or any of the Parent SubsidiariesCollaboration Partner, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the date of this Agreement, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for neither the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Company nor any of the Parent its Subsidiaries, or to the knowledge of the Company, any Collaboration Partner, is the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company or any of its Subsidiaries nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent Collaboration Partner or any officers, employees, agents or clinical investigators of the Parent SubsidiariesCompany, any of its Subsidiaries or any Collaboration Partner with respect to the Company Products, has been suspended or debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed result in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent (A) debarment under 21 U.S.C. Section 335a or any of the Parent Subsidiaries of similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectsimilar Legal Requirement.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(id) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries and, to the knowledge of the Company and to the extent relating to the research, development or manufacture of Company Products, each Collaboration Partner, are, and since January 10, 2022, have a Parent Material Adverse Effectbeen in compliance in all material respects, neither Parent with all healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.); (ii) the Federal Food, Drug, and Cosmetic Act (“FDCA”); (iii) the Health Insurance Portability and Accountability Act of 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company or any of its Subsidiaries. Neither the Company nor any of its Subsidiaries, nor to the Parent Subsidiaries knowledge of Company, any Collaboration Partner, is subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has experienced been threatened. Neither the Company nor any security breach or other incident resulting in of its Subsidiaries, nor to the knowledge of Company, any Collaboration Partner, has had any unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data “protected under applicable Law. Parent or Merger Sub is not a business associate, health information” (as that such term is defined in used under HIPAA) that would constitute a security incident or breach that would require the HIPAA regulations at 45 C.F.R. § 160.103Company to provide notice under HIPAA.
(je) Notwithstanding anything contained To the extent required by applicable Legal Requirements, all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in this Section 4.13human clinical trials have been conducted in accordance with GMP Regulations except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole.
(f) There have been no representation drug-related serious adverse events reported or warranty shall be deemed observed in connection with the Company’s monoclonal antibody TREM2 agonist known as VGL101 or Iluzanebart (“VGL101”) in any VGL101 clinical trial or research or development study conducted by or on behalf of Company (“VGL101 Program”), including the multicenter, open-label trial with identifier NCT05677659, titled “A Study of VGL101 in Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia”.
(g) Neither the Company, nor any of its Affiliates, is in breach, in any material respect, of any Company Contract related to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersthe VGL101 Program.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent RMT Partner Material Adverse EffectEffect and except with respect to Permits required under applicable Environmental Laws (which are addressed exclusively in Section 7.21), (i) each of Parent RMT Partner and the Parent RMT Partner Subsidiaries holds have obtained all of the Permits necessary under applicable Laws for RMT Partner and the RMT Partner Subsidiaries to own, lease and operate their assets in the manner in which they are now owned, leased and operated and to conduct their businesses as now conducted, including (xA) all permits, licenses, franchises, approvals, clearances, registrations, authorizations and authorizations approvals under the FDCAFDCA (including Sections 505, 510(k) and 515 thereof), the PHSA, PHSA and the regulations of the FDA promulgated thereunder, data protection laws thereunder and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labelingtesting, manufacturing, marketing, promotion, distribution, sale, storage, pricing, import or export of the Parent RMT Partner Products (any such Governmental Entity or Notified BodyAuthority, a “Parent RMT Partner Regulatory Agency”) ), in each case necessary for the lawful operating operation of the businesses of Parent or any of the Parent RMT Partner and its Subsidiaries as currently conducted or as planned to be conducted in each jurisdiction in which such Person operates (the “Parent RMT Partner Regulatory Permits”); (ii) all such Parent RMT Partner Regulatory Permits are valid and in full force and effect; and (iii) Parent RMT Partner is in compliance with the terms of all Parent RMT Partner Regulatory Permits.
(b) Except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent RMT Partner Material Adverse Effect, the businesses of each of Parent RMT Partner and each Parent RMT Partner Subsidiary are being conducted in compliance with with, and such Persons have appropriate internal controls that are reasonably designed to ensure compliance with, all applicable Laws, including (i) the FDCAFDCA (including all applicable registration and listing requirements set forth in Sections 505 and 510 of the FDCA and 21 C.F.R. Parts 207 and 807); (ii) the PHSA; (iii) the Prescription Drug Marketing Act, as amended; (iv) federal Medicare and Medicaid statutes and related state or local statutes; (ivv) the Patient Protection and Affordable Care Act, as amended (including the Biologics Price Competition and Innovation Act); (vi) the Veterans Health Care Act; (vii) the Physician Payments Sunshine Act; (viii) the Federal Trade Commission Act, as applicable; (ix) provincial formulary and drug pricing statutes; (x) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or soldforegoing; (vxi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute Statute, as amended (42 U.S.C. § 1320a-7(b)), ▇▇▇▇▇ Law (42 U.S.C. §1320a-7(b)1395nn), False Claims Act Act, as amended (42 U.S.C. §§ 1320a-7b(a)), Physician Payment Sunshine Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, state prescription drug marketing laws, and any comparable federal, state, provincial or local healthcare Laws; (xii) state or provincial licensing, disclosure and reporting requirements; (xiii) all applicable Laws analogous to the foregoing in the United States or in states and all other jurisdictions in which material quantities of RMT Partner or any of the Parent Products RMT Partner Subsidiary operates or Parent sells or distributes a RMT Partner Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programsRMT Partner Product candidate; and (viixiv) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent RMT Partner Healthcare and Data Protection Laws”). Since January 1, 20122017, neither Parent RMT Partner nor any of the Parent Subsidiaries RMT Partner Subsidiary has received any written notification or communication from any Parent RMT Partner Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human ServicesServices or any other “notified body” or corresponding Governmental Authority in any jurisdiction, of noncompliance by, or liability of Parent RMT Partner or the Parent any RMT Partner Subsidiaries under, any Parent RMT Partner Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent RMT Partner Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or Neither RMT Partner nor any other government healthcare program. None of the Parent or any Parent Subsidiary are a party RMT Partner Subsidiaries is subject to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, agreements or consent decrees, settlement orders, or similar agreements decrees with or imposed by any Parent RMT Partner Regulatory AgencyAgency and, to the knowledge of RMT Partner, (i) the imposition of any such agreement or decree is not currently pending and (ii) no RMT Partner Entity has received written notice that the imposition of any such agreement or decree is currently contemplated or proposed.
(d) All Except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a RMT Partner Material Adverse Effect, all pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent RMT Partner and the Parent RMT Partner Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesRMT Partner Healthcare Laws, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the designCode of Federal Regulations, conduct(ii) FDA standards for good clinical practice requirements (GCPs) and clinical study submissions, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained including as set forth in Title 21 parts 50, 54, 56, 312, 314 314, 320, 812 and 320 814 of the Code of Federal Regulations Regulations, (iii) 42 U.S.C. 282(j), (iv) any comparable foreign Laws for any of the foregoing or other Laws regulating the conduct of pre-clinical and clinical investigations and (iiv) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except. Except, in each case, for such noncompliance thatmatters that would not reasonably be expected to have, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent RMT Partner Material Adverse Effect, since January 1, 2017: (i) no clinical trial conducted by or on behalf of RMT Partner or any RMT Partner Subsidiary has been terminated, materially delayed or suspended prior to completion; and (ii) neither the FDA nor any other applicable Governmental Authority or institutional review board that has or has had jurisdiction over a clinical trial conducted by or on behalf of RMT Partner or any RMT Partner Subsidiary has commenced, or, to the knowledge of RMT Partner, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of RMT Partner or any RMT Partner Subsidiary.
(e) Since January 1, 20122017, neither Parent RMT Partner nor any of the Parent Subsidiaries RMT Partner Subsidiary has received any written notice from the FDA (including any inspection reports on Form 483, FDA warning letters or FDA untitled letters) or the EMA Employee Matters Agreement or any foreign agency other RMT Partner Regulatory Agency with jurisdiction over the development, marketing, labelinglabelling, sale, use use, handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, suspension or rescission of any Parent Regulatory Permits or revocation of any application or grant for marketing approval already granted or clearance with respect to any RMT Partner Product currently pending before or previously approved or cleared by the FDA or such other Parent RMT Partner Regulatory Agency, except, in each case, for such matters that would not reasonably be expected to have, individually or in the aggregate, a RMT Partner Material Adverse Effect.
(f) Since January 1, 20122017, all reports, documents, claims, permits permits, adverse event reports, notices and notices biological license, device or drug applications required to be filed, maintained or furnished to the FDA or any other Parent RMT Partner Regulatory Agency by Parent RMT Partner and the Parent RMT Partner Subsidiaries have been so filed, maintained or furnishedfurnished in a timely manner, except where failure to file, maintain or furnish such reports, documents, claims, permits permits, notices or notices applications would not reasonably be expected to have, individually or in the aggregate, a Parent RMT Partner Material Adverse Effect. All such reports, documents, claims, permits permits, notices and notices applications were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Neither RMT Partner nor any of the Parent SubsidiariesRMT Partner Subsidiary, nor, to the knowledge of ParentRMT Partner, any officer, employee, agent or distributor of Parent RMT Partner or any of the Parent SubsidiariesRMT Partner Subsidiary, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent RMT Partner Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent RMT Partner Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent RMT Partner and its Subsidiaries, that, at the time of such disclosure was madedisclosure, act or failure, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent RMT Partner Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. .
(g) Neither Parent RMT Partner nor any of the Parent SubsidiariesRMT Partner Subsidiary, nor, to the knowledge of ParentRMT Partner, any officer, employee, agent or distributor of Parent RMT Partner or any of the Parent SubsidiariesRMT Partner Subsidiary, has been (i) disqualified, suspended or debarred for any purpose, or received written notice of action or threat of action with respect to debarment under the provisions of 21 U.S.C. § 335a or any equivalent provisions in any other jurisdiction; (ii) excluded under 42 U.S.C. Section 1320a-7 or otherwise from participation in the Medicare program, any state Medicaid program or any other federal healthcare program; or (iii) formally charged with or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable Law, except in other jurisdictions each case as would not reasonably be expected to have, individually or in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldaggregate, a RMT Partner Material Adverse Effect. Since January 1, 2011, neither Parent Neither RMT Partner nor any of the Parent SubsidiariesRMT Partner Subsidiary, nor, to the knowledge of ParentRMT Partner, any officer, employee, agent or distributor of Parent RMT Partner or any of the Parent SubsidiariesRMT Partner Subsidiary, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gh) As to each Parent RMT Partner Product or Parent RMT Partner Product candidate subject to the FDCA and FDCA, the PHSA, the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent RMT Partner or any of the Parent RMT Partner Subsidiaries, except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent RMT Partner Material Adverse Effect, each such Parent RMT Partner Product or Parent RMT Partner Product candidate is being or has been developed, manufactured, storedtested, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelinglabelling, advertising, storing, promotion, import/export, distribution, provision of samples (PDMA), record keeping, reporting, reporting and security. There is no investigation, action or proceeding pending or, to the knowledge of ParentRMT Partner, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation of any Law applicable to any Parent RMT Partner Product or Parent RMT Partner Product candidate by Parent RMT Partner or any of the Parent Subsidiaries of any LawRMT Partner Subsidiaries, except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent RMT Partner Material Adverse Effect.
(hi) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122017, neither Parent nor any of the Parent Subsidiaries have no RMT Partner Entity has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, recall or any field correctionscorrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent RMT Partner Product, in each case which has not been publicly disclosed by the applicable RMT Partner Regulatory Agency, or is currently considering initiating, conducting or issuing any recall of any RMT Partner Product, in each case except as would not reasonably be expected to have, individually or in the aggregate, a RMT Partner Material Adverse Effect. To the knowledge of ParentRMT Partner, there are no facts which are would reasonably likely be expected to cause, and Parent no RMT Partner Entity has not received since January 1, 2017 any written notice from the FDA or any other Parent RMT Partner Regulatory Agency regarding regarding, (i) the recall, market withdrawal or replacement of any Company RMT Partner Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent RMT Partner or the Parent RMT Partner Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling labelling of any such Parent RMT Partner Products, (iii) a termination termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Parent RMT Partner Products, or (iv) a material negative change in reimbursement status of a Parent RMT Partner Product.
(i) Except as , that in each case, would not reasonably be expected to have have, individually or in the aggregate, a Parent RMT Partner Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (International Flavors & Fragrances Inc)
Regulatory Matters. (a) Except The Company and each of its Subsidiaries have all material permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct its business as has not had and currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to haveresult in a liability that is material to the Company and its Subsidiaries, individually or in the aggregate, taken as a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted whole (the “Parent Regulatory Company Permits”); .
(iib) all such Parent Regulatory The Company Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws except for any of the foregoing applicable failures to be in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud full force and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance effect that, individually or in the aggregate, has not had and would not reasonably be expected to have result in a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead liability that is material to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits Company and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent its Subsidiaries, nor, to the knowledge taken as a whole. The Company and each of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, its Subsidiaries is in each compliance under such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policyCompany Permits, except for any act or statement or failure such failures to make a statement comply that, individually or in the aggregate, has not had and would not reasonably be expected to have result in a Parent Material Adverse Effect. Neither Parent nor any of liability that is material to the Parent Company and its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, taken as amended, or any similar Parent Healthcare Law or programa whole.
(gc) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would notExcept for matters that, individually or in the aggregate, would not reasonably be expected to have result in a Parent Material Adverse Effectliability that is material to the Company and its Subsidiaries, taken as a whole, since January 1, 2020, the Company and each such Parent Product or Parent Product candidate of its Subsidiaries: (i) is being or and at all times has been developedin compliance, manufacturedto the extent applicable, stored, distributed and marketed in compliance with all statutes, rules, regulations (including all applicable Laws, including those requirements relating to investigational useGood Manufacturing Practices, marketing approvalGood Clinical Practices and Good Laboratory Practices), current good manufacturing practicesand with all orders and final guidance administered or issued by any Governmental Entity exercising authority applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, advertisingpromotion, record keepingsale, reportingoffer for sale, storage, import, export or disposal of any product tested, developed, promoted, marketed, manufactured or distributed by the Company and security. There each of its Subsidiaries; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Company Permits; and (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit and, to the Company’s Knowledge, there is no action or proceeding pending or, to the knowledge of Parent, threatened, or threatened (including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall), in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would notthat such Governmental Entity is considering such action.
(d) Except for matters that, individually or in the aggregate, would not reasonably be expected to have result in a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements liability that are not is material to Parent or the Parent Company and its Subsidiaries, taken as a whole), (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries are being conducted or have been conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable laws and regulations and (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Productssince January 1, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect2020, neither Parent the Company nor any of the Parent its Subsidiaries has experienced received any security breach written notices or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person correspondence from a Governmental Entity or any other data protected under applicable Law. Parent institutional review board or Merger Sub is not a business associatecomparable authority requiring the termination, as that term is defined in clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the HIPAA regulations at 45 C.F.R. § 160.103Company or any of its Subsidiaries.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Metacrine, Inc.)
Regulatory Matters. (a) Except Neither the Company nor any of its Affiliates nor any predecessor thereof has received any oral or written communication (including any Warning Letter, Courtesy Letter, untitled letter conveying adverse inspectional observations, Form 483 or similar notices) from any Governmental Authority, including but not limited to the FDA or FTC, or from any counterpart regulatory authorities in the European Union, or any other country, regarding the Company’s currently marketed products, or regarding claims that are currently being made for the Company’s currently marketed products, and to the Knowledge of the Company and its Affiliates, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries or Affiliates is not currently in compliance with any and all applicable Laws implemented by the FDA or FTC, or any counterpart regulatory authorities in the European Union or any other country, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. There are no pending voluntary or involuntary market withdrawals, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws field corrective actions (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)recalls), False Claims Act (42 U.S.C. §1320a-7b(a))destruction orders, Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating seizures or other regulatory enforcement actions related to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial product that have had or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(cb) Except as would notThe Company has, individually prior to the execution of this Agreement, made available to Parent copies of any and all documents in its or in its Subsidiaries’ possession that are material to assessing the aggregateCompany’s or any of its Subsidiaries’ material compliance with the Federal Food, reasonably be expected to have a Parent Material Adverse EffectDrug, Parent and Cosmetic Act, Federal Trade Commission Act, or the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid International Standards Organization and their respective implementing regulations or any other government healthcare programsimilar regulations in any applicable jurisdiction. None The Company and its Subsidiaries are in compliance in all material respects with all applicable requirements of the Parent or any Parent Subsidiary are a party to any Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act and the regulations promulgated thereunder (collectively, the “FDA Requirements”).
(c) To the extent currently required, all manufacturing, including testing, by the Company and its Subsidiaries have been conducted in all material corporate integrity agreementsrespects in compliance with applicable good manufacturing practices, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed and good laboratory practices as set forth by any Parent Regulatory Agencythe FDA.
(d) All pre-clinical The Company and clinical investigations in respect of a Parent Product its Subsidiaries have not filed any biologics license applications, new drug applications, medical device premarket notifications or Parent Product candidate conducted applications and neither the Company nor its Subsidiaries market any biologic, drug or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 medical device products.. None of the Code of Federal Regulations and (ii) any applicable federalCompany, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, of their respective officers or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, noremployees or, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any Knowledge of the Parent SubsidiariesCompany, agents has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, the Office of the Inspector General of the Department of Health and Human Services or failed to disclose a material fact required to be disclosed to the FDA FDA, FTC or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any Office of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programInspector General.
(ge) As to each Parent Product or Parent Product candidate subject to To the FDCA and the regulations Company’s Knowledge, as of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parentdate hereof, there are no facts which are reasonably likely to cause, or circumstances that would render unlikely the Company’s compliance with the Dietary Supplement and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding Nonprescription Drug Consumer Protection Act (i) the recall, market withdrawal or replacement of any Company Product sold or intended due to be sold by Parent or a Parent Subsidiary (other than recallseffective on December 22, withdrawals or replacements 2007), in the form in which that are not material to Parent Act currently exists, or the Parent Subsidiariesregulations for Current Good Manufacturing Practice in Manufacturing, taken as a wholePackaging, Labeling, or Holding Operations for Dietary Supplements (21 C.F.R. Part 111), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Productsas to which compliance is required by June 25, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product2009.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Natrol Inc)
Regulatory Matters. (a) Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, neither the Company nor any of its Subsidiaries is, nor since January 1, 2021, has not had been, or has been required to be, registered, licensed or qualified as a bank, trust company, commodity trading advisor, commodity pool operator, introducing broker, futures commission merchant, swap dealer, transfer agent, real estate broker, municipal advisor, insurance company or insurance broker.
(b) Since June 10, 2022, neither the Company nor any of its Subsidiaries has provided any investment management or investment advisory services, including sub-advisory services, that require such Company or Subsidiary to be registered (or to rely on an exemption from registration) as an “investment adviser” within the meaning of the Investment Advisers Act of 1940 (the “Investment Advisers Act”)or has been required to be registered (or to rely on an exemption from registration) under any similar applicable Law in any jurisdiction. Prior to such date, since January 1, 2021, to the extent the Company or any Subsidiary of the Company provided such services, such services were provided by a Subsidiary of the Company that was a duly registered investment adviser under the Investment Advisers Act and, to the extent required, duly registered in any similar capacity in any other jurisdiction, and all such services were provided by the Company and any Subsidiary of the Company in compliance with applicable Law, except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(bc) The Company Broker-Dealer is the only Subsidiary of the Company that is a Broker-Dealer. Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, either individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent (i) since January 1, 2021, the Company Broker-Dealer has been duly registered as a Broker-Dealer with the SEC and each state and other jurisdictions in which it is required to be so registered, (ii) the Parent Subsidiaries Company Broker-Dealer is, and since January 1, 2021 has been, a member in good standing of FINRA and has not been, nor been required to be, a member of any other Self-Regulatory Organization, and (iii) to the knowledge of the Company, each natural person whose functions require him or her to be licensed as a representative or principal of, and registered with, the Company Broker-Dealer is registered with FINRA and all applicable states and other jurisdictions, such registrations are not, and since January 1, 2021 have not engaged been, suspended, revoked or rescinded and remain in activities which arefull force and effect, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or and no such natural person is registered with more than one Broker-Dealer in any other government healthcare program. None of the Parent or jurisdiction where such multiple registrations would violate any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencyapplicable Law.
(d) All pre-clinical The Company has made available to Parent complete and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 correct copies of the Code Company Broker-Dealer’s current Form BD as of Federal Regulations the date of this Agreement. The Company will make available to Parent complete and (ii) correct copies of any applicable federal, state and provincial Laws restricting Form BD filed with the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually SEC before the Closing Date by it or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices its Subsidiaries. Except as would not reasonably be expected to have, either individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents(i) the current Form BD of the Company Broker-Dealer is, claimsand any Form BD of the Company Broker-Dealer filed before the Closing Date will be at the time of filing, permits and notices were complete and accurate in compliance in all material respects on with the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any applicable requirements of the Parent SubsidiariesExchange Act, northe rules thereunder and the rules of any Self-Regulatory Organization, as applicable and (ii) no fact relating to the knowledge of Parent, any officer, employee, agent or distributor of Parent Company Broker-Dealer or any “control affiliate” of the Parent SubsidiariesCompany Broker-Dealer, has made an untrue statement as defined in Form BD, requires any response in the affirmative to any question in Item 11 of a material fact or a fraudulent statement Form BD, except to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each extent that such case, related to the business of Parent or any facts have been reflected on Form BD of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935Company Broker-Dealer, as amended, or any similar Parent Healthcare Law or programapplicable.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ie) Except as would not reasonably be expected to have have, either individually or in the aggregate, a Parent Material Adverse Effect, neither Parent (i) none of the Company Broker-Dealer, or any of the Company’s other Subsidiaries, nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting Company Broker-Dealer’s “associated persons” (as defined in the unauthorized accessExchange Act) is (A) ineligible pursuant to Section 15(b) of the Exchange Act to serve as a Broker-Dealer or as an “associated person” of a Broker-Dealer, use or disclosure (B) subject to a “statutory disqualification” as defined in Section 3(a)(39) of data or information that is linked the Exchange Act, (C) subject to any reasonably identifiable material disciplinary proceedings or Orders that would be required to be disclosed on Form BD or Forms U-4 or U-5 (and which disciplinary proceedings or Orders are not actually disclosed on such person’s current Form BD or current Forms U-4 or U-5) to the extent that such person or its associated persons is required to file such forms, or (D) subject to a disqualification that would be a basis for censure, limitations on the activities, functions or operations of, or suspension or revocation of the registration of such person as broker-dealer, municipal securities dealer, government securities broker or government securities dealer under Section 15, Section 15B or Section 15C of the Exchange Act, and (ii) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of the Company, threatened by any other data protected under Governmental Entity that would reasonably be expected to result in any of the circumstances described in the foregoing clauses (i)(A), (i)(B), (i)(C) and (i)(D).
(f) The Brokerage Services performed by the Company Broker-Dealer since January 1, 2021 have been conducted in compliance with all material requirements of the Exchange Act, the rules and regulations of the SEC, FINRA, and any applicable state securities regulatory authority or Self-Regulatory Organization, as applicable, in each case except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect. Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (A) the Company Broker-Dealer has established, in compliance with requirements of applicable Law. Parent or Merger Sub is not , and maintained in effect at all times required by applicable Law since January 1, 2021, written policies and procedures reasonably designed to achieve compliance with the Exchange Act and the rules of each applicable Self-Regulatory Organization (“BD Compliance Policies”), including those required by (i) applicable FINRA rules, including FINRA Rule 3110, 3120 and 3130, (ii) anti-money laundering laws, including a business associatewritten customer identification program in compliance therewith, (iii) privacy laws including policies and procedures with respect to the protection of nonpublic personal information about customers, clients and other third parties and (iv) identity theft laws, and (B) such BD Compliance Policies have been approved by such principals, managers and other supervisors as that are required under the aforementioned laws, rules and regulations.
(g) The Company Broker-Dealer currently maintains, and since January 1, 2021 has maintained, “net capital” (as such term is defined in Rule 15c3-1(c)(2) under the HIPAA regulations at 45 C.F.R. § 160.103Exchange Act) equal to or in excess of the minimum “net capital” required to be maintained by the Company Broker-Dealer, and in an amount sufficient to ensure that it is not required to file a notice under Rule 17a-11 under the Exchange Act.
(jh) Notwithstanding anything contained Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (i) no Governmental Entity has, since January 1, 2021, formally initiated any administrative proceeding or investigation into the Company Broker-Dealer and (ii) the Company Broker-Dealer has not received a written “▇▇▇▇▇ notice”, other written indication of the commencement of an enforcement action from the SEC, FINRA or any other Governmental Entity, or other notice alleging any material noncompliance with any applicable Law governing the operations of Broker-Dealers. As of the date of this Section 4.13Agreement, the Company has no representation knowledge of any unresolved material violation or warranty shall material exception raised in writing by any Governmental Entity with respect to the Company Broker-Dealer. Except as would not reasonably be deemed expected to be made have, either individually or in this Section 4.13 the aggregate, a Material Adverse Effect, (i) since January 1, 2021, the Company Broker-Dealer has not settled any claim or proceeding of the SEC, FINRA or any other Governmental Entity and (ii) the Company Broker-Dealer has not had an order, decree or judgement entered against it by a Governmental Entity in respect connection with any applicable Law governing the operation of environmentalBroker-Dealers. As of the date hereof, Taxthe Company Broker-Dealer is not currently subject to, employee benefits or labor Law mattershas received any written notice of, an examination, inspection, investigation or inquiry by a Governmental Entity, and no examination or inspection has been started or completed for which no examination report is available.
Appears in 1 contract
Regulatory Matters. (ai) The Company has made all required filings under applicable insurance holding company statutes, and has received approvals of acquisition of control and/or affiliate transactions, in each jurisdiction in which such filings or approvals are required, except where the failure to have made such filings or receive such approvals in any such jurisdiction would not result, individually or in the aggregate, in a Material Adverse Effect. Each of the Company and its subsidiaries: (A) holds such permits, licenses, consents, exemptions, franchises, authorizations and other approvals from insurance departments and other governmental or regulatory authorities (each, an “Authorization”) (including, without limitation, insurance licenses from the insurance regulatory agencies of the various states or other jurisdictions where it conducts business (the “Insurance Licenses”)), and has made all filings with and notices to, all governmental or regulatory authorities and self-regulatory organizations and all courts and other tribunals, as are necessary to own, lease, license and operate its respective properties and to conduct its business in the manner described in the Confidential Information Memorandum and the SEC Filings, except where the failure to have any Authorization or Insurance License or to make any such filing or notice would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, and (B) has fulfilled and performed all material obligations necessary to maintain such Authorizations and Insurance Licenses. Except as has not had and would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect (A) each such Authorization and Insurance License is valid and in full force and effect and each of the Company and its Subsidiaries is in compliance with all the terms and conditions thereof and with the rules and regulations of the authorities and governing bodies having jurisdiction with respect thereto; and (B) no event has occurred (including, without limitation, the receipt of any notice from any authority or governing body, the execution, delivery and performance of this Agreement by the Sellers, the sale and delivery of the Series A Preferred Stock and the compliance by the Sellers with all of the provisions hereof and the consummation by the Sellers of the transactions contemplated in this Agreement) which allows or, after notice or lapse of time of both, would allow, revocation, suspension or termination of any such Authorization or Insurance License or results or, after notice or lapse of time or both, would result in any impairment of the rights of the holder of any such Authorization or Insurance License. Except as disclosed in the Confidential Information Memorandum and the SEC Filings, no insurance regulatory agency or body has issued any order or decree impairing, restricting or prohibiting the payment of dividends of any Company Subsidiary to its respective parent which would reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(ii) Neither the Company nor any of its Insurance Subsidiaries is in violation of, (i) each of Parent or in default in the performance, observance or fulfillment of, any obligation, agreement, covenant or condition contained in reinsurance treaties, contracts, agreements and arrangements to which the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of the Parent its Insurance Subsidiaries as currently conducted is a party, except for such violations or as planned to defaults which would not reasonably be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would notexpected to, individually or in the aggregate, reasonably be expected to have result in a Parent Material Adverse Effect, ; neither the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent Company nor any of the Parent its Insurance Subsidiaries has received any written notification or communication notice from any Parent Regulatory Agencyof the other parties to such treaties, including contracts, agreements or arrangements that such other party intends not to perform its obligations thereunder and none of them has any reason to believe that any of the FDAother parties to such treaties, the Drug Enforcement Administrationcontracts, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, agreements or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawsarrangements will be unable to perform its obligations thereunder, except where to the extent that such noncompliance or liability nonperformance would not reasonably be expected to haveto, individually or in the aggregate, result in a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Stock Purchase Agreement (Universal American Corp.)
Regulatory Matters. (a) Except At all times since January 1, 2018, (i) the Company has developed, tested, manufactured, labeled, marketed, promoted and stored, as applicable, each of the Company Products, and, (ii) to the Knowledge of the Company, all Company vendors have marketed and promoted each of the Company Products, in compliance with applicable Laws (in the United States and outside of the United States), including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices, as applicable, except in the case of both (i) and (ii) as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, . During the three (i3) each years prior to the date of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012this Agreement, neither Parent the Company nor any of the Parent its Subsidiaries has received any written notification notice or other communication from any Parent Regulatory AgencyGovernmental Authority alleging any violation of any Law with respect to such activities or any “warning letters” with respect to any Company Product or any manufacturing, including the FDApromotional, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, marketing or liability of Parent distribution processes or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawsprocedures, except where such noncompliance or liability as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except material impact on the Company and its Subsidiaries, taken as would nota whole. To the Knowledge of the Company as of the date of this Agreement, individually or in there are no existing conditions at the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid Company or any other government healthcare program. None of its Subsidiaries or, to the Knowledge of the Parent or Company as of the date of this Agreement, at any Parent Subsidiary are a party contract manufacturer with respect to any Company Product, that would result in a Governmental Authority shutdown or import or export prohibition, “warning letters,” “untitled letters” or written requests to make material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements changes with or imposed by respect to any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conductmanufacture or distribution of Company Products, performanceor the way in which the Company Products are marketed or promoted, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, except as has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reportsAs of the date hereof, documentsall material deficiencies and non-conformities discovered during audits and inspections performed by the Company, claims, permits its Subsidiaries or Governmental Authorities have been corrected and notices were complete and accurate resolved in all material respects on respects.
(b) During the three (3) years prior to the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1of this Agreement, 2012, neither Parent none of the Company nor any of the Parent Subsidiaries, norits Subsidiaries or, to the knowledge Knowledge of Parentthe Company as of the date of this Agreement, any officercontract manufacturer, employee, agent or distributor of Parent or with respect to any of the Parent SubsidiariesCompany Product, has made received any written notices, information request letters, correspondence, orders or other written communications from any Governmental Authority issuing, requiring or causing any recall, seizure, detention, market withdrawal or replacement, safety alert, warning letter, investigator notice or other notice relating to an untrue statement alleged lack of a material fact safety or a fraudulent statement to the FDA efficacy of or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted manufacturing deficiencies of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent SubsidiariesProduct, except as would not, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole. None of the Company nor any of its Subsidiaries or, to the Knowledge of the Company as of the date of this Agreement, any contract manufacturer with respect to any Company Product, has taken any such action voluntarily.
(c) All studies and trials conducted by or on behalf of the Company or any of its Subsidiaries have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed conducted in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have be material to the Company and its Subsidiaries, taken as a Parent Material Adverse Effect.
whole. As of the date of this Agreement, no trial conducted by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons. As of the date of this Agreement, no applicable Governmental Authority, clinical investigator who has participated or is participating in a trial conducted by or on behalf of the Company or any of its Subsidiaries, or institutional review board that has or has had jurisdiction over a trial conducted by or on behalf of the Company or any of its Subsidiaries, has commenced, or, to the Knowledge of the Company as of the date of this Agreement, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing investigation conducted by or on behalf of the Company or any of its Subsidiaries. There are no pending or, to the Knowledge of the Company as of the date of this Agreement, threatened actions or proceedings by any Governmental Authority seeking to (hor that would reasonably be expected to) Except prohibit or impede the sale of any Company Product into any market, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Company and its Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(id) All Authorizations exclusively relating to the Company Products as of the date of this Agreement are listed on Section 4.18(d) of the Company Disclosure Letter. Except as would not reasonably be expected to have a Parent Material Adverse Effectset forth on Section 4.18(d) of the Company Disclosure Letter, neither Parent the Company nor any of the Parent its Subsidiaries has experienced received any security breach written notice or other incident resulting in request within the unauthorized accesspast twelve (12) months from any Governmental Authority that requests or requires the conduct or generation of additional trials, use studies or disclosure of data or information that is linked tests to maintain any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103such Authorization.
(je) Notwithstanding anything contained None of the Company nor any of its Subsidiaries is a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Authority, and, to the Knowledge of the Company as of the date of this Section 4.13Agreement, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matterssuch action is pending.
Appears in 1 contract
Regulatory Matters. (a) Except Each of the products under development by the Company is identified in Section 4.15(a) of the Company Disclosure Schedule (the “Company Products”). The Company is not currently marketing any product. The Company holds all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the FDCA, PHSA and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity strength, purity, safety, efficacy or manufacturing of the Company Products (any such Government Authority a “Company Regulatory Agency”) required for the lawful operation of the business of the Company (the “Company Permits”), except, in each case, as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and Effect on the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any Company. All such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Company Permits are valid and in full force and effect; . None of such Company Permit will be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement. The Company is the sole and exclusive owner of Company Permit and the associated filings and applications with the FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (iiicollectively, the “Company Regulatory Filings”) Parent and hold all right, title and interest in and to all Company Regulatory Filings free and clear of any encumbrance. The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including any of the know-how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.
(b) Since January 1, 2010, there has not occurred any breach or violation of, default (with or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Company Permit. The Company is in compliance in all material respects with the terms of all Parent Regulatory Permits.
(b) Except as Company Permit, and no event has occurred and no facts or circumstances exist that, to the knowledge of the Company, would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectresult in the revocation, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Lawscancellation, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state non-renewal or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities adverse modification of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectCompany Permit.
(c) Except Since January 1, 2010, all material applications, submissions, information and data used by the Company as would notthe basis for, individually or in submitted by or, to the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None knowledge of the Parent Company, on behalf of the Company in connection with, any and all requests for Company Permit when submitted to the FDA or other Company Regulatory Agency, were, to the Company’s knowledge, accurate and complete in all material respects as of the date of submission, and any Parent Subsidiary are a party updates, changes, corrections or modifications to any material corporate integrity agreementssuch applications, deferred prosecution agreementssubmissions, monitoring agreements, consent decrees, settlement orders, information and data required under Applicable Law have been submitted to the FDA or similar agreements with or imposed by any Parent other Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 20122010, neither Parent nor the Company has not committed any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ” or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectpolicies under Applicable Law. Neither Parent nor any of the Parent Subsidiaries, Company nor, to the knowledge of Parentthe Company, any agent, subcontractor, director, officer, employee, agent employee or distributor of Parent other Person associated with or any acting on behalf of the Parent Subsidiaries, Company has been debarred or convicted of any crime or engaged in any conduct for which has resulted or could result in debarment is mandated or disqualification by 21 U.S.C. § 335a(a) the FDA or any similar Law other Government Authority, and there are no proceedings pending or authorized threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by 21 U.S.C. § 335a(b) the FDA or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, Government Authority.
(e) The Company nor, to the knowledge of Parentthe Company, any director, officer, employeeagent, agent employee or distributor of Parent other Person associated with or any acting on behalf of the Parent SubsidiariesCompany, has been debarredhas: (i) used any corporate funds for any unlawful contribution, suspended gift, entertainment or excluded other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from participation corporate funds; (iii) violated or is in any government health care program or convicted violation of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 provision of the Social Security Act of 1935, as amended, FCPA or any similar Parent Healthcare Law Applicable Law; or program.
(giv) As to each Parent Product made any bribe, rebate, payoff, influence payment, kickback or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and securityother unlawful payment. There is are no action or proceeding pending or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable threatened filings against the Company of an action relating to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectfederal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)).
(hf) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122010, neither Parent nor there has not been any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issuedconducted, or caused to be initiated, conducted or issued, any issued recall, field correctionsnotification, field correction, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator noticemarket correction, or other investigator notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged material lack of safety, safety or efficacy or regulatory compliance of any Parent Company Product.
(g) The Company is in compliance in all material respects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the clinical investigation, manufacture, sale, promotion, sampling and distribution of pharmaceutical products or biological, or device products in any jurisdiction. To The Company has at all times and is currently distributing, marketing, promoting, labeling and selling its products in accordance with the FDCA and Prescription Drug Marketing Act of 1987. There are no pending or, to the knowledge of Parentthe Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company. Since January 1, 2010 there are have been no facts which are written notices, reports, FDA Form 483 observations that have not been disclosed by the Company warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to the Company or any Company Product or any subpoenas or investigative demands or other written inquiries that would reasonably likely be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to cause, any Company Product.
(h) The manufacture of Company Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA. The Company has been in material compliance with FDA’s registration and Parent listing requirements to the extent required by FDA.
(i) The Company is and has not received any written notice from been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Parent Regulatory Agency Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. There have been no Serious Adverse Events or Serious Injuries associated with the use (including in clinical trials) of any Company Products that have not been reported to the FDA in accordance with Applicable Law.
(j) To the knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the knowledge of the Company, on behalf of the Company, are being, and at all times have been, conducted incompliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by the Company or, to the knowledge of the Company, on behalf of the Company, has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial.
(k) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing any Federal Health Care Program. The Company meets all the requirements of participation and payment of Medicare, Medicaid, and any Programs to the extent in which it participates. There is no action pending, received or, to the Company’s knowledge, threatened against the Company which relates in any way to a violation of any health care laws or which could result in the imposition penalties against or the exclusion of the Company from participation in any Programs. Neither the Company nor any officer, director or managing employee has engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from any Program. To the Company’s knowledge, there is no pending, proposed or final Medicare national or local coverage determination that, if finalized, would restrict coverage for the Company’s products. The Company has not established any reimbursement support program, such that payment for the Company product is contingent upon a purchaser’s receipt of payment from a third party payer. The Company does not furnish any coverage, coding or billing advice to any health care professionals regarding off-label indications of the Company products.
(l) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) the recallhas been debarred, market withdrawal excluded or replacement of any Company Product sold suspended under 21 U.S.C. § 335a, or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) any similar law, from participation in any Federal Health Care Program; (ii) has had a material change in civil monetary penalty assessed against it, him or her under Section 1128A of the marketing classification or a material change in the labeling of any such Parent Products, Social Security Act; (iii) a termination or suspension is currently listed on the General Services Administration published list of the manufacturing, marketing, or distribution of such Parent Products, or parties excluded from federal procurement programs and non-procurement programs; (iv) to the knowledge of the Company, is the target or subject of any current investigation by a material negative change Government Authority relating to any Federal Health Care Program related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; or (vi) is the subject of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in reimbursement status of a Parent Product56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(im) Except as would not reasonably be expected There are no pending or, to have a Parent Material Adverse Effect, neither Parent nor any the knowledge of the Parent Subsidiaries has experienced Company, threatened filings against the Company of an action relating to the Company under any security breach federal or other incident resulting state whistleblower statute, including under the civil False Claims Act of 1863 (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)) or the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)).
(n) To the knowledge of the Company, the Company is not under investigation by any Government Authority for a violation of HIPAA, or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the unauthorized access, use or disclosure United States Department of data or information that is linked the Company and Human Services Office of Civil Rights relating to any reasonably identifiable person such violations, or any other data protected under applicable Lawcomparable state or local laws. Parent or Merger Sub The Company is not a business associate, “covered entity” as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103HIPAA. The Company has been in compliance in all material respects with federal and state data breach laws.
(jo) Notwithstanding anything contained The Company is and has been in this Section 4.13compliance in all material respects with all Applicable Laws requiring state registration, no representation or warranty shall be deemed state reporting of applicable sales and marketing expenditures and transactions to be made in this Section 4.13 in respect health care professionals, and state compliance program requirements, which may include (depending on the state) but is not limited to adoption of environmentalthe OIG Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, Taxthe AdvaMed Code, employee benefits or labor Law matters.and/or the PhRMA Code. See Cal. Health & Safety Code §§ 119400 — 119402; Connecticut, Subst. Senate ▇▇▇▇ ▇▇. ▇▇▇, ▇▇▇▇ ▇▇. ▇▇▇, ▇▇▇. ▇▇. ▇▇▇; D.C., D.C. Code ▇▇▇. §§ 48-833.01—48-833.09; Maine, Maine Rev.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Biosante Pharmaceuticals Inc)
Regulatory Matters. (a) 15.1 Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, :
(a) each of the Company and its Subsidiaries holds:
(i) each all authorisations of Parent the US Food and Drug Administration (“FDA”) required to be held under the Parent Subsidiaries holds (x) all permitsUS Food, licenses, franchises, approvals, clearances, registrationsDrug, and authorizations under Cosmetic Act of 1938 (the “FDCA”), the US Public Health Service Act (the “PHSA”), and the regulations of the FDA promulgated thereunder, data protection laws and thereunder necessary for the lawful operations of the businesses of the Company or any of its Subsidiaries as currently conducted; and
(yii) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations other authorisations of any applicable Governmental Entity or Notified Body Authority that are concerned with the development, quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, packaging, labelling, storage, transport, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Company Products (any such Governmental Entity or Notified BodyAuthority, together with the FDA, a “Parent Company Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent the Company or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); ;
(iib) all such Parent Company Regulatory Permits are valid and in full force and effecteffect (subject to the Bankruptcy and Equity Exceptions to the extent applicable thereto); and
(c) the Company and (iii) Parent is its Subsidiaries are in compliance with the terms of all Parent Company Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any 15.2 As of the foregoing applicable in jurisdictions in which material quantities date of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012this Agreement, neither Parent the Company nor any of the Parent its Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, 15.3 Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(e) Since , during the period beginning on 1 January 1, 20122021 and ending on the date of this Agreement, neither Parent Company nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which other Company Regulatory Agency that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(f) 15.4 Since 1 January 1, 20122021 through the date of this Agreement, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent the Company and the Parent its Subsidiaries (“Submissions”) have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices Submissions have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. All Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such reports, documents, claims, permits Submissions were true and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, .
15.5 Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Company Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Company or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Company Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelinglabelling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parentand (b) since 1 January 2021, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent neither Company or any of the Parent its Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Company Regulatory Agency regarding (i) alleging any non-compliance with the recallFDCA, market withdrawal PHSA or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productcomparable Applicable Laws.
(i) 15.6 Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect, since 1 January 2021 neither Parent the Company nor any of its Subsidiaries, nor to the Parent Subsidiaries Knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries, has experienced been (a) debarred, convicted of, indicted for, or charged with any security breach crime or other incident resulting engaged in any conduct for which debarment or exclusion is mandated or permitted by 21 U.S.C. § 335a, 42 U.S.C. § 1320a-7, or relevant regulations in 42 C.F.R. Part 1001; or (b) is the unauthorized access, use or disclosure subject of data or information a proceeding that is linked likely to any reasonably identifiable person result in such debarment, exclusion, or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103suspension.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Transaction Agreement (Abcam PLC)
Regulatory Matters. (a) Except (i) Each Group Member has, and it and its Products are in conformance in all material respects with, all Regulatory Required Permits required to conduct its respective businesses as now conducted; (ii) to the knowledge of Holdings and the Borrower, neither the FDA nor other Governmental Authority has provided notice of or is considering limiting, suspending, revoking or terminating such Regulatory Required Permits; (iii) the Group Members have fulfilled and performed, in all material respects, their obligations under each material Regulatory Required Permit, and, to the knowledge of each Group Member, no event has occurred or condition or state of facts exists which would constitute a breach or default, or would cause revocation, limitation, suspension, or termination of any such Regulatory Required Permit, except (x) with respect to Core Business Segments, in each of cases (i), (ii) and (iii) to the extent such Regulatory Required Permit are not had material to the business of the Group Members, and (y) other than with respect to Core Business Segments, in each of cases (i), (ii) and (iii), to the extent it would not reasonably be expected expect to have, individually or in the aggregate, have a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except All Products that are subject to Health Care Laws, to the knowledge of each Group Member, have been and are being researched, designed, developed, tested, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance in all material respects with applicable Health Care Laws or any other Applicable Law, including, without limitation, the Applicable Laws related to clinical and non-clinical testing, product approval or clearance, current good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and listing, and medical device and other post-market reporting, and all other importation and distribution requirements, except as it would not, individually or in the aggregate, not be reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as it would not, individually or in the aggregate, not be reasonably be expected to have a Parent Material Adverse EffectEffect or as it has been publicly disclosed, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party (i) with respect to any material corporate integrity agreementsProduct, deferred prosecution agreementsthe Group Members have received all Regulatory Required Permits required in connection with the design, monitoring agreementstesting, consent decreesmanufacture, settlement ordersprocessing, assembly, packaging, labeling, marketing, distribution, commercialization, import, export, or similar agreements with sale of such Product as currently being conducted by or imposed by on behalf of such Group Member; and (ii) no Group Member has been restrained in its ability to manufacture, process, distribute, supply, import, export, market, or sell any Parent Regulatory Agencyof its Products.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 As of the Code of Federal Regulations and (ii) Closing Date, no Group Member is undergoing any applicable federalinspection related to Regulatory Required Permits, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectexcept as set forth on Schedule 4.26.
(e) Since January 1To the knowledge of each Group Member, 2012, neither Parent no Group Member nor any of the Parent Subsidiaries their respective officers, directors or employees has received (A) made any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the developmentuntrue statement of material fact, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityfraudulent statement, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished material omission to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually Governmental Authority or in any documents or records required to be maintained under the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed Applicable Laws; (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, B) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, Governmental Authority; or (C) committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a the basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” as set forth in 56 Fed. Reg. 46191 (September 10, 1991); or (D) been investigated by FDA or any other Governmental Authority, including but not limited to the Office of the Inspector General for the Department of Health and Human Services, or the Department of Justice, for data or healthcare program fraud. To the knowledge of each Group Member, no Group Member, nor any of their respective officers, directors, employees, or, to their knowledge, contractors, have made or offered any payment, gratuity, or other thing of value that is prohibited by any Applicable Law to personnel of the FDA or any other Parent Regulatory Agency Governmental Authority.
(f) None of the Products related to invoke the Core Business Segments have been subject to a Recall, nor is any similar policysuch action currently under consideration by any Group Member or, to the knowledge of the Group Members, any manufacturer or supplier of a Product, except for as this would not be reasonably expected to have a Material Adverse Effect.
(g) There are no civil, criminal, or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings, demand letters, or other communications relating to any act alleged hazard or statement alleged defect in design, manufacture, materials, or workmanship, including, without limitation, any failure to make a statement thatwarn or alleged breach of express or implied warranty or representation, individually relating to any Product provided by any Group Member, or alleging that any such Products are otherwise unsafe or ineffective for their intended use, that are presently pending or threatened in the aggregatewriting, has not had and other than as it would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect, (i) each the Company and its Subsidiaries have obtained all Permits (including, for the avoidance of Parent and the Parent Subsidiaries holds (x) doubt, all permits, licenses, franchises, approvals, clearances, establishment registrations, device listings and authorizations under 510(k) clearances (or their foreign equivalents)) required by any Health Authority to permit the FDCA, the PHSA, the regulations conduct of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the their respective businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); conducted, (ii) all of such Parent Regulatory Permits are valid and in full force and effect; and , (iii) Parent the Company is in compliance with with, and is not in default under, each such Permit and (iv) none of such Permits shall be terminated or impaired or become terminable, in whole or in part, as a result of the terms of all Parent Regulatory Permitstransactions contemplated by this Agreement.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since since January 1, 20122015, neither Parent nor none of the Company, any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, noror, to the knowledge of Parentthe Company, any officerof their respective directors, employeeofficers, agent employees or distributor of Parent or any of Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Parent Company and its Subsidiaries, has ) have (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyHealth Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyHealth Authority, or (iii) committed an any other act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its the policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Fraud Policy”) or for any other Health Authority to invoke a similar policy that may be applicable to the Company or any of its Subsidiaries in another jurisdiction. None of the Company, any of its Subsidiaries or, to the knowledge of the Company, any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and its Subsidiaries) are the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any other Parent Regulatory Agency Health Authority, that, assuming such investigations were determined or resolved adversely, would reasonably be expected to invoke any similar policy, except for any act or statement or failure to make a statement thathave, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ic) Except as would not reasonably be expected to have have, individually or in the aggregate, a Parent Company Material Adverse Effect, neither Parent nor since January 1, 2015, the Company and each of its Subsidiaries and, to the knowledge of the Company, each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries), has been in compliance in all material respects with all Health Laws, including those relating to laboratory developed tests. None of the Company, any of its Subsidiaries or, to the Parent Subsidiaries has experienced knowledge of the Company, any security breach Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries) (5) have received any written notice or other incident resulting written communication from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any failure to maintain systems and programs adequate to ensure compliance with any such Health Laws, or contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any product subject to any Health Law, or (6) are subject to any material enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(d) Except as would not reasonably be expected to have, individually or in the unauthorized accessaggregate, use a Company Material Adverse Effect, the Company and its Subsidiaries have, since January 1, 2015, filed with the applicable Health Authority all required and material Filings, including adverse event reports. Except as would not reasonably be expected to have, individually or disclosure of data or information that is linked in the aggregate, a Company Material Adverse Effect, all such Filings were in material compliance with Applicable Law when filed, and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any reasonably identifiable person such Filings.
(e) None of the Company or any of its Subsidiaries, any of their respective officers, directors or managing employees (as such terms are defined in 42 C.F.R. § 1001.1001) or, to the knowledge of the Company, any other data protected under applicable Law. Parent Company Service Provider or Merger Sub is not a business associate, agent (as that such term is defined in the HIPAA regulations at 45 42 C.F.R. § 160.1031001.1001) of the Company or any of its Subsidiaries has been disqualified, debarred or deregistered by any Governmental Authority.
(jf) Notwithstanding anything contained in this Section 4.13Except as disclosed on Schedule 5.14(f) of the Company Disclosure Schedule, no representation as of the date hereof, neither the Company nor any of its Subsidiaries have received any written coverage or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersreimbursement decision from any government payor.
Appears in 1 contract
Sources: Merger Agreement (Roche Holding LTD)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and Seller or its applicable Affiliate (including the Parent Subsidiaries holds (xTransferred Entity) possesses, or has rights to control directly or through Third Party distributors, all permitsTransferred Marketing Authorizations, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits the Transferred Marketing Authorizations are valid and in full force and effect; and , (iii) Parent no Proceeding is pending or, to the Knowledge of Seller, has been threatened in compliance with writing, regarding the withdrawal or suspension of any Transferred Marketing Authorization, (iv) none of Seller or its applicable Affiliates (including the Transferred Entity) nor, to the Knowledge of Seller, any of their Third Party distributors, have received during the three years prior to the date hereof any written communication from any Regulatory Authority or other Governmental Entity threatening to withdraw or suspend any Transferred Marketing Authorization and (v) none of Seller or its applicable Affiliates (including the Transferred Entity) nor, to the Knowledge of Seller, any of their distributors, are in material violation of the terms of any Transferred Marketing Authorization. All Products Sold by or on behalf of Seller or its Affiliates (including the Transferred Entity) during the last three years under the Transferred Marketing Authorizations have been Manufactured, marketed, Sold and otherwise Exploited in all Parent Regulatory Permitsmaterial respects in accordance with the specifications contained in such Transferred Marketing Authorizations.
(b) Except as would not, individually or in During the aggregate, reasonably be expected to have a Parent Material Adverse Effectlast three years, the businesses Product has been developed, tested, labeled, packaged, Manufactured, distributed, stored and otherwise Exploited by or on behalf of each of Parent Seller and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws its Affiliates (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), Transferred Entity) in compliance in all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.respects with all
(c) Except as would notSeller and its Affiliates (including the Transferred Entity) are in material compliance with all Transferred Entity Permits.
(i) No Transferred Entity Permits have lapsed, individually been cancelled, terminated, been withdrawn or in the aggregatebeen restricted and (ii) no Proceeding to modify, reasonably be expected to have a Parent Material Adverse Effectsuspend, Parent and the Parent Subsidiaries have not engaged in activities which arerevoke, as applicablewithdraw, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement ordersterminate, or similar agreements with otherwise limit any such Transferred Entity Permit is pending, or, to the Knowledge of Seller, threatened in writing. Seller and its Affiliates (including the Transferred Entity) do not own any Permits (other than Marketing Authorizations or imposed by any Parent Regulatory Agencythe Transferred Entity Permits) exclusively related to the Business.
(d) All pre-clinical Manufacturing operations conducted by or for Seller and clinical investigations its applicable Affiliates (including the Transferred Entity) with respect to the units of Product Manufactured or Sold in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent the Territory during the last three years have been and the Parent Subsidiaries are being conducted in material compliance with all applicable Laws administered or issued by Law, including cGMP. The Seller and its applicable Affiliates (including the Transferred Entity) have filed with the applicable Parent Regulatory AgenciesAuthorities, where required by applicable Law, including (i) FDA standards for Health Care Laws, all required notices, registration applications, reports, supplemental applications and annual or other reports or documents, including Medical Device Reports, that are material to the designcontinued development, conductManufacture, performanceSale, monitoring, auditing, recording, analysis distribution and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 other Exploitation of the Code Product in the Territory. During the three years prior to the date hereof, with respect to the Product in the Territory, neither Seller nor any of Federal Regulations and its applicable Affiliates (iiincluding the Transferred Entity) nor, to the Knowledge of Seller, any contract manufacturers, have received any Form 483 observations, warning letters, untitled letters, or other similar written correspondence from any applicable federalRegulatory Authority with respect to the Product in which such Regulatory Authority asserted that the operations of the Seller, state and provincial Laws restricting its applicable Affiliates (including the collectionTransferred Entity), use and disclosure or any of individually identifiable health information and personal information, except, their contract manufacturers were not in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectcompliance with applicable Law.
(e) Since January 1, 2012, neither Parent nor any All preclinical studies and clinical trials of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed conducted by or on behalf of Parent Seller or any its Affiliates (including the Transferred Entity) during the three years prior to the date hereof have been and, if still pending, are being, conducted in compliance, in all material respects, with the applicable protocol for such study or trial, good laboratory practices and good clinical practices and all Laws applicable to such studies and trials. No clinical trial of the Parent Subsidiaries, except as would not, individually Product conducted by or in on behalf of Seller or its Affiliates (including the aggregate, reasonably be expected Transferred Entity) during the three years prior to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or the date hereof has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating terminated or suspended prior to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingscheduled completion, and security. There is no action Regulatory Authority or proceeding pending institutional review board have initiated, or, to the knowledge Knowledge of ParentSeller, threatenedthreatened to initiate, including any prosecutionaction to place a clinical hold order on, injunctionor otherwise terminate or suspend, seizure, civil fine, debarment, suspension any proposed or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any ongoing clinical investigation of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Stock and Asset Purchase Agreement (Emergent BioSolutions Inc.)
Regulatory Matters. Infinity hereby represents and warrants the following to MICL as of the Effective Date:
(a) Except as Infinity has not had provided or made available, when requested by MICL to conduct its due diligence review, any and would not reasonably be expected all documents and communications in its possession from and to havethe FDA or any other Governmental Authority, individually or in prepared by the aggregateFDA or any other Governmental Authority, a Parent Material Adverse Effectrelated to any Alliance Product, (i) each of Parent and that may bear on compliance with the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations requirements of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any other Governmental Authority, including any notice of the Parent Subsidiaries as currently conducted inspection, inspection report, warning letter, deficiency letter, or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.similar communication;
(b) Except as would notNeither Infinity nor any of its Affiliates has received, individually with respect to any Alliance Product, any oral or written communication (including any warning letter, untitled letter, or similar notices) from the FDA and, to Infinity’s knowledge, there is no action pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in the aggregateeach case alleging that with respect to any Alliance Product, reasonably be expected to have a Parent Material Adverse Effect, the businesses Infinity or any of each of Parent and each Parent Subsidiary are being conducted its Affiliates is not currently materially in compliance with any and all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended implemented by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”)FDA. Since January 1, 2012, neither Parent Neither Infinity nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries its Affiliates has received any written notice from any Governmental Authority claiming that the FDA or the EMA or any foreign agency with jurisdiction over the research, development, marketingmanufacture, labelinguse, offer for sale, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission import of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, Alliance Product is not in material compliance with all reports, documents, claims, permits applicable Laws and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnishedpermits, except where the failure to file, maintain or furnish such reports, documents, claims, permits or notices so comply would not reasonably be expected to have, individually or in the aggregate, have a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects adverse effect on the date filed business of Infinity and its Affiliates taken as a whole;
(or were corrected in or supplemented by a subsequent filing). Since January 1c) To Infinity’s knowledge, 2012none of Infinity, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent its Affiliates or any of the Parent Subsidiariestheir respective officers, employees or agents has made made, with respect to any Alliance Product, an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Authority;
(d) There are no pending, abandoned, withdrawn, or committed an act, made a statement, rejected INDs or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except NDAs for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Alliance Product;
(e) Neither Parent Infinity nor any of its Affiliates has Commercialized any pharmaceutical product anywhere in the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.world;
(gf) As to each Parent Product or Parent Product candidate subject to the FDCA To Infinity’s knowledge, all testing and the regulations research of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Alliance Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or Infinity and its Affiliates has been developed, manufactured, stored, distributed and marketed conducted in compliance with all GMP, GCP and GLP applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. required at the time such activity was performed; and
(g) There is no action material matter which has not been disclosed by Infinity to MICL concerning the safety or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries efficacy of any Law, except as would not, individually or in Alliance Product Interacting with the aggregate, reasonably be expected to have a Parent Material Adverse EffectHedgehog Pathway.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Strategic Alliance Agreement (Infinity Pharmaceuticals, Inc.)
Regulatory Matters. (a) Except as has not had Section 3.15(a) of the Seller Disclosure Schedule sets forth a true, complete and would not reasonably be expected correct list of all Regulatory Authorizations from the FDA, EMA and all other Regulatory Authorities held by Seller or its Affiliates relating to have, individually or the Product and/or used in the aggregateProgram, a Parent Material Adverse Effectand there are no other Regulatory Authorizations required for the Product in connection with the conduct of the Program as currently conducted. Other than as set forth in Section 3.09, all such Regulatory Authorizations are (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; , (ii) validly registered and on file with applicable Regulatory Authorities, (iii) Parent is in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. Seller and its Affiliates have filed all required notices and responses to notices, supplemental applications, reports (including all adverse event/experience reports) and other information with the terms of FDA, EMA and all Parent other applicable Regulatory PermitsAuthorities, and all such information is accurate and complete in all material respects.
(b) Except as would notSeller and its Affiliates do not have any Contract with any third party to develop, individually promote or market the Product or that otherwise grants such third party any license to develop, manufacture, supply, distribute, market, commercialize, sell, offer, import or otherwise commercialize the Product.
(i) The Product and any other product that is or has been researched, developed, manufactured, processed, stored, labeled, supplied, promoted, tested, imported, exported, distributed, marketed, licensed, sold or otherwise commercialized in connection with the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses Program by or on behalf of each Seller or any of Parent and each Parent Subsidiary are being conducted its Affiliates is in compliance in all material respects with all applicable Health Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state none of Seller or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries its Affiliates has received any written notification notice or other communication from any Parent Regulatory AgencyAuthority (A) withdrawing or placing the Product on “clinical hold” or requiring the termination, including delay, suspension or investigation of any pre-clinical studies or clinical trials of the Product or (B) alleging any violation of any Health Law and (iii) there are no investigations, suits, claims, actions or proceedings against or affecting the Program, the Product or any of the Acquired Assets, Seller or any of its Affiliates relating to or arising under (A) Health Laws or (B) any Applicable Laws relating to government health care programs, private health care plans or the privacy and confidentiality of patient health information. Neither Seller nor any of its Affiliates, has, or has ever, entered into any agreement or settlement with any Governmental Entity with respect to noncompliance with, or violation of, any Health Law. Seller has made available to Purchaser complete and correct copies of all Regulatory Materials, Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other Regulatory Authority communications, documents and other information submitted by Seller or its Affiliates to or received by Seller or its Affiliates from the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid EMA or any other government healthcare program. None Regulatory Authority, including meeting minutes, annual reports, inspection reports, notices of adverse findings, warning letters, untitled letters and similar documents, relating to Seller or any of its Affiliates, the conduct of the Parent Program or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencythe Product.
(d) All pre-clinical studies and clinical investigations in trials conducted or being conducted with respect of a Parent to the Product or Parent Product candidate conducted the Program by or at the direction of (including any sponsored by each by) Seller or any of Parent its Affiliates have been and the Parent Subsidiaries are being conducted in material compliance with all applicable Laws administered or issued by Applicable Laws, including the applicable Parent Regulatory Agenciesrequirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects (including “Informed Consent” as such term is defined under Applicable Laws in the United States and equivalent Applicable Laws in other jurisdictions), including material compliance with applicable Privacy and Information Security Laws and Health Laws. Neither Seller nor any of its Affiliates have received any notifications or other communications from any institutional review board (iIRB), ethics committee or safety monitoring committee raising any issues, including from any Regulatory Authority in any jurisdiction requiring the termination delay, suspension or investigation of any clinical trials conducted by, or on behalf of, Seller or any of its Affiliates, or in which Seller or any of its Affiliates have participated and, to knowledge of Seller, no such action has been threatened. Further, no clinical investigator, researcher, or clinical staff participating in any clinical trial conducted by, or on behalf of, Seller or any of its Affiliates, or in which Seller or any of its Affiliates have participated, has been disqualified from participating in studies involving the Product, and to the knowledge of Seller, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. Accurate and complete copies of all material scientific, pre-clinical and clinical data of Seller or any of its Affiliates with respect to the Product or the Program have been made available to Purchaser.
(e) FDA standards Any manufacture of the Product, including any clinical supplies used in any clinical trials, by or on behalf of Seller and any of its Affiliates has been conducted in material compliance with the applicable specifications and requirements of current Good Manufacturing Practices and all other Applicable Laws. No manufacturing site used for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 manufacture of the Code Product is subject to a Regulatory Authority shutdown or import or export prohibitions or has received any Form FDA 483, notice of Federal Regulations and (ii) violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Regulatory Authority alleging or asserting noncompliance with any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, exceptApplicable Law, in each case, for such noncompliance thatthat have not been complied with or closed to the satisfaction of the relevant Regulatory Authority, individually or in and to the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012knowledge of Seller, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or any other Regulatory Authority is considering such action. To the EMA knowledge of Seller, no Product has been adulterated or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencymisbranded.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Neither Seller nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge nor any representative of Parent, any officer, employee, agent or distributor of Parent Seller or any of the Parent Subsidiariesits Affiliates, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyAuthority, failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Parent Regulatory AgencyGovernmental Entity, or committed an act, made a statement, or failed to make a statement, in each such case, related including with respect to the business of Parent any scientific data or any of the Parent Subsidiariesinformation, that, at the time such disclosure was mademade or failure to disclose occurred, would reasonably be expected to provide a basis for any Regulatory Authority or any other Governmental Entity to invoke the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ), or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Seller nor any of the Parent Subsidiariesits Affiliates, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or nor any of the Parent SubsidiariesSeller’s or its Affiliates’ current or former directors, officers, employees, representatives or independent contractors: (i), has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law Applicable Laws or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which Applicable Laws;(ii) are, or have ever been, convicted of, charged with or investigated for any material quantities violation of any Health Law; (iii) have been convicted of, charged with, or investigated for any violation of the Parent Products a federal health care program-related material offense or Parent Product candidates are sold Applicable Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation, or intended by the Parent to be sold. Since January 1controlled substances; (iv) are, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has have ever been debarred, excluded, or suspended from participation, or excluded from participation otherwise been deemed ineligible to participate, in any government health care program programs of any Governmental Entity, or convicted of any crime regarding health care products or services, or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to result in any such debarment, exclusion, suspension, or ineligibility, including, without limitation, (A) debarment under 21 U.S.C. § 335a or any similar law (B) exclusion under 42 U.S.C. § 1320a-7 or any similar law or regulation; or (C) exclusion under 48 CFR Subpart §9.4, the System for Award Management Nonprocurement Common Rule; and (v) have a Parent Material Adverse Effectbeen subject to any consent decree of, each such Parent Product or Parent Product candidate is being criminal or has been developedcivil fine or penalty imposed by, manufacturedany Governmental Entity related to fraud, storedtheft, distributed and marketed in compliance with all applicable Lawsembezzlement, including those relating to investigational usebreach of fiduciary responsibility, marketing approvalfinancial misconduct, current good manufacturing practicesor obstruction of an investigation of controlled substances. No debarment or exclusionary claims, packagingactions, labeling, advertising, record keeping, reporting, and security. There is no action proceedings or proceeding investigations are pending or, to the knowledge of ParentSeller, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent threatened against Seller or any of the Parent Subsidiaries its Affiliates, or any of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effecttheir respective representatives.
(hg) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent Neither Seller nor any of the Parent Subsidiaries have voluntarily its Affiliates is or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent ever has not received any written notice from the FDA or any other Parent Regulatory Agency regarding been (i) the recallsubject to any enforcement, market withdrawal regulatory or replacement administrative proceedings against or affecting Seller or any of its Affiliates relating to or arising under any Company Product sold Health Laws and no such enforcement, regulatory or intended to be sold by Parent administrative proceeding has been threatened, or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of party to any such Parent Productscorporate integrity agreement, (iii) a termination or suspension of the manufacturingmonitoring agreement, marketingdeferred prosecution agreement, consent decree, settlement order, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productsimilar agreement imposed by any Governmental Entity.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Asset Purchase Agreement (Fusion Pharmaceuticals Inc.)
Regulatory Matters. (a) Except The Company and each of its Subsidiaries have all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct its business as has not had and currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to haveresult in a liability that is material to the Company and its Subsidiaries, individually or in the aggregate, taken as a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted whole (the “Parent Regulatory Company Permits”); .
(iib) all such Parent Regulatory The Company Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws except for any of the foregoing applicable failures to be in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud full force and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance effect that, individually or in the aggregate, has not had and would not reasonably be expected to have result in a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead liability that is material to the denialCompany and its Subsidiaries, limitation, revocation, or rescission taken as a whole. The Company and each of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or its Subsidiaries is in compliance under such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnishedCompany Permits, except where failure for such failures to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to havecomply that, individually or in the aggregate, would not reasonably be expected to result in a Parent Material Adverse Effect. All such reportsliability that is material to the Company and its Subsidiaries, documentstaken as a whole.
(c) Except for matters that, claimsindividually or in the aggregate, permits would not reasonably be expected to result in a liability that is material to the Company and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by its Subsidiaries, taken as a subsequent filing). Since whole, since January 1, 20122022, neither Parent the Company and each of its Subsidiaries: (i) is and at all times has been in compliance, to the extent applicable, with all Healthcare Laws and with all Judgments and final guidance having the effect of Law administered or issued by any Governmental Entity exercising authority applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product tested, developed, promoted, marketed, manufactured or distributed by the Company and each of its Subsidiaries; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Company Permits; (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit; and, (iv) there is no Legal Proceeding pending or, to the Knowledge of the Company, threatened in writing (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case, alleging that such Governmental Entity is considering such action. The Company has not been required to make any written notices to any Governmental Entity or Person under any Healthcare Law.
(d) To the Knowledge of the Company, none of the Company nor its Subsidiaries, nor any of the Parent Company’s or its Subsidiaries’ directors, norofficers, to the knowledge of Parentemployees, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, contractors has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Entity, or (iii) committed an any other act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that), at the time such disclosure or statement was mademade or failure to make occurred, would reasonably be expected to provide establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the date of this Agreement, set forth in 56 Fed. Reg. 46191 (September 10none of the Company nor its Subsidiaries, 1991) nor any of the Company’s or for its Subsidiaries’ directors, officers, employees, or, to the Knowledge of the Company, contractors are the subject of any pending or threatened investigation by the FDA or any other Parent Regulatory Agency pursuant to invoke any similar policyits Fraud, except Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy.
(e) Except for any act or statement or failure to make a statement matters that, individually or in the aggregate, has not had and would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries are being conducted or have a Parent Material Adverse Effect. Neither Parent been conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable laws and regulations and (ii) since January 1, 2022, neither the Company nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the Parent termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries.
(f) None of the Company, northe Company Subsidiaries or any of their respective officers or directors or, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any Knowledge of the Parent SubsidiariesCompany, has been debarred employees or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1agents, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has have been debarred, suspended suspended, or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935Federal Healthcare Program, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.sanction pursuant to
Appears in 1 contract
Regulatory Matters. (a) Except Each of the Company and the Subsidiaries has obtained and currently possesses all material, necessary and applicable Permits required by any Governmental Authority, including the United States Food and Drug Administration (the “FDA”) or under the Customs & International Trade Laws to permit the design, development, pre clinical and clinical testing, manufacture, labeling, sale, import, export, distribution and promotion of Company and Subsidiary products in jurisdictions where they conduct such activities, except as has not had had, and would not be reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(cb) Except as would notSince January 1, individually or in 2010, each of the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent Company and the Parent Subsidiaries have not engaged has complied and remains in activities which arecompliance with, as applicable, cause for false and there are no material unresolved questions or claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or concerning any other government healthcare program. None liability of the Parent Company or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements the Subsidiaries with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including to: (i) FDA standards for all applicable Laws, including the designCustoms & International Trade Laws and the Healthcare Regulatory Laws, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) the terms and requirements of all necessary and applicable Permits required by any applicable federalGovernmental Authority to permit the design, state development, pre clinical and provincial Laws restricting clinical testing, manufacture, labeling, sale, import, export, distribution and promotion of the collection, use and disclosure of individually identifiable health information and personal informationCompany or Subsidiary products, except, in each case, for such noncompliance that, individually or in where the aggregate, has not had and failure to so comply would not reasonably be expected to have a Parent Material Adverse Effect. There is no (i) civil, criminal, administrative or other action, suit, demand, claim, hearing, proceeding, notice or demand pending, received or, to the Company’s knowledge, threatened in writing or (ii) civil or criminal investigation, audit or inquiry pending, received or, to the Company’s knowledge, threatened, in each case against the Company or the Subsidiaries, or any of their directors, officers or employees which relates to a violation or alleged violation of the Customs & International Trade Laws or the Healthcare Regulatory Laws.
(c) Except as set forth on Schedule 4.20(c), as of the date hereof, there have been no recalls, field notifications, injunctive actions, or other written warnings or seizures ordered or adverse regulatory actions taken (or, to the knowledge of the Company, threatened) by the FDA or any other Governmental Authority with respect to any of the Company or Subsidiary products, including any facilities where any Company or Subsidiary products are produced, processed, packaged or stored, and within the three (3) years preceding the date hereof neither the Company nor the Subsidiaries have, voluntarily nor at the request of any Governmental Authority, initiated or participated in a recall of any Company product or issued any written warning (other than labeling changes that were disclosed to or approved by any Governmental Authority) with respect thereto.
(d) Except as set forth on Schedule 4.20(d), All manufacturing operations of Company products by the Company or its Subsidiaries and, to the knowledge of the Company, for the benefit of the Company and its Subsidiaries, have been since January 1, 2010, and are being, conducted in material compliance with FDA regulations governing current good manufacturing practices, including 21 C.F.R. Parts 210 and 211 and applicable guidance documents, and all applicable similar requirements in countries where such compliance is required.
(e) Since January 1Except as set forth on Schedule 4.20(e), 2012all preclinical and clinical trials being conducted by or on behalf of the Company that have been submitted to any appropriate Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the experimental protocols, procedures and controls required pursuant to applicable Laws, including current good clinical practices and the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, and any applicable state privacy Laws. To the Company’s knowledge, none of the clinical investigators participating in Company trials has been or is disqualified, restricted from participating in such trials or otherwise sanctioned by the FDA or any other Governmental Authority. To the Company’s knowledge, no Person involved in any preclinical and clinical investigations sponsored by the Company has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. §335a(a) or any similar Law or authorized by 21 U.S.C. §335a(b) or any similar Law and there are no proceedings pending or, to the Company’s knowledge, threatened that might reasonably be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. The Company has not received any written notices, correspondence or other written communication from the FDA or any other Governmental Authority, or any institutional review board, requiring the termination, suspension or material modification of any preclinical or clinical trials conducted by, or on behalf of, the Company, or in which the Company has participated.
(f) Except as set forth on Schedule 4.20(f), no product liability claims have been asserted in writing against the Company or the Subsidiaries or, to the knowledge of the Company, threatened in writing against the Company or the Subsidiaries relating to any of their products or product candidates developed, tested, manufactured, marketed, distributed or sold by the Company or the Subsidiaries. There is no judgment, order or decree outstanding against the Company or any of its Subsidiaries relating to product liability claims or assessments.
(g) During the last three (3) years, neither Parent the Company nor any of the Parent Subsidiaries has received any written notice from that any products or materials imported by or on behalf of the FDA Company of the Subsidiaries where the Company or the EMA Subsidiaries is the importer of record, for which final liquidation has not yet occurred, is subject to or otherwise covered by an antidumping duty order or countervailing duty order that remains in effect or is subject to or otherwise covered by any foreign agency with jurisdiction over pending antidumping or countervailing duty investigation by agencies of the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory AgencyUnited States government.
(fh) Since January 1Neither the Company nor any Subsidiary, 2012nor any officer, all reports, documents, claims, permits and notices required to be filed, maintained director or furnished to employee of the FDA Company or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent SubsidiariesSubsidiary, nor, to the knowledge of Parentthe Company, any agents, distributors, and other Persons (including each of their respective officers, directors, employees) acting for or on behalf of the Company or any Subsidiary (the “Relevant Persons”): (i) has been debarred or excluded from any government program related to Company or Subsidiary products; (ii) has been or is designated on any list of any U.S. Governmental Authority, including OFAC’s list of Specially Designated Nationals and Blocked Persons, Commerce’s Denied Persons List, the Commerce Entity List, and the U.S. Department of State’s (“State Department”) Debarred List; (iii) has directly or indirectly participated in any transaction involving such designated person or entity, or any country that is subject to U.S. sanctions administered by OFAC or any applicable U.N., E.U. or other international sanctions regime; (iv) has exported (including deemed exportation) or re-exported, directly or indirectly, any good, technology or services in violation of any applicable U.S. export control or economic sanctions laws, regulations or orders administered by OFAC, Commerce or the State Department; or (v) has directly or indirectly participated in any export, re-export or transaction connected with any purpose prohibited by U.S. export control and economic sanctions laws, including, without limitation, support for international terrorism and nuclear, chemical or biological weapons proliferation’s Debarred List.
(i) To the knowledge of the Company, no officer, employee, employee or agent or distributor of Parent or any (in its capacity as agent) of the Parent Subsidiaries, Company has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Authority, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for such as FDA Compliance Policy Guide 120.100. To the knowledge of the Company, neither the Company nor its Subsidiaries has used in any act capacity the services of any individual or statement entity debarred under 21 U.S.C. § 335a(a) or failure to make any similar laws, rules or regulations in connection with a statement thatproduct of the Company or its Subsidiaries, individually or in and neither the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Company nor any of the Parent its Subsidiaries, nor, to the knowledge of Parentthe Company, any officerof their respective directors, employeeofficers, agent agents (in the capacity as agent) or distributor of Parent or any of the Parent Subsidiariesemployees, has been debarred or convicted of any crime or engaged in any conduct for which that has resulted, or would reasonably be expected to result, in debarment is mandated by under 21 U.S.C. § 335a(a) or any similar Law laws, rules or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103regulations.
(j) None of the Company or any of the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or other similar written agreements, in each case, entered into with or imposed by any Governmental Authority, other than any such agreement, decree or order that has been previously disclosed in any other filing with a Governmental Authority.
(k) Notwithstanding anything any other provision of this Agreement, the representations and warranties contained in this Section 4.134.20(a) through Section 4.20(j) (together with Section 4.03, no representation or warranty shall be deemed Section 4.04 and Section 4.09) constitute the sole and exclusive representations and warranties of the Company and the Subsidiaries relating to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law Laws relating to regulatory matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each To its knowledge, all notices, supplemental applications and annual or other reports or documents, including adverse experience reports that are material to the conduct of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations Business in the Territory as presently conducted have been filed with the relevant Governmental Authorities to the extent required under the FDCA, the PHSA, the regulations Requirements of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where to the extent failure to make such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would filings could not reasonably be expected to have a Parent Material Adverse EffectEffect with respect to the Business in the Territory as presently conducted.
(eii) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would Except as could not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Effect on the Business in the Territory as presently conducted, neither WFHC nor its Affiliates has received: (a) any of the Parent Subsidiaries, nor, FDA Form 483’s with respect to the knowledge Product; (b) any FDA Notices of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, Adverse Findings with respect to the knowledge of Parent, Product; or (c) any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, warning letters or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice correspondence from the FDA or any other Parent Regulatory Agency regarding Governmental Authority with respect to the Product during the one (i1) year prior to this Agreement, or at any time prior to this Agreement to the recallextent still active or pending, market withdrawal in which the FDA or replacement such other Governmental Authority asserted that the operations of any Company WFHC were not in compliance with applicable Requirements of Laws, with respect to the Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) United States. Except as would could not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of Effect on the Parent Subsidiaries has experienced any security breach or other incident resulting Business in the unauthorized accessTerritory as presently conducted, use there has not been any occurrence of any product recall, market withdrawal or disclosure replacement, or post-sale warning conducted by or on behalf of data or information that is linked to any reasonably identifiable person WFHC concerning the Product in the United States or any other data protected under applicable Law. Parent product recall, market withdrawal or Merger Sub is not replacement conducted by or on behalf of WFHC as a business associate, as that term is defined result of any alleged defect in the HIPAA regulations Product in the United States during the one (1) year prior to this Agreement, or, to WFHC’s knowledge, at 45 C.F.R. § 160.103any time prior to this Agreement to the extent still active or pending, and WFHC has made available to Shire every material complaint and notice of alleged defect or adverse reaction with respect to the Product that has been received in writing by WFHC and its Affiliates or that has been orally transmitted to and recorded by WFHC and its Affiliates.
(jiii) Notwithstanding anything contained in this Section 4.13To WFHC’s knowledge, WFHC has fulfilled and performed its obligations under the Transferred Regulatory Documentation pertaining to the Product. To WFHC’s knowledge, no representation event has occurred or warranty shall condition or state of facts exists which constitutes or, after notice or lapse of time or both, would constitute a breach or default or violation under any such Transferred Regulatory Documentation or which permits or, after notice or lapse of time or both, would permit revocation or termination of any such Transferred Regulatory Documentation, or which might adversely affect in any material respect the rights of WFHC under any Transferred Regulatory Documentation; provided, however, that a Phase IV regulatory study for the Product in the European Union is required. No written notice of cancellation, of default, of violation or of any material dispute concerning such Transferred Regulatory Documentation, or of any event, condition or state of facts described in the preceding clause, has been received by, or is known to, WFHC.
(iv) None of WFHC, any of its Affiliates or any sublicensee have sold the Product in the Territory prior to the Effective Date.
(v) WFHC has made available to Shire copies of all Transferred Regulatory Documentation in WFHC’s physical possession except for Transferred Regulatory Documentation containing information that would not be deemed reasonably be expected to be made have a Material Adverse Effect on the Business in this Section 4.13 the Territory as presently conducted.
(vi) There are no pending applications filed by or on behalf of WFHC with any Governmental Authority with respect to the Product in respect of environmental, Tax, employee benefits or labor Law mattersany country within the Territory for which Regulatory Documentation has not been issued.
Appears in 1 contract
Sources: License and Supply Agreement (Women First Healthcare Inc)
Regulatory Matters. At all times since January 1, 2018, except as would not (a) Except as has not had and would not reasonably be expected to haveto), individually or in the aggregate, result in a Parent Material Adverse Effectmaterial Liability or have an adverse effect in any material respect on any Transferred Assets, and in each case solely with respect to any Product:
(a) The Seller and each of its Affiliates has, to the extent applicable, developed, tested, labeled, packaged, manufactured and stored the Products in compliance in all material respects with (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrationsFDA Act, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (yii) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any other applicable Governmental Entity or Notified Body that are concerned with Entities in any other country where the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Seller or any of the Parent Subsidiaries as currently conducted its Affiliates has developed, tested, labeled, packaged, manufactured or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all stored any such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory PermitsProduct.
(b) Except as would notAll preclinical studies and other studies and tests of any Product conducted by or on behalf of the Seller have been, individually or in the aggregateand if still pending are being, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance material compliance, to the extent applicable, with good laboratory practices, good clinical practices and all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims FDA Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in respective counterparts thereof outside the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectStates.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party With respect to any material corporate integrity agreementsProduct, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent Seller has not received any written notice of FDA regulatory actions against the Seller or any of its Affiliates, including notice of adverse findings, regulatory, untitled or warning letters or mandatory recalls, or any other notice from any governmental entity alleging or asserting material noncompliance with any Law.
(d) Neither the Seller nor any of its Affiliates have received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit or, to the Seller’s Knowledge, investigation from the FDA or any other Parent Regulatory Agency regarding (i) Governmental Entity alleging that any operation or activity of the recallSeller or any of its Affiliates in connection with any Product is in material violation of the FDA Act or the respective counterparts thereof promulgated by applicable state Governmental Entities or Governmental Entities outside the United States, market withdrawal including, as applicable, the medicinal products and medical device Laws of the European Union. No civil, criminal or replacement administrative action, suit, demand, claim, complaint, hearing, proceeding or, to the Seller’s Knowledge, investigation for which the Seller has received written notice is pending or, to the Seller’s Knowledge, threatened against the Seller or any of its Affiliates in connection with any Product. To the Seller’s Knowledge, there has not been any material violation of any Company laws by the Seller or any of its Affiliates in its product development efforts, submissions or reports to any Governmental Entity in connection with any Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not could reasonably be expected to have a Parent Material Adverse Effectrequire investigation, neither Parent nor any of the Parent Subsidiaries has experienced any security breach corrective action or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103enforcement action.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Asset Purchase Agreement (Merrimack Pharmaceuticals Inc)
Regulatory Matters. (ai) Except Schedule 10.1(g) sets forth, as of the Effective Date, a list of all material Regulatory Approvals granted to any Depomed Entity by, or application therefor pending with, any Governmental Authority to manufacture, have made, test, market, package, import, distribute, sell and commercialize the Products in the Territory.
(ii) All Products sold under the Regulatory Approvals are manufactured, marketed, distributed and sold in accordance with such Regulatory Approvals, including the specifications and standards contained therein, except as has not had been and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, be materially adverse to the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; Business.
(iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of With respect to the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012Business, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent SubsidiariesDepomed Entity, nor, to the knowledge Knowledge of ParentDepomed, any officer, employee, or agent or distributor of Parent or any of the Parent SubsidiariesDepomed Entity, (A) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyFDA, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, Gratuities policy set forth in 56 Fedthe FDA’s Compliance Policy Guide Sec. Reg. 46191 120.100 (September 10CPG 7150.09), 1991or (B) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed result in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent debarment under 21 U.S.C. 335a or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectsimilar Legal Requirement.
(hiv) Except as would notSince April 2, individually or in the aggregate2015, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent no Depomed Entity has (A) voluntarily nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field correctionsalerts, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, or efficacy or regulatory compliance of any Parent Product, Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. To Confidential treatment has been requested with respect to the knowledge omitted portions marked [***]. and to the Knowledge of ParentDepomed, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding cause (i1) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole)any Depomed Entity, (ii2) a material change in the marketing classification or a material change in the labeling of any such Parent Products, Products or (iii3) a termination or suspension of the manufacturingmarketing of such Products; or (B) received any written notice that any Governmental Authority has (1) commenced, marketingor threatened to initiate, any action to request the recall or to enjoin the manufacture or distribution of such Parent Productsany Product sold or intended to be sold by any Depomed Entity or (2) commenced, or (iv) a material negative change in reimbursement status of a Parent threatened to initiate, any action to withdraw any Regulatory Approvals issued relating to any Product.
(iv) Except for ordinary course inquiries or as set forth on Schedule 10.1(g)(v), since April 2, 2015, Depomed has not received, with respect to the Products marketed and sold in the Territory, any written notice or communications from any Governmental Authority alleging any safety or quality concerns with respect to any Product or noncompliance with any applicable Legal Requirements or Regulatory Approvals, except as would not not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any be materially adverse to the operation of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that Business. Depomed is linked not subject to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associateenforcement proceedings by the FDA related to the Products and, as that term is defined in to the HIPAA regulations at 45 C.F.R. § 160.103Knowledge of Depomed, no such proceedings have been threatened.
(jvi) Notwithstanding anything contained All clinical trials and studies for the Products that have been or are being conducted by or on behalf of Depomed or its Affiliates, were conducted, and are being conducted, in this Section 4.13all material respects in accordance with all applicable Legal Requirements, including Health Legal Requirements. To the Knowledge of Depomed, there is no representation Legal Proceeding pending or warranty shall be deemed threatened by any Governmental Authority to be made in this Section 4.13 in respect of environmentalsuspend, Tax, employee benefits investigate or labor Law mattersterminate any ongoing clinical trials or studies for any Product.
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Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, have a Parent Company Material Adverse Effect, (i) each of Parent the Company and the Parent Company Subsidiaries holds have in effect all Regulatory Permits (x) all permitsincluding, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating avoidance of doubt, all establishment registrations and device listings, 510(k) clearances and Emergency Use Authorizations (EUAs) (or their foreign equivalents)) required by any Health Authority to permit the conduct of their respective businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); conducted, (ii) all of such Parent Regulatory Permits are valid and in full force and effect; effect and (iii) Parent the Company is in compliance with the terms of all Parent with, and is not in default under, each such Regulatory PermitsPermit.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect.
(e) Since , since January 1, 20122018, neither Parent nor none of the Company, any of the Parent Company Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, noror, to the knowledge Knowledge of Parentthe Company, any officerof their respective directors, employeeofficers, agent employees or distributor of Parent or any of Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Parent Company and the Company Subsidiaries, has ) have (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, Health Authority or (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyHealth Authority. None of the Company, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Company Subsidiaries or, to the Knowledge of the Company, any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and the Company Subsidiaries) are the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any other Health Authority, that, at the time assuming such disclosure was madeinvestigations were determined or resolved adversely, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ic) Except as would not reasonably be expected to have a Parent Company Material Adverse Effect, since January 1, 2018, the Company and each of the Company Subsidiaries and, to the knowledge of the Company, each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and the Company Subsidiaries), has been in compliance in all material respects with all Health Laws. None of the Company, any of the Company Subsidiaries or, to the Knowledge of the Company, any Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and the Company Subsidiaries) (i) have received any material written notice from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any allegations of failure to maintain systems and programs required by applicable Health Laws, or contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any product subject to any Health Law, (ii) are subject to any material enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened, or (iii) are a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Body, and, to the Knowledge of the Company, no such action is pending as of the date hereof.
(d) Except as would not reasonably be expected to have a Company Material Adverse Effect, the Company and the Company Subsidiaries have, since January 1, 2018, filed with the applicable Health Authority all required and material filings, including Medical Device Reports or similar required reports of adverse events or device malfunctions, and reports of corrections or removals. Except as would not reasonably be expected to have a Company Material Adverse Effect, all such filings were in material compliance with applicable Law when filed, and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any such filings.
(e) Except as would not reasonably be expected to have a Company Material Adverse Effect, (i) all preclinical studies and clinical trials conducted by or on behalf of the Company and the Company Subsidiaries have been conducted in compliance with all applicable Laws, (ii) as of the date hereof, no clinical trial conducted by or on behalf of the Company and the Company Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons, (iii) as of the date hereof, neither the FDA nor any other applicable Governmental Body, clinical investigator who has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company and the Company Subsidiaries has commenced, or, to the Knowledge of the Company and the Company Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any ongoing clinical investigation conducted by or on behalf of the Company and the Company Subsidiaries.
(f) Neither the Company nor the Company Subsidiaries operates or operate a clinical laboratory within the meaning of Health Laws. Except as would not reasonably be expected to have a Company Material Adverse Effect, neither Parent (i) the Company, (ii) the Company Subsidiaries, nor (iii) to the Company’s Knowledge, any customer of the Company or the Company Subsidiaries, has introduced into U.S. commercial distribution any Company Product as a laboratory developed test.
(g) None of the Company, any of the Parent Company Subsidiaries or, to the Knowledge of the Company, any of their respective directors, officers, employees, or Collaboration Partners has experienced been convicted of any security breach crime or other incident resulting engaged in the unauthorized accessany conduct that has resulted, use or disclosure of data would reasonably be expected to result in being disqualified, debarred or information that is linked to deregistered, or excluded by any reasonably identifiable person or Governmental Body from participation in any other data protected under applicable Law. Parent or Merger Sub is not a business associate, Federal Health Care Program (as that term is defined in the HIPAA regulations at 45 C.F.R. 42 U.S.C. § 160.1031320a-7b(f)) or under 21 U.S.C. § 335a or comparable foreign applicable Law.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
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Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent Apple and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the Federal Food, Drug, and Cosmetic Act of 1938 (the “FDCA”) and all amendments thereto, the Public Health Service Act (the “PHSA”), and the regulations of the FDA U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the research, quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, packaging, labelling, storage, transport, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Apple Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Apple Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent Apple or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Apple Regulatory Permits”); (ii) all such Parent Apple Regulatory Permits are valid and in full force and effect; and (iii) Parent is Apple and its Subsidiaries are in material compliance with the terms of all Parent Apple Regulatory Permits.
(b) Except as would notAs of the date hereof, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses neither Apple nor any of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including its Subsidiaries (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any entered into material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Apple Regulatory Agency, or (ii) has received written notice from any Apple Regulatory Agency that alleges any material noncompliance or notifies the recipient that it is under investigation or the subject of an inquiry by any such Apple Regulatory Agency for alleged material noncompliance with any Applicable Law related to the operation of the business of Apple.
(dc) All pre-clinical and clinical investigations in respect of a Parent an Apple Product or Parent Product candidate conducted or sponsored by each Apple or any of Parent its Subsidiaries for submission to an Apple Regulatory Agency are being, and the Parent Subsidiaries are being have been, conducted in material compliance with all applicable Applicable Laws administered or issued by the applicable Parent Apple Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such material noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect.
(d) Apple has submitted certain BLA filings to FDA in support of a marketing authorization approval for OLT-200, and Apple has not taken any action to withdraw these filings. Apple has not received any communication from FDA indicating that FDA has refused or will refuse to accept or file the BLA.
(e) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, during the period beginning on January 1, 20122017 and ending on the date of this Agreement, neither Parent Apple nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, distribution, storage, transport, packaging or manufacturing of drugs which Apple Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Apple Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Apple Regulatory Agency.
(f) Since January November 1, 2012, 2018 all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Apple Regulatory Agency by Parent Apple and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 20122017, neither Parent Apple nor any of the Parent its Subsidiaries, nor, to the knowledge of ParentApple, any officer, employee, agent or distributor of Parent Apple or any of the Parent its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Apple Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Apple Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent Apple or any of the Parent its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Apple Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) neither Apple nor any of the Parent its Subsidiaries, nor, to the knowledge of ParentApple, any officer, employee, agent or distributor of Parent Apple or any of the Parent its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Apple Products or Parent Product candidates are sold or intended by the Parent where Apple has publicly announced an intention to be sold. Since January 1, 2011, sell an Apple Product; and (ii) neither Parent Apple nor any of the Parent its Subsidiaries, nor, to the knowledge of ParentApple, any officer, employee, agent officer or distributor employee of Parent Apple or any of the Parent its Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare Law program, including any conduct that would constitute material non-compliance with the Federal Anti-Kickback Statute, Federal False Claims Act, or programtheir respective state equivalents.
(g) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, as to each Parent Apple Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Apple Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been researched, developed, manufactured, tested, distributed or marketed by or on behalf of Parent Apple or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Apple Product or Parent Product candidate is being or has been researched, developed, manufactured, stored, distributed and marketed in material compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is are no action or proceeding Proceedings pending or, to the knowledge of ParentApple, threatenedthreatened in writing, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Apple Product or Parent Product candidate by Parent Apple or any of the Parent its Subsidiaries of any Applicable Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, (i) neither Parent Apple nor any of the Parent its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory material compliance of any Parent Product. To Apple Product and (ii) to the knowledge of ParentApple, there are no facts which are reasonably likely to causeneither Apple nor any of its Subsidiaries has received, and Parent has not received any written notice from the FDA or any other Parent Apple Regulatory Agency regarding (iA) the recall, correction, market withdrawal withdrawal, or replacement of any Company Apple Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals corrections, withdrawals, or replacements that are not material to Parent or the Parent Apple and its Subsidiaries, taken as a whole), (iiB) a material change in the marketing classification or a material change in the labeling of any such Parent Apple Products, (iiiC) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Apple Products, or (ivD) a material negative change in reimbursement status of a Parent an Apple Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to be material to the business of the Acquired Companies, taken as a whole: (i) the Acquired Companies own, possess or validly have a Parent Material Adverse Effectthe right to use all permits required to research, develop, manufacture, market, commercialize, distribute and sell its products; (ii) all products of the businesses of each of Parent Acquired Companies are and, since January 1, 2019, have been researched, developed, manufactured and each Parent Subsidiary are being conducted marketed in compliance accordance with all applicable specifications, Permits and applicable Laws, including (i) the FDCA; (ii) the PHSAGMPs, GLPs, GCPs, GDPs and GVPs; (iii) federal Medicare and Medicaid statutes and related state since January 1, 2019, (A) no product of the Acquired Companies or local statutes; (iv) manufacturing site has shut down, been subject to any comparable foreign Laws import or export prohibition, received any FDA Form 483 or other Governmental Body notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to any product of the Acquired Companies or any manufacturing operations for any product of the foregoing applicable in jurisdictions in which material quantities Acquired Companies and (B) there have been no recalls, field notifications, field corrections, warnings, “dear doctor” letters, investigator notices, safety alerts or other written notices of action issued by a Governmental Body or the Acquired Companies relating to an alleged lack of safety, efficacy, or regulatory compliance of any product of the Parent Products Acquired Companies (collectively, “Safety Notices”). Each Acquired Company has complied in all material respects with its obligations to make filings, declarations, listings, registrations, reports or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws submissions with the applicable regulatory authorities (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), FDA and the exclusion laws (42 U.S.C. § 1320a-7), DEA or any other Governmental Body performing functions similar to those performed by the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws FDA and the DEA) relating to health care fraud and abuseAcquired Company drug products, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, adverse event reports. Except as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to haveexpected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a Parent Material Adverse Effectwhole, no written deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions.
(cb) Except as would notnot reasonably be expected, individually or in the aggregate, reasonably to be expected material to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None business of the Parent or any Parent Subsidiary are Acquired Companies, taken as a party to any material corporate integrity agreementswhole, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including no Acquired Company has (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the Agreement Date, set forth in 56 Fed. Reg. 46191 (September 10the Company is not the subject of any pending or, 1991) or for to the Knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any officers, directors, employees, agents or clinical investigators of any other Parent Regulatory Agency of the Acquired Companies or, to invoke any similar policythe Acquired Companies’ Knowledge, except for any act anyone acting on behalf of the Acquired Companies, is, has been, or statement is threatened in writing to be: (i) excluded, debarred, suspended or failure to make a statement thatotherwise
(c) Except as would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with all Healthcare Laws applicable to the operation of its business as currently conducted. As of the Agreement Date, to the Knowledge of the Company no enforcement, regulatory or administrative proceeding is pending, and no such enforcement, regulatory or administrative proceeding has not had and been threatened in writing, against the Company under the Healthcare Laws, other than any such proceeding that would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would notexpected, individually or in the aggregate, reasonably to be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, material to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any business of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent SubsidiariesAcquired Companies, taken as a whole). None of the Acquired Companies has received any written notice, warning letter, or similar written communication that (iiA) alleges a material change in the marketing classification violation of, or asserts a material change in the labeling of failure to comply with, any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Productsapplicable Healthcare Law, or (ivB) imposes a material negative change in reimbursement status written obligation to undertake, or to bear all or any portion of a Parent Productthe cost of, any remedial action of any nature.
(id) Except as would not reasonably be expected Since January 1, 2019 , the Company and its Subsidiaries have performed periodic audits of all manufacturing sites that supply regulatory starting materials, drug substances, drug product intermediates, drug products or finished products to have a Parent Material Adverse Effect, neither Parent nor the Company or the Subsidiaries to the extent permitted by any Contract relating to such manufacturing site or required by applicable Healthcare Law. To the Knowledge of the Company, there are no written findings deemed critical by the auditor or inspector resulting from such audits or inspections since January 1, 2019 that have not been remediated in all material respects. To the Knowledge of the Company, any such manufacturing site has performed in all material respects all tasks required by such written remediation plans. The Company has made available to Parent complete and accurate copies of all reports from all regulatory audits or inspections conducted since January 1, 2019 by the Company and its Subsidiaries has experienced any security breach or other incident resulting or, to the extent in the unauthorized accesspossession or control of the Company and its Subsidiaries, use or disclosure of data or information that is linked to any reasonably identifiable person by their Representatives or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Governmental Bodies.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Biodelivery Sciences International Inc)
Regulatory Matters. (a) Except as has not had described in the Registration Statement and would not reasonably be expected the Prospectus, the preclinical and clinical studies conducted by or, to havethe knowledge of the Company, individually on behalf of or sponsored by the Company or its subsidiaries, or in which the aggregateCompany or its subsidiaries have participated, a Parent Material Adverse Effect, (i) each the results of Parent which are referred to in the Registration Statement and the Parent Subsidiaries holds Prospectus, as applicable (x) all permitscollectively, licensesthe “Studies”), franchises, approvals, clearances, registrationswere, and authorizations under the FDCAif still pending are, the PHSA, the being conducted in all material respects in accordance with all applicable rules and regulations of the FDA promulgated thereunderU.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, data protection including the European Medicines Agency (collectively, the “Regulatory Authorities”). The Company has no knowledge of any other studies not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus. The Company and its subsidiaries are, and since May 1, 2018, have operated in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities and all other applicable federal, state or foreign health care laws and (y) all permitsregulations applicable to the ownership, licensestesting, franchisesdevelopment, approvalsmanufacture, clearancespackaging, registrationsprocessing, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the qualityuse, identitydistribution, strength, purity, safety, efficacymarketing, labeling, manufacturing, marketing, promotion, distribution, sale, pricingoffer for sale, import storage, import, export, or export disposal of any product candidates under development by the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of the Parent Subsidiaries as currently conducted or as planned to be conducted its subsidiaries (collectively, the “Parent Regulatory PermitsHealth Care Laws”); (ii) all , except where such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in non-compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually singly or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, . Neither the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent Company nor any of its subsidiaries, to the Parent Subsidiaries has knowledge of the Company, have received any written notification notices, correspondence or communication other communications from the Regulatory Authorities or any Parent Regulatory Agencyother governmental agency requiring or threatening the termination or suspension of any such Studies, including and, to the FDAknowledge of the Company, there are no reasonable grounds for the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) same. Except as would not, individually whether singly or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and neither the Parent Subsidiaries have not engaged Company nor any of its subsidiaries has received any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that it is in activities which areviolation of any Health Care Laws, as applicableand, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None to the knowledge of the Parent Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action has been threatened. Neither the Company, its subsidiaries nor, to the knowledge of the Company, any Parent Subsidiary are of the Company’s or its subsidiaries’ officers, directors, employees, contractors or agents is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in Authority with respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and to Health Care Laws. Neither the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesCompany, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, its subsidiaries nor, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent or any of the Parent SubsidiariesCompany’s or its subsidiaries’ employees, officers, directors, contractors or agents has made an untrue statement of been excluded, suspended or debarred from participation in any U.S. federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) or human clinical research or is subject to a material fact governmental inquiry, investigation, proceeding or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, similar action that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth result in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectexclusion.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Open Market Sale Agreement (Ayala Pharmaceuticals, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to haveTo the Knowledge of Seller, individually no director, manager, officer or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations service provider of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity Company or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Affiliates has made an any untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Authority, failed to disclose a any material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Authority, or committed an act, made a statement, statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure act, statement or omission was made, would reasonably be expected to provide a basis for the FDA any Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which policies regarding such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programmatters.
(gb) As to each Parent Product or Parent Product candidate subject to the FDCA All applications and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended other documents submitted by the Company to be sold that any Governmental Authority in connection with a Permit were true and correct, in all material respects, as of the date of submission, and any updates, changes, corrections or modification to such applications and other documents required under applicable Law have been submitted and were true and correct, in all material respects, at the time of submission.
(c) Neither the Company nor any of its officers, managers or directors is a Prohibited Person. The Company has not engaged in a transaction involving, directly or indirectly, a Prohibited Person or Iran, Sudan, Syria or any other country against which the United States imposes a trade embargo. The Company is and has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable export control and economic sanctions requirements administered by authorities of the United States and all other applicable jurisdictions (collectively, the “Export Control Laws”). The Company has all necessary authority under the Export Control Laws to conduct their businesses as presently conducted. None of the Company’s products is produced, including those relating to investigational usedesigned or modified for military-related end uses, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending orand, to the knowledge Knowledge of ParentSeller, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any none of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected Company’s products is normally devoted to have a Parent Material Adverse Effectmilitary-related end uses.
(hd) Except The Company is, and at all times during the last five years has been, in compliance with the Foreign Corrupt Practices Act of 1977, as would notamended, individually and any rules or in regulations thereunder (the aggregate“FCPA”), and any applicable comparable foreign Law and has instituted and maintained policies and procedures designed to ensure, and which are reasonably be expected to have a Parent Material Adverse Effectcontinue to ensure, since January 1, 2012, neither Parent compliance therewith.
(e) Neither the Company nor any of the Parent Subsidiaries have voluntarily its directors, officers, employees, agents or involuntarily initiatedconsultants, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketingPerson acting for, or distribution of such Parent Productson behalf of, the Company, directly or (iv) a material negative change in reimbursement status of a Parent Product.indirectly, has:
(i) Except made, undertaken or authorized the payment or giving of any bribe, rebate, payoff, influence payment, kickback or other payment or gift of money or anything of value (including meals or entertainment), to any officer, employee or ceremonial office holder of any government or instrumentality thereof, any political party or supra-national organization (such as would not reasonably be expected to have a Parent Material Adverse Effectthe United Nations), neither Parent nor any political candidate, any royal family member or any other person who is connected or associated personally with any of the Parent Subsidiaries has experienced foregoing for the purpose of influencing any security breach act or decision of such payee in his official capacity, inducing such payee to do or omit to do any act in violation of his lawful duty, securing any improper advantage or inducing such payee to use his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality (“Prohibited Payments”);
(ii) been subject to any investigation by any Governmental Authority with regard to any actual or alleged Prohibited Payment;
(iii) used funds or other incident resulting assets, or made any undertaking in such regard, for the unauthorized access, use establishment or disclosure maintenance of data a secret or information that is linked unrecorded fund (a “Prohibited Fund”);
(iv) knowingly made any false or fictitious entries in any books or records of the Company relating to any reasonably identifiable person Prohibited Payment or Prohibited Fund; or
(v) taken any action that has resulted in a violation by any such Persons of the FCPA or any other data protected under applicable comparable foreign Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Stock Purchase Agreement (Document Security Systems Inc)
Regulatory Matters. Each Company shall cause (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent Broker-Dealers to take all reasonable action to maintain all rights, privileges, broker-dealer licenses and the Parent Subsidiaries holds (x) all permitsmemberships, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity broker-dealer registrations necessary or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or desirable in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses normal conduct of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal informationits business, except, in each case, for such noncompliance that, individually or in to the aggregate, has not had and extent that failure to do so would not reasonably be expected to have result in a Parent Material Adverse Effect.
, (eii) Since January 1, 2012, neither Parent nor any each Broker-Dealer to comply with all material rules and regulations of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency SEC and FINRA applicable to it (including such rules and regulations dealing with jurisdiction over the developmentnet capital requirements) and, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of extent applicable to any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012Broker-Dealer, all reportssimilar, documentsequivalent or comparable foreign statutes, claimsrules, permits regulations and notices required to be filedother regulatory requirements, maintained or furnished to except, in each case, where the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices so comply would not reasonably be expected to haveresult in a Material Adverse Effect , individually (iii) all Broker-Dealers to deliver after the end of each fiscal quarter of each fiscal year of the Borrower or in promptly after the aggregatedate such information is filed with the SEC, a Parent Material Adverse Effect. All copy of each Broker-Dealer's Financial and Operational Combined Uniform Single Report filed with the SEC for such reports, documents, claims, permits fiscal quarter and notices were complete and accurate in (iv) all material respects on Broker-Dealers to promptly deliver copies of each notice or other correspondence received from the date filed SEC (or were corrected comparable agency in any applicable non-U.S. jurisdiction) concerning any investigation by such agency regarding financial or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor other operational results of any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statementCompany, in each such case, related case which are reasonably likely to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was madebe determined adversely and which if determined adversely, would reasonably be expected to provide result in a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, BriberyAdverse Effect , and Illegal Gratuities”(b) (i) all of its Investment Adviser Companies to take all reasonable action to maintain all rights, set forth privileges and investment adviser registrations necessary or desirable in 56 Fed. Reg. 46191 (September 10the normal conduct of its business, 1991) or for except, in each case, to the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or extent that failure to make a statement that, individually or in the aggregate, has not had and do so would not reasonably be expected to have result in a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole)Effect , (ii) a all of its Investment Adviser Companies to comply with all material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension rules and regulations of the manufacturingSEC applicable to it and, marketingto the extent applicable to any Investment Adviser Company, all similar, equivalent or distribution of such Parent Productscomparable foreign statutes, or (iv) a material negative change rules, regulations, and other regulatory requirements, except, in reimbursement status of a Parent Product.
(i) Except as each case, where the failure to so comply would not reasonably be expected to have result in a Parent Material Adverse Effect, neither Parent nor any and (iii) unless previously delivered, all of the Parent Subsidiaries has experienced any security breach its Investment Adviser Companies to promptly deliver copies of each notice or other incident resulting correspondence received from the SEC (or comparable agency in the unauthorized accessany applicable non-U.S. jurisdiction) concerning any investigation by such agency regarding financial or other operational results of any Investment Adviser Company, use or disclosure of data or information that is linked to any in each case which are reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed likely to be made determined adversely and which if determined adversely, would reasonably be expected to result in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattersa Material Adverse Effect.
Appears in 1 contract
Sources: Second Lien Term Loan Agreement
Regulatory Matters. (a) Except as has not had The Company and would not reasonably be expected to haveeach Company Subsidiary possesses all material approvals, individually or in the aggregateauthorizations, a Parent Material Adverse Effectcertificates, (i) each of Parent and the Parent Subsidiaries holds (x) all permitsregistrations, licenses, franchisesexemptions, approvalspermits, clearances, registrationsand consents (including all investigational new drug applications (as defined in 21 C.F.R. § 312.20 et seq., establishment registrations (as defined in 21 C.F.R. § 207), and authorizations under the FDCAproduct listings (as defined in 21 C.F.R. § 207), the PHSAall supplements or amendments thereto, the regulations of the FDA promulgated thereunderand all comparable approvals, data protection laws and (y) all permitsauthorizations, certificates, registrations, licenses, franchisesexemptions, approvalspermits, clearances, registrations, certificates and authorizations of any consents provided for in other applicable Governmental Entity Laws) (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Regulatory Authorities relating to the Company’s and each Company Product or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of the Parent Subsidiaries Company Subsidiary to conduct its business in all material respects as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) presently conducted. Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
, (ei) Since January 1all such Regulatory Authorizations are (A) in full force and effect, 2012(B) validly registered and on file with applicable Regulatory Authorities and (C) in compliance with all formal filing and maintenance requirements and (ii) the Company and each Company Subsidiary has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, neither Parent nor any of the Parent Subsidiaries and no event has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityoccurred which allows, or manufacturing after notice or lapse of drugs which time would allow, revocation or termination thereof. Except as would not reasonably be expected to lead be material to the denialbusiness of the Company and the Company Subsidiaries, limitationtaken as a whole, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before (1) the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits Company and notices required to be each Company Subsidiary has filed, maintained or furnished to the FDA FDA, Health Canada, or any other Parent applicable Governmental Bodies or other applicable Regulatory Agency by Parent Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and the Parent Subsidiaries have been so filedresponses to notices, maintained or furnishedapplications and supplemental applications, except where failure to file, maintain or furnish reports (including all adverse event/experience reports) and (2) all such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices submissions were complete and accurate and in compliance in all material respects on the date with applicable Laws when filed (or were corrected or completed in or supplemented by a subsequent filing). Since .
(i) The Company and each Company Subsidiary has never marketed, sold, distributed, promoted or advertised any pharmaceutical products (including the Company Products) and (ii) the Company and each Company Subsidiary is, and since January 1, 20122018 has been, neither in material compliance with applicable Laws, including the FDCA and its implementing regulations, relating to the development, testing, manufacturing, holding, marketing, selling, distributing, labeling, promoting, advertising, importing or exporting of pharmaceutical products, including without limitation, (i) requirements for obtaining Regulatory Authorizations, (ii) requirements for establishment registration and product listing; (iii) payment of all application and program fees invoiced for the Company Products, (iv) label and labeling requirements and (vi) applicable promotion and advertising requirements.
(c) All non-clinical studies and clinical investigations, preclinical studies or tests sponsored or conducted by or on behalf of the Company or any Company Subsidiary are being conducted in material compliance with applicable Laws, including Good Laboratory Practices, Good Clinical Practices, the FDCA, and all other Laws regarding developing, testing, labeling, manufacturing, storage, marketing, promotion, sale, commercialization, safety, quality, shipment, import, export, or distribution the products of the Company. None of the FDA, Health Canada, any other Regulatory Authority, or any institutional review board has sent any written notices or other correspondence with respect to any proposed, ongoing or completed clinical, preclinical or non-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical, preclinical and nonclinical data in the possession of and reasonably available to the Company or any Company Subsidiary and all material written correspondence that exists as of the date of this Agreement between the Company and any of its subsidiaries and the FDA, Health Canada, or any other Regulatory Authority performing functions similar to those performed by the FDA.
(d) Neither the Company nor any of the Parent Subsidiaries, Company Subsidiary nor, to the knowledge of Parentthe Company, any officerofficers, employee, agent employees or distributor agents of Parent the Company or any of the Parent SubsidiariesCompany Subsidiary, has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA FDA, Health Canada, or any other Parent Regulatory AgencyAuthority, (ii) failed to disclose a material fact required to be disclosed to the FDA or Health Canada or (iii) committed any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the date of this Agreement, set forth in 56 Fed. Reg. 46191 (September 10neither the Company nor any Company Subsidiary is the subject of any pending or, 1991) or for to the Company’s knowledge, threatened investigation by the FDA or any other Parent Regulatory Agency pursuant to invoke any similar policyits Fraud, except for any act or statement or failure to make a statement thatUntrue Statements of Material Facts, individually or in the aggregateBribery, has not had and would not reasonably be expected to have a Parent Material Adverse EffectIllegal Gratuities Final Policy. Neither Parent the Company nor any of the Parent Subsidiaries, Company Subsidiary nor, to the knowledge of Parentthe Company, any officerofficers, employeeemployees, agent agents or distributor clinical investigators of Parent the Company or any of the Parent Subsidiaries, Company Subsidiary has been suspended or debarred or convicted of any crime or engaged in any conduct for which that would reasonably be expected to result in (A) debarment is mandated by under 21 U.S.C. § 335a(a) Section 335a or any similar Law or authorized by 21 (B) exclusion under 42 U.S.C. § 335a(b) Section 1320a-7 or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programLaw.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ie) Except as would not reasonably be expected to be material to the business of the Company and the Company Subsidiaries, taken as a whole, (i) the Company, each Company Subsidiary and any contractor or other Person acting on their behalf is obtaining and since January 1, 2018, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company’s ongoing clinical studies; (ii) in using or disclosing patient information received by the Company in connection with the Company’s ongoing clinical studies, the Company, each Company Subsidiary and any contractor or other Person acting on their behalf have complied with all Laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996, the FDCA and the rules and regulations thereunder.
(f) To the extent required by applicable Laws, all manufacturing operations conducted with respect to any Company Product used in human clinical trials have been conducted in accordance with the FDCA, Laws, and Good Manufacturing Practices, except where the failure to comply would not reasonably be expected to have a Parent Material Adverse Effect.
(g) Since January 1, neither Parent 2018, no Company Product has been recalled, withdrawn, suspended or discontinued.
(h) Since January 1, 2018, no preclinical studies sponsored or conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have had any material adverse safety findings that the Company would reasonably expect to have a material adverse impact on clinical studies, and all material preclinical toxicology reports or preclinical toxicology studies conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have been disclosed to the FDA, Health Canada, and all other applicable Regulatory Authorities to the extent required by applicable Laws.
(i) The Company and each Company Subsidiary is, and since January 1, 2018 has been, in material compliance with all applicable Healthcare Laws. Neither the Company nor any Company Subsidiary is subject to any enforcement, regulatory or administrative proceedings regarding alleged non-compliance with any Healthcare Laws and, to the knowledge of the Parent Subsidiaries Company, no such enforcement, regulatory or administrative proceeding has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103been threatened.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed The Company and the Company Subsidiaries have adopted and maintain a compliance program that is intended to assist the Company and the Company Subsidiaries to be made in this Section 4.13 in respect material compliance with all Law, standards and guidelines relevant to its business, including all Healthcare Laws, and includes each of environmentalthe following elements: (i) a code of conduct and other applicable policies and procedures; (ii) training on the code of conduct, Taxpolicies and procedures for all employees; (iii) an auditing and monitoring function; (iv) an anonymous reporting process for potential violations of Law or the compliance program; (v) designation of a compliance officer; and (vi) a mechanism for ensuring the effectiveness of the compliance program. None of the Company and its Subsidiaries or, employee benefits to the Knowledge of the Company, any of its officers, directors, employees, contractors or labor Law mattersagents has materially violated any such compliance program.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent Company and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the U.S. Food, Drug, and Cosmetic Act of 1938 (the “FDCA”), the U.S. Public Health Service Act (the “PHSA”), and the regulations of the FDA U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, data protection laws as well as the comparable regulations in other territories including the European Regulation N°726/2004 for the authorisation, supervision and pharmacovigilance of medicinal products, and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, packaging, labelling, storage, transport, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Company Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Company Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent Company or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Company Regulatory Permits”); (ii) all such Parent Company Regulatory Permits are valid and in full force and effecteffect (subject to the Bankruptcy and Equity Exceptions to the extent applicable thereto) and have been timely renewed to maintain their validity without interruption; and (iii) Parent is Company and its Subsidiaries are in compliance with the terms of all Parent Company Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any As of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012date hereof, neither Parent Company nor any of the Parent its Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Company Regulatory Agency.
(dc) All pre-clinical and clinical investigations in respect of a Parent Company Product or Parent Product candidate conducted or sponsored by each Company or any of Parent and the Parent its Subsidiaries are being being, and since January 1, 2020 have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations Regulations, EU Directive N°2001/20 and Good Clinical Practices and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect.
(ed) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, during the period beginning on January 1, 20122020 and ending on the date of this Agreement, neither Parent Company nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, distribution, storage, transport, packaging or manufacturing of drugs which Company Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent of the Company Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(fe) Since January 1, 20122020, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Company Regulatory Agency by Parent Company and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, since January 1, 20122020, (i) neither Parent Company nor any of the Parent its Subsidiaries, nor, to the knowledge of ParentCompany, any officer, employee or contractor of Company or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Company Products are sold or where Company has publicly announced an intention to sell a Company Product in 2021; and (ii) neither Company nor any of its Subsidiaries, nor, to the knowledge of Company, any officer, employee or contractor of Company or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935 or any similar program, including any conduct that would constitute non-compliance with the Federal Anti-Kickback Statute, Federal False Claims Act, or their respective state equivalents. Since January 1, 2020, neither Company nor any of its Subsidiaries, nor, to the knowledge of Company, any officer, employee, agent or distributor of Parent Company or any of the Parent its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent Company or any of the Parent its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Company Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gf) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, as to each Parent Company Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Company Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Company or any of the Parent its Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Company Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is are no action or proceeding Proceedings pending or, to the knowledge of ParentCompany, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Company Product or Parent Product candidate by Parent Company or any of the Parent its Subsidiaries of any Applicable Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(hg) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Neither Company nor any of its Subsidiaries has received since January 1, 20122020 any written notifications from any institutional review board, neither Parent nor ethics committee or safety monitoring committee raising any material issues that require or would require the termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical studies proposed or currently conducted by, or on behalf of, Company or any of the Parent Subsidiaries have voluntarily or involuntarily initiatedits Subsidiaries, conducted or issuedand, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of ParentCompany, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productaction is currently threatened.
(ih) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent Company and each of its Subsidiaries is and since January 1, 2020, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in Company’s ongoing clinical or pre-clinical studies or tests. In using or disclosing patient information received by Company in connection with Company’s ongoing clinical or pre-clinical studies or tests, Company has complied with all laws and regulatory rules or requirements, in each case to the extent applicable, including the Health Insurance Portability and Accountability Act of 1996, the FDCA, the RGDP and the rules and regulations thereunder (or their foreign equivalent). Neither Company nor any of the Parent its Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and, to the knowledge of Company, no such enforcement, regulatory or administrative proceeding is currently threatened.
(i) To the extent required by Applicable Laws, to the knowledge of Company, all manufacturing operations conducted for the benefit of Company with respect to any Company Product, either approved or investigational, have been conducted in accordance with GMP Regulations, except where the failure to comply would not reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not be expected to have a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Material Adverse Effect.
(j) Notwithstanding anything contained With respect to the corporate integrity agreement set forth on Section 4.14(j) of the Company Disclosure Schedule, Company and its Subsidiaries are, and at all times since January 1, 2020 have been, in this compliance in all material respects with the terms thereof and are conducting, and have conducted, all compliance-related programs that have been implemented as part of such agreement.
(k) Company and each of its Subsidiaries has developed and implemented patient and/or product support activities, including co-pay assistance and provision of free drugs (provided directly by Company, its Subsidiaries, or its or their contractors to patients), and other access and reimbursement support and adherence services, health management services, and educational services (in each case as described on Section 4.134.14(k) of the Company Disclosure Schedule), no representation or warranty shall be deemed to be made and undertakes such activities in this Section 4.13 compliance in respect of environmental, Tax, employee benefits or labor Law mattersall material respects with all Applicable Laws.
Appears in 1 contract
Regulatory Matters. (a) The Company and each of the Company Subsidiaries possesses all material Regulatory Authorizations from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Entities relating to the Company’s and each of the Company Subsidiaries’ product candidates (“Company Products”) or that are necessary for the Company or any of the Company Subsidiaries to conduct its business in all material respects as presently conducted. Except as has not had and would not reasonably be expected to havebe material to the businesses of the Company and the Company Subsidiaries, individually or in the aggregate, taken as a Parent Material Adverse Effectwhole, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits Authorizations are valid and in full force and effect; , (ii) the Company and each of the Company Subsidiaries has fulfilled and performed all of its obligations with respect to such Regulatory Authorizations, and (iii) Parent is in compliance with the terms no event has occurred which allows, or after notice or lapse of all Parent Regulatory Permits.
(b) time would allow, revocation or termination thereof. Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to havebe material to the Company, individually or in (1) the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent Company and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None each of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Company Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, applicable Governmental Entities all required documents, claimscorrespondences, permits or filings, submissions, amendments, modifications, notices would not reasonably be expected and responses to havenotices, individually or in the aggregateapplications and supplemental applications, a Parent Material Adverse Effect. All reports (including all reportable adverse event/experience reports) and (2) all such reports, documents, claims, permits and notices submissions were complete and accurate and in all material respects on the date compliance with applicable Law when filed (or were corrected or completed in or supplemented by a subsequent filing).
(b) All preclinical and clinical investigations conducted or sponsored by the Company or any of the Company Subsidiaries have been conducted in material compliance with applicable Law, rules and regulations, including Good Clinical Practices. Since January 1To the Knowledge of the Company, 2012there have been no serious or unanticipated adverse effects associated with the Company Products during clinical trials that have not been reported to any applicable Governmental Entities as required by applicable Laws. Neither the FDA nor any other Governmental Entity performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of the Company Subsidiaries with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, neither Parent suspension or material modification of such studies or tests. Neither the Company nor any of the Parent SubsidiariesCompany Subsidiaries has received any written notifications from any institutional review board, norethics committee or safety monitoring committee responsible for review, oversight, or approval of any clinical trial involving a Company Product raising any material issues that require or would require the termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical trials proposed or currently conducted by, or on behalf of, the knowledge of Parent, any officer, employee, agent or distributor of Parent Company or any of the Parent Company Subsidiaries, and, to Knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company or any of the Company Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of the Company Subsidiaries and the applicable Governmental Entities, including the FDA.
(c) To the Knowledge of the Company, neither the Company nor any of the Company Subsidiaries has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, Governmental Entity or (iii) committed an any other act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, Gratuities Final Policy that is set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect). Neither Parent the Company nor any of the Parent SubsidiariesCompany Subsidiaries is the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company or any of the Company Subsidiaries nor, to the knowledge Knowledge of Parentthe Company, any officerofficers, employee, agent employees or distributor agents of Parent the Company or any of the Parent Subsidiaries, Company Subsidiaries has been suspended or debarred or convicted of any crime or engaged in any conduct for which that would reasonably be expected to result in (A) debarment is mandated by under 21 U.S.C. § 335a(a) Section 335a or any similar Law or authorized by 21 (B) exclusion under 42 U.S.C. § 335a(b) Section 1320a-7 or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programLaw.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(id) Except as would not reasonably be expected to have a Parent Company Material Adverse Effect, neither Parent the Company and each of the Company Subsidiaries is and since January 1, 2020, has been in compliance with the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”) and applicable rules and regulations implementing the FDCA. Neither the Company nor any of the Parent Company Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked subject to any enforcement, regulatory or administrative proceedings regarding compliance with such Laws and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(e) To the extent required by applicable Law, to the Knowledge of the Company, all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in human clinical trials have been conducted in accordance with GMP Regulations, except where the failure to comply would not reasonably identifiable person be expected to be material to the business of the Company. The Company has not engaged in activities that are, as applicable, prohibited under, or cause for false claim liability, civil penalties, or mandatory or permissive exclusion from, Medicare, Medicaid or any other data protected under applicable LawGovernmental Entity health care program. Parent or Merger Sub The Company is not a business associateparty to, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103or bound by, any Judgments, prosecution agreements, monitoring agreements or similar agreements with, or imposed by, any Governmental Entity.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as Since the Lookback Date, neither Seller nor any of its Affiliates has received any written adverse communication from any Regulatory Authority relating to the Product Business, the Products or the facilities in which any of the Products is manufactured that has not had been fully resolved, including (i) any FDA Form 483 or warning letters or in the form of other written correspondence directly relating to any of the Products or the facilities in which any of the Products is manufactured or (ii) any “Notices of Adverse Findings” from the FDA or similar written notices from other Governmental Authorities with respect to any of the Products, in each case (clauses (i) and (ii)), except as would not reasonably be expected to havenot, individually or in the aggregate, be reasonably expected to be material to the Product Business or the Purchased Assets and Assumed Liabilities, taken as a Parent Material Adverse Effect, whole. The Purchased Marketing Authorizations are all of the Marketing Authorizations held by Seller and its Affiliates in respect of the Products in the Territory. The Purchased Marketing Authorizations (i) each of Parent have been validly granted or acknowledged by the relevant Governmental Authority; and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except Since the Lookback Date, (i) there has not been any product recall (whether voluntary or involuntary), dear doctor letter, post-sale warning, safety notice, investigator notice or other written notice of action relating to the safety or efficacy of any Product or its compliance with applicable regulations, or market withdrawal or replacement conducted by or on behalf of Seller or any of its Affiliates in the Territory concerning a Product and to Seller’s Knowledge, no events exist that would reasonably be expected to require Seller or its relevant Affiliate to conduct the same, and (ii) neither Seller nor any of its Affiliates has received any written notice that any Governmental Authority in the Territory has commenced, or threatened to initiate, any action to request a recall of a Product in the Territory, in each case (clause (i) and (ii)), except as would not, individually or in the aggregate, be reasonably expected to be material to the Product Business or the Purchased Assets and Assumed Liabilities, taken as a whole. Since the Lookback Date, to Seller’s Knowledge, no Product has been Manufactured or sold which was or is defective or unsafe in any material respect, was or is of unmerchantable quality or unfit for its intended purpose in any material respect or does not comply in any material respect with any express or implied representation or warranties made with respect to such Product. Seller has made available to Buyer copies of all written notices of alleged material defect or material Adverse Events regarding the Product in the Territory received by Seller or its Affiliates from any Governmental Authority in the Territory in the 24 months prior to the date hereof. From the Lookback Date, there has not been reported to Seller or any of its Affiliates any Adverse Event related to the Products that resulted or, to Seller’s Knowledge, would be reasonably likely to result, in the FDA or equivalent Governmental Authority placing a clinical hold or taking any other action which would be material to the ongoing development, Manufacture or sale of the Products.
(c) From the Lookback Date, to Seller’s Knowledge, all units of Product distributed and sold in the Territory have been researched, developed, tested, Manufactured, distributed, imported, exported and marketed in compliance in all material respects with applicable Law, including cGMP, and the applicable Purchased Marketing Authorizations and Product specifications. Neither Seller nor any of its Affiliates has received written notice of any Product Liability Claim with respect to the Product in the Territory since the Lookback Date.
(d) All material reports, registrations, filings or submissions with respect to a Product or the Product Business that were required to be filed by Seller or any of its Affiliates since the Lookback Date with the FDA or any other similar Regulatory Authority in the Territory have been filed. All such reports and filings were in compliance with applicable Laws when filed or as amended or supplemented, and no material deficiencies have been asserted in writing to Seller or any of its Affiliates by any such Regulatory Authority with respect to such reports and filings that have not been cured, except, in each case, as would not, individually or in the aggregate, reasonably be expected to be material to the Product Business, taken as a whole. Seller and its Affiliates are and since the Lookback Date have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted been in compliance with in all applicable Lawsmaterial respects with, including (i) and possess and have possessed since the FDCA; (ii) Lookback Date, all licenses, permits and approvals necessary for the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any conduct of the foregoing applicable Product Business and have paid all material fees and assessments due and payable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; connection therewith.
(ve) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud All research and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information securitydevelopment activities, including all HIPAA preclinical studies and HITECH provisions pertaining clinical trials, of the Products conducted by or on behalf of Seller with respect to privacythe Product Business have been and, information security if still pending, are being, conducted in material compliance with the applicable protocol for such study or trial, to the extent applicable, good laboratory practices and breach notification; (vii) federalgood clinical practices, state as applicable, and all Laws applicable to such studies and trials. No clinical trial conducted by or provincial Laws regarding on behalf of Seller with respect to the collectionProduct Business has been terminated or suspended prior to scheduled completion, reporting and processing neither the FDA nor any other Regulatory Authority has initiated, or, to Seller’s Knowledge, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of any applicable rebateProduct conducted by or on behalf of Seller.
(f) To Seller’s Knowledge, chargeback Seller is not subject to any investigation that is pending or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate programthreatened, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, in each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including case by the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and or the Department of Health and Human Services, of noncompliance by, or liability of Parent Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected Federal False Claims Act (31 U.S.C. §3729) with respect to have, individually or in the aggregate, a Parent Material Adverse EffectProduct Business.
(cg) Except as would notWith respect to the conduct of the Product Business, individually or including arrangements with healthcare professionals in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None conduct of the Parent Product Business, or any Parent Subsidiary are the use of the Purchased Assets, Seller has not since the Lookback Date committed a material breach of the Corporate Integrity Agreement. Other than the Corporate Integrity Agreement and related provisions in the Stipulation and Order of Settlement and Dismissal entered into by Novartis Pharmaceuticals Corporation effective July 1, 2020, neither Seller nor its Affiliates, with respect to the Product Business, the Products or the Purchased Assets, is a party to any material corporate integrity agreementsagreement, consent decree, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, agreement or similar agreements agreement with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse EffectGovernmental Authority.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any As of the Parent Subsidiaries have voluntarily or involuntarily initiateddate hereof, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent Sandoz has not received any written notice from submitted an Abbreviated New Drug Application to the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or for a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension generic version of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productlifitegrast ophthalmic solution product being sold under the brand name Xiidra®.
(i) Except as would The Product Business (x) is majority owned by persons who are not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any citizens or residents of the Parent Subsidiaries has experienced any security breach or other incident resulting United States, (y) is comprised of assets, more than 50 percent of which are located outside the United States, and (z) meets the requirements for abbreviated financial statements set forth in Rule 3-05(e)(1)(i), (ii), (iii) and (iv) of Regulation S-X under the unauthorized access, use or disclosure Securities Act of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.1031933.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Stock and Asset Purchase Agreement (Bausch & Lomb Corp)
Regulatory Matters. (a) Except The Company and the Company’s Subsidiaries hold all permits, approvals, authorizations, certificates, registrations and licenses set forth in Section 3.21(a) of the Company Disclosure Letter issued by the FCC or the state public service or public utility commissions or other similar state regulatory bodies (“State PSCs”), and all other material regulatory permits, approvals, licenses and other authorizations, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to the Company or any of its Subsidiaries by a Governmental Entity (the “Company Licenses”) that are required for the Company and each Subsidiary of the Company to conduct its business, as presently conducted, except where the failure to hold Company Licenses has not had had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, Effect on the Company.
(ib) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are Each Company License is valid and in full force and effect; effect and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would nothas not been suspended, individually revoked, cancelled or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Lawsadversely modified, except where such noncompliance the failure thereof to be in full force and effect, or liability the suspension, revocation, cancellation or modification thereof, has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in Effect on the aggregate, reasonably be expected Company. No Company License is subject to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for any conditions or requirements that have not been imposed generally upon licenses in the designsame service, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 unless such conditions or requirements are set forth on the face of the Code of Federal Regulations applicable authorization or have not had, and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects Effect on the date filed Company, or (ii) any pending proceeding by or were corrected in before the FCC or supplemented by a subsequent filing). Since January 1State PSCs to suspend, 2012revoke or cancel such Company License, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement judicial review of a material fact decision by the FCC or a fraudulent statement to the FDA State PSCs with respect thereto, unless such pending proceeding or any other Parent Regulatory Agencyjudicial review has not had, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, and would not reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement thathave, individually or in the aggregate, a Material Adverse Effect on the Company. The Company has no knowledge of any event, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such Company License is renewable by its terms), except where the failure thereof to be renewed has not had had, and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would nothave, individually or in the aggregate, a Material Adverse Effect on the Company.
(c) The licensee of each Company License is in compliance with such Company License and has fulfilled and performed all of its obligations with respect thereto, including all reports, notifications and applications required by the Communications Act of 1934, as amended (the “Communications Act”), or the rules, regulations, written policies and orders of the FCC (together with the Communications Act, the “FCC Rules”) or similar state telecommunications laws (the “State Telecommunications Laws”) and the rules, regulations, written policies and orders of State PSCs (collectively with the State Telecommunications Laws, the, “PSC Rules”), and the payment of all regulatory fees and contributions, except (i) for exemptions, waivers or similar concessions or allowances and (ii) where such failure of such licensee to be in compliance, fulfill or perform its obligations or pay such fees or contributions has not had, and would not reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would nothave, individually or in the aggregate, a Material Adverse Effect on the Company.
(d) Section 3.21(d) of the Company Disclosure Letter sets forth a list of all material regulatory permits, approvals, authorizations, certificates, registrations and licenses issued or granted to the Company or any of its Subsidiaries by the FCC or any PSC, in each case, that constitute Company Licenses, together with the name of the entity holding such Company License. The Company or a wholly owned Subsidiary of the Company directly or indirectly owns one hundred percent (100%) of the equity interests and controls one hundred percent (100%) of the voting power and decision-making authority of each licensee of the Company Licenses, except where the failure to own such equity or control such voting power and decision making authority of such licensees has not had, and would not reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would nothave, individually or in the aggregate, a Material Adverse Effect on the Company. No Company License, order or other agreement, obtained from, issued by or concluded with any State PSC would impose restrictions of the ability of any Subsidiary of the Company to make payments, dividends or other distributions to the Company or any other Subsidiary of the Company that limits, or would reasonably be expected to have a Parent Material Adverse Effectlimit, since January 1, 2012, neither Parent nor any the cash funding and management alternatives of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused Company on a consolidated basis in a manner disproportionate to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or restrictions applied by other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductState PSCs.
(ie) Except as The Company does not have knowledge of any facts that would materially impair, delay or preclude the Company’s ability to obtain any Governmental Consents.
(f) The Company is not aware of any pending FCC, FERC or State PSC regulatory proceeding that has had or would reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect, neither Parent nor any of Effect on the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Company.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse EffectEffect or that, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent and the Parent its Subsidiaries holds (xA) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, data protection laws and (yB) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Entity or Notified BodyAuthority, a “Parent Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent or any of the Parent its Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is and its Subsidiaries are in compliance with the terms of all Parent Regulatory Permits.
. All Parent Regulatory Permits are in full force and effect, except where the failure to be in full force and effect (bA) Except as has not had, and would notnot reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or (B) individually or in the aggregate, would not reasonably be expected to have a Parent Material Adverse Effectprevent, materially delay or materially impair the businesses of each ability of Parent and each Parent Subsidiary are being conducted to perform its obligations under this Agreement or to consummate the Mergers (in compliance with all applicable Lawsthe case of this clause (B), including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any as of the foregoing applicable in jurisdictions in which material quantities date of any of the Parent Products or Parent Product candidates are manufactured or sold; this Agreement).
(vb) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Neither Parent nor any of the Parent its Subsidiaries has received are party to any written notification material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or communication from similar agreements with or imposed by any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, Agency that have had or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each Parent or any of Parent and the Parent its Subsidiaries are being being, and since January 1, 2019 have been, conducted in compliance with all applicable Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect.
(ed) Since Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on January 1, 20122019 and ending on the date of this Agreement, neither Parent nor any of the Parent its Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which the Parent Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(fe) Since January 1, 20122019, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect. Neither , since January 1, 2019,
(i) neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Subsidiaries has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, ; and (ii) neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Subsidiaries has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, 1935 or any similar Parent Healthcare Applicable Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (iSection 3.24(a) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws Company Disclosure Letter sets forth a true and complete list of each Permit received by (yor applied for by) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of its Subsidiaries from the Parent Subsidiaries FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to own or operate businesses regulated by Communications Laws. Except as currently conducted or as planned to be conducted (set forth on Section 3.24(a) of the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid Company Disclosure Letter and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, as of the businesses date of this Agreement, each Permit is valid and in full force and effect in accordance with its terms, and there is no outstanding written notice of Parent and each Parent Subsidiary cancellation, termination, modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of such Permits subject to any restrictions or conditions that limit the foregoing applicable in jurisdictions in which material quantities operations of the Company or any of the Parent Products its Subsidiaries (other than restrictions or Parent Product candidates are manufactured or sold; conditions generally applicable to Permits of that type).
(vb) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20122014 through the date of this Agreement, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability as would not reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, the Company and its Subsidiaries have taken all steps reasonably necessary to maintain and preserve the effectiveness of the Permits.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, Parent as of the date of this Agreement, there are no existing or, to the Knowledge of the Company, threatened Legal Actions before any Governmental Authority, including the FCC and the Parent Subsidiaries have not engaged in activities which areState PUCs, as applicable, cause for false claims liability, civil penalties regarding the Permits or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None the operations of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect Company of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of its Subsidiaries (except Legal Action of general applicability to the Parent Subsidiaries has received any written notice from industry and not specific to the FDA Company or the EMA or any foreign agency with jurisdiction over the developmentits Subsidiaries), marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which that would reasonably be expected to lead to result in the denial, limitation, revocation, cancellation, suspension, nonrenewal, placement of material restrictions on, or rescission material adverse modification of any Parent Regulatory of, the Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, each such Parent Product or Parent Product candidate . The Company is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those not aware of any fact relating to investigational useits or any of its Subsidiaries’ respective businesses, marketing approvaloperations (including but not limited to operations in foreign jurisdictions), current good manufacturing practicesfinancial condition, packagingdirect or indirect foreign ownership or control, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatenedlegal status, including any prosecutionofficer’s, injunctiondirector’s or current employee’s status, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, that might reasonably be expected to have impair the ability of the parties to this Agreement to obtain, on a Parent Material Adverse Effecttimely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement.
(hd) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, since January 1as of the date of this Agreement, 2012to the Company’s Knowledge, neither Parent nor no event has occurred that results in, or after notice or lapse of time, or both, would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of restrictions on, or material adverse modification of any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductPermits.
(ie) Except as would not not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, neither Parent nor to the Company’s Knowledge, the Company’s Subsidiaries are not in violation of any Communications Laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Parent Company and its Subsidiaries has experienced is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any security breach Permit, and have all Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any state regulatory authority, the FCC and the Universal Service Administrative Company (in connection with any federal Universal Service Fund assessments and contributions), required to conduct their respective businesses as presently conducted as of the date of this Agreement. Except as set forth in Section 3.24(e) of the Company Disclosure Letter, there is not pending, or to the Company’s Knowledge threatened, any audits, examinations, investigations, or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 proceedings in respect of environmentalany such filing and/or reporting requirements, Taxin each case, employee benefits or labor Law matterswhich would reasonably be expected to be material to the Company.
Appears in 1 contract
Sources: Merger Agreement (Inteliquent, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to haveThe Company, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent Bank and the Parent Subsidiaries holds (xother than the Bank) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on with all laws administered by and regulations of any Governmental Authority applicable to it or to them (including, without limitation, all regulations and orders of, or agreements with, the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any Office of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any Comptroller of the Parent SubsidiariesCurrency and the FDIC, has made an untrue statement of a material fact the HOLA, Equal Credit Opportunity Act, the Fair Housing Act, the Community Reinvestment Act, the Home Mortgage Disclosure Act, all other applicable fair lending laws or a fraudulent statement other laws relating to discrimination and the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any Bank Secrecy Act and Title III of the Parent SubsidiariesU.S.A. Patriot Act), that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and comply with which would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent the Company nor any of the Parent SubsidiariesSubsidiaries is subject or is party to, nor, or has received any notice or advice that any of them may become subject or party to the knowledge of Parentany investigation with respect to, any officercorrective, employeesuspension or cease-and-desist order, agent agreement, consent agreement, memorandum of understanding or distributor other regulatory enforcement action, proceeding or order with or by, or is a party to any commitment letter or similar undertaking to, or is subject to any directive by, or has been a recipient of Parent any supervisory letter from, or has adopted any board resolutions at the request of, any Regulatory Agency (as defined below) that currently restricts in any material respect the conduct of their business, that in any manner relates to their capital adequacy, or that in any material respect relates to credit policies or management (each, a “Regulatory Agreement”), nor has the Company or any of the Parent SubsidiariesSubsidiaries been advised by any Regulatory Agency that it is considering issuing or requesting any such Regulatory Agreement which, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any the reasonable judgment of the Parent Products Company, is expected to have a Material Adverse Effect. There is no unresolved violation, criticism or Parent Product candidates are sold exception by any Regulatory Agency with respect to any report or intended by the Parent statement relating to be sold. Since January 1, 2011, neither Parent nor any examinations of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent Company or any of the Parent SubsidiariesSubsidiaries which, has been debarredin the reasonable judgment of the Company, suspended is expected to result in a Material Adverse Effect. As used herein, the term “Regulatory Agency” means any federal or excluded from participation in any government health care program state agency charged with the supervision or convicted regulation of any crime depositary institutions or holding companies of depositary institutions, or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 the insurance of the Social Security Act of 1935, as amendeddepositary institution deposits, or any similar Parent Healthcare Law court, administrative agency or program.
(g) As to each Parent Product commission or Parent Product candidate subject other Governmental Authority having supervisory or regulatory authority with respect to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except Neither the Company nor any of its Affiliates has received any oral or written communication (including any warning letter, untitled letter, Form 483s or similar notices) from the FDA or any counterpart regulatory authorities in the European Union, and to the Knowledge of the Company and its Affiliates, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any of its Subsidiaries is not currently in compliance with any and all applicable Laws implemented by the FDA, the Drug Enforcement Administration, any counterpart regulatory authorities in the European Union or any other country, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect. There are no pending voluntary or involuntary market withdrawals, field corrective actions (i) each of Parent and the Parent Subsidiaries holds (x) all permitsincluding recalls), licensesdestruction orders, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of seizures or other regulatory enforcement actions related to any applicable Governmental Entity product that have had or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned would reasonably be expected to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would nothave, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect.
(b) Neither the Company nor any of its Affiliates has received any correspondence from the FDA, or a counterpart regulatory authority in the European Union, regarding, and, to the Knowledge of the Company, there is no pending or threatened action or proceeding against, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state Company or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of its Subsidiaries or any of their respective employees regarding any debarment action or investigation undertaken pursuant to the Parent Products or Parent Product candidates are manufactured or sold; Generic Drug Enforcement Act of 1992 (v21 U.S.C. Sections 335(a), (b) federal, state or provincial criminal or civil healthcare Laws and (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(bc)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), or any similar regulation of the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and FDA or any comparable federal, state, provincial or local healthcare Laws similar regulation of any counterpart regulatory authority in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsEuropean Union, except where such noncompliance for any action or liability proceeding that has not had or would not reasonably be expected to have, individually or in the aggregate, a Parent Company Material Adverse Effect.
(c) Except as would notNo data generated by the Company or any of its Affiliates with respect to its products that has been provided to its customers or otherwise made public is the subject of any regulatory or other action, individually either pending or in threatened, by the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid FDA or any other government healthcare program. None comparable Governmental Authority relating to the truthfulness or scientific adequacy of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencysuch data.
(d) All pre-clinical and clinical investigations in respect Neither the Company nor any of a Parent Product or Parent Product candidate conducted or sponsored its Subsidiaries is subject to any pending or, to the Knowledge of the Company, threatened, investigation by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) the FDA standards for the designpursuant to its Fraud, conductUntrue, performanceMaterial Facts, monitoringBribery, auditingand Illegal Gratuities Final Policy, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)) or the Civil False Claims Act (31 U.S.C. Section 3729 et seq.) or (iii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure equivalent statute or policy of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in any country in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse EffectEuropean Union.
(e) Since January 1The Company has, 2012prior to the execution of this Agreement, neither made available to Parent nor copies of any and all documents in its or its Subsidiaries’ possession that are material to assessing the Company’s or any of its Subsidiaries’ compliance with the Parent Subsidiaries has received any written notice from the FDA Federal Food, Drug and Cosmetic Act or the EMA International Standards Organization and their respective implementing regulations or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of other similar regulations in any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyapplicable jurisdiction.
(f) The Company and its Subsidiaries are in compliance in all material respects with all applicable requirements of the Act, the Public Health Service Act, and the regulations promulgated thereunder by the FDA (collectively, the “FDA Requirements”).
(g) Since January 1, 20122002, all reports, documents, claims, permits and notices required to be filed, maintained neither the Company nor any of its Affiliates has received any notice or furnished to other communication from the FDA or any other Parent Regulatory Agency Governmental Authority alleging any current violation of the FDA Requirements.
(h) All manufacturing, testing, research, and other scientific operations by Parent the Company and the Parent its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate conducted in all material respects on in compliance with good manufacturing practices, good clinical practices and good laboratory practices as set forth by the date FDA.
(i) The Company and its Subsidiaries have not filed (or were corrected in or supplemented by a subsequent filing)any biologics license applications. Since January 1None of the Company, 2012, neither Parent nor any of the Parent Subsidiaries, norits Subsidiaries or any of their respective officers or employees or, to the knowledge of Parentthe Company, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, agents has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or other Governmental Authority.
(j) None of the Company, any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent its Subsidiaries or any of the Parent Subsidiariestheir respective officers, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) employees or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, agents has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § Section 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable Law.
(k) The Company and its Subsidiaries are in other jurisdictions compliance in which all material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, respects with all Laws that apply to the knowledge of ParentMedicare and Medicaid Antikickback Act (42 U.S.C. § 1320a-7b(a)), any officerthe Civil False Claims Act (31 U.S.C. § 3729(a)), employeeSections 1128A, agent or distributor of Parent or any of the Parent Subsidiaries1128B, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 and 1877 of the Social Security Act (42 U.S.C. §§ 1320a-7a, -7b, 1395nn), the Health Care Fraud Act (18 U.S.C. § 1347), the Health Insurance Portability and Accountability Act of 19351996 (42 U.S.C. §§ 1171-79), and the Criminal False Claims Act (18 U.S.C. § 287), as amendedamended from time to time, or any as well as similar Parent Healthcare Law or programapplicable state Laws.
(gl) As to each Parent Product or Parent Product candidate subject Section 4.18(l) of the Company Disclosure Schedule sets forth a true, correct and complete list of all INDs, NDAs, sNDAs, and other Drug Approval Applications filed with a Governmental Authority relating to the FDCA Key Products.
(m) Each of IND #67,482, IND #70,109, IND #70,863 and IND #73,167 has been issued in the regulations name of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any Company and, to the Knowledge of the Parent Products or Parent Product candidates are sold or intended Company, constitutes all governmental approvals, permits and licenses required by the Company in connection with the performance of clinical trials concerning, respectively, NRP104 (ADHD), NRP104 (Cocaine), NRP290 and NRP409, as such clinical trials have been conducted by the Company as of the Effective Time.
(n) The Company and its Subsidiaries have complied in all material respects with all applicable Laws in connection with the preparation and submission to be sold the FDA of IND #67,482, IND #70,109, IND #70,863 and IND #73,167 and each such IND is in effect.
(o) The Company or any Subsidiary of the Company has complied in all material respects with the requirements of filing with the applicable regulatory authority all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to IND #67482, IND #70,109, IND #70,863 and IND #73,167.
(p) In the course of the conduct of the development of any Key Product, the Company and its Subsidiaries have not used any employee or consultant that is debarred by the FDA or, to the Knowledge of the Company or its Affiliates, is the subject of debarment proceedings by the FDA.
(q) Neither the Company nor any of its Affiliates has been developedreceived any written notice from any Governmental Authority claiming that the research, manufactureddevelopment, testedmanufacture, distributed or marketed and use of any Key Product by or on behalf of Parent the Company or any of its Subsidiaries as of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate Effective Time is being or has been developed, manufactured, stored, distributed and marketed not in compliance with all applicable LawsLaw and Permits, including those the Act.
(r) Since January 1, 2002, no Governmental Authority has served notice on the Company or any of its Affiliates that the Company Technology or any Key Product was or is in violation of any Law or the subject of any investigation.
(s) Since January 1, 2002, neither the Company nor any of its Affiliates has received written notice from any Governmental Authority that there are any circumstances currently existing that might reasonably be expected to lead to any loss or refusal to renew any material Permit relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action the Company Technology or proceeding pending any Key Product.
(t) No Governmental Authority (including the FDA) has commenced or, to the knowledge Knowledge of Parentthe Company or its Affiliates, threatenedthreatened to initiate any formal action to reject or withdraw the INDs or Drug Approval Applications for any Key Product, including or commenced or, to the Knowledge of the Company or its Affiliates, threatened to initiate any prosecutionaction to enjoin production of any Key Product at any facility, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent nor has the Company or any of the Parent Subsidiaries of its Affiliates received any Law, except as would not, individually or in the aggregate, reasonably be expected notice to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, such effect since January 1, 20122002.
(u) The Company has delivered or otherwise made available to Parent copies of all material (A) reports of FDA Form 483 inspection observations, neither Parent nor (B) establishment inspection reports, (C) warning letters and (D) other documents that assert ongoing lack of compliance in any material respect with any applicable Laws (including those of the FDA), in each case, to the extent received by the Company or any of its Affiliates from the FDA relating to any Key Product.
(v) The Company and its Affiliates have delivered or made available to Parent Subsidiaries have voluntarily any facts reasonably believed in good faith to be material regarding: (A) preclinical and clinical study results and protocols for any Key Product; (B) any communications to or involuntarily initiatedfrom the FDA with respect to any Key Product, conducted or issuedIND, NDA, or caused to be initiatedsNDA submissions, conducted or issuedand any FDA minutes of meetings and telephone conferences; (C) any FDA requests for data and studies on any Key Product; and (D) adverse drug experiences and other IND, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator noticeNDA, or other notice or action sNDA safety reports with respect to wholesalersany Key Product.
(w) Except as pursuant to the disclosures described in Section 4.18(v), distributors, retailers, healthcare professionals or patients relating to an alleged lack the Knowledge of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of ParentCompany, there are no facts which are reasonably likely to cause, and Parent has not received any written notice safety or efficacy issues that would preclude regulatory approval or cause withdrawal from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductNRP104.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Shire PLC)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (iSection 3.24(a) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws Company Disclosure Letter sets forth a true and complete list of each Permit received by (yor applied for by) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of its Subsidiaries from the Parent Subsidiaries FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to own or operate businesses regulated by Communications Laws. Except as currently conducted or as planned to be conducted (set forth on Section 3.24(a) of the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid Company Disclosure Letter and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, as of the businesses date of this Agreement, each Permit is valid and in full force and effect in accordance with its terms, and there is no outstanding written notice of Parent and each Parent Subsidiary cancellation, termination,modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of such Permits subject to any restrictions or conditions that limit the foregoing applicable in jurisdictions in which material quantities operations of the Company or any of the Parent Products its Subsidiaries (other than restrictions or Parent Product candidates are manufactured or sold; conditions generally applicable to Permits of that type).
(vb) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 20122014 through the date of this Agreement, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability as would not reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, the Company and its Subsidiaries have taken all steps reasonablý necessary to maintain and preserve the effectiveness of the Permits.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, Parent as of the date of this Agreement, there are no existing or, to the Knowledge of the Company, threatened Legal Actions before any Governmental Authority, including the FCC and the Parent Subsidiaries have not engaged in activities which areState PUCs, as applicable, cause for false claims liability, civil penalties regarding the Permits or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None the operations of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect Company of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of its Subsidiaries (except Legal Action of general applicability to the Parent Subsidiaries has received any written notice from industry and not specific to the FDA Company or the EMA or any foreign agency with jurisdiction over the developmentits Subsidiaries), marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which that would reasonably be expected to lead to result in the denial, limitation, revocation, cancellation, suspension, nonrenewal, placement of material restrictions on, or rescission material adverse modification of any Parent Regulatory of, the Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or individuallyor in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, each such Parent Product or Parent Product candidate . The Company is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those not aware of any fact relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent its or any of the Parent Subsidiaries of its Subsidiaries' respective businesses, operations (including but not limited to operations in foreign jurisdictions),financial condition, direct or indirect foreign ownership or control, or legal status, **MSPSC Electronic Copy ** 2016-UA-225 Filed on 11/14/2016 ** including any Lawofficer's, except as would notdirector's or current employee's status, individually or in the aggregate, that might reasonably be expected to have impair the ability of the parties to this Agreement to obtain, on a Parent Material Adverse Effecttimely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any GovernmentalAuthority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement.
(hd) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, since January 1as of the date of this Agreement, 2012to the Company's Knowledge, neither Parent nor no event has occurred that results in, or after notice or lapse of time, or both, would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of restrictions on, or material adverse modification of any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent ProductPermits.
(ie) Except as would not not, individually or in the aggregate, reasonably be expected to have a Parent Company Material Adverse Effect, neither Parent nor to the Company's Knowledge, the Company's Subsidiaries are not in violation of any Communications Laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Parent Company and its Subsidiaries has experienced is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any security breach Permit, and have all Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any state regulatory authority, the FCC and the Universal Service Administrative Company (in connection with any federal Universal Service Fund assessments and contributions), required to conduct their respective businessesas presently conducted as of the date of this Agreement. Except as set forth in Section 3.24(e) of the Company Disclosure Letter, there is not pending, or to the Company's Knowledge threatened, any audits, examinations, investigations, or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 proceedings in respect of environmentalany such filing and/or reporting requirements, Taxin each case, employee benefits or labor Law matterswhich would reasonably be expected to be material to the Company.
Appears in 1 contract
Sources: Agreement and Plan of Merger
Regulatory Matters. (a) The Company and each of its Subsidiaries possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Bodies relating to the Company’s and each of its Subsidiaries’ products and product candidates (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, have a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits Authorizations are valid and (A) in full force and effect; , (B) validly registered and on file with applicable Governmental Bodies and (iiiC) Parent is in compliance with all formal filing and maintenance requirements and (ii) the terms Company and each of its Subsidiaries has fulfilled and performed all Parent of its material obligations with respect to such Regulatory PermitsAuthorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be material to the Company, (1) the Company and each of its Subsidiaries has filed, maintained or furnished to FDA or other applicable Governmental Bodies all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and (2) all such submissions were complete and accurate and in compliance with applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing).
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012all preclinical and clinical investigations sponsored by the Company or any of its Subsidiaries are being conducted in material compliance with applicable Legal Requirements, neither Parent rules, regulations and guidances, including Good Clinical Practices. Neither the FDA nor any other Governmental Body performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of its Subsidiaries with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. Neither the Company nor any of the Parent its Subsidiaries has received any written notice notifications from any institutional review board, ethics committee or safety monitoring committee raising any material issues that require or would require the FDA termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical studies proposed or currently conducted by, or on behalf of, the EMA Company or any foreign agency of its Subsidiaries, and, to knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of and reasonably available to the Company or any of its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies, in each case with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityrespect to any clinical studies proposed or currently conducted by, or manufacturing on behalf of, the Company or any of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyits Subsidiaries.
(fc) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to To the FDA or any other Parent Regulatory Agency by Parent and knowledge of the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012Company, neither Parent the Company nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, its Subsidiaries has (i) made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a any statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide ) establishes a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”Gratuities Final Policy. As of the date of this Agreement, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for neither the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Company nor any of its Subsidiaries is the Parent Subsidiariessubject of any pending or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company or any of its Subsidiaries nor, to the knowledge of Parentthe Company, any officerofficers, employeeemployees, agent agents or distributor clinical investigators of Parent the Company or any of the Parent Subsidiaries, its Subsidiaries has been suspended or debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed result in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent (A) debarment under 21 U.S.C. Section 335a or any of the Parent Subsidiaries of similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectsimilar Legal Requirement.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(id) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent the Company and each of its Subsidiaries is and since January 1, 2019, has been in compliance with all healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.); (ii) the Federal Food, Drug and Cosmetics Act (“FDCA”); (iii) the Health Insurance Portability and Accountability Act of 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company or any of its Subsidiaries. Neither the Company nor any of its Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and, to the Parent knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. To the knowledge of the Company, neither the Company nor any of its Subsidiaries has experienced had any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data “protected under applicable Law. Parent or Merger Sub is not a business associate, health information” (as that such term is defined in used under HIPAA) that would constitute a security incident or breach that would require the HIPAA regulations at 45 C.F.R. § 160.103Company to provide notice under HIPAA.
(je) Notwithstanding anything contained To the extent required by applicable Legal Requirements, all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in this Section 4.13human clinical trials have been conducted in accordance with GMP Regulations, no representation or warranty shall except where the failure to comply would not reasonably be deemed expected to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law mattershave a Material Adverse Effect.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had Authorizations. The Company holds all Federal Communications Commission ("FCC"), state public utility commission ("PUC") and would not reasonably be expected to haveforeign regulatory authority permits, licenses, certificates, registrations and other similar authorizations necessary or appropriate for the conduct of its business (collectively, the "Authorizations"), the lack of which would, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, (i) each of Parent . The Company and the Parent its Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, have maintained and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and kept in full force and effect; , and (iiihave applied in a timely manner for renewal of all such Authorizations. Except as disclosed in Section 3.18(a) Parent is of the Disclosure Schedules, the Company and its Subsidiaries are in compliance with the all such Authorizations and any terms of all Parent Regulatory Permits.
(b) Except and conditions thereto except such non-compliance as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted . Except as disclosed in compliance with all applicable Laws, including (iSection 3.18(a) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in Disclosure Schedules, each Authorization which is material quantities of any to the business of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud Company is valid and abuse, including but not limited to 18 U.S.C. Sections 286 in full force and 287effect, and the health care fraud criminal provisions under HIPAACompany and its Subsidiaries have not received notice from the FCC, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance byPUC, or liability any foreign regulatory authority of Parent its intention to revoke, suspend, condition or the Parent Subsidiaries underfail to renew any such Authorization, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would notwhich would, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged . Except as disclosed in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None Section 3.18(a) of the Parent Disclosure Schedules, no event has occurred or any Parent Subsidiary are a party to any material corporate integrity agreementsfacts and circumstances exist, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, which allows or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocationallow, or rescission which after notice or lapse of any Parent Regulatory Permits time would allow or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraudallow, Untrue Statements of Material Factsrevocation, Briberysuspension, and Illegal Gratuities”, set forth non-renewal or termination or result in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency material impairment of the Company's or its Subsidiaries' rights under any of its Authorizations to invoke any similar policythe extent that such revocation, except for any act termination or statement or failure to make a statement that, individually or in the aggregate, has not had and impairment would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Securities Purchase Agreement (Skyterra Communications Inc)
Regulatory Matters. (a) Except as The Company is developing, testing, labeling, packaging, manufacturing, distributing, and storing, and at all times since incorporation has not had developed, tested, labeled, packaged, manufactured, distributed, and would not reasonably be expected to have, individually or stored the Product and each of the Product Candidates in the aggregate, a Parent Material Adverse Effect, compliance in all material respects with (i) the FDA Act and applicable implementing regulations and guidances issued by the FDA, including, as applicable, those requirements relating to the FDA’s current good manufacturing practices, good laboratory practices, good clinical practices and investigational use, in each case, for a new drug product, (ii) the Laws of Parent the European Union and applicable implementing regulations and guidelines issued by applicable Governmental Entities in the Parent Subsidiaries holds (x) all permitsEuropean Union, licenses, franchises, approvals, clearances, registrationsincluding the EMA, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (yiii) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any other applicable Governmental Entity Entities in any other country where the Company has actually developed, tested, labeled, packaged, manufactured, distributed or Notified Body that are concerned with stored the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Product or any of the Parent Subsidiaries as currently conducted Product Candidates. The Company has not received written notice of any pending or as planned to be conducted (threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent FDA or any other Governmental Entity alleging that any operation or activity of the Company is in compliance with material violation of the terms of all Parent Regulatory PermitsFDA Act or the respective counterparts thereof promulgated by applicable state Governmental Entities or Governmental Entities outside the United States.
(b) Except The Company owns good title, free and clear of all Security Interests, to (i) the NDA for Minocin and (ii) the rights to reference the NDA for Minocin in seeking and obtaining Regulatory Approval for RPX-602 within and outside of the United States. The Company is not subject to any third party contractual obligation that prevents, restricts or adversely affects the Company from marketing Minocin within the United States or seeking Regulatory Approvals for or marketing RPX-602 within or outside of the United States.
(c) The Company has made available to the Buyer, with respect to the Product and each of the Product Candidates, complete and correct copies, as would notof the date of this Agreement, individually or of (i) in the aggregatecase of the Product, reasonably be expected all NDAs in its possession or of which it has Knowledge submitted to have a Parent Material Adverse Effectthe FDA, (ii) all INDs or Clinical Trial Applications (“CTAs”) submitted to the FDA or to any other Governmental Entity, respectively, (iii) all ▇▇▇▇ submitted to the EMA and its respective counterparts in the European Union, (iv) all foreign counterparts to the NDAs, INDs, CTAs and ▇▇▇▇ (in any other country where the Company has undertaken any action to develop, test, label, manufacture, distribute or store the Product or any of the Product Candidates), (v) all supplements to and amendments of the items set forth in clauses (i) through (iv) and (vi) all material correspondence with the FDA or with any other Governmental Entity located in the United States or European Union with respect to the Product and each of the Product Candidates. All information, claims, reports, statistics, and other data and conclusions submitted by the Company in connection with the NDAs, the businesses INDs, the CTAs and the ▇▇▇▇ and any foreign counterparts thereof and in all supplements to and amendments of the same were true, complete and correct in all material respects as of the applicable date of submission and were in compliance in all material respects with all applicable Laws as of the respective dates such filings were made.
(d) All preclinical studies and clinical trials, and other studies and tests of each of Parent the Product Candidates conducted by or on behalf of the Company have been, and each Parent Subsidiary if still pending are being being, conducted in compliance material compliance, to the extent applicable, with the applicable protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Laws, including (i) the FDCA; (ii) FDA Act and the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign respective counterparts thereof outside the United States, including, as applicable, the Laws for any of the foregoing European Union. To the Knowledge of the Company, all preclinical studies and clinical trials, and other studies and tests of the Product have been, and if still pending are being, conducted in material compliance, to the extent applicable, with the applicable in jurisdictions in which material quantities protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Laws, including the FDA Act. No clinical trial conducted by or on behalf of the Company has been terminated or suspended prior to scheduled completion, and neither the FDA nor any other applicable Governmental Entity, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company has initiated, or, to the Company’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of any of the Parent Products Product Candidates conducted or Parent Product candidates are manufactured proposed to be conducted by or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any on behalf of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding Company. Neither the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent Company nor any of the Parent its Subsidiaries has received any written notification notice that the FDA or communication any other Governmental Entity has commenced, or, to the Company’s Knowledge, threatened in writing to initiate, any action to withdraw or suspend an IND, or commenced or, to the Company’s Knowledge threatened in writing to initiate, any action to enjoin production of the Product or any of the Product Candidates at any of its or its suppliers’ facilities. No clinical investigator who has conducted or, if still pending, is conducting any clinical trial sponsored by or on behalf of the Company has been disqualified from receiving investigational products by the FDA or any Parent Regulatory Agencyother Governmental Entity or received any written notice from the FDA or any other Governmental Entity of an intent to initiate such disqualification proceedings.
(e) The Company is not subject to any investigation that is pending or, including to the FDAKnowledge of the Company, that is pending and not served or threatened or that has been threatened, in each case by (i) the Drug Enforcement Administration, FDA or (ii) the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the or Department of Health and Human Services, of noncompliance by, or liability of Parent Justice pursuant to the U.S. Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in U.S. Federal False Claims Act (31 U.S.C. §3729) (known as the aggregate, a Parent Material Adverse Effect“Federal Civil False Claims Act”).
(cf) Except The Company has not submitted any claim for payment to any government healthcare program in connection with any referrals that violated any applicable self-referral Law, including the Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn (known as would notthe “▇▇▇▇▇ Law”), individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agencyapplicable state self-referral Law.
(dg) All pre-clinical and clinical investigations The Company has not submitted any claim for payment to any government healthcare program in respect violation of a Parent Product any Laws relating to false claims or Parent Product candidate conducted fraud, including the Federal Civil False Claim Act or sponsored by each of Parent and the Parent Subsidiaries are being conducted any applicable state false claim or fraud Law.
(h) The Company has complied in compliance all material respects with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including security and privacy standards regarding protected health information under (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations HIPAA and (ii) any applicable federalhealth privacy Laws.
(i) All manufacturing operations conducted for the benefit of the Company have been and are being conducted in material compliance with applicable Laws, including, to the extent applicable, the provisions of the FDA’s current good manufacturing practice regulations and the respective counterparts thereof promulgated by state and provincial Laws restricting Governmental Entities, or Governmental Entities in countries outside the collectionUnited States. To the Company’s Knowledge, use and disclosure none of individually identifiable health information and personal informationthe Company’s suppliers or contract manufacturers has received an FDA Form 483 or other Governmental Entity notice of inspectional observations, except“warning letters” or “untitled letters”, in each case, for such noncompliance that, individually related to or in affecting the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor Product or any of the Parent Subsidiaries Product Candidates. The Company has made available to the Buyer copies of all material (i) reports of inspection observations, if any, relating to the Product or any of the Product Candidates received by the Company or any written notice of its Subsidiaries, (ii) establishment inspection reports relating to the Product or any of the Product Candidates received by the Company or any of its Subsidiaries, and (iii) warning letters relating to the Product or any of the Product Candidates received by the Company or any of its Subsidiaries, if any, as well as any other documents received by the Company or any of its Subsidiaries, or to its Knowledge, its suppliers or contract manufacturers from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead other applicable Governmental Entities relating to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent Product or any of the Parent Product Candidates or arising out of the development of the Product or any of the Product Candidates that assert past or ongoing lack of compliance with any applicable Laws by the Company or any of its Subsidiaries, has made and to its Knowledge, its suppliers and contract manufacturers relating to clinical development of the Product or any of the Product Candidates.
(j) Section 3.18(j) of the Company Disclosure Schedule sets forth a list of (i) all Product or Product Candidate recalls, field notifications, investigator notices, safety alerts, “serious adverse event” reports or other notices of action relating to an untrue statement alleged lack of a material fact safety or a fraudulent statement regulatory compliance issued by the Company or by contracting Persons acting on behalf of the Company (“Safety Notices”), (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to the FDA Company’s Knowledge, any material Product or Product Candidate complaints that are currently unresolved.
(k) The Company has not committed any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, any statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” or any such similar policies set forth in 56 Fedany applicable Laws. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any None of the Parent Subsidiaries, norCompany or, to the knowledge of ParentCompany’s Knowledge, any officerof its officers, employee, agent key employees or distributor of Parent or any of the Parent Subsidiariesagents, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, that has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amendedresulted, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectresult, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all debarment under applicable LawsLaw, including those relating to investigational use21 U.S.C. Section 335a. To the Company’s Knowledge, marketing approvalno claims, current good manufacturing practicesactions, packaging, labeling, advertising, record keeping, reporting, and security. There is no action proceedings or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as investigations that would not, individually or in the aggregate, reasonably be expected to have result in such a Parent Material Adverse Effect.
(h) Except as would not, individually material debarment or in exclusion of the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor Company are pending or threatened against the Company or any of its officers, employees or agents. All documents filed by the Parent Company or any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from with the FDA or any other Parent Regulatory Agency regarding (i) Governmental Entity with respect to the recallProduct and any of the Product Candidates, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketinghandling, storage or distribution shipment of the Product or any of the Product Candidates were, at the time of filing, true, complete and accurate in all material respects, no adverse event information has come to the attention of the Company or any of its Subsidiaries that is materially different in terms of the incidence, severity or nature of such Parent Products, adverse events than any which were filed as safety updates to the documents filed by the Company or (iv) a any of its Subsidiaries with the FDA or any other Governmental Entity with respect to the Product and each of the Product Candidates and all written data summaries prepared by the Company or any of its Subsidiaries that were included in documents filed with the FDA or any other Governmental Entity with respect to the Product and each of the Product Candidates and that are based on clinical studies conducted or sponsored by the Company or any of its Subsidiaries accurately summarize in all material negative change in reimbursement status of a Parent Productrespects the corresponding raw data underlying such summaries.
(il) Except as would The Company is not reasonably be expected a party to have a Parent Material Adverse Effectany corporate integrity agreement, neither Parent monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Entity.
(m) The Company has complied in all material respects with ICH-GCP guidelines in the management of the clinical data that has been presented to the Buyer.
(n) The Company has disclosed to the Buyer all material information known by the Company or any of its Subsidiaries with respect to the safety and efficacy of the Product and each of the Product Candidates from nonclinical and/or clinical studies.
(o) Neither the Company nor any of the Parent its Subsidiaries has experienced received any security breach or other incident resulting in written notice questioning the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person good standing with the FDA or any other data protected under Governmental Entity of any of the documents filed by the Company or any of its Subsidiaries with the FDA or any other Governmental Entity with respect to the Product or any of the Product Candidates or the manufacturing, handling, storage or shipment of the Product or any of the Product Candidates. The Company has made available to the Buyer complete and accurate copies of all documents filed by the Company or any of its Subsidiaries with the FDA or any other Governmental Entity with respect to the Product and each of the Product Candidates. The Company and its Subsidiaries have filed with the FDA and other applicable Law. Parent Governmental Entity all required notices, registration applications, order forms, reports, supplemental applications and annual or Merger Sub is not a business associateother reports or documents, as including adverse experience reports, that term is defined in are material to the HIPAA regulations at 45 C.F.R. § 160.103continued development or handling of the Product or any of the Product Candidates.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Medicines Co /De)
Regulatory Matters. (a) Except To the Knowledge of Seller, the Target Company is in material compliance with all applicable laws, rules and regulations of the United States, including of the FDA, applicable to the sale and distribution of the Products except as has not had and would not reasonably be expected expects to havehave a Material Adverse Effect or as is caused by the failure of a manufacturer of a Product to comply with the provisions of this sentence. Target Company has all requisite permits, individually or in approvals, registrations, licenses from the aggregateFDA to conduct the Business as currently conducted, except as would not reasonably be expects to have a Parent Material Adverse Effect. There are no pending or, (i) each to the Knowledge of Parent and Seller, threatened, actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or complaints by the Parent Subsidiaries holds (x) all permitsFDA relating to the Business except as would not reasonably be expects to have a Material Adverse Effect. Target Company has not made any false statements on, licensesor omissions from, franchisesthe applications, approvals, clearances, registrations, reports and authorizations under other submissions to the FDCA, FDA prepared or maintained to comply with the PHSA, the regulations requirements of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except except as would not, individually or in the aggregate, not reasonably be expected expects to have a Parent Material Adverse Effect, . Target Company has properly handled and stored all Products included in the businesses of each of Parent and each Parent Subsidiary are being conducted Inventory in compliance with all applicable Lawslaws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules rule and regulations promulgated pursuant to all such applicable Laws, each except as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected expects to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reportsTarget Company has not, documentsnor to Knowledge of Seller has any officer or employee of Target Company, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed result in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) debarment under 21 U.S.C. Section 335a or (ii) exclusion under 42 U.S.C. Section 1320a-7. Certain Business Relationships with Parent and its Affiliates. Except as set forth on the recallSection 4(r) of the Disclosure Schedule, market withdrawal Target Company has not been involved in any material business arrangement or replacement of any Company Product sold or intended to be sold by relationship with Parent or a its Affiliates related to the Business within the past twelve months. Except as set forth on the Section 4(r) of the Disclosure Schedule, as of the Closing, Target Company will have no business arrangement, contract or relationship with Parent Subsidiary (or its Affiliates other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken (i) as a whole)contemplated by this Agreement, (ii) a material change in the marketing classification with respect to K▇▇▇▇▇ or a material change in the labeling of any such Parent Productsother branded pharmaceutical products on terms and conditions reasonably acceptable to Buyer, and (iii) on commercially reasonable terms and, in any case, as may be terminable by Target Company without advance notice or penalty. Organization, Qualification, and Corporate Power. Target Company is a termination or suspension corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of incorporation. Target Company is duly authorized to conduct business and is in good standing under the laws of each jurisdiction where such qualification is required. Target Company has full corporate power and authority to carry on the business in which it is engaged and to own and use the properties owned and used by it. Section 4(s) of the manufacturingDisclosure Schedule lists the directors and officers of each the Target Company. The Target Company has no direct or indirect subsidiaries. Capitalization. Section 4(t) of the Disclosure Schedule sets forth for the Target Company (A) its jurisdiction of incorporation, marketing(B) the number of authorized shares for each class of its capital stock, (C) the number of issued and outstanding shares of each class of its capital stock, and (D) the number of shares of its capital stock held in treasury. All of the issued and outstanding Target Shares have been duly authorized, are validly issued, fully paid, and non-assessable, and are held of record and beneficially by Seller. There are no outstanding or authorized options, warrants, purchase rights, subscription rights, conversion rights, exchange rights, or distribution of such Parent Productsother contracts or commitments that could require the Target Company to issue, sell, or (iv) a material negative change in reimbursement status otherwise cause to become outstanding any additional shares of a Parent Product.
(i) Except as would not reasonably be expected its capital stock. There are no outstanding or authorized stock appreciation, phantom stock, profit participation, or similar rights with respect to have a Parent Material Adverse Effect, neither Parent nor any the shares of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Target Company.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except During the past two (2) years the Company and the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, store, sale, commercialization or distribution of the products of the SpinCo Business (each, a “Specified SpinCo Governmental Authority”)) all required material filings, declarations, listings, registrations, reports or submissions, including, but not limited to, adverse event reports, except, in each case, as has would not had have, and would not reasonably be expected to have, individually or in the aggregate, a Parent SpinCo Material Adverse Effect. All such filings, (i) each of Parent and the Parent Subsidiaries holds (x) all permitsdeclarations, licenses, franchises, approvals, clearanceslistings, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity reports or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and submissions were in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in material compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including all applicable Regulatory Laws) when filed, and, as of the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b))date of this Agreement, False Claims Act (42 U.S.C. §1320a-7b(a))no deficiencies have been asserted in writing by any applicable Specified SpinCo Governmental Authority to the Company or any of its Subsidiaries with respect to any such filings, Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h)declarations, the exclusion laws (42 U.S.C. § 1320a-7)listing, the civil monetary penalties law (42 U.S.C. § 1320a-7a)registrations, all criminal laws relating to health care fraud and abusereports or submissions, including but except as would not limited to 18 U.S.C. Sections 286 and 287have, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent SpinCo Material Adverse Effect.
(cb) Except as would notnot have, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent SpinCo Material Adverse Effect. All such reports, documentsthe Company and the Company’s Subsidiaries (in each case, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, solely with respect to the knowledge of ParentSpinCo Business) have for the past two (2) years had appropriate internal controls that are reasonably designed to ensure compliance with, any officerall applicable Laws, employeeincluding all Regulatory Laws.
(c) Except as would not have, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, and would not reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement thathave, individually or in the aggregate, a SpinCo Material Adverse Effect, all preclinical and clinical studies or tests sponsored by the Company or the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group in the past two (2) years have been conducted in material compliance with applicable Law, including all applicable Regulatory Laws and Regulatory Authorizations, rules, regulations and binding guidance, including Good Clinical Practices and Good Laboratory Practice Requirements and federal and state laws, rules, regulations and binding guidance restricting the use and disclosure of individually identifiable health information. In the past two (2) years and through the date of this Agreement, the Company or the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group have not received any written notices or other material correspondence from any Specified SpinCo Governmental Authority with respect to any ongoing clinical or pre-clinical studies or tests withdrawing, placing, or threatening to withdraw or place any such studies on “clinical hold” requiring the termination, suspension or material modification of such studies or tests.
(d) Except as set forth on Section 5.14(d) of the SpinCo Disclosure Schedule, in the past two (2) years, neither the Company or the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) has received any written notification from any Specified SpinCo Governmental Authority of any material violation of any Food and Drug Law or Healthcare Law or any pending or threatened Actions under any Regulatory Laws, including any FDA warning letter, FDA Form 483, untitled letter, “it has come to our attention” letter, or other written notice of potential enforcement proceedings or similar correspondence or written notice from any Specified SpinCo Governmental Authority.
(e) Except as would not had have, and would not reasonably be expected to have have, individually or in the aggregate, a Parent SpinCo Material Adverse Effect. Neither Parent , during the past two (2) years and through the date of this Agreement, neither the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business), nor to the Knowledge of SpinCo, any of its or their officers, employees, or agents, have been (i) disqualified, suspended or debarred for any purpose, or received written notice of action or threat of action with respect to debarment under the Parent Subsidiaries, nor, to provisions of 21 U.S.C. § 335a or any equivalent provisions in any other jurisdiction; (ii) excluded under 42 U.S.C. Section 1320a-7 or otherwise from participation in the knowledge of ParentMedicare program, any officer, employee, agent or distributor of Parent state Medicaid program or any of the Parent Subsidiaries, has been debarred other federal healthcare program; or (iii) formally charged with or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programLaw.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(hf) Except as would notset forth on Section 5.14(f) of the SpinCo Disclosure Schedule, individually or in during the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012past two (2) years and through the date of this Agreement, neither Parent the Company nor any of its Subsidiaries (in each case, solely with respect to the Parent Subsidiaries have SpinCo Business) has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, recall or any field correctionscorrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent ProductSpinCo Business product, or is currently considering initiating, conducting or issuing any recall of any SpinCo Business product, except in each case as would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect. To the knowledge Knowledge of ParentSpinCo, there are no facts which are would reasonably likely be expected to cause, and Parent neither the Company nor any Subsidiary (with respect to the SpinCo Business) has not received in the past two (2) years any written notice from the FDA or any other Parent Regulatory Agency regarding Specified SpinCo Governmental Authority regarding, (i) the recall, market withdrawal or replacement of any Company Product SpinCo Business product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole)SpinCo Business, (ii) a material change in the marketing classification or a material change in the labeling labelling of any such Parent ProductsSpinCo Business products, (iii) a termination termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Parent ProductsSpinCo Business products, or (iv) a material negative change in reimbursement status of a Parent ProductSpinCo Business product, that in each case, would reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect.
(g) Neither the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business), (i) Except is a “business associate” or “covered entity” as such terms are defined in HIPAA, or (ii) has submitted or currently submits claims for its respective products or services to Medicare, or Medicaid, or any other U.S. federal healthcare program, except in each case as would not reasonably be expected to have have, individually or in the aggregate, a Parent SpinCo Material Adverse Effect.
(h) Except as would not have, and would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect, neither Parent during the past two (2) years, none of the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business), nor any of their respective directors, officers managing employees, nor to the Parent Subsidiaries has experienced Knowledge of SpinCo, any security breach of their independent contractors or other incident resulting agents, have knowingly and willfully offered or paid any remuneration (including any kickback, bribe, rebate, payoff, influence payment or inducement) directly or indirectly, overtly or covertly, in the unauthorized accesscash or in kind, use or disclosure of data or information that is linked to any reasonably identifiable person Person to induce such Person (i) to refer an individual to a Person for the furnishing or arranging for the furnishing of any other data protected under applicable item or service in violation of any Regulatory Law. Parent ; or Merger Sub is not a business associate(ii) to purchase, as that term is defined lease, order, arrange for or recommend purchasing, leasing or ordering any good, facility, service or item in the HIPAA regulations at 45 C.F.R. § 160.103violation of any Regulatory Law.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had Schedule 6.13(a) contains a complete and would not reasonably be expected correct list of the Products and to havethe Knowledge of Seller any and all improvements thereto or line extensions thereof that have been researched, individually investigated, developed, manufactured, sold or are in the aggregateprocess of being researched, investigated, developed, manufactured or sold by or on behalf of Seller or Carnrick.
(b) Schedule 6.14(b), to the Knowledge of Seller, contains a Parent Material complete and correct list of all NDA's and ANDA's related to the Purchased Assets, Seller has provided Buyer with true and complete copies of such filings.
(c) To the Knowledge of Seller, with respect to the Purchased Assets, there have been no (i) product recalls, field corrective activity, warning letters, Notice of Adverse EffectFinding letters, audit reports or administrative actions by the FDA or any similar action by any other Governmental or Regulatory Authority or (ii) withdrawals or expected withdrawals.
(d) To the Knowledge of Seller all NDA's and ANDA's for the Products are currently effective and valid and have been validly issued. Neither the execution, delivery or performance of this Agreement nor the mere passage of time will have any effect on the continued validity or sufficiency of such filings. There is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the Knowledge of Seller, threatened with respect to the Regulatory Documentation.
(e) To the Knowledge of Seller, neither Carnrick nor any of their employees has, with respect to the Purchased Assets or the business with respect thereto, (i) each been disbarred or received notice of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations action or threat of action with respect to debarment under the FDCA, the PHSA, the regulations provisions of the FDA promulgated thereunderGeneric Drug Enforcement Act of 1992, data protection laws 21 U.S.C. Section 335(a) and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”b); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and been subject to any other FDA enforcement Action or Proceeding, or (iii) Parent is used in compliance with any capacity the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities services of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating Person that has been subject to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid debarment or any other government healthcare program. None of the Parent FDA enforcement action or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyproceeding.
(f) Since January 1All of the Products included in the Inventory, 2012and to Seller's Knowledge all of the Products manufactured by or on behalf of Carnrick, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filedmanufactured in accordance with FDA requirements and they (i) have been manufactured, maintained held and shipped in accordance with applicable GMPs and all other applicable law; (ii) have been manufactured, held and shipped in accordance with the Products' specifications; (iii) have not been adulterated or furnishedmisbranded under the U.S. federal Food, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, BriberyDrug, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935Cosmetic Act, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or under any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or applicable law; and (iv) a material negative change in reimbursement status of a Parent Productmay be introduced into interstate commerce pursuant thereto.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as Each of the Company and its Subsidiaries has not had all material Licenses and would not reasonably be expected to haveother material governmental authorizations, individually or in the aggregateconsents, a Parent Material Adverse Effect, (i) each of Parent approvals and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrationsand has submitted all material notices to, all Governmental Entities, including the United States Food and Drug Administration (the “FDA”), and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable other Governmental Entity or Notified Body that are is concerned with the quality, identity, strength, purity, safety, efficacy, labelinguse, manufacturing, marketingadvertising, promotion, distribution, sale, pricing, import or export distribution and sale of the Parent Company Products (any such Governmental Entity or Notified BodyEntity, a “Parent Company Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Company or any of the Parent Subsidiaries such Subsidiary to own, lease and operate its properties or other assets and to carry on and operate its respective businesses as currently conducted or as planned to be conducted (the “Parent Regulatory Company Permits”); (ii) all , except those the absence of which would not reasonably be expected to have a Company Material Adverse Effect. All such Parent Regulatory Company Permits are valid valid, and in full force and effect; , except for such Company Permits that the failure to be in full force and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as effect would not, individually or in the aggregate, not reasonably be expected to have a Parent Company Material Adverse Effect. There has occurred no violation of, the businesses default (with or without notice or lapse of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (itime or both) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance byunder, or liability event giving to others any right of Parent termination, amendment or the Parent Subsidiaries undercancellation of, with or without notice or lapse of time or both, any Parent Healthcare and Data Protection LawsCompany Permit, except where such noncompliance or liability for matters that would not reasonably be expected to have, individually or in the aggregate, have a Parent Company Material Adverse Effect.
(cb) Except Since June 1, 2010, except as would not, individually or in the aggregate, not reasonably be expected to have a Parent Company Material Adverse Effect, Parent and all of the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid Company Products that are subject to the jurisdiction of the FDA or any other government healthcare program. Company Regulatory Agency are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, advertised, promoted, detailed and distributed by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries in compliance in all material respects with all applicable requirements under any Company Permit and all applicable Laws, including applicable statutes and implementing regulations administered or enforced by the FDA or other Company Regulatory Agency.
(c) Since June 1, 2010, neither the Company nor any of its Subsidiaries has had any Company Product or manufacturing site and, to the Knowledge of the Company, no contract manufacturer for Company Products has had any manufacturing site that performs any manufacturing for any Company Products, subject to a Company Regulatory Agency (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Company Regulatory Agency written notice of material inspectional observations, “warning letters”, “untitled letters” or written requests to make material changes, in each case as it applies to the Company Products or any of the Company’s manufacturing or distribution processes or procedures for Company Products or any of the manufacturing processes or procedures of any contract manufacturer of Company Products, in each case except for matters that would not reasonably be expected to have a Company Material Adverse Effect.
(d) Since June 1, 2010, all manufacturing operations conducted by the Company or any of its Subsidiaries have been conducted in material compliance with applicable Laws, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for Company Products sold in the United States, and the respective counterparts thereof promulgated by Company Regulatory Agencies in countries outside the United States, except where the failure to so comply would not reasonably be expected to have a Company Material Adverse Effect.
(e) None of the Parent Company or any Parent Subsidiary are of its Subsidiaries is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or other similar agreements written agreements, in each case, entered into with or imposed by any Parent Company Regulatory Agency.
(d) All pre-clinical and clinical investigations , other than any such agreement, decree or order that has been previously disclosed in respect of any other filing with a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Company Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained Neither the Company nor any of its Subsidiaries has received any written notice or furnished to information from the FDA or any other Parent Regulatory Agency by Parent and Governmental Entity that it has commenced, or threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the Parent Subsidiaries have been so filedrecall of any Company Product, maintained or furnishedthat it has commenced, except where failure or threatened to fileinitiate, maintain any action to enjoin or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects place restrictions on the date filed production of any Company Products.
(or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any g) To the Knowledge of the Parent SubsidiariesCompany, nor, to the knowledge of Parent, Company has not made any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agencycomparable foreign Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agencycomparable foreign Governmental Entity, or committed an act, made a statement, statement or failed to make a statement, that (in each any such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, ) would reasonably be expected to provide establish a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 the FDA’s Compliance Policy Guide Sec 120.100 (September 10, 1991CPG 7150,09) or for the FDA or any other Parent Regulatory Agency comparable foreign Governmental Entity to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any None of the Parent Subsidiaries, norCompany or, to the knowledge Knowledge of Parentthe Company, any officerof its employees, employee, agent agents or distributor of Parent or any of the Parent Subsidiariessubcontractors, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amendedthat would have resulted in, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectresult in, each such Parent Product debarment or Parent Product candidate is being disqualification by the FDA or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingany comparable foreign Governmental Entities, and security. There is there are no action or proceeding proceedings pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any Knowledge of the Parent Subsidiaries of any LawCompany, except as threatened that reasonably would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effectresult in criminal liability or debarment or disqualification by the FDA or any comparable foreign Governmental Entities.
(h) Except as would notThe Company is not debarred or otherwise excluded from, individually or restricted in any manner from, participation in any government program related to medical products and, to the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any Knowledge of the Parent Subsidiaries have voluntarily Company, the Company does not employ or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance use the services of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA individual who is debarred or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal otherwise excluded or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productrestricted.
(i) Except as would not reasonably be expected to have a Parent Material Adverse EffectNotwithstanding any other provision of this Agreement, neither Parent nor any this Section 5.20 sets forth the sole and exclusive representations and warranties of the Parent Subsidiaries has experienced any security breach or other incident resulting in Company with respect to the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained regulatory matters described in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters5.20.
Appears in 1 contract
Sources: Merger Agreement (Immucor Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that The Regulatory Approvals are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; . There is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the Knowledge of Seller, threatened seeking the recall of any Product or the revocation or suspension of the Regulatory Approvals. Seller has made available to Buyer complete and (iii) Parent is correct copies of the Regulatory Approvals. Seller has paid the FDA product and establishment fees for the Product for the FDA fiscal year 2001 and will have paid prior to Closing such fees for the FDA fiscal year in compliance with which the terms of all Parent Regulatory PermitsClosing shall occur.
(b) Except as would not, individually or set forth in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (iSection 6.09(b) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products Seller Disclosure Schedule or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, except as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would could not reasonably be expected to have a Parent Material an Adverse Effect.
, during the three (e3) Since January 1years prior to the date of this Agreement, 2012with respect to the Product only, neither Parent Seller nor any of the Parent Subsidiaries its Affiliates has received or been subject to: (i) any FDA Form 483's with respect to the Product; (ii) any FDA Notices of Adverse Findings with respect to the Product; or (iii) any warning letters or other written notice correspondence from the FDA or any other Governmental or Regulatory Authority with respect the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs Product in which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Governmental or Regulatory Agency.
(f) Since January 1Authority asserted that the operations of Seller were not in compliance with applicable Law, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished with respect to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or Product in the aggregate, a Parent Material Adverse EffectUnited States. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would Except as could not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material an Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, during the three (3) years prior to the knowledge date of Parentthis Agreement, threatened, including there has not been any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries occurrence of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any product recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice post-sale warning conducted by or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack on behalf of safety, efficacy or regulatory compliance of any Parent Product. To Seller concerning the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from Product in the FDA United States or any other Parent Regulatory Agency regarding (i) the product recall, market withdrawal or replacement conducted by or on behalf of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken entity as a whole), (ii) a material change result of any alleged defect in the marketing classification or a material change Product in the labeling United States, and Seller has made available to Buyer every complaint and notice of any such Parent Products, (iii) a termination alleged defect or suspension of adverse reaction with respect to the manufacturing, marketing, Product in the United States that has been received in writing by Seller and its Affiliates or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productthat has been orally transmitted to and recorded by Seller and its Affiliates.
(ic) Except as would not reasonably be expected to have a Parent Material Adverse EffectOther than the Regulatory Approvals and the IND, neither Parent nor any of the Parent Subsidiaries has experienced any security breach there are no licenses, permits, certificates or other incident resulting authorizations or approvals issued by any Governmental or Regulatory Authority held by Seller or its Affiliates that relate exclusively to the Product and are used in connection with the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Business.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Asset Purchase Agreement (First Horizon Pharmaceutical Corp)
Regulatory Matters. (a) Except The Save-A-Lot Entities hold, and are operating in compliance with, such permits, licenses, franchises, approvals, authorizations, certifications and clearances of the United States Food and Drug Administration (“FDA”), the United States Department of Agriculture (“USDA”) or other Governmental Authority required for the conduct of the Business as currently conducted (collectively, the “Regulatory Permits”), except where the failure to hold or operate in compliance with the Regulatory Permits would not, individually or in the aggregate, reasonably be expected to be material to the Business and the Save-A-Lot Entities, taken as a whole. Since January 1, 2014, the Save-A-Lot Entities have fulfilled and performed all of their material obligations with respect to the Regulatory Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not, individually or in the aggregate, reasonably be expected to be material to the Business and the Save-A-Lot Entities, taken as a whole. Since January 1, 2014, the Save-A-Lot Entities have operated and currently are in compliance with applicable statutes and implementing regulations administered or enforced by the FDA or the USDA, except where the failure to so comply has not had and would not reasonably be expected to have, individually or in the aggregate, a Business Material Adverse Effect. The Save-A-Lot Entities have not received written notice since January 1, 2014 of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from the FDA, USDA, or other Governmental Authority alleging that any operation or activity of the Business is in violation of any applicable Laws, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Business Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(db) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agenciesapplications, including (i) FDA standards for the designnotifications, conductsubmissions, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits reports and notices required to be filedstatistics, maintained and other data and conclusions derived therefrom, utilized as the basis for or furnished submitted in connection with any and all requests for a Regulatory Permit by the Save-A-Lot Entities from the FDA, USDA or other Governmental Authority relating to the FDA or any other Parent Regulatory Agency by Parent Business and the Parent Subsidiaries have been so filedits products were true, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on correct as of the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiariessubmission, except as would not, individually or in the aggregate, reasonably be expected to have be material to the Business and the Save-A-Lot Entities, taken as a Parent whole.
(c) The Business has not had since January 1, 2014 any product or distribution site subject to a Governmental Authority (including FDA and USDA) shutdown, nor received any FDA Form 483 or other Governmental Authority notice of inspectional observations or warning letters to make changes to the Business products, composition, labeling or packaging, that if not complied with has resulted or would reasonably be expected to result in a Business Material Adverse Effect.
(d) Section 3.21(d) of the Save-A-Lot Disclosure Schedule sets forth a complete and accurate list of all recalls, each such Parent Product field notifications, field corrections, market withdrawals or Parent Product candidate is being or has been developedreplacements, manufacturedproduct warnings, stored, distributed safety alerts and marketed in compliance with all applicable Laws, including those other notices of action relating to investigational usean alleged lack of safety or regulatory compliance (“Safety Notices”) since January 1, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending 2014 with respect to any product manufactured by or, to the knowledge Knowledge of ParentSupervalu, threatenedon behalf of, including the Business pursuant to Business specifications, except for those that have not had and would not reasonably be expected to have, individually or in the aggregate, a Business Material Adverse Effect. To Supervalu’s Knowledge, as of the date hereof there are no product complaints with respect to any prosecutionproduct manufactured by or on behalf of the Business pursuant to the Business specifications that would be reasonably likely to result in (A) a Safety Notice, injunction, seizure, civil fine, debarment, or (B) a termination or suspension of manufacturing or recallmarketing of any the Business products, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Lawcase, except as has not had and would not, individually or in the aggregate, reasonably be expected to have a Parent Business Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (Supervalu Inc)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Valeant Material Adverse Effect, (i) each of Parent Valeant and the Parent Valeant Subsidiaries holds (x) all permitsValeant Permits, licenses, franchises, approvals, clearances, registrations, and including all authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, data protection laws the Food and (y) all permitsDrugs Act, licensesthe CDSA and the regulations of Health Canada promulgated thereunder, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable other Governmental Entity or Notified Body that are is concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Valeant Products (any such Governmental Entity or Notified BodyEntity, a “Parent Valeant Regulatory Agency”) necessary for the lawful operating of the businesses of Parent Valeant or any of the Parent Valeant Subsidiaries and the testing, manufacturing, sale or distribution, as currently conducted or as planned to be conducted applicable, of each of the Valeant Products (the “Parent Valeant Regulatory Permits”); ) and (ii) all such Parent Valeant Regulatory Permits are valid and in full force and effect; . Since January 1, 2009, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Valeant Regulatory Permit, except as has not had and (iii) Parent is would not reasonably be expected to have, individually or in the aggregate, a Valeant Material Adverse Effect. Valeant and each of the Valeant Subsidiaries are in compliance in all material respects with the terms of all Parent Valeant Regulatory Permits, and no event has occurred that, to the Knowledge of Valeant, would reasonably be expected to result in a penalty under or the revocation, cancellation, non-renewal or adverse modification of any Valeant Regulatory Permit, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Valeant Material Adverse Effect.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Valeant Material Adverse Effect, the businesses of each of Parent Valeant and each Parent Subsidiary the Valeant Subsidiaries are being conducted in compliance with all applicable Laws, including (i) the FDCA, including the rules and regulations promulgated thereunder; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutesstatutes or regulations; (iii) the Food and Drugs Act and the CDSA, including the rules and regulations promulgated thereunder; (iv) provincial formulary and drug pricing statutes, including the rules and regulations promulgated thereunder; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or soldforegoing; (vvi) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), S▇▇▇▇ Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, §1320d et. seq. and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (viLaws) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules state or provincial licensing, disclosure and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effectreporting requirements.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent Valeant and the Parent Valeant Subsidiaries are being conducted in compliance in all material respects with all applicable Laws administered or issued by the applicable Parent Regulatory AgenciesAuthorities, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (iii) Division 5 of the Food and Drug Regulations regarding Drugs for Clinical Trials Involving Human Subjects, and (iiiv) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(ed) Since January 1, 2012, neither Parent Neither Valeant nor any of the Parent Valeant Subsidiaries has received any written notice information from the FDA FDA, the EMEA or the EMA Health Canada or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use use, handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or denial of any application for marketing approval already granted or currently pending before the FDA FDA, Health Canada or such other Parent Valeant Regulatory Agency.
(fe) Since January 1, 2012, all All material reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA FDA, Health Canada or any other Parent Valeant Regulatory Agency by Parent Valeant and the Parent Valeant Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing)) such that no liability exists with respect to such filing. Since January 1, 2012, neither Parent Neither Valeant nor any of the Parent Valeant Subsidiaries, nor, to the knowledge Knowledge of ParentValeant, any officer, employee, agent or distributor of Parent Valeant or any of the Parent Valeant Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA FDA, Health Canada or any other Parent Valeant Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA FDA, Health Canada or any other Parent Valeant Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA FDA, Health Canada or any other Valeant Regulatory Agency to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Valeant nor any of the Parent Valeant Subsidiaries, nor, to the knowledge Knowledge of ParentValeant, any officer, employee, agent or distributor of Parent Valeant or any of the Parent Valeant Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldLaw. Since January 1, 2011, neither Parent Neither Valeant nor any of the Parent Valeant Subsidiaries, nor, to the knowledge Knowledge of ParentValeant, any officer, employee, agent or distributor of Parent Valeant or any of the Parent Valeant Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any the federal health care program programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gf) As to each Parent Valeant Product or Parent Valeant Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder thereunder, the Food and Drugs Act, the CDSA and the regulations of Health Canada promulgated thereunder, or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Valeant or any of the Parent Valeant Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Valeant Product or Parent Valeant Product candidate is being or has been developed, manufactured, storedtested, distributed and or marketed in compliance in all material respects with all applicable Lawsrequirements under the FDCA and the regulations of the FDA promulgated thereunder, the Food and Drugs Act, the CDSA and the regulations of Health Canada promulgated thereunder, and similar Laws in any foreign jurisdiction, including those relating to investigational use, premarket clearance or marketing approval, current good manufacturing practices, packaginggood clinical practices, good laboratory practices, labeling, advertising, record keeping, reportingfiling of reports, and security. There is no action or proceeding pending or, to the knowledge of Parent, or threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Valeant Product or Parent Valeant Product candidate by Parent Valeant or any of the Parent Valeant Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Valeant Material Adverse Effect.
(hg) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since Since January 1, 20122009, neither Parent nor any each of Valeant and the Parent Valeant Subsidiaries have neither voluntarily or nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Valeant Product. To Each of Valeant and the knowledge Valeant Subsidiaries are not aware of Parent, there are no any facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding cause (i) the recall, market withdrawal or replacement of any Company Valeant Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent Valeant or the Parent Valeant Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Valeant Products, or (iii) a termination or suspension of the manufacturingmarketing of such Valeant Products.
(h) To Valeant’s Knowledge, marketingno data generated by Valeant or any of the Valeant Subsidiaries with respect to the Valeant Products that has been provided to its customers or otherwise made public or filed with a Valeant Regulatory Agency is the subject of any regulatory or other action, either pending or threatened, by any Valeant Regulatory Agency relating to the truthfulness or scientific adequacy of such data.
(i) Since January 1, 2009, neither Valeant nor any of the Valeant Subsidiaries has received any written notice that the FDA, Health Canada or any other Valeant Regulatory Agency has (i) commenced, or threatened to initiate, any action to request the recall of any product sold or intended to be sold by Valeant or the Valeant Subsidiaries, or (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of such Parent Productsany product sold or intended to be sold by Valeant or the Valeant Subsidiaries.
(j) Since January 1, 2009, neither Valeant nor any of the Valeant Subsidiaries has received any written notice from the FDA, Health Canada or (iv) any other Valeant Regulatory Agency regarding inappropriate advertising or marketing of a material Valeant Product or a negative change in reimbursement status of a Parent Valeant Product.
(ik) Except as would not not, individually or in the aggregate, reasonably be expected to have a Parent Valeant Material Adverse Effect, neither Parent nor no Valeant Product manufactured or distributed by Valeant or any of the Parent Valeant Subsidiaries has experienced any security breach or other incident resulting in is (i) adulterated within the unauthorized access, use or disclosure meaning of data or information that is linked to any reasonably identifiable person 21 U.S.C. § 351 (or any other data protected under applicable similar Law. Parent ), (ii) misbranded within the meaning of 21 U.S.C. § 352 (or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103any similar Law).
(jl) Notwithstanding anything contained To the Knowledge of Valeant, all of its vendors are in this compliance in all material respects with good manufacturing practice and similar regulations promulgated by regulatory agencies with jurisdiction over Valeant’s vendors.
(m) This Section 4.17 does not apply to environmental matters, which are the subject of Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Merger Agreement (BIOVAIL Corp)
Regulatory Matters. (a) Except as Since January 1, 2009, the Company has not had received any written notices or statements from the United States Food and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted Drug Administration (the “Parent Regulatory PermitsFDA”); , European Medicines Agency (iithe “EMEA”) all such Parent Regulatory Permits are valid or any other governmental agency, and in full force and effect; and (iii) Parent is in compliance with otherwise has no knowledge, that any license, approval, permit or authorization to conduct any clinical trial of any product of the terms of all Parent Regulatory Permits.
(b) Except Company has been, will be or may be suspended, revoked, modified or limited, except as would not, individually or in the aggregate, have or reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(cb) Except The Company has all franchises, permits, licenses, and any similar authority, including without limitation all franchises, permits and licenses required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous materials, necessary for the conduct of its business as now being conducted by it and as currently proposed to be conducted as disclosed in the SEC Reports, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have a Parent Material Adverse Effect. The Company is not in violation of or default under any of such franchises, Parent and the Parent Subsidiaries have not engaged in activities which arepermits, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orderslicenses, or other similar agreements with authority, except where such violation or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance thatdefault would not, individually or in the aggregate, has not had and would not have or reasonably be expected to have a Parent Material Adverse Effect.
(ec) Since January In connection with the Company’s product candidates known as Marqibo, Alocrest, Brakiva and topical menadione (the “Investigational Products”), the Company has made available to the Lead Investor all (i) approved and pending new drug applications (including Section 505(b)(2) applications) and abbreviated new drug applications as of the date hereof and (ii) all pre-clinical and clinical studies and trials and bioequivalence studies referenced in the Company’s investigational new drug applications, pending new drug applications (including Section 505(b)(2) applications) and abbreviated new drug applications previously or as of the date hereof currently undertaken or sponsored by the Company or any subsidiary of the Company. The Company has made available to the Lead Investor true, complete and accurate copies of all material data and reports with respect to such applications, studies and trials, and all other material information regarding the quality, efficacy and safety of the Investigational Products. The Company has made available to the Lead Investor all material correspondence and contact information between the Company, the FDA, EMEA and other Governmental Authorities regarding the Investigational Products, and, to the extent provided to the Company or any subsidiary of the Company, material correspondence between the FDA, EMEA and other Governmental Authorities relating thereto, including but not limited to (1) reports of inspection observations from any governmental authority related to manufacturing facilities where the Investigational Products are being manufactured, 2012to the extent such report relates to a product, neither Parent nor (2) establishment inspection reports from any Governmental Authority, to the extent such report relates to an Investigational Product, (3) any FDA Form 483s relating to the Investigational Products or any equivalent thereto from any Governmental Authority in any applicable jurisdiction, (4) any minutes of meetings between the Company and FDA, EMEA or other governmental authorities regarding the Investigational Products and (5) any notice, warning letter, regulatory letter, Section 305 notice, or any other similar communication to the Company or any of the Parent Subsidiaries has received subsidiaries stating that their businesses were or are in material violation of any written notice from the FDA law, clearance, Company Permit, consent, guidance or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityguideline, or manufacturing were or are the subject of drugs which would reasonably be expected to lead any material pending or, to the denialknowledge of the Company, limitationthreatened Governmental Authority investigation, revocationproceeding, review or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agencyinquiry.
(fd) Since January 1Except as would not result in a Material Adverse Effect, 2012none of the Company, all reportsany of its subsidiaries or any officers or, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA Company’s knowledge, employees of the Company or any of its subsidiaries is currently, or has been convicted of any crime or been debarred pursuant to 21 U.S.C. Section 335a(a) or 21 U.S.C. Section 335a(b) or any similar law or to the Company’s knowledge, engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) or any similar law or authorized by 21 U.S.C. Section 335a(b), or been charged with or convicted under U.S. law for conduct relating to the development or approval, or otherwise relating to the regulation of any product that is a drug under the Generic Drug Enforcement Act of 1992, or any other Parent Regulatory Agency by Parent and relevant or analogous law in any applicable jurisdiction.
(e) None of the Parent Subsidiaries have been so filedCompany, maintained any of its subsidiaries or furnishedany officers or, except where failure to filethe Company’s knowledge, maintain employees of the Company or furnish any of its subsidiaries is currently excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law, or otherwise made ineligible to participate in U.S. federal or state health care programs, or any other relevant or analogous law in any applicable jurisdictions or, to the Company’s knowledge, engaged in any conduct for which such reportsperson could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar law, documentsor otherwise made ineligible to participate in U.S. federal or state health care programs, claims, permits or notices any other relevant or analogous law in any applicable jurisdictions. Except as would not reasonably be expected to have, individually or result in the aggregate, a Parent Material Adverse Effect, none of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries is currently, or has violated or caused a violation of any federal or state health care fraud and abuse or false claims statute or regulation, including, without limitation, the Medicare/Medicaid Anti-kickback provisions of the Social Security Act, 42 U.S.C. § 1320a-7b(b), and the relevant regulations in 42 C.F.R. Part 1001, or any other relevant or analogous law in any applicable jurisdictions. All such reports, documents, claims, permits and notices were complete and accurate Except as would not result in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012Material Adverse Effect, neither Parent the Company nor any of the Parent Subsidiariessubsidiary, nor any officer, nor, to the knowledge Company’s knowledge, employee or agent acting on behalf of Parent, any officer, employee, agent or distributor of Parent the Company or any of subsidiary, has, unless corrected in a subsequent statement, act or disclosure made prior to the Parent Subsidiariesdate hereof, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Authority, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for violate the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material FactsFact, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Fed Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for policy or other relevant or analogous law in any act or statement or failure to make a statement that, individually or in the aggregate, has not had and applicable jurisdiction. Except as would not reasonably be expected to have result in a Parent Material Adverse Effect, none of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries has provided any false or fraudulent information to the Centers for Medicare & Medicaid Services, any of its contractors, or Part D prescription drug plans, for any purpose, including, but not limited to, coverage of any of its products or the setting of any reimbursement rates. Neither Parent nor Except as would not result in a Material Adverse Effect, none of the Company, any of its subsidiaries or any officers or, to the Company’s knowledge, employees of the Company or any of its subsidiaries has provided any false or fraudulent information to any compendia that are used by any Federal healthcare program to establish coverage or payment for any of the Parent SubsidiariesCompany’s products. Except as would not result in a Material Adverse Effect, nornone of the Company, any of its subsidiaries or any officers or, to the knowledge Company’s knowledge, employees of Parent, any officer, employee, agent or distributor of Parent the Company or any of the Parent Subsidiariesits subsidiaries has furnished any false or fraudulent reimbursement advice to any actual or potential customer, or has been debarred indicated how any actual or convicted of any crime or engaged in any conduct potential customer could profit from seeking reimbursement for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldCompany’s products. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except Except as would not, individually or not result in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developedof the Company, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending orits subsidiaries’ officers and, to the knowledge Company’s knowledge, employees of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent the Company or any of its subsidiaries, are all in material compliance with the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse EffectPhRMA Code on Interactions with Healthcare Professionals.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(if) Except as would not reasonably be expected to have result in a Parent Material Adverse Effect, neither Parent nor none of the Investigational Products manufactured, tested, distributed, held and/or marketed by the Company or any of its subsidiaries has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise) since the Parent Subsidiaries date such product was acquired by the Company or one of its subsidiaries. Except as would not result in a Material Adverse Effect, no proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product or pre-market approvals or marketing authorizations of any such product are pending, or to the knowledge of the Company, threatened, against the Company or any of its subsidiaries, nor have any such proceedings been pending at any time since the date such product was acquired by the Company or one of its subsidiaries. The Company has experienced provided or made available to the Lead Investor all material current U.S. annual periodic reports and all information about adverse drug experiences obtained or otherwise received by the Company, in each case since December 31, 2006, from any security breach or other incident resulting source, in the unauthorized accessUnited States or outside the United States, use or disclosure of data or including information that is linked derived from clinical investigations prior to any reasonably identifiable person market authorization approvals, commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers, relating to any product or, to the Company’s knowledge, Investigational Product manufactured, tested, distributed, held and/or marketed by the Company, any of its subsidiaries in the possession of the Company or any other data protected under applicable Law. Parent of its subsidiaries, except for any adverse drug experiences or Merger Sub is reports which would not result in a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Material Adverse Effect.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Securities Purchase Agreement (Hana Biosciences Inc)
Regulatory Matters. (ai) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Medtronic Material Adverse Effect, (i) each of Parent Medtronic and the Parent Medtronic Subsidiaries holds all Medtronic Permits and Clearances, including (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSAFDCA (including Section 510(k) thereof), the regulations of the FDA promulgated thereunderthereunder and the MDD, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body Relevant Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Medtronic Products (any such Governmental Entity or Notified BodyRelevant Authority, a “Parent Medtronic Regulatory Agency”) necessary for the lawful operating operation of the businesses of Parent Medtronic or any of the Parent Medtronic Subsidiaries as currently conducted or as planned to be conducted in each jurisdiction in which such person operates (the “Parent Medtronic Regulatory Permits”); (ii) all such Parent Medtronic Regulatory Permits are valid and in full force and effect; and (iii) Parent Medtronic is in compliance with the terms of all Parent Medtronic Regulatory Permits.
(b) Except as . All Medtronic Regulatory Permits are in full force and effect, except where the failure to be in full force and effect has not had and would notnot reasonably be expected to have, individually or in the aggregate, a Medtronic Material Adverse Effect.
(ii) Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Parent Medtronic Material Adverse Effect, the businesses of each of Parent Medtronic and each Parent Subsidiary the Medtronic Subsidiaries are being conducted in compliance with with, and such persons have appropriate internal controls that are reasonably designed to ensure compliance with, all applicable Laws, including (it) the FDCAFDCA (including all applicable registration and listing requirements set forth in Section 510 of the FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (ii) the PHSA; (iiiu) federal Medicare and Medicaid statutes and related state or local statutes; (ivv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of (including the Parent Products or Parent Product candidates are manufactured or soldMDD); (vw) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §§ 1320a-7(b)), ▇▇▇▇▇ Law (42 U.S.C. § 1395nn), False Claims Act (42 U.S.C. §§ 1320a-7b(a)), Physician Payment Sunshine Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320a-7h1320d et. seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or soldLaws); (vix) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial licensing, disclosure and reporting requirements; (y) Laws regarding with respect to the collection, reporting and processing protection of any applicable rebate, chargeback personally identifiable information collected or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) maintained by or under any state pharmaceutical assistance program on behalf of Covidien or U.S. Department of Veterans Affairs agreement, and any successor government programsCovidien’s Subsidiaries; and (viiz) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Medtronic Healthcare and Data Protection Laws”). Since January 1December 31, 20122011, neither Parent Medtronic nor any of the Parent Medtronic Subsidiaries has received any written notification or communication from any Parent Medtronic Regulatory Agency, including without limitation the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human ServicesServices or any other “notified body” or “competent authority” or corresponding Relevant Authority in any jurisdiction, of noncompliance by, or liability of Parent Medtronic or the Parent Medtronic Subsidiaries under, any Parent Medtronic Healthcare and Data Protection Laws, except where such noncompliance or liability has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Medtronic Material Adverse Effect.
(ciii) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent Medtronic and the Parent Medtronic Subsidiaries have are not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreementsagreement, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Medtronic Regulatory AgencyAgency and, to Medtronic’s knowledge, no such action is currently contemplated, proposed or pending.
(div) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent Medtronic and the Parent Medtronic Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Covidien Regulatory Agencies, including without limitation (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations Regulations, (iii) any comparable foreign Laws for any of the foregoing or other Laws regulating the conduct of pre-clinical and clinical investigations and (iiiv) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Medtronic Material Adverse Effect.
(ev) Since January 1December 31, 20122011, neither Parent Medtronic nor any of the Parent Medtronic Subsidiaries has received any written notice from the FDA or the EMA (including any inspection reports on Form 483) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use use, handling and control, safety, efficacy, reliability, or manufacturing of drugs medical devices which would reasonably be expected to lead to the denial, limitation, revocation, suspension or rescission of any Parent Regulatory Permits or revocation of any application or grant for marketing approval already granted or with respect to any material Medtronic Product currently pending before or previously approved or cleared by the FDA or such other Parent Medtronic Regulatory Agency.
(fvi) Since January 1December 31, 20122011, all reports, documents, claims, permits permits, notices and notices MDRs required to be filed, maintained or furnished to the FDA or any other Parent Medtronic Regulatory Agency by Parent Medtronic and the Parent Medtronic Subsidiaries have been so filed, maintained or furnishedfurnished in a timely manner, except where failure to file, maintain or furnish such reports, documents, claims, permits permits, notices or notices MDRs has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Medtronic Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent Neither Medtronic nor any of the Parent Medtronic Subsidiaries, nor, to the knowledge of ParentMedtronic, any officer, employee, agent or distributor of Parent Medtronic or any of the Parent Medtronic Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Medtronic Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Medtronic Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent Medtronic or any of the Parent Medtronic Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Medtronic Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent Medtronic nor any of the Parent Medtronic Subsidiaries, nor, to the knowledge of ParentMedtronic, any officer, employee, agent or distributor of Parent Medtronic or any of the Parent Medtronic Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be soldLaw. Since January 1, 2011, neither Parent Neither Medtronic nor any of the Parent Medtronic Subsidiaries, nor, to the knowledge of ParentMedtronic, any officer, employee, agent or distributor of Parent Medtronic or any of the Parent Medtronic Subsidiaries, has been debarred, suspended or excluded from participation in any government federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(gvii) As to each Parent Medtronic Product or Parent Medtronic Product candidate subject to the FDCA and FDCA, the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of (including the Parent Products or Parent Product candidates are sold or intended by the Company to be sold MDD) that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent Medtronic or any of the Parent Medtronic Subsidiaries, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Medtronic Material Adverse Effect, each such Parent Medtronic Product or Parent Medtronic Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labelinglabelling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of ParentMedtronic, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Medtronic Product or Parent Medtronic Product candidate by Parent Medtronic or any of the Parent Medtronic Subsidiaries of any Law, except as has not had and would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Parent Medtronic Material Adverse Effect.
(hviii) Except as would notSince December 31, individually or in 2011, each of Medtronic and the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Medtronic Subsidiaries have neither voluntarily or nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, issued any recall, “Class I” recall or any material field correctionscorrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Medtronic Product or is currently considering initiating, conducting or issuing any “Class I” recall of any Medtronic Product. To the knowledge of ParentMedtronic, there are no facts which are reasonably likely to cause, and Parent Medtronic has not received since December 31, 2011 any written notice from the FDA or any other Parent Medtronic Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Medtronic Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent Medtronic or the Parent Medtronic Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling labelling of any such Parent Medtronic Products, (iii) a termination termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Parent Medtronic Products, or (iv) a material negative change in reimbursement status of a Parent Medtronic Product.
(i) Except as , that in each case, has had or would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any material impact on the business of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Medtronic and its Subsidiaries.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Transaction Agreement (Covidien PLC)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to haveto, individually or in the aggregate, be material to the Company and the Company Subsidiaries (taken as a Parent Material Adverse Effectwhole), (i) the Company and each of Parent and the Parent Company Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrationsis, and authorizations under the FDCAsince January 1, the PHSA2020 has been, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory PermitsDrug Laws and Healthcare Laws applicable to its business or operations.
(b) Except as would notnot reasonably be expected to, individually or in the aggregate, reasonably be expected material to have the Company and the Company Subsidiaries (taken as a Parent Material Adverse Effectwhole), since January 1, 2020, the businesses of each of Parent Company and each Parent Subsidiary are being conducted the Company Subsidiaries have timely filed, maintained or furnished with the applicable regulatory authorities all required filings, declarations, listings, registrations, reports, field alerts, submissions, applications, amendments, modifications, notices and other documents (collectively “Health Care Submissions”) and all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws, including Laws when filed (or were corrected or completed by a subsequent filing).
(c) The Company has delivered or made available to Parent (i) the FDCA; (ii) the PHSA; (iii) federal Medicare a complete and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any correct copy of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws each Investigational New Drug application submitted in the United States or (each, an “IND”) including all supplements and amendments in jurisdictions respect of such INDs and each form of Investigational Medicinal Product Dossier submitted outside of the United States for currently active clinical trials (each, an “IMPD”) (together with a list of each country in which material quantities such IMPDs have been submitted), in each case, with respect to each Product, (ii) a complete and correct copy of any each New Drug Application (including the equivalent regulatory submission outside of the Parent Products or Parent Product candidates are manufactures or sold); (viUnited States, an “NDA”) all applicable foreign, federal, state and provincial Laws pertaining with respect to privacy, data protection and information securityeach Product, including all HIPAA supplements and HITECH provisions pertaining to privacyamendments thereto, information security and breach notification; (viiiii) federal, state or provincial Laws regarding the collection, reporting and processing copies of any applicable rebate, chargeback or adjustment all clinical study reports under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; such INDs and (viiiv) all material correspondence to or from the rules Company and regulations promulgated pursuant each Company Subsidiary and FDA or any other Governmental Entity with respect to all such applicable Laws, each INDs.
(d) Except as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to haveto, individually or in the aggregate, have a Parent Company Material Adverse Effect.
, since January 1, 2020, none of the Company, any Company Subsidiary or any of their respective employees is or has been debarred from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (ca) or (b). Except as would notnot reasonably be expected to, individually or in the aggregate, reasonably be expected material to have a Parent Material Adverse Effect, Parent the Company and the Parent Company Subsidiaries have not engaged in activities which are(taken as a whole), as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor2020, to the knowledge of Parentthe Company, the Company and the Company Subsidiaries have not, and none of their respective representatives have, made any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Entity, or committed an act, made a statement, statement or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that.
(e) Except as would not reasonably be expected to, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Company Material Adverse Effect. Neither Parent , since January 1, 2020, (i) all clinical trials conducted by or on behalf of the Company or any Company Subsidiary have been conducted in compliance with applicable protocols, procedures and applicable Drug Laws and Healthcare Laws, (ii) no Governmental Entity has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any Company Subsidiary and (iii) neither the Company nor any of Company Subsidiary has received any written notice or communication alleging that the Parent SubsidiariesCompany has violated or failed to comply with any applicable Drug Laws or Healthcare Laws with respect to such clinical trials.
(f) Since January 1, 2020, neither the Company nor any Company Subsidiary, nor, to the knowledge of Parentthe Company, any officer, employee, agent of their respective officers or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiariesemployees, nor, to the knowledge of Parentthe Company, any officerlicensor, employeelicensee, agent partner, third-party contractor, supplier, manufacturer, distributor, consultant or distributor vendor in relation to Products has been notified by any Governmental Entity (including through the receipt of Parent any FDA Form 483, Warning Letter, Untitled Letter, Notice of Violation or injunction), qui tam relator or other third party of any failure (or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amendedinvestigation with respect thereto) to comply with, or maintain systems and programs to ensure compliance with, any similar Parent Healthcare Drug Law or program.
(g) As Healthcare Law, including those pertaining to each Parent Product programs or Parent Product candidate subject systems regarding product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the FDCA debarment of individuals, postmarketing commitments and requirements, and requirements applicable to the regulations conflict of the FDA promulgated thereunder or interest of clinical investigators and Adverse Drug Reaction Reporting requirements, in each case with respect to any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent SubsidiariesProducts, except as for such failures or investigations, which would notnot reasonably be expected to, individually or in the aggregate, be material to the Company and the Company Subsidiaries (taken as a whole), and, to the knowledge of the Company, there are no facts or circumstances that, now or with the passage of time, would create a basis for the giving of any such notice.
(g) As of the date of this Agreement, (i) no Product has been recalled, withdrawn or suspended since January 1, 2020 and, to the knowledge of the Company, except as would not reasonably be expected to have be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a Parent Material Adverse Effectwhole), each no facts or circumstances exist that could reasonably be expected to result in such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingactions, and security. There is (ii) no action Proceedings (whether completed or proceeding pending) seeking the recall, withdrawal, suspension or seizure of any Product are pending or, to the knowledge of Parentthe Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent threatened against the Company or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse EffectCompany Subsidiary.
(h) Except as would notnot reasonably be expected to be, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, Company and the Company Subsidiaries (taken as a whole), (ii) the Company has implemented a material change in the marketing classification or a material change in the labeling of any such Parent Productscommercially reasonable compliance program, (iii) a termination or suspension of the manufacturingincluding appropriate policies, marketingprocedures, or distribution of such Parent Productsand trainings, or (iv) a material negative change in reimbursement status of a Parent Productdesigned to ensure compliance with applicable Drug Laws, Healthcare Laws and industry codes and standards.
(i) Except as would not reasonably be expected to to, individually or in the aggregate, have a Parent Company Material Adverse Effect, neither Parent since January 1, 2020, the collection, access, maintenance, transmission, use and disclosure of Personal Information by the Company and all Company Subsidiaries is and has been in compliance with HIPAA. Neither the Company nor any Company Subsidiary has received any written or, to the knowledge of the Parent Subsidiaries has experienced Company, oral complaint, claim, subpoena, demand or notice of investigation from any security breach Governmental Entity or other incident resulting in Person, including inquiries or other communications from the unauthorized accessDepartment of Health and Human Services Office for Civil Rights, regarding the Company or any Company Subsidiary’s collection, use or disclosure of data of, or information that is linked security practices or Cybersecurity Incidents regarding, Personal Information, including with respect to any reasonably identifiable person alleged “breach” or successful “security incident”, as such terms are defined under HIPAA, in the possession or under the control of the Company or any other data protected under applicable Law. Parent Company Subsidiary or Merger Sub is not being held by subcontractors on behalf of the Company or any Company Subsidiary, and, to the knowledge of the Company, there are no facts or circumstances that, now or with the passage of time, would create a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103basis for any inquiry or claim.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Global Blood Therapeutics, Inc.)
Regulatory Matters. (a) Except The Company and the Company Affiliates hold all material licenses and other material rights, accreditations, permits and authorizations required by law, ordinance, regulation or ruling of any Governmental Authority necessary to operate their businesses. The Company and the Company Affiliates are certified for participation and reimbursement under Titles XVIII and XIX of the Social Security Act and have current provider agreements for such Government Programs and with such Private Programs, including any private insurance program under which they directly or indirectly are presently receiving payments. Set forth in Section 3.26(a) of the Disclosure Letter is a correct and complete list in all material respects, with respect to the Company and the Company Affiliates, of such licenses and provider numbers under all Government Programs.
(b) No material violation, default, order or deficiency exists with respect to any material licenses and other material rights, accreditations, permits and authorizations required by law (collectively, the “Rights”), ordinance, regulation or ruling of any Governmental Authority necessary to operate the Company’s and the Company Affiliates’ businesses in all material respects as presently operated. The Company has not had received any written notice of any action pending or recommended by any state or federal agencies having jurisdiction over such Rights, either to revoke, withdraw or suspend any license, right or authorization, or to terminate the participation of the Company or any of the Company Affiliates in any Government or Private Program. Since September 30, 2004, the Company has renewed or intends to renew, and has not received any notice or communication from the other party of an intent to terminate or not renew, each provider or third-party payer agreement of the Company necessary for the operation of the Business.
(c) Except, individually or in the aggregate, as have not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, Company and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) Company Affiliates have timely filed all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices reports required to be filed, maintained filed and timely filed all claims or furnished b▇▇▇▇▇▇▇ prior to the FDA or any date hereof in accordance with the Government and Private Programs, all fiscal intermediaries and other Parent Regulatory Agency by Parent insurance carriers and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish all such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits reports and notices were b▇▇▇▇▇▇▇ are complete and accurate in all material respects on and have been prepared in compliance in all material respects with all applicable laws, rules and regulations governing reimbursement and payment claims. The Company and the date Company Affiliates have paid or caused to be paid all known and undisputed refunds, overpayments, discounts or adjustments which have become due pursuant to such reports and b▇▇▇▇▇▇▇ including any hospice Medicare cap liability and to the knowledge of the Company have no liability under any Government or Private Program (including, but not limited to any hospice Medicare cap liability) for any refund, overpayment, discount or adjustment. To the knowledge of the Company, there are no other reports or claims or b▇▇▇▇▇▇▇ required to be filed by the Company in order to be paid under any Government or Private Program for services rendered in connection with the business, except for reports not yet due.
(or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent d) Neither the Company nor any of the Parent SubsidiariesCompany Affiliates nor any of their employees is a party to, nor subject to, the terms of any corporate integrity agreement (“CIA”), certificate of compliance agreement (“CCA”), monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Governmental Authority (collectively, “Governmental Agreements”).
(e) Except as permitted under applicable Laws, to the knowledge of the Company, neither the Company nor any of the Company Affiliates have: (i) offered, paid, solicited or received anything of value, paid directly or indirectly, overtly or covertly, in cash or in-kind (including any kick-back, self referral, bribe, or rebate) (collectively, “Remuneration”) to or from any physician or actual or potential referral source, family member of a physician or actual or potential referral source, or an entity in which a physician or actual or potential referral source or physician family member or actual or potential referral source family member has an ownership or investment interest, including:(A) payments for personal or management services pursuant to a medical director agreement, consulting agreement, management contract, personal services agreement, or otherwise; (B) payments for the use of premises leased to or from a physician, a family member of a physician or an entity in which a physician or actual or potential referral source or family member has an ownership or investment interest; or (C) payments for the acquisition or lease of equipment, goods or supplies from a physician or actual or potential referral source, a family member of a physician or actual or potential referral source or an entity in which any of them has an ownership or investment interest; (ii) except for lawful discounts offered in the ordinary course of business consistent with industry practice, offered, paid, solicited or received any Remuneration (excluding fair market value payments for equipment or supplies) to or from any health care provider, pharmacy, drug or equipment supplier, distributor or manufacturer, including discounts, rebates, or other reductions in price on a good or service received by the Company or any of the Company Affiliates; (iii) except for lawful discounts offered in the ordinary course of business consistent with industry practice, offered, paid, solicited or received any Remuneration to or from any person or entity in order to induce business, including payments intended not only to induce actual or potential referrals of patients, but also to induce the purchasing, leasing, ordering or arrangement for any good, facility, service or item; (iv) entered into any financial relationships within the meaning of 42 C.F.R. § 411.354; including any joint venture, partnership, co-ownership or other arrangement involving any ownership or investment interest by any physician, or family member of a physician, or an entity in which physician or physician family member has an ownership or investment interest, directly or indirectly, through equity, debt, or other means, including an interest in an entity providing goods or services to the Company or any of the Company Affiliates; (v) entered into any compensation arrangement or business venture, including any joint venture, partnership, co-ownership or other arrangement involving any ownership or investment interest by any person or entity including a hospital, pharmacy, drug or equipment supplier, distributor or manufacturer, that is or was in a position to make or influence actual or potential referrals, furnish items or services to, or otherwise generate business for the Company or the Company Affiliates; or (vi) entered into any agreement providing for the actual or potential referral of any patient for the provision of goods or services by the Company or the Company Affiliates, or payments by the Company or any of the Company Affiliates as a result of any referrals of patients to a Company (excluding commercial payer Contracts providing for such referrals and payments).
(f) To the knowledge of the Company, neither the Company nor any of the Company Affiliates nor any independent contractor providing professional services on behalf of and in connection with the Company and the Company Affiliates has engaged in any activities which are prohibited under 42 U.S.C. §§ 1320a-7b, 42 U.S.C. §§ 1395nn or 31 U.S.C. §§ 3729-3733 (or other federal or state statutes related to false or fraudulent claims) or the regulations promulgated thereunder pursuant to such statutes, or similar state or local statutes or regulations, or which are prohibited by rules of professional conduct, including the following: (i) knowingly and willfully making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully submitting claims for services when such services did not fully satisfy any conditions for payment; (iii) knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit or payment; (iv) failing to disclose knowledge by a claimant of the occurrence of any event affecting the initial or continued right to any benefit or payment on its own behalf or on behalf of another, with intent to fraudulently secure such benefit or payment; (v) billing for referrals from physicians with a financial relationship with the Company or any of the Company Affiliates that does not meet an exception; and (vi) knowingly and willfully soliciting or receiving any Remuneration, directly or indirectly, overtly or covertly, in cash or in-kind or paying or offering to pay or receive such remuneration (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part by Medicare or Medicaid, or (B) in return for purchasing, leasing, or ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part by Medicare or Medicaid.
(g) To the knowledge of the Company, neither the Company nor any of the Company Affiliates have engaged in any activities which are prohibited under the Federal Controlled Substances Act, the Federal Food, Drug and Cosmetic Act, or the regulations promulgated pursuant to such statutes or any similar state or local statutes or regulations concerning the dispensing and sale of controlled substances.
(h) To the knowledge of the Company, neither the Company nor any of the Company Affiliates nor, to the knowledge of Parentthe Company, any officerof their respective officers, employeedirectors, agent employees, or distributor of Parent agents or persons who provide professional services to the Company or any of the Parent SubsidiariesCompany Affiliate, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statementhas, in each such case, connection with activities directly or indirectly related to the business of Parent Company or any of the Parent Subsidiariessuch Company Affiliate, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for activities which debarment is mandated by 21 U.S.C. § 335a(a) are prohibited under the Federal Controlled Substances Act, the Federal Food, Drug and Cosmetic Act, or the regulations promulgated pursuant to such statutes or any similar Law state or authorized by 21 U.S.C. § 335a(b) local statutes or any similar Law applicable in other jurisdictions in which material quantities regulations concerning the dispensing and sale of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or programcontrolled substances.
(gi) As to The Company and each Parent Product or Parent Product candidate subject of the Company Affiliates: (i) is in material compliance with all applicable Laws and any other applicable guidance relating to the FDCA operation of each of its pharmacies, the repackaging of drug products, the wholesale distribution of prescription drugs or controlled substances, and the regulations dispensing of the FDA promulgated thereunder prescription drugs or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that controlled substances; (ii) is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those Laws and any other applicable guidance relating to investigational use, marketing approval, current good manufacturing practicesthe labeling, packaging, labeling, advertising, record keeping, reporting, or adulteration of prescription drugs or controlled substances; and security. There (iii) is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable not subject to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, sanction or other notice or adverse action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of by any Parent Product. To Governmental Authority for the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding matters described above in clauses (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), and (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product).
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to haveto, individually or in the aggregate, have a Parent Company Material Adverse Effect, (i) each of Parent the Company and the Parent Company Subsidiaries holds (x) all permitshave filed, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity maintained or Notified Body that are concerned furnished with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuseregulatory authorities, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice Pharmaceuticals and Medical Devices Agency (including any United States Attorney’s Office“PMDA”), and European Medicines Agency (“EMA”) all required filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence, and other documents (collectively “Health Care Submissions”) and (ii) all such Health Care Submissions were complete and accurate and in compliance with applicable Laws when filed (or were corrected or completed by a subsequent filing).
(b) None of the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries underCompany, any Parent Healthcare and Data Protection LawsCompany Subsidiary or, except where such noncompliance to the Company’s knowledge, any of their respective employees is or liability has been debarred pursuant to 21 U.S.C. Section 335a (a) or (b). Except as would not reasonably be expected to havebe material to the Company and the Company Subsidiaries, individually or in taken as a whole, the aggregate, a Parent Material Adverse Effect.
(c) Except as would Company and the Company Subsidiaries have not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, norand, to the knowledge Company’s knowledge, none of Parenttheir respective representatives have, made any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory AgencyGovernmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AgencyGovernmental Entity, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(ic) Except as would not reasonably be expected to to, individually or in the aggregate, have a Parent Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of the Company or any Company Subsidiary have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported, and exported, as applicable, in compliance with applicable Drug Laws, and without limiting the generality of the foregoing, (ii) all clinical trials conducted by or on behalf of the Company or any Company Subsidiary have been conducted in compliance with applicable protocols, procedures and applicable Drug Laws, (iii) no Governmental Entity, institutional review board, or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any Company Subsidiary and (iv) neither Parent the Company nor any Company Subsidiary has received any written notice or communication alleging that the Company has violated or failed to comply with any applicable Drug Laws with respect to such clinical trials. Since January 1, 2016, neither the Company nor any Company Subsidiary has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Governmental Entity; or (B) except as would not reasonably be expected to be material to the Company and the Company Subsidiaries, taken as a whole, any other written notice of the Parent Subsidiaries has experienced any security breach violations, inspectional observations, untitled letters or other incident resulting in written administrative, regulatory or enforcement notice from the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person FDA or any analogous notice from any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103Governmental Entity.
(jd) Notwithstanding anything contained Since January 1, 2016, the Company and the Company Subsidiaries have been in compliance with, and have not been notified in writing by any Governmental Entity of any failure (or any investigation with respect thereto) by them or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, Drug Laws, including those Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, and including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements, and clinical trial disclosure requirements, in each case with respect to any Product Candidates of the Company or any Company Subsidiary, except for such failures or investigations which would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect.
(e) As of the date of this Section 4.13Agreement, (i) no representation Product Candidate manufactured, tested, distributed, or warranty shall be deemed held by the Company or any Company Subsidiary has been recalled, withdrawn or suspended since January 1, 2016 and (ii) no Proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any Product Candidate are pending or, to be made in the knowledge of the Company, threatened against the Company or any Company Subsidiary.
(f) As of the date of this Section 4.13 Agreement: (i) the Company and the Company Subsidiaries have provided to Parent complete and accurate copies of (A) all material Health Care Submissions, including material correspondence with and from, and contact reports summarizing interactions with, the FDA, EMA, PMDA, and other regulatory authorities and (B) all case report forms received by the Company and the Company Subsidiaries prior to the date of this Agreement in respect of environmentalany patient adverse event, Taxpatient adverse drug reaction or other patient safety event in respect of the clinical trials of the Product Candidates; and (ii) to the knowledge of the Company, employee benefits there has not been any patient serious adverse event, patient serious adverse drug reaction, or labor Law mattersother serious patient safety event related to the use of the Product Candidates that has not either been: (x) included or referenced in the Health Care Submissions or the case report forms referred to in clauses (A) and (B) above; or (y) otherwise disclosed by the Company to Parent.
Appears in 1 contract
Sources: Merger Agreement (AveXis, Inc.)
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or described in the aggregateRegistration Statement, a Parent Material Adverse Effect, (i) each the Time of Parent Sale Disclosure Package and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCAProspectus, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws Company and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.its subsidiaries:
(bA) Except as would not, individually or in the aggregate, reasonably be expected to are and at all times have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted been in compliance with all statutes, rules, regulations, policies, or guidances applicable Lawsto Company and its subsidiaries, including (i) relating to the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state ownership, testing, approval, clearance, safety, effectiveness, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export, disposal, laboratory quality, or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities analytical validation of any of the Parent Products product, product component, or Parent Product candidates are manufactured research-use only product manufactured, sold or sold; (v) federaldistributed, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuseany service provided, including but not limited to 18 U.S.C. Sections 286 and 287laboratory services, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH ActCompany or its subsidiaries or to billing, kickbacks, referral relationships or arrangements, ethics, claims processing, claims submission and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities privacy and security of any of the Parent Products or Parent Product candidates are manufactures or sold); health information (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Applicable Regulatory Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect;
(B) have not received any FDA Form 483, neither Parent nor any Establishment Inspection Report, notice of the Parent Subsidiaries adverse finding, warning letter, untitled letter, “It has experienced any security breach come to our attention” letter, or other incident resulting in correspondence or notice from the unauthorized accessU.S. Food and Drug Administration (the “FDA”), use or disclosure of data or information that is linked to any reasonably identifiable person the Centers for Medicare and Medicaid Services (CMS) or any other data protected under applicable Law. Parent Governmental Authority alleging, asserting, or Merger Sub is not a business associateinquiring about the Company’s or its subsidiaries’ noncompliance with any Applicable Regulatory Laws or the Company’s or its subsidiaries’ noncompliance with, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.or absence of, any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”);
(jC) Notwithstanding anything contained in this Section 4.13are aware that the FDA has indicated its intention to discontinue its exercise of enforcement discretion relating to many laboratory developed tests, but have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations, or to require the Company or any of its subsidiaries to obtain an Authorization thereto that Company does not currently possess, and, to the Company’s knowledge, no representation Governmental Authority is intending to take such action against the Company or warranty shall be deemed to be made any of its subsidiaries’ products specifically; and
(D) have filed, obtained, created and maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Regulatory Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in this Section 4.13 in respect of environmentalall material respects on the date filed, Taxcreated, employee benefits or labor Law matterssubmitted (or were corrected or supplemented by a subsequent filing, creation, or submission).
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) The Asset Sellers and each of Parent the Target Companies and the Parent Target Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information securityeach foreign jurisdiction, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such of the FDA and any governmental agency of any other country having jurisdiction of the Manufacturing Facilities or the manufacture, sale, labeling, storing, testing and distribution of the Products, as applicable Laws(each, each as amended from time to time (collectively, a “Parent Healthcare and Data Protection LawsRegulatory Authority”), with respect to the manufacture, sale, labeling, storing, testing and distribution of the Products, except for such instances of noncompliance that would not, individually and in the aggregate, have a Material Adverse Effect. Each of the Target Companies and the Target Subsidiaries have all material permits, approvals, registrations and licenses related to the Manufacturing Facilities from the Regulatory Authorities to conduct the Business as currently conducted.
(ii) Since January 1, 20122003 (or its date of formation, neither Parent nor if later), none of the Asset Sellers or any of the Parent Target Companies or the Target Subsidiaries is in receipt of notice of, has received been or is subject to, any written notification adverse inspection, compelled or communication from any Parent voluntary recall, investigation, penalty for corrective or remedial action or corrective action plan, in each case relating to the Products or the Manufacturing Facilities by the Regulatory AgencyAuthorities, including compliance with current good manufacturing practices as regulated and/or required by the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsRegulatory Authorities, except where for such noncompliance or liability instances which would not reasonably be expected to havenot, individually or and in the aggregate, have a Parent Material Adverse Effect.
(ciii) Except As of the date of this Agreement, there are no pending actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or complaints by the Regulatory Authorities relating to the Manufacturing Facilities or the Products.
(iv) None of the Asset Sellers or any of the Target Companies or the Target Subsidiaries has received, since January 1, 2003 (or its date of formation, if later), any written notification, that remains unresolved, from any Regulatory Authorities indicating that any Product is misbranded or adulterated as defined in the FDA Act and the rules and regulations promulgated thereunder or any similar Law, except for such instances which would not, individually or and in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent . The Asset Sellers and the Parent Target Table of Contents Companies and the Target Subsidiaries have not engaged properly handled and stored all Products included in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted Inventory in compliance in all material respects with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 none of the Code of Federal Regulations Products included in the Inventory are misbranded or adulterated as defined in the FDA Act and (ii) the rules and regulations promulgated thereunder or any applicable federalsimilar Law, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, except for such noncompliance thatinstances which would not, individually or and in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(ev) Since January 1This representation does not relate to Tax matters, 2012employee benefit matters, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA environmental matters or the EMA or any foreign agency with jurisdiction over the developmentlabor matters, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold covered by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a wholeSections 4(i), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Productsn), (iiio) a termination or suspension of the manufacturingand (p), marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productrespectively.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as To its Knowledge, Seller has not had filed with the FDA all notices, supplemental applications and would annual or other reports or documents, including adverse experience reports that are material to the conduct of the Business to the extent required under the FD&C Act, except to the extent failure to make such filings could not reasonably be expected to have, individually or in the aggregate, have a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would could not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1Effect on the Business, 2012, neither Parent Seller nor any of the Parent Subsidiaries its Affiliates has received or been subject to: (i) any FDA Form 483's with respect to the Product; (ii) any FDA Notices of Adverse Findings with respect to the Product; or (iii) any warning letters or other written notice correspondence from the FDA or any other Governmental or Regulatory Authority with respect to the EMA or any foreign agency with jurisdiction over Product during the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliabilityone (1) year prior to this Agreement, or manufacturing of drugs which would reasonably be expected at any time prior to lead this Agreement to the denialextent still active or pending, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before in which the FDA or such other Parent Governmental or Regulatory Agency.
(f) Since January 1Authority asserted that the operations of Seller were not in compliance with applicable Requirements of Laws, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished with respect to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or Product in the aggregate, a Parent Material Adverse EffectUnited States. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would Except as could not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor Effect on the Business, there has not been any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted occurrence of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or product recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice post-sale warning conducted by or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack on behalf of safety, efficacy or regulatory compliance of any Parent Product. To Seller concerning the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from Product in the FDA United States or any other Parent Regulatory Agency regarding (i) the product recall, market withdrawal or replacement conducted by or on behalf of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken entity as a wholeresult of any alleged defect in the Product in the United States during the one (1) year prior to this Agreement, or at any time prior to this Agreement to the extent still active or pending, and Seller has made available to Purchaser every complaint and notice of alleged defect or adverse reaction with respect to the Product in the United States that has been received in writing by Seller and its Affiliates or that has been orally transmitted to and recorded by Seller and its Affiliates.
(c) The Product Registration in the United States is the only regulatory approval necessary from the FDA for Seller to conduct the Business as conducted as of the Closing Date. To its Knowledge, all of the other Product Registrations held by the Seller, or BMS on the behalf of the Seller, are all of the regulatory approvals from the relevant regulatory authorities necessary for Seller to conduct the Business as conducted as of the Closing Date outside of the United States (it being acknowledged by the Parties that Seller is not conducting the Business outside of the United States as of the Closing Date).
(d) Seller has fulfilled and performed its obligations under the Product Registration in the United States and, to its Knowledge, under all of the other Product Registrations. To Seller's Knowledge, no event has occurred or condition or state of facts exists which constitutes or, after notice or lapse of time or both, would constitute a breach or default or violation under any such Product Registration or which permits or, after notice or lapse of time or both, would permit revocation or termination of any such Product Registration, or which might adversely affect in any material respect the rights of Seller under any such Product Registration; provided, however, post-marketing studies may be necessary or required by certain Governmental Entities. No notice of cancellation, of default, of violation or of any material dispute concerning the Product Registration in the United States or any of the other Product Registrations, or of any event, condition or state of facts described in the preceding clause, has been received by, or is known to, Seller. The Product Registration in the United States and, to the Knowledge of Seller, BMS and ▇▇▇▇▇▇▇▇, each of the other Product Registrations, is valid, subsisting and in full force and effect, and may, subject to applicable law, be assigned and transferred to Purchaser in accordance with this Agreement, and will continue in full force and effect thereafter, in each case so long as the Business is conducted by Purchaser in the manner currently conducted by Seller without (i) the occurrence of any breach, default or forfeiture of rights thereunder, or (ii) a material change in the marketing classification consent, approval or a material change in act of, or the labeling making of any such Parent Productsfiling with, (iii) a termination any Governmental Entity other than as set forth on Schedule 3.09(d); provided, however, post-marketing studies may be necessary or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Productrequired by certain Governmental Entities.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Sources: Asset Purchase Agreement (Women First Healthcare Inc)
Regulatory Matters. (a) Except as has not had The product development and would not reasonably be expected to have, individually manufacturing activities conducted by or on behalf of the Company that are described in the aggregate, a Parent Material Adverse Effect, (i) each of Parent General Disclosure Package and the Parent Subsidiaries holds (x) all permits, licenses, franchises, approvals, clearances, registrations, and authorizations under the FDCA, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted Prospectus (the “Parent Regulatory PermitsCompany Product Development and Manufacturing”)) were and, if still pending, are being, conducted in all material respects in accordance with protocols, procedures, specifications and controls pursuant to, where applicable, accepted professional scientific, manufacturing and quality standards; (ii) the descriptions of products resulting from the Company Product Development and Manufacturing contained in the General Disclosure Package and Prospectus are accurate in all such Parent Regulatory Permits material respects; the Company has no knowledge of any other products or manufacturing activities not described in the General Disclosure Package and the Prospectus, the results of which are valid inconsistent with or call in question the results described or referred to in the General Disclosure Package and in full force and effectthe Prospectus; and the Company has not received any written notices or correspondence (iiior, to the Company’s knowledge, any oral communication) Parent is in compliance with from the terms of all Parent Regulatory Permits.
(b) Except as would notFDA or any supranational, individually or in the aggregateforeign, reasonably be expected to have a Parent Material Adverse Effect, the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any governmental body exercising comparable foreign Laws for any of authority requiring the foregoing applicable in jurisdictions in which termination, suspension or material quantities modification of any of the Parent Products or Parent Company Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud Development and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, the Drug Enforcement Administration, the United States Department of Justice (including any United States Attorney’s Office), the United States Department of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection LawsManufacturing, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance thattermination, individually suspension or in the aggregate, has not had and material modification which would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1Effect and, 2012to the Company’s knowledge, neither Parent nor any there are no reasonable grounds for the same. The manufacture of the Parent Subsidiaries has received any written notice from Company’s products by or on behalf of the Company, to the knowledge of the Company, is being conducted in compliance with all applicable statutes, rules, regulations and policies of the FDA or by any supranational, foreign, federal, state or local governmental body exercising comparable regulatory authority, to which the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnishedCompany is subject, except where the failure to fileso comply, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, whether individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of the Parent Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. Neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Parent Healthcare Law or program.
(g) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of the Parent Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and the Parent Subsidiaries holds (x) The Acquired Companies hold all permits, licenses, franchises, approvals, clearances, registrationsmaterial, and authorizations under are operating in material compliance with, all Governmental Authorizations required for the FDCAconduct of its business as currently conducted, the PHSA, the regulations of the FDA promulgated thereunder, data protection laws and (y) all permits, licenses, franchises, approvals, clearances, registrations, certificates and authorizations of any applicable Governmental Entity or Notified Body that are concerned with the quality, identity, strength, purity, safety, efficacy, labeling, manufacturing, marketing, promotion, distribution, sale, pricing, import or export of the Parent Products (any such Governmental Entity or Notified Body, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of the Parent Subsidiaries as currently conducted or as planned to be conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits Authorizations are valid and in full force and effect; . The Acquired Companies have fulfilled and (iii) Parent is in compliance performed all of their material obligations with the terms of all Parent Regulatory Permitsrespect to such Governmental Authorizations.
(b) Except as would notnot reasonably be expected, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each Acquired Company has filed with the businesses of each of Parent and each Parent Subsidiary are being conducted in compliance with all applicable Laws, including regulatory authorities (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactured or sold; (v) federal, state or provincial criminal or civil healthcare Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), False Claims Act (42 U.S.C. §1320a-7b(a)), Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, as amended by the HITECH Act, and any comparable federal, state, provincial or local healthcare Laws in the United States or in jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are manufactures or sold); (vi) all applicable foreign, federal, state and provincial Laws pertaining to privacy, data protection and information security, including all HIPAA and HITECH provisions pertaining to privacy, information security and breach notification; (vii) federal, state or provincial Laws regarding the collection, reporting and processing of any applicable rebate, chargeback or adjustment under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Parent Healthcare and Data Protection Laws”). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notification or communication from any Parent Regulatory Agency, including the FDA, DEA or any other Governmental Body performing functions similar to those performed by the Drug Enforcement AdministrationFDA or DEA) all required filings, declarations, listings, registrations, reports or submissions necessary for the United States Department operations of Justice (including any United States Attorney’s Office), the United States Department business of Health and Human Services Office of Inspector General and Office for Civil Rights, the Centers for Medicare and Medicaid Services, the FTC and the Department of Health and Human Services, of noncompliance by, or liability of Parent or the Parent Subsidiaries under, any Parent Healthcare and Data Protection Laws, except where such noncompliance or liability Acquired Companies as presently conducted. Except as would not reasonably be expected to haveexpected, individually or in the aggregate, to have a Parent Material Adverse Effect, all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission), and no material deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions.
(c) Except as would notTo the Knowledge of the Company, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and the Parent Subsidiaries have not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid no Acquired Company or any other government healthcare program. None of the Parent or any Parent Subsidiary are a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency.
(d) All pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by each of Parent and the Parent Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including Person acting on an Acquired Company’s behalf has (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
(e) Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries has received any written notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any Parent Regulatory Permits or of any application for marketing approval already granted or currently pending before the FDA or such other Parent Regulatory Agency.
(f) Since January 1, 2012, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Agency by Parent and the Parent Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2012, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA FDA, DEA, or any other Parent Regulatory Agency, Governmental Body or (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency, DEA or (iii) committed an act, made a statement, or failed to make a statement, in each such case, related including with respect to the business of Parent any scientific data or any of the Parent Subsidiariesinformation, that, at the time such disclosure was mademade or failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) ), and any amendments thereto or for any other Governmental Body performing functions similar to those performed by the FDA or any other Parent Regulatory Agency DEA to invoke any similar policy, except for policy or any act other statute or statement regulation regarding the communication or failure submission of false information to make a statement that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effectany such applicable Governmental Body. Neither Parent nor any of the Parent Subsidiaries, Acquired Companies nor, to the knowledge Knowledge of Parentthe Company, any officerofficers, employeeemployees, agent agents or distributor clinical investigators of Parent or any of the Parent Subsidiaries, has Acquired Companies have been suspended or debarred or convicted of any crime or engaged in any conduct for which that would reasonably be expected to result in debarment is mandated by under 21 U.S.C. § 335a(a) 335a or any similar Law Law, debarment, or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Parent to be sold. Since January 1, 2011, neither Parent nor any of the Parent Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of the Parent Subsidiaries, has been debarred, suspended or excluded exclusion from participation in any government health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amendedthat term is defined by 42 U.S.C. § 1320a-7b(f) or excluded or suspended from any other health care program administered by a Governmental Body, or any similar Parent Healthcare Law exclusion from federal procurement programs and non-procurement programs, or programis, or has been, debarred, excluded, or suspended per the foregoing.
(gd) As to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Law applicable in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of Parent or any of the Parent Subsidiaries, except Except as would notnot reasonably be expected, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has the Acquired Companies are in compliance and, since January 1, 2021, have been developed, manufactured, stored, distributed and marketed in compliance with all healthcare Laws applicable to the operation of its business as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse Laws, including those the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)) and the civil False Claims Act (31 U.S.C. §§ 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto; (iii) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); (iv) Laws that are cause for exclusion from any federal health care program; (v) Laws relating to investigational usethe billing or submission of claims for health care products or services; (vi) Federal Food, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reportingDrug, and security. There Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the regulations promulgated pursuant thereto; and (vii) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated pursuant thereto.
(e) As of the Agreement Date, no enforcement, regulatory or administrative proceeding is no action or proceeding pending orpending, and, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any Knowledge of the Parent Subsidiaries of Company, no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), the Anti-Kickback Statute or similar Laws, other than any Law, except as such proceeding that would notnot reasonably be expected, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect.
(h) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, since January 1, 2012, neither Parent nor any of the Parent Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received any written notice from the FDA or any other Parent Regulatory Agency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by Parent or a Parent Subsidiary (other than recalls, withdrawals or replacements that are not material to Parent or the Parent Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Parent Products, or (iv) a material negative change in reimbursement status of a Parent Product.
(i) Except as would not reasonably be expected to have a Parent Material Adverse Effect, neither Parent nor any of the Parent Subsidiaries has experienced any security breach or other incident resulting in the unauthorized access, use or disclosure of data or information that is linked to any reasonably identifiable person or any other data protected under applicable Law. Parent or Merger Sub is not a business associate, as that term is defined in the HIPAA regulations at 45 C.F.R. § 160.103.
(j) Notwithstanding anything contained in this Section 4.13, no representation or warranty shall be deemed to be made in this Section 4.13 in respect of environmental, Tax, employee benefits or labor Law matters.
Appears in 1 contract