Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. (c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds. (d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated. (e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. (g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents. (h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 2 contracts
Sources: Merger Agreement (CalciMedica, Inc. /DE/), Agreement and Plan of Merger (Graybug Vision, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 2020 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeParent. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. .
(d) Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(de) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Parent or any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since Except as set forth in Section 3.14(e) of the Parent Disclosure Schedule, since January 1, 20192020, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and . Parent has no liability for failure made available to comply with the FDCACompany true and complete copies of all material notices, PHSA, correspondence or other similar Laws. To Parent’s Knowledgecommunications received by Parent from any Drug Regulatory Agency, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawsif any.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries or nor any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted Listany similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 2 contracts
Sources: Agreement and Plan of Merger (MorphImmune Inc.), Merger Agreement (Immunome Inc.)
Compliance; Permits; Restrictions. Except as disclosed on Schedule 3.9 or described in a Parent SEC Report filed prior to the date hereof:
(a) Neither Parent and each nor any of its SubsidiariesSubsidiaries is in conflict with, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregatedefault or violation of (i) any law, which would not be material rule, regulation, order, judgment or decree applicable to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Parent or any of its Subsidiaries is a party or by which Parent or any of its Subsidiaries or its or any of their respective properties is bound or affected except for those conflicts, defaults or violations which would not be reasonably expected to have a Parent Material Adverse Effect. Except as disclosed on Schedule 3.9 to the knowledge of Parent, no investigation or review by any Governmental Entity is pending or threatened against Parent or its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same other than those which would not reasonably be expected to have a Parent Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation conduct of the business of Parent except those the absence of which would not, individually or in the aggregate, reasonably be likely to have a Parent Material Adverse Effect or prevent or materially burden or materially impair the ability of Parent to consummate the Merger and its Subsidiaries as currently conducted the other transactions contemplated by this Agreement (collectively, the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which the Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAPermits.
Appears in 2 contracts
Sources: Agreement and Plan of Reorganization (Dynamic Health Products Inc), Agreement and Plan of Reorganization (GeoPharma, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each Neither Acquirer nor any of its SubsidiariesSubsidiaries is in conflict with, and since January 1or in default or in violation of any law, 2019 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Laws, including the FDCA, the PHSA and to Acquirer or any other similar Law administered of its Subsidiaries or promulgated by the FDA which Acquirer or other Drug Regulatory Agencyany of its Subsidiaries or any of their respective properties is bound or affected, except for any noncompliance, either conflicts and violations that (individually or in the aggregate, which ) would not be material reasonably likely to Parent and its Subsidiaries, taken as a wholehave an Acquirer Material Adverse Effect. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit No investigation or other action review by any Governmental Body Entity is pending or, to Parent’s KnowledgeAcquirer's knowledge, has been threatened in a writing delivered to Acquirer against Parent Acquirer or any of its Subsidiariesthe Material Acquirer Subsidiaries (except for threats delivered prior to January 1, 1995 regarding matters which were subsequently resolved or are no longer pending). There is no material agreement, judgment, injunction, order or decree binding upon Parent Acquirer or any of its the Material Acquirer Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Acquirer or any of its the Material Acquirer Subsidiaries, any acquisition of material property by Parent Acquirer or any of its the Material Acquirer Subsidiaries or the conduct of business by Parent Acquirer or any of its the Material Acquirer Subsidiaries as currently conducted.
(b) Acquirer and the Material Acquirer Subsidiaries hold, (ii) is to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from governmental authorities that are material to and required for the operation of their businesses as currently conducted, except where the failure to hold any such Acquirer Permit would be reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this AgreementAcquirer Target Adverse Effect (collectively, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent "Acquirer Permits”"). Section 3.14(b) of Acquirer and the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Material Acquirer Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements the Acquirer Permits, except where the failure to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect be in compliance with the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As terms of the date of this Agreement, neither Parent nor any of its Subsidiaries Acquirer Permits would not be reasonably likely to have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAAcquirer Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (Borland International Inc /De/), Merger Agreement (Borland International Inc /De/)
Compliance; Permits; Restrictions. (a) Parent Homology and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2020, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened against Parent Homology or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Homology or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Homology or any of its Subsidiaries, any acquisition of material property by Parent Homology or any of its Subsidiaries or the conduct of business by Parent Homology or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentHomology’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Each of Homology and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Homology and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Homology Permits”). Section 3.14(b4.14(b) of the Parent Homology Disclosure Schedule identifies each Parent Homology Permit. Each Parent Permit is valid and in full force and effect, and Parent of Homology and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Homology Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Homology Permit.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened in writing with respect to an alleged material violation by Parent Homology or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Each of Homology and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of Homology and Merger Sub as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Homology Product Candidates”) (collectively, the “Homology Regulatory Permits”) and no such Homology Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Parent Homology has timely maintained and is not currently conducting in compliance in all material respects with the Homology Regulatory Permits and neither Homology nor any of its Subsidiaries has, since January 1, 2020, received any written notice or addressingother written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Homology Regulatory Permit or (B) any revocation, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct withdrawal, suspension, cancellation, termination or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsHomology Regulatory Permit.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Homology or its Subsidiaries, or in which Parent Homology or its Subsidiaries or their respective current products or product candidates candidates, including the Homology Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019Other than as set forth on Section 4.14(e) of the Homology Disclosure Schedule, neither Parent Homology nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledgethe Knowledge of Homology, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Homology or any of its Subsidiaries or in which Parent Homology or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Homology Product Candidates, have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Homology nor any of its Subsidiaries has, and, to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other applicable Law. To Parent’s Knowledgethe Knowledge of Homology, neither Parent Homology nor any of its Subsidiaries nor any contract manufacturer with respect to any Homology Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its Homology’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) , or any other applicable Law. None of ParentHomology, any of its Subsidiaries Subsidiaries, and to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.7042 U.S.C. § 1320a-7, as amended; or (iii) disqualification as a testing facility under 21 C.F.R. Part 58any other applicable Law. To the Knowledge of Homology, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentHomology, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of their respective its officers, employees or agents. Neither Homology nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.
(hg) Parent and All manufacturing operations conducted by, or to the Knowledge of Homology, for the benefit of, Homology or its Subsidiaries in connection with any Homology Product Candidate, since January 1, 2020, have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent been and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms of all Business Associate Agreements to which Parent FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680 and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or any Subsidiary is a party manufacturing site owned by Homology or otherwise bound. Parent and its Subsidiaries, where requiredand to the Knowledge of Homology, have created and maintained written policies and procedures no manufacturing site of a contract manufacturer or laboratory, with respect to protect the privacy any Homology Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020, received any unresolved Form FDA 483, notice of all protected health informationviolation, provide training to all employees and agents as required under HIPAAwarning letter, and has implemented security proceduresuntitled letter, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the U.S. Department Knowledge of Health and Human Services or Homology, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAAuthority is considering such action.
Appears in 2 contracts
Sources: Merger Agreement (Homology Medicines, Inc.), Merger Agreement (Homology Medicines, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiariesis, and since January 1February 26, 2019 have been2014, each of Parent and its Subsidiaries has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the applicable Contemplated Transactions.
(b) Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the its business of Parent and its Subsidiaries as currently conducted (collectively, the “Parent Permits”)) as currently conducted. Section 3.14(b3.12(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each As of the date of this Agreement, Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each material Parent Permit will be available to Parent immediately after the Effective Time on terms substantially identical to those enjoyed by Parent as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of Parent holds all required Governmental Authorizations issuable by any Governmental Body necessary for the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any conduct of its Subsidiaries of business as currently conducted (the FDCA“Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, the PHSA withdrawn, suspended, canceled or terminated or (ii) modified in any other similar Law administered or promulgated by any Drug Regulatory Agencymaterially adverse manner. Parent is has not currently conducting received any written notice or addressingother written communication from any Governmental Body regarding any revocation, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct withdrawal, suspension, cancelation, termination or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsParent Regulatory Permit.
(d) All clinicalTo the Knowledge of Parent, pre-clinical and other studies and tests conducted by no material debarment or on behalf ofexclusionary claims, actions, proceedings or sponsored by, investigations in respect of their business or products are pending or threatened against Parent or its Subsidiariesofficers, employees or in which agents. Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Parent’s Knowledge, neither Parent nor any of its Subsidiaries has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Parent Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Parent, nor to the Knowledge of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; any similar applicable Legal Requirement.
(iiie) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, There are no proceedings or investigations in respect of their business or products are pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent, with respect to an alleged violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act or any of their respective officers, employees other similar Legal Requirements promulgated by the FDA or agentsother Drug Regulatory Agency.
(hf) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent and or in which Parent or its Subsidiaries products or services have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with applicable regulations of the terms Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2013, Parent has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of all Business Associate Agreements Parent threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or in which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where requiredProduct Candidates, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAparticipated.
Appears in 2 contracts
Sources: Merger Agreement (Flex Pharma, Inc.), Merger Agreement
Compliance; Permits; Restrictions. (a) Parent Each of Tigris and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been, in compliance 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Tigris, threatened against Parent Tigris or a Tigris Subsidiary, nor has any of its SubsidiariesGovernmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Tigris or any of its Subsidiaries a Tigris Subsidiary which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Tigris or any of its Subsidiariesa Tigris Subsidiary, any acquisition of material property by Parent Tigris or any of its Subsidiaries a Tigris Subsidiary or the conduct of business by Parent or Tigris and any of its Subsidiaries Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on Parent’s Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent Each of Tigris and its Subsidiaries hold holds all required Governmental Authorizations which are material to the operation of their businesses (collectively, the business of Parent and its Subsidiaries “Tigris Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 3.9(b) of the Parent Tigris Disclosure Schedule identifies each Parent Tigris Permit. Each Parent Permit is valid and in full force and effect, and Parent of Tigris and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Tigris Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Tigris, threatened with respect to an alleged material violation by Parent Tigris or any of its Subsidiaries a Tigris Subsidiary of the FDCA, the PHSA FDA regulations adopted thereunder, or any other similar Law administered or Legal Requirements promulgated by a Drug Regulatory Agency.
(d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Parent is not currently conducting Neither Tigris nor its Subsidiaries has received any written notice or addressingother written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Parent’s Knowledge there is no basis Potomac all information in its or its Subsidiaries’ possession or control relating to expect that it will be required to conduct or addressthe Tigris Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Tigris or its Subsidiaries, a Tigris Subsidiary or in which Parent Tigris or its Subsidiaries a Tigris Subsidiary or their respective current products or product candidates candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Tigris nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Tigris, neither Parent Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentTigris, any of its Subsidiaries Subsidiaries, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Tigris, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentTigris, any of its Subsidiaries Tigris Subsidiary or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 2 contracts
Sources: Merger Agreement (InterWest Partners IX, LP), Merger Agreement (Transcept Pharmaceuticals Inc)
Compliance; Permits; Restrictions. (a) Neither Parent and each nor any of its SubsidiariesSubsidiaries is in conflict with, and since January 1or in default or violation of (i) any law, 2019 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Lawsto Parent or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, including the FDCAor (ii) any note, the PHSA and any other similar Law administered or promulgated by the FDA bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agency, instrument or obligation to which Parent or any of its Subsidiaries is a party or by which Parent or any of its Subsidiaries or its or any of their respective properties is bound or affected except for any noncompliancethose conflicts, either individually defaults or in the aggregate, violations which would not be material reasonably expected to have a Parent and its Subsidiaries, taken as a wholeMaterial Adverse Effect. As To the knowledge of the date of this AgreementParent, no investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body Entity is pending or, to Parent’s Knowledge, or threatened against Parent or any of its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same; other than those which would not reasonably be expected to have a Parent Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material necessary to the operation conduct of the business of Parent and its Subsidiaries as currently conducted except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Parent Material Adverse Effect, (collectively, the “"Parent Permits”"). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is are in compliance in all material respects with the terms of all Business Associate Agreements to which the Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAPermits.
Appears in 1 contract
Sources: Merger Agreement (Eye Dynamics Inc)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesGC is, and since January July 1, 2019 have been2016, each of GC and the GC Subsidiaries has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeGC Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of GC, threatened against Parent GC or any of its SubsidiariesGC Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent GC or any of its Subsidiaries GC Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent GC or any of its SubsidiariesGC Subsidiary, any acquisition of material property by Parent GC or any of its Subsidiaries GC Subsidiary or the conduct of business by Parent GC or any of its Subsidiaries GC Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentGC’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Exchange or any of the Contemplated Transactions.
(b) Parent GC and its the GC Subsidiaries hold all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “GC Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent GC Disclosure Schedule identifies each Parent GC Permit. Each Parent Permit is valid As of the date of this Agreement, each of GC and in full force and effect, and Parent and its the GC Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent GC Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of GC, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent GC Permit. The rights and benefits of each material GC Permit will be available to GC immediately after the Effective Time on terms substantially identical to those enjoyed by GC and the GC Subsidiaries immediately prior to the Effective Time.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated GC holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to Governmental Body necessary for the conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by as currently conducted (the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991GC Regulatory Permits”) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, no such GC Regulatory Permit has been convicted of any crime or engaged in any conduct that could result in (i) debarment revoked, withdrawn, suspended, canceled or exclusion under 21 U.S.C. Section 335a, as amended; terminated or (ii) disqualification from participating modified in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted Listany materially adverse manner. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, GC has not received any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice or other written communication from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAGC Regulatory Permit.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Frequency and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2020, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened against Parent Frequency or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Frequency or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Frequency or any of its Subsidiaries, any acquisition of material property by Parent Frequency or any of its Subsidiaries or the conduct of business by Parent Frequency or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentFrequency’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Each of Frequency and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Frequency and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Frequency Permits”). Section 3.14(b4.14(b) of the Parent Frequency Disclosure Schedule identifies each Parent Frequency Permit. Each Parent Permit is valid and in full force and effect, and Parent of Frequency and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Frequency Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Frequency Permit.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened with respect to an alleged material violation by Parent Frequency or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Each of Frequency and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Frequency and Merger Sub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Frequency Product Candidates”) (collectively, the “Frequency Regulatory Permits”) and no such Frequency Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Frequency has timely maintained and is in compliance in all material respects with the Frequency Regulatory Permits and neither Frequency nor any of its Subsidiaries has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Frequency Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Frequency Regulatory Permit.
(e) All clinicalclinical trials, pre-clinical preclinical studies and other studies and tests conducted by or on behalf of, or sponsored by, Parent Frequency or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates the Frequency Product Candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019Other than as set forth on Section 4.14(e) of the Frequency Disclosure Schedule, neither Parent Frequency nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledgethe Knowledge of Frequency, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Frequency or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates the Frequency Product Candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Frequency nor any of its Subsidiaries has, and, to the Knowledge of Frequency, any contract manufacturer with respect to any Frequency Product Candidate, is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other applicable Law. To Parent’s Knowledgethe Knowledge of Frequency, neither Parent Frequency nor any of its Subsidiaries nor any contract manufacturer with respect to any Frequency Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its Frequency’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) , or any other applicable Law. None of ParentFrequency, any of its Subsidiaries Subsidiaries, and to the Knowledge of Frequency, any contract manufacturer with respect to any Frequency Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.7042 U.S.C. § 1320a-7, as amended; or (iii) disqualification as a testing facility under 21 C.F.R. Part 58any other applicable Law. To the Knowledge of Frequency, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentFrequency, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Frequency, any contract manufacturer with respect to any Frequency Product Candidate, or any of their respective its officers, employees or agents. Neither Frequency nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.
(hg) Parent and All manufacturing operations conducted by, or to the Knowledge of Frequency, for the benefit of, Frequency or its Subsidiaries in connection with any Frequency Product Candidate, since January 1, 2020, have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent been and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms of all Business Associate Agreements to which Parent FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or any Subsidiary is a party manufacturing site owned by Frequency or otherwise bound. Parent and its Subsidiaries, where requiredand to the Knowledge of Frequency, have created and maintained written policies and procedures no manufacturing site of a contract manufacturer or laboratory, with respect to protect the privacy any Frequency Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020, received any unresolved Form FDA 483, notice of all protected health informationviolation, provide training to all employees and agents as required under HIPAAwarning letter, and has implemented security proceduresuntitled letter, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the U.S. Department Knowledge of Health and Human Services or Frequency, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAAuthority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Buyer and each of its SubsidiariesBuyer Subsidiary are, and since January 1, 2019 2014 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatened in writing against Parent Buyer or any of its SubsidiariesBuyer Subsidiary. There is no agreement, judgment, injunction, order or decree binding upon Parent Buyer or any of its Subsidiaries Buyer Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Buyer or any of its SubsidiariesBuyer Subsidiary, any acquisition of material property by Parent Buyer or any of its Subsidiaries Buyer Subsidiary or the conduct of business by Parent Buyer or any of its Subsidiaries Buyer Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentBuyer’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Except for matters regarding the FDA and its except as would not reasonably be expected to have a Buyer Material Adverse Effect, Buyer and the Buyer Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Buyer (the “Parent Buyer Permits”)) as currently conducted. Section 3.14(bPart 2.11(b) of the Parent Buyer Disclosure Schedule identifies each Parent Buyer Permit. Each Parent Permit of Buyer and each Buyer Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Buyer Permits, except as would not reasonably be expected to have a Buyer Material Adverse Effect. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatenedthreatened in writing, which seeks to revoke, limit, suspend, or materially modify any Parent Buyer Permit. The rights and benefits of each material Buyer Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Buyer and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatened in writing with respect to an alleged material violation by Parent Buyer or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or Legal Requirements promulgated by any Drug the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds”).
(d) Buyer and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Buyer or such Subsidiary as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products (the “Buyer Products”) (collectively, the “Buyer Regulatory Permits”), except as would not reasonably be expected to have a Buyer Material Adverse Effect, and no such Buyer Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Buyer and each Buyer Subsidiary is in compliance in all material respects with the Buyer Regulatory Permits and has not received any written notice or other written communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Buyer Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Buyer Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Buyer Disclosure Schedule, Buyer has made available to Lpath all information requested by Lpath in Buyer’s or its Subsidiaries’ possession or control relating to the Buyer Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Buyer Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Buyer or its Subsidiaries, Subsidiaries or in which Parent Buyer or its Subsidiaries or their respective current products or product candidates candidates, including the Buyer Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Buyer nor any of its the Buyer Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Buyer or the Buyer Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Buyer or any of the Buyer Subsidiaries, neither Parent Buyer nor any of its the Buyer Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentBuyer, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Buyer, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentBuyer, any of its Subsidiaries Buyer Subsidiary or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Lpath, Inc)
Compliance; Permits; Restrictions. (a) Parent Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and each of its SubsidiariesCorautus Subsidiary are, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA Legal Requirements and has not received any other similar Law administered written notice of violation or promulgated by the FDA or other Drug Regulatory Agency, except for alleged violation of any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeapplicable Legal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Corautus, threatened against Parent Corautus or any of its SubsidiariesCorautus Subsidiary, nor has any Governmental Body or authority indicated to Corautus an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Corautus or any of its Subsidiaries Corautus Subsidiary which (i) has had or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsa Corautus Material Adverse Effect.
(b) Parent Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule: (i) Corautus and its the Corautus Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Corautus (collectively, the “Parent Corautus Permits”). Section 3.14(b3.11(b) of the Parent Corautus Disclosure Schedule identifies each Parent Corautus Permit. Each Parent Permit , each of which is valid and in full force and effect, . Each of Corautus and Parent and its Subsidiaries holding Parent Permits are each Corautus Subsidiary is in material compliance with the terms of the Parent Corautus Permits. No Legal Proceeding Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule: (i) no action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Corautus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Corautus Permit; and (ii) the rights and benefits of each Corautus Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Corautus and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As Except as set forth on Section 3.11(d) of the date of this AgreementCorautus Disclosure Schedule, there are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Corautus or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act, the Public Health Service Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other Drug Regulatory Agency.
(d) Except for such Governmental Authorizations listed in Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and its Subsidiaries holds (or at the relevant time, held) all Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its existing products (the “Corautus Products”) (the “Corautus Regulatory Permits”) and, except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, no such Corautus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Parent is Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and each of its Subsidiaries has complied in all material respects with the Corautus Regulatory Permits and has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any Corautus Regulatory Permit or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any Corautus Regulatory Permit. Except for the information and files identified in Section 3.11(d) of the Corautus Disclosure Schedule, Corautus has made available to Parent’s Knowledge there is no basis VIA all information in its possession or control relating to expect that it will be required to conduct or addressthe Corautus Products and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Corautus Products, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Corautus or its Subsidiaries, any Corautus Subsidiary or in which Parent Corautus or any Corautus Subsidiary or its Subsidiaries or their respective current products or product candidates candidates, including the Corautus Products, have participated, participated (the “Corautus Studies”) were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019Except for such notices listed in Section 3.11(e) of the Corautus Disclosure Schedule, neither Parent Corautus nor any of its Subsidiaries Corautus Subsidiary has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent Corautus or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates candidates, including the Corautus Products, have participated.
(e. Except for such material obligations listed in Section 3.11(e) As of the date Corautus Disclosure Schedule, Corautus and its Subsidiaries have fulfilled and performed all of this Agreementtheir material obligations with respect to the Corautus Studies, there and no event has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letteroccurred which causes, or proceeding pending after notice or in effect against Parent or any lapse of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that time would reasonably be expected to give rise to or form the basis for any civilcause, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawsa Corautus Material Adverse Effect.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesPERA is, and since January 1, 2019 have has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholePERA Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of PERA, threatened against Parent or any of its SubsidiariesPERA. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries PERA which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Parent or any of its SubsidiariesPERA, any acquisition of material property by Parent or any of its Subsidiaries PERA or the conduct of business by Parent or any of its Subsidiaries PERA as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentPERA’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Exchange or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold PERA holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted PERA (the “Parent PERA Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent PERA Disclosure Schedule identifies each Parent PERA Permit. Each Parent Permit As of the date of this Agreement, PERA is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent PERA Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of PERA, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent PERA Permit.
(c) As . The rights and benefits of each material PERA Permit will be available to PERA and GC immediately after the date Effective Time on terms substantially identical to those enjoyed by PERA immediately prior to the Effective Time. Neither the execution, delivery or performance of this Agreement, there are no proceedings pending ornor the consummation of the transactions contemplated hereunder, to Parent’s Knowledgewill result in the loss, threatened suspension, or impairment of the PERA Permits, or require the consent of any Person with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsPERA Permits.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Eiger and each of its SubsidiariesEiger Subsidiary are, and since January 1, 2019 2010 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Eiger, threatened against Parent Eiger or any of its SubsidiariesEiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Eiger or any of its Subsidiaries Eiger Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Eiger or any of its SubsidiariesEiger Subsidiary, any acquisition of material property by Parent Eiger or any of its Subsidiaries Eiger Subsidiary or the conduct of business by Parent Eiger or any of its Subsidiaries Eiger Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentEiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent Eiger and its the Eiger Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Eiger (the “Parent Eiger Permits”)) as currently conducted. Section 3.14(bPart 2.11(b) of the Parent Eiger Disclosure Schedule identifies each Parent Eiger Permit. Each Parent Permit of Eiger and each Eiger Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Eiger Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Eiger, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Eiger Permit. The rights and benefits of each material Eiger Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parentcomply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s Knowledge or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or addressand from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Eiger or its Subsidiaries, Subsidiaries or in which Parent Eiger or its Subsidiaries or their respective current products or product candidates candidates, including the Eiger Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192010, neither Parent Eiger nor any of its Subsidiaries has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent Eiger or any of its Subsidiaries or in which Parent Eiger or any of its Subsidiaries or their respective current products or product candidates candidates, including the Eiger Product Candidates, have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Eiger nor any of its the Eiger Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Eiger or any of the Eiger Subsidiaries, neither Parent Eiger nor any of its the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentEiger, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Eiger, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentEiger, any of its Subsidiaries Eiger Subsidiary or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Celladon Corp)
Compliance; Permits; Restrictions. (a) Parent Merger Partner and each of its SubsidiariesMerger Partner Subsidiary are, and since January 1, 2019 2005 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Merger Partner, threatened against Parent Merger Partner or any of its SubsidiariesMerger Partner Subsidiary, nor has any Governmental Body or authority indicated to Merger Partner an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Merger Partner or any of its SubsidiariesMerger Partner Subsidiary, any acquisition of material property by Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary or the conduct of business by Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentMerger Partner’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent Merger Partner and its the Merger Partner Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries Merger Partner (collectively, the “Merger Partner Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 2.11(b) of the Parent Merger Partner Disclosure Schedule identifies each Parent Merger Partner Permit. Each Parent Permit of Merger Partner and each Merger Partner Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Merger Partner Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Merger Partner, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Merger Partner Permit. The rights and benefits of each material Merger Partner Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Merger Partner and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Merger Partner or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Merger Partner holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not Agency necessary for the conduct of the business of Merger Partner as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including Intermezzo and TO-2060 (the “Merger Partner Product Candidates”) (the “Merger Partner Regulatory Permits”) and no such Merger Partner Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Merger Partner is in compliance in all material respects with the Merger Partner Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parentcomply materially with any term or requirement of any Merger Partner Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Merger Partner Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Merger Partner Disclosure Schedule, Merger Partner has made available to Pivot all information requested by Pivot in Merger Partner’s Knowledge there is no basis possession or control relating to expect that it will be required to conduct or addressthe Merger Partner Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Merger Partner Product Candidates, including without limitation, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Merger Partner or in which Parent Merger Partner or its Subsidiaries or their respective current products or product candidates candidates, including the Merger Partner Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192005, neither Parent nor any of its Subsidiaries Merger Partner has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledgethe Knowledge of Merger Partner, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Merger Partner or in which Parent Merger Partner or any of its Subsidiaries or their respective current products or product candidates candidates, including the Merger Partner Product Candidates, have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Merger Partner nor any of its the Merger Partner Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Merger Partner or the Merger Partner Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Merger Partner or any of the Merger Partner Subsidiaries, neither Parent Merger Partner nor any of its the Merger Partner Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, . Neither Merger Partner nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Merger Partner, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Merger Partner or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Novacea Inc)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesBombshell is, and since January 1, 2019 have has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeBombshell Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Bombshell, threatened against Parent or any of its SubsidiariesBombshell. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Bombshell which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Parent or any of its SubsidiariesBombshell, any acquisition of material property by Parent or any of its Subsidiaries Bombshell or the conduct of business by Parent or any of its Subsidiaries Bombshell as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentBombshell’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Exchange or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Bombshell holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Bombshell (the “Parent Bombshell Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Bombshell Disclosure Schedule identifies each Parent Permit. Each Parent Bombshell Permit As of the date of this Agreement, Bombshell is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Bombshell Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Bombshell, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Bombshell Permit.
(c) As . The rights and benefits of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged each material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it Bombshell Permit will be required available to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical Bombshell and other studies and tests conducted CG immediately after the Effective Time on terms substantially identical to those enjoyed by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, Bombshell immediately prior to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsEffective Time.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesDecoy is, and since January 1, 2019 have for the past 5 years has been, in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Decoy, threatened against Parent or any of its SubsidiariesDecoy. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Decoy which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesDecoy, any acquisition of material property by Parent or any of its Subsidiaries Decoy or the conduct of business by Parent or any of its Subsidiaries as currently conductedthe Decoy Business, (ii) is would reasonably likely be expected to have an adverse effect on ParentDecoy’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Merger or any of the Transactions.
(b) Parent and its Subsidiaries hold Decoy holds all required Governmental Authorizations which are material to issuable by any Drug Regulatory Agency necessary for the operation conduct of the business of Parent Decoy as currently conducted, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its Subsidiaries products or product candidates (the “Decoy Product Candidates”). Decoy holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Parent Decoy Permits”). , and Section 3.14(b2.12(b) of the Parent Decoy Disclosure Schedule identifies each Parent Decoy Permit. Each Parent No such Decoy Permit is valid has been: (i) revoked, withdrawn, suspended, canceled or terminated; or (ii) modified in any materially adverse manner. Decoy has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Decoy Permit. Decoy has made available to Intec all material information in its possession or control concerning the development, clinical testing, manufacturing, importation and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms exportation of the Parent PermitsDecoy Product Candidates, including complete copies of the following (to the extent there are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency. No Legal Proceeding is pending or, The rights and benefits of each material Decoy Permit will be available to Parent’s Knowledge, threatened, which seeks Decoy immediately after the Effective Time on terms substantially identical to revoke, limit, suspend, or materially modify any Parent Permitthose enjoyed by Decoy immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Decoy, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Decoy of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the PHSA Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds”).
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its SubsidiariesDecoy were, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any No preclinical or clinical trial conducted by or on behalf of its Subsidiaries Decoy has been terminated or suspended prior to completion for safety or non-compliance reasons. Decoy has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Decoy threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored byby Decoy or, Parent or any of its Subsidiaries or in which Parent Decoy or any of its Subsidiaries or their respective current products or product candidates candidates, including the Decoy Product Candidates, have participated.
(e) As of the date of this Agreement, there Decoy has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or complied in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied all material respects with all applicable Laws Legal Requirements relating to patient, medical or individual health information, including HIPAA. Parent the Health Insurance Portability and Accountability Act of 1996 and its Subsidiaries have implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. Decoy has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements (as defined in HIPAA) agreements to which Parent or any Subsidiary Decoy is a party or otherwise bound. Parent and its Subsidiaries, where required, have Decoy has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has have implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have Decoy has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h2.12(e) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Intec Pharma Ltd.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January November 1, 2019 2018 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries as currently conducted (collectively, the “Parent Permits”). Section 3.14(b3.15(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA FDA regulations adopted thereunder or any other applicable similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Parent and each of its Subsidiaries holds all material Governmental Authorizations issued by any Drug Regulatory AgencyAgency that are necessary for the conduct of the business of Parent or such Subsidiary as currently conducted, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Parent Product Candidates”) (collectively, the “Parent Regulatory Permits”). All such Parent Regulatory Permits are in full force and effect. Parent is not currently conducting and each of its Subsidiaries have fulfilled and performed all of its material obligations with respect to the Parent Regulatory Permits and, to the Knowledge of Parent, no event has occurred which allows, or addressingafter 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 Parent Regulatory Permit. Parent and each of its Subsidiaries are in compliance in all material respects with the terms of the Parent Regulatory Permits and neither Parent nor any of its Subsidiaries has received any written notice of Legal Proceedings relating to Parent’s Knowledge there is no basis to expect that it will be required to conduct the revocation, termination, suspension or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsParent Regulatory Permit.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws governing the privacy of patient medical records and other Personal Data. Since No clinical trial conducted by or, on behalf of, Parent or any of its Subsidiaries has been terminated or suspended by any Drug Regulatory Agencies. Other than as set forth in Section 3.14(e) of the Parent Disclosure Schedule, since January 1, 20192018, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Drug Regulatory Agency requiring, or, or to the Knowledge of Parent’s Knowledge, threatening to initiate, the termination or suspension of or investigation of, or place a clinical hold order on or otherwise delay or materially restrict, any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or Subsidiaries. With respect to each Parent Product Candidate, Parent has made available to the Company complete and accurate copies of all material clinical and preclinical data in which the possession of Parent or any of and its Subsidiaries or their respective current products or product candidates have participated.
(e) As and all material written correspondence that exists as of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Agreement between Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawsapplicable Drug Regulatory Agencies.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy final policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policyfinal policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries or or, to the Knowledge of Parent, any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(hg) Parent and each of its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent applicable security and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation standards regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAALaws.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesArcturus is, and since January 1, 2019 have 2014 has been, in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as a wholeconstitute an Arcturus Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Arcturus, threatened against Parent or any of its SubsidiariesArcturus. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Arcturus which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesArcturus, any acquisition of material property by Parent or any of its Subsidiaries Arcturus or the conduct of business by Parent or any of its Subsidiaries Arcturus as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentArcturus’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Arcturus holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Arcturus (the “Parent Arcturus Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Arcturus Disclosure Schedule identifies each Parent Arcturus Permit. Each Parent Permit As of the date of this Agreement, Arcturus is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Arcturus Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Arcturus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Arcturus Permit. The rights and benefits of each material Arcturus Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Arcturus immediately prior to the Effective Time except where the unavailability of such Arcturus Permit would not constitute an Arcturus Material Adverse Effect.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Arcturus, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Arcturus of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the PHSA Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds”).
(d) All To the Knowledge of Arcturus, Arcturus holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Arcturus as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Arcturus Product Candidates”). Arcturus holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Arcturus Regulatory Permits”), and no such Arcturus Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Arcturus not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Arcturus Regulatory Permit. Arcturus has made available to Alcobra all information in its possession or control relating to the development, clinical testing, manufacturing, importation and exportation of the Arcturus Product Candidates, including complete copies of the following (to the extent there are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(e) To the Knowledge of Arcturus, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Arcturus or in which Parent Arcturus or its Subsidiaries or their respective current products or product candidates candidates, including the Arcturus Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192012, neither Parent nor any of its Subsidiaries Arcturus has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Arcturus threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any Arcturus or, to the Knowledge of its Subsidiaries or Arcturus, in which Parent Arcturus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Arcturus Product Candidates, have participated.
(ef) As of the date of this Agreement, there has not been and Arcturus is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Arcturus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Arcturus, neither Parent nor any of its Subsidiaries Arcturus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Arcturus Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Arcturus, and to the Knowledge of ParentArcturus, nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Arcturus, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Arcturus or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Alcobra Ltd.)
Compliance; Permits; Restrictions. (a) Parent Arrow and each of its SubsidiariesOTI are, and since January 1, 2019 2013 have been, been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or Governmental Authority is pending or, to Parent’s Knowledgethe Knowledge of Arrow, threatened against Parent Arrow or OTI, nor has any of its SubsidiariesGovernmental Body or Governmental Authority indicated to Arrow or OTI in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Arrow or any of its Subsidiaries OTI which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Arrow or any of its SubsidiariesOTI, any acquisition of material property by Parent Arrow or any of its Subsidiaries OTI or the conduct of business by Parent or Arrow and any of its Subsidiaries Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentArrow’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, materially delaying, making illegal or otherwise interfering with the Mergers or any of the Contemplated Transactions.
(b) Parent Each of Arrow, OTI, and its Subsidiaries hold Merger Subs holds all required Governmental Authorizations which are material to the operation of their businesses (collectively, the business of Parent and its Subsidiaries “Arrow Permits”) as currently conducted (the “Parent Permits”)conducted. Section Part 3.14(b) of the Parent Arrow Disclosure Schedule identifies each Parent Arrow Permit. Each Parent Permit is valid and in full force and effectof Arrow, OTI, and Parent and its Subsidiaries holding Parent Permits are Merger Subs is in material compliance with the terms of the Parent Arrow Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Arrow, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Arrow Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Arrow, threatened with respect to an alleged material violation by Parent Arrow or any of its Subsidiaries OTI of the FDCA, the PHSA FDA regulations adopted thereunder, or any other similar Law administered or Legal Requirements promulgated by a Drug Regulatory Agency.
(d) Each of Arrow, OTI, and Merger Subs holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not currently conducting or addressingAgency necessary for the conduct of the business of Arrow, OTI, and Merger Subs as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Arrow Product Candidates”) (the “Arrow Regulatory Permits”) and no such Arrow Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Arrow nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Arrow Regulatory Permit. Except for the information and files identified in Part 3.14(d) of the Arrow Disclosure Schedule, Arrow and OTI have made available to Parent’s Knowledge the Company all information in its or its Subsidiaries’ possession or control relating to the Arrow Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Arrow Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or addressand from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Arrow or its Subsidiaries, OTI or in which Parent or its Subsidiaries Arrow, OTI, or their respective current products or product candidates candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent Arrow nor any of its Subsidiaries OTI is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Arrow, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Arrow, neither Parent Arrow nor any of its Subsidiaries OTI has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentArrow, any of its Subsidiaries Subsidiaries, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Arrow, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against ParentArrow, any of its Subsidiaries OTI, or any of their respective officers, employees or agents.
(hg) Parent Other than in connection with the winding down of its operations, Arrow has filed with the FDA, EMA, any other Governmental Body, and its Subsidiaries have materially complied with any institutional review board or comparable body, all applicable Laws relating to patientrequired notices, medical supplemental applications, and annual or individual health informationother reports, including HIPAA. Parent and its Subsidiaries have entered intoadverse experience reports, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements respect to which Parent each investigational new drug application or any Subsidiary is a party comparable foreign regulatory application, related to the manufacture, testing, study, or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy sale of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services products or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parentproduct candidates, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAas applicable.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 2020, have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA FDA regulations adopted thereunder, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeParent. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree by or with a Drug Regulatory Agency binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to the Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. .
(d) Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(de) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Parent or any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192020, neither Parent nor any of its Subsidiaries has have received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is are the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has have committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has agents have been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To Parent’s Knowledge, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesNautilus is, and since January 1, 2019 have been2014, has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA FDA regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA or other a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeNautilus. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened against Parent or any of its SubsidiariesNautilus. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Nautilus which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesNautilus, any acquisition of material property by Parent or any of its Subsidiaries Nautilus or the conduct of business by Parent or any of its Subsidiaries Nautilus as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Nautilus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Each of Nautilus and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent Nautilus and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Nautilus Permits”). Section 3.14(b) of the Parent Nautilus Disclosure Schedule identifies each Parent Nautilus Permit. Each Parent Permit of Nautilus and Merger Sub is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Nautilus Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Nautilus Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Nautilus of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Each of Nautilus and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency material to the conduct of the business of Nautilus and Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Nautilus Product Candidates”) (the “Nautilus Regulatory Permits”) and no such Nautilus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Each of Nautilus and Merger Sub is in compliance in all material respects with the Nautilus Regulatory Permits and neither Nautilus nor Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Nautilus Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Nautilus Regulatory Permit. Except for the information and files identified in Section 3.14(d) of the Nautilus Disclosure Schedule, Nautilus has made available to the Company all information requested by the Company in Nautilus’ possession or control relating to the Nautilus Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Nautilus Product Candidates, including complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar notices, letters, filings, correspondence and meeting minutes with any other Governmental Body. Parent is not currently conducting Each of Nautilus and Merger Sub has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented to the Company. To the Knowledge of Nautilus, there are no facts that would be reasonably likely to result in any warning, untitled or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct notice of violation letter or address, any corrective actions, including, without limitation, product recalls or clinical holdsForm FDA-483 from the FDA.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Nautilus or in which Parent Nautilus or its Subsidiaries or their respective current products or product candidates candidates, including the Nautilus Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since No preclinical or clinical trial conducted by or on behalf of Nautilus has been terminated or suspended prior to completion for safety or non-compliance reasons. Other than as set forth on Section 3.14(e) of the Nautilus Disclosure Schedule, since January 1, 20192014, neither Parent Nautilus nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Nautilus, threatening to initiate, the termination termination, suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Nautilus or in which Parent Nautilus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Nautilus Product Candidates, have participated. To the extent required, all clinical trials conducted by or on behalf of Nautilus have been registered on, and trial results have been reported on, the United States National Institutes of Health Website, ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any applicable additional state and local law requirements.
(ef) As Except as set forth on Section 3.14(f) of the date Nautilus Disclosure Schedule, Nautilus has withdrawn each IND submitted to the FDA and, for each such IND, notified FDA of this Agreementthe withdrawal, there ended all clinical investigations conducted under the IND, notified all clinical investigators, assured return or disposal of all stocks of the investigational drug and has otherwise wound down all IND-related activities in accordance with all applicable Laws.
(g) Nautilus has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Nautilus, neither Parent nor any of its Subsidiaries Nautilus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that has violated or would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentNautilus, any Merger Sub, or, to the Knowledge of its Subsidiaries or Nautilus, any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that has resulted in or could result in debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Nautilus, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Nautilus or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2022, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Each of Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger Subs as currently conducted (collectively, the “Parent Permits”), including Governmental Authorizations related to the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Parent Product Candidates”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are have timely maintained and is in material compliance with the terms of the Parent PermitsPermits and no Parent Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Except for the information and files identified in Section 4.14(d) of the Parent Disclosure Schedule, Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to the Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent Product Candidates, including, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. Parent is not currently conducting or addressing, All such information are accurate and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdscomplete in all material respects.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019Other than as set forth on Section 4.14(e) of the Parent Disclosure Schedule, neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Parent Product Candidates, have participated.
(e) As of the date of this Agreement. Further, there has not been and is not now any Form FDA-483 observationno clinical investigator, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letterresearcher, or proceeding pending or clinical staff participating in effect against any clinical study conducted by or, to the Knowledge of Parent, on behalf of Parent or any of its Subsidiaries or any of their respective officers and employeeshas been disqualified from participating in studies involving the Parent Product Candidates, and Parent to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Parent’s Knowledge, neither Parent nor any of its Subsidiaries and no contract manufacturer with respect to any Parent Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective its officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2018, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or manufacturing site owned by Parent or its Subsidiaries, and to the Knowledge of Parent, no manufacturing site of a contract manufacturer or laboratory, with respect to any Parent Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of Parent, neither the FDA nor any other Governmental Authority is considering such action.
(i) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA, including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is its Subsidiaries are a party or otherwise bound. Parent and its SubsidiariesSubsidiaries have, where if required, have created and maintained written policies and procedures to protect the privacy of all protected health informationProtected Health Information, provide have provided training to all employees and agents as required under HIPAA, and has have, if required, implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of and its Subsidiaries have not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body Authority of any allegation regarding its failure to comply with HIPAA or any other federal or state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “, Breach of Unsecured Protected Health Information” , unpermitted disclosure of Personal Health Information or breach of personally identifiable information under applicable state or federal laws have Laws has occurred with respect to information maintained or transmitted to Parent, Parent and its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not are, if required, currently submitting, receiving and handling or is capable of submitting, receiving and handling transactions governed by in accordance with the Standard Transaction Transactions and Code Sets Rule. All capitalized terms in this Section 3.14(h) 4.14 not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesCaladrius is, and since January 1, 2019 have 2019, has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened against Parent or any of its SubsidiariesCaladrius. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Caladrius which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCaladrius, any acquisition of material property by Parent or any of its Subsidiaries ▇▇▇▇▇▇▇▇▇ or the conduct of business by Parent or any of its Subsidiaries ▇▇▇▇▇▇▇▇▇ as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Caladrius’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Each of Caladrius and its Subsidiaries hold ▇▇▇▇▇▇ Sub holds all required Governmental Authorizations which that are material to the operation of the business of Parent Caladrius and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Caladrius Permits”). Section 3.14(b) of the Parent Caladrius Disclosure Schedule identifies each Parent Caladrius Permit. Each Parent Permit of Caladrius and Merger Sub is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Caladrius Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Caladrius Permit. The rights and benefits of each Caladrius Permit will be available to Caladrius and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by ▇▇▇▇▇▇▇▇▇ and Merger Sub as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Caladrius of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Each of Caladrius and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of Caladrius and Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Caladrius Product Candidates”) (the “Caladrius Regulatory Permits”) and no such Caladrius Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Parent Caladrius is not currently conducting in compliance in all material respects with the Caladrius Regulatory Permits and neither Caladrius nor Merger Sub has received any written notice or addressing, and other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parent’s Knowledge there is no basis to expect that it will be required to conduct comply materially with any term or address, requirement of any corrective actions, including, without limitation, product recalls or clinical holds.Caladrius
(de) All clinical, pre-clinical and other studies and tests conducted by or or, to the Knowledge of Caladrius, on behalf of, or sponsored by, Parent or its Subsidiaries, Caladrius or in which Parent Caladrius or its Subsidiaries or their respective current products or product candidates candidates, including the Caladrius Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and ethics and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent ▇▇▇▇▇▇▇▇▇ nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Caladrius, threatening to initiate, the termination or suspension of any clinical studies trials conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Caladrius or in which Parent Caladrius or any of its Subsidiaries or their respective current products or product candidates candidates, including the Caladrius Product Candidates, have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Caladrius is not the subject of any pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other Drug Regulatory Agency pursuant to any similar Laws or regulations promulgated or enforced thereby. To Parent’s Knowledgethe Knowledge of Caladrius, neither Parent nor any of its Subsidiaries ▇▇▇▇▇▇▇▇▇ has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) , or any other Drug Regulatory Agency pursuant to any similar Laws or regulations promulgated or enforced thereby. None of ParentCaladrius, any of its Subsidiaries Merger Sub, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Caladrius, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Caladrius or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Lpath and each of its SubsidiariesLpath Subsidiary are, and since January 1, 2019 2014 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Lpath, threatened in writing against Parent Lpath or any of its SubsidiariesLpath Subsidiary. There is no agreement, judgment, injunction, order or decree binding upon Parent Lpath or any of its Subsidiaries Lpath Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Lpath or any of its SubsidiariesLpath Subsidiary, any acquisition of material property by Parent Lpath or any of its Subsidiaries Lpath Subsidiary or the conduct of business by Parent Lpath or any of its Subsidiaries Lpath Subsidiary as currently conducted and planned to be conducted, (ii) is reasonably likely to may have an adverse effect on ParentLpath’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Except for matters regarding the FDA and its except as would not reasonably be expected to have an Lpath Material Adverse Effect, Lpath and the Lpath Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries Lpath (collectively, the “Lpath Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 3.9(b) of the Parent Lpath Disclosure Schedule identifies each Parent Lpath Permit. Each Parent Permit of Lpath and each Lpath Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Lpath Permits, except as would not reasonably be expected to have an Lpath Material Adverse Effect. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Lpath, threatenedthreatened in writing, which seeks to revoke, limit, suspend, or materially modify any Parent Lpath Permit. The rights and benefits of each material Lpath Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Lpath as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Lpath, threatened in writing with respect to an alleged material violation by Parent Lpath or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or Legal Requirements promulgated by any Drug the FDA or a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Lpath and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Lpath or such Subsidiary as currently conducted, and, as applicable, development, clinical testing and manufacturing as currently conducted of any of its product candidates (the “Lpath Product Candidates”) (collectively, the “Lpath Regulatory Permits”), except as would not reasonably be expected to have an Lpath Material Adverse Effect, and no such Lpath Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Lpath and each Lpath Subsidiary is in compliance in all material respects with the Lpath Regulatory Permits and have not received any written notice or other written communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Lpath Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Lpath Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Lpath Disclosure Schedule, Lpath has made available to Buyer all information requested by Buyer in Lpath’s or its Subsidiaries’ possession or control relating to the Lpath Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Lpath Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Lpath or its Subsidiaries, Subsidiaries or in which Parent Lpath or its Subsidiaries or their respective current products or product candidates candidates, including the Lpath Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Lpath is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Lpath, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Lpath, neither Parent nor any of its Subsidiaries Lpath has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, Lpath or any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Lpath, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Lpath or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Lpath, Inc)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSignal is, and since January 1, 2019 have been2011, each of Signal and its former Subsidiaries has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non- compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeSignal Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Signal, threatened against Parent or any of its SubsidiariesSignal. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Signal which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesSignal, any acquisition of material property by Parent or any of its Subsidiaries Signal or the conduct of business by Parent or any of its Subsidiaries Signal as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentSignal’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Signal holds all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Signal Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent Signal Disclosure Schedule identifies each Parent Signal Permit. Each Parent Permit As of the date of this Agreement, Signal is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Signal Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Signal, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Signal Permit. The rights and benefits of each material Signal Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Signal as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Signal, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Signal of the FDCAClinical Laboratory Improvement Amendments (“CLIA”), the PHSA state CLIA regulations, or any other similar Law administered or Legal Requirements promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsa Governmental Body.
(d) Signal holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Signal Regulatory Permits”) and no such Signal Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Signal has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Signal Regulatory Permit. Signal has made available to Miragen all information in its possession or control relating to the following (to the extent there are any): (A) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Governmental Body; and meeting minutes with any Governmental Body; and (B) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Body.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Signal or in which Parent Signal or its Subsidiaries or their respective current products or product candidates services have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar LawsLegal Requirements.
(f) Neither Parent nor any To the Knowledge of its Subsidiaries is the subject of any pending orSignal, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of Signal or its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesInnovate is, and since January 1December 31, 2019 have 2016 has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as a wholeconstitute an Innovate Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Innovate, threatened against Parent or any of its SubsidiariesInnovate. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Innovate which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Innovate or any of its SubsidiariesInnovate Subsidiary, any acquisition of material property by Parent or any of its Subsidiaries Innovate or the conduct of business by Parent or any of its Subsidiaries Innovate as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentInnovate’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Innovate holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Innovate (the “Parent Innovate Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Innovate Disclosure Schedule identifies each Parent Innovate Permit. Each Parent Permit As of the date of this Agreement, Innovate is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Innovate Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Innovate, threatened, which seeks to revoke, limit, suspend, revoke or materially modify suspend any Parent Innovate Permit. The rights and benefits of each material Innovate Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Innovate immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Innovate, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Innovate of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Innovate holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not Agency necessary for the conduct of the business of Innovate as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Innovate Product Candidates”) (collectively, the “Innovate Regulatory Permits”), and no such Innovate Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated. Innovate is in compliance in all material respects with the Innovate Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parentcomply materially with any term or requirement of any Innovate Regulatory Permit or (B) any revocation, withdrawal, suspension, cancelation, or termination of any Innovate Regulatory Permit. Innovate has made available to Monster all information requested by Monster in Innovate’s Knowledge possession or control relating to the Innovate Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Innovate Product Candidates, including complete copies of the following (to the extent there is no basis are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or address, and from any corrective actions, including, without limitation, product recalls or clinical holdsDrug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Innovate or in which Parent Innovate or its Subsidiaries or their respective current products or product candidates candidates, including the Innovate Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1December 31, 20192016, neither Parent nor any of its Subsidiaries Innovate has not received any notices, correspondence, correspondence or other written communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Innovate threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Innovate or in which Parent Innovate or any of its Subsidiaries or their respective current products or product candidates candidates, including the Innovate Product Candidates, have participated.
(ef) As of the date of this Agreement, there has not been and Innovate is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Innovate, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Innovate, neither Parent nor any of its Subsidiaries Innovate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Innovate Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Innovate nor to the Knowledge of ParentInnovate, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Innovate, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Innovate or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiary are, and since January 1March 31, 2019 2023, have been, been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesSubsidiary. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesSubsidiary, any acquisition of material property by Parent or any of its Subsidiaries Subsidiary or the conduct of business by Parent or any of its Subsidiaries Subsidiary as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its Subsidiaries hold Subsidiary holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Permits”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are Subsidiary is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiary as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Subsidiary of the FDCA, PHSA or FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Each of Parent and its Subsidiary holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Sub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (collectively, the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Schedule identifies and lists each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor its Subsidiary has, since March 31, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (w) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (x) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiary’s possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent Product Candidates, including, but not limited to, complete copies of the following (to the extent there are any): (y) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (z) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its SubsidiariesSubsidiary, or in which Parent or its Subsidiaries Subsidiary or their respective current products or product candidates candidates, including the Parent Product Candidates, have participatedparticipated were, were since March 31, 2023, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1Other than as set forth on Section 4.14(e) of the Parent Disclosure Schedule, 2019since March 31, 2023, neither Parent nor any of its Subsidiaries Subsidiary has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Parent Product Candidates, have participated.
(e) As . Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the date Parent, on behalf of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employeesSubsidiary has been disqualified from participating in studies involving the Parent Product Candidates, and Parent to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent, its Subsidiary nor, to the Knowledge of Parent, any contract manufacturer with respect to any Parent nor any of its Subsidiaries Product Candidate is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Neither Parent’s Knowledge, neither its Subsidiary nor, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent nor any of its Subsidiaries Product Candidate has committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, its Subsidiary, and, to the Knowledge of Parent, any of its Subsidiaries contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, its Subsidiary, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of its Subsidiaries or any of their respective officers, employees or agents.
(hg) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent or its Subsidiary in connection with any Parent Product Candidate, since March 31, 2023, have been and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is are being conducted in compliance and in all material respects with applicable Laws, including the terms FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) None of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and Parent, its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAASubsidiary, and to the Knowledge of Parent, any manufacturing site of a contract manufacturer or laboratory, with respect to any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has implemented security proceduresreceived any Form FDA 483, notice of violation, warning letter, untitled letter, reviews (including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored data integrity reviews) or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAADrug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesMarker is, and since January 1December 11, 2019 have 2015 has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeMarker Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Marker, threatened against Parent or any of its SubsidiariesMarker. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Marker which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Parent or any of its SubsidiariesMarker, any acquisition of material property by Parent or any of its Subsidiaries Marker or the conduct of business by Parent or any of its Subsidiaries Marker as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentMarker’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Marker holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Marker (the “Parent Marker Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Marker Disclosure Schedule identifies each Parent Marker Permit. Each Parent Permit As of the date of this Agreement, Marker is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Marker Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Marker, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Marker Permit. The rights and benefits of each material Marker Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Marker immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Marker, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Marker of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Marker holds no Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not currently conducting Marker holds no Governmental Authorizations issuable by any Governmental Body. Marker has made available to TapImmune all information requested by TapImmune in Marker’s possession or addressingcontrol relating, to the extent they exist, the development, clinical testing, manufacturing, importation and exportation of the Marker Product Candidates, including complete copies of the following (to the extent there are any): (x)copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to Parent’s Knowledge there is no basis and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or addressand from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Body.
(de) All clinicalSince December 11, pre-clinical and other studies and tests conducted by or on behalf of2015, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries Marker has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Marker threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Marker or in which Parent Marker or any of its Subsidiaries or their respective current products or product candidates candidates, including the Marker Product Candidates, have participated.
(ef) As To the Knowledge of the date Marker, no debarment or exclusionary claims, actions, proceedings or investigations in respect of this Agreementtheir business or products are pending or threatened against Marker or its officers, there has not been and employees or agents. Marker is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Marker, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Marker, neither Parent nor any of its Subsidiaries Marker has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Marker Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Marker, and to the Knowledge of ParentMarker, nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentssimilar applicable Legal Requirement.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Tapimmune Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesExcept as set forth in Schedule 3.11(a), the Acquiror is, and since January 1, 2019 have been, in compliance 2008 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or Legal Requirements. Except as set forth in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this AgreementSchedule 3.11(a), no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of the Acquiror, threatened against Parent or the Acquiror, nor has any of its SubsidiariesGovernmental Body indicated to the Acquiror an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries the Acquiror which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiariesthe Acquiror, any acquisition of material property by Parent or any of its Subsidiaries the Acquiror or the conduct of business by Parent or any of its Subsidiaries as currently conductedthe Acquiror Business, (ii) is could reasonably likely be expected to have an a material adverse effect on Parentthe Acquiror’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is could reasonably likely be expected to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) Parent and its Subsidiaries hold The Acquiror holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Acquiror Business (collectively, the “Parent Acquiror Permits”). Section 3.14(bSchedule 3.11(b) of the Parent Acquiror Disclosure Schedule Letter identifies each Parent Acquiror Permit. Each Parent Permit The Acquiror is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Acquiror Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of the Acquiror, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Parent Acquiror Permit. The rights and benefits of each Acquiror Permit will continue to be available to the Acquiror immediately after the Effective Time on terms substantially identical to those enjoyed by the Acquiror as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of the Acquiror, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries the Acquiror of the FDCA, the PHSA FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Law administered or Legal Requirements promulgated by a Drug Regulatory Agency.
(d) The Acquiror holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Acquiror Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Acquiror Regulatory Permits”) and no such Acquiror Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Acquiror is in compliance in all material respects with the Acquiror Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Acquiror Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Acquiror Regulatory Permit. Except for the information and files identified in Schedule 3.11(d) of the Acquiror Disclosure Letter, the Acquiror has made available to the Company true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency. Parent is not currently conducting or addressing; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, the Acquiror were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192008, neither Parent nor any of its Subsidiaries the Acquiror has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledgethe Knowledge of the Acquiror, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar LawsAcquiror.
(f) Neither Parent nor any of its Subsidiaries The Acquiror is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of the Acquiror, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of the Acquiror, neither Parent nor any of its Subsidiaries the Acquiror has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, . Neither the Acquiror nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of the Acquiror, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, the Acquiror or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesVital is, and since January 1, 2019 have been2018, Vital has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeVital Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Vital, threatened against Parent or any of its SubsidiariesVital. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Vital which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Transaction or any of the other Contemplated Transactions.
(b) Parent and its Subsidiaries hold Vital holds all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Vital Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b) As of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit date of this Agreement, Vital is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Vital Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Vital, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Vital Permit. The rights and benefits of each material Vital Permit will be available to Vital immediately after the Effective Time on terms substantially identical to those enjoyed by Vital as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Vital, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Vital of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act, EMEA or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All Vital holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Vital Regulatory Permits”) and no such Vital Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Except as set forth in Section 3.8(d) of the Vital Disclosure Schedule, Vital has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Vital Regulatory Permit.
(e) Except as set forth in Section 3.8(d) of the Vital Disclosure Schedule, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Vital or in which Parent Vital or its Subsidiaries or their respective current products or product candidates services have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participatedLegal Requirements.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesMolecular is, and since January 1, 2019 have 2012 has been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeMolecular Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Molecular, threatened against Parent or any of its SubsidiariesMolecular. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Molecular which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesMolecular, any acquisition of material property by Parent or any of its Subsidiaries Molecular or the conduct of business by Parent or any of its Subsidiaries Molecular as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentMolecular’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Molecular holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Molecular (the “Parent Molecular Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Molecular Disclosure Schedule identifies each Parent Molecular Permit. Each Parent Permit As of the date of this Agreement, Molecular is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Molecular Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Molecular, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Molecular Permit. The rights and benefits of each material Molecular Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Molecular immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Molecular, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Molecular of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Molecular holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not Agency necessary for the conduct of the business of Molecular as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Molecular Product Candidates”). Molecular holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Molecular Regulatory Permits”) and no such Molecular Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Molecular is in compliance in all material respects with the Molecular Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parentcomply materially with any term or requirement of any Molecular Regulatory Permit or (B) any revocation, withdrawal, suspension, cancelation, termination or material modification of any Molecular Regulatory Permit. Molecular has made available to Threshold all information requested by Threshold in Molecular’s Knowledge possession or control relating to the Molecular Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Molecular Product Candidates, including complete copies of the following (to the extent there is no basis are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or address, and from any corrective actions, including, without limitation, product recalls or clinical holdsDrug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Molecular or in which Parent Molecular or its Subsidiaries or their respective current products or product candidates candidates, including the Molecular Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192012, neither Parent nor any of its Subsidiaries Molecular has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Molecular threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Molecular or in which Parent Molecular or any of its Subsidiaries or their respective current products or product candidates candidates, including the Molecular Product Candidates, have participated.
(ef) As To the Knowledge of the date Molecular, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of this Agreementtheir business or products are pending or threatened against Molecular or its officers, there has not been and employees or agents. Molecular is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Molecular, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Molecular, neither Parent nor any of its Subsidiaries Molecular has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Molecular Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Molecular, and to the Knowledge of ParentMolecular, nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Molecular, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Molecular or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Biosight and each of its SubsidiariesSubsidiaries are, and since January November 1, 2019 2015 have been, in compliance in all material respects with all applicable LawsLegal Requirements, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeall Healthcare Laws. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Biosight, threatened against Parent Biosight or any of its Subsidiaries, nor has any Governmental Authority indicated to Biosight in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Biosight or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Biosight or any of its Subsidiaries, any acquisition of material property by Parent Biosight or any of its Subsidiaries or the conduct of business by Parent Biosight or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentBiosight’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Merger or any of the Transactions.
(b) Parent Biosight and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Biosight (the “Parent Biosight Permits”)) as currently conducted. Section 3.14(bPart 3.11(b) of the Parent Biosight Disclosure Schedule identifies each Parent Biosight Permit, including the holder of the Biosight Permit, the name of the Biosight Permit, and the date of expiration. Each Parent Permit is valid and in full force and effect, and Parent of Biosight and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Biosight Permits and the Biosight Permits are in full force and effect. All fees and charges with respect to the Biosight Permits, as of the date hereof, have been paid in full, and all filing, reporting, record keeping, and maintenance obligations required under the applicable Biosight Permits and Healthcare Laws have been completely and timely satisfied. All such reports, records, and filings were complete and accurate in all material respects, or were subsequently updated, changed, corrected, or modified. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Biosight, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Parent Biosight Permit. The rights and benefits of each material Biosight Permit will be available to the Surviving Company immediately after the Effective Time on terms substantially identical to those enjoyed by Biosight and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. There have been no occurrences, events, or Legal Proceedings that are pending, under investigation, or to the Knowledge of Biosight, threatened, nor has Biosight received any written notice which has resulted in or would reasonably be expected to result in any material limitation, adverse modification, revocation, withdrawal, cancellation, lapse, integrity review, suspension, or any other adverse action against any Biosight Permit.
(c) There are no proceedings pending or, to the Knowledge of Biosight, threatened with respect to an alleged violation by Biosight or any of its Subsidiaries of any Legal Requirements promulgated by any Drug Regulatory Agency. Biosight has not been restrained by any Governmental Authority or other Person in its ability to conduct or have conducted the manufacturing, clinical and pre-clinical investigation, handling, shipping, packaging, labeling, storage, import, export, or distribution of its Biosight Product Candidates.
(d) Biosight and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Biosight or such Subsidiary as currently conducted, and, to the extent applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Biosight Product Candidates”) (collectively, the “Biosight Regulatory Permits”), and no such Biosight Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Biosight and each of its Subsidiaries is in compliance in all material respects with the Biosight Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Biosight Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Biosight Regulatory Permit. Except for the information and files identified in Part 3.11(d) of the Biosight Disclosure Schedule, Biosight has made available to Advaxis all information requested by Biosight in Biosight’s or its Subsidiaries’ possession or control relating to the Biosight Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Biosight Product Candidates, including complete copies of the following (to the extent there are any) (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All material preclinical and clinical investigations conducted or sponsored by or on behalf of and intended to be submitted to a Governmental Authority to support a Governmental Authorization are being and have been conducted in compliance in all material respects with all applicable Healthcare Laws administered or issued by the applicable Governmental Authority, including, as applicable, (i) the FDA regulations for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) applicable FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56 and 312 of the Code of Federal Regulations and (iii) applicable federal, state and foreign Healthcare Laws restricting the use and disclosure of individually identifiable health information, including HIPAA. Neither Biosight or its Subsidiaries, nor, to the Knowledge of Biosight, any of third party conducting a clinical or preclinical study on their behalf, has received any written notice, correspondence or other written communication from the FDA or any other Governmental Authority or from IRB requiring or threatening the termination, suspension, delay, restriction, rejection, or material modification of any ongoing, completed, or planned clinical or pre-clinical trials conducted by, or on behalf of, Biosight. The study reports, protocols, and statistical analysis plans for all such material preclinical and clinical investigations, accurately, completely, and fairly reflect the results from and plans for such studies. Biosight has no Knowledge of any other studies, the results of which are inconsistent or otherwise call into question the results of the material preclinical and clinical investigations. Biosight does not have any Knowledge of any material facts or circumstances related to the safety or efficacy of the Biosight Product Candidates that would materially and adversely affect its ability to receive or maintain a Governmental Authorization.
(f) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted data generated by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent of Biosight or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with respect to the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Biosight Product Candidates is the subject of any pending orwritten regulatory action, either pending, or to the Knowledge of Biosight, threatened by any Governmental Authority relating to the truthfulness or scientific integrity of such data.
(g) Neither Biosight, any of its Subsidiaries, nor, to Parent’s Knowledgethe Knowledge of Biosight, any Person providing services on their behalf, is the subject of any pending, or to the Knowledge of Biosight, threatened investigation in respect of its business or products the Biosight Product Candidates by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or otherwise with respect to any other untrue or false statement or omission. To Parent’s Knowledgethe Knowledge of Biosight, neither Parent Biosight nor any of its Subsidiaries or Persons proving services on their behalf, has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products the Biosight Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of ParentBiosight, any of its Subsidiaries or Subsidiaries, to the Knowledge of Biosight, any of their respective officers, employees or to Parent’s Knowledge, agents, has or to the Knowledge of Biosight, any Person providing services on Biosight’s or its Subsidiaries’ behalf, have been debarred, disqualified, or excluded, or have been convicted of any crime or engaged in any conduct that could result in a debarment, disqualification, or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335aS▇▇▇▇▇▇ ▇▇▇▇, as amended; (ii▇▇) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70▇▇▇▇▇ ▇▇ ▇.▇.▇. §▇▇▇▇▇-▇, as amended; (iii) disqualification as a testing facility with respect to federal procurement or non-procurement programs, including those produced by the U.S. General Services Administration, (iv) under 21 C.F.R. Part 58Parts 312, Subpart K511, as amended; (iv) exclusion, debarment or suspension from 812 or otherwise becomes ineligible with respect to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f)the receipt of investigational products, including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat any similar applicable Legal Requirement. To the Knowledge of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/EntitiesBiosight, the General Services Administration’s System for Award Managementno debarment, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment ineligibility, or exclusionary claims, actions, proceedings or investigations in respect of their business or products the Biosight Product Candidates are pending or, to the Parent’s Knowledge, or threatened against ParentBiosight, any of its Subsidiaries or Subsidiaries, any of their respective officers, employees or agents, or any Person providing services on behalf of Biosight or its Subsidiaries.
(h) Parent and To the Knowledge of Biosight, no Biosight Product Candidate manufactured or distributed by or on behalf of Biosight or its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with (i) adulterated within the terms meaning of all Business Associate Agreements to which Parent 21 U.S.C. §351 (or any Subsidiary is a party similar Healthcare Law), (ii) misbranded within the meaning of 21 U.S.C. §352 (or any similar Healthcare Law); or (iii) otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required prohibited from introduction into interstate commerce under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic formapplicable Legal Requirements. As of the date of this Agreement, neither Parent nor the Biosight or its Subsidiaries nor, to the Knowledge of Biosight and with respect to services provided to Biosight, any of its Subsidiaries have their respective contractors, including, but not limited to, contract manufacturers, has received any FDA Form 483, warning letter, untitled letter, cyber letter, reprimand, regulatory letter, adverse inspectional findings, notice of integrity review or investigation, request for corrective or remedial action, deficiency notice, or other similar correspondence or written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services FDA or any other Governmental Body of regulatory authority alleging or asserting material noncompliance with any allegation regarding applicable Healthcare Laws or Biosight Permits issued to Biosight or its failure to comply with HIPAA Subsidiaries by the FDA or any other state law regulatory authority. No manufacturing site owned by Biosight or regulation applicable its Subsidiaries, to the protection Knowledge of individually identifiable health information Biosight, any of their respective contract manufacturers, is or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party has been subject to a Business Associate Agreement with Parent shutdown or import or export prohibition imposed by FDA or another regulatory authority.
(i) No Biosight Product Candidate has been or has been requested by a regulatory authority or other Person to be Recalled. Neither Biosight, its Subsidiaries. Parent and its Subsidiaries are not , nor, to the Knowledge of Biosight, any regulatory authority or other Person, has sought, is seeking, or, to the Knowledge of Biosight, has or is currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAthreatening or contemplating any Recall of any such Biosight Product Candidate.
Appears in 1 contract
Sources: Merger Agreement (Advaxis, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiariesis, and since January 1, 2019 have 2020 has been, in compliance in all material respects with all applicable Laws, including the FDCAFDCA by the FDA, the PHSA and any other similar Law administered or promulgated by the FDA or other comparable Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholethe Parent. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each such Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Parent as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its SubsidiariesParent, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192020, neither Parent nor any of its Subsidiaries ▇▇▇▇▇▇ has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is not the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, Parent or any of its Subsidiaries or any of their respective officers, employees or or, to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, Parent or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have has materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its SubsidiariesParent, where required, have has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have ▇▇▇▇▇▇ has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries Parent or an agent or third party subject to a Business Associate Agreement with Parent or its SubsidiariesParent. Parent and its Subsidiaries are is not currently submitting, receiving and handling transactions that are governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
(i) The preclinical studies and clinical trials conducted by or on behalf of or sponsored by Parent or its Subsidiaries, or in which Parent or its Subsidiaries have participated, that are described in the Parent SEC Documents, or the results of which are referred to in the Parent SEC Documents, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by Parent and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); (ii) the descriptions in the Parent SEC Documents of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived therefrom; (iii) to Parent’s Knowledge, there are no other studies or trials not described in the Parent SEC Documents, the results of which Parent believes are inconsistent with or reasonably call into question the results described or referred to in the Parent SEC Documents; (iv) Parent and its Subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Parent Material Adverse Effect; and (v) neither Parent nor any of its Subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Parent SEC Documents or the results of which are referred to in the Parent SEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials.
(j) Neither Parent nor any of its Subsidiaries has cultivated, produced, processed, imported or distributed, or has any current intention to cultivate, produce, process, import or distribute, any cannabis or cannabinoid product or has otherwise engaged, in any direct or indirect dealings or transactions in or to the United States of America, its territories and possessions, any state of the United States and the District of Columbia or any other federal, provincial, state, municipal, local or foreign jurisdiction where such activity is illegal. Neither the Parent nor any of its Subsidiaries has operated in or exported any cannabis or cannabinoid product to any jurisdiction outside of Canada where such activity is illegal. The Parent and its Subsidiaries have instituted and maintained policies and procedures reasonably designed to ensure that the Parent and its Subsidiaries do not carry on any activities in, or distribute any products to, any jurisdiction where such activities or products are not fully in compliance with all applicable federal, state or provincial Laws.
(k) Neither the Parent nor any of its Subsidiaries has engaged in (i) any direct or indirect dealings or transactions in violation of U.S. federal or state criminal laws, including, without limitation, the U.S. Controlled Substances Act, the U.S. Racketeering Influenced and Corrupt Practices Act or the U.S. Travel Act, or (ii) any “aiding and abetting” in any violation of U.S. federal or state criminal laws. No action, suit or proceeding by or before any U.S. court or governmental agency, authority or body or any arbitrator involving the Parent or any of its Subsidiaries with respect to U.S. federal or state criminal Laws is pending or threatened.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2023, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger SubsSub as currently conducted (collectively, the “Parent Permits”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule Letter identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving EntityCorporation immediately after the Second Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the First Effective Time.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Each of Parent and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger SubsSub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Letter identifies each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor or any of its Subsidiaries has, since January 1, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent Product Candidates, including, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participatedparticipated were, were since January 1, 2023, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 20192023, neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Parent Product Candidates, have participated.
(e) As . Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the date Parent, on behalf of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employeeshas been disqualified from participating in studies involving the Parent Product Candidates, and Parent to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Parent’s Knowledge, neither Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent Product Candidate has committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective its officers, employees or agents.
(hg) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent and or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2023, have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent been and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) None of all Business Associate Agreements to which Parent or Parent, any Subsidiary is a party or otherwise bound. Parent and of its Subsidiaries, where requiredand to the Knowledge of Parent, have created and maintained written policies and procedures any manufacturing site of a contract manufacturer or laboratory, with respect to protect the privacy any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of all protected health informationviolation, provide training to all employees and agents as required under HIPAAwarning letter, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored untitled letter or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAADrug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Sources: Agreement and Plan of Merger and Reorganization (Pulmatrix, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesQuoin is, and since January 1, 2019 have 2016, has been, in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeQuoin Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Quoin, threatened against Parent or any of its SubsidiariesQuoin. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Quoin which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesQuoin, any acquisition of material property by Parent or any of its Subsidiaries Quoin or the conduct of business by Parent or any of its Subsidiaries Quoin as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentQuoin’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Quoin holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Quoin (the “Parent Quoin Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Quoin Disclosure Schedule identifies each Parent Quoin Permit. Each Parent Permit As of the date of this Agreement, Quoin is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Quoin Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Quoin, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Quoin Permit. The rights and benefits of each material Quoin Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Quoin immediately prior to the Effective Time except where the unavailability of such Quoin Permit would not constitute a Quoin Material Adverse Effect.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Quoin, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Quoin of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the PHSA Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds”).
(d) All To the Knowledge of Quoin, Quoin holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Quoin as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Quoin Product Candidates”). Quoin holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Quoin Regulatory Permits”), and no such Quoin Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Quoin has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Quoin Regulatory Permit. Quoin has made available to Cellect all information in its possession or control relating to the development, clinical testing, manufacturing, importation and exportation of the Quoin Product Candidates, including complete copies of the following (to the extent there are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(e) To the Knowledge of Quoin, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Quoin or in which Parent Quoin or its Subsidiaries or their respective current products or product candidates candidates, including the Quoin Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192012, neither Parent nor any of its Subsidiaries Quoin has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Quoin threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any Quoin or, to the Knowledge of its Subsidiaries or Quoin, in which Parent Quoin or any of its Subsidiaries or their respective current products or product candidates candidates, including the Quoin Product Candidates, have participated.
(ef) As of the date of this Agreement, there has not been and Quoin is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Quoin, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Quoin, neither Parent nor any of its Subsidiaries Quoin has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Quoin Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Quoin, and to the Knowledge of ParentQuoin, nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Quoin, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Quoin or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiariesis, and since January 1, 2019 have 2020 has been, in compliance in all material respects with all applicable Laws, including the FDCAFDCA by the FDA, the PHSA and any other similar Law administered or promulgated by the FDA or other comparable Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholethe Parent. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
. (b) Parent and its Subsidiaries hold holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each such Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As . The rights and benefits of each Parent Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Parent as of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, Agreement and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, immediately prior to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsEffective Time.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
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Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2023, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger Subs as currently conducted (collectively, the “Parent Permits”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule Letter identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Entity immediately after the Second Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the First Effective Time.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Each of Parent and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Subs as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Letter identifies each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor or any of its Subsidiaries has, since January 1, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent Product Candidates, including, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participatedparticipated were, were since January 1, 2023, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 20192023, neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Parent Product Candidates, have participated.
(e) As . Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the date Parent, on behalf of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employeeshas been disqualified from participating in studies involving the Parent Product Candidates, and Parent to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Parent’s Knowledge, neither Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent Product Candidate has committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective its officers, employees or agents.
(hg) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent and or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2023, have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent been and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) None of all Business Associate Agreements to which Parent or Parent, any Subsidiary is a party or otherwise bound. Parent and of its Subsidiaries, where requiredand to the Knowledge of Parent, have created and maintained written policies and procedures any manufacturing site of a contract manufacturer or laboratory, with respect to protect the privacy any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of all protected health informationviolation, provide training to all employees and agents as required under HIPAAwarning letter, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored untitled letter or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAADrug/Device Regulatory Agency is considering such action.
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Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 2020 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA FDA regulations adopted thereunder and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeParent. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this AgreementTo Parent’s Knowledge, there are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. .
(d) Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(de) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Parent or any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192020, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To Parent’s Knowledge, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
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Compliance; Permits; Restrictions. (a) Parent PTI and each of its SubsidiariesPTI Subsidiary are, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of PTI, threatened in writing against Parent PTI or any of its SubsidiariesPTI Subsidiary. There is no agreement, judgment, injunction, order or decree binding upon Parent PTI or any of its Subsidiaries PTI Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent PTI or any of its SubsidiariesPTI Subsidiary, any acquisition of material property by Parent PTI or any of its Subsidiaries PTI Subsidiary or the conduct of business by Parent PTI or any of its Subsidiaries PTI Subsidiary as currently conducted, (ii) is reasonably likely to have an a material adverse effect on ParentPTI’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Except for matters regarding the FDA and its except as would not reasonably be expected to have a PTI Material Adverse Effect, PTI and the PTI Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries PTI (collectively, the “PTI Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 3.9(b) of the Parent PTI Disclosure Schedule identifies each Parent PTI Permit. Each Parent Permit of PTI and each PTI Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent PTI Permits, except as would not reasonably be expected to have a PTI Material Adverse Effect. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of PTI, threatenedthreatened in writing, which seeks to revoke, substantially limit, suspend, or materially modify any Parent PTI Permit. The rights and benefits of each material PTI Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by PTI and the PTI Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of PTI, threatened in writing with respect to an alleged material violation by Parent PTI or any of its the PTI Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or Legal Requirements promulgated by any Drug the FDA or a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinicalPTI and each of the PTI Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of PTI or such Subsidiary as currently conducted, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pendingas applicable, are being development, clinical testing and manufacturing as currently conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiateproduct candidates (the “PTI Product Candidates”) (collectively, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(fPTI Regulatory Permits”), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents except as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.would not
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesCarnivale is, and since January 1, 2019 have been, 2012 has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as result in a wholeCarnivale Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Carnivale, threatened against Parent or any of its SubsidiariesCarnivale. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Carnivale which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCarnivale, any acquisition of material property by Parent or any of its Subsidiaries Carnivale or the conduct of business by Parent or any of its Subsidiaries Carnivale as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentCarnivale’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, delaying or making illegal the Transaction or otherwise interfering with any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Carnivale holds all required Governmental Authorizations which are material to for the operation of its businesses (collectively, the business of Parent and its Subsidiaries “Carnivale Permits”) as currently conducted (conducted, except for any failure to hold any such Governmental Authorizations, either individually or in the “Parent Permits”)aggregate, which would not result in a Carnivale Material Adverse Effect. Section Part 3.14(b) of the Parent Carnivale Disclosure Schedule identifies each Parent Carnivale Permit. Each Parent Permit Carnivale is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Carnivale Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Carnivale, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Carnivale Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Carnivale, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Carnivale of the FDCA, the PHSA FDA regulations adopted thereunder, or any other similar Law administered or Laws promulgated by a Drug Regulatory Agency.
(d) Carnivale holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Carnivale as currently conducted, and, as applicable, for the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Carnivale Product Candidates”) (the “Carnivale Regulatory Permits”) and no such Carnivale Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Carnivale has not received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Carnivale Regulatory Permit. Except for the information and files identified in Part 3.14(d) of the Carnivale Disclosure Schedule, Carnivale has made available to the Company all information requested by the Company in Carnivale’s possession or control relating to the Carnivale Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Carnivale Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency. Parent is not currently conducting or addressing; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Carnivale or in which Parent Carnivale or its Subsidiaries or their respective current products or product candidates candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLaws, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Carnivale is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Carnivale, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Carnivale, neither Parent nor any of its Subsidiaries Carnivale has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, Carnivale or any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Carnivale, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Carnivale or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Share Purchase Agreement (Carbylan Therapeutics, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each NSC is not in conflict with, or in default or violation of (i) any law, rule, regulation, order, judgment or decree applicable to NSC or by which its Subsidiariesproperties is bound or affected, and since January 1or (ii) any note, 2019 have beenbond, in compliance in all material respects with all applicable Lawsmortgage, including the FDCAindenture, the PHSA and any other similar Law administered or promulgated by the FDA contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agencyinstrument or obligation to which NSC is a party or by which NSC or its property is bound or affected, except for any noncomplianceconflicts, either individually defaults or in the aggregate, violations which would not reasonably be material expected to Parent and its Subsidiaries, taken as have a wholeMaterial Adverse Effect on NSC. As of the date of this Agreement, no investigation, claim, suit, proceeding, audit No investigation or other action review by any Governmental Body governmental or regulatory body or authority is pending or, to Parent’s Knowledgethe knowledge of NSC, threatened against Parent NSC, nor has any governmental or any of its Subsidiaries. There is no agreement, judgment, injunction, order regulatory body or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected authority indicated to have NSC an intention to conduct the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionssame.
(b) Parent NSC holds all permits, licenses, variances, exemptions, orders and its Subsidiaries hold all required Governmental Authorizations approvals from governmental authorities which are material necessary to the operation of the business of Parent and its Subsidiaries as currently conducted NSC (collectively, the “Parent "NSC Permits”"). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit NSC is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent NSC Permits, except where the failure to so comply would not reasonably be expected to have a Material Adverse Effect on NSC. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe knowledge of NSC, threatened, which seeks to revokerevoke or limit any NSC Permit. A true, limit, suspend, or materially modify any Parent Permitcomplete and correct list of the material NSC Permits is set forth in Section 2.9(b) of the NSC. Disclosure Schedule. The rights and benefits of each material NSC Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by NSC immediately prior to the Effective Time.
(c) As All clinical trials or biological specimen collection conducted by or on behalf of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressingNSC have been, and are being conducted in material 'compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all applicable requirements relating to Parent’s Knowledge there is no basis to expect that it will be required to conduct protection of human subjects contained in 21 CFR Parts 50, 54, and 56 or address, any corrective actions, including, without limitation, product recalls other state or clinical holdslocal. requirements.
(d) All clinicalNeither NSC nor any representative of NSC, pre-clinical and other studies and tests conducted by or on behalf ofnor to the knowledge of NSC, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries licensees or assignees of NSC IP Rights has received any notices, correspondencenotice that the FDA or any other Governmental Entity has initiated, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by NSC or otherwise restrict the termination preclinical research on or suspension clinical study of any clinical studies conducted NSC product or any biological, medical device or drug product being developed by any licensee or assignee of NSC FP Rights based on behalf ofsuch intellectual property, or sponsored byto recall, Parent suspend or otherwise restrict the manufacture of any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participatedNSC product.
(e) As Neither NSC nor, to the knowledge of the date of this AgreementNSC, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and officers, key employees, and Parent agents or clinical investigators acting for NSC, has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no committed any act, omission, event, made any statement or circumstance failed to make any statement that would reasonably be expected to give rise to or form the provide a basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to invoke its “policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy " set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereof. To Parent’s KnowledgeAdditionally, neither Parent NSC, nor any to the knowledge of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of ParentNSC, any officer, key employee or agent of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, NSC has been convicted convicted. of any crime or engaged in any conduct that could would reasonably be expected to result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or any similar state law or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including exclusion under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment any similar state law or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsregulation.
(hf) Parent NSC has made available to Azurel copies of any and its Subsidiaries have materially complied all written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, that indicate or suggest lack of compliance with the regulatory requirements of the FDA. NSC has made available to Azurel for review all applicable Laws relating correspondence to patientor from the FDA, medical minutes of meetings, written reports of phone conversations, visits or individual health informationother contact with the FDA, including HIPAA. Parent and its Subsidiaries have entered intonotices of inspectional observations, where requiredestablishment inspection reports, and is all other documents concerning communications to or from the FDA, or prepared by the FDA or which bear in any way on NSC's compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As regulatory requirements of the date FDA, or on the likelihood of this Agreementtiming of approval of any NSC drug or medical device products. 9
(g) There are no proceedings pending with respect to a violation by NSC of the FDCA, neither Parent nor any of its Subsidiaries have received written notice from FDA regulations adopted thereunder, the Office for Civil Rights for the U.S. Department of Health and Human Services Controlled Substance Act or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law legislation or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed promulgated by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.any• other United States governmental entity..
Appears in 1 contract
Sources: Merger Agreement (Proteonomix, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesExcept where failure would not result in a PubCo Material Adverse Effect, PubCo is, and since January 1, 2019 have been2020, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As applicable provisions of the date of this AgreementPublic Health Service Act (“PHSA”), no the Controlled Substances Act (“CSA”) (21 U.S.C. § 801 et seq.), and regulations promulgated to implement the foregoing. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened against Parent or any of its SubsidiariesPubCo. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries PubCo which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesPubCo, any acquisition of material property by Parent or any of its Subsidiaries PubCo or the conduct of business by Parent or any of its Subsidiaries PubCo as currently conducted, or (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsresult in a PubCo Material Adverse Effect.
(b) Parent and its Subsidiaries hold Except where a failure would not result in a PubCo Material Adverse Effect, PubCo: (i) holds all required Governmental Authorizations which that are material to the operation of the business of Parent PubCo and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent PubCo Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are (ii) is in material compliance with the terms of the Parent PubCo Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent PubCo Permit.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries PubCo of the FDCA, the PHSA PHSA, the CSA, the implementing regulations adopted thereunder, or any other similar Law administered or promulgated by any the FDA or other Drug Regulatory Agency. Parent Agency that is not currently conducting or addressing, and material to Parentthe conduct of PubCo’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsbusiness.
(d) Except where failure would not result in a PubCo Material Adverse Effect, each of PubCo holds all required Governmental Authorizations issued or granted by any Drug Regulatory Agency or other Governmental Authority which is necessary for the conduct of the business of PubCo as currently conducted and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “PubCo Product Candidates”) (collectively, the “PubCo Regulatory Permits”) and no such PubCo Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated, or (ii) modified in any adverse manner, other than immaterial modifications. Except where failure would not result in a PubCo Material Adverse Effect, PubCo has timely maintained and are in compliance in all material respects with the PubCo Regulatory Permits and have not received any written notice or other written communication from any Drug Regulatory Agency or other Governmental Authority regarding (A) any material violation of or failure to comply materially with any term or requirement of any PubCo Regulatory Permit, or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any PubCo Regulatory Permit. PubCo has made available to the Company all information requested by the Company in PubCo’s possession or control relating to the PubCo Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the PubCo Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency, and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All clinicalsuch information is accurate and complete in all material respects.
(e) All clinical trials, pre-clinical studies and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its SubsidiariesPubCo, or in which Parent or its Subsidiaries PubCo or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries PubCo has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of PubCo threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries PubCo or in which Parent PubCo or any of its Subsidiaries or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated.
(e) As of the date of this Agreement. Further, there has not been and is not now any Form FDA-483 observationno clinical investigator, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letterresearcher, or proceeding pending or clinical staff participating in effect against Parent or any clinical study conducted by or, to the Knowledge of its Subsidiaries or any PubCo, on behalf of their respective officers and employeesPubCo has been disqualified from participating in studies involving the PubCo Product Candidates, and Parent to the Knowledge of PubCo, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor PubCo nor, to the Knowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, is the subject of any pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of PubCo, neither Parent PubCo nor any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither of ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of PubCo, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending oror threatened against PubCo, and to the Parent’s Knowledge, threatened against ParentKnowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or agents.
(hg) Parent All manufacturing operations conducted by, or to the Knowledge of PubCo, for the benefit of, PubCo in connection with any PubCo Product Candidate, since January 1, 2018, have been and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAAFDA’s standards for current good manufacturing practices for human pharmaceutical products codified at 21 C.F.R. Parts 210, and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by PubCo, and to the Knowledge of PubCo, no manufacturing site of a contract manufacturer, with respect to any PubCo Product Candidate, (i) is subject to a Drug Regulatory Agency or Governmental Authority shutdown or import or export prohibition, or (ii) has implemented security proceduresreceived any Form FDA 483, including physicalnotice of violation, technical and administrative safeguardswarning letter, to protect all personal information and Protected Health Information stored untitled letter, or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Governmental Authority, and, to the Knowledge of PubCo, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAAuthority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent Except where failure would not result in a PubCo Material Adverse Effect, PubCo and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2018, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened against Parent PubCo or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent PubCo or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent PubCo or any of its Subsidiaries, any acquisition of material property by Parent PubCo or any of its Subsidiaries or the conduct of business by Parent PubCo or any of its Subsidiaries as currently conducted, or (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsresult in a PubCo Material Adverse Effect.
(b) Parent Except where a failure would not result in a PubCo Material Adverse Effect, each of PubCo and its Subsidiaries hold Subsidiaries: (i) holds all required Governmental Authorizations which that are material to the operation of the business of Parent PubCo and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent PubCo Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit and (ii) is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent PubCo Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent PubCo Permit.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened with respect to an alleged material violation by Parent PubCo or any of its Subsidiaries of the FDCA, the PHSA PHSA, FDA regulations adopted thereunder, or any other similar Law administered promulgated by the FDA or promulgated other Drug Regulatory Agency which is material to the conduct of PubCo’s business.
(d) Except where failure would not result in a PubCo Material Adverse Effect, each of PubCo and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency or Governmental Authority which is necessary for the conduct of the business of PubCo as currently conducted and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “PubCo Product Candidates”) (collectively, the “PubCo Regulatory Permits”) and no such PubCo Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial modifications. Except where failure would not result in a PubCo Material Adverse Effect, PubCo and its Subsidiaries have timely maintained and are in compliance in all material respects with the PubCo Regulatory Permits and have not received any written notice or other written communication from any Drug Regulatory Agency or Governmental Authority regarding (A) any material violation of or failure to comply materially with any term or requirement of any PubCo Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any PubCo Regulatory Permit. PubCo has made available to the Company all information requested by the Company in PubCo’s or its Subsidiaries’ possession or control relating to the PubCo Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the PubCo Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. Parent All such information is not currently conducting or addressing, accurate and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdscomplete in all material respects.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its SubsidiariesPubCo, or in which Parent or its Subsidiaries PubCo or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries PubCo has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of PubCo threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries PubCo or in which Parent PubCo or any of its Subsidiaries or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated.
(e) As of the date of this Agreement. Further, there has not been and is not now any Form FDA-483 observationno clinical investigator, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letterresearcher, or proceeding pending or clinical staff participating in effect against Parent or any clinical study conducted by or, to the Knowledge of its Subsidiaries or any PubCo, on behalf of their respective officers and employeesPubCo has been disqualified from participating in studies involving the PubCo Product Candidates, and Parent to the Knowledge of PubCo, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor PubCo nor, to the Knowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, is the subject of any pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of PubCo, neither Parent PubCo nor any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither of ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in (i) a debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of PubCo, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending oror threatened against PubCo, and to the Parent’s Knowledge, threatened against ParentKnowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or agents.
(hg) Parent All manufacturing operations conducted by, or to the Knowledge of PubCo, for the benefit of, PubCo in connection with any PubCo Product Candidate, since January 1, 2018, have been and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its SubsidiariesFDA’s standards for current good manufacturing practices, where requiredincluding applicable requirements contained in 21 C.F.R. Parts 210, have created and maintained written policies and procedures to protect the privacy of all protected health information211, provide training to all employees and agents as required under HIPAA600-680, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by PubCo, and to the Knowledge of PubCo, no manufacturing site of a contract manufacturer, with respect to any PubCo Product Candidate, (i) is subject to a Drug Regulatory Agency or Governmental Authority shutdown or import or export prohibition or (ii) has implemented security proceduresreceived any Form FDA 483, including physicalnotice of violation, technical and administrative safeguardswarning letter, to protect all personal information and Protected Health Information stored untitled letter, or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Governmental Authority, and, to the Knowledge of PubCo, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAAuthority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesGC is, and since January July 1, 2019 have been2017, each of GC and the GC Subsidiaries has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeGC Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of GC, threatened against Parent GC or any of its SubsidiariesGC Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent GC or any of its Subsidiaries GC Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent GC or any of its SubsidiariesGC Subsidiary, any acquisition of material property by Parent GC or any of its Subsidiaries GC Subsidiary or the conduct of business by Parent GC or any of its Subsidiaries GC Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentGC’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Exchange or any of the Contemplated Transactions.
(b) Parent GC and its the GC Subsidiaries hold all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “GC Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent GC Disclosure Schedule identifies each Parent GC Permit. Each Parent Permit is valid As of the date of this Agreement, each of GC and in full force and effect, and Parent and its the GC Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent GC Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of GC, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent GC Permit. The rights and benefits of each material GC Permit will be available to GC immediately after the Effective Time on terms substantially identical to those enjoyed by GC and the GC Subsidiaries immediately prior to the Effective Time.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated GC holds all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to Governmental Body necessary for the conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by as currently conducted (the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991GC Regulatory Permits”) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, no such GC Regulatory Permit has been convicted of any crime or engaged in any conduct that could result in (i) debarment revoked, withdrawn, suspended, canceled or exclusion under 21 U.S.C. Section 335a, as amended; terminated or (ii) disqualification from participating modified in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted Listany materially adverse manner. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, GC has not received any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice or other written communication from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAGC Regulatory Permit.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2023, has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliancesuch non-compliance that would not reasonably be expected to have, either individually or in the aggregate, which would not be material to a Parent and its Subsidiaries, taken as a wholeMaterial Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Each of Parent and its Subsidiaries hold holds all required Governmental Authorizations which are material related to the operation of the business of Parent and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Permits”), except for any Parent Permits for which the failure to obtain or hold would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Section 3.14(b4.14(b) of the Parent Disclosure Schedule Letter identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit, except for any such limitation, suspension or modification which would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by The Parent or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with (i) the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its SubsidiariesTrading with the Enemy Act, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAAamended, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As each of the date economic sanctions regulations of this Agreementthe United States Treasury Department’s Office of Foreign Assets Control (31 CFR, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health Subtitle B, Chapter V, as amended) and Human Services or any other Governmental Body enabling legislation or executive order relating thereto and/or administered by OFAC, and (ii) the Uniting And Strengthening America By Providing Appropriate Tools Required To Intercept And Obstruct Terrorism (USA Patriot Act of any allegation regarding its failure to comply 2001) and regulations promulgated thereunder, as applicable.
(d) The operations of the Parent are and have been conducted at all times in compliance, in all material respects, with HIPAA or any other state law or regulation applicable to financial recordkeeping and reporting requirements of the protection Currency and Foreign Transactions Reporting Act of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable 1970, as amended, federal, state or federal laws have occurred foreign anti-money laundering statutes, the rules and regulations thereunder and any related or similar Applicable Laws, issued, administered or enforced by any Governmental Entity and no Proceeding by or before any Governmental Entity involving the Parent with respect to information maintained or transmitted such laws is pending or, to the knowledge of the Parent, its Subsidiaries threatened.
(e) The operations of the Parent are and have been conducted at all times in compliance, in all material respects, with applicable financial laws and regulations, including without limitation the Fair Credit Reporting Act, ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act, Credit Repair Organizations Act, ▇▇▇▇-▇▇▇▇▇ ▇▇▇▇ Street Reform and Consumer Protection Act, Federal Trade Commission Act, Electronic Fund Transfer Act, Telemarketing Sales Rule, federal securities laws, analogous or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent related state financial services and its Subsidiaries are not currently submittingfinancial privacy laws, receiving state insurance laws, state credit services organization laws and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAAstate debt management services laws.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent TorreyPines and each of its SubsidiariesTorreyPines Subsidiary are, and since January 1, 2019 2003 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of TorreyPines, threatened against Parent TorreyPines or any of its SubsidiariesTorreyPines Subsidiary, nor has any Governmental Body or authority indicated to TorreyPines an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent TorreyPines or any of its SubsidiariesTorreyPines Subsidiary, any acquisition of material property by Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary or the conduct of business by Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on Parent’s TorreyPines’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent TorreyPines and its the TorreyPines Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted TorreyPines (collectively, the “Parent TorreyPines Permits”). Section 3.14(bPart 2.11(b) of the Parent TorreyPines Disclosure Schedule identifies each Parent TorreyPines Permit. Each Parent Permit of TorreyPines and each TorreyPines Subsidiary is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent TorreyPines Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of TorreyPines, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent TorreyPines Permit. The rights and benefits of each material TorreyPines Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by TorreyPines and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent TorreyPines or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) TorreyPines holds all Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of TorreyPines as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including N▇▇-▇▇▇, ▇▇▇-▇▇▇, ▇▇▇-▇▇▇ and NGX-292 (the “TorreyPines Product Candidates”) (the “TorreyPines Regulatory Permits”) and no such TorreyPines Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Parent TorreyPines is in compliance in all material respects with the TorreyPines Regulatory Permits and has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any TorreyPines Regulatory Permit or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any TorreyPines Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the TorreyPines Disclosure Schedule, TorreyPines has made available to Parent’s Knowledge there is no basis Axonyx all information in its possession or control relating to expect that it will be required to conduct or addressthe TorreyPines Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the TorreyPines Product Candidates, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, TorreyPines or in which Parent TorreyPines or its Subsidiaries or their respective current products or product candidates candidates, including the TorreyPines Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries TorreyPines has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries TorreyPines or in which Parent TorreyPines or any of its Subsidiaries or their respective current products or product candidates candidates, including the TorreyPines Product Candidates, have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Axonyx Inc)
Compliance; Permits; Restrictions. (a) Parent Buyer and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken . Except as a whole. As set forth on Section 3.15(a) of the date of this AgreementBuyer Disclosure Schedule, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending oris, to Parent’s Knowledgethe Knowledge of Buyer, pending or threatened against Parent Buyer or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent Buyer or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Buyer or any of its Subsidiaries, any acquisition of material property by Parent Buyer or any of its Subsidiaries or the conduct of business by Parent Buyer or any of its Subsidiaries as currently conducted, (ii) is would be reasonably likely to have an adverse effect on ParentBuyer’s or its Subsidiaries’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would be reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent Buyer and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent Buyer and its Subsidiaries as currently conducted (the “Parent Buyer Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent Buyer and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Buyer Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Buyer Permit.
(c) As Buyer and its Subsidiaries have implemented and maintain, and since January 1, 2019 have maintained, policies, procedures, and practices governing Personal Information that comply in all material respects with all applicable Data Protection Laws and Buyer’s Contracts. Such policies, procedures, and practices have been followed in all material respects in the conduct of the date business of this AgreementBuyer and its Subsidiaries. Buyer and its Subsidiaries have adopted, there are no proceedings pending orand since January 1, 2019 have maintained, information security and privacy programs, including commercially reasonable administrative, physical, and technical safeguards consistent with industry standards, to Parent’s Knowledgeprotect the confidentiality, threatened with respect to an alleged material violation by Parent integrity, availability and security of Sensitive Data against unauthorized access, use, modification, disclosure or any of its Subsidiaries of the FDCA, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsmisuse.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of Buyer and its Subsidiaries has received have used commercially reasonable efforts to prevent the introduction (i) into any notices, correspondencesoftware owned by Buyer or its Subsidiaries, or other communications from any Drug Regulatory Agency requiring(ii) into the IT Systems, orand, to Parent’s Knowledgethe Knowledge of Buyer, threatening such IT Systems do not contain, any ransomware, disabling codes or instructions, spyware, Trojan horses, worms, viruses or other software routines that permit or cause unauthorized access to, or disruption, impairment, disablement, or destruction of, software, data or other materials in any material manner. Buyer and its Subsidiaries have used commercially reasonable efforts to initiatepromptly implement material security patches that are generally available for the IT Systems. To the Knowledge of Buyer, the termination IT Systems have not suffered any unplanned or suspension critical failures, continued substandard performance, errors, breakdowns or other adverse events that have caused any material disruption or interruption in the operation of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any the business of Buyer and its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participatedmaterial manner.
(e) As Buyer and its Subsidiaries are, and since January 1, 2019 have been, in material compliance with all applicable Data Protection Laws, Buyer’s and its Subsidiaries’ obligations under their Contracts, and Buyer and Subsidiaries privacy policies relating to Personal Information, including requirements regarding the acquisition, collection, storage, confidentiality, use, disclosure, transfer, destruction, and any other processing of the date Personal Information. Buyer and its Subsidiaries have not received any written subpoenas, demands, or other notices from any Governmental Body investigating, inquiring into, or otherwise relating to any actual or potential material violation of this Agreementany Data Protection Laws. To Buyer’s Knowledge, there has Buyer and its Subsidiaries are not under investigation, nor have they been and is not now threatened, by any Form FDA-483 observationGovernmental Body for any violation of any Data Protection Laws in any material respect. No written notice, civil, criminal or administrative action, suit, demandcomplaint, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letterenforcement action, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employeeslitigation has been served on, and Parent has no liability for failure or, to comply with the FDCA, PHSA, or other similar Laws. To ParentBuyer’s Knowledge, there is no actinitiated against Buyer or its Subsidiaries alleging violation of any Data Protection Laws. The execution of this Agreement by Buyer and the other documents contemplated hereby, omissionand the consummation of the transactions contemplated hereunder and thereunder, eventdo not violate any privacy policy, terms of use, Contract or circumstance that would reasonably be expected applicable Law relating to give rise to or form the basis for any civiluse, criminal or administrative actiondissemination, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA transfer or other similar Lawsprocessing of any Sensitive Data in any material respect.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy Except as set forth in 56 Fed. Reg. 46191 (September 10on Section 3.15(f) of the Buyer Disclosure Schedule, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent Buyer and its Subsidiaries have materially complied with all applicable Laws relating to patientnot suffered any material Security Incident. To the Knowledge of Buyer, medical no service provider (in the course of providing services for or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms on behalf of all Business Associate Agreements to which Parent Buyer or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or Subsidiaries) has suffered any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “material Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 2022, have been, in compliance in all material respects with all applicable Laws, including the FDCAFTC, the PHSA CPSC, and CPSIA, and regulations adopted thereunder and any other similar Law administered or promulgated by the FDA FTC, CPSC, CPSIA, or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeParent. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCAFTC, the PHSA CPSC, or CPSIA, or any regulations adopted thereunder, or any other similar Law administered or promulgated by any Drug Regulatory Agency. .
(d) Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participatedrecalls.
(e) As Parent and its Subsidiaries have made available to Company true and complete copies of all material notices, correspondence or other communications received by the date of this Agreement, there has not been Parent and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any each of its Subsidiaries or from any of their respective officers and employeesRegulatory Agency, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawsif any.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Kidpik Corp.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries is, and since January 1, 2019 have been2023, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit audit, Order or other action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger Subs as currently conducted (collectively, the “Parent Permits”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule Letter identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit, if any, will be available to Parent and Surviving Entity immediately after the Second Effective Time on terms substantially identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the First Effective Time.
(c) As of the date of this Agreement, there There are no proceedings Legal Proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Each of Parent and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Subs as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Letter identifies each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor or any of its Subsidiaries has, since January 1, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other communication from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s or its Subsidiaries’ possession or control relating to material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Parent Product Candidates, including, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participatedparticipated were, were since January 1, 2023, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 20192023, neither Parent nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Parent Product Candidates, have participated.
(e) As . Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the date Parent, on behalf of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employeeshas been disqualified from participating in studies involving the Parent Product Candidates, and Parent to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has no liability for failure to comply with the FDCA, PHSA, been threatened or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawspending.
(f) Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Parent’s Knowledge, neither Neither Parent nor any of its Subsidiaries and, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent Product Candidate has committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or to Parent’s Knowledge, agents, agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in (i) a material debarment or exclusion under (i) 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of their respective its officers, employees or agents.
(hg) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent and or its Subsidiaries in connection with any Parent Product Candidate, since January 1, 2023, have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent been and its Subsidiaries have entered into, where required, and is are being conducted in compliance in all material respects with applicable Laws, including the terms FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) None of all Business Associate Agreements to which Parent or Parent, any Subsidiary is a party or otherwise bound. Parent and of its Subsidiaries, where requiredand to the Knowledge of Parent, have created and maintained written policies and procedures any manufacturing site of a contract manufacturer or laboratory, with respect to protect the privacy any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of all protected health informationviolation, provide training to all employees and agents as required under HIPAAwarning letter, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored untitled letter or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written similar correspondence or notice from the Office for Civil Rights for FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the U.S. Department satisfaction of Health and Human Services or the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAADrug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Sources: Merger Agreement (Pulmatrix, Inc.)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesThreshold is, and since January 1, 2019 have been2014, each of Threshold and its Subsidiaries has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeThreshold Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Threshold, threatened against Parent Threshold or any of its SubsidiariesThreshold Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent Threshold or any of its Subsidiaries Threshold Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Threshold or any of its SubsidiariesThreshold Subsidiary, any acquisition of material property by Parent Threshold or any of its Subsidiaries Threshold Subsidiary or the conduct of business by Parent Threshold or any of its Subsidiaries Threshold Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentThreshold’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent Threshold and its the Threshold Subsidiaries hold all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Threshold Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent Threshold Disclosure Schedule identifies each Parent Threshold Permit. Each Parent Permit is valid As of the date of this Agreement, each of Threshold and in full force and effect, and Parent and its the Threshold Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Threshold Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Threshold, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Threshold Permit. The rights and benefits of each material Threshold Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Threshold and the Threshold Subsidiaries immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Threshold, threatened with respect to an alleged material violation by Parent Threshold or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other Drug Regulatory Agency.
(d) Threshold and each of its Subsidiaries hold all required Governmental Authorizations issuable by any Drug Regulatory Agency. Parent is not Agency necessary for the conduct of the business of Threshold or such Subsidiary as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Threshold Product Candidates”). Threshold holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Threshold Regulatory Permits”) and no such Threshold Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Threshold has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Threshold Regulatory Permit. Threshold has made available to Parent’s Knowledge Molecular all information in its possession or control relating the development, clinical testing, manufacturing, importation and exportation of the Threshold Product Candidates, including complete copies of the following (to the extent there is no basis are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or address, and from any corrective actions, including, without limitation, product recalls or clinical holdsDrug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Threshold or its Subsidiaries, any of the Threshold Subsidiaries or in which Parent Threshold or its Subsidiaries or their respective current products or product candidates services have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192014, neither Parent Threshold nor any of its the Threshold Subsidiaries has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Threshold threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Threshold or in which Parent or any of its Subsidiaries or their respective current products or product candidates Threshold Product Candidates, have participated.
(ef) As To the Knowledge of the date Threshold, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of this Agreementtheir business or products are pending or threatened against Threshold or its officers, there has not been and employees or agents. Threshold is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Threshold, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Threshold, neither Parent nor any of its Subsidiaries Threshold has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Threshold Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Threshold, nor to the Knowledge of ParentThreshold, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentssimilar applicable Legal Requirement.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesSubsidiaries are, and since January 1, 2019 2021, have been, in compliance in all material respects with all applicable Laws, including applicable provisions of the FDCA, the FDA regulations adopted thereunder, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeParent. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or, to Parent’s Knowledge, investigation or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Parent and its Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries holding hold all right, title and interest in and to all Parent Permits are free and clear of any Encumbrance. Parent and each of its Subsidiaries is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the FDA regulations adopted thereunder, the PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. Neither Parent nor any of its Subsidiaries is not currently conducting or addressing, and and, to Parent’s Knowledge Knowledge, there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, including product recalls or clinical holds.
(d) All clinical, pre-clinical nonclinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192021, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledge, threatening to initiate, initiate the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, or to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section §§ 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment 1320a-7a or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted Listany similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending orpending, or to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or or, to the Parent’s Knowledge, agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent VIA and each of its SubsidiariesVIA Subsidiary are, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA Legal Requirements and has not received any other similar Law administered written notice of violation or promulgated by the FDA or other Drug Regulatory Agency, except for alleged violation of any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeapplicable Legal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of VIA, threatened against Parent VIA or any of its SubsidiariesVIA Subsidiary, nor has any Governmental Body or authority indicated to VIA an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent VIA or any of its Subsidiaries VIA Subsidiary which (i) has had or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsa VIA Material Adverse Effect.
(b) Parent VIA and its the VIA Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted VIA (collectively, the “Parent VIA Permits”). Section 3.14(b2.11(b) of the Parent VIA Disclosure Schedule identifies each Parent VIA Permit. Each Parent Permit , each of which is valid and in full force and effect, . Each of VIA and Parent and its Subsidiaries holding Parent Permits are each VIA Subsidiary is in material compliance with the terms of the Parent VIA Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of VIA, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent VIA Permit. The rights and benefits of each material VIA Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by VIA and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent VIA or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the PHSA Controlled Substance Act, the Public Health Service Act or any other similar Law administered Legal Requirements promulgated by the FDA or promulgated other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Except for such Governmental Authorizations listed in Section 2.11(d) of the VIA Disclosure Schedule, VIA and its Subsidiaries holds all Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its existing products (the “VIA Products”) (the “VIA Regulatory Permits”) and no such VIA Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Parent VIA and each of its Subsidiaries is in compliance in all material respects with the VIA Regulatory Permits and has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any VIA Regulatory Permit or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any VIA Regulatory Permit. Except for the information and files identified in Section 2.11(d) of the VIA Disclosure Schedule, VIA has made available to Parent’s Knowledge there is no basis Corautus all information in its possession or control relating to expect that it will be required to conduct or addressthe VIA Products and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the VIA Products, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent VIA or its Subsidiaries, any VIA Subsidiary or in which Parent VIA or any VIA Subsidiary or its Subsidiaries or their respective current products or product candidates candidates, including the VIA Products, have participated, participated (the “VIA Studies”) were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019Except for such notices listed in Section 2.11(e) of the VIA Disclosure Schedule, neither Parent VIA nor any of its Subsidiaries VIA Subsidiary has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent VIA or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates candidates, including the VIA Products, have participated.
(e. Except for such material obligations listed in Section 2.11(e) As of the date VIA Disclosure Schedule, VIA and its Subsidiaries have fulfilled and performed all of this Agreementtheir material obligations with respect to the VIA Studies, there and no event has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letteroccurred which causes, or proceeding pending after notice or in effect against Parent or any lapse of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that time would reasonably be expected to give rise to or form the basis for any civilcause, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Lawsa VIA Material Adverse Effect.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiariesis, and since January 1, 2019 have been2016, has been in compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.
(b) Each of Parent and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Permits”). Section 3.14(b3.13(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and of Parent and its Subsidiaries holding Parent Permits are Merger Sub is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit.
(c) As of the date of this Agreement, there There are no proceedings pending or, to the Knowledge of Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substance Act or any other similar Law administered or promulgated by a Drug Regulatory Agency.
(d) Each of Parent and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of Parent and Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Parent Product Candidates”) (collectively, the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Parent is not currently conducting in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor Merger Sub has received any written notice or addressingother written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Except for the information and files identified in Section 3.13(d) of the Parent Disclosure Schedule, Parent has made available to the Company all information requested by the Company in Parent’s Knowledge possession or control relating to the Parent Product Candidates and, as applicable, the development, clinical testing, manufacturing, importation and exportation of the Parent Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to expect that it will be required to conduct or addressand from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar material reports, material study data, notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Body.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, or in which Parent or its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since Other than as set forth on Section 3.13(e) of the Parent Disclosure Schedule, since January 1, 20192016, neither Parent nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates candidates, including the Parent Product Candidates, have participated.
(ef) As of the date of this Agreement, there has not been and Parent is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Parent’s Knowledge, neither Parent nor any of its Subsidiaries has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, any Merger Sub, or, to the Knowledge of its Subsidiaries or Parent, any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Law. To the Knowledge of Parent, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Parent or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesCellect is, and since January 1, 2019 have been2016, each of Cellect and its Subsidiaries has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parent and its Subsidiaries, taken as constitute a wholeCellect Material Adverse Effect. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Cellect, threatened against Parent Cellect or any of its SubsidiariesCellect Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent Cellect or any of its Subsidiaries Cellect Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Cellect or any of its SubsidiariesCellect Subsidiary, any acquisition of material property by Parent Cellect or any of its Subsidiaries Cellect Subsidiary or the conduct of business by Parent Cellect or any of its Subsidiaries Cellect Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentCellect’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent To the Knowledge of Cellect, Cellect and its the Cellect Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Cellect (collectively, the “Cellect Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent Cellect Disclosure Schedule identifies each Parent Cellect Permit. Each Parent Permit As of the date of this Agreement, Cellect is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Cellect Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Cellect, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Cellect Permit. The rights and benefits of each material Cellect Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Cellect and the Cellect Subsidiaries immediately prior to the Effective Time except where the unavailability of such Cellect Permit would not constitute a Cellect Material Adverse Effect.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Cellect, threatened with respect to an alleged material violation by Parent Cellect or any of its Subsidiaries Cellect Subsidiary of the FDCA, PHSA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) All To the Knowledge of Cellect, Cellect and each of its Subsidiaries hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Cellect or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Cellect Product Candidates”). Cellect holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Cellect Regulatory Permits”) and no such Cellect Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Cellect has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Cellect Regulatory Permit. Cellect has made available to Quoin all information in its possession or control relating to the development, clinical testing, manufacturing, importation and exportation of the Cellect Product Candidates, including complete copies of the following (to the extent there are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency.
(e) To the Knowledge of Cellect, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent Cellect or its Subsidiaries, any Cellect Subsidiary or in which Parent Cellect or its Subsidiaries or their respective current products or product candidates services have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20192012, neither Parent Cellect nor any of its Subsidiaries Cellect Subsidiary has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Cellect threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Cellect or in which Parent Cellect or any of its Subsidiaries or their respective current products or product candidates Cellect Product Candidates, have participated.
(ef) As of the date of this Agreement, there has not been and Cellect is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Cellect, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Cellect, neither Parent nor any of its Subsidiaries Cellect has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Cellect Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None . Neither Cellect, nor to the Knowledge of ParentCellect, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Cellect, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of Cellect or its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesOpexa is, and since January 1, 2019 have been2011, each of Opexa and its Subsidiaries has been in material compliance in all material respects with all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Opexa, threatened against Parent or any of its SubsidiariesOpexa. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Opexa which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesOpexa, any acquisition of material property by Parent or any of its Subsidiaries Opexa or the conduct of business by Parent or any of its Subsidiaries Opexa as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentOpexa’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Opexa holds all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Opexa Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent Opexa Disclosure Schedule identifies each Parent Opexa Permit. Each Parent Permit As of the date of this Agreement, Opexa is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Opexa Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Opexa, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Opexa Permit. The rights and benefits of each material Opexa Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Opexa as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Opexa, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Opexa of the FDCA, FDA regulations adopted thereunder, the PHSA Controlled Substances Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds.
(d) Opexa holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Opexa Regulatory Permits”) and no such Opexa Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Opexa has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Opexa Regulatory Permit. Opexa has made available to Acer all information in its possession or control relating to the following (to the extent there are any): (A) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Governmental Body; and meeting minutes with any Governmental Body; and (B) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Body.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Opexa or in which Parent Opexa or its Subsidiaries or their respective current products or product candidates services have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar LawsLegal Requirements.
(f) Neither Parent nor any To the Knowledge of its Subsidiaries is the subject of any pending orOpexa, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, any of Opexa or its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries, and Celladon since January 1, 2019 have been, in compliance 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Celladon, threatened against Parent Celladon, nor has any Governmental Body or any of its Subsidiariesauthority indicated to Celladon an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Celladon which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCelladon, any acquisition of material property by Parent or any of its Subsidiaries Celladon or the conduct of business by Parent or any of its Subsidiaries Celladon as currently conducted and planned to be conducted, (ii) is reasonably likely to may have an adverse effect on ParentCelladon’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Celladon holds all required Governmental Authorizations which are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Celladon Permits”) as currently conducted (the “Parent Permits”)and planned to be conducted. Section 3.14(bPart 3.9(b) of the Parent Celladon Disclosure Schedule identifies each Parent Celladon Permit. Each Parent Permit Celladon is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Celladon Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Celladon, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Celladon Permit. The rights and benefits of each material Celladon Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Celladon as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Celladon, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Celladon of the FDCA, the PHSA FDA regulations adopted thereunder, or any other similar Law administered or Legal Requirements promulgated by a Drug Regulatory Agency.
(d) Celladon holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of its business as currently conducted, and, as applicable, development, clinical testing and manufacturing as currently conducted of any of its product candidates (the “Celladon Product Candidates”) (the “Celladon Regulatory Permits”) and no such Celladon Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Celladon has not received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Celladon Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Celladon Disclosure Schedule, Celladon has made available to Eiger all information in its possession or control relating to the Celladon Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Celladon Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency. Parent is not currently conducting or addressing; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Celladon or in which Parent Celladon or its Subsidiaries or their respective current products or product candidates have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Celladon is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Celladon, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Celladon, neither Parent nor any of its Subsidiaries Celladon has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) . None of Parent, Celladon or any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Celladon, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Celladon or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Celladon Corp)
Compliance; Permits; Restrictions. (a) Parent and each of its SubsidiariesPivot is, and since January 1, 2019 have been, in compliance 2007 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Laws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a wholeLegal Requirements. As of the date of this Agreement, no No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Pivot, threatened against Parent Pivot, nor has any Governmental Body or any of its Subsidiariesauthority indicated to Pivot an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Pivot which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesPivot, any acquisition of material property by Parent or any of its Subsidiaries Pivot or the conduct of business by Parent or Pivot and any of its Subsidiaries Subsidiary as currently conducted, conducted (ii) is reasonably likely to may have an adverse effect on ParentPivot’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Parent and its Subsidiaries hold Pivot holds all required Governmental Authorizations which are material to the operation of their businesses (collectively, the business of Parent and its Subsidiaries “Pivot Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 3.9(b) of the Parent Pivot Disclosure Schedule identifies each Parent Pivot Permit. Each Parent Permit Pivot is valid and in full force and effect, and Parent and its Subsidiaries holding Parent Permits are in material compliance with the terms of the Parent Pivot Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Pivot, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Pivot Permit. The rights and benefits of each material Pivot Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Pivot as of the date of this Agreement and immediately prior to the Effective Time.
(c) As of the date of this Agreement, there There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Pivot, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Pivot of the FDCA, the PHSA FDA regulations adopted thereunder, or any other similar Law administered or Legal Requirements promulgated by a Drug Regulatory Agency.
(d) Pivot holds all required Governmental Authorizations issuable by any Drug Regulatory AgencyAgency necessary for the conduct of the business of Pivot as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Pivot Product Candidates”) (the “Pivot Regulatory Permits”) and no such Pivot Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Parent is Pivot has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Pivot Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Pivot Disclosure Schedule, Pivot has made available to Parent’s Knowledge there is no basis Merger Partner all information in its possession or control relating to expect that it will be required to conduct or addressthe Pivot Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Pivot Product Candidates, including without limitation, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(de) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries, Pivot or in which Parent Pivot or its Subsidiaries or their respective current products or product candidates candidates, have participated, participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) Neither Parent nor any of its Subsidiaries Pivot is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Pivot, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledgethe Knowledge of Pivot, neither Parent nor any of its Subsidiaries Pivot has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto.
(g) None of Parent, . Neither Pivot nor any of its Subsidiaries or any of their respective officers, employees or to Parent’s Knowledge, agents, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) debarment or exclusion under 21 U.S.C. Section 335a, as amended; 335a or (ii) disqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70any similar applicable Legal Requirement. To the Knowledge of Pivot, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. No no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, or threatened against Parent, Pivot or any of its Subsidiaries or any of their respective officers, employees or agents.
(h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Sources: Merger Agreement (Novacea Inc)