FDA and Related Matters. (a) Except as set forth in Section 3.22 of the Company Disclosure Letter, the Company and its Subsidiaries are and, to the Knowledge of the Company, have been since January, 1 2008, in compliance in all respects with (1) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (b) Since January 1, 2008, the Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (c) Neither the Company nor any of its Subsidiaries has received any material written information since January 1, 2008 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products which would reasonably be expected to lead: (i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or (ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect. (d) Except as set forth in Section 3.22 of the Company Disclosure Letter, all material reports, documents, claims and notices required or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2008 have been so filed, maintained or furnished and, to the Knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (f) With respect to each matter disclosed in Section 3.22(e) of the Company Disclosure Letter, the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications. (g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor. (i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products. (l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2). (n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order. (o) For the purposes of this Section 3.22, “product” with respect to products of the Company or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.
Appears in 2 contracts
Sources: Merger Agreement (Akorn Inc), Merger Agreement (Hi Tech Pharmacal Co Inc)
FDA and Related Matters. Without limiting the generality of any of the foregoing representations and warranties of the Company:
(a) Except as set forth in Section 3.22 of the Company Disclosure Letterhas not had, the Company and its Subsidiaries are and, would not reasonably be expected to the Knowledge of the Company, have been since January, 1 2008, in compliance in all respects with (1) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would nothave, individually or in the aggregate, have a Company Material Adverse Effect, the Company holds all Permits, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing or distribution of the Company’s products (a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company, and all such permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any such permit except as has not had, and would not reasonably be expected to have, a Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have a Company Material Adverse Effect. The Company is in compliance in all material respects with the terms of all such permits, and no event has occurred that, to the knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any such permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Since January 1, 2008, the Company Except as has not had and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries has received any material written information since January 1, 2008 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products which would reasonably be expected to lead:
(i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, either individually or in the aggregate, would not reasonably be expected to have, a Company Material Adverse Effect.
(d) Except , all applications, submissions, information and data utilized by the Company as set forth in Section 3.22 the basis for, or submitted by or, to the knowledge of the Company, on behalf of the Company Disclosure Letterin connection with, any and all material reports, documents, claims and notices required or requested requests for any permit relating to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1business and products, 2008 have been so filed, maintained or furnished and, when submitted to the Knowledge of the CompanyFDA or other Company Regulatory Agency, were complete true and correct in all material respects on as of the date filed of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Company Regulatory Agency.
(c) The Company has not committed any act, made any statement or were corrected in or supplemented by a subsequent filing), except where the failure failed to do so make any statement that would not, individually or in the aggregate, have or reasonably be expected to have, provide a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 that basis for the FDA or any other Governmental Authority has (i) commenced, or threatened Company Regulatory Agency to initiate, any action to revoke or withdraw a product approval, or request the recall of any product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and invoke its Subsidiaries, taken as a whole.
(f) With policy with respect to each matter disclosed in Section 3.22(e) of the Company Disclosure Letter, the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
(i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy ”, or similar policies, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a wholeapplicable Laws.
(k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order.
(o) For the purposes of this Section 3.22, “product” with respect to products of the Company or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.
Appears in 1 contract
Sources: Merger Agreement (Neurotrope, Inc.)
FDA and Related Matters. (a) Except The Company has all licenses, permits, consents, approvals, authorizations, registrations, qualifications and certifications or other action of, or any filing, registration or qualification required by, the United States Food and Drug Administration (the “FDA”) and comparable foreign regulatory and governmental entities (collectively, “FDA Permits”), as set forth in Section 3.22 are necessary under applicable law to own or lease its property and conduct its business as currently conducted, except for any of the foregoing that could not, in the aggregate, reasonably be expected to have a Company Disclosure Letter, Material Adverse Effect; the Company has satisfied all of the requirements of and fulfilled and performed all of its Subsidiaries are obligations with respect to the FDA Permits, and, to the Knowledge of the Company’s knowledge, have been since January, 1 2008, in compliance in all respects with (1) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(b) Since January 1, 2008, the Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No no event has occurred which that allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of or any such Healthcare Regulatory AuthorizationFDA Permits, except where such occurrence would not, individually or in for any of the aggregate, have or foregoing that could not reasonably be expected to have, have a Company Material Adverse Effect.
(b) Except as disclosed in Section 3.28 of the Company’s Disclosure Schedule or as otherwise could not, in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) the Company has not failed to submit to the FDA an Investigational New Drug Application for each clinical trial it is conducting or sponsoring within the United States and (ii) all such submissions were in material compliance with applicable laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.
(c) Neither The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company nor any were, and if still pending, are being conducted in all material respects in accordance with applicable regulations, guidelines and generally accepted standards of its Subsidiaries good clinical practice, experimental protocols, requirements of a duly-constituted institutional review board (“IRB”) or animal care and use committee as appropriate, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company. The Company has not received any material written information since January 1, 2008 notices or correspondence from any Healthcare Regulatory Authority the FDA or any other foreign, state or federal regulatory agencies with jurisdiction over local governmental body exercising comparable authority or any IRB or comparable authority requiring the marketingtermination, salesuspension or material modification of any tests, usestudies or trials conducted by or on behalf of the Company which termination, handling and control, safety, efficacy, reliability, suspension or manufacturing of its products which material modification would reasonably be expected to lead:
(i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, have a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect.
(d) Except as set forth The Company (i) is not and has not been debarred from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 3.22 335a (a) or (b) (“Debarred”), (ii) does not employ or use the services of any person or entity that is Debarred and (iii) to the knowledge of the Company, has not employed or used the services of any person or entity that is or, during the time when such person or entity was employed by or providing services to the Company, was Debarred, except in the case of this clause (iii) as would not reasonably be expected to have a Company Disclosure Letter, all material reports, documents, claims and notices required Material Adverse Effect. The Company does not employ or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by use the Company and its Subsidiaries since January 1, 2008 have been so filed, maintained or furnished services of and, to the Knowledge of Company’s Knowledge, has not employed or used the Companyservices of, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a wholeinvestigator who has been disqualified under 21 C.F.R. Section 312.70.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(f) With respect to each matter disclosed in Section 3.22(e) of the Company Disclosure Letter, the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available has provided to Parent with true, correct and complete copies of all such “close out” letters each annual report filed by the Company with the FDA and any similar written communicationsstate or foreign regulatory or governmental entity with respect to any products and product candidates of the Company.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(hf) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
has provided Parent with (i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal each New Drug Application (“NDA”) and third party facility audits completed at each Investigational New Drug application (“IND”), and each similar state or foreign regulatory filing made on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither including all supplements and amendments thereto, (ii) all correspondence sent to and received from the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action and similar state and foreign Governmental Authorities that could concerns or would reasonably be expected to lead to such impact a request, requirement, demand product or order.
(o) For the purposes of this Section 3.22, “product” with respect to products product candidate of the Company or any of its Subsidiaries includes products marketedCompany, developed or produced, as applicable, by and (iii) all existing written records relating to all material discussions and all meetings between the Company and the FDA or any of its Subsidiaries and products and product candidates being evaluated by the Company similar foreign regulatory or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicablegovernmental entities.
Appears in 1 contract
Sources: Merger Agreement (Apex Bioventures Acquisition Corp)
FDA and Related Matters. (a) Except as set forth in Section 3.22 of the Company Disclosure Letter, the The Company and its Subsidiaries are and, to the Knowledge of the Company, have been since JanuaryJanuary 1, 1 20082010, in compliance in all respects with (1) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect.
(b) Since January 1, 20082010, the Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries has received any material written information since January 1, 2008 2010 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products Company Products which would reasonably be expected to lead:
(i) lead to the revocation, withdrawal, or denial of or any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect.
(d) Except as set forth in Section 3.22 of the Company Disclosure Letter, all All material reports, documents, claims and notices required or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2008 2010 have been so filed, maintained or furnished and, to the Knowledge knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the The Company and its Subsidiaries have not since January 1, 2008 2010 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 2010 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any productproduct or product candidate, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or product candidate or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product or product candidate produced at any facility where any product or product candidate is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a wholeMaterial Adverse Effect.
(f) With respect to each matter disclosed in Section 3.22(e) To the Knowledge of the Company Disclosure LetterCompany, the Company all clinical and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirementsapplicable Laws, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
(i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order.
(o) For the purposes of this Section 3.22, “product” with respect to products of the Company or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.Material
Appears in 1 contract
Sources: Merger Agreement (Cephalon Inc)
FDA and Related Matters. (a) Except as set forth in Section 3.22 of The Company and the Company Disclosure Letter, the Company and its Subsidiaries are andand have been, to the Knowledge of the Companysince January 1, have been since January, 1 20082010, in compliance in all respects with (1i) all Applicable Laws (including all rules, regulations and policies) of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (2ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its the Company Subsidiaries, or by which any property, product, or other asset of the Company and its the Company Subsidiaries (including, without limitation, any Product Candidate (as defined below)) is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. As of the date of this Agreement, neither the Company nor its the Company Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(b) Since January 1, 20082010, the Company and its the Company Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries has received any material written information since January 1, 2008 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products which would reasonably be expected to lead:
(i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect.
(d) Except as set forth in Section 3.22 of the Company Disclosure Letter, all material reports, documents, claims and notices required or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2008 have been so filed, maintained or furnished and, to the Knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(f) With respect to each matter disclosed in Section 3.22(e2.16(c) of the Company Disclosure Letter, Schedule contains a complete and accurate list of all of the Product Candidates of the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent trueEntities, correct and complete copies of all such “close out” letters and similar written communications.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiarieslisting, or in where applicable, those Product Candidates for which the Company Entities have applied for or have authorization or clearance through inaction to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and its Subsidiaries or their products have participated were and, if still pending, are being conducted listing the type of application made. For those Product Candidates listed in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(hSection 2.16(c) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
(i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company Disclosure Schedule as having Human Testing Authorization, such Human Testing Authorization has not been revoked or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fedrescinded. Reg. 46191 (September 10, 1991) and any amendments thereto (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, No notification has been convicted of received by any crime or engaged in Company Entity from any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations Regulatory Authority that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against preclude the Company or, from continuing to the Knowledge of the Company, any of its directors, officers, employees test such Product Candidates. No applications made or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs other materials submitted by the Company or any of its Subsidiaries Entities to any Health Regulatory Authority for approval contain any contained an untrue statement of material fact, or omitted to state a material fact required to be stated therein or omit to state any material fact necessary in order to make the statements made contained therein, in the light of the circumstances under which they were made, not misleadingmisleading on a material matter. To For the Knowledge purposes of the Companythis Agreement, all NDAs and ANDAs submitted “Product Candidates” means biologics, compounds or other products under development, current, active or otherwise, or consideration by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries Subsidiary or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a wholerespective licensees.
(m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order.
(o) For the purposes of this Section 3.22, “product” with respect to products of the Company or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.
Appears in 1 contract
FDA and Related Matters. (a) Except as set forth in Section 3.22 of the Company Disclosure Letter, the The Company and its Subsidiaries are and, to the Knowledge of the Company, have been since JanuaryJanuary 1, 1 20082010, in compliance in all respects with (1) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect.
(b) Since January 1, 20082010, the Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries has received any material written information since January 1, 2008 2010 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products Company Products which would reasonably be expected to lead:
(i) lead to the revocation, withdrawal, or denial of or any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect.
(d) Except as set forth in Section 3.22 of the Company Disclosure Letter, all All material reports, documents, claims and notices required or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2008 2010 have been so filed, maintained or furnished and, to the Knowledge knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the The Company and its Subsidiaries have not since January 1, 2008 2010 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2008 2010 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any productproduct or product candidate, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or product candidate or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product or product candidate produced at any facility where any product or product candidate is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a wholeMaterial Adverse Effect.
(f) With respect to each matter disclosed in Section 3.22(e) To the Knowledge of the Company Disclosure LetterCompany, the Company all clinical and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirementsapplicable Laws, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 2010 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies trials conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
(ig) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices alleging a lack of safety from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ productsAuthority, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect.
(jh) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”)thereto, or otherwise. Neither the Company nor any of its Subsidiaries, nor nor, to the Knowledge of the Company, any officer, employee, agent, contractor agent or distributor of the Company or any of its Subsidiaries, has committed or been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor agent or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order.
(o) For the purposes of this Section 3.22, “product” with respect to products of the Company or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.
Appears in 1 contract
Sources: Merger Agreement (Teva Pharmaceutical Industries LTD)
FDA and Related Matters. (a) Except as set forth would not reasonably be expected to be, individually or in Section 3.22 of the Company Disclosure Letteraggregate, material to the Company and its the Company Subsidiaries (taken as a whole), there are no actual or, to the Knowledge of the Company, threatened enforcement actions by the U.S. Food and Drug Administration (the “FDA”) or any comparable Governmental Authority against the Company or any Company Subsidiary. Since January 1, 2020, neither the Company nor any Company Subsidiary has received written notice of any pending or threatened claim, suit, Proceeding, hearing, audit, inspection, investigation, arbitration or other action by the FDA or any comparable Governmental Authority against the Company or any Company Subsidiary or relating to any Company Product (including product candidates), and, to the Knowledge of the Company, have been since January, 1 2008, in compliance in all respects with neither the FDA nor any comparable Governmental Authority is considering such action.
(1b) all Applicable Laws (including all rules, regulations and policies) of the FDA, DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable Except as would not reasonably be expected to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would notbe, individually or in the aggregate, have or reasonably be expected material to have, a Material Adverse Effect. As of the date of this Agreement, neither the Company nor its Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(b) Since January 1, 2008, the Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect.
(c) Neither the Company nor any of its Subsidiaries has received any material written information (taken as a whole), since January 1, 2008 from any Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products which would reasonably be expected to lead:
(i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or
(ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect.
(d) Except as set forth in Section 3.22 of the Company Disclosure Letter2020, all material applications, reports, documents, claims claims, submissions, and notices required or requested to be filed, maintained, or furnished to the FDA or any Healthcare Regulatory Authority comparable Governmental Authority, including all adverse event reports and registrations and reports required to be filed with ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, by the Company and its Subsidiaries since January 1or any Company Subsidiary, 2008 have been so filed, maintained or furnished andfurnished. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Knowledge of Company and the CompanyCompany Subsidiaries (taken as a whole), all such applications, reports, documents, claims, submissions, and notices were timely filed and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). As of the date hereof, except where the failure Company has delivered or made available to do so Parent (i) a complete and correct copy of each Investigational New Drug application (an “IND”), New Drug Application (an “NDA”), Biologics License Application (“BLA”), clinical trial applications in Canada and approval letters for clinical trial applications in jurisdictions other than the United States and Canada sponsored and presently held by the Company with respect to each Company Product or product candidate, including all supplements and amendments thereto, (ii) copies of all clinical study reports under such INDs, and (iii) all material correspondence to or from the Company and each Company Subsidiary and FDA or any other Governmental Authority with respect to such INDs.
(c) Except as would notnot reasonably be expected to be, individually or in the aggregate, have or reasonably be expected material to have, a material and adverse effect on the Company and its Subsidiaries, the Company Subsidiaries (taken as a whole. The Company and its Subsidiaries are and have been), since January 1, 20082020, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event or any other safety or efficacy data related to their products, except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(e) Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company and its Subsidiaries. Neither neither the Company nor any of its Subsidiaries has received any written notice since Company Subsidiary nor, from January 1, 2008 that 2020 through the FDA or any other Governmental Authority has (i) commenceddate hereof, or threatened to initiatethe Knowledge of the Company, any action supplier to revoke or withdraw a product approval, or request the recall of any product, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole.
(f) With respect to each matter disclosed in Section 3.22(e) of the Company Disclosure Letter, the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications.
(g) All pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Company or any of its SubsidiariesCompany Subsidiary, or in which to the extent pertaining to the Company or the any of its Subsidiaries have participated, except where such termination Company Subsidiary or suspension would not, individually any product or in the aggregate, have or reasonably be expected service provided to have, a Material Adverse Effect.
(h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor.
(i) Neither the Company nor or any of its Subsidiaries Company Subsidiary, has received any FDA Form 483, notice of adverse findingviolation, warning lettersletter, untitled letters letter or other notices correspondence or written notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Healthcare Regulatory Authority related Laws or Company Permits. Except as would not reasonably be expected to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would notbe, individually or in the aggregate, have or reasonably be expected material to have, a Material Adverse Effect.
(j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, (taken as a whole.
(k) To the Knowledge of the Company), no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made thereinsince January 1, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products.
(l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and2020, to the Knowledge of the Company, neither the FDA Company nor any other Health Regulatory Authority Company Subsidiary nor, from January 1, 2020 through the date hereof, to the Knowledge of competent jurisdiction the Company, any supplier to the Company or any Company Subsidiary, to the extent pertaining to the Company or any Company Subsidiary or any product or service provided to the Company or any Company Subsidiary, has taken received any action written notice from any Person alleging that could any operation or activity of the Company or any Company Subsidiary or such supplier is in violation of any Healthcare Law.
(d) Except as would not reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would notbe, individually or in the aggregate, have or reasonably be expected material to have, a material and adverse effect on the Company and its Subsidiaries, the Company Subsidiaries (taken as a whole.
(m) The Company ), since January 1, 2020, any and its Subsidiaries have made available to Parent trueall preclinical studies and clinical trials, correct and complete copies of all internal other studies and third party facility audits completed at and tests, being conducted by or on behalf of the Company during the past three years. All material facility registrations or any Company Subsidiary have been and product listings required of the Company are being conducted in compliance with all applicable study protocols and its Subsidiaries are timelyHealthcare Laws, complete rules and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed productsregulations, including an indication the applicable requirements of any such products’ identified status Good Laboratory Practices or Good Clinical Practices. Except as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have would not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2).
(n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead be, individually or in the aggregate, material to such the Company and the Company Subsidiaries (taken as a requestwhole), requirementsince January 1, demand 2020, no clinical studies conducted by or order.
on behalf of the Company or any Company Subsidiary have been placed on clinical hold or terminated or suspended prior to completion. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (otaken as a whole), since January 1, 2020, neither the Company nor any Company Subsidiary has received any written notice, written correspondence or other written communication from the FDA, any other comparable Governmental Authority, any Institutional Review Board (or equivalent, duly constituted under applicable local law(s)) or clinical investigator alleging a lack of compliance with any Healthcare Laws or requiring the termination, suspension or modification of any ongoing clinical studies conducted by or on behalf of the Company or any Company Subsidiary. For the purposes of this Section 3.22Agreement, (i) “productGood Clinical Practices” with respect to products means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Parts 11, 50, 54, 56 and 312, the Company International Council for Harmonization’s (“ICH”) Guideline for Good Clinical Practice, and any similar state, local or any of its Subsidiaries includes products marketed, developed or producedforeign Laws, as applicable, by the Company or any of its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the (ii) “Good Laboratory Practices” means applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.FDA regulations for conducting
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Sources: Acquisition Agreement