Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. The Company and, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly individually or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The conduct of business by the Company andcomplies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s Knowledgeproducts, others who perform services on in whatever stage of development or commercialization except to the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by extent that the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance failure to so comply would not, singly or in the aggregate, not have a Material Adverse Effect; . To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority or governmental agency. The Company has fulfilled and performed in all material respects its obligations under each such Permit, and, as of the date hereof, to the knowledge of the Company, the Company is not in breach or default of any such Permit except to the extent that such breach, default, would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is in compliance in all material respects with all such Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company has not received any Form FDA-483, notice citing of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or inaction by the Company refusal, or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written other notice or correspondence from the FDA or other governmental agency alleging or asserting noncompliance with any foreignapplicable laws or Permits. The Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable regulatory authority or governmental agency. The Company has made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign laws, except to the extent that the failure to make such notifications, submission or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold reports would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and, to the Company’s Knowledgeknowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All The tests and preclinical and clinical studies conducted by or on behalf of the Company that are described in the SEC Reports were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company contained in the SEC Reports are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and the Subsidiaries and, to the Company’s Knowledge, others who perform services on the Company’s or a Subsidiary’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and neither the Company has not nor any Subsidiary received any notice citing action or inaction by the Company Company, any Subsidiary or others who perform services on the Company’s or any Subsidiary’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company or any Subsidiary were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, neither the Company nor any Subsidiary has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the CompanyCompany or any Subsidiary, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and neither the Company nor any Subsidiary has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or any Subsidiary or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and(i) has not received any FDA Form 483, to written notice of adverse finding, warning letter, untitled letter or other written notice from the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable FDA or any other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws (defined below) or with respect to any licenses, certificates approvals, clearances, authorizations, exemptions, permits or supplements or amendments thereto required by any Health Care Laws to conduct the business of the Company as described in the 2022 SEC Reports (collectively, “Authorizations”); (ii) possesses all applicable Authorizations and foreign lawssuch Authorizations are valid and in full force and effect and the Company is not in violation of any such Authorizations except where such violation would not have a Material Adverse Effect; (iii) has not received written notice of any pending or completed claim, rulesaction, regulationssuit, standardsproceeding, orders and decrees governing their respective businesseshearing, including without limitationenforcement, all regulations promulgated by investigation, arbitration or other action from the FDA or any other federal, state, local or foreign agencies governmental or bodies engaged regulatory authority or third party alleging that any product, operation, or activity of the Company is in the regulation material violation of pharmaceuticals any Health Care Laws or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; Authorizations and the Company has does not received have any notice citing action knowledge that the FDA or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable other federal, state, local or foreign lawsgovernmental or regulatory authority or third party is considering any such claim, ruleslitigation, regulations arbitration, action, suit, investigation or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulationsproceeding; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company (iv) has not received any written notice or correspondence from that the FDA or any foreignother federal, state state, local or local foreign governmental body exercising comparable or regulatory authority has taken, is taking or intends to take action to suspend, or revoke any material Authorizations and has no knowledge that the FDA or any Institutional Review Board other federal, state, local or comparable foreign governmental or regulatory authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectis considering such action; and (v) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments were materially true, complete and correct on the Company has not received any written notices date filed (or correspondence from others concerning the termination, suspension, material modification were corrected or clinical hold of any tests or preclinical or clinical studies conducted supplemented by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectsubsequent submission).

FDA and Related Matters. The (a) Section 3.18 of the Company andDisclosure Schedule sets forth a complete and accurate list, to the Company’s Knowledgereferencing relevant records and documents, others who perform services on the Company’s behalf have been since January 1, 1993, of (i) all Regulatory or Warning Letters, Notices of Adverse Findings, and are in compliance with all applicable federal, state, local Section 305 Notices and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated similar letters or notices issued by the FDA Food and Drug Administration (the "FDA") or any other federal, state, local local, or foreign agencies governmental entity that is concerned with the safety, efficacy, reliability, or bodies engaged in manufacturing of medical products, including drugs and devices, relating to the regulation conduct of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and business of the Company has not and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received any notice citing action or inaction by the Company or others who perform services on any of its Subsidiaries and all Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company’s behalf that would constitute non-compliance with Company or any applicable federalof its Subsidiaries, statewhich complaints or reports pertain to any incident involving death, local serious injury, or foreign lawsa serious adverse drug experience, rules, regulations and for which incident there has been any (1) notice or standards excepting, however, such actions that have heretofore been resolved follow up inquiry to the satisfaction Company or any of such governmental entity. All tests its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving notice of a possible or actual claim against the Company or any of its Subsidiaries, (iii) all product recalls and preclinical and clinical studies safety alerts conducted by or on behalf of issued to the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures or any of its Subsidiaries and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence requests from the FDA or any foreign, state or local governmental body exercising comparable authority other drug and medical device regulatory agency requesting the Company or any Institutional Review Board of its Subsidiaries to cease to investigate, test, or comparable authority requiring market any product, (iv) any civil penalty actions begun by the terminationFDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees issued with respect to the Company or any of its Subsidiaries, suspensionand (v) any other written communications between the FDA or any other drug and medical device regulatory agency, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Companyone hand, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company or any of its Subsidiaries, on the other hand. The Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold delivered to Parent copies of any tests or preclinical or clinical studies conducted by others on any active ingredient contained all documents referred to in the existing products Section 3.18 of the Company Disclosure Schedule, as well as copies of all complaints and other information required to be maintained by the Company pursuant to Section 820 of Title 21 of the Code of Federal Regulations ("CFR") or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect21 CFR Section 211.