Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) Parent is in material compliance with all applicable Health Care Laws, which affect the business, Product Candidates, properties, assets and activities of Parent, (ii) there is no pending or, to Parent’s Knowledge, threatened action against Parent alleging any violation by Parent of any such Health Care Law, (iii) each of Parent’s Product Candidates has been developed, manufactured, labeled, stored, tested and otherwise produced in material compliance with applicable Health Care Laws, (iv) Parent holds, and is operating and has operated in material compliance with, all Regulatory Authorizations required by applicable Health Care Laws relating to the business, Product Candidates, properties, assets and activities of Parent and (v) Parent has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. With respect to each of its Product Candidates, Parent has made available to the Company complete and accurate copies of all material clinical and preclinical data in the possession of Parent and all material written correspondence between Parent and the applicable Regulatory Authority, in each case as requested by the Company. (b) All preclinical and clinical trials conducted by or on behalf of Parent are being, or have been, conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Clinical Practice, Informed Consent and the requirements and conditions imposed by the relevant “Institutional Review Board,” as such term is defined by the FDA, and all applicable Health Care Laws of the relevant Regulatory Authorities outside the United States. No clinical trial conducted by or on behalf of Parent has been terminated or suspended by the FDA or any other applicable Regulatory Authority or Institutional Review Board, and neither the FDA nor any other applicable Regulatory Authority has commenced or threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Parent. (c) All manufacturing operations conducted by, or for the benefit of, Parent with respect to any Product Candidate being used in human clinical trials have been and are being conducted in all material respects in accordance with the applicable requirements of Good Manufacturing Practices. Neither Parent nor, to the Knowledge of Parent any Person acting on its behalf has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority (including FDA) shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Product Candidate or any of Parent’s processes or procedures, or any similar correspondence or notice from the FDA or any other Regulatory Authority in respect of Parent or its business operations alleging or asserting noncompliance with any applicable Law, permit or such requests or requirements of a Regulatory Authority and, to the Knowledge of Parent, neither the FDA nor any Regulatory Authority is considering such action. (d) All applications, notifications, submissions, information, claims, reports, statistics and other data utilized as the basis for, or submitted in connection with, any and all Regulatory Authorizations from the FDA or any other Regulatory Authority relating to Parent, its business operations, Product Candidates, when submitted to the FDA or such other Regulatory Authority were complete and accurate in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authority. None of Parent or any of its officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of Parent or any of its officers, employees, agents or, to the Knowledge of Parent, any clinical investigator acting for Parent, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (e) No Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of Parent has been recalled, withdrawn, or suspended (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Product Candidate or pre-market approvals or marketing authorizations are pending or, to the Knowledge of Parent, threatened against Parent or any of its Affiliates, nor have any such proceedings been pending at any time. Parent has made available to the Company all information about material adverse drug experiences obtained or otherwise received by Parent from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to any Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of Parent or any of its licensors or licensees in the possession of Parent (or to which it has access). In addition, Parent has filed all annual and periodic reports, amendments and safety reports required for any of its Product Candidates required to be made to the FDA or any other Governmental Entity.

FDA and Regulatory Matters. (a) Parent The Company is in material compliance with all applicable Health Care Laws, which affect the business, Product Candidates, properties, assets and activities of Parentthe Company, (ii) there is no pending or, to Parentthe Company’s Knowledge, threatened action against Parent the Company alleging any violation by Parent the Company of any such Health Care Law, (iii) each of Parentthe Company’s Product Candidates has been developed, manufactured, labeled, stored, tested and otherwise produced in material compliance with applicable Health Care Laws, (iv) Parent the Company holds, and is operating and has operated in material compliance with, all Regulatory Authorizations required by applicable Health Care Laws relating to the business, Product Candidates, properties, assets and activities of Parent the Company and (v) Parent the Company has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. With respect to each of its Product Candidates, Parent the Company has made available to the Company Parent complete and accurate copies of all material clinical and preclinical data in the possession of Parent the Company and all material written correspondence between Parent the Company and the applicable Regulatory Authority, in each case as requested by the CompanyParent. (b) All preclinical and clinical trials conducted by or on behalf of Parent the Company are being, or have been, conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Clinical Practice, Informed Consent and the requirements and conditions imposed by the relevant “Institutional Review Board,” as such term is defined by the FDA, and all applicable Health Care Laws of the relevant Regulatory Authorities outside the United States. No clinical trial conducted by or on behalf of Parent the Company has been terminated or suspended by the FDA or any other applicable Regulatory Authority or Institutional Review Board, and neither the FDA nor any other applicable Regulatory Authority has commenced or threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Parentthe Company. (c) All manufacturing operations conducted by, or for the benefit of, Parent the Company with respect to any Product Candidate being used in human clinical trials have been and are being conducted in all material respects in accordance with the applicable requirements of Good Manufacturing Practices. Neither Parent With the exception of the Complete Response Letter from the FDA, dated July 22, 2021, in response to the submission of NDA 212282, neither the Company nor, to the Knowledge of Parent the Company, any Person acting on its behalf has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority (including FDA) shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Product Candidate or any of Parentthe Company’s processes or procedures, or any similar correspondence or notice from the FDA or any other Regulatory Authority in respect of Parent the Company or its business operations alleging or asserting noncompliance with any applicable Law, permit or such requests or requirements of a Regulatory Authority and, to the Knowledge of Parentthe Company, neither the FDA nor any Regulatory Authority is considering such action. (d) All applications, notifications, submissions, information, claims, reports, statistics and other data utilized as the basis for, or submitted in connection with, any and all Regulatory Authorizations from the FDA or any other Regulatory Authority relating to Parentthe Company, its business operations, Product Candidates, when submitted to the FDA or such other Regulatory Authority were complete and accurate in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authority. None of Parent the Company or any of its officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of Parent the Company or any of its officers, employees, agents or, to the Knowledge of Parentthe Company, any clinical investigator acting for Parentthe Company, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (e) No Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of Parent the Company has been recalled, withdrawn, or suspended (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Product Candidate or pre-market approvals or marketing authorizations are pending or, to the Knowledge of Parentthe Company, threatened against Parent the Company or any of its Affiliates, nor have any such proceedings been pending at any time. Parent The Company has made available to the Company Parent all information about material adverse drug experiences obtained or otherwise received by Parent the Company from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to any Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of Parent the Company or any of its licensors or licensees in the possession of Parent the Company (or to which it has access). In addition, Parent the Company has filed all annual and periodic reports, amendments and safety reports required for any of its Product Candidates required to be made to the FDA or any other Governmental Entity.

FDA and Regulatory Matters. (a) Parent has complied and is in material compliance complying with all applicable laws and regulations including, without limitation: (i) the Federal Food, Drug, and Cosmetic Act, the Public Health Care LawsService Act, which affect the businessControlled Substance Act, Product Candidates, properties, assets and activities of Parent, the regulations promulgated under each such statute; (ii) there is no pending or, to Parent’s Knowledge, threatened action against Parent alleging any violation relevant guidance or other instructions issued by Parent of any such Health Care Law, a Governmental Authority; (iii) each of Parent’s Product Candidates has been developed, manufactured, labeled, stored, tested relevant state laws and otherwise produced in material compliance with applicable Health Care Laws, regulations; and (iv) Parent holdsthe Anti-Kickback Statute (42 U.S.C. § 1320a-7b), the Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), and is operating and has operated in material compliance with, all Regulatory Authorizations required by applicable Health Care Laws relating to the business, Product Candidates, properties, assets and activities of Parent and (v) Parent has fulfilled and performed all of its material obligations with respect to the regulations promulgated under all such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. With respect to each of its Product Candidates, Parent has made available to the Company complete and accurate copies of all material clinical and preclinical data in the possession of Parent and all material written correspondence between Parent and the applicable Regulatory Authority, in each case as requested by the Companystatutes. (b) All preclinical and clinical trials conducted by or on behalf of Parent are being, or have been, conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Clinical Practice, Informed Consent and the requirements and conditions imposed by the relevant “Institutional Review Board,” as such term is defined by the FDA, and all applicable Health Care Laws of the relevant Regulatory Authorities outside the United States. No clinical trial conducted by or on behalf of Parent has not received notice of, nor has Parent been terminated or suspended by the FDA or any other applicable Regulatory Authority or Institutional Review Board, and neither the FDA nor any other applicable Regulatory Authority has commenced or threatened in writing to initiatesubject to, any action to place a clinical hold order onadverse inspectional finding, data integrity review, investigation, penalty, fine, sanction, assessment, request for corrective or otherwise terminateremedial action, delaywarning letter, suspend or materially restrictregulatory letter, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Parent. (c) All manufacturing operations conducted byuntitled letter, or for the benefit of, Parent with respect to any Product Candidate being used in human clinical trials have been and are being conducted in all material respects in accordance with the applicable requirements of Good Manufacturing Practices. Neither Parent nor, to the Knowledge of Parent any Person acting on its behalf has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority (including FDA) shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observationscompliance or enforcement notice, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Product Candidate or any of Parent’s processes or procedurescommunication, or any similar correspondence or notice from the FDA or any other Regulatory Authority in respect Governmental Authority. (c) None of the products designed, manufactured, processed, packaged, sold, marketed, or distributed by Parent or its business operations alleging designed, manufactured, processed, packaged, sold, marketed, or asserting noncompliance with distributed pursuant to any applicable LawPermit held by Seller, permit including, without limitation, any Parent 510(k) premarket notification, premarket approval application, investigational device exemption, new drug application, abbreviated new drug application, or such requests investigational new drug application (collectively, the “Parent Products”) have been recalled, whether voluntary or requirements of a Regulatory Authority andotherwise, or are or have been subject to device removal or correction reporting requirements, nor is any Parent Product recall, removal, market withdrawal, or other corrective action currently under consideration by Parent or, to the Knowledge knowledge of Parent, neither the FDA nor any Regulatory Governmental Authority is considering such actionor any of Parent’s customers. All Parent Product research, development, manufacturing, processing, testing, packaging, labeling, distribution, marketing, and sales activities have been performed in compliance with all applicable laws and regulations and any applicable Permits. (d) All applicationsNo Parent Products have been manufactured, notificationsprocessed, submissionspackaged, informationsold, claimsmarketed, reportsdistributed, statistics and other data utilized as the basis forlicensed, or submitted otherwise commercialized, nor have any Parent Products been tested in connection withhumans or other animals, within the past five (5) years. Parent has not, in the past five (5) years, engaged in any research, development, manufacturing, processing, testing, packaging, labeling, distribution, marketing, or sales activities with respect to any product or article regulated under the Federal Food, Drug, and all Regulatory Authorizations from Cosmetic Act, the Public Health Service Act, the Controlled Substance Act, or the regulations promulgated under each such statute. (e) Neither Parent nor any employee or agent of Parent has (i) made an untrue statement of material fact or fraudulent statement to FDA or any other Regulatory Authority relating Governmental Authority, or in any records or documentation prepared or maintained to Parentcomply with the applicable laws and regulations; (ii) failed to disclose a material fact required to be disclosed to any Governmental Authority; (iii) or has ever been investigated by the FDA, its business operationsNational Institutes of Health, Product Candidates, when submitted to the FDA or such other Regulatory Authority were complete and accurate in all material respects as Office of the date Inspector General for the Department of submission Health and any necessary Human Services, Department of Justice, or required updates, changes, corrections other comparable Governmental Authority for data or modifications to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authorityhealthcare program fraud. None of Neither Parent or nor any of its officers, employeesdirectors and employees have made or offered any payment, agents or, to the Knowledge gratuity or other thing of the Company, any clinical investigator acting for the Company, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of Parent or any of its officers, employees, agents or, to the Knowledge of Parent, any clinical investigator acting for Parent, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar Law, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (e) No Product Candidate value that is or has been manufactured, tested, distributed, held or marketed prohibited by or on behalf any Law to personnel of Parent has been recalled, withdrawn, or suspended (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Product Candidate or pre-market approvals or marketing authorizations are pending or, to the Knowledge of Parent, threatened against Parent or any of its Affiliates, nor have any such proceedings been pending at any time. Parent has made available to the Company all information about material adverse drug experiences obtained or otherwise received by Parent from any source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to any Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of Parent or any of its licensors or licensees in the possession of Parent (or to which it has access). In addition, Parent has filed all annual and periodic reports, amendments and safety reports required for any of its Product Candidates required to be made to the FDA or any other Governmental EntityAuthority. (f) Neither Parent nor any employee or agent of Parent has (i) violated or caused a violation of any federal or state health care fraud and abuse or false claims statute or regulation, including, without limitation, the anti-kickback provisions of the Social Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x(x); (xx) been excluded or threatened with exclusion under law or regulation, including, without limitation, under 42 U.S.C. § 1320a-7 or 42 C.F.R. Part 1001; (iii) been assessed or threatened with assessment of civil money penalties pursuant to 42 C.F.R. Part 1003; (iv) been debarred or threatened with debarment under any law or regulation, including, without limitation, 21 U.S.C. § 335a; (v) been convicted of any offense or engaged in any conduct which could result in exclusion or debarment under any law or regulation. (g) There are not presently pending, nor, to Parent’s knowledge, threatened, any civil, criminal or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings, demand letters, or other communications relating to any alleged hazard or alleged defect in design, manufacture, materials, or workmanship, including, without limitation, any failure to warn or alleged breach of express or implied warranty or representation, relating to any Parent Product, or alleging that any such Parent Product is otherwise noncompliant or unsafe or ineffective for its intended use. Parent has not made any modification to any Parent Product because of warranty, product liability, regulatory, or other claims or communications concerning any alleged hazard, defect, or other noncompliance concerning such Product.