Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. Except in each case as set forth in the SEC Documents, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of the Company or its Subsidiaries, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “DEA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Industry Laws or any licenses, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Industry Laws (“Healthcare Permits”); (iii) possess all material Healthcare Permits, which are valid and in full force and effect, and are not in material violation of any term of any such Healthcare Permit, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Industry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Industry Laws or Healthcare Permits, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) have not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Company, no third party has initiated, conducted or intends to initiate any such notice or action.

FDA and Regulatory Matters. Except in each case as set forth described in the SEC DocumentsRegistration Statement, the Company Prospectus and its Subsidiaries the Prospectus Supplement, and except as would not, singly or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) are and at all times have been in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf of neither the Company or nor any of its Subsidiaries, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not subsidiaries has received any FDA Form 483, written notice of adverse findingfiling, warning letter, untitled letter or other similar correspondence or notice from the U.S. Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “DEA”) EMA or other relevant regulatory authorities, or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority authority, alleging or asserting material noncompliance with any Industry Laws the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the regulations promulgated thereunder (the “FFDCA”), or any licensessimilar state, certificatesfederal or foreign law or regulation (collectively, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Industry Laws (“Healthcare PermitsHealth Care Laws”); (ii) the Company and its subsidiaries are and have been in compliance in all material respects with applicable Health Care Laws; (iii) possess all material Healthcare Permits, which are valid and in full force and effect, and are not in material violation neither the Company nor any of any term of any such Healthcare Permit, and no event its subsidiaries has occurred which allows, or after notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority Governmental Authority or third party alleging that any product operation or activity is in material violation of any Industry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingHealth Care Laws; (viv) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, Company and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Industry Laws or Healthcare Permitsapplicable Health Care Laws, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete complete, correct and correct not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (viiv) have not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge none of the Company, no third any of its subsidiaries or any of their respective directors, officers, employees or agents is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) neither the Company nor any of its subsidiaries is a party has initiatedto and the Company and its subsidiaries do not have any ongoing reporting obligations pursuant to, conducted any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or intends to initiate any such notice similar agreements with or actionimposed by an Governmental Authority.

FDA and Regulatory Matters. Except in each case as set forth in Section 3.20 of the SEC Documents, the Company and its Subsidiaries Disclosure Letter: (i) are and at all times have been no Seller Company has received, in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf respect of the Company or its SubsidiariesBusiness, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, written notice of adverse findingfiling, warning letter, untitled letter or other similar written correspondence or written notice from the U.S. Food FDA, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Drug Administration Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDAFFDCA”); (ii) each Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Drug Enforcement Administration FFDCA, and the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and the regulations promulgated pursuant to such laws, and comparable state laws (collectively, “DEA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Industry Laws or any licenses, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Industry Laws (“Healthcare PermitsHealth Care Laws”); (iii) possess all material Healthcare Permits, which are valid and in full force and effect, and are not in material violation of any term of any such Healthcare Permit, and no event Seller Company has occurred which allows, or after received written notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Industry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as Permits required by any Industry the Health Care Laws or Healthcare Permitsthat are applicable to the Business, and all which has not been resolved in such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission)Seller Company’s favor; and (viiiv) have notno Seller Company has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted or conducted, issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacementwithdrawal, safety alert, post-sale warning, “dear doctor” letter, or other notice or action material to the Business relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the CompanySellers’ Knowledge, no third party Person has initiated, initiated or conducted or intends to initiate any such notice or actionaction against any Seller Company. To Sellers’ Knowledge, the research, studies and tests conducted by or on behalf of each Seller Company in respect of the Business have been conducted with reasonable care and in accordance in all material respects with experimental protocols, procedures and controls adopted by such Seller Company pursuant to all Health Care Laws and Permits required by the Health Care Laws that are applicable to such Seller Company or the Business.

FDA and Regulatory Matters. Except in each case as set forth in Section 3.20 of the SEC Documents, the Company and its Subsidiaries Disclosure Letter: (i) are and at all times have been no Seller Company has received, in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf respect of the Company or its SubsidiariesBusiness, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, written notice of adverse findingfiling, warning letter, untitled letter or other similar written correspondence or written notice from the U.S. Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “DEA”) or any other federalGovernmental Entity, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Industry Laws or any licensesthe Federal Food, certificatesDrug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the "FFDCA"); (ii) each Seller Company is in compliance in all material respects with applicable health care laws, approvalsincluding without limitation, clearancesthe FFDCA, authorizationsand the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), permitsand the regulations promulgated pursuant to such laws, registrations and supplements or amendments thereto required by any such Industry Laws comparable state laws (“Healthcare Permits”collectively, "Health Care Laws"); (iii) possess all material Healthcare Permits, which are valid and in full force and effect, and are not in material violation of any term of any such Healthcare Permit, and no event Seller Company has occurred which allows, or after received written notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Industry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as Permits required by any Industry the Health Care Laws or Healthcare Permitsthat are applicable to the Business, and all which has not been resolved in such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission)Seller Company's favor; and (viiiv) have notno Seller Company has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted or conducted, issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacementwithdrawal, safety alert, post-sale warning, “"dear doctor” " letter, or other notice or action material to the Business relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the CompanySellers' Knowledge, no third party Person has initiated, initiated or conducted or intends to initiate any such notice or actionaction against any Seller Company. To Sellers' Knowledge, the research, studies and tests conducted by or on behalf of each Seller Company in respect of the Business have been conducted with reasonable care and in accordance in all material respects with experimental protocols, procedures and controls adopted by such Seller Company pursuant to all Health Care Laws and Permits required by the Health Care Laws that are applicable to such Seller Company or the Business.

FDA and Regulatory Matters. Except (a) the Seller has not has received, in each case as set forth in the SEC Documents, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all federal, state, local and foreign statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, handling, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, subject to an approved New Drug Application, or manufactured or distributed by or on behalf respect of the Company or its SubsidiariesBusiness, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act (“Industry Laws”); (ii) have not received any FDA Form 483, written notice of adverse findingfiling, warning letter, untitled letter or other similar written correspondence or written notice from the U.S. Food and Drug Administration (the “FDA”)Administration, the Drug Enforcement Administration (the “DEA”) or any other federalGovernmental Entity, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Industry Laws or any licensesthe Federal Food, certificatesDrug and Cosmetic Act (21 U.S.C. § 301 et seq.); (b) the Seller is in compliance in all material respects with applicable health care laws, approvalsincluding without limitation, clearancesthe Federal Food, authorizationsDrug and Cosmetic Act and the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), permitsand the regulations promulgated pursuant to such laws, registrations and supplements or amendments thereto required by any such Industry Laws comparable state laws (collectively, the “Healthcare PermitsHealth Care Laws”); (iiic) possess all material Healthcare Permits, which are valid and the Seller has not engaged in full force and effect, and are not in material violation of any term of any such Healthcare Permit, and no event the Business has occurred which allows, or after received written notice or lapse of time would allow, revocation or termination of any Healthcare Permit or results in any other material impairment of the rights of the holder of any Healthcare Permit; (iv) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Industry Laws or Healthcare Permits, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) have not received notice that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Healthcare Permit, and have no knowledge that the FDA, DEA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as permits required by any Industry the Health Care Laws or Healthcare Permitsthat are applicable to the Business, and all which has not been resolved in such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission)Seller Company’s favor; and (viid) have the Seller has not, in respect of the Business, either voluntarily or involuntarily, initiated, conducted or conducted, issued or caused to be initiated, conducted or issued, any recall, correction, market withdrawal or replacementwithdrawal, safety alert, post-sale warning, “dear doctor” letter, or other notice or action material to the Business relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the CompanySeller’s knowledge, no third party person has initiated, initiated or conducted or intends to initiate any such notice or actionaction against the Seller. To Seller’s knowledge, the research, studies and tests conducted by or on behalf of the Seller in respect of the Business have been conducted with reasonable care and in accordance in all material respects with experimental protocols, procedures and controls adopted by the Seller pursuant to all Health Care Laws and permits required by the Health Care Laws that are applicable to the Business or to the Seller.