Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. Except as set forth in Section 3.19 of the Disclosure Letter: (a) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received, in respect of the Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug Administration, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.); (b) each Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Federal Food, Drug and Cosmetic Act 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, the “Health Care Laws”); (c) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (d) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, 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 Sellers’ Knowledge, no Person has initiated or conducted any such notice or action against any Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business. 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 the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business.

FDA and Regulatory Matters. Except as set forth in Section 3.19 3.20 of the Disclosure Letter: (ai) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received, in respect of the Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug AdministrationFDA, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FFDCA”); (bii) each Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Federal FoodFFDCA, Drug and Cosmetic Act 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, the “Health Care Laws”); (ciii) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (div) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, 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 Sellers’ Knowledge, no Person has initiated or conducted any such notice or action against any Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the BusinessCompany. 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 the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business.

FDA and Regulatory Matters. Except as set forth otherwise might be noted in Section 3.19 of the Disclosure Letterthis Agreement or any associated Transaction Documents: (ai) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received, in respect of the Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug Administration, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FFDCA”); (bii) each Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Federal FoodFFDCA, Drug and Cosmetic Act 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, the “Health Care Laws”); (ciii) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (div) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, 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 Sellers’ Knowledge, no Person has initiated or conducted any such notice or action against any Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the BusinessCompany. 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 the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business.

FDA and Regulatory Matters. Except as set forth in Section 3.19 of the Disclosure Letter: (a) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has not has received, in respect of the Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug Administration, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.); (b) each the Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Federal Food, Drug and Cosmetic Act 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, the “Health Care Laws”); (c) no Seller Company or other direct or indirect Subsidiary of the Seller Companies has not engaged in the Business has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits permits required by the Health Care Laws that are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (d) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business hashas not, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, 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 Sellers’ KnowledgeSeller’s knowledge, no Person person has initiated or conducted any such notice or action against any Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the BusinessSeller. To Sellers’ KnowledgeSeller’s knowledge, the research, studies and tests conducted by or on behalf of each the 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 the Seller Company pursuant to all Health Care Laws and Permits permits required by the Health Care Laws that are applicable to the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the BusinessSeller.

FDA and Regulatory Matters. Except as set forth in Section 3.19 3.20 of the Disclosure Letter: (ai) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received, in respect of the Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and Drug AdministrationFDA, or any other Governmental Entity, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the "FFDCA"); (bii) each Seller Company is in compliance in all material respects with applicable health care laws, including without limitation, the Federal FoodFFDCA, Drug and Cosmetic Act 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, the “"Health Care Laws”"); (ciii) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that are applicable to the Business, which has not been resolved in such Seller Company’s 's favor; and (div) no Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, 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 Sellers’ ' Knowledge, no Person has initiated or conducted any such notice or action against any Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the BusinessCompany. 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 the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business.