Common use of Compliance with FDA Laws Clause in Contracts

Compliance with FDA Laws. Each Credit Party and, to the Knowledge of Parent, each of its Subsidiaries, are in compliance in all material respects with all applicable FDA Laws, including the Food Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder (the “FDCA”) and applicable FDA Guidance Documents, in any way relating to any research, development, manufacture, production, use, commercialization, marketing, importing, storage, transport, offer for sale or lease, distribution, sale or lease of any Product in the Territory. Any Product distributed or sold in the Territory at all times during the past five (5) years has been (i) manufactured in all material respects in accordance with current FDA Good Manufacturing Practices, FDA Good Clinical Practices and FDA Good Laboratory Practices (as applicable), and (ii) if and to the extent such Product is required to be approved or cleared by the FDA pursuant to the FDCA in order to be legally marketed in the Territory for such Product’s intended uses, such Product has been approved or cleared for such intended uses, and no inquiries regarding material issues have been initiated by FDA, except in each case referred to in sub-clauses (i) or (ii) above, to the extent that any failure to ensure the foregoing could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Compliance with FDA Laws. Each Credit Party and, to the Knowledge of ParentBorrower, each of its Subsidiaries, are in compliance in all material respects with all applicable FDA Laws, including the Federal Food Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder (the “FDCA”) and applicable FDA Guidance Documents), in any way relating to any research, development, manufacture, production, use, commercialization, marketing, importing, storage, record keeping, reporting, transport, offer for sale, distribution or sale or lease, distribution, sale or lease of any Product in the Territory. Any Each Product distributed or sold in the Territory at any and all times during the past five (5) years (or, with respect to Acquisition Product, during the time such Product has actually been distributed or sold by the Borrower) has been (i) manufactured manufactured, developed and tested in all material respects in accordance compliance with all applicable FDA Laws including any applicable current FDA Good Manufacturing Practices, FDA Good Clinical Practices and FDA Good Laboratory Practices (as applicable)and, and (ii) if and to the extent such Product is required to be approved or cleared by the FDA pursuant to the FDCA in order to be legally marketed in the Territory United States for such Product’s intended uses, such Product has been approved or cleared for such intended usesuses and meets in all material respects any additional conditions of approval or clearance by the FDA (as applicable). To the Knowledge of Borrower, and no inquiries regarding material issues have Product that is or has been initiated manufactured, tested, distributed, held or marketed by FDA, except in each case referred to in sub-clauses (i) or (ii) above, to the extent that on behalf of any failure to ensure the foregoing could not, individually Credit Party or in the aggregate, reasonably be expected to result in a Material Adverse Changeany of its Subsidiaries has been adulterated or misbranded.

Compliance with FDA Laws. Each Credit Party and, to the Knowledge of ParentBorrower, each of its Subsidiaries, are in compliance in all material respects with all applicable FDA Laws, including the Federal Food Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder (the “FDCA”) and applicable FDA Guidance Documents), in any way relating to any research, development, manufacture, production, use, commercialization, marketing, importing, storage, record keeping, reporting, transport, offer for sale, distribution or sale or lease, distribution, sale or lease of any Product in the Territory. Any Each Product distributed or sold in the Territory at any and all times during the past five (5) years (or, with respect to the Acquisition Products, during the time such Products have actually been distributed or sold by the Borrower) has been (i) manufactured manufactured, developed and tested in all material respects in accordance with current FDA Good Manufacturing Practices, FDA Good Clinical Practices and FDA Good Laboratory Practices (as applicable)) and, and (ii) if and to the extent such Product is required to be approved or cleared by the FDA pursuant to the FDCA in order to be legally marketed in the Territory United States for such Product’s intended uses, such Product has been approved or cleared for such intended uses. To the Knowledge of Borrower, and no inquiries regarding material issues have Product that is or has been initiated manufactured, tested, distributed, held or marketed by FDA, except in each case referred to in sub-clauses (i) or (ii) above, to the extent that on behalf of any failure to ensure the foregoing could not, individually Credit Party or in the aggregate, reasonably be expected to result in a Material Adverse Changeany of its Subsidiaries has been adulterated or misbranded.