Common use of Regulatory Authorities Clause in Contracts

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and below, the Company represents and warrants that (i) the Company and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “FDC Act”) and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the Company’s control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company comply in all material respects with any conditions of approval and the terms of the application by the Company to the appropriate Regulatory Authorities (as defined below), (iv) to the knowledge of the Company and its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the Company’s products, such as seizures or required recalls, and the Company uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company and its Subsidiaries are in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used herein, “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and belowparagraph (i) above, the Company represents and warrants that (i) the Company and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “FDC Act”) and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the Company’s control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company comply in all material respects with any conditions of approval and the terms of the application by the Company to the appropriate Regulatory Authorities (as defined below), (iv) to the knowledge of the Company and or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the Company’s products, such as seizures or required recalls, and the Company uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company and its Subsidiaries are in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used herein, “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and belowparagraph (a) above, the Company Seller represents and warrants that (i) the Company Seller and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “FDC Act”) and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company Seller or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the CompanySeller’s control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company Seller comply in all material respects with any conditions of approval and the terms of the application by the Company Seller to the appropriate Regulatory Authorities (as defined below)Authorities, (iv) to the knowledge of the Company and Seller or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the CompanySeller’s products, such as seizures or required recalls, and the Company Seller uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company Seller and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company Seller to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company Seller to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company Seller nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company Seller or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company Seller or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company Seller and its Subsidiaries are is in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used hereinFor purposes of this Article 3.26, “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of CompanySeller’s products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authorities. Without limiting the generality of the representations and warranties made in paragraph (a) above, except as disclosed in the paragraphs above and belowRecent Reports, the Company Seller represents and warrants that (i) the Company Seller and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “FDC Act”) and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company Seller or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the CompanySeller’s control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company Seller comply in all material respects with any conditions of approval and the terms of the application by the Company Seller to the appropriate Regulatory Authorities (as defined below)Authorities, (iv) to the knowledge of the Company and Seller or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the CompanySeller’s products, such as seizures or required recalls, and the Company Seller uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company Seller and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company Seller to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company Seller to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company Seller nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company and its Subsidiaries are in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used herein, “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.all

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and belowparagraph (a) above, the Company Seller represents and warrants that (i) the Company Seller and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “"FDC Act”ACT") and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company Seller or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the Company’s Seller's control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company Seller comply in all material respects with any conditions of approval and the terms of the application by the Company Seller to the appropriate Regulatory Authorities (as defined below)Authorities, (iv) to the knowledge of the Company and Seller or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the Company’s Seller's products, such as seizures or required recalls, and the Company Seller uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company Seller and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company Seller to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company Seller to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company Seller nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company Seller or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company Seller or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company Seller and its Subsidiaries are is in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used hereinFor purposes of this Article 3.26, “Regulatory Authority” "REGULATORY AUTHORITY" means any governmental authority in a country or region that regulates the manufacture or sale of Company’s Seller's products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and belowparagraph (a) above, the Company Seller represents and warrants that (i) the Company Seller and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “"FDC Act”ACT") and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company Seller or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the Company’s Seller's control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company Seller comply in all material respects with any conditions of approval and the terms of the application by the Company Seller to the appropriate Regulatory Authorities (as defined below)Authorities, (iv) to the knowledge of the Company and Seller or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the Company’s Seller's products, such as seizures or required recalls, and the Company Seller uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company Seller and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company Seller to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company Seller to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company Seller nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company and its Subsidiaries are in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used herein, “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.their

Regulatory Authorities. Without limiting the generality of the representations and warranties made in the paragraphs above and belowparagraph (a) above, the Company Seller represents and warrants that (i) the Company Seller and each of its Subsidiaries is in material compliance with all applicable provisions of the United States Federal Food, Drug, and Cosmetic Act and the rules and regulations promulgated thereunder (the “"FDC Act”") and equivalent laws, rules and regulations in jurisdictions outside the United States in which the Company Seller or its Subsidiaries do business, (ii) its products and those of each of its Subsidiaries that are in the Company’s Seller's control are not adulterated or misbranded and are in lawful distribution, (iii) all of the products marketed by and within the control of the Company Seller comply in all material respects with any conditions of approval and the terms of the application by the Company Seller to the appropriate Regulatory Authorities (as defined below)Authorities, (iv) to the knowledge of the Company and Seller or its Subsidiaries, no Regulatory Authority has initiated legal action with respect to the manufacturing of the Company’s Seller's products, such as seizures or required recalls, and the Company Seller uses best efforts to comply with applicable good manufacturing practice regulations, (v) its products are labeled and promoted by the Company Seller and its representatives in substantial compliance with the applicable terms of the marketing applications submitted by the Company Seller to the Regulatory Authorities and the provisions of the FDC Act and foreign equivalents, (vi) all adverse events that were known to and required to be reported by Company Seller to the Regulatory Authorities have been reported to the Regulatory Authorities in a timely manner, (vii) neither the Company Seller nor any of its Subsidiaries is, to their knowledge, employing or utilizing the services of any individual who has been debarred under the FDC Act or foreign equivalents, (viii) all stability studies required to be performed for products distributed by the Company Seller or any of its Subsidiaries have been completed or are ongoing in material compliance with the applicable Regulatory Authority requirements, (ix) any products exported by the Company Seller or any of its Subsidiaries have been exported in compliance with the FDC Act and (x) the Company Seller and its Subsidiaries are is in compliance in all material respects with all applicable provisions of the Controlled Substances Act. As used hereinFor purposes of this Article 3.26, “"Regulatory Authority” " means any governmental authority in a country or region that regulates the manufacture or sale of Company’s Seller's products, including, but not limited to, the United States Food and Drug Administration.