Product Samples. At the time Amylin delivers Product Samples to Xxxxx'x carrier as described in Section 3.2, Amylin represents and warrants to Xxxxx that such Samples: (i) comply in all material respects with the specifications in the NDA for Product, (ii) comply in all material respects with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and regulations issued hereunder, both as amended from time to time ("FDCA"), (iii) are not products that have been adulterated or misbranded within the meaning set forth in FDCA and any state or local law or regulation substantially similar to FDCA, (iv) are products that may be introduced into interstate commerce, and (v) have been manufactured, packaged, stored, and shipped in conformity with all applicable current good manufacturing practices.
Appears in 2 contracts
Samples: Co Promotion Agreement, Co Promotion Agreement
Product Samples. At the time Amylin delivers Product Samples to Xxxxx'x Lilly's carrier as described in Section 3.2, Amylin represents and warrants to Xxxxx Lilly that such Samples:
(i) comply in all material respects with the specifications in the NDA for Product,
(ii) comply in all material respects with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and regulations issued hereunder, both as amended from time to time ("FDCA"),
(iii) are not products that have been adulterated or misbranded within the withinthe meaning set forth in FDCA and any state or local law or regulation substantially similar to FDCA,
(iv) are products that may be introduced into interstate commerce, and
(v) have been manufactured, packaged, stored, and shipped in conformity with all applicable current good manufacturing practices.
Appears in 1 contract
Samples: Co Promotion Agreement
Product Samples. At the time Amylin delivers Product Samples to Xxxxx'x Lilly's carrier as described in Section 3.2, Amylin represents and warrants to Xxxxx Lilly that such Samples:
(i) comply in all material respects with the specifications in the NDA for Product,
(ii) comply in all material respects with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and regulations issued hereunder, both as amended from time to time ("FDCA"),
(iii) are not products that have been adulterated or misbranded within the meaning set forth in FDCA and any state or local law or regulation substantially similar to FDCA,
(iv) are products that may be introduced into interstate commerce, and
(v) have been manufactured, packaged, stored, and shipped in conformity with all applicable current good manufacturing practices.
Appears in 1 contract
Samples: u.s. Co Promotion Agreement (Amylin Pharmaceuticals Inc)