Common use of Product Samples Clause in Contracts

Product Samples. At the time Amylin delivers Product Samples to ▇▇▇▇▇'▇ carrier as described in Section 3.2, Amylin represents and warrants to ▇▇▇▇▇ 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

Sources: Co Promotion Agreement, Co Promotion Agreement

Product Samples. At the time Amylin delivers Product Samples to ▇▇▇▇▇'▇ Lilly's carrier as described in Section 3.2, Amylin represents and warrants to ▇▇▇▇▇ 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

Sources: Co Promotion Agreement

Product Samples. At the time Amylin delivers Product Samples to ▇▇▇▇▇'▇ Lilly's carrier as described in Section 3.2, Amylin represents and warrants to ▇▇▇▇▇ 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

Sources: u.s. Co Promotion Agreement (Amylin Pharmaceuticals Inc)