FDA Compliance. Company hereby represents that at the time of commercial sale of the Product Company will have received clearance from FDA to market the Product in the United States. In the event FDA or any other governmental entity withdraws its marketing clearance for the Product, Company shall promptly notify Distributor. Furthermore, Company represents and warrants that, at the time of shipment or delivery from Company, the Products (a) shall not be adulterated, misbranded, or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. Seq., as amended, and in effect at the time of shipment or delivery (the “Act”) or within the meaning of any applicable state or municipal law in which the definition of adulteration or misbranding are substantially the same as those contained in the Act; and (b) shall not be merchandise which may not be introduced or delivered for introduction into interstate commerce under the provisions of sections 301, 404 or 505 of the Act (21 U.S.C.A. 331, 344 and 355).
Appears in 2 contracts
Samples: Exclusive Wholesale Product Purchase Agreement, Exclusive Wholesale Product Purchase Agreement (Corcept Therapeutics Inc)
FDA Compliance. Company hereby represents that at the time of commercial sale of the Product Company will have received clearance from FDA to market the Product in the United States. In the event FDA or any other governmental entity withdraws its marketing clearance for the Product, Company shall promptly notify DistributorCuraScript. Furthermore, Company represents and warrants that, at the time of shipment or delivery from Company, the Products (a) shall not be adulterated, misbranded, or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. Seq., as amended, and in effect at the time of shipment or delivery (the “Act”) or within the meaning of any applicable state or municipal law in which the definition of adulteration or misbranding are substantially the same as those contained in the Act; and (b) shall not be merchandise which may not be introduced or delivered for introduction into interstate commerce under the provisions of sections 301, 404 or 505 of the Act (21 U.S.C.A. 331, 344 and 355).
Appears in 1 contract
Samples: Exclusive Pharmacy Product Purchase and Service Agreement (Corcept Therapeutics Inc)
FDA Compliance. Company hereby represents that at the time of commercial sale of the Product Company will have received clearance from FDA to market the Product in the United States. In the event FDA or any other governmental entity withdraws its marketing clearance for the Product, Company shall promptly notify DistributorAccredo. Furthermore, Company represents and warrants that, at the time of shipment or delivery from Company, the Products (a) shall not be adulterated, misbranded, or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. Seq., as amended, and in effect at the time of shipment or delivery (the “"Act”") or within the meaning of any applicable state or municipal law in which the definition of adulteration or misbranding are substantially the same as those contained in the Act; and (b) shall not be merchandise which may not be introduced or delivered for introduction into interstate commerce under the provisions of sections 301, 404 or 505 of the Act (21 U.S.C.A. 331, 344 and 355).
Appears in 1 contract
Samples: Pharmacy Services Agreement (Raptor Pharmaceutical Corp)
FDA Compliance. Company hereby represents that at the time of commercial sale of the Product Company will have received clearance from FDA to market the Product in the United States. In the event FDA or any other governmental entity withdraws its marketing clearance for the Product, Company shall promptly notify Distributor. Furthermore, Company represents and warrants that, at the time of shipment or delivery from Company, the Products (a) shall not be adulterated, misbranded, or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. Seq., as amended, and in effect at the time of shipment or delivery (the “"Act”") or within the meaning of any applicable state or municipal law in which the definition of adulteration or misbranding are substantially the same as those contained in the Act; and (b) shall not be merchandise which may not be introduced or delivered for introduction into interstate commerce under the provisions of sections 301, 404 or 505 of the Act (21 U.S.C.A. 331, 344 and 355).
Appears in 1 contract
Samples: Wholesale Product Purchase Agreement (Raptor Pharmaceutical Corp)
FDA Compliance. Company UT hereby represents that that, at the time of commercial sale of the Product Company Product, UT will have received clearance from FDA to market the Product in the United States. In the event FDA or any other governmental entity withdraws its marketing clearance for the Product, Company UT shall promptly notify Distributor. Furthermore, Company UT represents and warrants that, at the time of shipment or delivery from CompanyUT, the Products (ai) shall not be adulterated, misbranded, or otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. Seqet seq., as amended, and in effect at the time of shipment or delivery (the “ActFFDCA”) or within the meaning of any applicable state or municipal law Applicable Law in which the definition of adulteration or misbranding are substantially the same as those contained in the ActFFDCA; and (bii) shall not be merchandise which that may not be introduced or delivered for introduction into interstate commerce under the provisions of sections Sections 301, 404 or 505 of the Act FFDCA (21 U.S.C.A. 331, 344 and 355).
Appears in 1 contract
Samples: Wholesale Product Purchase Agreement (UNITED THERAPEUTICS Corp)