Common use of Supply Product Compliance Clause in Contracts

Supply Product Compliance. All Supply Products delivered pursuant to this Supply Agreement by such Manufacturer (or any sub-contractor thereof) to the Buyer or its designee during the Term will at shipment be in compliance in all material respects with this Supply Agreement, the Specifications, the Quality Agreement and applicable Governmental Rules, including the cGMP Requirements, and the Manufacturing of such Supply Products will have been in accordance with the cGMP Requirements. At the time such Manufacturer makes each shipment of Supply Product available for pick-up by Buyer (or Buyer’s carrier), the Supply Products shall: (i) not be adulterated or misbranded within the meaning of the FFDCA or within the meaning of any applicable state or municipal Law in which the definitions of adulteration and misbranding are substantially the same as those contained in the FFDCA, as such FFDCA and such Laws are constituted and in effect at the time of delivery; (ii) not be an article that may [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. not be introduced into interstate commerce under the provisions of Sections 404 and 505 of the FFDCA; and (iii) have a shelf life that is not more than [****] into the product expiration, provided, however, that with respect to the initial Firm Order, for Supply Products that have a normal shelf life of [****], such Supply Products will have a minimum remaining shelf life of not less than [****], except with respect to the Supply Products set forth on Schedule 4.1(a), which shall have a minimum shelf life as set forth therein.

Supply Product Compliance. All Supply Products delivered pursuant to this Supply Agreement by such the Manufacturer (or any sub-contractor thereof) to the Buyer or its designee during the Term will at shipment be in compliance in all material respects with this Supply Agreement, the Specifications, the Quality Agreement and applicable Governmental Rules, including the cGMP Requirements, and the Manufacturing of such Supply Products will have been in accordance with the cGMP Requirements. At the time such Manufacturer makes each shipment of Supply Product available for pick-up by Buyer (or Buyer’s carrier), the Supply Products shall: (i) not be adulterated or misbranded within the meaning of the FFDCA or within the meaning of any applicable state or municipal Law in which the definitions of adulteration and misbranding are substantially the same as those contained in the FFDCA, as such FFDCA and such Laws are constituted and in effect at the time of delivery; (ii) not be an article that may not be introduced into interstate commerce under the provisions of Sections 404 and 505 of the FFDCA; and (iii) have a shelf life that is not more than [****] into the product expiration, [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. not be introduced into interstate commerce under the provisions of Sections 404 and 505 of the FFDCA; and (iii) have a shelf life that is not more than [****] into the product expiration, provided, however, that with respect to the initial Firm Order, for Supply Products that have a normal shelf life of [****], such Supply Products will have a minimum remaining shelf life of not less than [****], except with respect to the Supply Products set forth on Schedule 4.1(a), which shall have a minimum shelf life as set forth therein.