Manufacturing Standards And Warranties. (a) OSGP hereby represents and warrants to P&GP SARL that the Products supplied to P&GP SARL hereunder shall, on the date of delivery to P&GP SARL and for the shelf life of the Products: (i) meet the requirements set forth in the Specifications and have been manufactured in accordance with cGMP's applicable to the Products and prevailing in the applicable Territory at the time of shipment for medicinal products for human use in the Territory, as well as any applicable laws or regulations relating to the manufacture of pharmaceutical chemicals in the Territory and ii) shall not be adulterated or misbranded within the meaning of any applicable food and/or drug law or regulation (federal, state or local) in the United States or any applicable equivalent law, rule or regulation elsewhere; iii) shall be of merchantable quality fit for P&GP SARL's use; and iv) comply with approved regulatory authorizations (INDs, NDAs, or local equivalents) and all applicable laws, rules and regulations (including, but not limited to, all applicable customs, laws and regulations, the rules of Good Manufacturing Practices applicable to the Products at the prevailing time of delivery to P&GP SARL) governing the manufacture, packaging, storage, transportation, delivery and/or testing of the Products. The warranty set forth in the preceding sentence shall not extend to any Product sold and purchased hereunder (or any product made with or from any such Product) which has been resold, treated, misused or improperly stored unless and to the extent such Product did not meet the requirements of the preceding sentence on the date of delivery to Buyer.
Manufacturing Standards And Warranties. (a) OSGP hereby represents and warrants to P&G that the Products shall, at the time of delivery to P&G for release consideration, have been manufactured to meet Release Specifications in accordance with cGMP’s applicable to the Products and prevailing in the applicable Territory at the time of shipment for medicinal products for human use in the Territory, and shall not be adulterated or misbranded within the meaning of the Specifications and cGMP’s, which include the prevention of cross contamination by such classes of products or materials as biologics (which contain live organisms), cytotoxins, and other highly active or sensitizing materials; and shall be of merchantable quality suitable for P&G’s use; provided, however, that OSGP shall not be liable for misbranding with respect to any Product labeling or package insert text provided or used by P&G if such Product meets the Specifications. In the event of a dispute between the parties as to whether Product meets the Release Specifications or the Specifications, final determination that a Product does or does not meet the Release Specifications or the Specifications shall be made only in accordance with the dispute resolution procedure set forth in Article 6.5 of this Agreement.
Manufacturing Standards And Warranties. (a) AHS hereby represents and warrants to Hemostemix that the Product(s) shall, at the time of delivery to Hemostemix for release consideration, have been manufactured to meet Release Specifications in accordance with cGMPs applicable to the Product(s) and prevailing in the Territory (or applicable jurisdiction(s) within it as applicable) at the time of shipment for medicinal or therapeutic products for human use in the Territory, and shall not be adulterated or misbranded within the meaning of the Specifications and cGMP's, which include the prevention of cross contamination by such classes of products or materials as biologics (which contain live organisms), cytotoxins, and other highly active or sensitizing materials; and shall be of merchantable quality suitable for Hemostemix's use (including use in the Study); provided, however, that AHS shall not be liable for misbranding with respect to any Product labeling or package insert text provided or used by Hemostemix if such Product meets the Specifications. In the event of a dispute between the Parties as to whether Product meets the Release Specifications or the Specifications, final determination that a Product does or does not meet the Release Specifications or the Specifications shall be made only in accordance with the dispute resolution procedure set forth in Section 4.3 of this Agreement.
