Manufacturing Quality. All Licensed Adjuvants shall be manufactured in accordance with the Quality Agreement. All Licensed Adjuvants shall be manufactured at Supplier’s facility or a designated facility of a Sub-Manufacturer (“Supplier Facility”) unless otherwise mutually agreed upon by the Parties. Supplier shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable specifications therefor. Supplier shall take all necessary steps to prevent contamination and cross contamination of Licensed Adjuvants. Licensed Adjuvants shall be unadulterated and free from contamination, diluents and foreign matter in any amount. Supplier shall perform the quality control tests with respect to Licensed Adjuvants in accordance with the methods of analysis that have been suitably qualified and approved as set forth in the Quality Agreement (the “Methods of Analysis”), the cost of the same to be included in the price hereinafter specified. Once established pursuant to the Quality Agreement, the Methods of Analysis will be considered as Exhibit C attached hereto and shall be incorporated herein by reference. The Methods of Analysis may be amended from time to time in accordance with this Agreement Supplier shall promptly, upon completion of such tests, deliver to Purchaser a copy of the record of such tests performed on, and a Certificate of Analysis for, each shipment of Licensed Adjuvant to Purchaser. Supplier shall deliver a representative sample from each shipment of Licensed Adjuvant to Purchaser’s designated representative by the date specified by such representative.
Manufacturing Quality. BIT shall manufacture Products in compliance with the Product Specifications outlined in Exhibit D and applicable quality standards outlined in the Parties’ separate quality agreement, effective November 1, 2013 (the “Quality Agreement”).
Manufacturing Quality. ADM will manufacture all Products for sale in a manner consistent with good manufacturing practises and applicable standards, and in compliance with all Applicable Laws.
Manufacturing Quality. ACSD shall manufacture Product for Cubist in accordance with Exhibit D of this Agreement and under Current Good Manufacturing Practices (cGMPs) as required by the FDA and set forth in Title 21 Code of Federal Regulations Parts 210 and 211 (§§210.1-211.204 et. seq.), with particular emphasis on 211.22, 211.25 and 211.28 or the equivalents thereto pertaining to the responsibilities of a quality unit, personnel qualifications and personnel responsibilities respectively. According to the provisions of Exhibit D, ACSD will develop a cGMP-compliant quality unit at the Facility. This quality unit will follow and implement policies and procedures mutually authorized by ACSD and Cubist. Compliance with this Agreement is dependent upon, among other factors, ACSD hiring or training a full-time senior level quality manager reasonably acceptable to Cubist dedicated to, and located at, the Facility, to establish and lead the cGMP-compliant quality unit. ACSD will develop a cGMP compliant quality control test laboratory for the testing and release of Product.
Manufacturing Quality. IMPAX shall obtain all Materials from WCH approved suppliers. All Products shall be Manufactured at the Facility and in accordance with GMPs. IMPAX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable specifications therefor. Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to ++ (or such other contract laboratory specified by WCH) to perform the ++ to ensure that such Loratadine and Product, as the case may be, meet the ++. IMPAX shall promptly provide WCH with the results of such ++. ++ (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not be included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the ++ and shall not ship any Product to WCH that does not meet the ++. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. IMPAX shall promptly, upon completion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH's request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH's designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. ---------------- ++ Confidential portions omitted and filed separately with the Commission.
Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX shall obtain all Materials from WYETH approved suppliers and shall pay such suppliers on a timely and current basis. All Product shall be Manufactured by XXXXXXXXX at the Facility using Materials and processing aids free of animal derived materials. XXXXXXXXX shall meet all applicable Regulatory Requirements and WYETH Requirements for the Manufacture of the Product, including but not limited to, the requirements set forth in the agreed upon Quality Agreement. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement.
Manufacturing Quality. Fenwal shall perform the obligations in accordance with the Quality Agreement for Manufacture, Testing, and Release of INTERCEPT Blood System Medical Devices, entered into between Fenwal France S.A.S. and Cerus (the “Quality Agreement”), effective May 21, 2008, as the same may be amended from time to time, which is incorporated herein by reference. All Manufactured Products shall meet the Product Specifications and shall be subjected to quality control inspections by Fenwal in accordance with Fenwal’s quality control standards and system.
Manufacturing Quality. IMPAX shall obtain all Materials from WCH approved suppliers. All Products shall be Manufactured at the Facility and in accordance with GMPs. IMPAX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable specifications therefor. Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to XXXXX (or such other contract laboratory specified by WCH) to perform the Identity Testing to ensure that such Loratadine and Product, as the case may be, meet the Identity Criteria. IMPAX shall promptly provide WCH with the results of such Identity Tests. XXXXX (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not be included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the Identity Criteria and shall not ship any Product to WCH that does not meet the Identity Criteria. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. IMPAX shall promptly, upon completion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH’s request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH’s designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement.
Manufacturing Quality. Almac shall obtain all Materials from Almac’s existing suppliers or such other suppliers as may be approved in accordance with the terms of the Quality Agreement, and shall pay such suppliers on a timely and current basis. All Product shall be Manufactured at the Facility. [* * *].
Manufacturing Quality. The Corporation will manufacture all Products for sale in a manner consistent with good manufacturing practises and applicable standards, and in compliance with all Applicable Laws.
