Common use of Manufacturing Quality Clause in Contracts

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. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, ▇▇▇▇▇▇▇▇▇ shall obtain all Materials from WYETH approved suppliers and shall pay such suppliers on a timely and current basis. All Licensed Adjuvants Product shall be manufactured Manufactured by ▇▇▇▇▇▇▇▇▇ at the Facility using Materials and processing aids free of animal derived materials. ▇▇▇▇▇▇▇▇▇ 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 the Quality Agreement. All Licensed Adjuvants shall be manufactured at Supplier’s facility or a designated facility of a Sub-Manufacturer such agreement. (“Supplier Facility”b) 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 Specifications therefor. Supplier ▇▇▇▇▇▇▇▇▇ shall take all necessary steps to prevent contamination and cross contamination of Licensed AdjuvantsProduct. Licensed Adjuvants Product 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 Product in accordance with the methods of analysis that have been suitably qualified and approved as set forth in Specifications using 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 WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each shipment Batch of Licensed Adjuvant to PurchaserProduct. Supplier Upon request, ▇▇▇▇▇▇▇▇▇ shall deliver a representative sample from each shipment Batch of Licensed Adjuvant Product to Purchaser’s WYETH's designated representative by the date and in the manner specified by such representative. ▇▇▇▇▇▇▇▇▇ shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, ▇▇▇▇▇▇▇▇▇ shall invoice WYETH for shipping costs.