Manufacturing Quality. Storage. ACCESS shall ensure that ACCESS or ACCESS’s Third Party Manufacturers shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated. Free of defects and meet the applicable specifications therefore. ACCESS shall take all necessary steps to attempt to prevent contamination and cross contamination of Products. The Products shall be delivered to DISCUS in fully finished form and in their final, FDA-approved packaging configuration(s), including all applicable labeling and package inserts, and with a minimum shelf-life remaining for each lot of Product delivered therein to DISCUS of three months less than the approved shelf life. All Products Manufactured by ACCESS shall be certified by ACCESS. ACCESS shall or shall cause ACCESS’s Third Party Manufacturers to (i) meet the standards for identity, quality, safety, strength and purity of the ingredients as specified in the approved New Drug Application for Products, and that the Products and their raw materials were handled and manufactured such that they meet FDA standards for identity and purity of the Product as specified in the approved New Drug Application for the Product, (ii) certify that each lot of Product has been manufactured in full compliance with Good-Manufacturing Practices (GMP)/Good Laboratory Practices (GLP) and all ISO regulations applicable to the manufacture, testing and release of pharmaceuticals, and certify that each lot of Product is unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Products specifications and generally accepted pharmaceutical standards, (iii) perform the quality control tests (both when the Products are in-process and when they are finished) with respect to the Products in accordance with the Methods of Analysis, the cost of such to be included in the price hereinafter specified, and shall promptly, upon completion of such tests, deliver to DISCUS a Certificate of Analysis for each Batch of Products which lists the results of such tests and demonstrates that the products meet identify and purity standards approved by the FDA in ‘s approved New Drug Application for the Product and (v) deliver a representative sample from each Batch of Products to DISCUS’s designated representative at the same time each batch is delivered to DISCUS.
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. 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. 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. 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. (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. 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. [* * *]. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Manufacturing Quality. SDIX shall operate, maintain and abide by the requirements of [***] or its replacement or equivalent, as applicable. SDIX shall use Commercially Reasonable Efforts to prevent contamination and cross contamination of the Supplied Products. Supplied Products shall be unadulterated and free from contamination, diluents and foreign matter in any amount. SDIX shall perform the quality control tests with respect to the Supplied Products in accordance with the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. SDIX shall promptly, upon completion of such tests, deliver to BD a copy of the record of such tests performed on, and a Certificate of Analysis for, each lot of Supplied Product delivered to BD hereunder. SDIX shall deliver to BD’s designated representative, by the date specified by such representative, a representative sample from each lot of Supplied Product delivered to BD hereunder.
Manufacturing Quality. Fresenius Kabi shall perform the obligations in accordance with the Quality Agreement. All Manufactured Products shall be subjected to quality control inspections by Fresenius Kabi in accordance with Fresenius Kabi’s quality control standards and system and by Cerus to ensure adherence to the obligations set forth in the Quality Agreement.
