Supplier Quality Release. Supplier shall test (or if approved in writing by the Client have tested by third parties), in accordance with the Specifications, each Batch of Product Manufactured pursuant to this Agreement before delivery to Client. Product will be Released in accordance with the Quality Agreement. Product may not be delivered to Client until a person authorized by Supplier having the necessary qualifications, experience, and authority to oversee quality assurance of the Manufacture, and review and determine the suitability of individual Batches for Release under Applicable Law, has (a) conducted analyses using the analytical methods agreed to in writing by the Parties, (b) executed the Certificate of Analysis applicable to the Product and such other Batch documentation that may be requested by Client and (c) completed any other certifications or documents and other activities that may be required to Release the Product under Applicable Law and the Quality Agreement or Other Quality Arrangements. A Certificate of Analysis for each Batch delivered shall set forth the items tested, Specifications, and test results. Supplier shall also indicate on the certificate of cGMP compliance that the Batch has been Manufactured and Released under full compliance of the cGMP system. Supplier shall send, or cause to be sent, all such certificates to Client prior to the shipment of Product. Client shall have the option to test, or cause to be tested, for final release each Batch of Product as meeting the Specifications or, at its election, may conduct a paper release based upon the documentation (including the Certificate of Analysis) provided by Supplier. As required by the FDA, Client shall be responsible for final release of each Batch of Product.
