Common use of Quality Release Clause in Contracts

Quality Release. Product may not be delivered to Client until a person authorized by Provider having the necessary qualifications, experience and authority to oversee quality assurance of the manufacture 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 (i.e., the written test results of a batch that is tested against the applicable criteria in the Specifications, and confirmation the batch passed the test) applicable to the Product and such other batch documentation that may be requested by Client and (c) completed any other certifications or documents including but not limited to Certificate of Compliance and other activities that may be required to release the Product under Applicable Law and the Quality Agreement. Provider will deliver a Certificate of Analysis, Documentation, completed batch documentation, any investigation reports of any Out of Specification result or Manufacturing deviation, and Certificate of Compliance along with delivery of samples of the Product for review by Client. Notwithstanding the foregoing, at Client’s request, Provider may deliver Product in quarantine prior to delivery of the Certificate of Analysis, batch documentation, and Certificate of Compliance. The request must be accompanied by Client’s written acknowledgement that (a) the Product has been delivered without a Certificate of Analysis, batch documentation, and Certificate of Compliance (b) accordingly, the Product cannot be administered to humans until transmittal of the Certificate of Analysis, batch documentation, and Certificate of Compliance and (c) that Client nevertheless accepts full risk of loss, title and ownership of the Product with the exception for any case in which the batch fails to meet Specifications. The delivery of Product in quarantine will be subject to such testing requirements as Provider may reasonably require.