Testing and Acceptance Process. 7.1 Testing by Manufacturer. The Products to be Manufactured under this Agreement will be Manufactured in accordance with cGMP, unless otherwise stated in the SOW, and the Manufacturing Process approved by Alnylam. Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable) and the Manufacturing Process.
Testing and Acceptance Process. Upon QP release or other comparable quality review procedure of any Batch of Clinical Product by Arrowhead in accordance with Arrowhead’s customary quality processes, Arrowhead shall notify Jxxxxxx in writing of (a) its acceptance of Clinical Product transferred hereunder or (b) its belief that such Batch of Clinical Product fails to conform to the Specifications or was not Manufactured in compliance with GMP and the Specifications. If the Parties determine that the Clinical Product is not in compliance with GMP or the Specifications, Arrowhead will not use the non-compliant Batch of Clinical Product in humans, and the Parties through the JSC will decide upon the course of action with respect to any non-conforming Clinical Product.
Testing and Acceptance Process
