Audit; Contract Manufacturers Sample Clauses

Audit; Contract Manufacturers. Each party shall have the right to inspect all manufacturing facilities utilized by the other party, and to review manufacturing procedures and practices employed, in order to verify their conformance with applicable GMP, GLP and other regulatory requirements. Prior to consummating any Third Party manufacturing arrangement contemplated hereunder, Vertex, Lilly and such Third Party shall promptly consider and mutually agree on reasonable manufacturing audit procedures, appropriate and customary under the circumstances, that may be implemented with respect to the Third Party manufacturing arrangement. Either party may employ reputable contract manufacturers to meet all or a part of their respective manufacturing responsibilities under this Agreement. Any such contract manufacturer shall have a previously demonstrated capacity to manufacture acceptable quality and quantities of drug products for use in pharmaceuticals sold in major industrial markets. Activities referred to a Third Party contract manufacturer shall nevertheless remain the overall responsibility of the referring party who will closely supervise the contract manufacturer and participate with it as appropriate in the particular task referred.
Sample 1
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