Common use of Batch Release Clause in Contracts

Batch Release. 3.1 Batch review and release to Client shall be the responsibility of Patheon who shall act in accordance with Patheon's standard operating procedures. 3.2 For each batch released by Patheon for shipment to the Client, Patheon shall deliver to the Client a certificate of analysis/certificate of compliance, which shall include a statement that the batch has been manufactured in accordance with cGMPs and the Specifications. The Client shall have sole responsibility for release of the Product to the market. 3.3 Patheon shall notify the Client in the event of (i) any major deviation during manufacture which affects the quality or efficacy of the Product or (ii) a confirmed OOS result.