Termination of a Batch Sample Clauses

Termination of a Batch. Catalent shall have full authority, subject to compliance with the Quality Agreement, to make the decision to terminate a Batch before completion, provided that Catalent will promptly confer with Passage Bio during the Batch Processing to determine whether a Batch that is otherwise outside agreed upon process parameters (based upon in-process testing) may ultimately be accepted by Passage Bio. For example, a Batch may be low yielding but otherwise meet all release specifications and deemed acceptable. Prior to terminating a Batch, Catalent shall confer with Passage Bio regarding acceptance of the Batch despite the fact that it is out of trend (or, for example, out of the in-process acceptance range on yield). If Passage Bio agrees in writing (e-mail is acceptable) to accept the Batch despite the low yield (or other related parameters) it may not later reject the Batch for that reason. The Parties agree that with respect to meeting the quality and safety specifications of a Batch, a Batch that does not meet the Specifications will be deemed a Failed Batch. As set forth in Section 8 below and following Passage Bio Approval of a Batch and Delivery by Catalent, Passage Bio may later reject the Batch and deem it a Defective Batch if it determines through its own release testing that the Batch does not meet the Product Requirements. ​

Termination of a Batch. [**] shall have full authority, subject to compliance with the Quality Agreement and the proviso below, to make the decision to terminate a Batch before completion and may confer with [**] during the Batch Processing to determine whether a Batch that is otherwise outside agreed upon process parameters (based upon in-process testing) may ultimately be accepted [**]. Prior to terminating a Batch, [**] may elect to confer with [**] regarding acceptance of the Batch despite the fact that it is out of trend. If Sarepta agrees to accept the Batch after notice of a deviation from agreed upon process parameters, it may not later reject the Batch for that reason. The Parties agree that with respect to meeting the quality and safety specifications of a Batch, a Batch that does not meet the Specifications will be deemed a Failed Batch. As set forth in Section 8 below and following Sarepta Approval of a Batch and Delivery by Catalent, Sarepta may later reject the Batch and deem it a Defective Batch if it determines through its own release testing that the Batch does not meet the Product Requirements.