Batch definition
Examples of Batch in a sentence
The Parties shall jointly define the objectives, success criteria, and reporting requirements for each Engineering Batch.
Cellares will maintain complete and accurate records of the production of each Batch of Product (including without limitation Batch Records) in electronic form accessible to Partner and as required by Applicable Laws, including without limitation cGMP, and in accordance with the Quality Agreement.
Cellares shall manufacture cGMP Batches in accordance with this Agreement (including the applicable Quality Agreement and SOW), cGMP, Applicable Law, the approved manufacturing Batch Records, and the applicable Specifications.
If a Batch of Product fails to comply with the applicable Specifications, Manufacturing Process or cGMP, and Cellares is responsible for such failure as provided in this Section 4.1, then [***].
Cellares shall deliver to Partner a Certificate of Analysis and Certificate of Compliance with respect to each cGMP Batch.