Common use of Specifications; Testing Clause in Contracts

Specifications; Testing. Subject to Section 9 below, CMO shall Manufacture Biologic that will conform to the Specifications for such Biologic as set forth in the applicable SOW or Quality Agreement or any Change Orders or amendments thereto. CMO shall test each Batch in accordance with the Specifications set forth in the applicable SOW or Quality Agreement (if applicable) and supply Client with batch-specific documentation (“Batch Documentation”) to be specified in the applicable Quality Agreement and which includes, but is not limited to: (a) a Certificate of Analysis for such Batch; (b) if such Batch is a GMP Batch, a Certificate of Compliance for such GMP Batch; (c) a summary report regarding the manufacture of such Batch in CMO’s standard form; and (d) other Batch-specific documents including analytical records (Quality Control), packaging records, material and component release records, master label templates, packaging configurations, etc. Batch Documentation shall be provided to Client at least 10 days prior to delivery of the Batch as set forth below in Section 5.2. Client shall take full responsibility for the suitability of the Specifications for Manufacturing a Biologic which possesses all desired characteristics and is suitable for the Manufacture of Client Product. CMO assumes no responsibility for any deficiency of the Specifications in this regard.