Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Adaptimmune, Merck shall provide Adaptimmune with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Adaptimmune shall, within the time defined in the Clinical Quality Agreement, perform with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Adaptimmune shall be solely responsible for taking all steps necessary to determine that Merck Compound or Adaptimmune Compound, as applicable, is suitable for release before making such Merck Compound or Adaptimmune Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Adaptimmune in connection with such determination with respect to the Merck Compound. Adaptimmune shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Adaptimmune shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Adaptimmune hereunder.
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Sources: Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC), Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)