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 Antigen Express, Merck shall provide Antigen Express with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Antigen Express 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. Antigen Express shall be solely responsible for taking all steps necessary to determine that Merck Compound or Antigen Express Compound, as applicable, is suitable for release before making such Merck Compound or Antigen Express Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Antigen Express in connection with such determination with respect to the Merck Compound. Antigen Express 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. Antigen Express 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 Antigen Express hereunder.
Appears in 2 contracts
Sources: Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (Generex Biotechnology Corp)