Common use of Quality Control and Quality Assurance Clause in Contracts

Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Unless otherwise set forth in the Quality Agreement, Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Unless otherwise set forth in the applicable Product Agreement or Quality Agreement, each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a certification that the Batch has been evaluated by Patheon’s Quality Control/Quality Assurance department and that the Product complies with the Specifications and was manufactured in accordance with cGMPs. Patheon will test each Batch of Product to be supplied pursuant to this Agreement in accordance with the methods for the Product set forth in the Specifications before delivery of the Batch to Client. Client reserves the right to test or have tested all Products supplied by Patheon and to reject Product that fails to comply with the applicable Specifications or Product that was not manufactured in accordance with cGMPs or Applicable Laws. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those Batch documents is Client Property.