Common use of Specifications and Test Methods Clause in Contracts

Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOP’s. Upon receipt, the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Cangene. Cangene will provide to Patheon the Active Material Specifications. Cangene will provide to Patheon test methods for Active Material and excipient’s (if non-compendial). Cangene is responsible for validating non-compendial testing methods. If these methods are not validated by Cangene, then Patheon may assist in validation development with the costs being borne by Cangene.