Common use of Specifications and Test Methods Clause in Contracts

Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the CTM in accordance with the approved Specifications, analytical methods, and Patheon’s SOP’s. The Client will provide to Patheon the Active Material Specifications including a certificate of analysis. The Client will provide to Patheon test methods for Active Material and excipient’s (if non-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development with [***].

Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the CTM in accordance with the approved Specifications, analytical methods, and Patheon’s SOP’s. The Client will provide to Patheon the Active Material Specifications including a certificate of analysis. CTM Quality Agreement QG01-05-T002-01 age2of16 The Client will provide to Patheon test methods for Active Material and excipient’s (if non-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development with [***].