Common use of Analysis of Materials Clause in Contracts

Analysis of Materials. Prior to use in production, Gilead shall have shipments of API and Product Materials analyzed for such matters as Eyetech may require in accordance with the Specifications, Quality Agreement, attached Product Supplements and Gilead standard operating procedures, and Gilead shall ensure that all API and Product Materials conform to the Specifications as determined by such required analysis. Such analyses may be conducted by Gilead internally or by an outside laboratory retained by Gilead and reasonably approved by Eyetech. For purposes of this Agreement, such tests shall be considered routine and shall be performed at Gilead's expense. All test results are to be documented in accordance with cGMP and available for inspection at Eyetech's request upon reasonable notice during reasonable business hours. Eyetech will be responsible for the costs of replacement and disposition for all API, except to the extent that such API fails to conform to Specifications due to Gilead's non-compliance with Section 5.4(a) or this Section 5.7. Gilead will be responsible for the costs of replacement and disposition of Product Materials that fail to conform to Specifications subject to the limitation set forth in Section 11.3(b).

Appears in 2 contracts

Sources: Manufacturing Agreement (Eyetech Pharmaceuticals Inc), Manufacturing and Supply Agreement (Osi Pharmaceuticals Inc)