Common use of Stability Studies Clause in Contracts

Stability Studies. Patheon shall conduct stability studies on the Finished Products according to the Specifications therefor, as required by the FDA or Foreign Regulatory Authorities as advised by Santarus or as requested by Santarus, and in any case on at least one batch of Finished Product from the Facility at least once per calendar year following Commencement of Commercial Manufacturing or more frequently as may be specified in the Quality Agreement. Patheon shall provide to Santarus a report of all results and data obtained from such stability studies annually or more frequently as may be specified in the Quality Agreement.

Appears in 3 contracts

Sources: Manufacturing Agreement (Santarus Inc), Manufacturing and Supply Agreement (Santarus Inc), Manufacturing and Supply Agreement (Santarus Inc)