Stability Activities. The responsibility for stability testing and reporting shall belong to BVL so long as Customer contracts such activities with BVL. Stability protocols will be prepared by BVL and jointly reviewed and approved by BVL and Customer. BVL will provide stability reports to Customer in accordance with specifications contained in stability proposals. Data interpretation and the updating of stability information to regulatory documents for the Product is the responsibility of Customer. Unless otherwise set forth in the applicable Proposal, all stability related activities under the responsibility of BVL shall be completed in accordance with Applicable Law and BVL SOPs, which, as to the portions of such SOPs that are Product-specific, shall be acceptable to Customer, which such acceptance shall not be unreasonably withheld.
Appears in 2 contracts
Sources: Manufacturing Agreement, Manufacturing and Service Contract (Targanta Therapeutics Corp.)