Product Maintenance Services. During the Term and subject to Reliant’s payment of the Product Maintenance Fee as set forth in Section 7.2, if applicable, Reliant shall be entitled to the Product maintenance services set forth below (collectively, the “Product Maintenance Services”). For the avoidance of doubt, in the event that, in accordance with the terms of Section 7.2, Reliant [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. is not required to pay the Product Maintenance Fee, Reliant shall nonetheless be entitled to the Product Maintenance Services: • Administration of Foreign Trade Zone; • One annual audit; • Annual Product review; • Access to document library over and above the Quality Agreement, including additional copies of batch paperwork or other batch documentation; • Annual Drug Master File update; • Preparation of Product licenses or permits under United States local, state or Federal regulations (in each case as more fully set forth in Article 10); • Product Document and Manufacturing Sample Storage relating to cGMP requirements; • Vendor re-qualification; • Maintenance and storage of Audit Reports; and • Bulk stability (6 months, warehouse conditions).
Appears in 4 contracts
Samples: Manufacturing Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)
