Product Maintenance Services. Catalent shall provide and Client will receive those product maintenance services specified in Attachment D (the “Product Maintenance Services”).
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).
Product Maintenance Services. Client will receive the following product maintenance services (the “Product Maintenance Services”): one annual audit (as further described in Section 9.5); regulatory audits (as further described in Section 9.4); one annual Product review (within the meaning of 21 CFR § 221.180); drug master file updates for the Territory, if applicable; access to document library over and above the Quality Agreement, including additional copies of Batch paperwork or other Batch documentation; assistance in preparing Regulatory Approvals; Product document and sample storage relating to cGMP requirements; vendor re-qualification; and maintenance, updates and storage of master batch records and audit reports. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: technology transfer; analytical work; stability; and process rework.
Product Maintenance Services. Palatin will receive the product maintenance services set out in Attachment B (the “Product Maintenance Services”).
Product Maintenance Services. During the Term and subject to Reliant’s payment of the Product Maintenance fee as set forth in section 7.2, Reliant shall be entitled to the following 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 Sample Storage relating to cGMP requirements; • Vendor re-qualification; • Maintenance and storage of Audit Reports; and • Bulk stability (6 months, warehouse conditions).
Product Maintenance Services. Client will receive the following product maintenance services (the “Product Maintenance Services”): […***…]. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: […***…].
Product Maintenance Services. Client will receive product maintenance services (the “Product Maintenance Services”), [*], as applicable. In the event Client does not [*] pursuant to Section 4.1 herein. Catalent shall keep accurate records of any Product Maintenance Services utilized by Client during a given Contract Year. Beginning at the end of Contract Year 2, either, party may request an annual review of the actual usage of Product Maintenance Services and Client shall be entitled to audit Catalent’s records regarding Product Maintenance Services rendered to Client. Thereafter, the parties shall [*].
Product Maintenance Services. Catalent shall provide the following product maintenance services on a timely basis and in accordance with the Specifications, Applicable Laws and the terms of this Agreement (the “Product Maintenance Services”): [*], if applicable; [*], including [*], as applicable. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: [*], as applicable.
Product Maintenance Services. Supernus will receive the following product maintenance services at no additional cost to Supernus (the “Product Maintenance Services”): one annual audit (as further described in Section 8); regulatory audits (as further described in Section 10); one annual Product review (within the meaning of 21 CFR § 211.180); Product document and sample storage relating to eGMP requirements; maintenance, updates and storage of master batch records and audit reports.
Product Maintenance Services. Client will receive the following product maintenance services (the “Product Maintenance Services”): one dedicated project manager at Winchester to coordinate and expedite all shipments in lieu of Client; [ * ] (as further described in the Quality Terms); regulatory audits (as further described in the Quality Terms); one annual Product review (within the meaning of 21 CFR § 211.180); Product document and sample storage relating to cGMP requirements (including without limitation storage of reference materials for assays); access to document library over and above the Quality Terms, including additional copies of Product Lot paperwork or other Product Lot documentation; assistance in preparing Regulatory Approvals; annual Raw Materials vendor re-qualification; maintenance, updates and storage of master batch records and audit reports; bulk stability ([ * ] months, warehouse conditions); and replacement product-dedicated fluid bed filter bags and HPLC columns, as applicable (including but not limited to ensuring the inventory of an adequate stock of replacement parts for instruments and equipment required in order to perform the Processing). For avoidance of doubt, the following services and items are not included in Product Maintenance Services: technology transfer; analytical work; stability, other than the bulk stability described above; and any process changes specifically requested by Client.
