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. 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. Palatin will receive the product maintenance services set out in Attachment B (the “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. 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. 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. Client will receive the following product maintenance services (the “Product Maintenance Services”): one annual audit (as further described in Section 9.4); regulatory inspections (as further described in Section 9.3); one annual product review (within the meaning of 21 CFR § 211.180) per Drug Product and Client Product; serialization per Drug Product and Client Product packaging configuration; drug master file updates for the Territory, if applicable; access to document library over and above the Quality Agreement, including additional copies of Batch Records, Batch paperwork or other Batch documentation; assistance in preparing Regulatory Approvals; monthly inventory reports, annual inventory support, Drug Product and Client Product documents and sample storage relating to cGMP requirements; vendor re-qualification; maintenance, updates and storage of master batch records and audit reports; and tooling and filter bag maintenance, as applicable. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: technology transfer; analytical work; stability, process rework, PPQ, maintenance and repair of Client Equipment and Validation Services.
Product Maintenance Services. Supernus will receive the following product maintenance services at no additional cost to Supernus (the “Product Maintenance Services”): one annual audit; regulatory audits; 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; assistance in preparing Regulatory Documentation as needed; Product document and sample storage relating to cGMP requirements; maintenance, updates and storage of ** This portion has been redacted pursuant to a confidential treatment request. master batch records and audit reports; and tooling and filter bag maintenance, as applicable. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: process validation (including cleaning and shipping validation; technology transfer; analytical work not specifically related to testing and release of excipients or in-process testing of Product; stability; replacement HPLC columns and replacement tablet tooling, as applicable. The list of services and items included in and excluded from the unit Price are set forth in Schedule 7.7.
