Common use of Product Maintenance Services Clause in Contracts

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. Client will receive the following product maintenance services (the “Product Maintenance Services”): one (other than for-cause audits) annual audit (as further described in Section 9.59.4); regulatory audits inspections (as further described in Section 9.49.3); one annual Product review (within the meaning of 21 CFR § 221.180211.180); 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 Approvalssubmissions; Product document and sample storage relating to cGMP requirements; vendor re-qualification; and maintenance, updates and storage of master batch 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. Client will receive the following product maintenance services (the “"Product Maintenance Services”"): one annual audit (as further described in Section 9.59.4); regulatory audits (as further described in Section 9.49.3); one annual Product review (within the meaning of 21 CFR § 221.180211.180); 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 documentation and sample storage relating to cGMP requirements; vendor re-qualification; and maintenance, updates and storage of master batch Batch records and audit reports. For clarity, Catalent will qualify Catalent directed vendors and Client is responsible for qualifying its vendors. For avoidance of doubt, the following services and items are not included in Product Maintenance Services: technology transfer; packaged Product retained samples, analytical work; stability; and process rework.