Processing Related Services Clause Samples
Processing Related Services. 2.1 Supply and Purchase of Packaging. PCI shall Package Bulk Product in accordance with the Specifications, Applicable Laws and the terms and conditions of this Agreement and the Quality Agreement for the consideration provided herein. Client shall be responsible for the manufacturing and testing of Bulk Products at the manufacturer. As agreed in writing by the Parties, including as required by the Specifications and the Quality Agreement, PCI shall be responsible for incoming testing of Bulk Products and testing of Packaged Products. Client shall be responsible for the transportation, sale and distribution of the Packaged Product.
Processing Related Services. 2.1 Supply and Purchase of Product. Catalent shall Process Product in accordance with the Specifications, Applicable Laws and the terms and conditions of this Agreement.
2.2 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.
Processing Related Services