Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, Client-supplied Materials, in quantities sufficient to meet Client’s requirements for Product. Client shall deliver such items and associated certificates of analysis to the Facility no later than [***] days (but not earlier than [***] days) before the Processing Date. Client shall be responsible at its expense for securing any necessary export, import or other governmental clearance, permit or certification required in respect of such supply. Catalent shall use Client-supplied Materials solely for Processing. Prior to delivery of any Client-supplied Materials, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any governmental certification or authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall provide promptly any update thereto. B. Catalent shall inspect all Client-supplied Materials received to verify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test Client-supplied Materials it receives to confirm that they meet the associated specifications, certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with the Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall not be liable for any defect in Client-supplied Materials, or in Product as a result of defective Client-supplied Materials, unless Catalent failed to properly perform the foregoing obligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s cost. C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss of any such Client-supplied Materials unless as a result of gross negligence by Catalent.
Appears in 1 contract
Sources: Commercial Supply Agreement (Biohaven Pharmaceutical Holding Co Ltd.)
Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, Client-supplied Materials, Materials in quantities sufficient to meet Client’s requirements for Product. Client shall deliver such items and associated certificates of analysis to the Facility no later than [***] days (but not earlier than [***] days) before the Processing Date. Client shall be responsible at its expense for securing any necessary DEA, export, import or other governmental clearance, permit or certification required in respect of such supply. Catalent shall use Client-supplied Materials solely for Processing. Prior to delivery of any Client-supplied Materials, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any governmental certification or authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall provide promptly any update thereto.
B. Catalent shall inspect all Client-supplied Materials received to verify their identity. Unless otherwise expressly required by identity and conformance with certificates of analyses and the Specifications, Catalent shall have no obligation to test Client-supplied Materials it receives to confirm that they meet the associated specifications, certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with the Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall not be liable for any defect in Client-supplied Materials, or in Product as a result of defective Client-supplied Materials, unless Catalent failed to properly did not perform or was negligent in performing the foregoing obligationsobligations in accordance with the Specifications. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s cost.
C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss of any such Client-supplied Materials unless as a result of gross negligence by CatalentMaterials. Client shall obtain and maintain insurance for such items while at the Facility and in transit to and from any Facility in accordance with Article 15.
Appears in 1 contract
Sources: Manufacturing Preparation and Commercial Supply Agreement (Avadel Pharmaceuticals PLC)