Common use of Client-supplied Materials Clause in Contracts

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, DDP (Incoterms 2020) the Facility, Client-supplied Materials in quantities sufficient to meet all binding orders for Product. Client shall deliver or cause to be delivered to the Facility such items and associated certificates of analysis, lot numbers (to the extent applicable), and expiration dates (to the extent applicable) at least [***] (but no more than [***] before the applicable Processing Date (unless another timeframe is set forth in the applicable Plan Document), or as otherwise set forth in the Acknowledgement (as referenced in Section 4.3(B)). Client shall be responsible at its expense for securing any necessary governmental approval required in respect of such supply, including any controlled-substance, export, import, or other governmental clearance, permit, or certification from the U.S. Drug Enforcement Administration, U.S. Immigration and Customs Enforcement, or any comparable non-U.S. governmental authority. Catalent shall use Client-supplied Materials solely for performing Services. Catalent shall not transfer the Client-supplied Materials, or otherwise provide access to the Client-supplied Materials to any Third Party without the prior written consent of Client (which may consist in the execution of a Change Order or a SOW). Catalent agrees that no express or implied licenses or other rights relating to the Client-supplied Materials are provided to Catalent under any Patents, trade secrets or other proprietary rights of Client except to use such Client-supplied Materials solely in accordance with this Agreement and the applicable Plan Documents. Prior to delivery of any Client-supplied Materials, Client shall provide to Catalent a copy of all associated safety data sheets, safe handling instructions, health and environmental information, and any governmental certification or authorization that may be required under Applicable Laws relating to Product, and thereafter shall provide promptly any updates thereto. B. Catalent shall inspect all Client-supplied Materials received to: (i) verify their identity and (ii) inspect any such Client-supplied Materials for any observable damage. Unless otherwise expressly required by the Specifications or any Plan Document, Catalent shall have no obligation to test Client-supplied Materials 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 Services or Product as a result of defective Client-supplied Materials, unless Catalent did not perform the foregoing obligations 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 and risk.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, DDP (Incoterms 2020) the Facility, Client-supplied Materials in quantities sufficient to meet all binding orders Client’s requirements for Product. Client shall deliver or cause to be delivered to the Facility such items and associated certificates of analysis, lot numbers (analysis to the extent applicable), and expiration dates (to the extent applicable) at least [***] Facility no later than 90 days (but no more not earlier than [***] 120 days) before the applicable Processing Date (unless another timeframe is set forth in the applicable Plan Document), or as otherwise set forth in the Acknowledgement (as referenced in Section 4.3(B))scheduled Delivery date. Client shall be responsible at its expense for securing any necessary governmental approval required in respect of such supply, including any controlled-substanceDEA, export, import, or other governmental clearancelicenses, permitclearances, permits, authorizations, or certification from the U.S. Drug Enforcement Administration, U.S. Immigration and Customs Enforcement, or any comparable non-U.S. governmental authoritycertifications required by Regulatory Authorities in respect of such supply. Catalent shall use Client-supplied Materials solely for performing Services. Catalent shall not transfer the Client-supplied Materials, or otherwise provide access Processing pursuant to the Client-supplied Materials to any Third Party without the prior written consent of Client (which may consist in the execution of a Change Order or a SOW). Catalent agrees that no express or implied licenses or other rights relating to the Client-supplied Materials are provided to Catalent under any Patents, trade secrets or other proprietary rights of Client except to use such Client-supplied Materials solely in accordance with this Agreement and the applicable Plan DocumentsAgreement. Prior to or together with delivery of any Client-supplied Materials, Client shall provide to Catalent a copy of all associated safety data sheets, safe handling instructions, 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 promptly provide promptly any updates thereto. B. Catalent shall inspect all Client-supplied Materials received to: (i) to verify their identity and (ii) inspect any such Client-supplied Materials for any observable damageidentity. Unless otherwise expressly required by the Specifications or any Plan Documentthe Quality Agreement, Catalent shall have no obligation to test Client-supplied Materials to confirm that they meet the associated applicable Specifications, certificate of analysis, 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 Services or Product as a result of defective Client-supplied Materials, unless Catalent did not perform the foregoing obligations in accordance with the Specificationsobligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s cost and risk. C. Catalent will receive Client-supplied Materials arriving at the Facility in accordance with established Facility procedures, and will handle, store, use and dispose of them in accordance with this Agreement, any safety data sheets, safe handling instructions and health and environmental information associated therewith. D. Subject to applicable limits on liability in Article 14, Catalent shall bear risk of loss to Client-supplied Materials wasted as a result of (i) Catalent Defective Processing, and (ii) Catalent’s gross negligence or willful misconduct. Client shall always retain title to Client-supplied Materials and shall bear the risk of loss of any such Client-supplied Materials other than as set forth in this subsection E. Client shall obtain and maintain insurance for Client-supplied Materials (other than In-Process Materials) while at the Facility and in transit to and from any Facility in accordance with Article 15. E. Subject to applicable limits on liability in Article 14, the Parties will conduct annual API reconciliations in accordance with Attachment D which includes loss of Client-supplied Materials as a result of (i) Catalent Defective Processing, and (ii) Catalent’s gross negligence or willful misconduct.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, DDP (Incoterms 2020) the Facility, all Client-supplied Materials Materials, in quantities sufficient to meet all binding orders Client’s requirements for Client Product as set forth in the Specifications with respect to such Client Product. Client shall deliver or cause to be delivered to the Facility such items Client-supplied Materials and associated certificates of analysis, lot numbers (analysis to the extent applicable), and expiration dates (to the extent applicable) at least [***] (but Facility no more later than [***] before the applicable Processing Date (unless another timeframe is set forth in the applicable Plan Document)days, or as otherwise set forth agreed to in writing by the Acknowledgement (as referenced in Section 4.3(B))Parties, before the Processing Date. Client shall be responsible at its expense for securing any necessary governmental approval DEA, export license or import permit, similar clearances, permits or certifications required by Regulatory Authorities in respect of such supply, including any controlledClient-substance, export, import, or other governmental clearance, permit, or certification from the U.S. Drug Enforcement Administration, U.S. Immigration and Customs Enforcement, or any comparable non-U.S. governmental authoritysupplied Materials. Catalent shall use Client-supplied Materials such items solely for performing Services. Catalent shall not transfer the Client-supplied Materials, or otherwise provide access to the Client-supplied Materials to any Third Party without the prior written consent of Client (which may consist in the execution of a Change Order or a SOW). Catalent agrees that no express or implied licenses or other rights relating to the Client-supplied Materials are provided to Catalent under any Patents, trade secrets or other proprietary rights of Client except to use such Client-supplied Materials solely in accordance with this Agreement and the applicable Plan DocumentsProcessing. Prior to delivery of any such Client-supplied MaterialsMaterials or Drug Product by Client to Catalent, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions, instructions and health and environmental information, information and any governmental certification Regulatory Authority certifications or authorization authorizations that may be required under Applicable Laws relating to Product, and thereafter shall provide promptly any updates thereto. B. Catalent shall inspect all the Client-supplied Materials and Drug Product, and shall promptly provide any updates thereto received to: (i) verify their identity by Client. If Drug Product is a List 1 chemical or controlled substance under Applicable Laws, including Drug Enforcement Agency regulations, then each Party will handle such Drug Product, Processing thereof and (ii) inspect any such Client Product in accordance with the material safety data sheets and all requirements set forth in the Specifications, the Quality Agreement and Applicable Laws. Cost for storage of Client-supplied Materials for any observable damageMaterials, Drug Product and Client Product is provided in Attachment C. B. Following receipt of Client-supplied Materials, including Drug Product, Catalent shall inspect such items to verify their identity. Unless otherwise expressly required by the Specifications or any Plan DocumentSpecifications, Catalent shall have no obligation to test Client-supplied Materials such items to confirm that they meet the associated Specifications, specifications or certificate of analysis, analysis or otherwise; but, but in the event that Catalent detects a nonconformity with the Specifications, Catalent shall give Client prompt written notice of such nonconformity. Catalent shall not be liable for any defect defects (including latent defects) in Client-supplied Materials, or in Services or Product as a result of including Drug Product, that are attributable to defective Client-supplied MaterialsMaterials (including defective Drug Product), unless Catalent did not failed to properly perform the foregoing obligations in accordance with the Specificationsobligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied MaterialsMaterials and Drug Product, at Client’s cost cost. C. Client shall retain title to Client-supplied Materials at all times and riskshall bear the risk of loss thereof, unless subject to Article 14.