Common use of Client-supplied Materials Clause in Contracts

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement. Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from 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 thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s [**] cost, all 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 60 between [**] days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) and [**] days before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement. Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing to verify their identity and comply with such measures as other obligations with respect to such items that are expressly set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or 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 defects in Client-supplied Materials, or in Product resulting from 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 thereof, except for losses to the extent due to that such loss results from the negligent acts gross negligence or omissions willful misconduct of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14its Affiliates.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) [**] before the Processing Date. , unless such Processing requires microbial testing in which case Client shall deliver such Client’s failure -supplied Materials no later than [**] before the Processing Date; provided, that such Processing Date shall be communicated to fulfill the foregoing obligations Client in this Section 3.1 shall not by itself give rise writing sufficiently in advance of its occurrence to a cause of action in Catalent or a right by it reasonably enable Client to terminate this Agreementmeet such obligations. Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for ProcessingProcessing hereunder. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto. B. Following Within [**] following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store to verify their identity and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items as contemplated by the Specifications to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in . 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 defects in Client-supplied Materials, or in Product resulting from 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 thereof; provided, except for losses to that during the extent due to time Client-supplied Materials are in Catalent’s control, Catalent shall bear the negligent acts risk of loss of such Client-supplied Materials arising from the negligence or omissions willful misconduct of, or breach of this Agreement or Applicable Laws by, Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each caseits Affiliates, subject to the limitations set forth in Article 14. Promptly following Client’s written request at any time during the Term, Catalent will, at Client’s option, either (i) ship to Client (at Client’s cost) or (ii) make available for collection by Client at the Facility at which such items are stored, any and all Client-supplied Materials (as specified by Client), in either case no later than [**] after Catalent’s receipt of Client’s request. Catalent will reasonably cooperate with and assist Client in connection with any such request.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all DDP (Incoterms 2020) the Facility, Client-supplied Materials, Materials in quantities sufficient to meet Client’s requirements all binding orders for Product. Client shall deliver or cause to be delivered to the Facility such items and associated certificates of analysis analysis, lot numbers (to the Facility no later than 60 days extent applicable), and expiration dates (to the extent applicable) at least [***] (but not earlier no more than 90 days, unless agreed to by the Parties or accepted by Catalent) [***] before the applicable Processing Date. Client’s failure to fulfill Date (unless another timeframe is set forth in the foregoing obligations applicable Plan Document), or as otherwise set forth in this the Acknowledgement (as referenced in Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement4.3(B)). Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications 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 such items Client-supplied Materials solely for Processingperforming 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 such itemsClient-supplied Materials, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and instructions, health and environmental information information, and any Regulatory certifications governmental certification or authorizations authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall provide promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws received to: (i) verify their identity and labeled storage requirements, or lacking labeled storage requirement, the written instructions of (ii) inspect any such Client, as agreed to by Catalent, such agreement not to be unreasonably withheld-supplied Materials for any observable damage. Unless otherwise expressly required by the SpecificationsSpecifications or any Plan Document, Catalent shall have no obligation to test such items Client-supplied Materials to confirm that they meet the associated specifications or Specifications, certificate of analysis analysis, or otherwise; but 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 defects defect in Client-supplied Materials, or in Services or Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed to properly did not perform 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 costcost and risk. C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 90 days (but not earlier than 90 120 days, unless agreed to by the Parties or accepted by Catalent) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreementscheduled Delivery date. Client shall be responsible at its expense for securing any necessary DEA, export or export, import, similar or other licenses, clearances, permits permits, authorizations, or certifications required by Regulatory Authorities in respect of such supply. Catalent shall use such items Client-supplied Materials solely for ProcessingProcessing pursuant to this Agreement. Prior to or together with delivery of any such itemsClient-supplied Materials, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and instructions, health and environmental information information, and any Regulatory certifications governmental certification or authorizations authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed received to by Catalent, such agreement not to be unreasonably withheldverify their identity. Unless otherwise expressly required by the SpecificationsSpecifications or the Quality Agreement, Catalent shall have no obligation to test such items Client-supplied Materials to confirm that they meet the associated specifications or applicable Specifications, certificate of analysis or otherwise; but 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 defects defect in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed to properly did not 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 costcost 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 at all times and shall bear the risk of loss thereofof 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, except for losses to the extent due to the negligent acts or omissions Parties will conduct annual API reconciliations in accordance with Attachment D which includes loss of Client-supplied Materials as a result of (i) Catalent or Defective Processing, and (ii) Catalent’s failure to follow storage and handling requirements gross negligence or mutually agreed to written instructions of Client, in each case, subject to Article 14willful misconduct.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all Client-supplied Materials, including API reference standards, in quantities sufficient to meet Client’s requirements for ProductProduct under this Agreement. Client shall deliver such items and associated certificates of analysis to the Facility no later than 60 days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement[…***…]. Client shall be responsible at its expense for securing any necessary DEA, export or import, or similar clearances, clearances or permits or certifications required in respect of such supply. Catalent will provide reasonable support in obtaining such permits and customs clearance. Catalent shall use such items solely for ProcessingProcessing and in accordance with all Applicable Laws and Specifications. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Productinformation, and shall promptly provide any updates thereto. MSDS will be supplied at the signing of this Agreement. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures to verify their identity and provide, at a minimum and as are set forth mutually agreed in the Specifications. Catalent will receive, handleID, store peroxide value, and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions anisidine value testing of each lot of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld’s API. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall at all times use, handle and store the Client-supplied Materials in accordance with all Applicable Laws, the documentation provided by Client pursuant to Section 3.1.A hereof and any other written instructions from Client agreed by Catalent. C. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed except to the extent such defects arise out of Catalent’s negligence, willful misconduct or failure to properly perform the foregoing obligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of any defective Client-supplied Materials, at Client’s cost; provided that any replacement, return or disposal of defective Client-supplied Materials shall be at Catalent’s cost if the defects arise out of Catalent’s negligence, willful misconduct or failure to properly perform its obligations hereunder. Catalent’s liability hereunder, if any, shall be limited as set forth in Article 14. C. D. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14thereof until […***…].

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 [***] days (but not earlier than 90 [***] days, unless agreed to by the Parties or accepted by Catalent) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement. Client shall be responsible at its expense for securing any necessary DEAexport, export import or importother governmental clearance, similar clearances, permits permit or certifications certification required in respect of such supply. Catalent shall use such items Client-supplied Materials solely for Processing. Prior to delivery of any such itemsClient-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 Regulatory certifications governmental certification or authorizations authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall provide promptly provide any updates update thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed received to by Catalent, such agreement not to be unreasonably withheldverify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items Client-supplied Materials it receives to confirm that they meet the associated specifications or 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 defects defect in Client-supplied Materials, or in Product resulting from 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 thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or any such Client-supplied Materials unless as a result of gross negligence by Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s 's cost, all Client-supplied Materials, in quantities sufficient to meet Client’s 's requirements for Product. Client shall deliver such items and associated certificates of analysis to the Facility no later than 60 days [redacted] (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalentone-hundred and [redacted]) before the Processing Date. Client’s failure to fulfill delivery date agreed in the foregoing obligations Acknowledgement (as referenced in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement4.6(B)). Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Product, and shall promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in to verify their identity and perform testing according to the Specifications. For clarity, Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications Specifications or certificate of analysis or otherwise; but in otherwise only to the extent such testing or inspection is required by the Specifications. In the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed to properly perform the foregoing obligations. Catalent shall follow Client’s 's reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s 's cost. C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s costcost (except as otherwise set forth in this Agreement), all Client-supplied Materials, in quantities sufficient to meet Client’s requirements Purchase Orders for ProductProduct under this Agreement. Client shall deliver such items and associated certificates of analysis to the Facility no later than 60 days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) [***] before the Processing Date. Client’s failure to fulfill delivery date for the foregoing obligations applicable Products agreed in this the Acknowledgement (as defined in Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement4.3(B)). Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory regulatory certifications or authorizations relating to such Client-supplied Materials that may be required under Applicable Laws relating to the API and Productfor Processing of Product under this Agreement, and shall promptly provide any updates thereto. B. Following Within [***] after receipt of Client-supplied Materials [***], Catalent shall [***] to confirm that they meet the associated specifications or certificate of analysis or otherwise. Thereafter during the Term, within [***] after receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures to [***]. Notwithstanding anything to the contrary in this Section 3.1, Catalent shall [***], as are required under Applicable Law. Except as set forth in the Specifications. Catalent will receivethis Section 3.1(B), handleabove, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in . In the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt written notice of such nonconformity. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed to properly perform any of the foregoing obligationsobligations or caused such defects. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s reasonable cost. C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, thereof except for losses to the extent due to the negligent acts or omissions of Catalent or caused by Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14. Within [***] after the end of each month during the Term, Catalent shall provide a monthly report (in a form mutually agreed upon by the parties) identifying, on a component-by-component basis for each item of Client-supplied Materials, [***] (such aggregate amount in clause (ii) is referred to herein as the “Pre-Processing Losses”). In the event that, during any such calendar month, the Pre-Processing Losses [***], as reflected on the monthly report for such month, Catalent shall promptly credit to Client the value of such Pre-Processing Losses, which shall be applied to subsequent Purchase Orders under this Agreement. D. The parties shall determine target yield of API supplied by Client for Processing of Bulk Product [***] (each such determined yield, the “Calculated Bulk Product Target Yield”). Catalent shall use reasonable efforts to minimize waste and loss of API and Bulk Product. Notwithstanding anything to the contrary in this Section 3.1, in no event shall the actual yield for Bulk Product be [***]. In addition, Catalent shall Process at least [***] (the “Packaged Product Target Yield”, and together with the Calculated Bulk Product Target Yield, the “Target Yield”). Catalent shall bear any and all costs and expenses in connection with any failure to meet [***]. Catalent shall use commercially reasonable efforts to improve yields in the Processing. From time to time, the parties shall meet to discuss and set targets and goals of yield improvements. Within [***] following the end of each Contract Year, Catalent shall provide a written report of Catalent’s actual yield for such Contract Year. Catalent shall include with such report any reasonable documentation in support of the actual yield. If the actual yield for all Batches of Product during any applicable Contract Year is [***], Catalent’s sole liability and Client’s exclusive remedy for such shortfall in the actual yield shall be [***]. E. Within [***], Catalent shall provide a written report (in form and substance as mutually agreed upon by the parties) documenting and identifying, on a component-by-component basis for each item listed on Attachment D, for such Contract Year, the yield loss (the “Annual Loss Report”), and calculating the aggregate amount thereof. To the extent that such aggregate amount in such report is [***]and Catalent has not previously credited such amount pursuant to Section 3.1(C), Catalent shall promptly credit to Client the aggregate value of all yield losses for the Contract Year, which shall be applied to subsequent Purchase Orders under this Agreement; provided, however, that in the event such credit is not sufficient to offset against subsequent Purchase Orders prior to or after expiration of the Term or earlier termination of this Agreement, Catalent shall pay the balance of such excess within [***] after delivery of the written report provided by Client pursuant to this Section 3.1(E).

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 days [*] (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent[*]) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement. Client shall be responsible at its expense for securing any necessary DEA, export or import, or similar clearances, clearances or permits or certifications required in respect of such supply. Catalent shall use such items solely for Processing. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Productinformation, and shall promptly provide any updates thereto. B. Following receipt of Client-supplied Materials, Catalent shall (i) promptly inspect such items employing such measures as are to verify their identity and (ii) with respect to API, Catalent shall be responsible for release of the API, in accordance with the Specification, including identification test, visual inspection for appearance and review of the certificate of analysis. Unless otherwise set forth in the Specifications. Catalent will receivethis Agreement, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld. Unless otherwise expressly required by including the Specifications, Catalent shall have no additional obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt notice of such nonconformitynonconformity pursuant to the requirements in the Quality Agreement. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from 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 thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all 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 60 […***…] days (but not earlier than 90 […***…] days, unless agreed to by the Parties or accepted by Catalent) before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreementscheduled delivery date. Client shall be responsible at its expense for securing any necessary DEA, export export, import or importother governmental clearance, similar clearances, permits permit or certifications certification required in respect of such supplysupply of Client-supplied Materials. Catalent shall use such items Client-supplied Materials solely for Processing. Prior to delivery of any such itemsClient-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 Regulatory certifications governmental certification or authorizations authorization that may be required under Applicable Laws relating to the API and Product, and thereafter shall provide promptly provide any updates update thereto. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed received to by Catalent, such agreement not to be unreasonably withheldverify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items Client-supplied Materials it receives to confirm that they meet the associated specifications or 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 defects defect in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed to properly did not perform 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 thereof, except of any such Client-supplied Materials; provided that Catalent shall be responsible for losses resulting from […***…] subject to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of limitations on liability for Client, -supplied Materials as set forth in each case, subject to Article 14.

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all Client-supplied Materials, including API reference standards, in quantities sufficient to meet Client’s requirements for ProductProduct under this Agreement. Client shall deliver such items and associated certificates of analysis to the Facility no later than 60 […***…] days (but not earlier than 90 days, unless agreed to by the Parties or accepted by Catalent) […***…] days before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement[…***…]. Client shall be responsible at its expense for securing any necessary DEA, export or import, or similar clearances, clearances or permits or certifications required in respect of such supply. Catalent will provide reasonable support in obtaining such permits and customs clearance. Catalent shall use such items solely for ProcessingProcessing and in accordance with all Applicable Laws and Specifications. Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the API and Productinformation, and shall promptly provide any updates thereto. MSDS will be supplied at the signing of this Agreement. B. Following receipt of Client-supplied Materials, Catalent shall inspect such items employing such measures to verify their identity and provide, at a minimum and as are set forth mutually agreed in the Specifications. Catalent will receive, handleID, store peroxide value, and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions anisidine value testing of each lot of Client, as agreed to by Catalent, such agreement not to be unreasonably withheld’s API. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with Specifications, Catalent shall give Client prompt notice of such nonconformity. Catalent shall at all times use, handle and store the Client-supplied Materials in accordance with all Applicable Laws, the documentation provided by Client pursuant to Section 3.1.A hereof and any other written instructions from Client agreed by Catalent. C. Catalent shall not be liable for any defects in Client-supplied Materials, or in Product resulting from as a result of defective Client-supplied Materials, unless Catalent failed except to the extent such defects arise out of Catalent’s negligence, willful misconduct or failure to properly perform the foregoing obligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of any defective Client-supplied Materials, at Client’s cost; provided that any replacement, return or disposal of defective Client-supplied Materials shall be at Catalent’s cost if the defects arise out of Catalent’s negligence, willful misconduct or failure to properly perform its obligations hereunder. Catalent’s liability hereunder, if any, shall be limited as set forth in Article 14. C. D. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, subject to Article 14thereof until […***…].

Client-supplied Materials. A. Client shall supply to Catalent for Processing, at Client’s cost, all Client-supplied Materials, in quantities sufficient to meet Client’s requirements for Client Product as set forth in the Specifications with respect to such Client Product. Client shall deliver such items Client-supplied Materials and associated certificates of analysis to the Facility no later than 60 days (but not earlier than 90 [***] days, unless or as otherwise agreed to in writing by the Parties or accepted by Catalent) Parties, before the Processing Date. Client’s failure to fulfill the foregoing obligations in this Section 3.1 shall not by itself give rise to a cause of action in Catalent or a right by it to terminate this Agreement. Client shall be responsible at its expense for securing any necessary DEA, export license or importimport permit, similar clearances, permits or certifications required by Regulatory Authorities in respect of such supplyClient-supplied Materials. Catalent shall use such items solely for Processing. Prior to delivery of any such itemsClient-supplied Materials or Drug Product by Client to Catalent, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory Authority certifications or authorizations that may be required under Applicable Laws relating to the API Client-supplied Materials and Drug Product, and shall promptly provide any updates thereto.thereto received 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 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, 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 employing such measures as are set forth in the Specifications. Catalent will receive, handle, store and use all Client-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the written instructions of Client, as agreed to by Catalent, such agreement not to be unreasonably withheldverify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; 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 defects (including latent defects) in Client-supplied Materials, or in Product resulting from including Drug Product, that are attributable to defective Client-supplied MaterialsMaterials (including defective Drug Product), 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 MaterialsMaterials and Drug Product, at Client’s cost. C. Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof, except for losses to the extent due to the negligent acts or omissions of Catalent or Catalent’s failure to follow storage and handling requirements or mutually agreed to written instructions of Client, in each case, unless subject to Article 14.