Common use of Api and Composition Clause in Contracts

Api and Composition. 2.1.1. Customer shall, at its own expense, supply BVL with sufficient quantities of API and other Customer-supplied Composition needed for the Development or Manufacture of Product, as specified in the Purchase Orders, in order to meet Customer’s requirements as set forth in Section 4.1 for commercial, Developmental and/or other quantities of Product in finished dosage form. Customer will provide API and any other mutually agreed Customer-supplied Composition at least thirty (30) calendar days in advance of the scheduled Manufacturing date in accordance with BVL’s SOP’s that are acceptable to Customer, which such acceptance shall not be unreasonably withheld, or in accordance with such other inventory procedures as may from time to time be mutually agreed upon by the Parties in writing. Customer’s provision of API to BVL shall not exceed that amount required for the existing, open Purchase Orders and, in any event, not to exceed six (6) months supply of API except as otherwise mutually agreed-to by the Parties in writing. BVL agrees: (i) to account for all API, Customer-supplied Composition and Product and to provide Customer with monthly inventory reports, in BVL’s standard format provided such format is consistent with industry standards, and, in addition, to provide stand-alone inventory reports from time to time at Customer’s specific request; (ii) to notify Customer when the amount of Customer-supplied Composition available at BVL reaches the minimum quantity of material as agreed by both Parties; (iii) to handle, store and use API and other Customer-supplied Composition in accordance with SOPs or other instructions provided by Customer; (iv) not to provide API or Customer-supplied Composition to any Third Party without the express prior written consent of Customer; (v) not to use API or Customer-supplied Composition for any purpose other than the Manufacture of Product or conducting other services under this Agreement, and with such restriction on use to include, but not be limited to, BVL’s agreement not to analyze, characterize, modify or reverse engineer any API, or take any action to determine the structure or composition of any API, unless the foregoing is required under this Agreement; and (vi) to destroy or return to Customer or its designee all unused quantities of API and Customer-supplied Composition according to Customer’s written directions. If no written directions are provided to BVL under clause (vi) above within thirty (30) days following termination of this Agreement, BVL may dispose of such Composition per cGMP(s) without liability to Customer. 2.1.2. BVL will do ID-only, by-label verification of any API or active drug substance, and will not perform any additional testing of API or active drug substance unless requested by Customer in writing. If Customer requests BVL to perform additional testing, then subject to BVL’s acceptance and a reasonable proposal which is acceptable to Customer and which Customer shall approve in writing, BVL will perform such additional testing in accordance with the standard operating procedures and specifications to be agreed upon by the Parties in writing. 2.1.3. BVL will release all materials provided by BVL. In the event the Product is being Manufactured for sale in the European Union, then Customer’s Qualified Person shall be responsible to certify compliance of the Customer-supplied API and for the release of Product within the European Union in accordance with the responsibilities set forth in ▇▇▇▇▇▇▇▇ ▇ of this Agreement, provided that BVL will continue to be responsible for release testing and issuance to Customer of the Certificate of Analysis and Certificate of Compliance. 2.1.4. Customer will provide, or cause BVL to Develop at mutually agreed upon fees, written quality control testing requirements, methods, specifications and reference standards for Product and, if applicable to the testing to be performed by BVL under this Agreement, quality control testing requirements, methods, specifications and reference standards for the API. BVL will obtain Customer’s approval in writing of initial testing documents, the Master Production Record and any revisions of the documents thereafter prior to first use in accordance with the change control procedures set forth in the Quality Agreement. Revisions of approved documents requested by Customer within eight (8) weeks prior to scheduled manufacturing or other services may cause a delay or postponement of manufacturing and/or other services requested by the Customer. BVL shall not be responsible for any losses or other expenses resulting from any such delay. Further, BVL shall be entitled to reimbursement for any and all additional costs and expenses incurred by BVL in connection with any such revision or delay, provided that BVL has given Customer written notice of the amount of such additional costs and expenses prior to implementation of Customer’s requested change, and Customer has decided to proceed. 2.1.5. Customer is responsible for notifying BVL with instruction for any special disposition of tailings and rejects, which such special instructions will be incorporated into the Master Production Record and include a shipment address for tailing and rejects if Customer requests return of tailings and rejects. If no special instructions are provided, BVL shall dispose of tailings and rejects in accordance with BVL’s SOPs and Applicable Law. 2.1.6. For the avoidance of doubt, reference to API in this Agreement shall not be construed as a non-compete and/or a covenant not to use the same pharmacologically active compound for a different product for an entity other than Customer.

Api and Composition. 2.1.1. Customer shall, at its own expense, supply BVL with sufficient quantities of API and other Customer-supplied Composition Composition, including API, needed for the Development or Manufacture of Product, as specified in the Forecasts and suppor[*]ting Purchase Orders, in order to meet Customer’s requirements as set forth in Section 4.1 for commercial, commercial and/or Developmental and/or other quantities of Product in finished dosage form. Customer will provide API and any other mutually agreed agreed, Customer-supplied Composition composition at least thirty (30) [*] calendar days in advance of the scheduled Manufacturing date in accordance with BVL’s SOP’s that are acceptable to Customer, which such acceptance shall not be unreasonably withheld, or in accordance with such other inventory procedures as may from time to time be mutually agreed upon by the Parties in writing’s. Customer’s provision of API to BVL shall not exceed that amount required for the existing, open Purchase Orders and, in any event, not to exceed six (6) [*] months supply of API except as otherwise mutually agreed-to by the Parties in writing. BVL agrees: (i) to account for all API, API and Customer-supplied Composition and Product and to provide Customer with monthly inventory reports, in BVL’s standard format provided such format is consistent with industry standards, and, in addition, to provide stand-alone inventory reports from time to time at Customer’s specific upon request; (ii) to notify Customer when the amount of Customer-supplied Composition available at BVL reaches the minimum quantity of material as agreed by both Parties; (iii) to handle, store and use API and other Customer-supplied Composition in accordance with SOPs or other instructions provided by Customer; (iv) not to provide API or Customer-supplied Composition to any Third Party without the express prior written consent of Customer; (viv) not to use API or Customer-supplied Composition for any purpose other than the Manufacture of Product or conducting other services under this Agreement, and with such restriction on use to includeincluding, but not be limited towithout limitation, BVL’s agreement not to analyze, characterize, modify or reverse engineer any API, or take any action to determine the structure or composition of any API, unless the foregoing is required under this Agreement; and (viv) to destroy or return to Customer or its designee all unused quantities of API and Customer-supplied Composition according to Customer’s written directions. If no written directions are provided to BVL under clause (vi) above within thirty (30) days following termination of this Agreement, BVL may dispose of such Composition per cGMP(s) without liability to Customer. 2.1.2. Customer must give written permission to BVL will to do ID-only, by-label verification of any API or active drug substance, and will not perform any additional testing of API or active drug substance unless if no identification test is requested by Customer in writing. If Customer requests BVL to perform additional testing, then subject to BVL’s acceptance and a reasonable proposal which is acceptable to Customer and which Customer shall approve in writing, BVL will perform such additional testing in accordance with the standard operating procedures and specifications to be agreed upon performed by the Parties in writingBVL. 2.1.3. BVL will release all materials provided by BVL. In the event the Product is being Manufactured for sale in Territory (Attachment “G”) includes the European Union, then Customer’s Qualified Person shall be responsible to certify compliance of the Customer-supplied API and for the release of Product within the European Union in accordance with the responsibilities set forth in ▇▇▇▇▇▇▇▇ ▇ of this Agreement, provided that BVL will continue to be responsible for release testing and issuance to Customer of the Certificate of Analysis and Certificate of ComplianceUnion. 2.1.4. Customer will provide, or cause BVL to Develop at mutually agreed upon fees, written quality control testing requirements, methods, specifications and reference standards for Product and, if applicable to the testing to be performed by BVL under this Agreement, quality control testing requirements, methods, specifications API and reference standards for the APIProduct. BVL Customer will obtain Customer’s approval approve in writing of initial testing documents, the Master Production Record and any revisions of the documents thereafter prior to first use in accordance with the change control procedures set forth in the Quality Agreementthereafter. Revisions of approved documents ______________ [*] Confidential Treatment Requested Manufacturing and Service Agreement (BVL and Vion Pharmaceuticals, Inc.) requested by Customer within eight (8) [*] weeks prior to scheduled manufacturing or other services may cause a delay or postponement of manufacturing and/or other services requested by the Customer. BVL shall not be responsible for any losses or other expenses resulting from any such delay. Further, BVL shall be entitled to reimbursement for any and all additional costs and expenses incurred by BVL in connection with any such revision or delay, provided that BVL has given Customer written notice of the amount of such additional costs and expenses prior to implementation of Customer’s requested change, and Customer has decided to proceed. 2.1.5. Customer is responsible for notifying BVL with instruction for any special disposition of tailings and rejects, which such special instructions will be incorporated into the Master Production Batch Record and include a shipment address for tailing and rejects if Customer requests return of tailings and rejects. If no special instructions are provided, BVL shall dispose of tailings and rejects in accordance with BVL’s SOPs and Applicable Law. 2.1.6. For the avoidance of doubt, reference to API in this Agreement shall not be construed as a non-compete and/or a covenant not to use the same pharmacologically active compound for a different product for an entity other than Customer.