Clinical Supply Agreement - 范本

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DrugAbuse Sciences, ("DAS"), a corporation incorporated under the laws of the State of California, with offices located at 1430 O'Brien Drive, Suite E, Menlo Park, California, 94025 and SP Pharmaceuticals, L.L.C., a New Mexico limited liability company ("SP"), located at 4272 Balloon Park Road, N. E., Albuquerque, New Mexico 87109 agree:

1. RECITALS. SP proposes to manufacture the Product for DAS for use in clinical trials in accordance with the terms of this Agreement.

2. THE WORK. SP will manufacture and supply DAS with the Product pursuant to DAS Purchase Orders in accordance with the Specifications, CGMPs and other terms described in the Statement of Work pursuant to the terms of this Agreement and all appendices, exhibits and other attachments, subject to DAS' right to have a third party perform the work specified in section 5.2 of this Agreement. Subject to Section 3.3 below, any amendments to the Statement of Work must be mutually agreed to by the Parties in writing and must be attached to the Statement of Work, whereupon such amendment will become part of this Agreement. Upon mutual agreement of the parties, DAS may add additional products to this Agreement to be finished by SP, and the Parties will amend this Agreement to cover such additional products. Any additional products added to this Agreement will require their own statements of work, and a statement of work for the related work. SP will have a right of first refusal to manufacture each lot of clinical supply of Product required by DAS on the same terms and conditions as may be offered by DAS to a third party.

2.1 SUPPLIED MATERIALS. SP will order the Supplied Materials from vendors mutually agreed upon by the parties. SP agrees to inspect the Supplied Materials and agrees to use all diligent efforts to replace non-conforming Supplied Materials on a timely basis. All materials and products, including Supplied Materials, paid for or provided by DAS pursuant to this Agreement shall be and remain the property of DAS.

2.2 ACTIVE INGREDIENT AND [****]. DAS shall furnish to SP [********] in these quantities as are reasonably necessary to enable SP to manufacture the desired quantities of Product in accordance with the Statement of Work. All shipments of Active Ingredient shall be accompanied by a certificate of analysis from the bulk supplier of the Active Ingredient, confirming the quantity and purity of such Active Ingredient. S P shall verify the labeled quantity of Active Ingredient against the bill of lading and shall perform release testing to confirm that the Active Ingredient conforms with specifications defined in Appendix B. If SP fails to properly carry out the above-referenced inspection and analysis obligations, or its storage and handling obligations, SP shall be responsible for the non-conformance or other failure of the Active Ingredient. SP will inform DAS of any discrepancies in quantity and identity of the Active Ingredient or failure of the Active Ingredient to conform to the bulk supplier's certificate of analysis in any respect as soon as reasonably practical after receipt of the Active Ingredient. SP shall also inform DAS of any damage to the Active Ingredient received that is visually obvious (e. g., damaged or punctured containers) within twenty (20) days of SP's receipt of the Active Ingredient. Active Ingredient that is rejected in accordance with the foregoing or SP's standard operating procedures will be returned to the bulk supplier at DAS' expense and direction and DAS will be responsible for arranging replacement Active Ingredient on a timely basis to allow SP to produce the Product.

2.3 PACKAGING REQUIREMENTS. SP shall furnish all labor, packaging materials, and packaging supplier necessary to package the Product in sealed vials in accordance with the Statement of Work and at the prices set forth in with the Pricing Appendix. SP guarantees that is packaging procedures shall comply with all relevant laws, rules and regulations of the FDA and the Foreign Authorities.

2.4 RECORDS. SP will maintain and provide to DAS adequate documentation with respect to the manufacture of Product to properly document and support all of DAS' filings as they relate to Product production with the FDA. Further, during the Hold Period, SP shall maintain records and samples relating to such Product batches sufficient to substantiate and verify its duties and obligations hereunder, including but not limited to, records of Active Ingredient used, Product manufactured, work in progress, Product analyses, quality control tests and the like. During the Hold Period, SP shall not destroy any records relating to regulatory compliance or quality assurance without giving DAS notice and an opportunity to take possession of or copy such records as DAS may reasonably require. After the Hold Period, SP will transfer all such records to DAS or at DAS' request destroy such records in accordance with SP's standard operating procedures then in effect (but which shall be at least as protective as the SP Standard Operating Procedure attached hereto as Appendix D). DAS will reimburse SP for reasonable out-of-pocket costs incurred for such transfer.

3. QUALITY CONTROL.

3.1 SPECIFICATIONS. SP shall not implement any changes relevant to the Product which are not in compliance with the Specifications without obtaining DAS' prior written approval.

3.2 3.2 SP LABORATORY SERVICES. SP will test the Active Ingredient, [****] and finished Product in accordance with the Statement of Work attached as Appendix B. SP will provide required manning and supervision, training, procedures, qualifications, reagents, analysis, investigating, data collection and reporting with respects the Product, and DAS will provide all validated analytical methodologies and standards, including method transfer protocols needed for the testing of Active Ingredient, [****] and finished Product.

3.3 MODIFICATIONS. DAS will inform SP in writing of any modifications to the Specifications or Statement of Work as soon as reasonably practicable. SP will inform DAS of the amount of reasonable additional costs, if any, SP would incur due to the modification. If DAS elects to adopt the modification, DAS will (i) at DAS' election either directly purchase required additional equipment or materials which are approved by SP, or reimburse SP for required direct capital expenditures, and (ii) pay SP for any increased services or materials which are necessary to implement the modification to the Specifications or Statement of Work at SP's then current pricing rates for such services and materials. SP will provide DAS a detailed and itemized written explanation of capital expenditures and additional charges for services and materials incurred due to the modification. If the parties agree that SP is technically unable to comply with a proposed modification or if DAS is unwilling to pay SP's costs for direct capital expenditures in advance, DAS shall have the option to withdraw the proposed modification or negotiate a payment plan acceptable to SP. When a cost-saving modification is recommended by DAS and implemented by SP, SP will decrease its charges to DAS by an amount equal to the reduction in price resulting from the decreased services or materials afforded by the modification. SP and DAS will revise the Pricing Appendix, Statement of Work, Specifications and related schedules to account for any modifications agreed to and implemented by the parties pursuant to this paragraph. SP is not required to accept any modification which in SP's reasonable belief would create a compliance risk for any regulatory requirement.

 

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Clinical Supply Agreement - DrugAbuse Sciences Inc. and SP Pharmaceuticals LLC (Nov 24, 1999).docx 下载
发布于 2021-12-07 15:43:22
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