Development Supply Agreement. Unless otherwise agreed by the Parties, no later than (a) March 31, 2022, with regards to the Lead Product, and (b) no later than nine months following the effective date of exercise of the Option with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of such Licensed Product by Sarepta to Roche in the Roche Territory at the Supply Price (the “Development Supply Agreement”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of such Licensed Product for Development purposes. The Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product.
Development Supply Agreement. At such time as directed by the JMC following identification of any Candidates and Products and subject to the oversight of the JMC, the Parties will negotiate in good faith a definitive supply agreement for HMI to Manufacture and supply Candidates and Products to NVS for use in conducting Preclinical Development and Clinical Development of such Candidates and Products until the completion of the Phase I/II Clinical Trial for Candidates and Products that Modulate such Target in accordance with this Agreement (“Development Supply Agreement(s)”) along with the associated Development Quality Assurance Agreement (which Development Quality Assurance Agreement will contain terms related to HMI’s rights and obligations as the Manufacturer of such Product(s) as well as terms related to NVS’ rights and obligations as the Regulatory Responsible Party for such Product(s), including each Party’s respective review, comment, and approval rights thereunder). The Development Supply Agreement and the Development Quality Assurance Agreement will provide for customary terms and conditions, including quality requirements, those provisions required under Sections 8.1.3 (Objective Criteria) and 8.6.1 (Manufacturing Related Rights), forecasting, ordering, delivery, technical criteria to be met, payment, and supply, in accordance with the terms of this Agreement.
Development Supply Agreement. Within [***] months after the Effective Date, the Parties will negotiate in good faith and enter into a supply and technical transfer agreement (the “Development Supply Agreement”) pursuant to which Alnylam will (a) subject to the terms of Section 5.3, promptly provide MedCo or Third Party contract manufacturer(s) selected by MedCo and reasonably acceptable to Alnylam with Alnylam Know-How reasonably necessary or useful for the Manufacture of the Bulk Drug Substance, Bulk Drug Product and Finished Product, as the case may be, and shall make available its personnel on a reasonable basis to consult with MedCo with respect thereto, all at MedCo’s expense for the Costs reasonably incurred by Alnylam in connection with such technology transfer activities; and (b) supply Finished Product to MedCo as set forth in Section 5.1(a)(ii). The terms and conditions of the Development Supply Agreement shall be commercially reasonable and consistent with industry standards, as well as, if applicable, Alnylam’s agreements with its Third Party contract manufacturers. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Development Supply Agreement. At such time as directed by the JSC, the Parties will negotiate in good faith the terms of the Development Supply Agreement, and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of the MG Manufactured Components for Development purposes; provided that if Ionis needs any MG Manufactured Components for its Development activities prior to the Parties entering into the Development Supply Agreement, then Metagenomi will supply such MG Manufactured Components on a per-batch basis and Ionis will pay Metagenomi on a per-batch basis at the Supply Price for each such batch. The Development Supply Agreement and the related quality agreement will include terms and conditions consistent with the principles set forth on Schedule 8.2 (Development Supply Agreement Key Terms).
Development Supply Agreement. Within [***] following the Effective Date (or such other timeframe as may be agreed by the Parties), the Parties shall negotiate and enter into a definitive supply agreement for Regeneron’s supply to Kiniksa of its Clinical Supply Requirements solely for use in conducting Development activities (“Development Supply Agreement”). The Development Supply Agreement shall provide for customary terms and conditions, including forecasting, ordering, delivery, payment, and supply, and shall be consistent with the terms set forth in Schedule 8.3 and the terms of this Agreement. Regeneron may designate an Affiliate to enter into the Development Supply Agreement.
Development Supply Agreement. Within [**] months after the Effective Date, the Parties will negotiate in good faith and enter into a supply and technical transfer agreement (the “Development Supply Agreement”) pursuant to which Alnylam will (a) subject to the terms of Section 5.3, promptly provide MedCo or Third Party contract manufacturer(s) selected by MedCo and reasonably acceptable to Alnylam with Alnylam Know-How reasonably necessary or useful for the Manufacture of the Bulk Drug Substance, Bulk Drug Product and Finished Product, as the case may be, and shall make available its personnel on a reasonable basis to consult with MedCo with respect thereto, all at MedCo's expense for the Costs reasonably incurred by Alnylam in connection with such technology transfer activities; and (b) supply Finished Product to MedCo as set forth in Section 5.1(a)(ii). The terms and conditions of the Development Supply Agreement shall be commercially reasonable and consistent with industry standards, as well as, if applicable, Alnylam's agreements with its Third Party contract manufacturers.
Development Supply Agreement. Unless otherwise agreed by the Parties, no later than [**] following (a) the Effective Date with regards to the Lead Product, and (b) the effective date of exercise of the Option with regards to every other Licensed Product, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of the Licensed Products by Sarepta to Roche in the Roche Territory at the Supply Price (the “Development Supply Agreement”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing the Licensed Products for Development purposes. 79445843_10
Development Supply Agreement. Of even date with this Agreement, the Parties shall enter into a development supply agreement providing for the manufacturing, shipment, and use of Clinical Trial Materials (the “Development Supply Agreement”). The Development Supply Agreement shall provide for the supply of (a) vaccine (with relevant supporting documentation) from BCI to Alopexx and (b) Alopexx proprietary pentadimer (with relevant supporting documentation) from Alopexx to BCI and shall include other comprehensive provisions customary for transactions of the nature contemplated.
Development Supply Agreement. (a) Subject to Section 7.4, pursuant to a development supply agreement (the “Development Supply Agreement”) to be entered into between the Parties, BBIL shall be responsible for the Manufacture and supply of all Clinical Trial Materials required for Ocugen’s non-clinical and clinical Development of the Product in the Field in and for the Ocugen Territory (including the performance of the Ocugen Development Activities). The Parties will enter into the Development Supply Agreement within [***] days after the Effective Date. The Development Supply Agreement shall contain mutually agreeable terms, including, among other things, that the maximum purchase price payable by Ocugen for Clinical Trial Materials manufactured and supplied thereunder shall not exceed [***].
(b) Except as set forth in the Development Supply Agreement, prior to the completion of the technology transfer as provided in Section 7.3(a), BBIL shall be responsible, in accordance with the Development Supply Agreement or as may otherwise be agreed between the Parties, to (i) Manufacture and supply Ocugen with such form and quantity of Clinical Trial Materials as Ocugen reasonably requires to conduct the Ocugen Development Activities and carry out Clinical Trials necessary to seek and obtain Regulatory Approval of the Product in the Field in and for the Ocugen Territory, and (ii) perform release and stability testing of the Product for use in the Field in and for the Ocugen Territory in accordance with FDA requirements and Applicable Law. In furtherance of the forgoing, within [***] days after the Effective Date, and thereafter on an as needed basis during the Term or as may otherwise be discussed and agreed by the Parties at the JSC, BBIL shall share all CMC Technology and related information for the Product with Ocugen.
Development Supply Agreement. Pursuant to the Development Supply Agreement (as defined below), Dermira shall be responsible for the supply of DRM04 drug substance and supply of Product for Maruho’s non-clinical and clinical Development meeting the specifications provided to Maruho prior to the Effective Date ([*****], the “Specifications”) and if [*****] for the Development in the Territory, the Parties will [*****] as provided by Section 3.2. For avoidance of doubt, the Parties have explicitly agreed that Maruho shall reimburse Dermira for all [*****] incurred by Dermira, in support of Maruho’s Development of Product, including all costs specific only for the Territory. [*****] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Dermira’s baseline costs are based on the [*****] (meeting Dermira’s then-current specifications (the “Dermira Specifications”), manufacturing processes, in-process tests, and in-process specifications for Product for Dermira’s development and Commercialization) [*****]. Dermira will notify Maruho of any changes to the Dermira Specifications as soon as reasonably practicable. In addition, the Parties have explicitly agreed that the transfer price of the Product will be Dermira’s [*****] the Product. The Parties will make reasonable effort to execute the supply agreement of supply of DRM04 drug substance and the Product for non-clinical and clinical Development containing the terms set for the on Schedule B (the “Development Supply Agreement”). If the Parties are unable to reach agreement on the terms of the Development Supply Agreement by [*****] days after the Effective Date, then within [*****] days following the end of such period the Parties shall submit the matter to a neutral arbitrator located in London, England as follows: (a) the arbitrator will be selected by the Parties and shall have expertise in pharmaceutical manufacturing and supply agreements (if the Parties are unable to reach mutual agreement on an arbitrator, then each Party will select its neutral arbitrator and the two selected arbitrators shall select the arbitrator), (b) each Party shall deliver to the arbitrator and the other Party its proposed draft of the Development Supply Agreement based on the terms set forth on Schedule B, (c) the arbitrator shall give each Party the opportunity to explain to the arbitrator why its draft of the D...
