Development Supply Agreement. Unless otherwise agreed by the Parties, no later than (a) May 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 Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd. 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. (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 [***].
Development Supply Agreement. As soon as reasonably practicable following the nHCM Supplemental Agreement Effective Date, and in any event no later than [***] prior to the planned first shipment of any quantity of the Licensed Product for the conduct of the China Study, the Parties shall amend the Development Supply Agreement to provide for each Party’s rights and responsibilities with respect to Company’s supply, and Licensee’s, its Affiliates’ and Permitted Subcontractors’ exclusive purchase from Company, of Licensed Product for the conduct of the China Study.
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. Pursuant to that certain Development Supply Agreement entered into between the Maruho and Dermira and effective as of March 1, 2017 (the “Development Supply Agreement”), Dermira agreed to be responsible for the supply of [***]for Xxxxxx’s non-clinical and clinical Development meeting the specifications set forth in Exhibit A attached thereto (as amended from time to time by the Parties). The Parties acknowledge and agree that as of the First Restatement Date, the Development Supply Agreement has expired based on the mutual agreement of Maruho and Dermira, except that Sections 3.3 (with respect to Drug Substance, as defined therein, delivered by Dermira prior to the First Restatement Date) and 7.5 of the Development Supply Agreement shall survive such expiration, and from and after the First Restatement Date, Maruho shall be solely responsible for the procurement and manufacture of [***]and the Product for Xxxxxx’s non-clinical and clinical Development. If, following the First Restatement Date, either Party reasonable determines that events or circumstances require the amendment or modification of the terms of any pharmacovigilance agreement between the Parties, the Parties agree to negotiate in good faith with respect to such amendment or modification.
