Clinical Supply Agreement. Within ** (**) days after the ------------------------- Effective Date, the Parties shall negotiate and agree in good faith a supply agreement relating to supply to GSK of its worldwide requirements of API Compound and its short-term requirements of formulated Collaboration Products for Development activities, addressing the standard terms of supply set forth in ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Clinical Supply Agreement. Within [**] after the Effective Date, or at such earlier or later date as may be mutually agreed in writing, the Parties will negotiate in good faith and enter into an agreement for clinical supply by Epizyme to Hutchmed of Drug Substance or Drug Product and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Clinical Supply Agreement”). The Clinical Supply Agreement will contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. From and after the execution of the Clinical Supply Agreement and until Manufacturing Technology Transfer Completion, and subject to the terms of such Clinical Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Substance and Drug Product in sufficient quantities for the Development activities for Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Clinical Development Plan, including supply by Epizyme of Drug Product for clinical sites in the Territory for Joint Global Trials and Local Trials. Hutchmed Entities shall not use any quantity of Drug Substance or Drug Product supplied by Epizyme hereunder for any purpose other than Pre-Clinical Research, Local Trials, or Joint Global Trials in the Field in the Territory in accordance with the CDP and the terms of this Agreement. For clarity, in no event shall Epizyme supply to Hutchmed under the Clinical Supply Agreement any quantity of Drug Substance or Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Substance or Drug Product supplied by Epizyme to Hutchmed pursuant to the Clinical Supply Agreement for the Development of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Clinical Supply Price for such quantity, payable within [**] after receipt of an invoice therefor.
Clinical Supply Agreement. For each Program, the Parties shall enter into good faith negotiations regarding the terms of a clinical supply agreement, pursuant to which MacroGenics shall provide clinical supply of Program DARTs and/or Licensed Products from such Program for (a) Phase 1 Clinical Trials and the first two (2) Phase 2 Clinical Trials of Licensed Products to be conducted by Servier and its Affiliates and Sublicensees and (b) at MacroGenics’ option, Clinical Trials of Licensed Products conducted by Servier and its Affiliates and Sublicensees *** of Licensed Products to be conducted by Servier and its Affiliates and Sublicensees (the “Clinical Supply Agreement”). The cost for such supply of Program DARTs and/or Licensed Products for Clinical Trials shall be equal to MacroGenics’ Fully Burdened Manufacturing Cost; ***. The Fully Burdened Manufacturing Cost for supply of Program DARTs and/or Licensed Products for clinical trials used by Servier in connection with the Development of a Program DARTs and/or Licensed Products outside a Global Development Plan shall be invoiced by MacroGenics on a quarterly basis.
Clinical Supply Agreement. Within [***] months after the Effective Date, and subject to the terms and conditions set forth in this Section 6, the Parties will negotiate in good faith the terms of and enter into a clinical supply agreement (the “Clinical Supply Agreement”), pursuant to which 3SBio will supply Licensed Compounds to Selecta, its Affiliates and Sublicensees for use in Research and Clinical Supplies on an at-cost basis.
Clinical Supply Agreement. In accordance with the Clinical Supply Agreement attached as Exhibit J and an associated quality agreement, Takeda will supply the specific quantity of Clinical Trial materials to Licensee for use in the Clinical Trials set forth in the Initial Development Plan and for any Additional Required Clinical Trials, and Licensee will reimburse Takeda’s fully loaded cost of Manufacturing for such quantity of Clinical Trial material provided under the Clinical Supply Agreement. Licensee shall be solely responsible for the Manufacture and supply of any and all additional quantities of Product needed by Licensee, including all additional Clinical Trial materials and Product for Commercialization.
Clinical Supply Agreement. If the CMC Development Plan allocates responsibility for Manufacture and supply of Compound API or Drug Product for any Phase 2 Activities to Protagonist, the Parties shall negotiate in good faith and attempt to agree within [ * ] after the Effective Date upon a supply agreement for such supplies by Protagonist to Xxxxxxx at cost with no markup (the “Clinical Supply Agreement”) and a related quality agreement.
Clinical Supply Agreement. Within [***] following the Effective Date, the Parties shall negotiate in good faith a clinical supply agreement containing supply terms and conditions consistent with the principles set forth on Exhibit 5.1 hereto (Supply Agreement Key Terms) and such other terms as are customary for such agreements, including provisions addressing technology transfer of the Eidos Know-How related to the Manufacture of the Licensed Compound and Licensed Products (the “Clinical Supply Agreement”), pursuant to which Eidos will Manufacture and supply to Alexion the Licensed Compound and Licensed Products for the Territory.
Clinical Supply Agreement. The parties shall use commercially reasonable efforts to negotiate and enter into the Supply Agreement on the basis of the terms set forth in Exhibit D within sixty (60) days after the Effective Date; provided that neither party shall be obligated to enter into the Supply Agreement unless and until all of the terms thereof, including terms in addition to those set forth in Exhibit D, are reasonably satisfactory to such party.
Clinical Supply Agreement. In accordance with the Clinical Supply Agreement attached as Exhibit C and the Quality Agreement set forth in the Clinical Supply Agreement, Takeda may supply the specific quantity of Clinical Trial materials set forth therein to Licensee, for use in the pediatric Phase 2 Clinical Trials and the Phase 1 Clinical Trial in healthy Japanese subjects set forth in the Initial Development Plan, and [***]. Takeda’s inability to supply the same as set forth in the Clinical Supply Agreement shall not constitute a breach of Takeda’s obligations under this Agreement or any of the Ancillary Agreements. Licensee shall be solely responsible for the Manufacture and supply of any and all additional quantities of Product needed by Licensee, including all additional Clinical Trial materials and Product for Commercialization. If Takeda is required to or elects to perform any additional Clinical Trials outside the Territory beyond the Licensee Japan Development Activities, then the Parties shall use good faith efforts to enter into a supply agreement whereby Licensee would supply Takeda with the quantity of Clinical Trial materials needed for such additional Clinical Trials. The terms of any such supply agreement shall be negotiated in good faith by the Parties based upon reasonable and customary terms typically associated with supply of Clinical Trial materials utilizing, as appropriate, terms from the Clinical Supply Agreement attached hereto as Exhibit C .
Clinical Supply Agreement. The Parties will enter into a clinical supply agreement between each other or among the Parties and an Affiliate or a Third Party manufacturer covering the Manufacture and supply of *** for *** activities no later than *** prior to the *** (the “Clinical Supply Agreement”). The Clinical Supply Agreement shall include but not be limited to the terms set forth in the term sheet attached as Exhibit G to the Supplemental Information Package.
