Common use of Clinical Supply Agreement Clause in Contracts

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. Except as otherwise provided herein, MacroGenics shall have the responsibility for Manufacturing clinical supplies of the Licensed Compound Bulk Drug Substance (and at any time prior to the completion of the Manufacturing Technology Transfer, MacroGenics shall also have the responsibility for Manufacturing clinical supplies of the Licensed Compound Drug Product) for (i) MacroGenics’ use in connection with any MacroGenics Combination Studies, (ii) Incyte’s use in connection with any Monotherapy Studies or Incyte Combination Studies, and (iii) Collaborator’s or Incyte’s use in connection with any Collaborator Combination Studies. 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 shall initiate negotiations for a 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 agreement (collectively, the “Clinical Supply Agreement”) that will set forth the terms and conditions for MacroGenics’ (or Incyte’s per Section 7.2(d). The Clinical Supply Agreement will contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations ) provision of liability, and quality assurance and control. From and after the execution clinical supplies 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 Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product, as applicable, to Incyte, MacroGenics, and any Collaborators and which will include all applicable provisions set forth in this Article 7 with respect to clinical supply and such other provisions as are customary and reasonable under the circumstances. The Parties shall also initiate negotiations to execute a quality agreement that shall further address and govern issues related to the quality of the Licensed Compound Bulk Drug Substance and Licensed Compound 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 to be 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 MacroGenics pursuant to the Clinical Supply Agreement (the “Clinical Quality Agreement”). All negotiations for the Development of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Clinical Supply Price for such quantityAgreement and Clinical Quality Agreement shall be undertaken by each Party in good faith. MacroGenics (or Incyte, payable within per Section 7.2(d)) will use Commercially Reasonable Efforts to supply, or cause to be supplied, the Licensed Compound Bulk Drug Substance or Licensed Compound Drug Product, as applicable, in accordance with the provisions of this Agreement, and once executed, the Parties shall comply with their respective obligations to supply, or cause to be supplied, the Licensed Compound Bulk Drug Substance or Licensed Compound Drug Product, as [**] after receipt = Portions of an invoice thereforthis exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Clinical Supply Agreement. Except as otherwise provided herein, MacroGenics shall have the responsibility for Manufacturing clinical supplies of the Licensed Compound Bulk Drug Substance (and at any time prior to the completion of the Manufacturing Technology Transfer, MacroGenics shall also have the responsibility for Manufacturing clinical supplies of the Licensed Compound Drug Product) for (i) MacroGenics’ use in connection with any MacroGenics Combination Studies, (ii) Incyte’s use in connection with any Monotherapy Studies or Incyte Combination Studies, and (iii) Collaborator’s or Incyte’s use in connection with any Collaborator Combination Studies. 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 shall initiate negotiations for a 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 agreement (collectively, the “Clinical Supply Agreement”) that will set forth the terms and conditions for MacroGenics’ (or Incyte’s per Section 7.2(d)) provision of clinical supplies of the Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product, as applicable, to Incyte, MacroGenics, and any Collaborators and which will include all applicable provisions set forth in this Article 7 with respect to clinical supply and such other provisions as are customary and reasonable under the circumstances. The Parties shall also initiate negotiations to execute a quality agreement that shall further address and govern issues related to the quality of the Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product to be supplied by MacroGenics pursuant to the Clinical Supply Agreement (the “Clinical Quality Agreement”). All negotiations for the Clinical Supply Agreement and Clinical Quality Agreement shall be undertaken by each Party in good faith. MacroGenics (or Incyte, per Section 7.2(d)) will contain commercially reasonable terms including terms addressing forecastinguse Commercially Reasonable Efforts to supply, orderingor cause to be supplied, deliverythe Licensed Compound Bulk Drug Substance or Licensed Compound Drug Product, acceptance and rejection proceduresas applicable, indemnification, limitations in accordance with the provisions of liabilitythis Agreement, and quality assurance and control. From and after once executed, the execution Parties shall comply with their respective obligations to supply, or cause to be supplied, the Licensed Compound Bulk Drug Substance or Licensed Compound Drug Product, as applicable, in accordance with the provisions of the Clinical Supply Agreement and until the Clinical Quality Agreement. MacroGenics shall supply all quantities of Licensed Compound Bulk Drug Substance from the MacroGenics Manufacturing Technology Transfer CompletionFacilities, and subject shall not have the right to subcontract the terms Manufacture of such Clinical Supply Agreement and this Agreement and compliance with Applicable Lawthe Licensed Compound Bulk Drug Substance. Further, Epizyme will, either itself or through Third Parties, Manufacture and MacroGenics shall supply Hutchmed with all quantities of Licensed Compound Bulk 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 that are required for any purpose other than Pre-Clinical Researchparticular Incyte Monotherapy Study or Incyte Combination Study from the same MacroGenics Manufacturing Facility, 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 provided [**] after receipt = Portions of an invoice thereforthis exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. CONFIDENTIAL TREATMENT REQUESTED that such supply requirements do not exceed the reasonably available then-current planned capacity of the applicable Manufacturing Facility.