Common use of Commercial Supply Clause in Contracts

Commercial Supply. In the event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of the launch of the first Licensed Product in the Territory, 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 commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply Agreement”). The Commercial Supply Agreement 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 Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Commercialization Plan and the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities in the Territory. In addition, in no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for purposes of Commercialization of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Commercial Supply Price for such quantity, payable within [**] after receipt of an invoice therefor.

Commercial Supply. In Subject to the event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance oversight of the launch of JMC as described in Section 3.4, SeaGen or its Affiliates shall Manufacture and supply the first commercial requirements for the Licensed Product in the Territoryfully packaged and labelled, or at such earlier or later date finished form (except as may be mutually agreed in writing, the Parties will negotiate in good faith and enter into an agreement for commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply Agreement”). The Commercial Supply Agreement 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 Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products set forth in the Field European Collaboration Territory Distribution Agreement or as otherwise set forth in the Territory by the Hutchmed Entities Manufacturing Plan) in accordance with the Commercialization Plan terms hereof (and the terms of this Agreement. Hutchmed Entities SeaGen Supply Agreement contemplated by Section 7.4.2, as applicable) for Commercialization worldwide by each Party; provided that Merck shall not use any quantity of Drug Product supplied by Epizyme be responsible for any purpose other than Commercialization specific Manufacturing responsibilities for the Licensed Product as set forth in and designated to Merck in the Field and Territory Manufacturing Plan. For clarity, such Licensed Product shall be labelled in accordance with the Commercialization Plan labelling specifications provided by Merck for the Merck Territory, provided by SeaGen for the SeaGen Territory and as agreed upon between the terms of this Agreement, and Epizyme shall not be obligated under Parties for the Commercial Supply Agreement Collaboration Territory. With respect to supply quantities of Drug the Licensed Product for sale in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities a given country: (a) in the Merck Territory. In addition, in no event Merck shall Epizyme supply to Hutchmed under be responsible for ensuring that such labelling complies with the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed approved label and Applicable Laws for purposes of Commercialization of Licensed Products the applicable country in the Field Merck Territory; (b) in the SeaGen Territory, Hutchmed SeaGen shall pay to Epizyme be responsible for ensuring that such labelling complies with the Commercial Supply Price approved label and Applicable Laws for the applicable country in the SeaGen Territory; (c) in the US Collaboration Territory, SeaGen shall be responsible for ensuring that such quantitylabelling complies with the approved label and Applicable Laws in the US Collaboration Territory; and (d) in the European Collaboration Territory, payable within [**each Party shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws for the applicable country in the European Collaboration -85- [ * ] after receipt of an invoice therefor.= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED

Commercial Supply. In Subject to the event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance other provisions of the launch this Section 2.4.3, Celgene shall Manufacture and supply all Commercial Supplies. Within [* * *] after initiation of the first a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the TerritoryPH Field by Acceleron, its Affiliate or at such earlier or later date as may be mutually agreed Sublicensee, if Celgene elects to Manufacture Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in writingthe PH Field, the Parties will shall negotiate in good faith and enter into an the terms of a supply agreement for commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Agreement”)) for the supply by Celgene to Acceleron of Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field. The Commercial Supply Agreement contain shall provide: (i) that Celgene shall use Commercially Reasonable Efforts to Manufacture and supply to Acceleron or its designee Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field at a price equal to [* * *] of Celgene’s Fully Loaded Cost to Manufacture such Sotatercept Drug Product, and (ii) for such other terms and conditions as are reasonable and customary for similar commercial supply agreements in the pharmaceutical industry. In the event that, (a) despite having used good faith commercially reasonable efforts, the Parties are unable to reach agreement on the 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 a Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2within [* * *] following initiation of a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the PH Field by Acceleron, and subject its Affiliate or Sublicensee or (b) Celgene elects not to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Sotatercept Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field PH Field, Acceleron shall have the right to Manufacture Commercial Supplies of Sotatercept Licensed Compounds and Sotatercept Licensed Products for Commercialization in the Territory PH Field, in which case Celgene shall use good faith efforts to assist Acceleron in securing a source of supply for such Commercial Supplies and shall, and shall use Commercially Reasonable Efforts to cause those CMOs engaged by Celgene in the Hutchmed Entities Manufacture of Sotatercept Licensed Compounds and Sotatercept Licensed Products to, provide a technology transfer in accordance with Applicable Laws and industry standards to Acceleron or its designee of manufacturing processes and Know-How to the Commercialization Plan extent necessary to Manufacture Sotatercept Licensed Compounds and the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme Sotatercept Licensed Products for any purpose other than Commercialization in the Field and Territory in accordance PH Field; provided that, with respect to any CMO, to the Commercialization Plan and the terms of this Agreement, and Epizyme shall extent not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities permitted or provided for in the Territoryagreement(s) with such CMO, such transfer shall be subject to such CMO’s consent. In addition, in no event The cost of any technology transfer pursuant to this Section 2.4.3 shall Epizyme supply to Hutchmed under be borne equally by the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for purposes of Commercialization of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Commercial Supply Price for such quantity, payable within [**] after receipt of an invoice thereforParties.

Commercial Supply. In the event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of the launch of the first Licensed Product in the Territory, 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 commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply Agreement”). The Commercial Supply Agreement 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 Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Commercialization Plan and the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities in the Territory. In addition, in no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for purposes of Commercialization of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Commercial Supply Price for such quantity, payable within [**] after receipt of an invoice therefor.

Commercial Supply. In The Parties will negotiate in good faith and enter into a supply agreement for commercial supply of Ivosidenib Materials and a related quality agreement (collectively, the event that it is “Commercial Supply Agreement”; the Commercial Supply Agreement and the Clinical Supply Agreement each a “Supply Agreement”) at least [**] prior to the anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance date of receipt of the launch of first Regulatory Approval for the first Licensed Product in the Territory, 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 commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply Agreement”). The Commercial Supply Agreement contain commercially reasonable will be consistent with the terms including terms set forth in this Section 7.02 (Commercial Supply) and may include means of addressing forecastingdisruptions in Manufacturing consistent with Section 7.07 (Supply Disruption), orderingwhether such disruptions in Manufacturing are of Licensee, delivery, acceptance and rejection procedures, indemnification, limitations Licensee’s CMO or a manufacturer of liability, and quality assurance and controlAgios. From and after the execution of the Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2Agreement, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable LawAgreement, Epizyme willAgios will use Commercially Reasonable Efforts, either itself or through Third Parties, to Manufacture and supply Hutchmed with Drug Product to Licensee Ivosidenib Materials in quantities that are reasonably sufficient quantities for the conduct of Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Licensee Entities in accordance with the Commercialization Launch Plan and the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities in the Territory. In addition, in no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination DrugPlan. For any quantity of Drug Product Ivosidenib Materials supplied by Epizyme Agios to Hutchmed Licensee pursuant to this Section 7.02 (Commercial Supply) for purposes of Commercialization of Licensed Products in the Field in the Territory, Hutchmed Licensee shall pay to Epizyme Agios the Commercial Supply Price for such quantityIvosidenib Materials, payable within [**] after receipt of an invoice therefor. Prior to the Manufacturing Technology Transfer, Licensee shall be responsible for the Manufacturing of Bulk Drug Product into Finished Drug Product for Commercialization in the Territory at its sole expense. After the Manufacturing Technology Transfer, Licensee shall be responsible for the Manufacturing of API Bulk Drug Substance into Finished Drug Product for Commercialization in the Territory at its sole expense; provided, however, that Licensee shall only be permitted to Manufacture API Bulk Drug Substance into Finished Drug Product (a) through a CMO approved by the JMC or (b) solely if Licensee is able to conduct such Manufacturing in compliance with cGMP and all specifications provided by Agios from time to time, in-house.