Common use of Global Development Plans Clause in Contracts

Global Development Plans. With respect to each Licensed Product, the JDC shall prepare and present a Global Development Plan for approval by the JSC, and the JSC shall approve a Global Development Plan for such Licensed Product, within three (3) months after the time such Licensed Product first becomes a Licensed Product in accordance with the terms of the Discovery Agreement and this Agreement, and shall, subject to the further provisions of this Section 5.2, determine which Party will take the lead in the Development of such Licensed Product. Prior to such JSC approval of the first Global Development Plan for any Licensed Product, the Parties shall Develop the Licensed Product in accordance with the applicable Initial Development Plan. An updated Global Development Plan for such Licensed Product will be presented by the JDC for approval by the JSC, and approved by the JSC, at least two (2) months prior to the end of each Contract Year. Each Global Development Plan for a Licensed Product will set forth the plan for Development of such Licensed Product in the Field over at least three (3) Contract Years and will include (a) strategies and timelines for Developing and obtaining Approvals for such Licensed Product in the Field in the Territory, and (b) the allocation of responsibilities for Development activities between the Parties, and/or Third Party service providers. Each Global Development Plan will be reviewed and informally updated by the JDC not less frequently than once every six (6) months for the ensuing three (3) year period. Unless and to the extent otherwise agreed by the Parties with respect to a particular Licensed Product, (i) the Parties shall alternate, on a Licensed Product-by-Licensed Product basis, in being allocated principal responsibility for formulating, and carrying out, the principal Development activities for the applicable Licensed Product under the applicable Global Development Plan(s) from the time the applicable Product Candidate is advanced into Development in accordance with the Discovery Agreement (whereupon such Product Candidate automatically constitutes a Licensed Product) through proof of concept as defined in the Global Development Plan for the Licensed Product (the "POC Time") (with respect to any Licensed Product, the Party with such principal responsibility through the POC Time being referred to as the "POC Principal Party") and (ii) the Parties shall alternate being allocated principal responsibility for formulating, and carrying out, all clinical trials conducted subsequent to the POC Time for the applicable Licensed Product(s) under the applicable Global Development Plan(s) (with respect to a Licensed Product, the Party with such principal responsibility being referred to as the "Post-POC Principal Party"), with Sanofi being the Post-POC Principal Party for two (2), and Regeneron being the Post-POC Principal Party for one (1), out of each three (3) Licensed Products. The Parties shall cause their respective representatives on the JDC and the JSC, in preparing, updating and approving Global Development Plans, to allocate principal Development responsibilities thereunder as provided in this Section 5.2.

Global Development Plans. With respect to each Licensed Product, the JDC shall prepare and present a Global Development Plan for approval by the JSC, and the JSC shall approve a Global Development Plan for such Licensed Product, within three (3) months after the time such Licensed Product first becomes a Licensed Product in accordance with the terms of the Discovery Agreement and this Agreement, and shall, subject to the further provisions of this Section 5.2, determine which Party will take the lead in the Development of such Licensed Product. Prior to such JSC approval of the first Global Development Plan for any Licensed Product, the Parties shall Develop the Licensed Product in accordance with the applicable Initial Development Plan. , including, in the case of REGN88 (IL-6RmAb), a summary outline of an Initial Development Plan attached hereto as Exhibit B. An updated Global Development Plan for such Licensed Product will be presented by the JDC for approval by the JSC, and approved by the JSC, at least two (2) months prior to the end of each Contract Year. Each Global Development Plan for a Licensed Product will set forth the plan for Development of such Licensed Product in the Field over at least three (3) Contract Years and will include (a) strategies and timelines for Developing and obtaining Approvals for such Licensed Product in the Field in the Territory, and (b) the allocation of responsibilities for Development activities between the Parties, and/or Third Party service providers. Each Global Development Plan will be reviewed and informally updated by the JDC not less frequently than once every six (6) months for the ensuing three (3) year period. Unless and to the extent otherwise agreed by the Parties with respect to a particular Licensed Product, (i) the Parties shall alternate, on a Licensed Product-by-Licensed Product basis, in being allocated principal responsibility for formulating, and carrying out, the principal Development activities for the applicable Licensed Product under the applicable Global Development Plan(s) from the time the applicable Product Candidate is advanced into Development in accordance with the Discovery Agreement (whereupon such Product Candidate automatically constitutes a Licensed Product) through proof of concept as defined in the Global Development Plan for the Licensed Product (the "“POC Time"”) (with respect to any Licensed Product, the Party with such principal responsibility through the POC Time being referred to as the "“POC Principal Party"”) and (ii) the Parties shall alternate being allocated principal responsibility for formulating, and carrying out, all clinical trials conducted subsequent to the POC Time for the applicable Licensed Product(s) under the applicable Global Development Plan(s) (with respect to a Licensed Product, the Party with such principal responsibility being referred to as the "“Post-POC Principal Party"”), with Sanofi being the Post-POC Principal Party for two (2), and Regeneron being the Post-POC Principal Party for one (1), out of each three (3) Licensed Products. The Parties shall cause their respective representatives on the JDC and the JSC, in preparing, updating and approving Global Development Plans, to allocate principal Development responsibilities thereunder as provided in this Section 5.2.

Global Development Plans. With (A) The global Development of the Licensed Products shall be conducted in accordance with the GDPs, and the Parties agree to conduct all their (and their Affiliates’) Development activities relating to the Licensed Products in accordance with the GDPs (subject to clauses 6.3 and 6.4). The initial GDP for the [*] Product is attached hereto as Schedule 8. (B) The JDC shall prepare initial GDPs for other Licensed Products at a time mutually agreed by the Parties (and in any event [*] after the Parties have preliminary clinical proof of concept (as agreed by the JSC) for the applicable Licensed Compound and determined the [*] of such Licensed Compound for any Phase II Clinical Study); such initial GDPs shall then be submitted to the JSC for final approval. Pending such GDPs, the Parties agree that the Parties ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ ​ shall execute the Development activities set out in the interim Development workplans appended at Schedule 9. (C) The GDPs shall allocate responsibility to a Party for each Development activity, including regulatory and CMC Development activities set out in the GDPs and in accordance with the terms and conditions of this Agreement. The GDPs shall include [*] and shall be consistent with the terms of this Agreement. Guidelines for additional data or criteria, if any, to be generated for assessment prior to commencement of any specific Clinical Study, shall be included in the GDPs. The GDPs shall also include: (i) the applicable Global Development Budget; and (ii) the Development Manufacturing and Supply Plan for the applicable Licensed Product in respect to each of activities before Regulatory Approval of that Licensed Product. Any activities set out in the GDPs shall at all times be designed to be in compliance with the Law and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry, taking into account where applicable each Party’s health care compliance policies and applicable SOPs. (D) The Global Development Budgets included in the GDPs shall include: (a) budgeted amounts for the Development Costs to be incurred in performing the activities allocated to the Parties under the GDPs during the then-current [*] thereafter, including budgets for each Clinical Study and each category of other Development activities included in the GDP (such categories shall include Manufacturing and any other categories to be determined by the JDC) for each Indication. (b) if the duration of a Clinical Study included in the GDP is anticipated to be longer than [*], a non-binding forecast of the Development Costs for the entire duration of that Clinical Study; (c) a budget for each Party setting out the Development Costs for the specific Development activities allocated to such Party under such GDP, broken down by [*] for the then-current [*]. As part of the annual update of the GDPs, the JDC shall prepare and present a Global Development Plan for approval by also prepare, with assistance from the JSCJFS, and the JSC shall review and approve a as part of the updated GDPs, the applicable updated Global Development Plan Budget covering the [*] and a forecast of the annual Global Development Budget until receipt of Regulatory Approval for the Indications reflected in such Global Development Budget and for the entire duration of the applicable Clinical Studies. (E) The Parties shall jointly develop, with the JCMCS, Development Manufacturing and Supply Plans for each Licensed Product setting out the Manufacturing activities to be performed pre-Regulatory Approval of the Licensed Product. Such Development Manufacturing and Supply Plans shall be incorporated into, within three (3and form part of, the GDP. Such Development Manufacturing and Supply Plans shall be reviewed and approved as part of the GDP pursuant to clause 6.2.1(A) months after the time such Licensed Product first becomes a Licensed Product and updated annually in accordance with the procedures set out in clause 9.1. The terms of the Discovery Agreement such Development Manufacturing and this Agreement, and shall, subject Supply Plans shall at all times be designed to the further provisions of this Section 5.2, determine which Party will take the lead be in the Development of such Licensed Product. Prior to such JSC approval of the first Global Development Plan for any Licensed Product, the Parties shall Develop the Licensed Product in accordance compliance with the GDP, all applicable Initial Laws, taking into account where applicable each Party’s applicable SOPs. The initial Development Plan[*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. An updated Global Development Plan for such Licensed Product will be presented by the JDC for approval by the JSC, ​ ​ Manufacturing and approved by the JSC, at least two (2) months prior to the end of each Contract Year. Each Global Development Plan for a Licensed Product will set forth the plan for Development of such Licensed Product in the Field over at least three (3) Contract Years and will include (a) strategies and timelines for Developing and obtaining Approvals for such Licensed Product in the Field in the Territory, and (b) the allocation of responsibilities for Development activities between the Parties, and/or Third Party service providers. Each Global Development Plan will be reviewed and informally updated by the JDC not less frequently than once every six (6) months for the ensuing three (3) year period. Unless and to the extent otherwise agreed by the Parties with respect to a particular Licensed Product, (i) the Parties shall alternate, on a Licensed Product-by-Licensed Product basis, in being allocated principal responsibility for formulating, and carrying out, the principal Development activities for the applicable Licensed Product under the applicable Global Development Plan(s) from the time the applicable Product Candidate is advanced into Development in accordance with the Discovery Agreement (whereupon such Product Candidate automatically constitutes a Licensed Product) through proof of concept as defined in the Global Development Plan Supply Plans for the Licensed Product (the "POC Time") (with respect to any Licensed Product, the Party with such principal responsibility through the POC Time being referred to as the "POC Principal Party") and (ii) the Parties shall alternate being allocated principal responsibility for formulating, and carrying out, all clinical trials conducted subsequent to the POC Time Products for the applicable Licensed Product(s) under rest of the applicable Global Development Plan(s) (with respect to a Licensed Product, Calendar Year after the Party with such principal responsibility being referred to Effective Date is attached as the "Post-POC Principal Party"), with Sanofi being the Post-POC Principal Party for two (2), and Regeneron being the Post-POC Principal Party for one (1), out of each three (3) Licensed Products. The Parties shall cause their respective representatives on the JDC and the JSC, in preparing, updating and approving Global Development Plans, to allocate principal Development responsibilities thereunder as provided in this Section 5.2Schedule 13.

Global Development Plans. With respect to For each Regional Licensed Product, the JDC shall prepare Development activities that are necessary or useful to be undertaken for such Regional Licensed Product to achieve initial Regulatory Approval for each of the indications to be sought pursuant to the Global Development Strategy in at least all of the MMCs in a proximal fashion (including the design of necessary or useful Clinical Studies) will be set forth in reasonable detail in a written work plan and present time table (each, a “Global Development Plan”). Alnylam will provide a draft of the initial Global Development Plan for approval by the JSCALN-TTR02 to Genzyme on or before [***], and within [***] days thereafter the JSC shall PJSC will review, update and approve a such Global Development Plan and it will be attached hereto as Schedule 2.2.2.1-1. The initial Global Development Plan for such Licensed Product, within three (3) months after the time such Licensed Product first becomes a Licensed Product in accordance with the terms of the Discovery Agreement and this Agreement, and shall, subject to the further provisions of this Section 5.2, determine which Party will take the lead in the Development of such Licensed Product. Prior to such JSC approval of the first Global Development Plan for any Licensed Product, the Parties shall Develop the Licensed Product in accordance with the applicable Initial Development Plan. An updated Global Development Plan for such each subsequent Regional Licensed Product will be presented included in the Option Data Package for such Regional Licensed Product provided by Alnylam to Genzyme under the JDC for approval by the JSCMaster Agreement, and approved by within [***] days of the JSCImplementation Date for such Regional Licensed Product the PJSC responsible for such Regional Licensed Product will review, at least two (update and approve such Global Development Plan and it will be attached hereto as Schedules 2.2.2.1-2) months prior to the end of each Contract Year, 2.2.2.1-3 and so forth. Each Global Development Plan for a Licensed Product will set forth must, at all times, be consistent with the plan for Global Development Strategy and include all Development activities that (i) are reasonably necessary to obtain initial Regulatory Approval of such the applicable Regional Licensed Product in each MMC for each of the Field over at least three indications, including Secondary Indications, to be sought pursuant to the Global Development Strategy in a proximal fashion and (3ii) Contract Years and Secondary Indication Studies included in the initial Global Development Plan or added pursuant to Section 2.2.2.6 (Secondary Indications) (all such Development activities collectively, the “Global Development Activities”); provided, however, that, unless otherwise agreed by the Parties, in no event will any Global Development Plan include (a) strategies and timelines any Post-Marketing Study or Secondary Indication Study, except for Developing and obtaining Approvals for such Licensed Product Secondary Indication Studies included in the Field in the Territoryinitial Global Development Plan or added to a Global Development Plan pursuant to Section 2.2.2.6 (Secondary Indications), and (b) any Development activity solely intended or designed to achieve initial Regulatory Approval in a country other than an MMC or (c) after the allocation of responsibilities last Regulatory 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. REGIONAL LICENSE TERMS Approval in all MMCs, any Development activity that is useful solely to achieve initial Regulatory Approval in a country that is not an MMC, except for Secondary Indication Studies included in the initial Global Development activities between the Parties, and/or Third Party service providersPlan or added to a Global Development Plan pursuant to Section 2.2.2.6 (Secondary Indications). Each Global Development Plan will be reviewed and informally updated by the JDC not less frequently than once every six (6) months allocate responsibility for the ensuing three (3) year periodperformance of each Global Development Activity to one of the Parties. Unless and The time table for the completion of the Global Development Activities included in each Global Development Plan will be designed to obtain initial Regulatory Approval of the extent otherwise agreed by the Parties with respect to a particular Licensed Product, (i) the Parties shall alternate, on a Licensed Product-by-applicable Regional Licensed Product basis, in being allocated principal responsibility for formulatingeach MMC in a proximal fashion and as soon as reasonably possible. The terms of, and carrying out, the principal Development activities for the applicable Licensed Product under the applicable set forth in, each Global Development Plan(s) from the time the Plan will at all times be designed to be in compliance with all applicable Product Candidate is advanced into Development Laws and in accordance with the Discovery Agreement (whereupon such Product Candidate automatically constitutes a Licensed Product) through proof of concept as defined professional and ethical standards customary in the Global Development Plan for the Licensed Product (the "POC Time") (with respect to any Licensed Product, the Party with such principal responsibility through the POC Time being referred to as the "POC Principal Party") and (ii) the Parties shall alternate being allocated principal responsibility for formulating, and carrying out, all clinical trials conducted subsequent to the POC Time for the applicable Licensed Product(s) under the applicable Global Development Plan(s) (with respect to a Licensed Product, the Party with such principal responsibility being referred to as the "Post-POC Principal Party"), with Sanofi being the Post-POC Principal Party for two (2), and Regeneron being the Post-POC Principal Party for one (1), out of each three (3) Licensed Products. The Parties shall cause their respective representatives on the JDC and the JSC, in preparing, updating and approving Global Development Plans, to allocate principal Development responsibilities thereunder as provided in this Section 5.2pharmaceutical industry.