Common use of Global Development Plans Clause in Contracts

Global Development Plans. For each Co-Co Licensed Product, the Development activities that are necessary or useful to be undertaken for such Co-Co 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 time table (each, a “Global Development Plan”). Alnylam will provide a draft of the initial Global Development Plan for ALN-TTRsc to Genzyme on or before March 31, 2014, and within [***] days thereafter the PJSC will review, update and approve such Global Development Plan and it will be attached hereto as Schedule 2.2.2-1. The initial Global Development Plan for ALN-AT3 will be prepared by Alnylam and included in the Option Data Package for ALN-AT3 provided by Alnylam to Genzyme under the Master Agreement, and if Genzyme exercises the Co-Co/Global Option for ALN-AT3, within [***] days of the Implementation Date for ALN-AT3 the PJSC responsible for ALN-AT3 will review, update and approve such Global Development Plan and it will be attached hereto as Schedule 2.2.2-2. Each Global Development Plan must, at all times, be consistent with the Global Development Strategy and include all Development activities that (i) are reasonably necessary to obtain initial Regulatory Approval of the applicable Co-Co Licensed Product in at least each MMC for each of the indications, including Secondary Indications, to be sought pursuant to the Global Development Strategy in a proximal fashion, (ii) Post-Marketing Studies for the Co-Co Territory and (iii) Secondary Indication Studies included in the initial Global Development Plan or added pursuant to Section 2.2.2.5 (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) any Post-Marketing Study in the Genzyme Territory, (b) any Secondary Indication Study, except for Secondary Indication Studies included in the initial Global Development Plan or added to a Global Development Plan pursuant to Section 2.2.2.4 (Secondary Indications) or (c) after the last Regulatory Approval in all MMCs, any Development activity that is useful solely to achieve initial Regulatory Approval in a country in the Genzyme Territory that is not a Genzyme Territory MMC, except for Secondary Indication Studies included in the initial Global Development Plan or added to a Global Development Plan pursuant to Section 2.2.2.5 (Secondary Indications). In addition, for the period following the first Regulatory Approval in an MMC of a Co-Co Licensed Product, the Global Development Plan (and the Global Development Activities thereunder) must be established by the PJSC in a manner that reconciles the Parties’ preferences regarding short- and long-term profitability of such Co-Co Licensed Product. Each Global Development Plan will allocate responsibility for the performance of each Global Development Activity to one of the Parties. The time table for the 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. CO-CO LICENSE TERMS completion of the Global Development Activities included in each Global Development Plan will be designed to obtain initial Regulatory Approval of the applicable Co-Co Licensed Product in each MMC in a proximal fashion and as soon as reasonably possible. The terms of, and Development activities set forth in, each Global Development Plan will at all times be designed to be in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical industry.

Global Development Plans. For each Co-Co Regional Licensed Product, the Development activities that are necessary or useful to be undertaken for such Co-Co 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 time table (each, a “Global Development Plan”). Alnylam will provide a draft of the initial Global Development Plan for ALN-TTRsc TTR02 to Genzyme on or before March 31, 2014[***], and within [***] days thereafter the PJSC will review, update and approve such Global Development Plan and it will be attached hereto as Schedule 2.2.22.2.2.1-1. The initial Global Development Plan for ALN-AT3 each subsequent Regional Licensed Product will be prepared by Alnylam and included in the Option Data Package for ALN-AT3 such Regional Licensed Product provided by Alnylam to Genzyme under the Master Agreement, and if Genzyme exercises the Co-Co/Global Option for ALN-AT3, within [***] days of the Implementation Date for ALN-AT3 such Regional Licensed Product the PJSC responsible for ALN-AT3 such Regional Licensed Product will review, update and approve such Global Development Plan and it will be attached hereto as Schedule 2.2.2Schedules 2.2.2.1-2, 2.2.2.1-3 and so forth. Each Global Development Plan must, at all times, be consistent with the Global Development Strategy and include all Development activities that (i) are reasonably necessary to obtain initial Regulatory Approval of the applicable Co-Co Regional Licensed Product in at least each MMC for each of the indications, including Secondary Indications, to be sought pursuant to the Global Development Strategy in a proximal fashion, fashion and (ii) Post-Marketing Studies for the Co-Co Territory and (iii) Secondary Indication Studies included in the initial Global Development Plan or added pursuant to Section 2.2.2.5 2.2.2.6 (Secondary Indications) (all such Development activities, 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) any Post-Marketing Study in the Genzyme Territory, (b) any or Secondary Indication Study, except for Secondary Indication Studies included in the initial Global Development Plan or added to a Global Development Plan pursuant to Section 2.2.2.4 2.2.2.6 (Secondary Indications), (b) any Development activity solely intended or designed to achieve initial Regulatory Approval in a country other than an MMC or (c) after the last Regulatory Approval in all MMCs, any Development activity that is useful solely to achieve initial Regulatory Approval in a country in the Genzyme Territory that is not a Genzyme Territory MMC, except for Secondary Indication Studies included in the initial Global Development Plan or added to a Global Development Plan pursuant to Section 2.2.2.5 (Secondary Indications). In addition, for the period following the first Regulatory Approval in an MMC of a Co-Co Licensed Product, the Global Development Plan (and the Global Development Activities thereunder) must be established by the PJSC in a manner that reconciles the Parties’ preferences regarding short- and long-term profitability of such Co-Co Licensed Product. Each Global Development Plan will allocate responsibility for the performance of each Global Development Activity to one of the Parties. The time table for the 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. CO-CO 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 Plan or added to a Global Development Plan pursuant to Section 2.2.2.6 (Secondary Indications). Each Global Development Plan will allocate responsibility for the performance of each Global Development Activity to one of the Parties. 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 applicable Co-Co Regional Licensed Product in each MMC in a proximal fashion and as soon as reasonably possible. The terms of, and Development activities set forth in, each Global Development Plan will at all times be designed to be in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical industry.