Common use of Genzyme Territory Development Plan Clause in Contracts

Genzyme Territory Development Plan. Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Genzyme with respect to the Genzyme Territory, including Secondary Indication Studies, shall be set forth in a written work plan and time table (each, a “Genzyme Territory Development Plan”). The initial Genzyme Territory Development Plan for each Split Territory Licensed Product shall be prepared by Genzyme and, following review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be and attached hereto as Schedules 5.2.7-1, 5.2.7-2 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such Genzyme Territory Development Plan. Each Genzyme Territory Development Plan shall set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Licensed Product from the Option Exercise Date until the later of (a) [***] from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product. Each Genzyme Territory Development Plan shall subsequently be updated by Genzyme from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product. Genzyme shall present each Genzyme Territory Development Plan and any proposed amendments thereto to the applicable PSC at least [***] days in advance of implementation of the Genzyme Territory Development Plan, and following review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be attached hereto as the applicable Schedule. In addition, notwithstanding anything to the contrary in this Agreement, Genzyme shall not conduct any Clinical Study for a Split Territory Licensed Product in the Voyager Territory without Voyager’s prior written consent.

Genzyme Territory Development Plan. Other than Split Territory Global Development Activities, all The Development activities and Post-Approval Studies to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Genzyme with respect to the Genzyme Territory, including Secondary Indication Studies, shall will be set forth in a written work plan and time table (each, a “Genzyme Territory Development Plan”). The initial Genzyme Territory Development Plan for each Split Territory Licensed Product shall , which will be prepared by Genzyme and, by [**] and following review and approval approval, subject to Section 5.5.3(a), by the PSCJSC, shall will then be attached to the PSC meeting minutes and deemed to be and attached hereto as Schedules 5.2.7-1, 5.2.7-2 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such Genzyme Territory Development PlanSchedule 2.2.3. Each Genzyme Territory Development Plan shall will set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Post-Approval Studies for the applicable Split Territory a Licensed Product from the Option Exercise Effective Date until the later of (a) [***] years from the date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product. Each The Genzyme Territory Development Plan Plans shall subsequently be updated by Genzyme from time-to-time at least once to time not later than [**] of each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Post-Approval Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed ProductProduct in the Genzyme Territory. Genzyme will have final decision-making authority over the Genzyme Territory Development Plans; provided, however, that the Genzyme Territory Development Plans shall present each at all times be materially consistent with the Global Development Strategy and shall not be amended in a manner that would have a material adverse effect on the Development of Licensed Products in the Alnylam Territory; provided, however, that Genzyme may, in accordance with Section 5.5, amend the Genzyme Territory Development Plan in a manner that materially adversely affects the Development of Licensed Products in the Alnylam Territory if the Development activities contemplated by such amendment are reasonably required to obtain Regulatory Approval of a Licensed Product in the Genzyme Territory and there is no reasonable alternative to such activity that would similarly enable Genzyme or its Related Parties to obtain such Regulatory Approval in the Genzyme Territory with a lesser adverse effect on the Development of Licensed Products in the Alnylam Territory. Genzyme will present the Genzyme Territory Development Plans and any proposed amendments thereto to the applicable PSC at least [***] days JSC reasonably in advance of implementation of the Genzyme Territory Development Planimplementing such plans or amendments, and following Alnylam shall have the right to review and approval by the PSC, shall then be attached to the PSC meeting minutes comment thereon and deemed to be attached hereto as the applicable Schedule. In addition, notwithstanding anything to the contrary in this Agreement, Genzyme shall not conduct any Clinical Study for a Split Territory Licensed Product consider in the Voyager Territory without Voyagergood faith Alnylam’s prior written consenttimely comments.

Genzyme Territory Development Plan. Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Regional Licensed Product by or on behalf of Genzyme with respect to the Genzyme Territory, including Secondary Indication Studies and Post-Marketing Studies, shall will be set forth in a written work plan and time table (each, a “Genzyme Territory Development Plan”). Each Genzyme Territory Development Plan shall be consistent with the requirements of the then-current Global Development Strategy (provided that Alnylam did not exercise its deciding vote with respect thereto pursuant to Section 5.6.3 ([***]). Prior to [***], Genzyme will prepare the Genzyme Territory Development Plan for ALN-TTR02 and then promptly thereafter will submit it to the PJSC for review and approval. Following review and approval by the PJSC, it will then be attached to the PJSC meeting minutes and deemed to be attached hereto as Schedule 2.2.4-1. The initial Genzyme Territory Development Plan for each Split Territory subsequent Regional Licensed Product shall will be prepared by Genzyme and, and following review and approval by the PSCPJSC, shall will then be attached to the PSC PJSC meeting minutes and deemed to be and attached hereto as Schedules 5.2.72.2.4-12, 5.2.72.2.4-2 3 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such Genzyme Territory Development Plan. Each Genzyme Territory Development Plan shall will set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Regional Licensed Product from the Option Exercise Implementation Date until the later of (a) [***] two (2) years from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Regional Licensed Product. Each Genzyme Territory Development Plan shall subsequently be updated by Genzyme from time-to-time at least once each Calendar Year not later than September 1 [***] until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Regional Licensed Product. Genzyme shall will present each Genzyme Territory Development Plan and any proposed amendments thereto to the applicable PSC PJSC at least [***] days in advance of implementation of the Genzyme Territory Development Plan, and following review and approval by the PSCPJSC, shall will then be attached to the PSC PJSC meeting minutes and deemed to be attached hereto as the applicable Schedule. In addition, notwithstanding anything to the contrary in this Agreementthese Regional License Terms, Genzyme shall not conduct any Clinical Study for a Split Territory Regional Licensed Product in a country in the Voyager Alnylam Territory without Voyager’s prior written consentafter receipt of initial Regulatory Approval of such Regional Licensed Product in such country in the Alnylam Territory.

Genzyme Territory Development Plan. Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Co-Co Licensed Product by or on behalf of Genzyme with respect to the Genzyme Territory, including Secondary Indication Studies and Post-Marketing Studies, shall will be set forth in a written work plan and time table (each, a “Genzyme Territory Development Plan”). Each Genzyme Territory Development Plan shall be consistent with the requirements of the then-current Global Development Strategy. The initial Genzyme Territory Development Plan for each Split Territory Licensed Product shall ALN-TTRsc will be prepared by Genzyme and delivered to the applicable PJSC by [***] and, following review and approval by the PSCPJSC, shall will then be attached to the PSC PJSC meeting minutes and deemed to be and attached hereto as Schedules 5.2.7Schedule 2.2.3-1. If Genzyme exercises the Co-Co/Global Option with respect to ALN-AT3, 5.2.7-2 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such initial Genzyme Territory Development PlanPlan for ALN-AT3 (if any) will be prepared by Genzyme and following review and approval by the PJSC, will then be attached to the PJSC meeting minutes and deemed to be attached hereto as Schedule 2.2.3-2. Each Genzyme Territory Development Plan shall will set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Co-Co Licensed Product from the Option Exercise Implementation Date until the later of (a) [***] from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product. Each Genzyme Territory Development Plan shall subsequently be updated by Genzyme from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Co-Co Licensed Product. Genzyme shall will update each such Genzyme Territory Development Plan from time-to-time but at least annually on or before [***]. Genzyme will present each Genzyme Territory Development Plan and any proposed amendments thereto to the applicable PSC PJSC at least [***] days in advance of implementation of the Genzyme Territory Development Plan, and following review and approval by the PSCPJSC, shall will then be attached to the PSC PJSC meeting minutes and deemed to be attached hereto as the applicable Schedule. In addition, notwithstanding anything to the contrary in this Agreement, Genzyme shall not conduct any Clinical Study for a Split Territory Licensed Product in the Voyager Territory without Voyager’s prior written consent.