Common use of Initial Development Plan Clause in Contracts

Initial Development Plan. Alnylam shall be responsible for the global Development of Licensed Products and all Development activities with respect thereto through Phase I Completion as set forth in the Initial Development Plan. Alnylam shall be responsible for one hundred percent (100%) of all Costs for the Development activities that are conducted by Alnylam for the Licensed Product in the Territory pursuant to the Initial Development Plan up to a total of (a) [***] dollars ($[***]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (b) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant to the Initial Development Plan that exceed such amount to the extent such excess Costs [***]. MedCo shall be responsible for all Costs with respect to Development activities for the Licensed Product pursuant to the Initial Development Plan that (a) are conducted by Alnylam, (b) are in excess of the then-applicable Development Costs Cap, and (c) are approved by the JSC (the “Extra Early Development Costs”). 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.

Initial Development Plan. Alnylam shall The Parties have agreed upon an Initial Development Plan setting forth the design, costs, protocols, roles and responsibilities, and timelines of the Development activities to be responsible undertaken with the objective of obtaining Regulatory Approval for the global Product in the Development of Licensed Products Indication by the FDA, Health Canada and all Development activities with respect thereto through Phase I Completion EMA, as further set forth in this Section 5.1. The clinical and regulatory strategy contemplated by the agreed Initial Development Plan will be submitted to the FDA in advance of the FDA Development Meeting, which meeting will be held as soon as practicable after the Effective Date but in any event the Parties shall endeavor to schedule such FDA Development Meeting to occur within [*] Calendar Months after the Effective Date. Following the FDA Development Meeting: (a) If no material changes or alterations of the Initial Development Plan (including the JDC-Approved Development Budget) are required, then it shall be deemed a JSC approved Development Plan, and, subject to the satisfaction of the conditions set out in Section 2.2, the Parties shall commence Development of the Product in the Development Indication in the Development Territory in accordance with such Development Plan as soon as practicable thereafter; (b) If either Party believes that any decision, recommendation or other feedback from the FDA requires amendment of the Initial Development Plan, the JDT shall promptly meet and decide how to implement such amendment. Alnylam Except as otherwise set forth in Section 5.1(c), if the JDC approves such proposed amendment by the JDT, then the Initial Development Plan (including the JDC-Approved Development Budget contained in such Development Plan, which shall be responsible for one hundred percent (100%amended accordingly in a manner that minimizes any increase in such JDC-Approved Development Budget whilst still giving effect to such JDC approved amendment) of all Costs for shall be amended accordingly and shall, subject to JSC approval, be deemed to be the Development activities that are conducted by Alnylam for Plan and the Licensed new JDC-Approved Development Budget, and, subject to the satisfaction of the conditions set out in Section 2.2, the Parties shall commence Development of the Product in the Development Indication in the Development Territory pursuant in accordance with such Development Plan as soon as practicable thereafter; (c) If any amendment to the Initial Development Plan up (including the JDC-Approved Development Budget therein) required to a total address such FDA feedback will (i) significantly increase the costs of Development, and/or (aii) [***] dollars extend the projected timeline for completion of Development, and/or ($[***]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (biii) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant otherwise require material modifications to the Initial Development Plan Plan, then either Party may object if it reasonably determines that exceed such amount amendment will adversely affect the medical and scientific basis and/or commercial objectives for undertaking the Development of the Product in the Development Indication in the Development Territory. The objecting Party shall inform the JDC which shall promptly meet to discuss the factual basis for such determination; (d) Any amendment to the extent such excess Costs [***]. MedCo shall be responsible for all Costs with respect to Development activities for the Licensed Product pursuant to the Initial Development Plan that (aincluding the JDC-Approved Development Budget) are conducted by Alnylam, (bunder Section 5.1(b) are in excess of the then-applicable Development Costs Cap, and or (c) are shall be finalized and approved by the JSC (the “Extra Early Development Costs”). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “within [*] days after the FDA Development Meeting. Following any such amendment over a Party’s objection under Section 5.1(c), such Party may terminate this Agreement pursuant to Section 20.3 on [*] Business Days’ written notice to the other Party and the consequences set out in Section 21.1 shall apply, provided that: such Party shall provide such notice within [*]”. 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] Business Days after the approval of such Development Plan (including the JDC-Approved Development Budget).

Initial Development Plan. Alnylam As soon as AVEO has prepared the initial Development Plan (even if prior to delivery of the Data Package), AVEO shall deliver to Biogen Idec the initial Development Plan. During the period between Data Package delivery by AVEO and Option Exercise Date, AVEO and Biogen Idec, including appropriate members of the clinical development and regulatory teams of both AVEO and Biogen Idec shall meet to discuss the initial Development Plan, including the design thereof as well as the indication being studied, and the Development activities and timelines contemplated thereunder. In anticipation of Biogen Idec’s exercise of the Option, AVEO shall (x) consider in good faith all reasonable Biogen Idec proposals to such initial Development Plan and (y) deliver to Biogen Idec a revised initial Development Plan (or if no revised initial Development Plan is delivered, the initial Development Plan shall be responsible for deemed re-delivered) no less than thirty (30) days prior to the global Development end of Licensed Products and all Development activities with respect thereto through Phase I Completion as set forth in the Option Exercise Period (the “Delivered Initial Development Plan”). Alnylam shall be responsible for one hundred percent (100%) of all Costs for the Development activities that are conducted by Alnylam for the Licensed Product in the Territory pursuant to the The Delivered Initial Development Plan up to a total of shall meet the following criteria: (ai) [***] dollars ($[***]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (b) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant to the Delivered Initial Development Plan that exceed such amount shall be directed only to the extent indication that was the subject of the Proof of Concept Study; (ii) the size of the pivotal trial included in such excess Costs [***]. MedCo shall be responsible for all Costs with respect to Development activities for the Licensed Product pursuant to the Delivered Initial Development Plan that (a) are conducted by Alnylam, (b) are in excess shall be reasonable given the scope of the then-applicable indication, in light of then prevailing industry standards and regulatory guidance; (iii) such Delivered Initial Development Plan shall in addition include, at a minimum, study designs, assignment of responsibilities (both among the Parties and Third Parties), timelines, decision criteria, supply plans, quality standards, expected resources, costs and a budget for Development Costs; and (iv) the budget for Development Costs Cap, and (c) are approved by in such Delivered Initial Development Plan shall be for no longer than through the JSC (end of completion of the “Extra Early Development Costs”). 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 1934pivotal trial for the indication that was the subject of the Proof of Concept Study.

Initial Development Plan. Alnylam As soon as AVEO has prepared the initial Development Plan (even if prior to delivery of the Data Package), AVEO shall deliver to Biogen Idec the initial Development Plan. During the period between Data Package delivery by AVEO and Option Exercise Date, AVEO and Biogen Idec, including appropriate members of the clinical development and regulatory teams of both AVEO and Biogen Idec shall meet to discuss the initial Development Plan, including the design thereof as well as the indication being studied, and the Development activities and timelines contemplated thereunder. In anticipation of Biogen Idec’s exercise of the Option, AVEO shall (x) consider in good faith all reasonable Biogen Idec proposals to such initial Development Plan and (y) deliver to Biogen Idec a revised initial Development Plan (or if no revised initial Development Plan is delivered, the initial 18 Development Plan shall be responsible for deemed re-delivered) no less than thirty (30) days prior to the global Development end of Licensed Products and all Development activities with respect thereto through Phase I Completion as set forth in the Option Exercise Period (the “Delivered Initial Development Plan”). Alnylam shall be responsible for one hundred percent (100%) of all Costs for the Development activities that are conducted by Alnylam for the Licensed Product in the Territory pursuant to the The Delivered Initial Development Plan up to a total of shall meet the following criteria: (ai) [***] dollars ($[***]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (b) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant to the Delivered Initial Development Plan that exceed such amount shall be directed only to the extent indication that was the subject of the Proof of Concept Study; (ii) the size of the pivotal trial included in such excess Costs [***]. MedCo shall be responsible for all Costs with respect to Development activities for the Licensed Product pursuant to the Delivered Initial Development Plan that (a) are conducted by Alnylam, (b) are in excess shall be reasonable given the scope of the then-applicable indication, in light of then prevailing industry standards and regulatory guidance; (iii) such Delivered Initial Development Plan shall in addition include, at a minimum, study designs, assignment of responsibilities (both among the Parties and Third Parties), timelines, decision criteria, supply plans, quality standards, expected resources, costs and a budget for Development Costs; and (iv) the budget for Development Costs Cap, and (c) are approved by in such Delivered Initial Development Plan shall be for no longer than through the JSC (end of completion of the “Extra Early Development Costs”). 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 1934pivotal trial for the indication that was the subject of the Proof of Concept Study.

Initial Development Plan. Alnylam Within [***]of the Amendment and Restatement Date, MSB shall be responsible provide Grünenthal with a copy of a plan for the global Development of Licensed Products and all the Product within the Field during the Initial Period (including the conduct of the New Phase III Clinical Trial) (“Initial Development activities with respect thereto through Phase I Completion as set forth in Plan”). During the Initial Period, MSB shall have the right to update the Initial Development PlanPlan in its sole discretion, provided that (i) such updates are consistent with its Development obligations under this Article 4, (ii) MSB shall make such updates as are reasonably required to implement any requirements or recommendations of any relevant Regulatory Authority or HTA, and (iii) MSB provides Grünenthal with a copy of any such updated Initial Development Plan promptly after the update has been made. Alnylam MSB shall be responsible for one hundred percent (100%) of all Costs ensure that the Initial Development Plan and each update thereto includes as a minimum: 4.3.1 the clinical trial protocol for the New Phase III Clinical Trial (or, to the extent the full protocol has not yet been developed, a synopsis of the clinical trial protocol); 4.3.2 details of major CMC/non-clinical studies and activities; 4.3.3 scope and timelines for the conduct of the new Phase III Clinical Trial; and 4.3.4 regulatory and reimbursement matters including Regulatory Materials to be filed with Regulatory Authorities, including estimated timing of meetings with Regulatory Authorities in support of Development activities that are conducted by Alnylam for during the Licensed Product Initial Period. The Parties shall discuss the Initial Development Plan and the progress of MSB’s Development activities in the Territory pursuant relation to the Initial Development Plan up to a total of (a) [***] dollars ($[***]), prior to at the receipt by Alnylam meetings of the Milestone Payment JSC during the Initial Period. At such JSC meetings, Grünenthal shall be permitted to (i) comment on the Initial Development Plan and MSB shall reasonably consider whether the Initial Development Plan should be updated to reflect such comments and (ii) raise questions in Section 7.2(a)(i), or (b) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant relation to the Initial Development Plan that exceed such amount to the extent such excess Costs [***]. MedCo shall be responsible for all Costs with respect to and MSB’s Development activities for the Licensed Product pursuant to the Initial Development Plan that (a) are conducted by Alnylam, (b) are thereunder which MSB shall answer in excess of the then-applicable Development Costs Cap, and (c) are approved by the JSC (the “Extra Early Development Costs”). 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 1934good faith.

Initial Development Plan. Alnylam shall be responsible Revance will retain primary responsibility, at Revance’s expense (subject to the cap described in Section 5.2(b) below) and in collaboration with Mylan, for conducting the global Development of Licensed Products further Product characterization and all Development activities with respect thereto through Phase I Completion necessary to prepare for and conduct an FDA Scientific Advice Meeting, as set forth on Exhibit 5.2 (the “Initial Development Plan”). Revance shall use Commercially Reasonable Efforts to complete the activities set forth in the Initial Development Plan. Alnylam Plan in accordance with this Agreement and Applicable Law, and shall maintain complete and accurate records of such activities, which shall be responsible for one hundred percent (100%) subject to audit by Mylan in accordance with Section 9.4. All briefing packages and other materials submitted to the FDA in advance of all Costs the FDA Scientific Advice Meeting, including the FDA Advisory Package for the Development activities that are conducted Product as a Biosimilar, shall be subject to review and approval by Alnylam for the Licensed Product in the Territory pursuant JSC prior to submission to the Initial Development Plan up to a total of (a) [***] dollars ($[***]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (b) [***] ($[***]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam FDA. Revance shall also bear any Costs for Development activities conducted by Alnylam pursuant to the Initial Development Plan that exceed such amount to the extent such excess Costs [***]. MedCo shall be responsible for all Costs coordinate with Mylan with respect to Development activities scheduling the FDA Scientific Advice Meeting and shall provide Mylan with written notice of the timing for the Licensed Product pursuant to FDA Scientific Advice Meeting within five (5) days of such meeting being scheduled. Mylan shall participate in all preparatory meetings for the Initial Development Plan that (a) are conducted by Alnylam, (b) are in excess of the then-applicable Development Costs CapFDA Scientific Advice Meeting, and at least two (c2) are approved by representatives from Mylan shall attend and participate in the JSC FDA Scientific Advice Meeting. Revance shall provide Mylan with a copy of Revance’s meeting minutes from the FDA Scientific Advice Meeting for review and comment prior to finalizing such minutes. Further, Revance shall provide Mylan with the FDA’s final minutes from the FDA Scientific Advice Meeting (the “Extra Early Development CostsFDA Minutes”). 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) within two (2) Business Days of Revance’s receipt of such minutes.