Development Plan Amendments. (a) Within [**] days following the completion of activities under the Joint Research Plan, the Parties shall prepare an initial Development plan (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Development Plan”) that will cover Development activities commencing with IND-Enabling Studies through Phase I Completion with respect to the proposed development candidate(s) under the Program, including a [**] budget for Development Costs. Each annual update to the Development Plan shall cover Development activities through completion of the next phase of Development and a [**] budget (or longer, if the Development activities covered by the Development Plan extend for longer than [**]). (b) Unless and until either Party exercises its Opt-Out Right, in addition to annual updates or modifications to the Development Plan decided by the JSC pursuant to Section 2.1(d), either Party may develop and submit to the JSC from time to time proposed amendments to the Development Plan (excluding any amendment to the budget, which amendment shall require the approval of both Parties outside the JSC). Upon approval of such proposed amendments by the JSC (subject to the limitations set forth in Section 2.1(d)), the Development Plan shall be amended accordingly.
Appears in 2 contracts
Sources: Collaboration Agreement (Arrowhead Research Corp), Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)