Initial Global Development Plan. The Development activities to be undertaken by Alnylam with respect to Licensed Products in the Territory prior to Phase I Completion will be set forth in a written workplan and timetable (the “Initial Development Plan”), which plan includes the Development activities to be undertaken (and all of which will be conducted by Alnylam) with respect to Licensed Products prior to Phase I Completion, and an estimated budget for such Development activities (“Initial Development Budget”). A draft of the Initial Development Plan is attached hereto as Schedule E. Alnylam shall submit an update to the Initial Development Plan for review and approval by the JSC of any material modifications or updates within forty-five (45) days of the Effective Date and thereafter on at least a semi-annual basis. The JSC shall have the right to modify the Initial Development Plan during such review and approval but only to the extent consistent with the budget and timelines contained in the Initial Development Plan attached hereto as Schedule E or as otherwise agreed by the Parties.
Initial Global Development Plan. The initial Global Development Plan is set forth in the Letter Agreement.
Initial Global Development Plan. The initial Global Development Plan shall be presented by the JDC to the JEC for approval by the JEC within [ * ] following the Effective Date.
Initial Global Development Plan. As soon as practicable following designation of a Collaboration Program in accordance with Article 3 (and consistent with BMS’ internal [ * ] process), the JDC shall prepare, and submit to the JEC for its approval, a Global Development Plan, or an amendment to an existing Global Development Plan, that meets the requirements set forth in Section 4.1(a).
Initial Global Development Plan. The initial Global Development Plan, which shall initially consist of the ADLS Study and the [***] Study, is attached hereto as Exhibit 4.3.
Initial Global Development Plan. The Initial Global Development Plan, is attached as Exhibit A. During the Term, the JDC shall review, discuss and approve potential amendments to the Initial Global Development Plan, at least […***…].
Initial Global Development Plan. The initial Global Development Plan for the Product is set forth as Schedule 4.3.2. To the extent that future meetings with the Regulatory Authorities in or outside the Territory provide guidance with respect to the risk management plan or Development Activities for the Territory or outside the Territory, the Parties shall consider such guidance in updating and amending the Global Development Plan pursuant to Section 4.3.3.
Initial Global Development Plan. The Initial Global Development Plan, which is attached hereto as Exhibit A, includes a detailed Clinical Trial plan which describes (a) the Initial Global Studies being conducted by XxxXxxx, (b) the Novartis-Initiated Trials conducted by Novartis, and (c) all other Clinical Trials, including data-generation Clinical Trials, to be conducted by Novartis. On and after […***…], the Parties may, subject to mutual written agreement, prepare amendments to the Initial Global Development Plan to include additional Clinical Trials as part of the Initial Global Development Plan.
Initial Global Development Plan. The initial global development plan and corresponding budget for the Licensed Compounds and Licensed Products is set forth on Schedule 5.2 (Initial Global Development Plan and Budget) (such global development plan attached as of signing, the “Initial Global Development Plan” and as it may be modified in accordance with the terms and conditions of this Agreement, the “Global Development Plan” and such corresponding budget, the “Global Development Budget”). The Initial Global Development Plan includes (and will at all times include): (a) all Research and Development activities for the Licensed Compounds and Licensed Products other than (i) Research or Development activities that are solely intended to support obtaining or maintaining Regulatory Approval or label expansion of the Licensed Compounds and Licensed Products in the Sanofi Territory (such excluded Research and Development activities in clause (i), “Sanofi Independent Development Activities”) and (ii) Research or Development activities that are solely intended to support obtaining or maintaining Regulatory Approval or label expansion of the Licensed Compounds and Licensed Products in the Fulcrum Territory (such excluded Research and Development activities in clause (ii), “Fulcrum Independent Development Activities”), (b) the allocation of responsibilities between the Parties for all activities under the Global Development Plan, and (c) the estimated timelines for all activities under the Global Development Plan. The Global Development Budget also includes (and will at all times include) a detailed written budget for the performance of the activities under the Global Development Plan for the current Calendar Year and at least [***] subsequent Calendar Years, broken down by Calendar Year; provided that, with respect to the Global Development Budget included in the Initial Global Development Plan, the budget for the performance of any Clinical Trials that are identified as “Open Budget Studies” in the Global Development Budget included in the Initial Global Development Plan (each such Clinical Trial, an “Open Budget Study”) will be reviewed, discussed, and approved by the JSC promptly after the Effective Date.
