Amendments to the Development Plan. (i) On an annual basis (no later than October 31st of the preceding Calendar Year), or more often as the Parties deem appropriate, the JDC shall prepare amendments to the then-current Development Plan and Development Budget for approval of the JSC. Each such amended Development Plan shall specify, with a reasonable level of detail, the items described in Section 3.2(a). Such amended Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by the Parties) and shall contain a corresponding budget for U.S. activities. Such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the JDC may prepare amendments for approval of the JSC to the Development Plan and corresponding Development Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the JDC shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSC, the amended annual Development Plan and Development Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget for the applicable period.
(ii) Each Party shall notify the other Party promptly upon becoming aware that it is likely to exceed, or has exceeded, the budget for a particular activity for U.S. Development of the Product allocated to such Party in the Development Plan. Thereafter, the JDC shall promptly meet and determine whether to amend the Development Plan or Development Budget accordingly, provided that the JDC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control or that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan. Any such amendment proposed by the JDC shall not be subject to the JSC’s review and will be deemed automatically approved by the JSC, unless such amendment would cause the total Development Costs incurred by a Party in any Cal...
Amendments to the Development Plan. On [**] basis, the JDC shall evaluate whether any amendment to the then-current Development Plans, and, subject to this Agreement, the corresponding Development Budget if applicable, are appropriate to reflect [**]. In the event that such amendment is deemed necessary, the JDC shall submit such amendment for approval of the JSC no later than [**] of the preceding Calendar Year. Each such amended Development Plan shall contain [**]. In addition, the JDC may prepare amendments to the Development Plan and any Development Budget (if applicable) for the JSC’s approval from time to time during a Calendar Year in order to reflect changes in such plan and budget allocations for such Calendar Year, in each case, in accordance with the foregoing. Once approved by the JSC, the amended [**] Development Plan (including the Development Budget, if any) shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan (including, as applicable, any amended Development Budget) for a Product shall supersede the previous Development Plan and Development Budget for such Product.
Amendments to the Development Plan. From time to time during the Term, the OC shall have the right to amend the Development Plan.
Amendments to the Development Plan. ACADIA may amend the Development Plan from time to time in its sole discretion. Prior to finalizing any such amendment to the Development Plan which […***…]
Amendments to the Development Plan. The parties recognize that the Development Plan, including the Budget, represent projections only and will be subject to changes during the term of Development Programs. The Development Plan, including the Budget, shall be updated quarterly as deemed appropriate by the Joint Steering Committee. Either party may decide from time to time, but no less often [***], to propose for approval by the Joint Steering Committee updates to the Development Plan and Budget as necessary to reflect changes in the progress of Development for the Licensed Product. Any proposed change to the Development Plan and Budget shall set forth all anticipated scope of Development activities, geographical territory and timelines, and propose any responsibility of Xxxxx or Takeda for carrying out any such activities. The Joint Steering Committee shall promptly review such proposed change and shall as soon as practicable but in any event within [***] following submission either (a) approve it or (b) provide comments to the party proposing the change for its consideration. The party proposing the change shall consider such comments (if any) and revise the proposed change to implement all such reasonable comments and provide such revised proposed change to the Development Plan, including the Budget, to the Joint Steering Committee. If disputes remain with respect to such amendments to the Development Plan, including the Budget, then such dispute shall be referred to the Joint Steering Committee for resolution thereof in accordance with Section 3.2(e).
Amendments to the Development Plan. On an annual basis, or more often as Gilead deems appropriate, Gilead, in accordance with its usual practices with respect to product development plans, shall prepare any needed amendments to the then-current Development Plan for review by the JSC.
Amendments to the Development Plan. Targacept may amend the Development Plan from time to time in its sole discretion. If any such amendment to the Development Plan would significantly reduce funding for development of the Compound or significantly extend the timeline for development of the Compound, Targacept shall, prior to finalizing the proposed amendment, provide the proposed amendment to the members of the DAC and to SMRI, and the DAC and SMRI shall have fifteen (15) days to review and provide Targacept comments on such proposed amendment. Targacept shall consider any such input in good faith when finalizing such amendment and shall distribute the finalized amendment to the DAC and SMRI. In the event that SMRI reasonably believes that the finalized amendment will have a material adverse effect on the development of the Compound, SMRI may notify the DAC and Targacept in writing of such belief, which notice shall include the basis for such belief in reasonable detail, provided that such notice is given within five (5) days of receipt of the final amendment. Within five (5) days after such notice from SMRI (or such longer period as agreed by Targacept and SMRI), each member of the DAC shall provide notice in writing to Targacept if he or she rejects the final amendment as proposed. If a majority of the members of the DAC reject the amendment as proposed, SMRI shall have the right to terminate this Agreement pursuant to Section 10.4(a); provided, if SMRI does not terminate this Agreement pursuant to Section 10.4(a), the proposed amendment shall take effect and this Agreement shall continue in full force and effect.
Amendments to the Development Plan. (i) On an annual basis (no later than September 30th of the preceding Calendar Year), or more often as the Parties deem appropriate, the China Committee shall prepare amendments to the then-current Development Plan and budget for approval of the JSC as appropriate. Each such amended Development Plan shall specify, with a reasonable level of detail, the items described in Section 3.2(a). Such amended Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by the Parties) and shall contain a corresponding budget. Such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the China Committee may prepare amendments for approval of the JSC to the Development Plan and corresponding Development Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the China Committee shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSC, the amended annual Development Plan and Development Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget for the applicable period.
(ii) Each Party shall notify the other Party promptly upon becoming aware that it is likely to exceed, or has exceeded, the budget for a particular Calendar Year or Calendar Quarter in the Development Budget. Thereafter, the China Committee shall promptly
Amendments to the Development Plan. Ra Pharma may update the Development Plan at any point to reflect changes in the progress of development.
Amendments to the Development Plan. Each Party agrees to keep the other Party informed of material amendments to its Development Plan via the JSC, which may review and discuss such amendments in accordance with Section 3.1(a)(iii) (Formation and Role). References to the “Development Plan” in this Agreement refer to the Development Plan as then in effect (including all amendments thereto). A Party, without notice to or review by the JSC, may make non-substantive changes to such Party’s Development Plan as long as such changes do no alter or adversely affect the other Party’s rights and obligations as provided under this Agreement and as provided under the Development Plan.
