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.
Amendments to the Development Plan. (A) Once per Calendar Quarter, or more often as the Board deems appropriate, the Product Development Subcommittee will review the then-current Development Plan (including the Development Budget) and if deemed appropriate prepare amendments to the then-current Development Plan and the corresponding Development Budget and submit such amendments for approval of the Board. Once approved by the Board, such amended Development Plan will cover the remaining current Calendar Year and the next Calendar Year (or such period that the Board will determine) and will contain a corresponding Development Budget, which will appropriately itemize the costs separately for each Product. Such updated and amended Development Plan will 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 Product Development Subcommittee may, of its own accord, prepare amendments to the Development Plan (including amendments to the Development Budget therein) for the Board’s approval from time to time during a Calendar Year in order to reflect changes in such plan and budget for such Calendar Year and the next Calendar Year, in each case, in accordance with the foregoing. Once approved by the Board, the amended annual Development Plan (including amendments to the Development Budget therein) will become effective for the applicable period on the date approved by the Board (or such other date as the Board will specify). Any Board-approved amended Development Plan (including the Development Budget therein) will supersede the previous Development Plan for the applicable period.
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 […***…] *** Certain confidential information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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. MEMORY may amend the Development Plan from time to time in its sole discretion. Prior to finalizing any such amendment to the Development Plan which materially reduces funding for development of the Compound or materially extends the timeline for development of the Compound, MEMORY shall provide the proposed amendment to the members of the DAC and SMRI, and the DAC and SMRI shall have fifteen (15) days from the date the DAC and SMRI receive such proposed amendment to review and provide MEMORY comments on such proposed amendment. MEMORY 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 MEMORY in writing of such belief, which notice shall include in reasonable detail the basis for such belief, provided that such notice is given within fifteen (15) days of receipt of the final amendment. If SMRI provides such notice within such fifteen (15) day period, SMRI may delay or withhold payment of any funding due under this Agreement pending resolution of the issue in accordance with this Section 2.2. Within fifteen (15) days after receipt of such notice from SMRI (or such longer period as agreed by MEMORY and SMRI), each member of the DAC shall provide notice in writing to MEMORY of whether it approves the final amendment as proposed, or not. If a majority of the members of the DAC approve the amendment as proposed, MEMORY may proceed with the amendment and this Agreement shall continue in effect. If a majority of the members of the DAC do not approve the amendment as proposed, MEMORY may, in its sole discretion, proceed with the amendment; provided, however, that if MEMORY proceeds with the amendment, SMRI shall have the right to terminate this Agreement pursuant to Section 10.4.
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 and approval by the JSC.
Amendments to the Development Plan. From time to time, but at least twice per Calendar Year, the JDC shall review any proposed amendments to the Development Plan, including the addition of new Clinical Studies or other Development activities (a) that are required by the FDA to obtain the Initial Approval ("MANDATORY DEVELOPMENT AMENDMENTS") or (b) desirable to obtain the Initial Approval, as may be suggested by the members of the JDC ("DISCRETIONARY DEVELOPMENT AMENDMENTS") (collectively, "DEVELOPMENT AMENDMENTS"). The JDC shall approve any Mandatory Development Amendments. The JDC may approve Discretionary Development Amendments only if the Parties mutually agree in writing. The performance of all activities set forth in any Development Amendment shall be the responsibility of Licensor, and the costs of performing such activities shall be budgeted and allocated pursuant to Section 4.4 below. Subject to Licensee's compliance with Section 4.4 below, Licensor's members of the JDC shall not withhold their consent for any Discretionary Development Amendment reasonably proposed by Licensee.
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.
