Updating and Amending the GDP Sample Clauses

Updating and Amending the GDP. The JDC shall review the GDP not less frequently than annually and shall develop detailed and specific GDP updates, which shall include the Development Budget for the subsequent Calendar Year and forecasted estimates for the succeeding Calendar Years for at least the period thereafter until Regulatory Approval of Cost Profit Sharing Products for each Indication in the GDP in [***]. The JDC shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [***] of each Calendar Year. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than [***] of each Calendar Year, at which time any updates shall be appended to the GDP. The JDC may also develop and submit to the JSC from time to time other proposed substantive amendments to the GDP. The JDC shall also review each Party’s (and its Affiliates’) performance under the then-current GDP (including the Development Budget) on a [***] basis, and shall develop detailed and specific updates and substantive amendments to the Development Budget that reflect such performance. The JSC shall review proposed amendments presented by the JDC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon such approval by the JSC, the GDP shall be amended accordingly. Amendments and updates to the GDP, including the Development Budget, shall not *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. be effective without the approval of the JSC (or a decision or determination pursuant to Section 13.1 or Section 13.3, if applicable). In the event that the JSC does not approve an updated GDP, including the Development Budget, prior to the start of the next Calendar Year, either Party may initiate procedures to resolve the issue pursuant to Sections 13.1 and 13.3, and the then-current GDP, and the forecasted amounts set forth for the applicable Calendar Year of the Development Budget shall continue to apply until the GDP is agreed by the JSC or decided or determined pursuant to Section 13.1 or Section 13.3.
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Related to Updating and Amending the GDP

  • Integration and Amendment This Agreement constitutes the entire agreement between the Parties with respect to the subject matter herein and merges all prior discussions between them. It shall not be amended except by written agreement dated subsequent to the date of this Agreement and signed by both Parties.

  • Entirety and Amendments This Agreement embodies the entire agreement between the parties and supersedes all prior agreements and understandings relating to the Property. This Agreement may be amended or supplemented only by an instrument in writing executed by the party against whom enforcement is sought.

  • Modification and Amendments If a Fund shall determine that the coverage required by Rule 17g-1 for the Fund has changed, or that the amount of the total coverage allocated to the Fund should otherwise by modified, it shall so notify the other Funds and shall set forth the modification which it believes to be appropriate, and the proposed treatment of any increase in or return of premium paid to the insurance company. Within 60 days after such notice, the Funds shall seek the approvals required by Rule 17g-1, and if the approvals are obtained, shall effect an amendment to this Agreement and the bond. Any Fund may terminate this Agreement (except with respect to losses occurring prior to such withdrawal) by giving at least 60 days’ written notice to the other Funds and to the Commission before the effective date of such termination. The Fund terminating the Agreement shall thereafter be removed as a named insured under the bond in accordance with Rule 17g-1 and the Fund shall be entitled to receive a pro rata portion of any return of premium paid to the insurance company.

  • Consultation and Amendment 1. Each Contracting Party may request that a consultation be held on any matter that both Contracting Parties agree to discuss. 2. This Agreement may amended at any time, if it deems necessary, by mutual consent.

  • Modification and Amendment This Agreement may not be amended or modified, except by a written instrument signed by Class Counsel and counsel for Defendant and, if the Settlement has been approved preliminarily by the Court, approved by the Court.