Common use of Updating and Amending the GDP Clause in Contracts

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.

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 two succeeding Calendar Years for at least the period thereafter until Regulatory Approval of Cost Profit Sharing Products for each Indication in the GDP in [***]Years. The JDC shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [***] September 1 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 [***] December 1 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 [***] quarterly 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 the Executive Officers pursuant to Section 13.1 or the Expert pursuant to 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 together with the forecasted budgeted amounts set forth for in the applicable Calendar Year of the [**] Development Budget Budget, shall continue to apply until the GDP is agreed by the JSC or decided or determined the Executive Officers pursuant to Section 13.1 13.1, or determined by the Expert pursuant to Section 13.3.

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 Collaboration Product for each Indication in the GDP in [***]the United States. 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 GDPGDP (including the Development Budget therein). The JDC shall also review each Party’s (and its Affiliates’) performance under the then-current GDP (including the Development Budget) on a [*****] basisbasis (or more often as the JDC determines), and shall develop detailed and specific updates and substantive amendments to the Development Budget that reflect and account for 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 (and Development Budget therein) shall be amended accordinglyaccordingly and will become effective and supersede the previous GDP (and Development Budget therein). 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 including via a decision or determination pursuant to Section 13.1 or Section 13.3, if applicable2.6.2). 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 previously-approved Development Budget shall continue to apply until the updated GDP (and corresponding Development Budget) is agreed by the JSC (including via a decision or decided or determined determination pursuant to Section 13.1 or Section 13.32.6.2).

Updating and Amending the GDP. (a) The JDC shall review the GDP GDP, including the Development Budget, not less frequently than annually and shall develop detailed and specific GDP updates, which updates in accordance with Section 4. 1.1. The JDC 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 meet no later than [***]. The JDC ] of each Calendar Year to prepare the updates to the GDP, and 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 such 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 If 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 13.3Section 2.9, and the then-current GDP, GDP and the forecasted amounts set forth for the applicable Calendar Year of the Development Budget shall continue to apply until the updated GDP is agreed approved by the JSC. The JDC may also develop and submit to the JSC from time to time other proposed amendments to the GDP. The JSC shall review proposed amendments presented to the JDC and may approve such proposed amendments or decided 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. (b) This Section 4.1.5(b) shall be subject in its entirety to Section 4.1.1: If, during any Calendar Year (the “First Year”), any Development activity expressly provided for in the GDP to be completed during such First Year is not completed during such First Year (to the extent incomplete, an “Incomplete Activity”) and the full expense budgeted in the Development Budget for such activity for such First Year is not incurred (to the extent not incurred, a “Non-Incurred Amount”), then such Incomplete Activity shall be completed during Calendar Years following such First Year (the “Succeeding Year(s)”) and the Non-Incurred Amount shall be included in the Development Budget for such Succeeding Year(s) as follows: If the Development Budget for such Succeeding Year(s) has not yet been approved by the JSC, then the Non-Incurred Amount shall be included in the proposed Development Budget for such Succeeding Year(s) without otherwise limiting any other Development activities or determined any amounts related thereto, unrelated to the Incomplete Activity, which, pursuant to Section 13.1 or Section 13.3the GDP, would have been performed during such Succeeding Year(s), and if the Development Budget for such Succeeding Year(s) has been approved by the JSC, then the Development Budget for such Succeeding Year(s) shall be revised automatically to include the Non-Incurred Amount.