Common use of Amendments and Updates Clause in Contracts

Amendments and Updates. The JPT shall review the Commercialization Plans (including, if applicable, the associated Commercialization Budgets) on a regular basis, and in no event less frequently than once each Calendar Year (as provided below), or more frequently as needed to take into account completion, commencement or cessation of Commercialization activities contemplated in the then-current applicable Commercialization Plan for, as well as any newly available Information related to, such Collaboration Program. Either Party, through its representatives on the JPT, may propose amendments to a Commercialization Plan (and/or, if applicable, the associated Commercialization Budget) for a given Collaboration Program from time to time. Any and all amendments to the Global Commercialization Plan or the Co-Commercialization Plan shall be subject to approval in accordance with Section 2.3.6. Any and all amendments to an Exclusive Market Commercialization Plan shall be approved by the JPT. In any event, an updated Commercialization Plan, including the associated Commercialization Budget (if applicable), shall be provided by the JPT (and approved by the JSC as required) no later than November 1 of each Calendar Year. If such revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is not approved by the JSC by December 1 of a Calendar Year, then, until such time as such a revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is approved in accordance with Section 2.3.6: (a) the then-current Commercialization Plan (and associated Commercialization Budget (if applicable)) for the relevant territory shall continue to govern the Parties’ commercialization activities under this Agreement with respect to the applicable Collaboration Program; and (b) each Party shall be permitted to conduct the activities allocated to such Party in such then-current Commercialization Plan and to incur costs consistent with such associated Commercialization Budget, which costs shall be shared by the Parties as Allowable Expenses in accordance with Section 8.6.

Amendments and Updates. Licensee will develop and submit to the JCC for review, an updated Commercialization Plan for Commercializing the Licensed Products in the Territory for each [***] thereafter, which will include an updated Commercialization Budget for such [***] period. The JPT shall JCC will submit each such Commercialization Plan to the JSC for review and approval in time to permit the JSC’s preliminary approval of the Commercialization Plans Budget to occur no later than [***] of the prior Calendar Year. Upon the JSC’s preliminary approval, such plan will be submitted to Licensee for its internal budgeting process with a target for final approval by the JSC no later than [***] of the prior Calendar Year, and after final approval by the JSC, such Commercialization Plan will take effect on the first day of the Calendar Year to which such Commercialization Plan applies. The JCC will review Licensee’s performance under the Commercialization Plan (including, if applicable, including the associated Commercialization BudgetsBudget) on a regular quarterly basis, and in no event less frequently than once each Calendar Year (as provided below), or more frequently as needed will develop detailed and specific updates and substantive amendments to take into account completion, commencement or cessation of Commercialization activities contemplated in the then-current applicable Commercialization Plan for, as well as that reflect such performance. The JSC will review such proposed amendments presented by the JCC and may approve such proposed amendments or any newly available Information related to, such Collaboration Program. Either Party, through its representatives on other proposed amendments that the JPT, JSC may propose amendments to a Commercialization Plan (and/or, if applicable, the associated Commercialization Budget) for a given Collaboration Program consider from time to timetime in its discretion and, upon such approval by the JSC, the Commercialization Plan will be amended accordingly. Any Amendments and all amendments updates to the Global Commercialization Plan or Plan, including the Co-Commercialization Plan shall Budget, will not be subject to effective without the approval in accordance with Section 2.3.6. Any and all amendments to an Exclusive Market Commercialization Plan shall be approved by of the JPTJSC. In any event, the event that the JSC does not approve an updated Commercialization Plan, including the associated Commercialization Budget (if applicable)Budget, shall be provided by prior to the JPT (and approved by start of the JSC as required) no later than November 1 of each Calendar Year. If such revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is not approved by the JSC by December 1 of a next Calendar Year, theneither Party may initiate procedures to resolve the issue pursuant to Section 2.6, until such time as such a revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is approved in accordance with Section 2.3.6: (a) the then-current Commercialization Plan (and associated Commercialization Budget (if applicable)) for Plan, together with the relevant territory shall continue to govern budgeted amounts set forth in the Parties’ commercialization activities under this Agreement with respect to the applicable Collaboration Program; and (b) each Party shall be permitted to conduct the activities allocated to such Party in such then-current Commercialization Plan and to incur costs consistent with such associated Commercialization Budget, which costs shall be shared will continue to apply until the Commercialization Plan is determined by the Parties as Allowable Expenses in accordance with Section 8.6JSC.

Amendments and Updates. The JPT JCC (or if applicable, the JSC) shall review the Commercialization Plans (including, if applicable, the associated Co-Commercialization BudgetsBudget) on a regular basis, and in no event less frequently than once each Calendar Year every [***] (as provided below), or more frequently as needed to take into account completion, commencement or cessation of Commercialization activities contemplated in the then-current applicable Commercialization Plan for, as well as any newly available Information related to, such Collaboration Program. Either Party, through its representatives on the JPTJCC (or if applicable, the JSC), may propose amendments to to, or comments on, a Commercialization Plan (and/oror, if applicable, the associated Co-Commercialization Budget) for a given Collaboration Program from time to time. Any and all amendments Amendments to the Global Commercialization Plan or the Co-Commercialization Plan shall be subject to approval in accordance with Section 2.3.6. Any and all amendments to an Exclusive Market Commercialization Plan shall be approved by the JPT‎2.4.5 (Joint Committee Decision Making). In any event, an updated Commercialization Plan, including the associated Commercialization Co‑Commercialization Budget (if applicable), shall be provided by the JPT JCC (and approved by the JSC as required) (or if applicable, provided to and approved by the JSC) no later than November 1 20 of each Calendar Year. If such a revised Commercialization Co‑Commercialization Plan *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. (and associated Commercialization Budget (if applicable)Co‑Commercialization Budget) is not approved by the JSC by December 1 15 of a Calendar Year, then, until such time as such a revised Commercialization Co‑Commercialization Plan (and associated Commercialization Co‑Commercialization Budget (if applicable)) is approved in accordance with Section 2.3.6: ‎2.4.5 (Joint Committee Decision Making): (a) the thenthen‑current Co-current Commercialization Plan (and associated Co-Commercialization Budget (if applicable)Budget) for the relevant territory shall continue to govern the Parties’ commercialization Commercialization activities under this Agreement with respect to the applicable Collaboration ProgramCNS Program in the Co-Commercialization Territory; and (b) each Party shall be permitted to conduct the activities allocated to such Party in such then-current Co-Commercialization Plan and to incur costs consistent with such associated Co-Commercialization Budget, which costs (with respect to the Cost Profit Sharing Products in each Cost Profit Sharing Country) shall be shared by the Parties as Allowable Expenses in accordance with Section 8.6‎7.7 (Cost Profit Sharing).

Amendments and Updates. The JPT shall review Unless otherwise approved by the JSC, the Commercialization Plans activities (includingand, if applicablein the case of the US Territory, the associated US Commercialization BudgetsBudget) on for the [**] Calendar Year of a regular basisCommercialization Plan shall become the Commercialization activities and US Commercialization Budget for the [**] Calendar Year in such subsequent Commercialization Plan unless the Parties otherwise agree; provided, however, that the Commercialization activities and the US Commercialization Budget shall be broken down by Calendar Quarter with respect to the first Calendar Year in each Commercialization Plan. The JCC shall meet no event less frequently later than once [**] of each Calendar Year (as provided below), or more frequently as needed to take into account completion, commencement or cessation of Commercialization activities contemplated in the then-current applicable approve updates to each Commercialization Plan for, as well as any newly available Information related toand shall submit all such updates to the JSC for review and approval, such Collaboration Programthat JSC preliminary approval would occur no later than [**] of the Calendar Year preceding such Commercialization Plan. Either PartyUpon the JSC’s preliminary approval, through such updates shall be submitted to each Party for its representatives on internal budgeting process with a target for final approval by the JPTJSC no later than [**] of such Calendar Year, may propose at which time such Commercialization Plan shall be amended accordingly. The JCC shall also reasonably consider for approval any proposed updates and amendments to a Commercialization Plan (and/or, if applicable, presented by either Party. The JSC shall review such proposed amendments presented the associated Commercialization Budget) for a given Collaboration Program JCC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time. Any and all amendments to time in its discretion and, upon such approval by the Global Commercialization Plan or JSC, the Co-Commercialization Plan shall be subject amended accordingly. Amendments and updates to a Commercialization Plan, including the US Commercialization Budget, shall not be effective without the approval in accordance with of the JSC or the Executive Officers or the relevant Party pursuant to Section 2.3.62.9. Any and all amendments to an Exclusive Market Commercialization Plan shall be approved by If the JPT. In any event, JSC does not approve an updated Commercialization Plan, including the associated US Commercialization Budget (if applicable)Budget, shall be provided by prior to the JPT (and approved by start of the JSC as required) no later than November 1 of each Calendar Year. If such revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is not approved by the JSC by December 1 of a next Calendar Year, theneither Party may initiate procedures to resolve the issue pursuant to Section 2.9, until such time as such a revised Commercialization Plan (and associated Commercialization Budget (if applicable)) is approved in accordance with Section 2.3.6: (a) the then-current Commercialization Plan (and associated Plan, together with the budgeted amounts set forth in the US Commercialization Budget (if applicable)) for the relevant territory Budget, shall continue to govern the Parties’ commercialization activities under this Agreement apply with respect to the applicable Collaboration Program; and (b) each Party shall be permitted to conduct relevant Products until the activities allocated to such Party in such then-current Commercialization Plan and to incur costs consistent with such associated Commercialization Budget, which costs shall be shared is agreed by the Parties as Allowable Expenses in accordance with JSC or the Executive Officers or the relevant Party pursuant to Section 8.62.9.

Amendments and Updates. The JPT JCC shall review the Commercialization Plans (including, if applicable, the associated Co-Commercialization BudgetsBudget) on a regular basis, and in no event less frequently than once each Calendar Year every [***] (as provided below), or more frequently as needed to take into account completion, commencement or cessation of Commercialization or Medical Affairs activities contemplated in the then-current applicable Commercialization Plan for, as well as any newly available Information related to, to such Collaboration ProgramCommercialization or Medical Affairs activities. Either Party, through its representatives on the JPTJCC, may propose amendments to a Commercialization Plan (and/orto, if applicableor comments on, the associated Co-Commercialization Budget) for a given Collaboration Program Plan/Budget from time to time. Any Biogen may update the Global Commercialization Plan from time to time, provided that Biogen shall provide an updated Global Commercialization Plan at least once every [***] and all amendments promptly provide any material update to the Global Commercialization Plan or Plan, in each case to the JCC and JSC for review. Amendments to the Co-Commercialization Plan Plan/Budget shall be subject to approval in accordance with Section 2.3.6. Any and all amendments to an Exclusive Market Commercialization Plan shall be approved by the JPT2.4.5 (Joint Committee Decision-Making). In any event, the JCC shall provide to the JSC an updated Commercialization Plan, including the associated Co-Commercialization Budget (if applicable), shall be provided by the JPT (and approved by the JSC as required) no later than November 1 of each Calendar Year. If such a revised Co-Commercialization Plan (and associated Commercialization Plan/Budget (if applicable)) is not approved by the JSC by December 1 of a Calendar Year, then, until such time as such a revised Co-Commercialization Plan (and associated Commercialization Plan/Budget (if applicable)) is approved in accordance with Section 2.3.6: 2.4.5 (Joint Committee Decision-Making): (a) the then-current Co-Commercialization Plan (and associated Commercialization Plan/Budget (if applicable)) for the relevant territory shall continue to govern the Parties’ commercialization activities under this Definitive LRRK2 Agreement with respect to Cost-Profit Sharing Product in the applicable Collaboration Programcorresponding Cost-Profit Sharing Countries; and (b) each Party shall be permitted to conduct the activities allocated to such Party in such then-current Co-Commercialization Plan Plan/Budget and to incur costs consistent with such associated Co-Commercialization Budget, which costs shall be shared by the Parties as Allowable Expenses in accordance with Section 8.67.7 (Cost-Profit Sharing).