Common use of Overruns Clause in Contracts

Overruns. (a) GSK shall notify IDEAYA promptly after becoming aware that the anticipated Allowable Expenses to be incurred by GSK for a Licensed Product for a given Calendar Year shall be in excess of the applicable approved Commercialization Budget for such Licensed Product for such Calendar Year. (b) Following such notification, the Financial Working Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Allowable Expenses is likely not to exceed [***] of the amounts budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK for its activities for the Licensed Product in such Calendar Year as set forth in the then-current applicable Commercialization Budget, then such anticipated costs or expenses shall be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss hereunder. (c) If the Financial Working Group, in consultation with the JSC, mutually concludes that the anticipated amount of the applicable Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs shall not be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss, unless mutually agreed by the Parties through the JSC to be shared. (d) Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK. Further, to the extent that Commercialization Excess Costs are directly attributable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs shall not be borne solely by GSK and shall be included in the calculation of the applicable Allowable Expenses.

Appears in 1 contract

Sources: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)

Overruns. Notwithstanding the foregoing: (a) GSK shall notify IDEAYA promptly after becoming aware that in the anticipated Allowable Expenses to be incurred by GSK event a Party performing Phase 1 Activities or Phase 2 Activities for a Licensed Product for a given Calendar Year shall be in excess of which it is responsible under the applicable approved Commercialization Budget Development Plan incurs more than [*] of aggregate Development Costs budgeted for such Licensed Product for activities in the applicable Development Budget (the amount more than [*], “Excess Development Costs”), the other Party shall not be obligated to bear its Specified Percentage of such Calendar Year.Excess Development Costs , except: (a) if the JSC approves such Excess Development Costs (either before or after they are incurred); or (b) to the extent such Excess Development Costs are attributable to (i) a change in Applicable Law, (ii) a force majeure event, (iii) variation in actual patient enrollment from [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. projected patient enrollment, (iv) a change to a Clinical Trial protocol required or requested by any Regulatory Authority, or (v) unanticipated increases in the cost of raw materials; and (b) Following such notification, in the Financial Working Group shall discuss event a Party performing Collaboration CMC Activities for the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Allowable Expenses, as applicable. To Phase 1 Activities or Phase 2 Activities for which it is responsible under the extent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Allowable Expenses is likely not to exceed CMC Development Plan incurs more than [***] of the amounts aggregate Development Costs budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK for its activities for the Licensed Product in such Calendar Year as set forth Collaboration CMC Activities in the then-current applicable Commercialization Development Budget, then such anticipated costs or expenses shall be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss hereunder. (c) If the Financial Working Group, in consultation with the JSC, mutually concludes that the anticipated amount of the applicable Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs other Party shall not be included in the calculation obligated to bear its Specified Percentage of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Losssuch Excess Development Costs, unless mutually agreed by the Parties through except: (a) if the JSC to be shared. approves such Excess Development Costs (deither before or after they are incurred); or (b) Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK. Further, to the extent that Commercialization such Excess Development Costs are directly attributable to and required by (i) a change in Applicable LawsLaw, (ii) a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure force majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs shall not be borne solely by GSK and shall be included (iii) unanticipated increases in the calculation cost of the applicable Allowable Expensesraw materials.

Appears in 1 contract

Sources: License and Collaboration Agreement (Protagonist Therapeutics, Inc)

Overruns. (a) GSK Each Party shall notify IDEAYA promptly after becoming aware the other Party [***] that the anticipated Development Costs or Allowable Expenses to be incurred by GSK such Party for a Licensed Collaboration Product for a given Calendar Year shall be in excess of the applicable approved Development Budget or Commercialization Budget Budget, respectively, for such Licensed Collaboration Product for such Calendar Year. (b) Following such notification, the Financial Working Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Development Costs or Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Development Costs or Allowable Expenses is likely not to exceed [***] of the aggregate annual amounts budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK the concerned Party for its activities for the Licensed Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, then respectively, such anticipated costs or expenses shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit Development Cost sharing pursuant to Section 11.4 or Loss hereundercalculating the profit or loss sharing pursuant to Section 11.5, provided that: (i) [***]; and (ii) [***]. (c) If the Financial Working Group, in consultation with the JSC, mutually Group concludes that that: (i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”); and (ii) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs the JSC shall not be included discuss in the calculation good faith a corresponding amendment of the applicable Allowable Expenses for concerned Development Budget or Commercialization Budget, as applicable, to reflect the purposes of calculating the Pre-Tax Profit or Loss, unless mutually agreed by the Parties through the JSC to be sharedanticipated Excess Costs. [***]. (d) Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK]. (e) [***]. Further, to the extent that Commercialization Excess Costs are directly attributable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs shall not be borne solely by GSK and shall be included in the calculation of the applicable Allowable Expenses▇▇▇▇▇▇▇▇▇ ▇▇▇ (▇) [***].

Appears in 1 contract

Sources: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)

Overruns. (a) GSK Each Party shall notify IDEAYA the other Party promptly after upon becoming aware that the anticipated Allowable Expenses Development Costs to be incurred by GSK for such Party under a Licensed Product particular Collaboration Plan or Development Plan for a given Calendar Year shall be in excess of the applicable approved Commercialization Collaboration Budget for such Licensed Product for such Calendar Year.or Development Budget. Thereafter, the following shall apply: (ba) Following such notification, the Financial Working Group Group, in consultation with the applicable JDC (as and if needed), shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Allowable Expenses, as applicableDevelopment Costs. To the extent, based on this discussion, that the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Allowable Expenses Development Costs is likely not to exceed [***] of the amounts budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK for its activities for the Licensed Product in such Calendar Year as set forth in the then-current applicable Commercialization Development Budget, then such anticipated costs or expenses Development Costs shall be included in the calculation of the applicable Allowable Expenses Development Costs for the purposes of calculating determining the Preamounts to be paid from one Party to the other Party to reflect the sharing percentages set forth in Sections 4.2 and 6.2.4. [***] Certain information in this document has been excluded pursuant to Regulation S-Tax Profit or Loss hereunderK, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. (cb) If the Financial Working Group, in consultation with the JSCJDC, mutually concludes that the anticipated amount of the applicable Allowable Expenses Development Costs is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs shall not be included in the calculation of the applicable Allowable Expenses for Shared Development Costs and shall be borne by the purposes of calculating the Pre-Tax Profit or LossParty incurring them, unless mutually agreed by the Parties through the JSC to be shared. (d) . Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK. Further, to the extent that Commercialization Excess Costs are directly attributable and reasonably allocable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs costs shall not be borne solely by GSK the Party incurring them and shall be included in the calculation of Shared Development Costs for the purposes of determining the amounts to be paid from one Party to the other Party for the applicable Allowable ExpensesCalendar Year. (c) Notwithstanding the foregoing, any WRN Program Costs, WRN Development Costs or MAT2A Development Costs that are incurred by a Party as a result of that Party’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to that Party’s negligence, whether or not such WRN Program Costs, WRN Development Costs or MAT2A Development Costs are in excess of [***] of the applicable Collaboration Budget or Development Budget for the applicable Calendar Year, shall be borne entirely by that Party.

Appears in 1 contract

Sources: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)

Overruns. (a) GSK Each Party shall notify IDEAYA promptly after becoming aware the other Party [***] that the anticipated Development Costs or Allowable Expenses to be incurred by GSK such Party for a Licensed Collaboration Product for a given Calendar Year shall be in excess of the applicable approved Development Budget or Commercialization Budget Budget, respectively, for such Licensed Collaboration Product for such Calendar Year. (b) Following such notification, the Financial Working Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Development Costs or Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Development Costs or Allowable Expenses is likely not to exceed [***] of the aggregate annual amounts budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK the concerned Party for its activities for the Licensed Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, then respectively, such anticipated costs or expenses shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit Development Cost sharing pursuant to Section 9.1 or Loss hereundercalculating the profit or loss sharing pursuant to Section 9.2, provided that: (i) [***]; and (ii) [***]. (c) If the Financial Working Group, in consultation with the JSC, mutually Group concludes that that: (i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”); and (ii) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs the JSC shall not be included discuss in the calculation good faith a corresponding amendment of the applicable Allowable Expenses for concerned Development Budget or Commercialization Budget, as applicable, to reflect the purposes of calculating the Pre-Tax Profit or Loss, unless mutually agreed by the Parties through the JSC to be sharedanticipated Excess Costs. [***]. (d) Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK. Further, to the extent that Commercialization Excess Costs are directly attributable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs shall not be borne solely by GSK and shall be included in the calculation of the applicable Allowable Expenses]. (e) [***]. (f) [***].

Appears in 1 contract

Sources: Collaboration Agreement (Vir Biotechnology, Inc.)