Overruns. (a) Each Party shall notify the other Party [***] that the anticipated Development Costs or Allowable Expenses to be incurred by such Party for a Collaboration Product for a given Calendar Year shall be in excess of the applicable approved Development Budget or Commercialization Budget, respectively, for such 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 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 “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, 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 Development Cost sharing pursuant to Section 9.1 or calculating the profit or loss sharing pursuant to Section 9.2, provided that: (i) [***]; and (ii) [***]. (c) If the Financial Working Group concludes that: (i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and (ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a corresponding amendment of the concerned Development Budget or Commercialization Budget, as applicable, to reflect the anticipated Excess Costs. [***]. (d) [***]. (e) [***]. (f) [***].
Appears in 1 contract
Overruns. Notwithstanding the foregoing:
(a) Each in the event a Party shall notify performing Phase 1 Activities or Phase 2 Activities for which it is responsible under the applicable Development Plan incurs more than [*] of aggregate Development Costs budgeted for such 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 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 [***] that = 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 anticipated Development Costs or Allowable Expenses to be incurred by such Party for a Collaboration Product for a given Calendar Year shall be in excess cost of the applicable approved Development Budget or Commercialization Budget, respectively, for such Collaboration Product for such Calendar Year.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 Phase 1 Activities or Phase 2 Activities for which it is responsible under the CMC Development Costs or Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group concludes that the anticipated amount of the concerned category of Development Costs or Allowable Expenses is likely not to exceed Plan incurs more than [***] of the aggregate annual amounts Development Costs budgeted (the “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the such Collaboration Product CMC Activities in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, respectively, such anticipated costs or expenses shall be included in the calculation of the applicable Development Budget, the other Party shall not be obligated to bear its Specified Percentage of such Excess Development Costs, except: (a) if the JSC approves such Excess Development Costs (either before or applicable Allowable Expenses for after they are incurred); or (b) to the purposes of calculating the extent such Excess Development Cost sharing pursuant Costs are attributable to Section 9.1 or calculating the profit or loss sharing pursuant to Section 9.2, provided that:
(i) [***]; and
a change in Applicable Law, (ii) [***]a force majeure event, or (iii) unanticipated increases in the cost of raw materials.
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and
(ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a corresponding amendment of the concerned Development Budget or Commercialization Budget, as applicable, to reflect the anticipated Excess Costs. [***].
(d) [***].
(e) [***].
(f) [***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Protagonist Therapeutics, Inc)
Overruns. (a) Each Party GSK shall notify the other Party [***] IDEAYA promptly after becoming aware that the anticipated Development Costs or Allowable Expenses to be incurred by such Party GSK for a Collaboration Licensed Product for a given Calendar Year shall be in excess of the applicable approved Development Commercialization Budget or Commercialization Budget, respectively, for such Collaboration 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 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 the concerned Party GSK for its activities for the Collaboration Licensed Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, respectively, then such anticipated costs or expenses shall be included in the calculation of the applicable Development 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 or shall not be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Development Cost sharing pursuant to Section 9.1 Pre-Tax Profit or calculating Loss, unless mutually agreed by the profit or loss sharing pursuant to Section 9.2, provided that:
(i) [***]; and
(ii) [***].
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and
(ii) there are no mitigation measures to prevent such Excess Costs, Parties through the JSC shall discuss in good faith a corresponding amendment of the concerned Development Budget or Commercialization Budget, as applicable, to reflect the anticipated Excess Costs. [***]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.
(e) [***].
(f) [***].
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)
Overruns. (a) Each Party shall notify the other Party [***] that the anticipated Development Costs or Allowable Expenses to be incurred by such Party for a Collaboration Product for a given Calendar Year shall be in excess of the applicable approved Development Budget or Commercialization Budget, respectively, for such 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 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 “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, 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 Development Cost sharing pursuant to Section 9.1 11.4 or calculating the profit or loss sharing pursuant to Section 9.211.5, provided that:
(i) [***]; and
(ii) [***].
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and
(ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a corresponding amendment of the concerned Development Budget or Commercialization Budget, as applicable, to reflect the anticipated Excess Costs. [***].
(d) [***].
(e) [***].. ▇▇▇▇▇▇▇▇▇ ▇▇▇
(f▇) [***].
Appears in 1 contract
Sources: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)
Overruns. (a) Each Party shall notify the other Party [***] promptly upon becoming aware that the anticipated Development Costs or Allowable Expenses to be incurred by such Party for under a particular Collaboration Product Plan or Development Plan for a given Calendar Year shall be in excess of the applicable approved Development Collaboration Budget or Commercialization Development Budget. Thereafter, respectively, for such Collaboration Product for such Calendar Year.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 Development Costs or Allowable Expenses, as applicableCosts. To the extent, based on this discussion, that the Financial Working Group 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 “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, respectively, such anticipated costs or expenses Development Costs shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of calculating determining the Development Cost amounts to be paid from one Party to the other Party to reflect the sharing pursuant to Section 9.1 or calculating the profit or loss sharing pursuant to Section 9.2, provided that:
(i) percentages set forth in Sections 4.2 and 6.2.4. [***]; and
(ii) [***]] Certain information in this document has been excluded pursuant to Regulation S-K, 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 Group, in consultation with the JDC, concludes that:
(i) that the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and
(ii) and there are no mitigation measures to prevent such Excess Costs, then such Excess Costs shall not be included in the calculation of the Shared Development Costs and shall be borne by the Party incurring them, unless mutually agreed by the Parties through the JSC shall discuss in good faith a corresponding amendment of to be shared. Notwithstanding the concerned Development Budget or Commercialization Budget, as applicableforegoing, to reflect the anticipated extent that 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 costs shall not be borne solely by 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 Calendar 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.
(d) [***].
(e) [***].
(f) [***].
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)
Overruns. (a) Each Party shall notify the other Party [***] promptly upon becoming aware that the anticipated Development Costs or Allowable Expenses to be incurred by such Party for a Collaboration Product under the Joint Development Plan for a given Calendar Year during the Development Term shall be in excess of the applicable approved Joint Development Budget or Commercialization Budget. Thereafter, respectively, for such Collaboration Product for such Calendar Year.the following shall apply:
(ba) Following such notification, the Financial Working Group Group, in consultation with the JDC and JMC (as and if needed), shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of the applicable Development Costs or Allowable Expenses, as applicableCosts. To the extentextent that, based on this discussion, the Financial Working Group concludes that the anticipated amount of the concerned category of Development Costs or Allowable Expenses is likely not to exceed [**] percent ([*] *]%) of the aggregate annual amounts budgeted for such Calendar Year during the Development -93- Term (the “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the Collaboration Product in such Calendar Year as set forth in the then-current applicable Joint Development Budget or Commercialization Budget, respectively, such anticipated costs or expenses actual Development Costs shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of calculating determining the amounts to be paid from one Party to the other Party to reflect the sharing percentages set forth in Section 5.2.4 (Shared Development Cost sharing pursuant to Section 9.1 or calculating the profit or loss sharing pursuant to Section 9.2, Costs); provided that:
(i) [***]; and
(ii) [***]that such costs are not incurred as a result of any breach of this Agreement by a Party.
(cb) If the Financial Working Group Group, in consultation with the JDC, concludes that:
(i) that the anticipated amount of the applicable Development Costs or Allowable Expenses for such Calendar Year during the Development Term is likely to exceed the Permitted Overage (such amount the “Development Excess Costs”); and
(ii) and there are no mitigation measures to prevent such Development Excess Costs, then such Development Excess Costs shall not be included in the calculation of the Development Costs and shall be borne by the Party incurring them, unless agreed by the Parties through the JSC shall discuss in good faith a corresponding amendment of to be shared. Notwithstanding the concerned Development Budget or Commercialization Budget, as applicableforegoing, to reflect the anticipated extent that Development Excess Costs. [***]Costs are directly attributable to 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 agreed by the Parties, then such costs shall not be borne solely by the Party incurring them and shall be included in the calculation of Development Costs for the purposes of determining the amounts to be paid from one Party to the other Party for the applicable Calendar Year during the Development Term.
(dc) [***]To the extent the Development Costs for a given Calendar Year during the Development Term are less than the Development Costs included in the Joint Development Budget for such Calendar Year, because Shared Global Development Activities planned for such Calendar Year have been delayed to a subsequent Calendar Year during the Development Term, the Financial Working Group shall adjust the Joint Development Budget for such subsequent Calendar Year(s) to reflect such delay (but without increasing such delayed Development Costs).
(e) [***].
(f) [***].
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (Mersana Therapeutics, Inc.)