Overruns. Each Party shall notify the other Party promptly upon becoming aware that the anticipated Development Costs to be incurred by such Party 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. Thereafter, the following shall apply: (a) Following such notification, the Financial Working 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. To the extent that, based on this discussion, the Financial Working Group concludes that the anticipated amount of the Development Costs is likely not to exceed [**] percent ([**]%) of the amounts budgeted for such Calendar Year during the Development -93- Term (the “Permitted Overage”) as set forth in the then-current applicable Joint Development Budget, such anticipated or actual Development Costs shall be included in the calculation of the applicable Development Costs for the purposes of 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 Costs); provided that such costs are not incurred as a result of any breach of this Agreement by a Party. (b) If the Financial Working Group, in consultation with the JDC, concludes that the anticipated amount of the applicable Development Costs for such Calendar Year during the Development Term is likely to exceed the Permitted Overage (such amount the “Development Excess Costs”) 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 to be shared. Notwithstanding the foregoing, to the extent that Development Excess 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. (c) 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).
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (Mersana Therapeutics, 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 under the Joint Development Plan for a Collaboration Product for a given Calendar Year during the Development Term shall be in excess of the applicable approved Joint Development Budget or Commercialization Budget. Thereafter, the following shall apply:respectively, for such Collaboration Product for such Calendar Year.
(ab) Following such notification, the Financial Working Group, in consultation with the JDC and JMC (as and if needed), Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of the applicable Development CostsCosts or Allowable Expenses, as applicable. To the extent thatextent, 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 actual Development Costs expenses shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of determining calculating the amounts Development Cost sharing pursuant to be paid from one Party Section 11.4 or calculating the profit or loss sharing pursuant to the other Party to reflect the sharing percentages set forth in Section 5.2.4 11.5, provided that:
(Shared Development Costs)i) [***]; provided that such costs are not incurred as a result of any breach of this Agreement by a Partyand
(ii) [***].
(bc) If the Financial Working Group, in consultation with the JDC, Group concludes that that:
(i) the anticipated amount of the applicable Development Costs for such Calendar Year during the Development Term or Allowable Expenses 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 the JSC shall not be included discuss in the calculation good faith a corresponding amendment of the concerned Development Costs and shall be borne by the Party incurring themBudget or Commercialization Budget, unless agreed by the Parties through the JSC to be shared. Notwithstanding the foregoingas applicable, to reflect the extent that Development anticipated Excess 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 TermCosts. [***].
(cd) 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[***].
(e) to reflect such delay [***]. 000000000 x00
(but without increasing such delayed Development Costs)x) [***].
Appears in 1 contract
Samples: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)
Overruns. Each Party shall notify the other Party promptly upon becoming aware that the anticipated Development Costs to be incurred by such Party under the Joint a particular Collaboration Plan or Development Plan for a given Calendar Year during the Development Term shall be in excess of the applicable approved Joint Collaboration Budget or Development Budget. Thereafter, the following shall apply:
(a) Following such notification, the Financial Working Group, in consultation with the applicable 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. To the extent thatextent, based on this discussion, that the Financial Working Group concludes that the anticipated amount of the concerned category of Development Costs is likely not to exceed [***] percent ([**]%) of the amounts budgeted for such Calendar Year during the Development -93- Term (the “Permitted Overage”) as set forth in the then-current applicable Joint Development Budget, such anticipated or actual Development Costs shall be included in the calculation of the applicable Development Costs for the purposes of 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 CostsSections 4.2 and 6.2.4. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10); provided that such costs are . Such excluded information is not incurred as a result of any breach of this Agreement by a Partymaterial and would likely cause competitive harm to the registrant if publicly disclosed.
(b) If the Financial Working Group, in consultation with the JDC, concludes that the anticipated amount of the applicable Development Costs for such Calendar Year during the Development Term is likely to exceed the Permitted Overage (such amount the “Development Excess Costs”) 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 Shared Development Costs and shall be borne by the Party incurring them, unless mutually agreed by the Parties through the JSC to be shared. Notwithstanding the foregoing, to the extent that Development 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 during the Development TermYear.
(c) To Notwithstanding the extent the foregoing, any WRN Program Costs, WRN Development Costs for a given Calendar Year during the Development Term are less than the or MAT2A Development Costs included 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 Joint applicable Collaboration Budget or Development Budget for such the applicable 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)be borne entirely by that Party.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)
Overruns. Each Party (a) GSK shall notify the other Party IDEAYA promptly upon after becoming aware that the anticipated Development Costs Allowable Expenses to be incurred by such Party under the Joint Development Plan GSK for a Licensed Product for a given Calendar Year during the Development Term shall be in excess of the applicable approved Joint Development Budget. Thereafter, the following shall apply:Commercialization Budget for such Licensed Product for such Calendar Year.
(ab) Following such notification, the Financial Working Group, in consultation with the JDC and JMC (as and if needed), Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of the applicable Development CostsAllowable Expenses, as applicable. To the extent thatextent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the Development Costs concerned category of Allowable Expenses is likely not to exceed [***] percent ([**]%) of the amounts budgeted for such Calendar Year during the Development -93- Term (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 Joint Development Commercialization Budget, then such anticipated costs or actual Development Costs expenses shall be included in the calculation of the applicable Development Costs Allowable Expenses for the purposes of determining calculating 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 Costs); provided that such costs are not incurred as a result of any breach of this Agreement by a PartyPre-Tax Profit or Loss hereunder.
(bc) If the Financial Working Group, in consultation with the JDCJSC, mutually concludes that the anticipated amount of the applicable Development Costs for such Calendar Year during the Development Term Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Development Commercialization Excess Costs”) and there are no mitigation measures to prevent such Development Commercialization Excess Costs, then such Development Commercialization Excess Costs shall not be included in the calculation of the Development Costs and shall be borne by applicable Allowable Expenses for the Party incurring thempurposes 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 Development 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 costs Commercialization Excess Costs shall not be borne solely by the Party incurring them GSK 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 TermAllowable Expenses.
(c) 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).
Appears in 1 contract
Samples: 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 under the Joint Development Plan for a Collaboration Product for a given Calendar Year during the Development Term shall be in excess of the applicable approved Joint Development Budget or Commercialization Budget. Thereafter, the following shall apply:respectively, for such Collaboration Product for such Calendar Year.
(ab) Following such notification, the Financial Working Group, in consultation with the JDC and JMC (as and if needed), Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of the applicable Development CostsCosts or Allowable Expenses, as applicable. To the extent thatextent, 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 actual Development Costs expenses shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of determining calculating the amounts Development Cost sharing pursuant to be paid from one Party Section 9.1 or calculating the profit or loss sharing pursuant to the other Party to reflect the sharing percentages set forth in Section 5.2.4 9.2, provided that:
(Shared Development Costs)i) [***]; provided that such costs are not incurred as a result of any breach of this Agreement by a Partyand
(ii) [***].
(bc) If the Financial Working Group, in consultation with the JDC, Group concludes that that:
(i) the anticipated amount of the applicable Development Costs for such Calendar Year during the Development Term or Allowable Expenses 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 the JSC shall not be included discuss in the calculation good faith a corresponding amendment of the concerned Development Costs and shall be borne by the Party incurring themBudget or Commercialization Budget, unless agreed by the Parties through the JSC to be shared. Notwithstanding the foregoingas applicable, to reflect the extent that Development anticipated Excess 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 TermCosts. [***].
(cd) 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[***].
(e) to reflect such delay [***].
(but without increasing such delayed Development Costs)f) [***].
Appears in 1 contract