Overruns. Notwithstanding the foregoing: (a) in the event a Party 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 [*] = 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) in the event a Party performing Collaboration CMC Activities for the Phase 1 Activities or Phase 2 Activities for which it is responsible under the CMC Development Plan incurs more than [*] of aggregate Development Costs budgeted for such Collaboration CMC Activities in 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 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, or (iii) unanticipated increases in the cost of raw materials.
Appears in 1 contract
Samples: License and Collaboration Agreement (Protagonist Therapeutics, Inc)
Overruns. Notwithstanding Each Party shall notify the foregoingother Party promptly upon becoming aware that the anticipated Development Costs to be incurred by such Party under a particular Collaboration Plan or Development Plan for a given Calendar Year shall be in excess of the applicable approved Collaboration Budget or Development Budget. Thereafter, the following shall apply:
(a) Following such notification, the Financial Working 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. To the extent, 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 [***] of the amounts budgeted (the “Permitted Overage”) as set forth in the event a Party performing Phase 1 Activities or Phase 2 Activities for which it is responsible under then-current applicable Development Budget, such anticipated Development Costs shall be included in the calculation of the applicable Development Plan incurs more than 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 Sections 4.2 and 6.2.4. [***] 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.
(b) If the Financial Working Group, in consultation with the JDC, concludes that the anticipated amount of aggregate Development Costs budgeted for such activities in the applicable Development Budget Costs is likely to exceed the Permitted Overage (such amount the amount more than [*], “Excess Development Costs”)) and there are no mitigation measures to prevent such Excess Costs, the other Party then such Excess Costs shall not be obligated to bear its Specified Percentage included in the calculation of such Excess the Shared Development Costs and shall be borne by the Party incurring them, except: (a) if unless mutually agreed by the Parties through the JSC approves such Excess Development Costs (either before or after they are incurred); or (b) to be shared. Notwithstanding the foregoing, to the extent such that Excess Development Costs are directly attributable and reasonably allocable to (i) and required by a change in Applicable LawLaws, (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) requirement of a change to a Clinical Trial protocol required or requested by any Regulatory Authority, a change required to mitigate a safety issue or (v) unanticipated increases 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 cost calculation of raw materials; andShared Development Costs for the purposes of determining the amounts to be paid from one Party to the other Party for the applicable Calendar Year.
(bc) in Notwithstanding the event 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 Collaboration CMC Activities for the Phase 1 Activities its obligations hereunder or Phase 2 Activities for which it is responsible under the CMC due to that Party’s negligence, whether or not such WRN Program Costs, WRN Development Plan incurs more than Costs or MAT2A Development Costs are in excess of [***] of aggregate Development Costs budgeted for such Collaboration CMC Activities in the applicable Collaboration Budget or Development BudgetBudget for the applicable Calendar Year, 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, or (iii) unanticipated increases in the cost of raw materialsborne entirely by that Party.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)
Overruns. Notwithstanding (a) Each Party shall notify the foregoingother 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 11.4 or calculating the profit or loss sharing pursuant to Section 11.5, provided that:
(ai) in the event a Party 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 [*] = 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
(bii) in the event a Party performing Collaboration CMC Activities for the Phase 1 Activities or Phase 2 Activities for which it is responsible under the CMC Development Plan incurs more than [*] **].
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of aggregate Development Costs budgeted for such Collaboration CMC Activities in the applicable Development Budget, Costs or Allowable Expenses is likely to exceed the other Party shall not be obligated to bear its Specified Percentage of Permitted Overage (such amount the “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, and
(ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a force majeure eventcorresponding amendment of the concerned Development Budget or Commercialization Budget, or as applicable, to reflect the anticipated Excess Costs. [***].
(iiid) unanticipated increases in the cost of raw materials[***].
(e) [***]. 000000000 x00
(x) [***].
Appears in 1 contract
Samples: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)
Overruns. Notwithstanding Each Party shall notify the foregoingother 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 event JDC and JMC (as and if needed), shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a Party performing Phase 1 Activities or Phase 2 Activities for which it is responsible under further increase of the applicable Development Plan incurs more than 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 aggregate Development Costs the amounts budgeted for such activities 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 Budget (Costs for the amount more than [*], “Excess Development Costs”), 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 obligated to bear its Specified Percentage included in the calculation of such Excess the Development Costs and shall be borne by the Party incurring them, except: (a) if unless agreed by the Parties through the JSC approves such Excess Development Costs (either before or after they are incurred); or (b) to be shared. Notwithstanding the foregoing, to the extent such that Development Excess Development Costs are directly attributable to (i) a change in Applicable LawLaws, (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) requirement of a change to a Clinical Trial protocol required or requested by any Regulatory Authority, a change required to mitigate a safety issue or (v) unanticipated increases 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 cost calculation of raw materials; and
(b) in the event a Party performing Collaboration CMC Activities Development Costs for the Phase 1 Activities or Phase 2 Activities for which it is responsible under purposes of determining the CMC Development Plan incurs more than [*] of aggregate Development Costs budgeted for such Collaboration CMC Activities in the applicable Development Budget, 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 not be obligated adjust the Joint Development Budget for such subsequent Calendar Year(s) to bear its Specified Percentage of reflect such Excess delay (but without increasing such delayed 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, or (iii) unanticipated increases in the cost of raw materials.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (Mersana Therapeutics, Inc.)
Overruns. Notwithstanding (a) Each Party shall notify the foregoingother 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:
(ai) in the event a Party 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 [*] = 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
(bii) in the event a Party performing Collaboration CMC Activities for the Phase 1 Activities or Phase 2 Activities for which it is responsible under the CMC Development Plan incurs more than [*] **].
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of aggregate Development Costs budgeted for such Collaboration CMC Activities in the applicable Development Budget, Costs or Allowable Expenses is likely to exceed the other Party shall not be obligated to bear its Specified Percentage of Permitted Overage (such amount the “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, and
(ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a force majeure eventcorresponding amendment of the concerned Development Budget or Commercialization Budget, or as applicable, to reflect the anticipated Excess Costs. [***].
(iiid) unanticipated increases in the cost of raw materials[***].
(e) [***].
(f) [***].
Appears in 1 contract
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:
(a) , 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 event a gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party performing Phase 1 Activities contractors, whether or Phase 2 Activities for which it is responsible under the applicable Development Plan incurs more than not such Allowable Expenses are in excess of [***] of aggregate Development Costs budgeted for such activities in the applicable Development Commercialization Budget (for the amount more than [*]applicable Calendar Quarter, “Excess Development Costs”)shall be borne entirely by GSK. Further, 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 that Commercialization Excess Development Costs are directly attributable to (i) and required by a change in Applicable LawLaws, (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) requirement of a change to a Clinical Trial protocol required or requested by any Regulatory Authority, a change required to mitigate a safety issue or (v) unanticipated increases in a Force Majeure event, or are otherwise mutually agreed by the cost of raw materials; and
(b) in the event a Party performing Collaboration CMC Activities for the Phase 1 Activities or Phase 2 Activities for which it is responsible under the CMC Development Plan incurs more than [*] of aggregate Development Parties, then such Commercialization Excess Costs budgeted for such Collaboration CMC Activities in 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 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, or (iii) unanticipated increases borne solely by GSK and shall be included in the cost calculation of raw materialsthe applicable Allowable Expenses.
Appears in 1 contract
Samples: Collaboration, Option and License Agreement (IDEAYA Biosciences, Inc.)