Decision-Making Authority. Each Party will use reasonable efforts to achieve consensus on the Joint Steering Committee. In the event that the Joint Steering Committee fails to reach unanimous agreement with respect to a particular matter within its authority within *** (***) days of the date such matter was first presented to the Joint Steering Committee, such dispute shall be referred to *** of KineMed and for GSK the *** (for the Acetylome Application R&D Program), the *** (for the Fibrosis Application R&D Program), or the *** (for the Muscle Application R&D Program), or in the case of GSK or KineMed, their respective designees who are members of senior management with the power and authority to resolve such matter (collectively, “Senior Management”). If such Senior Management representatives cannot agree on a matter within *** (***) Business Days after their first discussion regarding such matter, then: a. Subject to Section 3.1.5(b), GSK shall, in good faith and taking into consideration the comments of KineMed, have the final decision-making authority; provided that if either Party determines that GSK’s exercise of such final decision-making authority will *** KineMed’s costs prior to the initiation of Stage 3 activities to an amount that is equal to *** percent (***%) of the *** (“Received Fees”), then the following shall apply: i. the Parties shall first discuss, via the JRS and, if necessary, the JSC, whether such cost increase may be accounted for, in whole or in part, either by reallocation of costs budgeted under a specific R&D Program, or between all R&D Programs. In considering the reallocation of costs within and between R&D Programs to account for such increase in costs, the Parties may consider reallocation of any such amounts budgeted for Stage 1 activities across all R&D Programs and any such amounts budgeted for Stage 2 and/or Stage 3 activities in any R&D Program for which GSK has paid the Stage 2 Initiation Fee; and ii. KineMed shall be responsible for all such increases in costs up to an amount that is equal to *** percent (***%) of the *** and GSK shall be responsible for ***. EXECUTION COPY Confidential b. Modifications or amendments to the Clinical Fluid Biomarker Criteria, Clinical Tissue Biomarker Criteria, Fluid Biomarker Criteria and Tissue Biomarker Criteria made by the JSC shall not be subject to the final decision-making authority of GSK as set forth in Section 3.1.5(a), but shall be determined by mutual agreement of the Parties, acting in good faith, and without either Party unreasonably withholding consent. In the event that the Parties are unable to reach mutual agreement via the JSC with respect to modifications or amendments to Criteria as set forth in Section 3.1.4(c), then the applicable Criteria to which such disagreement relates shall not be modified or amended. c. For the avoidance of doubt, GSK shall be responsible for ***.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Kinemed Inc), Collaboration and License Agreement (Kinemed Inc)
Decision-Making Authority. Each Party will All decisions of the JSC shall be made in good faith in the best interest of this Agreement and the Parties shall use reasonable efforts their Commercially Reasonable Efforts to achieve consensus on the Joint Steering Committeetake decisions unanimously. In the event that the Joint Steering Committee fails JSC is unable to reach unanimous agreement agree on any matter after good faith attempts to resolve such disagreement in a commercially reasonable fashion, then either Party may refer the disagreement to a personal face-to-face meeting between the board member representing RD&M or his/her nominated designee of BI and the CEO or CCO of CureVac, and each Party shall ensure that such meeting takes place within [*****] after the date of the relevant referral. If the board member representing RD&M or his/her nominated designee of BI and the CEO or CCO of CureVac cannot resolve such disagreement in a mutually acceptable manner within a further [*****] period after such personal face-to-face meeting, then the vote of BI with appropriate consideration of the interests of CureVac shall be decisive regarding Development and Commercialization, except in the event the disputed topic would result in (a) a substantial reduction of Bl's diligence obligations under Section 4.2 hereof; (b) a delay of the Non-clinical and Clinical Development of more than [*****]; (c) a substantial change regarding the Manufacture of the Licensed Vaccines; (d) less FTE support of CureVac or an increase in FTE support of CureVac by more than [*****]; (e) the evaluation of the outcome of the ongoing feasibility study as referenced in Section 6.3.1(b) above; or (f) the evaluation of the outcome of the feasibility study with respect to the BI pDNA Process as referenced in Section 6.4 above. If BI casts its decisive vote in relation to a particular matter within its authority within *** (***) days of CMC Development matter, BI shall pay to CureVac compensation at the date such matter was first presented to the Joint Steering Committee, such dispute shall be referred to *** of KineMed and FTE Rates for GSK the *** (any CureVac FTEs needed for the Acetylome Application R&D Program), the *** additional CMC Development activities demanded by BI (if any) and reimburse CureVac for the Fibrosis Application R&D Program), or the *** (for the Muscle Application R&D Program), or any reasonable out of pocket costs incurred by CureVac in the case of GSK or KineMed, their respective designees who are members of senior management with the power and authority relation to resolve such matter (collectively, “Senior Management”)additional CMC Development activities. If such Senior Management representatives cannot agree on a matter within *** (***) Business Days after their first discussion regarding such matter, then:
a. Subject to Section 3.1.5(b), GSK shall, in good faith and taking into consideration the comments of KineMed, have the final decision-making authority; provided that if either Party determines that GSK’s exercise of such final decision-making authority will *** KineMed’s costs prior to the initiation of Stage 3 activities to an amount that is equal to *** percent (***%) of the *** (“Received Fees”), then the following shall apply:
i. the Parties shall first discuss, via the JRS and, if necessary, the JSC, whether such cost increase may be accounted for, in whole or in part, either by reallocation of costs budgeted under a specific R&D Program, or between all R&D Programs. In considering the reallocation of costs within and between R&D Programs to account for such increase in costs, the Parties may consider reallocation of any such amounts budgeted for Stage 1 activities across all R&D Programs and any such amounts budgeted for Stage 2 and/or Stage 3 activities in any R&D Program for which GSK has paid the Stage 2 Initiation Fee; and
ii. KineMed shall be responsible for all such increases in costs up to an amount that is equal to *** percent (***%) of the *** and GSK shall be responsible for ***. EXECUTION COPY Confidential
b. Modifications or amendments to the Clinical Fluid Biomarker Criteria, Clinical Tissue Biomarker Criteria, Fluid Biomarker Criteria and Tissue Biomarker Criteria made by the JSC shall not be subject to the final decision-making authority of GSK as set forth in Section 3.1.5(a), but shall be determined by mutual agreement of the Parties, acting in good faith, and without either Party unreasonably withholding consent. In the event that the Parties are unable to reach mutual agreement via the JSC with respect to modifications or amendments to Criteria as set forth in Section 3.1.4(c), then the applicable Criteria to which such disagreement relates shall not be modified or amended.
c. For the avoidance of doubt, GSK shall the FTE resource commitments in the Development Plans, as set forth in Section 4.1.1 above, can only be responsible for ***.reduced by the Parties and are not subject to the decision making process in the JSC. EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL EXECUTION VERSION
Appears in 2 contracts
Samples: Exclusive Collaboration and License Agreement (CureVac B.V.), Exclusive Collaboration and License Agreement (CureVac B.V.)