Common use of Referral to Executive Officers and Executive Management Clause in Contracts

Referral to Executive Officers and Executive Management. The JSC will refer any matter as to which the JSC cannot reach a consensus decision to the Executive Officers for resolution, which will include a written summary of the respective positions of the Parties. Such Executive Officers will use good faith efforts, in compliance with this Section 2.5.1, to resolve promptly such matter, which good faith efforts will include at least one meeting between such Executive Officers within 10 Business Days after the JSC’s submission of such matter to them, or such other reasonable time period upon which the Executive Officers mutually agree. If the Executive Officers are unable to reach unanimous agreement on any such matter within 60 days of the matter being presented to them, then: 2.5.1.1. except as required by applicable Laws, and subject to Section 2.5.1.3, Licensee will have final decision-making authority over any matter relating to the Development or Commercialization of the Licensed Products by or on behalf of Licensee for the Licensee Territory, provided that such decision will not materially adversely affect the Exploitation of the Licensed Products in the Eureka Territory; 2.5.1.2. except as required by applicable Laws, Eureka will have final decision- making authority over any matter to the extent relating to (a) the Exploitation of the Licensed Products by or on behalf of Eureka for the Eureka Territory or (b) the Manufacture of the Licensed Products for the Licensee Territory, provided that such decision will not materially adversely affect the Exploitation of the Licensed Products in the Licensee Territory; 2.5.1.3. Eureka will have final decision-making authority over: (a) any Clinical Trial involving a head-to-head comparison of a Licensed Product with another pharmaceutical product, including comparator trials; (b) any change in the dosing schedule for a Licensed Product; (c) any expansion of the label of a Licensed Product to include a new indication; (d) any Development regarding a High-Dose Trial; (e) any new formulation or new method of administration for a Licensed Product; and (f) any other Development matter that, in Eureka’s judgement based on reasonable rationale and written documentation, could have a detrimental impact on the Exploitation of a Licensed Product in and for the Eureka Territory.

Referral to Executive Officers and Executive Management. The JSC will may refer any matter as to which the JSC cannot reach a consensus decision to the Executive Officers for resolution. If the JSC does so, which the JSC will include a written summary of submit in writing the respective positions of the PartiesParties to their respective Executive Officers. Such Executive Officers will use good faith efforts, in compliance with this Section 2.5.1, to resolve promptly such matter, which good faith efforts will include at least one meeting between such Executive Officers within 10 five (5) Business Days after the JSC’s submission of such matter to them, or such other reasonable time period upon which the Executive Officers mutually agree. If the Executive Officers are unable to reach unanimous agreement on any such matter within 60 fifteen (15) days of the matter being presented to them, then: 2.5.1.1. except as required (a) if the matter escalated by applicable Laws, and subject the JSC relates to Section 2.5.1.3the Exploitation of the Licensed Products in the Field in the Licensee Territory, Licensee will have final decision-making authority over any such matter relating (other than with respect to the Development or Commercialization of the Licensed Products matters covered by or on behalf of (c)); provided, however, that Licensee for the Licensee Territory, provided that such decision will shall not materially adversely affect the Exploitation of the Licensed Products in the Eureka Territory; 2.5.1.2. except as required by applicable Laws, Eureka will have final decision- decision-making authority over any matter to the extent matters relating to (a) the Exploitation of the Licensed Products by or on behalf of Eureka for the Eureka Territory or (bi) the Manufacture of the Licensed Products for in the Field in the Licensee Territory, provided Territory unless and until the Parties agree that such decision Licensee will not materially adversely affect the Exploitation of Manufacture the Licensed Products in and (ii) the Licensee TerritoryGlobal Development Plan; 2.5.1.3. Eureka (b) if the matter escalated by the JSC relates to (i) the Global Development Plan or (ii) any amendment of the Initial Indications Development Plan, to the extent not covered by clause (a) (other than with respect to the matters covered by (c)), Cxxxxx will have final decision-making authority over: (a) any Clinical Trial involving a head-to-head comparison of a Licensed Product with another pharmaceutical product, including comparator trials; (b) any change in the dosing schedule for a Licensed Product;over such matter; and (c) any expansion of if the label matter escalated by the JSC relates to (i) whether a decision, strategy or implementation of a Licensed Product strategy is consistent with the Harmonization Principle, (ii) whether or not there has been a Clinical Failure or (iii) if the matter otherwise does not fall within those specified in either clause (a) or clause (b), the Executive Officers will submit their respective positions on such matter to include a new indication; (d) any Development regarding a High-Dose Trial; (e) any new formulation or new method of administration for a Licensed Product; and (f) any other Development matter thatbe resolved by Expedited Arbitration. Notwithstanding anything herein to the contrary, in Eureka’s judgement based on reasonable rationale and written documentation, could have a detrimental impact on the Exploitation no exercise of a Licensed Product Party’s decision-making authority on any matters may, without the other Party’s prior written consent, (i) result in and for a material increase in the Eureka Territoryother Party’s or its Related Parties’ obligations, costs or expenses, including expenditure of such Party’s resources, under this Agreement, the Initial Indications Development Plan, or the Licensee Territory Commercialization Plan, (ii) unilaterally modify, amend or waive its own compliance with the terms or conditions of this Agreement, or (iii) otherwise conflict with this Agreement.

Referral to Executive Officers and Executive Management. The JSC will may refer any matter as to which the JSC cannot reach a consensus decision to the Executive Officers for resolution. If the JSC does so, which the JSC will include a written summary of submit in writing the respective positions of the PartiesParties to their respective Executive Officers. Such Executive Officers will use good faith efforts, in compliance with this Section 2.5.12.3.1, to resolve promptly such matter, which good faith efforts will include at least one meeting between such Executive Officers within 10 Business Days after the JSC’s submission of such matter to them, or such other reasonable time period upon which the Executive Officers mutually agree. If the Executive Officers are unable to reach unanimous agreement on any such matter within 60 [***] ([***]) days of the matter being presented referred to themthe Executive Officers, then: 2.5.1.1. except as required : (a) if the matter escalated by applicable Lawsthe JSC relates to the execution or implementation of the approved strategy for the Development or Commercialization of the Licensed Products in the Field in the Shionogi Territory (excluding (i) the use of any compound or marketed product owned, controlled or in-licensed by a Third Party in combination with a Licensed Product in any Development activities in the Field in the Shionogi Territory (which decision will be made by the Parties and subject not the JSC), (ii) the Agreed Branding and Support Services Plan and (iii) any matters related to Section 2.5.1.3Pricing Approvals or Pricing Matters), Licensee Shionogi will have final decision-making authority over such matter, (b) if the matter relates to any matter relating technical issues related to the Development or Commercialization of the Licensed Products by or on behalf of Licensee for the Licensee Territory, provided that such decision will not materially adversely affect the Exploitation execution or implementation of the Licensed Products in the Eureka Territory; 2.5.1.2. except as required by applicable LawsSupport Services Plan, Eureka Xxxxx will have final decision- making authority over any matter to the extent relating to (a) the Exploitation of the Licensed Products by or on behalf of Eureka for the Eureka Territory or (b) the Manufacture of the Licensed Products for the Licensee Territory, provided that such decision will not materially adversely affect the Exploitation of the Licensed Products in the Licensee Territory; 2.5.1.3. Eureka will have final decision-making authority over: over such matter, and (c) if the matter otherwise does not fall within those specified in clause (a) any Clinical Trial involving a head-to-head comparison or (b), the Parties will submit their respective positions on such matter to be resolved by Expedited Arbitration and the arbitrator will select one Party’s position based on the available data. Notwithstanding anything herein to the contrary, no exercise of a Licensed Product with another pharmaceutical productParty’s decision-making authority on any matters may, including comparator trials; without the other Party’s prior written consent, (bi) any change result in a material increase in the dosing schedule for a Licensed Product; (c) any expansion of the label of a Licensed Product to include a new indication; (d) other Party’s or its Related Parties’ obligations, costs or expenses under this Agreement or any Development regarding a High-Dose Trial; Plan or Commercialization Plan, (eii) any new formulation unilaterally modify, amend or new method waive its own compliance with the terms or conditions of administration for a Licensed Product; and this Agreement, or (fiii) any other Development matter that, in Eureka’s judgement based on reasonable rationale and written documentation, could have a detrimental impact on the Exploitation of a Licensed Product in and for the Eureka Territoryotherwise conflict with this Agreement.