Final Decision-Making. (i) On matters concerning COVID Products, other than the matters under (ii) and (iii) on which GSK has the deciding vote, if the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****], the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] and attempt to resolve such matter in good faith. If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting, the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below.
(ii) Without limiting Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments to the COVID R&D Plan(s) for such Pathogen Combination Products (including the budget and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID Products, adopt a decision that would cause significant delay of the Development timelines as set forth in the respective COVID R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or the COVID R&D Plan for the respective Pathogen Combination Product.
(iii) GSK shall also have the deciding vote on any matter that jeopardizes GSK’s (or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification of Manufactured batches by a qualified person and batch release in accordance with GMP).
Final Decision-Making. If the JEC fails to reach *** on a matter before it for decision for a period in excess of ***, during the License Term for a Licensed Program, *** *** any matter involving the Development or Commercialization of Program DARTs and Licensed Products in the Field in the Servier Territory for such Licensed Program and the JEC representatives appointed by MacroGenics shall have the deciding vote on any matter involving the Development or Commercialization of Program DARTs and Licensed Products in the Field in the MacroGenics Territory for such Licensed Program.
Final Decision-Making. If a dispute referred to the Executives pursuant to Section 2.5(b) has not been resolved in accordance with Section 2.5(b), then, subject to Section 2.5(d), uniQure shall have the final decision-making authority. Any decision made by uniQure pursuant to this Section 2.5(c) shall be deemed a decision of the JRSC for purposes of this Agreement.
Final Decision-Making. Should the Executive Officers not be able to reach agreement with respect to any matter referred to them by the JSC pursuant to Section 2.9.2, such matter shall be resolved pursuant to Sections 13.1-13.11, except as follows (the matters described in clauses (a) - (h) below, the “Excluded Matters”):
(a) Except where specifically allocated in clauses (b) through (h) of this Section 2.9.3, decisions regarding (i) Development of Products specifically subject to approval by the JDC or JSC under this Agreement, including the global regulatory strategy and Development of Combination Products, (ii) Commercialization of Products specifically subject to approval by the JCC or JSC under this Agreement, including Commercialization of Combination Products, subject to Section 4.1.6, (iii) Medical Affairs Activities regarding Products specifically subject to approval by the JMAC or JSC under this Agreement, (iv) Research activities with respect to the Licensed Compound, and (v) whether or not an AbbVie Withholding Tax Action represents the only commercially reasonable alternative to Commercialize a Product shall in each case ((i) through (v)) require mutual agreement of the Parties (or the Parties’ respective representatives on the applicable Committee). If the Parties are unable to mutually agree upon any such matter, then neither Party shall have the right to resolve the matter over the objection of the other Party, the matter shall remain unresolved unless and until agreed upon by the JSC, and shall not be subject to resolution pursuant to ARTICLE 13;
(b) Except where specifically allocated to a Party in clauses (c) through (h) of this Section 2.9.3, decisions regarding (i) the Global Branding Strategy, (ii) the US Commercialization Plan, including the US Commercialization Budget (iii) the Sales Force Deployment Plan, and (iv) the MSL Deployment Plan for the Territory shall be resolved pursuant to Section 13.13.
(c) AbbVie’s Executive Officer shall have the deciding vote with respect to the following Commercialization matters to the extent related to the US Commercialization Plan in the US Territory, consistent with the Global Branding Strategy: (i) the promotional and educational materials for the Product; (ii) Sales Representative training materials related to the Product; (iii) managed care pricing activities and contracting, including final managed care pricing decisions consistent with each of the following: the established Product list price, targeted net pricin...
Final Decision-Making. If the JDC fails to reach unanimous agreement on a matter properly before it (in accordance with this ARTICLE III) for decision for a period in excess of thirty (30) days, the JDC representatives appointed by Lilly shall have the deciding vote on any matter. Incyte shall have the right to appeal any such decision of the JDC to the Lilly Executive Officer or a designee of the Lilly Executive Officer with decision-making authority for resolution. In such case, the Lilly Executive Officer or designee shall have the final decision-making authority on such issue.
Final Decision-Making. If the JEC fails to reach *** on a matter before it for decision for a period in excess of ***, the following provisions shall apply:
(a) During the Research Term, if the JEC is unable to resolve the matter within *** after the matter is referred to them, the matter shall be deadlocked until resolved by *** JEC consensus.
(b) During the License Term, the JEC representatives appointed by Servier shall have the deciding vote on any matter involving the Development or Commercialization of Program Antibodies and Licensed Products in the Field in the Servier Territory and the JEC representatives appointed by MacroGenics shall have the deciding vote on any matter involving the Development or Commercialization of Program Antibodies and Licensed Products in the Field in the MacroGenics Territory.
Final Decision-Making. If a dispute referred to the *** and *** has not been resolved in accordance with Section 2.5(b), then, subject to Section 2.5(d), *** ***. Any *** under this Section 2.5(c) shall be deemed a decision of the JSC for purposes of this Agreement.
Final Decision-Making. If a dispute referred to the Executives pursuant to Section 2.3(b) has not been resolved in accordance with Section 2.3(b), then, subject to Section 2.3(d), [***] shall have the final decision-making authority. Any decision made by [***] pursuant to this Section 2.3(c) shall be deemed a decision of the JRSC for purposes of this Agreement.
Final Decision-Making. If the JSC fails to reach unanimous agreement on a matter properly before it (in accordance with this Article III) for decision for a period in excess of thirty (30) days, the JSC representatives appointed by Incyte shall have the deciding vote; provided, however, that after the consummation of a Change in Control of Incyte, Agenus shall have the deciding vote with respect to all matters subject to approval by the JSC relating to the Profit-Share Projects. The Party that does not have the deciding vote shall have the right to appeal any such decision of the JSC to the Executive Officers for resolution pursuant to Section 12.2.
Final Decision-Making. Each Party will give due consideration to, and consider in good faith, the recommendations and advice of the JSC regarding the conduct of the activities under the Strategic Plan. The JSC will endeavor in good faith to reach consensus on all decisions, however, if the JSC cannot unanimously agree on a matter to be decided or approved by the JSC, then, except as otherwise set forth in Schedule 6.4.1, the matter may be referred to the Senior Representatives for resolution. If the Senior Representatives cannot reach agreement, then (i) without limiting Akcea’s obligations under Section 3.3, Akcea will have final-decision making authority with respect to (A) matters relating to the Commercialization or Akcea Non-Commercial Activities (other than Pre-Approval Akcea Development Activities) of any Product and Manufacture of the Products for such purposes, including approval of those sections of the Strategic Plan covering Commercialization, Akcea Non-Commercial Activities (other than Pre-Approval Akcea Development Activities), and Manufacturing of the Products for such activities (but not the Commercial Budget), and how to implement the JSC’s recommendations with respect thereto, and (B) matters relating to the strategy with regard to the defense against actual or potential allegations of infringement of any Patent Controlled by a Third Party, including the institution of any inter partes review, opposition, or other proceeding related to any such Patent, and (ii) Ionis will have final-decision making authority with respect to matters relating to the Development (other than Akcea Non-Commercial Activities that are not Pre-Approval Akcea Development Activities) of any Product and the Manufacture of the Product for such purposes, including approval of those sections of the Strategic Plan covering Development other than Akcea Non-Commercial Activities that are not Pre-Approval Akcea Development Activities (but not the Development Budget) and Manufacturing of the Products for such purposes, and how to implement the JSC’s recommendations with respect thereto.
