Common use of Decision-Making Authority Clause in Contracts

Decision-Making Authority. All decisions of the JRDC and JCC, as the case may be, shall be made by majority vote, with each Party’s JRDC Representatives or JCC Representatives collectively having one vote, and the goal of all decision making shall be to achieve consensus. Upon fifteen (15) days prior written notice, either Party may convene a special meeting of the JRDC or JCC, as the case may be, for the purpose of resolving any failure to reach agreement on a matter within the scope of the authority and responsibility of the JRDC or JCC, as the case may be. If the JRDC or JCC, as the case may be, is unable to reach agreement on any matter so referred to it for resolution by one or more of the Parties within thirty (30) days after the matter is so referred to it, such matter shall be referred to the Executive Officers for resolution. If the matter is not resolved by the Executive Officers within thirty (30) days after referral to the Executive Officers, then: (i) if such matter relates primarily to Collaboration Program activities with respect to any Alnylam siRNA, Alnylam shall have the right to decide the matter; provided that Alnylam has not discontinued its participation in the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Alnylam has discontinued its participation in the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4, Medtronic shall have the right to decide the matter; (ii) notwithstanding clause (i) above, if such matter relates primarily to the Development of Medtronic Devices for use in Licensed Products, Medtronic shall have the right to decide the matter; provided that Medtronic has not opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Medtronic has opted out of the Product Development Program pursuant to Section 2.4, Alnylam shall have the right to decide the matter; (iii) if such matter relates primarily to Commercialization matters, the Commercializing Party shall have the right to decide the matter; provided that the budget for Launch Costs for any Licensed Product shall be subject to the approval of both Parties, such approval not to be unreasonably withheld, delayed or conditioned; and (iv) if such matter is not described in paragraphs (i), (ii) or (iii) above, then neither Party shall have the unilateral right to decide the matter. Notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 2.2(e), any Workplan or the Parties’ respective rights and obligations thereunder. Furthermore, notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to amend or modify any Workplan if such amendment or modification would require the use of additional Know-How or a license under additional Patent Rights that is Controlled by the other Party and subject to financial obligations to any Third Party (other than financial obligations under a Section 2.5(d)(iii) [**] Agreement) unless in connection with such amendment or modification the applicable Third Party agreement (other than a Section 2.5(d)(iii) [**] Agreement) is approved by the JRDC as a Listed or Approved Third Party Agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Decision-Making Authority. Each Party shall have one vote on a Committee. All decisions of a Committee shall require unanimous agreement of the JRDC and JCC, as Parties. Any disagreement between the case may be, representatives of the Parties on a Subcommittee shall be made referred to the JSC for resolution. If the JSC fails to unanimously agree on any matter that is referred by majority votea Subcommittee or any matter within the JSC’s responsibilities, with in each Party’s JRDC Representatives or JCC Representatives collectively having one vote, and the goal of all decision making shall be to achieve consensus. Upon case within fifteen (15) days prior written noticedays, either Party may convene a special meeting of the JRDC or JCC, such other period as the case may be, for the purpose of resolving any failure to reach agreement on a matter within the scope of the authority and responsibility of the JRDC or JCC, as the case may be. If the JRDC or JCC, as the case may be, is unable to reach agreement on any matter so referred to it for resolution by one or more JSC representatives of the Parties may agree upon, after the JSC has met and attempted to agree on such matter, then: with respect to all matters relating to Commercialization in the Territory, Licensee shall have final decision-making authority and the decision of Licensee with respect to such matters shall be final and binding on the Parties; provided, however, that Teva may refer the following matters, ((A), (B) and (C)), to the Executive Officers, and Licensee shall not have the final decision-making authority with respect to such matters: (A) selection of an alternative Product ▇▇▇▇, if applicable, as provided in Section 9.5(a); (B) any Commercialization matter with respect to which, in Teva’s reasonable judgment, Licensee’s final decision is reasonably likely to have a material adverse effect on Teva’s development and regulatory strategy for Licensed Products outside the Territory; and (C) any Commercialization matter with respect to which, in Teva’s reasonable judgment, Licensee’s final decision is inconsistent with Teva’s global brand strategy and positioning for Licensed Products (“Global Brand Strategy”); with respect to all Development of the Specialty Product matters (including Development of any New Indications for the Specialty Product) in the Territory, Teva shall have final decision-making authority and the decision of Teva’s chairperson of the JSC with respect to such matters shall be final and binding on the Parties; provided however, that in the event Licensee does not agree with the decision of Teva, Licensee may, by written notice to Teva (“Escalation Notice”), refer such matter to the Executive Officers for resolution. In addition, Teva may provide an Escalation Notice regarding (A) selection of an alternative Product ▇▇▇▇, if applicable as provided in Section 9.5(a), (B) any Commercialization matter decided by Licensee that, in Teva’s reasonable judgment, is reasonably likely to have a material adverse effect on Teva’s development and regulatory strategy for the Specialty Product outside the Territory, and (C) any Commercialization matter decided by Licensee that, in Teva’s reasonable judgment, is inconsistent with the Global Brand Strategy. The Executive Officers shall use good faith efforts to resolve any matter referred to them as soon as practicable. Any final decision that the Executive Officers mutually agree to in writing shall be conclusive and binding on the Parties; and if the Executive Officers are unable to resolve any matter set forth in an Escalation Notice within thirty (30) days after the matter is so referred to it, receiving such matter shall be referred to Escalation Notice (or such longer period as the Executive Officers may agree upon), then (A) with respect to any decisions that, in Teva’s reasonable judgment, are reasonably likely to have an adverse impact on the global safety profile of the Licensed Product or are inconsistent with the Global Brand Strategy, Teva shall have final decision-making authority and the decision of Teva’s Executive Officer with respect to such decisions shall be final and binding on the Parties, provided, however, that if the Parties mutually agree upon a Territory-specific Licensed Product brand strategy, including any Licensed Product positioning or key messaging for resolution. If the matter Territory that is inconsistent with the Global Brand Strategy, Licensee shall have the right to implement such Territory-specific brand strategy, (B) subject to the foregoing clause (A), Licensee shall have final decision-making authority on all Commercialization matters, other than selection of an alternative Product ▇▇▇▇, if applicable, as provided in Section 9.5(a), and the decision of Licensee’s Executive Officer with respect to such matters shall be final and binding on the Parties, and (C) all other matters set forth in an Escalation Notice that are not resolved by the Executive Officers within thirty (30) days after referral to the Executive Officers, then: including selection of an alternative Product ▇▇▇▇, if applicable, as provided in Section 9.5(a) and, subject to clause (i) if such matter relates primarily to Collaboration Program activities with respect to any Alnylam siRNAA), Alnylam shall have the right to decide the matter; provided that Alnylam has not discontinued its participation all Development matters in the JRDC pursuant to Section 2.2(c) or opted out Territory (including Development of New Indications for the Specialty Product Development Program pursuant to Section 2.4; provided further that, if Alnylam has discontinued its participation in the JRDC pursuant to Section 2.2(cTerritory) or opted out of the Product Development Program pursuant to Section 2.4, Medtronic shall have the right to decide the matter; (ii) notwithstanding clause (i) above, if such matter relates primarily to the Development of Medtronic Devices for use in Licensed Products, Medtronic shall have the right to decide the matter; provided that Medtronic has not opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Medtronic has opted out of the Product Development Program pursuant to Section 2.4, Alnylam shall have the right to decide the matter; (iii) if such matter relates primarily to Commercialization matters, the Commercializing Party shall have the right to decide the matter; provided that the budget for Launch Costs for any Licensed Product shall be subject to the approval mutual agreement of both PartiesParties and shall not be subject to arbitration or any other form of external dispute resolution and, unless and until such approval not to be unreasonably withheld, delayed or conditioned; and (iv) if such matter mutual agreement is not described in paragraphs (i), (ii) or (iii) above, then neither Party shall have the unilateral right to decide the matter. Notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement reached or the Parties’ respective rights and obligations hereunder orApplicable Law or Regulatory Authority requires otherwise, except as expressly provided in this Section 2.2(e), any Workplan or the Parties’ respective rights and obligations thereunder. Furthermore, notwithstanding anything in this Section 2.2(e), neither Party status quo shall have a unilateral right to amend or modify any Workplan if such amendment or modification would require the use of additional Know-How or a license under additional Patent Rights that is Controlled by the other Party and subject to financial obligations to any Third Party (other than financial obligations under a Section 2.5(d)(iii) [**] Agreement) unless in connection with such amendment or modification the applicable Third Party agreement (other than a Section 2.5(d)(iii) [**] Agreement) is approved by the JRDC as a Listed or Approved Third Party Agreementbe maintained.

Appears in 1 contract

Sources: License, Collaboration and Distribution Agreement

Decision-Making Authority. All decisions Decisions of the JRDC and JCC, as the case may be, JSC shall be made by majority votetaken unanimously. In the event of a disagreement or a deadlock, with each Party’s JRDC Representatives or JCC Representatives collectively having one vote, and the goal of all decision making shall be to achieve consensus. Upon fifteen (15) days prior written notice, either Party may convene a special meeting of the JRDC or JCC, as the case may be, for the purpose of resolving any failure to reach agreement on a matter within the scope of the authority and responsibility of the JRDC or JCC, as the case may be. If the JRDC or JCC, as the case may be, is unable to reach agreement on any matter so referred to it for resolution by one or more of the Parties within thirty (30) days after the matter is so referred to it, such matter shall be referred to senior executives of the Executive Officers for resolutionParties pursuant to Section 15.1. If the matter disagreement or deadlock persists and is not resolved by in the Executive Officers within thirty (30) days after referral to the Executive Officersperiod provided for in Section 15.1, then: (i) if such matter relates primarily to Collaboration Program activities with respect to any Alnylam siRNA, Alnylam Licensor shall have the right to decide cast a tie-breaking vote which shall be reasonably exercised. It is understood and agreed that the matter; provided that Alnylam has not discontinued its participation exercise by Licensor of a tie-breaking vote so as to resolve a disagreement or deadlock at the JSC shall in no way result in the JRDC elimination or reduction of Licensor’s obligation to use Diligent Efforts to participate and co-fund the Initial Development Plan and any Joint Subsequent Development Plans under the terms of this Agreement. However, in the event that a dispute referred to the Parties pursuant to Section 2.2(c) 15.1 is in relation to matters contemplated in Section 3.2.3 of this Agreement as to which the JFC is to agree, including those matters set forth in Section 2.1.4, or opted out with respect to matters related to the manufacture, supply and marketing of the Licensed Product Development Program pursuant to Section 2.4; provided further that, if Alnylam has discontinued its participation in the JRDC pursuant Territory is referred [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. to Section 2.2(c) or opted out the JSC, Licensor shall have no tie-breaking vote in which event the provisions of Article 15 shall apply. For clarity, it is understood that as between the Product Development Program pursuant to Section 2.4Parties, Medtronic Licensor shall at all times have the right to decide the matter; (ii) notwithstanding clause (i) above, if such matter relates primarily control all decisions relating to the Development of Medtronic Devices for use in Licensed Products, Medtronic shall have the right to decide the matter; provided that Medtronic has not opted out marketing and selling of the Product Development Program pursuant to Section 2.4; provided further that, if Medtronic has opted out of the Product Development Program pursuant to Section 2.4, Alnylam shall have the right to decide the matter; (iii) if such matter relates primarily to Commercialization matters, the Commercializing Party shall have the right to decide the matter; provided that the budget for Launch Costs for any Licensed Product shall be subject to in the approval of both Parties, such approval not to be unreasonably withheld, delayed or conditioned; and (iv) if such matter is not described in paragraphs (i), (ii) or (iii) above, then neither Party shall have the unilateral right to decide the matter. Notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 2.2(e), any Workplan or the Parties’ respective rights and obligations thereunder. Furthermore, notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to amend or modify any Workplan if such amendment or modification would require the use of additional Know-How or a license under additional Patent Rights that is Controlled by the other Party and subject to financial obligations to any Third Party (other than financial obligations under a Section 2.5(d)(iii) [**] Agreement) unless in connection with such amendment or modification the applicable Third Party agreement (other than a Section 2.5(d)(iii) [**] Agreement) is approved by the JRDC as a Listed or Approved Third Party AgreementLicensor Territory.

Appears in 1 contract

Sources: License and Collaboration Agreement (Tercica Inc)

Decision-Making Authority. All (a) Subject to the remainder of this Section 2.6, all decisions of the JRDC and JCC, as the case may be, JSC shall be made by majority voteconsensus, with each Party’s JRDC Representatives or JCC Representatives JSC representatives collectively having one vote, and the goal of all decision making shall be to achieve consensus. Upon fifteen (15) days [***] Business Days’ prior written notice, either Party may convene a special meeting of the JRDC or JCC, as the case may be, JSC for the purpose of resolving any failure to reach agreement on a matter within the scope of the authority and responsibility of the JRDC or JCC, as the case may be. JSC. (b) If the JRDC or JCC, as the case may be, JSC is unable to reach agreement on any matter so referred a consensus with respect to it for resolution by one or more of a dispute within [***] days, then the Parties within thirty (30) days after the matter is so referred to it, such matter dispute shall be referred submitted to the Executive Officers of Alnylam and Vir for resolution. . (c) If such escalated dispute cannot be resolved within [***] of the matter is not resolved by the Executive Officers within thirty (30) days after referral dispute being submitted to the Executive Officers, then: then subject to clause (d) below, the Executive Officer of Vir shall have the deciding vote on any matter involving (i) the Development, Manufacture or Commercialization of HBV Licensed Products in the Field in the Territory, including updates and modifications to the Development Plan for the HBV Program, and (ii) the Development, Manufacture or Commercialization of ID Licensed Products in the Field in the Territory, including the selection of Development Candidates in an ID Program, the creation of an applicable Development Plan, and updates and modifications to the Development Plans for such ID Program, for the applicable ID Program. (d) Notwithstanding the foregoing, Vir may not exercise its final decision-making authority (i) with respect to the HBV Program, during the HBV Program Joint Funding Period or thereafter, to cause Alnylam to undertake any activities or financial obligations beyond those for which it is responsible under the then-current applicable HBV Development Plan; provided that Alnylam shall (x) undertake an Additional Alnylam Activity to the extent it has the resources to do so, and if Alnylam does not have the resources to do so, Vir may, in its sole discretion conduct (or have conducted) such Additional Alnylam Activity, and (y) fund Alnylam’s share of the Program Costs incurred by each of the Parties for any Additional Funded Activity during the HBV Program Joint Funding Period if such matter relates primarily Additional Funded Activity does not result in the applicable shared Program Cost budget in the then current HBV Development Plan during the HBV Program Joint Funding Period increasing by more than [***] (for clarity, if such Additional Funded Activity increases the shared Program Cost budget by more than [***], then Vir may elect to Collaboration Program activities fund [***] of such Additional Funded Activity, subject to partial reimbursement by Alnylam pursuant to Section 4.2(c)(v) in the event that Alnylam exercises its Profit-Sharing Option with respect to the ALN-HBV02; and Vir may conduct, at its sole expense, any Development activity for any HBV Licensed Product that will not [***], (ii) with respect to any ID Program, to make material changes to Alnylam’s DC Workplan under the ID Development Plan for such ID Program or to cause Alnylam siRNAto undertake any obligations beyond those for which it is responsible under the then-current applicable ID Development Plan, Alnylam shall have the right to decide the matter; provided that Alnylam has shall not discontinued unreasonably withhold its participation in the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Alnylam has discontinued its participation in the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4, Medtronic shall have the right to decide the matter; (ii) notwithstanding clause (i) above, if such matter relates primarily to the Development of Medtronic Devices for use in Licensed Products, Medtronic shall have the right to decide the matter; provided that Medtronic has not opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Medtronic has opted out of the Product Development Program pursuant to Section 2.4, Alnylam shall have the right to decide the matter; (iii) if such matter relates primarily to Commercialization matters, the Commercializing Party shall have the right to decide the matter; provided that the budget for Launch Costs for any Licensed Product shall be subject to the approval of both Parties, such approval not to be unreasonably withheld, delayed or conditioned; and (iv) if such matter is not described in paragraphs (i), (ii) or (iii) above, then neither Party shall have the unilateral right to decide the matter. Notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 2.2(e), any Workplan or the Parties’ respective rights and obligations thereunder. Furthermore, notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to amend or modify any Workplan if such amendment or modification would require the use of additional Know-How or a license under additional Patent Rights that is Controlled by the other Party and subject to financial obligations consent to any Third Party (other than financial obligations under material changes to a Section 2.5(d)(iii) DC Workplan that Vir reasonably and in good faith determines are necessary in order for the JSC to select a Development Candidate and that are funded by Vir, and [**] Agreement) unless in connection with such amendment or modification the applicable Third Party agreement (other than a Section 2.5(d)(iii) [**] Agreement) is approved by the JRDC as a Listed or Approved Third Party Agreement].

Appears in 1 contract

Sources: Collaboration and License Agreement (Vir Biotechnology, Inc.)

Decision-Making Authority. All decisions The Committee Deadlock shall be submitted by either Party to the Senior Managers of both Parties. The Senior Managers of each Party, or their respective designees, shall attempt to resolve such Committee Deadlock within [***] after submission. If the JRDC and JCCSenior Managers (or their respective designees) cannot resolve the Committee Deadlock, then GSK, as the case may beLead Party and the LCP for the applicable Collaboration Product, shall be made by majority votehave the final decision-making authority, except that: (a) if the JSC determines (with each Party’s JRDC Representatives or JCC Representatives collectively GSK having one vote, and the goal of all decision final decision-making authority) that Vir shall be the Lead Party for the Development of a Collaboration Product under the Expanded Functional Genomics Program or any Additional Pathogen Program, then, prior to achieve consensus. Upon fifteen (15) days prior written noticethe first filing for Drug Approval Application of such Collaboration Product, either Party may convene if a special meeting Committee Deadlock is with respect to Development and regulatory matters regarding such Collaboration Product, including clinical Manufacturing and supply of the JRDC or JCCclinical trial material for Clinical Studies, then Vir, as the case may beLead Party for such Collaboration Product, for shall have the purpose of resolving any failure to reach agreement on a matter within the scope of the final decision making authority and responsibility of the JRDC or JCC, as the case may be. If the JRDC or JCC, as the case may be, is unable to reach agreement on any matter so referred to it for resolution by one or more of the Parties within thirty [***]; (30b) days after the matter is so referred to it, such matter shall be referred [***]; (c) with respect to the Executive Officers for resolution. If the matter is not resolved by the Executive Officers within thirty (30) days after referral to the Executive Officers, then:Expanded Functional Genomics Program, (i) if such matter relates primarily to Collaboration Program activities with respect to any Alnylam siRNA, Alnylam shall have at the right to decide the matter; provided that Alnylam has not discontinued its participation in time a Target is submitted by the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4; provided further thatJSC for approval as an Expanded Functional Genomics Target, if Alnylam has discontinued its participation in the JRDC pursuant to Section 2.2(c) or opted out of the Product Development Program pursuant to Section 2.4, Medtronic shall have the right to decide the matter[***]; (ii) notwithstanding clause (i) above, if such matter relates primarily to the Development of Medtronic Devices for use in Licensed Products, Medtronic shall have the right to decide the matter; provided that Medtronic has not opted out of the Product Development Program pursuant to Section 2.4; provided further that, if Medtronic has opted out of the Product Development Program pursuant to Section 2.4, Alnylam shall have the right to decide the matter[***]; (iii) if the Parties [***]. (d) with respect to the Additional Pathogens Program, (i) except with respect to the [***] designated by GSK from the Listed Target Pathogens and any Program mAbs directed to such matter relates primarily to Commercialization mattersSelected Pathogen (for which, the Commercializing Party for clarity, GSK shall have the right to decide the matter; provided that the budget for Launch Costs for any Licensed Product shall be subject to the approval of both Parties, such approval not to be unreasonably withheld, delayed or conditioned; and (iv) if such matter is not described in paragraphs (ifinal decision-making authority), [***] (ii) or (iii) above, then neither Party shall have the unilateral right to decide the matter. Notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 2.2(e), any Workplan or the Parties’ respective rights and obligations thereunder. Furthermore, notwithstanding anything in this Section 2.2(e), neither Party shall have a unilateral right to amend or modify any Workplan if such amendment or modification would require the use of additional Know-How or a license under additional Patent Rights that is Controlled by the other Party and subject to financial obligations to any Third Party (other than financial obligations under a Section 2.5(d)(iiiA) [**] Agreement) unless in connection with such amendment *], or modification the applicable Third Party agreement (other than a Section 2.5(d)(iiiB) [***], and, 224298306 v10 in each case ((A) or (B)), such decision shall [***]; provided that, the foregoing [***] Agreement(x) is approved by [***], or (y) [***]; (ii) GSK shall not have the JRDC right [***]; (iii) GSK shall not have the right [***]; (e) with respect to inclusion of any additional Internal Policy of a Party as a Listed Relevant Internal Policy, Section 3.11 shall apply; (f) with respect to the [***] for each Collaboration Product, if the Committee Deadlock is with respect to (i) [***], or Approved Third Party Agreement(ii) [***] (A) [***]; and (B) [***], in each case ((A) and (B)) to the extent that [***], in each case ((x) or (y)), [***], then GSK shall have the final decision-making authority, but [***].

Appears in 1 contract

Sources: Definitive Collaboration Agreement (Vir Biotechnology, Inc.)