Common use of Decision Making Clause in Contracts

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budget.

Appears in 1 contract

Sources: License and Collaboration Agreement (Global Blood Therapeutics, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (ai) and (b) below, all All decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular any matter before within the JSC that is within its authoritydecision-making authority of the JSC, the representatives of the Parties on the JSC cannot reach unanimous an agreement as to such matter within [***] Business Days after such matter was brought to the JSC for resolutionresolution or after such matter has been referred to the JSC, such disagreement shall be referred to the Chief Executive Officers Officer of Allogene and the Chief Executive Officer of Licensee (or their designeesor, in each case, any designee with decision-making authority at a level of at least Senior Vice President) of each Party (collectively, the “Executive Officers”) for resolution. . (ii) If the Executive Officers (or their designees) cannot resolve such matter within [***] days after such matter has been referred to them, then: , (aA) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros Licensee shall have be empowered to make the final right decision with respect to decide such matter; all matters that are Licensee Territory-specific matters (bincluding without limitation, patent listings in the Licensee Territory under Section 11.6), other than Licensee Territory-specific matters that would reasonably be expected to adversely and materially affect Products in the Allogene Territory, which shall be subject to Allogene’s final decision making power and (B) if such matter concerns Allogene shall be empowered to make the final decision on all matters relating to (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or Products outside the Licensee Territory and (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the deMulti-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetRegion Trials.

Appears in 1 contract

Sources: Exclusive License Agreement (Allogene Therapeutics, Inc.)

Decision Making. Except for decisions The JSC shall serve as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject decision-making and dispute resolution body solely with respect to the decision of GBTmatters set forth in Sections [***], and except as provided in clauses (a) and (b) below, all decisions of the JSC relating thereto shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent effortsconsensus. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as a consensus decision on any of the foregoing matters, either Party may instruct the JSC to refer such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If any such Party does so, then each Party will submit in writing its respective position to each of the Executive Officers. Such Executive Officers (or their designees) cannot will use good faith efforts to resolve such matter within [***] Business days after the JSC’s submission of such matter has been referred to themsuch Executive Officers, which good faith efforts will include at least one (1) meeting between such Executive Officers. If the Executive Officers are unable to reach unanimous agreement on any such matter within such [***] Business Day period, then: (a) 3.2.1 if the matter relates to [***] then the matter will be decided by Licensee, [***]; 3.2.2 if the matter relates solely to [***], then the matter will be decided by Licensor, [***]; 3.2.3 if the matter relates to [***], then the matter will be decided by Licensee; 3.2.4 if the matter relates to [***], then the Executive Officers or their designees will submit their respective positions on such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed resolved by SyrosExpedited Arbitration, then GBT shall have provided however that if Licensee agrees to pay the final right excess costs associated with Licensee’s position in relation to decide such matter, then the matter will be decided by Licensee; and (c) 3.2.5 if such the matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b)relates to [***], then the status quo shall prevail with respect to Executive Officers or their designees will submit their respective positions on such matter and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budgetresolved by Expedited Arbitration.

Appears in 1 contract

Sources: License and Development Agreement (Selecta Biosciences Inc)

Decision Making. Except for decisions as The JDC shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the seek consensus in its actions and decision of GBTmaking process, and except as provided in clauses (a) and (b) below, all decisions of by the JSC JDC shall be made by unanimous voteconsensus, with each Party’s representatives Party having collectively having one (1) vote. The Parties will strive to reach consensus on vote in all such decisions of the JSC, acting in good faith and using diligent effortsdecisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJDC, the representatives of the Parties cannot reach unanimous an agreement as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within [***] ten (10) Business Days after such matter was brought to the JSC JDC for resolutionresolution or after such matter has been referred to the JDC, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] thirty (30) days after such matter has been referred to them, then: (a) if such matter concerns except as set forth in Section 3.3(b) below, the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros Apollomics Executive Officer shall have the final right decision making authority with respect to decide the Development or Commercialization of Licensed Products in the Field in the Apollomics Territory to the extent such matter;Development and Commercialization activities solely arise within the Apollomics Territory and solely impact the Development, Commercialization, and Manufacture of Licensed Products in the Apollomics Territory; and (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT GlycoMimetics Executive Officer shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail decision making authority with respect to such matter and no changes shall all other matters not allocated to Apollomics in Section 3.3(a), including any JDC decisions that would reasonably be made except by agreement of expected individually or in the Partiesaggregate to have an Adverse Risk or that relate to any global study worldwide. For clarity, any Dispute concerning whether the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets Apollomics Executive Officer or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to GlycoMimetics Executive Officer shall have the Research Plan, or (iii) any decreases to the Research Budgetfinal decision making authority shall be resolved through arbitration in accordance with Section 14.2.

Appears in 1 contract

Sources: Collaboration and License Agreement (Glycomimetics Inc)

Decision Making. Except for decisions as The JDC and JMT each shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidateact by consensus. The representatives from each Party on the JDC will have, which shall be subject solely to the decision of GBTcollectively, and except as provided in clauses (a) and (b) below, all decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) votevote on behalf of that Party; each Party will have one vote on the JMT. The Parties will strive If the JDC is unable to reach consensus on all any matter within the JDC’s authority within thirty (30) days after first considering such decisions of the JSCmatter, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to then such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party JMT for resolution. If the Executive Officers (or their designees) JMT, after good faith efforts and consideration of the other party’s position, cannot resolve such matter within [***] thirty (30) days after such matter has been referred to themthe JMT, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros Jazz shall have the final right decision making authority with respect to decide all matters relating to the HemOnc Products; provided that such matterfinal decision making authority shall not apply with respect to (i) the prosecution and enforcement of Pfenex Patents (for which decisions shall be made as set forth in Sections 7.3 and 7.4), and (ii) material changes to the Pfenex Expression Feasibility Activities; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant prior to Section 4.1(c)Option Exercise, or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT Pfenex shall have the final right decision making authority with respect to decide such matter, all matters relating to the development of the Pegaspargase Product; provided that Pfenex may not materially change any of its development obligations outlined in the applicable Development Plan with respect to the Pegaspargase Product without Jazz’s prior written consent; and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail prior to ROFN Exercise with respect to the applicable ROFN Product, Pfenex shall have the final decision making authority with respect to all matters relating to the development of such matter and no changes shall be made except by agreement ROFN Product. Notwithstanding the foregoing, a Party may not exercise such final decision making authority in a manner that would increase the financial obligations of the Partiesother Party. For clarity, the Parties shall mutually agree on (i) JDC and JMT have no authority to determine, and neither Party may exercise final-decision making authority to resolve, the selection achievement of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets a milestone set forth on Exhibit C, (ii) 6.3 or the allocation of responsibility for any amendments to the Research Plan, or (iii) any decreases to the Research Budgetdelay in achievement thereof.

Appears in 1 contract

Sources: License Agreement (Jazz Pharmaceuticals PLC)

Decision Making. Except for decisions as Each Committee shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the seek consensus in its actions and decision of GBT, making process and except as provided in clauses (a) and (b) below, all decisions of by the JSC Committees shall be made by unanimous voteconsensus, with each Party’s representatives Party having collectively having one (1) votevote in all decisions. The Parties will strive to reach consensus If after reasonable discussion and good faith consideration of each Party’s view on all such decisions a particular matter before any Subcommittee, the representatives of the JSCParties cannot reach an agreement as to such matter within ten (10) Business Days after such matter was brought to such Subcommittee for resolution (to the extent such matter requires the agreement of the Parties hereunder), acting in good faith and using diligent effortssuch disagreement shall be referred to the JSC for resolution. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJSC, the representatives of the Parties cannot reach unanimous an agreement as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within [***] ten (10) Business Days after such matter was brought to the JSC for resolutionresolution or after such matter has been referred to the JSC, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] thirty (30) days after such matter has been referred to them, then:then SAMR’s Executive Officer shall have the final decision making authority with respect to such matter if it is within the JSC’s authority and relates to Worldwide License Products, and Aridis’s Executive Officer shall have the final decision making authority with respect to such matter if it is within the JSC’s authority and relates to Limited License Products; in each case provided, however, that Aridis’s Executive Officer shall have the right to veto any decision by SAMR relating to any of the following matters (any such determination by Aridis shall be in writing and provided to SAMR): (a) if such matter concerns any amendments or updates to the conduct Development Plan or any Development work or product manufacture work that, in Aridis’s reasonable judgment, is likely to have a material adverse effect upon the procurement or maintenance of activities under Regulatory Approval or Commercialization of Licensed Products (including in the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matterApplicable Territory); (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter Worldwide License Products, global key product messages in promotional materials, key product messages and no changes shall be made except by agreement content of the Parties. For clarityscientific communications at conferences and events, the Parties shall mutually agree on (i) the selection of additional biological targets and communication to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budget.advisory boards; and

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Aridis Pharmaceuticals, Inc.)

Decision Making. Except for decisions as otherwise provided herein, including, without limitation, Section 3.1.7, with respect to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) belowgiven Development Program, all decisions of the JSC JDC shall be made by unanimous voteconsensus, ||| with each Party’s representatives collectively Party having one (1) vote. The Parties will strive If the JDC cannot agree on a matter within its authority hereunder within thirty (30) days after it has met and attempted to reach consensus on all such decisions of the JSCdecision, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authoritythen, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought either Party may, by written notice to the JSC for resolutionother, have such disagreement shall be issue referred to the Executive Officers (or their designees) of each Party for resolution. The Parties’ respective Executive Officers shall meet within fifteen (15) days after such matter is referred to them, and shall negotiate in good faith to resolve the matter. If the Executive Officers (or their designees) cannot are unable to resolve such the matter within [***] thirty (30) days after such the matter has been is referred to them, thenthen the issue shall be finally resolved as follows: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros Tevard shall have the final right decision-making authority with respect to decide such matter;any disputes with respect to all Development Programs for which Zogenix has not exercised its Option; except (i) for matters set forth in Sections 3.1.4(a) or 3.1.4(b), for which neither Party shall have final decision-making authority and (ii) as otherwise set forth in Section 3.1.4(c), for which decision-making authority shall be as set forth therein. (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT Zogenix shall have final decision-making authority with respect to any disputes following the final right exercise of its Option and with respect to decide such matterall Licensed Development Programs, andincluding disputes concerning the Development and Commercialization of Licensed Products thereunder. (c) if such Any dispute regarding a matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then within the status quo shall prevail JDC’s authority with respect to such matter and no changes shall be made except which final decision-making authority is not otherwise specified in this Section 3.1.5, if not resolved by agreement escalation to the respective Executive Officers of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budgetfinally decided by Zogenix.

Appears in 1 contract

Sources: Collaboration, Option and License Agreement (Zogenix, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all All decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJSC, the representatives of the Parties JSC cannot reach a unanimous agreement decision as to such matter within [*** * *] days after such matter was brought to the JSC for resolution, then such disagreement matter shall be referred to the Chief Executive Officers Officer of Verastem (or their designeesan executive officer of Verastem designated by the Chief Executive Officer of Verastem who has the power and authority to resolve such matter) and the Head of each Party Pharmaceutical Division of Licensee (collectively, the “Executive Officers”) for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [*** * *] Business Days after such matter has been referred to them, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget[* * *], then Syros provided that Licensee shall have the final right to decide such matter; (b) if such matter concerns not make any decision or take any action that (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant could reasonably be expected to Section 4.1(c), or (ii) any proposed increases to adversely impact the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement Licensed Product outside of the Parties. For clarityTerritory, including the Parties shall mutually agree on (i) Licensed Product brand as established under the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit CGlobal Strategy, (ii) requires Verastem to perform or refrain from performing any amendments to the Research Planactivity except as expressly required under this Agreement, or (iii) requires Verastem to provide any decreases resources or bear any costs except as expressly required under this Agreement, in each case ((i) through (iii)), without first obtaining Verastem’s prior written consent, which consent may be withheld in Verastem’s sole discretion. Notwithstanding the foregoing, for so long as Verastem owns the Regulatory Approvals in the Territory, Verastem will have final decision-making authority over all regulatory matters relating to the Research BudgetExploitation of Licensed Products in the Territory, including with respect to the applicable regulatory strategies, all activities associated with seeking and maintaining Regulatory Approvals, all communications with Regulatory Authorities regarding the Licensed Compounds or Licensed Products, and all Regulatory Documents.

Appears in 1 contract

Sources: License and Collaboration Agreement (Verastem, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and The JDC will take action by unanimous consent of its members, with each representative having a single vote, or by a written resolution signed by all of the representatives. (b) below, all decisions of If the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive JDC is unable to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view unanimous consent on a particular matter, then the matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall will be referred to the Chief Executive Officers (or their designees) of each Party for resolutionthe Parties who will use good faith efforts to resolve such matter. If the Executive Officers (or their designees) cannot such officers fail to resolve such matter within [***] after such matter has been referred to themmatter, then: : (a) if such matter concerns is primarily related to the conduct development of activities under Licensed Product in the Research Program which are consistent with Territory or the then current Research Plan development of a Commercial Process, the Chief Executive Officer of [***] will finally decide the issue; and Research Budget, then Syros shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases is primarily related to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syrosdevelopment of Licensed Product outside the Territory, then GBT shall have the final right to Chief Executive Officer of [***] will finally decide such matter, andthe issue. (c) Notwithstanding the provisions in this Section 2.1.5 above, if the matter concerns a dispute regarding the interpretation of this Agreement, the performance or alleged nonperformance of a Party’s obligations under this Agreement, or any other alleged breach of this Agreement, such matter concerns any issue not covered by will be decided in accordance with the terms of Section 4.3(a) or Section 4.3(b), then 20.4. *** Certain information on this page has been omitted and filed separately with the status quo shall prevail Commission. Confidential treatment has been requested with respect to the omitted portions. (d) The JDC will not have any power to amend this Agreement and will have only such matter and no changes shall be made except by agreement of powers as are specifically delegated to it under this Agreement. Without limiting the Parties. For claritypreceding sentence, the Parties shall mutually understand and agree on (i) that the selection JDC has no decision-making authority with respect to Commercialization of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetLicensed Product .

Appears in 1 contract

Sources: Collaboration and License Agreement (Micromet, Inc.)

Decision Making. Except for decisions as Each Committee shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the seek consensus in its actions and decision of GBT, making process and except as provided in clauses (a) and (b) below, all decisions of by the JSC Committees shall be made by unanimous voteconsensus, with each Party’s representatives Party having collectively having one (1) vote. The Parties will strive to reach consensus on vote in all such decisions of the JSC, acting in good faith and using diligent effortsdecisions. If after reasonable discussion discussion (i) Synergy’s Executive Officer shall have the final decision making authority with respect to matters related to the manufacture of the Licensed Compound or Licensed Product at all times during the Term prior to Luoxin’s exercise of its right to manufacture the Licensed Compound or Licensed Product, pursuant to Section 7.5; and good faith consideration (ii) Luoxin’s Executive Officer shall have the final decision making authority with respect to matters (x) related to the Development or Commercialization of the Licensed Compound or Licensed Product in the Field in the Luoxin Territory and (y) related to the manufacture of the Licensed Compound and/or Licensed Product in the Luoxin Territory after Luoxin’s exercise of its right to manufacture the Licensed Compound and/or Licensed Product pursuant to Section 7.5, in each Party’s view on a particular case if such matter before the JSC that is within its the JSC’s authority, provided, however, that Synergy’s Executive Officer shall have the representatives right to veto any decision by Luoxin relating to any of the Parties cannot reach unanimous agreement as following matters (any such determination by Synergy’s Executive Officer shall be in writing detailing the rationale for such determination and provided to Luoxin within twenty (20) Business Days following the submission of such matter within [***] after such matter was brought matters to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, then:Committee): (a) if such matter concerns the conduct of activities under initial Development Plan, any amendments or updates to the Research Program which are consistent with the then current Research Development Plan and Research Budgetor any Development work that, then Syros shall in Synergy’s reasonable judgment, could be reasonably proved to have the final right to decide such matter;an Adverse Impact; and (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant global key product messages in promotional materials, key product messages and content of scientific communications at conferences and events, and communication to Section 4.1(c)advisory boards that, or (ii) any proposed increases in Synergy’s reasonable judgment, could be reasonably proved to the Research Budget that do not entail have an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetAdverse Impact.

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Synergy Pharmaceuticals, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all All decisions of the JSC each Committee shall be made by unanimous vote[***], with each Party’s representatives collectively having one (1) vote[***]. The Parties will strive to reach Each Committee shall take action by such consensus on all such decisions at a meeting at which a quorum exists or by a written resolution signed by at least [***] representative of the JSC, acting in good faith and using diligent effortseach Party. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJCC or another subcommittee of the JSC, the representatives of the Parties cannot reach unanimous an agreement as to such matter within [***] after such matter was brought to such Committee for resolution, such disagreement shall be referred to the JSC for resolution. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as to such matter within [***] after such matter was brought to the JSC for resolutionresolution or after such matter has been referred to the JSC, such disagreement shall be referred to the Chief Executive Officers Officer of ARS and the Chief Executive Officer of Company or its designee (or their designeescollectively, the “Executive Officers”) of each Party for resolution. If The Executive Officers shall discuss in good faith a resolution of the matter, and if the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, thenthe following shall apply: (a) if [***], to the extent such matter concerns relates to obtaining or maintaining [***], then [***] shall be entitled to make the conduct of activities under the Research Program which are final decision regarding such matter; provided that such decision is consistent with the then current Research Plan terms and Research Budget, then Syros conditions of this Agreement and the Commercial Supply Agreement. Any such decision shall have be made in good faith with consideration of ARS’s views on the final right to decide such matter;matter and consistent with Applicable Law. (b) if such matter concerns If (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant such matter relates to Section 4.1(c)[***], or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros[***], then GBT [***] shall have be entitled to make the final right to decide decision regarding such matter, and (c) if ; provided that such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then decision is consistent with the status quo shall prevail with respect to such matter terms and no changes conditions of this Agreement and the Commercial Supply Agreement and shall be made except by agreement in good faith consideration of [***] views on the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budgetmatter and consistent with Applicable Law.

Appears in 1 contract

Sources: Collaboration, License and Distribution Agreement (ARS Pharmaceuticals, Inc.)

Decision Making. Except for decisions as Each Committee shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBTseek consensus in its actions and decision-making process, and except as provided in clauses (a) and (b) below, all decisions of by the JSC Committees shall be made by unanimous voteagreement, with each Party’s representatives having collectively having one (1) vote. The Parties will strive to reach consensus on vote in all such decisions of the JSC, acting in good faith and using diligent effortsdecisions. If the Parties’ representatives on a Subcommittee, after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityopinions, the representatives of the Parties cannot reach unanimous agreement as to such on a matter within [***] the Subcommittee’s responsibilities after endeavoring to do so for seven (7) days, then such matter was brought disagreement shall be referred to the JSC for resolution. If the Parties’ representatives on the JSC, after reasonable discussion and good faith consideration of each Party’s opinions, cannot reach agreement on a matter within the JSC’s responsibilities or on any matter that is referred to the JSC by a Subcommittee within fifteen (15) days after the JSC has met and attempted to agree on such matter (or such other period as the Parties may agree upon in writing), then such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. Any final decision that the Executive Officers mutually agree to in writing shall be conclusive and binding on the Parties. If the Executive Officers (or their designees) cannot resolve such reach agreement on a matter within [***] thirty (30) days after such matter has been referred to themthem by the JSC (or such other period as the Executive Officers may agree upon in writing), then: then SymBio shall have the tie-breaking vote, and the decision of SymBio’s Executive Officer shall be final and binding on the Parties, with respect to any Development matter, Regulatory Approval matter, or Commercialization Matter, in each case in the SymBio Territory, except that (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros Eagle shall have the tie-breaking vote, and the decision of Eagle’s Executive Officer shall be final right and binding on the Parties, with respect to decide such matter; (b) if such any matter concerns that may have an adverse impact on (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), the global safety profile of the Licensed Product or (ii) the procurement or maintenance of any proposed increases Regulatory Approval in the Eagle Territory, and (b) the decision whether and the terms on which to Develop Licensed Product in the SymBio Territory for any New Indication or any New Formulation shall be subject to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by mutual agreement of the both Parties. For clarity, SymBio shall not have the Parties shall mutually agree on (i) right to Develop, Manufacture or Commercialize any New Indication or New Formulation without the selection consent of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetEagle.

Appears in 1 contract

Sources: Product Collaboration and License Agreement (Eagle Pharmaceuticals, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all All decisions of the JSC shall be made by unanimous voteconsensus, with each Party’s representatives collectively having having, collectively, one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJSC, the representatives of the Parties JSC cannot reach unanimous agreement consensus as to such matter within [***] after such matter was brought to the JSC for resolutionresolution (or […***…] if the particular matter is with respect to any issue under consideration by the JSC pursuant to Sections 3.2(b)(iii), (iv) or (v)), such disagreement matter shall be referred to the Chief Executive Officers Officer of Zymeworks (or their designeesan executive officer of Zymeworks designated by the Chief Executive Officer of Zymeworks who has the power and authority to resolve such matter) and the Chief Executive Officer of each Party BeiGene (or an executive officer of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) (collectively, the “Executive Officers”) for resolution. If the Executive 32 Competitive Information – Commercially Sensitive Terms. 33 Competitive Information – Commercially Sensitive Terms. Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to themthem (or […***…] if the particular matter is with respect to any issue originally under consideration by the JSC pursuant to Sections 3.2(b)(iii), then:(iv) or (v)), then:34 (ai) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research BudgetSubject to Section 3.2(f)(ii), then Syros BeiGene shall have the final right decision-making authority for matters within the scope of the JSC’s decision-making authority with respect to decide such matter;(1) any […***…] for Licensed Products in the Field in the Territory […***…], (2) all […***…] with respect to Licensed Products, including […***…], in the Field in the Territory; and (3) all […***…] activities leading up to and including the […***…] and any […***…], as applicable, for Licensed Products in the Field from […***…] in the Territory; provided that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be expected to […***…].35 (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT Zymeworks shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then decision-making authority for matters within the status quo shall prevail scope of the JSC’s decision-making authority with respect to such matter and no changes shall (1) the […***…]; (2) any […***…] activities which […***…]; (3) any Development, manufacture or Commercialization activities in the Territory that would reasonably be made except by agreement expected to […***…] of the Parties. For clarityLicensed Product; or (4) any Development, manufacture or Commercialization activities in the Territory that would reasonably be expected to (y) result in a […***…] related to the Licensed Product outside the Territory or (z) otherwise […***…]; provided, that, Zymeworks shall not exercise its final decision-making authority in a manner that would […***…] under this Agreement, including (A) any of BeiGene’s obligations or expenses […***…] agreed between the Parties shall mutually agree on and/or (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (iiB) any amendments to […***…] involving a Licensed Product (including the Research PlanZW25 Multi-Regional Registrational Study), in any case without BeiGene’s written consent, which will not be unreasonably withheld, delayed or (iii) any decreases to the Research Budget.conditioned.36

Appears in 1 contract

Sources: License and Collaboration Agreement (Zymeworks Inc.)

Decision Making. Except for decisions as In addition to whether a proposed Collaboration Compound should be designated as an IND Candidateresolving issues specifically delegated to it, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all decisions of the JSC shall be made have the authority to resolve any disputes not resolved by unanimous voteany subcommittee. The representatives from each Party will have, with each Party’s representatives collectively having collectively, one (1) votevote on behalf of that Party on the JSC, and all decision making shall be by consensus to the extent feasible. The Parties will strive If the JSC is unable to reach consensus on all any issue for which it is responsible within thirty (30) days after first considering such decisions of the JSCissue, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, shall submit in writing the representatives respective positions of the Parties cannot reach unanimous agreement as to the Executive Officers. Such Executive Officers shall use good faith efforts, in compliance with Section 3.1(f), to resolve promptly such matter within matter, which good faith efforts shall include at least [*****] between such Executive Officers within ten (10) Business Days after the JSC’s submission of such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolutionthem. If the Executive Officers (or their designees) cannot resolve are unable to reach consensus on any such matter within [***] after such matter has been referred to themmatter, then: (ai) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall Sandoz will have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail say with respect to Commercialization matters for the Product, such matter as pricing, terms of sale, marketing, promotion and no changes shall selling decisions for the Product (and associated regulatory matters) and Promotional Materials (and associated Regulatory Materials), and for Medical Affairs; provided that disputes with respect to approval of any [*****] Commercialization Plan or any Medical Affairs Plan, and amendments to such plans, will be made except determined by mutual, unanimous agreement of the Parties. For clarity’ representatives to the JSC; provided, further, notwithstanding the Parties shall mutually agree on foregoing, Sandoz will have the final say with respect to any matter involving legal and/or compliance matters with respect to the Commercialization Plan or Medical Affairs Plan (and Sandoz will take into account the views expressed by Anacor in determining such matters); (ii) Additionally, without being limited by either subsection (i) the selection of additional biological targets to be included as Collaboration Targets above or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or subsection (iii) below, Sandoz will have, with respect to compliance with Applicable Law, the final say with respect to any decreases and all matters and decisions for the Development of the Product, design, conduct and management of Clinical Trials relating to the Research BudgetProduct and the Commercialization of the Product (and Sandoz will take into account the views expressed by Anacor in determining such matters); and (iii) Subject to the foregoing subsection (ii), Anacor will have final say with respect to manufacturing and Development for the Product (including Phase 4 Clinical Trials and other post-approval studies) and regulatory matters for the Product not covered by subsection (i), provided, that Anacor shall not unilaterally amend the scope of any Phase 4 Clinical Trials in the Development Plan without Sandoz’s prior written consent, which shall not be unreasonably withheld.

Appears in 1 contract

Sources: Distribution and Commercialization Agreement (Anacor Pharmaceuticals, Inc.)

Decision Making. Each Party’s designees on the JSC and JDC shall, collectively, have one (1) vote (the “Party Vote”) on all matters brought before the respective Committee. Except for decisions as expressly provided in this Section 3.1.3, each of the JSC and JDC shall decide as to whether all matters within its jurisdiction by unanimous Party Vote; provided, however, that neither the JSC nor the JDC shall have the authority to amend or modify, or waive compliance with, this Agreement. In the event of a proposed Collaboration Compound should tie Party Vote of the designees of Wyeth and Progenics on the JDC as to matters within such the jurisdiction of such Committee, the co-chairpersons of the JDC shall refer the matter to [*] CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION Table of Contents the JSC for resolution. In the event that such a matter cannot be designated as an IND Candidate, which shall be subject solely resolved by the JSC within ten (10) business days of it being referred to the decision JSC, or in the event of GBTa tie Party Vote of the designees of Wyeth and Progenics on the JSC with respect to any other matter within the JSC’s jurisdiction, and except as provided in clauses (a) and (b) below, all decisions the co-chairpersons of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) voterefer the matter to [*]. The Parties will strive to reach consensus on all In the event that such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authority, the representatives of the Parties matters cannot reach unanimous agreement as to such matter be resolved by these executives within [*] ([**] after such ]) business days, then the matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution[*]. If after good faith discussions by the Executive Officers (or their designees) [*], agreement cannot resolve such matter be reached within [*] ([**] after such matter has been referred to them, then: (a]) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b)business days, then the status quo [*] shall prevail with respect decide upon a mechanism to such matter and no changes shall be made except by agreement of resolve the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budgetmatter.

Appears in 1 contract

Sources: License and Co Development Agreement (Progenics Pharmaceuticals Inc)

Decision Making. Except Day-to-day operational level decisions concerning the Development, Manufacture and Commercialization of Licensed Products in the Territory shall be made by Licensee; provided, however, that such decisions are not inconsistent with the Development Plan. Licensee will review and finalize all protocols for decisions as the Licensed Products based on the recommendations of the PRC. Material updates or changes to whether a proposed Collaboration Compound should be designated as the Development Plan, including (for clarity) any changes to any protocols, new clinical protocols or material changes to an IND Candidateapproved clinical protocol or material changes to strategy with respect to regulatory activities in the Territory, which shall be subject solely to review by and feedback from the decision JSC, which Licensee shall consider in good faith. Each member of GBT, and except the JSC shall have only one vote. Except as otherwise provided in clauses (a) and (b) belowthis Article 6, all decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having ; provided that at least one (1) representative from each Party participates in such vote. The Parties will strive If the JSC does not reach unanimity with respect to reach consensus on all a particular matter, and the JSC is unable to resolve the Dispute after endeavoring for fifteen (15) business days to do so, then either Party may, by written notice to the other, have such decisions of matter referred to the JSCParties’ executive officers, acting who shall meet promptly (either in person or via teleconference) and negotiate in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before to resolve the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolutionDispute. If the Executive Officers (or their designees) executive officers cannot resolve such matter Dispute within [***] after such matter has been referred to them, then: fifteen (a15) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budgetdays, then Syros Licensee shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) decision making authority on any proposed increases and all matters that relate to the Research Budget that do not entail an increase Development, Manufacture or Commercialization of a Licensed Product in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement of the PartiesTerritory. For clarity, such authority of Licensee shall not extend to any decision that directly impacts the Parties shall mutually agree on (i) Development, Manufacture or Commercialization of a Licensed Product outside the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetTerritory.

Appears in 1 contract

Sources: Exclusive License Agreement (Seelos Therapeutics, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all All decisions of the JSC JDC shall be made by unanimous voteconsensus, with each Party’s representatives collectively having having, collectively, one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJDC, the representatives of the Parties JDC cannot reach unanimous agreement consensus as to such matter within [***] after such matter was brought to the JSC JDC for resolution, such disagreement matter shall be referred to the Chief Executive Officers Officer of Leap (or their designeesan executive officer of Leap designated by the Chief Executive Officer of Leap who has the power and authority to resolve such matter) and the Chief Executive Officer of each Party BeiGene (or an executive officer of BeiGene designated by the Chief Executive Officer of BeiGene who has the power and authority to resolve such matter) (collectively, the “Executive Officers”) for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, then:then:28 (ai) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research BudgetSubject to Section 3.2(f)(ii), then Syros BeiGene shall have the final right decision-making authority for matters within the scope of the JDC’s decision-making authority with respect to decide such matter;(1) any [***] for Licensed Products in the Field in the Territory, (2) all [***] with respect to Licensed Products, including [***], in the Field in the Territory; and (3) all [***] activities leading up to and including the [***] and any [***], as applicable, for Licensed Products in the Field from [***] in the Territory; provided that: BeiGene shall not exercise its final decision-making authority in a manner that would reasonably be expected to [***].29 (bii) if such matter concerns Leap shall have the final decision-making authority for matters within the scope of the JDC’s decision-making authority with respect to any Development, manufacture or Commercialization activities in the Territory that would reasonably be expected to (y) result in a [***] related to a Licensed Product outside the Territory or outside the Field or (z) otherwise [***]; provided, that, Leap shall not exercise its final decision-making authority in a manner that would: (A) [***] under this Agreement, including (i) selection criteria for characterizing compounds as Collaboration Compounds any of BeiGene’s obligations or Select Related Compounds pursuant to Section 4.1(c), or expenses [***] agreed between the Parties and/or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and [***] involving a Licensed Product (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(bincluding a Multi-Regional Clinical Trial), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) in any amendments to the Research Plan, case; or (iiiB) any decreases to the Research Budget.[***], without BeiGene’s written consent, which will not be unreasonably withheld, delayed or conditioned.30

Appears in 1 contract

Sources: Exclusive Option and License Agreement (Leap Therapeutics, Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all decisions For the avoidance of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authoritydoubt, the representatives Joint Development Committee shall not have the power to amend the terms of the Parties cannot reach unanimous agreement as to such matter within [***] after such matter was brought to the JSC for resolutionthis Agreement, such disagreement shall be referred to the Executive Officers (or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent amendment may occur only in compliance with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matter;procedures set forth in Section 14.3. (b) if The members of the Joint Development Committee shall endeavor to reach a consensus on all matters within its jurisdiction. All official actions, decisions or rulings of the Joint Development Committee must be made by a consensus of the members of the Joint Development Committee at a meeting at which a quorum exists or in a writing signed by all of the members of the Joint Development Committee. If the members of the Joint Development Committee cannot agree with respect to any action, decision or ruling (including relating to the Development Plan and amendments thereto and protocols for clinical trials) within twenty (20) days (or such matter concerns shorter time as may be reasonable under the circumstances) following the day that the Joint Development Committee first considers such matter, then the issue shall be finally and definitively resolved (i) selection criteria with respect to matters relating to the Development of Covered Products or Non-Required Post-Approval Clinical Studies for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c)the applicable Salix Territory, or by the representatives of Salix on the Joint Development Committee; (ii) any proposed increases with respect to matters relating to the Research Budget Development of Covered Products or Non-Required Post-Approval Clinical Studies for the applicable Cosmo Territory that do not entail could reasonably be expected to have an increase impact on the Exploitation of Covered Products for the applicable Salix Territory, by the representatives of Cosmo on the Joint Development Committee; provided, that such representatives of Cosmo will reasonably and in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail good faith consider all comments with respect to such matter matters provided by the representatives of Salix on the Joint Development Committee; and no changes shall be made except by agreement of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases with respect to all other matters within the Research Budgetjurisdiction of the Joint Development Committee, by the representatives of Cosmo on the Joint Development Committee.

Appears in 1 contract

Sources: Merger Agreement (Salix Pharmaceuticals LTD)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) The JEC may make decisions with respect to any subject matter that is subject to the JEC’s decision-making authority and (b) belowfunctions. Except as expressly provided in this Agreement, all decisions of the JSC JEC shall be made by unanimous votevote or written consent, with SkyePharma and Endo each Party’s representatives collectively having having, collectively, one (1) votevote in all decisions. The Parties will strive JEC shall use reasonable best efforts to reach consensus on all such decisions of resolve the JSCmatters within its roles and functions or otherwise referred to it. (b) If, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on with respect to a particular matter before the JSC that is within its subject to the JEC’s decision-making authority, the representatives of JEC cannot reach consensus within *** days after it has met and attempted to reach such consensus or the Parties cannot reach unanimous agreement as to such consensus on whether the JEC has decision-making authority regarding a matter within [***] * days after such matter was brought to first raised by either Party, the JSC for resolution, such disagreement dispute in question shall be referred to the Chief Executive Officers Officer of SkyePharma, Inc. on behalf of SkyePharma, or such other person holding a similar position designated by SkyePharma, Inc. from time to time, and the Chief Executive Officer of Endo, or such other person holding a similar position designated by Endo from time to time (or their designees) of each Party such officers collectively, the “Executive Officers”), for resolution. If the The Executive Officers (or their designees) cannot shall use reasonable efforts to resolve such the matter within [***] after such matter has been referred to them, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research Budget, then Syros shall have the final right to decide such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant to Section 4.1(c), or (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and. (c) With regard to matters other than (1) the addition to or any other change to the Target Labeling, Target Indications, New Indications or New Indication Development, in each case with respect to any Product, or (2) measuring Endo’s compliance with the obligations set forth in Section 2.5(a) or Section 2.5(b): (i) if such the dispute arising from the JEC pertains to any Development Program (including SkyePharma’s post-registration regulatory responsibilities) or the manufacture of any Product, and the Executive Officers cannot resolve the matter within *** days, then the matter shall be decided by the Executive Officer of SkyePharma in good faith, giving appropriate consideration to the reasonable business and scientific concerns of Endo; and (ii) if the dispute arising from the JEC pertains to any issue aspect of the Commercialization Program (other than the manufacture of Product), and the Executive Officers cannot resolve the matter within *** days, then the matter shall be decided by the Executive Officer of Endo in good faith, giving appropriate consideration to the reasonable business and scientific concerns of SkyePharma. (d) With respect to any dispute arising between the Parties not covered by Section 4.3(a) or Section 4.3(b3.4(c), then if the status quo Executive Officers cannot resolve the matter in accordance with Section 3.4(b), such matters shall prevail be conclusively settled in accordance with the Special Arbitration Provisions; provided, however, no Expert or arbitrator may add to or otherwise change the Target Labeling, Target Indications, New Indications or New Indication Development, in each case with respect to such matter and no changes any Product. (e) For all purposes under this Agreement, any decision made pursuant to this Section 3.4 shall be made except by agreement deemed to be the decision of the Parties. For clarity, the Parties shall mutually agree on (i) the selection of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetJEC.

Appears in 1 contract

Sources: Strategic Alliance Agreement (Endo Pharmaceuticals Holdings Inc)

Decision Making. Except for decisions as The JSC shall strive to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the seek consensus in its actions and decision of GBT, making process and except as provided in clauses (a) and (b) below, all decisions of by the JSC shall be made by unanimous voteconsensus, with each Party’s representatives Party having collectively having one (1) vote. The Parties will strive to reach consensus on vote in all such decisions of the JSC, acting in good faith and using diligent effortsdecisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJSC, the representatives of the Parties cannot reach unanimous an agreement as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within [***] ten (10) Business Days after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Executive Officers (resolution or their designees) of each Party for resolution. If the Executive Officers (or their designees) cannot resolve such matter within [***] after such matter has been referred to them, then: (a) if such matter concerns the conduct of activities under the Research Program which are consistent with the then current Research Plan and Research BudgetJSC, then Syros Launxp International shall have the final right decision making authority with respect to decide such matter; (b) if such matter concerns matters related to Launxp International’s Clinical Trials of the Licensed Products in the Field in the Launxp Territory, and Apollomics’s Executive Officer shall have the final decision making authority with respect to other matters within the JSC’s authority, including without limitation, (i) selection criteria for characterizing compounds as Collaboration Compounds matters primarily related to the Development, Manufacture, or Select Related Compounds pursuant to Section 4.1(c), Commercialization of the Licensed Product outside the Launxp Territory; or (ii) any proposed increases matters related to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail with respect to such matter and no changes shall be made except by agreement Development of the Parties. For clarityLicensed Product within the Launxp Territory but that would negatively and materially impact the Development of the Licensed Product outside the Launxp Territory, the Parties shall mutually agree on (i) the selection including but not limited to, continuation of additional biological targets to be included as Collaboration Targets or the de-designation as Collaboration Targets a clinical development program that has a significant risk of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research Budgetexacerbating safety signals.

Appears in 1 contract

Sources: Collaboration and License Agreement (Apollomics Inc.)

Decision Making. Except for decisions as to whether a proposed Collaboration Compound should be designated as an IND Candidate, which shall be subject solely to the decision of GBT, and except as provided in clauses (a) and (b) below, all All decisions of the JSC each Committee shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. The Parties will strive to reach consensus on all such decisions of the JSC, acting in good faith and using diligent efforts. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC that is within its authorityJDC, JCC or any subcommittee established by the JSC, the representatives of the Parties on such Committee cannot reach an unanimous agreement decision as to such matter within [**] Business Days after such matter was brought to such Committee for resolution, such matter shall be referred to the JSC for resolution. (b) If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC (including matter referred to the JSC by JDC, JCC or any subcommittee established by the JSC), the representatives of the Parties on the JSC cannot reach an unanimous decision as to such matter within [**] Business Days after such matter was brought to the JSC for resolutionresolution (or after such matter has been referred to the JSC), such disagreement matter shall be referred to the Chief Executive Officers Officer of ADCT and the Chief Executive Officer of NewCo (or their designeesthe “Executive Officers”) of each Party for resolution. The Executive Officers shall promptly meet and use good faith efforts to resolve such matter. (c) If the Executive Officers (or their designees) cannot resolve such matter within [***] days after such matter has been referred to themthem under Section 3.9(b), then: (ai) if such matter concerns NewCo shall have final decision making authority with respect to matters that relate specifically to the conduct Development and Commercialization of activities under the Research Program which are Products in the Field in the Territory; provided, however that: (1) NewCo’s decision must be consistent with the then current Research Plan terms and Research Budgetconditions of this Agreement, then Syros including its obligations to use Diligent Efforts to Develop and Commercialize the Products; (2) NewCo shall not have final decision making authority with respect to matters that could also affect any Product outside the final right Territory, and shall not make any decision (or take any action) that may reasonably be expected to decide adversely affect any Product outside the Territory; and (3) the study protocols of all Clinical Trials of the Products to be conducted by or on behalf of NewCo in the Territory (including any Clinical Trial conducted by NewCo under Section 4.5(e)) must be approved by ADCT prior to any patient enrollment, such matter; (b) if such matter concerns (i) selection criteria for characterizing compounds as Collaboration Compounds or Select Related Compounds pursuant consent not to Section 4.1(c)be unreasonably delayed, conditioned, or withheld; and (ii) any proposed increases to the Research Budget that do not entail an increase in FTE resources required to be deployed by Syros, then GBT ADCT shall have the final right to decide such matter, and (c) if such matter concerns any issue not covered by Section 4.3(a) or Section 4.3(b), then the status quo shall prevail decision making authority with respect to such matter matters that could reasonably be expected to adversely impact the Products outside the Territory, including matters that could reasonably be expected to adversely impact the Products both in and no changes shall be made except by agreement of outside the Parties. Territory, which may include but are not limited to Global Clinical Trials and any CMC (chemistry, manufacturing and controls) related matters in the Territory (including technology transfer to any contract manufacturing organization). (iii) For clarity, neither the Parties JSC nor any subcommittee established by the JSC shall mutually agree on (i) have any, and ADCT shall retain all, decision making authority over the selection Development, manufacture and Commercialization of additional biological targets the Product outside the Territory and all matters relating to be included as Collaboration Targets or the de-designation as Collaboration Targets of biological targets set forth on Exhibit C, (ii) any amendments to the Research Plan, or (iii) any decreases to the Research BudgetGlobal Clinical Trials.

Appears in 1 contract

Sources: License and Collaboration Agreement (ADC Therapeutics SA)