Common use of Decision Making Clause in Contracts

Decision Making. The JDC shall make decisions unanimously, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc)

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Decision Making. The JDC shall make All decisions unanimouslyof the JCC require unanimous agreement of the Parties, with each Party’s representatives collectively Party having one (1) vote and at least one (1) representative from each Party participating on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in such decisiongood faith to reach consensus on all matters before the JCC. In the event that the JDC determines that it JCC cannot not, after such good-faith efforts, reach an agreement regarding on a decision matter within the JDC’s authorityjurisdiction of the JCC, thenincluding any adoption, amendment or update to a Co-Promotion Plan within […*** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue…], the matter issue shall be referred elevated to FivePrime’s Chief a Executive Officer of each of Ambit and Astellas, to seek in good faith to reach agreement on the issue. Solely in the case of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included in the Co-Promotion Plan budget (or designeeany proposed amendment or update thereto) and HGS’ Chief (in each case, a “Proposed Expense Dispute”), the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to the Executive Officer (or designee) for resolutionOfficers. If In the event such executives cannot resolve the matter issue after good-faith efforts within […*** Business Days*…], then (a) if the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoingdispute is a Proposed Expense Dispute, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS either Party shall have the right to continue cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit E, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject to Astellas’s obligation to use Commercially Reasonable Efforts as set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such trial decision, which decision shall be final and binding on the Parties. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by itself at expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its expenseproposed Co-Promotion Plan budget, but the Direct Marketing/Promotion Expenses and Indirect Marketing Expenses incurred by Astellas during the Calendar Year covered by the disputed budget shall only be included in the calculation of the Annual U.S. Profit/Loss up to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. When *** make a final determination under this Section 3.4*Confidential Treatment Requested CONFIDENTIAL 4. FEES, that final determination must be consistent with the terms of this Agreement.MILESTONES, ROYALTIES AND PROFIT SHARE

Appears in 3 contracts

Samples: Commercialization Agreement (Ambit Biosciences Corp), Commercialization Agreement (Ambit Biosciences Corp), Commercialization Agreement (Ambit Biosciences Corp)

Decision Making. The JDC Decisions of the JRC shall make decisions unanimouslybe made by consensus, with each Party’s representatives collectively Party having one (1) vote and at least one (1) representative from each Party participating in such decisionvote. In the event the JDC determines that it canParties can not reach an agreement regarding agree on a decision within decision, then either Party may, by written notice to the JDC’s authorityother, then, within *** Business Days after have such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be issue referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** Array and the Executive Director, Research (metabolic disorders) of Amgen, or designeetheir designees who have equivalent authority or have been expressly given authority to resolve such dispute, for attempted resolution by good faith negotiations within fifteen (15) shall days after such notice is received; provided that, for decisions which by their nature need to be made quickly, the Amgen representatives will have the right to make the interim decision pending resolution by such Amgen and Array personnel. If such senior managers of Array and Amgen or their designees can not reach consensus after good faith discussion, then Amgen will have the right to make the final decision making authority on such matter. Notwithstanding the foregoingdecision; provided, the Development Plan however, that Amgen shall not be amendedhave the right, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion)agreement of Array, to: (i) increase alter or materially change amend the nature Discovery Plan to provide for less than the minimum number of FivePrime-Conducted Trials Array FTEs as provided in this Agreement, or Other FivePrime-Conducted Activitiesto require Array to utilize personnel in excess of the FTEs funded by Amgen under the Discovery Plan and this Agreement; or (ii) require FivePrime Array to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial be responsible for any business, scientific, safety, efficacy, enrollment tasks or ethical reason, provided that, activities of a materially different nature or scope than agreed by Array in the event FivePrime so decides initial Discovery Plan (or amended Discovery Plan agreed to discontinue by Array); (iii) require Array to bear extraordinary chemical costs unless reimbursed by Amgen; or (iv) cause Array to breach any obligation Array has under an agreement with any Third Party already executed by Array as of the Effective Date (and Array hereby represents, warrants and covenants that there is no agreement as of the Effective Date to which it is a party with a Third Party that would reasonably be expected to conflict with performing activities under the Discovery Plan as of the Effective Date, and Array will not enter into any such trialagreement that conflicts with the then-current Discovery Plan during the Discovery Program Term). For clarity, HGS the JRC shall have no further obligation right to reimburse FivePrime under amend or revise this Agreement, nor shall Amgen’s final decision-making authority as described in this Section 4.2(d2.2(c) except with respect be construed to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTEDpermit Amgen to amend or revise this Agreement without the mutual agreement of Array. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafterMinutes of the JRC meetings shall be taken, and HGS shall, at a minimum, record all decisions made. Such minutes shall have the right to continue such trial be approved by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreementboth Parties.

Appears in 1 contract

Samples: Collaboration and License Agreement (Array Biopharma Inc)

Decision Making. Regardless of the number of Pfizer JSC Members or Exact JSC Members, decisions by the JSC will be made by unanimous agreement. The JDC shall make decisions unanimouslyJSC will use good faith efforts to reach agreement on any and all matters properly brought before it. If, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in despite such decision. In good faith efforts, the event the JDC determines that it cannot JSC is unable to reach an agreement regarding a decision on a particular matter within the JDCJSC’s authorityresponsibilities (each such matter, thena “Disputed JSC Matter”), within *** five (5) Business Days after the JSC first meets to consider such matter, or such later date as may be mutually agreed by the Parties in writing, then either Party may refer such Disputed JSC Matter for resolution to the Alliance Managers. Within three (3) Business Days after such determination: Disputed JSC Matter is referred to the Alliance Managers, the Alliance Managers shall determine whether the Disputed JSC Matter requires the involvement of the Senior Officers. Should the Alliance Managers refer the Disputed JSC Matter to the Senior Officers, then the Senior Officers will promptly initiate good faith discussions to resolve such Disputed JSC Matter. If the Senior Officers are unable to resolve such Disputed JSC Matter within five (a5) for Business Days of it being referred to them, then, Exact, after having considered, in good faith, the advice and input from Pfizer, will have final decision-making authority with respect to such Disputed JSC Matter where the subject matter of the Disputed JSC Matter substantially relates to (i) Product pricing, including any matter rebates or discounts; (ii) manufacturing; (iii) research and development, including any trials; and (iv) engagement with Governmental Authorities; provided, however, that is Exact will not a Critical Issue *** shall have the final decision making authority to require Pfizer to conduct any activities that Pfizer, in good faith, believes violate Applicable Law or Pfizer’s Applicable Compliance/Review Policies. For all Disputed JSC Matters that are not resolved by the Senior Officers and are not subject to Exact’s final decision-making authority, neither Party will take any action on such matter; and (b) for any matter that is a Critical Issue, the matter shall Disputed JSC Matter until resolution can be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld reached in FivePrime’s sole discretionaccordance with this Section 2.1(e), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrimeand, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, except in the event FivePrime so decides case of a potential violation of Applicable Law, pending such resolution the Parties shall continue to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close carry out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination activities under this Section 3.4, that final determination must be consistent Agreement in accordance with the terms of this Agreementthen-current Annual Marketing Plan.

Appears in 1 contract

Samples: Promotion Agreement (Exact Sciences Corp)

Decision Making. The JDC All decisions of the JSC shall make decisions unanimouslybe made by unanimous vote, with each Party’s representatives collectively having one (1) vote vote. If after reasonable discussion and at least one (1) representative from good faith consideration of each Party participating in such decision. In Party’s view on a particular matter before the event JSC, the JDC determines that it JSC cannot reach an agreement regarding a unanimous decision as to such matter within the JDC’s authority, then, within [* * *** Business Days ] days after such determination: (a) matter was brought to the JSC for any matter that is not a Critical Issue *** shall have the final decision making authority on resolution, then such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s the Chief Executive Officer of Verastem (or designee) and HGS’ an 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 Pharmaceutical Division of Licensee (or designeecollectively, the “Executive Officers”) for resolution. If such executives the Executive Officers cannot resolve the such matter within [* * *** ] Business DaysDays after such matter has been referred to them, then [* * *], provided that Licensee shall not make any decision or take any action that (i) could reasonably be expected to adversely impact the Chief Executive Officer Licensed Product outside of *** the Territory, including the Licensed Product brand as established under the Global Strategy, (ii) requires Verastem to perform or designeerefrain from performing any activity except as expressly required under this Agreement, or (iii) shall have the final decision making authority on such matterrequires Verastem to provide any 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 Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, Regulatory Approvals in the event FivePrime so decides Territory, Verastem will have final decision-making authority over all regulatory matters relating to discontinue such trialthe Exploitation of Licensed Products in the Territory, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except including with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933the applicable regulatory strategies, AS AMENDED. already incurred by FivePrime prior to such discontinuation all activities associated with seeking and any maintaining Regulatory Approvals, all communications with Regulatory Authorities regarding the Licensed Compounds or Licensed Products, and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this AgreementRegulatory Documents.

Appears in 1 contract

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

Decision Making. The JDC shall make decisions unanimously, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** The Parties shall have the final joint decision making authority on with respect to all matters pertaining to the development of the Licensed Products inside the Prometheus Territory that would affect the Licensed Products outside the Prometheus Territory, which Prometheus acknowledges could potentially include certain regulatory matters and changes to the Development Plan. Except as set forth in the preceding sentence or in Sections 4.4.2 or 5, as between the Parties, Prometheus shall retain final decision-making authority with respect to all matters pertaining to the Licensed Products inside the Prometheus Territory, including development, regulatory and commercialization strategy and changes to the Development Plan. For clarification purposes, the Parties agree that the Development Plan shall be modified as necessary from time to time to include all activities and deliverables by each of the Parties necessary to adequately meet the requirements for obtaining any necessary Regulatory Approvals in the Prometheus Territory, provided that Prometheus shall (i) keep the Committee reasonably informed with respect to Prometheus’ regulatory strategy related to the Licensed Products inside the Prometheus Territory and otherwise keep the Committee reasonably involved through good faith discussions with respect to such matter; activities, (ii) provide Rosetta with copies of any relevant written or otherwise material correspondence received by Prometheus from and to be provided by Prometheus to, Regulatory Authorities inside the Prometheus Territory concerning the Licensed Products, and (biii) for any matter that is a Critical Issueconsider in good faith all reasonable suggestions and comments provided by the Committee with respect to Prometheus’ correspondence and other communications with Regulatory Authorities inside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the matter shall be referred Committee reasonable advance opportunity to FivePrime’s Chief Executive Officer (or designee) comment on initial submissions by Prometheus and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve subsequent amendments by Prometheus with respect to the matter within *** Business Days, then Regulatory Approvals inside the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matterPrometheus Territory. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime order to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except ensure timely progress with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Regulatory Approvals, AS AMENDED. already incurred by FivePrime prior Rosetta’ members of the Committee shall provide any suggestions and comments with respect to such discontinuation the subject matter of subsections 3.1.4(a)(iii) and any (iv) within fifteen (15) business days after receipt of the relevant correspondence, communication, initial submission or amendment, failing which Prometheus shall be relieved of its obligations thereunder to consider Rosetta’s suggestions and all standard close out costs incurred thereafter, and HGS shall have the right comments solely with respect to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreementitem.

Appears in 1 contract

Samples: License Agreement (Rosetta Genomics Ltd.)

Decision Making. The JDC shall make All decisions unanimouslywithin the JSC will be made by consensus, with each Party’s representatives collectively having one (1) vote vote. If the JSC is unable to reach consensus on a matter for which it has decision making authority within [***] after such matter is referred to the JSC for decision, then either Party may elect by written notice to refer such matter to the Chief Executive Officers of both Parties for resolution, and at least one (1) representative from each Party participating in the Chief Executive Officers of both Parties will use good faith efforts to resolve such decisiondispute within [***]. In If the event the JDC determines that it Chief Executive Officers of both Parties cannot reach an agreement regarding a decision within resolution with respect to such dispute, then (i) Disc will have final decision-making authority for all issues that relate to the JDC’s authorityLicensed Territory, then, within *** Business Days after such determination: (a) for except that Disc shall not make any matter that is not a Critical Issue *** shall have the final decision making authority on such matterthat would have a substantial likelihood of materially adversely affecting the Development or Commercialization of any Licensed Antibody or any Licensed Product in the Mabwell Territory; and (bii) Mabwell will have final decision-making authority for all issues that relate to the Mabwell Territory, except that Mabwell shall not make any matter final decision that is would have a Critical Issue, substantial likelihood of materially adversely affecting the matter shall be referred to FivePrime’s Chief Executive Officer (Development or designee) and HGS’ Chief Executive Officer (Commercialization of any Licensed Antibody or designee) for resolutionany Licensed Product in the Licensed Territory. If a Party reasonably believes in good faith that an action or inaction of the other Party would have a substantial likelihood of materially adversely affecting the Development or Commercialization of any Licensed Antibody or any Licensed Product in its respective Territory, such executives cannot resolve Party shall provide the matter within *** Business Days, then JSC with reasonably sufficient details to further assess the Chief Executive Officer of *** (circumstances and evaluate whether such material adverse effect exists or designee) shall have the final decision making authority on such matterwould exist. Notwithstanding Without limitation to the foregoing, the Development Plan shall not be amendedParties hereby agree that matters explicitly reserved to the consent, without FivePrime’s prior written approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with this Agreement (which approval may only be withheld amended or modified as provided in FivePrime’s sole discretionSection 13.8), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall Neither Party will have the right to continue such trial by itself at use its expense. When *** make a final determination decision-making authority to materially increase the other Party’s obligations under this Section 3.4Agreement or to a Third Party (including performance obligations of such other Party, that final determination must the costs and expenses to be consistent with the terms borne by such other Party, or payment or other obligations of this Agreementsuch other Party).

Appears in 1 contract

Samples: Exclusive License Agreement (Disc Medicine, Inc.)

Decision Making. The JDC JSC shall make strive to seek consensus in its actions and decision making process and all decisions unanimouslyby the JSC shall be made by consensus, with each Party’s representatives Party having collectively having one (1) vote in all decisions. If after reasonable discussion and at least one (1) representative from good faith consideration of each Party participating in such decision. In Party’s view on a particular matter before the event JSC, the JDC determines that it representatives of the Parties cannot reach an agreement regarding a decision as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within the JDC’s authority, then, within *** ten (10) Business Days after such determination: (a) matter was brought to the JSC for any resolution or after such matter that is not a Critical Issue *** has been referred to the JSC, then, Advaccine’s Executive Officer shall have the final decision making authority on with respect to such mattermatter within the JSC’s authority; and (b) for any matter provided, however, that is a Critical Issue, the matter shall be referred to FivePrimeInovio’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior such matter within the JSC’s authority that relates to such discontinuation the Global Phase 3 Study (including any amendment to the Global Phase 3 Study Plan) and any and all standard close out costs incurred thereafter, and HGS Inovio’s Executive Officer shall have the right in their sole discretion to continue such trial veto any decision by itself at its expense. When *** make a final determination under this Section 3.4Advaccine reasonably likely to result in Adverse Risk on the Inovio Technology, or the safety or efficacy of the Product, or the Development or Commercialization of the Product in the Inovio Territory, including any other global Clinical Trial of Product or Regulatory Approval of any Product in the Inovio Territory, and provided, further, that final determination must be consistent with (i) any decision to Develop, Manufacture or Commercialize the Product as a Combination Product in the Advaccine Territory will require the mutual agreement of the Parties, and (ii) Advaccine shall not have the right, by virtue of its decision-making authority, to cause Inovio to violate the terms of this Agreementany agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party, and Advaccine’s exercise of its decision-making authority shall be subject to the limitations set forth in Section 3.3; provided, that Inovio shall provide Advaccine with an explanation as to why any such decision of Advaccine would cause Inovio to violate the terms of any agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party. For clarity, the JSC shall be a forum for discussing, but shall not have any decision-making authority with respect to, Inovio’s Development of the Product in the Inovio Territory, and Inovio shall have full control and authority over the Development, Commercialization of the Product in the Inovio Territory.

Appears in 1 contract

Samples: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)

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Decision Making. The JDC shall Each Committee may make decisions unanimouslywith respect to any subject matter that is subject to its decision-making authority and functions as set forth in this Section 3.1. All decisions of the Committee shall be made by unanimous vote or written consent, with Licensee and VBL each Party’s representatives collectively having having, collectively, among its respective members, one (1) vote and at least one (1) representative from each Party participating in such decisionall decisions. In If any Committee other than the event the JDC determines that it JMC cannot reach an unanimous agreement regarding a decision within the JDC’s authorityon any issue, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter issue shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) the JMC for resolution. If such executives The JMC shall use good faith efforts to resolve the matters within its roles and functions or otherwise referred to it. Except as set forth in Section 6.2 with respect to the determination of Sales Targets in the Initial Commercialization Plan, if the JMC cannot resolve the matter within *** Business Daysreach consensus on a given matter, then the Chief Executive Officer of *** (or designee) shall have the final decision decision-making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), toallocated: (i) increase to Licensee to the extent the disagreement relates to development activities directed toward Development in the Territory or materially Commercialization Activities within the Territory (unless (x) a change in the nature Development Plan proposed by Licensee does not involve an investigator-initiated trial or a trial required or suggested by a Regulatory Authority and (y) VBL can show with reasonable evidence that such change proposed by Licensee is reasonably likely to have a material and adverse effect on Development and Commercialization of FivePrimethe Product outside the Territory, in which case VBL shall have final decision-Conducted Trials or Other FivePrime-Conducted Activitiesmaking authority); or and (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except VBL with respect to costs any matter other than the foregoing. If Licensee proposes a change in development activities directed toward the Territory that does not involve an investigator-initiated trial or a trial required or suggested by a Regulatory Authority, and VBL believes that such change is reasonably likely to materially and adversely affect Development and Commercialization of the Product outside the Territory, Licensee shall not implement such changes unless and until it is determined, in accordance with the provisions of Article 15, that such changes are not reasonably likely to materially and adversely affect Development and Commercialization of the Product outside the Territory. For the avoidance of doubt, no Committee shall have the power to alter the timelines included in the Development Plan or the Sales Targets included in the Initial Commercialization Plan, or to amend this Agreement, without the consent of both Parties. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED*]”. ALL SUCH OMITTED MATERIAL WAS ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 406 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1933, AS 1934,AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.

Appears in 1 contract

Samples: Certain Confidential (Vascular Biogenics Ltd.)

Decision Making. Regardless of the number of Pfizer JSC Members or Exact JSC Members, decisions by the JSC will be made by unanimous agreement. The JDC shall make decisions unanimouslyJSC will use good faith efforts to reach agreement on any and all matters properly brought before it. If, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in despite such decision. In good faith efforts, the event the JDC determines that it cannot JSC is unable to reach an agreement regarding a decision on a particular matter within the JDCJSC’s authorityresponsibilities (each such matter, thena “Disputed JSC Matter”), within *** five (5) Business Days after the JSC first meets to consider such matter, or such later date as may be mutually agreed by the Parties in writing, then either Party may refer such Disputed JSC Matter for resolution to the Alliance Managers. Within three (3) Business Days after such determination: Disputed JSC Matter is referred to the Alliance Managers, the Alliance Managers shall determine whether the Disputed JSC Matter requires the involvement of the Senior Officers. Should the Alliance Managers refer the Disputed JSC Matter to the Senior Officers, then the Senior Officers will promptly initiate good faith discussions to resolve such Disputed JSC Matter. If the Senior Officers are unable to resolve such Disputed JSC Matter within five (a5) for Business Days of it being referred to them, then, Exact, after having considered, in good faith, the advice and input from Pfizer, will have final decision-making authority with respect to such Disputed JSC Matter where the subject matter of the Disputed JSC Matter substantially relates to (i) Product pricing, including any matter rebates or discounts; (ii) Product Promotion, including the use of any Promotional Materials; (iii) manufacturing; (iv) research and development, including any trials; and (v) engagement with Governmental Authorities; provided, however, that is Exact will not a Critical Issue *** shall have the final decision making authority to require Pfizer to conduct any activities that Pfizer, in good faith, believes violate Applicable Law or Pfizer’s Applicable Compliance/Review Policies. For all Disputed JSC Matters that are not resolved by the Senior Officers and are not subject to Exact’s final decision-making authority, neither Party will take any action on such matter; and (b) for any matter that is a Critical Issue, the matter shall Disputed JSC Matter until resolution can be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld reached in FivePrime’s sole discretionaccordance with this Section 2.1(e), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrimeand, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, except in the event FivePrime so decides case of a potential violation of Applicable Law, pending such resolution the Parties shall continue to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close carry out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination activities under this Section 3.4, that final determination must be consistent Agreement in accordance with the terms of this Agreementthen-current Annual Marketing Plan.

Appears in 1 contract

Samples: Promotion Agreement (Exact Sciences Corp)

Decision Making. The JDC shall make All decisions unanimouslyof the JCC require unanimous agreement of the Parties, with each Party’s representatives collectively Party having one (1) vote and at least one (1) representative from each Party participating on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in such decisiongood faith to reach consensus on all matters before the JCC. In the event that the JDC determines that it JCC cannot not, after such good-faith efforts, reach an agreement regarding on a decision matter within the JDC’s authorityjurisdiction of the JCC, thenincluding any adoption, amendment or update to a Co-Promotion Plan within […*** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue…], the matter issue shall be referred elevated to FivePrime’s Chief a Executive Officer of each of Ambit and Astellas, to seek in good faith to reach agreement on the issue. Solely in the case of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included in the Co-Promotion Plan budget (or designeeany proposed amendment or update thereto) and HGS’ Chief (in each case, a “Proposed Expense Dispute”), the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to the Executive Officer (or designee) for resolutionOfficers. If In the event such executives cannot resolve the matter issue after good-faith efforts within […*** Business Days*…], then (a) if the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoingdispute is a Proposed Expense Dispute, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS either Party shall have the right to continue cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit E, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject to Astellas’s obligation to use Commercially Reasonable Efforts as set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such trial decision, which decision shall be final and binding on the Parties. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by itself at expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its expenseproposed Co-Promotion Plan budget, but the Direct Marketing/Promotion Expenses and Indirect Marketing Expenses incurred by Astellas during the Calendar Year covered by the disputed budget shall only be included in the calculation of the Annual U.S. Profit/Loss up to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.*Confidential Treatment Requested CONFIDENTIAL

Appears in 1 contract

Samples: Commercialization Agreement (Ambit Biosciences Corp)

Decision Making. The JDC JSC shall make strive to seek consensus in its actions and decision making process and all decisions unanimouslyby the JSC shall be made by consensus, with each Party’s representatives Party having collectively having one (1) vote in all decisions. If after reasonable discussion and at least one (1) representative from good faith consideration of each Party participating in such decision. In Party’s view on a particular matter before the event JSC, the JDC determines that it representatives of the Parties cannot reach an agreement regarding a decision as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within the JDC’s authority, then, within *** ten (10) Business Days after such determination: (a) matter was brought to the JSC for any resolution or after such matter that is not a Critical Issue has been referred to the JSC, then, Advaccine’s Executive Officer CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*** *], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933such matter within the JSC’s authority; provided, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafterhowever, and HGS that Inovio’s Executive Officer shall have the right in their sole discretion to continue such trial veto any decision by itself at its expense. When *** make a final determination under this Section 3.4Advaccine reasonably likely to result in Adverse Risk on the Inovio Technology, or the safety or efficacy of the Product, or the Development or Commercialization of the Product in the Inovio Territory, including any global Clinical Trial of Product or Regulatory Approval of any Product in the Inovio Territory, and provided, further, that final determination must be consistent with (i) any decision to Develop, Manufacture or Commercialize the Product as a Combination Product in the Advaccine Territory will require the mutual agreement of the Parties, and (ii) Advaccine shall not have the right, by virtue of its decision-making authority, to cause Inovio to violate the terms of this Agreementany agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party, and Advaccine’s exercise of its decision-making authority shall be subject to the limitations set forth in Section 3.3; provided, that Inovio shall provide Advaccine with an explanation as to why any such decision of Advaccine would cause Inovio to violate the terms of any agreement with a Third Party, or cause Inovio to violate any applicable Laws, ethical requirement, or intellectual property right of any Third Party. For clarity, the JSC shall be a forum for discussing, but shall not have any decision-making authority with respect to, Inovio’s Development of the Product in the Inovio Territory, and Inovio shall have full control and authority over the Development, Commercialization of the Product in the Inovio Territory.

Appears in 1 contract

Samples: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)

Decision Making. The JDC Decisions of the Joint Steering Committee shall make decisions unanimouslybe made by unanimous vote, with each Party’s representatives collectively Party having one (1) vote and with at least one (1) representative from each Party participating in such decisionany vote. In the event that the JDC determines that it cannot Joint Steering Committee fails to reach unanimous agreement with respect to a particular matter within its authority within thirty (30) days of the date such matter was first presented to the Joint Steering Committee, then either Party may, by written notice to the other Party (an agreement regarding a decision within “Escalation Notice”), have such matter referred to the JDC’s authority, then, within *** Business Days after such determinationsenior management (the “Senior Executives”) of VALEANT and GSK as follows for resolution: (ai) to the chief executive officer of VALEANT or his/her designee and the Chairman of Research and Development at GSK or his/her designee for issues involving the development of Product (and, as applicable, Additional Product), patent issues relating to the Product (and, as applicable, Additional Product), and/or any matter that is not a Critical Issue *** shall have issues pertaining to Regulatory Approvals and XXXx for the final decision making authority on such matterProduct (and, as applicable, Additional Products) in the Territory (including, without limitation, matters relating to the preparation and filing of any MAA in the Territory); and (bii) to the chief executive officer of VALEANT or his/her designee and the president of pharmaceuticals for any matter that is a Critical Issue, North America at GSK or his/her designee for all issues other than those relating to development of or matters pertaining to Regulatory Approvals for the matter Product. The Parties’ respective Senior Executives shall be referred meet promptly and negotiate in good faith to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, if following the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change Review Period the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime Joint Steering Committee fails to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except reach unanimous agreement with respect to costs *** INDICATES MATERIAL THAT WAS a matter involving the selling, marketing, promotion and/or commercialization of Product in the United States and GSK reasonably believes that it is in the best interests of the Product that such matters be resolved expeditiously, GSK, through the Senior Vice President having direct responsibility over the commercialization of Product in the United States, shall consult with the Chief Executive PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND PURSUANT TO A REQUEST FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER (THE SECURITIES ACT OF 1933, AS AMENDED"COMMISSION"). already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS ("*** make a *"), AND THE OMITTED TEXT HAS BEEN FILED SEPARATELY WITH THE COMMISSION. Officer of VALEANT to promptly resolve such matter, provided, however, if such matter is not resolved by the Senior Executives in three (3) business days, the final determination under this Section 3.4, that final determination must with respect to the matter shall be consistent with made by the terms Senior Vice President having direct responsibility over the commercialization of this AgreementProduct in the United States.

Appears in 1 contract

Samples: License and Collaboration Agreement (Valeant Pharmaceuticals International)

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