Common use of Decision Making Clause in Contracts

Decision Making. All decisions of the JCC require unanimous agreement of the Parties, with each Party having one (1) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to 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 any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, 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)

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Decision Making. All The JDC shall make decisions of the JCC require unanimous agreement of the Partiesunanimously, with each Party Party’s representatives collectively having one (1) vote on all matters presented to the JCC for resolution or and at least one (1) representative from each Party participating in such decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JCC cannotJDC’s authority, then, within *** Business Days after such good-faith efforts, reach agreement on determination: (a) for any matter that is not a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […Critical Issue ***…]* shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the issue matter shall be elevated referred to a FivePrime’s Chief 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 any proposed amendment designee) and HGS’ Chief Executive Officer (or update theretodesignee) (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 Officersfor resolution. In the event If such executives cannot resolve the issue after good-faith efforts matter within […***…]* Business Days, then the Chief Executive Officer of *** (aor 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 dispute is a Proposed Expense Disputeevent FivePrime so decides to discontinue such trial, either Party 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 cause the Dispute to be resolved continue such trial by expedited arbitration pursuant to Exhibit E, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in itself at 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 issueexpense. Astellas shall provide Ambit with a Decision Notice with respect to such 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 ***Confidential Treatment Requested CONFIDENTIAL 4. FEES* make a final determination under this Section 3.4, MILESTONES, ROYALTIES AND PROFIT SHAREthat 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)

Decision Making. All The JSC shall strive to seek consensus in its actions and decision making process and all decisions by the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the JCC Parties cannot reach 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 or after such matter 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 with respect to such matter within the JSC’s authority; provided, however, that Inovio’s Executive Officer shall have the right in their sole discretion to veto any decision by Advaccine 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 (i) any decision to Develop, Manufacture or Commercialize the Product as a Combination Product in the Advaccine Territory will require unanimous 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 any agreement with each Party having one (1) vote on all matters presented 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 JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to 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 any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 limitations set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit with respect to the issue. Astellas 3.3; provided, that Inovio shall provide Ambit Advaccine with an explanation as to why any such decision of Advaccine would cause Inovio to violate the terms of any agreement with a Decision Notice with respect Third Party, or cause Inovio to such decisionviolate any applicable Laws, which decision shall be final and binding on the Partiesethical requirement, or intellectual property right of any Third Party. For clarity, in the event of JSC shall be a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas mayforum for discussing, but shall not be required have any decision-making authority with respect to, perform Inovio’s Development of the activities contemplated in its proposed 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 Product in the calculation Inovio Territory, and Inovio shall have full control and authority over the Development, Commercialization of the Annual U.S. Profit/Loss up to Product in the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREInovio Territory.

Appears in 1 contract

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

Decision Making. All Except as set forth in this Section 2.3.4, decisions of the JCC require unanimous agreement and lower level committees shall be made by consensus of the Parties, with all members present; provided that at least one representative of each Party having one (1) vote on all matters presented to the JCC for resolution or decisionis present and so approves. The Non-attending members of the JCC will attempt may represent themselves by proxies in good faith to reach consensus on all matters before the JCCany decision. In the event that the JCC cannot, after such good-faith efforts, not reach agreement on a consensus any matter within the jurisdiction authority of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], then the issue resolution and/or course of conduct shall be elevated determined by Array, in its sole discretion, provided that: (i) if the JCC cannot reach consensus regarding a material modification of the Commercialization Plan and Budget, such matter shall first be referred to a Executive Officer of each of Ambit and Astellasthe Senior Officers, to seek who shall attempt in good faith to reach agreement on the issue. Solely resolve such disagreement within thirty (30) days of such matter being referred to them (and if such matter is not resolved within such 30-day period, Array may then exercise its deciding vote with respect to such matter); (ii) in the case of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included exercising such deciding vote, Array will consider Oncothyreon’s position in the Cogood faith; and (iii) in no event shall Array in exercising such final decision-Promotion Plan budget (or any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall making authority have the right to cause (A) unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement, (B) excuse Array from any of its obligations specifically enumerated under this Agreement, or (C) reduce the Dispute to be resolved by expedited arbitration pursuant to Exhibit Erights of Oncothyreon specifically enumerated under this Agreement. For the avoidance of doubt, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject to AstellasSection 10.2.3, Array’s obligation use of its final decision-making authority (i) to use Commercially Reasonable Efforts as set forth in Section 3.6.1 and taking into account increase the legitimate business issues of Ambit with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such decision, which decision shall be final and binding on the Parties. For clarity, budget in the event Commercialization Plan and Budget, or (ii) to establish a Commercialization Plan and Budget containing activities related to Commercialization of a dispute concerning the Product in the United States (which activities the Parties acknowledge will in part be conducted by Oncothyreon if Oncothyreon elects to Co-Promotion Plan budget which is resolved by expedited arbitrationPromote the Product in the United States), Astellas may, but shall not be required to, perform the construed to “unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement” as described in its proposed 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 clause (A) 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREpreceding sentence.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Oncothyreon Inc.)

Decision Making. All decisions Regardless of the JCC require number of Pfizer JSC Members or Exact JSC Members, decisions by the JSC will be made by unanimous agreement of the Parties, with each Party having one (1) vote on all matters presented to the JCC for resolution or decisionagreement. The members of the JCC JSC will attempt in use good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to a Executive Officer of each of Ambit and Astellas, to seek in good faith efforts to reach agreement on any and all matters properly brought before it. If, despite such good faith efforts, the issueJSC is unable to reach a decision on a particular matter within the JSC’s responsibilities (each such matter, a “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. Solely Within three (3) Business Days after such 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 (5) 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 rebates or discounts; (ii) manufacturing; (iii) research and development, including any trials; and (iv) engagement with Governmental Authorities; provided, however, that Exact will not have 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 Disputed JSC Matter until resolution can be reached in accordance with this Section 2.1(e), and, except 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 any proposed amendment or update thereto) (in each casepotential violation of Applicable Law, a “Proposed Expense Dispute”), pending such resolution the Parties shall exchange written proposals regarding continue to carry out activities under this Agreement in accordance with the portion of the budget in dispute in advance of elevating such dispute to the Executive Officers. In the event such executives cannot resolve the issue after goodthen-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed Co-Promotion Plan budget, but the Direct Marketing/Promotion Expenses and Indirect current Annual 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREPlan.

Appears in 1 contract

Samples: Promotion Agreement (Exact Sciences Corp)

Decision Making. All decisions Each of CEGEDIM's and GRAND CARD's representatives on a Steering Committee shall, collectively, have one vote (the JCC require unanimous agreement of the Parties, with each Party having one (1Vote”) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters brought before the JCCSteering Committee, which Party Vote shall be determined by majority vote of such representatives present at any meeting. Each Steering Committee meeting shall operate as to matters within its jurisdiction by unanimous vote. If the Steering Committee fails to achieve a unanimous vote with respect to any matter, CEGEDIM and GRAND CARD shall use their commercially reasonable best efforts to resolve such dispute as rapidly as possible on a fair and equitable basis. In the event that CEGEDIM and GRAND CARD fail to resolve such dispute (the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to 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 any proposed amendment or update thereto) (in each case, a Proposed Expense Dispute”), ) within ten (10) business days after the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute Steering Committee failed to the Executive Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is achieve a Proposed Expense Dispute, either Party shall have the right to 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 unanimous vote with respect to the issueapplicable matter, then the Parties agree to resolve the Dispute through mediation as hereinafter provided in this Subsection 5.3.3(B). Astellas If the Parties cannot agree on a person to act as mediator within five (5) days after the end of such ten (10) business day period, then each Party shall provide Ambit with select an independent person within such five (5) day period and such two (2) independent persons shall, within five (5) days after their selection, agree on a Decision Notice third independent person who shall serve as the sole mediator with respect to the Dispute. If either Party fails to select its independent person within the relevant five (5) day period, then such decisionParty shall be deemed to have waived its right to participate in the selection of the mediator and the independent person selected by the other Party shall be the sole mediator with respect to the Dispute. Each Party shall submit to the sole mediator a written presentation of such Party's position with respect to the Dispute within ten (10) days after selection of the sole mediator, and the Parties shall make their representatives on the Steering Committee available for such mediation sessions as the sole mediator may request. The sole mediator shall decide the Dispute within ten (10) days after the end of the ten (10) day period for submission of written presentations, which decision shall be final and binding on the Parties. For clarityNotwithstanding the foregoing, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 with regard to the amount of the Arbitrator-Determined Marketing Budget any Intellectual Property (as defined in Exhibit E)Section 8) matters, all of the foregoing time periods will be reasonably shortened or expedited if necessary to meet any official deadlines from the U.S. Patent and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHARETrademark Office or any foreign patent offices.

Appears in 1 contract

Samples: Alliance Agreement (GRANDPARENTS.COM, Inc.)

Decision Making. All decisions Decisions of the JCC require Joint Steering Committee shall be made by unanimous agreement of the Partiesvote, with each Party having (1) vote and with at least one (1) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt representative from each Party participating in good faith to reach consensus on all matters before the JCCany vote. In the event that the JCC cannot, after such good-faith efforts, Joint Steering Committee fails to reach unanimous agreement on with respect to a particular matter within the jurisdiction its authority within thirty (30) days of the JCCdate such matter was first presented to the Joint Steering Committee, including then either Party may, by written notice to the other Party (an “Escalation Notice”), have such matter referred to the senior management (the “Senior Executives”) of VALEANT and GSK as follows for resolution: (i) 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 adoptionissues pertaining to Regulatory Approvals and XXXx for the Product (and, amendment as applicable, Additional Products) in the Territory (including, without limitation, matters relating to the preparation and filing of any MAA in the Territory); and (ii) to the chief executive officer of VALEANT or update his/her designee and the president of pharmaceuticals for North America at GSK or his/her designee for all issues other than those relating to a Co-Promotion Plan within […***…], development of or matters pertaining to Regulatory Approvals for the issue Product. The Parties’ respective Senior Executives shall be elevated to a Executive Officer of each of Ambit meet promptly and Astellas, to seek negotiate in good faith to resolve such matter. Notwithstanding the foregoing, if following the Review Period the Joint Steering Committee fails to reach unanimous agreement on with respect to a matter involving the issue. Solely selling, marketing, promotion and/or commercialization of Product in the case of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included United States and GSK reasonably believes that it is in the Co-Promotion Plan budget (or any proposed amendment or update thereto) (in each case, a “Proposed Expense Dispute”), the Parties shall exchange written proposals regarding the portion best interests of the budget Product that such matters be resolved expeditiously, GSK, through the Senior Vice President having direct responsibility over the commercialization of Product in dispute in advance of elevating such dispute to the United States, shall consult with the Chief Executive OfficersPORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION (THE "COMMISSION"). In the event such executives cannot resolve the issue after good-faith efforts within […THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS ("***…]"), then (a) AND THE OMITTED TEXT HAS BEEN FILED SEPARATELY WITH THE COMMISSION. Officer of VALEANT to promptly resolve such matter, provided, however, if the dispute such matter is a Proposed Expense Dispute, either Party shall have the right to cause the Dispute to be not resolved by expedited arbitration pursuant to Exhibit Ethe Senior Executives in three (3) business days, 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 final determination with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such decision, which decision matter shall be final and binding on made by the Parties. For clarity, Senior Vice President having direct responsibility over the commercialization of Product in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREUnited States.

Appears in 1 contract

Samples: License and Collaboration Agreement (Valeant Pharmaceuticals International)

Decision Making. All decisions of the JCC require JSC shall be made by unanimous agreement of the Partiesvote, with each Party Party’s representatives collectively having one (1) vote vote. If after reasonable discussion and good faith consideration of each Party’s view on all matters presented a particular matter before the JSC, the JSC cannot reach a unanimous decision as to such matter within [* * *] days after such matter was brought to the JCC JSC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannotresolution, after then such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated referred to a the Chief 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 Verastem (or any proposed amendment or update theretoan 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 (in each case, a “Proposed Expense Dispute”)collectively, the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to “Executive Officers”) for resolution. If the Executive Officers. In the event such executives Officers cannot resolve the issue after good-faith efforts such matter within [* * *] Business Days after such matter has been referred to them, then [* * **…], then provided that Licensee shall not make any decision or take any action that (ai) if could reasonably be expected to adversely impact the dispute is a Proposed Expense DisputeLicensed Product outside of the Territory, either Party shall have including the right Licensed Product brand as established under the Global Strategy, (ii) requires Verastem to cause the Dispute perform or refrain from performing any activity except as expressly required under this Agreement, or (iii) requires Verastem to be resolved by expedited arbitration pursuant to Exhibit E, and (b) if the dispute concerns provide any other issue the issue shall be decided by Astellasresources or bear any costs except as expressly required under this Agreement, in its reasonable discretion but subject 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 Astellas’s obligation to use Commercially Reasonable Efforts as set forth the Exploitation of Licensed Products in Section 3.6.1 and taking into account the legitimate business issues of Ambit Territory, including with respect to the issue. Astellas shall provide Ambit applicable regulatory strategies, all activities associated with a Decision Notice seeking and maintaining Regulatory Approvals, all communications with respect to such decision, which decision shall be final and binding on Regulatory Authorities regarding the Parties. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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)Licensed Compounds or Licensed Products, and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREall Regulatory Documents.

Appears in 1 contract

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

Decision Making. All decisions of Actions to be taken by the JCC require JRC will be taken only following unanimous agreement of the Partiesvote, with each Party having one (1) vote on all matters presented to representing the JCC for resolution or decisionviews of its members. The members of If the JCC will attempt in good faith JRC fails to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach unanimous agreement on a matter within the jurisdiction before it for decision for a period in excess of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…]**, either Party may submit the issue shall be elevated matter in writing to a Executive Officer of each of Ambit the other, 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 any proposed amendment or update thereto) (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 will refer such dispute to the designated executive officer of Licensor and the designated executive officer of Licensee (or their respective designees) (the “Executive Officers”) for resolution in accordance with the decision-making procedures described in Section 14.2; provided, however, that the following disputes will not be submitted for resolution pursuant to Section 14.2 and instead will be decided as follows: for any dispute regarding an increase in operational responsibility of a Party greater than the operational responsibilities of such Party as previously agreed to by the Parties, the JRC members for the Party whose operational THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. In the event such executives cannot resolve the issue after good-faith efforts within […ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “***…]**”. responsibility would be increased will make the final decision; provided, then (a) if further, the dispute is foregoing proviso does not apply to the establishment of a Proposed Expense DisputeCollaboration Research Plan. Each Party retains the rights, either Party shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit Epowers, and (b) if the dispute concerns discretion granted to it under this Agreement and neither Party will delegate to or vest in any other issue the issue shall be decided by Astellassuch rights, in its reasonable powers, or 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 decision, which decision shall be final and binding on the Parties. For clarity, in the event JRC, unless such delegation or vesting of a dispute concerning rights is expressly provided for in this Agreement or the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated Parties expressly so agree in its proposed 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREwriting.

Appears in 1 contract

Samples: Option and License Agreement (Exicure, Inc.)

Decision Making. All decisions of With respect to each Patent-Related Matter, the JCC require unanimous agreement of the PartiesPatent Coordinators, in consultation with each Party having one patent counsel (1) vote on all matters presented provided that such consultation shall not be required with respect to the JCC for resolution or decision. The members of the JCC will attempt any Patent Coordinator who is a patent counsel), shall use diligent efforts in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after determine or resolve such goodPatent-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […Related Matter at least ***…]***** days, or such different number of days as the Patent Coordinators shall expressly agree in writing, before any action with respect to such Patent-Related Matter must be taken to be effective under applicable patent laws, regulations or administrative process in the applicable country or jurisdiction (such deadline for determination or resolution, the issue shall “Patent-Related Matter Resolution Deadline”); provided that, with respect to each Patent-Related Matter and unless the Parties otherwise agree, if such Patent-Related Matter has not been resolved pursuant to this Section 7.5 by the date any action with respect to such Patent-Related Matter must be elevated taken to a Executive Officer of each of Ambit and Astellasbe effective under applicable patent laws, regulations or administrative process in the applicable country or jurisdiction (such date, the “Patent-Related Matter Deadline”), AstraZeneca shall, to the extent permitted under applicable patent laws, regulations or administrative process in the applicable country or jurisdiction, (a) seek an extension of such Patent-Related Matter Deadline sufficient to resolve such Patent-Related Matter by the applicable Patent-Related Matter Deadline as so extended and (b) file, if the extension contemplated by clause (a) above is not permitted under applicable patent laws, regulations or administrative process in the applicable country or jurisdiction, a continuation or divisional patent application in such country or jurisdiction designed in good faith to reach agreement on preserve the issuestatus quo and to maintain full rights of further prosecution, in each case to the maximum extent possible under the circumstances. Solely in “Patent-Related Matter” means each of the case following matters: (i) whether any new or useful process, composition of a dispute regarding the Direct Marketing/Promotion Expenses matter, formulation, design, device, kit or the Indirect Marketing Expenses proposed method of use or manufacture is reasonably expected to be included in the Co-Promotion Plan budget patentable under Applicable Laws; (or ii) inventorship of Program Inventions and, as a result, whether any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute particular Program Invention is a Proposed Expense DisputeTargacept Program Invention, either Party shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit E, and AstraZeneca Program Invention or Joint Program Invention; (biii) if the dispute concerns whether 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 Program Invention is a Product Invention; (iv) whether any action or decision with respect to the issue. Astellas shall provide Ambit with Prosecution and Maintenance of any Consensus Patent Rights, including any action contemplated by clause (v) below, would be contrary to the best interests of the Development and Commercialization of the Lead Compound or Licensed Products that are comprised of or contain the Lead Compound on a Decision Notice global basis; and (v) with respect to such decisionPatent Rights that claim or cover any Program Invention, which decision shall be final whether it is reasonably practicable to separate into discrete applications (i) claims that solely claim the composition of matter, a method of use or Manufacture of or a pharmaceutical preparation containing or comprising (including the pharmaceutical composition of), or solely cover the research, development, Manufacture, use, import, offer to sell or sale of, any Compound or Licensed Product and binding on the Parties. For clarity, (ii) claims other than as specified in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 foregoing clause (i) (each of the Annual U.S. Profit/Loss up to the amount of the ArbitratorPatent-Determined Marketing Budget Related Matters in clauses (as defined in Exhibit Eiv) and (v), and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREa “Consensus Patent-Related Matter”).

Appears in 1 contract

Samples: Assignment and Assumption Agreement (Targacept Inc)

Decision Making. All Each Committee shall strive to seek consensus in its actions and decision-making process, and all decisions of by the JCC require Committees shall be made by unanimous agreement of the Partiesagreement, with each Party Party’s representatives having collectively one (1) vote in all decisions. If the Parties’ representatives on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in a Subcommittee, after reasonable discussion and good faith to reach consensus on all matters before the JCC. In the event that the JCC consideration of each Party’s opinions, cannot, after such good-faith efforts, not reach agreement on a matter within the jurisdiction of the JCCSubcommittee’s responsibilities after endeavoring to do so for seven (7) days, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue then such disagreement shall be elevated referred to a Executive Officer the JSC for resolution. If the Parties’ representatives on the JSC, after reasonable discussion and good faith consideration of each of Ambit and AstellasParty’s opinions, to seek in good faith to cannot reach agreement on a matter within the issue. Solely in JSC’s responsibilities or on any matter that is referred to the case of JSC by a dispute regarding Subcommittee within fifteen (15) days after the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed JSC has met and attempted to be included in the Co-Promotion Plan budget agree on such matter (or any proposed amendment or update thereto) (such other period as the Parties may agree upon in each case, a “Proposed Expense Dispute”writing), the Parties then such disagreement shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute be referred to the Executive OfficersOfficers for resolution. In Any final decision that the event such executives Executive Officers mutually agree to in writing shall be conclusive and binding on the Parties. If the Executive Officers cannot resolve reach agreement on a matter within thirty (30) days after such matter has been referred to them by the issue after good-faith efforts within […***…]JSC (or such other period as the Executive Officers may agree upon in writing), then (a) if the dispute is a Proposed Expense Dispute, either Party SymBio shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit Etie-breaking vote, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject to Astellasdecision of SymBio’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 decision, which decision 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) Eagle shall have the tie-breaking vote, and the decision of Eagle’s Executive Officer shall be final and binding on the Parties, with respect to any matter that may have an adverse impact on (i) the global safety profile of the Licensed Product or (ii) the procurement or maintenance of any 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 mutual agreement of both Parties. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but SymBio shall not be required tohave the right to Develop, perform Manufacture or Commercialize any New Indication or New Formulation without the activities contemplated in its proposed 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 consent 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREEagle.

Appears in 1 contract

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

Decision Making. All decisions of the JCC require JSC shall be made by unanimous agreement of the Partiesvote, with each Party Party’s representatives collectively having one (1) vote vote. If after reasonable discussion and good faith consideration of each Party’s view on all matters presented a particular matter before the JSC, the JSC cannot reach a unanimous decision as to such matter within [* * *] days after such matter was brought to the JCC JSC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannotresolution, after then such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated referred to a the Chief 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 Verastem (or any proposed amendment or update theretoan 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 (in each case, a “Proposed Expense Dispute”)collectively, the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to “Executive Officers”) for resolution. If the Executive Officers. In the event such executives Officers cannot resolve the issue after good-faith efforts such matter within [* * *] days after such matter has been referred to them, then [* * **…], then provided that Licensee shall not make any decision or take any action that (ai) if could reasonably be expected to adversely impact the dispute is a Proposed Expense DisputeLicensed Product outside of the Territory, either Party shall have including the right Licensed Product brand as established under the Global Strategy, (ii) requires Verastem to cause the Dispute perform or refrain from reforming any activity except as expressly required under this Agreement, or (iii) requires Verastem to be resolved by expedited arbitration pursuant to Exhibit E, and (b) if the dispute concerns provide any other issue the issue shall be decided by Astellasresources or bear any costs except as expressly required under this Agreement, in its reasonable discretion but subject to Astellaseach case without first obtaining Verastem’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 decisionprior written consent, which decision shall consent may be final and binding on the Partieswithheld in Verastem’s sole discretion. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. Profit/Loss up to the amount of the Arbitrator-Determined Marketing Budget SECURITIES AND EXCHANGE COMMISSION (as defined in Exhibit E“SEC”), and such additional amounts shall be borne solely by Astellas. REDACTED MATERIAL IS MARKED WITH [* * ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES ] AND PROFIT SHAREHAS BEEN FILED SEPARATELY WITH THE SEC.

Appears in 1 contract

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

Decision Making. All decisions of the JCC require unanimous The PARTIES shall endeavor to reach agreement of the Parties, with each Party having one (1) vote by consensus on all matters presented to the JCC BOARD. Each CO-CHAIR may introduce matters for resolution or review and decision-making by the BOARD. The members Each PARTY, regardless of the JCC will attempt in good faith number of its representatives who attend a meeting, shall have one vote, which shall be cast by its CO-CHAIR. If the Parties are unable to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on within 10 (TEN) days following a matter within the jurisdiction meeting of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…]BOARD, the issue matter shall promptly (but not later than 10 (ten) days following the aforementioned 10 (ten) day period) be elevated presented by the CO-CHAIRS to a the Chief Executive Officer of IROKO (“CEO”), with a summary of the PARTIES’ respective positions, and the CEO shall then promptly and finally decide the matter (the “TIE-BREAKING VOTE”); provided, however, that the following matters shall not be presented to the CEO but shall instead require the unanimous consent of the BOARD: (i) other than the BUDGET for each of Ambit the first three (3) years of this AGREEMENT, approval of the BUDGET and Astellas(ii) any new, to seek incremental spend in good faith excess of US$200,000.00 (TWO HUNDRED THOUSAND UNITED STATES DOLLARS) above the previous year’s approved BUDGET. For the avoidance of doubt, (i) in the event the PARTIES are unable to reach agreement on the issue. Solely in BUDGET for the case first three (3) years of a dispute regarding this AGREEMENT, the Direct Marketing/Promotion Expenses or matter shall be presented to the Indirect Marketing Expenses proposed CEO to be included in cast the CoTIE-Promotion Plan budget BREAKING VOTE; (or ii) the TIE-BREAKING VOTE shall not apply to the MANUFACTURE, PACKING and/or supply of the PRODUCTS (all of which being the subject matter of the WORLDWIDE MANUFACTURING AND SUPPLY AGREEMENT); (iii) the TIE-BREAKING VOTE shall not apply to any proposed amendment or update thereto) regulatory (in each caseincluding without limiting the generality of the aforegoing, a “Proposed Expense Dispute”technical transfer), the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute issues or matters relevant to this AGREEMENT to the Executive Officers. In extent that the event such executives cannot resolve the issue after good-faith efforts within […***…], then implementation or giving effect thereto may (a) if result in a breach of the dispute is a Proposed Expense Dispute, either Party shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit E, and APPLICABLE LAWS; and/or (b) if adversely impact upon ASPEN and/or its AFFILIATES’ reputation and/or relationship with any AGENCY. (In the dispute concerns any other issue the issue shall be decided by Astellasgiven circumstances IROKO shall, in its reasonable discretion but subject own name, be entitled to Astellas’s obligation implement or give effect to use Commercially Reasonable Efforts as set forth in Section 3.6.1 its decision and/or determination and taking into account the legitimate business issues of Ambit with respect costs associated therewith shall be deemed to be REGULATORY COSTS); (iv) the TIE-BREAKING VOTE shall not apply to any decision or determination taken by IROKO which is influenced by any factor extraneous to the issue. Astellas shall provide Ambit with a Decision Notice with respect terms and conditions of this AGREEMENT in circumstances where the implementation or giving effect to such decisiona decision or determination may materially prejudice ASPEN and/or its AFFILIATES under this AGREEMENT. (By way of example, where IROKO takes a decision or makes a determination influenced by factors relevant to the MANUFACTURE, PACKAGING and/or COMMERCIALISATION of the PRODUCTS outside of the TERRITORY, in circumstances where such a decision and/or determination may prejudice ASPEN and/or its AFFILIATES); (v) the TIE-BREAKING VOTE shall not apply to or extend over any issues or matters relevant to new formulations (as defined in clause 23.4); and/or (vi) the TIE-BREAKING VOTE shall not apply to or extend over the COMMERCIALISATION of the PRODUCTS in that part of the TERRITORY which does not constitute the PRIORITY COUNTRIES. Notwithstanding the foregoing, if there shall have occurred a change of CONTROL of IROKO, the CEO shall no longer have a TIE-BREAKING VOTE. In that case, either PARTY shall be entitled to refer the matter for determination by an independent expert appointed by agreement of the PARTIES, or failing such agreement within 5 (FIVE) days after either PARTY has requested such referral, appointed by the then President (or his successor-in-title) or his designee of the American Arbitration Association (if Aspen requests the appointment) or by the then President (or his successor-in-title) or his designee of the South African Institute of Chartered Accountants (if Iroko requests the appointment). The expert shall have significant expertise as a businessperson in the international pharmaceutical industry, including in the AREA or AREAS that are the subject of the dispute/deadlock between the PARTIES. The expert shall act in his or her capacity as a business expert and not as on arbitrator and his or her decision shall be final and binding on the PartiesPARTIES. For clarityHe or she shall render his/her decision, in writing, including the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitrationrationale thereof, Astellas may, but shall not be required to, perform the activities contemplated in its proposed Co-Promotion Plan budget, but the Direct Marketingwithin 45 (FORTY FIVE) days following his/Promotion Expenses her appointment. The fees and Indirect Marketing Expenses incurred by Astellas during the Calendar Year covered by the disputed budget shall only be included in the calculation expenses of the Annual U.S. Profit/Loss up to the amount expert and of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts appointing authority shall be borne solely equally by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREthe PARTIES.

Appears in 1 contract

Samples: Safety Agreement (Iroko Pharmaceuticals Inc.)

Decision Making. All decisions of the JCC require Steering Committee shall be made by unanimous agreement consent and documented in writing in the approved minutes of the Parties, with each Party having one (1) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCCSteering Committee. In the event that the JCC cannot, after such good-faith efforts, Steering Committee is unable to reach agreement on a matter relating to the activities under the Collaboration within the jurisdiction responsibilities of the JCCSteering Committee (a “Deadlock”), including any adoptionthen either party may notify the other of the Deadlock in writing, amendment or update such notice to a Codescribe the subject of the Deadlock in reasonable detail. Subject to the limitations in the following Section 2.2.1.6., Bayer shall retain ultimate decision-Promotion Plan within making authority over the Deadlocked matter, such authority to be exercised by Bayer in good faith (taking into Initials Bayer : page 20 of 89 Initials Evogene : *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission. Hecate: 4/10/b00917 consideration concerns raised by Evogene’s representative and the goals of the Collaboration) and notified to Evogene within thirty (30) days after delivery of the applicable Deadlock notice, or within such reasonable longer period of up to an additional sixty (60) days notified by Bayer to Evogene within thirty days after delivery of the issue shall applicable Deadlock notice. If Bayer fails to notify Evogene how Bayer has elected to exercise its authority on the Deadlocked matter, then Evogene may take the decision over the Deadlocked matter, such decision to be elevated to a Executive Officer of each of Ambit and Astellas, to seek taken by Evogene in good faith (taking into consideration concerns raised by Bayer’s representative and the goals of the Collaboration) and Evogene shall notify Bayer within thirty (30) days after expiration of Bayer’s notification period set forth the previous sentence. If Evogene fails to reach agreement notify Bayer how it has elected to exercise its authority to decide 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 any proposed amendment or update thereto) (in each case, a “Proposed Expense Dispute”)Deadlocked matter, the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to the Executive Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to cause the Dispute to matter will be resolved by expedited arbitration pursuant according to Exhibit E, and Section 15 (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject Dispute Resolution). With respect to Astellas’s obligation to use Commercially Reasonable Efforts as set forth matters described in Section 3.6.1 and taking into account the legitimate business issues of Ambit 2.2.1.6, for which Bayer is not entitled to exercise ultimate decision-making authority with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to any Deadlock, such decision, which decision Deadlock 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 pursuant to the amount provisions of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHARESection 15.

Appears in 1 contract

Samples: Wheat Collaboration and License Agreement (Evogene Ltd.)

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Decision Making. All decisions of Actions to be taken by the JCC require JRC will be taken only following unanimous agreement of the Partiesvote, with each Party having one (1) vote on all matters presented to representing the JCC for resolution or decisionviews of its members. The members of If the JCC will attempt in good faith JRC fails to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach unanimous agreement on a matter within the jurisdiction before it for decision for a period in excess of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…]**, either Party may submit the issue shall be elevated matter in writing to a Executive Officer of each of Ambit the other, 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 any proposed amendment or update thereto) (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 will refer such dispute to the designated executive officer of Licensor and the designated executive officer of Licensee (or their respective designees) (the “Executive Officers”) for resolution in accordance with the decision-making procedures described in Section 14.2; provided, however, that the following disputes will not be submitted for resolution pursuant to Section 14.2 and instead will be decided as follows: for any dispute regarding an increase in operational responsibility of a Party greater than the operational responsibilities of such Party as previously agreed to by the Parties, the JRC members for the Party whose operational 29 THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. In the event such executives cannot resolve the issue after good-faith efforts within […ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “***…]**”. responsibility would be increased will make the final decision; provided, then (a) if further, the dispute is foregoing proviso does not apply to the establishment of a Proposed Expense DisputeCollaboration Research Plan. Each Party retains the rights, either Party shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit Epowers, and (b) if the dispute concerns discretion granted to it under this Agreement and neither Party will delegate to or vest in any other issue the issue shall be decided by Astellassuch rights, in its reasonable powers, or 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 decision, which decision shall be final and binding on the Parties. For clarity, in the event JRC, unless such delegation or vesting of a dispute concerning rights is expressly provided for in this Agreement or the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated Parties expressly so agree in its proposed 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 Astellaswriting. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHARE5.2

Appears in 1 contract

Samples: Collaboration, Option and License Agreement

Decision Making. All decisions (a) The Parties shall have joint decision making authority with respect to all matters pertaining to the development of the JCC require unanimous agreement of 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 each Party having one (1) vote on respect to all matters presented pertaining to the JCC for resolution or decisionLicensed Products inside the Prometheus Territory, including development, regulatory and commercialization strategy and changes to the Development Plan. The members 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 JCC will attempt 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 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 (iii) consider in good faith all reasonable suggestions and comments provided by the Committee with respect to reach consensus on all matters before Prometheus’ correspondence and other communications with Regulatory Authorities inside the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to 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 any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to cause the Dispute to be resolved by expedited arbitration pursuant to Exhibit EPrometheus Territory, and (biv) 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 to allow the Committee reasonable advance opportunity to comment on initial submissions by Prometheus and taking into account the legitimate business issues of Ambit subsequent amendments by Prometheus with respect to the issueRegulatory Approvals inside the Prometheus Territory. Astellas shall provide Ambit with a Decision Notice Notwithstanding the foregoing, in order to ensure timely progress with respect to such decisionRegulatory Approvals, Rosetta’ members of the Committee shall provide any suggestions and comments with respect to the subject matter of subsections 3.1.4(a)(iii) and (iv) within fifteen (15) business days after receipt of the relevant correspondence, communication, initial submission or amendment, failing which decision Prometheus shall be final relieved of its obligations thereunder to consider Rosetta’s suggestions and binding on the Parties. For clarity, in the event of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 comments solely with respect to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREthat item.

Appears in 1 contract

Samples: License Agreement (Rosetta Genomics Ltd.)

Decision Making. All decisions Regardless of the JCC require number of Pfizer JSC Members or Exact JSC Members, decisions by the JSC will be made by unanimous agreement of the Parties, with each Party having one (1) vote on all matters presented to the JCC for resolution or decisionagreement. The members of the JCC JSC will attempt in use good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to a Executive Officer of each of Ambit and Astellas, to seek in good faith efforts to reach agreement on any and all matters properly brought before it. If, despite such good faith efforts, the issueJSC is unable to reach a decision on a particular matter within the JSC’s responsibilities (each such matter, a “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. Solely Within three (3) Business Days after such 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 (5) 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 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 Exact will not have 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 Disputed JSC Matter until resolution can be reached in accordance with this Section 2.1(e), and, except 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 any proposed amendment or update thereto) (in each casepotential violation of Applicable Law, a “Proposed Expense Dispute”), pending such resolution the Parties shall exchange written proposals regarding continue to carry out activities under this Agreement in accordance with the portion of the budget in dispute in advance of elevating such dispute to the Executive Officers. In the event such executives cannot resolve the issue after goodthen-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed Co-Promotion Plan budget, but the Direct Marketing/Promotion Expenses and Indirect current Annual 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREPlan.

Appears in 1 contract

Samples: Promotion Agreement (Exact Sciences Corp)

Decision Making. All Except as set forth in this Section 2.3.4, decisions of the JCC require unanimous agreement and lower level committees shall be made by consensus of the Parties, with all members present; provided that at least one representative of each Party having one (1) vote on all matters presented to the JCC for resolution or decisionis present and so approves. The Non‑attending members of the JCC will attempt may represent themselves by proxies in good faith to reach consensus on all matters before the JCCany decision. In the event that the JCC cannot, after such good-faith efforts, not reach agreement on a consensus any matter within the jurisdiction authority of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], then the issue resolution and/or course of conduct shall be elevated determined by Array, in its sole discretion, provided that: (i) if the JCC cannot reach consensus regarding a material modification of the Commercialization Plan and Budget, such matter shall first be referred to a Executive Officer of each of Ambit and Astellasthe Senior Officers, to seek who shall attempt in good faith to reach agreement on the issue. Solely resolve such disagreement within thirty (30) days of such matter being referred to them (and if such matter is not resolved within such 30-day period, Array may then exercise its deciding vote with respect to such matter); (ii) in the case of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included exercising such deciding vote, Array will consider Oncothyreon’s position in the Cogood faith; and (iii) in no event shall Array in exercising such final decision-Promotion Plan budget (or any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall making authority have the right to cause (A) unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement, (B) excuse Array from any of its obligations specifically enumerated under this Agreement, or (C) reduce the Dispute to be resolved by expedited arbitration pursuant to Exhibit Erights of Oncothyreon specifically enumerated under this Agreement. For the avoidance of doubt, and (b) if the dispute concerns any other issue the issue shall be decided by Astellas, in its reasonable discretion but subject to AstellasSection 10.2.3, Array’s obligation use of its final decision-making authority (i) to use Commercially Reasonable Efforts as set forth in Section 3.6.1 and taking into account increase the legitimate business issues of Ambit with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such decision, which decision shall be final and binding on the Parties. For clarity, budget in the event Commercialization Plan and Budget, or (ii) to establish a Commercialization Plan and Budget containing activities related to Commercialization of a dispute concerning the Product in the United States (which activities the Parties acknowledge will in part be conducted by Oncothyreon if Oncothyreon elects to Co-Promotion Plan budget which is resolved by expedited arbitrationPromote the Product in the United States), Astellas may, but shall not be required to, perform the construed to “unilaterally impose an obligation on Oncothyreon to conduct activities beyond those expressly provided in or contemplated by this Agreement” as described in its proposed 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 clause (A) 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREpreceding sentence.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Array Biopharma Inc)

Decision Making. All decisions Decisions of the JCC require unanimous agreement of the Parties, each Committee with each Party having one (1) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue making authority shall be elevated to 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 any proposed amendment or update thereto) (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 Officersmade by unanimous vote. In the event such executives cannot Committee fails to reach unanimous agreement with respect to a particular matter within its decision-making authority, then, either Party may, by written notice to the other Party (an “Escalation Notice”), have such matter referred to the following individuals of each Party or his/her designee (the “Negotiators”): for disputes originating in the JRC, the heads of research of each Party shall serve as Negotiators; and the Negotiators for disputes originating in the JDC and the JMC shall be the heads of clinical development and manufacturing, respectively. The Negotiators shall meet promptly and negotiate in good faith to resolve such matter. If the issue after good-Negotiators are unable to resolve such matter within thirty (30) days of the date of the applicable Escalation Notice, or such longer period of time as the Negotiators may agree, the matter shall be referred to the Chief Executive Officers of the Parties, who shall meet promptly and negotiate in good faith efforts to resolve such matter. If the Chief Executive Officers are unable to resolve such matter within […***…]thirty (30) days, then or such longer period of time as the Chief Executive Officers may agree: (a) if Celgene shall cast the dispute is a Proposed Expense Disputedeciding vote on any such matter before the JCC; (b) except as set forth in Section 3.5 below, either Array shall cast the deciding vote on any such matter before the JRC; (c) except as set forth in Section 3.5 below, the deciding vote on any such matter before the JDC shall be made by an arbitrator in accordance with Section 2.3 below, provided, however, that, Celgene shall have the exclusive right to select the indication for each Development Compound from the list attached hereto as Schedule 2.2.3(c); and (d) Array shall cast the deciding vote on any such matter before the JMC. Notwithstanding the foregoing, neither Party [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. nor the arbitrator (for matters subject to Section 2.3 below) shall have the right to cause cast the Dispute to be resolved by expedited arbitration pursuant to Exhibit Edeciding vote in any manner that would unilaterally impose a financial obligation on Array or Celgene, and (b) if as the dispute concerns any other issue case may be, beyond the issue shall be decided by Astellas, in its reasonable discretion but subject to Astellas’s obligation to use Commercially Reasonable Efforts as commitments set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit herein or cause it to violate any obligation or agreement it may have with respect to the issue. Astellas shall provide Ambit with a Decision Notice with respect to such 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREany Third Party.

Appears in 1 contract

Samples: Drug Discovery and Development Agreement (Array Biopharma Inc)

Decision Making. All decisions Decisions of the JCC require unanimous agreement of the PartiesJRC shall be made by consensus, with each Party having one (1) vote on all matters presented to the JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCCvote. In the event that the JCC cannot, after such good-faith efforts, reach agreement Parties can not agree on a matter within decision, then either Party may, by written notice to the jurisdiction of other, have such issue referred to the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to a Chief Executive Officer of each Array and the Executive Director, Research (metabolic disorders) of Ambit and AstellasAmgen, or their designees who have equivalent authority or have been expressly given authority to seek in resolve such dispute, for attempted resolution by 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 negotiations within fifteen (15) days after such notice is received; provided that, for decisions which by their nature need to be included in the Co-Promotion Plan budget (or any proposed amendment or update thereto) (in each case, a “Proposed Expense Dispute”)made quickly, the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute to the Executive Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall Amgen representatives will have the right to cause make the Dispute 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; provided, however, that Amgen shall not have the right, without agreement of Array, to: (i) alter or amend the Discovery Plan to provide for less than the minimum number of Array FTEs as provided in this Agreement, or to require Array to utilize personnel in excess of the FTEs funded by Amgen under the Discovery Plan and this Agreement; (ii) require Array to be resolved responsible for tasks or activities of a materially different nature or scope than agreed by expedited arbitration pursuant Array in the initial Discovery Plan (or amended Discovery Plan agreed to Exhibit Eby 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 (b) if Array will not enter into any such agreement that conflicts with the dispute concerns any other issue then-current Discovery Plan during 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 decision, which decision shall be final and binding on the PartiesDiscovery Program Term). For clarity, the JRC shall have no right to amend or revise this Agreement, nor shall Amgen’s final decision-making authority as described in this Section 2.2(c) be construed to permit Amgen to amend or revise this Agreement without the event mutual agreement of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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 Array. Minutes of the Annual U.S. Profit/Loss up to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E)JRC meetings shall be taken, and such additional amounts shall, at a minimum, record all decisions made. Such minutes shall be borne solely approved by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREboth Parties.

Appears in 1 contract

Samples: Collaboration and License Agreement (Array Biopharma Inc)

Decision Making. All The JSC shall strive to seek consensus in its actions and decision making process and all decisions by the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the JCC Parties cannot reach 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 or after such matter has been referred to the JSC, then, Advaccine’s Executive Officer shall have the final decision making authority with respect to such matter within the JSC’s authority; provided, however, that Inovio’s Executive Officer shall have the final decision making authority with respect to such matter within the JSC’s authority that relates to the Global Phase 3 Study (including any amendment to the Global Phase 3 Study Plan) and Inovio’s Executive Officer shall have the right in their sole discretion to veto any decision by Advaccine 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 (i) any decision to Develop, Manufacture or Commercialize the Product as a Combination Product in the Advaccine Territory will require unanimous 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 any agreement with each Party having one (1) vote on all matters presented 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 JCC for resolution or decision. The members of the JCC will attempt in good faith to reach consensus on all matters before the JCC. In the event that the JCC cannot, after such good-faith efforts, reach agreement on a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated to 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 any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 limitations set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit with respect to the issue. Astellas 3.3; provided, that Inovio shall provide Ambit Advaccine with an explanation as to why any such decision of Advaccine would cause Inovio to violate the terms of any agreement with a Decision Notice with respect Third Party, or cause Inovio to such decisionviolate any applicable Laws, which decision shall be final and binding on the Partiesethical requirement, or intellectual property right of any Third Party. For clarity, in the event of JSC shall be a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas mayforum for discussing, but shall not be required have any decision-making authority with respect to, perform Inovio’s Development of the activities contemplated in its proposed 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 Product in the calculation Inovio Territory, and Inovio shall have full control and authority over the Development, Commercialization of the Annual U.S. Profit/Loss up to Product in the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREInovio Territory.

Appears in 1 contract

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

Decision Making. All decisions of the The JSC, JDC, JCC require unanimous and all other committees and working groups will use reasonable efforts to reach agreement of the Parties, with each Party having one (1) vote on any and all matters presented that such committee has the authority to the JCC for resolution or decision. The members of the JCC will attempt in good faith decide and endeavor to reach consensus on all matters before such matters, taking into consideration the JCCviews of each Party. JDCA Disputes arising out of the JDC, JCC or any other committee or working group will be escalated to the JSC for resolution. If the JSC is unable to reach consensus (with the CRISPR JSC members collectively having one vote and the ViaCyte JSC members collectively having one vote) with respect to any such matter within ten (10) Business Days, the matter will be referred to the dispute resolution procedures set forth in Schedule 2.2. In the event resolving any matter that the JCC canJSC has authority to decide, the JSC will not (and the Expert resolving any dispute regarding a JSC decision will not) have the right to: (a) amend, after such good-faith efforts, reach modify or waive compliance with any term or condition of this Agreement; (b) make any decision that is expressly stated to require the mutual agreement on a matter within the jurisdiction of the JCC, including Parties; (c) resolve any adoption, amendment claim or update dispute regarding whether or in what amount a payment is owed under this Agreement; (d) exercise its final decision-making authority in a manner that would (i) require the other Party to perform any act that such other Party reasonably believes would constitute a Co-Promotion Plan within violation of an Applicable Law or (ii) require such other Party to expend funding on activities in excess of its budget if such other Party does not have reasonable access to alternative funding for such activities; or (e) make a determination that a Party is in material breach of any obligation under this Agreement. [***…]] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, the issue shall be elevated to 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 any proposed amendment or update thereto) (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 Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right to 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 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 expedited arbitration, Astellas may, but shall not be required to, perform the activities contemplated in its proposed 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. ***Confidential Treatment Requested CONFIDENTIAL 4. FEES, MILESTONES, ROYALTIES AND PROFIT SHAREAS AMENDED

Appears in 1 contract

Samples: Research Collaboration Agreement (CRISPR Therapeutics AG)

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