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
Appears in 4 contracts
Sources: Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp), Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp), Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp)
Decision Making. (a) All decisions of the JCC require a Committee 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 to a particular matter, the JCC for resolution or decision. The members representatives of the JCC will attempt in good faith Parties cannot reach an agreement as 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 […***…] after such matter was first considered, then if such disagreement arose within the JPT, it shall be referred to the CGB for resolution. If the CGB cannot resolve such matter within a further [***], or if the disagreement first arose within the CGB, then prior to any formal dispute resolution process such 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 referred to the Executive Officers. In Officers for resolution.
(b) If the event such executives Executive Officers cannot resolve the issue after good-faith efforts such matter within […***…] after such matter has been referred to them, then:
(i) Ovid shall have the final decision making authority, which shall be exercised in its reasonable discretion, with respect to (A) Ovid’s Independent Development Activities, (B) the Ovid Ongoing Trials, (C) all manufacturing matters outside the Licensee Territory, and (D) Joint Development Activities necessary for obtaining Regulatory Approvals for Products in any Indication in the Licensee Territory for which Ovid is the sponsor (including any necessary updates to the Development Plan and Development Budget pursuant to Section 4.2, but subject in all cases to Sections 3.4(b)(i)(1) and 3.4(b)(i)(2)), except for:
(1) the addition of new Clinical Trials to the Development Plan as Joint Development Activities (the cost of which would be shared by the Parties); and
(2) any material modification to a previously agreed upon Clinical Trial that is set forth in the Development Plan as Joint Development Activities (unless such modification is required by a Regulatory Authority or any local or regional IRB/ethics committee, or is reasonably necessary to protect patient safety); for the purpose of this Section 3.4(b)(i)(2), “material modification” means [***].
(ii) Licensee shall have the final decision making authority with respect to (A) Joint Development Activities necessary for obtaining Regulatory Approvals for Products in any Indication in the Licensee Territory for which Licensee is the sponsor (including any necessary updates to the Development Plan and Development Budget pursuant to Section 4.2, then but subject in all cases to Sections 3.4(b)(i)(1) and 3.4(b)(i)(2)), (aB) if the dispute determination of whether the Additional Pivotal Trial is a Proposed Expense Disputenecessary to obtain Regulatory Approval in the Licensee Territory (although [***] for the Additional Pivotal Trial) (C) Commercialization of the Product in the Licensee Territory, either (D) Licensee Territory Development Activities and (E) Licensee’s Independent Development Activities in the Licensee Territory, and (F) Phase 4 Clinical Trials for the Licensee Territory (but subject in all cases to Sections 3.4(b)(i)(1) and 3.4(b)(i)(2)), in each case (A) through (F) provided that Licensee’s exercise of any such decision right does not adversely affect, the Development, manufacture, or Commercialization of the Product in the Ovid Territory, and complies with the terms and conditions of this Agreement. For clarity, [***].
(iii) Neither 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 final decision making authority with respect to the issue. Astellas matters in Sections 3.4(b)(i)(1) and (2), and the status quo shall provide Ambit with a Decision Notice persist with respect to such decision, which decision shall be final matter unless and binding on until 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 Parties are able to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. CONFIDENTIALagree.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Ovid Therapeutics Inc.), Collaboration and License Agreement (Ovid Therapeutics Inc.)
Decision Making. All decisions of the JCC require unanimous agreement of (a) Except as set forth in Section 2.4 and Section 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 Product inside the Prometheus Territory, including development, regulatory and commercialization strategy and (subject to subsection (b) below) changes to the Development Plan; provided that Prometheus shall (i) consult with the Committee with respect to the regulatory strategy related to the Product inside the Prometheus Territory and otherwise keep the Committee reasonably involved through good faith discussions with respect to such activities, (ii) provide Alizyme with copies of any relevant written or otherwise material correspondence received from and to be provided to, Regulatory Authorities inside the Prometheus Territory concerning the Product, (iii) consider in good faith all reasonable suggestions and comments provided by the Committee with respect to such correspondence and other communications with Regulatory Authorities inside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the Committee reasonable advance opportunity to comment on initial submissions and subsequent amendments with respect to the Regulatory Approvals inside the Prometheus Territory. For clarification purposes, the Parties agree that the Development Plan shall be modified as necessary from time to time to include all activities and deliverables by each of the Parties necessary to adequately meet the requirements for resolution or decisionobtaining Regulatory Approval in the Prometheus Territory. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) If a change is made to the Development Plan that is deemed not to be necessary by Prometheus in order to obtain Regulatory Approval for the First Indication in the Prometheus Territory, then Prometheus shall bear the incremental costs associated with such change. If any change to the Development Plan is deemed necessary by Prometheus in order to obtain Regulatory Approval for the First Indication in the Prometheus Territory AND if such change requires an additional incremental financial expenditure by Alizyme over what has already been agreed upon by Alizyme, then Prometheus shall provide written notice of such change to Alizyme as set forth in this Agreement. If Alizyme disagrees with Prometheus that the change to the Development Plan is necessary in order to obtain Regulatory Approval for the First Indication in the Prometheus Territory, then Alizyme shall, within three (3) weeks of receipt of such notice from Prometheus, notify Prometheus in writing of Alizyme's disagreement and the rationale for such disagreement. The members of the JCC will Parties shall thereafter attempt in good faith to reach consensus on all matters before agree upon whether such change is necessary and who shall bear the JCCcosts due to such change by negotiation and consultation between the Chief Scientific Officer of Prometheus and the R&D Director of Alizyme. In the event that said executives are unable to reach a consensus within three (3) weeks, 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 will be forwarded 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 mutually agreed upon neutral Third Party located in the case of a dispute regarding Prometheus Territory who is qualified to evaluate whether such proposed change is necessary in order to obtain Regulatory Approval for the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included First Indication in the Co-Promotion Plan budget Prometheus Territory (a "Neutral Expert"). The Neutral Expert shall provide a written determination within three (3) weeks of his 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 Officersher appointment. In the event the Parties are unable to agree upon a Neutral Expert within three (3) weeks (or such executives cannot resolve longer time as may be agreed upon by the issue after goodParties in writing), each Party will, within three (3) weeks, appoint an independent expert and the two (2) independent experts will appoint a Neutral Expert and, based upon majority rule, the experts shall notify the Parties of their determination within three (3) weeks. The determination made by the expert(s) will be binding upon the Parties, and the costs of the Neutral Expert will be aggregated and borne equally by the Parties. The costs of any independent experts shall be borne by the Party appointing such independent expert.
(c) As between the Parties, Alizyme shall retain final decision-faith efforts within making authority with respect to all matters pertaining to the Product outside the Prometheus Territory, including development, regulatory and commercialization strategy; provided that Alizyme shall (i) consult with the Committee with respect to the […***…]] related to the Product [***] and otherwise keep the Committee reasonably involved through good faith discussions with respect to such activities, then (aii) if the dispute is a Proposed Expense Dispute, either Party shall have the right to cause the Dispute provide Prometheus with copies of any relevant written or otherwise material correspondence received from and to be resolved by expedited arbitration pursuant provided to Exhibit E[***] concerning the Product, and (biii) if consider in good faith all reasonable suggestions and comments provided by the dispute concerns any Committee with respect to such correspondence and other issue the issue shall be decided by Astellascommunications [***], in its reasonable discretion but subject to Astellas’s obligation to and (iv) use Commercially Reasonable Efforts as set forth in Section 3.6.1 to allow the Committee reasonable advance opportunity to comment on initial submissions and taking into account subsequent amendments with respect to [***]. *** Certain information on this page has been omitted and filed separately with the legitimate business issues of Ambit Securities and Exchange Commission. Confidential treatment has been requested 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. CONFIDENTIALomitted portions.
Appears in 2 contracts
Sources: License Agreement (Prometheus Laboratories Inc), License Agreement (Prometheus Laboratories 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. CONFIDENTIALInovio Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)
Decision Making. All decisions of the JCC require JSC will be made by unanimous agreement of the Partiesvote, with each Party Party’s representatives collectively having one (1) vote vote. If the representatives of the Parties on all matters presented the JSC cannot reach an agreement as to any matter within the decision-making authority of the JSC within [***] 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 cannot, after such good-faith effortsmatter has been referred to the JSC, reach agreement on a such disagreement will be referred to the Chief Executive Officer of Lepu and the Chief Executive Officer of ArriVent (collectively, the “Executive Officers”) for resolution. If the Executive Officers cannot resolve such matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the issue shall be elevated ] after such matter has been referred 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 them (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 notifies the other Party that such matter needs immediate attention), then:
(i) ArriVent will have final decision-making authority with respect to any matter that solely relates to the right Exploitation of the Licensed Compounds or Licensed Products in the Field in the ArriVent Territory; provided that ArriVent will not make any decision that (A) is inconsistent with its diligence obligations set forth in Section 4.1 (Development; Overview; Diligence) or Section 6.1 (Commercialization; Overview; Diligence) or (B) would reasonably be expected to cause create an Adverse Risk in the Dispute Lepu Territory;
(ii) Lepu will have final decision-making authority with respect to any matter that solely relates to the Exploitation of the Licensed Compounds or Licensed Products in the Field in the Lepu Territory; provided that, Lepu will not make any decision that would reasonably be resolved by expedited arbitration pursuant expected to Exhibit E, and create an Adverse Risk in the ArriVent Territory; and
(biii) if The determination as to whether a Third Party Patent is necessary for Exploitation of 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 Licensed Compound or Licensed Product as set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit 3.2(a)(vi) (Formation; Purpose), will be resolved in accordance with Article 14;
(iv) with respect to all other matters, including whether to initiate a Global Trial or to include any Backup Compounds under this Agreement, the issue. Astellas shall provide Ambit with a Decision Notice with respect to such decision, which decision shall be final status quo will remain in effect unless and binding on until 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. CONFIDENTIALParties reach mutual agreement.
Appears in 1 contract
Sources: Exclusive License Agreement (ArriVent BioPharma, 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 ▇▇▇▇ 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 best interests of the Product that such matters be resolved expeditiously, GSK, through the Senior Vice President having direct responsibility over the commercialization of Product in the United States, shall consult with the Chief Executive Officer of VALEANT to promptly resolve such matter, provided, however, if such matter is not resolved by the Senior Executives in three (or any proposed amendment or update thereto3) (in each case, a “Proposed Expense Dispute”)business days, the Parties shall exchange written proposals regarding the portion of the budget in dispute in advance of elevating such dispute final determination with respect to the Executive Officers. In matter shall be made by the event such executives cannot resolve Senior Vice President having direct responsibility over the issue after good-faith efforts within […***…], then commercialization of Product in the United States.
(a) if Impasse Prior to the dispute is a Proposed Expense Dispute, either Party shall have Expiration of 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 Review Period. Except as set forth in Section 3.6.1 2.2.2 and taking this Section 3.1.7(a), if, during the period prior to the expiration of the Review Period, despite good faith efforts, the Senior Executives are unable to resolve such matter within thirty (30) days of the date of any Escalation Notice, then upon the written request of either Party, the Senior Executive of VALEANT may cast the deciding vote on such matter (which shall become the decision of the Joint Steering Committee); provided that VALEANT cannot make any deciding vote with respect to (i) entering into account any binding agreements relating to the legitimate business issues manufacture or commercialization of Ambit the Products or Additional Products in the Field and in the Territory; (ii) any material amendments to the Development Plans or Marketing Plans, including, without limitation, those that could reasonably be expected to have an adverse effect on the commercial profile or viability of the Product or Additional Product or would increase any research and development costs or commercialization costs; and (iii) any MAA to be filed in the United States or European Union prior to the Joint Steering Committee’s agreement as to the actions to be taken based on the results of the studies set forth in the ***, but rather in the case of the foregoing clauses (i), (ii) and (iii), GSK’s prior consent must be obtained; and provided further that, any disputes with respect to the issuedesign of the *** that are not resolved by the Joint Steering Committee will be resolved in accordance with the procedures set forth in Section 2.2.2(d)(ii), and any disputes relating to the *** that are not resolved by the Joint Steering Committee will be referred to the Chief Executive Office of Valeant and the Chairman of GSK having direct responsibility over research and development. Astellas shall provide Ambit with a Decision Notice with respect If any dispute relating to such decisionthe *** is not resolved by the Chief Executive Office of VALEANT and the Chairman of GSK having direct responsibility over research and development, which decision the matter shall be final and referred to *** whose written opinion on the matter shall be 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.
Appears in 1 contract
Sources: License and Collaboration Agreement (Valeant Pharmaceuticals International)
Decision Making. Each Committee may make decisions with respect to any subject matter that is subject to its decision-making authority and functions as set forth in this Section 3.1. All decisions of the JCC require Committee shall be made by unanimous agreement of the Partiesvote or written consent, with Licensee and VBL each Party having having, collectively, among its respective members, one (1) vote on in all matters presented to decisions. If any Committee other than the JCC for resolution or decision. The members of the JCC will attempt in good faith to JMC cannot 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 of the JCCany issue, including any adoption, amendment or update to a Co-Promotion Plan within […***…], the such issue shall be elevated referred to a Executive Officer of each of Ambit and Astellas, to seek in the JMC for resolution. The JMC shall use good faith efforts 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 matters within […***…], then (a) if the dispute is a Proposed Expense Dispute, either Party shall have the right its roles and functions or otherwise referred 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 it. Except as set forth in Section 3.6.1 and taking into account the legitimate business issues of Ambit 6.2 with respect to the issue. Astellas determination of Sales Targets in the Initial Commercialization Plan, if the JMC cannot reach consensus on a given matter, then decision-making authority shall provide Ambit be allocated: (i) to Licensee to the extent the disagreement relates to development activities directed toward Development in the Territory or Commercialization Activities within the Territory (unless (x) a change in the Development Plan proposed by Licensee does not involve an investigator-initiated trial or a trial required or suggested by a Regulatory Authority and (y) VBL can show with reasonable evidence that such change proposed by Licensee is reasonably likely to have a Decision Notice material and adverse effect on Development and Commercialization of the Product outside the Territory, in which case VBL shall have final decision-making authority); and (ii) to VBL with respect to any matter other than the foregoing. If Licensee proposes a change in development activities directed toward the Territory that does not involve an investigator-initiated trial or a trial required or suggested by a Regulatory Authority, and VBL believes that such decisionchange is reasonably likely to materially and adversely affect Development and Commercialization of the Product outside the Territory, which decision Licensee shall be final not implement such changes unless and binding on until it is determined, in accordance with the Partiesprovisions of Article 15, that such changes are not reasonably likely to materially and adversely affect Development and Commercialization of the Product outside the Territory. For claritythe avoidance of doubt, in no Committee shall have the event of a dispute concerning power to alter 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 timelines included in the calculation Development Plan or the Sales Targets included in the Initial Commercialization Plan, or to amend this Agreement, without the 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 Astellasboth Parties. CONFIDENTIALCERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.
Appears in 1 contract
Sources: Development, Commercialization and Supply Agreement (Vascular Biogenics Ltd.)
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. CONFIDENTIALboth Parties.
Appears in 1 contract
Sources: Collaboration and License Agreement (Array Biopharma 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) 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. CONFIDENTIALPlan.
Appears in 1 contract
Decision Making. All decisions of within the JCC require unanimous agreement of the PartiesJSC will be made by consensus, with each Party Party’s representatives collectively having one (1) vote on all matters presented to vote. If the JCC for resolution or decision. The members of the JCC will attempt in good faith JSC is 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 a matter within the jurisdiction of the JCC, including any adoption, amendment or update to a Co-Promotion Plan for which it has decision making authority within […***…] after such matter is referred to the JSC for decision, then either Party may elect by written notice to refer such matter to the Chief Executive Officers of both Parties for resolution, and the Chief Executive Officers of both Parties will use good faith efforts to resolve such dispute within [***]. If the Chief Executive Officers of both Parties cannot reach resolution with respect to such dispute, then (i) Disc will have final decision-making authority for all issues that relate to the issue Licensed Territory, except that Disc shall be elevated not make any final decision that would have a substantial likelihood of materially adversely affecting the Development or Commercialization of any Licensed Antibody or any Licensed Product in the Mabwell Territory; and (ii) Mabwell will have final decision-making authority for all issues that relate to the Mabwell Territory, except that Mabwell shall not make any final decision that would have a Executive Officer substantial likelihood of each materially adversely affecting the Development or Commercialization of Ambit and Astellas, to seek any Licensed Antibody or any Licensed Product in the Licensed Territory. If a Party reasonably believes in good faith to reach agreement on that an action or inaction of the issue. Solely in other Party would have a substantial likelihood of materially adversely affecting the case Development or Commercialization of a dispute regarding the Direct Marketing/Promotion Expenses or the Indirect Marketing Expenses proposed to be included in the Co-Promotion Plan budget (any Licensed Antibody or any proposed amendment Licensed Product in its respective Territory, such Party shall provide the JSC with reasonably sufficient details to further assess the circumstances and evaluate whether such material adverse effect exists or update thereto) (in each case, a “Proposed Expense Dispute”)would exist. Without limitation to the foregoing, the Parties shall exchange written proposals regarding hereby agree that matters explicitly reserved to the portion consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the budget JSC, including amendment, modification or waiver of compliance with this Agreement (which may only be amended or modified as provided in dispute in advance of elevating such dispute to the Executive OfficersSection 13.8). 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 Neither Party shall will have the right to cause use its final decision-making authority to materially increase the Dispute other Party’s obligations under this Agreement or to a Third Party (including performance obligations of such other Party, the costs and expenses to be resolved borne by expedited arbitration pursuant to Exhibit Esuch other Party, and (b) if the dispute concerns any or payment or 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 obligations 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 Eother Party), and such additional amounts shall be borne solely by Astellas. CONFIDENTIAL.
Appears in 1 contract
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. CONFIDENTIALPlan.
Appears in 1 contract
Decision Making. (a) All decisions of the JCC require each Committee shall be made by unanimous agreement of the Partiesvote, with each Party Party’s representatives having one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JDC, JCC or any subcommittee established by the JSC, the representatives of the Parties on such Committee cannot reach an unanimous decision as to such matter within [**] Business Days after such matter was brought to such Committee for resolution, such matter shall be referred to the JSC for resolution.
(b) If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC (including matter referred to the JSC by JDC, JCC or any subcommittee established by the JSC), the representatives of the Parties on the JSC cannot reach an unanimous decision as to such matter within [**] Business Days after such matter was brought to the JSC for resolution (or after such matter has been referred to the JSC), such matter shall be referred to the Chief Executive Officer of ADCT and the Chief Executive Officer of NewCo (the “Executive Officers”) for resolution. The Executive Officers shall promptly meet and use good faith efforts to resolve such matter.
(c) If the Executive Officers cannot resolve such matter within [**] days after such matter has been referred to them under Section 3.9(b), then:
(i) NewCo shall have final decision making authority with respect to matters that relate specifically to the Development and Commercialization of the Products in the Field in the Territory; provided, however that: (1) vote on all matters presented to NewCo’s decision must be consistent with the JCC for resolution or decision. The members terms and conditions 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 JCCthis Agreement, 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 obligations to use Commercially Reasonable Diligent Efforts as set forth in Section 3.6.1 to Develop and taking into account Commercialize the legitimate business issues of Ambit Products; (2) NewCo shall not have final decision making authority with respect to matters that could also affect any Product outside the issue. Astellas Territory, and shall provide Ambit with a Decision Notice not make any decision (or take any action) that may reasonably be expected to adversely affect any Product outside the Territory; and (3) the study protocols of all Clinical Trials of the Products to be conducted by or on behalf of NewCo in the Territory (including any Clinical Trial conducted by NewCo under Section 4.5(e)) must be approved by ADCT prior to any patient enrollment, such consent not to be unreasonably delayed, conditioned, or withheld; and
(ii) ADCT shall have final decision making authority with respect to such decisionmatters that could reasonably be expected to adversely impact the Products outside the Territory, including matters that could reasonably be expected to adversely impact the Products both in and outside the Territory, which decision shall be final may include but are not limited to Global Clinical Trials and binding on any CMC (chemistry, manufacturing and controls) related matters in the Parties. Territory (including technology transfer to any contract manufacturing organization).
(iii) For clarity, in neither 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 JSC nor any subcommittee established by the disputed budget JSC shall only be included in have any, and ADCT shall retain all, decision making authority over the calculation Development, manufacture and Commercialization of the Annual U.S. Profit/Loss up Product outside the Territory and all matters relating to the amount of the Arbitrator-Determined Marketing Budget (as defined in Exhibit E), and such additional amounts shall be borne solely by Astellas. CONFIDENTIALGlobal Clinical Trials.
Appears in 1 contract
Sources: License and Collaboration Agreement (ADC Therapeutics SA)
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 Licensed Products inside the Prometheus Territory, including development, regulatory and commercialization strategy and changes to the Development Plan. For clarification purposes, the Parties agree that the Development Plan shall be modified as necessary from time to time to include all activities and deliverables by each of the Parties necessary to adequately meet the requirements for resolution 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 decisionotherwise 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 Prometheus’ correspondence and other communications with Regulatory Authorities inside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the Committee reasonable advance opportunity to comment on initial submissions by Prometheus and subsequent amendments by Prometheus with respect to the Regulatory Approvals inside the Prometheus Territory. The Notwithstanding the foregoing, in order to ensure timely progress with respect to Regulatory Approvals, Rosetta’ members of the JCC will attempt 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 Prometheus shall be relieved of its obligations thereunder to consider Rosetta’s suggestions and comments solely with respect to that item.
(b) The Parties shall have joint decision making authority with respect to all matters pertaining to the development of the Licensed Products by Rosetta outside the Prometheus Territory that would affect the Licensed Products inside the Prometheus Territory, which Rosetta acknowledges could potentially include certain regulatory matters and development matters. Except as set forth in the preceding sentence or in Section 5, as between the Parties, Rosetta shall retain final decision-making authority with respect to all matters pertaining to the Licensed Products outside the Prometheus Territory, including development, regulatory and commercialization strategy; provided that Rosetta shall (i) keep the Committee reasonably informed with respect to Rosetta’s (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) regulatory strategy related to the Licensed Products outside the Prometheus Territory and otherwise keep the Committee reasonably involved through good faith discussions with respect to such activities, (ii) provide Prometheus with copies of any relevant written or otherwise material correspondence received by Rosetta (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) from and to be provided by Rosetta to, Regulatory Authorities outside 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 Rosetta’s (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) correspondence and other communications with Regulatory Authorities outside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the Committee reasonable advance opportunity to comment on all matters before the JCC. In the event that the JCC cannotinitial submissions by Rosetta and subsequent amendments by Rosetta (and, 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”)its other licensees to the extent Rosetta has obtained similar rights from such other licensees) with respect to the Regulatory Approvals outside the Prometheus Territory. Notwithstanding the foregoing, the Parties shall exchange written proposals regarding the portion in order to ensure timely progress with respect to Regulatory Approvals, Prometheus’ members of the budget in dispute in advance of elevating such dispute Committee shall provide any suggestions and comments with respect to the Executive Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (asubject matter of subsections 3.1.4(b)(iii) 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 (biv) if within fifteen (15) business days after receipt of the dispute concerns any other issue the issue relevant correspondence, communication, initial submission or amendment, failing which Rosetta shall be decided by Astellas, in relieved of its reasonable discretion but subject obligations thereunder to Astellas’s obligation consider Prometheus’ suggestions and comments solely with respect to that item. Rosetta shall use Commercially Reasonable Efforts to include similar provisions as those set forth in Section 3.6.1 (i) through (iv) above in its license agreements with third parties. Portions of this Exhibit were omitted and taking into account have been filed separately with the legitimate business issues Secretary of Ambit with respect the Commission pursuant to the issue. Astellas shall provide Ambit with Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(c) The Parties acknowledge and agree that any changes to the Development Plan or the allocation of the work thereunder that increase a Decision Notice with respect to such decision, which decision Party’s costs under the applicable project budget by more than the [***] shall be final outside the authority of the Committee and binding on the Parties. For clarityescalated for discussion and approval to an executive officer of each Party, or their delegate, in accordance with 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. CONFIDENTIALParty’s respective internal budgetary approvals processes.
Appears in 1 contract
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 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. CONFIDENTIALInovio Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)
Decision Making. All decisions of the JCC require unanimous agreement of the Parties, with each Party having one (1) vote on The JSC shall attempt to resolve any and all matters presented disputes relating to the JCC for resolution or decisionCollaboration by consensus. The members of If the JCC will attempt in good faith JSC is unable to reach a consensus on all matters before with respect to a dispute, then the JCCdispute shall be submitted to escalating levels of Alnylam and Kyowa Hakko senior management for review. If such dispute cannot be resolved despite escalation, then the Chief Executive Officers of Alnylam and Kyowa Hakko shall attempt to resolve such dispute. In the event that the JCC Chief Executive Officers cannot, after not reach an agreement regarding 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 dispute within […***…]] days after submission to them for resolution, 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 then:
(a) if the dispute is a Proposed Expense Disputeone over which the JSC has authority pursuant to Section 3.1, either Party then Kyowa Hakko shall have the right final decision-making authority; provided, however, that Kyowa Hakko (x) has no final decision-making authority over the Development or Commercialization of the Licensed Product in the Alnylam Territory or the Manufacture of the Licensed Product by Alnylam, (y) may not conduct, sponsor, fund or otherwise support a Clinical Study or Post-Approval Study of the Licensed Product that would materially and adversely affect the Development or Commercialization of the Licensed Product in the Alnylam Territory, without Alnylam’s prior written consent; provided however, that Alnylam will consider in good faith any Clinical Study design required by the Regulatory Authority in order to cause obtain Regulatory Approval in Japan and will work diligently with Kyowa Hakko to identify Clinical Study designs which meet such requirements in a way that does not materially and adversely affect the Dispute to be resolved by expedited arbitration pursuant to Exhibit EDevelopment and Commercialization of the Licensed Product in the Alnylam Territory, and (bz) if the dispute concerns any other issue the issue shall be decided by Astellas, in may not exercise its reasonable discretion but subject final decision-making authority (A) to Astellas’s obligation require Alnylam to use other than Commercially Reasonable Efforts as set forth in Section 3.6.1 and taking into account to perform its obligations under the legitimate business issues Collaboration, (B) to require Alnylam to perform any activities for which it is not responsible under this Agreement, (C) to require Alnylam to take or fail to take any action that would violate any applicable law, rule or regulation or any agreement with any Third Party or infringe the intellectual property rights of Ambit Third Parties, (D) over any [**] conducted by Alnylam, or (E) to expand or narrow the responsibilities of the JSC; and
(b) 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 all other disputes between the Parties. For clarity, in the event dispute resolution provisions of a dispute concerning the Co-Promotion Plan budget which is resolved by expedited arbitration, Astellas may, but Section 12.11 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. CONFIDENTIALapply.
Appears in 1 contract
Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Decision Making. (a) All decisions of the JCC require each Committee shall be made by unanimous agreement of the Partiesvote, with each Party Party’s representatives collectively having one (1) vote vote. Any Additional Indication may only be included in a Development Plan as provided in Section 4.7. If after reasonable discussion and good faith consideration of each Party’s view on all matters presented a particular matter before the JCC or another subcommittee of the JSC, the representatives of the Parties cannot reach an agreement as to such matter within five (5) Business Days after such matter was brought to such Committee for resolution, such disagreement shall be referred to the JCC JSC for resolution.
(b) If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as to such matter within five (5) Business Days after such matter was brought to the 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 cannot, after such good-faith effortsmatter has been referred to the JSC, 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 such disagreement shall be elevated referred to a the Chief Executive Officer of each ChemoCentryx and the Chief Executive Officer of Ambit VIT (collectively, the “Executive Officers”) for resolution.
(c) If the Executive Officers cannot resolve such matter within thirty (30) days after such matter has been referred to them, then:
(i) if such matter relates to the Development of the Product in an Indication (other than CKD from and Astellasafter the time that the CKD Option has been exercised), including the content of any Development Plan and whether to develop the Product for a particular Indication in the Field (other than CKD from and after the time that the CKD Option has been exercised), then ChemoCentryx shall be entitled to make the final decision, provided that ChemoCentryx shall not amend any Development Plan in a manner that (A) would result in the clinical Development strategy therein being insufficient to satisfy requirements for Regulatory Approval by the EMA in the Initial Indication and any Additional Indication included therein or (B) fails to comply with the scientific advice provided by the EMA for Regulatory Approval of the Product in an Indication included in such Development Plan, to seek in good faith the extent such advice can be technically implemented. If VIT reasonably believes that any amendment to reach agreement on a Development Plan would materially adversely affect the issue. Solely safety and efficacy profile of the Product in the case of a dispute regarding Territory, or that any Additional Indication proposed by ChemoCentryx would satisfy 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”)Additional Indication Rejection Condition, the Parties shall exchange written proposals regarding appoint a mutually agreed independent Third Party scientific expert to evaluate and advise the portion Parties on the effect of such amendment on the safety and efficacy profile of the budget Product in dispute the Territory or whether such Additional Indication satisfies the Additional Indication Rejection Condition, which advice ChemoCentryx shall consider in advance of elevating good faith in exercising its final decision-making authority; provided that if such dispute to the Executive Officers. In the event such executives cannot resolve the issue after good-faith efforts within […***…], then (a) if the Parties shall resolve 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 15.4; and
(ii) if such matter relates to the issue. Astellas Development of the Product in CKD from and after the time that the CKD Option has been exercised, including the content of the Development Plan for CKD, then VIT shall provide Ambit with a Decision Notice with respect be entitled to such make the final decision, which decision provided that VIT shall be final not amend the Development Plan for CKD in a manner that (A) would require ChemoCentryx to incur any expenses that are not fully reimbursed by VIT or (B) ChemoCentryx reasonably believes would materially adversely affect the safety and binding on efficacy profile of the Parties. For clarityProduct, 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 each case (A) 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. CONFIDENTIALB) without ChemoCentryx’s prior written consent.
Appears in 1 contract
Sources: Collaboration and License Agreement (ChemoCentryx, 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 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 Astellas. CONFIDENTIALwriting.
Appears in 1 contract
Sources: Research Collaboration, Option and License Agreement
Decision Making. (a) All decisions of the JCC require unanimous agreement each Subcommittee shall be made by consensus of the Partiesapplicable Co-Chairs or their designees. All decisions of each Working Group shall be made by consensus of its members, with the representatives of each Party having collectively one (1) vote on all matters presented behalf of such Party. Should the members of a Working Group or a Subcommittee disagree on any matter for which consensus has been sought and Ophthotech or Novartis requests a resolution, the matter shall be referred to the JCC for resolution or decision. The members applicable Subcommittee in the case of a Working Group, and to the JOC in the case of the JCC will Subcommittees, for resolution.
(b) All decisions of the JOC shall be made by consensus of the Co-Chairs. Should the Co-Chairs disagree on any matter within the authority of the JOC, either Party may issue a notice to the other requiring that the Co-Chairs attempt in good faith to agree on the matter by consensus. If the Co-Chairs are unable to reach a decision by consensus on all matters before within [**] Business Days of such notice then the JCC. In the event that the JCC cannotmatter will be resolved as set forth in subsections (c) and (d) below, after such good-faith efforts, reach agreement on a as applicable.
(c) If any matter within the jurisdiction authority of the JCC, including any adoption, amendment or update JOC and as to a which the JOC and Co-Promotion Plan within […***…], the issue shall be elevated to a Executive Officer of each of Ambit and Astellas, to seek in good faith Chairs fail 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 consensus pursuant 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 subsections (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 above arises, then
(i) with respect to the dispute concerns any other issue following issues, the issue Ophthotech Co-Chair shall have decision-making authority:
A. the Existing Fovista Clinical Program, including regulatory matters and filing of applications for, and seeking of, EU Regulatory Approval for the Standalone Product, including decisions concerning the initial labelling of the Standalone Product based on the Existing Fovista Clinical Program; provided that Novartis shall be decided by Astellasresponsible for post-approval commitments related to EU Regulatory Approval and Ophthotech shall not have final decision-making authority with respect thereto;
B. the API Supply (excluding any areas expressly stated in the Supply Agreement or any Related Agreements addressing quality requirements for the API Supply); and
C. the design and conduct of any study undertaken in the Development of a Product that is initiated prior to the first EU Regulatory Approval of the Standalone Product as to which Ophthotech has bona fide scientific or safety concerns or concerns relating to consistency with Ophthotech’s global Development strategy for Fovista, (A-C together, “Ophthotech Casting Vote Matters”), and the Ophthotech Co-Chair shall provide Novartis with prompt notice in its reasonable discretion but subject writing of such decision; and
(ii) the Novartis Co-Chair shall have decision-making authority with respect to Astellas’s obligation to use Commercially Reasonable Efforts as all matters within the authority of the JOC other than those set forth in Section 3.6.1 2.08(c)(i) above solely relating to Novartis’ Development (including regulatory), Manufacturing and taking into account the legitimate business issues of Ambit Commercialization activities under this Agreement with respect to Products for the issue. Astellas shall provide Ambit with a Decision Notice with respect to Novartis Territory (such decisionmatters together, 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“Novartis Casting Vote Matters”), and the Novartis Co-Chair shall provide Ophthotech with prompt notice in writing of such additional amounts shall be borne solely by Astellas. CONFIDENTIALdecision.
Appears in 1 contract
Sources: Licensing and Commercialization Agreement (Ophthotech Corp.)