Decision-Making Authority BMS shall have the sole decision-making authority for the operations and Commercialization strategies and decisions, including funding and resourcing, related to the Commercialization of Products; provided that such decisions are not inconsistent with the express terms and conditions of this Agreement, including BMS’ diligence obligations set forth in Section 5.1.
Decision-Making The JDC shall make decisions unanimously, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.
Selection of Reviewing Party; Change in Control If there has not been a Change in Control, any Reviewing Party shall be selected by the Board of Directors, and if there has been such a Change in Control (other than a Change in Control which has been approved by a majority of the Company's Board of Directors who were directors immediately prior to such Change in Control), any Reviewing Party with respect to all matters thereafter arising concerning the rights of Indemnitee to indemnification of Expenses under this Agreement or any other agreement or under the Company's Certificate of Incorporation or Bylaws as now or hereafter in effect, or under any other applicable law, if desired by Indemnitee, shall be Independent Legal Counsel selected by Indemnitee and approved by the Company (which approval shall not be unreasonably withheld). Such counsel, among other things, shall render its written opinion to the Company and Indemnitee as to whether and to what extent Indemnitee would be entitled to be indemnified hereunder under applicable law and the Company agrees to abide by such opinion. The Company agrees to pay the reasonable fees of the Independent Legal Counsel referred to above and to indemnify fully such counsel against any and all expenses (including attorneys' fees), claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto. Notwithstanding any other provision of this Agreement, the Company shall not be required to pay Expenses of more than one Independent Legal Counsel in connection with all matters concerning a single Indemnitee, and such Independent Legal Counsel shall be the Independent Legal Counsel for any or all other Indemnitees unless (i) the employment of separate counsel by one or more Indemnitees has been previously authorized by the Company in writing, or (ii) an Indemnitee shall have provided to the Company a written statement that such Indemnitee has reasonably concluded that there may be a conflict of interest between such Indemnitee and the other Indemnitees with respect to the matters arising under this Agreement.
Committee Determinations The Committee shall have absolute discretion to determine the date and circumstances of the termination of your Service, and its determination shall be final, conclusive and binding upon you.
Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]
Committee Determination Any adjustments or other action pursuant to this Section 4 shall be made by the Committee, and the Committee's determination as to what adjustments shall be made or actions taken, and the extent thereof, shall be final and binding.
Joint Remediation Committee If the Sellers (acting reasonably) determine that the Purchasers have committed a Major Default, then, at the election of the Sellers, within three (3) Business Days of the Sellers providing the Purchasers written notice of such determination, the Sellers and the Purchasers shall establish a joint remediation committee of designated executives from the Sellers and the Purchasers (“Joint Remediation Committee”) consisting of three (3) members of each of the Sellers and the Purchasers. The Joint Remediation Committee shall be responsible for overseeing the development of a mutually agreeable plan in accordance with subsection 3 below to either (i) remediate any breaches giving rise to the Major Default to the extent such breaches can be remediated and/or (ii) prevent similar breaches from recurring in the future (clauses (i) and (ii), a “Corrective Action Plan”). Each member of the Joint Remediation Committee shall have sufficient authority on the part of his or her respective party to make decisions relating to matters reviewed by the Joint Remediation Committee, and shall be approved by the other party (such approval not to be unreasonably delayed, conditioned or withheld). The Joint Remediation Committee shall have access to Purchaser Personnel that are primarily responsible for the area of the business relationship (such as information technology, data security or regulatory) where the breaches giving rise to the Major Default arise (such Purchaser Personnel, collectively, the “Subject Matter Experts”). The Sellers and the Purchasers shall cause their respective members on the Joint Remediation Committee to, and the Purchasers shall cause the Subject Matter Experts to, act in good faith in connection with the development of the Corrective Action Plan.
Joint Development Committee The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.
Independent Due Diligence and Decision Making Each Consenting Stakeholder hereby confirms that its decision to execute this Agreement has been based upon its independent investigation of the operations, businesses, financial and other conditions, and prospects of the Company Parties.
Appeal Panel Award The Appeal Panel shall issue its decision (the “Appeal Panel Award”) through the lead arbitrator on the Appeal Panel. Notwithstanding any other provision contained herein, the Appeal Panel Award shall (a) supersede in its entirety and make of no further force or effect the Arbitration Award (provided that any protective orders issued by the Original Arbitrator shall remain in full force and effect), (b) be final and binding upon the parties, with no further rights of appeal, (c) be the sole and exclusive remedy between the parties regarding any Claims, counterclaims, issues, or accountings presented or pleaded in the Arbitration, and (d) be promptly payable in United States dollars free of any tax, deduction or offset (with respect to monetary awards). Any costs or fees, including without limitation attorneys’ fees, incurred in connection with or incident to enforcing the Appeal Panel Award shall, to the maximum extent permitted by law, be charged against the party resisting such enforcement. The Appeal Panel Award shall include Default Interest (with respect to monetary awards) at the rate specified in the Note for Default Interest both before and after the Arbitration Award. Judgment upon the Appeal Panel Award will be entered and enforced by a state or federal court sitting in Salt Lake County, Utah.
