Development Committee Role, Decisions Sample Clauses

Development Committee Role, Decisions. The Development Committee shall determine and monitor the Development Collaboration Program, including making recommendations regarding the performance of the Development Collaboration Plan and generally on the conduct of research and development under this Agreement. The Development Committee shall approve all modifications to the Development Collaboration Plan, and shall carry out such other activities as the parties may agree to. At each meeting of the Development Committee it shall evaluate the progress of the Development Collaboration Program and determine whether it is reasonable to believe that the endpoints set forth in the Development Collaboration Plan are likely to be achieved in the time specified. It is expected (but not required) that any decisions made or actions taken by the Development Committee shall be made unanimously by its members. Each committee member shall have one vote. As development of the Licensed Product proceeds toward human clinical trials, the Development Committee shall be replaced with a Management Committee that will meet at least twice each year to determine, manage and oversee the clinical phases of development and determine, manage and oversee the regulatory approval process for the Licensed Product.
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Development Committee Role, Decisions. The JDC shall write the Development Collaboration Plan, determine and monitor the Development Collaboration Program, including making recommendations regarding the performance of the 15

Related to Development Committee Role, Decisions

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • 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.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Steering Committee Each Party shall name a mutually agreed upon equal number of representatives for the Steering Committee, which shall meet twice per calendar year, or as otherwise mutually agreed by the Parties. In the event that a Steering Committee dispute cannot be resolved, such dispute shall be escalated to a senior executive of each of Customer and Lonza. The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:

  • Operating Committee 7.01 To coordinate the operation of their respective generating, transmission and substation facilities, in order that the advantages to be derived hereunder may be realized by the parties hereto to the fullest practicable extent, the parties shall establish a committee of authorized representatives to be known as the Operating Committee. Each of the parties shall designate in writing delivered to the other party, the person who is to act as its representative on said committee (and the person or persons who may serve as alternates whenever such representative is unable to act). Each of such representatives and alternates shall be persons familiar with the generating, transmission, and substation facilities of the system of the party he represents, and each shall be fully authorized (1) to cooperate with the other representative (or alternates) and (2) to determine and agree from time to time, in accordance with this agreement and with any other relevant agreements then in effect between the parties, upon the following:

  • Major Decisions (a) any proposed or actual foreclosure upon or comparable conversion of the ownership of the Property or the exercise of any other remedies with respect to the Loan;

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Advisory Committee (a) The Partnership shall have a committee (the “Advisory Committee”) consisting of Fund Investors or their representatives or designees selected by the Managing General Partner; provided that no member of the Advisory Committee shall be an Affiliate of the Managing General Partner (or a designee or representative thereof). The Managing General Partner will meet with the Advisory Committee at least semi-annually to consult on various matters concerning the Partnership, including financial statements and appraisals, the status of existing investments and such other matters as the Managing General Partner may determine or any member of the Advisory Committee may reasonably propose.

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

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