Composition of the Joint Development Committee Sample Clauses

Composition of the Joint Development Committee. The Joint Development Committee shall be comprised of an equal number of representatives from each Party, initially consisting of four persons (two persons from each Party), each of whom has relevant experience and skill appropriate for service on the Joint Development Committee, such as heads of clinical, manufacturing, and commercial development. The Parties may establish and later change the number of representatives that each Party has on the Joint Development Committee, as long as an equal number of representatives from each Party is maintained (unless such Party desires to have fewer representatives). Each Party may change any of its representatives on the Joint Development Committee at any time upon notice to the other Party.
Sample 1Sample 2See All (6)
AutoNDA by SimpleDocs
Composition of the Joint Development Committee. Prior to the earlier of: (a) [**] following a decision by the JSC that a joint development committee would be appropriate given the stage of Development of one or more Licensed Products and (b) [**] after the Parties agree on an Initial Development Plan for the first Licensed Product, the Parties shall establish a committee to oversee Development of Products and to coordinate the Development and regulatory activities of the Parties with respect to such Products (the “JDC”). Unless otherwise expressly provided in this Agreement or agreed by the Parties in writing, the JDC shall serve solely in an advisory capacity and have no independent decision-making authority. Each Party shall initially appoint [**] to the JDC, with each representative having knowledge and expertise in the development of products or in obtaining and maintaining Marketing Authorizations of products, having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities and being duly authorized under their respective company’s internal governance procedures to make the decisions or carry out the activities given to them under this Agreement. The Parties may agree to increase the number of representatives from each Party on the JDC; provided, however, that the JDC shall at all times be comprised of an equal number of representatives from each Party.
Sample 1Sample 2
Composition of the Joint Development Committee. Within [ * ] days after the Effective Date, the Parties shall establish a committee to oversee Development of the Licensed Compounds and the Licensed Product for the Territory in accordance with the Development Plan and to coordinate the Development and regulatory activities of the Parties with respect to the Licensed Compounds and the Licensed Product (the “JDC” or “Joint Development Committee”). Each Party shall initially appoint [ * ] employees of such Party or its Affiliates as representatives to the JDC, with each Party’s representatives having appropriate technical credentials, experience and knowledge for their specific role within the JDC for the development of products, and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities and being duly authorized under their respective company’s internal governance procedures to make the decisions or carry out the activities given to them under this Agreement. The JDC may change its size from time to time by mutual, unanimous consent of its members; provided that the JDC shall consist at all times of an equal -48- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
Sample 1
Composition of the Joint Development Committee. The Collaboration shall be conducted under the direction of a joint development committee (the "Committee") comprised of three representatives of MERCK and three representatives of DOV. Each Party may change its representatives to the Committee from time to time, in its sole discretion, effective upon notice to the other Party of such change. These representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Collaboration. Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend Committee meetings, subject to such representative's or consultant's written agreement to comply with the requirements of Article 4. The Committee shall be chaired by a representative of MERCK, and MERCK will have final decision making authority on all issues related to the research, development, regulatory approval, manufacturing and commercialization of Compounds and Products. DOV shall have a right to review and provide comments on the Drug Development Plan, and in the event DOV has a substantive dispute in regard to the Drug Development Plan, the Parties' representatives may refer the issue in dispute to the appropriate Executive Vice President, MERCK Research Laboratories, for MERCK and the Chief Executive Officer for DOV. In the event that the appropriate Executive Vice President of MERCK Research Laboratories or the Chief Executive Officer of DOV requests, in writing within fifteen (15) business days after the referral of the dispute to such parties, or within such extended period agreed upon by such executives, such executives shall meet in-person to attempt to resolve the dispute. If unresolved, the final resolution and/or course of conduct shall be determined by MERCK's President, MERCK Research Laboratories, in such executive's sole discretion. Each Party shall bear its own expenses related to the attendance of such meetings by its representatives. Each Party shall provide Committee members with reasonable access during regular business hours to all its records and documents that are related to the Collaboration or to the development of the Product. [LOGO] Restricted Confidential Limited Access
Sample 1
Composition of the Joint Development Committee. The JDC shall be comprised of three (3) representatives of AngioChem and three (3) representatives of Geron. Each Party may change its representatives to the JDC from time to time, in its sole discretion, effective immediately upon prior written notice to the other Party of such change. JDC representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with ANG1005 and other Licensed Products containing ANG1005 to participate meaningfully in decisions made by JDC. Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend JDC meetings, subject to such representative’s or consultant’s written agreement to comply with the confidentiality obligations set forth in Section 7.1. The JDC shall be chaired by a representative of Geron. The JDC shall strive to reach unanimous agreement on any decisions to come before it, but in the event that the JDC cannot or does not, after good faith efforts, reach unanimous agreement, the resolution and/or course of conduct shall be determined by Geron, in its sole discretion; provided, however, that Geron’s right to resolve a decision if the JDC does not reach a unanimous approval shall not apply to any dispute that relates to whether or not a milestone event has been achieved, which shall be submitted to dispute resolution in accordance with Section 11.6. Each Party shall bear its own expenses related to the attendance of JDC meetings by its representatives.
Sample 1
Composition of the Joint Development Committee. The Joint Development Committee shall consist of three (3) persons (two (2) from Parent and one (1) from Licensor), each of whom shall have relevant experience and skill appropriate for service on the Joint Development Committee, such as having served as heads of clinical, manufacturing, and commercial development. Parent and Licensor may establish and later change the number of representatives that Parent and Licensor has on the Joint Development Committee. Parent and Licensor may change any of its representatives on the Joint Development Committee at any time upon notice to Parent, in the case of Licensor, and to Licensor, in the case of Parent.
Sample 1
Composition of the Joint Development Committee. The Development Program shall be conducted under the direction of a joint development committee (the “Joint Development Committee” or “JDC”) comprised of [ * ] Merck representatives of Merck and [ * ] representatives of Dynavax. The Parties shall identify their representative to the JDC within [ * ] after the Effective Date. Each Party may change its representatives to the JDC from time to time in its sole discretion, effective upon written notice to the other Party of such change. These representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Development Program. Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend JDC meetings, subject to such representative’s or consultant’s written agreement to comply with the requirements of Section 4.1. The JDC shall be chaired by a representative of Merck. Decisions of the JDC shall be made unanimously by the representatives. In the event that the JDC cannot or does not, after good faith efforts, reach agreement on an issue, the resolution and/or course of conduct shall be determined by [ * ]; provided, however, if such dispute relates to [ * ], the JDC (or either Party’s members thereof) may refer such dispute to a discussion (to be held within [ * ], or such other period as mutually agreed) by a vice president responsible for clinical research for Merck and the Chief Executive Officer of
Sample 1
AutoNDA by SimpleDocs
Composition of the Joint Development Committee. Within [***] after the Parties agree upon a Development Plan for the first Opt-In Product that becomes a Collaboration Product in accordance with Section 5.2.2, the Parties shall establish a committee to oversee Development of each Collaboration Product and to coordinate the Development and regulatory activities of the Parties with respect to each such Collaboration Product (the “JDC”). Each Party shall initially appoint [***] to the JDC, with each representative having knowledge and expertise in the development of products similar to the Collaboration Products or in obtaining and maintaining Marketing Authorizations of such products, having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities and being duly authorized under their respective company’s internal governance procedures to make the decisions or carry out the activities given to them under this Agreement. The Parties may agree to increase the number of representatives from each Party on the JDC; provided, however, that the JDC shall at all times be comprised of an equal number of representatives from each Party.
Sample 1

Related to Composition of the Joint Development Committee

  • Joint Development Committee (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

  • Development Committee Arcadia and Xxxxxx shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and Xxxxxx. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of Xxxx Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

  • The Joint Committee (a) shall be composed of representatives of the Governments of the Parties; and (b) may establish and delegate its responsibilities to Sub-Committees.

  • Professional Development Committee There shall be a Professional Development Committee composed of two (2) members of the Association one of whom shall be the Bargaining Unit President or designate and two (2) representatives of the Hospital one of whom shall be the Chief Nursing Officer or designate and one human resources representative.

  • Steering Committee A. CIFNAL/ICBFN shall be managed by a Steering Committee comprised of elected representatives from the membership. B. The Steering Committee is empowered to conduct the business of CIFNAL/ICBFN in accordance with the recommendations of the membership; approve and enact project activities; discuss and recommend future policy or changes in policy to be adopted by the membership; make budgetary decisions for CIFNAL/ICBFN; approach funding agencies; conduct periodic membership drives; and maintain communication with scholarly and professional associations as well as with other, similar cooperative projects. C. The Steering Committee shall consist of at least five representatives of CIFNAL/ICBFN. 1. Four representatives shall be elected to at-large positions on the Steering Committee in accordance with the procedures in Section VIII. At least one representative shall be from a French or francophone institution. 2. The Chair of CIFNAL/ICBFN shall chair the Steering Committee. 3. Elected Coordinators of standing Working Groups shall serve on the Steering Committee for the period of their elected terms. 4. A representative of CRL shall serve as an ex officio member of the Steering Committee. D. An advisory group of scholars and end-users, including representatives from academic organizations concerned with library and scholarly issues in francophone studies as well as non-academic information users and providers, shall be appointed by the Steering Committee as appropriate. The makeup of the advisory group shall be formulated to provide a balance of opinion and diversity of expertise. Members of the advisory group need not be from institutions that are a member of CIFNAL/ICBFN, and shall serve as ex officio members of the Steering Committee. E. All elected representatives on the Steering Committee, including the Chair, shall have equal votes on matters requiring a formal approval by the Committee. Each member shall be accorded one vote. Ex officio members shall be non-voting members. F. Steering Committee Members shall serve three-year terms, with staggered elections; re- election is permitted for one additional term. Elected members begin their term of office immediately following the annual membership meeting. G. In the event a member is unable to serve a full term, the Chair shall appoint a replacement to serve the remainder of the term. Following this period, the replacement shall be eligible to stand for election according to the terms of Section V.

  • Local Professional Development Committee A. There shall be a Local Professional Development Committee (LPDC) to oversee, review, and approve individual professional development plans (IPDP) for course work, continuing education units and/or other equivalent activities. 1. The LPDC shall be responsible to recommend for the Superintendent’s approval, all in-service activities and workshops offered in the district during the school year for staff professional development. 2. Recommendations for District Workshops and In-Service activities should be submitted to the LPDC for approval and recommendation no later than the last school day of the year prior to the year it will be implemented. 3. The LPDC chair shall review and approve all “Professional Growth Reimbursement Application” forms. B. The LPDC shall consist of three (3) teachers appointed by the Association President and two (2) members appointed by the Superintendent. One of the Superintendent's appointees will be a Principal employed by the district. C. Appointments shall be for two (2) years with half of the committee members being appointed every other year. 1. Appointments shall be made on or before May 1. 2. The Appointments shall be made by each party outlined above, notifying the other of those appointed. 3. In the event of a vacancy, the committee members shall be replaced in accordance with "B." above. 4. The Association shall name a fourth teacher member and the Superintendent shall name a third administrative member to serve as alternates and attend trainings. These two (2) people shall act as substitutes when a committee member is absent. D. This committee shall meet monthly. 1. The committee may also be convened by the request of two sitting members. 2. A quorum shall consist of five (5) members. When administrative licenses/certificates are reviewed, two (2) sitting teacher members will abstain and the decision will be decided by three (3) members. 3. If the committee determines it is needed, they will be provided two (2) professional release days to meet during regular school hours. Substitutes will be provided for the committee members on these release days. 4. Committee members shall be provided an additional annual stipend of $1,000 for meetings beyond the normal work day or year. This stipend shall be paid in two (2) semi-annual payments. Any member who fails to serve the full year shall have the above compensation prorated on a monthly basis for each month served. 5. Decisions of the LPDC will be made by consensus of the committee members present. 6. The committee minutes shall be prepared and maintained in compliance with the laws governing the operation of committees of public bodies.

  • Project Steering Committee 1. For a sound implementation and management of the project, a steering committee shall be set up in line with provisions of the programme manual. 2. The steering committee is the decision-making body of the project and it shall be composed by representatives of the LP and all PPs duly authorised to represent the respective LP and PP institutions. It shall be chaired by the LP and it shall meet on a regular basis. Associated partners shall be invited to take part in the steering committee in an advisory capacity. External key stakeholders may also be invited to take part to one or more meetings in an observer/advisory capacity. 3. The steering committee shall at least: a. be responsible for monitoring and validating the implementation of the project and the achievement of the planned results as in the approved application form; b. perform the financial monitoring of the project implementation and to decide on any budget modifications as in § 11 of this agreement; c. monitor and manage deviations of the project implementation; d. decide on project modifications (e.g. partnership, budget, activities, and duration) if needed; e. be responsible for the settlement of any disputes within the partnership (as stipulated in § 22 of this agreement). 4. Further aspects, including the creation of sub-groups or task forces, may be set out in the rules of procedure of the steering committee.

  • Joint Research Committee The Parties hereby establish a committee to facilitate the Research Program as follows:

  • Operating Committee the Consortium’s managing body, composed of representatives of the Manager and the Contractors, pursuant to Annex XI.

  • 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: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!