Global Development Committee Sample Clauses

Global Development Committee. At such time as any Preclinical Development or clinical trial is undertaken by or under authority of Taiho or MG (including by an Additional Partner) anywhere in the world within the Field with respect to a Compound and/or Product outside of the Funded Work, the Parties shall establish a joint committee among MG, Taiho and any Additional Partner(s) to discuss and coordinate such development of such Compound and/or Product (the “Global Development Committee”). To the extent there are not Additional Partners, and if Funded Work is still ongoing at the time, the function of the Global Development Committee set forth in this Section 3.4 shall be handled by the JSC. The primary role of such Global Development Committee shall be to provide a forum for communication between MG, Taiho and any Additional Partner(s) with respect to activities related to the ongoing Preclinical Development and clinical development of Compounds and/or Products in the Field, outside the Funded Work. Taiho, MG and each Additional Partner having rights to such Compounds or Products shall each have at least two (2) representatives on such Global Development Committee. Each member of the Global Development Committee shall keep the other members fully informed in English (subject to Section 6.6) as to the ongoing Preclinical Development and clinical development of, and regulatory activities with respect to, such Compounds or Products in the Field. It is understood and agreed, however, that formal approval of such Global Development Committee shall not be required for any such activities. The Global Development Committee shall meet no less frequently than twice each calendar year, or as otherwise agreed by the Parties, until the termination or expiration of this Agreement and each of Taiho, MG and any Additional Party shall give a full report in English (subject to Section 6.6) at each such meeting of activities relating to the particular Compounds and Products such Party or Additional Partner has rights to that is undergoing Preclinical Development or clinical development in the Field. Additional Partners will participate in such meeting only with respect to Compounds and/or Products for which they have rights. It is further understood that MG shall not be deemed in breach of this Section 3.4 in the event an Additional Partner fails to comply with this Section 3.4, provided that MG has obtained in its agreement with such Additional Partner the obligation to comply with this Section 3.4, and...
Sample 1Sample 2See All (4)
AutoNDA by SimpleDocs
Global Development Committee. The Parties hereby establish a global development committee (the “Global Development Committee” or the “GDC”). The GDC shall consist of three (3) representatives of each Party that have knowledge and expertise in the development of therapeutic products in the Field. The GDC shall monitor and coordinate the Development of the Compounds and Products under the Collaboration, and shall in particular: (a) coordinate the activities of the Parties under each Development Plan and oversee the implementation of each Development Plan; (b) prepare and approve each Development Plan and amendments thereto in accordance with Section 5.2; (c) following completion of a POC Development Plan for a Product, determine whether to further develop such Product for Regulatory Approval; (d) if the GDC determines to further Develop a Product for Regulatory Approval, develop the EOP2 Package for such Product in accordance with Section 5.2(b); (e) provide a forum for and facilitate communications between the Parties with respect to the Development of the Compounds and Products; (f) monitor and coordinate all regulatory actions, communications and submissions for the Compounds and Products under the Development Plans; (g) determine whether to research, develop and/or commercialize a companion diagnostic for a Product; (h) oversee and coordinate the Manufacturing of the Compounds and Products for clinical supply in accordance with ARTICLE 7, unless the Parties designate a manufacturing committee or subcommittee to perform such activities; (i) establish subcommittees, as appropriate, to carry out its functions; and (j) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development of the Compounds and Products, as directed by the ESC, except where in conflict with any provision of this Agreement.
Sample 1Sample 2
Global Development Committee. Pursuant to the terms of the Tripartite Agreement, the Parties have established with Genentech a Global Development Committee to, among other things, direct development of OSI-774. In addition, the Parties and Genentech have established an OSI-774 Liaison Team to coordinate the development activities of the OSI-Genentech Project Team and the Roche Project Team as more fully described in the Tripartite Agreement.
Sample 1
Global Development Committee. 33 5.17 NO OBLIGATION TO TRANSLATE......................................34 5.18
Sample 1
Global Development Committee. Pursuant to the terms of the Tripartite Agreement, the Parties have established with Roche a Global Development Committee ("GDC") to, among other things, direct development of OSI-774. In addition, the Parties and Roche have established a OSI-774 Liaison Team to coordinate the development activities of the Joint Project Team and the Roche Project Team as more fully described in the Tripartite Agreement. Members of the JSC hereunder will serve as the OSI and Genentech members of the GDC. The GDC will meet, review and approve a Global Development Plan, pursuant to the terms of the Tripartite Agreement.
Sample 1
Global Development Committee 
Sample 1

Related to Global 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).

  • 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.

  • 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.

  • Labour Management Committee (a) Where the parties mutually agree that there are matters of mutual concern and interest that would be beneficial if discussed at a Labour Management Committee Meeting during the term of this Agreement, the following shall apply. (b) An equal number of representatives of each party as mutually agreed shall meet at a time and place mutually satisfactory. A request for a meeting hereunder will be made in writing prior to the date proposed and accompanied by an agenda of matters proposed to be discussed, which shall not include matters that are properly the subject of grievance or negotiations for the amendment or renewal of this agreement. Any representative(s) attending such meetings during their regularly scheduled hours of work shall not lose regular earnings as a result of such attendance. (c) It is agreed that the topic of a rehabilitation program for drug and alcohol abuse is an appropriate topic for the Labour-Management Committee. It is also agreed that the topic of the utilization of full-time and part-time staff is an appropriate topic for the Labour-Management Committee. The committee shall have access to work schedules and job postings upon request. (d) It is understood that joint meetings with other Labour-Management Committees in the Hospital may be scheduled concerning issues of mutual interest if satisfactory to all concerned. (e) Where two or more agreements exist between a Hospital and CUPE the Committee may be a joint one representing employees under both agreements, unless otherwise agreed.

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

  • JOINT LABOUR MANAGEMENT COMMITTEE A Joint Labour Management Committee shall be established to attend to those matters which are of mutual interest. To ensure its effectiveness the Committee shall be separate and apart from the grievance procedure.

  • Oversight Committee The Company and Union shall each appoint three members to be part of an Oversight Committee. The Oversight Committee will attempt to resolve any issues that may arise regarding this Letter of Agreement within forty-five (45) days. Issues that the Oversight Committee cannot resolve will be subject to the party’s grievance procedure Subsection 102.3(a)(2) timelines will be waived for the forty-five (45) day period.

  • 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.

  • 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.

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