Joint Steering Committee. Promptly after the Effective Date, the Parties will form a Joint Steering Committee (the “JSC”) composed of an equal number of employees of each of Curis and Genentech, but in no event to exceed four (4) members from each Party. The JSC shall determine the specific goals for the Collaboration, shall manage the ongoing research conducted under the Collaboration in accordance with the Research Plan, shall monitor the progress and results of such work, and shall oversee and coordinate the development and commercialization of Compounds (other than Collaboration Products); provided, however, that the JSC shall not have decision-making authority with respect to the development and commercialization of Collaboration Products, which shall be governed by the CSC. The presence of at least one (1) representative of each Party shall constitute a quorum for the conduct of any JSC meeting. All decisions of the JSC shall require unanimous approval, with the representatives of each Party collectively having one (1) vote, provided in the event of a deadlock, the issue shall be referred to the Chief Executive Officer of Curis and the Senior Vice President of Research of Genentech, or their respective designees, who shall promptly meet and attempt in good faith to resolve such issue within thirty (30) days. If such executives cannot resolve such matter, then Genentech shall have final decision-making authority with regard to decisions regarding the Collaboration (including, without limitation, the JSC’s designation of a Compound as either a Lead Product or Excluded Product); provided, however, that in no event shall Genentech have the right or power to take any of the following actions without the approval of Curis’ representatives on the JSC:
(a) approve the initial Research Plan (an outline of which has been agreed upon by the Parties as of the Effective Date);
(b) amend or modify this Agreement or the Research Plan;
(c) resolve any such matter in a manner that conflicts with the provisions of this Agreement (including, without limitation, the Research Plan);
(d) make any decision with respect to the development or commercialization of Curis Products; or
(e) make any decision with respect to the prosecution, maintenance, defense or enforcement of any Curis Patents. The JSC shall meet at such frequency as the JSC agrees, except that, until the filing of the first IND for a Lead Product utilizing Systemic Delivery in a Major Market, the JSC shall meet on at least a quarterly...
Joint Steering Committee. The Parties hereby establish a joint steering committee (the “JSC”) to facilitate the Collaboration as follows:
Joint Steering Committee. (a) The parties expect in the future to cooperate in the management of the Clinical Supply Work so as to assure its completion in the most effective manner and to communicate regularly concerning the production supply and commercialization of the Product. The joint steering committee shall review and approve any modification to the scope and goals of the Project Plan (the “Joint Steering Committee”). Any modification to the scope and goals of the Project Plan shall require a majority vote of the Joint Steering Committee. If the Joint Steering Committee is unable to reach such a majority vote on the modification of this Plan or for all matters except those involving Exhibit C in Section 5.1(b) within 10 days or, in the case of those matters in Section 5.1(b) involving Exhibit C, 60 days, it shall refer the issue to the President of Aveva and the President of Arius for resolution.
(b) The Joint Steering Committee shall meet from time to time as agreed to by the Joint Steering Committee to: (i) review the Clinical Supply Work, (ii) modify the scope and goals of the Project Plan, (iii) to set priorities for achieving the objectives of the Project Plan, and allocating the parties’ resources in connection therewith, (iv) review and approve, pursuant to Exhibits B and C, Additional Capital Investment, if any, and payment arrangements with respect thereto; and (v) review manufacturing and delivery issues as identified by the representatives on the committee. ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”.
(c) Within 60 days after Aveva has supplied Phase III and stability batches as provided in the Project Plan, the Joint Steering Committee shall meet in order to review Aveva’s Fully-Burdened Manufacturing Costs with respect to the Product and determine an estimate of such cost for commercial production of the Product. Such cost will be an estimate only and not binding on Aveva as the basis for calculating the Product Price pursuant to this Agreement.
(d) Aveva’s initial representatives on the Joint Steering Committee shall be Xxxxxx Xxxxxx and Xxxxxx Xxxxxx and Arius’ initial representatives shall be Xxxxxx Xxxx and Xxxxx Xxxxxxx. Either party may change its representatives to the Joint Steering Committee upon prior notice to the other party.
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.
Joint Steering Committee. The Parties shall establish the Joint Steering Committee within [***] ([***]) days of the Effective Date of this Agreement. The Parties’ initial members of the JSC are identified in Exhibit E. Promptly after the Effective Date, one member of the JSC will be selected by each Party to act as the chairperson of the JSC. The JSC will meet at least [***] per year during the Research Term. Such meetings may be conducted by videoconference, teleconference or in person, as agreed by the Parties, and each Party shall bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel serving on the JSC or attending any meeting of the JSC. Upon completion of the Research Term, the JSC will be disbanded. Promptly after the Effective Date, the Parties will establish a project team (the “Project Team”) consisting of key employees of both [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Parties performing or involved in the Research Program. One of the Project Team members of each Party shall be appointed as a project manager (a “Project Manager”) to coordinate its part of the activities under the Research Program. The Project Managers will be the primary contacts between the Parties with respect to all Research activities performed under the Research Program. Meetings of the Project Team may be conducted by videoconference, teleconference or in person, to discuss the results of the Research and progress or delay thereof, at least once a month, or will be held ad hoc upon reasonable request of Project Manager of a Party and acceptable by the same of the other Party, acceptance of which will not be unreasonably withheld or delayed. Either Party may change its Project Manager upon written notice to the other Party. A Project Manager may be a member of the JSC.
Joint Steering Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a committee (“Joint Steering Committee” or “JSC”) to coordinate and oversee the Parties exchange of information and materials pursuant and subject to the terms of this Agreement.
Joint Steering Committee. (a) Within twenty (20) days after the Effective Date, the parties shall form a Joint Steering Committee ("JSC"), consisting of an
(i) approve the annual development plans and related budgets for the worldwide development of the Product with a focus on Regulatory Approval in the USA, Canada and the EU ("Development Program"), (ii) monitor the Development Program and modifications thereto, including the assignment of contributions by the parties to the conduct of clinical trials and the responsibility for filings, interactions with the USA FDA and the appropriate time for transfer of regulatory responsibility to Roche; (iii) establish subcommittees and project teams on an as-needed basis; and (iv) undertake such other activities as may be agreed upon by the parties. The JSC shall meet at least twice per year, once in Europe and once in the USA.
(b) To implement its policies, within forty (40) days after the Effective Date, the JSC shall establish a Development Project Team ("DPT") containing an appropriate number of representatives from Roche and Trimeris. The DPT will (i) prepare and submit to the JSC for approval the Development Program, and, (ii) under the oversight of the JSC, implement and monitor the Development Program, including submitting proposed modifications thereof to the JSC for its approval. The DPT shall be chaired by a Roche representative who shall direct the day-to-day operations of the DPT in implementing the Development Program.
(c) The DPT will annually establish the Development Program, consisting of a development plan and a development budget for the development of the Product directed to the Regulatory Approval of the Product in the USA, Canada and the EU. The first version of the Development Program shall be submitted for approval by the JSC within sixty (60) days from the Effective Date. The JSC shall determine and agree which activities and costs shall be considered as pertaining to the Development Program and which are a priori incurred with the primary purpose of Regulatory Approval of the Product in the USA and Canada. The development plan shall be prepared on a Product-by Product and activity-by activity basis, for at least eight (8) calendar quarters in advance and shall be updated on a quarterly basis.
Joint Steering Committee. The Parties hereby establish a committee to facilitate the Research Program as follows:
Joint Steering Committee.
3.10.1 The Joint Steering Committee shall consist of 2 members appointed by the College and 2 members appointed by the Association. These 4 members shall be the quorum for a Joint Steering Committee meeting. With the written agreement of the parties, subcommittees which may include non-Joint Steering Committee members may be established to deal with specific matters.
3.10.2 The Joint Steering Committee shall be a standing union management committee with a mandate for the following:
a) Performance Appraisal – to oversee the performance appraisal process for all faculty members as detailed in the attached Appendix VI, (Guidelines for the Performance Appraisal of Permanent Regular Faculty Members and as per Article 15, (Performance Appraisal of Permanent Regular Faculty Members).
b) Evaluation – to oversee the evaluation process for all faculty members as detailed in the attached Appendix VII, (Guidelines for the Evaluation of Term and Probationary Regular Faculty Members) and as per Article 16, (Evaluation of Probationary Regular and Term Faculty Members).
c) Evaluation and Appraisal of Instructors with Responsibility Allowances – to oversee the evaluation and appraisal of Faculty Members with Responsibility Allowances as detailed in the attached Appendix VIII (Guidelines for the Evaluation and Appraisal of Faculty Members with Responsibility Allowances) and as per Articles 15 and 16.
d) Any other matters that the College and the Association agree in writing to refer to the Article 3.10, (Joint Steering Committee).
3.10.3 Human Resources, Institutional Research, and the Association shall provide assistance to the departments in the administration of forms and procedures for evaluation and performance appraisal. In the event that these bodies are unable to resolve issues arising from the administration of forms and procedures, such issues shall be referred to the Joint Steering Committee for resolution.
3.10.4 The Joint Steering Committee may make recommendations to the parties on matters arising from its mandate outlined above, and shall make recommendations to the parties on issues and procedures referred to it by the bodies pursuant to Article 3.10.3.
3.10.5 The Association appointed members of the Joint Steering Committee shall be granted a reasonable period of paid leave in order to carry out their responsibilities.
3.10.6 Should the members of the Joint Steering Committee be unable to reach agreement on any of the matters within its purview, the matte...
Joint Steering Committee. Except as otherwise explicitly provided herein, in the event of any controversy or claim arising out of or relating to any provision of this Agreement, or the collaborative effort contemplated hereby, the Parties shall, and either Party may, refer such dispute to the JDC, and failing resolution of the controversy or claim within thirty (30) days after such referral, the matter shall be referred to a joint steering committee (the “Joint Steering Committee”) established by the Parties comprising one (1) representative of each Party, who shall be appointed (and may be replaced at any time) by such Party on notice to the other Party in accordance with this Agreement. Any matters originating with the JDC on which it is unable to reach consensus within thirty (30) days after the initial discussion thereof shall also be referred to the Joint Steering Committee. Each Party’s representative to the Joint Steering Committee shall be an executive officer of the respective Party. The Joint Steering Committee will meet as needed and agreed by the Joint Steering Committee to resolve controversy or claims referred to it by the JDC and to conduct such other activities as the Joint Steering Committee may deem appropriate. Each member of the Joint Steering Committee shall have one vote in decisions, with decisions made by unanimous vote. If the Joint Steering Committee is unable to resolve the controversy or claim within thirty (30) days of its referral to it, then those matters with respect to which MITSUBISHI or VERTEX have final decision making authority as described in Section 3.1.3 shall be referred to the applicable Party for decision. All other matters shall be referred to the Chief Executive Officer of VERTEX and the Chief Executive Officer of MITSUBISHI for resolution pursuant to Section 10.2.2 hereof.
