The Joint Steering Committee. Promptly and in any event within ninety (90) days after the Effective Date, the Parties shall establish a committee (the “Joint Steering Committee” or “JSC”) as more fully described in this Section 2.3. The JSC shall have review and oversight responsibilities for all research and Development activities performed hereunder during the Research Term and with respect to each Early Development Program prior to exercise of a Product Option by GSK, and shall serve as a vehicle to facilitate the conduct of information between the Parties with respect to any commercialization activities and the Product Candidate Commercialization Program, in each case as more specifically provided herein. Each Party agrees to keep the JSC informed of its progress and activities within the Research Program, each Early Development Program, and each Product Candidate Commercialization Program, respectively.
The Joint Steering Committee. Promptly after the Effective Date, the Parties shall establish a Joint Steering Committee (the "JSC") as set forth in this Section 2.5. The JSC will exist throughout the term of this Agreement.
The Joint Steering Committee. 2.2.1 shall hold meetings in person as frequently as the members of the JSC may agree shall be necessary and otherwise by teleconference or a video-conference but in any event no less frequently than four times a Year until the end of December 2007, with the first such meeting occurring not later than 31 March in each Year and the third such meeting not later than 31 October in such Year. Thereafter, the Parties shall discuss and agree the frequency with which JSC meetings shall be held. Dates of meetings shall be agreed by the Parties not less than thirty (30) days beforehand; responsibility for arranging the meetings, including, at least, providing notice and an agenda, shall be the responsibility of the Chairperson for that meeting; the first meeting will take place as soon as practicable after the Effective Date, but in no event later than twenty (20) Business Days after the Effective Date and will be organised by Licensee. At such first meeting the JSC shall agree and establish a timetable for the transfer of the Licensor Know How;
2.2.2 shall by 31 October in each Year determine the detail of the Lifecycle Management Plan and Commercialisation Plan for the following Year. The Lifecycle Management Plan and Commercialisation Plan shall contain reasonable target dates for major events as appropriate, and the JSC shall discuss these in good faith with reference to progress made in the current Year. The JSC may, at the request of the Licensee only, add to and/or amend each Lifecycle Management Plan and Commercialisation Plan during the course of any Year as it considers appropriate from time to time, as long as each amendment is reduced to writing and signed and dated in accordance with the decision making process described in Clause 2.1.3 above. The JSC shall retain copies of all such authorised versions of the Lifecycle Management Plan and Commercialisation Plan and each shall become incorporated in this Agreement as of the date of signature by the JSC Chairperson;
2.2.3 shall, for the avoidance of doubt, not manage the progress of the Initial NDA on a day-to-day basis (this being the responsibility of the Licensor);
2.2.4 shall, for the avoidance of doubt, not manage the implementation of the Commercialisation Plan on a day-to-day basis (this being the responsibility of the Licensee);
2.2.5 as an output of each meeting shall prepare a report to the respective management of each Party detailing the progress of the Initial NDA and the implementation of t...
The Joint Steering Committee. Promptly and in any event within ninety (90) days after the Effective Date, the Parties shall establish a committee (the “Joint Steering Committee” or “JSC”) as more fully described in Sections 2.3.1 through 2.3.8 of this Section 2.3. The JSC shall have review and oversight responsibilities for all research and Development activities performed hereunder during the Research Term and with respect to each Early Development Program prior to exercise of a Product Option by GSK, and shall serve as a vehicle to facilitate the conduct of information between the Parties with respect to any commercialization activities and the Product Candidate Commercialization Program, in each case as more specifically provided herein. Each Party agrees to keep the JSC informed of its progress and activities within the Research Program, each Early Development Program, and each Product Candidate Commercialization Program, respectively. At its sole discretion, ChemoCentryx may terminate its participation in the JSC upon the earlier of (a) the date on which GSK exercises its Product Option for the sixth (6th) Option Compound, (b) the date on which the JSC agrees to terminate the Research Program and all Early Development Programs then in progress without either the JSC or GSK nominating a substitute Backup Compound for the lead Development Candidate against Collaboration Targets being developed under such Early Development Programs; or (c) ten (10) years from the Effective Date. In the event that ChemoCentryx elects to terminate its participation on the JSC pursuant to subsection (c) herein, the Parties understand and agree that (i) if at such time there is on-going an Early Development Program as of such election date, such Early Development Program shall remain in effect and continue (unless otherwise terminated in accordance with Section 3.2.3) and remain subject to the terms and conditions of this Agreement; and (ii) GSK shall assume sole decision-making authority with respect to all decisions otherwise delegated to the JSC under Section 2.3.7 with respect to any such continuing Early Development Program.
2. Section 2.3.4
The Joint Steering Committee. 2.1 Within [***] days after the Closing Date, the Parties shall establish a joint steering committee, or JSC, which shall have overall responsibility for overseeing the collaboration between the Parties.
2.2 The JSC will comprise up to (at the discretion of each Party) [***] representatives of each Party, who shall be appointed (and may be replaced at any time by providing written notice thereof) by such Party on notice to the other Party in accordance with this Agreement. Such representatives shall include individuals within the senior management of each Party, and any such representative may send a delegate in their place as appropriate for a particular meeting. JSC members may invite participation of additional ad hoc representatives from either Party on specific issues as the need arises.
2.3 To conduct the activities described in Clause 2.4 below, the JSC will meet at least [***] times each Calendar Year or more frequently if agreed by the JSC or as needed in order to address material issues raised at the DT, MT, JPC or CT that cannot be postponed until the next scheduled JSC meeting. Where decision-making power is vested in the JSC in accordance with Clause 2.4, the representatives from each Party shall collectively have one vote in decisions, with decisions made by unanimous vote unless expressly stated to the contrary in this Agreement, or as agreed by the JSC by previous unanimous vote.
2.4 The Parties hereby vest the power in the JSC to perform, and the JSC shall perform, the following functions:
(A) where the members of the JSC are not themselves members of the DT, MT or CT, they will liaise with members of the DT, MT and CT to review and approve strategies for the Development of the Product, and to review and discuss Manufacture and Commercialisation of the Product, and provide direction to the DT, MT and CT as provided herein;
(B) review and approve Substantive Amendments to the Development Plan and Budget, including in respect of further Development of the Product such as for a any new indication or formulation that is not covered in the Development Plan as of the Execution Date;
(C) review and discuss each Operational Commercialisation Plan where necessary (including the annual budget), and any Substantive Amendments thereto, formulated by the CT;
(D) review and discuss global strategy with respect to the Commercialisation of the Product;
The Joint Steering Committee. Within thirty (30) days after the Effective Date, the Parties shall establish the Joint Steering Committee (“JSC”) to oversee and manage the relationship between the Parties. In particular, the JSC shall be responsible for:
2.1.1 providing a forum for addressing strategic issues and holding discussions between the Parties related to the development and commercialization of Licensed Products in the Field and in the Territory;
2.1.2 review and approval of the Development Plan;
2.1.3 review, consideration and approval of any Clinical Study to be undertaken by Licensee in relation to any Licensed Product, together with the associated Study Plan, pursuant to Clause 4.5.2;
2.1.4 review and coordination of branding strategies and guidelines for each Licensed Product;
2.1.5 review and approval of any Licensed Product Xxxx to be used by Licensee in relation to a Licensed Product;
2.1.6 review of regulatory strategies for obtaining and maintaining Marketing Authorizations for each Licensed Product in the Territory, including review and approval of any deadline extension requests submitted by Licensee pursuant to Clauses 4.3 and 6.5.1 of this Agreement;
2.1.7 review and approval of the Sales and Marketing Plan;
2.1.8 [**];
2.1.9 review of annual reports provided by Licensee of its sales and marketing activities and otherwise monitoring if Licensee’s performance and compliance against the current Sales and Marketing Plan;
2.1.10 proposing any amendments to the Sales and Marketing Plan;
2.1.11 development of the core scientific and promotional messages and advertising strategies for Licensed Product in the Field and in the Territory, and planning and implementing educational and professional symposia and meetings in the Territory;
2.1.12 review issues concerning the manufacture, procurement, packaging, distribution and supply of Licensed Products in the Field and in the Territory;
2.1.13 review the supply chain for Licensed Products to identify risks and appropriate actions to avoid or address those risks, including without limitation, identifying sources of supply and second sources of supply, reviewing quality assurance/quality control procedures, records and compliance with current good manufacturing practices (CGMP) and recommending changes or improvements to address issues or problems in those areas, and recommending inventory levels and methods of allocating of supplies in the event of shortfalls;
2.1.14 working with and advising the Parties in connection with th...
The Joint Steering Committee. The Joint Steering Committee (JSC) oversees the joint selection of projects, but is not actually involved in the selection process. The Joint Evaluation Committee operates in full autonomy. The JSC cannot change the Evaluation Committee's scores or recommendations and cannot alter the evaluation grids. The JSC formally ratifies the Evaluation Report and the award proposals and pass them on (together with recommendations, as appropriate) to the IA/CA for endorsement and onward transmission to EC Delegations for final approval.
The Joint Steering Committee. The parties will establish a Joint Steering Committee (the “Joint Steering Committee”) to coordinate the parties’ activities with respect to the Manufacturing and supply of Product under this Agreement and to providing support to the Relationship Managers (as defined below). The Joint Steering Committee will be composed of [***] representatives (or a greater number as determined by the Joint Steering Committee) appointed by each of Client and Patheon, including the parties’ respective Relationship Manager (as defined below) and representing the functional areas of quality assurance, manufacturing/product supply or such other function areas as the Joint Steering Committee will determine, with at least one representative of each party having decision making authority for that party. Either party may replace any of its representatives on the Joint Steering Committee at any time upon prior written notice to the other party. The Joint Steering Committee will meet at least [***] or as otherwise agreed by the Joint Steering Committee, which meetings will occur by teleconference, videoconference or in person. The Joint Steering Committee will keep minutes of its meetings. The Joint Steering Committee will make decisions by consensus and the members of the Joint Steering Committee will act in good faith. A member of the Joint Steering Committee may invite other individuals to meetings of the Joint Steering Committee as the need arises and these invitees will not be unreasonably be objected to by the other members of the Joint Steering Committee.
The Joint Steering Committee. On or within thirty (30) days after the Effective Date, the Parties shall establish the Joint Steering Committee (“JSC”) to oversee and manage the relationship between the Parties. In particular, the JSC shall be responsible for: ***
The Joint Steering Committee. As soon as practicable after the Effective Date, the BCGT and Xxxxx will establish a Joint Steering Committee (the “JSC”). The JSC will have review and oversight responsibilities for all research, discovery and development activities performed under this Agreement during the Research Term, as more specifically provided herein; provided, however, that the JSC will have no authority to amend this Agreement. BCGT and Xxxxx agree to keep the JSC reasonably informed of its progress and activities under the Research Program during the Research Term.
