Project Steering Committee. (a) The Parties’ cooperation hereunder shall be overseen by a Project Steering Committee which shall be formed as soon as reasonably practicable upon acceptance of the first Potential Product (if any) by Novartis pursuant to Section 2.1 and to which each Party shall be entitled to appoint up to *****representatives. A member of the Project Steering Committee appointed by Novartis shall assume the chairmanship of this Project Steering Committee. ***** Notwithstanding the foregoing but without limiting any obligations expressly provided for in this Agreement, no action may be taken by the Project Steering Committee to impose or increase upon either Party financial or any other obligations not expressly contained in this Agreement except with the prior written consent of such Party. (b) The Project Steering Committee shall: (i) agree from time to time on the Development and detailed working program (including timetable) to be carried out and the budgets thereto, whereby the Project Steering Committee shall set up the priorities and determine various tasks of each Party as hereinafter described; (ii) coordinate and monitor the progress of such Development work; (iii) provide for a free exchange of any relevant information and results relating to the Development work under this Agreement, in each case (i), (ii) and (iii) subject to the terms of this Agreement; and (iv) facilitate the implementation of Commercialization (other than Co-Marketing) of Products in accordance with this Agreement and approve any Phase IV clinical trials proposed to be conducted in any country in which the Parties are Co-Marketing the applicable Product. (c) As necessary or required, the Project Steering Committee shall hold meetings at intervals and locations to be mutually agreed upon, but at least once a year following its formation. Meetings of the PSC may be held in person or in reasonable manner including, without limitation, by telephone or video conference. The results of such meetings shall be recorded in writing. The minutes shall be approved and signed by or on behalf of both Parties. The minutes to the meetings shall be marked as “Confidential” and shall be subject to the secrecy obligations and restrictions on use as per Section 11 hereinafter.
Appears in 2 contracts
Samples: Development and Licensing Agreement, Development and Licensing Agreement (Tanox Inc)
Project Steering Committee. (a) The Parties’ cooperation hereunder For a sound implementation and management of the Project, a steering committee shall be overseen by a Project Steering Committee which shall be formed as soon as reasonably practicable upon acceptance set up in line with provisions of the first Potential Product (if any) by Novartis pursuant to Section 2.1 and to which each Party shall be entitled to appoint up to *****representativesprogramme implementation manual. A member The steering committee is the decision-making body of the Project Steering Committee appointed and it shall be composed of one representatives of each PP duly authorised to represent the respective LP and PP institutions. It shall be chaired by Novartis the LP and it shall assume meet on a regular basis. Each PP may appoint a substitute or a proxy to attend and vote at any meeting. Associated partners shall be invited to take part in the chairmanship 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. Associated partners and external key stakeholders will have no voting rights. The steering committee shall at least: be responsible for monitoring and validating the implementation of the Project and the achievement of the planned results as in the approved application form; perform the financial monitoring of the project implementation and to decide on any budget changes as in § 11 of this Project Steering Committee. ***** Notwithstanding agreement; monitor and manage deviations of the foregoing but without limiting project implementation; decide on project modifications (e.g. partnership, budget, activities, and duration) if needed; be responsible for the settlement of any obligations expressly provided for disputes within the partnership (as stipulated in § 22 of this Agreement, no action may agreement); Any decision required or permitted to be taken by the Project Steering Committee to impose or increase upon either Party financial or any other obligations not expressly contained in this Agreement except with the prior written consent of such Party.
(b) The Project Steering Committee shall:
steering committee may be also taken (i) agree from time to time on the Development and detailed working program (including timetable) to be carried out and the budgets thereto, whereby the Project Steering Committee shall set up the priorities and determine various tasks of each Party as hereinafter described;
in meetings via teleconference and/or via email; (ii) coordinate and monitor without a meeting with if the progress of such Development work;
(iii) provide for a free exchange of any relevant information and results relating LP circulates to the Development work under this Agreement, in each case (i), (ii) and (iii) subject to the terms of this Agreement; and
(iv) facilitate the implementation of Commercialization (other than Co-Marketing) of Products in accordance with this Agreement and approve any Phase IV clinical trials proposed to be conducted in any country in which the Parties are Co-Marketing the applicable Product.
(c) As necessary or required, the Project Steering Committee shall hold meetings at intervals and locations to be mutually agreed upon, but at least once a year following its formation. Meetings all members of the PSC steering committee a written document which is then agreed by all members of the steering committee. Such document shall include the deadline for responses. Each PP shall have one (1) vote. Decisions shall be taken unanimously. Further aspects, including the creation of sub-groups or task forces, may be held set out in person or in reasonable manner including, without limitation, by telephone or video conference. The results the rules of such meetings shall be recorded in writing. The minutes shall be approved and signed by or on behalf procedure of both Parties. The minutes to the meetings shall be marked as “Confidential” and shall be subject to the secrecy obligations and restrictions on use as per Section 11 hereinaftersteering committee.
Appears in 1 contract
Samples: Partnership Agreement
Project Steering Committee. (a) The Parties’ cooperation hereunder To facilitate communication between the Parties and the review of the strategic decisions under this Agreement, the Parties shall be overseen by appoint a Project Steering Committee. The Project Steering Committee which shall be formed comprised of appropriate representatives of both Parties, initially consisting of two (2) representatives from each of Sponsor and Pharms. Each Party shall appoint a Project Steering team leader (and other key contacts, as soon necessary) to serve as reasonably practicable upon acceptance principal Project Steering Committee liaisons for the Parties. Employees of the first Potential Product (if any) by Novartis pursuant to Section 2.1 and to which each Party shall be entitled to appoint up to *****representatives. A member who are not on the Project Steering Committee may attend meetings of the Project Steering Committee appointed by Novartis Committee, as required to further the efforts set forth in the Work Order. The initial team leader and Party representatives shall assume the chairmanship of this Project Steering Committee. ***** Notwithstanding the foregoing but without limiting any obligations expressly provided for in this Agreement, no action may be taken by the Project Steering Committee to impose or increase upon either Party financial or any other obligations not expressly contained in this Agreement except with the prior written consent of such Party.
(b) The Project Steering Committee shall:
(i) agree from time to time on the Development and detailed working program (including timetable) to be carried out and the budgets thereto, whereby the Project Steering Committee shall set up the priorities and determine various tasks of each Party as hereinafter described;
(ii) coordinate and monitor the progress of such Development work;
(iii) provide for a free exchange of any relevant information and results relating to the Development work under this Agreement, identified in each case (i), (ii) and (iii) subject Work Order that is entered into pursuant to the terms of this Agreement; and
(iv) facilitate . Any representative of the implementation Project Steering Committee may designate another individual from such representative's Party to attend a meeting of Commercialization (the Project Steering Committee in his or her place. In such case, the representative shall notify the other than Co-Marketing) Party's representative in writing prior to the applicable meeting. A representative of Products in accordance with this Agreement a Project Steering Committee may be changed by a Party at any time following written confirmation of the change to the other Party. The Project Steering Committee shall plan and approve any Phase IV clinical trials proposed manage the project and associated activities to be conducted in connection with the work set forth in each Work Order and to facilitate communication on the project between the Parties. The Project Steering Committee shall also be responsible for the sharing of certain data relating to the Parties’ project efforts in connection with each Work Order. Modification to, and implementation of, the work set forth in each Work Order and other day-to day clinical and development activities shall be managed by the Project Steering Committee. The Project Steering Committee shall meet no less frequently than once a month in person, by teleconference, web-conference or video conference as agreed upon by the Parties. Notwithstanding anything herein to the contrary, the Project Steering Committee shall operate by consensus with representatives of Sponsor having one collective vote and representatives of Pharms having one collective vote. In the event of any country in which disagreements between the Parties, and the inability of the Parties are Co-Marketing to reasonably resolve the applicable Product.
disagreements within thirty (c30) As necessary or days of when the dispute was presented to the Project Steering Committee, then the dispute shall be referred to the senior management representatives of each Party. For purposes of the Project Steering Committee, Sponsor’s senior management representative shall be its Chief Executive Officer and Pharm’s senior management representative shall be its Chairman. If the senior management is not able to reasonably settle the dispute, the Sponsor shall have the deciding vote. If required, the Project Steering Committee shall hold meetings at intervals be responsible for discussing in good faith and locations agreeing on issues relating to be mutually agreed upon, but at least once forecasting and contingency planning with regard to a year following its formation. Meetings of the PSC may be held in person or in reasonable manner including, without limitation, by telephone or video conference. The results of such meetings shall be recorded in writing. The minutes shall be approved and signed by or on behalf of both Parties. The minutes to the meetings shall be marked as “Confidential” and shall be subject to the secrecy obligations and restrictions on use as per Section 11 hereinafterWork Order.
Appears in 1 contract
Samples: Master Services Agreement (Xenetic Biosciences, Inc.)
Project Steering Committee. (a) The Parties’ cooperation hereunder shall be overseen by Borrower shall, within 15 Business Days from the date of this Agreement, form a Project Steering Committee which shall be formed as soon as reasonably practicable upon acceptance of the first Potential Product (if any) by Novartis pursuant to Section 2.1 and to which each Party shall be entitled to appoint up to *****representatives. A member duly constituted project steering committee in respect of the Project Steering Committee appointed by Novartis (the “PSC”), and shall assume procure that the chairmanship PSC has oversight of, and, together with the Lender in respect of this Project Steering Committee. ***** Notwithstanding its designated members, provides guidance on:
(i) the foregoing but without limiting any obligations expressly provided for delivery and execution of a bankable feasibility study in this Agreementrespect of the Project;
(ii) the performance of the Agreed Budget, no action may be taken by the Project Steering Committee to impose or increase upon either Party financial or Execution Plan and Schedule and the Project Financial Model;
(iii) the Project’s performance against the conditions of the Special Mining Licence;
(iv) the implementation of the Hive-Out; and
(v) any other obligations matters concerning the development of the Project, including but not expressly contained in this Agreement except limited to:
i. environmental and social governance;
ii. health, safety and environmental compliance;
iii. security;
iv. compliance (including, without limitation, compliance with applicable Anti-Corruption Laws, Sanctions Laws and applicable anti-money laundering and counter-terrorism financing laws);
v. resource evaluation;
vi. geological drilling;
vii. mine planning;
viii. process development;
ix. marketing; and
x. human resources matters, together, the prior written consent of such Party“PSC Remit”.
(b) The Project Steering Committee Borrower undertakes that the terms of the PSC shall provide that the PSC shall:
(i) agree from time subject to time on Clause 14.6(d), make recommendations to the Development and detailed working program (including timetable) to be carried out board of directors of each member of the Borrower’s Group, and the budgets theretorelevant teams within such member of the Borrower’s Group, whereby in respect of the Project Steering Committee shall set up the priorities and determine various tasks of each Party as hereinafter describedPSC Remit;
(ii) coordinate comprise five members, with three members appointed by the Borrower (from time to time) and monitor two members appointed by the progress of such Development workLender (from time to time);
(iii) provide for meet (whether in person or by teleconference) as often as necessary and no less than monthly until completion of a free exchange bankable feasibility study in respect of any relevant information the Project (and results relating to the Development work under this Agreement, in each case (ithereafter on a monthly basis at least), (ii) and (iii) subject to the terms of this Agreement; and
(iv) facilitate permit any member of the implementation PSC to request to convene a meeting of Commercialization the PSC upon giving reasonable notice to the other members of the PSC (other than Co-Marketing) of Products in accordance with this Agreement and approve any Phase IV clinical trials proposed to be conducted in any country in which the Parties are Co-Marketing the applicable Productevent not more than ten Business Days’ notice).
(c) As necessary or required, Each Party shall notify the Project Steering Committee other of the persons that constitute their respective appointees to the PSC and the Parties shall hold meetings be entitled to change the persons that are their appointees to the PSC provided that the other Party is notified of such change in appointee and that at intervals all times there shall be no more than three Borrower appointees and locations to be mutually agreed upon, but at least once a year following its formation. Meetings two Lender appointees.
(d) The Parties agree that the decisions of the PSC may shall not be held in person or in reasonable manner includingbinding on any member of the Borrower’s Group, without limitation, and any recommendations made by telephone or video conference. The results of such meetings shall be recorded in writing. The minutes shall be approved and signed by or on behalf of both Parties. The minutes to the meetings shall be marked as “Confidential” and shall it will be subject to final approval of the secrecy obligations management or directors (as applicable) of such member of the Borrower’s Group. The Parties further agree that the conduct of the PSC shall be carried out in strict compliance with all applicable competition and/or anti-trust Laws and restrictions on use as per Section 11 hereinafterwill be subject to any measures reasonably necessary to comply with applicable competition and/or anti-trust Laws from time to time.
(e) The Borrower shall procure that the members of the PSC are provided with monthly management reports in respect of TNCL and any other material reports and/or information that is produced by, or for the benefit of, TNCL and provided to the management of TNCL or the Borrower, including but not limited to all:
(i) drilling results;
(ii) mine and other studies;
(iii) metallurgical test work; and
(iv) correspondence with Governmental Authorities and communities, in each case, subject to applicable Law, without any edits or redactions.
Appears in 1 contract
Samples: Loan Agreement (Lifezone Metals LTD)