3. Joint Steering Committee
3.01 Joint Steering Committee
During the term of the ETEC, the joint steering committee appointed under the ETEC [Technological Order Agreement] will oversee the activities under this Agreement and the provisions of the ETEC will govern the JSC.
After expiry of the ETEC, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to oversee the activities to be conducted by or on behalf of the Licensees contemplated by this Agreement. The role of the JSC is:
a) to review, discuss and propose suggestions to the overall strategy for the manufacture and Supply of the Licensed Product in the Territory, to be defined by the Licensees;
b) to review, discuss and approve the Regulatory Plan and any amendments to the Regulatory Plan submitted to the JSC for approval;
c) to review, discuss and suggest improvements to the Supply Plan and any amendment to the Supply Plan submitted to the JSC for approval by the Licensees;
d) to review, discuss and approve the Manufacturing Plan and any amendments to the Manufacturing Plan submitted to the JSC for approval;
e) to review, discuss and approve a policy to govern any donations of Licensed Product Manufactured under this Agreements;
f) to perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
AstraZeneca and Licensees will initially appoint two (2) representatives to the JSC, each of whom will be an officer or employee of such Party having sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities. The JSC may changes its size from time to time by mutual consent of its members and each Party may replace its representatives at any time upon written notice to the other Party; provided, however, that the JSC will at all times consist of an equal number of members appointed by each Party. If a JSC representative from either Party is unable to attend or participate in a meeting of the JSC, the Party who designated such representative may designate an appropriately qualified substitute representative for the meeting. The chairperson of the JSC shall be selected by AstraZeneca. From time to time, AstraZeneca may change the representative who will serve as chairperson on written notice to Licensees. The role of the chairperson is to convene and preside at all meetings of the JSC and to ensure the preparation of meeting minutes, but the chairperson has no additional powers or rights beyond those held by other JSC representatives.
During the term of the ETEC, the JSC will meet as often as set forth under the ETEC. After expiry of the ETEC, until such time as the JSC unanimously agrees otherwise, the JSC will meet at least once every two weeks during the Term. Such meetings may be held via remote videoconference or teleconference or another method mutually agreeable to the Parties. In addition, either Party may also call a special meeting of the JSC (including by videoconference or teleconference) upon at least five (5) Business Days’ prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed before the next regularly scheduled meeting, and such Party will provide the JSC no later than five (5) Business Days before the special meeting with materials reasonably adequate to enable an informed decision to be made by its members. As appropriate, other employee representatives, subject matter specialists or agents of the Parties may attend JSC meetings as non-voting observers, advisors or presenters. The chairperson of the JSC will prepare reasonably detailed written minutes of all JSC meetings that reflect and include all material decisions made at such meetings. The JSC chairperson will send draft meeting minutes to each member of the JSC for review and approval within ten (10) Business Days after each JSC meeting. Such minutes will be approved unless one or more members of the JSC object to the accuracy of such minutes within ten (10) Business Days of receipt.
3.04 Decision Making
Actions to be taken by the JSC will be taken only following unanimous vote, with each Party having one (1) vote representing the views of its members. If the JSC fails to reach unanimous agreements on a matter before it for decision for a period in excess of five (5) Business Days, either Party may submit the matter in writing to the other, and the Parties will refer such dispute to their respective Executive Officers, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed by the Executive Officers shall be conclusive and binding on the Parties.
3.05 Final Decision Making Authority
If the Executive Officers are not able to agree on the resolution of any such issue within five (5) Business Days after such issue was first referred to them, unless otherwise expressly stated herein, then (x) AstraZeneca shall have final decision-making authority with respect to any issue related to the conduct of clinical studies or trials, any issues implicating the Head License and an interactions with the Head Licensor and (y) Licensees shall have final decision-making authority with respect to all other matters.
3.05.1 The Parties agree that the decision making referred to in Section 3.05 will be conducted based on the principles of good faith and fairness, in order to ensure the proper development of the works and performance and conclusion of the Objectives.
3.06 Limitations on Authority
Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JSC does not have the power to amend, modify, or waive compliance with this Agreement.
3.07. Alliance Manager
Promptly after the Effective Date, each Party shall appoint a person who shall oversee contact between the Parties for all matters between meetings of the JSC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an “Alliance Manager”). The Alliance Managers shall work together to manage and facilitate the communication between the Parties under this Agreement, including the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement. The Alliance Managers shall not have final decision-making authority with respect to any matter under this Agreement. If not already a member of the JSC and shall be permitted to attend JSC meetings as appropriate as non-voting participants. Each Party may replace its Alliance Manager at any time by thirty (30) days’ prior notice in writing to the other Party. Each Party shall bear the costs of its Alliance Manager.
15.13. Dispute Resolution
In the event of a dispute arising under this Agreement between the Parties (save for the disputes referred to in Section 3.04 and 3.05), the parties shall refer such dispute to their Executive Officers. Either party may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and, within twenty (20) days of such notice, the Executive Officers shall meet and attempt to resolve the dispute by good faith negotiations.
15.14 Law and Jurisdiction
Brazilian law shall govern this Agreement, including its formation, validity, construction, performance and any non-contractual causes of action arising out of or in connection with this Agreement or the activities carried out pursuant to this Agreement provided that all questions regarding the inventorship, construction or effect of patents under this agreement shall be determined in accordance with the laws of the country or other jurisdiction in which the particular patent has been filed or granted, as the case may be. The parties submit irrevocably to the exclusive jurisdiction of the Federal Court of Justice, Judiciary Section of the State of Rio de Janeiro, City of Rio de Janeiro in relation to any dispute arising out of or in connection with this Agreement or the activities carried pursuant to this Agreement.