Provision Language
2. PROJECT ORGANISATION AND MANAGEMENT
2.1 Team Charter. The Project shall be managed by the Parties under the oversight of the Parties’ designated representatives as described in the Team Charter in Annex B.
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2.4 Joint Monitoring and Advisory Group. Promptly following the Effective Date, the Parties will establish a joint monitoring and advisory group (“JMAG”) that shall meet regularly as specified in the applicable Team Charter to monitor progress of and advance the Project. The JMAG shall coordinate the efforts of CEPI and the Partners, with respect to the following activities for each Work Package (in addition to the responsibilities set out in the applicable Team Charter):
2.4.1 facilitate communications between the Parties;
2.4.2 monitor the performance and technical content of each Work Package against the milestones and their dates, and critically assess the results on an on-going basis to identify and address any weaknesses or delays in any Work Package;
2.4.3 approve the achievement of milestones (but the JMAG shall not have the right to approve final Project completion or confirm completion of Stage Gates, which shall be subject to the provisions of Clause 2.6);
2.4.4 provide a forum for discussion as to whether the activities currently agreed to are sufficient to satisfy CEPI’s mission;
2.4.5 have the authority to approve extensions to Work Package timelines up to ten (10) percent of the originally planned timeframe as set out in the relevant Work Package, provided that each such extension is at no cost to CEPI and does not impact the overall completion date of the Project;
2.4.6 have the authority to approve transfer of funds between cost categories within a Budget, to the extent that any such changes are cost neutral;
2.4.7 review and approve proposed changes and updates to the iPDP including, but not limited to, the Project Continuity Plan;
2.4.8 review and discuss pre-clinical and clinical trial protocols, including CMC development study protocols, and any substantial changes;
2.4.9 review and approve the regulatory strategy for the use of the Project Vaccine and receive regular updates on regulatory filings and submissions;
2.4.10 review the contractual and operational status and capabilities of Trusted Collaborator(s);
2.4.11 review and discuss publications;
2.4.12 discuss each Partner’s willingness to share any Project Results with any other CEPI awardees, such sharing of Project Results not to occur without the agreement of the Parties, unless otherwise agreed in a Work Package;
2.4.13 review and update the Equitable Access Plan (until the Equitable Access Group is established in accordance with Clause 14.3 in which case this will become a function of the Equitable Access Group);
2.4.14 discuss plans, as appropriate, for the development and manufacturing of the Project Vaccine and their scale-up and scale-out;
2.4.15 approve the Technical Reports and Project Results made available by a Partner pursuant to Clause 2.5;
2.4.16 review any reports and updates provided by any site visit groups;
2.4.17 keep CEPI updated on any progress with regard to the SPV, including plans for it to be established, funded, its proposed remit, any funding sources it may benefit from, the associated business case and any other relevant details;
2.4.18 provide a forum for coordinating the Parties’ responses to issues with respect to the Project Vaccine, to the extent relating to CEPI’s use, including unexpected disruptions to the supply of the Project Vaccine, recalls, safety issues or withdrawals of the Project Vaccine;
2.4.19 receive written notification of all Project Results;
2.4.20 discuss (i) any further cooperation of the Parties as further set forth in Clause 4.1 and Clause 4.3, and (ii) any collaboration in the event of an Outbreak as further set forth in Clause 4.2; and
2.4.21 discuss plans, as appropriate, for the development of manufacturing for the Project Vaccine, and its scale-up and scale-out.
The JMAG shall disband on completion of the Project.
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2.6 Stage Gate Review. Unless otherwise addressed in a Work Package for a given Stage Gate, when a Partner believes that a Stage Gate in a Work Package will be achieved in the near term, such Partner shall notify the JMAG promptly and provide relevant information (including the completion of a form provided by CEPI) and request a meeting of CEPI’s committee authorised to assess whether Stage Gates have been completed (the “Stage Gate Review Committee”). Each Partner’s Project Lead shall coordinate with CEPI’s Project Lead to schedule a Stage Gate Review Committee meeting as early as possible, but generally no later than [***] before the planned meeting date. CEPI shall notify each Partner of the Stage Gate Review Committee’s decision as to whether such Stage Gate was completed as soon as possible, but generally no later than [***] after the meeting date. If the Stage Gate Review Committee, acting reasonably, determines that the Stage Gate was not completed by the Stage Gate Deadline, the relevant Partner shall have the right either to (i) [***] or (ii) [***]. If following [***], CEPI reasonably determines that the Stage Gate has not been completed, then, without prejudice to the relevant Partner’s rights and remedies under this Agreement, including Clause 20, CEPI shall have the right to terminate this Agreement pursuant to Clause 19.4.2.
7. CLINICAL TRIALS
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7.5 Sponsorship and Management of Project Clinical Trials
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7.5.2 In respect of each Project Clinical Trial, upon discussion with CEPI, the sponsoring Partner shall establish either an internal Trial Steering Committee (“TSC”) or a Safety Monitoring Committee or Data Safety Monitoring Board (each, a “DSMB”), as applicable. CEPI shall be entitled to appoint, and the sponsoring Partner shall permit, a CEPI representative or designee to attend all meetings of each Project Clinical Trial’s TSC and/or DSMB as an observer (either in person or by telephone, video or other electronic means), to the extent permitted by applicable laws and regulations and agreed by the TSC or DSMB, as applicable. Subject to Clause 7.5.3 below, the sponsoring Partner shall provide a copy to CEPI of all documents, correspondence and records that a member of the TSC and/or DSMB would be entitled to receive at the same time as any such documents, correspondence and records are provided to the members of the TSC and/or DSMB (as applicable), subject to compliance with applicable laws and regulations.
12. COMPLIANCE
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12.3 Partner Responsibilities. Each Partner:
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12.3.8 to the extent applicable to the Project, rely upon its own reasonable and customary policies and principles so as to comply with, and/or enable CEPI to comply with: (i) CEPI’s Clinical Trials Policy; (ii) CEPI’s Managing Conflicts of Interest Policy;(iii) CEPI’s Scientific Integrity Policy; (iv) CEPI’s Transparency and Confidentiality Policy; and (v) CEPI’s Travel and Expenses Policy; and […]
14. EQUITABLE ACCESS
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14.3 Equitable Access Group. The Parties will establish an Equitable Access Group that shall meet regularly to monitor the progress of and advance the Partners commitment to Equitable Access. The Equitable Access Group shall coordinate the efforts of the Parties to update the Equitable Access Plan and set out how the Project Vaccine will be used to enable Equitable Access. The rules and frequency of meeting of the Equitable Access Group shall be the same as for the JMAG, unless otherwise agreed by the Parties in writing.
20. RESOLVING DIFFERENCES
20.1 Resolution by the Joint Oversight Committee. The Partners and CEPI shall cooperate in good faith to attempt to resolve differences and disputes at the JMAG.
20.2 Escalation to Senior Management of the Parties. Any difference or dispute that cannot be resolved by the JMAG shall be submitted to the Parties’ respective Chief Executive Officers or designees for resolution. If the Parties remain unable to resolve such dispute within [***] (or such additional time as mutually agreed in writing), then the Parties irrevocably submit to arbitration for its resolution upon referral of such dispute by a Party pursuant to Clause 20.3.
20.3 Arbitration. Any controversy, dispute, or claim arising out of or relating to this Agreement, or the breach thereof, shall be determined by binding arbitration (including any question regarding its existence, validity or termination or this Agreement), and be referred to and finally resolved under the Rules of the London Court of International Arbitration, which Rules are incorporated by reference into this Clause 20.3. The number of arbitrators shall be three (3). The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English. Notwithstanding the foregoing, any Party may seek specific performance, interim or final injunctive relief or any other relief of similar nature or effect in any court of competent jurisdiction. This Clause shall be governed by and construed in accordance with the law of England and Wales without giving effect to any choice of law or conflict of law provisions or rules that would cause the application of the laws of any other jurisdiction.