Master Alliance Provisions Guide (MAPGuide)

CEPI – VBI, COVID-19 Vaccine Development Funding Agreement

  • Business model | Governance

Definitions

Stage Gate” means a mutually agreed “go/no go” decision point to continue a given Work Package or to commence activities in another Work Package, as set out in the iPDP.

2. Project Organisation and Management

2.1 Team Charter. The Project shall be managed by the Parties as described in the Team Charter in Annex B.

2.2 iPDP and Work Packages. Awardee shall use Commercially Reasonable Efforts to undertake the Project as described in the iPDP, including achieving the milestones and timelines of each Work Package and achieving each Stage Gate within the agreed timeframe, it being understood that neither Party can assure a positive technical outcome for any Work Package. The Project is organised into one or more Work Packages and each Work Package has an associated budget as set out in the Budget. The Work Packages shall be pursued and performed by Awardee in accordance with the Budget and the iPDP. CEPI will pay the Awardee in accordance with the Budget and the iPDP and, where applicable, upon completion of a Stage Gate (as determined pursuant to Clause 2.5). Additional Work Package(s) may be agreed in writing by the Parties after the Effective Date, which, upon execution by both Parties, shall be annexed to and become a part of this Agreement. Work Packages may also be modified or extended with the mutual written consent of both Parties in accordance with Clause 22.6.

2.3 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 Team Charter to monitor progress of and advance the Project. The JMAG shall coordinate the efforts of CEPI and Awardee to:

(a) facilitate communications between the Parties;

(b) review the progress of the Project;

(c) discuss substantial proposed changes in the scope or conduct of applicable clinical and animal studies;

(d) discuss clinical trial protocols, publications and regulatory submissions;

(e) coordinate the sharing of any Project Results identified in a Work Package as intended for use by other CEPI awardees;

(f) review and update the Project Continuity Plan;

(g) review and update the Equitable Access Plan; and

(h) discuss plans, as appropriate, for the development of manufacturing and its scale-up and scale-out.

2.4 Technical Reports and Access to Project Results. Awardee shall disclose all Project Results to CEPI’s Project Lead, at meetings of the JMAG and shall provide written reports of progress made under the iPDP using a template provided by CEPI (“Technical Reports”), within twenty (20) Business Days of the end of each calendar quarter during the term of the Project as set out in the iPDP. In addition, the Awardee shall make Project Results available to CEPI as described in the iPDP or otherwise as may reasonably be requested from time to time by CEPI.

2.5 Stage Gate Review. Unless otherwise addressed in a Work Package for a given Stage Gate, when Awardee believes that a Stage Gate in a Work Package will be achieved in the near term, Awardee 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”). Awardee’s Project Manager shall coordinate with CEPI’s Project Manager to schedule a Stage Gate Review Committee meeting as early as possible, but no later than fifteen (15) Business Days before the planned meeting date. CEPI shall notify Awardee of the Stage Gate Review Committee’s decision as soon as possible, but no later than twenty (20) Business Days after the meeting date. If the Stage Gate Review Committee determines that the Stage Gate was not completed, CEPI shall promptly discuss with Awardee potential actions to be taken in order to complete such Stage Gate.

21. Resolving Differences

21.1 Resolution by the JMAG. Awardee and CEPI shall cooperate in good faith to resolve differences and disputes about the Project (including any disputes under Clause 15.3) at the JMAG.

21.2 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 sixty (60) days of referral to the Chief Executive Officers or designees for resolution (or such additional time as mutually agreed in writing), then, with the exception of disputes relating to intellectual property, the Parties irrevocably submit to arbitration for its resolution upon referral of such dispute by either Party pursuant to Clause 21.3.

21.3 Arbitration. Any disputes to be resolved by binding arbitration (including any question regarding its existence, validity or termination or this Agreement), shall be referred to and finally resolved by arbitration under the Rules of the London Court of International Arbitration, which Rules are incorporated by reference into this Clause. 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.

21.4 Public Health Licence. If CEPI invokes its rights under a Public Health Licence under Clause 13, then the Parties shall pursue an expedited resolution of any differences under Clause 21.2 within fourteen (14) days. However, because of the exigent circumstances in the Outbreak, Awardee agrees that CEPI may proceed under a Public Health Licence and the ultimate resolution of any dispute shall be limited to the recovery of monetary damages by Awardee under Clause 21.3 rather than any injunctive relief except to the extent that the dispute relates to disclosure of Confidential Information or to public safety.