“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.
2. Project Management and Organization
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. The Project shall be described in an iPDP in Annex C and organized into one or more Work Packages, having an associated Budget attached in Annex D. The Parties may agree to multiple Work Packages as of the Effective Date, some of which shall be pursued in parallel, others of which shall commence upon the occurrence of Stage Gates and others being optional and exercisable in CEPI’s discretion. A Work Package may include one or more Stage Gates. Additional Work Packages may be added as additional annexes to this Agreement as agreed in writing by the Parties pursuant to Section 21.6. Work Packages may also be modified or extended with mutual written consent pursuant to Section 21.6.
2.3 Joint Monitoring and Advisory Group. The Team Charter establishes a joint monitoring and advisement group (“JMAG”) that shall meet and interact regularly on a [***] basis to advance the Project. The JMAG shall undertake to provide coordinated efforts by CEPI and Awardee to: (i) facilitate communications between the Parties; (ii) review the progress of the Project; (iii) discuss substantial proposed changes in the scope or conduct of applicable clinical and animal studies; (iv) discuss clinical trial protocols, publications and regulatory submissions; (v) coordinate the sharing of any Project Results identified in a Work Package as intended for use by other CEPI awardees; (vi) review and update the Project Continuity Plan; (vii) review and update the Equitable Access Plan; and (viii) 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 Project Results informally to CEPI’s Project Lead, at meetings of the JMAG and through regular written reports of progress made under the iPDP using a template provided by CEPI (“Technical Reports”), within [***] of a Project’s [***]. Awardee also shall make Project Results available to CEPI as described in the iPDP or otherwise as may reasonably be requested.
2.5. Stage Gates. When Awardee believes that a Stage Gate in a Work Package will be achieved, Awardee shall notify the JMAG, [***] provide relevant information and request a meeting of CEPI’s committee authorized to assess completion of Stage Gates (“Stage Gate Review Committee”). Awardee’s Project Manager shall coordinate with CEPI’s Project Manager to schedule the Stage Gate Review Committee meeting to be held no more than [***] after the request. CEPI shall notify Awardee of the Stage Gate Review Committee’s decision no more than [***] after its meeting. If the Stage Gate Review Committee agrees that a Stage Gate has been successfully achieved, the JMAG shall [***] authorize Awardee to continue previously agreed Work Package activities. When a Stage Gate has not been achieved to the reasonable satisfaction of the Stage Gate Review Committee, the JMAG shall [***] discuss in good faith how to address this and whether amendments to the relevant Work Package would address the issue or increase the probability of a successful outcome to the Project.
2.6 Affiliates and Subawardees. Awardee’s activities may be undertaken by Affiliates and contracted third parties (collectively, “Subawardees”) that are identified in a Work Package or reasonably approved by JMAG. Awardee shall be responsible for the acts and omissions of all of its Subawardees. Awardee shall ensure that: (i) Subawardees engaged as procurements pursuant to Clause 14 of the Third Party Code agree to the terms of the Third Party Code applicable to their activities; and (ii) Subawardees engaged as sub–grant awardees pursuant to Clause 15 of the Third Party Code (“Sub–Grant Awardees”) agree to be subject to the Third Party Code and to all of the obligations applicable to Awardee under this Agreement, including obligations for the auditing, inspections, record keeping, use of funds and all other compliance obligations as are applicable to Awardee under this Agreement.
2.7 Services Provided by Other CEPI Funding Recipients. Awardee acknowledges that a particular Work Package may require a further contract to be negotiated directly between Awardee and another recipient of CEPI funding, through which certain Services are provided directly to Awardee.
2.8. [***] Awardee shall use [***] to achieve the objectives and timelines of each Work Package and to meet each Stage Gate in a Work Package within the agreed timeframe, it being understood that neither Party can assure a positive technical outcome for any Work Package.
20. Resolving Differences
20.1. Resolution by the JMAG. Awardee and CEPI shall cooperate in good faith to resolve differences and disputes about the Project 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, then the Parties irrevocably submit to arbitration for its resolution.
20.3. 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 [***], which Rules are incorporated by reference into this Clause. The number of arbitrators shall be three. The seat, or legal place, of arbitration shall be [***]. 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. The seat, or legal place, of arbitration shall be [***]. 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.
20.4. Public Health License. If CEPI invokes its rights under a Public Health License under Clause 13, then the Parties shall pursue [***]. However, because of the exigent circumstances in the Outbreak, Awardee agrees that CEPI [***] and the ultimate resolution of any dispute shall be [***].
Annex B – Team Charter For the COVID–19 agreement package Novavax, Inc. – Development of a SARS–CoV–2 recombinant spike protein nanoparticle vaccine (SARS–CoV–2 rS) with Matrix–M Adjuvant
This “Team Charter” describes the operation and the governance of the SARS–CoV–2 rS Vaccine Development Program. The aim of this Team Charter is to provide project management and operational guidance. It is designed to function as an operational document to explain the roles and responsibilities of Awardee (“Project Team”) and CEPI while also setting out how the Project will operate in practice. In the event of any conflict between this Team Charter and the Terms and Conditions of the Agreement, the Terms and Conditions shall prevail in all circumstances. Unless specifically defined in this Team Charter, all defined terms shall have the same meaning as set out in the Terms and Conditions. The objectives of the Project are described in the Integrated Product Development Plan (“IPDP”). For document locations, please refer to section 7 “Document Management and Archiving”, below.
1. Project Team Composition and Responsibility. It is the responsibility of the Project Team to perform the work described in the IPDP pursuant to certain Work Packages on the terms of the Agreement. The Project Team will be comprised of: Awardee’s Project Lead (“Project Lead”): [***] Awardee’s Project Manager (“Project Manager”): [***] Additional details of the Project Team members and Project Team structure are set out in Schedule 1 to this Annex.
2. CEPI Team Composition and Responsibility. The CEPI team will be composed of a project lead (CEPI Project Lead), a project manager (CEPI Project Manager), and a contract manager (CEPI Contract Manager). This team will be supplemented from time to time by relevant experts, internal or external to CEPI under appropriate confidentiality arrangements to be parts of the JMAG or sub–teams depending on the specific needs of the project. The responsibility of the CEPI team in the Project is:
- To mobilize experts and consultants in order to support the Project Team to overcome obstacles during the Project. This function is offered on an ad–hoc basis;
- To be part of the JMAG with its responsibilities;
- To oversee that project milestones and deliverables are met according to the Agreement and its schedules; and
- To ensure that CEPI ’ s investment is closely monitored and that funds are distributed in accordance with the Agreement.
3. Project Governance Structure. The Project governance structure is set out in Schedule 2 to this Annex.
- The Awardee’s Project Lead should encourage all Project Team members to contribute to the development strategy.
- The style of communication is encouraged to be objective, open and direct.
- Personal accountability in the Project Team should be pre–defined and clearly articulated along with a set of measurable actions and deadlines, together with definition of roles and responsibilities.
- If there is a risk that deadlines or other Project requirements will not be met, the first approach is for precautions and counter measures to be taken by the Project Team.
4. Joint Monitoring and Advisory Group Composition (JMAG) JMAG’s Remit. The JMAG shall be entitled to:
- 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;
- approve the achievement of milestones (but shall not have the right to approve final Project completion);
- provide a forum for discussion as to whether the activities currently agreed to are sufficient to satisfy CEPI’s Mission;
- have the authority to approve extensions to Work Package timelines up to [***] of the originally planned timeframe as set out in the relevant Work Package[***];
- have the authority to approve transfer of funds between cost categories within a Project Budget, [***];
- review and approve proposed changes and updates to the IPDP;
- review and approve the regulatory strategy for the use of the Product and receive regular updates on regulatory filings and submissions;
- review the contractual and operational status and capabilities of Trusted Collaborator(s);
- approve the [***] IPDP Reports;
- review any reports and updates provided by any site visit groups;
- provide a forum for coordinating the Parties’ responses to issues with respect to a Product, to the extent relating to CEPI’s use in the Field, including unexpected disruptions to the supply of the Product, recalls, safety issues or withdrawals of Product;
- receive written notification of all Project Results; and
- make such other decisions as may be delegated to the JMAG pursuant to the Agreement or by written agreement of the Parties.
Limitations on JMAG
The JMAG has no right to do any of the acts set out below. These acts can only be done by CEPI or jointly by the Parties as set out in the Agreement:
- confirm willingness to fund any additional Work Packages (such decision is to be made solely by CEPI);
- approve the Financial Reports;
- approve completion of the Project;
- amend or vary the provisions of the Terms and Conditions
- approve any Sub–Awardee(s) to the extent not identified in the IPDP
- alter the fundamental scope or objectives or agreed completion date of the Project; and
- approve an overall increase to a Project Budget or timeline.
The JMAG Members shall be comprised of the following persons:
- Two “Voting Members”, who will be the Awardee Project Lead (who shall also be the chairperson of the JMAG) and the CEPI Project Lead. The Awardee Project Lead or nominee and the CEPI representative or nominee shall both have the right to vote on matters brought before the JMAG and falling within the JMAG remit. CEPI may, at its sole discretion, appoint or remove the CEPI representative or nominee by notice in writing to theAwardee; and
- “Non–Voting Members” Each of the Parties may invite those persons whose special skills or knowledge might advance the Project, to attend and address the JMAG meetings as observers. Such Non–Voting Members shall not have a right to participate in the JMAG decision–making process. The Project Lead shall ensure that any such attendees sign confidentiality agreements in a form acceptable to all Parties. Each Party shall pay for the reasonable documented travel expenses and/or consulting fees of the Non–Voting Members it proposed and shall ensure that such travel is conducted in accordance with CEPI’s TravelPolicy.
The quorum for JMAG meetings shall be the [***]. Decisions of the JMAG shall be made by [***]. Where consensus cannot be reached, the matter shall be escalated in accordance with Clause 21 of the Agreement.
The Project Lead or his/her designee, shall be responsible for organising JMAG meetings, including preparing meeting papers and ensuring that minutes of meetings are produced promptly after each meeting and circulated to Members in a timely manner.
5. Project Team and JMAG Team Meetings. Each team, sub–team and JMAG will have a kickoff meeting to start its activities and a final meeting to end the operation of the team/sub–team and capture the lessons learned.
It is suggested that the following meetings will take place throughout the Project.
Please note, that this list is only suggested best practice. Given the nature of the COVID–19emergency, it is likely that more frequent communication may well be necessary.
6. Communication with Stakeholders. Stakeholder communications regarding the Project between CEPI and the Awardee should be reviewed and approved by the JMAG. In order to maintain open communication with these stakeholders, copies of the final minutes will be distributed on request to CEPI and Awardee organization members, who are bound by confidentiality restrictions. The two Project Leads(Awardee and CEPI) will consult each other prior to any communication to third parties, presentations, press releases, conference data presentation about the Project.
7. Special treatment of Data and Materials with the COVID–19 Community. The Awardee shall advise the JMAG when they believe that the sharing of any particular data set or biological material might foster the development of vaccine candidates against COVID–19. The JMAG will discuss whether and how such data or materials could be shared with other CEPI awardees or the broader COVID–19 research community, under appropriate contractual provisions, including confidentiality.
Following agreement by the JMAG, it is the responsibility of the Awardee’s Project Leader to ensure such data or material is shared The identification and distribution of the material will be identified in the IPDP during the Project as mutually agreed.
8. Document Management and Archiving. The Awardee shall provide and maintain a secure computer platform satisfactory to the Parties to serve as a repository of Project documents (“the Secure Portal”).
It is the responsibility of the Project Manager to ensure that relevant documents are posted on theSecure Portal in a timely manner, including: agenda and meeting minutes of JMAG and Project team meetings, target product profile, the IPDP, planning documents, Risk Register, Project Budget,Financial and IPDP Reports and organizational charts.
The JMAG will agree to a list of JMAG members that will have access to the Secure Portal.
9. Planning. The Project Lead, or their nominated deputy, is responsible for maintaining the following plans for the Project (“Project Plans”), the frequency of updates of which will be agreed by the JMAG:
- Project Gantt chart: used for tracking and risk management (Microsoft Project file)
- iPDP: should be regarded as a “living document” and updated regularly (Microsoft Word document). These updates should be reviewed by JMAG.
- Risk register: used for risk management, updated every [***]
10. Budgets. Within each Work Package, the Awardee Project Lead is accountable for managing the budget, and CEPI is accountable for making payments in accordance with the Agreement.
11. Review of Team Charter. This Team Charter may be amended as required by a decision of the JMAG.
Schedule 1: Project Team Members and Structure
Schedule 2: Project Governance Structure