MAPGuideⓇ: Equitable Access Toolkit
How Can Governance Provisions Support
the Achievement of Equitable Access?
the Achievement of Equitable Access?
Governance provisions, alongside reporting requirements, are a mechanism that enables funders to monitor a developer’s progress and use of funds on a project. Joint governance bodies, such as a steering committee, often support decision making on important strategic or technical aspects of the project and can provide a forum for problem-solving and discussion of potential matters of disagreement.
While joint steering committees are a common approach to project governance, some agreements use a less formal structure such as periodic update meetings between the project leaders. Other agreements, particularly those involving a substantial scope of work and amount of funding, have multiple committees for advice on different aspects of the project, for example, scientific or regulatory management committees.
Funding agreement provisions that establish governance committees should address:
- Structure: The required number of committee members from each party varies depending on the context of the agreement. Some agreements establish fairly small committees, whereas others may require attendance from a wide range of subject matter experts and collaboration partners. Additionally, some governance committee structures allow occasional attendance from third party experts or observers upon the execution of appropriate confidentiality agreements.
- Responsibilities: The responsibilities of a governance committee depend on whether it is intended to act as an overall steering committee or to address specific technical aspects of a project. Some common responsibilities of overall steering committees include reviewing progress against a project plan, discussing any challenges or delays to progress, approving the achievement of milestones, reviewing written progress and financial reports, and reviewing proposed publications.
- Decision-making authority: There are varying approaches in funding agreements as to what decisions a governance committee can make and which members can make the decision. Governance committees often have decision-making authorities related to changes to the details of a project plan but do not have wider authority to make changes to the scope of the project or to the terms and conditions of the funding agreement. Some agreements allocate a decision-making vote to each committee member, whereas others may only give a voting right to a project leader from each party. Additionally, some agreements require consensus between voting members on the decisions made, whereas others grant one party a casting vote in case of differences in opinion. There may also be escalation procedures in case of a lack of consensus.
- Meeting frequency and format: The frequency at which a governance committee is required to meet can depend on the scope, duration, and perceived risk level of the project. Some projects may require monthly meetings, whereas others may be quarterly or annually. Some agreements set expectations that meetings will be held in-person, whereas others specify the use of teleconferences. There are advantages and challenges with both formats that may need to be addressed by allowing for flexibility depending on the needs of the project at different points in time. Other considerations for meeting frequency and format should include resource capacity for meeting attendance and follow-up as well as the associated costs, particularly for in-person meetings with significant travel requirements
Examples from the MAPGuide
“PVS and Aridis shall form a Scientific/Technical Management Committee. The purpose of such Committee shall be to review, evaluate and offer input with respect to the efforts and activities under the Project Plan on an ad hoc basis. Without limiting the foregoing, the Committee shall be responsible for overseeing the Project Plan in a manner consistent with the Agreement, including, but not limited to, (i) reviewing the progress of the Project Plan, including by way of example, review of Aridis activities and progress; (ii) providing technical guidance and recommendations in support of the selected formulations; and (iii) such other matters as from time to time the Parties consider necessary for the advancement of the Project Plan.”
Source: taken from a development funding & collaboration agreement between PATH (Funder) and Aridis (Developer) for the formulation development of a rotavirus vaccine. Read in context.
“The [Developer] and the [Funder] will each designate up to [**] individuals to be part of a progress review group (the “Progress Review Group”) that will provide a forum for discussion of the progress of the Company’s [product] development program (including [product] being developed for use in developed countries) and the Funded Developments. The Progress Review Group will meet via teleconference at least [**] (unless both parties agree that any [**] meeting will be conducted via teleconference). With the agreement of both parties and subject to the execution of appropriate confidentiality agreements, third parties may be invited from time to time to participate in certain Progress Review Group discussions.“
Source: taken from a strategic relationship agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer) in connection with an $8 million investment by the Foundation to support a Staphylococcus aureus antibody development program. Read in context.
“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 [Funder] and [Developer] to: (a) facilitate communication 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 [Funder] 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. “
Source: taken from an outbreak response agreement between CEPI (Funder) and Variation Biotechnologies Inc (Developer) for the development of COVID-19 vaccine candidates. Read in context.
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 [Funder]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 [product development plan];
- 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 [Funder]’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 [Funder] 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 [Funder]);
- 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.
JMAG Composition: The JMAG Members shall be comprised of the following persons:
Two “Voting Members”, who will be the [Developer] Project Lead (who shall also be the chairperson of the JMAG) and the CEPI Project Lead. The [Developer] Project Lead or nominee and the [Funder] representative or nominee shall both have the right to vote on matters brought before the JMAG and falling within the JMAG remit. [Funder] may, at its sole discretion, appoint or remove the [Funder] representative or nominee by notice in writing to the [Developer]; 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 [Funder]’s Travel Policy.
Quorum: 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.
Meeting Organisation: 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.”
Source: taken from a development funding agreement between CEPI (funder) and Novavax (developer) for a COVID-19 vaccine. Read in context.
For the Term of this Agreement the Parties shall establish a Steering Committee (“SC”) for the governance of the Research Plan.
The SC shall be responsible for overseeing the progress and implementation of the Research Plan in a manner consistent with the terms of this Agreement, including, but not limited to (i) making routine decisions about the direction of the research program and for advising on allocation of resources and (ii) recommending the modification of the Research Plan (which recommendation shall be adopted or not by the Parties in accordance with this Agreement). The SC may decide to establish subsidiary bodies, with functions and memberships they chose. Such subsidiary bodies may include a technical advisory group to provide supplemental scientific or technical advice to the SC that adds to such advice available to the SC from the Parties themselves.
The SC will be comprised of the Project Leaders from ………………….. The Foundation will be represented on the SC in an ex officio capacity and will not have a vote.
All decisions of the SC shall be made by unanimous agreement of the Parties, with each member of the SC having one (1) vote each. The Parties shall use their best efforts to resolve any differences brought to the attention of the SC. In the event the SC cannot reach unanimity with respect to any issues, such issues shall be referred for further review and resolution to a senior executive of the Parties identified by them for this purpose (including, for example the President/Chief Executive Officer, in the case of the Companies, or an academic dean, in the case of the Institutes). Such officers of each Party shall use reasonable efforts to decide such matter by mutual agreement within thirty (30) days after the matter is referred to them.
The SC shall meet as needed during the Term of this Agreement. The Parties shall meet via teleconference or in person at a location to be mutually agreed upon.
The initial chairperson of the SC shall be selected by the members of the SC having a vote on the SC. The role of the chairperson shall be to convene and preside at meetings of the SC and to ensure the preparation of the agenda and the minutes, but the chairperson shall have no additional powers or rights beyond those held by the other SC representatives. Each Party shall be responsible for all travel and related costs for its representatives to attend meetings of, and otherwise participate in, the SC.
Source: taken from an anonymised agreement for a collaboration between an academic institution and a company, supported by a funder. Read in context.
The Parties shall form a collaboration management team (the “Steering Committee”) consisting of a maximum of four members, two of whom shall be nominated by each Party, whose responsibilities shall include:
(i) monitoring the progress of the Project under this Agreement;
(ii) making recommendations to both Parties for continuation, modification or termination of the Agreement;
(iii) overseeing all operational activities under the Project; and
(iv) any other matter attributed to the Steering Committee under this Agreement.
Steering Committee meetings shall be conducted at least every 2 months, unless otherwise agreed between the Parties. Meetings may be at a mutually agreed location or by conference call, or video conference, or any combination of these. The Steering Committee shall take all its decisions by consensus, provided however that if no consensus is reached, FIND shall have a casting vote, except for resolutions on any matter requiring additional financial commitment not provided for under this Agreement from any Party, which always require the consent of all members of the Steering Committee. At its first meeting, the Steering Committee shall agree on its operating rules and procedures such as standing agenda items, recording of minutes and action items. The Parties may mutually agree to the participation of Third Parties in the Steering Committee.
Source: taken from template terms and conditions included in a FIND (funder) request for proposals for the development of a point-of-care liver function tests platform adapted to low resource settings. Read in context.
As soon as practicable following the Commencement Date, the [Funder] and [Developer] shall establish a Research Steering Group (“RSG”) to oversee the Programme, which shall:
- monitor the performance and technical content of the Programme against the description outlined in the Application;
- assess the ongoing results of the Programme and what has been learnt and agree future research;
- critically assess the results of the Programme;
- identify and address any weaknesses or delays in the Programme;
- co-ordinate internal and outsourced components of the Programme, including agreeing on whether to pursue any collaborations or subcontracts not specifically identified in the Application;
- modify or authorise modifications to the implementation of the Programme (including the implementation of theProgramme objectives) as necessary from time to time;
- operate as the key forum through which the [Funder] shall be informed as to progress of the Programme and through which the [Funder] shall liaise with [Developer] concerning the conduct of the Programme, including preparing an annual written report for the [Funder] on progress;
- advise the [Funder] when and whether each of the research phases, Milestones or targets of the Programme have been achieved; and
- review all proposed public disclosures relating to the Programme, including proposed presentations, posters and papers (ensuring that the contribution of the [Funder] is acknowledged in all such proposed publications and that the [Funder]’s Award number is quoted) and advise the [Funder] as to the RSG’s reasonable recommendations in respect of such proposed publications;
provided that the RSG shall have no right to amend or vary the terms of this Agreement or to alter the fundamental scope or objectives of the Programme which power is reserved to the Parties.
The RSG shall be established and run by the Parties as follows:
- The RSG shall comprise the following persons (“Members”): (i) [**] representatives of [Developer], one of whom shall be the Principal Investigator; (ii) at least one independent industry adviser with experience which is relevant to the Programme; (iii) [**] representatives or nominees of the [Funder]’s Technology Transfer Division (at the [Funder]’s option).
- The [Funder] shall have the option to appoint up to [**] Members and up to [**] observers to the RSG, to remove any Member or observer appointed by it and to appoint any person to fill a vacancy arising from the removal or retirement of such Member or observer. In the event that the [Funder] does not appoint any Member or observer, the [Funder] shall have the right to receive all papers that a Member or observer would be entitled to receive.
- [Developer] shall have the option to appoint up to [**] Members and up to [**] observers to the RSG, to remove any Member or observer appointed by it and to appoint any person to fill a vacancy arising from the removal or retirement of such Member or observer; provided, that the Principal Investigator shall always be one of [Developer]’s Members.
- [Developer] and the [Funder] shall jointly agree the identity of the Members of the RSG who are independent industry adviser(s). The costs and expenses of the independent industry adviser(s) shall be met out of the Award Amount.
- The Principal Investigator shall be the chairperson of the RSG (“RSG Chair ”) and shall be responsible for organising meetings of the RSG, including preparing papers prior to meetings and ensuring that minutes of meetings are produced promptly after each meeting. All papers and minutes shall be circulated to each Member in a timely manner. Except in exceptional circumstances (when the Principal Investigator may nominate another person as his alternate), the Principal Investigator shall attend all RSG meetings.
- The quorum for RSG meetings shall be [**] Members including a [**]. Decisions of the RSG shall be made by majority agreement with each Party entitled to cast one (1) vote regardless of the number of Members present. If the RSG is unable to reach agreement on a decision, the decision shall be escalated to the Director of Technology Transfer at the [Funder] and the head of Discovery Research at [Developer] for resolution. For the avoidance of doubt, any observers appointed by the Parties shall not be Members of the RSG and shall not have a right to participate in its decision-making process unless otherwise agreed in writing by [Developer] and the [Funder].
Meetings of the RSG shall be convened by the Principal Investigator as required but at least [**] months (or less frequently with the consent of the [Funder]) for the duration of the Programme Term, on not less than [**] Business Days’ written notice (to be accompanied by an agenda for the meeting). Following the end of the Programme Term, the RSG shall meet within [**]Business Days to discuss and report on the outcomes of the Programme, and shall thereafter be dissolved.
Any or all Members may, with the prior consent of the RSG Chair, attend a meeting of the RSG by telephone or other electronic means rather than in person, provided that all Members attending the meeting can hear and be heard for all parts of the meeting. For the avoidance of doubt, RSG Members attending a meeting by telephone or other electronic means shall have the same voting rights as an RSG Member present in person.
A representative from any key outsourcing suppliers, collaborators or subcontractors involved in the Programme (if any) shall be invited to RSG meetings as an observer. The RSG shall also have power to invite persons whose special skills or influence might advance the Programme to attend and address meetings of the RSG. Such persons shall not be Members of the RSG and shall not have a right to participate in its decision-making process. The RSG Chair shall ensure that any such invitees sign confidentiality agreements in a form acceptable to all parties
Source: taken from a research funding agreement between the Wellcome Trust (funder) and PTC Therapeutics (developer) under the Trust’s Seeding Drug Discovery Strategic Award Programme for the discovery and development of a novel glioblastoma treatment. Read in context.
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.
Authors: Bridie Telford
First publication date: November 21, 2022