MAPGuide
Equitable Access Toolkit

Dispute Resolution Mechanisms in R&D Funding Agreements

While the partnerships formed through funding agreements may start with the best of intentions, the parties may need to address disagreements at some point during the project. Dispute resolution provisions provide a clear process to follow if disagreements arise, and can support the achievement of swift solutions so that work on the funded project can continue. 

Dispute resolution can take place through informal ‘amicable’ or ‘good faith’ discussions, or through a formal arbitration procedure. Funding agreements often provide for dispute resolution by the project steering committee in the first instance, followed by escalation to senior officials (for example, Chief Executive Officers) for each party, and finally formal arbitration if the informal process is unsuccessful. Some dispute resolutions also provide for different processes depending on the nature of the dispute. For example, expedited processes might be required if a funder considers that there is a need to act to address a public health emergency, or disputes related to specific access commitments may be referred for expert determination.

Examples from the MAPGuide

 The parties shall attempt to resolve disputes through good faith negotiations. Any dispute arising under or related to this Subaward Agreement shall be resolved to the maximum possible extent through informal dispute resolution. Unresolved issues shall be arbitrated in accordance with the International Arbitration Rules of the American Arbitration Association.

Source: taken from the CARB-X (Funder) portfolio company agreement template with subrecipients (Developer). Partner types: non-profit funder, industry/non-profit research organizations/academic institutions; Product type: innovative therapeutics, preventatives and rapid diagnostics targeting drug-resistant bacteria; Development stage at signature: early stage development. Read in context.

Escalation process. Any question, difference or dispute which may arise concerning the construction, meaning or effect of this Agreement, or concerning the rights or liabilities of the Parties hereunder, or any other matter arising out of or in connection with this Agreement shall first be submitted to the Chief Executive Officer of [Funder] and to the Chief Executive Officer of the [Developer] (the “Senior Officers”) for resolution (each of whom may call on others to advise them as they see fit). The Senior Officers shall discuss the matter arising in good faith and in a timely manner and endeavour to reach a mutually agreeable solution. If the Parties are unable to resolve such dispute through such negotiations within [***] of such dispute being escalated to the Senior Officers, then in respect of any dispute, controversy or claim the Parties irrevocably submit to arbitration in accordance with Clause [x – arbitration].

Arbitration. Any disputes to be resolved by binding arbitration pursuant to Clause [x – escalation]  (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 deemed to be incorporated by reference into this Clause. The number of arbitrators shall be one. 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.

Public Health License. If [Funder] invokes its rights under a Public Health License, then the Parties will pursue an expedited resolution of any differences under Clause [x – escalation] within [***]. However, because of the exigent circumstances when there is an Outbreak, [Developer] agrees that [Funder] may proceed under a Public Health License, but [Developer] retains its right right to seek injunctive relief in addition to any other rights or remedies it may have under this Agreement, at law or in equity.

Source: taken from a USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.

In the event that the Parties acting in good faith are unable to agree the terms of the licences or assignments referred to in Clause [x – funder exploitation rights] above in connection with the Project IPRs and the Products within the one hundred eighty (180) day time period, the Parties shall escalate the dispute for resolution by a senior executive of each Party, who shall attempt to resolve the dispute within a further thirty (30) days. If the Parties remain unable to resolve the dispute, any Party may refer the matter for resolution in accordance with Clause [x – expert determination] prior to referral for final resolution under Clause [x – governing law].

Where any [Funder] nominee referred to in Clause [x – funder exploitation rights] above is not acceptable to the Company (acting in good faith) on reasonable grounds, the Company shall notify [Funder] promptly in writing of the objection and the reasonable grounds, [Funder] shall not appoint such third party as its nominee (unless subsequently approved by an Expert) and [Funder] shall propose an alternative nominee. Where the Parties are unable to agree upon a mutually acceptable [Funder] nominees, the Parties shall escalate the dispute for resolution by a senior executive of each Party, who shall attempt to resolve the dispute within a further thirty (30) days. If the Parties remain unable to resolve the dispute, any Party may refer the matter for resolution in accordance with Clause [x – expert determination] prior to referral for final resolution under Clause [x – governing law].

[…]

Where any Clause of this Agreement provides for a matter to be referred for non-binding resolution by an expert, the expert appointed to resolve such matter (the “Expert“) shall be an independent expert whose appointment is agreed between the Parties.

If the Parties are unable to agree on an Expert within ten (10) Business Days of either Party serving details of a suggested expert on the other, either Party shall then be entitled to request the President for the time being of the Institute of Intellectual Property Licensing or of the Chartered Accountants in England and Wales (as is most applicable to the matter in dispute) to appoint an Expert of repute with appropriate qualifications, expertise, experience and skill in the issue in dispute.

The Parties shall be required to make submissions to the Expert with respect to the matter in dispute, which shall be limited to forty (40) pages, inclusive of exhibits, provided that with respect to any dispute referred to the Expert under Clause [x – disputes regarding funder exploitation rights], each Party may include a draft of such Party’s proposed license agreement or license terms, which may be in excess of the foregoing 40-page limit. The Parties shall provide (or procure that others provide) the Expert with such assistance and documents as the Expert shall reasonably require for the purposes of making their determination. The Expert shall prescribe the time period in which the Parties will be required to provide such submissions, which shall not exceed thirty (30) Business Days following the Expert’s appointment.

The Expert shall be required to use their diligent efforts to deliver a notice setting out his/her determination within thirty (30) Business Days following receipt of the Parties’ submissions. With respect to any dispute as to valuation, the Expert shall adopt a valuation method which he/she considers, in his/her absolute discretion, to be the most appropriate method for the matter upon which determination is required.

 The Parties shall provide each other with such reasonable information as will enable them to make submissions under Clause [x].

The Expert shall act as an expert and not as an arbitrator and either Party shall have the right to refer the dispute, if not resolved on the basis of the Expert’s determination, to final resolution in accordance with Clause [x – governing law].

The costs of any reference to an Expert under this Clause 16 shall be borne by the Parties equally.

Source: taken from a USD $11.7 million convertible loan agreement between the Wellcome Trust (Funder) and Alto Neuroscience (Developer). Partner types: philanthropic funder, industry; Product type: bipolar depression therapeutic; Development stage at signature: phase 2b clinical trials. Read in context.

Price Commitment: In the event that the Parties are unable to agree on a revised Price Commitment, an independent third–party, with specific expertise in assessing costs, [**]. and with experience with vaccines, reasonably acceptable to both Parties, shall be appointed to provide analysis of such potential adjustment upon the request of either Party and the cost of such analysis shall be shared equally by the Parties. That analysis will be shared with [Developer] and the [Funder] who will work together to resolve any adjustments to the Price Commitment. If there is no resolution within forty–five (45) days, the matter will be referred to [Developer]’s President/CEO and the [Funder]’s President of Global Health (or the equivalent in the event of any reorganization following which such position no longer exists). If these individuals are unable to resolve the matter of the revised Price Commitment based on this analysis within a further forty–five (45) days, then the price will be adjusted upwards in event that the third party analysis points to an upward adjustment or downwards if the third party analysis points to a downward adjustment, in each case, capped as follows: if the parties are unable to agree with respect to the first adjustment of the [**], then the adjustment shall be [**], as the case may be (based on the direction of the third party analysis) and if the parties are unable to agree as to any subsequent adjustments to the [**], then the adjustment shall be [**] as the case may be (based on the direction of the third party analysis).

Dispute resolution: Any disputes or conflicts relating to the Project will first be attempted to be resolved by the Parties designated representatives in a timely manner. In the event an issue cannot be resolved by the Parties representatives, the President/CEO of the [Developer] and the President of Global Health of the [Funder] will meet within thirty (30) days for the purposes of resolution. Notwithstanding the forgoing, neither party waives any legal or other remedy it may have in law or equity under the Grant Agreement or this GACA.

Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.

Related Considerations

What are each party’s rights and obligations if unsuccessful dispute resolution results in agreement termination? What are the funder’s rights for ensuring continuity of product development and the access objectives of the agreement if dispute resolution is unsuccessful?

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.