This issue identifies provisions that describe the responsibilities and decision-making authorities of parties to an agreement, as well as dispute resolution procedures. Governance provisions are important in order to establish clear boundaries between the roles of each party and to describe any matters requiring joint decision-making input. These provisions often set out the framework for joint committees to oversee project progress and provide technical or strategic advice.

Questions to consider when developing governance provisions

• Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
• Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
• Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
• What are the resolution mechanisms for disputes related to the agreement?
• Are there any requirements for policies or procedures to manage potential conflicts of interest?
  

Example approaches found in the MAPGuide

• Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
  
  • Provisions establishing a JSC or similar joint project governance committee are most commonly found in R&D funding, licensing, and collaboration agreements in the MAPGuide. These provisions often address:
    
    • Structure: The composition of a JSC varies between agreements, but it is often composed of an equal number of participants from each party. Some agreements also include mechanisms for third parties to be invited to attend JSC meetings under appropriate confidentiality arrangements.
    • Responsibilities: Some common responsibilities of JSCs include reviewing progress against a project plan, discussing any challenges or delays to progress, providing advice on development, manufacturing and/or commercialization plans, reviewing and providing input on clinical trial protocols, providing input on regulatory matters, reviewing written progress and financial reports, reviewing proposed publications, and acting as a forum for dispute resolution.
    • Decision-making authority: Examples of JSC decision-making authorities in MAPGuide agreements include approving the completion of milestones or deliverables, and making changes to product development or commercialization plans. Limitations on JSC authority often include changes to the overall budget or scope of the project, or to the terms and conditions of the agreement.
    • Voting rights and decision-making processes: 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. Some agreements also include escalation procedures in case of a lack of consensus (see dispute resolution below).

• Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
  
  • Some MAPGuide agreements provide for committees to oversee specific technical aspects of a project. Examples include:
    
    • An IP committee to discuss the management of intellectual property generated under the agreement (particularly joint IP under collaboration agreements).
    • An independent clinical trial steering committee and/or a Data Safety Monitoring Board for agreements that provide for the conduct of clinical trials.
    • An equitable access committee to review, update, and monitor an equitable access plan.
  • Some agreements also designate a principal investigator or project lead from one or both parties, who is considered critical to the delivery of the project. Replacement of this individual is often subject to an approval process, and potentially agreement termination if no suitable replacement can be agreed.
  • Another individual position designated in some MAPGuide agreements is an alliance or collaboration manager from each party who is responsible for facilitating communications and coordination between the parties.

• Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
  
  • The meeting schedules set out in MAPGuide provisions related to roles and responsibilities range from ‘every two weeks’ to ‘quarterly’, with some agreements requiring only ‘regular’ or ‘ad hoc’ meetings.
  • Some agreements set expectations that meetings will be held in-person, whereas others specify the use of teleconferences.

• What are the resolution mechanisms for disputes related to the agreement?
  
  • Dispute resolution provisions included in the MAPGuide often outline the following process:
    
    • The parties will first attempt to resolve the dispute through good faith discussions, sometimes conducted through a joint steering committee;
    • Failing resolution, the matter is escalated to the chief executive officers (or other senior representatives) of the parties;
    • In the event that a dispute cannot be resolved through good faith discussions or escalation processes, the parties may pursue arbitration (or in some cases litigation) in accordance with the rules of a specified arbitrator or under the jurisdiction of a certain court.
  • In some cases, dispute resolution provisions include mechanisms for expedited resolution of certain matters, for example due to urgent needs to resolve the dispute in order to respond to a public health emergency.
    Some agreements in the MAPGuide also outline different resolution processes, such as referral to a third party expert, for specific matters.

• Are there any requirements for policies or procedures to manage potential conflicts of interest?
  
  • Some agreements in the MAPGuide include provisions related to the management of potential conflicts of interest including requiring agreement parties to have a conflict of interest policy in place, and prompt notification of any perceived or actual conflicts.