Master Alliance Provisions Guide (MAPGuide)

Information Sharing

This issue refers to the sharing of project-related data and information between the parties to an agreement. Some information sharing obligations are triggered by the occurrence of specific events, for example the achievement of milestones, new project inventions or product improvements, or major delays. In addition, structured reports are often required on a quarterly or annual basis as an opportunity to review key performance indicators related to a project.

Information sharing provisions are important because they enable agreement parties to assess whether their partners continue to be willing and able to meet their obligations.

Public disclosure of data and information is addressed under Publication of ResultsProvisions relating to the sharing of regulatory information can be found under Regulatory Strategy.

Questions to consider when developing provisions for information sharing

  • What information must be shared between the parties?
  • What is the required timeline for sharing information?
  • How is the receiving party permitted to use the information received?
  • What are the requirements for structured progress or financial reports?
  • Do the parties have the right to verify the information reported?

Example approaches found in the MAPGuide

  • What information must be shared between the parties?
    • Some agreements in the MAPGuide, particularly those for product development funding, include a general requirement for the developer to share project-related data.
    • A number of MAPGuide agreements require one party to inform the other if they become aware of any information that would affect the possibility for successful completion of the project. This could include clinical trial data that indicates the product is unlikely to obtain regulatory approval.
    • In some advance purchase agreements in the MAPGuide, the purchaser is entitled to request progress updates or access to data from the product developer with respect to information including clinical development, manufacturing capacity, supply chain and the use of upfront payments. Some of these provisions include caveats in the event that the developer is not legally permitted to share certain information.
    • Some agreements in the MAPGuide require the disclosure of intellectual property used or created as part of the project. This may include both background intellectual property (i.e. it existed prior to the execution of the agreement) and foreground intellectual property (for example, new inventions or improvements to existing products).
  • What is the required timeline for sharing information?
    • Some information sharing provisions in the MAPGuide require proactive sharing of information in certain circumstances (e.g. information that may impact successful completion of the project), but other information may only be required upon the request of the other party.
    • Some of the advance purchase agreements in the MAPGuide restrict the information sharing obligations to the period prior to the grant of full marketing authorization for the product.
  • How is the receiving party permitted to use the information received?
    • Some development funding agreements in the MAPGuide allow the funder to share the project-related information shared by the developer with third parties, as long as they have signed a confidentiality agreement. In some cases, sharing with third parties is also limited to a specified purpose such as performing comparative assessments across a portfolio of projects, or analysis of safety data.
  • What are the requirements for structured progress or financial reports?
    • Many agreements in the MAPGuide include a requirement for financial reports to provide information about costs and/or revenues associated with a project. Development funding agreements often require the developer to provide reports of their actual costs to date compared to what was included in the project budget. License agreements are likely to include a requirement for the licensee to provide details of their total revenue from sales of the product and how they have calculated the royalties due to the licensor.
    • Some MAPGuide agreements, particularly those related to product development, also require reports on the progress of development, manufacturing and/or commercialization activities under the agreement.
  • Do the parties have the right to verify the information reported?
    • Agreements in the MAPGuide often include audit rights which allow one party to review the original records that support the reports from the other party. These rights are most commonly found in relation to financial reports, but in some cases may extend to other records that could be used to assess a party’s compliance with the terms of an agreement.