MAPGuideⓇ
Equitable Access Toolkit
Product Uptake and Adoption Considerations for License Agreements
Equitable access to a licensed product depends on successful product introduction and adoption so that the product can reach the patients that need it. Consideration of the activities needed to support the sustainable uptake of a product can be addressed through the development of an access roadmap. These activities may also form part of an innovator and/or licensee’s broader access programs. In some circumstances, it may also be appropriate to include activities that will directly support product uptake within the scope of a license agreement. These obligations could include:
Undertaking studies to support implementation of the licensed product.
Engagement with communities or end users during the product development process.
Cooperating with activities undertaken by the licensor or third parties to support the inclusion of the licensed product in national policy or treatment guidelines.
Undertaking publication and dissemination activities to increase product visibility and make data available to support uptake activities.
Providing training to local practitioners to promote awareness and appropriate use of the product.
Incorporating stewardship considerations into product sales and marketing activities, for example acting in compliance with recognized industry guidelines for combating AMR.
Ensuring timely launch readiness planning, potentially with oversight from a joint steering committee.
If applicable for the product (e.g., diagnostics or devices), establishing mechanisms for local product maintenance services.
Examples from the MAPGuide
Licensee (itself or through a permitted sublicensee) will use Commercially Reasonable Efforts (without regard to profitability of the Licensed Product to Licensee or any permitted sublicensee) to perform the outreach activities described in the plan attached as Schedule [x] hereto (“Outreach Plan”). As part of the Outreach Plan, Licensee will publicly announce a reduced price program for underrepresented communities to the extent not already described in the press release described in Section [x].
Source: taken from a license agreement between The Population Council (Licensor), and TherapeuticsMD, Inc. (Licensee). Partner types: non-profit research organization, industry; Product type: contraceptive (Nestorone); Development stage at signature: FDA regulatory review. Read in context.
SIIPL shall use best efforts to implement the Launch Readiness Plan for Key Countries in accordance with agreed timelines. […] SIIPL shall use best efforts to ensure the SIIPL Product is added onto the National Immunization Program of India and other Key Countries within [***] of Regulatory Approval of the SIIPL Product in India and other Key Countries, as applicable.
Source: taken from a license agreement between Valneva (Licensor) and Serum Institute of India (Licensee). This provision is passed through from a funding agreement between CEPI and Valneva. Partner types: industry, industry; Product type: chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
Specific activities of the Steering Committee: […] Conferences and meetings: decide on conference participation for presentation on the data relating to the project with the goal of improving visibility of the ARV-SDN formulations and help with uptake; review and approve publications, including conference abstracts, presentations and posters, and publications intended for submission to academic/clinical journals.
Source: taken from a license agreement between the University of Liverpool (Licensor) and MPP (Licensee). Partner types: multilateral, academic institution; Product type: HIV therapeutic (nanomedicine); Development stage at signature: early clinical. Read in context.
If the Licensed Product meets the TRP [Target Regimen Profile] and Licensee elects in its sole discretion to directly seek marketing authorization and to itself commercialize the Licensed Product, Licensee will then launch the Licensed Product(s) in a manner that facilitates its widespread availability in Target Countries (which will be prioritized by Licensee based on cost-effectiveness, impact and other relevant factors), which reasonable efforts shall include seeking to obtain adequate manufacturing capacity, adequate supply of product meeting specifications, registration of Licensed Product(s) with applicable local and global health authorities, participation in local tenders and making available to local policy makers information regarding the Licensed Product(s).
Source: taken from a sublicense agreement between MPP and Gates MRI under a head license agreement between Pfizer and MPP. Partner types: multilateral, non-profit research institution; Product type: TB therapeutic (sutezolid); Development stage at signature: phase IIa clinical trials. Read in context.
The Licensee agrees, after its First Commercial Sale and as part of its marketing and product promotion, to develop educational materials (e.g., brochures, website, etc.) directed to patients and physicians detailing the Licensed Products or medical aspects of the prophylactic and therapeutic uses of the Licensed Products.
Source: taken from the standard terms and conditions for an exclusive or non-exclusive patent license from the U.S. National Institutes of Health. Partner types: public research agency, industry; Product type: multiple; Development stage at signature: multiple. Read in context.
How will the requirements to support product uptake under the license agreement integrate with broader activities as part of end-to-end access planning?
How will the publication of data and results support policy decisions and increase product visibility?
Will a joint steering committee or other governance body or advisory committee have oversight over product launch planning?
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.