MAPGuideⓇ
Equitable Access Toolkit
Target Product Profile Obligations in Collaboration and License Agreements
Target Product Profiles (TPPs) set out the desired characteristics for innovative vaccines, therapeutics, diagnostics or medical devices. The WHO develops TPPs for priority products (or Preferred Product Characteristics for product classes at early stages of development), however funders, product development partnerships and/or innovators may also develop TPPs or target characteristics for products in their portfolios. TPPs that are developed in consultation with relevant stakeholders, including patients, can be used to guide R&D activities and increase the likelihood that an end product will be appropriate and adoptable for all of the patients that need it.
In some circumstances, license agreements may include commitments to undertake product development activities to achieve a TPP or target characteristics intended to facilitate access to a licensed product. However, such provisions are most likely to be appropriate for earlier stage license and collaboration agreements where the development activities under the agreement may still have an impact on the characteristics of the end product, rather than licenses to manufacture and commercialize generic or biosimilar medicines.
Where relevant, TPP-related considerations may be included in access plans or development plans attached to a license and collaboration agreements. Agreements may also include mechanisms for the parties to assess progress towards, and make amendments to, the target profile as product development progresses. An additional consideration for collaboration agreements may be the inclusion of a “first option” for an organization to continue as a development or commercialization partner in a future project if the initial collaboration identifies a product candidate meeting a target profile.
Examples from the MAPGuide
“Development Plan” shall mean a development plan outlining the non-clinical and clinical development plans and CMC plans for the Drug Product to meet the criteria of the TPP, which Development Plan is attached as Schedule [x] hereto, as amended from time to time in accordance with the terms of this Agreement;
Related Definitions: “Target Product Profile” or “TPP” shall mean the set of potential characteristics and attributes for the Drug Product, described in Schedule [x] hereto, and revised from time to time by mutual consent through the JSC.
Source: taken from a collaboration agreement between Entasis Therapeutics and GARDP. Partner types: PDP, industry; Product type: gonorrhea treatment (zoliflodacin); Development stage at signature: Phase III clinical trials. Read in context.
Partner shall have the right of first negotiation to become the Development Partner and participate in the Development Program pursuant to the Development Agreement (such right, the “Development Option”). Partner (or its Affiliate) may exercise the Development Option within a period of < ninety (90) days > after the designation by the JRC of a Clinical Candidate by giving notice in writing to DNDi.
Related definitions: “Clinical Candidate” shall mean any active pharmaceutical ingredient derived from a Molecule, which: a) has completed all the Investigational New Drug /Investigational Medicinal Product (or equivalent) enabling studies; b) meets DNDi’s published target candidate profile (TCP) and has the potential to meet the target product profile (TPP) for < a disease of > the Field; c) has the potential to be developed as a Product for < such disease/the Field >; and d) is a suitable candidate for the Development Program as a result of the Research Program.
Source: taken from DNDi’s template Research Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from early stage discovery through to pre-clinical studies. Read in context.
How will development of a TPP be coordinated as part of end-to-end access planning?
Will the TPP form part of an access plan annexed to the agreement?
Are affordable and sustainable pricing commitments aligned with any target pricing identified in the TPP?
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.