DNDi Template Development Collaboration and License Agreement

Business model | Benefit sharing

Annotations

This template Development Collaboration and License Agreement (“DCLA”) was published by DNDi alongside a paper in the Journal of Intellectual Property Law and Practice which explains the rationale for some key provisions. The paper also includes examples of DNDi’s approaches to negotiating the template language, recognizing the importance of adapting provisions for different contexts.

The DCLA is intended for collaboration on activities from Phase 1 clinical trials through to proof of concept in humans. DNDi may enter into a DCLA as a follow-on from an initial Research Collaboration and License Agreement, or as a standalone development collaboration. The parties will undertake a Development and Distribution Program including clinical development, manufacturing and distribution of a product for treatment of specified disease(s) (“Field”). Distribution will be on an Affordable Basis in all countries in which one or more of the diseases of the Field is endemic (“Territory”).

The parties will draw-up a high level Access and Implementation Plan at the start of the program and establish detailed plans on a country level upon agreement of a Regulatory Strategy for a particular country. The parties will also prepare a product needs forecast for the Territory which will be used to inform the Access and Implementation Plan and the Regulatory Strategy.

The DCLA includes mutual license grants between the parties under background and foreground intellectual property. The licenses are non‐exclusive, worldwide, perpetual, irrevocable, fully paid, royalty‐free and sublicensable. The licenses may be used for the performance of the Development and Distribution Program, as well as for other non-commercial research purposes. The partner may also commercialize the product in the Field outside of the Territory, as long as it is at a price that allows a purchaser to buy the product in sufficient quantity to meet public health or individual needs. The partner may only grant sublicenses if the sublicense undertakes to commercialize the product on an Affordable Basis in the Territory.

Provision Language

Definitionsstrong>em>p>
“PRVstrong>” shall mean the Food and Drug Administration (“FDA”) priority review voucher program in the United States of America.p>
“Regulatory Advantagestrong>” shall mean the PRV or any equivalent incentive program to the PRV from a <a href=”#kt“>Regulatory Authoritya> regarding a Product.p>
8. REGULATORY ADVANTAGEstrong>span>p>
8.1strong> The Parties acknowledge that both Parties will actively contribute to the Development and Distribution Program and agree to share the economic benefits of any Regulatory Advantage.p>
8.2strong> In the event Partner (or any of its Affiliates) obtains a Regulatory Advantage from the <a href=”#kt“>Marketing Authorisation a> of a Product: a) < to complete >p>

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DNDi Template Development Collaboration and License Agreement

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Master Alliance Provisions Guide (MAPGuide)

DNDi Template Development Collaboration and License Agreement

Provision Language

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