DNDi Template Development Collaboration and License Agreement

Intellectual property | Ownership of IP
Intellectual property | Protection of IP

Structural Questions

Ownership of IP

Is the ownership of background intellectual property impacted by this agreement?
What is the scope of background intellectual property?
How will sideground intellectual property be treated?
Who will own new intellectual property arising from the project?

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
Can the IP owner abandon the prosecution or maintenance of a patent?
How should IP protection expenses be allocated between the parties?

Summary of Approaches

Ownership of IP

Is the ownership of background intellectual property impacted by this agreement?
- Each party retains ownership of its own background IP.
What is the scope of background intellectual property? How will sideground intellectual property be treated?
- Background Technology is that which is: (i) owned by or licensed to an agreement party by any third party with a right to sublicense; ii) exists as of the agreement Effective Date or is developed by a party after the Effective Date but outside the scope of the agreement; and c) is necessary or useful for the other party to perform the activities under the Research Program and to exercise the licenses granted.
Who will own new intellectual property arising from the project?
- Each party will own the Collaboration Technology that it develops.

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
- The parties acknowledge that DNDi’s policy is that technology should be available to all interested persons in order to support DNDi’s mission. In the paper accompanying the publication of this template, DNDi states that “patenting by DNDi is the exception rather than the rule”. It also notes that, in several agreements, DNDi and its partners committed to place results in the public domain rather than protecting them. The paper provides details of the patents that have been filed by DNDi, along with the rationale for the filings.
- The parties agree not to seek or enforce any regulatory exclusivities that are obtained as a result of a Marketing Authorization.

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

Definitions

“Collaboration Technology” shall mean any Technology that is made, developed, conceived and reduced to practice by either Party (or on its behalf) during the performance of the Development and Distribution Program. Collaboration Technology includes Partner Collaboration Technology and DNDi Collaboration Technology.

“DNDi Background Technology” shall mean any Technology that: a) is owned by or licensed to DNDi or its Affiliates by any Third Party with a right to sublicense; b) exists as of the Effective Date or is made, developed or conceived and reduced to practice thereafter by DNDi (or on its behalf) or its licensor outside the scope of this Agreement; and c) is necessary or useful for the Partner to perform the activities under the Development and Distribution Program and to exercise the licenses granted hereunder.

“DNDi Collaboration Technology” shall mean any Technology that is made, developed, conceived and reduced to practice by DNDi (or on its behalf) during the performance of the Development and Distribution Program.

“Partner Background Technology” shall mean any Technology that: a) is owned by or licensed to Partner or its Affiliates by any Third Party with a right to sublicense; b) exists as of the Effective Date or is made, developed, conceived and reduced to practice thereafter by Partner (or on its behalf) or its licensor outside the scope of this Agreement; and c) is necessary or useful for DNDi to perform the activities under the Development and Distribution Program and to exercise the licenses granted hereunder.

“Partner Collaboration Technology” shall mean any Technology that is made, developed, conceived and reduced to practice by Partner (or on its behalf) during the performance of the Development and Distribution Program.

16. OWNERSHIP OF TECHNOLOGY

16.1 All rights in, title to and interest in the DNDi Background Technology and DNDi Collaboration Technology shall be owned by DNDi.

16.2 All rights in, title to and interest in the Partner Background Technology and Partner Collaboration Technology shall be owned by Partner.

16.3 For the avoidance of doubt, any Regulatory Dossier developed by Partner for Regulatory Approval shall be the property of Partner, subject to the rights of DNDi to the Technology contained in such dossier, as described in this Agreement.

16.4 Both Parties agree, where applicable and to the extent that they are able, (a) to not seek or (b) to waive, regulatory exclusivity in relation to any data relating to the Product and arising directly or indirectly from the Marketing Authorization of the Product.

16.5 Each Party shall take all necessary and proper acts to effectuate the ownership provisions provided in this Article 16.

16.6 It is understood that, as of the Effective Date, DNDi’s policy with regard to Technology is that it should be accessible to all interested persons to foster DNDi’s Mission.

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DNDi Template Development Collaboration and License Agreement

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