Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • Intellectual Property | Ownership of results

Definitions

Access Right” means rights to use Results or Background.

Direct Exploitation” means developing results for commercialization, including through clinical trials, or commercializing results themselves. Examples of Direct Exploitation include:

– clinical trials performed on a compound or biomarker itself (to the extent such compound or biomarker can be qualified a Result) with a view to market that compound or biomarker;
– commercialization of a biomarker (to the extent such biomarker can be qualified a Result) as a diagnostic kit.

Research Use” means the use of Results (or Background necessary to use Results), for all purposes other than for completing the Action or for Direct Exploitation, and which includes but is not limited to the application of Results as a tool for research, including clinical research and trials, and which directly or indirectly contributes to the objectives set out in the societal challenges health, demographic change and well-being referred to in Regulation (EU) No 1291/2013 (establishing Horizon 2020). For the avoidance of doubt, the field of Research Use includes, without limitation:

– all pre-clinical research and development activities,
– all human clinical studies on compounds which were not Results of this Action (to the extent Results are used in such activities, e.g. as a tool),
– all activities relating to developing the ability to commercialize any drug substance or drug product (including process development work),
– all activities relating to seeking, obtaining and/or maintaining any regulatory approvals from regulatory authorities [or for the purposes of a medicinal product assessment (as provided for in the applicable local legislation].

To illustrate the distinction between Research Use and Direct Exploitation, an example of Research Use is the application of Results (like an animal model or a biomarker) as a tool for research and clinical research in the discovery, development or commercialisation of pharmaceutical products by for-profit institutions and organisations. However, the commercialization of such biomarker itself as a diagnostic kit would be Direct Exploitation.

7. Intellectual Property – General Provisions on Results

7.1 Ownership of Results

7.1.1 Results are owned by the Beneficiary who generates them.

Option 1: Beneficiaries may agree here that ownership of certain Results, once said Results have been generated, shall be transferred from the initial owner to another Beneficiary.

Option 2: Beneficiaries may agree here that where Results have been generated by one Beneficiary as a result of a cash contribution from another Beneficiary, these Results would be transferred to that second Beneficiary.

7.2 Joint Ownership

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7.2.2 Co-Owners shall conclude in writing a joint ownership agreement defining their respective rights and obligations with respect to the Results.

7.2.3 Unless otherwise agreed in the joint ownership agreement pursuant to Clause 7.2.2, in the case of joint ownership of Results, each Co-Owner is granted a non-exclusive, world-wide, fully paid up, royalty-free, perpetual, irrevocable licence to use the jointly owned Results for Research Use, including the right to grant non-exclusive sub-licences to its Affiliated Entities and to Third Parties without the need to inform the other Co-Owners. Each Co-Owner and its Affiliated Entities shall have a license to use for Direct Exploitation the jointly owned Results, including the right to grant non-exclusive licences subject to the following conditions [Different terms can be determined here]:

[(a)prior notice of at least forty-five (45) Days must be given to any other Co-Owner(s); and,

(b) fair and reasonable compensation must be provided to the other Co-Owners, to be decided on a case-by-case basis.]

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8. Intellectual Property – Access Rights

8.1 General Provisions on Access Rights

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8.1.9 Unless otherwise specified herein, each Beneficiary remains the exclusive owner of its Sideground. Beneficiaries are not required to grant any Access Rights to Sideground.