Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • Intellectual Property | Exploitation 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

7.3 Transfer of Ownership and Granting of License on Results

7.3.1. Each Beneficiary remains free to transfer its ownership rights in Results.

7.3.2. Where a Beneficiary transfers ownership of Results, it must pass on its obligations specified under the Grant Agreement and the Consortium Agreement to the transferee.

7.3.3. Unless agreed otherwise (in writing) for specifically-identified Third Parties or unless impossible under applicable EU and national laws on mergers and acquisitions, a Beneficiary that intends to transfer ownership of Results must give at least forty-five (45) Days’ notice to the other Beneficiaries that still have (or still may request) Access Rights to the Results. This notification must include sufficient information on the new owner to enable any Beneficiary concerned to assess the effects on its Access Rights.
Unless agreed otherwise (in writing), any other Beneficiary may object within thirty (30) Days of receiving the notification if it can show that the transfer would adversely affect its Access Rights. In this case, the transfer may not take place until an agreement has been reached between the Beneficiaries concerned.

7.3.4.  Notwithstanding the above, a Beneficiary may, without the consent of the other Beneficiaries but provided that the other Beneficiaries are informed [within 60 Days] from the date of transfer and that the transferee agrees in writing to be bound by the Grant Agreement and the Consortium Agreement, transfer its Results to any of the following: a) its Affiliated Entity, b) any purchaser of all or a substantial amount of its relevant assets, and c) any successor entity resulting from the merger with or consolidation of such a Beneficiary.

7.3.5.  Provided that any Access Right to the Results can be exercised (requested and granted) and that any additional obligations under the Grant Agreement or the Consortium Agreement are complied with by the Beneficiary who owns Results, each Beneficiary may license its own Results to any legal entity as it deems fit.

8. Intellectual Property – Access Rights

8.1 General Provisions on Access Rights

8.1.1 Unless otherwise specified in this Consortium Agreement, in order for a Beneficiary to exercise its Access Rights, these must first be requested in writing.

8.1.2 Access Rights under Clauses 8.2.1 (Background for implementation) and 8.3.1. (Results for implementation) are hereby requested in writing by the Beneficiaries by means of signature of the Consortium Agreement. Such Access Rights are hereby granted by the respective Beneficiary by means of signature of the Consortium Agreement. […]

8.1.5 All Access Rights pursuant to the Consortium Agreement shall be granted on a nonexclusive basis and are worldwide, perpetual and irrevocable.

8.1.6 Unless otherwise specified herein, Access Rights granted pursuant to the Consortium Agreement shall not include the right to sub-license such Access Rights. However, a Beneficiary who enjoys Access Rights pursuant to Clauses 8.2.1. (Background for implementation), 8.2.2. (Background for Research Use), 8.3.1. (Results for implementation) and 8.3.2. (Results for Research Use) may authorize another legal entity, for instance an Affiliated Entity, to exercise those rights on the Beneficiary’s behalf, provided that the following conditions are fulfilled: a) the Beneficiary that enjoys Access Rights is liable for the acts of the other legal entity as if those acts had been performed by the Beneficiary; and b) Access Rights granted to the other legal entity do not include the right to sub-license. […]

8.1.10 [Option:][The Research Use Access Right includes that any Beneficiary, or its Affiliated Entities, licensees and designees, may refer to any Results or Background necessary to use such Results of another Beneficiary, in regulatory documentation relating to any product owned by such Beneficiary, or its Affiliated Entities, licensees and designees. Such regulatory documentation may include the marketing authorisation application, patient information leaflet, summary of product characteristics and equivalent documentation anywhere in the world. Prior to the submission of such Results or Background in such regulatory documentation, the submitting Beneficiary shall provide notice of its intent to make such submission to enable the owning Beneficiary to file for Intellectual Property protection covering such Results or Background (related to such Results). In such case the submission may be delayed for [a reasonable period of time] necessary to obtain such a protection.]

8.3 Access Rights to Results

8.3.1 Results – Access Rights to Beneficiaries for implementation

8.3.1.1 During the Action, the Beneficiaries enjoy Access Rights to the Results of the other Beneficiaries, solely for the purpose and to the extent necessary for undertaking and completing the Action.
8.3.1.2 Such Access Rights are granted under Royalty-Free Conditions. […]

8.3.2 Results – Access Rights for Research Use

8.3.2.1 Subject to the provisions of this Consortium Agreement, in particular Clauses 7, 8.1 and 10, during and after completion of the Action, Beneficiaries and their Affiliated Entities enjoy Access Rights to the Results for Research Use.
8.3.2.2 Such Access Rights to Results for the purposes of Research Use are granted on the following Fair and Reasonable Conditions: [Please indicate the option chosen and, if applicable, work out an appropriate arrangement for Option 2.] [___] [Option 1:] [on Royalty-Free Conditions] [Option 2:] [on Fair and Reasonable Conditions other than Royalty Free Conditions] [Detail applicable terms which may include Financial Terms. Conditions for Option 2] […]

8.3.4 Results – Access Rights for Direct Exploitation

8.3.4.1 Beneficiaries are not required to grant Access Rights for Direct Exploitation to their Results.<
8.3.4.2 Where Direct Exploitation of Results owned by a Beneficiary requires Results owned by another Beneficiary, the Access Rights to the Results owned by the other Beneficiary may be negotiated between the Beneficiary owning such Results and the Beneficiary wishing to perform Direct Exploitation.

8.4 Access Rights to Third Parties for Research Use

8.4.1 After completion of the Action, Third Parties have the right to request Access Rights to the Results for Research Use. Such conditions may not be more favorable than the conditions applied between Beneficiaries (and their Affiliated Entities) for Research Use, pursuant to Clause 8.3.2 of the Consortium Agreement.