Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • Intellectual Property | Use of background IP

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.

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 sublicense 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.]

8.2 Access Rights to Background

8.2.1 Access Rights for Implementation

8.2.1.1 During the Action, the Beneficiaries enjoy, unless prevented or restricted from doing so by obligations to others identified pursuant to Clauses 6.1.1 and 6.1.2, Access Rights to the Background of the other Beneficiaries, solely for the purpose and to the extent necessary for undertaking and completing the Action.

8.2.1.2 Such Access Rights are granted under Royalty-Free Conditions. […]

8.2.2 Access Rights for purpose of Research Use of Results

8.2.2.1 [During] and after completion of the Action, Beneficiaries and their Affiliated Entities enjoy Access Rights to the Background of the other Beneficiaries, only to the extent reasonably required for the purpose of the Research Use of Results.

8.2.2.2 Such Access Rights for the purposes of Research Use are granted under Clause 8.2.2.1 on the following Fair and Reasonable Conditions: [Please indicate the option chosen and, if applicable, work out an appropriate arrangement for Option 2. Conditions for Option 2 can also be outlined in the appropriate Annex pursuant to Clause 6.1 of the Consortium Agreement, on a Beneficiary per Beneficiary basis.] [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.] […]

8.2.4 Access Rights for Direct Exploitation

8.2.4.1 Beneficiaries are not required to grant Access Rights for Direct Exploitation to their Background and may use, exploit, sublicense or otherwise commercialize their Background as they see fit, subject to the Access Rights granted for implementation as set forth in Clause 8.2.1.1 and for Research Use as set forth in Clauses 8.2.2.1 and 8.4.2.

8.2.4.2 In the event that Direct Exploitation of Results by a Beneficiary requires Background of another Beneficiary necessary to use such Results the Access Rights to such Background may be negotiated between the Beneficiary owning such Background and the Beneficiaries involved.