Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • Intellectual Property | Exploitation of results

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

8.3.2 Results – Access Rights for Research Use 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. 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 Beneficiaries are not required to grant Access Rights for Direct Exploitation to their Results. 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.