Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • IP ownership & licensing | Use of background IP

§8.1 General Provisions on Access Right

Request in Writing: Unless otherwise specified in this Consortium Agreement, in order for a Beneficiary to exercise its Access Rights, these must first be requested in writing. (§8.1.1) Access Rights to Background for implementation, Access Rights to Results for implementation, and Access Right for Research Use are hereby requested in writing by the Beneficiaries by way of signature of the Consortium Agreement, and are hereby granted by the respective Beneficiary, by means of signature of the Consortium Agreement. (§8.1.2 & §8.1.3)

Scope of Access Rights: All Access Rights pursuant to the Consortium Agreement shall be granted on a nonexclusive basis and are worldwide, perpetual and irrevocable. (§8.1.5) Such Access Rights shall not include the right to sub-license such Access Rights. However, a Beneficiary who enjoys Access Rights 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. (§8.1.6)

The Research Use Access Right (As an 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 authorization 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.] (§8.1.10)

§8.2 Access Rights to Background

Access Rights for Implementation: 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. Such Access Rights are granted under Royalty-Free Condition. (§8.2.1.1)

Access Rights for purpose of Research Use of Results: 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. [The parties can indicate the choice of Royalty-Free condition or Fair and Reasonable Conditions other than Royalty Free condition.] (§8.2.2)

Access Rights for Direct Exploitation: 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. (§8.2.4.1) 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. (§8.2.4.2)

§8.4 Access Rights to Third Parties for Research Use

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.