Master Alliance Provisions Guide (MAPGuide)

Funder Development Partnering Agreement

  • Intellectual Property | Ownership of IP

Definitions

Project Invention” means any discovery, development, Know-How, invention or improvement created, devised or arising out of the undertaking and performance of any Work Phase.

Project Patents” means any patent applications made which claim any Project Inventions, any patents resulting from any such applications, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them in all countries, including any divisional applications and divisional patents, refiling, renewals, continuations, continuations-in-part, patents of addition, extensions (including patent term extensions), reissues, substitutions, confirmations, registrations, revalidations, pipeline and administrative protections and additions, and any equivalents of the foregoing in any and all countries of or to any of them, as well as any supplementary protection certificates and equivalent protection rights in respect of any of them.

10. Intellectual Property – Ownership and Protection

10.1 Foreground Intellectual Property. The Partner shall procure that the Project Lead monitors the work carried out under all Work Phases for material that may be the subject of Project Inventions and shall promptly notify the JMAG of any such Project Invention. The Partner shall additionally promptly disclose all Project Inventions and Foreground Intellectual Property to Funder in writing.

10.2 In the event that any Foreground Intellectual Property arises, it shall be the property of the Partner; any Project Patents shall be applied for in the name of the Partner. To this end, the Partner shall procure that:

10.2.1 Any Affiliate, third party collaborator, third party funder or sub-contractor shall assign all its right, title and interest in any results or Foreground Intellectual Property arising from work carried out under the Project promptly to the Partner and shall retain no rights in the same; and

10.2.2 it shall have in place contracts with those working on or funding all Work Phases of the Project to ensure that the Foreground Intellectual Property shall vest in the Partner and not with any members of staff individually. Where by local applicable law such rights do vest in individual members of staff, the Partner shall promptly exercise all rights to take and assignment of all right title and interest in the same. The Partner shall bear the costs of any necessary contribution to such individual or other costs of assignment.

11. Intellectual Property – Management and Exploitation

11.1 Consent. In order to ensure that any proposed exploitation is in accordance with the FUNDER’s Mission, the Partner shall obtain FUNDER’s prior written consent before exploiting any of the Foreground Intellectual Property or any Product. FUNDER shall only withhold its consent to exploitation:

11.1.1. where the proposed exploitation in the Field in the Affected Territory is inconsistent with the FUNDER Mission, the FUNDER Policies or the provisions of this Clause;

11.1.2. FUNDER has material concerns about the capability, solvency or reputation of any third party who is proposed to be involved in the exploitation; or

11.1.3. the Partner plans to transfer the Foreground Intellectual Property to a third party but does not also intend to transfer to the third party the Partner’s obligations to FUNDER under this Agreement in such a way that FUNDER could enforce such obligations directly against such third party.

11.2. Exploitation outside the Field or outside the Affected Territory. Where any proposed exploitation by the Partner is either:

11.2.1. in the Field, but with Development and Marketing Activities directed outside the Affected Territory; or

11.2.2. outside the Field and for Development and Marketing Activities directed outside the Affected Territory;

11.2.3. FUNDER’s consent shall be conditional on the following: (i) the Partner shall be the sponsor of any clinical trial of a pharmaceutical composition which infringes the Foreground Intellectual Property (a “Similar Product”) unless FUNDER otherwise agrees in writing; (ii) the Partner shall consult with and agree the protocol for such clinical trial with FUNDER in advance and shall not proceed with any such clinical trial without FUNDER’s approval, such approval not to be unreasonably withheld, conditioned or delayed; (iii) the Partner shall communicate to FUNDER in writing any data relating to a Similar Product of which it becomes aware which discloses a serious adverse event, promptly (and in any event within forty-eight (48) hours) and where that serious adverse event is a suspected, unexpected, serious adverse reaction or death or raised any other material safety signal, immediately; (iv) any relevant event under any pharmacovigilance activities and (v) shall grant FUNDER a right of reference to the regulatory materials relating to any and all Similar Products.