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:
11.1.2. 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.