“Data” means any and all scientific, technical or test data pertaining to Product that is generated by or on behalf of the Partner in the course of performance of studies or activities contemplated in any Work Phase, the Development Plan or this Agreement including Know-How, research data, clinical pharmacology data, CMC data (including analytical and quality control data and stability data), pre-clinical data, clinical data, information concerning clinical trials, pharmacoeconomic data, and also including any and all such data in publications, presentations or submissions made in association with a Regulatory Filing with respect to Product.
“Escrow Materials” means Confidential Information, Data, Materials and Regulatory Filings that is retained by an escrow agent in accordance with Clause 9.4
“Increased Outbreak Preparation Need” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates in the Field, Funder determines, in its sole discretion, that there is a heightened need for the Product.
“Material” means any chemical or biological substance used in or created, devised or generated during the Project including any: i. organic or inorganic element; ii. nucleotide or nucleotide sequence including DNA and RNA sequences; iii. gene; iv. vector or construct including plasmids, phages or viruses; v. host organism including bacteria, fungi, algae, protozoa and hybridomas; vi. eukaryotic or prokaryotic cell line or expression system or any development strain or product of that cell line or expression system; vii. protein including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or a peptide enzyme or antibody; viii. drug or pro-drug including bulk drug substance, filled product and any manufacturing intermediates; ix. assay or reagent; x. any other genetic or biological material or micro-organism; xi. transgenic animals; and xii. clinical samples.
“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.
9. Conditions Precedent and Funder step-in Rights
9.1 Funder Step-in Rights and Conditions Precedent. Funder shall not be entitled to Develop, Market or otherwise exploit Product whether itself or through third parties unless and until one or more of the events set out below occurs:
9.1.1. the Partner materially fails to Develop the Product in accordance with the Development Plan except where the Parties agree such failure is due to reasonable scientific, safety or regulatory issues;
9.1.2. the Partner fails to use Reasonable Efforts to satisfy any Milestone by the relevant Milestone Date;
9.1.3. the Partner notifies Funder that it has elected either not to (i) Develop the Product for use in the Field or (ii) Market Product for use in the Field in one or more countries or regions in the Affected Territory;
9.1.4. the occurrence of any of the events set out in Clauses 15.2 or 15.3 (or both);
9.1.5 in the event of an Outbreak or Increased Outbreak Preparation Need, and (i) the Partner informs Funder that it will not be able to manufacture or deploy the Product in appropriate timescales and quantities or at a cost appropriate to the Outbreak or Increased Outbreak Preparation Need; or (ii) in Funder’s reasonable judgement, the Partner cannot or will not take all necessary steps in a timely manner to manufacture or deploy the Product in quantities and at a cost appropriate to the Outbreak or Increased Outbreak Preparation Need.
9.1.6. if Funder opts to exercise its step-in rights in either of the events set out in Clause 8.2 and 8.3; (each a “Condition Precedent” and together, the “Conditions Precedent”).
9.2. Effects of the occurrence of one or more Conditions Precedent. On the occurrence of one or more of the Conditions Precedent:
9.2.1. Funder shall notify the Partner in writing of the occurrence of one or more Conditions Precedent;
9.2.2. Funder may exercise the rights granted under the Licences;
9.2.3. Funder shall have the discretion to make any and all decisions in relation to the Development and Marketing of the Product in the Field for use in the Affected Territory and if so instructed by Funder in writing, the Partner shall cease Developing and Marketing Product.
9.2.4. The Partner shall use all reasonable endeavours to give assistance to Funder (or its nominees) in relation to the Development and Marketing of the Product for use in the Affected Territory including: i. assisting in the transfer to Funder or its nominee Existing Data, Data, Materials, Confidential Information and Regulatory Filings (including the Master File) necessary or desirable for the Funder or its nominee to conduct such Development and Marketing of the Product in the Field for use in the Affected Territory; and ii. executing any necessary documents.
9.2.5. Funder shall have the right to take all such action as it shall consider necessary or appropriate at its discretion and expense to bring or defend an action on behalf of the Partner. The Partner shall (at the Partner’s cost) provide all reasonable assistance to Funder as Funder may request in relation to such action, including granting Funder the right to bring an action in the name of the Partner if necessary.
9.2.6. The Escrow Materials shall be released immediately to Funder or its nominee.
9.3 Development and Use Licenses. The Partner hereby grants to Funder with effect from the Effective Date and for all rights, data and materials not in existence at the Effective Date, shall grant on their creation:
9.3.1. a non-exclusive, irrevocable, worldwide, royalty-free licence, under the Foreground Intellectual Property with the right to grant sublicences to (i) Develop the Product worldwide for use in the Field, (ii) Manufacture the Product worldwide for use in the Field and (iii) Market the Product in the Field for use in the Affected Territory; and
9.3.2. a non-exclusive, irrevocable, worldwide, royalty-free licence, with the right to grant sublicenses under Background Intellectual Property to (i) Develop the Product worldwide for use in the Field, (ii) Manufacture the Product worldwide for use in the Field and (iii) Market the Product in the Field for use in the Affected Territory; and
9.3.3. a non-exclusive, irrevocable, worldwide, royalty-free licence, with the right to grant sub licences to use the Existing Data, the Data, Confidential Information, Regulatory Filings, Master File and Materials to (i) Develop the Product worldwide for use in the Field, (ii) Manufacture the Product worldwide for use in the Field and (iii) Market the Product in the Field for use in the Affected Territory; and
9.3.4. where the Condition Precedent is also a breach of this Agreement by Partner, the licence granted under Clause 9.3.1 shall be an exclusive, irrevocable, worldwide, royalty-free licence;
(together, the “Licences”); provided however that Funder may not exercise the rights granted under the Licences unless and until the occurrence of one or more Conditions Precedent.
9.4 Escrow. The Partner shall as soon as reasonably practical after the Effective Date, establish escrow arrangements with a mutually agreed third party escrow agent (the “Escrow Agent”) upon terms which are acceptable to Funder (acting reasonably), pursuant to an escrow agreement entered into by the Escrow Agent, the Partner and Funder. Such escrow agreement shall allow Funder access to Confidential Information, Existing Data, Data, Materials and Regulatory Filings, including the Master File, and any supporting data for the Background Intellectual Property and Foreground Intellectual Property relating to Product in the Field for use in the Affected Territory as necessary or useful for the Development and Marketing of the Product in the Field for use in the Affected Territory by Funder or a third party. The escrow arrangements may extend, as necessary and appropriate to biological materials, cell-lines, software, source code for manufacturing processes, assays, most up to date pathogen samples and the like. The Partner shall make ensure that all materials required to be placed in escrow are in escrow and complete and up to date at the time Partner requests any Milestone Payment from Funder. Funder shall only be able to access the escrow with the consent of the Partner or if any of the events described in Clause 9.1 have occurred.
9.5. No implied licences. Except for the rights and licences expressly granted under this Agreement, the Partner retains all rights under its Intellectual Property and no rights shall be deemed granted by the Partner to FUNDER by implication, estoppel or otherwise.
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.
10.4 Background Intellectual Property. The Partner shall make the Background Intellectual Property available for use in all Work Phases and for the protection or exploitation of the Foreground Intellectual Property. The Partner shall retain responsibility for seeking and maintaining protection for the Background Intellectual Property at its own cost and shall not assign or otherwise convey any of its interest, right and title in the same without Funder’s prior written consent, not to be unreasonably withheld, conditioned or delayed.
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.