Funding agreement for not-for-profit organisations - HEALTH by nyut545e2

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									Draft. Subject to contract                                                                 Confidential



                      HEALTH INNOVATION CHALLENGE FUNDING AGREEMENT



This Agreement is made on                                      2010 between the following parties

A.     TRUST

       Name:                 THE WELLCOME TRUST LIMITED, a company registered in England &
                             Wales as Trustee of the Wellcome Trust, a charity registered in England
                             under no. 210183 (the “Trust”)

       Company no:           2711000

       Address:              Technology Transfer, The Wellcome Trust, 215 Euston Road,
                             London, NW1 2BE

       Contact:              Wellcome Technology Transfer

       Tel:                  +44 (0)20 7611 8202

       E-mail:               techtransfer@wellcome.ac.uk

B.     DEPARTMENT

       Name:                 THE SECRETARY OF STATE FOR HEALTH acting through the
                             DEPARTMENT OF HEALTH (the "Department")

       Address:              Central Commissioning Facility, Grange House, 15 Church Street,
                             Twickenham, TW1 3NL


       Contact:              Assistant Director, Health Innovation Challenge Fund

       Tel:                  +44 (0)208 8843 8000

       E-mail:               [email]

C.     ORGANISATION

       Name:                 [name] (the “Organisation”)

       Address:              [address]

       Contact:              [contact]

       Tel:                  [telephone]

       E-mail:               [email]




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TABLE OF CONTENTS



1.     INTERPRETATION ........................................................................................................................ 3

2.     USE OF FUNDING......................................................................................................................... 7

3.     MILESTONE PAYMENTS ............................................................................................................. 7

4.     REPORTING .................................................................................................................................. 8

5.     PROJECT STAFF AND CONDUCT............................................................................................... 8

6.     PROJECT MANAGEMENT............................................................................................................ 9

7.     SITE VISIT GROUP........................................................................................................................ 9

8.     PROJECT COLLABORATORS AND SUBCONTRACTORS ...................................................... 10

9.     INTELLECTUAL PROPERTY – OWNERSHIP, PROTECTION AND MANAGEMENT ............... 10

10.        AUDIT ...................................................................................................................................... 12

11.        PUBLICATIONS AND ANNOUNCEMENTS............................................................................ 12

12.        CONFIDENTIALITY ................................................................................................................. 13

13.        DURATION AND TERMINATION ............................................................................................ 15

14.        WARRANTIES AND LIABILITY............................................................................................... 16

15.        ESCALATION AND DISPUTE RESOLUTION PROCEDURE................................................. 17

16.        FORCE MAJEURE .................................................................................................................. 17

17.        GENERAL................................................................................................................................ 17

SCHEDULE 1 ....................................................................................................................................... 21

SCHEDULE 2 ....................................................................................................................................... 22

SCHEDULE 3 ....................................................................................................................................... 23

SCHEDULE 4 ....................................................................................................................................... 35

SCHEDULE 5 ....................................................................................................................................... 36

SCHEDULE 6 ....................................................................................................................................... 37

SCHEDULE 7 ....................................................................................................................................... 39

SCHEDULE 8 ....................................................................................................................................... 42

[SCHEDULE 9] ..................................................................................................................................... 55

SCHEDULE 10 ………………………………………………………………………………………………...56




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RECITALS:

      (A)   The Grantors have agreed in principle to make an award of £● (● pounds sterling) (the
            “Award Amount”) to the Organisation to support a study entitled “[xx]”.

      (B)   The Parties have agreed that the Project (as defined below) shall be managed and carried
            out in accordance with the provisions of this Agreement.



IT IS AGREED as follows:

1.             INTERPRETATION

               In this Agreement:

1.1            "Agreement" means this agreement;

1.2            "Application" means the application made by the Organisation for a grant under the
               Healthcare Innovation Challenge Fund and attached at Schedule 1;

1.3            “Award Amount” has the meaning given in Recital A;

1.4            "Award Letter" means the letter from the Grantors specifying the amount of the Grant
               that has been awarded;

1.5            “Background Intellectual Property” means any Intellectual Property created, devised,
               generated, owned or licensed by the Organisation or to which the Organisation has rights
               prior to the Effective Date, which is necessary or useful for undertaking the Project or the
               protection or exploitation of the Project Intellectual Property , including without limitation
               [list any specific patents];

1.6            "Business Day" means any day which is not a Saturday, Sunday or a bank holiday or
               public holiday in [Scotland or] England and Wales;

1.7            "Commencement Date" means the date of the last signature of this Agreement;

1.8            “Conditions” means the conditions set out at Schedule 2 [(if any)] which must be
               satisfied (to the reasonable satisfaction of the Grantors) at all times during the Project;

1.9            “Confidential Information” means any and all data, results, Know-How, show how,
               software, plans, details of research work, discoveries, inventions, intended publications,
               intended or pending patent applications, designs, technical information, business plans,
               budgets and strategies, business or financial information or other information in any
               medium and in any form, and any physical items, prototypes, compounds, samples,
               components or other articles or Materials disclosed on or after the Effective Date of this
               Agreement by one Party to another Party whether orally or in writing or in any other form;

1.10           “Documents” means reports, research notes, charts, graphs, comments, computations,
               analyses, recordings, photographs, paper, notebooks, books, files, ledgers, records,
               tapes, discs, diskettes, CD-ROMs, computer programs and documents thereof, computer
               information storage means, samples of material, other graphic or written data and any
               other media on which Know-How can be permanently stored;

1.11           “Drawdown Notice” means a notice in writing signed by the Organisation as detailed in
               Schedule 10 of this Agreement;

1.12           "End of Grant Research Report" means a form on which the Organisation reports on
               the activities funded by the Grant, which must be completed by the principal Grantholder



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               and submitted to the Grantors within two (2) months of the end of the Grant Period or as
               otherwise required by the Grantors;

1.13           "End of Grant Spend Report" means a form completed by the Organisation that must
               be submitted to the Grantors within three (3) months of the end of the Grant Period or as
               otherwise required by the Grantors and that sets out:

                a)           a comparison of (i) actual expenditure by the Organisation during the Grant
                             Period on the Grant and (ii) the total amount awarded by the Grantors in
                             respect of the Grant;

                b)           an explanation for any variances between (i) and (ii) above, and

                c)           any further information that the Grantors request from the Organisation;

1.14           “Equity Holdings” means any equity or other interest (whether by way of debenture,
               warrant, security or otherwise) in any company transferred or issued in consideration of
               the assignment or grant of a licence or an option thereto to such company in respect of
               any Project Intellectual Property;

1.15           “Exploiting Party” means one of the Organisation or the Grantors, being the Party
               responsible for commercialising and exploiting the Project Intellectual property and/or the
               Background Intellectual Property in accordance with Clause 9 which shall be the
               Organisation, until the exercise of the option set out in Clause 9.7;

1.16           "Grant" means the grant funding to the Organisation by the Grantors, details of which are
               set out in the Award Letter and in Schedule 5;

1.17           "Grant Conditions" means the grant conditions for the Health Innovation Challenge
               Fund programme, as may be amended from time to time, a current copy of which is
               attached at Schedule 3;

1.18           "Grantholder and Grantholders" means the Principal Investigator (and any
               co-applicant, as specified in the Award Letter) who has responsibility for the leadership of
               the Grant funded project and for overall management of the research;

1.19           "Grantors" means the Department of Health and the Wellcome Trust Limited;

1.20           "Grant Period" means the period of the Grant set out in the Award Letter, commencing
               on the start date confirmed by the Organisation in the manner indicated by the Grantors;

1.21           "Intellectual Property" (or “IP”) means (i) patents, designs, trade marks and trade
               names (whether registered or unregistered), copyright and related rights, database
               rights, Know-How and confidential information, (ii) all other intellectual property rights, in
               each case whether registered or unregistered and similar or equivalent rights anywhere
               in the world which currently exist or are recognised in the future; and (iii) all applications,
               renewals or extensions (including supplementary protection certificates) in relation to any
               such rights;

1.22           “IPMG” means (if applicable) the intellectual property management group constituted in
               accordance with Schedule 7;

1.23           “Know-How” means any technical and other information which is not in the public
               domain, including information comprising or relating to concepts, discoveries, data,
               designs, formulae, ideas, inventions, methods, models, assays, research plans,
               procedures, designs for experiments and tests and results of experimentation and testing
               (including results of research or development), processes (including manufacturing
               processes,    specifications    and      techniques),    laboratory     records,      chemical,
               pharmacological, toxicological, clinical, analytical and quality control data, trial data, case
               report forms, data analyses, reports, manufacturing data or summaries and information
               contained in submissions to and information from ethical committees and regulatory


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               authorities and computer programs or algorithms. Know-How includes Documents
               containing Know-How, including but not limited to any rights including trade secrets,
               copyright, database or design rights protecting such Know-How. The fact that an item is
               known to the public shall not be taken to preclude the possibility that a compilation
               including the item, and/or a development relating to the item, is not known to the public;

1.24           “Material” means any chemical or biological substance including any:

               (a) organic or inorganic element;

               (b) nucleotide or nucleotide sequence including DNA and RNA sequences;

               (c) gene;

               (d) vector or construct including plasmids, phages or viruses;

               (e) host organism including bacteria, fungi, algae, protozoa and hybridomas;

               (f) eukaryotic or prokaryotic cell line or expression system or any development strain or
                   product of that cell line or expression system;

               (g) 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;

               (h) drug or pro-drug;

               (i) assay or reagent;

               (j) any other genetic or biological material or micro-organism;

               (k) data for the derivation of molecular structures including NMR spectra, X Ray
                   diffraction patterns and other primary experimental information, assignments and
                   other calculations required for determination of the structure, and co-ordinates of the
                   derived molecular structure; and

               (l) transgenic animals;

1.25           "Milestones" means the milestones set out at Schedule 4 which must be met to the
               reasonable satisfaction of the Grantors by the Milestone Dates in order for further
               tranches of the Award Amount to be released;

1.26           “Milestone Dates” means the dates set out in Schedule 4 for the achievement of the
               Milestones;

1.27           “Organisation” means the organisation named at the head of this Agreement at which
               some or all of the Project will be carried out and which takes responsibility for the
               management of the Project and accountability for the Grant provided;

1.28           "Parties" means the parties to this Agreement, or any of them, as the context may
               require and “Party" shall be interpreted accordingly;

1.29           “Policies and Provisions” means the policies and positions of the Grantors for grants
               from time to time, which are set out at http://www.doh.gov.uk and
               http://www.wellcome.ac.uk;

1.30           “Principal Investigator” means [name of researcher] of the Organisation;




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1.31           "Project" means the research entitled “[title]” (as more particularly detailed in the
               Application) to be undertaken by the Organisation and funded by the Grantors under the
               terms of this Agreement;

1.32           “Project Intellectual Property” means any Intellectual Property created, devised, or
               arising out of the Organisation’s undertaking and performance of the Project or any part
               of it;

1.33           “Project Inventions” means any inventions created, devised or arising out of the
               Organisation’s undertaking and performance of the Project or any part of it;

1.34           "Project Start Date" means the date upon which the Organisation commences work on
               the Project, as agreed in writing between the Grantors and the Organisation;

1.35           “PubMed Central” means an archive of life science journal literature operated by the
               National Center for Biotechnology Information, a division of the US National Library of
               Medicine accessible at http://www.pubmedcentral.nih.gov;

1.36           “Research Steering Group” or “RSG” means (if applicable) the group constituted in
               accordance with the provisions set out in Schedule 6;

1.37           “Site Visit Group” means the group constituted in accordance with Clause 7;

1.38           “Staff” means all scientific and technical staff who are employees, students, officers,
               contractors, independent consultants, visiting researchers or otherwise of the
               Organisation and who participate in the Project including the Principal Investigator and
               [names of other key researchers]; and

1.39           “Treasury Policy” means a policy which outlines what type of bank deposit or treasury
               instruments the Organisation’s funds can be held in and which typically also states the
               minimum ratings of banks with which funds can be deposited (e.g. Standard and Poor’s).

1.40           The Schedules and Recitals are incorporated in and form part of this Agreement and any
               reference to this Agreement shall include the Schedules and Recitals.

1.41           In this Agreement: (a) the masculine gender shall include the feminine and neuter and
               the singular number shall include the plural and vice versa; (b) references to persons
               shall include bodies corporate, unincorporated associations, partnerships and individuals.

1.42           The headings in this Agreement are inserted for convenience only and shall not affect the
               construction of the provision to which they relate.

1.43           Any phrase introduced by the terms “including”, “include”, “in particular” or any similar
               expression shall be construed as illustrative and shall not limit the sense of the words
               preceding those terms.

1.44           Where reference is made in this Agreement to the prior written consent of the Grantors
               being required in respect of any matter, the Organisation shall give not less than twenty
               (20) Business Days notice to the Trust of the matter for which such consent is required.

1.45           Reference to any statute, statutory instrument, regulation, bylaw or other requirement of
               English law and to any English legal term for any actions, remedy, method of judicial
               proceeding, legal document, legal status, court, official or any legal concept or doctrine
               shall, in respect of any jurisdiction other than England, be deemed to include that which
               most nearly approximates in that jurisdiction to the relevant legal term.

1.46           Reference to the winding up of a person include the amalgamation, reconstruction,
               reorganisation, administration, dissolution, liquidation, bankruptcy, merger or
               consolidation of such person and an equivalent or analogous procedure under the law of
               any jurisdiction in which that person is incorporated, domiciled or resident or carries on
               business or has assets.


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1.47           The rights of the Grantors may be exercised individually or jointly.

2.             USE OF FUNDING

2.1            The Grantors and the Organisation agree that the Project, the Project Intellectual
               Property and the Background Intellectual Property and associated matters shall be
               governed in accordance with this Agreement, the Award Letter, the Grant Conditions and
               the Policies and Provisions. If there is any conflict between the provisions of this
               Agreement and the Award Letter, Grant Conditions or the Policies and Provisions, then
               the provisions of this Agreement and the Award Letter shall prevail.

3.             MILESTONE PAYMENTS

3.1            The Award Amount will be payable in tranches as follows:

             Tranche                   Amount of Advance                              Payable:

                     1                          £●                       Within 20 Business Days of the
                                                                             Commencement Date

                     2                          £●                      On achievement of Milestone One
                                                                         in accordance with Clause 3.3

                     3                          £●                      On achievement of Milestone Two
                                                                         in accordance with Clause 3.3

                     4                          £●                         Within 20 Business Days of
                                                                         acceptance of an End of Grant
                                                                        Research Report by the Grantors
                                                                         in accordance with Clause 4.2


3.2            The Grantors shall pay the first tranche of the Grant to the Organisation within 20
               Business Days of the Commencement Date. The Project shall be commenced within six
               (6) months of the Commencement Date.

3.3            When the Organisation considers that any of the Milestones have been achieved by the
               relevant Milestone Date:

                a)           The Organisation shall as soon as reasonably practicable send a detailed
                             report (the “Milestone Report”) to the Grantors evidencing how the relevant
                             Milestone has been achieved and a Drawdown Notice requesting payment of
                             the next tranche of the Grant;

                b)           The Grantors shall confirm to the Organisation in writing, within twenty (20)
                             Business Days of receipt by the Grantors of the Milestone Report and a
                             Drawdown Notice either that:

                              i)      the Milestone has been achieved by the Milestone Date to the
                                      Grantors' reasonable satisfaction, in which case, the Grantors shall
                                      make payment of the next tranche of the Grant within twenty
                                      (20) Business Days of the date of such written confirmation in the
                                      amounts set out in this Agreement; or

                              ii)     the Milestone has not been achieved to the Grantors' reasonable
                                      satisfaction by the relevant Milestone Date and that the payment
                                      shall not take place, in which case the Grantors shall provide the
                                      Organisation with reasonable details of the grounds on which they
                                      have reached this decision.




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3.4            The Grantors may, at their sole discretion, grant the Organisation a reasonable period of
               time (“Milestone Extension”), in order to address the reasons why the Grantors have
               judged that a particular Milestone has not been met. Upon the expiry of a Milestone
               Extension, the Grantors shall, at their sole discretion, decide whether or not to permit full
               or partial payment of the relevant tranche of funding to the Organisation.

3.5            The final tranche of the Grant will be paid within twenty (20) Business Days of receipt by
               the Organisation of the Grantors’ acceptance of the End of Grant Research Report in
               accordance with Clause 4.2.

3.6            All payments due to the Organisation under this Agreement shall be made in pounds
               sterling. Payment shall be made by electronic wire transfer of immediately available
               funds directly to the Organisation’s account designated below or to any other account
               which the Organisation may specify by written notice.

               Bank Account for the Organisation:

               Account Name:            [                   ]
               Account No.:             [                   ]
               Bank:                    [                   ]
               Sort code:               [                   ]
               SWIFT code:              [                   ]
               Branch:                  [                   ]

3.7            The Grantors shall not be under any obligation to pay any part of the Grant to the
               Organisation if, at the time of request by the Organisation, (i) any of the events described
               in Clause 13.1 has occurred or (ii) if so requested by the Grantors, the Organisation has
               failed to submit its Treasury Policy for the Grantors’ review or the Treasury Policy fails to
               provide the Grantors with adequate assurance over the security of the funds to be
               provided.

4.             REPORTING

4.1            The Organisation shall make reports on work being carried out under the Project to the
               Grantors in accordance with the Grant Conditions and this Agreement.

4.2            The Organisation shall complete and submit an End of Grant Research Report on the
               form provided by the Grantors (at www.wellcome.ac.uk/hicf) within two (2) months after
               completion of the Project or at such other time as may be agreed with the Grantors. The
               Grantors will evaluate the End of Grant Research Report and will notify the Organisation
               within [thirty (30)] Business Days of receipt whether the report is acceptable to the
               Grantors. If the End of Grant Research Report is not acceptable to the Grantors, each
               of the Grantors shall notify the Organisation of its reasons which may include that the
               report is incomplete or insufficiently detailed.

4.3            Up to ten per cent (10%) of the Award Amount, subject to a maximum amount of one
               hundred thousand pounds sterling (£100,000) (the “Retained Amount”) shall be retained
               by the Grantors until the receipt of an End of Grant Research Report acceptable to the
               Grantors in accordance with Clause 4.2. The Retained Amount will be paid to the
               Organisation within twenty (20) Business Days of receipt by the Organisation of the
               Grantors’ acceptance of the End of Grant Research Report.

4.4            Within three (3) months following completion of the Project, the Organisation shall
               complete and submit an End of Grant Spend Report to the Grantors in the form provided
               by the Grantors (at www.wellcome.ac.uk/hicf). For the avoidance of doubt, it is a
               requirement that the financial information in this report must be presented with reference
               only to the currency in which the Award Amount was advanced by the Grantors.

5.             PROJECT STAFF AND CONDUCT




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5.1            The Organisation warrants that it has or that it shall have in place contracts with its Staff
               such that any Project Intellectual Property shall vest in the Organisation and that each
               member of the Staff is obliged to waive (to the extent that such rights are waivable) all
               moral rights and rights of a like nature in the Project Intellectual Property. The Grantors
               may upon reasonable notice require the Organisation to produce all and any Staff
               contracts for inspection by the Grantors.

5.2            The Organisation shall cause to be kept full, detailed and accurate records of all of its
               activities and results obtained in connection with the Project. In this respect, the
               Organisation shall and shall procure that the Staff shall at all times:
               (a)     observe professional standards; and
               (b)     keep scientific notebooks recording all research, development and other work
                       carried out in respect of the Project and the results of such research, development
                       and other work, including keeping bound note books with page numbering
                       recording all results and observations signed by the persons obtaining such results
                       or making such observations, and countersigned appropriately.

5.3            The Organisation shall be responsible for the management, monitoring and control of all
               research work undertaken by it. This shall include, as appropriate, the requirements of
               all applicable laws and regulatory authorities, including those governing the use of
               radioactive isotopes, diagnostic tools, animals, pathogenic organisms, genetically
               modified organisms, toxic and hazardous substances, research on human subjects and
               human embryos, and shall also include appropriate ethical approvals and consents,
               including such approvals and consents for obtaining human tissues and other relevant
               human samples. For any clinical trial carried out pursuant to the Project, the Organisation
               shall on the Grantors’ written request supply details of such clinical trial for publication on
               the Trust’s clinical trials register and the NIHR CRN portfolio database.

5.4            The Organisation shall upon request make available to the Grantors [and/or the RSG]
               copies of all records generated in connection with the Project, including for the avoidance
               of doubt, records generated by its Staff under Clause 5.2 and by any third parties
               working on the project pursuant to Clause 8.

5.5            The Organisation shall ensure that data reported to the Grantors [and/or the RSG] which
               are relevant to the progress of the Project are reliable, accurate and not misleading.

5.6            The Organisation shall procure that the Principal Investigator monitors the work carried
               out under the Project for material that may be the subject of Project Inventions and shall
               promptly notify the [Organisation and Grantors] [RSG and IPMG] of any such Project
               Inventions. [Without prejudice thereto, the Organisation shall make reports on work
               being carried out under the Project to the RSG each quarter, or from time to time as the
               RSG may reasonably request.]

6.             PROJECT MANAGEMENT

6.1            [Subject to Clause 6.2] The Principal Investigator shall be responsible for the overall
               management of the Project and for ensuring that the Project is administered in
               accordance with this Agreement.

6.2            [The Grantors and the Organisation shall establish a Research Steering Group to
               oversee the Project, as detailed in Schedule 6.]

6.3            [The Organisation shall appoint a project manager from its Staff who shall be responsible
               on a day-to-day basis for co-ordinating the internal and external components of the
               Project.]

7.             SITE VISIT GROUP

7.1            Either of the Grantors may take the lead in appointing a Site Visit Group, made up of a
               small team of independent experts, and observers from the Trust’s Technology Transfer


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               Division and/or the Department of Health’s NIHR Central Commissioning Facility. The
               Organisation shall ensure that the Site Visit Group shall have reasonable access during
               normal working hours and at mutually agreed times to visit the premises where the
               Project is being conducted to consult informally with the Organisation’s Staff working on
               the Project, to evaluate progress, performance and key issues and to report back to the
               Grantors [and the RSG] on its findings.

7.2            The Site Visit Group may recommend that the Grantors terminate the Project due to a
               serious failure in the progress, management or conduct of the Project (including a finding
               that the Project will be unable to achieve the next Milestone within a reasonable time
               period after the relevant Milestone Date), or due to a major external scientific, technical
               or commercial barrier which means that the Project is unlikely to succeed in its
               objectives. If the Site Visit Group makes such a recommendation pursuant to this Clause
               7.2, the Grantors may terminate this Agreement pursuant to Clause 13.2b.

7.3            The Grantors may, in their sole discretion, allow the Organisation a reasonable period of
               time to take corrective action to address any failings identified by the Site Visit Group (if
               such failings are capable of correction). If the Grantors grant the Organisation a period
               of time to correct such failings and the Organisation does not correct such failings within
               the period specified by the Grantors (if any), the Grantors shall retain the right to
               terminate this Agreement pursuant to Clause 13.2b.

8.             PROJECT COLLABORATORS AND SUBCONTRACTORS

8.1            If the Organisation wishes to use a third party collaborator or sub-contractor to conduct
               any part of the Project, it shall seek the consent of [the RSG] [the Grantors] unless such
               sub-contractor or collaborator is specified in the Application. The Organisation shall
               ensure in all cases that any collaborations or sub-contracts are on the following terms:

                a)           That the third party shall not have any rights to any results emerging from such
                             work, and all such results shall as between the Parties and the third party be
                             deemed to be Project Intellectual Property and owned in accordance with the
                             provisions of this Agreement;

                b)           That the third party shall be under obligations of confidence concerning such
                             results on terms equivalent to those set out under this Agreement;

                c)           That the third party shall keep detailed records including scientific notebooks
                             of all of its activities and upon request shall make available copies to the
                             Grantors;

                d)           That the third party will upon reasonable request make available its employees
                             and/or consultants for discussion with the Site Visit Group [and/or RSG] as
                             referred to in Clause 7 [and Schedule 6]; and

                e)           That the provisions of such sub-contract or collaboration agreement shall be
                             consistent with the milestoned nature of the Award and the termination
                             provisions of this Agreement, and shall terminate if this Agreement terminates.

9.             INTELLECTUAL PROPERTY – OWNERSHIP, PROTECTION AND MANAGEMENT

9.1            If any Project Intellectual Property arises, it shall be the property of the Organisation. In
               accordance with paragraph 10 of the Grant Conditions, the Organisation shall be
               responsible for the identification, protection, management and exploitation of the Project
               Intellectual Property to achieve public benefit. If the Organisation fails to do so, the
               Grantors shall have the right but not the obligation to do so.

9.2            The Organisation shall seek the prior written consent of the Grantors (not to be
               unreasonably withheld) to any commercial use of, or granting to any third party any
               exploitation rights over Project Intellectual Property. Such consent shall be sought by
               completing the consent application form available from www.wellcome.ac.uk/hicf. As a


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               condition of granting consent, the Grantors will require the Organisation to accept the
               then current standard revenue and equity sharing agreement for the Health Innovation
               Challenge Fund, the current version of which is set out in Schedule 8.

9.3            In accordance with clause 10 of the Grant Conditions, the Department may opt to receive
               its share of any revenue or equity as discounted products or services.

9.4            The Organisation shall make the Background Intellectual Property available for use in the
               Project and for the protection or exploitation of the Project Intellectual Property. Unless
               otherwise agreed in writing with the Grantors, the Organisation shall retain responsibility
               for filing, prosecuting, maintaining, defending, and enforcing protection for the
               background Intellectual Property at its own cost. If the Organisation wishes to cease
               doing so in relation to any of the Background Intellectual Property, it shall notify the
               Grantors and the Grantors shall have the right but not the obligation to take over
               responsibility for the Background Intellectual Property. The Organisation shall not grant
               any rights to any third parties over the Background Intellectual Property without the prior
               written consent of the Grantors.

9.5            If required to do so by the Grantors, the Organisation shall establish an IPMG in
               accordance with the provisions of Schedule 7.

9.6            The Organisation shall use its reasonable efforts to manage the commercialisation and
               exploitation of the Project Intellectual Property.

9.7            The Organisation accepts that in order to exploit the Project Intellectual Property, it may
               be necessary or useful to grant a licence to the Background Intellectual Property and at
               the request of the Grantors (where a Grantor is the exploiting party) shall grant such a
               licence (to the extent that this does not conflict with any pre-existing third party rights).
               Any such licence grant shall be non-exclusive, free of charge and only to the extent
               necessary or useful to exploit the Project Intellectual Property.

9.7            If the Organisation:

               (a) is subject to any of the events listed in Clause 13.1(c);

               (b) has failed to maintain, protect, defend or enforce the Project Intellectual Property or
                   any part of it where it is reasonable to do so and where the Grantors have expressly
                   advised the Organisation to do so;

               (c) notifies the Grantors in writing that it has decided at any time not to exploit any Project
                   Intellectual Property; or

               (d) does not protect, manage or exploit any Project Intellectual Property to the
                  reasonable satisfaction of the Grantors (including if after five (5) years since its
                  creation any Project Intellectual Property has not been commercially exploited by the
                  Organisation),

               then the Grantors shall have the right, but not the obligation, to protect, manage and
               exploit such Project Intellectual Property and/or to have the Project Intellectual Property
               assigned to either of them by the Organisation in hole or in part (at the Grantors’ request)
               and the Organisation undertakes at the request of the Grantors and at its own cost to do
               (or to procure others to do) everything necessary for vesting in the Grantors the full
               benefit of such Project Intellectual Property to be transferred to it under this Agreement.
               Unless the Grantors reasonably consider that the opportunity to protect, manage or
               exploit the Project Intellectual Property for the public benefit could be lost and that more
               immediate action is required, such right shall only be exercised six (6) months after the
               Grantors have given the Organisation notice in writing that it is failing to protect, manage
               and exploit the Project Intellectual Property to the Grantors’ satisfaction.

9.8            For the avoidance of doubt, if either of the Grantors do exploit the Project Intellectual
               Property, the Organisation shall procure that the Principal Investigator and other


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               members of its Staff who contributed to the creation of Project Intellectual Property (and
               any third party acting on its behalf) do all acts required to assist the Grantors in relation
               to the commercialisation and exploitation of the Project Intellectual Property and (if
               applicable) the Background Intellectual Property, including:

               (a) executing any necessary documents;

               (b) assisting in the transfer of Know-How generated in the course of the Project to a
                   third party licensee or corporate vehicle; or

               (c) co-operating in any litigation of any dispute relating to the Project Intellectual
                   Property.

               Any such exploitation by either of the Grantors shall be subject to the provisions of the
               revenue sharing agreement set out in Schedule 8.

10.            AUDIT

10.1           The Organisation shall procure that the control of expenditure to be funded under the
               Grant is governed by the normal standards and procedures of the Organisation and is
               covered by the formal audit arrangements that exist in the Organisation. The Grantors
               shall have the right to ask for confirmation from the external auditors of the Organisation
               that the external auditors have signed their opinion on the annual accounts of the
               Organisation without qualification and that the management letter from the auditors
               raises no matters that did or could significantly affect the administration of grants
               awarded by the Grantors. If the auditors have raised any such matters in their
               management letter, the Grantors may require the Organisation to provide them with
               relevant extracts from the letter.

10.2           The Organisation shall provide access to accounting and other financial records relating
               to the Grant and the activities funded by it for auditors and other personnel from or
               appointed by the Grantors at any time (at the Grantors’ expense), if requested. Such
               access shall include the right to inspect any equipment or facilities acquired or funded
               under the Grant. Where elements of expenditure under the Grant have been
               subcontracted, the Organisation shall ensure that the rights of access extend to the
               accounts and records of any such subcontractor.

10.3           The Grantors shall have the right, each at its individual discretion and expense, to audit
               (either directly or via third parties engaged by it) the Grant and the income and
               expenditure on the activities funded by the Grant and/or the systems used by the
               Organisation to administer the Grantors’ grants generally at any time.

10.4           The Organisation shall maintain a separate accounting cost code specific to the Grant,
               and all costs and income properly relating to the Award shall be accounted for through
               that cost code. The Organisation shall ensure that appropriate records are kept to
               support the entries made on the cost code.

10.5           The Organisation acknowledges and agrees that pursuant to Clause 3 of the Grant
               Conditions, references to an audit by the Department includes any audit by the National
               Audit Office or Audit Commission.

11.            PUBLICATIONS AND ANNOUNCEMENTS

11.1           The Grantors acknowledge the Organisation’s need to publish details of the results of the
               Project in learned journals and to present such results at academic conferences. So as
               not to jeopardise any Project patent filing or exploitation being carried out by the
               Exploiting Party (in any case where the Exploiting Party is not the Organisation), the
               Organisation shall procure that the Principal Investigator furnishes the Exploiting Party
               [and the IPMG] with copies of any proposed publication or presentation which relates to
               any Project Intellectual Property in advance of the submission of such proposed
               publication or presentation to a journal, editor or publication. The Exploiting Party and


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               the IPMG shall have twenty (20) Business Days from and including the date of receipt
               from the Organisation of any proposed publication or presentation to object to the same
               because there is patentable subject matter relating to a Project Invention that needs
               protection or such publication would materially jeopardise any exploitation activity. The
               Exploiting Party shall not seek to withhold consent where such publication or
               presentation will not prejudice the protection or exploitation of the Project Intellectual
               Property.

11.2           If the Exploiting Party [or the IPMG] object to any such publication or presentation on the
               basis that it would disclose patentable information, the Organisation shall refrain (and
               shall procure that the Principal Investigator and the Staff also refrain) from making such
               publication or presentation for a period of forty (40) Business Days from the date of
               receipt of such objection in order for the Exploiting party to file the relevant patent
               application(s) with respect to the patentable subject matter contained in the proposed
               publication or presentation.

11.3           A copy of the final manuscript of all research publications that relate to the Project must
               be deposited into PubMed Central (or UK PubMed Central) upon acceptance for
               publication, to be made freely available as soon as possible and in any event no later
               than six (6) months after the journal publisher’s official date of final publication.

11.4           Save as required by law or any competent regulatory authority, no announcement
               concerning this Agreement or its subject matter shall be made by the Organisation
               without the prior written approval of the Grantors. For the avoidance of doubt the
               Organisation and the Principal Investigator must consult with the Grantors (and the
               relevant media office as directed by the Grantors) on any press statements that may be
               issued about the Project or any findings from the Project.

12.            CONFIDENTIALITY

12.1           Subject to Clauses 12.2 to 12.8 (inclusive) each Party undertakes that both during this
               Agreement and for a period of five (5) years after its termination, it shall keep confidential
               and not disclose to any person (other than to its officers, employees, consultants or
               professional advisors whose province it is to know), any Confidential Information of
               another party disclosed to or obtained by it in connection with this Agreement. Each
               Party shall take all reasonable security precautions in relation to the Confidential
               Information under its control.

12.2           The Organisation shall only disclose the Confidential Information to those of its Staff
               (together with its administrative or technology transfer staff involved in monitoring the
               Project) who need to know it strictly for the purposes of the Project and the administration
               of the Grant, provided that they are bound by confidentiality and non-use obligations in
               respect of such Confidential Information and are first made aware of the Organisation’s
               confidentiality obligations towards the Grantors.

12.3           If the Organisation considers it necessary for the purpose of the Project to disclose the
               Confidential Information to employees, officers, students, visiting academics, contractors,
               sub-contractors, independent consultants or third parties who are not members of the
               Organisation’s Staff undertaking the Project, then before any such disclosure takes place
               the Organisation shall procure that each of the persons concerned are bound by
               confidentiality and non-use obligations in respect of such Confidential Information and
               are first made aware of the Organisation’s confidentiality obligations.

12.4           If the Organisation is not the Exploiting Party, the Exploiting Party shall be entitled to
               disclose any Confidential Information of the Organisation or Confidential Information
               generated during the Project if it is reasonably necessary or desirable to do so in order to
               protect or exploit the Project Intellectual Property.

12.5           Without prejudice to Clause 12.1, and save in the case of publication in which case the
               provisions of Clause 11 shall apply, the Parties shall each use reasonable endeavours



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               to keep details of any Project Inventions confidential pending filing of a patent application
               claiming such Project Invention.

12.6           Clause 12.1 shall not apply to:
                   (a)       information which is or was already known to the receiving party at the time
                             of disclosure under this Agreement, as shown by the receiving party’s written
                             records, without any obligation to keep it confidential;

                   (b)       information which is independently developed by employees of the receiving
                             party who have not had access to the confidential information of the
                             disclosing party;

                   (c)       information which at the time of being disclosed or obtained by the receiving
                             party under this Agreement or at any time thereafter, is published or
                             otherwise generally available to the public other than due to default by the
                             receiving party of its obligations hereunder;

                   (d)       the disclosure of information by the Grantors for the purposes of publishing
                             summary details of awards made by the Grantors consisting of the name of
                             the Organisation, the name of the Principal Investigator, the title of the
                             Project and the amount of the Award or (in the event that the Project includes
                             a clinical trial) for the purpose of registering a clinical trial on the Trust’s
                             clinical trial register or the NIHR CRN portfolio database;

                   (e)       the disclosure to a Party’s professional advisers or to the Grantors’ Site Visit
                             Group of information reasonably required to be disclosed for purposes
                             relating to this Agreement, or

                   (f)       information which is required to be disclosed by a competent Court or
                             regulatory authority or otherwise by applicable law (including any
                             requirements for disclosure under the Freedom of Information Act 2000),
                             provided that where it is free to do so, the receiving party shall give notice of
                             such disclosure as soon as reasonably practicable. Where such disclosure of
                             information is required under the Freedom of Information Act 2000 from the
                             Organisation and such information relates to the Trust or the Department, the
                             Organisation shall notify the applicable Party within five (5) Business Days of
                             receiving an information request that such a request has been made and the
                             details thereof. The Organisation shall allow five (5) Business Days to consult
                             with and, to the extent permitted by law, shall take into account any
                             representations made by either the Trust or the Department before such
                             information is disclosed to the requestor and shall on request provide an
                             update of the status of the Organisation’s response and the information that it
                             is intending to disclose.
12.7           Each Party shall ensure that all personnel and third parties to whom Confidential
               Information of the other Party is disclosed are informed of the provisions of Clauses 11
               (Publications and Announcements) and Clause 12 (Confidentiality).

12.8           [The Parties acknowledge that the information contained or listed in Schedule 9 is
               information which the Parties reasonably consider is exempt from disclosure under the
               Freedom of Information Act 2000 on the basis that it is confidential and/or commercially
               sensitive information, which if disclosed without the prior consent of the Party to which
               the information relates, would, or would be likely to breach confidentiality and/or
               prejudice the commercial interests of that Party.]

12.9           Nothing in this Agreement shall prevent the Grantors disclosing any Confidential
               Information for the purpose of any examination pursuant to Section 6(1) of the National
               Audit Act 1983 of the economy, efficiency and effectiveness with which the Grantors
               have used their resources.

12.10          The Parties acknowledge and agree that the National Audit Office has the right to publish
               a brief outline of this Agreement in its relevant reports to Parliament.

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13.            DURATION AND TERMINATION

13.1           In addition to the termination rights under the Grant Conditions, the Grantors or the
               Organisation shall have the right to terminate this Agreement forthwith at any time by
               giving written notice of termination to the other Party (“Defaulting Party”), upon the
               occurrence of any of the following events:

               a)            the Defaulting Party commits a breach of a material obligation set out in this
                             Agreement which is not capable of remedy;

               b)            the Defaulting Party commits a breach of a material obligation set out in this
                             Agreement which is capable of remedy but has not been remedied within sixty
                             (60) days of the receipt by it of a notice from the other Party identifying the
                             breach and requiring its remedy;

               c)            If the Defaulting Party is subject to any of the following, or any similar events in
                             any jurisdiction:

                             i)        goes into liquidation or passes a resolution for voluntary winding up or
                                       its directors convene a meeting of shareholders to consider passing
                                       such a resolution (except for the exclusive purpose of amalgamation
                                       or bona fide reconstruction not involving insolvency and in such
                                       manner that the entity resulting therefrom effectively agrees to be
                                       bound by or assumes the obligations imposed on that other party
                                       under this Agreement);

                             ii)        has an encumbrancer take possession of or an administrative
                                       receiver or receiver or similar officer appointed over all or any part of
                                       its assets or undertaking; or an application is made for the
                                       appointment of an administrative receiver, receiver or similar officer
                                       over all or any part of its assets or undertaking;

                             iii)      has an administrator appointed (by court order or otherwise (including
                                       without limitation by its directors or by a floating charge holder)), or
                                       has an application made either for the appointment of an
                                       administrator or for an administration order, or has a notice of
                                       intention to appoint an administrator given;

                             iv)       is the subject of any judgment or order made against it which is not
                                       complied with or discharged within 30 days or is the subject of any
                                       execution, distress, sequestration or other process levied upon or
                                       enforced against any of its assets;

                             v)         has proposed in respect of it a company voluntary arrangement
                                       pursuant to the Insolvency Act 1986 or any other composition or
                                       scheme or arrangement with or assignment for the benefit of any of
                                       its creditors;

                             vi)       has a petition presented for its winding up (which is not dismissed
                                       within 14 days of its service) or has an application made for the
                                       appointment of a provisional liquidator or has a creditors' meeting
                                       convened pursuant to s 98 Insolvency Act 1986;

                             vii)      ceases or threatens to cease to carry on business; or

                             viii)     is or becomes unable to pay its debts as they fall due, suspends
                                       making payments on any of its debts or, by reason of actual or
                                       anticipated financial difficulties commences negotiations with one or
                                       more of its creditors with a view to rescheduling any of its


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                                      indebtedness.

               d)            the Defaulting Party is prevented from performance of its obligations by an
                             event of force majeure (as defined in Clause 16.1) for more than six (6)
                             months.

13.2           In addition, the Grantors shall be entitled to terminate this Agreement by notice in writing
               to the Organisation if:

               (a) the Organisation fails to comply with any of the Conditions (if any are set); or

               (b) the Site Visit Group recommends termination of the Project in accordance with
                   Clause 7 and the Organisation fails to correct any identified failings within the time
                   period granted by the Grantors (if any) under Clause 7.3.

13.3           If the Principal Investigator ceases to be involved with the Project, ceases to be
               employed by or provide services to the Organisation, ceases to carry out research at
               premises controlled by the Organisation, or is prevented through illness or injury from
               promptly fulfilling his obligations under it, the Grantors shall consult with the Organisation
               to ascertain whether the Project or its progress will be jeopardised by such event. If in
               the reasonable opinion of the Grantors:

               (a) such event will jeopardise the Project or its progress, the Grantors may terminate this
                   Agreement by written notice; or

               (b) the Project has reached a stage such that the services of the Principal Investigator
                   are not key to the completion of the Project, the Grantors and the Organisation shall
                   negotiate in good faith any amendments necessary to this Agreement so as to
                   enable the satisfactory completion of the Project within a reasonable time.

13.4           Termination of this Agreement howsoever arising shall be without prejudice to the rights
               and duties of any Party accrued prior to termination. The clauses in this Agreement
               which expressly or impliedly have effect after or notwithstanding termination (including
               Clauses 1, 2, 5, 6 , 9, 10, 12 and 14) shall continue to be enforceable notwithstanding
               termination.

13.5           Upon termination prior to the end of the Project, the Organisation shall return any part of
               the Grant funds received from the Grantors under this Agreement which is unspent at the
               date of termination (after deduction of reasonable, properly incurred non-cancellable
               commitments incurred prior to the date of termination, the Organisation being under a
               duty to mitigate such commitments as far as is reasonably practicable to do so).

14.            WARRANTIES AND LIABILITY

14.1           The Organisation warrants that:

               (a) it has the requisite authority to enter into this Agreement;

               (b) it has full power and authority to assume all of its obligations under this Agreement;

               and

               (c) to the best of its knowledge and belief:

                    i) it is the legal and beneficial owner of all right, title and interest in and to the
                    Background Intellectual Property, and will be the legal and beneficial owner of all
                    right, title and interest in and to the Project Intellectual Property;

                    ii) it has not granted any third party any right in respect of the Project Intellectual
                    Property (other than in accordance with the provisions of this Agreement), and has
                    not charged or encumbered and will not charge or encumber any of the same;

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                   iii) has not itself nor through any of its Staff disclosed to any third party (other than
                   under appropriate confidentiality obligations) any Confidential Information relating to
                   the Project, nor is it obliged to do so.

14.2           Except as expressly provided in this Agreement, none of the Parties gives any warranties
               or makes any representations with respect to any of the Project Intellectual Property
               and/or Background Intellectual Property or any products derived from them, or their
               fitness for any purpose, or that any material produced or supplied by any Party and any
               processes or techniques used, proposed or recommended by any Party will not infringe
               any patent or other Intellectual property rights of any person in any country.

14.3           Subject to Clause 14.5, the maximum liability of any one Party to any of the other Parties
               arising out of this Agreement shall not exceed the Award Amount.

14.4           Except in circumstances of fraud or wilful misconduct by a Party or its affiliates, no Party
               or any of its affiliates shall be liable to another Party or any affiliate of another party for
               special, indirect, incidental or consequential damages, whether in contract, warranty,
               negligence, tort, strict liability or otherwise, arising out of any breach of or failure to
               perform any of the provisions of this Agreement.

14.5           Nothing in this Agreement shall limit the liability of any Party in respect of:

               (a) personal injury or death arising out of that party’s negligence or wilful misconduct; or

               (b) fraud or fraudulent misrepresentation.

15.            ESCALATION AND DISPUTE RESOLUTION PROCEDURE

15.1           If any dispute arises out of or in connection with this Agreement then any Party may give
               a notice that a dispute exists (a “Dispute Notice”) to the other Parties and if the Parties
               (or the RSG) have not resolved the dispute within ten (10) Business Days of the date of
               the Dispute Notice, the Parties shall escalate such dispute to the Director of Technology
               Transfer at the Trust, the Director General of Research and Development at the
               Department and [enter title of official] at the Organisation (collectively, the “Executive
               Officers”) and the respective Executive Officers shall use reasonable endeavours to
               resolve the dispute as soon as is reasonably practicable but in any case by ten (10)
               Business Days of the date at which the dispute was escalated to them.

15.2           If the Executive Officers of the Parties are not able to resolve a dispute referred to them
               pursuant to Clause 15.1, the Parties will, at the request of any of them, attempt in good
               faith to resolve the dispute through an agreed Alternative Dispute Resolution (“ADR”)
               procedure.

15.3           If the matter has not been resolved by an agreed ADR procedure within twenty (20)
               Business Days of the initiation of such procedure, any Party may bring proceedings in
               accordance with Clause 17.12. For the avoidance of doubt, any Party may apply to the
               court for an injunction whether or not any issue has been escalated under Clause 15.

16.            FORCE MAJEURE

16.1           In the event that either Party is delayed or prevented from the performance of its
               obligations under this Agreement by an event of force majeure, the obligations of the
               Parties shall remain in suspense during the continuation of the force majeure event
               (subject to Clause 13.1(d)). Force majeure events shall mean any event outside of the
               reasonable control of a Party and include, without limitation, riot, sabotage, acts of war or
               piracy, fire, flood, storm, earthquake, epidemic or pandemic, delay caused by failure of
               power supply or transport.

17.            GENERAL




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17.1           This Agreement, together with the Award Letter, the Application and any revenue and
               equity sharing agreement entered into pursuant to Clause 9 constitute the entire
               agreement and understanding between the Parties relating to the subject matter of this
               Agreement and together they supersede and replace all prior drafts, previous
               understandings, arrangements, representations or agreements, whether in writing or oral,
               between the Parties relating to the subject matter of this Agreement.

17.2           No Party shall be deemed to have waived any of its rights or remedies under this
               Agreement unless the waiver is expressly made in writing and signed by a duly
               authorised representative of that Party. In particular, no delay or failure of any party in
               exercising or enforcing any of its rights or remedies under this Agreement shall operate
               as a waiver of those rights or remedies nor shall any single or partial exercise or
               enforcement of any right or remedy by any Party preclude or impair any other exercise or
               enforcement of that right or remedy by that Party.

17.3           The Parties shall not make any press or other public announcement concerning any
               aspect of this Agreement without first obtaining the agreement of the other Parties to the
               text of that announcement, such agreement not to be unreasonably withheld or delayed,
               save that the Grantors shall be permitted to publish summary details of the Project
               including the name of the Principal Investigator, the name of the Organisation, the title of
               the Project, the Award Amount and the following description of the Project:

               [Grantors to insert web paragraph here]

17.4           Nothing in this Agreement shall give rise to any partnership or the relationship of principal
               and agent between the Grantors and the Organisation.

17.5           Any notice to be given pursuant to this Agreement shall be in writing in the English
               language and shall be delivered by personal service, overnight courier, by registered,
               recorded delivery or certified mail (postage prepaid) to the address or facsimile number
               of the recipient Party set out below or such other address or facsimile number as a Party
               may from time to time designate by written notice to the other Parties. Any notice by
               facsimile shall be confirmed by the sender sending a confirmatory copy of the notice by
               registered, recorded delivery or certified mail (postage prepaid). The Parties agree that
               email is not a valid method of giving notice under this Agreement.

               Address of the Organisation

               [enter postal address]

               Fax No: [enter fax number]

               For the attention of: [enter contact name]

               Address of the Trust
               Technology Transfer Division
               The Wellcome Trust Limited
               215 Euston Road
               London NW1 2BE
               Fax No: +44 (0)20 7611 8857

               For the attention of: The Contracts Officer

               With a copy to: Dr Tim Knott

               Address of the Department

               Central Commissioning Facility
               Grange House


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               15 Church Street
               Twickenham
               TW1 3NL
               Fax No: +44 (0)208 8843 8001

               For the attention of: The Assistant Director, Health Innovation Challenge Fund

               With a copy to: The Director, Central Commissioning Facility

17.6           Any notice given pursuant to Clause 17.5 shall be deemed to have been received:

                       (a)        in the case of personal service, delivery by courier or sending by
                                  certified mail, on the day of receipt, provided receipt occurs on a
                                  Business Day of the recipient Party or otherwise on the next following
                                  Business day of the recipient; or

                       (b)        in the case of facsimile, on acknowledgement by the recipient
                                  facsimile receiving equipment on a Business Day if the
                                  acknowledgement occurs before 5:00pm local time of the recipient
                                  Party and in any other case on the following Business Day

17.7           None of the rights or obligations under this Agreement may be assigned or transferred
               without the prior written consent of the other Parties. This Agreement shall be binding on
               and take effect for the benefit of the successors in title of the Parties.

17.8           If any provisions of this Agreement are held to be invalid, illegal or unenforceable (in
               whole or in part) such provisions or parts shall to that extent be deemed not to form part
               of this Agreement but the remainder of this Agreement shall continue in full force and
               effect.

17.9           This Agreement does not create any right enforceable by any person not a party to it
               under the Contracts (Rights of Third Parties) Act 1999.

17.10          Each Party shall at its own cost do and execute or procure to be done and executed all
               necessary acts, deeds, documents and things reasonably within its power to give effect
               to this Agreement.

17.11          Each Party shall do and execute or arrange for the doing or executing of all acts,
               documents and things as may be necessary in order to implement this Agreement.

17.12          This Agreement shall be governed by and construed in accordance with English law.
               The Parties irrevocably submit to the exclusive jurisdiction of the English courts provided
               that nothing in this clause shall prevent any Party from seeking injunctive relief in any
               court of competent jurisdiction in respect of a breach or threatened breach of Clause 12
               (confidentiality).

IN WITNESS whereof the Parties or their duly authorised representatives have executed this
Agreement on the date written at the head of this Agreement.



For and on behalf of

The Wellcome Trust Limited as trustee of The Wellcome Trust

Signed:                                                 Signed:

Name:                                                   Name:

Date:                                                   Date:



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For and on behalf of

The Secretary of State for Health acting
through the Department of Health

Signed:

Name:

Date:




For and on behalf of                                 [For and on behalf of

[Organisation]                                       [Organisation]

Signed:                                              Signed:

Name:                                                Name:

Date:                                                Date:




Read and understood by the Principal Investigator who is not personally a party to this Agreement:


………………………………………………




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SCHEDULE 1

                              The Application




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SCHEDULE 2
                                              Conditions

1. [Compliance with the Organisation’s obligations with respect to the formation and operation of the
   RSG in accordance with Schedule 6].

2. [Engagement and involvement of an independent industry adviser to the RSG with relevant
   experience in accordance with [Schedule 6]].

3. Co-operation with the Site Visit Group prior to and during visits in accordance with Clause 7.

4. [Timely consultation with the IPMG on patent strategy and patent prosecution in accordance with
   Clause [11 ] and Schedule 7].


[If none applied – state none]




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SCHEDULE 3


                   HEALTH INNOVATION CHALLENGE FUND – GRANT CONDITIONS



1.       ADMINISTRATION

2.       RESEARCH PRACTICE AND ETHICS

3.       AUDIT

4.       EQUIPMENT

5.       EMPLOYMENT

6.       UNLAWFUL DISCRIMINATION

7.       PUBLICATION, PUBLICITY AND REPORTING

8.       FREEDOM OF INFORMATION

9.       DATA PROTECTION, PERSONAL DATA AND MEDICAL RECORDS

10.      INTELLECTUAL PROPERTY AND COMMERCIAL ACTIVITIES

11.      LIMITATION OF LIABILITY

12.      INSURANCE

13.      TRANSFER

14.      GENERAL

15.      DEFINITIONS



These Grant Conditions, which form part of the Contract Documents, set out the terms and conditions
on which the Grant is made by the Grantors to the Organisation. These Grant Conditions are subject
to an Exploitation Consent and Revenue/Equity Sharing Agreement between the Grantors and the
Organisation which is a schedule to the Funding Agreement. The Wellcome Trust policies and
positions for grants are available on the Wellcome Trust's website www.wellcome.ac.uk/about-
us/policy/policy-and-position-statements/index.html and hard copies are available on request by
e-mail to grantenquiries@wellcome.ac.uk. The Department of Health policies are available on the
Department of Health website www.dh.gov.uk.

The Organisation must ensure that the Grantholders and others supported by the Grant are made
aware of and comply with all Contract Documents.

The Grantors may exercise their rights pursuant to these Grant Conditions jointly or individually.




1.       ADMINISTRATION
 1.1      Initial payments will not be made from the Grant until twenty (20) Business Days following
          the date of the last signature to the Funding Agreement. Any further payments will be made
          20 Business Days after the Grantors’ written confirmation to the Organisation that a project



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           milestone has been met, pursuant to the Organisation submitting a detailed Milestone
           Report and Drawdown Notice according to Clause 3 of the Funding Agreement..

1.2        The Organisation must ensure that sufficient resources are provided to support the activities
           described in the Funding Agreement.

1.3        HICF awards will be funded at a proportion of the Full Economic Cost of the application to
           the Grantors, reflecting the weighted average of the Department of Health contribution of up
           to 100% of Full Economic Cost and the Wellcome Trust’s funding for the directly incurred
           costs and other allowable costs, as detailed on the Wellcome Trust’s website (at
           http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-
           statements/WTX026852.htm). Successful applicants will receive an Award Letter in which
           the amounts contributed by each of the Grantors will be set out together with the allowable
           costs awarded.

1.4        The Grantors must be consulted in the event of any material change in the proposed
           research, including failure to gain access to facilities or services or to gain ethical committee
           approval. If appropriate, revised proposals may be required. In such an event the Grantors
           reserve the right to revise or terminate the Grant.

1.5        The duration of the Grant Period may be extended by periods up to a total maximum of six
           (6) months, with the prior written consent of the Grantors. Extensions may cover breaks or
           delays in the appointment of staff, periods of maternity leave, paternity leave, adoption
           leave, parental leave or paid sick leave exceeding 3 months (or possibly shorter periods of
           sick leave if the member of staff is disabled as defined in the Disability Discrimination Act
           1995) or other exceptional cases with the prior written consent of the Grantors.

1.6        The Grantors shall have the right to seek reimbursement in the event of an overpayment in
           relation to any Grantors grant made to the Organisation, including by setting such
           overpayment off against payments due under other Grantors grants to the Organisation or
           any other payments which the Grantors are due to make to the Organisation. The Grantors
           shall also have the right to suspend payments to the Organisation in the event of
           non-delivery of a Spend Report or an End of Grant Spend Report or where the Organisation
           has failed to respond to any queries raised by the Grantors in relation to a Spend Report or
           an End of Grant Spend Report, to the reasonable satisfaction of the Grantors.

1.7        The Grantors reserve the right to amend the payment profile at their discretion.            The
           Organisation will be advised at least thirty (30) days in advance of any such change.

2.         RESEARCH PRACTICE AND ETHICS

2.1        The Organisation shall ensure that the research is conducted using good laboratory
           notebook practice. There must be effective and verifiable systems in place for managing
           research quality, progress and the safety and wellbeing of patients and other research
           participants. The Organisation shall manage and monitor statutory requirements for medical
           and health research, including legislation on clinical trials and use of human organs, tissues
           and data.

2.2        The Organisation shall ensure that before the research funded by the Grant commences
           and during the Grant Period that there is clarity of role and responsibility among the
           research team and any collaborators. The Grantors expect the research to be conducted in
           accordance with the highest standards of scientific integrity and research methodology.
           Where any element of the research funded by the Grant is to be conducted outside the UK,
           such legal and regulatory requirements, and such licences and approvals should include
           those applicable in the additional countries involved.

2.3        The Organisation will ensure that research in any way connected with the Grant is
           conducted in accordance with the Department of Health Guidance "Research Governance
           Framework for Health and Social Care" and, if relevant, in accordance with the Department
           of Health guidance "Governance Arrangements for NHS Research Ethics Committees" or



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           such other guidelines as may be issued from time to time by the Department of Heath and
           copies of which are made available to the Organisation.

2.4        The Organisation shall comply with all relevant legislation including but not limited to:

           a)          the Medicines for Human Use (Clinical Trials) Regulations (SI2004/1031);

           b)          the Human Tissue Act 2004;

           c)          the Animals (Scientific Procedures) Act 1986.

           d)          The Data Protection Act 1998.

2.5        The Organisation will submit for review by a Research Ethics Committee recognised by the
           Grantors any project involving:

           a)          NHS patients and users including those treated under agreement with private
                       sector providers;

           b)          individuals identified as potential research participants because of their status as
                       relatives or carers of NHS patients;

           c)          NHS staff - recruited as research participants by virtue of their professional role;

           d)          access to data, organs or other bodily material (including foetal material) of past
                       and present individual and identifiable NHS patients;

           e)          IVF involving NHS patients;

           f)          the recently dead in NHS premises;

           g)          the use of, or potential access to, NHS premises or facilities;

           h)          animals

           with a view to obtaining the approval of the Research Ethics Committee to the project and
           will inform the Grantors when such approvals have been given (whether unconditionally or
           subject to conditions) or withheld.
2.6        Where possible, the Organisation should adopt procedures and techniques that avoid the
           use of animals. Where that is not possible, any research involving animals undertaken by
           the Organisation, collaborators or service providers in the UK or internationally must comply
           with (i) the Wellcome Trust’s policy on the use of animals in research and the principles set
           out in the document “Responsibility in the use of animals in bioscience research:
           Expectations of the major research council and charitable funding bodies”
           (http://www.welcome.ac.uk/About-us/Policy/Policy-and-position-
           statements/WTD040129.htm), and (ii) Home Office advice on ethical review practice in
           relation to the Animals (Scientific Procedures) Act 1986. If procedures regulated under the
           Animals (Scientific Procedures) Act 1986 will be used, the research must comply with the
           Act, be approved by the local ethical review process and be conducted with due
           consideration for the 3Rs (replacement, reduction and refinement of the use of animals in
           research).     The Organisation must ensure that research involving the use of animals
           complies at all times with the relevant laws and regulation in the host country. Any element
           of research funded by the Grant that is conducted outside the UK must, as a minimum
           standard, be conducted in accordance with the principles of UK legislation (including the
           Animals (Scientific Procedures) Act 1986).

2.7        The Organisation must ensure that it has in place formal written procedures for managing
           the process for obtaining any necessary or appropriate ethical approval for the research
           funded by the Grant, and must accept full responsibility for ensuring that any such ethical



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           approval is in place at all relevant times during the Grant and before any work requiring
           approval commences.

2.8        The Organisation must have in place formal written procedures for the handling of
           allegations of research misconduct, such procedures to meet at least the minimum criteria
           set out in the Trust’s statement on the handling of allegations of research misconduct.

3.         AUDIT

3.1        The Organisation must ensure that any part of the Full Economic Cost of the research
           project and any NHS Costs not eligible for funding by the Grantors has been secured from
           other sources before the commencement of the project.

3.2        The value of the Grant may not be increased and is provided solely for use in the Project.
           Under no circumstances may Directly Incurred Costs funds or Exceptions funds be applied
           to meet costs on any other activity without the prior written permission of the Grantors.

3.3        The control of expenditure to be funded under the Grant must be governed by the normal
           standards and procedures of the Organisation and must be covered by any formal audit
           arrangements that exist in the Organisation.

3.4        During the Grant Period and for six years thereafter, the Grantors (and/or the National Audit
           Office or Audit Commission) shall have the right to request from the Organisation, at any
           time, any financial information or technical information or results of the research in respect
           of the Grant or the activities it funds and/or to ask for confirmation from the external auditors
           of the Organisation that the external auditors have signed their opinion on the annual
           accounts of the Organisation without qualification; and the management letter from the
           auditors raises no matters that did or could significantly affect the administration of grants
           awarded by the Grantors. If the auditors have raised any such matters in their management
           letter, the Grantors (and/or the National Audit Office or Audit Commission) may require the
           Organisation to provide them with relevant extracts from the letter.

3.5        During the Grant Period and for six years thereafter, the Organisation must provide access
           to accounting and other records relating to the Grant and the activities funded by it for
           auditors and other personnel from or appointed by the Grantors (or the National Audit Office
           or Audit Commission) at any time (at the auditing Grantor’s expense), if requested. Such
           access must include the right to inspect any equipment or facilities acquired or funded under
           the Grant, laboratory notebooks or other records of research carried out using the Grant and
           any outcomes of such research. For the avoidance of doubt, audit may include audit of
           technical and scientific work and patient benefit as well as financial audit. Where elements
           of expenditure under the Grant have been subcontracted, the Organisation should ensure
           that the right of access extends to the accounts, records, procurement procedures (and
           records of procurements), equipment and facilities of any such subcontractor.

3.6        During the Grant Period and for six years thereafter, the Grantors (and/or the National Audit
           Office or Audit Commission) shall have the right, at their discretion and expense, to audit
           (directly or via third parties engaged by it) the Grant, income and expenditure in relation to
           the activities funded by the Grant and/or the systems used by the Organisation to administer
           the Grant at any time and compliance with the Grant Conditions.

3.7        The Organisation should maintain a separate accounting cost code specific to the Grant,
           and all costs and income properly relating to the Grant should be accounted for through that
           cost code. The Organisation should ensure that appropriate records are kept to support the
           entries made on the cost code.

4.         EQUIPMENT

4.1        The Organisation must ensure that it has in place clearly defined procedures for the
           procurement of equipment and that equipment funded by the Grant is acquired by it using
           these procedures. Procurement of equipment, consumables and services must comply with
           all relevant EU procurement law.


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4.2        The Organisation must ensure that equipment purchased with Grant funds is appropriately
           insured and maintained during the period of the Grant.

4.3        Equipment funded by the Grant is awarded to the Organisation specifically for the research
           for which the Grant is awarded. Written prior permission from the Grantors must be
           obtained to use the equipment for any other purpose (including to charge, hire, lend or
           dispose of it). The Grantors must be informed if, during the Grant Period, the need for the
           equipment diminishes substantially or it is proposed to use it for other research purposes.
           In such event, the Grantors reserve the right to determine the disposal of such equipment
           and to claim the proceeds from any sale.

5.         EMPLOYMENT

5.1        The Grantors do not act as an employer with respect to the Grant, and therefore in all cases
           where support is provided on the Grant for the employment of staff, the Organisation
           undertakes to issue a contract of employment to such staff that is in compliance with
           relevant laws and regulations. The Grantors accept no liability and disclaim all and any
           liability for any employees the Organisation uses to carry out the work on the Grant funded
           research, including without limitation any liability in respect of unfair dismissal,
           discrimination, breach of employment contracts or employment law or any TUPE liabilities.

5.2        The Organisation shall have full responsibility for all staff funded from the Grant and, in
           consequence, fulfil all duties and obligations owed as an employer to such staff.

5.3        The Organisation shall ensure that any individuals employed by or having a contract for
           services with the Organisation who are involved in any way with activities funded by the
           Grant comply with the rules and regulations of the NIHR faculty as set out in the Department
           of Health's "NIHR Faculty Regulations".

6.         UNLAWFUL DISCRIMINATION

6.1        The Organisation shall ensure that it complies with all current employment legislation and in
           particular, does not unlawfully discriminate within the meaning of the Race Relations Act
           1976 (as amended), the Sex Discrimination Act 1975 (as amended) and 1986, the Disability
           Discrimination Act 1995 (as amended) and 2005, the Equality Act 2006, the Employment
           Equality (Religion or Belief) Regulations 2003 [SI 2003 No 1660] (as amended), The
           Employment Equality (Sexual Orientation) Regulations 2003 [SI 2003 No 1661] (as
           amended), the Employment Equality (Sex Discrimination) Regulations 2005, the
           Employment Equality (Age) Regulations 2006, or any other relevant legislation relating to
           discrimination in the employment of employees (collectively, the “Employment Legislation”).

6.2        The Organisation shall notify the Grantors immediately of any investigation of or
           proceedings against the Organisation under the Employment Legislation and shall
           cooperate fully and promptly with any requests of the person or body conducting such
           investigation or proceedings, including allowing access to any documents or data required,
           attending any meetings and providing any information requested.

6.3        The Organisation shall indemnify the Grantors against all costs, claims, charges, demands,
           liabilities, damages, losses and expenses arising out of or in connection with any
           investigation conducted or any proceedings brought under the Employment Legislation due
           directly or indirectly to any act or omission by the Organisation, its agents, employees or
           sub-contractors.

7.         PUBLICATION, PUBLICITY AND REPORTING

7.1        The findings from research funded by the Grant should be published in an appropriate form,
           usually as papers in a refereed, peer-reviewed journal.

7.2        The publication or release of such findings may be reasonably delayed to enable protection
           of any intellectual property. The identification, protection, management and exploitation of



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           intellectual property is subject to Clause 10 on "Intellectual property and commercial
           activities".

7.3        All research papers that have been accepted for publication in a peer-reviewed journal, and
           are supported in whole or in part by the Grant, must be made available from UK PubMed
           Central as soon as possible, and in any event within six months of publication, in line with
           the      Wellcome        Trust’s     Open       Access        policy      (available      at
           http://www.wellcome.ac.uk/node3302.html ).

7.4        Grantors may at any time publish any report, executive summary, paper, abstract or other
           document provided by the Organisation for any non-commercial purpose and in conjunction
           with the Grantor's statement on Open Access to research "Statement on DH/NIHR-funded
           research and UK PubMed Central". Such purposes may include but are not limited to any
           entry in a register of research findings or an individual issue of or a review article in a
           monograph series prepared on the Grantor's behalf. The timing of any such publication will
           be subject to consultation with the Organisation and will take account of publication
           timetables in other peer-reviewed journals and the need to make research findings publicly
           available as soon as practicable.

7.5        To assist the Grantors in tracking the outputs of research to which they have contributed
           funding either wholly or in part, the Grantors' contributions must be acknowledged in all
           publications and other forms of media communication including media appearances, press
           releases and conferences according to the Wellcome Trust’s Guidance for Research
           Publication          Acknowledgement               Practice         (available         at
           http://www.wellcome.ac.uk/doc_wtx038642.html ) and the Department of Health's statement
           on Open Access in research (available on the http://www.nihr.ac.uk website).

7.6        To meet the Grantors' obligations for public accountability and the dissemination of
           information, details of Grants may also be made available on the web sites of each of the
           Grantors and other publicly available databases and in reports and documents.

7.7        The form and content of the End of Grant Research Report and the End of Grant Spend
           Report shall be as directed by the grantors at www.wellcome.ac.uk/hicf.
8.         FREEDOM OF INFORMATION

8.1        Attention is drawn to the Freedom of Information Act 2000 (“FOIA”) and the Environmental
           Information Regulations (“EIRs”). The Department of Health (“DOH”) has a publication
           scheme which sets out the type of information publicly available on its website or published
           as documents. In addition, the DOH has an obligation to respond to specific requests and
           may be required to disclose information about or provided by the Organisation. In some
           cases the DOH may consult the Organisation before deciding whether to disclose
           information requested under the FOIA, but it is not obliged to do so. If an Organisation
           considers that any information it provides to the DOH would be subject to an exemption
           under FOIA or the EIRs it should clearly identify such information and explain why it
           considers the information exempt. The DOH will consider such explanation. For the
           avoidance of doubt, notwithstanding the previous sentence, whether or not information will
           be disclosed shall be at the DOH’s sole discretion.

8.2        Where the DOH considers that an Organisation is holding information that it requires in
           order to comply with its obligations under FOIA or the EIRs, the Organisation undertakes to
           (and shall procure that its collaborators and sub-contractors shall) provide access to such
           information as soon as reasonably practicable, at its own expense and at no charge to the
           DOH, on the request of the DOH and in any case within five working days.

9.         DATA PROTECTION, PERSONAL DATA and MEDICAL RECORDS




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9.1        The Organisation shall ensure that the collection, handling and use of personal data (as
           defined in the Data Protection Act 1998 ("DPA") shall be treated as confidential at all times,
           and stored securely (including in any electronic format).

9.2        Any and all medical information used by the Organisation in carrying out a Grant-funded
           research shall be used in accordance with the following guidance (as updated from time to
           time):

                       (a)   the Medical Research Council’s “Personal Information in Medical Research”,
                             January 2003 available at http://www.mrc.ac.uk; and

                       (b)   “The NHS Confidentiality Code of Practice”, guidelines on the use and
                             protection of patient information, November 2003 available at
                             http://www.dh.gov.uk

9.3        No information which could lead to the identification of an individual shall be included in any
           publication without the prior agreement in writing of the individual concerned.

9.4        The Grantors shall not be entitled to inspect, take or be supplied with copies of any specific
           basic factual (or "raw") data obtained in connection with the Grant-funded research other
           than in an anonymised form. The Organisation shall ensure that all basic factual data is
           anonymised as and when it is obtained and that the key to personal identities of all persons
           to whom the data relates is kept in a separate and secure place.

9.5        The Organisation shall fully indemnify and hold harmless the Grantors, their directors,
           officers, employees and agents against all liabilities, losses, costs, charges and expenses
           incurred as a result of any claims, demands, actions and proceedings made or brought
           against the Grantors by any person in respect of any loss or distress to that person by the
           loss, unauthorised disclosure of personal data or medical records by the Organisation, or
           any collaborator, sub-contractor, servant or agent of the Organisation or any person within
           the control of the Organisation.

9.6        The Organisation shall at its own expense conduct any litigation arising from any such
           claims, demands, actions or proceedings and all the negotiations for the settlement of the
           same and the Grantors hereby agree to grant the Organisation exclusive control of any such
           litigation or the negotiations for the settlement of the same.

10.        INTELLECTUAL PROPERTY AND COMMERCIAL ACTIVITIES

10.1       The Organisation shall notify the Grantors of any Project Intellectual Property which is
           capable of exploitation (whether patentable or not) in a timely manner.

10.2       The Organisation shall develop, implement and maintain procedures for the management of
           Project Intellectual Property and shall use reasonable endeavours to ensure that:

           a)          the Project Intellectual Property is identified, recorded and carefully distinguished
                       from the outputs of other research;

           b)          prior to any publication of the results of the research, the Organisation shall
                       identify (pursuant to Clause 10.6) whether patenting is appropriate and, where it is
                       reasonable so to do, make applications for patents; and

           c)          all such applications are diligently prosecuted having regard to all relevant
                       circumstances.

10.3       The Grantors require the Organisation to ensure that all persons in receipt of the Grantors’
           funding or working on a Grant-funded activity (including employees, students, visiting
           fellows, collaborators and subcontractors) are employed or services are engaged on terms
           that vest all Grant-funded IP in the Organisation.

10.4       Project Intellectual Property shall vest in the Organisation.


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10.5       The Organisation shall seek the prior written consent of the Grantors (not to be
           unreasonably withheld) to any commercial use of, or granting to any third party any
           exploitation rights over Project Intellectual Property. Such consent shall be sought by
           completing the consent application form available from www.wellcome.ac.uk/hicf. As a
           condition of granting consent, the Grantors will require the Organisation to accept the then
           current standard revenue and equity sharing agreement for the Health Innovation Challenge
           Fund.

10.6       The Organisation shall grant (and shall procure that any collaborators grant) to the Grantors
           a perpetual worldwide, royalty free, non-exclusive and irrevocable licence to use or publish
           information or results from the research. However this licence does not include the right to
           exploit the results commercially.

10.7       If the Organisation does not protect, manage or exploit any Project Intellectual Property
           arising out of the Grant to the reasonable satisfaction of the Grantors, then the Grantors
           shall have the right, but not a duty, to protect, manage and exploit such Project Intellectual
           Property. Unless the Grantors reasonably consider that the opportunity to protect, manage
           or exploit such Grant-funded IP for the public benefit could be lost and more immediate
           action is required, such right shall only be exercised six (6) months after the Grantors have
           given the Organisation notice in writing that it is failing to protect, manage and exploit such
           Project Intellectual Property to the Grantors’ satisfaction. The Organisation agrees to do,
           and will ensure that its employees, students and any third party acting on its behalf do, all
           acts required to assist the Grantors in such protection and exploitation.

10.8       In addition to, or as an alternative to, the income sharing and/or equity sharing provisions of
           this clause 10, the DOH may opt for another method of receiving some or all of its return on
           the Grant. For example where the Grant-funded Project results in the development of any
           products or services, the Exploiting Party or it’s licensees shall make such products OR
           such services available to the DOH for application in the treatment of NHS funded patients
           (whether by direct or indirect supply of such products or services or by granting of full paid-
           up licences or by other means) at a discounted price to the DOH. For example, the DOH
           may received free services such as training or maintenance, for application in the treatment
           of NHS funded patients, alongside products purchased under normal commercial terms or
           vice versa.

10.9       Where the DOH elects to receive some or all of its return in the form of Product Discounts
           then the Exploiting Party agrees to procure and provide the necessary financial information
           according to the principles of open book costing.

10.10      Where the DOH elects to receive all of its return in the form of Quasi-Equity or Product
           Discounts then the levels of Product Discounts or Quasi-Equity returns will be negotiated to
           be equivalent to the returns due under revenue or equity sharing as set out in Clauses 3.3
           and 3.4 of the Revenue and Equity Sharing Agreement. The Contractor will provide the
           DOH with sufficient financial information including details of product and service sales
           forecasts to allow compliance with State Aid Legislation.

11.        LIMITATION OF LIABILITY

11.1       The Grantors accept no responsibility or liability, financial or otherwise, for expenditure (or
           liabilities arising out of such expenditure) or liabilities arising out of the activities funded by
           the Grant. The Grantors will not indemnify the Organisation, any Grantholder or any other
           person working on the Grant (including employees, students, visiting fellows, collaborators
           and subcontractors) against any claims for compensation or against any other claims
           (whether under any statute or regulation or at common law) for which the Organisation may
           be liable as an employer or otherwise or for which any such person may be liable, including
           in respect of any termination or reduction in value of the Grant.

12.        INSURANCE

12.1           Without prejudice to Clause 11, and if requested by the Grantors, the Organisation shall,
               throughout the duration of the Grant-funded research, effect and maintain with a


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               reputable insurance company a policy or policies of insurance providing an adequate
               level of cover in respect of all risks which may be incurred by the Organisation arising out
               of or in connection with the Organisation’s performance of the Grant-funded research.

12.2           If requested by the Grantors, the Organisation shall produce documentary evidence to
               demonstrate that any insurance policies pursuant to Clause 12.1 are in force.

12.3           The provisions or the amount of cover of any insurance shall not relieve the Organisation
               of any liabilities incurred by the Organisation. It shall be the responsibility of the
               Organisation to determine the amount of insurance that will be adequate to enable the
               Organisation to satisfy its liabilities in undertaking the Grant-funded research.


13.        TRANSFER

13.1       The Organisation shall promptly inform the Grantors if the Grantholder intends to transfer to
           another organisation. If that organisation is in the UK and is eligible to hold the Grant and is
           able to provide a suitable environment to enable the project to be successfully completed,
           the expectation is that the Grant would be transferred with the Grantholder, subject to (i) the
           written consent of the Grantors and (ii) written agreement from the Organisation and the
           receiving organisation. If suitable arrangements for transfer or continuation of the Grant
           funded research cannot be agreed then the Grantors may terminate the Grant.

13.2       Grants will not be re-costed following any transfer pursuant to Clause 13.1. The unspent
           balance of Directly Incurred Costs funds and Exceptions funds, together with a pro rata
           share of Directly Allocated Costs funds and Indirect Costs funds, will be transferred to the
           new receiving organisation. The receiving organisation will be required to confirm to the
           Grantors that it will provide any balance of resources needed to complete the project.

13.3       The Organisation must consult the Grantors if it is proposed to change the Grantholder, for
           example following retirement, resignation or sickness. Where the Grantholder is transferring
           to another organisation in the UK and eligible to receive grants, the provisions of Clause
           13.1 and 13.2 will apply. In other circumstances, the Organisation will nominate a
           replacement Grantholder. The Grantors shall determine in their sole discretion whether the
           nominated replacement meets the eligibility criteria and has the expertise and experience to
           lead the project to a successful conclusion. If the Grantors do not approve the nominated
           replacement then the Grantors may terminate the Grant.

14.        GENERAL

14.1       The Grantors reserve the right to amend these Grant Conditions.

14.2       In the event of any conflict between the provisions of these Grant Conditions as amended
           from time to time, and of the Funding Agreement, the provisions of the Funding Agreement
           will take precedence.

14.3       The Organisation (or the Grantholders if appropriate) must inform the Grantors without delay
           of any change to the status of the Organisation or the Grantholders which might affect their
           ability to comply with these Grant Conditions.

14.4       The Grantholders must inform the Grantors as soon as practicable of any significant
           divergence from the original aims and directions of the research that is being funded by the
           Grant.

14.5       The Grantors reserve the right to terminate the Grant on notice with immediate effect.

14.6       The Grantors and the Organisation do not intend that any of these Grant Conditions should
           be enforceable by any third party.




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14.7       These Grant Conditions shall be governed by and construed in accordance with English law.
           The Organisation and the Grantholders irrevocably submit to the jurisdiction of the English
           courts to settle any disputes in connection with these Grant Conditions.

15.        DEFINITIONS

           "Contract Documents"           means these Grant Conditions, the Award Letter, and the Funding
                                          Agreement between the Grantors and the Organisation, the
                                          Wellcome Trust policies and positions on grants and the
                                          Department of Health policies on grants and any other documents
                                          recording the arrangements between the Parties with regard to the
                                          Grant

           "Department of Health" or      means the Secretary of State for Health acting through the
           “DOH”                          Department of Health

           "Directly Allocated Costs"     means the costs of resources used by a project that are shared by
                                          other activities. Such costs are charged to projects on the basis of
                                          estimates rather than actual costs and do not represent actual
                                          costs on a project-by-project basis

           "Directly Incurred Costs"      means costs that are explicitly identifiable as arising from the
                                          conduct of a project and are charged as the cash value actually
                                          spent and supported by an audit record [used in FEC def only]

           "End of Grant Research         means a form on which the Organisation reports on the activities
           Report"                        funded by the Grant, which must be completed by the principal
                                          Grantholder and submitted to the Grantors within three months of
                                          the end of the Grant Period or as otherwise required by the
                                          Grantors

           "End of Grant Spend            means a form completed by the Organisation that must be
           Report"                        submitted to the Grantors within two months of the end of the Grant
                                          Period or as otherwise required by the Grantors and that sets out:

                                          (a)        a comparison of (i) actual expenditure by the Organisation
                                                     during the Grant Period of the Grant and (ii) the total
                                                     amount awarded by the Grantors in respect of the Grant

                                          (b)        an explanation for any variances between (i) and (ii)
                                                     above, and

                                          (c)        any further information that the Grantors request from the
                                                     Organisation

           "Exceptions"                   means any Directly Incurred Costs which the Grantors fund at
                                          100% of Full Economic Cost, subject to actual expenditure
                                          incurred, or items which are outside of Full Economic Cost

           "Full Economic Cost"           means a cost which, if recovered across an Organisation's full
                                          programme, would recover the total cost (Directly Allocated Costs,
                                          Directly Incurred Costs, Indirect Costs and total overhead) including
                                          an adequate recurring investment in the Organisation's
                                          infrastructure

           “Funding Agreement”            means he not-for-profit funding agreement entered into between
                                          the Organisation and the Grantors in relation to the Grant

           "Grant"                        means the grant described in the Funding Agreement




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           "Grant Period"               means the period of the Grant set out in the Funding Agreement or
                                        the Award Letter, commencing on the start date confirmed by the
                                        Organisation in the manner indicated by the Grantors

           "Grantholder and             means the principal applicant (and any co-applicant, as specified in
           Grantholders"                the Funding Agreement) who has responsibility for the leadership
                                        of the Grant funded research and for overall management of the
                                        research

           "Grantors"                   means the Department of Health and the Wellcome Trust Limited

           "Indirect Costs"             means any non-specific costs charged across all projects based on
                                        estimates that are not included as Directly Allocated Costs. They
                                        include the costs of the Organisation's administration such as
                                        personnel, finance, library and some departmental services

           "Intellectual Property” or   means (i) patents, designs, trade marks and trade names (whether
           “IP"                         registered or unregistered), copyright and related rights, database
                                        rights, Know-how and confidential information; (ii)        all other
                                        intellectual property rights, in each case whether registered or
                                        unregistered and similar or equivalent rights anywhere in the world
                                        which currently exist or are recognised in the future; and (iii) all
                                        applications, renewals or extensions (including supplementary
                                        protection certificates) in relation to any such rights

           “NHS Costs”                  means NHS support costs, NHS treatment costs and NHS excess
                                        treatment costs

           "Organisation”               means the university, NHS trust, institution, research council or
                                        other body at which some or all of the research funded by the Grant
                                        will be carried out or which employs the Grantholder(s) and which
                                        takes responsibility for the management of the research project and
                                        the accountability for Grant funds provided

           “Product Discounts”          means discounts on the prices charged for products and services
                                        incorporating or derived from the Project IP

           "Project"                    means the research detailed in the Application to be undertaken by
                                        the Organisation and funded by the Grantors

           “Project Intellectual
                                        means any Intellectual Property created, devised, or arising out of
           Property”
                                        the Organisation’s undertaking and performance of the Project or
                                        any part of it
           "PubMed Central"             means a free digital archive of biomedical and life science journal
                                        literature operated by the National Center for Biotechnology
                                        Information, a division of the U.S. National Library of Medicine

           “Quasi Equity”               means the issuing of loans, debentures or convertible debt from
                                        time to time in any company in consideration, or part consideration,
                                        of the assignment or grant of a licence or an option thereto to such
                                        company of any Project IP

           "Spend Report"               means a form that must be completed by the Organisation and
                                        submitted to the Grantors that sets out:

                                        (a)        a comparison of (i) actual expenditure by the Organisation
                                                   during a particular period on a particular Grantors grant or
                                                   (in the case of Organisation Spend Reports), on all active
                                                   Grantors grants held by an Organisation and (ii) the
                                                   amount paid by the Grantors during that period in respect


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                                            of that grant or (in the case of Organisation Spend
                                            Reports) in respect of all active Grantors grants held by
                                            an Organisation

                                 (b)        an explanation for any variances between (i) and (ii)
                                            above, and

                                 (c)        any further information that the Grantors request from the
                                            Organisation

           "UK PubMed Central"   means a UK counterpart of PubMed Central developed by the
                                 Wellcome Trust and various funding partners

           "Wellcome Trust"      means the Wellcome Trust (a charity registered in England with
                                 number 210183), acting through its trustee, The Wellcome Trust
                                 Limited (a company registered in England with number 2711000)




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SCHEDULE 4

                                               Milestones



 Milestone          Description of Milestone                Milestone Date

 1                                                           [x] months from
                                                             the Project Start
                                                                   Date

 2                                                           [x] months from
                                                             the Project Start
                                                                   Date

 3                                                           [x] months from
                                                             the Project Start
                                                                   Date




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SCHEDULE 5


                                       Costs Schedule


[Grantors to insert budget table from Award Letter]




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SCHEDULE 6

                                          The Research Steering Group



1              The Grantors and the Organisation shall establish a Research Steering Group (“RSG”) to
               oversee the Project, which shall:

               (a)           monitor the performance and technical content of the Project against the Plan;

               (b)           assess the ongoing results of the Project and what has been learnt and agree
                             future research;

               (c)           critically assess the results of the Project;

               (d)           identify and address any weaknesses or delays in the Project;

               (e)           co-ordinate internal and outsourced components of the Project, including
                             agreeing any collaborations or sub-contracts not specifically identified in the
                             Plan;

               (f)           modify or authorise modifications to the implementation of the Project (including
                             the implementation of the Project objectives) as necessary from time to time;

               (g)           operate as the key forum through which the Grantors and the Organisation
                             shall be informed as to progress of the Project and through which the Grantors
                             shall liaise with the Organisation concerning the conduct of the Project,
                             including preparing an annual written report for the Grantors on progress; and

               (h)           advise the Organisation when and whether each of the research phases,
                             Milestones or targets of the Project have been achieved,

               provided that the RSG shall have no right to amend or vary the provisions of this
               Agreement or to alter the fundamental scope of objectives of the Project which power is
               reserved to the Parties.

2             The RSG shall be established and run by the Parties as follows:

               (a)           The RSG shall be comprised of the following persons (“Members”):

                             (i)        the Principal Investigator(s);

                             (ii)      at least one independent industry adviser with experience which is
                                       relevant to the Project;

                             (iii)     one representative of the Organisation’s technology transfer office (at
                                       the Organisation’s option); and

                             (iv)      two (2) representatives or nominees of the Grantors (at the Grantors’
                                       option) from the Trust’s Technology Transfer Division and/or the
                                       NIHR Central commissioning Facility.

                (b)           Each of the Grantors shall have the option to appoint one (1) Member, to
                             remove any Member appointed by it and to appoint any person to fill a vacancy
                             arising from the removal or retirement of such Member. If either of the Grantors
                             does not appoint such a Member, it shall have the right to receive all papers that
                             a Member would be entitled to receive.




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                (c)          The Organisation shall have the option to appoint one Member from its
                             technology transfer office, to remove any Member appointed by it and to appoint
                             any person to fill a vacancy arising from the removal or retirement of such
                             Member.

               (d)           The Organisation and the Grantors shall agree jointly on the identity of the other
                             Members. The costs and expenses of the independent industry adviser(s) shall
                             be met out of the Award Amount.

               (e)           The Principal Investigator shall be the chairperson of the RSG (“RSG Chair”)
                             and shall be responsible for organising meetings of the RSG, including
                             preparing papers prior to meetings and ensuring that minutes of meetings are
                             produced promptly after each meeting. All papers and minutes shall be
                             circulated to each Member in a timely manner. Except in exceptional
                             circumstances (when the Principal Investigator may nominate another person
                             as his alternate), the Principal Investigator shall attend all RSG meetings.

               (f)           The quorum for RSG meetings shall be three (3) Members including a Member
                             appointed by one of the Grantors, the Principal Investigator and at least one of
                             the independent industry advisers. Decisions of the RSG shall be made by
                             majority agreement of the Members present. The RSG Chair shall not have a
                             casting vote. If the RSG is unable to reach agreement on a decision, the
                             decision shall be escalated to the Director of Technology Transfer at the Trust,
                             the Director of the NIHR Central Commissioning Facility and [suitably senior
                             representative of Organisation] for resolution.

               (g)           Meetings of the RSG shall be convened by the Principal Investigator as
                             required but at least once every three (3) months (or less frequently with the
                             consent of the Grantors) during the Project, on not less than ten (10) Business
                             Days’ written notice (to be accompanied by an agenda for the meeting and a
                             report on the progress of the Project). Following the end of the Project, the
                             RSG shall meet within twenty (20) Business Days to discuss and report on the
                             outcomes of the Project.

               (h)           Any or all Members may, with the prior consent of the RSG Chair, attend a
                             meeting of the RSG by telephone or other electronic means rather than in
                             person, provided that all Members attending the meeting can hear and be
                             heard for all parts of the meeting. For the avoidance of doubt, RSG Members
                             attending a meeting by telephone or other electronic means shall have the
                             same voting rights as an RSG Member present in person.

               (i)           A representative from any key outsourcing suppliers, collaborators or
                             subcontractors involved in the Project (if any) shall be invited to RSG meetings
                             as an observer. The RSG shall also have power to invite persons whose
                             special skills or influence might advance the Project to attend and address
                             meetings of the RSG. Such persons shall not be Members of the RSG and
                             shall not have a right to participate in its decision-making process. The RSG
                             Chair shall ensure that any such invitees sign confidentiality agreements in a
                             form acceptable to all parties.




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SCHEDULE 7

                             The Intellectual Property Management Group (IPMG)



1              The Organisation and the Grantors shall establish an IPMG, which shall:

               (a) approve all public disclosures relating to the Project, including presentations,
                   posters and papers (provided that the contribution of the Grantors is acknowledged
                   in all such publications and quoting the Award number);

               (b) identify new inventions arising out of the Project and make recommendations for IP
                   strategy, including patent filing and prosecution strategy and assessment of
                   freedom to operate issues; and

               (c) approve the Exploiting Party’s commercialisation and translation strategy in relation
                   to the Project Intellectual Property.

2              The IPMG shall be established and run by the Parties as follows:

               (a) The IPMG shall be comprised of the following persons (“IPMG Members”):

                             (i)     the Principal Investigator;

                             (ii)    an independent adviser appointed by mutual agreement between the
                                     Grantors and the Organisation;

                             (iii)   one representative of the Organisation’s technology transfer office or
                                     its nominee; and

                             (iv)    no more than two (2) representatives of the Grantors’ departments
                                     dealing with technology transfer or their nominees.

              (b)    Each of the Grantors shall have the option to appoint one (1) IPMG Member, to
                     remove any IPMG Member appointed by it and to appoint any person to fill a
                     vacancy arising from the removal or retirement of such IPMG Member. In the event
                     that either of the Grantors does not appoint such IPMG Members, it shall have the
                     right to receive all papers that an IPMG Member would be entitled to receive.

              (c)    The Organisation shall have the option to appoint one IPMG Member from the
                     Organisation’s Technology Transfer office, to remove any IPMG Member appointed
                     by it and to appoint any person to fill a vacancy arising from the removal or
                     retirement of such IPMG Member. If the Organisation does not appoint such an
                     IPMG Member, the Organisation shall have the right to receive all papers, which an
                     IPMG Member would be entitled to receive. The costs and expenses of the
                     independent industry adviser(s) shall be met out of the Award Amount.

              (d)    The Principal Investigator shall chair the IPMG (“IPMG Chair”) and shall be
                     responsible for organising meetings of the IPMG, including preparing papers prior to
                     meetings and ensuring minutes of meetings are produced. All papers and minutes
                     shall be circulated to each IPMG Member in a timely manner.

              (e)    The quorum for IPMG meetings shall be two (2) IPMG Members, provided that at
                     least one is an IPMG Member appointed by the Organisation and at least one is an
                     IPMG Member appointed by one of the Grantors. Decisions of the IPMG shall be
                     made by majority agreement of the persons present. The IPMG Chair shall not have
                     a casting vote. If the IPMG is unable to reach agreement on a decision, the decision
                     shall be escalated to Director of Technology Transfer at the Trust, the Head of
                     Intellectual Property of NIHR Central Commissioning Facility and [Head of


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                     Organisation’s Technology Transfer office] for resolution. If the IPMG Chair is
                     unable to attend an IPMG meeting, the Organisation and the Grantors shall, in good
                     time before the meeting, nominate an alternative IPMG member to act as Chair.

              (f)    Meetings of the IPMG shall be convened by the IPMG Chair at least once per year
                     and otherwise on an “as needed” basis, either in person at the premises of the
                     Organisation or by ‘virtual private network’ videoconference if necessary. Any or all
                     IPMG Members may, with the prior consent of the IPMG Chair, attend a meeting of
                     the IPMG by telephone or other electronic means rather than in person, provided
                     that all IPMG Members attending the meeting can hear and be heard for all parts of
                     the meeting. For the avoidance of doubt, IPMG Members attending a meeting by
                     telephone or other electronic means shall have the same voting rights as an IPMG
                     Member present in person

3             The Exploiting Party shall use its reasonable efforts to manage the commercialisation and
              exploitation of the Project Intellectual Property. If the Exploiting Party is either of the
              Grantors, it shall do so on behalf of the Organisation.

4              [In the event that:

               (a)           the Exploiting Party fails to take steps to commercialise or exploit any of the
                             Project Patents by the date sixty (60) months from the filing date of such
                             Project Patent; or

               (b)           if at any time the Exploiting Party notifies the Non-Exploiting Parties in writing
                             that it has decided not to exploit any Project Intellectual Property,

               then the Non-Exploiting Parties (the Grantors) shall have the option (by serving written
               notice on the Exploiting Party) to commercialise and exploit the Project Intellectual
               Property instead of the then Exploiting Party, such exploitation to be subject to the
               provisions of the revenue sharing agreement set out in Schedule 8.]

5              The Exploiting Party shall have discretion to make any and all decisions in relation to the
               negotiation, acceptance and conclusion of terms for any agreement regarding the
               translation, development and exploitation of the Project Intellectual Property provided
               that it informs the IPMG in advance of all substantive steps which it intends to take in
               relation to the above and (if the Exploiting Party is not either of the Grantors) obtains the
               written consent of the Grantors prior to entering into any agreements granting any rights
               over the Project Intellectual Property.

6              Following the establishment of the IPMG and prior to the exploitation of any Project
               Intellectual Property the Parties shall enter into a separate revenue and/or equity sharing
               agreement to detail how any such benefits are managed and shared. The current
               standard form revenue and equity sharing agreement for the Health Innovation
               Challenge Fund is set out in Schedule 8.

7              The Organisation accepts that in order to exploit the Project Intellectual Property and
               Project Patents, it may be necessary or useful to grant a licence to the Background
               Intellectual Property and at the request of the Exploiting Party shall grant such a licence
               (to the extent that this does not conflict with any pre-existing third party rights). Any such
               licence grant shall be non-exclusive, free of charge and only to the extent necessary or
               useful to exploit the Project Intellectual Property and Project Patents.

8              If any exploitation of the Project Intellectual Property results in the acquisition of any
               Equity Holding (for example, but without limitation, because the Project Intellectual
               Property is assigned or licensed to a corporate vehicle spun out of the Organisation) then
               the following principles shall apply:

                a)           the Exploiting Party shall at its discretion in accordance with the terms of the
                             IPMG take the lead in connection with the finding of potential investors and in
                             negotiation of the transaction resulting in the Equity Holding;


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                b)           the Exploiting Party shall require at its discretion either (i) observer status for
                             meetings of the board of directors (including the right to receive copies of
                             board minutes and board papers), or (ii) actual board membership;

                c)           the Parties acknowledge that it would be advantageous for the board of
                             directors and any scientific advisory board to include external representation,
                             such representation to incorporate business, pharmaceutical and scientific
                             expertise and to be chosen by or in conjunction with the IPMG, and shall use
                             reasonable endeavours to include such representation; and

                d)           the Organisation accepts that it will have to assign or license the Project
                             Intellectual Property into such a corporate vehicle.

9              The Organisation shall procure that the Principal Investigator and other members of its
               Staff who contributed to the creation of Project Intellectual Property will give all
               reasonable assistance to the Exploiting Party in relation to the commercialisation and
               exploitation of the Project Intellectual Property and (if applicable) the Background
               Intellectual Property, including:

                a)            executing any necessary documents; and

                b)            assisting in the transfer of Know-How generated in the course of the Project
                              to a third party licensee or corporate vehicle.

The Non-Exploiting Party agrees that it shall pass to the Exploiting Party immediately any or all
exploitation opportunities that it becomes aware of from time to time in connection with the Project
Intellectual Property. The Non-Exploiting Party further undertakes that it shall not engage in any
activities (including in relation to the Background Intellectual Property) that could reasonably lead to
the loss of an exploitation opportunity without the prior written consent of the Exploiting Party.




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SCHEDULE 8


     HEALTH INNOVATION CHALLENGE FUND: INTELLECTUAL PROPERTY, EXPLOITATION
                CONSENT AND REVENUE/EQUITY-SHARING AGREEMENT


This Agreement is made between the parties whose details are set out below on [date]:

A.     TRUST

       Name:                 THE WELLCOME TRUST LIMITED, a company registered in England &
                             Wales as Trustee of the Wellcome Trust, a charity registered in England
                             under no. 210183 (the “Trust”)
       Company no:           2711000
       Address:              Technology Transfer, The Wellcome Trust, 215 Euston Road,
                             London, NW1 2BE
       Contact:              Wellcome Technology Transfer
       Tel:                  +44 (0)20 7611 8202
       E-mail:               techtransfer@wellcome.ac.uk
B.     DEPARTMENT

       Name:                 THE SECRETARY OF STATE FOR HEALTH acting through the
                             DEPARTMENT OF HEALTH (the "Department")
       Address:              [address]
       Contact:              [contact]
       Tel:                  [telephone]
       E-mail:               [email]
C.     ORGANISATION

       Name:

       Address:              [address]
       Contact:              [contact]
       Tel:                  [telephone]
       E-mail:               [email]
D.     TECHNOLOGY TRANSFER GROUP (if applicable)

       Name:

       Company no:
       Address:              [address]
       Contact:              [contact]
       Tel:                  [telephone]
       E-mail:               [email]




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                               TABLE OF CONTENTS



1.       DEFINITIONS

2.       CONSENT TO EXPLOIT GRANT-FUNDED IP

3.       REVENUE SHARING

4.       ACCOUNTING, REPORTING AND PAYMENTS

5.       MONITORING GRANT-FUNDED IP

6.       DISPUTE RESOLUTION

7.       GENERAL

SCHEDULE 1 – CONSENT APPLICATION FORM

SCHEDULE 2 - AGREEMENT(S) TO BE ENTERED INTO

SCHEDULE 3 - COMMERCIALLY SENSITIVE INFORMATION




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THE PARTIES HEREBY AGREE as follows:

1.      DEFINITIONS

1.1    ‘Cumulative Income’ means total Net Income received by the Exploiting Party as a result of
       exploitation of the Project IP.

1.2    ‘Direct Costs’ means all reasonable patent and legal costs and other expenses that are
       incurred directly in connection with exploitation of the Project IP, including official patent filing,
       prosecution, maintenance and renewal fees;

1.3    ‘Equity’ means the issuing of equity or any other interest (whether by way of debenture,
       warrant, security or otherwise) from time to time in any company in consideration of the
       assignment of, or grant of a licence to or an option in respect of any Project IP.

1.4    ‘Exploiting Party’ means whichever of the Organisation or Technology Transfer Group (if there
       is one) named above as is or will be responsible for technology transfer and commercialisation
       matters with respect to the Project IP for and on behalf of the Organisation. For these purposes,
       ‘exploitation’ includes but is not limited to commercialisation by way of licence, assignment,
       option, sale of goods or services, hire or lease, research collaboration or other agreement, or
       for cash or equity consideration.

1.5    ‘Funding Agreement’ means the not-for-profit funding agreement entered into on [insert date]
       between the Organisation and the Grantors in relation to the Grant;

1.6    ‘Grant’ means the grant funding provided to the Organisation by the Grantors.

1.7    ‘Grant Conditions’ means the Grant Conditions for the Health Innovation Challenge Fund
       programme, as may be amended from time to time.

1.8    'Grantors' means the Department of Health and the Wellcome Trust Limited.

1.9    ‘Gross Income’ means all cash sums or other monetary consideration actually received in
       respect of exploitation of the Project IP, including licence, signing and option fees, royalties,
       and milestones, but excludes any Equity or other interests (whether by way of debenture,
       warrant, security or otherwise) or monies paid specifically to fund the undertaking of a research
       programme. Where commercialisation takes place (i) other than in an arm's length transaction
       at market rates, the Gross Income shall be deemed to be the income which would have been
       obtained under this Agreement, had such Project IP been exploited on an independent at arm's
       length basis.

1.10 'Indirect Costs' means any non-specific costs charged across all projects including non Grant
     funded projects based on estimates that are not included as Direct Costs. They include the
     costs of the Organisation's administration such as personnel, finance, library and some
     departmental services.

1.11 ‘Intellectual Property’ (or ‘IP’) means (i) patents, designs, trade marks and trade names
     (whether registered or unregistered), copyright and related rights, database rights, Know-How
     and confidential information, (ii) all other intellectual property rights, in each case whether
     registered or unregistered and similar or equivalent rights anywhere in the world which currently
     exist or are recognised in the future; and (iii) all applications, renewals or extensions (including
     supplementary protection certificates) in relation to any such rights.

1.12 ‘Net Income’ means Gross Income less (a) Direct Costs, and (b) any applicable taxes on Gross
     Income and Direct Costs.

1.13 ‘Other Parties’ means the Parties which are not the Exploiting Party.



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1.14 ‘Participation Round’ means a company’s equity financing following the date of this
     Agreement, where a company is or has been established by the Exploiting Party or otherwise
     used as a vehicle to exploit the Project IP or any part of it.

1.15 ‘Parties’ means the parties to this Agreement and ‘Party’ shall be interpreted accordingly;

1.16 ‘Project Intellectual Property’ means any Intellectual Property created, devised or arising out
     of the Organisation’s undertaking and performance of the Project or any part of it;

1.17 ‘Technology Transfer Fee’ means the percentage of Net Income which the Exploiting Party is
     entitled to for its exploitation of the Project IP.

1.18 ‘Technology Transfer Group’ means a body which is responsible for providing technology
     transfer services to the Organisation and which has been approved by the Grantors to carry out
     exploitation activities with respect to the Project IP, details of which are set out above.

1.19 ‘Trust’ means The Wellcome Trust Limited as trustee of the Wellcome Trust, a charity
     registered in England with number 210183, details of which are set out above.

1.20 ‘WTT’ means the Trust’s technology transfer division, Wellcome Technology Transfer.

1.21 The Schedules form an integral part of this Agreement and have effect as if set out in full in the
     body of this Agreement. A reference to this Agreement includes the Schedules.

1.22 Capitalised terms in this Agreement shall be interpreted in accordance with the definitions as
     set out in the Funding Agreement or above. Where a capitalised term is defined in both this
     Agreement and the Funding Agreement, the definition in this Agreement shall apply.

2.     CONSENT TO EXPLOIT PROJECT IP

2.1    In consideration for entering into the terms of this Agreement and pursuant to the Grant
       Conditions, the Grantors consent to the exploitation of the Project IP in accordance with the
       details set out in the Schedules to this Agreement.

3.     REVENUE SHARING

3.1    In consideration for consent being granted pursuant to Clause 2 above, the Exploiting Party
       shall share Gross Income and Equity received in respect of Project IP as set out in this Clause
       3.

3.2    The Exploiting Party shall first determine if:

       a)      the Grant (together with any other funding provided by the Grantors) is the sole source
               of funding for the Project IP, in which case Clauses 3.3 and 3.4 shall apply to the total
               Gross Income or Equity received in respect of that Project IP, or

       b)      the Grant (together with any other funding provided by the Grantors) is not the sole
               source of funding for the Project IP, in which case the Gross Income or Equity received in
               respect of that Project IP shall be pro-rata calculated to take into account:

               i)      the inventive contribution of the inventors; followed by

               ii)     the proportionate funding contributions of the Grantors, the Organisation and other
                       third party funders of each inventor as appropriate (such funding contribution to
                       exclude any salary support provided by the Organisation from its internal funding,
                       overhead or other Indirect Costs including for the avoidance of doubt the Higher
                       Education Funding Council (HEFCE, SHEFC or HEFCW) funding);

and the revenue-sharing formulae set out in Clauses 3.3 and 3.4 shall then apply to the portions of
Gross Income or Equity attributed to the Grantors contribution pursuant to this Clause 3.2b).

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       Income Sharing:

3.3    Where income is received then the Exploiting Party shall in respect of each item of Project IP
       that is exploited:

       a)      receive and account for Gross Income due;

       b)      deduct and reimburse as appropriate any and all Direct Costs;

       c)      be entitled to receive a Technology Transfer Fee on Net Income received (determined by
               reference to Cumulative Income) as follows:

                 Cumulative Income                             Technology Transfer Fee

                 £0 – £100 000                                 30% (thirty per cent)

                 £100 001 – £500 000                           25% (twenty-five per cent)

                 ≥ £500 001                                    20% (twenty per cent)

       d)      distribute remaining Net Income received in the following revenue shares (determined by
               reference to Cumulative Income) as follows:

                 Cumulative        Organisation and Technology           Grantors
                 Income            Transfer Group

                 £0 – £100 000     65% (sixty-five per cent)             35% (thirty-five per cent)

                 ≥ £100 001        60% (sixty per cent)                  40% (forty per cent)



       Equity sharing and potential future investment

3.4    The taking of an Equity share is an option for the Grantors but is not compulsory, in some
       circumstances the Grantors may prefer to take all benefits as income. Where Equity or rights to
       take Equity are received then the Exploiting Party shall in respect of each item of Project IP that
       is exploited:

       a)      share any Equity received in the following proportions;

                 Organisation and Technology Transfer          Grantors
                 Group

                 60% (sixty per cent)                          40% (forty per cent)



       b)      use all reasonable endeavours to ensure that the Equity is issued on terms whereby:

               i)      the proportionate shareholdings due to the Parties are issued direct to them;

               ii)     each of the Grantors is given no less than two months’ written notice prior to
                       completion of a Participation Round, and is provided with copies of the business
                       plan, signed or proposed term sheet, and any other relevant documentation that is
                       being provided to the other investors;

               iii)    at the Participation Round, each of the Grantors is entitled (but not obliged) to
                       invest in the company at the same rate as the other investors.


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3.5    For the avoidance of doubt, each Grantor's share of any Net Income or Equity shall be
       allocated to that Grantor prior to the deduction of any reward to the Organisation's employees
       or students who are inventors of the Project IP (whether pursuant to Section 40 of the Patents
       Act 1977 or the Organisation's own policies or any other cause). The Organisation shall be
       solely responsible for the payment of such reward (in accordance with its internal policies) out
       of the revenue and equity share to which it is entitled under Clauses 3.3 and 3.4.

3.6     Notwithstanding the terms of Clause 3, the Organisation and its Technology Transfer Group
       shall be free to agree how to share between themselves any Technology Transfer Fees, or
       shares of Net Income and/or Equity due to either or both of them under this Agreement.

3.7    Any shares of Net Income and/or Equity due to the Grantors under this Agreement shall be
       shared equally between the Grantors.

4.     ACCOUNTING, REPORTING AND PAYMENTS

4.1    Within three (3) months following each anniversary of the date of this Agreement, and within
       three (3) months of the date of expiry or termination of this Agreement, the Exploiting Party
       shall provide to the Other Parties a statement or statements setting out financial information for
       the preceding 12-month period ending on such annual accounting date in respect of each item
       of Project IP exploited or commercialised, including Gross Income, Net Income, Cumulative
       Income, Direct Costs, Technology Transfer Fee(s), Equity, revenue shares and taxes. All such
       statements shall include a breakdown of the calculations on which the amounts involved were
       determined. The Exploiting Party shall send with such statements the appropriate payments, if
       any, required in respect of such statements. The Grantors shall have the right to request and
       the Exploiting Party shall have the obligation to supply information as the Grantors see fit. The
       Exploiting Party shall also copy to the Grantors any reports prepared by or on behalf of the
       Technology Transfer Group in relation to (i) the commercialisation of the Project IP or (ii) any
       results of the Project.

4.2    The Exploiting Party shall keep, and shall require permitted subcontractors to keep, such
       records as are necessary to determine accurately payments due to the Grantors under this
       Agreement. At the request of the Grantors, with reasonable advance notice, the Exploiting
       Party shall make such records available for inspection, review, audit and copying by the
       Grantors or their designated representative and/or the National Audit Office or audit
       Commission. If a discrepancy is identified with respect to any payment, then the Exploiting
       Party shall pay the Grantors the amount of such discrepancy within thirty (30) days after
       receiving notice thereof. The Grantors may pay for any of their audits conducted pursuant to
       this Clause 4.2, unless the audit reveals that the Exploiting Party has underpaid more than five
       percent (5%) greater than the actual amount owed in any circumstance, in which case the
       Exploiting Party shall pay for such audit. Late payments shall be subject to interest payable on
       demand at the rate of 4 (four) per cent above the then current Bank of England base rate.
       Interest shall be calculated daily and compounded quarterly from the due date to the actual
       date of payment inclusive.

4.3    All payments shall be made in pounds sterling unless otherwise agreed, and shall be exclusive
       of any taxes or duties that may be imposed, including value added tax which shall, where
       applicable, be payable in addition at the rate in force at the due time for payment. With respect
       to Gross Income invoiced in a currency other than pounds sterling, the income payable shall be
       expressed in pounds sterling equivalent calculated using the fixing rates for pounds sterling
       published by European Central Bank (ECB) on the last business day of the calendar quarter to
       which the royalty report relates. In case the ECB does not provide a fixing for one of the
       currencies involved, the respective rate published by the Financial Times of the same day shall
       be applied.

4.4    The Organisation shall be free to agree accounting, reporting and payment practices with its
       Technology Transfer Group in respect of the revenue shares due to them under this
       Agreement.

4.5    If the Grantors take over responsibility as Exploiting Party in accordance with the Funding
       Agreement and the Grant Conditions, then references to Exploiting Party herein shall be


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       construed as references to the Grantors, and the Grantors shall share any Gross Income or
       Equity received in accordance with Clause 3 of this Agreement.

5.     MONITORING PROJECT IP

5.1    With respect to the Project IP, the Exploiting Party must:

       a)      unless otherwise scheduled to this Agreement at Schedule 2, provide to the Other
               Parties as and when they arise:

               i)        copies of any signed agreements entered into; and

               ii)       details of any applications for any registered Intellectual Property, and any grants
                         and abandonments (including title, filing number and date) of such;

       b)      develop, market, exploit and support the Project IP in a diligent and active manner, using
               appropriately qualified, trained and incentivised staff and use all reasonable endeavours
               to promote the exploitation of the Project IP in territories where it is likely to be
               commercially viable;

       c)      deliver at least annually an exploitation report detailing the commercialization activities
               for that year to the Other Parties; and

       d)      arrange and hold update meetings at least once every six (6) months, or at such other
               intervals as may be otherwise agreed with the Other Parties.

5.2    If the Exploiting Party elects to discontinue the prosecution or maintenance of any Project IP (or
       chooses not to register any Project IP which may be protectable as a registered Intellectual
       Property right) then it shall so advise the Grantors in writing at least three (3) months in
       advance of discontinuing such prosecution or maintenance (or making the decision not to
       register) and the Grantors shall have the right, but not the obligation, to continue such
       prosecution or maintenance or apply for registration at the Grantors' cost, and have such
       Intellectual Property right assigned to it free of charge.

5.3    The Party/ies receiving information about exploitation activities from the Exploiting Party
       pursuant to this Agreement or otherwise shall keep such information confidential. For these
       purposes, ‘information’ includes but is not limited to any data, results, inventions, intended
       publications, intended or pending applications for Intellectual Property, designs, plans,
       agreements, commercial and/or financial information, whether disclosed in writing or orally.
       However, ‘information’ does not include information which is already in the public domain,
       which is otherwise lawfully known to the receiving party at the time of disclosure, is obtained
       lawfully from a third party or independently developed by the receiving party, or which is
       required to be disclosed in order to comply with a legal requirement.

5.4    Where disclosure of information is required under the Freedom of Information Act 2000 from a
       Party designated as a public authority under the Act and such information relates to another
       Party, the Organisation shall notify that Party within five (5) business days of receiving an
       information request that such a request has been made and the details thereof. The
       Organisation shall allow five (5) business days to consult with and, to the extent permitted by
       law, take into account any representations made by the Party concerned before such
       information is disclosed to the requestor and shall on request provide an update of the status of
       the Organisation's response and the information which it is intending to disclose.

5.5    The Parties acknowledge that the information contained or listed in Schedule 3 to this
       Agreement is information which the Parties reasonably consider may be exempt from
       disclosure under the Freedom of Information Act 2000 on the basis that it is confidential and/or
       commercially sensitive information, which if disclosed without the prior consent of the Party to
       which the information relates, would, or would be likely to prejudice the commercial interests of
       that Party.

6.     DISPUTE RESOLUTION


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6.1    If any dispute arises out of or in connection with this Agreement then any Party may give a
       notice that a dispute exists (a "Dispute Notice") to the other Parties and if the Parties have not
       resolved the dispute within seven days of the date of the Dispute Notice, the Parties shall
       escalate this dispute to the [Chief Executive Officer] of the Organisation, [the Chief Executive
       Officer (or equivalent) of the Technology Transfer Group], the Director of the Wellcome Trust
       and the Director General of Research and Development of the Department of Health (the
       "Executive Officers") and the respective Executive Officers shall endeavour to resolve the
       dispute as soon as is reasonably practicable but in any case by fourteen days of the date at
       which the dispute is escalated to them.

6.2    If the Executive Officers of the Parties are not able to resolve a dispute referred to them
       pursuant to Clause 6.1, the Parties will, at the request of either of them, attempt in good faith to
       resolve the dispute through an agreed Alternative Dispute Resolution ("ADR") procedure.

6.3    If the matter has not been resolved by an agreed ADR procedure within one month of the
       initiation of such procedure, any Party may bring proceedings in accordance with Clause 7.12.
       For the avoidance of doubt, any Party may apply to the court for an injunction whether or not
       any issue has been escalated under Clause 6..

6.4    No Party may initiate any legal action until the dispute resolution process outlined above has
       been completed, unless such Party has reasonable cause to do so to avoid damage to its
       operation (including infringement or threatened infringement of confidential information or
       Intellectual Property) or to protect or preserve any right of action it may have, in which case the
       provisions of this Clause 6 shall not prevent a party from seeking such interim injunctive relief.

7.     GENERAL

7.1    The Organisation shall be responsible for ensuring that the Exploiting Party complies with this
       Agreement where the Exploiting Party is its Technology Transfer Group.

7.2    This Agreement shall take effect from whichever is the earlier of the date of last signature of
       this Agreement or the date that exploitation takes place, and shall terminate on whichever is the
       later of the expiry of any patent or any supplementary protection certificate issued in respect of
       the Project IP or when all revenues due in respect of exploitation of the Project IP have been
       distributed to the Parties in accordance with the provisions herein. Alternatively this Agreement
       shall be terminable by mutual agreement of all the Parties.

7.3    This Agreement is in addition to the Grant Conditions (as may be amended from time to time),
       which continue to apply. Should there be any conflict between this Agreement and the Grant
       Conditions, then this Agreement shall prevail.

7.4    Nothing in this Agreement shall give rise to any partnership or the relationship of principal and
       agent between the Grantors and either of the Organisation or the Technology Transfer Group.

7.5    Any notice to be given pursuant to this Agreement shall be in writing in the English language
       and shall be delivered by overnight courier, by registered, recorded delivery or certified mail
       (postage prepaid) or by facsimile confirmed by registered, recorded delivery or certified mail
       (postage prepaid), or delivered personally to the address or facsimile number of the recipient
       Party set out below or such other address or facsimile number as a Party may from time to time
       designate by written notice to the other Parties. The Parties agree that email is not a valid
       method of giving notice under this Agreement.



       Address of Organisation

       [address]

       Fax No: [number]



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       For the attention of: [name]



       [Address of Organisation’s Technology Transfer Group]

       [address]

       Fax No: [number]

       For the attention of: [name]



       Address of the Trust
       Technology Transfer Division
       The Wellcome Trust Limited
       215 Euston Road
       London NW1 2BE
       Fax No: (+)44 (0) 20 7611 8857
       For the attention of: The Contracts Manager
       With a copy to: Dr Richard Seabrook


       Address of the Department

       Central Commissioning Facility
       Grange House
       15, Church Street
       Twickenham
       TW1 3NL

       Fax No: 020 8843 8001
        For the attention of: The Assistant Director, Health Innovation Challenge Fund
        With a copy to: The Director, Central Commissioning Facility

7.6    Any notice given pursuant to Clause 7.5 shall be deemed to have been received:

       a)      in the case of delivery (i) by courier, (ii) sending by registered, recorded or certified mail
               or (iii) if delivered personally, on the day of receipt provided receipt occurs on a Business
               Day of the recipient Party or otherwise on the next following Business Day of the
               recipient; or

       b)      in the case of facsimile, on acknowledgement by the recipient facsimile receiving
               equipment on a Business Day if the acknowledgement occurs before 5:00pm local time
               of the recipient Party and in any other case on the following Business Day.

7.7    None of the rights or obligations under this Agreement may be assigned or transferred without
       the prior written consent of the other parties. This Agreement shall be binding on and take
       effect for the benefit of the successors in title of the parties.

7.8    No waiver of any breach or default under this Agreement or any of the terms herein shall be
       effective unless such waiver is in writing and signed by the Parties’ authorised signatories. No
       waiver of any such breach or default shall constitute a waiver of any other or subsequent
       breach or default.

7.9    If any provisions of this Agreement are held to be invalid, illegal or unenforceable (in whole or in
       part) such provisions or parts shall to that extent be deemed not to form part of this Agreement
       but the remainder of this Agreement shall continue in full force and effect.


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7.10 This Agreement does not create any right enforceable by any person not a party to it under the
     Contracts (Rights of Third Parties) Act 1999.

7.11 Each Party shall at its own cost do and execute or procure to be done and executed all
     necessary acts, deeds, documents and things reasonably within its power to give effect to this
     Agreement.

7.12 This Agreement (and any dispute, controversy, proceedings or claim of whatever nature arising
     out of this Agreement or its formation) shall be governed by and construed in accordance with
     the laws of England and the Parties irrevocably submit to the jurisdiction of the English courts.




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                                              SCHEDULE 1

                                     CONSENT APPLICATION FORM



                             (Insert completed Consent Application Form here)




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                                                SCHEDULE 2

                                   AGREEMENT(S) TO BE ENTERED INTO



                             (Insert copies of relevant proposed agreements here)




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                                         SCHEDULE 3

                             COMMERCIALLY SENSITIVE INFORMATION




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[SCHEDULE 9]



                             [Commercially Sensitive Information]




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SCHEDULE 10
                                    Drawdown Notice
                                                                             [Organisation]
                                                                                 [Address]
                                                                                 [Address]
                                                                                 [Address]



The Contracts Officer
Technology Transfer Division
The Wellcome Trust Limited
215 Euston Road
London NW1 2BE
                                                                                     [Date]

Dear Sirs
The Funding Agreement (the “Agreement”) made on [                  ] 201[•] between
[Organisation] and The Wellcome Trust Limited as trustee of the Wellcome Trust and
The Secretary of State for Health acting through The Department of Health.

We refer to Milestone [number] as described in Schedule [●] of the Agreement and hereby
confirm the completion of the achievement of such Milestone. A report detailing achievement
of Milestone [number] [is attached to this letter]/[has been provided to the Grantors].

Please confirm that Milestone [number] has been achieved to your reasonable satisfaction
and that we may proceed to drawdown [●] Pounds Sterling (£[●]) in respect of the [number]
tranche of the Award Amount in the instalments set out at Schedule [●] of the Agreement.

Terms and expressions defined in the Agreement shall have the same meanings in this
Letter.


Yours faithfully


……………………………
For and on behalf of
[Organisation]




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