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NIHR i4i FAST Contract

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Published: 02 November 2023

Version: V1 - November 2023

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Funding Agreement – i4i FAST

Form of the Contract

Is made by and between:

1. THE SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE of 39 Victoria Street, Westminster, London SW1H 0EU acting as part of the Crown (Authority) and

2. [Contractor] …………………. (Contractor)


Each a Party and together the Parties.

Background

  1. The Authority’s funding scheme i4i FAST (Funding At the Speed of Translation) is aimed at innovators in need of a small amount of funding to answer a specific question or to fund a single piece of activity.
  2. The Parties wish to enter into an agreement for the purpose of the scheme in accordance with the terms of this Agreement.

Terms and Conditions

Interpretation

"Agreement" means this agreement and its schedules.

"Approved Cost" means the funding to be paid by the Authority to the Contractor in accordance with this Agreement and the payment timetable detailed at Schedule

"Arising Know How" means Know How that is created, devised or generated by or on behalf of any of the Contractor or a Collaborator or Sub-Contractor in the course of the performance of the Research.

"Background IP" means any Intellectual Property in existence at the date of this Agreement or created, devised or generated other than in the performance of the Research and which is actually used in the performance of the Research.

"Commencement Date" means the date of the Authority’s confirmation of the award of the Approved Cost.

"Collaborator" means a person or organisation who works with the Contractor in connection with the Research on a collaborative basis.

"Collaboration Agreement" means an agreement between the Contractor and any Collaborator relating to the performance of the Research and compliance with this Agreement.

"Commercial Use" means any use, activity and/or agreement that supports the generation of revenue including but not limited to:

  1. any use in support of an application for regulatory approval for a product or service;
  2. any use in support of the development, promotion or use of a product or service that will be made available on a fee paying basis;
  3. any use in support of the development, promotion or provision of health or social care or public health services direct to an individual on a fee paying basis; or
  4. the provision of a product or a service to any health or social care or public health provider; and/or
  5. the granting of an option, a licence, and/or an assignment of Intellectual Property. For the avoidance of doubt, this does not include licences granted to academic or research institutions for the purposes of academic research or teaching.

"Completion Date" means the date for completion of the Research as indicated by the Authority on the [Authority’s portal-details to be added here].

"Due Diligence Requirements" means the requirements of the Authority with which the Contractor must comply in order to conduct the Research as detailed in the Outcome Notification, which may include the review and/or approval of a Collaboration Agreement by the Authority.


"Due Diligence Milestone Date" means the date or dates by which the Due Diligence Requirements must have been put in place by the Contractor if required, as detailed in the Outcome Notification.

"Foreground IP"means any Intellectual Property that is created, generated or developed (whether in whole or in part) during the course of and for the purpose of any part of the Research.

For the avoidance of doubt, this:

  1. includes Foreground IP generated by or on behalf of the Contractor or by any Collaborator in the course of performing the Research;
  2. excludes Arising Know How and Research Data;
  3. excludes Intellectual Property that has been generated by the Contractor or any Collaborator without financial and/or material and measurable in-kind support from the Authority.

"Intellectual Property or IP" means all patents, rights to inventions, copyright and related rights, trademarks and trade names, rights to goodwill or to sue for passing off, rights in designs, database rights, rights in confidential information and any other intellectual property rights, in each case whether registered or unregistered and including all applications (or rights to apply) for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.

"Know How" means a package of practical information, resulting from experience and testing, which is:

  1. secret, meaning not generally known or easily accessible,
  2. substantial, meaning significant and useful, and
  3. identified, meaning, described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality.

"Outcome Notification" means the communication from the Authority that confirms the outcome of an application, and where the applicant has been successful, which records the details of the Authority’s award.

"Policies" means the policies and strategies in place or introduced by the Authority including but not limited to those listed at Schedule 3 and as each may be updated by the Authority from time to time.

"Research" means the programme of work to be undertaken that will be funded by monies paid under this Agreement as described in the application and summarised in Schedule 1.

"Research Data" means information or data that is collected, collated or generated in the performance of the Research. For the avoidance of doubt, Research Data:

  1. does not include, without limitation, information or data that has been analysed as part of the Research;
  2. does include, but is not limited to, images.

"Sub-contract" means a contract between one or more suppliers at any stage of remoteness from the Contractor in a sub-contracting chain, made wholly or substantially for the purposes of the Contractor performing the whole or any part of this Agreement.

"Sub-Contractor" means a party to a Sub-contract other than the Contractor.

Agreement

2.1 In consideration of the rights and obligations recorded in this Agreement:

  1. The Contractor will undertake the Research in accordance with this Agreement; and
  2. The Contractor will and will procure that any Collaborators and Sub-contractors will comply with the Policies in the performance of this Agreement and the Research.

2.2 Without prejudice to the generality of clause 2.1, the Contractor shall procure that the Authority may enforce any right or benefit it enjoys under this Agreement against any Collaborator as appropriate, including but not limited to clauses 6.4 and 10.

Payment

3.1 Subject to the Contractor’s compliance with the terms of this Agreement, the Authority shall pay the Approved Cost to the Contractor.

3.2 Payments are made by the Authority in accordance with Schedule 2.

3.3 The total amount payable by the Authority will not exceed the Approved Cost.

3.4 The Contractor is responsible for any payments to third parties (including any Collaborator or Sub-Contractor) and shall ensure that such payments are made promptly. The Authority is not obliged to make any payments to any third party and the Contractor shall indemnify the Authority against any loss, damage, cost or expense incurred by the Authority as a result of the Contractor’s failure to pay any third party promptly or at all.

3.5Without prejudice to the Authority’s right to terminate under Clause 8.2, the Authority may either suspend payment or demand repayment of the Approved Cost if in the view of the Authority:

  1. The Due Diligence Requirements have not been put in place on or before the Due Diligence Milestone Date;
  2. Reasonable progress on the Research has not been maintained;
  3. Reports or information have not been provided as required under this Agreement;
  4. The Contractor or any Collaborator has failed to comply with the terms of this Agreement or any of the Policies.

Governance

4.1 At the Authority’s request, the Contractor shall provide detailed reports and permit the Authority or its nominee to conduct reasonable audits and other checks on the Contractor and any Collaborator to ensure that any funds paid under this Agreement are used appropriately and to ensure that the Research is performed in accordance with the terms of this Agreement.

4.2 The Authority may use and publish any reports or other information received from the Contractor in respect of the allocation of the Approved Cost and the performance of the Research.

Contractor Responsibilities

5.1 The Contractor shall be responsible for the acts and omissions of its Sub-Contractors as though they were its own.

5.2 The Contractor shall ensure that adequate policies and procedures are in place to ensure that the Research is conducted and managed in accordance with applicable laws.

5.3 The Contractor shall ensure that the Authority’s rights under this Agreement are accepted by and are binding on any Collaborator. The Contractor shall enter into a Collaboration Agreement with any Collaborator before the Research commences and/or no later than the relevant Due Diligence Milestone Date. The Contractor warrants that the terms of the Collaboration Agreement shall provide that:

  1. The Authority, in its discretion, can enforce its rights directly against the Collaborator;
  2. The Collaborator shall comply with the provisions of this Agreement to the extent that they apply to the Collaborator’s performance of the Research; and
  3. The Collaborator shall comply with or fulfil the Policies in performing the Research.

5.4 The Contractor shall ensure that each of the Due Diligence Requirements are complied with by the relevant Due Diligence Milestone Dates.

5.5 The Contractor shall provide a comprehensive report to the Authority within 28 days of the Completion Date or date of termination howsoever terminated. The report shall be in the format prescribed by the Authority and shall include an outline of the Foreground IP, Arising Know How and Research Data and final conclusions of the Research. The Contractor shall not include any third party IP and/or confidential information in the report unless it is authorized by the third party to do so and the third party permits the Authority to use the third party IP or confidential information in the Authority’s publication of the report. The Authority may publish its own report on the findings of the Research if the Contractor fails to do so within one year of the conclusion of the Research.

Intellectual Property

6.1 Background IP: Nothing in this Agreement does or is intended to grant or transfer any right title or interest to any Background IP except that the Contractor shall make the Background IP available for the purposes of the Research and ensure that the Authority may use the Background IP to the limited extent necessary to use the Foreground IP, Research Data and any Arising Know How pursuant to clause 6.4.

6.2 Foreground IP: Unless agreed otherwise by the Authority, the Contractor will own the Foreground IP and the Research Data subject to the Authority’s rights as recorded in this Agreement.

6.3 Consent: The Contractor shall inform the Authority in a timely manner of any Foreground IP or Research Data which is capable of exploitation either by direct adoption into the healthcare system or by commercialisation. In the event of such notification, the Authority may in its sole discretion require that the Contractor or any Collaborator shall obtain the written consent of the Authority before it makes any Commercial Use of or permits and third party to make Commercial Use of the Foreground IP, Research Data or Arising Know How. The Authority may request such information as it may reasonably require in order to assess the proposed Commercial Use and may impose such conditions as it thinks fit when granting consent.

6.4 Authority’s rights: In the event that, in the Authority’s view, the Foreground IP, Research Data or Arising Know How are not being managed, used or disseminated appropriately, the Authority may take such steps as it sees fit to take a licence of that IP (including but not limited to requiring the grant by the Contractor or any Collaborator of a royalty free licence of the Foreground IP, Research Data or Arising Know How to the Authority or its nominee) for any use that is not Commercial Use. For the avoidance of doubt, the Authority reserves the right to take into account its contribution to the Approved Cost when considering the Commercial Use of Foreground IP in any contract between it and the Contractor.

6.5 Publicity: The Contractor shall provide the Authority with a copy of any proposed press release relating to the performance of the Research or matters arising from the Research (whether it will be issued by the Contractor or any Collaborator) at least three (3) business days in advance. For the avoidance of doubt, this obligation shall continue in full force and effect following completion of the Research or termination of this Agreement.

6.6 Branding: Nothing in this Agreement does, or is intended to, permit the Contractor or any Collaborator to use the name, logo or branding of the Authority without the prior written consent of the Authority.

6.7 Notification: The Contractor shall promptly notify the Authority if any claim or demand is made or action brought for infringement or alleged infringement of Intellectual Property which might affect the Research and shall discuss with the Authority the steps it proposes to take.

Warranties and Indemnities

7.1 The Contractor warrants that it has:

  1. The requisite capacity and authority and all necessary licences, permits and consents to enter into this Agreement;
  2. Access to sufficient resources to perform the Research and to meet its other obligations under this Agreement.

7.2 The Contractor warrants that the Research will be carried out by appropriately experienced, qualified and trained personnel with all due skill, care and diligence.

7.3 The Contractor indemnifies the Authority, their officers, servants and agents fully against:

  1. Any liability, loss, claim or proceedings whatsoever arising under this Agreement or as a direct result of the Research in respect of any damage to property, real or personal, including any infringement of the Intellectual Property of a third party; and
  2. Any injury to persons including injury resulting in death arising out of, or in the course of, or in connection with this Agreement or the Research,

in each case, except in so far as such damage or injury is due to any act or neglect of the Authority, or their officers, servants or agents.

Termination

8.1 Either Party may terminate this Agreement by giving one (1) months’ notice in writing to the other. Should the Authority terminate this Agreement under this Clause 8.1, the Authority shall indemnify the Contractor from and against all and any actual loss unavoidably incurred by reason or in consequence of the termination provided that the Contractor and ensures that any Collaborator and any Sub Contractor takes all immediate and reasonable steps to minimise the loss.

8.2 The Authority may terminate this Agreement by giving notice in writing without liability for any damage, loss or expenses arising as a result of where:

  1. The Research has not commenced to the reasonable satisfaction of the Authority, and/or the Due Diligence Requirements have not been put in place on or before the relevant Due Diligence Milestone Date;
  2. The Contractor or any Collaborator is in breach of this Agreement or the Collaboration Agreement;
  3. The Contractor is unable or unwilling to continue with the Research;
  4. The Contractor is, in the reasonable opinion of the Authority, consistently failing to progress the Research or to achieve an acceptable standard in relation to the Research.

Liability

9.1 Nothing in this Agreement shall limit the liability of any Party in respect of personal injury or death arising out of that Party’s negligence or from willful misconduct; or fraud or fraudulent misrepresentation.

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

9.3 Neither Party shall be liable for or be deemed to be in breach of this Agreement for any delays or failures in performance of this Agreement (except for any obligation to make a payment) which result from any event beyond the reasonable control of that Party, and which renders the performance of this Agreement impossible.

Compliance

10.1 The Contractor shall procure that:

  1. The Research is performed in compliance with all applicable laws, regulations and statutes, including those relating to data protection, modern slavery, fraud and anti-bribery;
  2. The Contractor and any Collaborator each perform the Research in accordance with applicable standards and guidelines.

10.2 Anti-embarrassment: The Contractor shall not act, or omit to act, in such a way which would or would be likely to bring it, the Research or the Authority into disrepute or diminish or damage the trust that the public places in the Authority and its activities and the Contractor shall promptly inform the Authority should any such act or omission occur or appear likely to occur.

General

11.1 Independent contractors: The Parties are independent contractors and are not partners, principal and agent or employer and employee and this Agreement does not establish any joint venture, trust, fiduciary or other relationship between them, other than the contractual relationship expressly provided for in it. None of the Parties shall have, nor shall represent that they have, any authority to make any commitments on the other Party’s behalf.

11.2 Third Parties: No person who is not a party to this Agreement is intended to receive a benefit under or have the right to enforce any terms of this Agreement whether pursuant to the Contracts (Rights of Third Parties) Act 1999. For the avoidance of doubt (in accordance with clause 2.2), it is intended that the Authority may enforce any right or benefit that it enjoys under this Agreement as against the Contractor, against any Collaborator.

11.3 Amendment - Agreement: No amendment or variation to this Agreement (including its Schedules 1 and 2) is valid or effective unless and until it has been recorded in writing (including by email) and signed by the duly authorised representatives of each Party.

11.4 Amendment - Policies: The Authority may revise the Policies as it sees fit.

11.5 Execution: This Agreement may be executed in any number of counterparts, each of which when executed shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement.

11.6 Governing Law: This Agreement and any non-contractual obligations arising out of or in connection with it shall be considered as a contract made in England and be construed in accordance with the laws of England and Wales and the parties irrevocably submit to the exclusive jurisdiction of the courts of England save that this exclusive jurisdiction may be waived by the Authority in order to allow disputes, actions, claims or applications to be made in other courts.

Policies

Source:
https://www.nihr.ac.uk/documents/?start=1&custom_in_type=9697