NIHR research contract - mental health research groups

The NIHR funds research by contracting researchers’ institutions on behalf of the Secretary of State for Health and Social Care. The standard contracts differ slightly depending on the type of host institution.

This document provides an example of a research contract between Secretary of State for Health and the contracting organisation.

Section 1 - Form of contract

This Form of Contract is made by and between The Secretary of State for Health and Social Care of 39 Victoria Street, Westminster, London, SW1H 0EU ("the Authority") and «Institution» of «Institution Contact Address» ("the Contractor") who may, from time to time, be hereinafter referred to individually as the “Party” or collectively as the “Parties”. 

It is agreed that:

1. In consideration of the rights and obligations recorded in this contract:
   1. The Contractor shall use the funding provided under this Contract for the establishment of a Mental Health Research Group (“NIHR MHRG”) and to undertake a research programme in accordance with the work specified in Section 3 (the “Research”);
   2. In the event of a Public Health Emergency (as defined below), the Authority may direct the Contractor to perform further work in addition to (or in replacement of) the Research in accordance with Section 2, Clause 3.
2. The Authority will pay the Contractor the Approved Cost as set out in Section 4 in respect of undertaking the Research in accordance with this Contract.
3. This Form of Contract (Section 1) together with the attached Section 2 to Section 7 inclusive are the documents which collectively form the "Contract" (as defined in Section 2).
4. Where the Contractor is a health service body within the meaning of section 9 of the National Health Service Act 2006 then this Contract is an NHS Contract within the meaning of that Act.
5. The Contract effected by the signing of this Form of Contract constitutes the entire agreement between the Parties relating to the subject matter of the Contract and supersedes all prior negotiations, representations or understandings.

Signed:

For the Authority: 
Signature …
Full name …
Position held … (On behalf of the authority)
Date …

For the Contractor:
Signature …
Full name …
Position held … (On behalf of the contractor)
Date …

Section 2 -Terms and Conditions 

Conditions of agreement

Definitions and interpretations

1.1 As used in this Contract the following terms and expressions shall have the meaning shown below:

“Applicable Law” means:

1. any law, statute, regulation, by law or subordinate legislation in force from time to time to which a party is subject and/or in any jurisdiction that the Research is provided to or in respect of;
2. the common law and laws of equity as applicable to the parties from time to time;
3. any binding court order, judgement or decree;
4. any applicable direction, policy, rule or order that is binding on a party and that is made or given by any regulatory body having jurisdiction over a party or any of that party’s assets, resources or business.

"Approved Cost" means the total cost agreed for the Research as set out in Section 4.

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

"Authority's Representative" means a person authorised to represent the Authority in respect of this Contract as identified in Section 5.

"Award" means the award letter addressed to the Contractor.

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

“Business Day” means a day other than Saturday, Sunday and bank holidays in London.

“Care Services” means in:

• England – NHS and adult Social Care;
• Wales – NHS and Social Care;
• Scotland – NHS and adult Social Care;
• Northern Ireland – Health and Social Care.

“Chief Investigator” means the individual identified in Section 5 or their approved successor.

"Collaborator" means a person or organisation who works with the Contractor on the Research being done under this Contract subject to Clause 15.6.

"Commencement Date" means «Grant Start Date» notwithstanding the last day of signature of this Contract.

“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 Care direct to an individual on a fee paying basis;
4. the provision of a product or a service to any Health Service Body or to any patient under the care of a Health Service Body; 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 the academic or research institutions or any Health Service Body for the purposes of academic research or teaching.

"Completion Date" means «Grant End Date».

“Confidential Information” means information of any form, however conveyed and irrespective of the media on which it is stored, that is:

1. information which has been designated as confidential by either Party; or
2. information that reasonably ought to be considered as confidential including information which relates to the business, affairs, properties, assets, trading practices, goods/services, developments, trade secrets, Intellectual Property, knowhow, personnel, customers and suppliers and commercial sensitive information of either Party; or
3. Personal Data and/or special category data within the meaning of the Data Protection Legislation; or
4. the Research Data.

"Contract" means the contract concluded between the Parties, consisting of the following Sections:

• Section 1: Form of contract
• Section 2: Terms and conditions
• Section 3: Research
• Section 4: Financial Arrangements
• Section 5: Key staff
• Section 6: Reporting schedule
• Section 7: Policies schedule

including in each case any Variation to any of the above agreed and executed in accordance with Clause 6. 

"Contractor Background IP" means any Background IP or Know How:

1. owned by the Contractor or to which the Contractor has rights; and/or
2. created, devised or generated by the Contractor’s staff (including visiting researchers) working in the research group of and/or supervised by the Chief Investigator during the term of the Research 

 and in each case which is used in the performance of the Research.

“Contractor’s Collaboration Agreement” means the agreement(s) between the Contractor and its Collaborators who are party to delivering the Research.

"Contractor’s Representative" means the person authorised to represent the Contractor in respect of this Contract as identified in Section 5.

“Crown” means the government of the United Kingdom (including the governments of Northern Ireland, Scotland, and Wales), including, but not limited to, government ministers, government departments, government agencies and particular bodies. 

“Data Controller” has the meaning ascribed to it in the Data Protection Legislation.

“Data Processor” has the meaning ascribed to it in the Data Protection Legislation.

“Data Protection Legislation” means any Applicable Law relating to the processing, privacy, and use of Personal Data, as applicable to the performance of the Research from time to time.

"Drop Dead Date" means «!Drop Dead Date!» the last date by which work on doing the Research must have started.

“Excess Treatment Costs” has the meaning ascribed to it in the Department of Health and Social Care’s guidance on “Attributing the Costs of Health and Social Care Research and Development (AcoRD)”. This guidance is subject to amendment from time to time.

“Final Report” means the comprehensive report prepared by the Contractor at the conclusion of the Research for the Authority as described in Clause 14. For the avoidance of doubt this definition does not extend to any Arising Know How, Research Data, Foreground IP or other Intellectual Property described therein.

“Final Report Summary” means a summary of the findings of the Research as described in Clause 14. 

"FOIA" means the Freedom of Information Act 2000 and any subordinate legislation made under this Act from time to time together with any guidance and/or codes of practice issued under this Act or by the Information Commissioner in relation to such legislation.

“Foreground IP” means Intellectual Property that is, or has been created, exemplified or developed (whether in whole or in part) during the course and for the purpose of the Research. For the avoidance of doubt, this:

1. includes Foreground IP generated by or on behalf of the Contractor or any Collaborator in the course of performing the Research;
2. includes any Intellectual Property that may subsist in Samples or in the meta data associated with the Samples to the extent that the terms of any relevant licence under Applicable Law and/or ethics or other approval permits the use of the Samples in accordance with the Contract;
3. includes the rights of possession and/or control of physical and tangible Samples to the extent that such Samples are not subject to third party rights and to the extent that the terms of any relevant licence under Applicable Law and/or ethics or other approval permits; and
4. excludes Arising Know How and Research Data; and
5. excludes Intellectual Property that has been generated by the Contractor without financial support and/or material and measurable in-kind support from the Authority.

“Fraud” means any offence under laws creating offences in respect of fraudulent acts or at common law in respect of fraudulent acts in relation to the Contract or defrauding or attempting to defraud or conspiring to defraud the Crown.

“Good Industry Practice” means standards, practices, methods and procedures conforming to the law and the degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person or body engaged in a similar type of undertaking under the same or similar circumstances.

“Health Care” has the meaning ascribed to it in section 64 of the Health & Social Care Act 2012 and includes both health care and social care provided to individuals on a non-fee paying basis. For the avoidance of doubt, Health Care is deemed to include (but is not limited to) evaluation, training and teaching purposes relating to the provision of care and treatment.

“Health Research Authority Approval” means the approval process for all study types within the NHS in England that brings together the assessment of governance and legal compliance undertaken by the Health Research Authority with the independent Research Ethics Committee opinion provided through the UK Health Departments’ research ethics service.  Further detail, which may be amended from time to time, is available on the Health Research Authority website.

“Health Service Body” has the meaning ascribed to it in section 9 of the National Health Service Act 2006.

"Intellectual Property” (“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.

“Key Staff” means the persons named in Section 5.

“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 for the production of the contract products; and
3. identified, that is to say, described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality.

“NIHR” means the National Institute for Health and Care Research.

“NIHR Coordinating Centre” means the NIHR Coordinating Centre, Grange House, 15 Church Street, Twickenham, TW1 3NL.

“Patient Benefit” means achieving any one or more of the following:

1. identifiable improvements in the quality of treatment and clinical care offered by any Health Service Body;
2. identifiable improvements in the experience of patients receiving care from any Health Service Body;
3. identifiable improvements in patient health outcomes;
4. identifiable improvements in the efficiency of any Health Service Body;
5. identifiable and measurable cost savings in any Health Service Body;
6. generating revenue for any Health Service Body; or
7. any other outcome that has been accepted in writing by the Authority and that is designed to benefit any Health Service Body or a significant number of patients receiving Health Care from any Health Service Body.

"Personal Data" has the meaning ascribed to it in the Data Protection Legislation.

“Public Health Emergency” means any situation that the Chief Medical Officer for England deems it necessary to activate urgent public health research in response to taking account of the World Health Organisation health emergencies list as amended from time to time.

“Public Health Emergency Services” means any work specified by the Authority that directly relates to responding to a Public Health Emergency.

“Reports” means any report, executive summary, paper, abstract or other document provided by the Contractor under this Contract pursuant to Clauses 13 and 14 and Section 6 including but not limited to any interim report, the Final Report and any Final Report Summary. For the avoidance of doubt this does not extend to Arising Know How, Research Data, Foreground IP or other Intellectual Property described therein.

"Research" means the scope of work specified in Section 3.

“Research Data” means information or data that is collected, collated or generated in the performance of the Research and includes (but is not limited to) information or data that is presented or stored in searchable form. 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.

“Research on Research” means research intended to:

1. inform, improve and enhance the research commissioning, management, and delivery processes; and/or
2. build on areas of innovation, impact and value adding approaches to further improve the quality of research and knowledge mobilization

including by addressing gaps in the evidence base.

"Research Period" means the period commencing on the Commencement Date and ending on the Completion Date or such later date as may be agreed between the Parties unless otherwise determined in accordance with the terms of the Contract.

“Samples” means material (including but not limited to biological material, organisms and chemical compounds), specimens or extracts collected, obtained or generated (whether in whole or in part) during the course of and for the purpose of any part of the Research.

“Serious Misconduct” means any of the following: abuse or harassment of any form (including but not limited to bullying, sexual abuse, sexual harassment, psychological abuse and physical violence); non-consensual or unlawful sexual activity; or, any other form of violence, exploitation or abuse.

"Third Party IP" means any Intellectual Property which is owned or controlled by any party (including any Collaborator) other than the Contractor and over which the Contractor has or can reasonably expect to secure a formal agreement or license to use in the performance of the Research or to perform the provisions of this Contract.

"Variation" means a variation to this Contract agreed and executed in accordance with Clause 6.

1.2. The interpretation and construction of this Contract shall be subject to the following provisions:

1.2.1. a reference to any statute, enactment, order, regulation or other similar instrument shall be construed as a reference to the statute, enactment, order, regulation or instrument as subsequently amended or re-enacted;

1.2.2. references to Clauses, Sections and Schedules are to clauses, sections and schedules to this Contract. where the context allows, references to male gender include the female gender and the neuter, and the singular includes the plural and vice versa;

1.2.3. references to a Party shall include that Party's personal representatives, successors or permitted assignees;

1.2.4. general words are not to be given a restrictive meaning because they are followed by particular examples, and any words introduced by the terms "including", "include", "in particular" orany similar expression will be construed as illustrative and the words following any of those terms will not limit the sense of the words preceding those terms; and

1.2.5. the headings in this Contract are for convenience only and shall not affect its interpretation.

Commencement and duration

2.1 This Contract shall commence on the Commencement Date and, subject to earlier termination in accordance with its terms, shall continue in full force and effect until the Completion Date.

2.2 If in the Authority's reasonable opinion, the Research has not effectively commenced by the Drop Dead Date or by such other date as the Parties may agree in writing, the Authority may withdraw the Award and/or any offer of funding and this Contract will terminate.

2.3 The Authority may carry out a review of the Contractor’s work on the Research at any time following the second anniversary of the Commencement Date following notice to the Contractor. As a result of the findings of this review, the Authority may either:

2.3.1 confirm the continuation of the Contract for the remaining term; or

2.3.2 terminate the Contract by three months’ notice in accordance with Clause 21.

Administration and direction of research 

3.1. Research commissioned by the Authority is open and, subject to the provisions of this Contract, details of Research are normally published.

3.2. The Authority may publish non-confidential details of the Research or any Research Project and the actual or projected costs of the Research or any Research Project.

3.3. The Contractor shall ensure that:

3.3.1. each member of staff (whether a member of staff of the Contractor or the Partner (s)) engaged on the Research is contractually obliged to observe the terms of this Contract and any further or supplementary contract entered into between the Parties hereto; and

3.3.2. all such members of staff are advised promptly of any changes in the scope of this Contract or the Research.

3.4. The objectives and general timeline of the Research are set out in Section 3. Within such objectives, details of the exact programme of work to be followed and the day-to-day responsibility for carrying out this programme of work, the Research or any Research Project will be under the control of the Contractor, in consultation, as appropriate, with the Authority's Representative.

3.5. The Contractor shall provide the Research in accordance with the provisions of this Contract and establish and implement best practice and associated benefits.

3.6. The Contractor shall comply with relevant policies and related strategies in place or introduced by the Authority and that are notified to the Contractor including but not limited to:

3.6.1. Policies listed at Section 7 as may be updated by the Authority from time to time; and

3.6.2. Policies relating to informatics and open access.

3.7. The Contractor shall produce a full Patient and Public Involvement and Engagement strategy and a full Equality, Diversity and Inclusion strategy consistent with the Authority’s requirements and where reasonably possible, make it publicly accessible within six (6) months of the Commencement Date.

3.8. In the event of a Public Health Emergency, the Authority may:

3.8.1. direct the Contractor to suspend or cease any part of its current activity insofar as it is reasonably possible, having regard to:

a) the interests of individual study participants; and
b) any binding commitments that cannot be delayed, deferred or cancelled; and

3.8.2. direct the Contractor to perform Public Health Emergency Services in replacement to any part of the Research.

Accounting and payments

4.1. Payments will be made by the Authority during the Research Period in accordance with dates and amounts specified in Section 4. The Authority may suspend or reduce its payment of amounts due under Section 4 at any time if in the view of the Authority:

4.1.1. and without prejudice to its rights under Clause 21.3 reasonable progress on the Research has not been maintained; or

4.1.2. reports have not been submitted as required under Clauses 13, 14 and Section 6; or

4.1.3. the Contractor has substantially failed to comply with the terms of this Contract (including where the Contractor has failed to procure that the Partner (s) complies with certain obligations as required by this Contract).
Subject to the terms of this Contract the Contractor is free to administer the funds paid in accordance with Section 4 within the terms of this Contract without further reference to the Authority.

4.2. The total amount to be paid by the Authority to the Contractor in any financial year shall not exceed the relevant amount detailed in Section 4 unless the Authority instructs the Authority’s Representative to apply a compounded annual inflationary uplift. The Authority shall apply uplifts only after obtaining approval from finance and HM Treasury.

4.3. The Authority reserves the right to recover from the Contractor any sum of money allocated in a specific financial year but not actually spent by the financial year ending 31st March. Where reasonably possible such recovery will be by way of set off against future payments. In the event of the Authority exercising its right under this Clause 4.3, a new payment schedule will be issued with the Approved Cost adjusted accordingly.

4.4. The Contractor is responsible for any payments to third parties and shall ensure that such payments are made promptly.

4.5. The Authority may request from the Contractor at any time such evidence as may reasonably be required to show that the Contractor has used the amounts paid in accordance with Section 4 within the terms of this Contract. The Contractor shall maintain proper financial records relating to the Research at all times during the Research Period and for a period of six (6) years after the end of the Research Period.

4.6. The Contractor grants to the Authority and to any statutory or regulatory auditors of the Authority and to its or their authorised agents the right of reasonable access to (and if necessary to copy) the relevant financial records and/or other information relating to the financial records during normal business hours for the duration of the Research Period and for a period of six (6) years after the end of the Research Period.

4.7. The Contractor shall provide all reasonable cooperation and assistance at all times during the currency of this Contract and for a period of six (6) years after termination or expiry of this Contract for the purposes of allowing the Authority to obtain such information as is necessary to fulfil the Authority's obligations to supply information for Parliamentary, Governmental, Judicial or other regulatory or administrative purposes and/or to carry out an audit of the Contractor's compliance with this Contract including all activities, performance, security and integrity in connection therewith.

4.8. On completion of the Research Period, the final payment in respect of costs properly incurred under this Contract will be paid by the Authority to the Contractor within thirty (30) calendar days of all of the following objectives being satisfied:

4.8.1. the Research has been completed to the reasonable satisfaction of the Authority;

4.8.2. the Reports required under Clauses 13 and 14 have been submitted by the Contractor to the Authority;

4.8.3. agreement has been reached in respect of any items remaining for disposal.

4.9. If at any time an overpayment has been made to the Contractor for any reason whatsoever, the amount of such overpayment shall be taken into account in assessing any further payments, or shall be recoverable from the Contractor at the Authority's discretion.

4.10. The Authority shall be under no obligation to make any payment on claims received more than twelve (12) months after the completion of the Contract Period and there will be a general presumption against paying claims received after this date, unless an extension has been requested and agreed in writing.

Set off

5.1. If any sum of money shall be due from the Contractor to the Authority or any other Government department office or agency of the Crown, the same may be deducted from any sum then due or which at any time thereafter may become due to the Contractor under this Contract or under any other agreement with the Authority or with any other department, office or agency of the Crown. Such deduction shall not be made unless the Contractor has been notified in writing in advance by the Authority.

Variation

6.1. If at any time it appears likely that any provision of the Contract, in particular the Research, needs to be varied, then the Contractor shall immediately in writing, request a Variation to the Contract, giving full details of the justification for the request and giving proposals for the Variation to the Contract.

6.2. Upon receipt of such a request from the Contractor under Clause 6.1, the Authority may:

6.2.1. agree to vary the Contract;

6.2.2. vary the Research in a manner which the Contractor agrees can be carried out within the Research Period and Approved Cost;

6.2.3. refuse the request and require the continuation of the Research in accordance with the Contract; or

6.2.4. give notice of termination in accordance with Clause 21.3.

6.3. Any variation of the Contract shall not be valid or effective unless and until it has been recorded in a Variation to Contract Form as set out at Schedule B to Section 2 and signed by the duly authorized representatives of both Parties.

6.4. The Authority may vary the Contract at any time by giving written notice to the Contractor:

6.4.1. in the event of a Public Health Emergency;

6.4.2. to the extent that any policy listed in Section 7 or that has been notified to the Contractor in accordance with Clause 3.6 is revised or updated.

Staff appointments

7.1. The Contractor agrees to use sufficient appropriately skilled resources to enable it to comply with its obligations under this Contract.

7.2. All staff providing services in connection with this Contract shall be bound by the same terms and conditions of service which are normally applicable to the Contractor's employees or the relevant employing Partner(s) or Collaborator. Subject to the compatibility with this Contract, the Contractor shall take into account, as far as possible, the recommendations from Universities UK and the University and College Union on Codes of Practice for the employment of research staff on fixed term contracts. The Contractor will ensure that the terms and conditions of staff employed to provide services in connection with this Contract contain provisions in respect of intellectual property and academic publication compatible with the terms of this Contract and in particular allow those staff to where reasonable and practicable publish the outcome of the Research or a Research Project in appropriate research journals.

7.3. Subject to Clause 9, the Contractor shall cause to be kept full, detailed and accurate records of all of activities and results obtained in connection with the Research. In this respect, the Contractor shall, and shall procure that the Contractor’s staff, the Partner’s staff, any Collaborators and Sub-contractors shall at all times:

7.3.1. observe professional standards; and

7.3.2. comply with the relevant provisions of Clause 37 (Safeguarding).

7.4. The Contractor shall upon request make available to the Authority copies of all records generated in connection with the Research, including for the avoidance of doubt, records generated by employees of the Contractor, or any employees of the Partner or Collaborators or other Sub-contractors under Clause 7.3 and by any third parties working on the Research.

Publicity and branding

8.1. Before and after the start of the Research Period, and prior to any publication of the Research, Foreground IP, Research Data or of matters arising from the Research or Research Data in accordance with Clauses 3.1 and this Clause 8, the Contractor shall not without the prior written consent of the Authority, which shall not be unreasonably withheld or delayed, release, or otherwise make available to third parties, any information relating to this Contract or the Research by means of any public statement, in particular any media announcement or display or by putting on any website or oral presentation to meetings where the results are likely to be reported by the media. This Clause shall not apply where the Contractor has a contractual, legal or similar obligation to publish specific details about the Contract or the Research.

8.2. The Contractor must notify the Authority’s Representative of any intention to issue a press release (whether it will be issued by the Contractor or any other party) at least three (3) business days prior to any press release issued by it or on its behalf, directly related to the Research or Foreground IP, Arising Know How or Research Data or of matters arising from such Research. The Contractor shall send one draft copy of the proposed press release to the Authority’s Representative at least two (2) business days before the date intended for release. For the avoidance of doubt this obligation shall continue in full force and effect following expiry of the Research Period.

8.3. In the event that the Contractor fails to comply with Clause 8.1 and subject to Clause 21.4, the Authority reserves the right to:

8.3.1. suspend or reduce its payment of amounts due under the payment schedule in Section 4 of the Contract; and/or

8.3.2. require repayment of all or part of the funding provided under this Contract.
The Contractor further acknowledges that a breach of Clause 8.1 by the Contractor may be taken into account by the Authority when considering future applications for NIHR funding from the Contractor.

8.4. The Contractor shall comply with guidance and advice from the Authority on branding and publicity which may be issued from time to time including, but not limited to NIHR guidance on the format for websites, press releases and use of social media, permitted use of the NIHR, NHS and Department of Health and Social Care brands, names and logos and ensuring all branding references to the MHRG are prefixed with the term “NIHR”.

Confidentiality

9.1 In respect of any Confidential Information it may receive from the other Party and subject always to the remainder of this Clause 9, the receiving party undertakes: to keep such Confidential Information secret and strictly confidential; and, not disclose any such Confidential Information to any third party (other than those involved in the Research who are bound by similar confidentiality obligations) without the disclosing Party's prior written consent; and, not to make any use of the Confidential Information save to the limited extent necessary for the performance of the Research, provided in each case that:

9.1.1 the receiving party shall not be prevented from using any general knowledge, experience or skills which were in its possession prior to the commencement of this Contract; and

9.1.2 nothing herein shall prevent either party from using data processing techniques, ideas, Know How and the like gained during the performance of this Contract in the furtherance of its normal business, to the extent that this use: is consistent with Clause 16.2; and, does not result in a disclosure of any Confidential Information or infringement of any valid Intellectual Property of either Party or the unauthorised processing of any Personal Data.

9.2 Clause 9.1 shall not apply to any Confidential Information received by one Party from the other:

9.2.1 which is or becomes public knowledge (otherwise than by breach of this Clause 9);

9.2.2 which was in the possession of the receiving party, without restriction as to its disclosure, before receiving it from the disclosing party;

9.2.3 which is received from a third party who lawfully acquired it and who is under no obligation restricting its disclosure;

9.2.4 where the disclosing Party has authorised the disclosure of the Confidential Information;

9.2.5 which is independently developed by the receiving party without access to the Confidential Information; or

9.2.6 which must be disclosed pursuant to a statutory, legal or parliamentary obligation placed upon the Party making the disclosure, including any requirements for disclosure under the FOIA or the Environmental Information Regulations pursuant to Clause 34 (Freedom of Information).

9.3 The obligations of each of the Parties contained in Clause 9.1 above shall continue without limit of time.

9.4 In the event that the Contractor fails to comply with Clause 9, the Authority may, without prejudice to any other rights or remedies available to the Authority, terminate this Contract with immediate effect by giving notice in writing to the Contractor.

Data protection

10.1 The Contractor undertakes to the Authority that, in relation to its performance of this Contract and the Research and/or as required for the proper and lawful operation of this Contract and the Research, it will (and shall procure that the Partner(s) will) comply with the directly applicable requirements and obligations of the Data Protection Legislation.

10.2 The Contractor shall ensure that any Personal Data obtained, collected or used in the course of performing the Research shall be treated as Confidential Information at all times including during collection, handling and use, and that the Personal Data (including in any electronic format) shall be stored securely at all times and with all technical and organisational security measures that would be necessary for compliance with data protection legislation. The Contractor shall take appropriate measures to ensure the security of all Personal Data and guard against unauthorised access thereto or disclosure thereof or loss or destruction while in its custody.

10.3 The Contractor shall defend, fully indemnify and keep indemnified and shall hold harmless the Authority, its officers, employees and agents from and against any and all liabilities, losses, costs, charges and expenses incurred (either directly or notwithstanding Clause 25.6, indirectly) as a result of any claims, demands, actions and proceedings made or brought against the Authority by any third party in respect of any loss or distress suffered by the loss or unauthorised disclosure of Personal Data or medical records by the Contractor, Partner(s) or any of its Collaborators, Sub-contractors, employees, agents or person within its control.

10.4 The Contractor shall at its own expense conduct any litigation arising from any claims, demands, actions or proceedings by any third party in respect of the loss or unauthorised disclosure of Personal Data or medical records by the Contractor, Partner(s) or any of its Collaborators, Sub-contractors, servants, agents or persons within its control and all the negotiations for the settlement of the same and the Authority hereby agrees to grant the Contractor exclusive control of any such litigation or the negotiations for the settlement of the same.

10.5 The Contractor shall ensure that medical information relating to the individuals who are the subjects of the Research shall be used in accordance with:

10.5.1 the Medical Research Council's "Personal Information in Medical Research", as amended from time to time; and

10.5.2 “The NHS Confidentiality Code of Practice”, guidelines on the use and protection of patient information, as amended from time to time.

10.6 No information which may lead to the identification of an individual shall be included in any publications without the prior agreement in writing of the individual concerned. No mention shall be made of individual officers (whether current or past) of the Authority, nor shall information be included which might lead to their identification, without the prior agreement in writing of the Authority.

10.7 Both Parties shall comply with their respective obligations under the Data Protection Legislation in the performance of this Contract.

10.8 The Authority reserves the right upon giving reasonable notice and within normal working hours to request the Contractor to provide reasonable evidence in order to enable it to ascertain compliance with relevant applicable laws and the terms of this Clause 10.

10.9 The Contractor shall, from time to time, comply with any reasonable request made by the Authority to ensure compliance with the measures of these data protection clauses and any relevant and applicable data protection and/or privacy laws.

10.10 The Contractor shall not, by any statement, act or omission, cause the Authority to be in breach of, or to incur any civil, criminal or other liability under any other law or regulation relating to data protection or privacy.

Research Data

11.1 Subject to the provisions of Clauses 9, 10 and 11.4, and in the event that in the Authority’s reasonable opinion the Research Data is not being appropriately managed, disseminated or used, the Authority reserves the right to have access to and to use the Research Data compiled during the course of the Research, and will respect existing confidentiality obligations in respect of any Research Data which it obtains, and to permit any Health Service Body to access and use the Research Data in order to: (i) support the development, promotion or provision of Health Care; or, (ii) for any other purpose that is not a Commercial Use.

11.2 Unless agreed otherwise by the Authority in advance and in writing, the Contractor shall not (and shall procure that the Partner shall not) enter into any agreements with any third party that:

11.2.1 limits or restricts the use of Research Data; and/or

11.2.2 grants any form of exclusivity to a third party
provided that the Authority recognizes that a third party that has supported the generation of Research Data may have a legitimate interest in limited exclusivity and therefore the Authority acknowledges that nothing in this clause 11.2 is intended to prevent the provision of Research Data directly related to Background IP provided by a third party to that third party on an exclusive basis for a reasonable period of no longer than 18 months and subject always to clause 17.6.

11.3 The Contractor shall, at the request of the Authority, deposit both qualitative and quantitative Research Data in a relevant data archive subject to any reasonable delay necessary to enable the protection or exploitation of Foreground IP.

11.4 The Authority shall not be entitled to inspect, take or be supplied with copies of the Research Data other than in an anonymised or pseudonymized form.

11.5 The Contractor shall ensure that all Research Data is anonymised or pseudonymized and that the key to personal identities of all persons to whom the Research Data relates is kept in a separate and secure place. As a minimum, the Contractor shall ensure that such anonymisation or pseudonymization is appropriate having regard to the nature of the Research Data and satisfies the appropriate standard recommended by the Information Commissioner’s Office from time to time.

11.6 In order to reflect the Authority’s position on open access to research materials, where research materials recording the outcome of the Research or of a Research Project or details of the progress of the Research or of any Research Project are submitted for publication, the Contractor:

11.6.1 shall subject to confidentiality requirements and to applicable data protection considerations, make all information and data (including but not limited to Research Data) on which the research materials are based available on an open access basis; or

11.6.2 in the event that it is not legally possible to fulfil the obligation in 11.6,1, shall include a statement with the research materials detailing how such information and data can be accessed.

11.7 Subject to the provisions of Clauses 9, 10 and 16, the Contractor shall (and shall procure that the Partner(s) shall) use all reasonable endeavours to ensure that:

11.7.1 a copy of all Research Data, pertaining to genomic sequencing Research Data, is submitted to the National Genomic Research Library; and

11.7.2 storage and access to all Research Data must conform with the NCS data sharing (FAIR) Principles as set out by Health Data Research UK within a reasonable period following initial analysis and publication.

Research practice and ethics

12.1 The Contractor will ensure that the Research and any other research directly connected to the Research is conducted in accordance with:

12.1.1 The Department of Health and Social Care guidance “UK Policy Framework For Health and Social Care Research” or any guidance replacing it;

12.1.2 “The Concordat to support Research Integrity”;

12.1.3 If relevant, in accordance with the Department of Health and Social Care guidance “Governance Arrangements for Research Ethics Committees (“GAfREC”)”; and/or

12.1.4 Such other relevant guidance as may be issued from time to time by the Authority or the Health Research Authority and made available to the Contractor.

12.2 The Contractor shall (and shall procure that each Partner and each Collaborator shall):

12.2.1 use all reasonable endeavours to comply with guidance and advice from the Authority on research governance; and

12.2.2 use and implement NIHR model research agreements or those issued by Health Research Authority, which may be updated from time to time.

12.3 The Contractor shall comply with all relevant legislation including but not limited to:

12.3.1 The Medicines for Human Use (Clinical Trials) Regulations (SI2004/1031) as Amended;

12.3.2 The Human Tissue Act 2004; and

12.3.3 The Mental Capacity Act 2005.

12.4 The Contractor will submit for review by a Research Ethics Committee recognised by the Authority any aspect of the Research where applicable and in accordance with Authority’s prevailing guidance with a view to obtaining the approval of an appropriate Research Ethics Committee to the Research and any Research Project. The Contractor shall inform the Authority’s Representative when such approval has been given (whether unconditionally or subject to conditions) or withheld.

12.5 The Contractor shall ensure that any part of the Research requiring the approval opinion of a Research Ethics Committee shall not commence until such approval is given.

12.6 The Contractor shall not use any funding provided under this Contract to support Research performed using animals.

12.7 The Contractor shall comply and shall ensure that the Partner(s) and any Collaborator complies, with the relevant legislation and guidance and advice from the Authority on bio banking which may be issued from time to time.

Monitoring and reporting

13.1 Progress of the Research will be reviewed periodically by the Authority’s Representative against the specifications detailed in Section 3.

13.2 The Contractor shall provide an interim written reports on the progress of the Research according to the schedule set out in Section 6. The interim reports shall be in a form set out by the Authority’s Representative as amended from time to time and shall include an outline of the Research Data, methods, an outline of any Foreground IP, Arising Know How results, Background IP and provisional conclusions together with management information and any other relevant information relating to the Authority's Monitoring, Evaluation and Learning plan's process and funding programme wide evaluations as published on the NIHR website from time to time.

13.3 During the Research Period the Contractor shall provide verbal or written reports as reasonably required by the Authority on any aspect of the Research.

Final report and research outputs and information

14.1 The Contractor shall provide a draft Final Report on the Research within thirty (30) calendar days of the Completion Date or date of termination howsoever terminated. The draft Final Report shall be in a form to be agreed with the Authority as amended from time to time or as otherwise required by the Authority’s Representative and shall include an outline of the Research Data, methods, an outline of any Foreground IP, Arising Know How, results, Background IP, the final conclusions of the Research together with management information, information on the potential impact of the Research and any other information relating to the Research up to the Completion Date, such as publications.

14.2 The Contractor shall:

14.2.1 Ensure that no Confidential Information and/or Third Party IP is referenced or included in the Final Report unless:

a) the Contractor or Partner (as appropriate) is authorised to use the relevant Third Party IP and to permit the Authority to use and publish the relevant Third Party IP in accordance with this Contract, including in the publication of the Final Report and in support of Research on Research;

b) the Contractor or Partner (as appropriate) is authorised to disclose the relevant Confidential Information as part of the Final Report and to permit the Authority to use and publish the relevant Confidential Information in accordance with this Contract, including in the publication of the Final Report and in support of Research on Research.

14.2.2 Ensure that appropriate measures (including but not limited to applying for registration of Intellectual Property and ensuring that the proposed publication does not contain any commercially sensitive information) are in place to ensure that Foreground IP, Arising Know How and Research Data referred to in the Final Report or the Final Report Summary are each adequately protected.

14.2.3 Provide written confirmation that 14.2.1 and 14.2.2 have been completed for the benefit of the Authority when submitting the draft Final Report and the Final Report to the Authority.

14.3 The Contractor shall also provide, in a form to be agreed with the Authority and within thirty (30) calendar days of the Completion Date or date of termination, a draft summary of the findings of the Research. Subject to the Contractor’s obligations under Clause 14.2, 17.2 and 18.6, the Contractor shall make such findings available on Researchfish in accordance with the Authority’s policies, or such other platform for reporting research outcomes as the Authority may direct.

14.4 The Authority shall make retentions of up to 1% of the sums due to the Contractor until the Final Report is received.

14.5 If within one (1) year of the end of the Research Period the Contractor has not produced a Final Report which satisfies the Authority, the Authority may, at the cost and expense of the Contractor, prepare and publish, or arrange for the preparation and publication of, such a report.

14.6 For the duration of the Research Period and for a period of up to five (5) years after completion of the Research the Contractor will comply with requests for survey information collected through NIHR authorised web-based systems.

14.7 In addition to the Authority’s rights to use and publish reports and the Final Report, the Authority may use or authorize others to use the Final Report and any reports or information provided in accordance with Clauses 13 or 14 to support or perform Research on Research.

Site visit group

15.1 In addition to informal visits made by the Authority’s Programme Management Representative, the Authority may appoint a Site Visit Group, made up of a small team of independent experts, and observers of the Authority and NIHR Coordinating Centre. The Contractor 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 Research is being conducted to consult informally with the staff working on the Research, to evaluate progress, performance and key issues and have access to any scientific, technical, operational, financial or legal information relevant to this Contract and to report back to the Authority on its findings. The Site Visit Group shall be subject to the same confidentiality obligations as specified in this Contract.

15.2 The Contractor shall be given one (1) month’s written notice prior to any visit by the Site Visit Group.

15.3 The Site Visit Group may recommend that the Authority terminate the Research or an element of the Research where it has identified a serious failure in the progress, management or conduct of the Research (including a finding that the Research will be unable to achieve the next milestone within a reasonable time period). The Site Visit Group may also alert the Authority to any external scientific, technical or commercial barrier which means that the Research is unlikely to succeed in its objectives. If the Site Visit Group makes such a recommendation pursuant to this Clause 15.3 the Authority may, after hearing representation from the Contractor, take action at its discretion and acting reasonably which may include variation or termination of the Contract or an element of the Research pursuant to Clause 21.3.

15.4 The Authority may, at its sole discretion, and acting reasonably, allow the Contractor 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). Where the Authority grants the Contractor a period of time to correct such failings and the Contactor does not correct such failings within the period specified by the Authority (if any), the Authority shall retain the right to terminate this Contract pursuant to Clause 21.3.

15.5 The Contractor will co-operate fully with the Site Visit Group prior to and during visits.

Intelluctual property rights

16.1 The Contractor will maintain Intellectual Property in accordance with its standard institutional policy (“Contractor IP Policy”). The Contractor will make available a copy of the Contractor IP Policy on the request of the Authority in order to demonstrate to the Authority that:

16.1.1 The Contractor IP Policy is consistent with the Contract; and

16.1.2 The Contractor IP Policy provides a pragmatic process for assessing and implementing appropriate Intellectual Property protection (whether by way of application for registration, restricted licence or otherwise) for the outputs of the Research.

16.2 No later than six (6) months after the Commencement Date, the Contractor shall put in place a Partnership Agreement(s) consistent with the Contractor IP Policy and in a form approved by the Authority to ensure that:

16.2.1 each Partner shall perform the Research and Research Projects in accordance with this Contract and either assign all Foreground IP and Research Data to the Contractor or where Foreground IP or Research Data vests in the Partner (s), these parties shall irrevocably agree in writing that:

a) any Foreground IP and/or Research Data it retains will be subject to and be managed by that Partner in accordance with the provisions of this Contract as if such Partner were a party to this Contract; and

b) such rights, licences and obligations will be directly enforceable against such Partner by the Authority pursuant to The Contracts (Rights of Third Parties) Act 1999 or other suitable mechanism.

16.2.2 Arising Know How may be used by the Contractor on a world-wide, royalty free, non-exclusive, transferable and sub-licensable basis in the course of the Contractor’s normal activities or to achieve Patient Benefit. However:

a) the Contractor may not, and shall ensure that the Partner (s) may not, use, or permit any other party to use, the Arising Know How for any Commercial Use without the prior written consent of the Authority obtained in accordance with Clause 17.6;

b) the Contractor, Partner(s) and Collaborators may only use the Arising Know How in accordance with Clause 9.1.2;
the Partner will, upon reasonable request, make available its employees and/or consultants for discussion with the Site Visit Group as referred to in Clause 15;

16.2.3 the Partner(s) shall, be under obligations of confidence concerning the Foreground IP and Research Data on terms equivalent to those set out under this Contract; and

16.2.4 the Partner(s) shall keep detailed records including where relevant scientific notebooks of all of its activities and upon request shall make available copies to the Authority.

16.3 The Partnership Agreement(s) must cover access to each party’s Background IP and the ownership and exploitation of Foreground IP and Research Data, including apportioning revenue and other shares between the parties. The Contractor shall submit to the Authority a draft copy of each of the Partnership Agreement(s) no less than thirty (30) days prior to execution for comment and approval. From the date of submission of the draft copy of the Partnership Agreement(s) by the Contractor, the Authority shall be entitled, within thirty (30) days, to require reasonable amendments to the Partnership Agreement to the extent necessary for compliance with this Contract.

16.4 Foreground IP, Arising Know How and Research Data which may arise as part of, incidental to or resulting from the Research shall vest in the Contractor, or subject to Clause 16.2 and 16.7, the relevant Partner or Collaborator.

16.5 The Contractor shall use reasonable efforts to make available, and, subject to Clause 16.2, ensure that the Partner(s) shall make available the Background IP or Know-How that is owned or controlled by the Contractor or the Partner that is necessary or useful for undertaking the Research and for the protection, dissemination or exploitation of the Foreground IP. Where the Contractor and subject to Clause 16.2, the Partner(s) have responsibility for filing, prosecuting, maintaining, defending and enforcing protection for such Background IP, the Contractor or, subject to Clause

16.2, the Partner(s) shall retain this responsibility unless otherwise agreed in writing and in any event at no cost to the Authority. If the Contractor, or subject to Clause 16.2, the Partner wishes to cease doing so in relation to any of such Background IP, it shall notify the Authority as soon as reasonably practical and in any event no less than two (2) month prior to discontinuing its maintenance, defence or enforcement of such Background IP, the Authority shall have the right but not the obligation to take over responsibility for such Background IP. To the extent that it is legally able to do so, the Contractor or Partner(s) shall licence or assign the Background IP to a nominee of the Authority’s choosing, in all other cases, such licence or assignment shall be made on fair and reasonable terms taking account of the permitted use of such Background IP.

16.6 The Contractor shall grant (and shall procure that the Partner(s) and Collaborators grant) to the Authority a non-exclusive, irrevocable, royalty-free, worldwide licence together with the right to grant sub-licences to Health Service Bodies or others directly engaged in providing Health Care, permitting the Authority to:

16.6.1 use and publish (in accordance with Clause 9):

a) any information relating to the Research which is not Confidential Information of the Contractor;
b) any Foreground IP;
c) Research Data;
d) Reports;
e) Arising Know How; and,
f) conclusions arising from the Research.
and in each case, the Authority intends to exercise the right recorded at 16.6.1 only where, in the Authority’s reasonable opinion the Contractor, Partner, Associate Partner or Collaborator (as appropriate) is not appropriately managing, disseminating or using such items and in each case the Authority is permitted to use or make available such items as it sees fit in support of: (i) the development, promotion or provision of Health Care that is not a Commercial Use; and/or (ii) for any other purpose that is not a Commercial Use; and

16.6.2 use the Contractor's Background IP and any Partner’s Background IP but solely to the extent that it is necessary in order to exercise the licence granted in Clause 16.6.1.
In each case, where any third party has rights existing at the date of the licence granted in this Clause such licence will be subject to the third party rights and the Contractor shall: (i) notify the Authority of such rights; and (ii) make reasonable efforts to overcome or to negotiate exclusions from such rights for the benefit of the Authority.

16.7 Subject to Clause 16.2, the Contractor shall, and shall ensure that the Partner(s) shall:

16.7.1 ensure that for any Research Project involving a third party, a Collaborator not party to the Partnership Agreement(s) shall have in place suitable agreements (“Research Project Agreements”) to ensure effective performance of the Research Project, ownership of Foreground IP, access to Background IP and reporting obligations in order to enable the Contractor to successfully deliver the Research and ensure the effective exploitation of and maximise the use of any arising Intellectual Property and Background IP and Foreground IP; and

16.7.2 ensure that access to Background IP shall be on fair and reasonable terms at no charge where access to the Background IP is necessary for the delivery of the Research or on fair and reasonable commercial terms where access to the Background IP is necessary for the exploitation of any arising Intellectual Property and Background IP and Foreground IP

16.8 Where the Contractor and the Partner(s) can reasonably expect to do so they shall enter into agreements in which the Intellectual Property arrangements do not adversely affect or restrict the Contractor’s ability to comply with the terms of this Contract.

16.9 Draft Partnership Agreement(s) agreed with the Partner(s) pursuant to Clause 16.2 will be submitted to the Authority for comment and approval no later than thirty (30) days before finalisation.

Exploitation of intellectual property

17.1 The Contractor shall inform the Authority in a timely manner and in any event before making any Commercial Use of, or accepting any proposal to make Commercial Use of, the Foreground IP, Arising Know How or Research Data.
17.2 The Contractor shall procure that any party (including but not limited to the Partner(s), the Collaborators, Sub-contractors or any other party involved in a Research Project) performing the Research develops, implements and maintains procedures for the management of Intellectual Property in the outcome of the Research or a Research Project and in particular, but without limitation, shall ensure that:

17.2.1 the Foreground IP is identified and recorded;

17.2.2 prior to any publication, any patentable or registrable elements of the Foreground IP are identified, duly considered for patentability or other registration and, where it is commercially reasonable to do so and is an appropriate means of achieving Patient Benefit, patent applications or other registrations are filed in respect thereof at patent offices in territories where products or services arising from the inventions may be made, sold or used in accordance with the Contractor IP Policy;

17.2.3 the Authority is notified within six (6) months of receipt of disclosure of Foreground IP that may be protected by any form of registration and in the event that the Contractor or, subject to Clause 16.2, the Partner(s), decides not to protect the Foreground IP by applying to register the appropriate Foreground IP, the Contractor agrees to or, subject to Clause 16.2, agrees to ensure that the Partner(s), agrees to communicate this decision to the Authority and the Authority shall have the right but not the obligation to take assignment of the Intellectual Property associated with the disclosure free of charge and to manage the associated Intellectual Property, save that the Contractor or subject to Clause 16.2, the Partner(s), may reasonably request an extension of up to one (1) year from the date of any such notification under this Clause 17.1 to enable further validation or development of the Foreground IP prior to protection;

17.2.4 in exercising the rights in Clause 17.2 the Contractor takes due consideration of the Authority’s attitude to the inappropriate use of patents which it considers detrimental to scientific endeavour or to advances in healthcare. The Authority believes that the basic DNA sequence of humans and other organisms should be placed in the public domain as soon as is practical, without any fees, patents, licences or limitations on use, giving free and equal access to all;

17.2.5 all such applications for registration are diligently prosecuted having regard to all relevant circumstances; and

17.2.6 in the event that the Contractor or, subject to Clause 16.2, the Partner(s), elect to abandon prosecution of an application for registration of Intellectual Property protecting applications of the outcome of the Research or a Research Project, the Contractor shall inform the Authority’s Representative as soon as reasonably practical and in any event no less than two (2) months in advance of the patent application lapsing and the Authority shall have the right but not the obligation to take assignment of the Intellectual Property associated with the application free of charge and to manage its prosecution.

17.3 The Contractor shall, and shall procure through the Partnership Agreement(s) that the Partner(s) shall, permit the Authority to monitor the operation and effectiveness of the Contractor’s and any Partner’s procedures for the management of Intellectual Property in such ways as the Authority considers reasonably necessary to ensure that any Foreground IP, Arising Know How or Research Data generated is disseminated and/or exploited for the public benefit and to maximise Patient Benefit. This right shall include but not be limited to the right of the Authority (or its authorised representative) to inspect and audit the Contractor’s and/or the Partner(s) records kept pursuant to Clause 17.4.3, subject to the Authority providing ten (10) Business Days’ written notice to the Contractor. This right of inspection and audit may be performed once in each twelve (12) month period following the Commencement Date.

17.4 Consistent with the good management of Intellectual Property and the terms of the Contractor IP Policy, the Contractor and subject to Clause 16.2, the Partner(s) shall:

17.4.1 where reasonable and practicable, promote the dissemination of the Foreground IP, Arising Know How and Research Data in order to achieve Patient Benefit;

17.4.2 where reasonable and practicable and subject to obtaining the prior written consent of the Authority, exploit such Foreground IP, Arising Know How and Research Data in order to generate either capital or revenue or both; and

17.4.3 pursuant to Clause 7.4 keep proper records showing the description of the Background IP used and Foreground IP generated.

17.5 The Contractor, the Partner(s), and for each specific Research Project, the relevant Collaborator, shall agree between themselves who shall take principal responsibility for the exploitation and/or commercialisation of each part of Foreground IP (and the associated Background IP), Arising Know How and Research Data and shall inform the Authority accordingly.

17.6 The Contractor shall, and shall ensure that the Partner(s) shall, obtain the written consent of the Authority prior to:

17.6.1 making any Commercial Use of; or

17.6.2 permitting any third party to make any Commercial Use of
in each case, the Foreground IP or Arising Know How or Research Data. Any request for such consent must: (i) be submitted to the Authority in writing with sufficient notice having regard to the development of the Foreground IP or Arising Know How or Research Data and the progress of the proposed Commercial Use; and (ii) be accompanied by sufficient information (including but not limited to reasonable details of the proposed Commercial Use and proposed commercialisation arrangements (including but not limited to any deal sheet, draft agreements or commercial terms in circulation, which information the Authority shall keep confidential), and any parties involved in the proposed Commercial Use) to allow the Authority to give reasonable consideration to the request. The Authority will within thirty (30) Business Days of receipt of a written request for consent and adequate accompanying information inform the Contractor or Partner(s) if the Authority requires the Contractor or Partner(s) to enter into a commercialisation agreement with the Authority as a condition of granting such consent. Any such commercialisation agreement shall, as a minimum:

17.6.3 address the distribution of revenue, equity or other benefits arising from the proposed commercialisation arrangements and rights to use the Foreground IP, Arising Know How or Research Data;

17.6.4 reflect the Authority’s policy from time to time relating to the allocation and use of revenue, equity or other benefits arising from the proposed commercialisation arrangements and rights to use the Foreground IP, Arising Know How or Research Data;

17.6.5 take into consideration the relative contribution of the Authority, the Contractor, the Partner(s), the Collaborators and other third party funders or contributors to the Foreground IP, the Arising Know How or the Research Data.

17.7 Unless agreed otherwise in writing, the Contractor shall ensure that any proceeds of commercialisation allocated to the Authority as a result of any Commercial Use are:

17.7.1 distributed according to the terms of the relevant revenue sharing agreement; or

17.7.2 retained by the Contractor or Partner(s) for use as directed by the Authority in support of further research.

17.8 In the event that the Contractor or pursuant to Clause 16.2, any Partner fails to comply with either of Clauses 17.6 or 17.7 the Authority reserves the right to deem this to be a material breach and terminate this Contract in accordance with Clause 21.3 herein.

17.9 In the event that the Contractor or Partner(s) notifies the Authority of intended commercialisation under Clause 17.5, then the Contractor or Partner(s) should take due consideration of the Authority’s attitude to access to essential health related technologies including medicines in low and middle income countries.

17.10 If the Contractor or, subject to Clause 16.2, the Partner(s), does not reasonably protect, manage or exploit any Foreground IP arising out of the Research according to the terms of this Contract or if this Contract is terminated according to Clause 21.3, then the Authority shall have the right acting reasonably and subject to the prior rights of third party licensees or Collaborators, but not the obligation, to take assignment of and protect, manage and exploit such Foreground IP. Such right shall be exercised no earlier than six (6) months after the Authority has given the Contractor or Partner(s) notice in writing that it is failing to protect, manage and exploit such Foreground IP to the Authority’s satisfaction. However, the Authority may exercise such right sooner where it reasonably considers that the opportunity to protect, manage or exploit such Foreground IP for the public benefit could be lost if more immediate action is not taken. The Contractor agrees (and shall procure that the Partner(s) shall) to do, and will ensure that its employees, students and any third party acting on its behalf do, all acts required by the Authority to further such protection and exploitation including the delivery of all necessary written information including copies of any notebooks maintained throughout the Research.

17.11 If the Contractor wishes to use any third party (excluding its professional advisors) to carry out its obligations with respect to this Clause 17 other than any third party specified in the Partnership Agreement(s) then it must provide details of the proposed third party to the Authority and obtain the Authority’s prior written approval to such third party carrying out exploitation activities with respect to the Foreground IP, Arising Know How or Research Data. Notwithstanding the foregoing, the Contractor will work in collaboration with the Partner to fulfil its obligations subject to the provisions of Clauses 16 and 17.

17.12 The Contractor should communicate with and keep informed the Authority’s Representative, NIHR Coordinating Centre and such other individuals as the Authority may notify to the Contractor from time to time in all matters relating to this Clause 17.

17.13 The Contractor shall do or procure to be done all such further acts and things and execute or procure the execution of all such other documents as the Authority may from time to time require for the purpose of giving the Authority the full benefit of the provisions of this Contract.

Publication

18.1 The Contractor shall and shall ensure that the Partner(s) shall (and in each case shall procure that each member of staff engaged on the Research shall), use all reasonable endeavours to comply with the Authority’s NIHR policy and guidance on the publication of research outputs which may be issued by the Authority from time to time. This condition shall not apply where the Contractor and/or Collaborator has a contractual, legal or similar obligation to publish specific details about the Contract or the Research. For the avoidance of doubt this obligation continues after the end of the Research Period.

18.2 Subject to the provisions of Clause 9 (Confidentiality) and notwithstanding the provisions of Clause 16 (Intellectual Property Rights) and 17 (Exploitation of Intellectual Property) and in addition to the rights of the Authority under Clause 14.7:

18.2.1 the Contractor hereby grants to the Authority (and shall procure that the Partner(s) grants to the Authority) the irrevocable, perpetual, non-exclusive, sub-licensable, royalty-free licence to publish the Reports at any time either: (a) under CC-BY licence terms or equivalent; or, (b) pursuant to the Open Government Licence v3.0 or equivalent as appropriate;

18.2.2 subject to the Contractor’s right to submit a request under Clause 18.4 the Authority may publish the Reports in accordance with the licence granted under this Clause 18.2 for any purpose including: in accordance with the Authority’s position on Open Access to research (as updated from time to time); and, any entry in a register of research findings or an individual issue of or a review article in a monograph series prepared on the Authority’s behalf. Where it is reasonably possible, the timing of any such publication will be subject to consultation with the Contractor and will take account of the Authority’s position and policies on publication in force from time to time, publication timetables in other peer-reviewed journals and the need to make research findings publicly available as soon as practicable;

18.2.3 for the avoidance of doubt, the licence granted under this Clause 18.2 relates to the copyright in the Report and does not extend to the Intellectual Property described therein.

18.3 Consistent with Clause 14.2, the Contractor undertakes to obtain any and all appropriate third party licences and permissions necessary to grant the licences under Clauses 14.7 and 18.2 to the Authority of any Intellectual Property rights in the Reports where such rights are the property of a person or organisation other than the Contractor. The Contractor shall provide the Authority with all appropriate details, consistent with Clause 14.2, including proof that the Contractor has obtained such licences and/or permissions and details of the acknowledgements required by owners of the rights licensed.

18.4 The Authority is entitled to publish the whole or any part of the Final Report. If the Contractor wishes the Authority to delay such publication, it must submit a request in writing to the Authority’s Representative giving reasons for the requested delay which shall be considered in accordance with the NIHR’s Information for Authors’ Dual Publication Guidance and Embargo Policy as amended from time-to-time.

18.5 The Authority will ensure that any King’s Printer and Controller of HMSO copyright publication arising from the Reports carries the following statement:
“© King’s Printer and Controller of HMSO 20xx [year of publication].
This work was produced by (name of author/organisation) under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care”.
18.6 The Contractor shall ensure that the outcome of the Research is prepared for publication in a suitable peer-reviewed journal and shall ensure that:

18.6.1 prior to publication, appropriate measures (including but not limited to applying for registration of Intellectual Property and ensuring that the proposed publication does not contain any commercially sensitive information) are in place to ensure that Foreground IP, Arising Know How and Research Data are each adequately protected;

18.6.2 it and any other publication, including patent applications, of or resulting from research carried out under this Contract shall acknowledge the Authority’s financial support and carry a disclaimer relevant to the programme as set out in the Authority’s NIHR research outputs and publications guidance as amended from time to time.

Biosample storage and processing, genomics and submissions

19.1 Subject to the provisions of Clause 9 and notwithstanding the provisions of Clauses 16 and 17, in relation to biosample storage, the Contractor shall only use (and shall procure that the Partner(s) shall only use) the funding provided under this Contract to pay for:

19.1.3 long-term biosample storage (being storage for a period of greater than six (6) months) if it is at the NIHR National Biosample Centre and/or

19.1.4 processing and dispatch of biosamples if it is at the NIHR National Biosample Centre.
The Contractor and Partner shall obtain prior written consent from the Authority for use of funding provided under this Contract for any long-term biosample storage and processing and dispatch of biosamples other than at the NIHR National Biosample Centre. The Contractor acknowledges that the Authority shall grant such approval only where in the Authority’s reasonable opinion there are factors which preclude the use of the NIHR National Biosample Centre.

19.2 The Authority wishes to promote the use of biosamples that are collected as part of the Research or whose collection is supported by funding provided by the Authority. The Contractor and the Partner(s), where legally possible and appropriate, should use all reasonable endeavors to provide information and access on biosamples collected for the Research, and will be expected to adhere to policies on biobanking that may be introduced from time to time.

19.3 The Contractor shall (and shall procure that the Partner(s) shall) take all practical steps to undertake genomic sequencing at a fair and reasonable price. The Contractor and Partner(s) shall not use any funding provided by the Contract for genomic testing on conditions included in the Genomic Medicine Service Test Directory. All genomic sequencing of such conditions should be conducted by the Genomic Medicine Service. The Authority may inspect the procurement documents or business cases issued to the Contractor and Partner(s) for genomic sequencing in connection with the Research.

NIHR Research and support staff

20.1 The Contractor shall identify to the Authority all individual staff employed to provide services in connection with this Contract, to enable the Authority to maintain a record of individuals in receipt of NIHR funding including NIHR Academy members.

20.2 The Contractor shall inform the Authority immediately of any suspension or termination of employment of any staff providing services in connection with this Contract.

20.3 The Contractor shall make reasonable efforts to ensure that individuals employed to provide services in connection with this Contract abide by the rules, regulations and codes of conduct of their employer; of their professional regulatory bodies where applicable; with relevant guidance published by the Authority from time to time on the conduct of research including the Researcher Development Concordat; and with guidance on membership of NIHR Academy set out on the NIHR website.

Termination upon occurrence of events

21.1 Without prejudice to any other provision of this Contract, this Contract may be terminated by either Party giving three (3) months' notice in writing to the other. Should the option to terminate be exercised by the Authority under this Clause 21, it 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 takes all immediate and reasonable steps to minimise the loss.

21.2 The Authority will not pay any sum under Clause 21 which, when taken together with any sums paid or due or becoming due to the Contractor under this Contract, will exceed such total sums as would have been payable under this Contract if the Contractor had fulfilled its obligations under this Contract.

21.3 The Authority may at any time by notice in writing terminate this Contract without liability for any damage, loss or expenses arising as a result of or in connection with such termination if:

21.3.1 the Contractor is in material breach of any of the terms and conditions of this Contract;

21.3.2 in the case of a breach capable of remedy, it fails to remedy that breach within thirty (30) calendar days (or any other period agreed in writing with the Authority) of the service of a written notice by the Authority specifying the breach and requiring its remedy; or

21.3.3 the breach is not capable of remedy; and where the Authority then makes other arrangements for the provision of the Research, the Authority is entitled to recover from the Contractor the direct cost of making those other arrangements; or

21.3.4 an event of Force Majeure, as defined in Clause 24 exists for more than six (6) months;

21.3.5 if any member of the Contractor’s or the Partner’s Key Staff is not available to fulfil his part in the Research for any part of the Research Period, subject to prior discussion with the Contractor to first attempt to identify a mutually acceptable replacement;

21.3.6 should the Contractor be unable or unwilling for any reason to continue with the Research or if in the reasonable opinion of the Authority the Contractor is consistently failing to achieve an acceptable standard in relation to the Research; or

21.3.7 any provision of this Contract (other than as previously specified in the preceding provisions of this Clause 21) expressly entitles the Authority to terminate this Contract; or

21.3.8 the Contractor shall be subject to the exercise of any powers conferred on the regulator by:

(a) sections 52 to 55 (failing NHS foundation trusts); or

(b) sections 56 and 57 (mergers),
of the National Health Service Act 2006 provided that in respect of the exercise of powers conferred on the regulator by sections 56 and 57 of that Act such exercise impacts adversely and materially on the performance of this Contract and the Authority exercises its right to terminate within six (6) months of the date of any authorisation made in accordance with those sections.

21.4 In the event that the Contractor fails to comply with Clause 8.1, the Authority reserves the right to deem this to be a material breach and terminate this Contract in accordance with Clause

21.3 herein

21.5 In addition, the Authority shall be entitled to terminate this Contract with immediate effect by notice in writing to the Contractor if the Site Visit Group recommends termination of the Research in accordance with Clause 15 and/or the Contractor fails to correct any identified failings within the time period granted by the Authority (if any) under Clause 15.3

21.6 Termination of this Contract by the Authority under Clauses 21.3 and 21.4 of this Clause 21 shall be: (i) with immediate effect; or, (ii) otherwise with effect from the expiry of such notice period as the Authority provides, in its discretion and which shall be a minimum of three (3) months and not exceeding six (6) months.

Consequences of termination

22.1 Termination of this Contract, however caused, shall not:

22.1.1 release the Contractor from any duty or obligation of confidence, in particular as imposed by Clauses 8 – 11 inclusive, which falls on it, or its Sub-contractors, agents, employees or former employees, under this Contract or under the general law governing confidential information; or

22.1.2 prejudice or affect any rights, action or remedy which shall have accrued before termination or shall accrue thereafter to any Party.

Equipment

23.1 The Contractor shall take all practical steps to purchase all materials and equipment at a fair and reasonable price. The Authority may inspect the original quotations and invoices issued to the Contractor for equipment purchased in connection with the Research and recover any funds provided for the purchase if the Contractor does not provide this documentation on request.

23.2 At the end of the Research Period, and after the final presentation of the Final Report required under Clause 14 all equipment purchased for use on the Research with funds provided by the Authority shall become the property of the Contractor.

Force majeure

24.1 In the event that any Party is delayed in the performance of its obligations under this Contract by an event of Force Majeure, the obligations of the Parties under this Contract shall remain in suspense until the cause thereof has ceased. "Force Majeure" shall include any of the following: riots, sabotage, acts of war or piracy, destruction of essential equipment by fire, explosion, storm, flood or earthquake, and delay caused by failure of power supplied or transport facilities or any other cause beyond the control of the Parties which renders performance of this Contract impossible.

24.2 Neither of the Parties shall be liable to the other for any loss including but not limited to any damages or abatement of charges whether directly or indirectly caused or incurred by any failure or delay in the performance of its obligations due to Force Majeure.

24.3 If either of the Parties shall become aware of Force Majeure which give or are likely to give rise to any failure or delay on its part it shall forthwith notify the other by the most expeditious method then available and shall say how long it is estimated that such failure or delay shall continue.

Warranties and liability

25.1 The Contractor warrants that:

25.1.1 it has the requisite capacity and authority and all necessary licences, permits and consents to enter into this Contract;

25.1.2 it has full capacity, power and authority and all necessary licences, permits and consents to assume and fully perform all of its obligations under this Contract;

25.1.3 it has, or has access to, sufficient resources to perform the Research as contemplated under this Contract and to meet its other obligations under this Contract;

25.1.4 there are no actions, suits or proceedings pending or, to the Contractor's knowledge, threatened against or affecting the Contractor before any court or administrative body or tribunal that might affect the ability of the Contractor to meet and carry out its obligations under this Contract;

25.1.5 it will be the legal and beneficial owner of all right, title and interest in and to the Foreground IP; or

25.1.5.1 the Contractor has an unrestricted and free right to use and to make available the Contractor Background IP for the purposes of the Contract];

25.1.5.2 in the case of Foreground IP created by the Partner, will enter into a legally binding Partnership Agreement(s) no later than six (6) months after the Commencement Date which ensure that such Foreground IP is owned and managed in accordance with, and subject to the terms of this Contract;

25.1.5.3 in the case of Foreground IP created by all other Collaborators, it will enter into legally binding agreements with such Collaborators within six (6) months of the relevant commencement date of any Research Project as applicable, which ensure that where it can be reasonably expected such Foreground IP is owned and managed in accordance with, and subject to the terms of this Contract.

25.1.6 in performing the Contract, the Contractor will use all reasonable efforts to ensure that:

25.1.6.1 sufficient authorisation has been obtained to permit the use of any Intellectual Property that is reasonably necessary to enable the use of the Foreground IP, Arising Know How or Research Data to the extent necessary to exercise any rights under, or to perform, this Contract;

25.1.6.2 the Research will be carried out by appropriately experienced, qualified and trained personnel with all due skill, care and diligence; and

25.1.6.3 the Contractor will and will ensure that the Partner(s) will, discharge its obligations under this Contract with all due skill, care and diligence including Good Industry Practice and (without limiting the generality of the foregoing) in accordance with its own established internal procedures.

25.2 Except as expressly provided in this Contract, none of the Parties gives any warranties or makes any representations:

25.2.1 with respect to any of the Foreground IP and/or Contractor Background IP or any products derived from them, or their fitness for any purpose; or

25.2.2 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.

25.3 Notwithstanding any other provision of this Contract, each Party shall use its reasonable endeavours to mitigate losses it may incur that are covered by indemnities provided by the other Party.

25.4 The Contractor shall indemnify the Authority, their officers, servants and agents fully against any liability, loss, claim or proceedings whatsoever arising under this Contract or as a direct result of the Research or any Research Project in respect of:

25.4.1 any damage to property, real or personal, including any infringement of third party Intellectual Property rights, patents, copyright and registered designs`; and

25.4.2 any injury to persons including injury resulting in death arising out of, or in the course of, or in connection with this Contract;
except in so far as such damage or injury shall be demonstrated by the Contractor to be due to any act or neglect of the Authority, or their officers, servants or agents.

25.5 The Contractor shall promptly notify the Authority if any claim or demand is made or action brought against the Contractor for infringement or alleged infringement of Intellectual Property which might affect the Research and the Contractor shall discuss with the Authority the steps it proposes to take to keep the Authority informed of the progress in respect of such claims, demands or action.

25.6 Except in circumstances of fraud or willful misconduct by a Party or its affiliates, no Party or any of its affiliates shall be liable to another Party or any affiliate of the other 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 Contract.

25.7 Nothing in this Contract shall limit the liability of any Party in respect of:

25.7.1 personal injury or death arising out of that Party’s negligence or willful misconduct; or

25.7.2 fraud or fraudulent misrepresentation.

Insurance

26.1 Without prejudice to clause 25.4, the Contractor shall throughout the duration of the Contract effect and maintain with a 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 Contractor arising out of the Contractor's performance of this Contract.

26.2 The Contractor shall produce on demand by the Authority documentary evidence that any insurance policies required by clause 26.1 are in force.

26.3 The terms or the amount of cover of any insurance shall not relieve the Contractor of any liabilities under the Contract. It shall be the responsibility of the Contractor to determine the amount of insurance that will be adequate to enable the Contractor to satisfy any liability referred to in clause 26.1.

Assignability

27.1 Except as set out in Section 3, the Contractor shall not sub-contract, transfer or assign the whole or any part of this Contract without the prior written approval of the Authority, which approval may be subject to such terms and conditions as the Authority may specify. For the avoidance of doubt:

27.1.1 approval of a Sub-contractor shall be signified by the inclusion of the name in Schedule A “Approved Sub-Contractors”. Sub-contractors can be added to this list only by a Variation;

27.1.2 the Authority’s approval is required where the Contractor wishes to rely on a Sub-contractor to provide services tailored to the delivery of the Research. The Authority’s approval is not required where the Contractor relies on a Sub-contractor to provide routine support to the Contractor and that support incidentally assists in the delivery of the Research.

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

27.3 Notwithstanding Clause 27.1.2, the Contractor shall ensure that, to the extent that they are relevant, and where reasonable to do so, the terms of this Contract are incorporated into any Sub-contract (including any agreement with the Partner) and that all reasonable steps are taken by it to ensure that its Sub-contractors are aware of and adhere to the terms of this Contract.

Severability

28.1 If any provision of this Contract is held invalid, illegal or unenforceable for any reason by any court of competent jurisdiction, such provision shall be severed and the remainder of the provisions hereof shall continue in full force and effect as if this Contract had been executed with the invalid provisions eliminated.

28.2 In the event of a holding of invalidity so fundamental as to prevent the accomplishment of the purpose of this Contract, the Parties shall immediately commence good faith negotiations to remedy such invalidity.

Waiver

29.1 The waiver by the Authority of any right or remedy in respect of any breach of any term or condition or requirement of this Contract shall not prevent the subsequent enforcement thereof and shall not be deemed to be a waiver of any right or remedy in respect of any subsequent breach.

Corrupt gifts or payments

30.1 The Contractor shall not do (and warrants that in entering the Contract it has not done) any of the following (referred to in this Clause as "prohibited acts"):

30.1.1 offer, give or agree to give to any servant of the Crown any gift or consideration of any kind as an inducement or reward for doing or not doing (or having done or not having done) any act in relation to the obtaining or performance of this or any other contract with the Crown, or for showing or not showing favour or disfavour to any person in relation to this or any other contract with the Crown; and

30.1.2 enter into this or any other contract with the Crown in connection with which commission has been paid or has been agreed to be paid by it or on its behalf, or to its knowledge, unless before the Contract is made particulars of any such commission and the terms and conditions of any such agreement for the payment of it have been disclosed in writing to the Authority.

30.2 If the Contractor, its employees, agents or any Sub-contractor, or anyone acting on its or their behalf, does any of the prohibited acts or commits any offence as the case may be under the Bribery Act 2010 with or without the knowledge of the Contractor, in relation to this or any other contract with the Crown, the Authority shall be entitled:

30.2.1 to terminate the Contract immediately by giving notice in writing and recover from the Contractor the amount of any loss resulting from the termination;

30.2.2 to recover from the Contractor the amount or value of any such gift consideration or commission; and

30.2.3 to recover from the Contractor any other loss sustained in consequence of any breach of this Clause, whether or not the Contract has been terminated.

30.3 In exercising its rights or remedies under this Clause, the Authority shall:

30.3.1 act in a reasonable and proportionate manner having regard to such matters as the gravity of the prohibited act, and the identity of the person performing the prohibited act, and, the nature of the procedures and precautions previously put in place by the Contractor to prevent such prohibited acts;

30.3.2 give all due consideration, where appropriate, to action other than termination of the Contract, including (without limitation to):

30.3.2.1 requiring the Contractor to procure the termination of a Sub-contract where the prohibited act is that of a Sub-contractor;

30.3.2.2 requiring the Contractor to procure the dismissal or removal from any involvement with any NIHR-funded Research of an employee (whether its own or that of a Sub-contractor) where the prohibited act is that of such employee.

Fraud

31.1 The Contractor shall take all reasonable steps, in accordance with Good Industry Practice, to prevent Fraud by any of the Contractor's employees and the Contractor (including where appropriate its shareholders, members, directors) in connection with the receipt of monies from the Authority.

31.2 The Contractor shall notify the Authority immediately if it has reason to suspect that any Fraud has occurred or is occurring or is likely to occur.

31.3 If the Contractor or any of the Contractor's employees commits Fraud in relation to this or any other contract with the Crown (including the Authority) the Authority may:

31.3.1 terminate the Contract immediately by giving notice in writing and recover from the Contractor the amount of any loss suffered by the Authority resulting from the termination, including the cost reasonably incurred by the Authority of making other arrangements for the supply of the Research and any additional expenditure incurred by the Authority throughout the remainder of the Contract Period; or

31.3.2 recover in full from the Contractor any other loss sustained by the Authority in consequence of any breach of this Clause 31.

Dispute Resolution

32.1 Nothing in this Clause shall prevent a Party from seeking an interim injunction in any court of competent jurisdiction.

32.2 If any dispute, difference or question arises between the Parties with respect to any matter arising out of or relating to this Contract, the Parties shall first seek to resolve the dispute, difference or question shall be resolved in confidence by negotiation.

32.3 If the matter cannot be resolved through negotiation within one (1) month of the negotiations beginning, 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.

32.4 If the matter has not been resolved by an agreed ADR procedure within one (1) month of the initiation of such procedure, the dispute shall be referred to a single arbitrator to be agreed upon by the Parties or in default of agreement within fourteen (14) calendar days to be nominated by the President for the time being of the Chartered Institute of Arbitrators in accordance with the Arbitration Act 1996. The arbitration shall take place in London and shall be in accordance with the Arbitration Act 1996 and such arbitration rules as the Parties may agree or, in default of agreement, in accordance with the Rules of the London Court of International Arbitration which Rules are deemed to be incorporated by reference into this Clause.

32.5 The decision of the arbitrator shall be final and binding on the Parties.

Notices

33.1 All notices to be given hereunder shall be in writing (which for these purposes does not include email) and may be served either personally at or by registered post to the address of the relevant Party as set out in Section 5, or as it may from time-to-time be notified in writing to the other Party and in the case of postal service shall be deemed to have been given three (3) calendar days after the day on which the notice was posted.

Relationships

34.1 This Contract does not make any Party the employee, agent, partner or legal representative of the other Party for any purpose whatsoever. No Party is granted any right or authority to assume or create any obligation or responsibility, expressed or implied, on behalf of or in the name of the other Party. In fulfilling obligations pursuant to this Contract the Contractor shall be acting as an independent contractor.

Freedom of information act 2000

35.1 The Parties are each subject to the requirements of the FOIA and the Environmental Information Regulations and shall assist and cooperate with each other at their own expense to enable the Parties to comply with these requirements. The Contractor shall (and shall procure that the Partner(s) and the Collaborators shall) comply with the provisions of this Clause 35 so that the Parties can comply with their obligations under the FOIA.

35.2 Where a Party receives a request for information under FOIA or the Environmental Information Regulations (“Requests for Information”) in relation to information which it is holding on behalf of the other Party, it shall (and shall procure that its Sub-contractors shall):

35.2.1 transfer the Request for Information to the other Party as soon as practicable after receipt and in any event within two (2) Business Days of receiving a Request for Information;

35.2.2 provide the other Party with a copy of all Information in its possession or power in the form that the other Party requires within five Business Days (or such other period as the Party may specify) of the Party’s requesting that information; and

35.2.3 provide all necessary assistance as reasonably requested by the Party to enable the Party to respond to a Request for Information within the time for compliance set out in section 10 of the FOIA or regulation 5 of the Environmental Information Regulations.

35.3 Where a Party receives a Request for Information which relates to the Contract, it shall inform the other Party of the Request for Information as soon as practicable after receipt and in any event within two (2) Business Days of receiving a Request for Information.

35.4 If a Party determines that Information (including Confidential Information) must be disclosed pursuant to this Clause 35, it shall, if it is legally able to do so notify the other Party of that decision at least two (2) Business Days before disclosure.

35.5 The Party receiving the request shall be responsible for determining at its absolute discretion whether the Commercially Sensitive Information and/or any other Information:

35.5.1 is exempt from disclosure under the Code of Practice on Government Information, FOIA or the Environmental Information Regulations; and

35.5.2 is to be disclosed in response to a Request for Information.

35.6 Each Party acknowledges that the other Party may, acting in accordance with the Secretary of State’s section 45 Code of Practice on the Discharge of the Functions of Public Authorities under Part 1 of the FOIA, be obliged under the FOIA or the Environmental Information Regulations to disclose Information:

35.6.1 without consulting with the other Party, or

35.6.2 following consultation with the other Party and having taken its views into account.
Provided always that where Clause 35.5.1 applies the Authority shall, in accordance with any recommendations of the Code, take responsible steps where appropriate, to give the Contractor advance notice, or failing that to draw to the Contractor’s attention after any such disclosure.

Transparency

36.1 The Parties acknowledge that, except for any information which is exempt from disclosure in accordance with the provisions of the FOIA and or the Environmental Information Regulations, the content of this Contract is not Confidential Information. The Authority shall be responsible for determining in its absolute discretion whether any of the content of this Contract is exempt from disclosure in accordance with the provisions of the FOIA and or the Environmental Information Regulations.

36.2 The Authority may consult with the Contractor to inform its decision regarding any redactions but the Authority shall have the final decision in its absolute discretion.

36.3 The Authority may, at its sole discretion, redact information from the Contract prior to publishing on any one or more of the following grounds:

36.3.1 national security;

36.3.2 personal data;

36.3.3 information protected by intellectual property law;

36.3.4 third party confidential information;

36.3.5 IT security; or

36.3.6 prevention of Fraud.

36.4 The Contractor shall assist and cooperate with the Authority to enable the Authority to publish this Contract.
36.5 Notwithstanding any other term of the Contract, the Contractor hereby gives consent for the Authority to publish the Contract in its entirety, including from time to time any agreed changes to the Contract, to the general public.

Unlawful Discrimination

37.1 The Contractor shall ensure that it complies with all current employment legislation and in particular, does not unlawfully discriminate within the meaning of the Equality Act 2010 or any other relevant legislation relating to discrimination in the employment of employees, for the avoidance of doubt this includes having due regard, where so required, for any additional equality duties imposed on public authorities (collectively, the “Employment Legislation”).
37.2 The Contractor shall notify the Authority immediately of any investigation of or proceedings against the Contractor 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.
37.3 The Contractor shall indemnify the Authority 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 Contractor, its agents, employees or Sub-contractors.
37.4 The Contractor shall, and shall use reasonable endeavours to ensure that its employees or agents and/or Sub-contractors shall, at all times, act in a way which is compatible with the Convention rights with the meaning of Section 1 of the Human Rights Act 1998.

Safeguarding Provisions

38.1 The Contractor shall and shall procure that each Partner shall take all reasonable steps to comply with the “NIHR Policy on Preventing Harm in Research” and “NIHR Safeguarding Guidance” as published from time to time but not limited to:

38.1.1 taking all reasonable steps to prevent actual, attempted or threatened Serious Misconduct by its employees or any other persons engaged and controlled by it to perform any activities under this Contract; and

38.1.2 adopting robust safeguarding and whistleblowing policies and procedures to promote and support the reporting and investigation of suspected bullying, harassment, misconduct, illegal acts, Serious Misconduct, or failures to investigate any such matter; and

38.1.3 providing regular training as appropriate to Key Staff and any other persons engaged and controlled by it to perform any activities under this Contract; and

38.1.4 taking any other Good Industry Practice measures (including any innovative solutions).

38.2 The Contractor shall:

38.2.1 maintain detailed records of any allegation of Serious Misconduct relating to the performance of any activities under this Contract; and

38.2.2 report any complaints or concerns promptly regarding possible Serious Misconduct relating to the performance of any activities under this Contract to the relevant authorities (including law enforcement or other agencies) and the Authority’s Representative; and

38.2.3 take all reasonable steps to ensure that individuals are enabled to report concerns and complaints of any Serious Misconduct through supportive, confidential and accountable mechanisms.

38.3 The Contractor shall take all reasonable steps to investigate allegations or suspicions of Serious Misconduct and take appropriate corrective action, including disciplinary action, against individuals, and will keep the Authority and relevant authorities informed of the progress of the investigations as appropriate, such investigations and actions to be reported to the Authority as soon as is reasonably practicable.

38.4 The Contractor shall, and shall use reasonable efforts to ensure that each Sub-contractor or any other person involved in the performance of any activities under this Contract shall comply with all Applicable Laws relating to safeguarding and the protection of children and vulnerable adults including but not limited to the vetting of personnel working closely with children andvulnerable adults in accordance with the UK Safeguarding Vulnerable Groups Act 2006 (as amended).

38.5 In the event that the Contractor fails to comply with any of this Clause 38, the Authority reserves the right to:

38.5.1 deem this to be a material breach and terminate this Contract in accordance with Clause 21.3 herein; and/or;

38.5.2 suspend or reduce its payment of amounts due under the payment schedule in Section 4 of this Contract; and/or require repayment of all or part of the funding provided under this Contract; and/or

38.5.3 take a breach of this Clause 38 by the Contractor into account when considering future applications for funding from the Contractor.

Further assistance

39.1 The Contractor will, at the request of the Authority, do (or procure others to do) everything necessary to give the Authority the full benefit of this Contract. 

Contracts ( Rights of Third Parties ) Act 1999 

40.1 No person who is not a Party to this Contract is intended to receive a benefit under or have the right to enforce any terms of this Contract whether pursuant to the Contracts (Rights of Third Parties) Act 1999 or otherwise.

Law

41.1 This Contract 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 subject to Clause 32 the Parties irrevocably submit to the exclusive jurisdiction of the courts of England.

Schedule A: Approved - Partners and Sub-Contractors

Schedule B: Variation to contract form

Project Title: «Grant Title»
Project Application No: «Grant Reference»

Contract between the Secretary of State for Health and Social Care (“the Authority”) and «Host Institution» (“the Contractor”) dated (“the Contract”)

Variation No: ...
Date: ...

1. The Contract is varied as follows:
2. Words and expressions in this Variation shall have the meanings given to them in the Contract.
3. The Contract, including any previous Variations, shall remain effective and unaltered except as amended by this Variation.

Signed:

For the Authority: 
By: ...
Full name: ...
Position: ...
Date: ...

For the Contractor:
By: ...
Full name: ...
Position: ...
Date: ...

Section 3 - Research

[Insert summary of the Research to be undertaken]

Funding provided by the Authority under the NIHR MHRG is to be used to undertake the following:

Section 4 - Financial Arrangements

The Authority may fund reasonable and allowed costs in accordance with the rules of the scheme. Disallowed costs may be recovered.

An appropriate inflation uplift may be added by the Authority to these payments.

Upon conclusion of the Research, the Contractor shall submit a Final Statement of Expenditure to the Authority, accounting for all costs properly incurred under the Contract. Only upon receipt of this document, and with agreement from the Authority’s Representative, will the final payment of any outstanding funds be made.

Payment details to be added

Section 5 - Key Staff

Chief Investigator name and address

«Lead Applicant»

«Lead Applicant Institution»

«Lead Applicant Address New Line»

The Contractor's representative name and address

[ Contractor contact name and address details to be inserted ]

The Authority's Representative, Contracting Issues name and address

Dr Kay Pattison

Section Head, Research Programmes & Contracts

Science, Research and Evidence Directorate

Department of Health and Social Care

Quarry House

Quarry Hill

Leeds LS2 7UE

The Authority's Representative, name and address

Mr Rajinder Flora

Assistant Director, Mental Health Research Groups

NIHR Coordinating Centre

Grange House

15 Church Street

Twickenham TW1 3NL

Section 6 - Reporting Schedule

The interim report schedule is set out in the following table:

Report	Due date
First report	Within 12 months of the Commencement Date
Subsequent interim reports	Every 12 months after the first interim report
Review under Clause 2.3	Within [24-30] months of the Commencement Date [at the request of the Authority]
Final report	Within 30 days of completion date

Section 7 - Policies

• NIHR policy on preventing harm in research
• NIHR Safeguarding Guidance
• NIHR Policy on Bullying and Harassment
• NIHR Privacy Policy
• NIHR Research Outputs and Publications Guidance
• UK Policy Framework for Health and Social Care Research
• NIHR Journals Library Dual Publication Guidance
• NIHR Journals Library Embargo Policy
• NHS England Standard NHS Accounting Policy and Guidance
• NIHR Open Access Publication Policy
• NIHR Open Access Publication Policy Guidance
• NIHR Open Access Publications Funding Guidance