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MRC UNIT FOR LIFELONG HEALTH AND AGEING AT UCL DATA SHARING AGREEMENT

This Agreement is made on [INSERT DATE]

BETWEEN:

1. The UNIVERSITY COLLEGE LONDON, whose principal place of business is Gower Street, London WC1E 6BT (“UCL”);

AND

2. [INSERT] whose principal place of business is at [INSERT] (“Institution”).

UCL and the Institution are individually referred to as a Party and collectively known as the Parties to this Agreement.

BACKGROUND
  1. UCL is the custodian of Data (as defined below) generated in the National Survey of Health and Development (NSHD). UCL’s Unit for Lifelong Heath and Aging (LHA) undertakes the role of custodian of the Data at UCL.

  2. The Institution wishes to enter into an agreement with UCL to access Data for its research purposes over a period of time.

  3. This Agreement sets the terms and conditions under which Data, for Approved Projects (as defined below), will be released to the Institution.

IT IS AGREED:

1. DEFINITIONS AND INTERPRETATIONS

In this Agreement the following words and expressions have the following meanings:

Agreement this agreement, together with all attachments and Schedules as amended from time to time in accordance with its terms.

Approved Project A research project that has been submitted to the LHA Data Sharing Committee and approved in accordance with the procedures set out on the LHA website. An approved project is described through documentation as set out in Schedules 1, 2, 3 and 4.

Background Intellectual Property Rights owned; controlled by or licensed to either of the Parties and provided by one Party to the other for use in the Research (whether before or after the Commencement Date) otherwise than as a result of, or pursuant to, the carrying out of the Research.

Confidential Information any rmation or materials (whether in writing, electronic form, oral or otherwise) including any Results which are disclosed by one party (the “Discloser”) to the other Party (the “Recipient”) pursuant to this Agreement, where any such rmation or materials:

(a) shall at the time of disclosure, have been marked as confidential;

(b) shall, where disclosed orally, have been advised to the Recipient as being confidential and which advice shall have been followed up with confirmation thereof in writing within thirty (30) calendar days of such disclosure; or

© ought to be regarded by the Recipient exercising reasonable skill and care as being of a confidential nature.

Data information collected in the course of the NSHD (including information from biological samples) and/or used in the , which can be processed manually, electronically or by other means.

Database the database storing the DATA.

Derived Data any cleaned or checked derivation of the Data stored in the Database or that which is created by researchers in the course of carrying out the Research.

Discloser shall have the meaning given to that expression within the definition of “Confidential Information”.

Document any report, executive summary, paper, abstract or other document provided by the Institution to UCL pursuant to the terms and conditions of this Agreement.

Event of Force Majeure any event which is outside the reasonable control of a Party including: riot, civil unrest, military action or terrorism, damage to or destruction of premises or equipment, earthquake, storm, flood or other natural disaster, deliberate sabotage of, or malicious damage to, equipment or data, industrial action, strikes or lock-outs by employees of third parties (excluding suppliers or sub-contractors except where no substitute is reasonably available), inability to obtain supplies of power, fuel, or transport, and exercise of emergency powers by any United Kingdom governmental authority whether national, regional or local.

Implementing Letter as provided in Schedule 5, completion and execution of which is required by both Parties for each of the Approved Projects to specify the details of particular terms as such terms relate to each Approved Project.

Intellectual Property Rights (IPR) all patents, rights to inventions, copyright and related rights, moral rights, database rights, rights in designs, trade marks, domain names, rights in undisclosed or confidential rmation (such as Know-how, trade secrets and inventions whether patentable or not) and rights to the ownership or control of materials and other similar or equivalent rights or forms of protection (whether registered or unregistered) and all applications (or rights to apply) for, and for renewals and extensions of, such rights as may now or in the future exist anywhere in the world.

Key Staff the persons on each named for Approved Project in Schedule 1 part 1.

Know-how unpatented technical information (including, without limitation, information relating to inventions, discoveries, concepts, methodologies, models, research, development and testing procedures, the results of experiments, tests and trials, manufacturing processes, techniques and specifications, quality control data, analyses, reports and submissions) that is not in the public domain.

LHA Data Sharing Committee the body within LHA that considers applications for use the Data in the Research.

NSHD Study Team staff working on the NSHD Data at the LHA.

Outputs are the products of the research which may, or may not be published either electronically or in hard copy. The outputs will include, but not be limited to manuscripts, (including books, book chapters, articles, conference papers, thesis, pamphlets, abstracts, code books and manuals), posters, presentations, teaching materials and web pages.

Project Proposal description of the work as set out in the project proposal form as indicated in the template of Schedule 1

Recipient shall have the meaning given to that expression within the definition of “Confidential Information”

the research work that will be undertaken as per the Approved Project under the terms of this Agreement

Results All information (excluding derived data) such as materials or other information, inventions, software or materials that are created by, or on behalf of, the Institution, and where appropriate UCL, in the course of carrying out the Research

1.2 Interpretations

In this Agreement (except where the context otherwise requires):

    1. use of the singular includes the plural (and vice versa) and use of any gender includes the other genders;
    2. a reference to a party is to a party to this Agreement and shall include that party’s personal representatives, successors or permitted assignees;
    3. a reference to persons includes individuals, corporations, charities and unincorporated bodies or associations, that are recognised at law (whether or not having separate legal personality and irrespective of their jurisdiction of origin, incorporation or residence);
    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” or any 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;
    5. a reference to a Recital or Clause is to the relevant recital or clause of this Agreement; a reference to a Schedule is to the relevant Schedule to this Agreement; and a reference to a paragraph is to the relevant paragraph of the Schedule in which it appears; and
    6. a reference to any statute, enactment, order, regulation, code 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. The Schedules form an integral part of this Agreement and have effect as if set out in full in the body of this Agreement. A reference to this Agreement includes the Schedules.
  2. The headings are included for convenience only and are not to affect the construction or interpretation of this Agreement.

2. **The Research**

  1. The Institution shall perform the in accordance with the terms and conditions of this Agreement and, if required, shall provide any deliverables as set out in this Agreement to UCL.
  2. The Institution shall, in the performance of the , be solely responsible for its own organisational arrangements and procedures, provided that its performance of the shall be consistent with its obligations under this Agreement.
  3. The shall be performed by the Institution in accordance with:
    1. the timescales, set out Schedule 4 of the Approved Project
    2. the reasonable instructions of UCL.
  4. The Institution will ensure that the is carried out by, or under the supervision of, the Key Staff. UCL may terminate any Approved Project, with immediate effect by written notice to the Institution if any of the Key Staff are not available for the entire period needed to fulfil their part in the , subject to prior discussion with the Institution to first attempt to identify a mutually acceptable replacement.
  5. The Institution shall ensure full communication takes place between the Parties and such others as may be notified to the Institution by UCL and shall advise as required on the . In particular, the Institution must notify UCL and the relevant research ethics committee of any proposed deviation by it from the agreed protocol or if significant developments occur as the progresses, whether in relation to the safety of individuals or to scientific direction.
  6. If UCL believes that an Approved Project or the way in which Institution is undertaking or is proposing to undertake a Approved Project is deficient, it shall formally notify the Institution in writing at the earliest possible opportunity, discuss the matter with the Institution and give it clear indications as to how the Approved Project has not been satisfactory. After such discussions, Institution shall remedy any agreed faults within an agreed, reasonable time, not generally to exceed 21 working days unless otherwise agreed. Should Institution not to remedy any such agreed faults within the period agreed with the UCL, the UCL shall be entitled to terminate the Approved Project as set out elsewhere herein.

3. Responsibilities of the Institution

  1. The Institution shall ensure that each member of staff, student or others engaged by the Institution in the undertakes to observe the terms of this Agreement and any further or supplementary agreement entered into between the parties and that such members of staff, students and others are advised of any changes in the scope of the Agreement or the .
  2. The Institution will ensure that the Data are used only by the Key Staff and only for the purpose of the Research, as specified, and are not passed to anyone outside of the Research without the prior written consent of UCL.
  3. The Institution will ensure that the Data are used in compliance with all applicable law including, without limitation, the Data Protection Act 1998, and in compliance with any of UCL's policies or guidelines.
  4. The Institution will ensure that the Key Staff sign a confidentiality and publication agreement (Schedule 2 and Schedule 3), templates of which are attached to this Agreement, and will return it to the UCL contacts listed in Section 14 ‘Notices’. The Institution will ensure that the Key Staff adhere to the aforementioned confidentiality and publication agreement.
  5. The Institution will ensure that the is conducted in accordance with, if relevant, the Department of Health guidance: “ Governance Framework For Health and Social Care” and “Governance Arrangements for NHS Ethics Committees”, and such other relevant guidelines and/or guidance as may be issued, amended or replaced from time to time by UCL and/or the Department of Health.
  6. The Institution shall comply with all other legislation relevant to the including (without limitation and to the extent applicable):
    1. The Medicines for Human Use (Clinical Trials) Regulations (SI 2004/1031); and
    2. The Human Tissue Act 2004.

4. Applications for Data

  1. All requests to use the Data must be submitted, in advance, using the appropriate form as found in Schedule 1. The form should then be returned in accordance with the instructions supplied.
  2. All applications for the use of Data are judged independently by the LHA Data Sharing Committee and nothing in this Agreement should be taken as awarding any priority or preferential treatment to the Institution.
  3. The LHA Data Sharing Committee reserves the right to prioritise applications where necessary. Proposed projects that will incur significant extra work by LHA staff may be subject to a charge to cover the additional costs incurred by the LHA. Any such costs will be notified in advance.

5. Type of Data sharing

  1. When the LHA Data Sharing Committee approves a proposal it will recommend the level of collaboration required with the NSHD Study Team. The collaboration required takes into account the quality, sensitivity or amount of data/meta-data requested, the extent of biomedical data requested, and the scientific investments of the NSHD Study Team and their key specialist collaborators.
  2. A NSHD co-ordinator may be assigned, at UCL’s sole discretion, to a research project by the LHA Data Sharing Committee.
  3. Facilitated collaborations between the external researcher and the NSHD Study Team are encouraged. This means that a NSHD co-ordinator (either from the study team or one of their key expert collaborators) is assigned to help the external scientist make the best use of the Data, advise on interpretation of a specialist database, or supervise the use of sensitive or restricted data. Facilitated collaborations may be required in the following circumstances and may involve additional conditions for use of the data: this list is indicative rather than exhaustive.
    1. Proposals that require access to a specialist database created by a key collaborator or have required significant investments in time by the study team.
    2. Proposals that require access to sensitive data. Sensitive data include, but are not limited to, the cause and date of death of a study member, data on residential or emigration history, and medical and other information with small cell counts (e.g. hospital admissions, or illnesses).
    3. Proposals requiring access to data or meta-data that have not yet been through the vigorous quality assurances protocols that are in place and will require a significant amount of time to check and/or clean.
    4. Proposals requiring access to extensive biomedical data or that significantly overlap with the current scientific programmes of the NSHD Study Team.
  4. This Agreement covers all proposed data sharing ranging from full collaborations to independent projects with little involvement of the NSHD Study Team.

6. **Data Supply**

  1. UCL will supply Data for each Approved Project as specified in Schedule 1 section 9.
  2. UCL will provide the Data to the Institution in the format specified in Schedule 1 section 10.
  3. This Agreement does not restrict the right of UCL to distribute the Data to third parties or to publish any document relating to the Data or to use the Data in any other way.

7. Confidentiality

  1. The Institution will ensure the security of Data and that it is treated as confidential. In particular the Institution will ensure that:
    1. Data remains confidential as governed by common law obligations of confidentiality and/or medical confidentiality, requirements of the Data Protection Act 1998, the Human Tissue Act 2004, any other applicable laws, and UCL published guidelines, each as amended from time to time;
    2. no attempt is made by ers to re-identify, trace or contact the NSHD subjects, or to access data which could identify the NSHD subjects, or to use the Data in any way that could infringe the rights of the NSHD subjects, or otherwise affect them or the NSHD adversely;
  2. Parties to this Agreement which are subject to the Freedom of Information Act 2000 (“FOIA”) or the Freedom of Information (Scotland) Act 2002 (“FOI(S)A”) or any equivalent legislation in another jurisdiction (“Equivalent”) and which receive a request under FOIA or FOI(S)A or an Equivalent to disclose any information that belongs to the other Party will notify and consult that Party in writing as soon as reasonably practicable, and in any event, not later than five working days after receiving the request. The Parties acknowledge and agree that the decision on whether any exemption applies to a request for disclosure of recorded information under FOIA or FOI(S)A or Equivalent is a decision solely for the Party responding to the request. Where the Party responding to an FOIA or FOI(S)A or Equivalent request determines that it will disclose information that belongs to the other Party it will notify the other Party in writing, giving at least five working days’ notice of its intended disclosure.
  3. The Parties acknowledge that remedies at law may be inadequate to protect against a breach of the provisions of this clause 7 and that the UCL may seek injunctive relief to restrain such breach, in addition to any other remedies available to the UCL.

8. Security

  1. The Institution will ensure that all Data are held securely as outlined in the UCL security policies for LHA (available on the LHA website). Including ensuring that:
    1. Data may only be stored and processed in a secure networked environment. Data should not be stored and processed on laptop computers unless they have full disk encryption and are solely connected to a secure networked environment within the institution’s IT infrastructure;
    2. Data are stored only on computer systems where access to NSHD data is limited by password protected individual user accounts and for which only authorised Researchers have access to such accounts;
    3. the medium on which the Data are supplied to the Institution is stored in a secure location;
    4. current anti-virus and anti-malware software is installed on all systems and hardware being used to store or access Data. In addition any portable hardware device being used in conjunction with the Data must be encrypted in accordance with British Government approved standards as advised by UCL;
    5. Researchers do not transfer, or allow to be transferred, Data over the Internet in an unencrypted format; any encryption used must be in accordance with British Government approved standards as advised by UCL;
    6. Researchers do not store, or allow to be stored, Data in a folder which is shared or otherwise made accessible to anyone other than ers; and
    7. the Institution reports to UCL as soon as it becomes aware but not later 24 hours after it becomes aware any breach of this clause 8.1.
  2. The Institution will at UCL’s request, pay UCL for the cost of secure courier services to transfer the Data to the Institution. Payment shall be in advance of the transfer or upon submission of an invoice by UCL, at UCL’s option.

9. Publication of Results and Derived Data

  1. The Institution will acknowledge the contribution of LHA, UCL and principal investigators of the NSHD in any Output arising from the Project.
  2. It is the intention of the Parties that where the Results have been obtained from collaborative working then Results will be published by way of joint academic publication between the Institution and UCL. The Parties will co-operate in the preparation and submission of joint academic publications containing the Results. Authorship of such publication shall be determined in accordance with standard academic practice. Notwithstanding the foregoing, in no event shall the Institution publish or disclose any of the Results without the prior written consent of UCL.
  3. The Institution will provide UCL with advance notice of any proposed Outputs involving the Results of the Approved Project, which UCL shall hold in confidence until such time as they are published or otherwise disseminated. The UCL reserves the right to ask for a copy of any proposed Output involving the Results of the Approved Project five working days before publication or presentation and will remove or adapt as agreed with UCL information that is considered by UCL to be confidential and/or potentially damaging to the NSHD subjects or the continuation of the NSHD. In any event the Institution must provide a copy of the final Outputs involving the Results of this Agreement within twenty-one days of publication of each Output.
  4. UCL supports unrestricted access to the published Outputs of research as a fundamental part of its mission and a public benefit. The UCL expects authors of research papers to maximise the opportunities to make their results available for free and, where possible, to retain their copyright.
  5. The NSHD is fully funded by the Medical Research Council as such any research papers accepted for publication in peer-reviewed journals that make use of NSHD data should adhere to the RCUK Open Access Policy and be made freely available and where appropriate deposited into PubMed Central (PMC) or UK PMC. It is the responsibility of ers to arrange for the open access of their publications.
  6. In the event that, during the Project, Derived Data is generated, the Institution shall provide UCL with a copy of such Derived Data and the Derived Data will be incorporated into the Database and made available to other third parties for use in academic research. UCL acknowledge that Derived Data would not be released to a third party until after initial publication of the Derived Data by the Institution.

10. Publicity

  1. Prior to the publication of any Results of the or any Data or of matters arising from such Results or Data in accordance with Clause 9, neither Party shall without the prior written consent of the other (which shall not unreasonably be withheld) release, or otherwise make available to third parties, rmation relating to the Agreement or the by means of any public statement and in particular any press announcement or displays or oral presentations to meetings.
  2. In the event that the Institution fails to comply with the provisions of Clause 10.1, then UCL shall have the right to terminate the Agreement with immediate effect by the provision of notice in writing to the Institution.
  3. Any publicity relating to the shall acknowledge the contribution of UCL in a form approved by UCL.
  4. Neither Party shall use the name nor trade mark of the other or the names of any of its staff except as expressly provided for in this Agreement without the prior written consent of that Party or individual.

11. Data Ownership and Intellectual Property

  1. The UCL will remain the custodian of the Data and the owner of any intellectual property rights subsisting in the Data and/or Database.
  2. This Agreement does not affect the ownership of any Intellectual Property Rights in any Background . Background will remain the property of the Party that contributes the Background to the (or its licensors). No licence to use any Background is granted or implied by this Agreement except the rights explicitly granted in this Agreement.
  3. Each Party grants to the other party a royalty-free, non-transferable, non-exclusive licence for the period from the Commencement Date to the Completion Date to use any Background that it contributes to the for the sole purpose of use in the and for no other purpose. Neither Party may grant any sub-licence to use the other Party’s Background except that UCL shall have the right to sub-licence the rights granted to it pursuant to this Clause 11.3 to other parties collaborating or requesting Data from UCL to the extent necessary in connection with the carrying out of the work of LHA and to the extent that a party is free to grant such rights to its Background IPR.
  4. The Institution acknowledges that the Data are being provided for non-commercial research only. It confirms that it will not use the Data or the Results: for the provision of a commercial service; or in the development of a commercial product; or on behalf of a commercial entity; or upon terms where a commercial entity obtains any right to the Results or Data. The Institution acknowledges that the UCL may use all lawful and reasonable measures at its disposal to prevent the use of the Data or the Results for any commercial or other unauthorised purpose.
  5. Results shall be owned by the Parties as follows:
    1. All Results that are generated, exclusively as a consequence of use of Data from the NSHD or the Database only, shall be owned by UCL.
    2. All Results that are generated using Background IPR belonging to UCL only shall be owned by UCL
    3. Any Results that are generated using the Background IPR of UCL and the Institution shall be owned jointly (“Joint IPR”), in shares to be agreed, taking into account inventive contribution of the Parties.
  6. All Derived Data shall be owned solely by UCL.
  7. UCL is hereby granted:
    1. an irrevocable, royalty-free, worldwide, nonexclusive, sub-licensable right to use the Joint IPR for non-commercial academic research purposes; and
    2. to provide the Results in the Joint IPR or the Outcomes to any third party for further research.
  8. The provisions of this Clause will survive the expiry or earlier termination of the Agreement.

12. Indemnity and Liability

  1. Institution (“Indemnifying Party”) shall indemnify UCL (“Indemnified Party”) and its Council members, advisory body members, officers, directors, employees and agents fully against any liability, loss, claim, damage, cost, expense (including legal fees), or proceedings whatsoever arising under any statute or at common law in respect of:
    1. any damage to property, real or personal, including any infringement of third party Intellectual Property Rights;
    2. any injury to persons, including injury resulting in death; in each case arising out of or in the course of or in connection with the Indemnifying Party’s performance of its obligations under this Agreement, including but not limited to conduct of the Research and the use or misuse of Data, except to the extent that such damage or injury shall be due to any act or omission of the Indemnified Party.
  2. The Indemnifying Party shall at its own expense conduct any litigation arising from any such claims, demands, actions or proceedings and all the negotiations for the settlement of the same and the Indemnified Party hereby agrees to grant the Indemnifying Party exclusive control of any such litigation or the negotiations for the settlement of the same, subject to the Indemnifying Party indemnifying the Indemnified Party in accordance with Clause 12.1 and provided that such settlement shall not make any concession on the part of the Indemnified Party aside from those to be funded by the Indemnifying Party pursuant to the indemnity.
  3. Each Party shall promptly notify the other Party if any claim or demand is made or action brought against the Institution for infringement or alleged infringement of Intellectual Property Rights which might affect the Research.
  4. Without prejudice to the provisions of Clause 12.1 the Indemnifying Party shall throughout the period of this Agreement ensure that it has appropriate arrangements in place to meet its obligations and liabilities under this Agreement either through insurance or directly from public funds.
  5. The Data are research products. UCL gives no undertaking, warranty or representation that the Data, are of satisfactory quality, fit for any particular purpose, correspond to any description or sample or that the Data will not infringe the intellectual property rights of any third party insofar as the foregoing may legally be excluded.
  6. The Results generated from the are research products. Neither Party gives an undertaking, warranty or representation that the Results are of a satisfactory quality (subject to Clause 3.6), fit for any particular purpose, correspond to any description or sample and that they will not infringe the IPR of any third party in so far as the foregoing may legally be excluded.
  7. In no event will UCL be liable for any use of Data by the Institution.
  8. In no event will one Party be liable for the use of their Results and IPR by the other Party.
  9. Each Party undertakes to make no claim in connection with this Agreement against any employees, students, agents or appointees of the other Party (apart from claims based on fraud or wilful misconduct). This undertaking is intended to give protection to individual researchers and officers, and does not prejudice any right which one Party might have to claim against the other Party.
  10. The liability of any Party for any breach of this Agreement, or arising in any other way out of the subject-matter of this Agreement, will not extend to loss of business or profit, or to any indirect or consequential damages or losses.
  11. Notwithstanding the provisions of this clause 12 nothing in this Agreement limits or excludes either party's liability for:
    1. death or personal injury;
    2. any fraud or for any sort of liability that, by law, cannot be limited or excluded; or
    3. any loss or damage caused by a deliberate breach of this Agreement or a breach of clause 12.
  12. Subject to clause 12.11, the maximum aggregate liability of the Indemnifying Party arising out of or in the course of or in connection with the Indemnifying Party’s performance of its obligations under this Agreement will not exceed in total £500,000.

13. Term and Termination

  1. This Agreement will be deemed to commence on [INSERT DATE] and will be subject to regular review.
  2. Either Party may terminate this Agreement with immediate effect at any time by four weeks’ notice in writing to the other Party if the other Party is in material breach of the terms and, if remediable, the breach is not remedied within thirty working days of the other Party receiving written notice to remedy if so.
  3. On termination of this Agreement all work on the Approved Project(s) listed in Appendix 1 at the time of termination will cease. and the Data supplied by the UCL and any copies made subsequently by the Institution must be destroyed. Termination of an Approved Project will not affect the currency or validity of this Agreement.
  4. On conclusion of the Approved Project(s) or their termination under Clause 13.2, the Institution will not be permitted to make any further use of the Data used in the applicable Approved Project and should destroy any copy of the Data supplied by the UCL and any copies made subsequently by the Institution.
  5. For the avoidance of doubt, no copies of the Data may be retained by the Institution other than Data embedded in Results and any Data captured in the course of the Institutions routine computer system back-up procedures which may only be used for the purpose of using the Results and for back-up purposes respectively. Upon notification by the UCL to the Institution, at any time, that one or more NSHD subjects have withdrawn their consent for the continued use of their Data, the Institution will destroy those parts of the Data identified by the UCL.
  6. Upon termination of this Agreement the following clauses will continue in force: clauses 7, 9, 10, 11, 12, 13.5, 13.6 and 14 to 19 inclusive. For the avoidance of doubt, termination of individual Approved Projects does not remove them from the effect of these clauses.

14. Notices

  1. Contact for notices:
For UCL For the Institution
Stephanie Pilling

Manager

LHA

WC1B 5JU

0207 670 5706

stephanie.pilling@ucl.ac.uk

14.2 All notices will be in the English language.

15. Disputes, Governing Law and Jurisdiction

  1. This Agreement will be subject to and construed and interpreted in accordance with English law and will be subject to the exclusive jurisdiction of the Courts of England. This clause 15.1 shall not prevent a party from seeking interim relief in any court of competent jurisdiction.
  2. If any dispute arises in connection with this Agreement, directors or other senior representatives of the Parties with authority to settle the dispute will, within thirty working days of a written request from one Party to the other, meet (or speak by telephone) in a good faith effort to resolve the dispute.
  3. If the dispute is not resolved at that meeting, the Parties will attempt to settle it by mediation in in accordance with the Centre for Effective Dispute Resolution (CEDR) Model Mediation Procedure. Unless otherwise agreed between the Parties, the mediator will be nominated by CEDR. To initiate the mediation a Party must give notice in writing (ADR notice) to the other Party to the dispute requesting mediation. A copy of the ADR notice should be sent to CEDR Solve. The mediation will start not later than sixty days after the date of the ADR notice. No Party may commence any court proceedings in relation to any dispute arising out of this Agreement until it has attempted to settle the dispute by mediation and either the mediation has terminated or the other Party has failed to participate in the mediation, provided that the right to issue proceedings is not prejudiced by a delay and provided that this will not prevent a Party from seeking interim relief from court.
16. General
  1. No Party shall assign this Agreement without the prior written consent of the other Party, which shall not unreasonably be withheld.
  2. All Parties shall agree any amendments to this Agreement in writing.
  3. Except as otherwise expressly provided for herein, nothing in this Agreement shall confer or purport to confer on any third party any benefit or any right to enforce any term of this Agreement
  4. Termination of this Agreement shall not affect the survival of any clauses or provisions herein which are stated, or which by their nature are intended, to continue after termination or expiry.

17. Further Assurance

  1. Each party will, at the request of the other party and its own cost, do (or procure others to do) everything necessary to give the other party the full benefit of the Agreement

18. Costs and Expenses

  1. Each party shall bear its own costs and expenses (including legal fees) in relation to the preparation and execution of this Agreement.

Precedence of Agreements

  1. If the parties are both party to a collaboration agreement in relation to the Project, then should there be any inconsistency between the terms of that collaboration agreement and the terms of this Agreement, then the terms of the collaboration agreement will prevail to the extent of such inconsistency.


Signed for and on behalf of the University College London

Signature
Name
Date

Signed for and on behalf of the Institution

Signature
Name
Date

TEMPLATE: SCHEDULE 1

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UCL National Survey of Health and Development

Request to access data and/or biological samples
1. Name of all applicants, affiliations and contact details (include telephone numbers and email addresses and extend form as necessary where there are more applicants)

Principal Applicant:

Co-applicant (1)

Co-applicant (2)

Employing Institution of each applicant

NSHD Co-ordinator /co-applicant: If known please state name, else record as ‘to be agreed’
2. Title of project (less than 30 words):

Start Date: End Date:
3. Funding: Has/will the project be(en) peer reviewed and funded?\\
(If yes, please state organisation which has reviewed (or will review) project and their decision. Please enclose grant proposal, response, and referees’ comments as an appendix)
4. Brief description of project including proposed outputs\\
(no more than 1-2 sides A4 with up to 10 key references.
5. Rationale for undertaking this project with the UCL NSHD data set
6. Are other datasets included on this project? (If yes, please specify the other studies involved)
7a. Does your project involve genotyping?\\
(If yes, please a) list of SNPs to be genotyped, b) pre-existing data on genotype frequency and c) reference any of the applicant’s previous experience in this area)
7b. Does your project involve DNA?\\
(This is only provided in certain circumstances, please see guidelines. State amount, rationale for request for DNA, and describe the processes to be carried out, then continue to questions 7c, 7d and 7e)
7c. DNA samples: Are there any special requirements for the DNA extraction or potential problems with using pre-amplified rather than genomic DNA? Please specify
7d. Does your project involve RNA or other cellular material?\\
(If yes, please state amount and rationale for request, and describe the processes to be carried out. Also answer questions 7e)
7e. Feasibility and quality control: Does(Do) the applicant(s) have sufficient experience and expertise to carry out the DNA or RNA investigations described? (please cite relevant publications)

===== =====
8. Have you undertaken a sample size calculation? (If yes, please provide details of sample size calculations on your proposed study. If no, please justify why these have not been undertaken. Applications that have not considered sample size requirements adequately may be rejected.)
9. Analyses: What variables from the NSHD database will be required for statistical analysis?\\
(If you need clarification on our existing variables, please email mrclha.swiftinfo@ucl.ac.uk to arrange a time to visit to look at study materials and discuss your request with the study team; exact variable names are not needed)
10. Please indicate which format you require the data to be supplied in?\\
(SPSS or STATA)
11. Do you require statistical input from NSHD statisticians to undertake the analyses?
12. Electronic data: Will the project require deriving or producing new variables from existing data? (Please specify)
Signature ________________________ Date ___________

Name ___________________________

SCHEDULE 2 Publication agreement – to be returned to the UCL

Each er to sign and complete contact details below:

I have read and understood and agree to adhere to the provisions at clause 9 (publication) and clause 10 (publicity) of the Data Sharing Agreement relating to the use of data from the UCL National Survey of Health and Development Study in the [SPECIFY TITLE OF PROJECT] at the [SPECIFY NAME OF INSTITUTION].

___________________________________________

Signature date

Contact details:

First name: ____________________________________________

Surname: _____________________________________________

Address: _______________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

_______________________________________________________

Post Code: ______________________________________________

City: __________________________________________________

Tel: ___________________________________________________

Email: __________________________________­­­­­­­­­­­­­­­­­­­­­­­­­­_______________

TEMPLATE: SCHEDULE 3 Publication Notification

UCL ULHA - New Article Submission Form

This form should be filled out for all peer-reviewed articles prior to submission in as much detail as possible.

You will also need to provide the front sheet of manuscript containing the authors, addresses and abstract.

If there is more than one Unit member listed as an author on a manuscript, then responsibility for filling out this form falls to the first LHA listed author unless otherwise arranged.

If a manuscript is rejected from a journal, then a new form is to be filled out for any subsequent submission to another journal.

Name of submitting author

Other authors

LHA authors

Title of Manuscript

Approx date of intended submission (DD/MM/YY)

Title of Journal

Have you agreed the costs of Open Access with your Institution?

(Double click on boxes to tick them)

Yes No N/A

Please tick to confirm that you have sent a copy at the Manuscript Front Page

TEMPLATE: SCHEDULE 4 Timetable

Project Title

Project Start Date

Project End Date

Major milestones

E.G. You should include here any key work necessary for the timely completion pf the project, the name of the researchers responsible and the date by which the work will be completed. It is especially important to note if subsequent work will depend on earlier milestones being achieved.

Milestone 1 – Create new longitudinal variable – Key Staff 1 – 1/1/2020

Dissemination Plans

E.G. you should include here any proposed conferences that it is intended the research be presented at or article deadlines etc.

In addition the LHA reserves the right to ask for regular updates on the .

TEMPLATE: SCHEDULE 5 Implementing Letter

Implementing Letter for UCL NSHD Data Sharing Agreement between the University College London (“UCL”) and [insert name of Institution] (“Institution”) dated [insert date of master agreement] (“Agreement”)

The purpose of this Implementing Letter is to specify further terms relating to the following Approved Project:

Title:

Principal Applicant:

Start Date:

End Date:

The capitalised words in this Implementing Letter shall have the meanings given in the Agreement unless such words are otherwise defined herein.

The Parties agree as follows in relation to the above-referenced Approved Project:

  1. The Data shall be released by UCL to the Institution according to the terms provided on the NSHD website (http://www.nshd.mrc.ac.uk/data/data_sharing.aspx) and pursuant to the terms of the Agreement.
  2. The Lead Collaborating Party shall be UCL. UCL agrees to undertake all obligations assigned to the Lead Collaborating Party pursuant to the Agreement.
  3. This Implementing Letter may be amended upon written agreement between the Parties.

Signed for and on behalf of the University College London

Signature
Name
Date

Signed for and on behalf of the Institution

Signature
Name
Date