Retrotransposable Element Reactivation in Clonal Hematopoiesis

CLONAL HEMATOPOIESIS GROUP AT KING'S COLLEGE LONDON ACCESS AGREEMENT FOR RESEARCH DATA This Agreement is made on the date of last signature here to between: 1. KING’S COLLEGE LONDON of Strand, London, WC2R 2LS (the “University”) and 2. [INSERT RECIPIENT INSTITUTION LEGAL NAME] a [XXXX] incorporated and existing under the laws of [XXXX] having its registered office at [XXXX] The University and the Recipient are each a “Party” and collectively the “Parties”. Background (A) The University has, in collaboration with Bristol Myers Squibb (“BMS”), collected and acts as custodian for certain datasets and collections of interpretable data (“Information”) derived from information provided by or obtained from research participants (“Participants”) within the study entitled “Retrotransposable Element Reactivation in Clonal Hematopoiesis” (the “Project”) through its Comprehensive Cancer Centre. (B) The University with BMS, is the controller of the data from the Project. (C) The Investigator(s) are employees of or under an honorary research contract with the Recipient and wish to use the Licensed Datasets comprised in the Information. The Licensed Datasets are to be used by the Investigator for the purposes of the Authorised Research only. The University is willing to provide the Recipient (and through the Recipient, the Investigator) with access to the Licensed Datasets for the Access Period on the terms and subject to the conditions of this Agreement. “Access Period” means [Insert the period for which access to the Licensed Datasets is to be granted] [One] year from receipt of signed agreement. “Anonymised Data” means any data that relates to an individual that has been stripped of personal identifiers to the extent that an individual cannot be identified from such data by the Recipient or any third party. “Authorised Research” means [Title of the study for which access to the Licensed Datasets is to be granted] “Contributor” Means a contributor of Licensed Data, including without limitation BMS; “Data Security Policies” means [Insert link(s) to the Recipient’s data protection/data security/information security policies] “Delete(d)(ion)” means, with respect to electronically held data, data that have been put ‘beyond use’, i.e. the data have either (a) been deleted with no intention to use or access these data again, but which may still exist in the electronic ether, (e.g. awaiting over-writing with other data), or (b) data that should have been deleted but are held on a live system because, for technical reasons, it is not possible to delete these data without also deleting other data held in the same batch. Such electronically held data shall be deemed to be ‘beyond use’ if the Recipient (i) is not able, or will not attempt, to use the data for any purpose, and (ii) does not give any other organisation access to the data, and (iii) surrounds the data with appropriate technical and organisational security; and (iv) commits to permanent deletion of the information if, or when, this becomes possible. “Effective Date” means [Date from which access is to be granted (to be added by KCL upon signature)] “Investigator(s)” means [Names of the investigator(s) who will have access to the Licensed Datasets] “Licensed Datasets” Means anonymised targeted DNA sequencing and RNA-Seq data collected from research participants by the University. “Project” Retrotransposable Element Reactivation in Clonal Hematopoiesis “UK GDPR” means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27th April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) as it forms part of the law of England and Wales, Scotland and Northern Ireland by virtue of section 3 of the European Union (Withdrawal) Act 2018 and as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019. Agreed terms The Parties agree as follows: 1. Grant of licence: Subject to the terms of this Agreement, the University grants the Recipient (and through the Recipient, the Investigator) a non-exclusive, non-transferable, revocable, royalty-free licence from the Effective Date and during the Access Period to access, hold, store, view, combine or aggregate (wholly or in part), adapt and make copies of the Licensed Datasets solely for the purposes of the Authorised Research. For the avoidance of doubt, nothing in this Agreement shall prevent or restrict the University from granting access to the Licensed Datasets to any third party on such terms as it may agree. Unless this Agreement is varied in writing by the Parties to extend the Access Period, the Recipient shall Delete all copies of the Licenced Datasets held by it, included copies combined or aggregated, and confirm that such Deletion has taken place in writing to the University. 2. Reservation of rights: The Recipient acknowledges that all intellectual property rights throughout the world, whether existing now or in the future and whether registered or unregistered, subsisting in the Licensed Datasets (including copyright and related rights, database rights and sui generis database rights) shall remain the property of the University and that it shall not have any rights in or to the Licensed Datasets other than in accordance with this Agreement. 3. Licence restrictions: The Recipient shall: i) only use the Licensed Datasets for the purposes of carrying out the Authorised Research; ii) only make copies of the Licensed Datasets to the extent reasonably necessary to undertake the Authorised Research and for back-up and disaster recovery purposes; iii) not permit any third party other than the Investigator and bona fide members of the Investigator’s research team, to have access to the Licensed Datasets; iv) not attempt to link the Licensed Datasets (wholly or partly) with any other data held by different recipients or by the Recipient for other projects unless agreed by the University in advance or at any time during Access Period; v) not disseminate, distribute, extract, exploit or otherwise use the Licensed Datasets (wholly or in part) for any commercial purposes or for any purpose that is subject to consulting or licensing obligations to third parties; vi) not remove any reference to the University or any Contributor or the Project which may be incorporated into or accompany the Licensed Data when provided to the Recipient or which may be incorporated into the Licensed Data pursuant to clause xxx vii) attempt to identify any identifiable living or deceased individual from the Licensed Data. viii) in making any use of the Licensed Data pursuant to the Authorised Research or as otherwise agreed by the University, display a notice in a form approved by the University acknowledging the University and, as required by the University, the Project and the Contributors as the source of the Licensed Data; and ix) only use the Licensed Data in the format in which they are provided or made available by the University, subject to the provisions of this clause 3 and clause 16. x) be responsible for ensuring that it has (and for configuring) the telecommunications and other equipment and software (including security and virus-checking software), with appropriate licences, necessary in order safely and securely to receive, access and use the Licensed Data for the Authorised Research. 4. Anonymised Data: In the event that the Parties share any Anonymised Data relating to individuals: i) The University undertakes not to provide any key that relates Anonymised Data to the identities of Participants or other individuals whose data are included in the Anonymised Data; ii) The Recipient shall not attempt to trace or re-identify any individual from the Anonymised Data provided; iii) The Recipient undertakes not to use or attempt to use the Anonymised Data in any way that may compromise or otherwise infringe the confidentiality of Participants. Without prejudice to the generality of the foregoing, the Recipient agrees to use at least the measures set out in Schedule 1 of this Agreement to protect the Anonymised Data received under it. 5. Deletion: The Recipient undertakes that, upon written request from the University, it will immediately cease using and Delete any individual-level data (i.e. excluding aggregated data relating to multiple Participants that have been consolidated and cannot be reverse-engineered to reconstitute individual-level data and therefore cannot be traced back to a specific individual) contained in the Licenced Dataset relating to any individual who has either withdrawn their consent to participate, and/or objects to the use of their data, and provide prompt written confirmation of such Deletion to the University. 6. Investigator: The Recipient warrants that the Investigator is an employee of or under an honorary research contract with the Recipient. In the event that the Investigator ceases to be an employee of or under an honorary research contract with the Recipient during the Access Period, the Recipient shall promptly notify the University in writing. The Recipient shall be responsible for ensuring that the Investigator is aware of the Recipient’s obligations under this Agreement and shall at all times remain liable for the acts or omissions of the Investigator. The Recipient shall at the earliest opportunity and in any event on later than the date of signature of this Agreement provide a copy Schedule 2 (Privacy Notice) to the Investigator(s). 7. Authorised Research: The Recipient warrants that where appropriate ethical approval has been obtained for the Authorised Research (having regard to the nature of the Authorised Research and applicable law) and that, where the Authorised Research has not been approved by a recognised funder, the Authorised Research will be undertaken with the intention of generating new knowledge and understanding using rigorous scientific methods and with the intention of publishing the research findings in the scientific community for wider scientific and eventual public benefit. If the Recipient wishes to test any additional hypotheses which are outside the scope of the Authorised Research, it shall obtain the University’s prior written consent. 8. Custodianship: The Recipient shall ensure that the Licensed Datasets are kept in a secure manner and only transferred in an encrypted form and shall use all reasonable security practices and systems applicable to the use of the Licensed Datasets to prevent, and take prompt and proper remedial action against, unauthorised access, copying, modification, storage, reproduction, display or distribution of the Licensed Datasets. The Recipient agrees to comply with the University’s reasonable directions regarding the security of the Licensed Datasets as requested in writing by the University and accepted in writing by the Recipient in addition to the Recipient’s own Data Security Policies. In the event that the Recipient makes any amendment to the Data Security Policies or changes the location at which the Data Security Policies may be accessed by the University, it shall promptly notify the University of the same. 9. Data protection: (a) The Parties agree not to share any personal data or special category data (“Protected Data”) (as defined under the UK GDPR) unless the Parties first enter into a separate agreement for sharing Protected Data. (b) Should the University inadvertently transfer Protected Data or should the Recipient inadvertently identify any individual from the Licensed Dataset, the Party that becomes aware of such transfer shall inform the other as soon as reasonably practicable. The Recipient shall upon such transfer: i. neither record the identity of that Individual nor share the identification of that individual with any other person, nor attempt to contact that individual; ii. shall either (1) return where practicable or otherwise Delete all such Protected Data and confirm that such Deletion has taken place in writing to the University or (2) protect such Protected Data with appropriate physical and technical security measures, as required for the protection of Protected Data in accordance with the UK GDPR and the UK Data Protection Act 2018; iii. shall give the University all reasonable assistance in determining the circumstances under which re-identification occurred; iv. shall not process (as defined by the UK GDPR) the Protected Data, except in accordance with the University’s instructions; v. shall follow all reasonable instructions of the University that are given in order to protect the privacy of Individuals. (c) The Parties recognise that in certain circumstances, depending on (i) the characteristics of the Licensed Dataset being made available to the Recipient, and any other information which is, or later becomes, available to the Recipient, or (ii) advances in technology, such Licensed Dataset could at some stage legally constitute Protected Data, and in such circumstances: i. The University shall inform the Recipient as soon as reasonably practicable in writing if there may be any Licensed Dataset that constitutes Protected Data; ii. The Recipient shall comply with Clause 9(b)(i) – (v); and iii. The Parties agree to promptly amend this Agreement to make it compliant with the UK GDPR and the UK Data Protection Act 2018. 10. Complaints by data subjects: If the Recipient receives any complaint, notice or communication which relates directly or indirectly to the processing of the Protected Data or to either Party's compliance with the UK GDPR, it shall immediately notify the University’s Data Protection Officer (by email to info-compliance@kcl.ac.uk) and it shall provide such person with full cooperation and assistance in relation to any such complaint, notice or communication. The Recipient also agrees to provide the University’s Data Protection Officer with full co-operation and assistance in relation to any complaint, notice or communication which the University receives in relation to the Recipient’s processing of the Protected Data or the Recipient’s compliance with the GDPR. 11. Notification: If any Protected Data is lost or destroyed or becomes damaged, corrupted, or unusable or the Recipient becomes aware of any misuse of the Licensed Datasets or any security breach that could compromise the security or integrity of the Licensed Datasets, the Recipient shall promptly notify the University (by email to research.data@kcl.ac.uk) and the University’s Information Compliance team (by email to info-compliance@kcl.ac.uk) and, at the Recipient’s expense, fully cooperate with the University’s requests to remedy the issue as soon as reasonably practicable. 12. Errors: The Recipient shall promptly notify the University if it discovers any errors or inconsistencies in the Licensed Datasets and provide the University with such information as it reasonably requires for the purpose of evaluating the same. 13. Audit: The Recipient shall keep detailed, accurate and up-to-date records (Records) sufficient to enable the University to verify the Recipient’s compliance with the terms of this Agreement. The Recipient shall permit the University and its third-party representatives, on reasonable notice during the Recipient’s normal business hours, to have access to and take copies of such Records for the purpose of auditing the Recipient’s compliance with the terms of this Agreement. Such audit rights shall continue for three years after termination of this Agreement. 14. Confidentiality: The Recipient shall keep the Licensed Datasets confidential and, in particular, undertakes not to use or disclose any Protected Data in such a manner as to compromise or otherwise infringe the rights of any data subject in relation to such Protected Data. 15. Disclaimer: The University expressly does not guarantee, represent or warrant that: i) the Licensed Datasets are accurate, complete, reliable or secure; ii) the Licensed Datasets are of satisfactory quality or fit for any particular purpose or capable of being used in connection with the Authorised Research; or iii) use of the Licensed Datasets will be free from infringement of third party intellectual property rights, including other third party rights, and to the maximum extent permissible by law, the Recipient will indemnify and hold the University harmless for any claims, losses, damages, costs (including all legal fees) and expenses incurred by or awarded against the University arising out of or in connection with the Recipient’s use of the Licensed Datasets except to the extent that such claims have arisen out of or in connection with any negligence or wilful default of the University. 16. Limitation of liability: (a) The University does not exclude or limit its liability to the Recipient for death or personal injury arising from its negligence or for any other matter in respect of which it would be unlawful for the University to exclude or limit its liability. (b) Subject to clause 16(a), the University shall not in any circumstances be liable whether in contract, tort (including negligence and breach of statutory duty however arising), misrepresentation (whether innocent or negligent), restitution or otherwise for: i. any loss (whether direct or indirect) of profits, business, business opportunities, revenue, turnover, reputation or goodwill; ii. any loss or corruption (whether direct or indirect) of data or information; iii. loss (whether direct or indirect) of anticipated savings or wasted expenditure including management time; or iv. any loss or liability (whether direct or indirect) under or in relation to any other contract. (c) (c) Subject to clause 16(a), the University’s total aggregate liability in contract, tort (including negligence and breach of statutory duty howsoever arising), misrepresentation (whether innocent or negligent), restitution or otherwise, arising in connection with the performance or contemplated performance of this Agreement shall in all circumstances be limited to £1,000 one thousand pounds. 17. Termination: This Agreement and the licence granted to the Recipient under clause 1. shall terminate automatically upon expiry of the Access Period subject to earlier termination by: (a) the Recipient to the University at any time in writing; (b) the University in the event that the Investigator ceases to be an employee of or under an honorary research contract with the Recipient and the Recipient is unable to procure a replacement acceptable to the University; (c) the University in the event that any Participant withdraws consent to the use of their Protected Data (though the University may ask the Recipient to delete any relevant records without terminating this Agreement at its discretion); (d) the University in the event that the Recipient commits a material breach of any term of this Agreement which, if capable of remedy, has not been remedied within a period of thirty days after being notified by the University in writing to do so; (e) the University in the event that the Recipient and/or Investigator has acted in any manner which in the University’s reasonable opinion has brought or is likely to being the University into material disrepute or is materially adverse to the University’s interests; (f) either Party in the event that the other Party: i. is deemed unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986; ii. is the subject of a petition filed, notice given, resolution passed or order made for or in connection with its winding up (other than for the purpose of a solvent amalgamation or reconstruction of that Party); iii. is the subject of an application or order made for the appointment of an administrator or if a notice of intention to appoint an administrator is given or an administrator is appointed in respect of that Party; or iv. suspends or ceases, or threatens to suspend or cease, carrying on all or a substantial part of its operations. 18. Consequences of termination: On termination of this Agreement for any reason, the Recipient shall as soon as reasonably practicable destroy the Licensed Datasets and all other data or information provided by the University in connection with this Agreement. Termination or expiry of this Agreement shall not affect any rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination or expiry, including the right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination or expiry. 19. Publications and acknowledgment: The University will be given an opportunity to review any results and/or papers intended for publication or presentation at symposia or otherwise at least one month prior to submission or presentation or concurrent with submission for publication. The Recipient will acknowledge the Licensed Datasets in all publications and presentations arising from the Authorised Research in the form specified in any data distribution notes, metadata or publication checklist provided by the University and shall include reference to those individuals identified by the University as having played a key scientific role in the generation of the Licensed Datasets. 20. Costs: The Licensed Datasets are supplied without cost, but the Recipient shall reimburse the University for any costs properly and reasonably incurred when preparing and sending the Licensed Datasets to the Recipient with the Recipient’s prior written consent. Where applicable, the University shall not be obliged to provide the Licensed Datasets until the Recipient’s consent for the University to incur such costs has been obtained. 21. General provisions (a) Interpretation: The following rules shall apply to the interpretation of this Agreement: i. any obligation on the Recipient not to do something includes an obligation not to allow that thing to be done; ii. clause headings shall not affect the interpretation of this Agreement; iii. unless the context otherwise requires, words in the singular include the plural and vice versa; iv. a reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time and shall include all subordinate legislation made from time to time under that statute or statutory provision; v. any words following the terms include or including or similar shall be illustrative and not limit the sense of the words preceding those terms; vi. a reference to writing or written includes e-mail but not fax. (b) Notices: Any notice given to a Party under or in connection with this Agreement shall be in writing and shall be delivered by hand or by pre-paid first-class post or other next working day delivery service to the addresses specified at the beginning of this Agreement or to such other addresses as the parties shall notify to the other in writing. Any notice shall be deemed to have been received, if delivered by hand, on signature of a delivery receipt or, if sent by pre-paid first-class post or other next working day delivery service, at 9.00 am on the second working day after posting or at the time recorded by the delivery service. This clause does not apply to the service of any proceedings or other documents in any legal action. (c) Entire agreement: This Agreement constitutes the entire agreement between the parties and supersedes all previous discussions, correspondence, negotiations, arrangements, understandings and agreements between them relating to its subject matter. Each Party acknowledges that in entering into this Agreement it does not rely on, and shall have no remedies in respect of, any representation or warranty (whether made innocently or negligently) that is not set out in this Agreement. (d) Assignment and other dealings: This Agreement is personal to the Recipient and it shall not assign, transfer or otherwise deal in any other manner with any of its rights and obligations under this Agreement without the prior written consent of the University. The University may at any time assign, transfer or otherwise deal in any other manner with any of its rights and obligations under this Agreement without the prior written consent of the Recipient. (e) Variation: No variation of this Agreement shall be effect unless made in writing and signed by the parties. (f) Waiver: No failure or delay by a Party to exercise any right or remedy provided under this Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of any right or remedy shall preclude or restrict the further exercise of that or any other right or remedy. (g) No partnership or agency: Nothing in this Agreement is intended to, or shall be deemed to, establish any partnership or joint venture between any of the parties, constitute any Party the agent of another Party, or authorise any Party to make or enter into any commitments for or on behalf of any other Party. (h) Third Party rights: A person who is not a Party to this Agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of its terms. This does not affect any right or remedy of a third Party which exists or is available apart from that Act. (i) Governing law and jurisdiction: This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales and each Party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle the same. Notwithstanding the foregoing, all such disputes and claims shall be first referred to the Parties’ respective authorised senior management representatives for amicable settlement through good faith negotiations before a Party resorts to legal proceedings. Signed for and on behalf of King’s College London Signature Print name Date Signed for and on behalf of the Recipient Signature Print name Date Acknowledgement by the Investigator: The Investigator confirms by signing below that: a. they have read and understood their responsibilities under this Agreement; b. they act as an academic researcher and/or a clinician; and c. they will not use the data that is the subject of this Agreement for any commercial purpose, and understand that this dataset is not available for use by commercial companies for any purpose. Signed………………………………………………………………. Date ………………………………………………………………… Schedule 1 Information Security The Recipient will: • Maintain a secure environment in which to store and use the Licensed Datasets, and protect them from unauthorised use and disclosure. • Maintain adequate physical controls and password protections for any server or system on which the Licensed Datasets are stored, ensuring that the Licensed Dataset are not stored on any mobile device (for example, a laptop or smartphone) or transmitted electronically unless encrypted. • Restrict access to the Licensed Datasets only to members of the research team who strictly need to access to undertake the Authorised Research and shall ensure that all members are informed of the terms of this Agreement. • Limit the number of copies to those essential to carry out the Authorised Research, including for back-up purposes. All copies will be managed under the same conditions as detailed in this Agreement. Schedule 2 Privacy Notice Who are we? We are Research Support, Library Services part of King’s College London. If you need to contact us about this privacy notice, please write to research.data@kcl.ac.uk. Why do we process your personal information? We process your personal information in order to assess requests to access restricted datasets and provide that access. What is our ‘legal basis for processing’? Data protection legislation allows us to use your personal information in this way because it is required for our public purpose as a teaching and research institution. Do you have to provide your personal information and what are the consequences of not doing so? You must provide the personal information requested so that we can contact you to facilitate this request. If you do not, it will not be possible to action the request. How long do we keep your information for? We will keep your information for the length of the authorised period as set out in the data access agreement and for 12 months afterwards in order to enable record keeping in the unlikely event of a data breach. Do we share your information with other organisations? We will not share your information with any external organisations. On rare occasions, we may be required or permitted to share personal information by law (e.g for law enforcement purposes). What are your rights and who can you contact if you have a concern? To find out more about how the university deals with your personal information, including your rights and who to contact if you have a concern, please see the university’s core privacy notice at https://www.kcl.ac.uk/terms/privacy.aspx. [INSERT TITLE OF STUDY] STUDY ACCESS AGREEMENT FOR RESEARCH DATA Research Use Statement. The approval of project requests depends primarily on a carefully written Research Use Statement (2,200 characters max). The statement should include the following components: • Objectives of the proposed research; • Study design; • Analysis plan, including the phenotypic characteristics that will be evaluated in association with genetic variants; • Explanation of how the proposed research is consistent with the data use limitations for the requested dataset(s); and • Brief description of any planned collaboration with researchers at other institutions, including the name of the collaborator(s) and their institution(s). Project Title Research Use Statement