Common clonal origin of chronic myelomonocytic leukemia and B cell acute lymphoblastic leukemia in a patient with a germline CHEK2 variant

Data Access Agreement: CHEK2 clonal evolution project

DATA ACCESS AGREEMENT These terms and conditions govern access to the managed access datasets (details of which are set out in Appendix 1) to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions. Definitions Authorised Personnel: The individuals at the User Institution to whom Provider Institution grants access to the Data. This includes the User, the individuals listed in Appendix 2 and any other individuals for whom the User Institution subsequently requests access to the Data. Details of the initial Authorized Personnel are set out in Appendix 2. Agreement: this Data Access Agreement. Data: The managed access datasets to which the User Institution has requested access described in Appendix 1. Data Producers: Provider Institution and the collaborators listed in Appendix 1 responsible for the collection, development, organization, and oversight of these Data. External Collaborator: A collaborator of the User, working for an institution other than the User Institution. Project: The research project for which the User Institution has requested access to these Data. A description of the Project is set out in Appendix 2. Provider Institution: Sir Mortimer B. Davis Jewish General Hospital (a public healthcare establishment administered by CIUSSS (Centre intégré universitaire de santé et de services sociaux / Integrated University Health and Social Services Center) du Centre-Ouest-de-l'Île-de-Montréal) Publications: Includes, without limitation, articles published in print journals, electronic journals, reviews, books, posters, and other written and verbal presentations of research. Research Participant: An individual whose data form part of these Data. Research Purposes: Shall mean research that is seeking to advance the understanding of genetics and genomics, including the treatment of disorders, and work on statistical methods that may be applied to such research. User: The principal investigator for the Project. User Institution: The Institution that has requested access to the Data, i.e. legal name of the institution 1. The User Institution certifies that it will comply with all applicable laws and regulations applicable to the User Institution's use, handling, disposal or destruction and storage of the Data. Further, the User Institution certifies that it has obtained all relevant authorizations and approvals, including, as applicable, approval from a competent Research Ethics Board to receive, use and store the Data for the Project and shall act in compliance with such authorizations and approvals. 2. The User Institution agrees to only use these Data solely for the purpose of the Project and only for Research Purposes. The User Institution further agrees that it will only use these Data for Research Purposes which are within the limitations (if any) set out in Appendix 1. 3. The User Institution agrees to preserve, at all times, the strict confidentiality of these Data. In particular, it undertakes not to use, or attempt to use these Data to compromise or otherwise infringe the confidentiality of information on Research Participants. Without prejudice to the generality of the foregoing, the User Institution agrees to use use appropriate safeguards (including, without limitation, the measures set out in Appendix 1) to protect these Data. 4. The User Institution agrees to protect the confidentiality of Research Participants in any research papers or publications that they prepare by taking all reasonable care to limit the possibility of identification. 5. The User Institution agrees not to link or combine these Data to other information or archived data available in a way that could re-identify the Research Participants, even if access to that data has been formally granted to the User Institution or is freely available without restriction. Further, the User Institution shall not use the Data and any Project results to identify or to contact a Research Participant, unless the Provider Institution first obtains the individual’s consent to be contacted. 6. The User Institution agrees only to transfer or disclose these Data, in whole or part, or any material derived from these Data, to the Authorized Personnel who are bound by confidentiality obligations at least as stringent as those contained herein. Should the User Institution wish to share these Data with an External Collaborator, the External Collaborator must complete a separate application for access to these Data. 7. The User Institution agrees that the Data Producers, and all other parties involved in the creation, funding or protection of these Data: a) make no warranty or representation, express or implied as to the accuracy, quality or comprehensiveness of these Data; b) exclude to the fullest extent permitted by law all liability for actions, claims, proceedings, demands, losses (including but not limited to loss of profit), costs, awards damages and payments made by the User Institution that may arise (whether directly or indirectly) in any way whatsoever from the User Institution’s use of these Data or from the unavailability of, or break in access to, these Data for whatever reason and; c) bear no responsibility for the further analysis or interpretation of these Data. 8. The User Institution agrees to follow the guidelines set forth by the International Committee of Medical Journal Editors (ICMJE). This includes but is not limited to recognizing the contribution of the Data Producers and including a proper acknowledgement in all reports or publications resulting from the use of these Data. 9. The User Institution agrees to follow the Publication Policy in Appendix 3. This includes respecting the moratorium period for the Data Producers to publish the first peer-reviewed report describing and analyzing these Data. 10. Except as expressly provided herein, no right, title or interest in and to the Data is granted to the User Institution or implied hereunder. The User Institution agrees not to make intellectual property claims on these Data and not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of these Data, or conclusion drawn directly from these Data. 11. The User Institution agrees to destroy/discard in a secured manner the Data held, once it is no longer used for the Project, unless obliged to retain the data for archival purposes in conformity with audit or legal requirements. 12. The User Institution will notify Provider Institution in writing within thirty (30) days of any changes or departures of Authorized Personnel. 13. The User Institution will notify Provider Institution in writing prior to any significant changes to the protocol for the Project. 14. The User Institution will notify Provider Institution in writing as soon as it becomes aware of a breach of the terms or conditions of this Agreement. 15. Provider Institution may terminate this Agreement by written notice to the User Institution. If this Agreement terminates for any reason, the User Institution will be required to destroy any Data held, including copies and backup copies. This clause does not prevent the User Institution from retaining these data for archival purpose in conformity with audit or legal requirements; provided that the obligations of confidentiality shall survive the termination of this Agreement. 16. The User Institution accepts that it may be necessary for the Data Producers to alter the terms of this Agreement from time to time. As an example, this may include specific provisions relating to the Data required by Data Producers other than Provider Institution. In the event that changes are required, the Data Producers or their appointed agent will contact the User Institution to inform it of the changes and the User Institution may elect to accept the changes or terminate the Agreement. For certainty, this Agreement shall not be amended, modified, varied or supplemented except in writing signed by each of the parties to this Agreement or their duly authorized representatives. 17. If requested, the User Institution will allow data security and management documentation to be inspected to verify that it is complying with the terms of this Agreement. 18. The User Institution will procure that the Authorized Personnel comply with the terms of this Agreement. For this purpose, the User Institution is allowed to share a copy of this Agreement to the Authorized Personnel, provided this Agreement shall be kept confidential. 19. This Agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this Agreement or its formation) shall be construed, interpreted, and governed by the laws of the Province of Quebec and applicable federal laws of Canada and shall be subject to the exclusive jurisdiction of the competent courts in the Province of Quebec located in the city of Montreal. 20. This Agreement may be executed electronically and in any number of counterparts, each of which shall be deemed an original but all of which taken together shall constitute one and the same instrument. Signatures to this Agreement transmitted by facsimile, email, portable document format or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as the physical delivery of the paper document bearing original signatures. 21. The parties to this Agreement have agreed that this Agreement and all documents and notices in connection therewith be drafted in English. / Les parties aux présentes confirment avoir accepté que cette entente et tout document ou avis s’y rattachant soient rédigés en anglais. 22. All notices, requests or communications to be delivered hereunder may be delivered only by personal delivery or by registered or certified mail, or courier, all postage and other charges prepaid, or by facsimile, or by email (with receipt of delivery) to the parties at the addresses set forth below or at such other address as a party to this Agreement may designate in writing to the others.