Clonal hematopoiesis detection in the INSPIRE trial cohort of Pembrolizumab in patients with metastatic solid tumours

DATA ACCESS AGREEMENT These terms and conditions govern access to the managed access datasets (details of which are set out in Appendix I) to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions. Definitions Authorized Personnel: The individuals at the User Institution to whom the Data Access Committee (DAC) grants access to the Data. This includes the User, and those individuals under the direct supervision of the User, as well as any other individuals listed in Appendix II. Details of the initial Authorized Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access, as is outlined in the Appendix 1 attached hereto. Data Producers: The Principal Investigator responsible for the creation of this Data and other investigators responsible for the creation of this Data. External Collaborator: A collaborator of the User, working for an institution other than the User Institution. Project: The project for which the User Institution has requested access to these Data. A description of the Project is set out in Appendix II. 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. Research Ethics Board Approval shall mean approval of the Project by the User Institution’s research ethics board or other research ethics board or independent review board for whom said User Institution obtains research ethics approval(s). User: The principal investigator for the Project. User Institution(s): The Institution that has requested access to the Data. University Health Network: The University Health Network (UHN) is the largest clinical and research hospital in Canada. UHN is affiliated with the University of Toronto and is a member of the Toronto Academic Health Science Network. 1. The User Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) within the Research Purposes, and only in accordance with Research Ethics Board Approval, and any conditions or restrictions imposed pursuant to such Research Ethics Board Approval. 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 I. 2. The User Institution agrees to preserve, at all times, the confidentiality of these Data. In particular, it undertakes not to use, or attempt to use these Data to compromise or otherwise breach the anonymity of the Research Participants, including agreeing to not attempt to re-identify or contact any Research Participant. Without prejudice to the generality of the foregoing, the User Institution agrees to use at least the measures set out in Appendix I to protect the Data. Despite the confidentiality of the Data, the User Institution may publish aggregate data and other results arising from use of the Data and may refer to the Data by reference to the accession number(s) as documented in Appendix I in further support of any publication resulting from use of said Data. 3. 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 re-identification. 4. The User Institution agrees not to link or combine these Data to other information or archived data in a way that could re-identify the Research Participants, even if access to that other data has been formally granted to the User Institution or is freely available without restriction. 5. 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. 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 and enter into a separate Data Access Agreement. 6. The User Institution agrees that the Data Producers, and all other parties involved in the creation, funding or provision 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 Recipient that may arise (whether directly or indirectly) in any way whatsoever from the Recipient’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. 7. The User Institution agrees recognize the contribution of the Data Producers and include a proper acknowledgement in all reports or publications resulting from the use of these Data. 8. The User Institution agrees to follow the Publication Policy in Appendix III. This includes respecting the moratorium period for the Data Producers to publish the first peer-reviewed report describing and analyzing these Data. 9. 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. 10. The User Institution can elect to perform further research that would add intellectual and resource capital to these data and decide to obtain intellectual property rights on these downstream discoveries. 11. The User Institution agrees to destroy/delete the Data held, once it is no longer being used for the Project, or in the event that the User departs the User Institution or otherwise can no longer complete the Project, with the proviso that the User Institution can retain a copy of the Data for archival purposes only in conformity with audit or legal requirements. 12. The User Institution will notify the DAC within 30 days of any changes or departures of the User, at which point the Project will terminate and the User Institution delete or destroy the Data (as per Section 11) unless otherwise agreed by the DAC. 13. The User Institution will notify the DAC prior to any significant changes to the protocol for the Project. 14. The User Institution will notify the DAC as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. Either party may terminate this agreement by written notice to the other party. 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. 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. 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. 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 agrees to distribute a copy of these terms to the Authorized Personnel. The User Institution will procure that the Authorized Personnel comply with the terms of this agreement. 19. The Parties agree to remain silent on choice of law.