Exome Sequencing of Longitudinal Tumor and Matched Germline Samples from CCL21-Vaccinated Patients

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 Regents of the University of California, on behalf of its Los Angeles campus ("UCLA"), is the institutional data provider and has designated the Data Access Committee ("DAC") identified below to administer access to the Data on UCLA's behalf. The User Institution agrees to be bound by these terms and conditions. Institutional Data Provider UCLA User Institution [Legal name of institution requesting access] Principal Investigator / User [Name, title, department] EGA Study / Dataset Accession(s) [EGAS... / EGAD...] Project Title [Title of approved project] Definitions: Authorised Personnel: The individuals at the User Institution to whom the DAC, acting on behalf of UCLA, grants access to the Data. This includes the User, the individuals listed in Appendix II and any other individuals for whom the User Institution subsequently requests and receives approval for access to the Data. Details of the initial Authorised Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access. Data Access Committee (DAC): The UCLA-designated committee identified above that reviews data access applications and, on UCLA's behalf, determines whether access to the Data will be granted, continued, modified or withdrawn. The DAC is not a separate legal party to this Agreement. Data Producers: UCLA and the collaborators listed in Appendix I responsible for the development, organisation, and oversight of these 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. User: The principal investigator for the Project. User Institution(s): The Institution that has requested access to the Data. UCLA: The Regents of the University of California, on behalf of its Los Angeles campus, the institutional data provider. Terms and Conditions: 1. The User Institution agrees to only use these Data for the purpose of the Project (described in Appendix II) 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 I, and that it will not use the Data for the creation of products for sale or for any commercial purpose. 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 infringe the confidentiality of information on Research Participants. 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 these 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 identification. 4. The User Institution agrees not to identify or attempt to identify any Research Participant, or 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. 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 Authorised Personnel. Access will be limited to Authorised Personnel working on the Project under the direction or supervision of the User. 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 receive approval from the DAC. 6. The User Institution agrees that UCLA, 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 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 to follow the Fort Lauderdale Guidelines and the Toronto Statement. This includes but is not limited to recognising the contribution of the Data Producers and including 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 analysing these Data. 9. UCLA and the other Data Producers retain their respective rights in the Data, and nothing in this Agreement transfers ownership of the Data to the User Institution. 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 conclusions 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. The User Institution can elect to obtain intellectual property rights on such downstream discoveries. In this case, the User Institution agrees to implement licensing policies that will not obstruct further research and to follow the U.S. National Institutes of Health Best Practices for the Licensing of Genomic Inventions (2005) in conformity with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of Genetic Inventions (2006). 11. The User Institution agrees to destroy/discard 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 the DAC within 30 days of any changes or departures of Authorised Personnel. 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. UCLA 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 purposes 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. As an example, this may include specific provisions relating to the Data required by Data Producers other than UCLA. In the event that changes are required, UCLA or the DAC 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 Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this Agreement. 19. The User Institution agrees to use the Data in compliance with all applicable statutes, regulations, institutional policies, ethical approvals, and terms and conditions governing access to the Data. Signatures Agreed for User Institution Signature Print Name Title Date Principal Investigator I confirm that I have read, understood, and will comply with this Agreement. Signature Print Name Title Date Agreed for UCLA Signature Print Name Title Date APPENDIX I – DATASET DETAILS EGA Study ID / Dataset ID(s) [EGAS... / EGAD...] Dataset title / description [Insert] Project that created the dataset [Insert] Data Producer(s) UCLA Specific research-use limitations Research use only; commercial applications are prohibited Minimum Protection Measures • Data must be stored and processed only on institutional or institutionally approved systems, with access limited to Authorised Personnel and administrators who have a legitimate operational or security need. • Institutional compute systems must be protected by appropriate access controls and a secure firewall. Where Unix-style permissions are used, Data must not be made world-readable or world-writable. • Computers used to access or store the Data must use password-protected logins and automatic screen locking after a reasonable period of inactivity. • If Data are stored on laptops, USB devices, portable hard drives, or other portable media, the Da-ta must be encrypted. • The User Institution must promptly revoke access when an Authorised Person leaves the Project or the User Institution, or otherwise no longer requires access. APPENDIX II ––PROJECT DETAILS Requested EGA Study / Da-taset Accession(s) [Insert] Project title [Insert] Project start / expected end [Insert] Brief project abstract (max. 500 words) [Insert] Specific analyses proposed [Insert] Other datasets proposed for linkage [None / describe and justify] Computing environment / in-stitution [Insert] Authorised Personnel Name Email Job Title / Role Supervisor [Insert] [Insert] [Insert] [Insert] APPENDIX III –– PUBLICATION POLICY UCLA and the Data Producers intend to publish the results of their analysis of this dataset and do not consider its deposition into public databases to be the equivalent of such publications. UCLA anticipates that the dataset could be useful to other qualified researchers for a variety of purposes. In any publications based on these Data, please describe how the Data can be accessed, including the name of the hosting database (e.g., The European Genome-phenome Archive at the European Bioinformatics Institute) and its accession, and acknowledge its use in a form agreed by the User Institution with UCLA. The Data themselves must not be included in a publication, supplement, public repository, code repository, or other public disclosure. Derived summary results may be published if they comply with this Agreement and do not create a reasonable risk of participant identification or enable reconstruction of the controlled Data.