Sequence data from stage I of the CCTG BR.36 ctDNA-directed, multi-center phase II study of molecular response adaptive immunotherapy in non-small cell lung cancer

Data Access policy for study EGAS00001007298.

DATA ACCESS AGREEMENT (“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 DAC: The data access committee for EGA study accession: EGAS00001007298, Sequence Data from “Early ctDNA molecular response captures therapeutic response in the first stage of CCTG BR.36 ctDNA-directed, multi-center phase II study of molecular response adaptive immunotherapy in non-small cell lung cancer”, EGA DAC EGAC00001003422. Authorized Personnel: The individuals at the User Institution to whom the DAC 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 access to the Data. 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 and for which the DAC has agreed to grant such access. Data Producers: The DAC and the collaborators listed in Appendix I responsible for the 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 project for which the User Institution has requested access to these Data. A description of the Project and protocol 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. For sake of clarity, Research Purposes does not include commercialization of research. User: The individual at User Institution who will serve as principal investigator for the Project. User Institution(s): The Institution that has requested access to the Data. Please include your Institution details here: 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. 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 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. The User Institution shall not make contact or attempt to make contact with a Research Participant unless DAC agrees to make reasonable efforts to contact the Research Participant and the DAC has first obtained the Research Participant’s consent to being contacted. 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 who need to know such Data for the purposes of the Project or for the administration of this Agreement, and only if the foregoing persons are bound and obligated by the same requirements of confidentiality as contained in this Agreement. 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. 6. The User Institution agrees that the Data Producers, and all other parties involved in the creation, funding or protection of these Data: a) provide the Data “AS IS” and 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. 7. Data Producers will not be liable for any use or disclosure of the Data by User Institution, the investigators, or User Institution’s other directors, officers, employees, medical staff, research fellows, students, consultants, contractors, and advisors, or for any claims, damages, losses, or liabilities of whatsoever kind or nature, which may arise out of or in connection with the use, access, storage, disclosure of the Data by the User Institution, investigators or User Institution’s other directors, officers, employees, medical staff, research fellows, students, consultants, contractors, and/or advisors. 8. User Institution shall defend, indemnify and hold harmless the Data Producers and its trustees, officers, employees, faculty agents or representatives from any loss, claim, damage or liability of any kind or nature, which may arise from or in connection with this Agreement or from User Institution’s acceptance, use, storage, disclosure or disposal of the Data, except for loss, claims, damages or liability arising directly from the negligence or willful misconduct of Data Producers. 9. The User Institution agrees to follow the Fort Lauderdale Guidelines (http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf ) and the Toronto Statement (http://www.nature.com/nature/journal/v461/n7261/full/461168a.html). This includes but is not limited to recognising the contribution of the Data Producers including a proper acknowledgement in all reports or publications resulting from the use of these Data. 10. 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. Copies of all Publications arising from the Project must be sent to DAC at least 30 days prior to submission. If requested in writing by DAC, User Institution shall withhold material from submission for publication or presentation for an additional 90 days from the date of DAC’s request to allow for the filing of a patent application or the taking of such measures as DAC deems appropriate to establish and preserve proprietary rights in the information and the material being submitted for publication or presentation. 11. The DAC shall own and retain all right, title and interest in and to the Data and any derivatives, modifications, replications or compositions made or discovered by or on behalf of User Institution in relation to the Data. 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. 12. 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. 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) (https://www.icgc.org/files/daco/NIH_BestPracticesLicensingGenomicInventions_2005_en.pdf ) in conformity with the Organisation for Economic Co-operation and Development Guidelines for the Licensing of the Genetic Inventions (2006) (http://www.oecd.org/science/biotech/36198812.pdf ). 13. 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. 14. The User Institution will notify the DAC within 30 days of any changes or departures of Authorized Personnel. 15. The User Institution will notify the DAC prior to any significant changes to the protocol for the Project. Any material changes to the Project shall be subject to an amendment to Appendix II of this Agreement. 16. 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. This Agreement shall commence upon the date last signed below and shall continue until the Project is completed, unless earlier terminated by the DAC. The DAC 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 immediately discontinue use of the Data and destroy any Data held, as directed by DAC, including copies and backup copies. This clause does not prevent the User Institution from retaining these Data confidentially for archival purpose in conformity with audit or legal requirements. User Institutions obligations under this Agreement pertaining to the Data shall continue as long as the User Institution has access to such Data. 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 the DAC. 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. User Institution shall use appropriate safeguards to prevent the unauthorized use, access, storage or disclosure of the Data and promptly report to the DAC any unauthorized use, access, storage or disclosure of which the User Institution becomes aware. If requested, the User Institution will allow data security and management documentation to be inspected by the DAC and/or the Data Producers to verify that it is complying with the terms of this Agreement. Upon request, User Institution will promptly provide access and respond to DAC’s inquiries regarding privacy and security of the Data. 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. If the Data Producer is a HIPAA Covered Entity, and if the Data will be a Limited Data Set as defined by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), in accordance with Section 164.514(e)(2) of the HIPAA Privacy Rule, the Data shall exclude the following direct identifiers of the individual or of relatives, employers, or household members of the individual: (i) Names; (ii) Postal address information, other than town or city, State, and zip code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses; (vi) Social security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix) Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric identifiers, including finger and voice prints; and (xvi) Full face photographic images and any comparable images. If the Data being provided is coded, the Data Producer will not release, and the User Institution will not request, the key to the code. In the event the User Institution comes into contact with the key to the code, it shall immediately return the key to the code to DAC and represents and warrants that it will not use the key to the code for any purpose. Agreed for User Institution Signature of University Official: Name: Title: Date: Principal Investigator I confirm that I have read and understood this Agreement. Signature: Name: Title: Date: Agreed for the DAC Signature: Name: Title: Date: APPENDIX I – DATASET DETAILS APPENDIX II ––PROJECT DETAILS APPENDIX III –– PUBLICATION POLICY APPENDIX I – DATASET DETAILS Dataset reference (EGA Study ID and Dataset Details) EGA study accession EGAS00001007298: Sequence data from “Early ctDNA molecular response captures therapeutic response in the first stage of CCTG BR.36 ctDNA-directed, multi-center phase II study of molecular response adaptive immunotherapy in non-small cell lung cancer”. EGA dataset for study @EGAStudyID: The dataset for the study “Early ctDNA molecular response captures therapeutic response in the first stage of CCTG BR.36 ctDNA-directed, multi-center phase II study of molecular response adaptive immunotherapy in non-small cell lung cancer” includes 134 bam files from targeted error-correction next-generation sequencing (PGDx Elio plasma resolve) from plasma cell-free DNA and matched white blood cell DNA from 35 individuals with non-small cell lung cancer on the BR.36 clinical trial, alongside 19 bam files from targeted next generation sequencing (PGDx Elio tissue complete) from tumor derived genomic DNA from 19 individuals with non-small cell lung cancer on the BR.36 clinical trial. Name of project that created the dataset EGA study accession EGAS00001007298: Sequence data from “Early ctDNA molecular response captures therapeutic response in the first stage of CCTG BR.36 ctDNA-directed, multi-center phase II study of molecular response adaptive immunotherapy in non-small cell lung cancer”. Names of other data producers/collaborators Valsamo Anagnostou, Cheryl Ho, Garth Nicholas, Rosalyn Anne Juergens, Adrian Sacher, Andrea S. Fung, Paul Wheatley-Price, Scott A. Laurie, Benjamin Levy, Julie R. Brahmer, Archana Balan, Noushin Niknafs, Egor Avrutin, Liting Zhu, Mark Sausen, Penelope A. Bradbury, Jill O'Donnell-Tormey, Pierre Olivier Gaudreau, Keyue Ding and Janet Dancey. Specific limitations on areas of research The User Institution agrees that it will only use these Data for Research Purposes. Use of this data by for-profit organizations is not allowed. Minimum protection measures required File access: Data can be held in unencrypted files on an institutional computer system, with Unix user group read/write access for one or more appropriate groups but not Unix world read/write access behind a secure firewall. Laptops holding these Data should have password protected logins and screenlocks (set to lock after 5 min of inactivity). If held on USB keys or other portable hard drives, the Data must be encrypted. APPENDIX II – PROJECT/PROTOCOL DETAILS (to be completed by the Requestor) Details of dataset requested i.e., EGA Study and Dataset Accession Number Brief abstract of the Project in which the Data will be used All Individuals who the User Institution to be named as registered users Name of Registered User Email Job Title Supervisor* All Individuals that should have an account created at the EGA Name of Registered User Email Job Title APPENDIX III – PUBLICATION POLICY The DAC 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. The DAC anticipate that the dataset could be useful to other qualified researchers for a variety of purposes. However, some areas of work are subject to a publication moratorium. The publication moratorium covers any publications (including oral communications) that describe the use of the dataset. For research papers that do not describe the use of the dataset, submission for publication should not occur until 2 months after these Data were first made available on the relevant hosting database, unless the DAC has provided written consent to earlier submission. 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 numbers (e.g., EGAS000000000XX), and acknowledge its use in a form agreed by the User Institution with the DAC.