Optimized large-scale longitudinal biorepository of gastroesophageal adenocarcinoma patient-derived organoids: High-fidelity models for personalized treatment to overcome resistance

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. The Research Institute of the McGill University Health Centre (RI-MUHC), a nonprofit organisation having its head offices at 2155 Guy Street, Suite 500, Montreal, Quebec, H3H 2L9 Canada (herein the “Provider Institution”) and Dr. Lorenzo Ferri, a researcher with privileges at the RI-MUHC and an address at McGill University Health Centre, The Montreal General Hospital, 1650 Cedar Avenue, Montreal, Quebec H3G 1A4 (herein “EGCDB Biobank Director") and XXXXX (herein the “User Institution”) Whereas, the “DATA PROCESSING AGREEMENT FOR THE SUBMISSION AND DISTRIBUTION OF PERSONAL DATA BY THE EUROPEAN GENOME-PHENOME ARCHIVE” was signed by the PROVIDER INSITUTION, the EUROPEAN MOLECULAR BIOLOGY LABORATORY, and the FUNDACIÓ CENTRE DE REGULACIÓ GENÒMICA (CRG), effective October 9, 2025, for the transfer of data from the Provider Institution’s EGCDB Bank (as defined below) to the European Genome-phenome Archive (EGA). NOW THEREFORE, the parties enter into this agreement on the following terms and conditions: Definitions Authorised Personnel: The individuals at the User Institution to whom Data Producers 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 Authorised Personnel are set out in Appendix II. Data: The managed access datasets to which the User Institution has requested access. Data Producers: The Research Institute of the McGill University Health Centre 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 coincides with the objective of the RI-MUHC’s Esophageal and Gastric Data- and Bio-Bank (“EGCDB Bank”) in accordance with the EGDB Bank Management Framework, and 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. User 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. In accordance with the EGCDB Bank Management Framework, the User Institution further agrees that its research project must have scientific value, be scientifically sound, be performed by qualified researchers, and be approved by a duly-consituted Research Ethics Board. 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. The User Institution agrees that the Data shall not be used to create a new bank and/or repository. 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. The User Institution agrees to recognize the contribution of the Esophageal, Gastric and Colorectal Data and Bio-Bank, MUHC, in the publication and/or communication of research results. 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. 5.1 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. 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. 5.2 The parties shall comply with all applicable federal and provincial privacy laws, regulations, guidelines and policies including but not limited to the Personal Information Protection and Electronic Documents Act, S.C. 2000, c. 5 (“PIPEDA”), the Quebec Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information, CQLR c A-2.1, the Quebec Act Respecting Health Services and Social Services, CQLR c S-4.2, the Quebec Act respecting the protection of personal information in the private sector, CQLR c P-39.1 the Privacy Act, RSC 1985, c P-21 or substantially similar privacy laws. The parties shall make their employees, consultants, students and agents aware of the importance of maintaining the confidentiality of any collected or transferred personal health information or personal information 6. 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 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 (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 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. 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. The User Institution agrees that, where possible, to return results from primary experiments to the Data Producers following publication so that these can be added to the data available in the EGCDB Bank. 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. 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 ). 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 Data Producers within 30 days of any changes or departures of Authorised Personnel. 13. The User Institution will notify Data Producers prior to any significant changes to the protocol for the Project. 14. The User Institution will notify Data Producers as soon as it becomes aware of a breach of the terms or conditions of this agreement. 15. Data Producers 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. 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. 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 Authorised Personnel. The User Institution will procure that the Authorised Personnel comply with the terms of this agreement.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 defending party’s jurisdiction, and shall be subject to the exclusive jurisdiction of the courts of the defending party’s jurisdiction. 20. All notices or other communication under this agreement will have binding legal effect only if written and addressed to any Party at its address provided below, in writing or by email, or at such other address as it may provide notice of from time to time.. Each Party may change its address set forth below by notice in writing to the other Party. Notices will be sent to the following addresses: If to Provider Institution: Research Agreements Office The Research Institute of the McGill University Health Centre 2155 Guy Street, Suite 500 Montreal, Quebec, H3H 2R9 Canada Email: contracts@muhc.mcgill.ca With a copy to: Dr. Swneke Bailey, McGill University Health Centre 1001 Decarie Blvd, Room E02.6248 Montreal, Quebec H4A 3J1 Canada Email: swneke.bailey@mcgill.ca And Name: Dr. Lorenzo Ferri McGill University Health Centre, The Montreal General Hospital 1650 Cedar Avenue Montreal, Quebec H3G 1A4 Email: lorenzo.ferri@mcgill.ca If to the User Institution: Name: Title: Address: Tel: Email If to User Investigator: 21. The relationship between the parties is that of independent contractors and nothing in this agreement shall constitute an agency relationship, employment relationship, partnership or a joint-venture between the parties or any two of them. No party shall have the authority to act on behalf of any other party or to bind another party in any manner. 22. The failure of a party to enforce at any time for any period any provision hereof will not be construed to be a waiver of such provision or of the right of such party thereafter to enforce each such provision, nor shall any single or partial exercise of any right or remedy hereunder preclude any other or further exercise thereof or the exercise of any other right or remedy. 23. No party shall use the name, insignia, logo or other identifying characteristic of the other Party or of its affiliates, directors, officers, appointees or employees without the other Party’s express written consent. 24. This agreement may be executed 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, and portable document format (PDF) 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. Further, an electronic signature shall have the same force and effect as an original signature written by hand by such party and shall be considered a valid and binding obligation of the executing party. 25. This agreement may only be amended by a document signed by the authorized representatives of the Parties and no other purported amendment is effective. 26. If any portion of this agreement is held invalid by a court of competent jurisdiction, the invalid portion must be severed and neither the decision that it is invalid nor the severance affects the validity of the remainder of this agreement 27. The parties declare that they have accepted that this agreement and all writings relating thereto be drawn in English. Les parties déclarent avoir accepté que la présente entente et tous écrits s’y rapportant soient rédigés en anglais. Agreed for User Institution Signature: Name: Title: Date: Principal Investigator I confirm that I have read and understood this agreement. Signature: Name: Title: Date: Agreed for The Research Institute of the McGill University Health Centre Signature: Name: Susan James, MBA Title: Director, Research Services Date: The Esophageal and Gastric Data- and Bio-Bank (EGDB) Bank Director Signature: Name: Dr. Lorenzo Ferri Title: EGDB Bank Director Date: Read and understood: Signature: Name: Dr. Swneke Bailey Title: RI-MUHC Researcher Date: APPENDIX I – DATASET DETAILS APPENDIX II ––PROJECT DETAILS APPENDIX III –– PUBLICATION POLICY APPENDIX I – DATASET DETAILS (to be completed by the data producer before passing to applicant) Dataset reference (EGA Study ID and Dataset Details) Name of project that created the dataset Names of other data producers/collaborators Specific limitations on areas of research Minimum protection measures required File access: Data can be held in unencrypted files on an institutional compute 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 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 (500 words max) 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 XXXXX 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. XXXXX 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, submission for publication should not occur until XX months after these data were first made available on the relevant hosting database, unless XXXXX 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., EGAS00000000029), and acknowledge its use in a form agreed by the User Institution with XXXXX.