HER2-negative primary breast cancers WES

The temporal mutational and immune tumour microenvironment remodelling of HER2-negative primary breast cancers Data Access and Use Agreement

The temporal mutational and immune tumour microenvironment remodelling of HER2-negative primary breast cancers Data Access and Use Agreement This agreement governs the terms on which access will be granted to the next-generation sequencing data generated as a result of the The temporal mutational and immune tumour microenvironment remodelling of HER2-negative primary breast cancers study, deposited by members of the Data Access Committee. In signing this agreement, you are agreeing with the Data Access Committee to be bound by the terms and conditions set out in this agreement. NOW THEREFORE in consideration of the access to the Data provided by the Data Access Committee to User Institution, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound hereby, the parties hereto agree as follows: Definitions: Application: means an application made by an entity (including You) to request access to the Data for a specific project and/or purpose. Data: means non personal data including all and any human genetic and raw expression data obtained from the Data Access Committee (which is currently available through the European Genome-phenome Archive). Data Access Committee (DAC): means the members listed in Appendix I, which are responsible for the development, organisation, oversight of these Data, and consider Applications. Data Subject: means a person, who has been informed of the purpose for which the Data was collected, is currently held, and the purposes for which it can and will be distributed and disclosed, and has given his/her informed consent thereto. All references to individual Data Subjects have been removed and the Data is no longer personal data. User means a researcher whose User Institution has signed this Data Access Agreement and has received acknowledgement of the acceptance of its Application. Publications means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. User Institution means the organisation at which the User is employed, affiliated or enrolled User Institution is referred to within this Agreement as “You” (and “Your” shall be construed accordingly). Terms and Conditions: 1. You agree to preserve, at all times, the confidentiality and privacy of information and Data pertaining to Data Subjects. In particular, you undertake not to use, or attempt to use the Data to compromise or otherwise breach or infringe the confidentiality and privacy of information on Data Subjects. 2. You agree not to attempt to link the Data to any other data source on the same samples, link the Data to any person or otherwise identify any Data Subject from the Data. We have taken organisational and technical measures to ensure this cannot happen. 3. You agree not to transfer or disclose the Data, in whole or part to others, except to persons within the User Institution for the fulfilment of the Purpose as reasonably necessary for Data/safety monitoring or programme management. If You wish to disclose the Data to a collaborator outside the User Institution, the third party must make a separate Application for access to the Data and enter into a separate Agreement. 4. You agree to use the Data for the advancement of medical research, and solely for the approved purpose and project described in Your Application and for no other purpose, which is attached hereto as Appendix III (the “Purpose”); provided that any use of the Data beyond the scope of the Purpose will require a new Application, approval and Agreement. You agree to destroy the raw data once the project is completed, and upon request of the DAC, provide written certification of such destruction. 5. You agree that Data may be reissued from time to time, with suitable versioning. If the reissue is at the request of sample donors and/or other ethical scrutiny, you will destroy earlier versions of the Data, and upon request of the DAC, provide written certification of such destruction. 6. You agree to acknowledge in any work or Publications based in whole or part on the Data, the published paper from which the Data derives, the version of the Data, and the role of the DAC, in accordance with the Publications Policy attached as Appendix II. 7. You agree and acknowledge that the DAC members, the original Data creators, depositors or copyright holders: a) bear no legal responsibility or liability for the accuracy or comprehensiveness of the Data, or from any use of the Data including further analysis or interpretation of such Data; and b) shall have no liability for any direct or indirect, consequential, or incidental damages or losses whatsoever arising out of Your use of the Data, or from the unavailability of, or lack of access to, the Data for whatever reason; and c) disclaim any and all representations, conditions or warranties (either express, implied or statutory) regarding the Data, including accuracy of the Data or that the Data corresponds with a particular description or is fit for a particular purpose. 8. You shall indemnify, hold harmless and defend each of the DAC members and their respective directors, officers, employees and agents against any and all claims (including all associated legal fees and disbursements actually incurred) arising out of this Agreement, including without limitation against any damages or losses, consequential or otherwise, arising in any manner at all from or out of Your use of the Data. Section 8 shall not apply to any public body or institution that is prevented by applicable laws from providing indemnification. 9. You understand and acknowledge that the Data is owned by the DAC and protected by copyright, database rights and other intellectual property rights owned by the DAC. You agree that you shall not reproduce or copy the Data, except as reasonably required to carry out the Purpose and for no other purpose, or sell all or any part of the Data in any circumstances. 10. You recognize that nothing in this Agreement shall operate to transfer to You any ownership or intellectual property rights relating to the Data. 11. You accept that this Agreement will terminate immediately upon any breach of this Agreement by You and You will be required to destroy or return any Data, and upon request, provide written certification of such destruction. For the avoidance of doubt clause 3, 7, 8, 14, 15 will continue to operate in full force and effect. 12. You accept that it may be necessary for the DAC to alter the terms of this Agreement from time to time in order to address new concerns. In this event, one of the DAC members will contact You to inform You of any changes and You agree that Your continued use of the Data shall be dependent on the parties entering into a new version of the Agreement. 13. You agree that you will submit a report to the Data Access Committee, if requested, on completion of the Purpose. The Data Access Committee agrees to treat the report and all information, data, results, and conclusions contained within such report as confidential information belonging to the User Institution. 14. You agree that the Data is protected by and subject to applicable international laws, which may include without limitation the UK Data Protection Act 1998, and that You are responsible for ensuring compliance with any such laws. The Data Access Committee reserve the right to request and inspect Your data security and management documentation to ensure the adequacy of data protection measures in countries that have no privacy legislation comparable with that contained herein. 15. You agree 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 DAC and including a proper acknowledgement in all reports or publications resulting from the use of these Data. 16. Part or all of any section of this Agreement that is indefinite, invalid, illegal or otherwise voidable or unenforceable may be severed and the balance of this agreement will continue in full force and effect. Appendix I Membership Data Access Committee Leticia De Mattos-Arruda, IrsiCaixa Foundation Carla Dos Anjos De Souza, IrsiCaixa Foundation Juan Blanco Heredia, IrsiCaixa Foundation   Appendix II Publications Policy Any use of Data must be acknowledged using the following wording: "This study makes use of data generated by the “The temporal mutational and immune tumour microenvironment remodelling of HER2-negative primary breast cancers”." and cite the relevant primary publication (De Mattos-Arruda et al NPJ Breast Cancer 2021) which is the source of the Data. Appendix III Application (approved by the Data Access Committee)   For and on behalf of User Institution: Signature of Institutional or Administrative Authority: Print name: User Institution: Date: For and on behalf of User: Although I am not a party to this Agreement I have read, understood and acknowledge its terms and conditions. Name of Applicant(s): Signature of Applicant(s): Date: WHEN SUBMITTING THIS DOCUMENT, PLEASE INCLUDE ALL PAGES OF THE AGREEMENT WITH THIS SIGNATURE PAGE