TGCT_OncoArray_Cases

Access agreement for genetic data produced at the Molecular and Population Genetics group of the Institute of Cancer Research

Data Access Agreement For access and use of Data generated by The Institute of Cancer Research This Data Access Agreement (the “Agreement”) between The Institute of Cancer Research: Royal Cancer Hospital of 123 Old Brompton Road, London SW7 3RP, UK (“ICR”) and the Recipient (as defined below) governs the terms on which access will be granted to Data (as defined below) generated by ICR. In accessing this Data, the Recipient agrees to be bound by the terms and conditions of access and use set out in this Agreement. For the sake of clarity, the Recipient shall procure that the Recipient Scientist and any Registered Users (as defined below) comply with the terms of access set out in this Agreement. BACKGROUND Capitalised terms used in this background section have the meanings set out in Clause 1. A. ICR has produced datasets as result of work undertaken by Cancer Genomics team at ICR under the direction of the ICR Scientist using funding as follows: Datasets EGAD00001003257 and EGAD00001003258 funded by Cancer Research UK grant (C1298/A8362), the European Union Seventh Framework Programme (FP7/207–2013) under grant 258236 and FP7 collaborative project SYSCOL Dataset EGAD00010001246 funded by The Institute of Cancer Research and the Everyman Campaign, the Prostate Cancer Research Foundation, Prostate Research Campaign UK (now Prostate Action), the Orchid Cancer Appeal, the National Cancer Research Network UK and the National Cancer Research Institute (NCRI) UK, NIHR funding to the Biomedical Research Centre at the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, Swedish Cancer Society (CAN2011/484 and CAN2012/823), the Norwegian Cancer Society (grants 418975-71081-PR-2006-0387 and PK01-2007-0375) and the Nordic Cancer Union (grant S-12/07). This study was supported by the Movember Foundation and The Institute of Cancer Research. K.L. is supported by a PhD fellowship from Cancer Research UK. R.S.H. and P.B. are supported by Cancer Research UK (C1298/A8362 Bobby Moore Fund for Cancer Research UK). Dataset EGAD00010001247 funded by 19167/CRUK_/Cancer Research UK/United Kingdom, G1001799/MRC_/Medical Research Council/United Kingdom, 17528/CRUK_/Cancer Research UK/United Kingdom, MR/N01104X/1/MRC_/Medical Research Council/United Kingdom, WT_/Wellcome Trust/United Kingdom, G0700491/MRC_/Medical Research Council/United Kingdom, 15007/CRUK_/Cancer Research UK/United Kingdom, 10589/CRUK_/Cancer Research UK/United Kingdom, 16563/CRUK_/Cancer Research UK/United Kingdom, MR/N01104X/2/MRC_/Medical Research Council/United Kingdom, U01 CA188392/CA/NCI NIH HHS/United States, U19 CA148537/CA/NCI NIH HHS/United States, 13065/CRUK_/Cancer Research UK/United Kingdom. B. ICR has submitted such datasets to the European Genome-Phenome Archive (EGA). C. Further to the access request submitted via the EGA to the ICR Scientist, the Recipient has requested access to the Data in the EGA in order to carry out the Research Project. D. The Data is is proprietary to ICR, and ICR is willing to grant the Recipient access to the Data in the EGA for use in the Research Project only and the Recipient is willing to accept the Data on the following terms.   AGREED TERMS 1. Definitions For the purposes of this Agreement, the following terms have the following meanings: 1.1. Agreement: this agreement. 1.2. Applicable Laws: all applicable laws, rules, regulations, codes of practice, research governance or ethical guidelines or other requirements of regulatory authorities as amended from time to time. 1.3. ICR Scientist: Professor Richard Houlston, Head of Division, Genetics and Epidemiology. 1.4. IPR: patents, utility models, rights to inventions, copyright and neighbouring and related rights, rights in designs, database rights, rights to use, and protect the confidentiality of, confidential information, Know-how, trade secrets and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world, but excluding all trade marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off or unfair competition. 1.5. Know-how: any unpatented technical and other information which is not in the public domain including any: (a) trade secrets; (b) unpublished patent applications; (c) information comprising or relating to concepts, data, discoveries, formulae, ideas, inventions, research models or specifications; (d) methods, research plans, procedures for experiments and tests and results of experimentation and testing; and (e) information about biological or chemical structure or functi{ons. 1.6. Data: data of the type and in the quantities detailed in Appendix A or as otherwise agreed in writing between ICR and the Recipient from time to time. 1.7. Data IPR: is as defined in Clause 5.1. 1.8. Data Protection Addendum: as set out in Appendix B. 1.9. Personal Data: information relating to natural persons who: (i) can be identified or who are identifiable, directly from the information in question; or (ii) can be indirectly identified from that information in combination with other information. 1.10. Recipient: the non-commercial organisation requesting access to the Data in the EGA. 1.11. Recipient Scientist: the researcher who has requested access to the Data and is (i) employed by the Recipient; and (ii) a registered user of the EGA. 1.12. Registered Users: researchers employed by the Recipient working under the direct supervision of the Recipient Scientist. 1.13. Research Project: the non-commercial research approved by the ICR Scientist that the Recipient will perform using the Data. 1.14. Results: all data, inventions and developments made through the Recipient's use of the Data and all IPR and Know-how made, invented, developed, created, conceived or reduced to practice by or on behalf of the Recipient that: (a) necessarily or otherwise actually use or incorporate; or (b) result from the use of, or are derived from or based on; or (c) otherwise relate to, the Data or any of ICR’s Know-how relating to the Data. 2. Data transfer and data use 2.1. ICR will grant access to the Data to the Recipient in the format, quantities and according to the description set out in Appendix A. 2.2. The Recipient will use the Data solely and exclusively for the non-commercial Research Project and no other purpose. The Recipient warrants that its use of the Data aligns with ICR’s values and mission. No express or implied licences or other rights are provided to use the Data or any related rights of ICR for other non-commercial or commercial purposes including research funded by a commercial third party. 2.3. The Recipient shall not use the Data in research that is subject to consulting or licensing obligations to a third party (except if otherwise permitted under this Agreement) unless prior written permission is obtained from ICR. 2.4. The Recipient shall not use or rely on the Data to determine treatment of patients or human subjects in a clinical trial or for diagnostic purposes. 2.5. The Recipient shall obtain all necessary approvals and consents required to use the Data (including from a relevant ethics committee, if applicable). 2.6. The Recipient shall use the Data only in compliance with all Applicable Laws. 2.7. The Recipient will retain control over the Data at all times and agrees that the Data shall only be used at the Recipient organisation (or on the Recipient organisation’s private servers subject to compliance with ICR’s information security policy) by the Recipient Scientist or the Registered Users. The Recipient shall only grant access to Data, in whole or in part, to the Recipient Scientist and/or the Registered Users. The Recipient will not without ICR's prior written approval (provided by a duly authorised ICR staff member) transfer the Data to any person or third party (including within the Recipient organisation) other than the Recipient Scientist or the Registered Users. The Recipient shall refer third party requests for the Data to the ICR. 2.8. The Recipient shall take all reasonable information security precautions to guard against: (a) unauthorised or unlawful processing of the Data; and (b) accidental loss of the Data, destruction of the Data and/ or damage to the Data. 2.9. ICR reserves the right to distribute the Data to others and to use the Data for its own purposes. 2.10. The Recipient shall ensure that any return or deletion of the Data is in accordance with prior written instructions given by ICR (if any) and all applicable regulations and best practice recommendations. If not previously returned or deleted the Recipient will return or delete the Data at such time and in such manner as ICR may direct. 2.11. The Recipient agrees to notify the ICR Scientist of any errors detected in the Data. 2.12. The Recipient accepts that Data may be reissued from time to time, with suitable versioning. If Data is reissued at the request of the donors of such Data and/or as the result of other ethical scrutiny, the Recipient agrees to destroy all earlier versions of the Data. 3. Confidential information 3.1. The Recipient will permanently treat in confidence any Personal Data (except as otherwise required by law). 3.2. The Recipient will treat in confidence for a period of ten (10) years from the date of its disclosure, the Data (except for any Personal Data contained within the Data which the Recipient will permanently treat in confidence) and any of ICR’s written information about the Data that is marked "CONFIDENTIAL", except (i) if otherwise permitted by this Agreement or (ii) the information was previously made known to the Recipient without a confidentiality obligation, or (iii) the information is or becomes publicly available or (iv) is disclosed to the Recipient without a confidentiality obligation otherwise than in breach of this Clause, or (v) is independently discovered by the Recipient without reliance on information received from ICR. The Recipient will not disclose such Confidential Information to any person except as required by law or a competent authority. Any oral disclosures from ICR to the Recipient relating to unpublished information shall be considered confidential unless ICR informs the Recipient otherwise in writing. 3.3. The Recipient agrees that it shall not at any time: (i) analyse or make any use of the Data in such a way that has the potential to compromise the anonymity or lead to the identification of any donor(s) of the Data; or (ii) attempt to use the Data and/or Results, either alone or in conjunction with any other information, to try to identify the donor(s) of the Data; or (iii) try to contact any donor(s) of the Data. 4. Publication 4.1. In all oral presentations or written publications referring to research involving use of the Data and/or the Results the Recipient must acknowledge ICR's provision of the Data, as well as any relevant funder appropriately, unless otherwise requested by ICR. In all publications, the Recipient shall acknowledge the Cancer Genomics team at ICR responsible for the generation of the Data by citing the respective manuscript: For Datasets EGAD00001003257 and EGAD00001003258: Orlando G, Law PJ, Cornish AJ, et al. Promoter capture Hi-C-based identification of recurrent noncoding mutations in colorectal cancer. Nature Genetics. 2018 Oct;50(10):1375-1380. DOI: 10.1038/s41588-018-0211-z. PMID: 30224643; PMCID: PMC6380472 For Dataset EGAD00010001246: Litchfield, K., Levy, M., Orlando, G. et al. Identification of 19 new risk loci and potential regulatory mechanisms influencing susceptibility to testicular germ cell tumor. Nat Genet 49, 1133–1140 (2017). https://doi.org/10.1038/ng.3896 For Dataset EGAD00010001247: Litchfield K, Levy M, Orlando G, Loveday C, Law PJ, Migliorini G, Holroyd A, Broderick P, Karlsson R, Haugen TB, Kristiansen W, Nsengimana J, Fenwick K, Assiotis I, Kote-Jarai Z, Dunning AM, Muir K, Peto J, Eeles R, Easton DF, Dudakia D, Orr N, Pashayan N; UK Testicular Cancer Collaboration; PRACTICAL Consortium; Bishop DT, Reid A, Huddart RA, Shipley J, Grotmol T, Wiklund F, Houlston RS, Turnbull C. Identification of 19 new risk loci and potential regulatory mechanisms influencing susceptibility to testicular germ cell tumor. Nat Genet. 2017 Jul;49(7):1133-1140. doi: 10.1038/ng.3896. Epub 2017 Jun 12. PMID: 28604728; PMCID: PMC6016736 4.2. Subject to Clause 4.5, this Agreement shall not be interpreted to prevent or delay publication of research findings resulting from the use of the Data. 4.3. If the event that any publishable Results arise from the collaborative effort of the Recipient and ICR, then the publication of such Results shall be a joint publication between the Recipient and ICR. If so requested by ICR, Recipient will also declare in any such publications that ICR, in carrying out the original analysis and collection of the Data, bears no responsibility for the further analysis or interpretation of the Data by the Recipient. 4.4. Further to Clause 4.3, authorship of such joint publications shall be determined in accordance with the International Medical Journal Editors (IMCJE) guidelines. 4.5. The Recipient shall inform ICR no less than forty five (45) days in advance of any oral presentation or written publication or similar (and furnish one copy thereof to ICR) referring to research involving the use of the Data to allow ICR the opportunity, if it so wishes, to file relevant patent applications for its protection or request removal of its confidential information by the Recipient, such request to be granted by the Recipient. 5. Results and intellectual property 5.1. Except as expressly set out in this Agreement, ICR (or its licensors, as the case may be) retains all right, title and interest in and to all IPR and Know-how subsisting in and relating to the Data, including any database rights (“Data IPR”). The Recipient shall retain title to any patent or other IPR subsisting in the Results (other than the Data IPR, which shall be retained by ICR). 5.2. Upon written request from ICR, the Recipient shall keep ICR informed of the Results and provide to ICR copies of the documents that disclose such Results. 5.3. Without prejudice to the foregoing, the Recipient hereby grants to ICR a fully paid-up, worldwide, irrevocable, royalty-free, non-exclusive, perpetual licence to use the Results and any reports or publications which describe the Research Project (or parts of it), as well as any raw data, and IPRs arising therefrom, for research purposes. ICR shall keep the Results confidential until published by the Recipient. The Recipient shall send ICR a copy of any reports or publications which describe the Results and / Research Project (or parts of it), as well as any raw data. 5.4. Except as expressly set out in this Agreement, no express or implied licences or other rights are provided to the Recipient under any patents, patent applications, trade secrets or other proprietary rights of ICR. 5.5. The Recipient agrees to do all such things and to sign and execute all such documents and deeds as may reasonably be required in order to achieve or perfect any of ICR’s rights set out in Clause 5. 6. Data Protection 6.1. The Parties shall comply with their obligations in respect of the protection of Personal Data in accordance with Applicable Laws. 6.2. The Parties acknowledge and agree that the Data may contain Personal Data (including pseudonymised data) and that that ICR and Recipient will each be a data controller in relation to those Personal Data. 6.3. If Personal Data (as defined in the UK General Data Protection Regulation) is transferred as part of the Data under this Agreement, the Parties shall comply with the Data Protection Addendum. 7. Liability and indemnity 7.1. The Recipient understands and acknowledges that the Data is made available “as is” and is experimental in nature. 7.2. The Data is supplied to the Recipient with no warranties or representations, express or implied. In particular all warranties as to satisfactory quality or fitness for a particular purpose are excluded. ICR makes no representations that the use of the Data will not infringe any patent or proprietary rights of third parties. 7.3. Subject to Clause 7.4, the Recipient shall defend and hold ICR harmless and shall indemnify ICR, its employees, agents, directors, successors and assigns from and against all claims, liabilities, demands, damages, expenses (including legal costs) and losses (the “Losses”) arising directly or indirectly out of the Recipient's use of the Data, except to the extent the Losses are due to ICR’s negligence. The Recipient shall be liable to ICR and shall indemnify ICR for any breach of this Agreement or Losses caused by a third party or person acting on behalf of the Recipient as though such breach and/or Losses were caused by the Recipient. 7.4. Under no circumstances shall either Party be liable to the other, whether in contract, tort (including negligence or breach of statutory duty) or otherwise howsoever arising for any loss of profit, business, reputation, contracts or anticipated savings or any other indirect, special or consequential losses which arise, directly or indirectly, from any default on the part of the other Party. 7.5. Nothing in this Agreement is intended to limit or exclude any liability for fraud, death or personal injury caused by negligence, or any other liability which may not be so excluded or restricted under the applicable law. 8. Miscellaneous 8.1. The Recipient shall not claim, infer, or imply ICR's endorsement of the Recipient's use of the Data, the Recipient as an institution or its personnel conducting research with the Data, or any resulting product(s). 8.2. Nothing in this Agreement shall be construed as creating a partnership, contract of employment or relationship of principal and agent between the Parties hereto. 8.3. This Agreement contains the entire understanding between the Parties hereto in respect of its subject matter and supersedes all other negotiations, representations and undertakings in relation to the transfer of the Data. 8.4. Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties hereto. 8.5. Except as permitted herein, no third party shall have any right to enforce any term of this Agreement under the Contracts (Rights of Third Parties) Act 1999, which is hereby excluded to the maximum extent permitted by applicable law. 8.6. This Agreement is effective from the date of last Party’s signature and will terminate upon the earlier of completion of the Research Project or thirty (30) days written notice by either Party to the other. 8.7. ICR may terminate this Agreement immediately on written notice if the necessary ethical approval is withdrawn or if the Recipient is in breach of the Agreement. 8.8. The Recipient accepts that due to the changing regulatory and ethical framework of human genetic research ICR shall have the right to: (a) amend the provisions of this Agreement, in which case the Recipient may accept such amendment(s) or terminate this Agreement; and/or (b) terminate this Agreement with immediate effect in extreme circumstances. 8.9. Upon termination under Clauses 8.6, 8.7 and 8.8, the Recipient shall discontinue its use of the Data and return or permanently destroy the Data and any of ICR’s Confidential Information as instructed by ICR and return a copy of the Results to ICR. 8.10. This Agreement (including (i) any non-contractual obligations arising out of or in relation to it and (ii) the arbitration agreement in this Clause 8.10) is governed by English law. Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination shall be resolved as follows: 8.10.1. if the Data are transferred to the Recipient within the United Kingdom, the Parties hereby submit to the exclusive jurisdiction of the courts of England and Wales; or 8.10.2. if the Data are transferred to the Recipient outside of the United Kingdom, the Parties agree that a dispute shall be shall be referred to and finally resolved by arbitration under the Rules of Arbitration of the International Chamber of Commerce (the Rules). There shall be a sole arbitrator, appointed in accordance with the Rules. The seat, or legal place, of arbitration shall be London. The language to be used in the arbitral proceedings shall be English. Appendix A – The Data DAC - EGAC00001000639 - Experimental Data The datasets under this DAC are: EGAD00001003257 EGAD00001003258 EGAD00010001246 EGAD00010001247 Appendix B – Data Protection Addendum Not applicable as no Personal Data will be transferred under this Agreement.