Chronic lymphocytic leukemia IGHV somatic hypermutation detection by targeted capture next-generation sequencing

Data Distribution Agreement

PRELIMINARY STATEMENT BC CANCER wishes to provide to the Recipient certain clinical annotation information. This information is the confidential and proprietary property of BC CANCER, and the Recipient shall maintain the confidentiality of all such materials and information and use same only for the purposes as provided herein. BC CANCER has supported collection of de-identified data from certainin dividuals collected under BC CANCER’s studies approved by the UBC BC CANCER Research Ethics Board on April 4 2022, Protocol H18-00946, entitled: LSARP: Genomics of Relapsed Lymphoid Cancers (the “Study”). This well-characterized population provides a rare and valuable scientific resource. The data for the Study has been deposited to the European Genotype Archive (“EGA”) by BC CANCER. BC CANCER and the researchers it supports have a responsibility to the public in general, and to the scientific community in particular, to encourage as rapid scientific progress as possible using these resources, subject to appropriate terms and conditions. In order to take full advantage of such resources and maximize their research value, it is important that data collected with public funds be made available, on appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner. Data collected by the Study have been stripped of all personal identifiers but the wealth of data available on them might make possible the individual identification of some Study participants. To protect the confidentiality and privacy of these Study participants, the Recipient who is granted access to these data must adhere to the requirements of this Agreement. Failure to comply with this Agreement could result in denial of further access to Data. Violation of the confidentiality requirements of this agreement is considered a breach of confidentiality and may leave requesting investigators liable to legal action on the part of Study participants, their families, or the Government of Canada. The Study Investigator has made a substantial long-term contribution in establishing and maintaining the clinical database. BC CANCER seeks to encourage appropriate collaborative relationships by outside investigators with the Study Investigator and to ensure that the contribution of the Study Investigator is appropriately acknowledged. NOW THEREFORE THIS AGREEMENT WITNESSETH that in consideration of the premises and of the mutual covenants herein set forth, the parties hereto have covenanted and agreed as follows: I. DEFINITIONS For purposes of this Agreement: A. “Agreement” means this agreement and any exhibits, schedules or appendices attached to this agreement and updated by the parties from time to time. B. “Data” refers to the information included in Exhibit A, which has been collected and recorded from Study participants through the periodic examinations and follow-up contacts conducted pursuant to the Study Investigator’s contract with BC CANCER. C. “FOIPPA” means the Freedom of Information and Protection of Privacy Act, R.S.B.C. 1996, c.165, as amended from time to time. D. “PIPA” means the Personal Information Protection Act, S.B.C. 2003, c.63, as amended from time to time. E. “PIPEDA” means the Personal Information Protection and Electronic Documents Act, S.C. 2000, c.5, as amended from time to time. F. “Principal Investigator” is <<Insert Name>> with a principal address at <<Insert Address>>. G. “Recipient” organization is a (check one): 0 non-profit OR 0 for-profit corporation organized under the laws of <<Insert Jurisdiction>> OR 0 a government agency governed under the laws of <<Insert Jurisdiction>>. H. “Research Project” refers to the project as described in Exhibit B. I. “Study Investigator” is defined as a research investigator with a current and active contract or employment with BC CANCER or one of its contractors to work on the Study. II. AGREED TERMS AND CONDITIONS 1. Research work: The Recipient requests access to the Data at its sole risk and at no expense to BC CANCER solely for the non-commercial purpose outlined in Exhibit B. This Agreement covers only the appended Research Project. Recipient will submit a completed Data Distribution Agreement for each research project for which Data are requested. 2. Non-transferability. This Agreement is not transferable. Recipient agrees that substantive changes made to the Research Project described above, and/or appointment by Recipient of another Principal Investigator to complete the Research Project, require execution of a new Data Distribution Agreement in which the new Principal Investigator and/or new Research Project are designated. 3. Provision of Data. The Data to be sent to the Recipient has been uploaded to a secure server with EGA. The Recipient Principal Investigator will be required to fill out this Data Access Agreement and complete the description of the Research Project in the Exhibits. Recipient will store and analyze Data electronically in a password-protected database. Access to Data will be determined by BC CANCER Data Access Committee (“DAC”). Access will be directly granted by BC CANCER to the Principal Investigator, with any further access restricted to those co-applicants set forth in Exhibit B who require access for the Research Project. The Recipient covenants and agrees that before any Data is made available to said co-applicants, it shall first ensure such said co-applicants are under obligations of confidentiality which are equivalent to or greater than those set forth in this Agreement. 4. Control of Data. The parties agree that despite disclosure of Data to the Recipient: (a) the Data remains solely in BC CANCER’s control for the purposes of the FOIPPA; (b) as between BC CANCER and the Recipient, the disclosure does not transfer to the Recipient any intellectual or other property rights or interests in or respecting the Data itself. 5. Use of Data. The Recipient agrees as follows: (a) the Data must be used only for the Research Project as detailed in Exhibit B and for no other use or purpose; (b) the Data must not be used to contact any individual whose personal information is included in the Data; (c) despite §§ 32 and 33 of the FOIPPA, the Data must only be used and disclosed as expressly provided in this Agreement; (d) except as expressly provided in the Research Project, or with the express authorization of BC CANCER, and then only to the extent necessary to accomplish the Research Project, the Data must not be disclosed to anyone for any reason; (e) except as expressly provided in the Research Project, or with the express authorization of BC CANCER, the Data must not be linked, matched or otherwise combined with other information (including information that is available from other sources); (f) any case identifiers (including case numbers) created by the Recipient will not relate to any case numbers found in BC CANCER Records. The Recipient’s identifiers are to be used for statistical purposes only; (g) all works must be written and presented in a way that ensures no individuals are or can be directly or indirectly identified; (h) the Data is protected by and subject to applicable international laws, which may include without limitation PIPEDA, PIPA, and FOIPPA and that Recipient is responsible for ensuring compliance with such laws; (i) except as expressly provided in the Research Project, or with the express authorization of BC CANCER and the express consent of the individual to whom the information relates, no identifiable data may be sent outside Canada for any reason; and (j) to immediately report to BC CANCER, any foreign demand for disclosure. 6. Non-Identification. The Recipient agrees that Data will not be used, either alone or in conjunction with any other information, in any effort whatsoever to establish the individual identities of any of the Study participants from whom Data were obtained. 7. No Distribution. The Recipient agrees to retain control over Data, and further agrees not to transfer Data, with or without charge, to any other entity or any individual. 8. Notice of Breach. The Recipient will advise BC CANCER immediately of any circumstances, incidents or events which to its knowledge have jeopardized or may in future jeopardize; (i) the privacy of individuals, (ii) the security of any computer system in its custody that is used to access the shared data, and/or (iii) any suspected or apparent risk of a breach, or actual breach, of any term of this Agreement. 9. Remedy for breach. BC CANCER may give the Recipient notice of breach of this Agreement and, if the breach has not been cured to BC CANCER’s reasonable satisfaction (including by retrieving Data that has been used or disclosed contrary to this Agreement) within thirty (30) days after the notice is given, BC CANCER may give notice of termination of this Agreement, which becomes effective five (5) days after it is given. Within thirty (30) days after termination of this Agreement the Recipient must return all copies of Data in any medium or must securely destroy all copies to BC CANCER’s reasonable satisfaction, as BC CANCER directs in a notice given to the Recipient. The Recipient’s obligations under this Agreement respecting use, disclosure and security of Data remain in force despite termination of the rest of this Agreement. 10. Compliance Monitoring and Investigations. The Recipient will record and monitor access to the data in its custody, in order to establish a chain of responsibility, as follows: (a) Recipient will investigate all reported cases of: i) Unauthorized access to or modification of the Data in its custody; ii) Unauthorized use of the Data in its custody; iii) Unauthorized disclosure of the Data in its custody; iv) Breaches of privacy or security with respect to the Data in its custody or with respect to any computer system in its custody that is used to access the Data. (b) Recipient will report to BC CANCER the results of any such investigations and the steps taken to address any remaining issues or concerns about the security of the Data or computer systems, or the privacy of individuals to whom the Data relates. 11. Non-Data. Notwithstanding the definition of “Data” or the agreed terms and conditions of this Agreement, if BC CANCER transfers written confidential information concerning the Data along with the Data, then to the extent permitted by law, Recipient agrees to treat in confidence, for a period of ten (10) years from the date of its disclosure, any of BC CANCER’s said confidential information. Recipient’s obligations of confidentiality under this Agreement shall not extend to any information: (a) that can be demonstrated to have been publicly known at the time of disclosure; or (b) that can be demonstrated to have been in the possession of or that can be demonstrated to have been readily available to Recipient from another source prior to the disclosure; (c) that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by Recipient; (d) that can be demonstrated as independently developed or acquired by Recipient without reference to or reliance upon Data provided under this Agreement; or (e) that is required to be disclosed by law, provided the Recipient takes responsible and lawful actions to avoid and/or minimize such disclosure. 12. Publication. Prompt publication or any public disclosure of the results of the Research Project is encouraged. Recipient agrees to provide to BC CANCER a copy of any manuscript or other disclosure document thirty (30) days in advance of submission for publication, in order to ensure compliance with the requirements set forth in paragraphs 5, 6, 7, 11, and 13 of this Agreement. 13. Acknowledgments. The Recipient agrees to acknowledge the contribution of the Study Investigator in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of Data. (a) Collaborations/Acknowledgments. If the Research Project involves a collaboration with Study Investigator, then the manuscript will be reviewed by BC CANCER and Recipient will acknowledge Study Investigator and/or participants as required by the Study’s publications committee. In addition, the Recipient will acknowledge the source of the Data by including language similar to the following either in the acknowledgment or in the text of the manuscript: “This manuscript was prepared using a limited access dataset obtained from BC CANCER”. (b) Other Studies/Acknowledgments. If the Research Project does not involve collaboration with Study Investigator, then the manuscripts or other disclosure documents should be submitted to BC CANCER thirty (30) days in advance of submission for publication. The manuscripts will be reviewed by BC CANCER and Recipient will use the following acknowledgment: “This manuscript was prepared using a limited access dataset obtained from BC CANCER and does not necessarily reflect the opinions or views BC CANCER.” 14. Non-Endorsement, Indemnification. The Recipient agrees not to claim, infer, or imply endorsement of the Research Project by BC CANCER, the Study Investigator, the entity, or personnel conducting the Research Project or any resulting commercial product(s), except as described in paragraph 13. To the extent permitted by law, Recipient agrees to hold BC CANCER, Study Investigator, the Provincial Health Services Authority, directors, officers, and all other investigator(s) who generated Data and the agents, employees, students, and invitees of each of them, harmless and to defend and indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of Recipient's use for any purpose of Data. The obligations of the parties as set forth in this paragraph survive expiration or termination of this Agreement. This paragraph 14 shall not apply to any public body or institution that is prevented by applicable laws from providing indemnification. 15. Recipient's Compliance with REB Requirements. If the conditions for use of these Data require approval from the Recipient's Research Ethics Board (“REB”) in accordance with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or such equivalent policy as applicable to the relevant REB, the Recipient confirms that it has obtained such REB approval, has attached the REB approval certificate as Exhibit C and agrees to comply fully with all REB approval conditions. Recipient agrees to report promptly to BC CANCER any proposed change in the Research Project and any unanticipated problems involving risks to Study participants or others. This Agreement is made in addition to, and does not supersede, any of Recipient’s institutional policies or any local, provincial, state, and/or federal laws and regulations which provide additional protections for human subjects. 16. Representations and Warranties. BC CANCER makes no representations or warranties, either express or implied, with respect to the Data and specifically disclaims any implied warranty of non-infringement or merchantability or fitness for a particular purpose, or that the use of the Data will not infringe on any patent, copyright, trademark, or other proprietary rights. BC CANCER shall in no event be liable for any loss of profits, be they direct, consequential, incidental, or special or other similar or like damages arising from any defect, error or failure to perform with respect to the Data, even if BC CANCER has been advised of the possibility of such damages. The Recipient hereby acknowledges that it has been advised by BC CANCER to undertake its own due diligence with respect to the Data. 17. Termination. BC CANCER may terminate this Agreement; (i) if Recipient is in default of any condition of this Agreement and such default has not been remedied within thirty (30) days after the date of written notice by BC CANCER of such default, or (ii) in the event of a conflict between the terms of this Agreement with any law or regulation applicable to either Party. 18. Destruction of Information. Recipient will destroy the Data upon the earlier of (i) completion of the Research Project, (ii) at the request of BC CANCER, or (iii) within five (5) days of the early termination of this Agreement. If requested by BC CANCER, Recipient will provide written certification of its destruction. 19. Disqualification, Enforcement. Failure to comply with any of the terms specified herein may result in disqualification of Recipient from receiving additional Data. BC CANCER shall have the right to institute and prosecute any proceeding at law or in equity against the Recipient for violating or threatening to violate the confidentiality requirements of this agreement, the limitations on the use of the Data provided, or both. Proceedings may be initiated against the violating party, legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages, mandamus, and/or any other proceeding in law or equity, including obtaining the proceeds from any intellectual property or other rights that are derived in whole or in part from the breach of the confidentiality requirements or use limitations of this Agreement. In addition, Recipient acknowledges and agrees that a breach or threatened breach of the confidentiality requirements or use limitations of this agreement may subject Recipient to legal action on the part of Study participants, their families, or both. 20. Governing Law and Arbitration. This Agreement shall be governed by and construed in accordance with the laws of the Province of British Columbia and the laws of Canada in force therein without regard to its conflict of law rules. All parties agree that by executing this Agreement they have attorned to the jurisdiction of the Supreme Court of British Columbia. Subject to the following, the Supreme Court of British Columbia shall have exclusive jurisdiction over this Agreement. In the event of any dispute arising between the parties concerning this Agreement, its enforceability, or its interpretation, said dispute shall be settled by a single arbitrator appointed pursuant to the provisions of the International Commercial Arbitration Act, or any successor legislation then in force. The place of arbitration shall be Vancouver, British Columbia, Canada and the language to be used in the arbitration proceedings shall be English. Notwithstanding the foregoing, either party may apply to a court of competent jurisdiction for interim protection such as, by way of example, an interim injunction. This paragraph 20 shall not apply to any public body or institution that is prevented by applicable laws from agreeing to governing law and/or arbitration. 21. Accurate Representations. Recipient expressly certifies that the contents of any statements made or reflected in this document are truthful and accurate. 22. Duplication of Research. The Recipient of the limited access Data acknowledges that other researchers have access to this Data, and that duplication of research is a distinct possibility. 23. GENERAL (a) Designated representatives. The parties agree that the individuals named in Exhibit D of this Agreement are their designated representatives for all purposes of this Agreement. A party may give notice to the other designating a new representative, and must do so promptly after its representative changes. (b) Notice. Any notice, direction or waiver which may be or is required to be given under this Agreement must be in writing to be effective and must be delivered or sent by fax transmission or e-mail using the address information set out in Exhibit D. Any notice, direction or waiver that is delivered is considered to have been given on the next business day after it is dispatched for delivery. Any notice, direction or waiver that is sent by fax transmission or e-mail is considered to have been given on the day it is sent if that day is a business day, but if that day is not a business day, it is considered to have been given on the next business day after the date it is sent. If a party changes its address, fax number, e-mail address or all of them, it must immediately give notice of the new address, fax number or e-mail address to the other party as provided in this section. (c) Binding on Successors. This Agreement enures to the benefit of and is binding upon the parties and their respective successors, contractors, trustees, administrators and receivers, despite any rule of law or equity to the contrary. (d) Whole Agreement. This Agreement is the entire agreement between the parties and it terminates and supersedes all previous communications, representations, warranties, covenants and agreements, whether verbal or written, between the parties with respect to the subject matter of this Agreement. (e) Waiver. Waiver of any breach of this Agreement must be express and in writing to be effective and a waiver of a particular default does not waive any other default. (f) Counterparts. This Agreement may be executed in counterparts, each of which shall be an original as against either party whose signature appears thereon, but all of which taken together shall constitute one and the same instrument. An executed facsimile or electronic scanned copy of this Agreement shall have the same force and effect as an original. (g) Severance. 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. (h) Amendments. This Agreement may only be amended by a document signed by the authorized representatives of the parties and no other purported amendment is effective. (i) Survival. Any provision in this Agreement which by its nature is intended to survive expiration or termination shall survive expiration or termination of this Agreement for any reason.