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CLINICAL DATA DISCLOSURE AGREEMENT

CLINICAL DATA DISCLOSURE AGREEMENT This Agreement is made by and between: PARTIES (1) UNIVERSITY OF LEEDS whose principal place of business is Leeds, LS2 9JT, United Kingdom ("UOL"); AND (2) […………………….] whose principal place of business is [………………….] ("Institution"). UOL and the Institution are individually referred to as a Party and collectively known as the Parties to this Agreement. BACKGROUND A. UOL via the Leeds Insistute of Cancer and Pathology at UOL undertakes research on the study of Ibrutinib Induces a Global Chromatin Reorganisation in Chromic Lymphocytic Leukaemia. UOL is custodian of data generated in Bloodwise TAP IcICLLe Trial ("Study"). B. Schedule 1 contains details of certain data generated, or to be generated, by the Study ("Data"). C. Schedule 2 contains a description of a research project at the Institution entitled "[INSERT TITLE]" ("Project"). D. Schedule 3 contains the names of certain researcher(s) ("Researchers") from the Institution. E. The Institution wishes the Data to be disclosed to the Researchers for the conduct of the Project and UOL wishes to provide the Data for this purpose on the terms set out in this Agreement. F. For the avoidance of doubt UOL does not undertake the role of Sponsor or any duties associated with the role of Sponsor for research undertaken by Researchers using the data from the Institution unless as agreed in a separate agreement defining those roles and responsibilities for a specific research project. AGREED TERMS 1. Data Supply 1.1. UOL will provide the Data to the Institution in the format specified in Schedule 1. 1.2. This Agreement does not restrict the right of UOL to distribute the Data to third parties or to publish any document relating to the Data or to use the Data in any other way. 2. Confidentiality 2.1. The Institution will ensure the security of Data and that it is treated as confidential. In particular the Institution will ensure that: 2.1.1. Data remains confidential as governed by common law obligations of confidentiality and/or medical confidentiality, requirements of the Data Protection Act 1998, the General Data Protection Regulation 2016/679, the Human Tissue Act 2004, and any other applicable laws, , each as amended from time to time; 2.1.2. no attempt is made by Researchers to re-identify, trace or contact the Study subjects, or to access data which could identify the Study subjects, or to use the Data in any way that could infringe the rights of the Study subjects, or otherwise affect them or the Study adversely; 2.1.3. Data is stored only on a computer system to which access is password protected for an account which can only be accessed by Researchers, and for which only Researchers know the password; 2.1.4. unless provided by secure file transfer, the medium on which the Data is supplied to the Institution is stored in a secure location; 2.1.5. current anti-virus, anti-malware and encryption software is installed on all systems and hardware being used to store or access Data. For the avoidance of doubt, any portable hardware device being used in conjunction with the Data must be encrypted; 2.1.6. Researchers do not export the Data from the United Kingdom, nor allow it to be exported; 2.1.7. Researchers do not transfer, or allow to be transferred, Data over the Internet; 2.1.8. Researchers do not store, or allow to be stored, Data in a folder which is shared or otherwise made accessible to anyone other than Researchers; and 2.1.9. it reports to the UOL immediately any breach of this clause 2.1. 2.2. The Institution will ensure that the Researchers sign a confidentiality and publication agreement (attached at Schedule 4 to this Agreement) and will return it to the UOL contact listed in this Agreement and will ensure that the Researchers adhere to the confidentiality and publication agreement. 2.3 The Institution will ensure that the Data is used only by the Researchers and only for the purpose of the Project and is not passed to anyone outside of the Project without the prior written consent of UOL. 2.4 The Institution will ensure that any regulatory ethics committee approvals required for use of the Data in the Project are obtained before the Data is used. 2.5 The Institution will ensure that the Data is used in compliance with all applicable law including without limitation the Data Protection Act 1998. 2.6 Parties to this Agreement which are subject to the Freedom of Information Act 2000 ("FOIA") or the Freedom of Information (Scotland) Act 2002 ("FOI(S)A") or any equivalent legislation in another jurisdiction ("Equivalent") and which receive a request under FOIA or FOI(S)A or an Equivalent to disclose any information that belongs to the other Party will notify and consult that Party in writing as soon as reasonably practicable, and in any event, not later than five working days after receiving the request. The Parties acknowledge and agree that the decision on whether any exemption applies to a request for disclosure of recorded information under FOIA or FOI(S)A or Equivalent is a decision solely for the Party responding to the request. Where the Party responding to an FOIA or FOI(S)A or Equivalent request determines that it will disclose information that belongs to the other Party it will notify the other Party in writing, giving at least five working days' notice of its intended disclosure. 2.7 The Parties acknowledge that remedies at law may be inadequate to protect against a breach of the provisions of this clause 2 and that UOL may seek injunctive relief to restrain such breach, in addition to any other remedies available to UOL. 3. Data ownership and Intellectual Property 3.1. UOL will remain the custodian of the Data and the owner of any intellectual property rights subsisting in the Data. 3.2. The Institution will be the custodian of any data or other results which the Institution derives or develops in the Project from the Data ("Results") and the owner of any intellectual property rights subsisting in the Results. 3.3. Upon completion of the Project or termination of this Agreement, the Institution will provide to UOL a copy of the Results for internal teaching and research purposes by the UOL unless UOL notifies the Institution in writing that this is not required. The Results provided shall be in a format readable and usable by UOL using standard third party software. 3.4. The Institution acknowledges that the Data is being provided for non-commercial research only. It confirms that it will not use the Data or the Results: for the provision of a commercial service; or in the development of a commercial product; or on behalf of a commercial entity; or upon terms where a commercial entity obtains any right to the Results. The Institution acknowledges that UOL may use all measures at its disposal to prevent the use of the Data or the Results for any commercial or other unauthorised purpose. In the event that the Institution wishes to exploit or use any Data or Results upon a commercial basis then it shall make a formal written request to UOL seeking whether, at UOL's discretion, a licence may be granted and if so, upon what terms. 4. Publication 4.1. The Institution will provide UOL with a copy of any proposed presentation, poster, abstract or other publication involving the Results twenty-one days in advance of the submission date and will remove information that is considered by UOL to be confidential and/or potentially damaging to the Study subjects or is an infringement of IP rights or other contractual terms which the UOL is bound by. 4.2. The Institution will acknowledge UOL's contribution in any publication (including posters and abstracts) arising from the research as follows: naming of the host database (e.g., The European Genome-phenome Archive at the European Bioinformatics Institute) and its accession numbers (e.g., EGAS00000000029), publication the data originated from (). 5. Indemnity and Liability 5.1. The Data is a research product. UOL gives no undertaking, warranty or representation that the Data is of satisfactory quality, fit for any particular purpose, corresponds to any description or sample or that the Data will not infringe the intellectual property rights of any third party insofar as the foregoing may legally be excluded. 5.2. In no event will UOL be liable for any use of Data by the Institution. 5.3. The Institution agrees to indemnify fully and hold harmless UOL, its advisory body members, officers, directors, employees and agents (each an "Indemnified Party") from and against any and all loss, claim, damage, cost, expense (including legal fees) or liability, of whatsoever kind or nature, which may arise from, or in connection with this Agreement or the Institution's use of the Data. 6. Term and Termination 6.1. This Agreement will commence on the date of the last signature to this Agreement and will terminate on the earlier of: 6.1.1. completion of the Project; or 6.1.2. the end of the Term (as defined in Schedule 2). 6.2. Either Party may terminate this Agreement with immediate effect at any time by notice in writing to the other Party if the other Party is in material breach of this Agreement and, if remediable, the breach is not remedied within thirty days of the other Party receiving written notice of it. 6.3. On termination of this Agreement, the Institution will destroy any copy of the Data supplied by UOL and any copies made subsequently by the Institution. For the avoidance of doubt, no copies of the Data may be retained by the Institution other than Data embedded in Results and any Data captured in the course of the Institutions routine computer system back-up procedures which may only be used for the purpose of using the Results and for back-up purposes respectively. Upon notification by UOL to the Institution, at any time, that one or more Study subjects have withdrawn their consent for the continued use of their Data, the Institution will destroy those parts of the Data identified by UOL. 6.4. Upon termination the following clauses will continue in force: clauses 3, 4, 5, 6.3, this 6.4 and 7 to 10 inclusive. 7. Notices 7.1. Contact for notices: For UOL For the Institution Andy Duley Director of Commercialisation Research & Innovation Service Level 11 Worsley Building Clarendon Way Leeds LS2 9NL United Kingdom Email: a.j.m.duley@leeds.ac.uk [INSERT NAME OR JOB TITLE, ADDRESS AND TEL/FAX] 7.2 All notices will be in the English language. 8. Disputes, Governing Law and Jurisdiction 8.1. This Agreement will be subject to and construed and interpreted in accordance with English law and will be subject to the exclusive jurisdiction of the Courts of England. This clause 8.1 shall not prevent a party from seeking interim relief in any court of competent jurisdiction. 8.2. If any dispute arises in connection with this Agreement, directors or other senior representatives of the Parties with authority to settle the dispute will, within thirty days of a written request from one Party to the other, meet (or speak by telephone) in a good faith effort to resolve the dispute. 8.3. If the dispute is not resolved at that meeting, the Parties will attempt to settle it by mediation in London in accordance with the Centre for Effective Dispute Resolution (CEDR) Model Mediation Procedure. Unless otherwise agreed between the Parties, the mediator will be nominated by CEDR. To initiate the mediation a Party must give notice in writing (ADR notice) to the other Party to the dispute requesting a mediation. A copy of the ADR notice should be sent to CEDR Solve. The mediation will start not later than sixty days after the date of the ADR notice. No Party may commence any court proceedings in relation to any dispute arising out of this Agreement until it has attempted to settle the dispute by mediation and either the mediation has terminated or the other Party has failed to participate in the mediation, provided that the right to issue proceedings is not prejudiced by a delay and provided that this will not prevent a Party from seeking interim relief from court. 9. General 9.1. This Agreement is personal to the Parties and no Party will, without the prior written consent of the other Party, assign, transfer, mortgage, charge or deal in any manner with this Agreement or any of its rights and obligations under this Agreement, or purport to do any of the same. No Party will subcontract or delegate in any manner any or all of its obligations under this Agreement to any third party or agent. 9.2. Each Party is acting on its own behalf and not for the benefit of another person. 9.3. No failure or delay by any Party to exercise any right under this Agreement will operate as a waiver of it, nor will any partial exercise preclude any future exercise of the same. 9.4. If any clause or part of this Agreement is found by any court, tribunal, administrative body or authority of competent jurisdiction to be illegal, invalid or unenforceable then that provision will, to the extent required, be severed from this Agreement and will be ineffective without, as far as possible, modifying any other clause or part of this Agreement and will not affect any other provisions of this Agreement which will remain in full force and effect. 9.5. Other than the rights granted to Indemnified Parties in clause 5.3, nothing in this Agreement will confer or purport to confer on any third party any benefit or any right to enforce any term of this Agreement. 9.6. No amendment of the terms of this Agreement shall bind either Party unless in writing and signed by both Parties. 9.7. This Agreement may be executed in any number of counterparts, each of which when executed and delivered will constitute an original of this Agreement, but all the counterparts will together constitute the same Agreement. 10. Precedence of agreements If the Parties are both party to a clinical trial agreement in relation to the Study, then should there be any inconsistency between the terms of that clinical trial agreement and the terms of this Agreement, then the terms of the clinical trial agreement will prevail to the extent of such inconsistency. [SIGNATURE PAGE FOLLOWS] Signed for and on behalf of University of Leeds -------------------------------------------------------- Title Date Signed for and on behalf of the Institution ------------------------------------------------------ Title Date Schedule 1 Data to be supplied Dataset reference (EGA Study ID and Dataset Details) Study ID: EGAS00001002827 Encrypted ChIP-Seq data looking at specific histone marks in 5 patients from the IciCLLe trial Name of project that created the dataset Ibrutinib induces a global chromatin reorganisation in chronic lymphocytic leukaemia. Names of other data producers/collaborators Dr. Pascal Leferve Dr. Katherine Holmes Dr. Ildar Sadreev Prof. Peter Hillmen 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. The Data will be deemed to include any other data arising from the Study and disclosed to the Institution by UOL which is not covered by a specific written agreement between the Parties. Schedule 2 Project description [SPECIFY IN AS MUCH DETAIL AS POSSIBLE] Term [SPECIFY THE INTENDED DURATION OF THE PROJECT] [Collection of data will take place as soon as possible - no more than 1 week to prepare the data Statistical analyses will take place within a 6 month time period Writing of manuscript: time unknown] Please see completed data release form for further information Schedule 3 Researchers [LIST NAMES AND DEPARTMENTS] Schedule 4 Confidentiality and publication agreement - to be returned to UOL Each Researcher please sign and complete contact details below: I have read and understood and agree to adhere to the provisions at clause 2 (confidentiality) and clause 4 (publication) of the clinical data disclosure agreement relating to the use of clinical data from UOL Bloodwise TAP IcICLLe Trial in the [SPECIFY TITLE OF PROJECT] at the [SPECIFY NAME OF INSTITUTION]. ______________________________ ___________________________________________ signature date Contact details: First name: ____________________________________________ Surname: _____________________________________________ Address: _______________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ Post Code: ______________________________________________ City: __________________________________________________ Tel: ___________________________________________________ Email: _________________________________________________