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NKI-AVL data transfer agreement for EGAS00001002175

This agreement (hereinafter referred to as “Agreement”) is made and entered by and between: The Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis having its principle office at Plesmanlaan 121, 1066 CX Amsterdam, hereinafter referred to as “NKI-AVL”; and xxxxxxxxxxxxxxxxxxxx having its principle office at xxxxxxxxxxxxxxxxxxxx, represented by its legal representative, xxxxxxxxxxxxxxxxxxxx, hereinafter referred to as “Recipient”. Hereinafter jointly referred to as “Parties” and individually as “Party”; WHEREAS NKI-AVL is the exclusive owner of the coded patient data set (EGAS00001002175) (“Data”) specified in Annex I to this Agreement; Recipient, has requested NKI-AVL, through Dr. Ian Majewski, Dr. Daphne de Jong, or Rene Bernards, hereinafter referred to as “NKI-AVL’s Scientist”, to provide Recipient with the Data for use by Recipient for the specific purpose as described in the Research Plan as specified in Annex II; NKI-AVL is willing, subject to the terms and conditions of this Agreement, to provide the Data to Recipient; Dr Ian Majewski is affiliated with The Walter and Eliza Hall Institute of Medical Research (WEHI). Nevertheless for clarity, neither Dr Majewski nor WEHI is a party to this Agreement and neither have any ownership interest in the Data and Information I Definitions Completion Date means the date as specified in Annex I to this Agreement. Confidential Information means all information, know-how, data and experience of NKI-AVL regarding the Data, its characteristics, NKI-AVL’s research concerning the Data, whether of a scientific, technical, engineering, operational, or economic nature, supplied to or obtained by Recipient in written form, in the form of drawings or in the recording of oral conversation, or samples, which is reasonably required by Recipient for performance of Research. Data means the data being transferred under this Agreement as specified in Annex I to this Agreement. Effective Date means the date of last signing of this Agreement. Research Plan means the research plan specified in Annex II to this Agreement for which the Data will be used. Results means all research activities, analyses, tests or studies performed using the Data. II. Terms and Conditions of this Agreement: 1. The Data and any other information provided is and remains the property of NKI-AVL and is made available for use in ethically approved research as a service. 2. The Recipient agrees that the Data: (a) is to be used only for the purposes as described in the Research Plan not for any other purpose; (b) will not be used for any commercial purposes and (c) will not be transferred to any third party. Recipient shall not carry out the Research Plan with any third party or entity without prior written approval of NKI-AVL. 3. The Data will be transferred with a code. Under no circumstances will the identity of the patient or any means to derive such identity be provided to Recipient. Recipient shall not carry out any procedures with the Data (linking, comparison, processing) through which the identity of the patient could be derived. 4. The Data is collected in accordance with the informed consent form (ICF) and/or the applicable (Dutch and international) rules and legislation including but not limited to protection of privacy aspects of the medical and personal data of the patients. Recipient acknowledges that the patients shall at all times have the right to request NKI-AVL to destroy their data. In the event a patient files such a request with NKI-AVL, Recipient shall – upon first request by NKI-AVL - promptly destroy the Data in an approved manner. Any Results (defined in article 5) already obtained through the use of the Data shall remain at the disposal of Recipient. 5. The Results shall be owned by the NKI-AVL and the Recipient, and Recipient shall keep NKI-AVL’s Scientist informed of the Results arising from the Research Plan and when requested shall provide an update of such Results. Within thirty (30) days after the completion of the Research Plan or the expiration or earlier termination of this Agreement, whichever occurs earlier, Recipient shall provide NKI-AVL with a written description of all Results. Within two (2) days after the Completion Date of the Research Plan or the expiration or earlier termination of this Agreement, whichever occurs earlier, Recipient shall destroy all Data received and will send NKI-AVL a written confirmation hereof. 6. Except as provided in this agreement, no express or implied licenses or other rights are provided to the Recipient under any Intellectual Property (IP) rights of NKI-AVL. 7. Data will be provided to the Recipient in a format to be agreed upon by the Recipient and the NKI-AVL’s Scientist. 8. All Data and Confidential Information are made available “as is” and parties understand and agree that all Data and Confidential Information are experimental in nature and are made available without any representation or warranty, express or implied, including any implied warranty of merchantability, satisfactory quality or fitness for any particular purpose or any warranty that the use of the Data and/or Confidential Information will not infringe or violate any patent or other proprietary rights of any third party. Recipient accepts all liability for any loss, claims and damages which may arise from the use, storage or disposal of the Data, Confidential Information or the use of the Results by Recipient. Recipient shall hold harmless, defend and indemnify and its employees, directors, agents and representatives against any and all loss, damage, liability, costs and expenses arising out of or in connection with third party claims relating to use, handling, storage or disposal of the Data. Confidential Information and the Results by Recipient, except to the extent that such loss or damage are attributable to any gross negligent or willful misconduct on the part of NKI-AVL. 9. Recipient agrees in its use of the Data to comply with all applicable international and national laws, statutes, regulations and guidelines. 10. Recipient shall treat all Confidential Information confidential for the duration of this Agreement including any extension thereof and thereafter for a period of five (5) years following termination or expiry of this Agreement. Excluded from this obligation of confidentiality shall be any Confidential Information of which the Recipient can reasonably demonstrate that it (a) was previously known to the Recipient, or (b) is, and/or becomes, publicly available during said five (5) year period through no fault of Recipient, or (c) is independently and lawfully developed by the Recipient. This obligation of confidentiality shall not apply to any disclosure required by law, provided that receiving Party shall notify the NKI-AVL of any disclosure required by law in sufficient time so that the NKI-AVL may contest such requirement, if NKI-AVL so chooses. 11. Recipient will be free to publish and disclose the Results but agrees to submit the proposed disclosure to NKI-AVL for review at least thirty (30) days prior to the scheduled submission for publication or disclosure. If NKI-AVL believes that the publication or disclosure contains Confidential Information, NKI-AVL has the right to request to postpone the publication for up to sixty (60) days from the date of submission of the documents to NKI-AVL. Any such Confidential Information will be removed from the publication or disclosure. NKI-AVL also has the right to provide comments on the manuscript and both Parties shall discuss in good faith to incorporate such comments in the publication or disclosure. 12. This Agreement will become effective on the Effective Date and will terminate one (1) year after the Effective Date. Parties can terminate this Agreement by giving a one (1) month prior written notice. Any clauses that will be expected or intended by its nature to survive the termination or the expiration of this Agreement, shall survive the termination or the expiration of this Agreement. Upon expiration or termination of this Agreement, the right to use the Data and Confidential Information will automatically end and Recipient will return or destroy all data received from NKI-AVL. Upon request from NKI-AVL, Recipient shall confirm in writing the complete deletion of such Data and Confidential Information. 13. This Agreement will be construed, governed, interpreted and enforced according to the laws of The Netherlands. All disputes arising out of or in relation to this agreement will be brought before the competent court in Amsterdam, The Netherlands. 14. This Agreement will be binding upon and inure to the benefit of the respective successors and assignees of the parties hereto. However, Recipient may not assign this Agreement in whole or in part without the prior written consent of the NKI-AVL. 15. This Agreement represents this entire Agreement among the Parties with respect to the subject matter hereof, and may only be altered or amended by an instrument in writing signed by all of the Parties. 16. If any portion of this Agreement is in violation of any applicable regulation, or is unenforceable or void for any reason whatsoever, such portion will be inoperative and the remainder of this Agreement will be binding upon the parties. Recipient represents that there are no agreements with any third party that might affect its ability to meet any of Recipient’s obligations under this Agreement. 17. Both Parties acknowledge that the signatories to this Agreement are authorized representatives of each of the Parties and legally authorized to sign this Agreement. 18. If the lawful performance of any part of this Agreement by a Party is rendered impossible by or as a result of any cause beyond such Party's reasonable control, such Party will not be considered in breach hereof as a result of failing so to perform. 19. In case of disputes where this Agreement does not provide a decisive answer, the Parties will consult each other before taking legal action. Agreed, executed and effective as of this [●] day of [●] Month, [●]Year, by: Organization: Address: Authorized Official: Title: Signature: Date: Please return an executed copy of this Agreement to the Technology Transfer Office of the NKI-AVL <tto@nki.nl>. The NKI-AVL will be maintaining signed originals and the list of signatory organizations. ?ANNEX I Description of the DATA This is a dataset is composed of sequencing data from 16 patients diagnosed with follicular lymphoma between 1993 and 2009 who developed transformed disease and for whom representative frozen tumor biopsy samples were available, as well as information on staging, treatment and follow-up. For 14 patients there is paired material from both disease stages. DNA and RNA libraries were constructed and captured with a kinome bait library (Agilent Technologies), before sequencing on an Illumina platform. ANNEX II Title project: Primary location project: Evidence of ethical approval: Completion Date of the Project: xx/xx/xxxx Research plan: References: