The mutant TP53 allelic state in human hematopoietic stem and progenitor cells

Here below a template DAA related to the DAC study "mutant TP53 allelic state in human HSCs" Oversight and control of access to restricted data is managed by the Data Access Commitee headed by Dr. Karin Lind karin.lind (at) medunigraz.at --- DATA ACCESS AGREEMENT by and between Medical University of Graz Neue Stiftingtalstraße 6, 8010 Graz, AUSTRIA (hereafter referred to as “Supplier”) and [XY] [address] (hereafter referred to as “Recipient”). The Supplier and the Recipient are hereinafter also referred to individually as a “Party” and collectively as the “Parties”. Preamble The Supplier possesses Data (as hereinafter defined) and is willing to provide the Recipient with such Data for the Recipient to perform analyses within its non- commercial research project entitled “[XXX]” (“Project”), in accordance with the terms and conditions set forth in this Agreement. A description of the Project is attached hereto as Exhibit 2 (“Project Plan”). For the avoidance of doubt, the Project Plan applies only with regard to scientific and technical aspects. The Project’s aim is to obtain new and/or further development of knowledge already existing in the field of health care. The scientist responsible as regards this Agreement on side of the Recipient is [XXX] (“Recipient Scientist”). The scientist responsible as regards this Agreement on side of the Supplier is [XXX] (“Supplier Scientist”). Now, therefore, in consideration of their mutual promises to each other, hereinafter stated, the Parties agree as follows: 1. Definitions “anonymized” means information processed in such a manner that the information can’t be attributed to a certain individual (anymore) whether with or without the use of additional information (from both Parties’ perspective). “commercial purposes” means the sale, license, lease, export, transfer or other distribution of the Data and/or Results to a person or entity not party to this Agreement for financial gain or other commercial purposes and/or the use of the Data and/or Results: (a) to provide a service to a person or entity not party to this Agreement for financial gain; (b) to produce or manufacture products for general sale or products for use in the manufacture of products ultimately intended for general sale; or (c) to perform laboratory services or contract research. “Confidential Information” means, including without limitation, know-how, technology, methodologies, procedures, data, business- and trade secrets, information related to the Data, and other information which, according to its content, is to be classified as confidential, whether marked confidential or not, disclosed in any form whatsoever by the disclosing Party to the receiving Party for the purpose of this Agreement. “Data” means the anonymized set of patient derived data as specified in Exhibit 1, which the Supplier will provide to the Recipient under this Agreement. 2. Costs The Data will be provided to the Recipient free of charge. 3.Use 3.1.The Supplier is willing to provide the Recipient with a limited, non-exclusive, non- transferable, non-sublicensable right to use the Data for the sole purpose and duration of performing the Project. Any other (e.g. directly or indirectly commercial) use is strictly prohibited without the Supplier’s prior written consent. 3.2.The Data shall not be disclosed to any third party (including non-employee agent or subcontractor), without prior written permission of the Supplier. 3.3.The Data shall be disclosed only to those employees, which have a need-to-know for the purpose of the Project and are working under the direct supervision of the Recipient Scientist. 3.4.The Recipient represents and warrants that the Data shall be used and the analyses shall be performed in accordance with this Agreement, and all applicable local and international laws and regulations. 3.5.To the extent that the Recipient intends to use the Data for other purposes, negotiation of a separate written agreement is required. The Recipient undertakes to refrain from pursuing any activities on/with the Data prior to the execution of such an agreement. 3.6.The Recipient shall report to the Supplier within twenty-four (24) hours of the Recipient becoming aware of any use or disclosure of the Data in violation of this Agreement and/or applicable law. 4.Data Protection 4.1.The Data will be provided by the Supplier to the Recipient in anonymized form. The Recipient agrees that the 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 patient. 4.2.In the event any patient, for whatever reason, becomes identifiable to the Recipient, the Recipient agrees to (a) immediately notify the Supplier, (b) to immediately and demonstrably remove the reference to that patient and destroy any information which would allow for identification of the patient and (c) to preserve, at all times, the confidentiality of information pertaining to such patient. 5.Ownership and Intellectual Property 5.1.The Supplier retains ownership of as well as all right, title and interest to the Data. 5.2.All results and inventions generated by the Recipient as a result of conducting the Project (“Results”) shall be the property of the Recipient. For the avoidance of doubt, the Results shall not contain/incorporate any parts of the Data itself. 5.3.The Recipient shall promptly disclose such Results to the Supplier in writing and specify the Supplier’s role as the supplier of the Data used, as well as the role, if any, of any Supplier’s employee in creating such Results. 5.4.If the Results are generated by collaborative efforts of the Supplier and the Recipient, such Results shall be held in co-ownership by the Parties. In such a case, a written joint ownership or licence agreement shall be executed between the Parties in good faith. 5.5.Except as provided in this Agreement, no express or implied licenses or other rights under any proprietary rights of the Supplier are provided to the Recipient. 5.6.The Recipient hereby grants to the Supplier a non-exclusive, perpetual and royalty free right to use the Recipient’s Results for non-commercial research, teaching and patient care purposes. 5.7.A separate written agreement - based on fair and reasonable conditions - shall be executed in case the Recipient intends to use its Results for commercial purposes, such agreement to be agreed on in advance. 6.Confidentiality 6.1.The receiving Party undertakes to keep any Confidential Information strictly confidential, shall disclose such Confidential Information only to internal (employee) or external (e.g. consultant, student) persons, which have a need-to-know for the purpose of this Project, and shall utilize it solely for the purpose and duration of this Agreement. These persons shall be bound by substantially similar confidentiality obligations as set out herein. 6.2.The confidentiality obligation shall also apply for a period of seven (7) years following expiration or termination of this Agreement. 6.3.The obligation to keep Confidential Information confidential shall not apply to information which: 6.4. a.was in the public domain prior to being transferred to the receiving Party, or becomes part of the public domain thereafter, except by breach of this Agreement by the receiving Party; b.was known by the receiving Party prior to being transferred to the receiving Party as can be proved by the receiving Party ’s written records predating the date it was learned under this Agreement and without an obligation to confidentiality; c.the receiving Party received – on a non-confidential basis – from a third party that is or was, to the best of the receiving Party’s knowledge, authorized to disclose such information at the time such information was disclosed; d.was independently developed by the receiving Party’s personnel who did not have access to the Confidential Information as demonstrated by the receiving Party’s written records contemporaneous with such development. The receiving Party shall be responsible for providing the corresponding proof. 6.5.Apart from that, the confidentiality obligation shall not apply where applicable laws or a decision by a competent authority requires disclosure, provided that the receiving Party shall first inform the disclosing Party and shall limit the disclosure to the content absolutely necessary, with express reference to its confidential nature and with the guarantee of confidential treatment of the information. 6.6.Upon expiration or termination of this Agreement, the receiving Party shall return or demonstrably destroy all Confidential Information of the disclosing Party (including copies, if any) except that the receiving Party may, subject to the confidentiality obligations set forth herein, retain one (1) copy of those parts of the Confidential Information as are necessary for record keeping purposes as required by applicable law and/or for the purpose of determining the scope of its obligations under this Agreement. 7.Publications 7.1.The provision of the Data to the Recipient in no way prevents or restricts the Supplier’s right to publish any document relating to the Data. 7.2.In all oral presentations or written publications, the Recipient agrees to provide academically and scientifically appropriate acknowledgement of the source of the Data (the Supplier and the Supplier Scientist), unless requested otherwise. 7.3.The Recipient may publish or otherwise publicly disclose its Results of the Project, but such public disclosure may be made only after the Supplier has had forty-five (45) calendar days to review the proposed disclosure to determine if it includes any Confidential Information. 7.4.The Supplier reserves the right to have deleted from the disclosure all Confidential Information which may be contained therein. In addition, at the request of the Supplier, any sensitive matter will be withheld from disclosure to third parties for an additional ninety (90) calendar days if required in order to enable the Supplier to apply for patent protection or similar protection rights. 8.Warranty Disclaimer Except as expressly set forth otherwise in this Agreement, the Data is provided by the Supplier without any warranties whatsoever, express or implied, including any warranties for merchantability or fitness for a particular purpose, or that the use of the Data will not infringe upon any patent, copyright, trademark, or other rights. 9.Liability 9.1.In no event shall the Supplier be liable for any use by the Recipient of the Data and/or Results, or any loss, claim, damage or liability of whatsoever kind of nature, which may arise from or in connection with this Agreement or the use, handling, storage or deletion of the Data and/or Results, except for cases of gross negligence, willful misconduct or personal injury. 9.2.The Recipient is responsible for compliance with all relevant statutes, legislation, regulations and guidelines applicable to the use, handling, storage and deletion of the Data. The Recipient will obtain all permits, licenses or other approvals required by governmental authorities and/or the competent ethics committee in connection with the Project. 10. Term and Termination 10.1. This Agreement shall be effective as of the date of the last signature of the Parties and shall terminate after conclusion of the Project (add, if not sufficiently clear: or on [Date], whichever occurs earlier). 10.2. This Agreement may be terminated upon forty-five (45) calendar days written notice by either Party. The Parties remain bound by any provisions which by their nature should survive termination or expiration of this Agreement. 11. Return of the Data In the event the Recipient is not using and does not intend to use the Data or as soon as the Project is concluded or this Agreement expires or is terminated for whatever reason, the Recipient is obliged to return to the Supplier or delete the Data unless retention is required by applicable law and/or necessary for internal validation or quality assurance purposes with respect to the Results of the Project and subject to ongoing compliance with the relevant provisions of this Agreement. 12. Governing Law and Jurisdiction 12.1. In the event of any dispute between the Parties arising in connection with this Agreement, including any dispute regarding its existence, validity or termination, the Parties shall make reasonable efforts to first resolve the dispute on an amicable basis through negotiation. If, after reasonable efforts, the Parties are unable to settle their dispute amicably, any such dispute shall be resolved exclusively by the competent court of Graz, Austria. 12.2. This Agreement shall be governed by Austrian law, without giving effect to its conflict of laws provisions. 13. Miscellaneous 13.1. Neither Party shall use the other Party’s name, emblem, logo, trademark or variation thereof, or the name of any director, officer, agent, student or employee, for advertising or promotional purposes without the other Party’s prior written consent. 13.2. This Agreement may not be assigned to any third party, without prior written consent of the other Party. 13.3. Should any provision of this Agreement prove to be invalid or incapable of fulfillment, or subsequently become invalid or incapable of fulfillment, whether in whole or in part, this shall not affect the validity of the remaining provisions of this Agreement. In such a case, the contracting Parties shall be entitled to demand that a valid and practicable provision be negotiated which most nearly fulfils the purpose of the invalid or impracticable provision. 13.4. This Agreement constitutes the entire and only agreement between the Parties for the transfer and terms of use of the Data and all other prior representations, agreements, and understandings thereto are superseded hereby. There are no side-agreements. 13.5. No modification of this Agreement shall be effective unless made in writing and duly executed by the authorized signatories on behalf of each Party. The Parties agree that the transmission of an electronic copy (e.g. scanned pdf) of the Agreement signed in wet ink or an electronic signature pursuant to the EU-eIDAS-Regulation shall in any case be sufficient to comply with the agreed written form requirement. 13.6. This Agreement may be executed in one or more counterparts, which shall be deemed an original and all of which shall together constitute one (1) agreement.