smallRNA sequencing data from PAXgene blood from control and MCI individuals

Agreement on Use of Data from the DZNE’s Clinical Research Databases (academic partner non-EU Version 3.0 of April 28, 2020)

Agreement on Use of Data from the DZNE’s Clinical Research Databases (“AGREEMENT”) between the Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE) (German Center for Neurodegenerative Diseases) Venusberg-Campus 1, Gebäude 99, 53127 Bonn, Germany represented by the Head of the Clinical Research Platform and Click here to enter names, such as University Hospital XYZ Name of the INSTITUTION Click here to enter the address Address of the INSTITUTION Person with legal power of respresentation, such as a member of the Executive Board Represented by Click here to enter the name of the institution, such as department of neurology Responsible department of INSTITUTION Click here to enter the name. EXTERNAL RESEARCHER 1. Definitions (1) "DATA" within the meaning of this AGREEMENT means all data that are collected and stored in the framework of Clinical Research studies or registries, such as medical data, image data, voice recordings or analysis results. The term does not include biomaterials or accompanying data for biomaterials. (2) “COMMERCIAL USE OF DATA” within the meaning of this AGREEMENT means the sale, license or other transfer of the MATERIAL or MODIFICATIONS for profit purposes and all research activities aimed at such use. COMMERCIAL USE shall also include performance of contract research for a for-profit organization; screening of compound libraries; production or manufacturing of products for general sale. However, the use of MATERIAL or MODIFICATIONS in academic collaborations with for-profit or academic organizations shall not be considered a use of the MATERIAL or MODIFICATIONS for COMMERCIAL USE. (3) "USE OF DATA" within the meaning of this AGREEMENT means every instance of use, storage or forwarding of DATA. In particular, USE OF DATA includes review or statistical analysis of provided DATA, or of a subset of provided DATA, for scientific publications or presentations, or for preparation of additional statistical evaluations pursuant to Annex 1. (4) "RESEARCHER/RESEARCHERS" within the meaning of this AGREEMENT means all persons who are seeking to carry out a research project involving the use of DATA and/or biomaterials. (5) "EXTERNAL RESEARCHERS" within the meaning of this AGREEMENT means RESEARCHERS who – for the purpose of the RESEARCH PROJECT - are not employed by the DZNE and who, within the meaning of this AGREEMENT, are responsible recipients of DATA. (6) "RESEARCH PROJECT" within the meaning of this AGREEMENT has the meaning described in the request (Annex 1). (7) "PUBLICATION/PUBLICATIONS" within the meaning of this AGREEMENT means for example scientific papers/manuscripts, conference contributions or similar. 2. Scope of the AGREEMENT and right to USE OF DATA (1) This AGREEMENT covers the provision and USE OF DATA from the DZNE’s Clinical Research databases according to the relevant request. The request, attached as Annex 1, is part of this AGREEMENT. (2) The DATA are provided to the INSTITUTION, and to the EXTERNAL RESEARCHER, solely for use in the framework of the RESEARCH PROJECT described in the submitted request, and in accordance with the terms set forth in this AGREEMENT. The period for which the DATA may be used is the period for which the RESEARCH PROJECT is to run (cf. Annex 1). The provisions set forth in this AGREEMENT and its annexes shall be binding. An additional, separate request shall be submitted for any and all further use of the DATA. (3) The INSTITUTION shall be responsible for ensuring that the DATA are used in compliance with all applicable legal provisions, in particular with data protection laws, with the rules of good scientific practice and with the rules of good epidemiological practice. (4) No re-identification measures shall be carried out and no single data set (“Einzeldatensätze”) may be published. Combination with non-anonymized or non-pseudonymized DATA is not permitted without the explicit consent of the DZNE. (5) In the event that the INSTITUTION inadvertently identifies any donor, DZNE shall be notified without delay setting out in reasonable detail the circumstances. Following such notification DZNE will inform the INSTITUTION of any further actions or omissions and the INSTITUTION is obliged to follow instructions of DZNE in order to ensure data protection of the donor. DZNE is entitled to request immediate deletion of the DATA according to § 5 (1) of this Agreement. The INSTITUTION shall promptly inform DZNE once DATA has been deleted. (6) The DATA remain the property of the DZNE at all times. (7) The right to USE OF DATA is not transferable. (8) No DATA shall be copied for, or provided to, other researchers who are not directly under the supervision by the EXTERNAL RESEARCHER. (9) No COMMERCIAL USE OF DATA is permitted without the explicit written consent of the DZNE. Where COMMERCIAL USE OF DATA is legally permissible pursuant to the consent of the relevant DATA and biomaterial donors, the parties may, entirely at the discretion of the DZNE, conclude a separate agreement on such use. (10) The provision of DATA per se, for scientific and non-commercial purposes, is free of charge. 3. EXTERNAL RESEARCHERS (1) The INSTITUTION shall ensure, and shall be responsible for ensuring, that the EXTERNAL RESEARCHER, and all other RESEARCHERS participating in the RESEARCH PROJECT, comply with the provisions of this AGREEMENT in their USE OF DATA and fulfill their obligations resulting from the execution of this AGREEMENT. (2) If the EXTERNAL RESEARCHER leaves the INSTITUTION, the INSTITUTION shall inform the DZNE (Data.ManagementKF@DZNE.de) accordingly without delay. The right to USE OF DATA under this AGREEMENT automatically expires in such a case. (3) The INSTITUTION shall then be responsible for ensuring that, after the EXTERNAL RESEARCHER's departure, the departing EXTERNAL RESEARCHER, and all other RESEARCHERS participating in the RESEARCH PROJECT, have no further access to the DATA. (4) If the departing EXTERNAL RESEARCHER then wishes to continue the RESEARCH PROJECT a new agreement on the use of DATA shall be concluded with her/his future employing research institution. (5) If the INSTITUTION wishes to continue the RESEARCH PROJECT with a new, suitable EXTERNAL RESEARCHER, a new agreement on use of DATA shall be concluded. 4. Term of the RESEARCH PROJECT and termination of the right to USE OF DATA (1) The term of the RESEARCH PROJECT is set forth in Annex 1. (2) In particular, the right to USE OF DATA ends a) upon expiry of the term of the AGREEMENT (cf. Art. 14), b) upon effectiveness of the termination (cf. Art. 13), c) without further notice in cases of legal succession on the part of the INSTITUTION, d) without further notice in the case the INSTITUTION ceases to exist (such as its insolvency), or e) without further notice in the case the EXTERNAL RESEARCHER leaves the INSTITUTION (cf. Art. 3 (2)). (3) The INSTITUTION shall inform the DZNE without delay in the event that any of the reasons for expiry set forth in (2) apply. (4) In the event the right to USE OF DATA expires, use of the provided DATA shall be discontinued immediately, and the DATA shall be deleted without delay pursuant to Art. 5 (Deletion of the DATA). 5. Deletion of the DATA (1) Upon termination of the right to USE OF DATA, and regardless of the reason for such termination, and upon request by DZNE due to the obligation to delete DATA according to data protection regulation, the INSTITUTION shall return to the DZNE, without delay, all original data-storage media in its possession and delete any copies of the DATA that have been made. (2) Without any further request, the INSTITUTION shall confirm to the DZNE (Data.ManagementKF@dzne.de), in writing, that it has fulfilled these obligations. 6. Reporting obligations (1) The INSTITUTION, or its EXTERNAL RESEARCHER, shall report to the DZNE (Klinische-Studien@DZNE.de), on request, regarding the progress and results achieved in the RESEARCH PROJECT. (2) Within a maximum of one year following the end of the RESEARCH PROJECT's term (cf. the request), the INSTITUTION, or its EXTERNAL RESEARCHER, shall send to the DZNE (Klinische-Studien@DZNE.de) a final report on the RESEARCH PROJECT. 7. Intellectual property rights (1) The INSTITUTION is entitled to all rights to results obtained via USE OF DATA. The INSTITUTION grants the DZNE, for purposes of its own internal research and development, a non-exclusive, non-transferable, irrevocable and royalty-free right to use to results, including intellectual property rights (“Schutzrechte”), resulting from USE OF DATA. (2) The INSTITUTION shall inform the DZNE, without special request, without delay and in writing (Technologietransfer@DZNE.de), regarding any inventions related to the DATA obtained via this AGREEMENT. The parties shall negotiate and conclude a separate formal agreement, regarding the DZNE’s possible joint ownership of such inventions and their commercialization. 8. Publications (1) The following acknowledgement of the DZNE's serving as the data source shall be included in all PUBLICATIONS that refer to the RESEARCH PROJECT: "The data were provided by the study group 'Study DELCODE' of the Clinical Research of the German Center for Neurodegenerative Diseases (DZNE)." (2) The DZNE reserves the right to be named as a co-author pursuant to Annex 1 in cases where such mention is appropriate according to the rules of good scientific practice. (3) At least 30 days prior to their submission for publication, all PUBLICATIONS shall be submitted to the DZNE (klinische-studien@dzne.de) for evaluation. Within a period of 30 days, the DZNE may demand co-authorship pursuant to the agreement in Annex 1 or object to the PUBLICATION for important reasons (“aus wichtigem Grund”). In particular, the important reasons in this context include the threat of pre-release of patentable results; this shall apply, however, only until a priority-establishing patent request (provisional patent application) has been filed, and for no longer than an additional 90 days following the DZNE’s objection to publication. If the DZNE identifies patentable results, it may propose changes to the PUBLICATION that rule out the possibility of any pre-release. If the DZNE does not object within 30 days after the draft of the PUBLICATION has been sent to it, the PUBLICATION may be published. (4) Once the PUBLICATION has been published, the INSTITUTION, or the EXTERNAL RESEARCHER, shall promptly provide the DZNE with a specimen copy. 9. Confidentiality (1) The parties, along with their legal representatives, employees and agents participating in the RESEARCH PROJECT, especially, the EXTERNAL RESEARCHER and other RESEARCHERS, promise, for a period of 5 years, to treat the information and DATA exchanged under this AGEEMENT as confidential and not to make it available to any third parties. (2) This shall not apply to information and DATA for which the recipient is clearly able to demonstrate by documentary evidence (a) that were already known to the recipient, (b) that were already publicly known or that became publicly known through no fault of the recipient, (c) that, demonstrably, have been independently generated by the recipient, or (d) that are made available to the recipient by a third party authorized for such disclosure (e) that have to be disclosed due to regulatory or judicial order or due to mandatory statutory provisions. 10. Liability (1) The provided DATA may contain errors or defects. (2) The DZNE assumes no responsibility for the correctness, completeness (including completeness in number), consistency or accuracy of the provided DATA or for the suitability of the DATA for any specific purpose. (3) The DZNE is liable for any damage caused intentionally (“Vorsatz”) or by gross negligence (“grobe Fahrlässigkeit”). In the case of damages caused by simple negligence (“einfache Fahrlässigkeit”), the DZNE shall only be liable for breach of a material contractual obligation (“wesentliche Vertragspflicht”) limited to the amount of the typical and foreseeable damage (“typischer und vorhersehbarer Schaden”) at the time this AGREEMENT was concluded. The above restrictions and exclusions of liability shall not apply in the event of death, injuries or damage to health, or in the case of claims under the Product Liability Act (“Produkthaftungsgesetz”). (4) The INSTITUTION's liability for damages incurred by the DZNE, especially damages resulting from illegal USE OF DATA, including but not limited to fines resulting from a breach of data protection regulation, shall be governed by statutory liability. 11. Contractual fine (1) The parties agree that in case the PROVIDER is exposed to third parties’ claims due to negligent violation of the INSTITUTION of the provisions of this AGREEMENT(Art. 2-9), especially but not limited to unauthorized USE OF DATA or violation of data protection law, the INSTITUTION shall indemnify the PROVIDER for any payment which it may be obligated to make under final ruling of a competent court or other authority ("Claims") provided that: i) PROVIDER promptly notifies INSTITUTION of any such Claim; ii) PROVIDER shall not compromise and/or settle any Claim without the consent of the INSTITUTION; and iii) INSTITUTION shall have the opportunity to defend the Claim and the parties shall cooperate and assist each other as shall be necessary in defending such Claim.. (2) Further claims of the DZNE against the INSTITUION, particularly in the event of violations based on INSTITUTION’s negligence, shall not be affected. In this case the contractual fine shall be set off against further claims that may exist. 12. Force Majeure (1) Except for any obligations to make payments to the other party hereunder, either party’s delay or failure to perform any term or condition of the Agreement as a result of circumstances beyond its control such as, but not limited to, wars, invasions, hostilities (whether war is declared or not), terrorist threats or acts, epidemics, strikes, fires, floods, earthquakes, explosions, acts of God, governmental restrictions, market manipulations, insurrection, rioting, orders or laws, embargos or blockades, national or regional emergencies, power failure on a regional or national level, telecommunications or Internet failures, or damage or destruction of any external network facilities or servers, shall not be deemed a breach of the Agreement or a basis for liability and such party will be excused from performing its obligations under this Agreement. Performance of such party’s obligations will be excused only to the extent of and during the reasonable continuance of such disability to fulfill its obligations.  (2) Any deadline or time for performance specified hereunder that falls due during or subsequent to occurrence of any force majeure will be automatically extended for a period of time equal to the period of such disability.  13. Termination (1) In the case of violations of the terms regarding the USE OF DATA according to this AGREEMENT or any violation of data protection law by INSTITUTION, the DZNE shall be free to terminate the AGREEMENT with immediate effect, via notice given in writing. (2) This shall apply, but not be limited to, cases in which a) the DZNE’s property rights are disregarded, b) the USE OF DATA exceeds the permissible scope, c) obligations to maintain confidentiality are violated, d) the reporting obligations or other obligations pursuant to Arts. 6 through 8 are not fulfilled or e) the provisions of Art. 8 (Publications) are disregarded. 14. Duration of the AGREEMENT (1) The AGREEMENT enters into force upon being signed by both parties. The AGREEMENT expires upon expiry of the term of the RESEARCH PROJECT as set forth in Art. 4 (Term of the RESEARCH PROJECT and termination of the right to USE OF DATA) and complete fulfillment of the reporting obligations set forth in Art. 6 (Reporting obligations) and, at the latest, three (3) years after the signature of the AGREEMENT. The duration may be extended by the DZNE by request of the INSTITUTION to Klinische-Studien@DZNE.de. (2) The obligations set forth in Art. 7 (Intellectual property rights), Art. 8 (Publications) and Art. 9 (Confidentiality) shall continue to apply after the termination or expiry of the AGREEMENT. 15. Final provisions (1) If any provision of this AGREEMENT is wholly or partially invalid or unenforceable for any reason, all other provisions will continue in full force and effect. The parties shall negotiate if and how the invalid or unenforceable provision can be replaced with one which comes closest to the intended purpose of the invalid or unenforceable provision. The foregoing provision is also applicable in case the AGREEMENT is incomplete. (2) This AGREEMENT constitutes the entire agreement and understanding between the parties hereto relating to the subject matter hereof. No modifications, amendments, or waiver of any provision of this AGREEMENT shall be valid unless in writing and signed by a duly authorized representative of each of the parties hereto. (3) The law of the Federal Republic of Germany shall apply. (4) The place of jurisdiction for any disputes arising from or in connection with this AGREEMENT shall be Bonn. The following Annexes are part of this AGREEMENT: 1. Confirmed Data and Biomaterial Request form 2. Regulations for use of Clinical Research databases, data and biomaterial of the DZNE For the INSTITUTION For the DZNE Place, date Place, date Last name Function of the authorized signatory. Dr. Annika Spottke Head Clinical Research Platform For the INSTITUTION For the DZNE Place, date Place, date Last name Function of the authorized signatory. Dr. Annette Frontzek Member Clinical Research Platform