ALS-FTD brain motor cortex single-nucleus RNA-seq of NeuN+ nuclei sorted for TDP-43 low vs. high

Data Access Agreement for anonymized human post-mortem data of high-throughput RNA-sequences (Prof. Dr. Karin Danzer) for the databank (European Genome-Phenome Archive) – non-negotiable 1. Definitions (1) “COMMERCIAL USE” means any use, sale, license or transfer of the DATA or DERIVED DATA for commercial or for-profit purposes, including, but not limited to: conducting research with the objective of developing products or services for commercialization; contract research conducted on behalf of third parties; screening of compound libraries for commercial development; and the production or manufacturing of products intended for sale or commercial distribution. For the avoidance of doubt, COMMERCIAL USE includes all activities, whether research-oriented or otherwise, that are primarily directed toward achieving commercial outcomes. However, the use of DERIVED DATA within academic collaborations involving for-profit organizations shall not in itself be considered COMMERCIAL USE, provided that none of the aforementioned criteria apply. (2) "DATA" means the dataset(s) of anonymized human data, namely high-throughput RNA-sequences. For the avoidance of doubt, the term does not include biomaterials or accompanying data for biomaterials. (3) “DERIVED DATA” means any data, results, analyses, models, or other information that are generated by the RECIPIENT through the use of the DATA, provided that such data: (a) do not contain or reproduce the DATA in a form that would allow the original DATA to be reverse-engineered, re-identified, or otherwise reconstructed; and (b) do not enable third parties to access or infer the DATA itself. DERIVED DATA may include, without limitation, aggregated results, predictive models, or other analytical outputs, as long as they meet the criteria above. (4) “PROVIDER” is the DZNE that provides the DATA. (5) “RECIPIENT” is the institution that uses the DATA. (6) “RECIPIENT SCIENTIST” is/are the scientist(s) working at RECIPIENT who have a need-to-know to use the DATA. (7) "USE OF DATA" means any access to, storage, handling, processing, analysis, or other utilization of the DATA or a subset thereof, excluding any COMMERCIAL USE. USE OF DATA includes, but is not limited to, review or statistical analysis of DATA or a subset thereof for scientific publications or presentations as well as the generation of DERIVED DATA for review or statistical analysis for scientific publications or presentations. 2. Provision and USE OF DATA (1) DATA and DERIVED DATA shall be used exclusively for non-COMMERCIAL USE only. COMMERCIAL USE of DERIVED DATA is expressly excluded and requires a separate written agreement. (2) The USE OF DATA is not transferable. In case any third party, or any person within RECIPIENT’s institution who is not authorized under this agreement expresses interest in obtaining access to or using the DATA, such party shall be referred to the European Genome-Phenome Archive (EGA) to conclude a DTA with PROVIDER. (3) The provision of DATA for non-COMMERCIAL USE is free of charge and does not give rise to any fees or other remuneration. 3. Ethical, Legal and Regulatory Issues (1) PROVIDER warrants that the DATA provided to RECIPIENT has been fully and irrevocably anonymized. PROVIDER further warrants that, for each donor who contributed to the DATA, valid written consent has been obtained for its transfer, storage, processing, and use for scientific purposes. Where such consent is not the legal basis for the transfer, PROVIDER warrants that the transfer is lawfully permitted under applicable statutory provisions. (2) In the event RECIPIENT inadvertently identifies any individual donor, RECIPIENT shall notify PROVIDER without undue delay. The notification shall include a reasonably detailed description of the circumstances surrounding the incident. Following such notification PROVIDER will inform RECIPIENT of any further actions or omissions and RECIPIENT is obliged to follow instructions of PROVIDER in order to ensure data protection of the donor. (3) RECIPIENT shall be responsible for ensuring that DATA are received and used in compliance with all applicable legal provisions and data protection laws. RECIPIENT undertakes to determine whether approval by any competent ethics committee or similar authority is required for the receipt and the USE OF DATA. In such case, RECIPIENT undertakes to secure all positive votes from the competent ethics committee or approval of similar authorities, before any USE OF DATA. (4) RECIPIENT guarantees that no re-identification measures shall be carried out and no single data set will be published. Combination with non-anonymized or non-pseudonymized DATA is not permitted without the explicit consent of PROVIDER. 4. Confidentiality (1) RECIPIENT acknowledges the confidential nature of DATA. RECIPIENT undertakes to respect and maintain strictly confidential all DATA. (2) The PARTIES agree, as long as the DTA is in to treat the DATA exchanged under this DTA as confidential, protect it by adequate and appropriate security measures and not make it available to any third parties. (3) RECIPIENT agrees to disclose DATA solely to RECIPIENT SCIENTIST. RECIPIENT shall ensure that RECIPIENT SCIENTIST shall use DATA in accordance to the confidentiality obligations set out in Article 4. The confidentiality obligations of RECIPIENT hereto do not apply to DATA that, as evidenced by written records: a. was or becomes generally available to the public prior to the disclosure by PROVIDER; b. was already known to the RECIPIENT before this DTA entered into force; c. has been legitimately furnished by a third party not bound by obligations of confidentiality; or d. is or has been developed by RECIPIENT independently and without use of, or recourse to, DATA. (4) RECIPIENT may disclose DATA if and to the extent that such disclosure is required by law, regulation, or order of any governmental or competent regulatory authority. In such case, RECIPIENT informs PROVIDER of the proposed form, timing, nature, purpose and extent of the disclosure in writing in sufficient detail to allow PROVIDER to seek an appropriate protective order or other legal remedy. RECIPIENT shall reasonably cooperate with and assist PROVIDER, at PROVIDER’s expense, in seeking to limit or prevent such disclosure or to ensure that the DATA receives confidential treatment to the fullest extent possible. (5) RECIPIENT’s information submitted in the process of obtaining the DATA under this DTA shall be treated by PROVIDER with the same level of care as used to protect the DATA. 5. Intellectual Property and Ownership (1) PROVIDER retains ownership of DATA. (2) Results, including DERIVED DATA, realized by RECIPIENT shall be the property of RECIPIENT. (3) Ownership of DERIVED DATA does not grant the RECIPIENT any usage rights beyond those expressly set out in Section 2 of this DTA. No implied license or other right, in particular for COMMERCIAL USE, is granted to RECIPIENT, whether expressly, impliedly, or by estoppel. (4) This DTA does not grant RECIPIENT any license or rights to any pre-existing proprietary rights, including patents, or know-how, except as otherwise explicitly contained herein. 6. Publication (and Dissemination) In all written or oral publications concerning research using DATA or DERIVED DATA, RECIPIENT shall acknowledge PROVIDER as the source of the original DATA. PROVIDER reserves the right to request co-authorship where such attribution is appropriate in accordance with the standards of Good Scientific Practice. In such case, PROVIDER shall be contacted in writing at least thirty (30) days prior to publication (Karin.Danzer@dzne.de). 7. Warranties and Liability (1) RECIPIENT uses DATA at its own risk and responsibility and shall use DATA with prudence and appropriate caution. (2) DATA may contain errors and may be incomplete, inconsistent or inaccurate. DATA is provided to RECIPIENT “as is”, without warranties of merchantability or fitness for a particular purpose. Particularly, PROVIDER does not warrant that the use of DATA does not infringe any patent, copyright, trademark or any other proprietary rights of a third party. However, RECIPIENT agrees to promptly notify PROVIDER in writing if it becomes aware of any actual or alleged infringement of third-party rights related to the DATA or its use under this DTA. (3) RECIPIENT's liability for damages incurred by PROVIDER, especially damages resulting from illegal use of DATA or INFORMATION shall be governed by statutory liability. 8. Applicable Law/Place of jurisdiction (1) This agreement is governed by, and construed according to, German law under the exclusion of the United Nations Convention On Contracts For The International Sale Of Goods (CISG). (2) The PARTIES agree to submit to the exclusive jurisdiction of the courts in Bonn, Germany. 9. Effectiveness, Term and Termination (1) This agreement shall commence on the date this DTA is fully executed. (2). This agreement shall terminate on the earliest of the following dates: (a) when RECIPIENT scientist ceases to work for or to be employed by RECIPIENT, (b) upon any legal succession or change of control of RECIPIENT, (c) if RECIPIENT enters into liquidation or ceases to carry on business, (d) upon termination in accordance with Section 10 (3) (3) PROVIDER may terminate this agreement in case RECIPIENT infringes the provisions set out hereunder. A breach shall include but not be limited to cases in which: a) PROVIDER’s property rights are disregarded, b) confidentiality obligations are violated. (4) Upon termination of this agreement, RECIPIENT is no longer entitled to use DATA and INFORMATION and shall promptly cease any use of DATA and INFORMATION and shall verifiably delete all DATA and all INFORMATION and any copies thereof. This shall not apply to such copies of electronically exchanged or stored DATA which are necessary for routine information technology back-up. The RECIPIENT SCIENTIST may retain one (1) copy of the DATA for archival, audit, dispute resolution or other legal purposes according to mandatory law or internal compliance regulations, subject to the obligations hereunder. RECIPIENT, at its discretion, shall either delete DERIVED DATA and any copies thereof or remain bound by the terms of this agreement as they apply to DERIVED DATA. Without any further request, RECIPIENT shall confirm to PROVIDER (techtransfer@dzne.de), in writing, that it has fulfilled these obligations. (5) The provisions of Sections 3 - 7, 9 and 10 together with any necessary definitions, will survive termination of this agreement. 10. 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 foregoing also applies in case the DTA is incomplete. (2) This agreement constitutes the entire agreement and understanding between the PARTIES hereto. No modifications, amendments, or waiver of any provision of this agreement shall be valid .