GR@ACE_StageI.v02

Data Transfer Agreement of GR@ACE/DEGESCO GWAS datasets.

Fundació ACE. Institut Català de Neurociències Aplicades on Behalf of the Genome research at Fundació ACE (GR@ACE) consortium and Dementia Genetics Spanish Consortium (DEGESCO) and (Data Receptor Herewith) ______________________________________ Data Transfer Agreement of GWAS datasets for research purposes. These terms and conditions govern access to the managed access datasets (details of which are set out in Appendix) to which the User Institution has requested access. The User Institution agrees to be bound by these terms and conditions. ______________________________________   THE UNDERSIGNED, Fundació ACE. Institut Català de Neurociències Aplicades with a registered address at Gran Via de Carles III, 85bis, 08028, Barcelona, Catalonia, Spain represented by Mr. Lluís Tárraga Mestre , CEO, hereinafter referred to as “Provider” And Your Project/University/Company/Address ……………………………………………………………………… represented by Dr………………………., and approved by Ethical Review Board (ERB) ………………………………………. hereinafter referred to as the “Recipient”; Hereinafter collectively referred to as the “Parties”. WHEREAS: The Providers has GWAS data available, which has been obtained on the basis of Ethics Committee approvals and informed consent and the informed consent restricts the use of the data to research purposes only. The Recipient is interested in conducting research with this GWAS Data. The Providers are willing to provide Data to the Recipient, under the conditions set out in this agreement hereto. The Provider and the Recipient agree that the Applicant is not a party to this Agreement. All provisions stating a direct duty or obligation of the Applicant are to be interpreted as an obligation of the Recipient to obligate the Applicant internally only. Article 1. Definitions 1. "Original Data" The description of the Data being transferred, specified in the Implementing Letters of this Agreement. 2. "Data" Original Data and Unmodified Derivatives. The Data shall not include: (a) modifications, or (b) other data created by the Recipient through the use of the Data which are not Modifications or Unmodified Derivatives. 3. “Databank” Collections of GWAS/sequencing data 4. "Unmodified Derivatives" Data created by the Recipient which constitute an unmodified functional subunit or product expressed by the original data. Examples include: files containing a fraction of genotyped and phenotypic data in different formats or genotypes imputed using different methodologies, or analyzed in other ways to generate information of human haplotypes or gene dosage (Copy Number Variation data, etc). 6. "Modifications" File data created by the Recipient which may contain/incorporate or mix part the data, such as, but not limited to, specific phenotypes, haplotypes, polygenic risk scores, genotypes, loci, chromosome or gene-sets 7. "Pseudo-anonymized Donor Information" Pseudo-anonymized coded information concerning the donor of the human data: I. Clinicopathological information of the donor including, age and sex of the donor, clinical information and recent drug history. II. The information provided does not allow identification of the donor without disproportionate efforts. 8. “Applicant” The scientist employed by working for or working under auspices of the Recipient requesting for Data required for a research project specified in the Application Form. 9. "Commercial Purposes" The sale, lease or license of the Data. Commercial purposes shall also include uses of the Data to produce or manufacture products for general sale. Commercial Purposes shall also include uses of the Data or Modifications by any organization, including Recipient, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the Data or Modifications to a for-profit organization. However, industrially sponsored academic research shall not be considered a use of the Data or Modifications for Commercial Purposes per se, unless any of the above conditions of this definition are met. 10. “Collection” All Data remaining after completion of the research project as specified in the Application Form, retained by the Recipient subject to this DTA. 11. Article 2. The Data Provided 1. The “Original Data” that is covered by this Agreement includes Original Data to be specified in the Implementing Letters of this Agreement including Pseudo-anonymized Donor Information and available associated know-how. 2. Each Provider represents and warrants, a. the Data has been collected and maintained in full compliance with all applicable national and international laws and regulations including requirements for informed consent; b. it is not aware of any defects in the Data or of any other circumstances that would limit the intended use and value of the Data to Recipient under this Agreement. 3. The Data accompanied by Pseudo-anonymized Donor Information when provided will be transferred coded. Under no circumstances shall the identity of the donor be provided to the Recipient. 4. The Recipient shall not carry out any procedures with the Pseudo-anonymized Donor Information (linking, comparison, processing) with which the identity of the donor could be derived. 5. Recipient shall not distribute or release the Data to any person other than personnel under Recipient’s scientist’s direct supervision. Recipient shall ensure that no one will be allowed to take or send the Data to any other location, unless written permission is obtained from Provider. Article 3. Scope of this Agreement 1. This Agreement contains the terms and conditions under which the Data shall be transferred to the Recipient and subsequently made available to the scientists employed by or working for the Recipient. 2. The Data shall be used only for research in Recipient’s institution, such research to be limited to conducting biomedical research in the data received related to human genetics and that nothing in this Agreement is intended to change or modify Recipient’s rights and obligations under such agreement. Article 4. Rights to the Data 1. The Provider retains the ownership rights to the Data, including Unmodified Derivatives and any Data contained or incorporated in Modifications. The Data remains subject to each Provider’s ownership during and after completion of the research projects conducted by the scientists employed by or working for the Recipient. 2. Recipient shall not distribute or release the Data to any person other than the scientists specified by the Recipient, and shall ensure that no one will be allowed to take or send this Data to any other institution. In all other circumstances, when the Recipient wishes to make the Data available to a third party, the third party is required to subject an Application Form to the Provider and to conclude a separate DTA with the Provider. In cases of secondary use of the Data by the third party, no further financial contribution is required, provided that the third party is a non-profit organisation. 3. Recipient shall no use the data for including it or for participating in International Consortia because Dementia Genetics Spanish Consortium (DEGESCO) and Genome Research at Fundació ACE consortium (GR@ACE) will never delegate their participation in International Consortia to thirty parties or other active research groups or consortia. 4. Neither Recipient nor the scientists employed by the Recipient, nor any other third party shall have rights in the Data other than as provided for in this Agreement. 5. At all times each Provider retains the right to recall the Data on reasonable grounds. Upon a notified request from the Provider, the Recipient shall discontinue the use of the Data and remove it. Reasonable grounds to recall the Data shall include the following: a. The Applicant or scientists employed by the Recipient fail to comply with conditions of this Agreement; b. The Recipient fails to fulfill the obligations laid down in art. 9 paragraph 1 of this Agreement; c. The donor or, in case of death, the family of the donor, insists on withdrawing the consent to the use of the Data in research; d. Other grounds substantiated for by the Provider. The Recipient shall be indemnified for eventual financial contribution paid subject to art. 9 paragraph 1 of this Agreement in cases where the Data is recalled on the grounds mentioned under c and d. Article 5. Commercial Purposes The Data are made available for the research mentioned in art. 3 paragraph 2 only. Recipient agrees that the Data will not be used for any other purpose. This Agreement and the resulting transfer of Data constitute a license to use the Data solely for non-for-profit purposes. Recipient agrees that nothing herein shall be deemed a grant under any Provider’s patents (either existing or future) or any rights to use the Data for any products or processes for profit-making or Commercial Purposes. The Data will not be used in research that is subject to consulting or licensing obligations to another institution, corporation or business entity unless written permission is obtained from Provider. Recipient shall have no rights in the Data other than as provided in this Agreement. Article 6. Application for the Data and Transfer 1. The Applicant can file an application by the Provider via EGA (European Genome Phenome Archive), requesting for certain Data needed for a research project specified in the Application Form. The Applicant will answer questions in the Application Form and disclose all information needed for evaluation of the application by the Data Accesing committee (D.A.C) of DEGESCO. Solely when the Application Form has been also evaluated positively by the Provider, the available Data shall be transferred subject to this Agreement and signing of the Implementing Letter. 2. Except reasonable doubt, the Provider assumes that the person filing the Application Form and signing the Implementing Letter has been authorized by the Recipient thereto. Specifically, a letter by the Local Institutional Review Board (IRB) will be requested indicating that they reviewed and authorized to the signing Recipient to get access the GR@ACE/DEGESCO dataset for research purposes. 3. The Recipient has the obligation to inform the Applicant(s) and scientists employed by the Recipient of the provisions of this Agreement. Article 7. Delivery 1. When application for the Data has been evaluated positively, the Provider shall hold the GWAS Data, subject to this Agreement, available for the Recipient. The Applicant shall either electronically collect the Data from the respective Provider via EGA repository. 2. The Recipient shall be responsible for all potential costs, insurance and liability related to the sending of the Data. Article 8. Inventions 1. The Recipient retains ownership of the results obtained through research conducted by the scientists employed by the Recipient. The Provider gets in return a non-exclusive, non-transferable, royalty free, with no right to sub-license, license to use the Results of Recipient for internal scientific and research purposes. 2. If research results obtained through the use of the Data provided under this Agreement give rise to the inventions including substances of potential commercial value, the Recipient agrees to enter into a separate agreement with the Providers in accordance with art. 9 paragraph 2 of this Agreement. 3. The Recipient will not file patent application(s) claiming inventions made by the Recipient through the use of the Data or sell or transfer to a third party including its affiliated legal entities any intellectual property rights arising from these inventions without prior written agreement as mentioned in paragraph 2 of this article. Article 9. Financial Contribution 1. In principle no financial contribution is asked, but it can be decided otherwise on a case by case basis. On a case by case basis, the Data shall be provided to the Recipient at the amount of the fee indicated in the Implementing Letters, meant to compensate for part of the costs involved in Databank. The exact amount of financial contribution shall be determined per application by each Provider and specified in the respective Implementing Letters. 2. When inventions resulting from research performed on the Data lead to proceeds by the means of commercial exploitation of the invention including income from royalties or lump sum payments from licensees, in consideration of Providers’ role in the invention as the supplier of the Data, the respective Provider shall be entitled to a reasonable share in these proceeds. Further conditions thereto will be set out in a separate agreement. Article 11. Reporting results to the Providers 1. After completion of the study, the Applicant will send a one page progress report on the research specified. The progress report should be sent to contact person of GR@ACE/DEGESCO GWAS project, Dr Agustín Ruiz, aruiz@fundacioace.org 2. The Recipient will provide Provider the research Results derived from the Data within the time frame specified in this DTA. 3. Additional findings on individual Data relevant for maintenance and improvement of the collection quality of the Databank should be made available to the respective Provider. Such additional findings may include but are not limited to the results obtained by research procedures. In case these research findings are of confidential nature, the respective Provider shall enter into a separate non-disclosure agreement with Recipient thereto. 4. In exceptional cases the pressing health interests of the donor can take precedence above the confidentiality of the findings as mentioned in second paragraph of this article. Article 12. Publications and Acknowledgement 1. The Providers should be mentioned in all publications resulting from research using the Data, under authors section, started in the following manner: “GR@ACE/DEGESCO consortium”. See Appendix Table. 2. Research Articles/Authorship/Publication policy. See Appendix Table. a. For manuscripts signed by the Recipient group or small collaborations, the GR@ACE/DEGESCO consortium request only the authorship for the consortium as a whole. Hence the recipient only needs i) to include the “GR@ACE/DEGESCO consortium” author in authorship, ii) to introduce literally the acknowledgement formula specified by the Provider (annex 1) describing the collaborating group and the GR@ACE/DEGESCO origin of funds. b. For manuscripts authored by large International consortia (i.e. but not limited to IGAP, CHARGE, EADB, IFTDGC), the authorship of articles will be negotiated directly between the Steering committee (SC) of the GR@ACE/DEGESCO consortium and the SC of the international consortium requesting access. The number and position of authors should be requested in a negotiated, fair and proportional way. GR@ACE/DEGESCO consortium will never delegate these negotiations to thirty parties nor the Recipient researchers. 3. Every year the Recipient will send the list of publications resulting from research in which the Data has been used. A list of publications will appear on the website of DEGESCO (https://ciberned.es/proyectos/degesco.html). Article 13. Advisory tasks of the Providers When requested by the Recipient or the Applicant, the Provider, in its sole discretion, may decide to offer scientific advice on how to obtain the best results with the Data, communicate additional Pseudo-anonymized donor information or provide other services relating to a certain research project. Co-authorship should be considered where possible and when needed, special conditions for such services shall be set out in a different agreement. Article 14. Completion of the research project and Collections 1. Within thirty days after the completion of the research project the Applicant shall remove all Data under this DTA. 2. The Recipient, only after written approval of respective Provider, may retain the Data remaining after the completion of the research for the purpose of: a. validation of conducted scientific research as specified in the Application Form; b. and/or other purposes explicitly approved for by the respective Provider, provided that these purposes are research related, via an amendment of the original application form. 3. The Applicant is considered to be responsible for the Collection, unless another person has been explicitly designated by the Recipient. When Applicant’s employment is terminated, the Recipient shall inform the Providers whether the Collection will be retained by the Recipient subject to this Agreement and shall designate a person responsible for the dataset collection. When Applicant wishes to retain the Collection, but is no longer employed by the Recipient, a separate DTA must be signed. 4. The collection may not be used for purposes inconsistent with this Agreement. Article 15. No Warranty The Data is provided as a service to the research community. It is being supplied to the Recipient with no warranties, express or implied, including any warranty of fitness for a particular purpose. The Provider makes no representations that the use of the Data will not infringe any patent or proprietary rights of third parties. Article 16. Term 1. This Agreement shall enter into force on the date of its signature by the Parties. 2. This Agreement is concluded for an indefinite period of time. Either Party may terminate this Agreement at any time and for any reason upon ninety (90) calendar days prior to written notice. Such termination shall not affect any obligations by either Party incurred up to the date of termination, nor shall it affect the ability of the Recipient to complete any research use of Data or Pseudo-anonymized Donor Information transferred hereunder. 3. When this Agreement is terminated the scientists employed by the Recipient will discontinue the use of Data and will, upon direction of the respective Provider, erase any remaining Data. The Recipient shall furnish the respective Provider with a certificate attesting to such destruction. Article 17. Miscellaneous 1. The articles 4, 8, 9, 12, 15 will survive termination of this Agreement. 2. The Recipient shall ensure that the Data is used in compliance with all applicable laws and regulations. 3. This Agreement is not assignable, whether by operation of law or otherwise, without the prior written consent of the Provider. 4. This Agreement shall be governed and enforced in accordance with the Laws of Spain. All disputes arising in connection with this Agreement shall be attempted to be resolved amicably. If the dispute persists it shall be submitted exclusively to the competent court in Barcelona, Spain.   PROVIDER: Name: ¿? Job Title: Date: Signature:____________________ RECIPIENT: Institution: Name: Job Title: Date: Signature: PROVIDER: Name: ¿? Job Title: Date: Signature:____________________ APPLICANT: I have read and understood the conditions and obligations imposed by this Agreement, Name: Job Title: Date: Signature:   Annex 1 1. Paragraph to be included in Acknowledgements section: “The Genome Research at Fundacio ACE and Dementia Genetics Spanish consortium (GR@ACE/DEGESCO) would like to thank patients and controls who participated in this project. GR@ACE/DEGESCO GWAS program is funded by Fundacion bancaria “La Caixa”, Grifols SA and Fundació ACE. Institut Català de Neurociències Aplicades. P.S.J and A.R. has received also support by grant PI16/01861. Accion Estrategica en Salud integrated in the Spanish National I+D+i Plan and financed by ISCIII (Instituto de Salud Carlos III)-Subdireccion general de Evaluacion and the Fondo Europeo de Desarrollo Regional (FEDER- “Una manera de Hacer Europa”). DEGESCO is also sponsored by the Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED, Spain). Control samples and data from patients included in this study were provided in part by the National DNA Bank Carlos III (www.bancoadn.org, University of Salamanca, Spain) and Hospital Universitario Virgen de Valme (Sevilla, Spain) and they were processed following standard operating procedures with the appropriate approval of the Ethical and Scientific Committee. The genotyping service to generate GR@ACE/DEGESCO GWAS data was carried out at CEGEN-PRB3-ISCIII; it is supported by grant PT17/0019, of the PE I+D+i 2013-2016, funded by ISCIII and ERDF”. GR@ACE/DEGESCO consortia would also like to thank to all researchers contributing to this project. A complete list of collaborators involved in the GR@ACE/DEGESCO GWAS can be found at https://ciberned.es/proyectos/degesco.html.” 2. List of authors appearing as collaborators in manuscripts using this dataset (secondary lists of authors). The GR@ACE study group Abdelnour C1,2, Aguilera N1, Alarcon E, Alegret M1,2, Boada M1,2, Buendia M1, Cañabate P1,2, Carracedo A3,4, de Rojas I1, Diego S1, Espinosa A1,2, Gailhajenet A1, García González P. Gil S1, Guitart M1, González Pérez A5, Hernández I1,2, Ibarria, M1, Lafuente A1, Macias J5, Martín E1, Mauleón A1, Monté G1, Montrreal L, Morañas O3, Moreno-Grau S1,2, Orellana A1, Ortega G1,2, Pancho A1, Pelejà E1, Pérez-Cordon A1, Pineda JA, Preckler S1, Quintela I3, Real LM6, Rodríguez-Gómez O1,2, Rosende-Roca M1, Ruiz A1,2, Ruiz S1,2, Sáez ME5, Sanabria A1,2, Santos-Santos MA1, Sotolongo-Grau O1, Tárraga L1,2, Valero S1,2, Vargas L1 (1. Research Center and Memory clinic Fundació ACE. Institut Català de Neurociències Aplicades. Universitat Internacional de Catalunya. Barcelona. Spain; 2. CIBERNED, Center for Networked Biomedical Research on Neurodegenerative Diseases, National Institute of Health Carlos III, Ministry of Economy and Competitiveness, Spain; 3. Grupo de Medicina Xenómica, Centro Nacional de Genotipado (CEGEN-PRB3-ISCIII). Universidade de Santiago de Compostela, Santiago de Compostela, Spain; 4. Fundación Pública Galega de Medicina Xenómica- CIBERER-IDIS, Santiago de Compostela, Spain; 5. CAEBI. Centro Andaluz de Estudios Bioinformáticos., Sevilla, Spain; 6. Unidad Clínica de Enfermedades Infecciosas y Microbiología. Hospital Universitario de Valme, Sevilla, Spain) DEGESCO consortium Adarmes-Gómez AD1, 2, Alarcón-Martín E3, 4, Álvarez V5, 6, Antequera M7, Antúnez C7, Baquero M8, Bernal M1, Blesa R2, 9, Boada M2,4, Buiza-Rueda D1,2, Bullido MJ2,10,11, Burguera JA8, Calero M2, 12, Carrillo F1, 2, Carrión-Claro M1, 2, Casajeros MJ13, Clarimón J2,10, Cruz-Gamero JM4, de Pancorbo MM14, de Rojas I3, del Ser T13, Fortea J2, 10 , Franco E1, Frank-García A2, 15, 16, García-Alberca JM17, Garcia Madrona S13, Garcia-Ribas G13, Gómez-Garre P1,2, Hernández I2,3, Hevilla S17, Jesús S1, 2, Labrador Espinosa MA1, 2, Lage C18, Legaz A7, Lleó A2, 10 , López de Munáin A19, López-García S17, Macias D1, 2, Manzanares S7,19, Marín M1, Marín Muñoz J7, Marín T17, Marquié M3, Martín Montes A2,15,16, Martínez B7, Martínez C6,21, Martínez V7, Martínez-Lage Álvarez P22, Medina M2, 12,, Mendioroz Iriarte M23, Menéndez-González M6, 24, Mir P1, 2, Molinuevo JL25, Monté G3, Montrreal L3, Moreno-Grau S2,3, Orellana A3, Pastor AB12, Pastor Muñoz P26, Pérez Tur J2, 27, 28, Periñán-Tocino T1, 2, Piñol Ripoll-Ripoll G2,29, Rábano A2,12,30, Rodrigo S1, Rodríguez-Rodríguez E17, Royo JL4, Ruiz A2,3, Sanchez del Valle Díaz R31, Sánchez-Juan P17, Sastre I2, 10, Sotolongo-Grau O3, Tárraga L2,3, Valero S2,3, Vicente MP7, Vivancos L7 (1. Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología. Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain; 2. Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain; 3. Research Center and Memory clinic Fundació ACE. Institut Català de Neurociències Aplicades. Universitat Internacional de Catalunya. Barcelona; 4. Dep. of Surgery, Biochemistry and Molecular Biology, School of Medicine. University of Málaga. Málaga. Spain; 5. Laboratorio de Genética Hospital Universitario Central de Asturias, Oviedo; 6. Instituto de Investigación Biosanitaria del Principado de Asturias (ISPA); 7. Unidad de Demencias. Hospital Clínico Universitario Virgen de la Arrixaca; 8. Servei de Neurologia, Hospital Universitari i Politècnic La Fe; 9. Memory Unit, Neurology Department and Sant Pau Biomedical Research Institute, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; 10. Centro de Biologia Molecular Severo Ochoa (C.S.I.C.-U.A.M.), Universidad Autonoma de Madrid, Madrid, Spain: 11. Instituto de Investigacion Sanitaria "Hospital la Paz" (IdIPaz), Madrid, Spain; 12. CIEN Foundation; 13. Hospital Universitario Ramón y Cajal; 14. BIOMICs, País Vasco; Centro de Investigación Lascaray. Universidad del País Vasco UPV/EHU; 15. Instituto de Investigacion Sanitaria "Hospital la Paz" (IdIPaz), Madrid, Spain; 16. Neurology Service, Hospital Universitario La Paz (UAM), Madrid, Spain; 17. Alzheimer Research Center & Memory Clinic. Andalusian Institute for Neuroscience. Málaga. Spain; 18. Neurology Service and CIBERNED, 'Marqués de Valdecilla' University Hospital (University of Cantabria and IDIVAL), Santander, Spain; 19. Hospital Donostia de San Sebastían; 20. Fundación para la Formación e Investigación Sanitarias de la Región de Murcia; 21. Servicio de Neurología -Hospital de Cabueñes-Gijón; 22. Centro de Investigación y Terapias Avanzadas. Fundación CITA-alzheimer; 23. Navarrabiomed; 24. Servicio de Neurología -Hospital Universitario Central de Asturias, Oviedo; 25. Barcelona βeta Brain Research Center – Fundació Pasqual Maragall. 26. Department of Neurology, Hospital Universitari Mutua de Terrassa, University of Barcelona School of Medicine, Barcelona, Spain; 27. Unitat de Genètica Molecular. Institut de Biomedicina de València-CSIC. 28. Unidad Mixta de Neurologia Genètica. Instituto de Investigación Sanitaria La Fe; 29. Sección de Neurología, Unidad de Ictus, Hospital Universitari Arnau de Vilanova de Lleida, Universitat de Lleida, Institut de Recerca Biomédica de Lleida (IRBLLeida), Lleida, España; 30. BT-CIEN; 31. Hospital Clínic Barcelona)   Appendix Table Publication Policy for Researchers accessing to GR@ACE/DEGESCO dataset and including GR@ACE/DEGESCO results in their manuscripts Methodological Papers manuscripts not describing new loci related to Human diseases Single researcher or research institution conducting new discovery studies using the GR@ACE/DEGESCO dataset for replication purposes National or International consortia accessing GR@ACE/ dataset for replication or validation purposes Acknowledgment Section YES YES YES Side list of Collaborators No YES YES Authorship Request No No YES. Negotiation required.* * Proportional authorship is ever requested. According to the MDTA, GR@ACE/DEGESCO authors will not delegate to thirty parties the participation in other nationwide or international consortia. No researcher accessing to this dataset can incorporate results derived from GR@ACE/DEGESCO to International consortia. A formal negotiation between GR@ACE/DEGESCO DAC/SC and the Steering committee of the accessing International consortium is required in these cases.