Microarray analysis of mtDNA

DAA of Biobank Lodz, University of Lodz

DAA nr XXXX This agreement governs the transfer of human personal data and genetic database data. 1. Parties This Agreement is made by and between: a) Dept. of Molecular Biophysics, University of Łódź, 14 Pilarskiego St., 90-237 Łódż, Poland, (“Provider”), with its principal office at Prez. Gabriela Narutowicza street 68, 90-136 Łódź, Poland hereby legally represented by Dominik Strapagiel, and b) XXXXXX, Both Provider and Recipient Institution are incorporated, organized and duly existing under the laws of Poland. Whereas, the Provider Institution is a University with a population biobank established with the aim to facilitate research on its collection of human biological data; the Recipient Institution (hereinafter: Recipient) is a XXXXX willing to conduct research on certain Data from the Provider; The Provider is willing to transfer certain Data to the Recipient; this Data was produced under funding from POIG grant 01.01.02-10-005/08 TESTOPLEK from the European Regional Development Fund. 2. Scope of Supply The Provider provides to the Recipient the following Data (hereafter referred to as „Data”): Genetic data derived from microarray experiments with 5800 individuals (hereafter referred to as „Subjects”). The Recipient acknowledges that the Data are provided on an “as is” basis without any warranty of satisfactory quality or fitness for a particular purpose or use or any other warranty, express or implied. 3. Data Protection Access Procedures: Data access by IP or FTP, login information will be given after signing the DAA for a period of 12 months. During this time, login password has to be changed on a regular base. The Provider confirms that for the purposes of this DAA it is entitled to supply the Data/and or personal Data to the Recipient and that consent covering the intended use has been obtained from the relevant Providers/Subjects. The Provider confirms that the project used to generate the Data has been subject to independent scientific review by a recognised body and that the planned use of the Data has approval of the appropriate ethics and scientific committees. The Recipient will use Data for purposes of the analyses set forth and within the limits set by the Research Protocol only (hereafter referred to as „Protocol”). The Protocol consists of a bioinformatic analysis within subjects. The Recipient confirms that all work using the Data will be carried out in compliance with all applicable laws, regulations, guidelines and approvals. The Recipient will retain the Data in a secure network system at such standard as would be reasonably expected for the storage of valuable and proprietary for sensitive/confidential Data. The Recipient shall refrain from tracing or identifying the identity of any Subjects who provided the Data. Recipient agrees to preserve, at all times, the confidentiality of information pertaining to identifiable Subjects. The Recipient agrees not to give access to Data, in whole or part, or any identifiable Data derived from the Data, to any third party. The Recipient shall limit access to and processing of the Data to those employees or other authorized representatives of the Recipient who: (i) need to process such Data in order to conduct their work in connection with the Data and the Protocol and (ii) have signed agreements with the Provider obligating them to maintain the confidentiality of the Data and any information to be derived thereof or disclosed to them. The Recipient shall not attempt to contact any Data subject. The Recipient shall take reasonable steps to delete Data for a given subject when the Provider deems that subject to have withdrawn his or her consent. The Recipient confirms that it will deal promptly and appropriately with any withdrawals by Providers/Subjects which the Provider notifies to the Recipient. On the Completion of the Research Project or on the termination of this agreement, the Recipient will delete the Data and confirm to the Provider (in writing) that this has taken place. On reasonable notice to the Recipient, and in order to confirm or investigate compliance with the provisions of this DAA, the Provider may itself or via appropriate third parties: • choose to inspect the premises and other relevant facilities of the Recipient, in order to review the security, storage or other arrangements for the Data; • request such additional information about the Protocol and/or its progress as the Provider may, from time to time, reasonably require. • the Provider will bear the costs of such audits unless a Data default within the procedures and processes of the Recipient is discovered, in which case the Recipient will be obliged to re-imburse the reasonable costs of the Provider and any relevant third parties. Any provisions of this agreement intended to protect the rights of human Providers/Subjects shall survive the expiry or termination of this agreement. 4. Intellectual Property Title to the Data is and remains in the ownership of the Provider and the Data are made available to the Recipient as a service to the research community. The Recipient shall be entitled to any inventions to the extent that these result from his own independent use of the Data. He shall grant the Provider a worldwide non-exclusive royalty-free irrevocable research licence with respect to any such inventions. If the Recipient elects not to seek any intellectual property protection with respect to such inventions he shall transfer any such rights to the Provider at no cost. To the extent that the Provider and the Recipient have each contributed to an invention with respect to the material, they shall jointly own any rights to such an invention. Inventions made solely by the employees or agents of one party shall be owned by that party. Except as expressly set forth in this Section, nothing herein shall be deemed to grant to either the Provider or Recipient any rights under the other party’s patents, patent applications, trademarks, copyrights, trade secrets, know how (whether patentable or unpatentable) or other intellectual property rights. 5. Return and publication of Results The Recipient agrees that the Provider will publish a paper that describes the results of any analyses of the Material, according to the following: • XXXX • XXXX • XXXX 6. Credits The Recipient agrees to acknowledge the source of the Data in any publications or other public disclosures reporting use of it. The following form of words should be used: “We acknowledge the Provider, funded by [..] for the supply of the Data”. 7. Reports/Notification The Recipient shall provide a copy of any report of its Results that derive from use of the Data before publication to the Provider in any format requested. Notices required under this DAA will be in writing and will be delivered by email to the addresses set out below or (in the event of a failure to deliver an email) by post to the Provider or the Recipient and will be deemed to be given, in the case of delivery by email, upon receipt at the Recipient ’s email server (unless an automatic response indicating an undeliverable message is received) and, in the case of delivery by post, on the date of delivery (or, if not a business day, on the first business day thereafter). 8. Expiry/Termination This agreement shall expire XXXXXX, unless earlier terminated by the mutual written agreement of the parties. The Provider will be entitled to terminate this DAA forthwith by written notice to the Recipient if: • The Recipient commits any breach of a data provision of this DAA and, in the case of a breach capable of remedy, fails to remedy the same within 20 days after receipt of a written notice giving particulars of the breach and requiring it to be remedied; a breach will be considered capable of remedy if the Recipient can comply with the provision in question in all respects other than as to the time of performance, provided that time of performance is not of the essence. • The Recipient personnel cease to be employed (or otherwise engaged by) the Recipient Institution; or • The Recipient Institution ceases, is likely to cease, or threatens to cease carrying on business. The rights to terminate this DAA given by this clause will be without prejudice to any other right or remedy of either party in respect of the breach concerned, if any, or any other breach. Upon expiry or termination of this Agreement: • The grant of rights to the Recipient will be automatically terminated; • The Recipient shall delete the data. 9. Charges/Payment In consideration for the Provider’s entering into this Agreement, the Recipient agrees not to pay the Provider for access to the Data. 10. Assignment and sub-contracting The Recipient will not be entitled to assign this DAA or any of its rights or obligations hereunder without first having received the written approval of the Provider. The Recipient will not sub-contract the performance of any of its obligations under the DAA or any part thereof without having first obtained the prior written consent of the Provider. In the event that consent is granted, the Recipient shall be responsible for the acts, defaults and omissions of its sub-contractors as if they were the Recipient’s own, and any consent given will not relieve the Recipient of any of its obligations under this DAA. 11. Limitation of Liability and Indemnity The XXXXXX will indemnify the Provider against all losses (whether direct or indirect, reasonably foreseeable or specifically contemplated by the parties), damages, costs, expenses (including but not limited to reasonable legal costs and expenses) that it incurs as a result of: (i) the use, storage or disposal of human personal data by the Recipient; or (ii) any negligence or wilful default of the Recipient, provided that the Provider agrees to use its reasonable endeavours to mitigate any loss. BOTH PARTIES ACKNOWLEDGE AND AGREE THAT THE DATA IS BEING SUPPLIED WITH NO WARRANTIES, EXPRESS OR IMPLIED, AND THE PROVIDER EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR THAT THE DATA WILL NOT DEGRADE IN RECIPIENT’S SAFE KEEPING. NEITHER PARTY MAKES ANY REPRESENTATION THAT THE USE OF THE DATA WILL NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT WHETHER OR NOT THAT PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF OR IS OTHERWISE ON NOTICE OF SUCH POSSIBILITY. 12. Force majeure If any party is prevented from, hindered or delayed in performing any of its obligations under this DAA by reason of a Force Majeure Event, such party will promptly notify the other of the date of its commencement and the effects of the Force Majeure Event on its ability to perform its obligations under this DAA. If mutually agreed by the parties, then the obligations of the party so affected will thereupon be suspended for so long as the Force Majeure Event may continue. The party affected by a Force Majeure Event will not be liable for any failure to perform such of its obligations as are prevented by the Force Majeure Event provided that such party will use every reasonable effort to minimise the effects thereof and will resume performance as soon as possible after the removal of such Force Majeure Event. If the period of non-performance exceeds 28 days from the start of the Force Majeure Event then the non-affected party will have the option, by written notice to the other party, to terminate this DAA. For the purpose of this clause, Force Majeure Event means any event beyond the reasonable control of a party including, without limitation, acts of God, war, terrorism, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, fire, flood or storm. For the avoidance of doubt, strike, industrial action, failure of technology systems, third party insolvency and failure of the Provider or any other third party will not be considered to be Force Majeure Events. The provisions of this clause will not affect any other right which either party may have to terminate this DAA. 13. Applicable law and jurisdiction This DAA will be governed by and construed in accordance with the laws of Poland; parties agree that the Polish courts will have exclusive jurisdiction over any suit, action, proceedings or dispute arising out of, or in connection with, this Agreement. 14. General This DAA governs the relationship between the parties to the exclusion of any other terms and conditions and, together with any other document referred to in this Agreement, constitutes the whole agreement between the parties in relation to the subject matter hereof. If there is any conflict between the provisions of this DAA and any of the annexes and related documents (including, but without limitation, the provisions of the Access Procedures) then the provisions of this DAA will apply. A waiver, delay or forbearance by either party, whether express or implied, in enforcing or exercising any of its rights or remedies hereunder will not constitute a waiver of such right or remedy. No provision of this DAA is intended to be enforceable by any person who is not a party to this Agreement and nor are any rights granted to any third party under statute or otherwise. All variations to this DAA must be agreed, set out in writing and signed on behalf of the parties before they take effect. 15. Language and Copies of the Agreement. This Agreement has both an English version and a Polish version. Both versions are equally authentic. Where a comparison of the authentic texts of both versions of this Agreement discloses a difference in meaning, the meaning which best reconciles the texts, having regard to the object and purpose of this Agreement shall be adopted. Each Party has received one (1) duplicate original in English and Polish, and each original has the same legal effect. Signatures Yours faithfully Accepted and agreed For and on behalf of the Provider Institution For and on behalf of Recipient Institution Dominik Strapagiel XXXXX strapag@biol.uni.lodz.pl