License Agreement

LICENSE AGREEMENT

between

The Rotterdam Ophthalmic Institute

and

User

The Rotterdam Ophthalmic Institute (hereinafter: ROI) intends to make certain anonymized data sets concerning, in short, eye measurements publicly available in order to facilitate scientific research.

Each data set is to be considered a database in the sense of Directive 96/9/EC. ROI is the maker of these databases. The ROI offers these data sets free of charge under this License Agreement.

By downloading Data one becomes a User and agrees with the terms of the License Agreement.

Definitions

ROI

The Rotterdam Ophthalmic Institute, a private company under Dutch law, based at Schiedamse Vest 160D, 3011 BH Rotterdam, The Netherlands

User

The single natural person who, after registration, has downloaded data or the legal person, such as a foundation or a company, whose employee, intern or any other person affiliated with the legal person, has, after registration, downloaded the data.

Data

The data sets which have been downloaded. These data sets are a database in terms of Directive 96/9/EC on the legal protection of databases. The ROI is the maker of the Data in terms of mentioned Directive.

Third Party

Any party other than ROI and User.

Study Participants

The patients or volunteers in observational studies, whose anonymized eye measurement data are embedded in the Data.

Incidental Findings

Findings made in the course of the research which would have been or still could be of particular relevance for the treatment of the Study Participants.

Portal

The site of the ROI where prospective Users can register and from which the Data can be downloaded.

Terms of the License

1. The ROI grants User a non exclusive and non transferable license to use the Data for research. Transfer of ‘ownership’ of the Data to User is neither intended or achieved by this license.
2. The Data shall be used for research purposes only. User shall respect the intention of the ROI to make the Data available as a contribution to the scientific commons and use the Data accordingly. Commercial use of the Data is not permitted under this License Agreement.
3. The ROI does not make any representations or extend any warranties of any kind, either expressed or implied, in regards to the fitness of Data for the intended research or for any other purpose.
4. The Data are anonymous regarding the Study Participants and are intended to remain anonymous. The ROI has taken the necessary precautions to secure this anonymity and guarantees that according to the ethical and regulatory conditions to which the ROI is subject, the Data can be lawfully made available for research under the terms of this license agreement.
5. It is the sole responsibility of User whether User may, under the regulatory conditions applicable to User, use the Data for research. The ROI cannot be held accountable if User has used the Data for research while it has not met all the necessary regulatory requirements applicable to User for such use.
6. To the full extent permitted by applicable law in no event will the ROI be liable to the User or any Third Party on any legal theory (including, without limitation, negligence) for any loss or damage whatsoever, which may result from downloading, using the Data for research, publication of the results of the research or any other action which User may perform with the Data. If because of any action with the Data, such as, but not limited to, transmission, storage, searches on the Data, release of the Data or publication of the results of the research, the ROI would be held liable to a Third Party, User will indemnify the ROI for any damages which may result from this liability, unless it would be established that the ROI has acted grossly negligent when making the Data available for research through the Portal.
7. In the context of its research User can combine the Data with other data, which User may lawfully use for research. However, User will refrain from any activities, such as linking the Data with other data, whether publicly available or not, by which the identity of the Study Participants could in theory be retrieved.
8. User maintains policies concerning confidentiality of research data and scientific integrity and has taken all necessary administrative, technical and physical safeguards to preserve the integrity and confidentiality of the Data and to prevent non-permitted or violating use or disclosure of the Data.
9. User may not in any way transfer the Data to a Third Party, without the explicit written authorisation of the ROI, unless such transfer would be part of the standard procedures for handling data by User, such as making use of an ‘applied service provider’, or another ‘processor’ in terms of Directive 95/46/EC. It should be contractually secured that the previous section applies to this processor correspondingly. If, in the context of the research project, data from various sources need to be combined at a Third Party, the ROI will not unreasonably withhold this authorisation but may state further conditions, such as the extension of the conditions of this license agreement to that third party.
10. If, in the context of the research project, User is of the opinion to have found Incidental Findings, User shall inform the ROI as soon as possible about such findings through the contact address at the portal. Given the anonymisation procedures the ROI cannot in any way guarantee that such Incidental Findings, even if they would be still relevant for the Study Participants concerned, can be linked to those Study Participants and be used to alter or improve their treatment. Such information about Incidental Findings will nevertheless be valuable input for the quality assurance procedures of the ROI.
11. Any information about Incidental Findings will be considered confidential information by User and shall not be disclosed to any Third Party unless:
    • This information is already in the public domain, or after the date of this License Agreement becomes part of the public domain, other than as a result of an unauthorised disclosure by User;
      
    • User is required to disclose this information by a Court order. The ROI will be notified as soon as possible about any request of competent authorities or others for the confidential information which may result in such an order and will be involved in the defense against such a request.
12. User can contact the ROI if User needs additional information about the Data. The ROI will try to answer such questions insofar as reasonable, considering the efforts which the ROI must make in this respect and the anonymous nature of the Data. If the questions are more complex, the ROI will require a joint research agreement between the ROI and User first before any further steps are taken.
    
13. The ROI must be acknowledged in all publications, partially or wholly based on the Data, by formally citing at least one of the papers that are related to the Data. A list of these papers is available from the portal. The ROI welcomes a copy of such publications and may add a reference to it at the portal.
14. For the avoidance of doubt: the terms of this license agreement apply to any employee, intern, co-worker, or any other person which User has given access to the Data under the terms of this agreement.
15. The performance of this agreement shall be governed by and shall be subject to the law of the Netherlands. Any disputes will be brought before the competent Court in the ‘arrondissement’ (district) Rotterdam.