In the following, we would like to present our Terms of Use, which we apply to the free use of our Classifier. The Classifier is an AI-based tool (“Tool”) that can be useful to predict the tumor class from methylation profiles with high accuracy.
The Tool is a research tool that provides research results which are not clinically validated nor is it a medical device or has a CE marking. The Tool is not intended for any medical, diagnostic or commercial use. It may be used only in accordance with the following Terms of Use. User is any individual accessing the Tool (“User”).
Section 1 Subject-matter of the Agreement
- The Tool is based on a DNA methylation-based molecular classification algorithm. Different implementations of the Tool can be used for the classification of brain tumors, sarcomas or other tumors. The Tool facilitates a comparison between the individual methylation profile of a tumor with a reference database as well as the production of a confidence score. In addition to this, the Tool potentially facilitates other data analysis tasks such as for example but not limited to working out a DNA copy number profile or the predication of the MGMT-promoter methylation status.
- The User shall be entitled to use the Tool for the research and scientific purposes described herein upon acceptance of this End User Licensing Agreement (“EULA”).
- The right to use the data and certain data sets used to develop the Tool is not subject of this Agreement and must be agreed separately.
- Any general terms and conditions of the User shall not apply.
- The Tool can be used free of charge.
Section 2 Software Description and Function of the Tool
- Epignostix will provide a current version of the Tool with each usage.
- The function of the Tool and instructions for use of the Tool are described on the website www.epignostix.com.
Section 3 Use of the Tool, Registration and Authentication, Technical Preconditions
- The Tool can be accessed and used through the website www.epignostix.com.
- Active use of the Tool through the website requires registration and authentication of the User. A registration is assigned to an organization engaged in activities establishing relevant scientific interest for using the Tool. The registration of a private user is not permissible. Epignostix therefore reserves the right to only grant those Users access who can prove that they have an affiliation with an organization with a relevant scientific interest for using the Tool. The User shall be obliged to give Epignostix correct and full responses to the data requested during registration and authentication.
- The individual carrying out the registration request must have the authority to accept these Terms of Use on behalf of the organization.
- After registration, the User shall receive a user identification code, a license number, a password and a user account. The User has to protect and keep the user identification allocated to the User and the password safe from access by third parties. In the event of unauthorized access, the User shall inform Epignostix immediately. The identification code includes five individual User identifications; additional codes may be provided on request.
- If an incorrect password is entered on three consecutive occasions during sign in using the same user identification, the User will be blocked temporarily from accessing the Tool until the User proves their identity via security enquiry.
- In order to use the Tool for classification of tumor samples the User is requested to upload files from such samples. File names of samples which are uploaded by the User must not contain patient information but shall be anonymized. It is the User’s responsibility to use only such samples, with regard to which the User has all rights for classification. Should a third party claim damages from Epignostix due to an alleged infringement of rights based on the used samples for which User is responsible, the User will indemnify Epignostix from all costs incurred in relation to such claim, including, but not limited to, reasonable legal costs.
- In order to have uninterrupted access to the website the User shall ensure to upload raw data files.
- The Tool will anonymize raw files. After anonymization, original files will be deleted and are no longer accessible.
Section 4 Scope of the Right of Use
- Epignostix grants User the royalty-free and non-exclusive right to use the Tool for the classification of tumor samples for research and scientific purposes only, including but not limited to lecturing or publications.
- The rights of use of the Tool do include performing validation, assessing the reproducibility of the classifier predictions across laboratories, and testing the functionality of the Tool in general.
- User shall not be entitled to use the Tool in any other way, i.e. the User is not entitled to copy, modify, reverse-engineer, distribute or make available the Tool to third parties or otherwise use the Tool in a commercial way or for diagnostic purposes. Also any results of the use of the Tool may be used for research and scientific purposes only and may not be used commercially or for diagnostic purposes. Commercial use within the meaning of this EULA shall be any use that directly or indirectly has the purpose to generate revenue. Diagnostic purposes within the meaning of this EULA shall be any use that directly or indirectly has the purpose to provide a diagnostic result in the context of patient management.
- Epignostix alone is entitled to all intellectual property rights in the Tool, in particular patent rights and copyright. The Tool contains patented parts.
- The rights of use granted according to this section 3 may be terminated by Epignostix with good cause, in particular in the event of a breach of these Terms of User. Epignostix reserves the right to discontinue access to the Tool temporarily or permanently.
- Additional rights of use, in particular pertaining to joint collaborations between Epignostix and User, and which are not disclosed as part of this agreement, could be granted to User under a separate agreement.
- If the User breaches any of the above-mentioned provisions, in particular section 4.3, all rights of use granted under these Terms of Use shall immediately become invalid and automatically revert to Epignostix as licensor. In this case, Epignostix is authorized to deny the User the right to access the Tool and delete its user account.
Section 5 Maintenance, Upgrades and Support
- Epignostix will not furnish any warranty with regard to availability or freedom from defects of the Tool. However, Epignostix endeavors to ensure an uninterrupted availability of the Tool and to resolve any technical defects occurring within its sphere of responsibility as quickly as possible.
- Epignostix is entitled to modify the Tool including its service offer and its user interface at any time. Epignostix will inform the User clearly and comprehensively about such modifications through its website. In the event that Epignostix modifies the Tool older versions may still be made available.
Section 6 Collection of User Data and Data Protection
- Important objectives of the Tool are the expansion of the reference database with DNA methylation profiles, a comparison of individual methylation profiles of a tumor with the reference database as well as the preparation of the confidence score for scientific purposes. Epignostix therefore reserves the right to only grant those Users access who can prove that they have a relevant scientific or research interest and who are willing to contribute to the further development of the Tool.
- To contribute to the aforementioned objectives User agrees for the anonymized data collected during the use of the Tool, to be used for further development and improvement of the Tool.
- The Parties agree that in the course of performing their activities hereunder and to the extent one Party provides to the other Party access to personal data, they shall comply with their obligations under all applicable privacy laws, including without limitation the Regulation EU 2019/679 (“GDPR”).
- The data privacy policy for the Tool applies.
Section 7 Warranty and Liability
- As a result of the use of the Tool being free of charge, Epignostix can only be held liable for intent and gross negligence. Any further liability of Epignostix is excluded. The liability of Epignostix is in particular excluded in cases where the User, in breach of section 4.3 would use the results of the Tool for diagnostic purposes.
- Epignostix does not offer any warranty with regard to the Tool or with regard to any information provided by the Tool. The User is aware that the Tool is for research and scientific purposes only and it is not a medical or diagnostic device. The User is solely responsible for the use of the Tool.
Section 8 Term and Termination
- The Parties agree that this Agreement shall remain in effect for an initial period of one year from the date of the registration and thereafter automatically extends for one additional year unless terminated by either Party with three months’ prior written notice to the end of the initial period or any extension term.
- The User may request deletion of registration at any point in time.
Section 9 Final provisions
- Epignostix may update the Terms of Use by posting updated Terms of Use on its website www.epignostix.com. All changes become effective when posted. Epignostix shall inform the User by e-mail at least six (6) weeks before any amendments to these Terms of Use come into effect. Unless Epignostix receives an objection from the User in writing (e.g. by e-mail, letter, fax) within one (1) month of receipt of the notification regarding the amendments, these amended Terms of Use shall be deemed to have been accepted. Epignostix shall specifically draw User’s attention to this consequence upon notification of the amendments. In the event of an objection, the User has a special right of termination which User may exercise within a period of one (1) month after receipt of the announcement of the amended Terms of Use. The termination must be in writing (e.g.) by e-mail, letter, fax). The termination shall take effect on the date on which Epignostix intends the amendment to take effect.
- This Agreement shall be governed by German law under the exclusion of the United Nations Convention on Contracts for the International Sale of Goods (CISG).
- If the Partner is a legal entity created under public law or a public law special fund, or businesspersons within the meaning of commercial law regulations, the sole place of jurisdiction shall be Heidelberg, Germany.
- Should any of the provisions in this Agreement be or become invalid or impracticable, the Parties shall undertake to replace the invalid or impracticable provision or the provision that has become invalid or impracticable with another valid and practicable provision which approximates so closely to the invalid or impracticable provision that it can be assumed that the Parties would also have concluded the present Agreement with this provision instead of the invalid or impracticable provision. Should it be impossible to find such a provision, the invalidity or impracticability of one or several provisions shall not affect the validity of the present Agreement as a whole. An alternative shall apply if the provisions that are or have become invalid or impracticable are of such significance for this Agreement that it is reasonable to assume that the parties would not have entered into this Agreement without the invalid or impracticable provisions. The above shall apply correspondingly in the event of a loophole in the contractual provisions.
- This Agreement contains all the provisions agreed by the Parties in connection with the License of the Tool that constitutes the subject of this Agreement. No ancillary agreements have been concluded.