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Soteria One Point Zero

Version 1.0 (Soteria one point zero-20170721143733)

Soteria Biotech Co., Ltd.
12F, No. 365, Fude 3rd Rd.,
Xizhi Dist. New Taipei City 22151

MT Promedt Consulting GmbH
Altenhofstrasse 80, 66386 St. Ingbert, Germany
+49 6849 581020


License Agreement

License agreement version: 01
Use of the software is subject to acceptance of the License Agreement. Read the terms and conditions of this License Agreement carefully. The material is copyrighted and licensed (not sold). This License Agreement represents the entire agreement concerning the Licensed Material between Licenser and Licensee and it supersedes any prior proposal, representation or understanding between the parties.

Licenser: Soteria Biotech. Co. Ltd, having its principal offices at 12F, No. 365, Fude 3rd Rd., Xizhi Dist., New Taipei City 22151, Taiwan ROC
Licensee: Holder of the license.
Licensed Material: the software and the user documentation.

1. License Grant
    (a) License
Licenser hereby grants Licensee, which accepts, a nonexclusive license to use the Licensed Material, only as authorized in this License Agreement. Licensee agrees not have the right to assign, sub license, transfer, pledge, lease, rent or share the rights proceeding from this License Agreement, nor sell Licensed Material or any part or copy thereof, unless the Licenser has granted prior explicit permission, and any applicable fees have been paid.
    (b) Username and Password
Access to the Software is granted by the use of username and password associated with the Licensee. Each username and password has a specified validity period. On request, the specified validity period of Licensee will be extended.

2. Licenser's Rights
Licensee acknowledges and agrees that the Licensed Material proprietary products of Licenser protected under copyright law. Licensee further acknowledges and agrees that all right, title and interest in and to the Licensed Material, associated intellectual property rights, are and shall remain with the Licenser. This License Agreement does not convey to Licensee any interest in or to the Licensed Material, but only a limited right of use, revocable in accordance with the terms of this License Agreement.

3. License Fees
The license fees paid by Licensee are paid in consideration of the licenses granted under this License Agreement. Communication of a valid username and password is subject to payment of the License fees.

4. Term
This License Agreement is effective upon the first use of the software, and shall continue until terminated. Licensee may terminate this License Agreement at any time. Licenser may terminate this License Agreement only upon breach by Licensee of any term hereof.

5. Limitation of Liability
It is the clinician's ultimate obligation to exercise his/her professional judgment in any decision to follow or not follow recommendations made by this device (software). Licenser's cumulative liability to Licensee for any loss or damages resulting from any claims, demands or actions arising out of or relating to this Agreement shall not exceed the license fee paid to Licenser for use of the Licensed Material. Licenser cannot be held liable for any claims, demands or actions, arising from the faulty performance of the software, if such faulty performance is caused by the input of data from the Licensee or any third party. In no event shall Licenser be liable for any indirect, incidental, consequential, special or exemplary damages or lost profits, even if Licenser has been advised of the possibility of such damages.

6. Governing Law
This License Agreement shall be construed and governed in accordance with the laws of Republic of China (Taiwan).

7. Severability
Should any court or competent jurisdiction declare any term of this License Agreement void or unenforceable, such declaration shall have no effect on the remaining terms hereof.

8. No Waiver
The failure of either party to enforce any rights granted hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement of rights or subsequent actions in the event of future breaches.

9. Privacy notice
In the course of using the software, the Licensee MUST ONLY upload de-identified data (DICOM standard compatible image files WITHOUT patient's personal health information in the header). Soteria Biotech Co., Ltd. cannot be held liable for any claims, demands or actions, arising from Licensee upload data with privacy information.

10. Indications
Soteria One Point Zero is intended for use as a software platform to display and analyze head and neck medical images.

11. Contraindications

12. Warnings
  • This product should be used by persons who fully read the instructions for use and being trained.
  • The software shall only be used with PCs that has at least minimum requirements
  • Output of the software must be verified by the responsible clinician.
  • It is the clinician’s ultimate obligation to exercise his/her professional judgment in any decision to follow or not follow the report from this medical device (software).
  • Images that are not compatible with DICOM format cannot be displayed or processed by the software
  • The resolution of uploaded DICOM image must have pixel size of 0.06cm * 0.06cm * 0.06cm or better

13. Adverse effects