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TERMS OF USE

These Terms of Use ("Terms") govern your individual access to and use of the Sonio Solution. Capitalized terms used but not defined in these Terms have the meanings assigned to them by the Master Services Agreement (the “MSA”) between Sonio Corporation and the institution through which your access is provisioned (the “Customer”).

PLEASE READ THESE TERMS CAREFULLY. BY ACCESSING OR USING THE SOLUTION, YOU CONFIRM THAT YOU ACCEPT THESE TERMS AND AGREE TO COMPLY WITH THEM.

  1. PROFESSIONAL RESPONSIBILITY

    1. No Replacement for Medical Judgment. The Solution and any Output Data generated are in no circumstances intended to replace your professional judgment and/or your interpretation as a healthcare professional.
    2. Sole Responsibility. The information and diagnoses you provide to your patients, including those based on the Solution's Output Data, are your sole responsibility as a healthcare provider.
    3. Qualifications & Appropriate Use. You represent and warrant that you are a qualified healthcare professional authorized to perform and/or interpret ultrasound examinations under Applicable Laws. Each clinical and AI-based functionality of the Solution must be used solely in accordance with its respective intended use, indications for use, and instructions for use, as set forth in the applicable product labeling and regulatory clearances. You remain solely responsible for ensuring that your use of the Solution complies with these Terms and with the laws and regulations applicable to your professional practice. Sonio does not bear any responsibility for any use not in accordance with these Terms or Applicable Laws and regulations.
  2. ACCOUNT SECURITY

    1. Personal Credentials. Each Authorized User's login credentials are personal and confidential. Licenses are granted to individual users and must not be shared between multiple users.

    2. Accountability. You must take reasonable security measures to protect the confidentiality of your credentials. Any access to the Solution made using your login credentials is deemed to have been made by you, and you are solely responsible for all actions taken and omissions made using your login credentials.

    3. Security. You are responsible for ensuring that unauthorized individuals do not access the Solution through your active session. You must lock your workstation or log out of the Solution when stepping away from the device.

    4. Monitoring. Sonio reserves the right to review and monitor all use of the Solution to verify compliance with the terms of this Agreement.

  3. ACCEPTABLE USE

    1. Data Ownership. You acknowledge that the Customer acts as the data controller, retains ownership of all Input Data, and may monitor, access, or restrict your use of the Solution at any time.

    2. Adherence to User Manual. You agree to read the User Manual prior to use and operate the Solution strictly in accordance with its instructions.

    3. Data Accuracy. As an AI-assisted tool, the Solution's output is dependent on the data you provide. You are solely responsible for the quality, accuracy, and completeness of the Input Data, and for the lawfulness of the Input Data you process with the Solution.

    5. Prohibitions. You must not, and must not permit any third party to:

      1. Copy, attempt to copy, modify, duplicate, reproduce, reverse engineer, or create any derivative of the Solution, or any source code of the Solution;
      2. Sub-license, sell, rent, lease, distribute, disclose, transfer, assign or otherwise exploit your access rights;
      3. Alter or remove any proprietary markings or copyright notice or identification that indicates Sonio's ownership of the Solution;
      4. Use the Solution in any manner whatsoever for the purpose of design, production, distribution, or marketing of a similar product, equivalent or substitute;
      5. Intentionally or knowingly take any steps to avoid or defeat the purpose of security measures associated with the Solution;
      6. Knowingly introduce into the Solution any Malicious Code; or
      7. Use the Solution in any way that could harm any patient or violate applicable laws or regulation, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the California Consumer Privacy Act (CCPA), or the European General Data Protection Regulation (GDPR).
  4. INTELLECTUAL PROPERTY

    1. IP Ownership. Sonio is the exclusive owner of all Intellectual Property present in the Solution. Nothing grants you any claim to or property rights in anything whatsoever relating to Sonio's Intellectual Property.

    2. Feedback. You hereby assign to Sonio all right, title, and interest in and to any ideas, suggestions, enhancement requests, recommendations, or other feedback provided by you relating to the Solution. Sonio will have the right to use, modify, and incorporate such feedback without restriction or obligation.

    3. Confidentiality. You must maintain the confidentiality of any Confidential Information that you access through your use of the Solution.

  5. OTHER FEATURES.

    1. Sonio Share. If you use Sonio Share to distribute visuals and medical information to patients, you represent and warrant that you will follow the Customer’s protocols and policies regarding patient consent and data sharing.

    2. Sonio Detect. Sonio Detect is a medical device with the sole intended purpose of analyzing fetal ultrasound images and clips. You must not use Sonio Detect for any "off-label" purposes or outside of its intended regulatory scope.

    3. Sonio Suspect. Sonio Suspect is a medical device with the sole intended purpose of assisting physicians in identifying and characterizing abnormal fetal ultrasound findings during or after fetal ultrasounds.

  6. SUSPENSION OF ACCESS. Sonio may suspend your access to the Solution if Sonio reasonably believes that your access interferes with the normal operations of the Solution, creates any threat to the security of the Solution, or if Sonio is required to do so by applicable laws or regulation. Your continued access to the Solution is contingent upon the good standing of the Customer, and may be revoked or suspended without notice if the Customer’s license is revoked or suspended in accordance with the terms of the MSA.
  7. REPORTING. You will promptly report to both Customer and Sonio any concerns regarding the performance or safety of the Solution, such as suspected errors or malfunctions, even if the issue identified did not generate an immediate health risk for the user or third parties.
  8. DISCLAIMERS AND LIMITATIONS OF LIABILITY. To the maximum extent permitted by applicable law, the Solution is provided "AS IS" and without warranty of any kind. Sonio does not represent or warrant that the Solution will be uninterrupted, error-free, or completely secure. Neither Sonio nor any of its Affiliates will be liable for special, indirect, consequential, exemplary or punitive costs. In no event will Sonio be liable for loss or inaccuracy of data, loss of use of systems, loss of privacy, business interruptions, and/or loss of profits.
  9. MODIFICATIONS. Sonio reserves the right to modify, amend, or replace these Terms at any time upon notice to you, which will be made available through the Solution. Your continued access to the Solution will be conditioned upon your acceptance of any such modifications.
  10. HIERARCHY OF AGREEMENTS. These Terms govern your individual access to and use of the Solution. In the event of a direct conflict between these Terms of Use and the Master Services Agreement signed by the Customer, the terms of the MSA will prevail.
  11. DEFINITIONS.
    1. Affiliate means any person or entity that directly or indirectly controls, is controlled by, or is under common control with a party provided that such person or entity will be an Affiliate only for so long as such control exists during the Subscription Period. For the purpose of this definition, "control" will mean an entity, directly or indirectly, holding more than fifty per cent (50%) of the issued share capital, or more than fifty per cent (50%) of the voting power at general meetings, or which has the power to appoint and to dismiss a majority of the directors or otherwise to direct the activities of such legal entity.
    2. Applicable Laws means all applicable laws, regulations, policies, ethical rules, codes, guidelines and any other applicable rules, whether local, state, or federal, in force at the time you access and use the Solution, as may be updated from time to time, including without limitation the General Data Protection Regulation (“GDPR”), and the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”).
    3. Authorized Users means anyone that Customer allows to use its accounts to access and use the Solution.
    4. Confidential Information means any and all non-public information of or relating to Sonio or the Solution that is disclosed to, observed by, or otherwise made available to you (whether before or after the Effective Date), in any form or medium, including without limitation: (i) the design, appearance, structure, user interface, screens, layouts, workflows, navigation, and feature set of the Solution; (ii) the behavior, logic, outputs, results, processing methodology, models, algorithms, and decision-support functionality of the Solution, including without limitation any annotations, classifications, measurements, or other outputs generated by or through the Solution; and (iii) the performance characteristics of the Solution, including without limitation accuracy, sensitivity, specificity, latency, throughput, error rates, failure modes, and benchmarking or comparative performance data. Provided, however, that Confidential Information does not include information that is inherently apparent to any user of medical imaging software generally, or generic to the field of medical imaging and not specific to the Solution. Provided further, that Confidential Information shall not include Protected Health Information (PHI) as defined by HIPAA, nor shall it include any clinical interpretations, medical diagnoses, measurements, or patient-specific outputs generated by the Product that are communicated to patients or incorporated into a patient's medical record.
    5. Input Data means the data Customer, including through an Authorized User, inputs into the Solution when using the Solution's functionalities, such as data Customer inputs when carrying out a prenatal medical examination, including patient identity, date of birth, weight, medical history and pregnancy history, ultrasound images, voice recording and related medical report.
    6. Intellectual Property means any and all intellectual, industrial, and intangible property and creations, in any jurisdiction throughout the world, whether registered or unregistered, including but not limited to: patents, patent applications, copyrights and related works, trade secrets, know-how (whether or not patentable or copyrightable), trademarks, service marks, trade names, domain names, designs, computer software, databases, data, specifications, inventions, processes, improvements, and developments.
    7. Malicious Code means: (i) any code, program, or sub-program, the knowing or intended purpose or effect of which is to damage or maliciously interfere with the operation of a computer system containing the code, program or sub-program, or to halt, disable, or interfere with the operation of the software, code, program, or sub-program, itself, or (ii) any device, method, or token that permits any person to circumvent without authorization the normal security of any software or systems containing the code.
    8. Output Data means data generated by and displayed to Customer on the Solution, when Customer uses the Solution, including medical reports, quality criteria, and data visualization, but not including any Intellectual Property related to the Solution.
    9. Solution means, in accordance with the products to which Customer has subscribed, one or more of the following Sonio products or package of products: Sonio Pro (including Sonio Checklist, Sonio Report, Sonio Share Dashboard, Sonio Share Application) and/or Sonio Detect, and/or Sonio Suspect and the related Services.
    10. Sonio Detect means the medical device used to analyze fetal ultrasound images and clips, automatically detect views and the anatomical structures therein, and verify the quality criteria and characteristics of those views.
    11. Sonio Suspect means the medical device used to assist physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques.
    12. Sonio Share means the application edited by Sonio allowing Customer’s patients to access visuals and medical information Customer shares with them.
    13. User Manual means the document(s) that provide Customer with instructions to access and use the Solution.