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    Legal

    END USER LICENSE AGREEMENT (EULA)

    Last Updated: February 2026

    This End User License Agreement ("Agreement" or "EULA") is a legally binding agreement between you ("Customer", "Licensee", "you") and:

    Medicalix Ltd.
    6 Hashfels St., Kochav Yair 4486400, Israel
    ("Medicalix", "Company", "we", "us", or "our").

    By accessing, installing, or using ExcursionAssess AI (the "Software" or "Service"), you agree to be bound by this Agreement.

    If you do not agree, you must not use the Service.

    1. DEFINITIONS

    "Software" means the ExcursionAssess AI SaaS platform, including web interface, backend systems, AI models, algorithms, documentation, updates, and related components.

    "AI Output" means any automated analysis, narrative, classification, recommendation, or report generated by the Software.

    "Customer Data" means data uploaded or entered by Customer, including product stability data, excursion records, attachments, and related documentation.

    "Regulatory Frameworks" include but are not limited to EMA guidance, FDA guidance, ICH guidelines, USP chapters, GDP/GMP requirements, and related standards.

    2. LICENSE GRANT

    Subject to compliance with this Agreement and payment of applicable fees, Medicalix grants Customer a:

    • Limited
    • Non-exclusive
    • Non-transferable
    • Non-sublicensable
    • Revocable

    license to access and use the Software during the subscription term solely for internal business purposes.

    No ownership rights are transferred.

    3. LICENSE RESTRICTIONS

    Customer shall not:

    • Reverse engineer, decompile, or disassemble the Software
    • Attempt to extract or replicate AI models
    • Benchmark or publish performance results without written consent
    • Use the Software to develop a competing product
    • Resell or sublicense access
    • Circumvent usage limitations or AI credit systems
    • Attempt unauthorized access to other tenant environments
    • Use automated scripts to scrape outputs

    Violation constitutes material breach.

    4. INTENDED USE

    The Software is intended solely as:

    • A documentation support system
    • A scientific decision-support tool
    • An analytical assistant

    The Software is NOT:

    • A regulatory authority
    • A Qualified Person (QP)
    • A validated system on behalf of the Customer
    • A substitute for scientific judgment
    • A product release decision-maker
    • A medical device
    • A clinical decision system

    All final decisions regarding product disposition remain exclusively the responsibility of Customer.

    5. AI-SPECIFIC DISCLOSURES

    Customer acknowledges:

    • AI outputs are probabilistic.
    • AI outputs may contain inaccuracies.
    • AI conclusions must be independently reviewed.
    • AI recommendations are advisory only.
    • Degradation kinetics and MKT calculations depend on Customer-provided data.

    Medicalix disclaims all liability for reliance on AI Output without independent human validation.

    6. REGULATORY RESPONSIBILITY

    Customer is solely responsible for:

    • Compliance with GDP/GMP
    • 21 CFR Part 11 validation (if applicable)
    • EU Annex 11 compliance
    • Internal QMS integration
    • Regulatory submissions
    • Audit readiness
    • Record retention

    Medicalix does not warrant that the Software:

    • Is compliant with any specific regulation
    • Meets validation standards of Customer
    • Will be accepted by regulatory authorities

    Validation of the Software in GxP environments is Customer's sole responsibility.

    7. CUSTOMER DATA RESPONSIBILITY

    Customer represents and warrants that:

    • All uploaded data is accurate
    • Stability parameters are scientifically valid
    • Activation energy inputs are correct
    • Product data reflects approved labeling
    • Customer has authority to upload data

    Medicalix is not responsible for errors resulting from incorrect data entry.

    8. INTELLECTUAL PROPERTY

    All rights in the Software, including:

    • Algorithms
    • AI models
    • Stability methodologies
    • MKT engines
    • Report templates
    • Interface design
    • Databases

    are owned exclusively by Medicalix Ltd.

    Customer retains ownership of Customer Data.

    Medicalix may use anonymized, aggregated data for service improvement.

    9. DATA SECURITY

    Medicalix implements commercially reasonable technical and organizational safeguards.

    However:

    • No system is completely secure
    • Customer must maintain its own backups
    • Customer remains data controller

    Medicalix is not liable for breaches caused by Customer credential misuse.

    10. THIRD-PARTY SERVICES

    Payments are processed by FastSpring as Merchant of Record.

    Customer enters into:

    • A payment agreement with FastSpring
    • A license agreement with Medicalix

    Medicalix is not responsible for FastSpring's actions.

    11. DISCLAIMER OF WARRANTIES

    THE SOFTWARE IS PROVIDED "AS IS" AND "AS AVAILABLE."

    TO THE MAXIMUM EXTENT PERMITTED BY LAW:

    MEDICALIX DISCLAIMS ALL WARRANTIES, INCLUDING:

    • MERCHANTABILITY
    • FITNESS FOR A PARTICULAR PURPOSE
    • NON-INFRINGEMENT
    • REGULATORY COMPLIANCE
    • ACCURACY OF AI OUTPUT
    • UNINTERRUPTED OPERATION

    No oral or written information creates a warranty.

    12. LIMITATION OF LIABILITY

    TO THE MAXIMUM EXTENT PERMITTED BY ISRAELI LAW:

    MEDICALIX SHALL NOT BE LIABLE FOR:

    • Product loss
    • Product recall costs
    • Regulatory penalties
    • Lost profits
    • Business interruption
    • Loss of goodwill
    • Consequential damages

    TOTAL AGGREGATE LIABILITY SHALL NOT EXCEED THE FEES PAID BY CUSTOMER IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM.

    THIS LIMITATION APPLIES REGARDLESS OF LEGAL THEORY.

    13. INDEMNIFICATION

    Customer shall indemnify and hold harmless Medicalix from claims arising from:

    • Customer's regulatory non-compliance
    • Improper product release decisions
    • Misuse of AI outputs
    • Incorrect stability data
    • Breach of this Agreement
    • Violation of applicable laws

    14. TERM AND TERMINATION

    This Agreement remains effective during subscription.

    Medicalix may suspend or terminate access if:

    • Customer breaches this Agreement
    • Fraud or misuse is suspected
    • Payment failure occurs
    • Legal or regulatory risk arises

    Upon termination:

    • License immediately ceases
    • AI credits are forfeited
    • Access is revoked

    15. EXPORT CONTROL

    Customer represents that it is not located in a sanctioned jurisdiction and will not use the Software in violation of export laws.

    16. GOVERNING LAW AND JURISDICTION

    This Agreement is governed exclusively by the laws of the State of Israel.

    The competent courts of Tel Aviv, Israel shall have exclusive jurisdiction.

    Customer irrevocably waives any objection to forum.

    17. CLASS ACTION WAIVER

    To the extent permitted by law, disputes shall be resolved individually and not as part of class proceedings.

    18. FORCE MAJEURE

    Medicalix shall not be liable for delays due to events beyond reasonable control.

    19. MODIFICATIONS

    Medicalix may update this Agreement.

    Continued use constitutes acceptance.

    20. ENTIRE AGREEMENT

    This Agreement, together with the Terms of Service, Acceptable Use Policy, and Privacy Policy, constitutes the entire agreement between the parties.