LEGAL DISCLAIMER

ExcursionAssess AI is developed and operated by:

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

By accessing or using the Service, you acknowledge and agree to the following:

1. DECISION-SUPPORT TOOL ONLY

ExcursionAssess AI is a software platform designed to assist pharmaceutical professionals in documenting and analyzing temperature excursions.

The Service:

• Provides structured data analysis
• Performs algorithmic calculations (including MKT)
• Generates AI-assisted analytical outputs
• Produces draft reports

The Service does not:

• Make regulatory decisions
• Authorize batch release
• Certify product suitability
• Replace Qualified Person (QP) review
• Provide regulatory approval
• Provide medical advice
• Provide legal advice

All final product disposition and compliance decisions remain exclusively the responsibility of qualified Customer personnel.

2. NO REGULATORY CERTIFICATION

The Service may reference regulatory frameworks, including but not limited to:

• EMA guidance
• FDA guidance
• ICH guidelines
• USP chapters (including <1079.2>)
• GDP/GMP principles

Such references are informational only.

Medicalix does not represent or warrant that:

• The Service is approved by any regulatory authority
• Use of the Service ensures regulatory compliance
• Reports generated will be accepted by regulators
• The Service satisfies 21 CFR Part 11 or EU Annex 11 requirements unless separately contracted

Validation of the Service within Customer's quality system is solely the Customer's responsibility.

3. AI OUTPUT DISCLAIMER

The Service includes AI-generated outputs.

Customer acknowledges:

• AI outputs are probabilistic
• AI models may produce incomplete or inaccurate results
• AI recommendations are advisory only
• AI-generated narratives require independent review
• AI outputs must not be relied upon without qualified human assessment

Medicalix disclaims all liability arising from reliance on AI-generated outputs.

4. DATA ACCURACY RESPONSIBILITY

All analyses performed by the Service depend on Customer-provided data, including:

• Stability parameters
• Activation energy inputs
• Storage conditions
• Excursion duration
• Temperature values
• Packaging data

Medicalix does not verify the scientific accuracy of Customer data.

Errors in data input may materially affect outputs.

Customer is solely responsible for ensuring the accuracy and completeness of all submitted data.

5. NO PRODUCT LIABILITY ASSUMPTION

Medicalix does not:

• Manufacture pharmaceutical products
• Control storage or transport conditions
• Supervise cold-chain logistics
• Control packaging integrity

Medicalix shall not be liable for:

• Product degradation
• Product recalls
• Product destruction
• Loss of potency
• Adverse events
• Regulatory enforcement actions
• Financial losses arising from product disposition decisions

6. NO WARRANTY

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

TO THE MAXIMUM EXTENT PERMITTED BY LAW, MEDICALIX DISCLAIMS:

• All express or implied warranties
• Warranties of merchantability
• Warranties of fitness for a particular purpose
• Non-infringement warranties
• Accuracy guarantees
• Uninterrupted availability guarantees

No oral or written communication creates a warranty.

7. LIMITATION OF LIABILITY

To the maximum extent permitted by Israeli law:

Medicalix shall not be liable for:

• Indirect damages
• Consequential damages
• Loss of profits
• Business interruption
• Regulatory penalties
• Recall costs
• Loss of goodwill

Total aggregate liability shall not exceed fees paid during the twelve (12) months preceding the claim.

8. PROFESSIONAL RESPONSIBILITY

The Service is intended for use by qualified pharmaceutical professionals.

It is not intended for:

• Consumer use
• Clinical decision-making
• Direct patient care
• Diagnosis
• Treatment decisions

Customer represents that users are appropriately trained professionals operating within a regulated environment.

9. NO MEDICAL DEVICE CLASSIFICATION

ExcursionAssess AI is not:

• A medical device
• A diagnostic device
• A therapeutic device
• A clinical decision support system

It is a documentation and analytical support tool only.

10. FORCE MAJEURE

Medicalix shall not be liable for performance delays caused by events beyond reasonable control.

11. GOVERNING LAW

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

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