ACCEPTABLE USE POLICY

This Acceptable Use Policy ("AUP") forms part of the Terms of Service of ExcursionAssess AI and governs all use of the Service.

The Service is owned and operated by:

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

By accessing or using the Service, you agree to comply with this AUP.

1. Permitted Use

The Service may only be used:

• By legitimate business entities
• For lawful pharmaceutical quality, stability, and supply-chain documentation purposes
• By qualified professionals acting within their scope of authority
• In accordance with applicable pharmaceutical, data protection, and export control laws

The Service is not intended for consumer use.

2. Prohibited Regulatory Reliance

You may not:

• Represent that the Service independently certifies regulatory compliance
• Represent that AI outputs constitute regulatory approval
• Use the Service as a substitute for Qualified Person (QP) decision-making
• Submit AI-generated reports to regulators without human review
• Misrepresent the system as "regulator-endorsed" or "authority-approved"

The Customer remains solely responsible for regulatory decisions.

3. AI System Misuse

You may not:

• Attempt to reverse engineer AI models
• Extract training data
• Perform model probing to reconstruct system logic
• Conduct prompt injection or adversarial testing
• Attempt to bypass safety guardrails
• Use automated scripts to systematically query the AI
• Benchmark the AI for competitive publication
• Use the AI to develop a competing product

All AI outputs must undergo qualified human review before operational decisions.

4. Data Integrity and Accuracy

You may not:

• Upload knowingly false, fabricated, or misleading stability data
• Manipulate excursion data to influence AI results
• Alter system outputs outside approved workflows
• Falsify electronic records
• Use the system to conceal regulatory deviations

Any attempt to use the system for fraudulent documentation constitutes material breach.

5. GxP and Compliance Safeguards

You may not:

• Claim that Medicalix is responsible for validating your quality system
• Use the Service without appropriate internal SOP controls
• Circumvent electronic signature safeguards (if enabled)
• Share user credentials among personnel
• Disable audit logging mechanisms (where configurable)

You are solely responsible for ensuring that use of the Service aligns with:

• GDP requirements
• GMP obligations
• FDA 21 CFR Part 11 (where applicable)
• EU Annex 11 (where applicable)
• Internal QMS procedures

6. Security Restrictions

You may not:

• Attempt unauthorized access to other tenant environments
• Attempt to access system infrastructure
• Use automated scraping tools
• Interfere with system availability
• Introduce malware or malicious code
• Perform denial-of-service activities
• Test system vulnerabilities without written authorization

Security testing requires prior written consent from Medicalix.

7. Commercial Misuse

You may not:

• Resell access to the Service
• Provide Service access to third parties outside your licensed organization
• Use the Service to offer consulting services without authorization
• Embed the Service into another software product
• Use output to train external AI models
• Use output in marketing without permission

8. Export Controls and Sanctions

You may not use the Service:

• In violation of Israeli export control laws
• In violation of U.S., EU, or UN sanctions
• In embargoed jurisdictions
• For military or dual-use prohibited applications

Customer represents that it is not located in a sanctioned jurisdiction and is not on any restricted party list.

9. Personal Data Restrictions

You may not:

• Upload unnecessary personal data
• Upload protected health information (PHI) unless explicitly covered by a separate written agreement
• Upload sensitive personal data unrelated to excursion analysis
• Use the Service to monitor individuals

The Service is intended for product-related quality data, not individual patient data.

10. Excessive or Abusive Usage

You may not:

• Abuse AI credit mechanisms
• Use automated scripts to generate excessive outputs
• Circumvent subscription limits
• Attempt to overload system resources

Medicalix reserves the right to throttle excessive usage.

11. Investigations and Enforcement

Medicalix may:

• Monitor usage patterns for abuse
• Suspend accounts during investigation
• Remove content that violates this policy
• Terminate access for material violations

Medicalix may cooperate with regulatory or law enforcement authorities if required.

12. Reporting Violations

Suspected misuse may be reported to: support@excursionassess.com

13. Consequences of Violation

Violation of this AUP may result in:

• Immediate suspension
• Permanent termination
• Forfeiture of unused credits
• Legal action
• Regulatory reporting where required

No refund shall be provided for termination due to policy violation.