Terms of Use

1. Acceptance of Terms

By accessing or using Ilana Protocol Intelligence (the "Service"), you ("User," "you," or "your") agree to be bound by these Terms of Use ("Terms"). If you do not agree to these Terms, you may not use the Service.

Ilana Immersive, LLC** ("we," "our," or "Company") reserves the right to modify these Terms at any time. Continued use of the Service after changes constitutes acceptance of the updated Terms.

2. Service Description

Ilana Protocol Intelligence is a Microsoft Word add-in that provides:

- AI-powered analysis of clinical trial protocols

- Regulatory compliance checking against ICH-GCP E6/E9 guidelines

- Automated suggestions for protocol clarity and precision

- Real-time feedback on statistical analysis language

The Service is a decision-support tool and does NOT constitute regulatory, legal, or medical advice.**

3. License Grant

3.1 Limited License

Subject to these Terms, we grant you a limited, non-exclusive, non-transferable, revocable license to:

- Install and use the Ilana Word add-in on devices you own or control

- Submit protocol text for analysis via the Service

- Access analysis results and suggestions generated by the Service

3.2 Restrictions

You may NOT:

- Reverse engineer, decompile, or disassemble the Service

- Rent, lease, loan, resell, or sublicense access to the Service

- Modify, adapt, or create derivative works of the Service

- Remove or alter any proprietary notices or labels

- Use the Service to violate any applicable laws or regulations

- Attempt to circumvent usage limits or technical restrictions

4. User Obligations

4.1 Account Responsibility

You are responsible for:

- Maintaining the confidentiality of your Microsoft account credentials

- All activities that occur under your account

- Compliance with your organization's policies regarding third-party software

4.2 Content Responsibility

You represent and warrant that:

- You have the legal right to submit protocol text to the Service

- Your use of the Service complies with all applicable laws, including data privacy regulations

- You will NOT submit Protected Health Information (PHI) or personally identifiable information (PII) of trial participants

- You will de-identify any protocol content containing sensitive information before submission

4.3 Professional Judgment

You acknowledge that:

- All AI-generated suggestions must be reviewed by qualified clinical research professionals

- You are solely responsible for verifying the accuracy and appropriateness of suggestions before use

- The Service does not replace human expertise in protocol development or regulatory submission

5. Intellectual Property Rights

5.1 Service Ownership

Ilana Immersive, LLC retains all right, title, and interest in and to:

- The Ilana Protocol Intelligence software and Service

- All algorithms, models, and AI systems

- All trademarks, service marks, logos, and trade names

- All documentation, user interfaces, and design elements

5.2 User Content

You retain ownership of all protocol text you submit to the Service. By using the Service, you grant us:

- A limited, temporary license to process your protocol text solely to provide the Service

- The right to use anonymized, aggregated usage data to improve the Service

We do NOT claim ownership of your protocol content and will NOT use it to train AI models or share it with third parties (except as necessary to provide the Service via Azure OpenAI and other processors).

5.3 Feedback

If you provide feedback, suggestions, or ideas about the Service:

- You grant us a perpetual, irrevocable, worldwide, royalty-free license to use such feedback

- We have no obligation to compensate you for feedback or implement your suggestions

6. Privacy and Data Protection

Your use of the Service is subject to our [Privacy Policy](./PRIVACY_POLICY.md). By using the Service, you consent to:

- Processing of protocol text via Azure OpenAI, Pinecone, and HuggingFace

- Collection of anonymized usage telemetry to improve Service quality

- Data transfers to United States data centers

**IMPORTANT**: Do NOT submit PHI or PII to the Service. We are NOT a HIPAA-compliant Business Associate.

7. Service Availability

7.1 Uptime

We strive to maintain Service availability but do NOT guarantee:

- Uninterrupted or error-free operation

- Specific uptime percentages (except for enterprise customers with SLAs)

- Compatibility with all versions of Microsoft Word

7.2 Maintenance

We may perform scheduled or emergency maintenance that temporarily interrupts Service availability. We will provide advance notice when feasible.

7.3 Third-Party Dependencies

Service functionality depends on third-party services (Azure OpenAI, Pinecone, HuggingFace, Render). We are not liable for disruptions caused by third-party service outages.

## 8. Payment Terms

8.1 Subscription Plans

If you subscribe to a paid plan:

- **Billing:** Subscriptions are billed monthly or annually in advance

- **Auto-Renewal:** Subscriptions automatically renew unless canceled before the renewal date

- **Cancellation:** You may cancel at any time; access continues until the end of your current billing period

- **Price Changes:** We may change prices with 30 days' advance notice

### 8.2 Free Trial

If we offer a free trial:

- Trial period is 14 days unless otherwise specified

- No payment required during trial

- You may cancel before trial ends to avoid charges

- Some features may be limited during trial

8.3 Refunds

Payments are generally non-refundable, except:

- Service is unavailable for more than 48 consecutive hours due to our error

- Billing errors (we will refund overcharges)

- As required by applicable law

8.4 Seat-Based Pricing

For team subscriptions:

- You purchase a specific number of seats

- Each seat can be assigned to one user at a time

- Unused seats do not roll over or carry credit

- Additional seats can be purchased at any time (prorated)

9. Disclaimers

9.1 No Warranties

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO:

- **Merchantability**

- **Fitness for a particular purpose**

- **Non-infringement**

- **Accuracy or completeness of AI-generated suggestions**

9.2 No Regulatory Approval Guarantee

Ilana does NOT guarantee that:

- Use of the Service will result in regulatory approval of your protocol

- Suggestions comply with all applicable regulatory requirements in your jurisdiction

- AI-generated content is error-free or suitable for direct use without review

9.3 Professional Responsibility

You acknowledge that:

- Regulatory submissions are YOUR responsibility, not ours

- You must verify all suggestions with qualified regulatory professionals

- Final decisions on protocol language are made by you, not by the Service

10. Limitation of Liability

10.1 Damages Cap

TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT SHALL ILANA LABS BE LIABLE FOR:

- **Indirect, incidental, special, consequential, or punitive damages**

- **Lost profits, lost revenue, or loss of data**

- **Regulatory rejection or delays caused by use of Service suggestions**

- **Damages arising from reliance on AI-generated content**

**MAXIMUM LIABILITY**: Our total liability for all claims arising from your use of the Service shall not exceed the greater of (a) $100 USD or (b) the amount you paid to us in the 12 months preceding the claim.

10.2 Exceptions

Some jurisdictions do not allow the exclusion of certain warranties or limitation of liability for incidental or consequential damages. In such jurisdictions, our liability will be limited to the maximum extent permitted by law.

11. Indemnification

You agree to indemnify, defend, and hold harmless Ilana Immersive, LLC, its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or in any way connected with:

- Your use of the Service

- Your protocol content submitted to the Service

- Your violation of these Terms

- Your violation of any rights of another party

- Regulatory submissions made using Service suggestions

12. Term and Termination

12.1 Term

These Terms remain in effect while you use the Service.

12.2 Termination by You

You may stop using the Service at any time by uninstalling the Word add-in.

12.3 Termination by Us

We may suspend or terminate your access to the Service at any time, with or without cause, with or without notice, for reasons including but not limited to:

- Violation of these Terms

- Fraudulent, abusive, or illegal activity

- Non-payment (for paid subscriptions)

- Service discontinuation

12.4 Effect of Termination

Upon termination:

- Your license to use the Service immediately ceases

- Cached data is automatically purged within 15 minutes

- Sections 5 (IP Rights), 9 (Disclaimers), 10 (Limitation of Liability), 11 (Indemnification), and 14 (Governing Law) survive termination

13. Compliance and Regulatory Matters

13.1 Export Controls

The Service may be subject to U.S. export control laws. You agree NOT to export or re-export the Service to prohibited countries or entities.

13.2 Regulatory Compliance

You are solely responsible for ensuring:

- Compliance with FDA 21 CFR Part 11 (if applicable)

- Compliance with ICH-GCP guidelines

- Compliance with local and international clinical trial regulations

- Accuracy of regulatory submissions

13.3 Not a Medical Device

Ilana Protocol Intelligence is NOT a medical device and does NOT require FDA clearance or CE marking. It is a document editing tool that does not directly interact with patients or clinical data systems.

14. Governing Law and Dispute Resolution

14.1 Governing Law

These Terms are governed by and construed in accordance with the laws of the **State of Tennessee, United States**, without regard to its conflict of law provisions.

14.2 Jurisdiction

You agree to submit to the exclusive jurisdiction of the state and federal courts located in Davidson County, Tennessee for the resolution of any disputes.

14.3 Arbitration (Optional)

For team customers, disputes may be resolved through binding arbitration under the rules of the American Arbitration Association (AAA), at the election of either party.

14.4 Class Action Waiver

You agree to resolve disputes with us on an individual basis and waive any right to participate in a class action lawsuit or class-wide arbitration.

15. Miscellaneous

15.1 Entire Agreement

These Terms, together with the Privacy Policy, constitute the entire agreement between you and Ilana Immersive, LLC regarding the Service.

15.2 Severability

If any provision of these Terms is found to be invalid or unenforceable, the remaining provisions will remain in full force and effect.

15.3 No Waiver

Our failure to enforce any provision of these Terms does not constitute a waiver of that provision.

15.4 Assignment

You may not assign or transfer these Terms without our prior written consent. We may assign these Terms without restriction.

15.5 Force Majeure

We are not liable for delays or failures in performance resulting from causes beyond our reasonable control, including but not limited to acts of God, natural disasters, pandemics, or third-party service outages.

16. Contact Information

For questions about these Terms of Use:

**Ilana Immersive, LLC**

501 Union St. Ste 545 PMB 696328, Nashville, Tennessee 37219

Email: legal@ilanaimmersive.com

Support: support@ilanaimmersive.com

Website: https://ilanaimmersive.com

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**Document Version**: 1.0

**Applicable Jurisdictions**: United States, European Union, United Kingdom

**Governing Law**: Tennessee, United States

**By using Ilana Protocol Intelligence, you acknowledge that you have read, understood, and agree to be bound by these Terms of Use and our Privacy Policy.**