Terms of Service.

**Effective Date:** November 23, 2025

**Last Updated:** November 23, 2025

## 1. Acceptance of Terms

By installing, accessing, or using the Ilana Microsoft Word add-in ("Service"), you ("User," "you," or "your") agree to be bound by these Terms of Service ("Terms"). If you do not agree to these Terms, do not use the Service.

These Terms constitute a legally binding agreement between you and Ilana Immersive, LLC ("we," "us," or "our").

## 2. Description of Service

Ilana AI provides an AI-powered Microsoft Word add-in that:

- Analyzes clinical trial protocol text for clarity, regulatory compliance, and best practices

- Provides real-time suggestions and recommendations

- Identifies potential issues in protocol language

- Offers protocol optimization insights

The Service uses artificial intelligence (Azure OpenAI GPT-4) and may not be 100% accurate. **You are responsible for reviewing and validating all suggestions before applying them to your protocols.**

## 3. User Eligibility

You must be at least 18 years old and have the legal capacity to enter into binding agreements to use this Service. By using the Service, you represent and warrant that you meet these requirements.

## 4. License and Restrictions

### 4.1 License Grant

We grant you a limited, non-exclusive, non-transferable, revocable license to use the Ilana AI add-in for your internal business purposes, subject to these Terms.

### 4.2 Restrictions

You agree NOT to:

- Reverse engineer, decompile, or disassemble the Service

- Use the Service to create a competing product or service

- Share your account credentials with unauthorized users

- Attempt to access or tamper with backend systems

- Use the Service for any illegal or unauthorized purpose

- Remove or modify any proprietary notices or labels

- Use the Service to process Protected Health Information (PHI) without a separate Business Associate Agreement

- Exceed reasonable usage limits (rate limiting may apply)

## 5. User Responsibilities

You are responsible for:

- **Accuracy of Output:** Reviewing all AI-generated suggestions before incorporating them into protocols

- **Data Security:** Ensuring protocol content does not contain patient-identifiable information (PHI/PII)

- **Compliance:** Ensuring your use complies with applicable regulations (FDA, EMA, ICH-GCP, etc.)

- **Confidentiality:** Maintaining confidentiality of proprietary protocol content

- **Proper Use:** Using the Service only for legitimate clinical trial protocol development

**IMPORTANT:** Ilana AI provides suggestions only. Final responsibility for protocol content, regulatory compliance, and scientific accuracy rests solely with you.

## 6. Intellectual Property

### 6.1 Ownership

- **Your Content:** You retain all rights to your protocol text and content

- **Our Service:** We retain all rights to the Ilana AI software, algorithms, models, and infrastructure

- **Suggestions:** AI-generated suggestions are provided for your use, but our underlying AI models remain our property

### 6.2 Feedback

If you provide feedback, suggestions, or ideas about the Service, we may use them without obligation or compensation to you.

## 7. Privacy and Data Use

Your use of the Service is also governed by our [Privacy Policy](PRIVACY_POLICY.md). Key points:

- We process text temporarily to provide suggestions

- We do NOT permanently store your protocol text

- We do NOT use your content to train AI models for other customers

- Usage analytics are collected to improve the Service

## 8. Payment Terms (If Applicable)

### 8.1 Subscription

If you subscribe to a paid plan:

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

- **Auto-Renewal:** Subscriptions automatically renew unless canceled

- **Cancellation:** You may cancel at any time; no refunds for partial periods

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

### 8.2 Free Trial

If we offer a free trial:

- Trial period is specified at signup

- No payment required during trial

- You may cancel before trial ends to avoid charges

- 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 law

## 9. Service Availability and Support

### 9.1 Uptime

We strive to maintain high availability but do not guarantee uninterrupted access. The Service may be unavailable due to:

- Scheduled maintenance (we will notify you in advance)

- Emergency maintenance

- Third-party service outages (Azure, Render, etc.)

- Force majeure events

### 9.2 Support

We provide email support at support@ilanaimmersive.com with:

- Response time: 1-2 business days for standard inquiries

- Priority support may be available for enterprise customers

## 10. Disclaimers and Limitations of Liability

### 10.1 NO WARRANTY

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

- Warranties of merchantability, fitness for a particular purpose, or non-infringement

- Guarantees of accuracy, completeness, or regulatory compliance of suggestions

- Guarantees of uninterrupted or error-free operation

### 10.2 Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW:

- **WE ARE NOT LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES** arising from your use of the Service

- This includes but is not limited to: loss of data, loss of revenue, regulatory rejections, study delays, or reputational harm

- **OUR TOTAL LIABILITY SHALL NOT EXCEED THE AMOUNT YOU PAID US IN THE 12 MONTHS PRECEDING THE CLAIM** (or $100 if you have not paid us)

### 10.3 Regulatory Compliance

**CRITICAL:** Ilana AI is a writing assistance tool, NOT a regulatory compliance product. We do NOT:

- Guarantee FDA, EMA, or other regulatory approval

- Provide legal or regulatory advice

- Replace qualified regulatory professionals

- Warrant that protocols will meet regulatory standards

**YOU ARE SOLELY RESPONSIBLE FOR ENSURING YOUR PROTOCOLS COMPLY WITH ALL APPLICABLE REGULATIONS.**

## 11. Indemnification

You agree to indemnify, defend, and hold harmless Ilana AI and its officers, employees, and contractors from any claims, damages, losses, or expenses (including legal fees) arising from:

- Your use of the Service

- Your violation of these Terms

- Your violation of applicable laws or regulations

- Any protocol content you submit or create using the Service

- Regulatory actions related to protocols you created using the Service

## 12. Termination

### 12.1 By You

You may terminate your account at any time by:

- Uninstalling the add-in

- Emailing support@ilanaimmersive.com to request account deletion

### 12.2 By Us

We may suspend or terminate your access immediately if:

- You violate these Terms

- You engage in abusive or fraudulent behavior

- Required by law or court order

- We discontinue the Service (with 30 days' notice)

### 12.3 Effect of Termination

Upon termination:

- Your license to use the Service ends immediately

- You must cease using the Service

- We may delete your account data (subject to legal retention requirements)

- Sections that should survive (liability, indemnification, disputes) remain in effect

## 13. Changes to Terms

We may update these Terms at any time. When we do:

- We will update the "Last Updated" date

- We will notify you via email or in-app notification for material changes

- Continued use after changes constitutes acceptance

- If you do not agree to changes, you must stop using the Service

## 14. Governing Law and Disputes

### 14.1 Governing Law

These Terms are governed by the laws of the State of Tennessee, United States, without regard to conflict of law principles.

### 14.2 Dispute Resolution

**Informal Resolution:** Before filing a claim, you agree to contact us at legal@ilanaimmersive.com to attempt informal resolution.

**Arbitration (Optional):**

[If you want to include arbitration, add details here. Many startups omit this initially.]

### 14.3 Venue

Any legal action must be brought in the state or federal courts located in Davidson County, Tennessee.

## 15. Miscellaneous

### 15.1 Entire Agreement

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

### 15.2 Severability

If any provision is found unenforceable, the remaining provisions remain in full effect.

### 15.3 No Waiver

Our failure to enforce any right or provision does not constitute a waiver of that right.

### 15.4 Assignment

You may not assign these Terms without our written consent. We may assign these Terms to any successor entity.

### 15.5 Third-Party Services

The Service integrates with Microsoft Word and relies on third-party services (Azure, Render, Pinecone). We are not responsible for:

- Microsoft Office availability or functionality

- Third-party service outages or changes

- Compatibility with future Word versions

### 15.6 Export Compliance

You agree to comply with all applicable export laws and regulations. The Service may not be exported or re-exported to certain countries or individuals on restricted lists.

### 15.7 Force Majeure

We are not liable for delays or failures due to events beyond our reasonable control (natural disasters, pandemics, war, government actions, internet outages, etc.).

## 16. Contact Information

For questions about these Terms:

**Ilana Immersive, LLC**

**Address:** 41 Peabody St., Nashville, Tennessee 37210

**Email:** legal@ilanaimmersive.com

**Support:** support@ilanaimmersive.com

**Website:** https://ilanaimmersive.com

## 17. Acknowledgments

By using Ilana AI, you acknowledge that:

- You have read and understood these Terms and our Privacy Policy

- You accept full responsibility for protocol content and regulatory compliance

- AI-generated suggestions require human review and validation

- The Service is a tool to assist, not replace, qualified regulatory professionals

- You will not rely solely on AI suggestions for critical regulatory decisions

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**IMPORTANT NOTICE FOR CLINICAL TRIAL SPONSORS:**

Ilana AI is a writing assistance tool designed to help optimize protocol language. It is NOT:

- A substitute for qualified medical writers

- A regulatory compliance certification tool

- A guarantee of FDA/EMA approval

- A replacement for quality control processes

All AI-generated suggestions must be reviewed by qualified personnel before inclusion in regulatory submissions.

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**Last Updated:** November 23, 2025