Terms of Service.
# Terms of Use for Ilana
**Effective Date:** December 1, 2025
**Last Updated:** December 1, 2025
## 1. Acceptance of Terms
By accessing or using Ilana (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. Disclaimers
### 8.1 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**
### 8.2 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
### 8.3 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
## 9. Limitation of Liability
### 9.1 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.
### 9.2 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.
## 10. 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
## 11. Term and Termination
### 11.1 Term
These Terms remain in effect while you use the Service.
### 11.2 Termination by You
You may stop using the Service at any time by uninstalling the Word add-in.
### 11.3 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
### 11.4 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), 8 (Disclaimers), 9 (Limitation of Liability), 10 (Indemnification), and 13 (Governing Law) survive termination
## 12. Compliance and Regulatory Matters
### 12.1 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.
### 12.2 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
### 12.3 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.
## 13. Governing Law and Dispute Resolution
### 13.1 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.
### 13.2 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.
### 13.3 Arbitration (Optional)
For enterprise customers, disputes may be resolved through binding arbitration under the rules of the American Arbitration Association (AAA), at the election of either party.
### 13.4 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.
## 14. Miscellaneous
### 14.1 Entire Agreement
These Terms, together with the Privacy Policy, constitute the entire agreement between you and Ilana Immersive, LLC regarding the Service.
### 14.2 Severability
If any provision of these Terms is found to be invalid or unenforceable, the remaining provisions will remain in full force and effect.
### 14.3 No Waiver
Our failure to enforce any provision of these Terms does not constitute a waiver of that provision.
### 14.4 Assignment
You may not assign or transfer these Terms without our prior written consent. We may assign these Terms without restriction.
### 14.5 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.
## 15. Contact Information
For questions about these Terms of Use:
**Ilana Immersive, LLC**
501 Union St Ste 545 PMB 696328, Nashville, TN 37219-1876
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.**