Terms of Use &
Intellectual Property Rights
Definitions
The following terms, as used throughout this Agreement, shall have the meanings set forth below. Capitalized terms used but not defined herein carry the meaning ascribed to them in applicable context.
Acceptance of Terms
By accessing, evaluating, integrating, or using any component of the Platform — including participation in a live demonstration, proof of concept, pilot program, or production deployment — the User agrees to be bound by these Terms in their entirety. If you are accessing the Platform on behalf of an organization, you represent and warrant that you have authority to bind that organization.
Access to the Platform is restricted to authorized Users under a valid executed agreement. Unauthorized access, use, reproduction, or distribution of any Platform component is strictly prohibited and may give rise to civil and criminal liability.
These Terms govern all interactions with the Platform, including but not limited to: API access, dashboard use, document ingestion, AI Output consumption, system integrations, and any derived reporting or analytics activities.
Platform Overview
The Platform consists of two purpose-built AI engines that converge into a single unified intelligence architecture — the Aurelyn Trial | OS™ — continuously monitoring, classifying, and surfacing insights across the User's clinical trial technology stack.
AI-driven document ingestion, auto-classification against CDISC eTMF Reference Model zones and artifacts, continuous monitoring for audit gaps, predictive readiness scoring, and automated site notifications.
Real-time endpoint tracking, safety signal detection, CDISC-aligned evidence synthesis across EDC, CTMS, IRT, safety databases and central labs, and submission-ready evidence package assembly.
The Platform is designed for use by sponsors, CROs, and AI-forward biotechs operating clinical trials subject to 21 CFR Part 11, FDA, ICH/GCP (E6(R2)), HIPAA, GDPR, and related regulatory requirements. Aurelyn AI Clinical does not warrant that Platform use alone constitutes regulatory compliance; Users retain responsibility for their regulatory obligations.
License Grant & Restrictions
Subject to the User's compliance with this Agreement and payment of applicable fees, Aurelyn AI Clinical grants the User a limited, non-exclusive, non-transferable, non-sublicensable, revocable license to access and use the Platform solely for the User's internal clinical trial operations during the applicable subscription term.
This license expressly excludes the right to:
- Copy, reproduce, distribute, or publicly display any portion of the Platform, AI models, or AI Output beyond the User's authorized internal use;
- Sublicense, resell, transfer, assign, or otherwise make the Platform available to any third party;
- Reverse engineer, decompile, disassemble, or attempt to derive source code or model weights from any Platform component;
- Create derivative works, competing products, or services based in whole or in part on the Platform or any AI Output;
- Use the Platform to train, fine-tune, or develop any external AI or machine learning model;
- Remove, alter, or obscure any proprietary notices, trademarks, or attributions embedded in the Platform;
- Use the Platform in any manner that violates applicable law, including regulatory requirements governing clinical trial conduct.
| Activity | Authorized Users | Third Parties | Competitors |
|---|---|---|---|
| Access Platform dashboards & APIs | ✓ Permitted | ✗ Prohibited | ✗ Prohibited |
| Use AI Output in internal reports | ✓ Permitted | Restricted | ✗ Prohibited |
| Submit AI Output to regulators | ✓ Permitted | N/A | N/A |
| Reproduce or redistribute Platform | ✗ Prohibited | ✗ Prohibited | ✗ Prohibited |
| Reverse engineer AI models | ✗ Prohibited | ✗ Prohibited | ✗ Prohibited |
| Use to train external AI systems | ✗ Prohibited | ✗ Prohibited | ✗ Prohibited |
Intellectual Property Rights
All intellectual property comprising or embedded in the Platform — including the Aurelyn Clinical Engines™ and Aurelyn Trial | OS™ — is and shall remain the sole and exclusive property of Aurelyn AI Clinical. No rights are transferred to the User except the limited license expressly granted in § 04.
Aurelyn AI Clinical's intellectual property includes, without limitation:
- The dual-engine AI architecture, including all model weights, training pipelines, inference logic, and calibration methodologies underlying the eTMF Intelligence Engine and Clinical Evidence Engine;
- The Aurelyn Trial | OS™ AI Core — the unified intelligence layer, data harmonization schema, compliance validation architecture, and cross-engine orchestration framework;
- All CDISC eTMF Reference Model mappings, auto-classification taxonomies, audit readiness scoring algorithms, and predictive models developed by or for Aurelyn AI Clinical;
- All signal detection frameworks, MedDRA coding logic, endpoint tracking methodologies, evidence synthesis protocols, and regulatory package assembly workflows;
- The TMF Completeness Index™ dashboard and all associated analytical models, visualizations, and reporting frameworks;
- All software source code, object code, APIs, database schemas, and data models constituting any part of the Platform;
- All trade secrets, proprietary know-how, technical documentation, research, and development investments embedded in or supporting the Platform;
- All copyrightable works including user interfaces, technical documentation, marketing materials, and training content developed by Aurelyn AI Clinical.
User Data Ownership. The User retains all rights to Trial Data submitted to the Platform. The User grants Aurelyn AI Clinical a limited, non-exclusive license to process Trial Data solely as necessary to operate and deliver the Platform services. Aurelyn AI Clinical shall not use Trial Data to train models for deployment to other clients except in anonymized, aggregated, de-identified form in accordance with applicable law and the executed Data Processing Agreement.
AI Output Ownership. AI Outputs are generated by Aurelyn AI Clinical's proprietary models. The User receives a license to use AI Outputs for its internal clinical operations and regulatory submissions. Aurelyn AI Clinical retains all underlying model and methodology rights. The User shall not represent AI Outputs as independently developed analytical conclusions without appropriate attribution to the Platform.
Trademarks & Brand Identity
The following marks are proprietary trademarks and service marks of Aurelyn AI Clinical, whether registered or unregistered:
The dual-engine clinical AI platform brand and all associated engine identities, product names, and commercial designations.
The proprietary clinical trial operating system brand, including all associated platform names, logos, and product identifiers.
Additional protected marks and designations include: Aurelyn AI Clinical®, TMF Completeness Index™, eTMF Intelligence Engine™, Clinical Evidence Engine™, and any other product names, slogans, or design elements associated with the Platform.
Users are prohibited from:
- Using any Aurelyn AI Clinical mark in commerce, advertising, or promotional materials without prior written authorization;
- Registering or attempting to register any mark confusingly similar to any Aurelyn AI Clinical mark;
- Using any Aurelyn AI Clinical mark in a manner that implies endorsement, partnership, or affiliation not established by an executed agreement;
- Incorporating any Aurelyn AI Clinical mark into any domain name, company name, product name, or social media handle;
- Modifying, stylizing, or creating derivative versions of any Aurelyn AI Clinical logo or brand asset.
Authorized Users may identify themselves as a licensed user of the Aurelyn Clinical Engines™ platform in limited factual contexts, using only the unmodified marks and subject to any brand guidelines provided by Aurelyn AI Clinical.
Data, Privacy & Regulatory Compliance
The Platform is designed with compliance at its core, incorporating architectural controls for the following frameworks. Compliance certifications and control documentation are available upon request under a Non-Disclosure Agreement:
While the Platform incorporates extensive compliance controls, Users retain ultimate responsibility for their own regulatory compliance obligations. AI Outputs, including audit readiness scores, evidence syntheses, and regulatory packages, should be reviewed by qualified clinical, medical, and regulatory professionals prior to submission to or reliance upon by any regulatory authority.
Prohibited Uses
In addition to the restrictions in § 04, Users shall not use the Platform to:
- Engage in any fraudulent, deceptive, or misleading clinical trial conduct;
- Submit falsified, fabricated, or manipulated Trial Data to the Platform for processing or regulatory submission;
- Circumvent or attempt to circumvent any access control, authentication mechanism, or security feature of the Platform;
- Conduct automated scraping, crawling, or systematic extraction of AI Outputs, Platform data, or underlying model behaviors beyond API rate limits;
- Probe, scan, or test the Platform for security vulnerabilities without prior written authorization from Aurelyn AI Clinical;
- Use the Platform in connection with clinical trials involving human subjects outside of the applicable regulatory framework in the relevant jurisdiction;
- Transmit to the Platform any malicious code, viruses, or disruptive data payloads;
- Violate any applicable law, regulation, or guideline, including export control laws or international data transfer restrictions.
Disclaimers & Warranties
THE PLATFORM AND ALL AI OUTPUTS ARE PROVIDED "AS IS" AND "AS AVAILABLE." AURELYN AI CLINICAL MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR REGULATORY COMPLIANCE. AURELYN AI CLINICAL DOES NOT WARRANT THAT THE PLATFORM WILL BE ERROR-FREE, UNINTERRUPTED, OR FREE FROM CYBERSECURITY THREATS.
Aurelyn AI Clinical warrants that: (i) the Platform will perform materially in accordance with its documentation under normal use conditions; (ii) Aurelyn AI Clinical will implement commercially reasonable security measures; and (iii) Aurelyn AI Clinical has the right to grant the licenses provided herein.
AI Outputs are generated by probabilistic models and do not constitute medical advice, legal advice, or regulatory determinations. Users bear full responsibility for human review, validation, and professional judgment applied to all AI Outputs before clinical, regulatory, or operational reliance.
Limitation of Liability
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, AURELYN AI CLINICAL SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES ARISING FROM OR RELATED TO THE PLATFORM OR THESE TERMS, INCLUDING DAMAGES FOR LOSS OF DATA, REGULATORY FINDINGS, TRIAL DELAYS, PROFITS, OR GOODWILL.
AURELYN AI CLINICAL'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS SHALL NOT EXCEED THE GREATER OF: (i) THE TOTAL FEES PAID BY THE USER TO AURELYN AI CLINICAL IN THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE CLAIM; OR (ii) ONE THOUSAND US DOLLARS ($1,000).
The limitations set forth in this section shall apply even if Aurelyn AI Clinical has been advised of the possibility of such damages. Some jurisdictions do not permit the exclusion of certain implied warranties or limitation of certain damages; in such jurisdictions, limitations shall apply to the fullest extent permitted by law.
Indemnification
The User shall defend, indemnify, and hold harmless Aurelyn AI Clinical and its officers, directors, employees, agents, licensors, and partners from and against any claims, liabilities, damages, losses, costs, and expenses (including reasonable legal fees) arising out of or related to:
- The User's breach of any representation, warranty, or obligation under this Agreement;
- The User's use of the Platform in violation of applicable law or regulatory requirements;
- Any Trial Data submitted by the User to the Platform, including any claims that such Trial Data infringes third-party rights or violates any applicable law;
- The User's reliance upon AI Outputs without appropriate professional review and validation;
- Any unauthorized access to the Platform enabled or facilitated by the User.
Aurelyn AI Clinical shall indemnify the User against third-party claims that the Platform, as delivered, infringes any valid patent, copyright, or trade secret, subject to the User promptly notifying Aurelyn AI Clinical of any such claim and cooperating fully in the defense.
Governing Law & Disputes
This Agreement shall be governed by and construed in accordance with the laws of the United States and the State of Delaware, without regard to conflict of laws principles. The United Nations Convention on Contracts for the International Sale of Goods (CISG) shall not apply.
Dispute Resolution. The parties agree to first attempt resolution of any dispute through good-faith negotiation for a period of thirty (30) days from written notice of the dispute. If unresolved, disputes shall be submitted to binding arbitration under the Commercial Arbitration Rules of the American Arbitration Association (AAA), with proceedings conducted in English in Wilmington, Delaware, before a single arbitrator. The arbitrator's award shall be final and may be entered as a judgment in any court of competent jurisdiction.
Equitable Relief. Notwithstanding the foregoing, either party may seek emergency injunctive or other equitable relief in any court of competent jurisdiction to prevent irreparable harm, including enforcement of intellectual property rights or confidentiality obligations, without waiving the right to arbitration.
Class Action Waiver. All disputes shall be resolved on an individual basis; class actions, class arbitrations, and consolidated proceedings are not permitted.
Modifications
Aurelyn AI Clinical reserves the right to modify these Terms at any time. Material changes will be communicated to Users via: (i) notice posted to the Platform; (ii) email to the User's registered contact address; or (iii) updated version posting at the official platform URL with a revised effective date.
Continued use of the Platform following the effective date of modified Terms constitutes acceptance of such modifications. Users who do not agree to material changes may terminate their agreement in accordance with the applicable notice period in their executed services agreement.
Aurelyn AI Clinical also reserves the right to modify, update, or discontinue any feature, engine, integration, or component of the Platform at any time upon reasonable notice, provided that core contracted functionality is maintained through the applicable subscription term.
Contact & Legal Notices
All legal notices, IP rights inquiries, trademark permissions, data privacy requests, and compliance inquiries should be directed to:
Aurelyn Clinical Engines™ · Aurelyn Trial | OS™
These Terms constitute the complete agreement between Aurelyn AI Clinical and the User with respect to Platform use and intellectual property rights, superseding all prior discussions, representations, and agreements on the subject matter hereof.
EFFECTIVE DATE: JANUARY 1, 2026 · VERSION 1.0 · © 2026 AURELYN AI CLINICAL