Terms of Service — AEGCompliance Ops™

1. Definitions

"Software" or "AEGCompliance Ops" means the AEGCompliance Ops™ platform, including the Progressive Web App (PWA), Cloudflare Workers backend, D1 database, and all associated documentation.
"Operator" means the individual user who installs and uses the Software on behalf of a healthcare or pharmaceutical facility.
"Facility" means the 503B outsourcing facility, 503A compounding pharmacy, peptide clinic, med-spa, BHRT practice, or other healthcare facility using the Software.
"Local Data" means all lot records, SOP versions, chain of custody logs, and related information stored in the Operator's browser local storage.
"Cloud Data" means any data transmitted to or stored in our Cloudflare Workers infrastructure, including version telemetry, authentication records, and (if cloud sync is enabled) facility data.

2. License Grant

Subject to your payment of all applicable fees and compliance with these Terms, AIM Elemental Health Solutions, Inc. grants you a limited, non-exclusive, non-transferable license to install and use the Software during your subscription term solely for your Facility's internal compliance operations.

This license is restricted to your own Facility. Resale, sublicensing, or use on behalf of third parties is prohibited without prior written consent.

3. Local-First Architecture (Default)

Default mode: The Software is designed to operate entirely on your local device, with Local Data stored in your browser's local storage. In this configuration:

No lot records, SOP data, or facility information is transmitted to any external system.
No Business Associate Agreement (BAA) is required.
The Software may be used indefinitely in local-only mode without an internet connection.

Version telemetry (email, name, facility, app version, IP) is transmitted on each login regardless of mode to support 503B audit trail accountability. This is required for regulatory compliance and cannot be disabled while signed in.

4. Cloud Sync Add-On (Optional — Requires BAA)

Operators may optionally enable cloud sync, which stores Facility data (lot records, SOP versions, operator accounts) in our Cloudflare D1 infrastructure to support team access and cross-device synchronization.

Cloud sync is available only when ALL of the following conditions are met:

(a) BAA Execution: Your Facility and AIM Elemental Health Solutions must execute a Business Associate Agreement (BAA) before any Facility data is transmitted to the cloud backend. Contact travers@aimelemental.com to initiate BAA execution.
(b) Opt-in acceptance: Your Facility's authorized administrator must explicitly accept these Cloud Sync Terms through the Software settings.
(c) HIPAA Responsibility: Your Facility bears sole responsibility for confirming that a valid BAA is in place before enabling cloud sync. Enabling cloud sync without a BAA may violate HIPAA (45 CFR Parts 160 and 164).

Cloud sync is an optional add-on. The Software is fully functional in local-only mode. There is no requirement to enable cloud sync to use the core lot tracking and SOP management features.

5. Responsible Use

You agree to use AEGCompliance Ops only:

For lawful compliance operations at your Facility
In compliance with FDA 21 CFR Parts 11, 203, 211, and all applicable state and federal regulations governing your Facility type
In accordance with the facility's own SOPs as documented in the Software

You shall not:

Use the Software to generate fraudulent compliance records
Attempt to reverse engineer, decompile, or extract the underlying compliance logic for competitive purposes
Use the Software to process PHI without a BAA and appropriate safeguards in place
Share operator credentials across multiple, unaffiliated facilities

6. Fees & Payment

Fees are as specified at aegcompliance.com/ops#pricing or your Order Form. Fees are billed annually unless otherwise specified. All fees are non-refundable except as expressly provided.

7. Intellectual Property

AIM Elemental Health Solutions, Inc. retains all right, title, and interest in the Software, including all documentation, design, algorithms, and trade secrets. You receive only a limited license to use the Software as provided. AEGCompliance Ops™ and the AEGCompliance logo are trademarks of AIM Elemental Health Solutions, Inc.

8. Data & Audit Trail

The Software is designed to support FDA 21 CFR Part 11 compliance by maintaining a tamper-evident electronic audit trail of all lot movements, SOP version changes, and operator sign-offs. The integrity of this audit trail depends on proper use:

Each operator must maintain their own unique login credentials
Lot movements and SOP sign-offs must be recorded contemporaneously with the action
Local Data should be backed up regularly — AEGCompliance is not a backup service

9. Warranties & Disclaimer

Local mode warranty: When operated in local-only mode (default), the Software transmits no Facility data to any external system.

Cloud sync warranty: When cloud sync is enabled under a valid BAA, Facility data is processed in accordance with HIPAA Security Rule requirements.

Disclaimer: THE SOFTWARE IS PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND. AEGCOMPLIANCE DOES NOT WARRANT THAT THE SOFTWARE ENSURES REGULATORY COMPLIANCE. COMPLIANCE WITH FDA 21 CFR PARTS 11, 203, AND 211 DEPENDS ON PROPER USE, INCLUDING APPROPRIATE POLICIES, TRAINING, AND OVERSIGHT BY YOUR FACILITY. AEGCOMPLIANCE IS NOT A LEGAL, REGULATORY, OR COMPLIANCE ADVISOR.

10. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, AEGCOMPLIANCE'S TOTAL LIABILITY SHALL NOT EXCEED THE FEES PAID BY YOUR FACILITY IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM. AEGCOMPLIANCE SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING DAMAGES ARISING FROM REGULATORY FINDINGS, FDA AUDITS, CONSENT DECREES, OR LOSS OF FACILITY LICENSE.

11. Indemnification

You shall indemnify and hold harmless AIM Elemental Health Solutions from any claim, action, regulatory proceeding, or penalty arising from: (a) your Facility's use of the Software; (b) your Facility's failure to maintain proper compliance policies and oversight; (c) your breach of these Terms; or (d) any regulatory non-compliance by your Facility.

12. Governing Law

Governed by the laws of the State of Washington. Disputes resolved exclusively in King County, Washington courts.

13. Questions

Contact: travers@aimelemental.com

BAA requests: travers@aimelemental.com