Terms of Service

These Terms of Service ("Terms") are a binding agreement between you ("Customer", "you") and ANZLabsAI LLC, a Virginia limited liability company, doing business as "340B Audit OS"("ANZLabsAI", "we", "us"). By creating an account, uploading data, purchasing a mock audit, or otherwise using the Service, you agree to these Terms. If you do not agree, do not use the Service.

2.1 What the Service Is

340B Audit OS is a software-as-a-service analytics platform that produces automated, software-generated mock-audit outputs intended to support a covered entity's internal 340B Program readiness review. The Service applies deterministic rules, document parsing, and AI/ML models to Customer-supplied data.

2.2 What the Service Is Not

The Service is not a HRSA audit, a licensed professional audit, a certification of compliance, a legal opinion, accounting advice, billing advice, or a substitute for qualified internal or external professional review. Outputs are forecasts and indicators, not determinations.

2.3 No-PHI Warranty & Indemnification

The Service is designed to operate on de-identified administrative, financial, and program-eligibility data. You represent, warrant, and covenant that you will not upload, transmit, paste, or otherwise submit to the Service any Protected Health Information ("PHI") as defined under HIPAA (45 C.F.R. § 160.103), patient identifiers, or any other individually identifiable health information. You acknowledge that the Service has implemented automated PHI scanners designed to detect and block submissions containing common PHI patterns prior to persistence, but such scanners are not perfect and your obligation to withhold PHI is absolute and independent of any technical control.

You agree to defend, indemnify, and hold harmless ANZLabsAI LLC, its officers, members, employees, contractors, and affiliates from and against any and all claims, demands, investigations, regulatory actions, fines, penalties, settlements, judgments, losses, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or relating to (a) your submission of PHI or other regulated personal information to the Service in breach of this Section 2.3, (b) any resulting HIPAA, state privacy, or other regulatory exposure, and (c) any breach by you of your representations under this Section 2.3. ANZLabsAI is not, and shall not be deemed to be, a HIPAA Business Associate of Customer by virtue of providing the Service, and no Business Associate Agreement is in effect unless separately executed in writing by an authorized officer of ANZLabsAI.

You must be at least 18 years old and authorized to bind the entity on whose behalf you are using the Service. You are responsible for maintaining the confidentiality of your credentials and for all activity under your account.

You retain all rights to data you submit ("Customer Data"). You grant ANZLabsAI a non-exclusive, worldwide, royalty-free license to host, process, analyze, and display Customer Data solely to provide and improve the Service to you. We may use aggregated, de-identified, statistically derived data to operate, secure, and improve the Service. We do not sell Customer Data.

The Service uses third-party AI/ML models accessed via the Lovable AI Gateway (which routes to upstream model providers including Google). AI outputs may be incomplete, inaccurate, or out of date. See our AI Disclaimer for details on how to interpret and rely on outputs. You are solely responsible for human review of any output before acting on it.

Fees are charged in U.S. dollars and processed by Stripe, Inc. Mock-audit purchases are non-refundable once analysis has begun. Subscription fees, if applicable, renew automatically until cancelled.

You will not (a) reverse engineer the Service, (b) use the Service to violate any law or third-party right, (c) upload malicious code, (d) attempt to access another customer's data, or (e) use the Service to provide a substantially similar competing service.

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, ACCURACY, OR REGULATORY COMPLIANCE. ANZLabsAI DOES NOT WARRANT THAT OUTPUTS WILL IDENTIFY ALL ACTUAL OR POTENTIAL 340B PROGRAM ISSUES OR THAT USE OF THE SERVICE WILL RESULT IN A FAVORABLE HRSA AUDIT OUTCOME.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, ANZLabsAI'S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO THE SERVICE WILL NOT EXCEED THE GREATER OF (a) THE FEES PAID BY YOU TO ANZLabsAI IN THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO THE CLAIM OR (b) ONE HUNDRED U.S. DOLLARS ($100). IN NO EVENT WILL ANZLabsAI BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR LOST PROFITS, LOST REVENUE, LOST DATA, OR REGULATORY PENALTIES.

You may stop using the Service at any time. We may suspend or terminate access for breach of these Terms or for risk to the Service or other customers. Sections 2.3, 4, 8, 9, and 11 survive termination.

These Terms are governed by the laws of the Commonwealth of Virginia, without regard to conflict-of-laws principles. Any dispute will be resolved exclusively in the state or federal courts located in Virginia, and you consent to personal jurisdiction there.

We may update these Terms; the "Last updated" date above will change. Continued use after an update constitutes acceptance.

ANZLabsAI LLC — Legal: [email protected] · Support: [email protected]