Last Updated: October 29, 2025
By accessing or using the AEGIS platform ("Platform") provided by Mahalo Health ("Mahalo," "we," "our," or "us"), you agree to be bound by these Terms of Service ("Terms"). If you do not agree to these Terms, do not use the Platform.
AEGIS is a regulatory-grade software platform designed to support pharmaceutical companies in:
You must create an account to access the Platform. You agree to provide accurate, current, and complete information and to update such information to maintain its accuracy.
You are responsible for maintaining the confidentiality of your account credentials and for all activities under your account. You must notify us immediately of any unauthorized access or security breach.
Access to Platform features is controlled through role-based permissions. You may only access features and data authorized for your role.
You agree to use the Platform only for lawful purposes and in accordance with these Terms. You agree NOT to:
While AEGIS provides tools and infrastructure for regulatory compliance, the pharmaceutical sponsor remains ultimately responsible for all regulatory submissions, approvals, and ongoing compliance with FDA and other regulatory authorities.
AEGIS provides validation documentation and audit trails to support regulatory submissions. Users are responsible for reviewing and incorporating this documentation into their regulatory filings.
Users implementing ACNU or SaMD programs must ensure their use of the Platform complies with all applicable FDA guidance, IEC 62304, ISO standards, and other regulatory requirements.
You retain ownership of all data you input into the Platform. Mahalo does not claim ownership of your data.
By using the Platform, you grant Mahalo the right to process your data as necessary to provide services, maintain compliance, and improve the Platform.
For users processing PHI, a separate Business Associate Agreement (BAA) is required and governs HIPAA compliance obligations.
The Platform, including all software, designs, documentation, and related intellectual property, is owned by Mahalo Health and protected by copyright, trademark, and other intellectual property laws.
Subject to these Terms, Mahalo grants you a limited, non-exclusive, non-transferable license to access and use the Platform for your internal business purposes.
Access to the Platform requires payment of subscription fees as specified in your service agreement. Fees are billed in advance and are non-refundable except as required by law.
You agree to provide valid payment information and authorize Mahalo to charge applicable fees. Failure to pay may result in suspension or termination of access.
We strive to maintain Platform availability but do not guarantee uninterrupted access. Scheduled maintenance will be communicated in advance when possible.
Support services are provided according to your service tier. Response times and support channels vary by subscription level.
Mahalo warrants that the Platform will perform substantially in accordance with its documentation under normal use.
EXCEPT AS EXPRESSLY PROVIDED, THE PLATFORM IS PROVIDED "AS IS" WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. MAHALO DISCLAIMS ALL WARRANTIES INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.
AEGIS provides tools and infrastructure but does not guarantee regulatory approval. Users are solely responsible for obtaining and maintaining all necessary regulatory approvals.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, MAHALO SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS OR REVENUES, WHETHER INCURRED DIRECTLY OR INDIRECTLY, OR ANY LOSS OF DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES.
MAHALO'S TOTAL LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY YOU IN THE 12 MONTHS PRECEDING THE CLAIM.
You agree to indemnify and hold harmless Mahalo from any claims, damages, losses, liabilities, and expenses arising from your use of the Platform, violation of these Terms, or infringement of any rights of another party.
These Terms remain in effect while you use the Platform or maintain an account.
You may terminate your account at any time by providing written notice. You remain responsible for fees incurred prior to termination.
We may suspend or terminate your access immediately for violation of these Terms, non-payment, or other good cause.
Upon termination, your access will cease. We will retain data as required for regulatory compliance and may provide data export upon request, subject to applicable fees.
We may modify these Terms at any time. Material changes will be communicated via email or Platform notification. Continued use after changes constitutes acceptance of modified Terms.
These Terms are governed by the laws of [Jurisdiction], without regard to conflict of law principles.
Any disputes shall be resolved through binding arbitration in accordance with [Arbitration Rules], except that either party may seek injunctive relief in court for intellectual property matters.
These Terms, together with your service agreement and any applicable BAA, constitute the entire agreement between you and Mahalo.
If any provision is found unenforceable, the remaining provisions remain in full effect.
Failure to enforce any provision does not constitute a waiver of that provision.
You may not assign these Terms without our written consent. We may assign these Terms in connection with a merger, acquisition, or sale of assets.
For questions about these Terms, please contact us:
Mahalo Health
Email: legal@mahalo.health
Address: [Company Address]