Terms of Service & End User Agreement

Effective Date: March 1, 2026  ·  Last Updated: March 1, 2026  ·  GalenLogic, LLC

Beta

AURA is currently in Beta. The platform is under active development. Features, functionality, and data models may change without notice. Beta access is provided for evaluation purposes and does not constitute a production-ready service. Do not rely solely on AURA output for regulatory submission decisions without independent qualified review.

Contents
  1. Acceptance of Terms
  2. Description of Service
  3. Beta Program
  4. License Grant & Restrictions
  5. Accounts & Access
  6. Regulatory Responsibility
  7. AI-Generated Content
  8. Your Data
  9. Subscription & Payment
  10. Intellectual Property
  11. Confidentiality
  12. Disclaimers
  13. Limitation of Liability
  14. Indemnification
  15. Termination
  16. Governing Law
  17. Changes to Terms
  18. Contact

1. Acceptance of Terms

These Terms of Service and End User License Agreement ("Agreement") constitute a legally binding contract between you and/or the organization you represent ("Customer," "you," or "your") and GalenLogic, LLC ("GalenLogic," "we," "us," or "our"), the developer of the AURA pharmacovigilance platform.

By accessing, registering for, or using AURA in any capacity — including during a beta, trial, or demonstration period — you agree to be bound by this Agreement. If you do not agree, you must not access or use the Service.

If you are accepting on behalf of an organization, you represent and warrant that you have the authority to bind that organization to this Agreement.


2. Description of Service

AURA is a cloud-based pharmacovigilance software-as-a-service (SaaS) platform designed to assist qualified safety professionals with adverse event case management and regulatory reporting workflows. The Service includes, but is not limited to:

GalenLogic reserves the right to modify, add, or remove features at any time, particularly during the Beta period.


3. Beta Program

The AURA platform is currently offered as a Beta release. Access is provided on an as-is, as-available basis for evaluation, testing, and early adoption purposes. The following conditions apply specifically to Beta access:


4. License Grant & Restrictions

4.1 Grant

Subject to your compliance with this Agreement and timely payment of applicable fees, GalenLogic grants you a limited, non-exclusive, non-transferable, revocable license to access and use AURA solely for your internal pharmacovigilance and drug safety operations, for the subscription term purchased.

4.2 Restrictions

You may not, and may not permit any third party to:


5. Accounts & Access

You are responsible for maintaining the confidentiality of your account credentials and for all activities that occur under your account. You agree to notify GalenLogic immediately of any unauthorized access or suspected security breach at Demo@aurapv.com.

Customer administrators are responsible for provisioning, managing, and deactivating user accounts within their tenant. GalenLogic is not liable for unauthorized access resulting from Customer's failure to manage user access appropriately.

Each user seat is for a single named individual. Sharing credentials across multiple individuals is prohibited.


6. Regulatory Responsibility

AURA is a software tool to assist trained pharmacovigilance professionals. It does not replace regulatory expertise, qualified person for pharmacovigilance (QPPV) oversight, or organizational accountability for regulatory compliance.

You acknowledge and agree that:


7. AI-Generated Content

AURA uses artificial intelligence and machine learning models to assist with certain tasks including MedDRA term suggestions, case narrative drafting, signal detection scoring, and document parsing. You acknowledge that:


8. Your Data

8.1 Ownership

You retain ownership of all case data, patient information, and content you input into AURA ("Customer Data"). GalenLogic does not claim ownership of Customer Data.

8.2 License to Process

You grant GalenLogic a limited, non-exclusive license to process Customer Data solely to provide and maintain the Service, including for backup, security, and technical support purposes.

8.3 Data Processing

Customer Data is stored and processed using Google Firebase (Google Cloud Platform), including Firestore (database) and Firebase Storage (file attachments). Data is stored in multi-tenant architecture with logical tenant isolation enforced through Firestore security rules. Google's applicable data processing terms govern GalenLogic's relationship with Firebase.

8.4 No Sale of Data

GalenLogic does not sell, rent, or share Customer Data with third parties for their marketing or commercial purposes.

8.5 Aggregated Analytics

GalenLogic may use aggregated, de-identified, and anonymized usage data to improve the platform and develop new features. Such data will not identify any individual or organization.

8.6 Data Return & Deletion

Upon termination of your subscription, GalenLogic will make Customer Data available for export for 30 days. After that period, GalenLogic may delete Customer Data in accordance with its data retention practices. You are responsible for exporting any data you wish to retain prior to termination.


9. Subscription & Payment

9.1 Fees

Access to AURA requires a paid subscription at the rates agreed upon at order time. Current plan pricing is listed on our website and is subject to change with 60 days' notice for existing subscribers.

9.2 Billing

Subscriptions are billed annually in advance unless otherwise agreed in writing. All fees are quoted in USD and are non-refundable except as expressly required by applicable law.

9.3 Taxes

Fees are exclusive of applicable taxes. You are responsible for all taxes, duties, and levies associated with your subscription, excluding taxes on GalenLogic's net income.

9.4 Overages

Exceeding plan limits (user seats or case volumes) without prior written agreement may result in service restriction or additional charges. GalenLogic will provide reasonable notice before restricting access.

9.5 Non-Payment

GalenLogic reserves the right to suspend or terminate access for accounts with overdue balances after 15 days' written notice.


10. Intellectual Property

AURA, including all software, algorithms, models, interfaces, documentation, and branding, is the exclusive intellectual property of GalenLogic, LLC and is protected by copyright, trade secret, and other applicable laws.

This Agreement does not transfer any ownership interest in AURA to you. All rights not expressly granted herein are reserved by GalenLogic.

Any feedback, suggestions, or feature requests you provide regarding AURA may be used by GalenLogic without obligation to you.


11. Confidentiality

Each party agrees to keep confidential any non-public information of the other party disclosed in connection with this Agreement ("Confidential Information"), including pricing, technical specifications, and Customer Data.

Confidential Information does not include information that: (a) is or becomes publicly available through no fault of the receiving party; (b) was known to the receiving party prior to disclosure; (c) is independently developed without reference to the Confidential Information; or (d) is required to be disclosed by law or court order, provided the disclosing party is given reasonable prior notice.

This confidentiality obligation survives termination of this Agreement for a period of three (3) years.


12. Disclaimers

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, GALENLOGIC EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT.

Without limiting the foregoing, GalenLogic does not warrant that:

AURA is a decision-support tool. It is not a medical device, and it does not constitute medical advice, legal advice, or regulatory advice.


13. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL GALENLOGIC, ITS OFFICERS, DIRECTORS, EMPLOYEES, PARTNERS, OR LICENSORS BE LIABLE FOR ANY:

WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR ANY OTHER THEORY, EVEN IF GALENLOGIC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

GALENLOGIC'S TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT SHALL NOT EXCEED THE GREATER OF: (A) THE TOTAL FEES PAID BY YOU TO GALENLOGIC IN THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE CLAIM, OR (B) ONE HUNDRED US DOLLARS ($100).

Some jurisdictions do not allow the exclusion of certain warranties or limitation of liability. In such jurisdictions, the above limitations apply to the fullest extent permitted by law.


14. Indemnification

You agree to defend, indemnify, and hold harmless GalenLogic and its affiliates, officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising out of or related to:


15. Termination

15.1 By You

You may terminate your subscription at the end of the current billing period by providing written notice to GalenLogic at least 30 days before renewal. No refunds are provided for unused portions of a subscription term.

15.2 By GalenLogic

GalenLogic may suspend or terminate your access immediately upon written notice if you: (a) materially breach this Agreement and fail to cure within 10 days of notice; (b) fail to pay fees when due; (c) use the Service in a manner that poses a security risk or legal liability; or (d) become insolvent or subject to bankruptcy proceedings.

15.3 Effect of Termination

Upon termination, your license to use the Service immediately ceases. Sections 10 (Intellectual Property), 11 (Confidentiality), 12 (Disclaimers), 13 (Limitation of Liability), 14 (Indemnification), and 16 (Governing Law) survive termination.


16. Governing Law & Disputes

This Agreement is governed by the laws of the State of Tennessee, United States, without regard to its conflict of law principles.

Any dispute arising out of or related to this Agreement that cannot be resolved through good-faith negotiation within 30 days shall be submitted to binding arbitration administered by JAMS under its Streamlined Arbitration Rules, with proceedings conducted in English in Tennessee. Notwithstanding this, either party may seek injunctive or other equitable relief in any court of competent jurisdiction to prevent irreparable harm.

You waive any right to participate in a class action lawsuit or class-wide arbitration against GalenLogic.


17. Changes to Terms

GalenLogic reserves the right to modify this Agreement at any time. Material changes will be communicated via email to your registered account address at least 30 days before taking effect. Continued use of the Service after the effective date constitutes acceptance of the updated terms.

For non-material changes (corrections, clarifications, additions that do not reduce your rights), updates take effect upon posting.


18. Contact

For questions about these Terms, please contact:

GalenLogic, LLC
AURA Pharmacovigilance Platform
Demo@aurapv.com

© 2026 GalenLogic, LLC All rights reserved. AURA is a trademark of GalenLogic, LLC