LC-MS-IQ End User License Agreement (EULA)

Version 1.1

LCMS IQ, LLC

IMPORTANT: PLEASE READ THIS AGREEMENT CAREFULLY.

BY INSTALLING, ACCESSING, REGISTERING FOR, CONFIGURING, OR USING LC-MS-IQ, YOU AGREE TO BE BOUND BY THIS AGREEMENT.

IF YOU DO NOT AGREE TO THESE TERMS, DO NOT INSTALL, ACCESS, OR USE THE SOFTWARE.

1. Definitions

“Software” means LC-MS-IQ, including all updates, modifications, documentation, reports, interfaces, and related materials provided by LCMS IQ, LLC.

“User” means any individual or organization that installs, accesses, configures, or uses the Software.

“Company” means LCMS IQ, LLC.

2. License Grant

Subject to compliance with this Agreement, LCMS IQ, LLC grants User a limited, non-exclusive, non-transferable, revocable license to access and use LC-MS-IQ solely for User’s internal business purposes.

The Software is licensed and not sold.

All rights not expressly granted are reserved by LCMS IQ, LLC.

3. Ownership

LCMS IQ, LLC retains all right, title, and interest in and to:

• LC-MS-IQ
• Source code
• Object code
• Algorithms
• Reports
• Documentation
• Calculations
• User interfaces
• Trademarks
• Trade secrets
• Intellectual property

No ownership rights are transferred to User.

4. Restrictions

User shall not:

• Copy the Software except as permitted by law.
• Reverse engineer the Software.
• Decompile the Software.
• Disassemble the Software.
• Attempt to derive source code.
• Create derivative works.
• Resell the Software.
• Rent the Software.
• Lease the Software.
• Sublicense the Software.
• Circumvent licensing controls.
• Remove copyright notices.
• Use the Software to create competing products.

5. Intended Use

LC-MS-IQ is intended solely as a laboratory analytical review, quality review, health monitoring, and decision-support tool.

The Software is designed to assist qualified laboratory personnel in evaluating analytical data and identifying potential analytical issues.

LC-MS-IQ is not intended for:

• Clinical diagnosis
• Patient management
• Treatment decisions
• Medical decision making
• Method validation
• Method verification
• Regulatory submissions
• Accreditation determinations
• Laboratory information system functions
• Electronic medical record functions

All final laboratory, operational, quality, reporting, accreditation, regulatory, and clinical decisions remain solely the responsibility of User.

6. PHI and Patient Information

LC-MS-IQ is not intended to store, process, transmit, manage, or archive:

• Protected Health Information (PHI)
• Electronic Protected Health Information (ePHI)
• Patient medical records
• Patient-identifiable information

Users shall not upload:

• Patient names
• Dates of birth
• Medical record numbers
• Social Security numbers
• HIPAA-regulated identifiers
• Any information capable of identifying an individual patient

unless expressly authorized by a separate written agreement.

User is solely responsible for ensuring compliance with privacy laws, regulations, and institutional policies.

7. No Business Associate Relationship

Use of LC-MS-IQ does not create a Business Associate relationship under HIPAA.

LCMS IQ, LLC shall not be considered a Business Associate unless a separate written Business Associate Agreement has been executed by both parties.

8. User Responsibilities

User is solely responsible for:

• Software configuration
• Data review
• Data interpretation
• Method performance
• Method validation
• Quality decisions
• Regulatory compliance
• Accreditation compliance
• Reporting decisions
• Laboratory procedures
• Personnel training

User shall independently verify all software-generated outputs before relying upon them.

9. Operational Reliance and Contingency Requirements

Independent Laboratory Operations

Customer acknowledges that LC-MS-IQ is intended solely as a quality review and decision-support tool.

LC-MS-IQ is not intended to function as a mission-critical system or sole operational platform.

Customer shall maintain independent procedures, records, software systems, documentation, and contingency plans sufficient to continue laboratory operations without LC-MS-IQ.

No Operational Dependency

Customer shall not rely upon LC-MS-IQ as the sole mechanism by which laboratory data are:

• Reviewed
• Analyzed
• Interpreted
• Approved
• Stored
• Reported
• Archived
• Retrieved

Alternative procedures must be maintained at all times.

Alternative Review Procedures

Customer is solely responsible for maintaining alternative review procedures sufficient to continue laboratory operations during software unavailability.

Examples include:

• Native instrument software
• Vendor review software
• Manual review procedures
• Existing laboratory workflows
• Alternative software systems

Availability Disclaimer

LCMS IQ, LLC does not guarantee:

• Continuous operation
• Continuous availability
• Continuous accessibility
• Uninterrupted service
• Error-free operation
• Historical data availability
• Report availability
• Trend availability

The Software may become unavailable temporarily or permanently.

Customer Business Continuity Responsibility

Customer is solely responsible for maintaining:

• Business continuity plans
• Disaster recovery plans
• Backup procedures
• Operational contingency plans

sufficient to support laboratory operations independent of LC-MS-IQ.

No Service Level Agreement

Unless expressly stated in a separate written agreement executed by LCMS IQ, LLC, no Service Level Agreement (SLA) exists.

LCMS IQ, LLC makes no commitments regarding:

• Uptime
• Availability
• Response times
• Resolution times
• Recovery times
• Support availability

Exclusion of Business Interruption Claims

Customer acknowledges that laboratory operations must remain capable of functioning independently of LC-MS-IQ.

The temporary or permanent unavailability of LC-MS-IQ shall not constitute grounds for claims relating to:

• Business interruption
• Lost productivity
• Lost profits
• Lost revenue
• Delayed reporting
• Regulatory findings
• Accreditation findings
• Operational disruptions

10. Data Ownership

User retains ownership of data uploaded into the Software.

User grants LCMS IQ, LLC only those rights reasonably necessary to store, process, display, transmit, analyze, and back up such data for operation of the Software.

11. Feedback

Any suggestions, recommendations, comments, ideas, or feature requests submitted by User may be used by LCMS IQ, LLC without restriction or compensation.

12. Software Updates

LCMS IQ, LLC may provide updates, patches, enhancements, bug fixes, or new features at its sole discretion.

LCMS IQ, LLC is under no obligation to provide updates, maintenance, support, enhancements, or future versions.

13. Disclaimer of Warranties

THE SOFTWARE IS PROVIDED “AS IS” AND “AS AVAILABLE.”

TO THE MAXIMUM EXTENT PERMITTED BY LAW, LCMS IQ, LLC DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING:

• MERCHANTABILITY
• FITNESS FOR A PARTICULAR PURPOSE
• NON-INFRINGEMENT
• ACCURACY
• RELIABILITY
• AVAILABILITY
• PERFORMANCE

LCMS IQ, LLC DOES NOT WARRANT THAT:

• THE SOFTWARE WILL BE ERROR FREE.
• THE SOFTWARE WILL BE UNINTERRUPTED.
• ALL DEFECTS WILL BE CORRECTED.
• SOFTWARE OUTPUTS WILL ALWAYS BE ACCURATE.
• SOFTWARE OUTPUTS WILL ALWAYS IDENTIFY ANALYTICAL ISSUES.

14. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, LCMS IQ, LLC SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, REGULATORY, OR ECONOMIC DAMAGES.

THIS INCLUDES DAMAGES ARISING FROM:

• SOFTWARE ERRORS
• SOFTWARE DEFECTS
• DATA LOSS
• DATA CORRUPTION
• REPORTING DECISIONS
• QUALITY DECISIONS
• CLINICAL DECISIONS
• REGULATORY ACTIONS
• ACCREDITATION FINDINGS
• BUSINESS INTERRUPTION
• LOST PROFITS
• LOST REVENUE
• LOST DATA
• OPERATIONAL DISRUPTIONS
• SOFTWARE UNAVAILABILITY

REGARDLESS OF LEGAL THEORY.

15. Maximum Liability

THE TOTAL CUMULATIVE LIABILITY OF LCMS IQ, LLC ARISING FROM ANY CLAIM RELATED TO LC-MS-IQ SHALL NOT EXCEED THE TOTAL FEES PAID BY USER DURING THE TWELVE (12) MONTHS PRECEDING THE CLAIM.

IF NO FEES WERE PAID, LIABILITY SHALL NOT EXCEED ONE HUNDRED U.S. DOLLARS (US $100.00).

16. Indemnification

User agrees to defend, indemnify, and hold harmless LCMS IQ, LLC from claims arising from:

• User configuration
• User integrations
• User workflows
• Upload of PHI
• Regulatory violations
• Accreditation violations
• Laboratory reporting decisions
• Clinical use of results
• Failure to maintain contingency procedures

17. Termination

LCMS IQ, LLC may suspend or terminate access if:

• User violates this Agreement.
• User engages in unlawful activity.
• User compromises system security.
• User fails to pay applicable fees.

Upon termination, all license rights immediately cease.

18. Governing Law

This Agreement shall be governed by the laws of the State of Florida.

Any dispute arising from or relating to LC-MS-IQ shall be brought exclusively in state or federal courts located in Florida.

User consents to the jurisdiction of such courts.

19. Severability

If any provision of this Agreement is determined invalid or unenforceable, the remaining provisions shall remain in full force and effect.

20. Entire Agreement

This Agreement, together with any applicable Subscription Terms, Privacy Policy, Intended Use Statement, and Limitation of Liability provisions, constitutes the complete agreement between the parties regarding LC-MS-IQ.

21. Acceptance

By installing, accessing, configuring, subscribing to, or using LC-MS-IQ, User acknowledges that they have read, understood, and agreed to this Agreement.