1. Acceptance of Terms

By accessing or using BioProcess Nexus (“the Platform”), you agree to be bound by these Terms of Service (“Terms”). If you disagree with any part of these terms, you may not access the Platform.

2. Description of Service

BioProcess Nexus provides digital CMC (Chemistry, Manufacturing, and Controls) services and software solutions for biopharmaceutical process engineering, including:

• Process engineering consulting services
• Software tools for experimental design, analysis, and simulation
• Platform licensing and enterprise integration services
• Secure client workspace for data management and collaboration

3. Intellectual Property Protection

3.1 Platform IP

All software, tools, algorithms, user interfaces, documentation, and other materials provided through the Platform are the exclusive property of FM Prime Systems LLC and its licensors. These materials are protected by copyright, trademark, patent, and other intellectual property laws.

3.2 Software Tools

The software tools provided on the Platform, including but not limited to:

• DoE Generator
• Lyophilization Cycle Development tools
• Formulation Analysis modules
• P&ID Walkdown Assistant
• Process Simulator

Are proprietary software products owned by FM Prime Systems LLC. Use of these tools is subject to the licensing terms specified in your service agreement.

3.3 User Data Ownership

You retain ownership of all process data, experimental results, and proprietary information you upload or generate using the Platform. However, you grant FM Prime Systems LLC a limited license to use anonymized, aggregated data for platform improvement and analytics purposes.

3.4 Restrictions

You may not:

• Reverse engineer, decompile, or disassemble any software tools
• Copy, modify, or create derivative works of the Platform software
• Remove or alter any proprietary notices or labels
• Use the Platform to develop competing products or services
• Share access credentials or allow unauthorized access

4. User Accounts and Responsibilities

You are responsible for maintaining the confidentiality of your account credentials and for all activities that occur under your account. You agree to:

• Provide accurate and complete registration information
• Notify us immediately of any unauthorized access
• Comply with all applicable laws and regulations
• Not use the Platform for illegal or unauthorized purposes

5. Service Availability

We strive to maintain high availability but do not guarantee uninterrupted or error-free service. We reserve the right to modify, suspend, or discontinue any part of the Platform with reasonable notice.

6. GxP Compliance and Data Integrity

For users subject to GxP regulations (21 CFR Part 11, etc.), the Platform provides audit trails, electronic signatures, and validation documentation. However, you are responsible for:

• Ensuring your use complies with applicable regulatory requirements
• Validating the Platform for your specific use case
• Maintaining appropriate quality systems and documentation
• Backing up critical data independently

7. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, FM PRIME SYSTEMS LLC SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, DATA, OR USE, ARISING FROM YOUR USE OF THE PLATFORM.

8. Termination

We may terminate or suspend your access to the Platform immediately, without prior notice, for conduct that we believe violates these Terms or is harmful to other users, us, or third parties.

9. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Colorado, United States, without regard to its conflict of law provisions.

10. Contact Information

For questions about these Terms, contact:

FM Prime Systems LLC
Westminster, CO
Email: jaime@biopronexus.com