Terms of Service

Welcome to Module3 AI Incorporated. These Terms of Service ("Terms") govern your access to and use of our integrated drug development platform, human-in-the-loop agent architecture, and agentic services. By using our platform, you agree to be bound by these Terms.

1. The Service

Module3 AI provides an agentic ecosystem designed to accelerate the drug development lifecycle. Our platform unifies critical phases of development into a single collaborative environment:

• Integrated Workflow: Support for pre-pivotal and pivotal stages, process development, quality assurance, and regulatory compliance.
• Agentic Models: We provide a highly collaborative agentic platform featuring human-in-the-loop AI agents designed to help you make sense of vast amounts of data.
• Scope Limitation: Module3 AI provides platforms, agents, and tools for drug development and process acceleration, but we do not engage in or provide services for de novo drug discovery.

2. Human-in-the-Loop

The platform functions entirely under human-in-the-loop (HITL) architecture, where AI agents act as co-pilots requiring explicit human validation for all critical regulatory or process outputs.

3. Infrastructure and Instance Isolation

To ensure the highest level of security, performance, and regulatory compliance for drug development workflows, Module3 AI employs a hybrid architecture strategy:

• Physical and Logical Instance Isolation: Every client environment is hosted on a separate, dedicated virtual infrastructure. This prevents data commingling and ensures that one client's development logic or regulatory data never resides in a shared application space or shares computational resources with another client.
• Tenant-Specific Data Protection: We utilize a single-tenant architecture for all enterprise deployments. Proprietary process development and CMC (Chemistry, Manufacturing, and Controls) data are completely segmented at the application, database, and network layers. Furthermore, all data at rest within these instances is encrypted using industry-standard protocols to ensure confidentiality.
• Shared API Service Architecture: Our API-based products and services utilize a shared-resource model. Because these services are stateless and do not require the persistence of client data within a dedicated database, they are hosted on a common, high-availability server cluster to optimize performance and efficiency.
• Data Handling in Shared Services: For functionality, transient client data may be processed in temporary server memory (RAM) or utilized within high-speed caching layers. This data is ephemeral and is not retained beyond the immediate processing cycle. All data in transit between the client and both our dedicated instances and shared API services is encrypted using TLS 1.3.

4. Data Integrity and Ownership

In the context of GxP and regulatory environments:

• Client Data Ownership: You retain full ownership of all process data, quality records, and regulatory filings processed through the platform. Module3 AI acts only as a data processor.
• Data Integrity and Audit Trails: To meet FDA 21 CFR Part 11 and EU GMP Annex 11 requirements, all data ingested by the platform is subject to immutable logging. Comprehensive audit trails are maintained, capturing the "who, what, when, and why" of any action taken within the system.
• Data Portability and Offboarding: Upon contract termination or upon request, Module3 AI ensures the timely and secure retrieval of all client data in a industry-standard, machine-readable format. Following data verification, all client-specific data is permanently purged from our active systems in accordance with our retention policy.
• Compliance Responsibility: Users are responsible for ensuring that their specific use cases and internal SOPs (Standard Operating Procedures) comply with regional regulatory requirements. Module3 AI provides the secure, compliant infrastructure required to support these efforts.

5. Regulatory Disclaimer

6. Limitation of Liability and Indemnification