Master Terms and Conditions of Business

PREAMBLE AND OPERATIONAL SCOPE

These Master Terms and Conditions of Business ("Terms" or "Agreement") regulate the licensing, implementation, and operational management of the LABA Laboratory Information Management System ("LABA" or the "Application"), provided by Biomed Systems Limited ("Biomed Systems", "we", or "us") to the research, clinical, or institutional entity specified in an executed commercial Order Form ("Client" or "you").

1. DEFINITIONS AND INTERPRETATION

In this Agreement, unless the context otherwise requires, the following capitalised expressions shall bear the precise legal meanings ascribed below:

2. LICENCE GRANT AND THE BOUNDLESS OPERATIONAL METRIC

2.1 Licence Grant

Subject to the settlement of agreed implementation milestones and maintenance retainers, Biomed Systems Limited grants the Client a non-exclusive, perpetual licence (subject to termination provisions) to operate LABA for internal laboratory, biobanking, and clinical research workflows.

2.2 The Boundless Infrastructure Commitment

The licence contains no volumetric restrictions. The Client is entitled to operate:

• Unlimited named and concurrent user accounts across administrative, laboratory, and scientific tiers.
• Unlimited registered virtual storage units (including -80°C mechanical freezers, liquid nitrogen cryo-tanks, dewars, and ambient shelving).
• Unlimited transactional inventory records, audit events, and sample lineage entries without triggering tier upgrades or volumetric fees.

2.3 Access Stewardship

Access to the Application is individualised. Sharing, delegation, or pooling of user credentials (usernames, passwords, or authentication tokens) is strictly prohibited. Individualised authentication maintains unbroken audit traceability under the Computer Misuse Act 1990.

2.4 Reverse Engineering Prohibitions

LABA is protected under the Copyright, Designs and Patents Act 1988. The Client shall not decompile, reverse engineer, disassemble, scrape, decrypt, or attempt to derive the underlying Microsoft SQL Server schemas, compiled assemblies, or core application logic.

3. DEPLOYMENT MODELS AND RESPONSIBILITIES DELINEATION

Operational, infrastructural, and administrative duties are strictly allocated in accordance with the deployment architecture selected in the applicable Order Form:

3.1 Infrastructure Provision

(a) For cloud-hosted deployments, Biomed Systems Limited shall provision, monitor, and maintain dedicated cloud server instances.

(b) For on-premises deployments, the Client shall procure, provision, and maintain all hardware related to Windows Server and Microsoft SQL Server, including virtual environments, within its corporate perimeter.

3.2 Operating System and Database Administration

(a) For cloud-hosted deployments, the responsibilities of operating system hardening, runtime environment management, and SQL database maintenance shall be managed directly by Biomed Systems Limited.

(b) For on-premises deployments, the Client's IT department shall be solely responsible for internal operating system patching, hypervisor administration, and local firewall configurations.

3.3 Disaster Recovery and Backups

(a) For cloud-hosted deployments, Biomed Systems Limited shall perform automated daily off-site encrypted backup snapshots, including managed verification of restoration procedures.

(b) For on-premises deployments, the Client assumes full responsibility for automated database backups, transaction log shipping, off-site archiving, and disaster recovery procedures.

3.4 Maintenance Delivery

(a) For cloud-hosted deployments, software upgrades and security patches shall be deployed directly to the hosted application container by Biomed Systems Limited.

(b) For on-premises deployments, maintenance shall be conducted exclusively through pre-compiled, zero-Touch update packages and database migration scripts, which are deployed by Client personnel without the need for inbound network backdoors.

3.5 Data Residency and Administrative Access

(a) For cloud-hosted deployments, data shall be maintained within sovereign UK facilities governed by Singular Data Sovereignty, with administrative database access restricted solely to the Managing Director.

(b) For on-premises deployments, all data shall physically and digitally reside within the Client's private firewall, with no persistent remote access granted to Biomed Systems Limited.

4. IMPLEMENTATION, PRICING, AND INVOICING

4.1 Implementation Milestones

Engineering onboarding fees, which encompass workflow digitisation, legacy dataset migration, and optional GxP validation support, will be invoiced upon the formal completion of the milestones specified in the Order Form.

4.2 Annual Stewardship Retainers

The annual Cloud Stewardship Retainers and On-Premise Maintenance Retainers are billed annually in advance. Invoices are due within thirty (30) calendar days of issuance and are payable via electronic bank transfer, net of remittance charges.

4.3 Value Added Tax (VAT)

All quoted fees are exclusive of Value Added Tax. Standard UK VAT at 20% applies to all transactions within the United Kingdom under VAT Registration No. 515912105. Statutory research exemptions, NHS Trust invoicing procedures, and international reverse-charge mechanisms are applicable upon receipt of the necessary statutory documentation.

5. REGULATORY COMPLIANCE AND FORENSIC AUDITING

5.1 Architectural Facilitation versus Certification

LABA provides the necessary technical safeguards, cryptographic validation, and data verification routines to support institutional compliance with FDA 21 CFR Part 11, UK GDPR, EU GDPR, ISO 17025, ISO 20387, and the Human Tissue Act 2004 (HTA). Biomed Systems Limited acts solely as the software architect; responsibility for obtaining, validating, and auditing statutory facility accreditations remains exclusively with the Client.

5.2 Immutable Audit Footprints

The Application enforces an unalterable, append-only forensic audit trail. Every user interaction, sample lineage modification, aliquot derivation, and metadata update is recorded with immutable timestamps, authenticated user IDs, and session metadata.

5.3 Telemetry Sanctity

System diagnostic logs, performance metrics, and operational telemetry managed by Biomed Systems Limited are regarded as strictly confidential. These will never be shared, commercialised, or disclosed, except when ordered by a competent court under the laws of England and Wales.

6. INTELLECTUAL PROPERTY AND ESCROW SAFEGUARDS

6.1 Software Ownership

Biomed Systems Limited retains exclusive ownership of all rights, titles, and interests in LABA, including its database structures, interface layouts, and source code.

6.2 Client Data Ownership

The Client retains absolute, unencumbered ownership, custody, and copyright in all Client Data. Biomed Systems Limited asserts no proprietary interest in biological records, patient phenotypes, or experimental results.

6.3 Tripartite Escrow Option

To provide assurance of institutional continuity for NHS Trusts and enterprise research facilities, Biomed Systems Limited facilitates a standard tripartite software escrow agreement with an accredited UK escrow agent (such as NCC Group) upon request. Escrow release conditions are strictly limited to formal corporate insolvency, dissolution, or voluntary abandonment of software support obligations.

7. WARRANTIES AND LIMITATION OF LIABILITY

7.1 Performance Warranty

Biomed Systems Limited guarantees that LABA will perform substantially in accordance with its published technical documentation throughout the duration of any active retainer agreement.

7.2 On-Premise Hosting Disclaimer

In cases where LABA is deployed on-premises, Biomed Systems Limited disclaims any liability for data corruption, security breaches, hardware failures, or downtime that may result from the Client's internal network environment, storage failures, firewall modifications, or operating system incompatibilities. The Client assumes exclusive responsibility for the security of local infrastructure and the integrity of backups.

7.3 Consequential Loss Exclusion

Neither party shall be liable to the other for any consequential losses, including but not limited to loss of research grants, operational delays, or the indirect physical deterioration of biological specimens.

7.4 Aggregate Financial Cap

The total financial liability of Biomed Systems Limited arising under or in connection with this Agreement within any twelve-month contractual cycle shall be limited to 100% of the total fees paid by the Client to Biomed Systems Limited during that period.

8. TERM, TERMINATION, AND SOVEREIGN DATA EXTRACTION

8.1 Termination for Cause

Either party may terminate this Agreement immediately upon written notice if the other party commits an incurable material breach or fails to remedy a remediable breach within thirty (30) calendar days of written notice.

8.2 Exit Data Portability (Cloud Deployments)

Upon termination of a Cloud-Hosted Deployment, Biomed Systems Limited will deliver a complete, open-standard SQL database extract and a structured CSV dataset within thirty (30) calendar days, followed by the permanent, verified sanitisation of the hosted production instances.

9. GOVERNING LAW AND JURISDICTION

This Agreement and any dispute or claim arising out of it (including non-contractual disputes) shall be governed by, and construed in accordance with, the laws of England and Wales. Both parties irrevocably submit to the exclusive jurisdiction of the courts of England and Wales.

COMMERCIAL GOVERNANCE & COMPLIANCE FAQ

Clear technical, operational, and regulatory clarifications regarding our contractual baselines, deployment security boundaries, and licensing policies: