Terms of Service

1. Introduction & Scope

Welcome to the Aevum Zenth Pharma Logistics platform ("Platform"). These Terms of Service ("Terms") govern your access to and use of our pharmaceutical supply chain, cold chain logistics, tracking, and compliance management services. By accessing, registering, or utilizing any services provided by Aevum Zenth Conglomerate’s Pharma Logistics division ("Company," "we," "us," or "our"), you agree to be bound by these Terms.

2. Definitions

• "Services" refers to our temperature-controlled warehousing, freight coordination, real-time IoT monitoring, batch tracking, customs brokerage, and GxP-compliant documentation systems.
• "Client" means the authorized organization or individual contracting for our logistics services.
• "Pharmaceutical Goods" includes APIs, finished dosage forms, biologics, vaccines, clinical trial materials, and related medical supplies.
• "Compliance Standards" refers to FDA 21 CFR Part 11, EMA GDP Guidelines, ICH Q9/Q10, GDP, GSP, and applicable national pharmacopeias.

3. Eligibility & Acceptance

To access our Platform, you must be a legally registered entity with valid pharmaceutical distribution licenses or manufacturer credentials in your jurisdiction. By creating an account or initiating a service request, you represent and warrant that:

• You possess all necessary regulatory approvals to handle, store, or transport pharmaceutical goods.
• You are authorized to bind your organization to these Terms.
• You will provide accurate, verifiable business and compliance documentation.

Access is granted on a provisional basis pending successful completion of our Vendor Due Diligence (VDD) and Quality Agreement review process.

4. Services Description

Aevum Zenth Pharma Logistics provides end-to-end pharmaceutical supply chain solutions, including but not limited to:

• Cold Chain Management: 2–8°C, 15–25°C, frozen (-20°C to -80°C), and ambient storage with continuous IoT temperature/humidity logging.
• Track & Trace: GS1-compliant serialization, batch-level visibility, and predictive analytics for transit optimization.
• Customs & Regulatory Brokerage: Import/export documentation, export health certificates, and controlled substance compliance.
• Clinical Trial Logistics: Randomization, decanting, temperature mapping, and return/ destruction of trial materials.

Service specifications, SLAs, and pricing are detailed in the individual Master Service Agreement (MSA) or Statement of Work (SOW) executed between the parties.

5. User Obligations & Compliance

Clients are responsible for:

• Providing accurate product specifications, including stability data, packaging requirements, and handling instructions.
• Ensuring all shipments comply with destination country import regulations and export controls.
• Maintaining valid insurance coverage for high-value or controlled pharmaceutical goods as required by contract.
• Reporting adverse events, product recalls, or quality deviations to our Quality Assurance team within 24 hours.

Failure to comply with these obligations may result in service suspension, shipment holds, or termination per Section 10.

6. Data Privacy & Security

Your data is processed in accordance with the Aevum Zenth Global Privacy Policy and applicable regulations including GDPR, HIPAA (where applicable), and China PIPL. We implement:

• End-to-end encryption (AES-256) for all shipment data and temperature logs.
• Role-based access controls and multi-factor authentication for Platform users.
• Regular ISO 27001 and SOC 2 Type II audits.
• Data retention policies aligned with 21 CFR Part 11 and EU GDP requirements (minimum 5 years post-product expiry).

Personal health information (PHI) is never collected unless explicitly required for clinical trial services, in which case a separate Data Processing Agreement (DPA) applies.

7. Intellectual Property

All proprietary algorithms, IoT telemetry systems, dashboard interfaces, and compliance frameworks developed by Aevum Zenth remain the exclusive property of the Company. Clients retain full ownership of their product data, formulations, and commercial information. By using the Platform, you grant us a limited, non-exclusive license to process and transmit your data solely for the purpose of fulfilling our logistics obligations.

8. Limitation of Liability & Indemnification

To the maximum extent permitted by law, Aevum Zenth shall not be liable for indirect, incidental, consequential, or punitive damages, including loss of profits, supply chain disruption, or product degradation resulting from forces outside our direct control (e.g., extreme weather, port strikes, regulatory embargoes).

Your total recoverable damages shall not exceed the total fees paid by you for the specific service during the twelve (12) months preceding the claim. You agree to indemnify and hold harmless Aevum Zenth, its affiliates, directors, and employees from any claims, fines, or losses arising from your breach of these Terms, regulatory violations, or misrepresentation of product classifications.

9. Regulatory Compliance & Audits

Aevum Zenth maintains full compliance with WHO GMP, PIC/S, FDA, EMA, and national regulatory standards. We reserve the right to conduct periodic compliance audits, temperature mapping validations, and mock recall exercises. Clients may request audit access upon 30 days' written notice, subject to site security and confidentiality protocols.

In the event of a regulatory inspection or health authority audit, we will cooperate fully and provide all required documentation, batch records, and monitoring logs within the statutory timeframe.

10. Termination & Suspension

Either party may terminate the service agreement with sixty (60) days' written notice. Immediate suspension or termination may occur if:

• Client breaches GxP, GDP, or customs regulations.
• Payment defaults exceed 30 days.
• Client is de-licensed or loses regulatory standing.
• A material security or data breach occurs.

Upon termination, we will securely archive and return all data per our Data Retention Policy and facilitate handover of inventory to an approved alternate provider.

11. Governing Law & Dispute Resolution

These Terms shall be governed by the laws of the State of Delaware, United States, without regard to its conflict of law principles. Any disputes arising from or relating to these Terms or the Services shall first be submitted to good-faith negotiation between designated executives. If unresolved within 30 days, disputes shall be settled by binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules, with proceedings held in Wilmington, Delaware.

12. Contact & Support

For questions regarding these Terms, service specifications, or compliance documentation, please contact:

• Legal & Compliance: legal-compliance@aevumzenth.com
• Pharma Logistics Support: pharma-support@aevumzenth.com
• Quality Assurance: qa-pharma@aevumzenth.com
• Headquarters: Zenth Tower, Level 42, Neo Geneva | Mailing: P.O. Box 88901, International Trade District

We reserve the right to update these Terms at any time. Material changes will be communicated via email and Platform notification at least 15 days prior to the effective date. Continued use constitutes acceptance of revised Terms.