Terms of Service
Effective Date: Sep 17, 2025
Agreement for Mobile Sterile Room Services
These Terms of Service ("Terms") constitute a binding agreement between you ("Customer") and Medointec Corporation ("Company"), governing the provision of mobile sterile room containers, monitoring software, and related services. By executing a service agreement or accepting delivery of equipment, you acknowledge acceptance of these Terms.
Important: These services are designed for pharmaceutical companies, hospitals, and medical facilities requiring sterile environments for cell therapy, biosafety, and biopharmaceutical manufacturing.
About Medointec Corporation
• Established 1996, derived from MEIYANG
• Class A design & consulting qualification
• 8 invention patents, 20 utility patents
• 3,000+ completed projects globally
• Operations in China, USA, Vietnam, Bangladesh
• 5 national standards, 5 industry standards
1. Service Scope and Specifications
Company provides containerized mobile sterile rooms with patented technology addressing small-area cleanliness challenges. Services include:
Equipment Services:
- • Mobile sterile room design and manufacturing
- • Transportation and installation
- • Commissioning and validation testing
- • Preventive maintenance programs
Software Services:
- • Real-time monitoring software
- • Work record management systems
- • Custom software development
- • Data analytics and reporting
2. Regulatory Compliance and Standards
All equipment and services comply with applicable pharmaceutical and medical device regulations including but not limited to:
- • FDA 21 CFR Part 211 (Current Good Manufacturing Practice)
- • ISO 14644 (Cleanrooms and associated controlled environments)
- • EU GMP Annex 1 (Manufacture of Sterile Medicinal Products)
- • China GMP Standards (Good Manufacturing Practice for Pharmaceuticals)
- • USP <797> and <800> (Pharmaceutical Compounding)
- • Local health authority requirements
3. Installation and Commissioning
Company will provide installation services including site preparation requirements, utility connections, and performance qualification testing. Customer responsibilities include:
Site Requirements:
- • Level foundation
- • Electrical power supply
- • Water and drainage connections
- • Site access for delivery
Customer Obligations:
- • Obtain necessary permits
- • Provide trained operators
- • Maintain security protocols
- • Ensure environmental conditions
4. Operational Requirements and Training
Company provides comprehensive training for Customer personnel. Customer must ensure only qualified, trained personnel operate the equipment and maintain sterile protocols.
Training Includes:
- • Equipment operation procedures
- • Monitoring software utilization
- • Maintenance and troubleshooting
- • Documentation and record-keeping
- • Emergency response protocols
5. Maintenance and Service Level Agreements
Company provides scheduled preventive maintenance and emergency support services. Response times and service levels are defined in individual service agreements.
Emergency Support
Critical Response
Uptime Guarantee
6. Intellectual Property and Confidentiality
All patented technology, proprietary designs, software, and documentation remain the exclusive property of Company. Customer receives limited usage rights during the service term.
Restrictions:
- • No reverse engineering or copying
- • No transfer of software licenses
- • Confidential information protection required
- • Third-party access restrictions apply
7. Performance Warranties and Guarantees
Company warrants that equipment will meet specified performance criteria and cleanliness standards when operated according to established procedures.
Warranty Coverage:
- • Equipment defects: 12 months from installation
- • Software bugs: Ongoing during service term
- • Performance parameters: As specified in contract
- • Excludes damage from misuse or normal wear
8. Limitation of Liability and Indemnification
Company's total liability is limited to the contract value. Customer assumes responsibility for product quality, regulatory compliance, and patient safety in their operations.
Important: Company provides equipment and software tools; Customer retains full responsibility for pharmaceutical/medical processes, product quality, and regulatory compliance.
9. Data Management and Privacy
Monitoring software collects operational data for performance optimization. Customer retains ownership of all production and patient data. Company implements appropriate data security measures.
Data Security:
- • Encrypted data transmission
- • Secure cloud storage options
- • Access control and audit trails
- • HIPAA compliance support
Customer Rights:
- • Data ownership retention
- • Export capabilities
- • Deletion upon termination
- • Third-party audit support
10. Contract Duration and Termination
Service agreements typically range from 12 months to 60 months. Either party may terminate with 30-day written notice for convenience, or immediately for material breach.
Termination Procedures:
- • Equipment return or purchase option
- • Data export and system decommissioning
- • Final maintenance and cleaning
- • Software license termination
- • Outstanding payment settlement
11. Force Majeure and Business Continuity
Neither party shall be liable for delays or failures due to circumstances beyond reasonable control, including natural disasters, pandemics, or regulatory changes affecting pharmaceutical operations.
12. Governing Law and Dispute Resolution
These Terms are governed by applicable commercial law. Disputes shall be resolved through binding arbitration, with emergency injunctive relief available for intellectual property matters.
Legal and Contract Questions?
Our legal and technical teams are available to clarify terms, discuss custom requirements, or address compliance questions.
Document Information
Last Updated: Sep 17, 2024 | Version 2.0 | Document ID: Medointec-TOS-2025-002These terms supersede all previous agreements. Customers will receive 30-day advance notice of material changes.
This document is available in multiple languages. English version controls in case of conflicts.