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Clinical Supply Agreement for Hong Kong

Clinical Supply Agreement Template for Hong Kong

A comprehensive legal agreement governed by Hong Kong law that establishes the terms and conditions for the supply of pharmaceutical products, medical devices, or other clinical materials for use in clinical trials. The agreement ensures compliance with Hong Kong's pharmaceutical regulations, including the Pharmacy and Poisons Ordinance and Good Clinical Practice Guidelines, while defining quality standards, delivery requirements, and responsibilities of all parties involved. It includes detailed provisions for quality control, regulatory compliance, storage conditions, and risk management specific to the Hong Kong healthcare and pharmaceutical regulatory environment.

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Clinical Supply Agreement

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What is a Clinical Supply Agreement?

The Clinical Supply Agreement is a critical document used when establishing a formal relationship between suppliers and recipients of clinical trial materials in Hong Kong. This agreement is essential for clinical trials conducted under Hong Kong's regulatory framework, including compliance with the Pharmacy and Poisons Ordinance (Cap. 138) and Hong Kong Good Clinical Practice Guidelines. It covers crucial aspects such as product specifications, quality requirements, delivery terms, regulatory compliance, and risk allocation. The document is particularly important given Hong Kong's strict pharmaceutical regulations and its position as a major clinical research hub in Asia. It includes specific provisions for handling, storing, and distributing clinical supplies while maintaining product integrity and compliance with local regulatory requirements.

What sections should be included in a Clinical Supply Agreement?

1. Parties: Identification of the supplier and recipient/sponsor, including full legal names and addresses

2. Background: Context of the agreement, including the clinical trial reference and purpose of the supply arrangement

3. Definitions: Detailed definitions of technical terms, products, specifications, and other key terms used throughout the agreement

4. Supply Obligations: Core obligations of the supplier, including product specifications, quantities, and delivery requirements

5. Quality Requirements: Standards, specifications, and quality control requirements for the clinical supplies

6. Regulatory Compliance: Obligations regarding compliance with GMP, GDP, and other applicable regulations

7. Ordering and Delivery: Process for placing orders, lead times, delivery terms, and acceptance procedures

8. Price and Payment: Pricing structure, payment terms, invoicing requirements, and any price adjustment mechanisms

9. Title and Risk: Transfer of ownership and risk in the products

10. Quality Assurance and Control: Quality management systems, testing requirements, and batch release procedures

11. Recalls and Safety Reporting: Procedures for product recalls, adverse event reporting, and safety measures

12. Confidentiality: Protection of confidential information and trade secrets

13. Intellectual Property: IP rights, licenses, and related protections

14. Liability and Indemnification: Allocation of risks, limitations of liability, and indemnification provisions

15. Term and Termination: Duration of agreement, renewal provisions, and termination rights

16. General Provisions: Standard boilerplate clauses including governing law, notices, and dispute resolution

What sections are optional to include in a Clinical Supply Agreement?

1. Storage and Warehousing: Specific requirements for storage conditions and warehouse management, required if supplier provides storage services

2. Temperature Control: Detailed requirements for temperature-sensitive products, needed for cold chain items

3. Customs and Import/Export: Requirements for international shipping, needed if cross-border supply is involved

4. Insurance: Specific insurance requirements beyond standard coverage, needed for high-value or high-risk products

5. Business Continuity: Backup supply arrangements and emergency procedures, important for critical supplies

6. Data Protection: Specific data protection provisions, required if personal data processing is involved

7. Technology Transfer: Provisions for transfer of manufacturing technology, needed if manufacturing process may be transferred

8. Forecasting: Detailed forecasting obligations and procedures, needed for complex supply chains

9. Packaging and Labeling: Specific requirements for custom packaging or labeling, needed for special handling requirements

What schedules should be included in a Clinical Supply Agreement?

1. Product Specifications: Detailed technical specifications of the clinical supplies

2. Pricing Schedule: Detailed pricing information, including unit prices and volume-based adjustments

3. Quality Agreement: Detailed quality requirements and procedures

4. Service Level Requirements: Specific performance metrics and service levels

5. Storage and Handling Requirements: Detailed requirements for product storage and handling

6. Delivery Locations: List of approved delivery locations and specific requirements

7. Key Personnel: List of key contacts and responsible persons from both parties

8. Form of Purchase Order: Template purchase order form

9. Complaint Handling Procedures: Detailed procedures for handling product complaints

10. Regulatory Compliance Checklist: Checklist of regulatory requirements and compliance measures

Authors

Alex Denne

Head of Growth (Open Source Law) @ Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

Hong Kong

Publisher

Ƶ

Cost

Free to use
Relevant legal definitions



























































Clauses









































Relevant Industries

Pharmaceuticals

Biotechnology

Healthcare

Clinical Research

Medical Devices

Contract Manufacturing

Logistics and Supply Chain

Laboratory Services

Relevant Teams

Clinical Operations

Supply Chain

Quality Assurance

Regulatory Affairs

Legal

Procurement

Compliance

Manufacturing

Research and Development

Logistics

Quality Control

Contract Management

Relevant Roles

Clinical Operations Director

Supply Chain Manager

Quality Assurance Manager

Regulatory Affairs Director

Clinical Trial Manager

Procurement Manager

Legal Counsel

Compliance Officer

Clinical Research Associate

Manufacturing Director

Logistics Coordinator

Quality Control Specialist

Contract Manager

Clinical Supply Manager

Medical Director

Industries










Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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