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Clinical Supply Agreement

Clinical Supply Agreement Template for Netherlands

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Key Requirements PROMPT example:

Clinical Supply Agreement

"I need a Clinical Supply Agreement for a Phase III trial of a biologic product, where we are engaging a Dutch CMO to manufacture and supply clinical trial materials for multiple EU trial sites starting March 2025."

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Document background
The Clinical Supply Agreement is a critical document used when a pharmaceutical company or research organization requires manufacturing and supply of investigational medicinal products for clinical trials in the Netherlands and EU. It establishes the quality standards, manufacturing requirements, and supply chain arrangements between the sponsor and the manufacturer, ensuring compliance with EU Clinical Trials Regulation 536/2014, Dutch Medicines Act, and GMP guidelines. This agreement is essential for clinical trials as it defines responsibilities for product quality, testing, storage, delivery, and handling of clinical supplies. The document must account for specific Dutch legal requirements while maintaining alignment with broader EU pharmaceutical regulations and international best practices in clinical research.
Suggested Sections

1. Parties: Identification of contracting parties including manufacturer/supplier and recipient/sponsor

2. Background: Context of the agreement including trial overview and purpose

3. Definitions: Defined terms used throughout the agreement

4. Supply Obligations: Core obligations regarding manufacturing and supply of clinical materials

5. Quality Requirements: GMP compliance and quality standards for manufacturing

6. Forecasting and Ordering: Process for forecasting needs and placing orders

7. Delivery and Storage: Terms for delivery, acceptance, and storage requirements

8. Price and Payment: Pricing structure and payment terms

9. Quality Control and Testing: Requirements for testing and quality control procedures

10. Regulatory Compliance: Compliance with applicable laws and regulations

11. Records and Audits: Requirements for documentation and audit rights

12. Intellectual Property: IP rights and obligations

13. Confidentiality: Protection of confidential information

14. Warranties: Warranties regarding products and services

15. Indemnification: Allocation of risks and liabilities

16. Term and Termination: Duration and termination provisions

17. General Provisions: Standard boilerplate clauses

Optional Sections

1. Import/Export Controls: Required when clinical supplies cross international borders

2. Third Party Manufacturers: Include when subcontractors are used for manufacturing

3. Stability Testing: Include when ongoing stability testing is required

4. Technology Transfer: Required when manufacturing process transfer is involved

5. Safety Data Exchange: Include for products requiring specific safety monitoring

6. Comparator Sourcing: Include when agreement covers sourcing of comparator products

7. Emergency Supply: Include procedures for emergency supply situations

8. Returns and Destruction: Include when specific procedures for returns/destruction are needed

Suggested Schedules

1. Product Specifications: Detailed technical specifications of clinical supplies

2. Quality Agreement: Detailed quality requirements and responsibilities

3. Pricing Schedule: Detailed pricing information and calculations

4. Manufacturing Sites: List of approved manufacturing locations

5. Storage and Transportation Requirements: Detailed requirements for handling products

6. Testing Requirements: Specific testing protocols and acceptance criteria

7. Forecast and Order Forms: Template forms for forecasting and ordering

8. Contact Details: Key contact persons and escalation procedures

9. Service Level Requirements: Specific performance metrics and requirements

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions














































Clauses








































Relevant Industries

Pharmaceuticals

Biotechnology

Healthcare

Clinical Research

Contract Manufacturing

Life Sciences

Medical Devices

Healthcare Technology

Relevant Teams

Legal

Clinical Operations

Supply Chain

Quality Assurance

Regulatory Affairs

Manufacturing

Procurement

Research and Development

Compliance

Clinical Supply Operations

Project Management

Relevant Roles

Clinical Operations Director

Supply Chain Manager

Quality Assurance Manager

Regulatory Affairs Director

Clinical Trial Manager

Manufacturing Director

Legal Counsel

Procurement Manager

Chief Medical Officer

Clinical Supply Manager

Head of Clinical Operations

Quality Control Manager

Compliance Officer

Contract Manager

Project Manager Clinical Supplies

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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