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1. Technology Transfer: Required when manufacturing process needs to be transferred from sponsor to supplier

2. Stability Testing: Include when supplier will perform ongoing stability testing of products

3. Equipment and Materials: needed when sponsor provides specific equipment or materials for manufacturing

4. Validation Services: Include when supplier will perform validation of manufacturing processes

5. Third Party Manufacturers: Required when supplier will use subcontractors for manufacturing

6. Safety Stock: Include when maintaining minimum inventory levels is required

7. Import/Export Compliance: Required for cross-border supply arrangements

8. Pharmacovigilance: Include when supplier has specific safety reporting obligations

9. Crisis Management: Add for high-risk products or critical supply arrangements

10. Development Services: Include when supplier will perform additional development work

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

2. Quality Agreement: Detailed quality control and assurance requirements

3. Pricing Schedule: Detailed pricing structure and cost breakdown

4. Manufacturing Process: Detailed description of manufacturing procedures and requirements

5. Service Level Agreement: Performance metrics and service level requirements

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

7. Batch Documentation Requirements: Required documentation for each manufactured batch

8. Testing Requirements: Specifications for in-process and finished product testing

9. Shipping Requirements: Packaging and transportation specifications

10. Key Personnel: List of key contacts and responsible personnel from both parties