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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
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
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
Pharmaceuticals
Biotechnology
Healthcare
Clinical Research
Medical Devices
Contract Manufacturing
Logistics and Supply Chain
Laboratory Services
Clinical Operations
Supply Chain
Quality Assurance
Regulatory Affairs
Legal
Procurement
Compliance
Manufacturing
Research and Development
Logistics
Quality Control
Contract Management
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
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