A Clinical Supply Agreement is essential when a company needs to secure reliable manufacturing and supply of investigational products for clinical trials in the United States. This agreement addresses critical aspects such as quality standards, regulatory compliance, manufacturing processes, testing requirements, and supply chain management. It ensures adherence to FDA regulations, GMP requirements, and other applicable healthcare laws while protecting both parties' interests through clearly defined terms and conditions.
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1. Parties: Identification of contracting parties, including legal names and addresses
2. Background/Recitals: Context of the agreement, including purpose of clinical trial and supply arrangement
3. Definitions: Key terms used throughout the agreement
4. Supply Obligations: Core obligations regarding supply of clinical materials, including quantities, specifications, and timelines
5. Quality Requirements: GMP compliance, quality standards, testing requirements
6. Delivery and Storage: Shipping terms, storage conditions, handling requirements
7. Price and Payment: Pricing structure, payment terms, invoicing procedures
8. Regulatory Compliance: Compliance with applicable laws, regulations, and guidelines
9. Confidentiality: Protection of confidential information
10. Term and Termination: Duration of agreement and termination provisions
1. Technology Transfer: Procedures for transfer of manufacturing technology when supplier needs to receive manufacturing technology from sponsor
2. Equipment: Terms regarding specialized equipment provision and use when specific equipment must be provided by either party
3. Third Party Manufacturers: Terms governing use of subcontractors when supplier intends to use third-party manufacturers
4. Safety Stock: Requirements for maintaining backup supply when continuous supply is critical
1. Product Specifications: Detailed technical specifications of clinical supplies
2. Quality Agreement: Detailed quality control and assurance requirements
3. Pricing Schedule: Detailed pricing structure and terms
4. Manufacturing Process: Detailed manufacturing procedures and requirements
5. Storage and Shipping Requirements: Detailed requirements for storage and shipping conditions
6. Testing Procedures: Detailed procedures for product testing and acceptance
7. Regulatory Certificates: Copies of relevant regulatory certifications
Relevant legal definitions
Clauses
Relevant Industries
Relevant Teams
Relevant Roles
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