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Clinical Supply Agreement
"I need a Clinical Supply Agreement governed by Austrian law for supplying investigational cancer treatment drugs to multiple research sites across Austria, with specific provisions for temperature-controlled storage and transport, to be effective from March 2025."
1. Parties: Identification of contracting parties including full legal names and addresses
2. Background: Context of the agreement including the clinical trial purpose and supply relationship
3. Definitions: Definitions of key terms used throughout the agreement
4. Supply Obligations: Core obligations regarding the manufacture and supply of clinical trial materials
5. Forecasting and Ordering: Process for forecasting requirements and placing orders
6. Quality Requirements: Quality standards, testing requirements, and compliance with GMP
7. Delivery and Storage: Terms for delivery, acceptance, and storage requirements
8. Price and Payment: Pricing structure, payment terms, and invoicing procedures
9. Regulatory Compliance: Compliance with applicable laws and regulations, including maintenance of authorizations
10. Quality Assurance and Audits: Quality control procedures and audit rights
11. Confidentiality: Protection of confidential information exchanged between parties
12. Intellectual Property: IP rights and obligations related to the clinical supplies
13. Representations and Warranties: Standard and specific warranties regarding the supplies and services
14. Indemnification: Allocation of risks and indemnification obligations
15. Insurance: Insurance requirements for both parties
16. Term and Termination: Duration of agreement and termination provisions
17. Force Majeure: Provisions for handling events beyond reasonable control
18. Governing Law and Jurisdiction: Application of Austrian law and jurisdiction
19. General Provisions: Standard boilerplate clauses including notices, assignment, and amendments
1. Safety Stock: Requirements for maintaining minimum inventory levels, used when supply continuity is critical
2. Technology Transfer: Provisions for transfer of manufacturing technology, needed if manufacturing process is unique or complex
3. Stability Testing: Obligations for ongoing stability testing, included when required by regulatory requirements
4. Clinical Trial Support Services: Additional services beyond basic supply, included when supplier provides additional trial support
5. Import/Export Requirements: Specific provisions for cross-border supply, needed for international trials
6. Packaging and Labeling: Detailed requirements for special packaging or labeling, when non-standard requirements exist
7. Material Safety: Special handling requirements for hazardous materials, included when applicable
8. Pharmacovigilance: Safety reporting obligations, included when supplier has safety reporting responsibilities
9. Disaster Recovery: Business continuity provisions, included for critical supplies
10. Data Protection: Detailed GDPR compliance provisions, needed when personal data is processed
1. Product Specifications: Detailed technical specifications of the clinical trial materials
2. Quality Agreement: Detailed quality requirements and responsibilities
3. Pricing Schedule: Detailed pricing information including any volume-based adjustments
4. Service Level Requirements: Specific performance metrics and service levels
5. Manufacturing Sites: List of approved manufacturing facilities
6. Key Personnel: List of key contacts and responsible persons
7. Handling and Storage Requirements: Detailed requirements for product handling and storage
8. Form of Quality Certificate: Template for certificate of analysis or conformity
9. Form of Purchase Order: Standard form for ordering supplies
10. Technical Transfer Plan: Details of any required technology transfer process
Authors
Pharmaceuticals
Biotechnology
Healthcare
Clinical Research
Medical Devices
Contract Manufacturing
Life Sciences
Research & Development
Legal
Procurement
Quality Assurance
Regulatory Affairs
Supply Chain
Clinical Operations
Research & Development
Compliance
Manufacturing
Logistics
Business Development
Medical Affairs
Contract Management
Clinical Operations Director
Procurement Manager
Quality Assurance Manager
Regulatory Affairs Director
Supply Chain Manager
Clinical Trial Manager
Legal Counsel
Compliance Officer
Contract Manager
Manufacturing Director
Clinical Research Director
Quality Control Manager
Logistics Manager
Business Development Director
Chief Medical Officer
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