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The Clinical Supply Agreement is essential for organizations conducting clinical trials in India, establishing the legal and operational framework for the manufacture and supply of pharmaceutical products used in clinical research. This agreement is particularly relevant when a pharmaceutical company or research institution needs to source clinical trial materials from a manufacturer or supplier. It ensures compliance with Indian regulatory requirements, including the Drugs and Cosmetics Act, New Drugs and Clinical Trials Rules, and CDSCO guidelines. The document covers critical aspects such as quality standards, manufacturing processes, supply logistics, regulatory compliance, and risk allocation. It's designed to protect both parties while ensuring the reliable supply of high-quality clinical trial materials that meet all regulatory and safety requirements.

1. Parties: Identification of the parties entering into the agreement, including full legal names, addresses, and registration details

2. Background: Context of the agreement, including the purpose of the clinical trial and the relationship between the parties

3. Definitions: Detailed definitions of technical terms, industry-specific terminology, and key concepts used throughout the agreement

4. Supply Obligations: Core obligations regarding the manufacture and supply of clinical trial materials, including quantities, specifications, and timelines

5. Quality Requirements: Standards for product quality, manufacturing processes, and compliance with GMP requirements

6. Regulatory Compliance: Obligations regarding compliance with applicable laws, regulations, and guidelines

7. Ordering and Delivery: Procedures for placing orders, delivery terms, packaging requirements, and logistics arrangements

8. Price and Payment: Pricing structure, payment terms, invoicing procedures, and any cost adjustments

9. Quality Control and Testing: Requirements for product testing, quality control procedures, and acceptance criteria

10. Storage and Handling: Requirements for proper storage, handling, and transportation of clinical supplies

11. Confidentiality: Provisions for protecting confidential information and trade secrets

12. Intellectual Property: Rights and obligations regarding IP, including ownership of trial data and developments

13. Term and Termination: Duration of the agreement and circumstances for termination

14. Liability and Indemnification: Allocation of risks, liability limitations, and indemnification obligations

15. Force Majeure: Provisions for unforeseen circumstances affecting performance

16. Governing Law and Dispute Resolution: Choice of law and procedures for resolving disputes

17. General Provisions: Standard boilerplate clauses including notices, amendments, and assignment