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Toll Manufacturing Agreement
1. Parties: Identification of the principal company (who owns the product and process) and the toll manufacturer
2. Background: Context of the agreement including the principal's need for manufacturing services and manufacturer's capabilities
3. Definitions: Key terms used throughout the agreement including Products, Specifications, Manufacturing Process, etc.
4. Scope of Services: Detailed description of manufacturing services to be provided, including production, packaging, and any ancillary services
5. Supply of Materials: Obligations regarding the supply, quality, and management of raw materials and components
6. Manufacturing Process: Requirements for following specified manufacturing procedures and any process validation requirements
7. Quality Requirements: Quality standards, testing procedures, and acceptance criteria for manufactured products
8. Forecasting and Ordering: Process for providing forecasts and placing manufacturing orders
9. Delivery and Risk: Terms for delivery of finished products and transfer of risk
10. Price and Payment: Manufacturing fees, payment terms, and any cost adjustment mechanisms
11. Intellectual Property: Protection of IP rights, ownership of developments, and licensing provisions
12. Confidentiality: Protection of confidential information exchanged during the manufacturing relationship
13. Warranties: Warranties regarding manufacturing services, facility compliance, and product quality
14. Liability and Indemnification: Allocation of risks and responsibilities between parties
15. Term and Termination: Duration of agreement and grounds for termination
16. General Provisions: Standard legal provisions including governing law, dispute resolution, and notice requirements
1. Equipment Provision: Used when principal provides specific manufacturing equipment, detailing ownership, maintenance, and usage rights
2. Dedicated Facility Requirements: Include when manufacturer must dedicate specific facilities or production lines
3. Regulatory Compliance: Detailed section needed for highly regulated industries (e.g., pharmaceuticals, food)
4. Environmental Requirements: Additional environmental obligations beyond standard compliance
5. Technology Transfer: Detailed provisions for transfer of manufacturing technology and know-how
6. Capacity Commitments: Used when specific manufacturing capacity must be reserved
7. Safety Stock: Requirements for maintaining safety stock of materials or finished products
8. Business Continuity: Detailed disaster recovery and business continuity requirements
9. Quality Agreement Reference: When a separate quality agreement exists between parties
1. Product Specifications: Detailed technical specifications for products to be manufactured
2. Manufacturing Process Description: Step-by-step manufacturing procedures and requirements
3. Quality Control Procedures: Detailed testing and quality control requirements
4. Pricing Schedule: Detailed pricing structure, including volume-based pricing if applicable
5. Bill of Materials: List of required materials and components with specifications
6. Service Levels: Specific performance metrics and service level requirements
7. Facility Requirements: Specific requirements for manufacturing facilities and equipment
8. Contact Details: Key personnel and escalation procedures
9. Form of Purchase Order: Template for placing manufacturing orders
10. Form of Quality Certificate: Template for certificate of analysis or conformity
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