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Toll Processing Agreement
"I need a Toll Processing Agreement for our Swiss pharmaceutical company to engage a local manufacturer to process our active ingredients into final tablet form, with special attention to GMP requirements and quality control procedures, starting from March 2025."
1. Parties: Identification of the contract parties - typically the principal (who owns the materials/products) and the processor (who performs the manufacturing)
2. Background: Context of the agreement, including the principal's business, processor's capabilities, and purpose of the arrangement
3. Definitions: Definitions of key terms used throughout the agreement
4. Scope of Services: Detailed description of the processing services to be performed
5. Supply of Materials: Terms regarding the provision of raw materials, including delivery, timing, and quality requirements
6. Processing Standards: Quality standards, GMP requirements, and processing specifications to be followed
7. Quality Control: Quality control procedures, testing requirements, and acceptance criteria
8. Title and Risk: Ownership of materials and products, risk allocation during processing
9. Delivery and Acceptance: Terms for delivery of finished products and acceptance procedures
10. Pricing and Payment: Processing fees, payment terms, and any additional costs
11. Warranties: Warranties regarding processing capabilities, product quality, and compliance with specifications
12. Liability and Indemnification: Allocation of liability and indemnification obligations
13. Confidentiality: Protection of confidential information and trade secrets
14. Term and Termination: Duration of agreement and termination provisions
15. General Provisions: Standard boilerplate clauses including governing law, notices, and dispute resolution
1. Intellectual Property Rights: Required when the processing involves patented processes or results in new IP
2. Equipment and Facility Requirements: Needed when specific equipment or facility specifications are critical to the processing
3. Environmental Compliance: Required when processing involves environmental risks or specific environmental regulations
4. Storage and Warehousing: Include when the processor will store materials or finished products
5. Insurance Requirements: Detailed insurance obligations beyond standard coverage
6. Regulatory Compliance: Specific when processing is subject to particular regulatory requirements
7. Performance Metrics: Include when specific KPIs or performance standards need to be met
8. Subcontracting: Required if processor may need to subcontract certain activities
9. Force Majeure: Detailed force majeure provisions if standard clause insufficient
10. Import/Export Compliance: Required for cross-border movement of materials or products
1. Schedule 1 - Processing Specifications: Detailed technical specifications for the processing services
2. Schedule 2 - Quality Requirements: Specific quality standards, testing procedures, and acceptance criteria
3. Schedule 3 - Pricing Schedule: Detailed breakdown of processing fees and cost calculations
4. Schedule 4 - Material Specifications: Specifications for raw materials to be provided by principal
5. Schedule 5 - Service Levels: Specific performance metrics and service level requirements
6. Schedule 6 - Equipment Specifications: Details of required equipment and maintenance standards
7. Appendix A - Contact Details: Key contact persons and communication protocols
8. Appendix B - Form of Quality Certificate: Template for quality certification of processed products
9. Appendix C - Operating Procedures: Standard operating procedures for processing activities
Authors
Pharmaceuticals
Chemicals
Food and Beverage
Cosmetics
Industrial Manufacturing
Biotechnology
Agricultural Products
Consumer Goods
Electronics
Textiles
Legal
Operations
Supply Chain
Quality Control
Procurement
Regulatory Affairs
Manufacturing
Production
Compliance
Technical Operations
Risk Management
Commercial
Supply Chain Manager
Operations Director
Quality Control Manager
Manufacturing Manager
Procurement Director
Legal Counsel
Regulatory Compliance Officer
Production Manager
Contract Manager
Chief Operations Officer
Quality Assurance Director
Technical Operations Manager
Facilities Manager
Risk Manager
Commercial Director
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