The Food Contract Manufacturing Agreement serves as the primary legal framework for outsourced food production in the United States. This document is essential when a food brand owner wants to engage a third-party manufacturer to produce their products while maintaining quality standards and regulatory compliance. The agreement addresses crucial aspects such as FDA requirements, FSMA compliance, quality control procedures, manufacturing specifications, and risk allocation. It's particularly important in scenarios where specialized manufacturing capabilities are needed or when companies want to scale production without investing in their own facilities.
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1. Parties: Identification of manufacturer and client, including legal entities
2. Background: Context of the agreement and business relationship
3. Definitions: Key terms used throughout the agreement including regulatory references to FSMA, FDCA, and cGMP
4. Services: Detailed description of manufacturing services to be provided, including compliance with FDA regulations
5. Quality Requirements: Standards, specifications, quality control procedures, and compliance with HACCP requirements
6. Regulatory Compliance: Obligations regarding FDA regulations, food safety standards, and applicable state laws
7. Facilities and Equipment: Requirements for manufacturing facilities, equipment maintenance, and compliance with cGMP
8. Pricing and Payment Terms: Cost structure, payment schedule, and related terms
9. Term and Termination: Duration of agreement and termination conditions
10. Warranties and Representations: Guarantees regarding compliance, quality, and manufacturing capabilities
11. Insurance and Liability: Required insurance coverage and allocation of liability
1. Exclusivity: Terms regarding exclusive manufacturing rights and territorial restrictions
2. Minimum Purchase Requirements: Minimum order quantities and related commitments
3. Equipment Ownership: Provisions for specialized equipment ownership, maintenance, and use
4. Intellectual Property Rights: Protection of recipes, formulations, and manufacturing processes
5. Environmental Compliance: Specific environmental requirements and waste management procedures
1. Schedule A - Product Specifications: Detailed technical specifications for products and ingredients
2. Schedule B - Quality Control Procedures: Specific testing, sampling, and quality control requirements
3. Schedule C - Pricing Schedule: Detailed pricing structure and volume-based pricing arrangements
4. Schedule D - Manufacturing Process Documentation: Step-by-step manufacturing procedures and controls
5. Schedule E - Compliance Certificates: Required certifications, permits, and compliance documentation
6. Schedule F - HACCP Plan: Hazard Analysis and Critical Control Points plan specific to the products
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