Food Contract Manufacturing Agreement Template for United States

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Key Requirements PROMPT example:

Food Contract Manufacturing Agreement

"I need a Food Contract Manufacturing Agreement for my protein bar company to engage a manufacturer in California for producing our new line of organic protein bars, with specific requirements for allergen control and organic certification compliance, starting production in March 2025."

Document background
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.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions
Clauses
Industries

Food Safety Modernization Act (FSMA): Primary federal law governing food safety in the US, focusing on prevention of food safety issues rather than responding to contamination

Federal Food, Drug, and Cosmetic Act (FDCA): Foundational federal law that provides FDA authority to oversee safety of food, drugs, and cosmetics

FDA Food Safety Regulations (21 CFR): Code of Federal Regulations Title 21 containing detailed requirements for food manufacturing, processing, packaging, and storage

Current Good Manufacturing Practices (cGMP): FDA regulations providing systems that assure proper design, monitoring, and control of manufacturing processes and facilities

HACCP Requirements: Hazard Analysis and Critical Control Points - systematic preventive approach to food safety and biological, chemical, and physical hazards

Food Allergen Labeling and Consumer Protection Act: Federal law requiring food labels to clearly identify products containing major food allergens

State Food Manufacturing Regulations: Specific requirements set by individual states for food manufacturing operations within their jurisdiction

Fair Labor Standards Act: Federal law establishing standards for wage, overtime pay, recordkeeping, and child labor

Occupational Safety and Health Act: Federal law ensuring safe and healthful working conditions by setting and enforcing standards

Environmental Protection Agency Requirements: Federal regulations governing environmental impact, emissions, and waste management in manufacturing facilities

Uniform Commercial Code: Standardized set of laws governing commercial transactions, including sales contracts and warranties

Product Liability Laws: Laws governing manufacturer responsibility for injuries or damages caused by their products

Trade Secret Protection: Laws protecting confidential business information that provides competitive advantage

Insurance Requirements: Mandatory insurance coverage including product liability, general liability, and workers' compensation

Quality Certification Standards: Industry standards such as ISO, SQF certifications ensuring quality and safety in food manufacturing

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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