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1. Parties: Identification of the toll manufacturer and the customer, including full legal names and registered addresses
2. Background: Context of the agreement, including brief description of parties' businesses and purpose of the toll manufacturing arrangement
3. Definitions: Definitions of key terms used throughout the agreement, including technical manufacturing terms
4. Scope of Services: Detailed description of the manufacturing services to be provided, including production processes and capacity commitments
5. Supply of Materials: Obligations regarding the supply, quality, and timing of raw materials, including ownership and risk of loss
6. Quality Requirements: Quality standards, testing procedures, and acceptance criteria for manufactured products
7. Manufacturing Process and Standards: Specific requirements for the manufacturing process, including compliance with GMP if applicable
8. Delivery and Logistics: Terms for delivery, packaging, and transportation of finished products
9. Pricing and Payment: Manufacturing fees, payment terms, and any volume-based pricing arrangements
10. Title and Risk: Transfer of title and risk in materials and finished products
11. Intellectual Property: Ownership and protection of IP rights, including manufacturing processes and improvements
12. Confidentiality: Protection of confidential information and trade secrets
13. Warranties and Indemnities: Product warranties, service level guarantees, and related indemnification provisions
14. Term and Termination: Duration of agreement, renewal provisions, and termination rights
15. Force Majeure: Events excusing performance and related procedures
16. Governing Law and Jurisdiction: Choice of Dutch law and jurisdiction for dispute resolution
1. Regulatory Compliance: Specific section for highly regulated industries (e.g., pharmaceuticals, food) detailing compliance requirements
2. Environmental Compliance: Required when manufacturing involves significant environmental impacts or hazardous materials
3. Equipment Provision: Include when specific manufacturing equipment is provided by either party
4. Insurance Requirements: Detailed insurance obligations beyond standard coverage
5. Exclusivity: Required when parties agree to exclusive manufacturing arrangements
6. Technology Transfer: Include when significant technical knowledge transfer is required
7. Capacity Reservation: Include when customer requires guaranteed manufacturing capacity
8. Disaster Recovery: Required for critical manufacturing relationships needing business continuity provisions
9. Personnel Requirements: Include when specific staffing or training requirements apply
10. Change Control: Required when formal change management procedures are needed for process modifications
1. Product Specifications: Detailed technical specifications for the products to be manufactured
2. Quality Control Procedures: Specific testing and quality control requirements
3. Pricing Schedule: Detailed breakdown of manufacturing costs, fees, and payment terms
4. Service Levels: Specific performance metrics and standards
5. Manufacturing Process Description: Detailed description of the manufacturing process and requirements
6. Material Specifications: Specifications for raw materials and components
7. Equipment List: Inventory of equipment used or provided for manufacturing
8. Key Personnel: List of key contacts and responsible personnel from both parties
9. Compliance Requirements: Detailed regulatory and quality compliance requirements
10. Storage and Handling Procedures: Requirements for material and product storage and handling
Applicable Laws
Batch
Certificate of Analysis
Confidential Information
Contract Year
Delivery Date
Effective Date
Equipment
Facility
Force Majeure Event
Good Manufacturing Practice (GMP)
Intellectual Property Rights
Manufacturing Process
Manufacturing Services
Manufacturing Specifications
Materials
Non-Conforming Product
Product
Product Specifications
Purchase Order
Quality Agreement
Quality Control
Quality Standards
Raw Materials
Regulatory Authority
Regulatory Requirements
Representatives
Services
Specifications
Standard Operating Procedures
Technical Documentation
Technology
Term
Territory
Toll Manufacturing Fee
Waste
Work Order
Appointment and Scope
Manufacturing Services
Raw Materials Supply
Quality Control
Manufacturing Standards
Regulatory Compliance
Delivery and Logistics
Price and Payment
Title and Risk
Warranties
Liability and Indemnification
Insurance
Intellectual Property
Confidentiality
Data Protection
Force Majeure
Term and Termination
Health and Safety
Environmental Compliance
Record Keeping
Audit Rights
Non-Competition
Assignment and Subcontracting
Change Control
Dispute Resolution
Governing Law and Jurisdiction
Notices
Severability
Entire Agreement
Anti-Corruption
Capacity Commitment
Storage and Warehousing
Personnel and Training
Equipment Use and Maintenance
Pharmaceuticals
Chemical Manufacturing
Food and Beverage
Electronics
Automotive
Consumer Goods
Textiles
Industrial Equipment
Medical Devices
Cosmetics
Legal
Operations
Manufacturing
Supply Chain
Quality Control
Procurement
Regulatory Affairs
Production
Technical Operations
Commercial
Risk Management
Compliance
Manufacturing Director
Supply Chain Manager
Quality Control Manager
Operations Director
Procurement Manager
Legal Counsel
Regulatory Compliance Officer
Production Manager
Contract Manager
Chief Operating Officer
Technical Director
Quality Assurance Director
Manufacturing Engineer
Supply Chain Director
Commercial Director
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