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Toll Manufacturing Agreement
"I need a Toll Manufacturing Agreement for my pharmaceutical company to engage a New Zealand-based manufacturer to produce specialized medical supplements, with strict quality control requirements and compliance with local health regulations, starting from March 2025."
1. Parties: Identification and details of the principal and the manufacturer
2. Background: Context of the agreement and brief description of the parties' business relationship
3. Definitions: Definitions of key terms used throughout the agreement
4. Appointment and Scope: Appointment of manufacturer and scope of manufacturing services
5. Supply of Materials: Terms regarding the supply, quality, and handling of raw materials
6. Manufacturing Process: Requirements and standards for the manufacturing process
7. Quality Control: Quality assurance procedures, testing requirements, and acceptance criteria
8. Delivery and Logistics: Terms for packaging, delivery, and transfer of manufactured goods
9. Pricing and Payment: Manufacturing fees, payment terms, and cost adjustments
10. Intellectual Property: Protection and usage rights of IP, including manufacturing processes and product designs
11. Confidentiality: Protection of confidential information and trade secrets
12. Warranties and Indemnities: Warranties regarding manufacturing quality and related indemnifications
13. Term and Termination: Duration of agreement and termination provisions
14. Force Majeure: Provisions for unforeseen circumstances affecting performance
15. General Provisions: Standard legal provisions including notices, amendments, and governing law
1. Regulatory Compliance: Specific section for heavily regulated industries requiring additional compliance measures
2. Environmental Requirements: Additional environmental obligations beyond standard requirements
3. Insurance: Detailed insurance requirements beyond standard coverage
4. Exclusivity: Terms for exclusive manufacturing arrangements
5. Technology Transfer: Provisions for transfer of manufacturing technology or know-how
6. Capacity Commitment: Specific commitments regarding manufacturing capacity and minimum volumes
7. International Trade: Additional provisions for cross-border manufacturing arrangements
8. Change Control: Formal process for managing changes to specifications or processes
1. Product Specifications: Detailed technical specifications for the products to be manufactured
2. Quality Standards: Specific quality requirements, testing procedures, and acceptance criteria
3. Pricing Schedule: Detailed breakdown of manufacturing costs, fees, and payment terms
4. Manufacturing Process Requirements: Step-by-step manufacturing procedures and requirements
5. Equipment and Facility Requirements: Specifications for manufacturing equipment and facility standards
6. Key Performance Indicators: Metrics for measuring manufacturing performance
7. Raw Material Specifications: Detailed specifications for raw materials and components
8. Service Level Agreement: Performance standards and metrics for the manufacturing service
9. Compliance Certificates: Required regulatory and quality certifications
10. Contact Details: Key personnel and emergency contact information
Authors
Affiliate
Applicable Laws
Background IP
Batch
Business Day
Commencement Date
Confidential Information
Contract Year
Defective Product
Delivery Point
Facility
Force Majeure Event
Good Manufacturing Practice
Intellectual Property Rights
Manufacturing Process
Manufacturing Services
Manufacturing Specifications
Master Batch Record
Materials
Minimum Order Quantity
Non-Conforming Product
Output
Principal Materials
Principal's Technology
Product
Product Specifications
Purchase Order
Quality Agreement
Quality Control
Quality Standards
Raw Materials
Regulatory Authority
Regulatory Requirements
Related Agreements
Services
Shipping Instructions
Standard Operating Procedures
Technical Documentation
Term
Territory
Third Party
Toll Manufacturing Fee
Trade Secrets
Validation
Waste
Supply of Materials
Manufacturing Services
Quality Control
Product Specifications
Testing and Inspection
Acceptance and Rejection
Delivery
Pricing
Payment Terms
Intellectual Property
Confidentiality
Non-Competition
Warranties
Indemnification
Insurance
Liability
Force Majeure
Term and Duration
Termination
Health and Safety
Regulatory Compliance
Environmental Compliance
Record Keeping
Audit Rights
Subcontracting
Assignment
Change Control
Dispute Resolution
Governing Law
Notice
Entire Agreement
Severability
Waiver
Amendment
Counterparts
Relationship of Parties
Capacity Requirements
Storage
Risk and Title
Exclusivity
Pharmaceuticals
Food and Beverage
Chemical Manufacturing
Consumer Goods
Electronics
Automotive Components
Textiles and Apparel
Cosmetics and Personal Care
Industrial Equipment
Medical Devices
Legal
Operations
Manufacturing
Quality Assurance
Supply Chain
Procurement
Regulatory Affairs
Finance
Risk Management
Research & Development
Commercial Operations
Technical Services
Chief Operations Officer
Production Manager
Quality Assurance Manager
Supply Chain Director
Procurement Manager
Legal Counsel
Regulatory Compliance Officer
Commercial Director
Manufacturing Engineer
Contract Manager
Technical Operations Manager
Chief Financial Officer
Risk Manager
Intellectual Property Manager
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