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Toll Manufacturing Agreement
"I need a Toll Manufacturing Agreement for pharmaceutical production in Australia, where my company will engage a contract manufacturer to produce prescription medications starting March 2025, with strict GMP compliance requirements and detailed quality control procedures."
1. Parties: Identification of the toll manufacturer and the customer
2. Background: Context of the agreement, including brief description of parties' businesses and purpose of the arrangement
3. Definitions: Defined terms used throughout the agreement
4. Appointment and Scope: Appointment of manufacturer and general scope of manufacturing services
5. Manufacturing Obligations: Core manufacturing requirements, processes, and standards
6. Quality Control: Quality assurance processes, testing requirements, and acceptance criteria
7. Forecasting and Orders: Process for providing forecasts and placing manufacturing orders
8. Delivery and Logistics: Terms for delivery, packaging, and shipping of manufactured products
9. Pricing and Payment: Manufacturing fees, payment terms, and price adjustment mechanisms
10. Title and Risk: Transfer of title and risk in materials and finished products
11. Warranties: Warranties regarding manufacturing quality and compliance with specifications
12. Liability and Indemnification: Allocation of risks and liability between parties
13. Term and Termination: Duration of agreement and termination rights
14. Confidentiality: Protection of confidential information exchanged
15. Force Majeure: Provisions for handling events beyond parties' control
16. General Provisions: Standard boilerplate clauses including governing law, notices, and assignment
1. Raw Materials Supply: Used when customer supplies raw materials - includes ordering, specifications, and handling requirements
2. Equipment and Facility Requirements: Included when specific equipment or facility requirements are necessary for manufacturing
3. Intellectual Property Rights: Required when manufacturing involves proprietary processes or creates new IP
4. Regulatory Compliance: Needed for heavily regulated industries like pharmaceuticals or food production
5. Insurance Requirements: Detailed insurance obligations beyond standard coverage
6. Import/Export Compliance: Required for international manufacturing arrangements
7. Environmental Compliance: Detailed environmental obligations for environmentally sensitive manufacturing
8. Staff Training and Qualification: When specific staff qualifications or training are required
9. Business Continuity: Detailed disaster recovery and business continuity requirements
10. Technology Transfer: When manufacturing process requires transfer of technical knowledge
1. Manufacturing Specifications: Detailed technical specifications for the manufacturing process
2. Quality Standards: Specific quality requirements and testing procedures
3. Pricing Schedule: Detailed pricing structure including volume discounts and cost adjustments
4. Service Levels: Key performance indicators and service level requirements
5. Raw Materials Specifications: Specifications for raw materials whether supplied by customer or manufacturer
6. Equipment Specifications: Details of required manufacturing equipment and maintenance
7. Standard Operating Procedures: Detailed manufacturing procedures and protocols
8. Compliance Requirements: Specific regulatory or industry compliance requirements
9. Form of Purchase Order: Template for placing manufacturing orders
10. Form of Quality Certificate: Template for quality certification of manufactured products
Authors
Applicable Laws
Batch
Business Day
Certificate of Analysis
Commencement Date
Confidential Information
Customer Materials
Defective Products
Delivery Point
Equipment
Facility
Force Majeure Event
Good Manufacturing Practice
Intellectual Property Rights
Manufacturing Process
Manufacturing Services
Manufacturing Specifications
Minimum Order Quantity
Non-Conforming Product
Order
Products
Purchase Order
Quality Control Procedures
Quality Standards
Raw Materials
Recall
Regulatory Approvals
Regulatory Authority
Service Levels
Specifications
Standard Operating Procedures
Term
Territory
Toll Manufacturing Fee
Trade Secrets
Waste
Work Order
Yield
Manufacturing Services
Raw Materials Supply
Quality Control
Testing and Inspection
Acceptance and Rejection
Forecasting
Purchase Orders
Pricing
Payment Terms
Delivery
Title and Risk
Equipment and Facilities
Health and Safety
Environmental Compliance
Regulatory Compliance
Quality Assurance
Intellectual Property
Confidentiality
Non-Competition
Warranties
Indemnification
Liability
Insurance
Force Majeure
Term
Termination
Dispute Resolution
Governing Law
Assignment
Subcontracting
Record Keeping
Audit Rights
Business Continuity
Product Recall
Staff Training
Capacity Commitment
Change Control
Notices
Relationship of Parties
Entire Agreement
Pharmaceuticals
Food and Beverage
Chemical Manufacturing
Consumer Goods
Automotive Parts
Electronics
Textiles
Industrial Products
Medical Devices
Cosmetics
Operations
Manufacturing
Quality Control
Procurement
Supply Chain
Legal
Regulatory Affairs
Production
Commercial
Finance
Technical Operations
Quality Assurance
Business Development
Operations Director
Manufacturing Manager
Quality Control Manager
Procurement Manager
Supply Chain Director
Commercial Director
Legal Counsel
Regulatory Compliance Officer
Production Manager
Chief Operating Officer
Contract Manager
Technical Director
Finance Director
Quality Assurance Manager
Business Development Manager
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