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Toll Manufacturing Agreement
"I need a Toll Manufacturing Agreement under Malaysian law for my pharmaceutical company to engage a local manufacturer to produce generic medications, with strict quality control requirements and compliance with Malaysian Ministry of Health regulations, planned to commence in March 2025."
1. Parties: Identification of the toll manufacturer and the principal company
2. Background: Context of the agreement and business relationship
3. Definitions: Key terms used throughout the agreement
4. Scope of Services: Detailed description of manufacturing services to be provided
5. Supply of Materials: Responsibilities for raw material procurement, delivery, and storage
6. Manufacturing Process: Requirements and standards for the manufacturing process
7. Quality Control: Quality standards, testing procedures, and acceptance criteria
8. Delivery Terms: Timing, logistics, and delivery requirements for finished products
9. Pricing and Payment: Manufacturing fees, payment terms, and invoicing procedures
10. Intellectual Property Rights: Protection and ownership of IP, including manufacturing processes
11. Confidentiality: Protection of confidential information and trade secrets
12. Warranties and Representations: Standard warranties regarding manufacturing capabilities and product quality
13. Liability and Indemnification: Allocation of risks and responsibilities between parties
14. Term and Termination: Duration of agreement and termination provisions
15. Force Majeure: Provisions for unforeseen circumstances affecting performance
16. Governing Law and Dispute Resolution: Applicable law and dispute resolution mechanisms
17. General Provisions: Standard boilerplate clauses including notices, amendments, and assignment
1. Equipment Provision: Used when specific manufacturing equipment is provided by either party
2. Technology Transfer: Required when manufacturing process involves transfer of technical knowledge
3. Regulatory Compliance: Included when products require specific regulatory approvals or certifications
4. Environmental Compliance: Added when manufacturing involves significant environmental considerations
5. Training and Support: Needed when manufacturer requires training on specific processes
6. Import/Export Provisions: Required for international movement of materials or products
7. Insurance Requirements: Detailed insurance obligations beyond standard coverage
8. Performance Metrics: Specific KPIs and performance measurement criteria
9. Disaster Recovery: Required for critical manufacturing operations
10. Subcontracting Rights: Included when subcontracting may be necessary
1. Product Specifications: Detailed technical specifications of products to be manufactured
2. Quality Standards and Testing Procedures: Specific quality control requirements and testing methodologies
3. Pricing Schedule: Detailed breakdown of manufacturing costs and pricing structure
4. Manufacturing Process Flow: Step-by-step manufacturing procedures and requirements
5. Equipment Specifications: Details of manufacturing equipment to be used
6. Key Personnel: List of key personnel responsible for various aspects of the manufacturing process
7. Service Level Requirements: Specific performance metrics and service levels to be maintained
8. Compliance Certificates: Required regulatory and quality certifications
9. Material Specifications: Detailed specifications for raw materials and components
10. Form of Purchase Orders: Template for placing manufacturing orders
Authors
Agreement
Batch
Business Day
Commencement Date
Confidential Information
Delivery Point
Effective Date
Finished Products
Force Majeure Event
Good Manufacturing Practice
Intellectual Property Rights
Manufacturing Fee
Manufacturing Process
Manufacturing Services
Manufacturing Site
Manufacturing Specifications
Material Safety Data Sheet
Product Specifications
Quality Control Procedures
Quality Standards
Raw Materials
Regulatory Requirements
Rejected Products
Service Levels
Specifications
Standard Operating Procedures
Technical Documentation
Term
Territory
Toll Manufacturer
Principal Company
Purchase Order
Quality Control Tests
Working Hours
Appointment
Term
Manufacturing Services
Raw Materials Supply
Equipment and Facilities
Quality Control
Product Testing
Acceptance and Rejection
Delivery
Price and Payment
Intellectual Property Rights
Confidentiality
Warranties
Indemnification
Liability
Insurance
Force Majeure
Termination
Environmental Compliance
Health and Safety
Regulatory Compliance
Record Keeping
Audit Rights
Personnel
Non-Competition
Assignment
Notices
Governing Law
Dispute Resolution
Entire Agreement
Pharmaceuticals
Electronics Manufacturing
Automotive Parts
Consumer Goods
Chemical Products
Food and Beverage
Textiles and Apparel
Industrial Equipment
Cosmetics and Personal Care
Medical Devices
Legal
Operations
Manufacturing
Supply Chain
Quality Assurance
Procurement
Finance
Regulatory Affairs
Commercial
Technical Operations
Manufacturing Director
Operations Manager
Supply Chain Manager
Quality Control Manager
Procurement Manager
Legal Counsel
Commercial Director
Chief Operations Officer
Production Manager
Regulatory Compliance Officer
Contract Manager
Business Development Director
Finance Director
Technical Director
Manufacturing Engineer
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