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Toll Manufacturing Agreement
"Need a Toll Manufacturing Agreement for our pharmaceutical company to engage a Singapore-based manufacturer to produce our new line of generic drugs, with strict quality control measures and compliance with GMP standards, planned to commence in March 2025."
1. Parties: Identification of the toll manufacturer and the principal company
2. Background: Context of the agreement and brief description of the business relationship
3. Definitions: Key terms used throughout the agreement including relevant legislative references and manufacturing terminology
4. Scope of Services: Detailed description of manufacturing services to be provided
5. Supply of Materials: Terms regarding the supply of raw materials and components
6. Quality Standards and Specifications: Manufacturing standards, quality control procedures, and product specifications
7. Intellectual Property Rights: Ownership and protection of IP related to the manufacturing process and products
8. Pricing and Payment Terms: Manufacturing costs, payment schedule, and related financial terms
9. Term and Termination: Duration of agreement and conditions for termination
10. Confidentiality: Protection of trade secrets and proprietary information
1. Minimum Purchase Commitments: Terms establishing guaranteed minimum order volumes - used for long-term manufacturing relationships with significant capital investment
2. Equipment Provision: Terms regarding supply and maintenance of manufacturing equipment - used when principal provides specific manufacturing equipment
3. Technology Transfer: Process for transferring manufacturing knowledge and technology - used when complex manufacturing processes need to be transferred
4. Environmental Compliance: Specific environmental requirements and certifications - used for environmentally sensitive manufacturing processes
5. Disaster Recovery: Business continuity and emergency procedures - used for critical manufacturing operations
1. Product Specifications: Detailed technical specifications for products to be manufactured
2. Quality Control Procedures: Detailed procedures for quality assurance and testing
3. Pricing Schedule: Detailed breakdown of manufacturing costs and pricing structure
4. Manufacturing Process Flow: Step-by-step manufacturing process documentation
5. Key Performance Indicators: Metrics for measuring manufacturing performance
6. Material Specifications: Specifications for raw materials and components
7. Compliance Certificates: Required regulatory and quality certifications
Authors
Applicable Laws
Business Day
Confidential Information
Delivery Date
Effective Date
Equipment
Force Majeure Event
Good Manufacturing Practice (GMP)
Intellectual Property Rights
Manufacturing Process
Manufacturing Services
Manufacturing Site
Materials
Minimum Order Quantity
Product Specifications
Products
Purchase Order
Quality Control Procedures
Quality Standards
Raw Materials
Regulatory Requirements
Services
Specifications
Storage Requirements
Technical Documentation
Term
Territory
Toll Manufacturing Fee
Trade Secrets
Work Order
Audit Rights
Change Control
Compliance with Laws
Confidentiality
Dispute Resolution
Environmental Compliance
Force Majeure
Forecasting
Governing Law
Health and Safety
Indemnification
Insurance
Intellectual Property Rights
Liability Limitation
Manufacturing Standards
Material Supply
Non-Competition
Payment Terms
Performance Standards
Product Quality
Quality Assurance
Record Keeping
Regulatory Compliance
Representations and Warranties
Risk Allocation
Storage and Handling
Subcontracting
Term and Termination
Title and Risk
Warranties
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