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Toll Manufacturing Agreement
"I need a Toll Manufacturing Agreement under Austrian law for our pharmaceutical company to engage a contract manufacturer to produce specialty medications, with strict quality control requirements and compliance with EU GMP standards, planned to commence from March 2025."
1. Parties: Identification of the Principal (customer) and Toll Manufacturer, including full legal names and registered addresses
2. Background: Context of the agreement, 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 manufacturing services to be provided, including production processes and specifications
5. Supply of Materials: Terms regarding the supply, delivery, and handling of raw materials, including quality requirements and timing
6. Quality Standards: Required quality standards, testing procedures, and acceptance criteria for manufactured products
7. Production Schedule: Terms regarding production planning, lead times, and capacity commitments
8. Price and Payment Terms: Pricing structure, payment terms, invoicing procedures, and any cost adjustment mechanisms
9. Title and Risk: Transfer of title and risk in materials and finished products
10. Intellectual Property: Protection and usage rights of both parties' intellectual property
11. Confidentiality: Protection of confidential information exchanged during the manufacturing process
12. Warranties and Liability: Warranties regarding manufacturing quality and limitation of liability provisions
13. Term and Termination: Duration of agreement, renewal terms, and termination rights
14. Force Majeure: Provisions for handling events beyond parties' reasonable control
15. Governing Law and Jurisdiction: Specification of Austrian law as governing law and jurisdiction for disputes
16. General Provisions: Standard boilerplate provisions including notices, amendments, and assignment
1. Regulatory Compliance: Special section when manufacturing involves regulated products requiring specific compliance measures
2. Environmental Requirements: Additional section when manufacturing processes have significant environmental impacts or requirements
3. Equipment Provision: Section needed when specific manufacturing equipment is provided by either party
4. Storage and Warehousing: Additional terms when the manufacturer provides storage services for materials or finished products
5. Insurance Requirements: Detailed insurance provisions when manufacturing involves high-value products or special risks
6. Staff Training: Special requirements for staff training when manufacturing involves complex or proprietary processes
7. Subcontracting: Terms regarding subcontracting rights when manufacturer may need to involve third parties
8. Product Recall: Specific procedures for product recalls when manufacturing consumer or sensitive products
9. Export Control: Required when manufactured products are subject to export control regulations
1. Schedule 1 - Product Specifications: Detailed technical specifications for the products to be manufactured
2. Schedule 2 - Quality Control Procedures: Specific quality control and testing procedures to be followed
3. Schedule 3 - Pricing and Payment Details: Detailed pricing structure, including processing fees, material costs, and payment terms
4. Schedule 4 - Production Capacity and Timeline: Agreed production capacity, lead times, and delivery schedules
5. Schedule 5 - Material Specifications: Specifications for raw materials and components to be used in manufacturing
6. Schedule 6 - Key Performance Indicators: Metrics for measuring manufacturing performance and quality
7. Schedule 7 - Contact Details: Key contact persons and escalation matrix for both parties
8. Schedule 8 - Standard Operating Procedures: Detailed manufacturing and handling procedures
9. Appendix A - Compliance Requirements: Specific regulatory or industry compliance requirements
10. Appendix B - Health and Safety Requirements: Health and safety procedures specific to the manufacturing process
Authors
Applicable Laws
Batch
Batch Records
Business Day
Confidential Information
Delivery Date
Effective Date
Facility
Finished Products
Force Majeure Event
Good Manufacturing Practice
Industrial Property Rights
Initial Term
Intellectual Property Rights
Know-How
Manufacturing Process
Manufacturing Services
Materials
Minimum Order Quantity
Non-Conforming Product
Principal
Principal Materials
Processing Fee
Product Specifications
Production Schedule
Quality Agreement
Quality Control
Quality Standards
Raw Materials
Regulatory Authority
Regulatory Requirements
Renewal Term
Services
Specifications
Standard Operating Procedures
Technical Documentation
Term
Territory
Toll Manufacturer
Trade Secrets
Validation Protocols
Waste
Supply of Materials
Manufacturing Process
Quality Control
Testing and Acceptance
Delivery
Price and Payment
Title and Risk
Intellectual Property
Confidentiality
Non-Competition
Warranties
Indemnification
Liability
Insurance
Force Majeure
Term and Termination
Regulatory Compliance
Environmental Compliance
Health and Safety
Record Keeping
Audit Rights
Personnel
Subcontracting
Equipment
Storage
Product Recall
Dispute Resolution
Governing Law
Assignment
Notices
Entire Agreement
Severability
Amendment
Waiver
Relationship of Parties
Survival
Pharmaceuticals
Chemical Manufacturing
Food and Beverage
Automotive
Electronics Manufacturing
Textiles and Apparel
Consumer Goods
Industrial Equipment
Medical Devices
Cosmetics and Personal Care
Legal
Operations
Manufacturing
Supply Chain
Quality Control
Procurement
Regulatory Compliance
Research & Development
Finance
Production
Contract Management
Manufacturing Director
Supply Chain Manager
Operations Manager
Quality Control Manager
Procurement Director
Contract Manager
Production Manager
Legal Counsel
Chief Operations Officer
Regulatory Compliance Officer
Technical Director
Business Development Manager
Factory Manager
Industrial Relations Manager
Project Manager
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