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Manufacturing Service Agreement
"I need a Manufacturing Service Agreement for my Swiss medical device company to engage a contract manufacturer in Basel for producing specialized cardiac monitoring devices, with strict quality control requirements and FDA/EU MDR compliance, starting from March 2025."
1. Parties: Identification and details of the contracting parties - the manufacturer and the client
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. Scope of Services: Detailed description of manufacturing services to be provided
5. Quality Requirements: Manufacturing standards, quality control procedures, and acceptance criteria
6. Production Planning and Forecasting: Requirements for production scheduling, forecasting, and capacity planning
7. Pricing and Payment Terms: Pricing structure, payment schedule, and invoicing procedures
8. Intellectual Property Rights: Ownership and usage rights of IP, including pre-existing IP and newly developed IP
9. Confidentiality: Protection of confidential information and trade secrets
10. Warranties and Liability: Product warranties, limitations of liability, and indemnification provisions
11. Term and Termination: Duration of agreement, renewal terms, and termination rights
12. Force Majeure: Provisions for unforeseen circumstances affecting performance
13. Governing Law and Jurisdiction: Specification of Swiss law application and jurisdiction for disputes
14. General Provisions: Standard boilerplate clauses including notices, amendments, and assignment
1. Exclusivity: Terms of exclusive manufacturing rights, if applicable
2. Environmental Compliance: Specific environmental requirements and certifications
3. Regulatory Compliance: Industry-specific regulatory requirements and certifications
4. Insurance Requirements: Specific insurance coverage requirements beyond standard provisions
5. Technology Transfer: Provisions for transfer of manufacturing technology or know-how
6. Customs and Export Control: Requirements for international shipping and trade compliance
7. Supplier Management: Requirements for managing sub-suppliers and raw material sourcing
8. Business Continuity: Disaster recovery and business continuity requirements
1. Schedule 1 - Product Specifications: Detailed technical specifications of products to be manufactured
2. Schedule 2 - Pricing Schedule: Detailed pricing structure, including volume discounts and cost adjustments
3. Schedule 3 - Quality Control Procedures: Detailed quality control processes and acceptance testing procedures
4. Schedule 4 - Production Capacity and Timeline: Manufacturing capacity commitments and production timelines
5. Schedule 5 - Key Performance Indicators: Metrics for measuring manufacturing performance
6. Schedule 6 - Approved Sub-contractors: List of approved sub-contractors and their roles
7. Appendix A - Technical Documentation: Manufacturing process documentation and technical requirements
8. Appendix B - Contact Details: Key contact persons and escalation procedures
Authors
Electronics Manufacturing
Pharmaceutical Production
Automotive Components
Consumer Goods
Industrial Equipment
Medical Devices
Food and Beverage
Chemicals and Materials
Aerospace Manufacturing
Textiles and Apparel
Legal
Operations
Supply Chain
Quality Assurance
Production
Procurement
Engineering
Compliance
Technical Operations
Contract Management
Chief Operations Officer
Production Manager
Quality Assurance Director
Supply Chain Manager
Legal Counsel
Procurement Director
Manufacturing Engineer
Contract Manager
Compliance Officer
Technical Director
Business Development Manager
Project Manager
Operations Director
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