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Manufacturing Under License
"I need a Manufacturing Under License agreement for my medical device company to authorize a manufacturer in Cork, Ireland to produce our patented cardiac monitoring devices, starting from March 2025, with exclusive manufacturing rights for the EU market and strict quality control requirements."
1. Parties: Identification and details of the licensor and licensee
2. Background: Context of the agreement, including brief description of the licensed products and parties' authority to enter into the agreement
3. Definitions: Definitions of key terms used throughout the agreement
4. Grant of License: Scope of the manufacturing license, including any territorial restrictions and exclusivity provisions
5. Intellectual Property Rights: Details of the IP being licensed and ownership rights
6. Manufacturing Requirements: Specifications, quality standards, and production requirements
7. Quality Control: Quality assurance processes, testing requirements, and inspection rights
8. Commercial Terms: Payment terms, royalties, minimum guarantees, and payment mechanisms
9. Reporting and Audit Rights: Requirements for production reports, sales reports, and audit provisions
10. Confidentiality: Protection of confidential information and trade secrets
11. Warranties and Indemnities: Standard warranties, representations, and indemnification provisions
12. Term and Termination: Duration of the agreement and termination provisions
13. Post-Termination Obligations: Rights and obligations after agreement termination
14. General Provisions: Standard boilerplate clauses including governing law, notices, and assignment
1. Training and Technical Support: Used when the licensor needs to provide manufacturing training or ongoing technical support
2. Raw Materials and Components: Include when there are specific requirements for sourcing materials or components
3. Environmental Compliance: Required when manufacturing involves specific environmental considerations or regulations
4. Export Control: Include for international manufacturing arrangements with export restrictions
5. Sub-manufacturing Rights: Used when sub-manufacturing or sub-contracting may be permitted
6. Marketing and Branding: Include when the licensee has rights to market or brand the manufactured products
7. Insurance Requirements: Detailed insurance obligations beyond standard requirements
8. Regulatory Compliance: Specific regulatory requirements for particular industries or products
1. Schedule 1 - Licensed Products: Detailed description and specifications of products to be manufactured
2. Schedule 2 - Manufacturing Specifications: Technical specifications and manufacturing processes
3. Schedule 3 - Quality Standards: Detailed quality control requirements and acceptance criteria
4. Schedule 4 - Licensed IP: Detailed list of patents, trade secrets, and other IP being licensed
5. Schedule 5 - Royalty Calculations: Detailed formula and examples for calculating royalties
6. Schedule 6 - Reporting Templates: Templates for required production and sales reports
7. Schedule 7 - Approved Manufacturing Facilities: List of approved manufacturing locations and facilities
8. Schedule 8 - Key Personnel: List of key personnel responsible for manufacturing oversight
9. Appendix A - Technical Documentation: Additional technical documents and manufacturing guides
10. Appendix B - Quality Control Procedures: Detailed quality control and testing procedures
Authors
Pharmaceuticals
Medical Devices
Electronics Manufacturing
Automotive
Consumer Goods
Industrial Equipment
Food and Beverage
Textiles and Apparel
Chemical Manufacturing
Aerospace and Defense
Legal
Operations
Manufacturing
Quality Control
Research & Development
Commercial
Compliance
Supply Chain
Technical Operations
Intellectual Property
Manufacturing Director
Licensing Manager
IP Counsel
Quality Control Manager
Operations Director
Commercial Director
Contract Manager
Technical Director
Production Manager
Compliance Officer
Chief Technology Officer
Supply Chain Manager
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