1. Parties: Identification of the licensor and licensee, including their registered addresses and company details
2. Background: Context of the agreement, including brief description of the medical device and the parties' intentions
3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts used throughout the agreement
4. Grant of License: Scope of the license, including territory, exclusivity, and any field-of-use restrictions
5. Regulatory Compliance: Obligations regarding medical device regulations, permits, and maintenance of regulatory approvals
6. Quality Standards: Required quality control measures, compliance with Good Manufacturing Practices, and quality assurance protocols
7. Technical Documentation: Requirements for technical files, device specifications, and maintenance of documentation
8. Commercial Terms: License fees, royalties, payment terms, and financial obligations
9. Intellectual Property Rights: IP ownership, protection of rights, and handling of improvements
10. Manufacturing and Supply: Manufacturing requirements, quality control, and supply chain obligations
11. Training and Support: Technical support, training obligations, and ongoing assistance
12. Representations and Warranties: Standard and specific warranties regarding the medical device and regulatory compliance
13. Liability and Indemnification: Allocation of risks, product liability, and indemnification obligations
14. Term and Termination: Duration of agreement, renewal terms, and termination rights
15. Post-Termination Obligations: Obligations surviving termination and wind-down procedures
16. Confidentiality: Protection of confidential information and trade secrets
17. Governing Law and Jurisdiction: Choice of law and jurisdiction for dispute resolution
18. General Provisions: Standard boilerplate clauses including force majeure, notices, and amendment procedures
