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A Medical Device License Agreement is essential when a medical device manufacturer or rights holder wishes to grant another party the right to distribute, sell, or potentially manufacture their medical device in specified territories. This agreement, governed by German law, ensures compliance with both German national requirements and EU regulations, particularly the Medical Device Regulation (MDR). It outlines the terms for device licensing, quality standards, regulatory compliance, technical support, and risk allocation. The agreement is crucial for medical device commercialization in Germany and potentially other EU markets, requiring careful attention to local regulatory requirements, safety standards, and liability considerations.

1. Parties: Identification of licensor and licensee, including regulatory status and authorizations

2. Background: Context of the agreement, description of the medical device, and relevant regulatory approvals

3. Definitions: Definitions of key terms, including technical, regulatory, and commercial terms

4. Grant of License: Scope of license, territorial restrictions, and usage rights for the medical device

5. Regulatory Compliance: Obligations regarding MDR compliance, maintenance of certifications, and ongoing regulatory requirements

6. Quality Requirements: Quality management system requirements, testing protocols, and quality control measures

7. Supply and Distribution: Terms for supply, storage, and distribution of the medical device

8. Training and Support: Requirements for training, technical support, and maintenance

9. Payments: License fees, royalties, and payment terms

10. Intellectual Property: IP ownership, protection, and enforcement rights

11. Representations and Warranties: Specific warranties regarding device safety, regulatory compliance, and performance

12. Liability and Indemnification: Allocation of risks, product liability, and indemnification obligations

13. Term and Termination: Duration, renewal terms, and termination rights

14. Post-Termination: Obligations following termination, including handling of inventory and documentation

15. Confidentiality: Protection of confidential information and trade secrets

16. General Provisions: Standard boilerplate clauses adapted to German law requirements