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The Medical Device License Agreement is a crucial document used when one party (licensor) grants another party (licensee) the rights to commercialize, distribute, or manufacture medical devices in Ireland and potentially other territories. This agreement is essential for companies operating in the medical device sector within Ireland's jurisdiction, requiring strict compliance with both Irish national laws and EU regulations, particularly the Medical Device Regulation 2017/745 (MDR). The document addresses key aspects such as regulatory compliance, quality standards, safety requirements, and post-market surveillance obligations. It's particularly important given Ireland's position as a major hub for medical device manufacturing and distribution within the EU, and the document must reflect both local Irish legal requirements and broader European regulatory frameworks.

1. Parties: Identification of the licensor and licensee, including registered addresses and company numbers

2. Background: Context of the agreement, including brief description of the medical device and purpose of the license

3. Definitions: Definitions of key terms, including 'Medical Device', 'Regulatory Approvals', 'Territory', 'Field of Use', and other relevant terms

4. Grant of License: Scope of license grant, including territory, field of use, and any restrictions

5. Regulatory Compliance: Obligations regarding EU MDR compliance, CE marking, and Irish regulatory requirements

6. Quality and Safety Requirements: Quality control standards, safety measures, and compliance with ISO standards

7. Commercialization Obligations: Requirements for commercializing the device, including marketing and distribution obligations

8. Royalties and Payments: Financial terms, including royalty rates, payment terms, and reporting requirements

9. Intellectual Property Rights: IP ownership, protection, and enforcement provisions

10. Regulatory Approvals and Maintenance: Responsibilities for obtaining and maintaining regulatory approvals

11. Record Keeping and Audits: Requirements for maintaining records and allowing audits

12. Confidentiality: Protection of confidential information and trade secrets

13. Term and Termination: Duration of agreement and termination provisions

14. Warranties and Representations: Standard and specific warranties regarding the medical device

15. Indemnification: Indemnification obligations and liability allocation

16. Insurance: Insurance requirements and coverage obligations

17. General Provisions: Standard boilerplate clauses including governing law, notices, and assignment