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1. Parties: Identification of the licensor and licensee, including full legal names, registration details, and addresses
2. Background: Context of the agreement, including brief description of the pharmaceutical product(s), relevant intellectual property rights, and parties' authority to enter into the agreement
3. Definitions: Detailed definitions of key terms used throughout the agreement, including technical and regulatory terminology
4. Grant of License: Scope of the license, including territory, exclusivity/non-exclusivity, and any field-of-use restrictions
5. Regulatory Compliance: Obligations regarding UAE pharmaceutical regulations, MOHAP requirements, and other applicable regulatory frameworks
6. Quality Control and Standards: Requirements for maintaining product quality, GMP compliance, and quality assurance procedures
7. Financial Terms: License fees, royalties, payment terms, and financial reporting obligations
8. Intellectual Property Rights: Ownership and protection of IP, including patents, trademarks, and know-how
9. Manufacturing and Supply: Terms relating to product manufacturing, supply chain requirements, and quality standards
10. Term and Termination: Duration of the agreement, renewal provisions, and termination rights
11. Confidentiality: Protection of confidential information and trade secrets
12. Representations and Warranties: Parties' warranties regarding product quality, IP rights, and regulatory compliance
13. Indemnification: Mutual indemnification obligations and liability allocation
14. Governing Law and Dispute Resolution: UAE law as governing law and dispute resolution mechanisms
15. General Provisions: Standard boilerplate clauses including force majeure, notices, and assignment
1. Technology Transfer: Used when the agreement includes transfer of technical knowledge or manufacturing processes
2. Clinical Trials: Include when the agreement covers ongoing or future clinical trials in the UAE
3. Marketing and Promotion: When the licensee has rights or obligations regarding product marketing
4. Training and Technical Support: Include if the licensor provides ongoing technical support or training
5. Export Rights: When the license includes rights to export to other GCC countries
6. Pharmacovigilance: Include for products requiring specific adverse event monitoring and reporting
7. Data Protection: When the agreement involves significant data processing or transfer
8. Local Content Requirements: Include if there are specific UAE local content or employment requirements
9. Sub-licensing Rights: When sub-licensing is permitted under specific conditions
10. Research and Development: Include for agreements involving ongoing R&D activities
1. Schedule 1 - Licensed Products: Detailed description of licensed pharmaceutical products, including specifications and registrations
2. Schedule 2 - Patents and Trademarks: List of all relevant IP rights with registration numbers and status
3. Schedule 3 - Quality Standards: Detailed quality control requirements and specifications
4. Schedule 4 - Territory Definition: Detailed description of licensed territory and any excluded areas
5. Schedule 5 - Royalty Calculations: Detailed methodology for calculating royalties and other payments
6. Schedule 6 - Technical Documentation: Required technical documentation and regulatory filings
7. Schedule 7 - Manufacturing Requirements: Detailed manufacturing specifications and requirements
8. Appendix A - MOHAP Compliance Requirements: Specific regulatory compliance requirements for UAE
9. Appendix B - Quality Control Procedures: Detailed quality control and testing procedures
10. Appendix C - Approved Manufacturing Facilities: List of approved manufacturing and storage facilities
Pharmaceuticals
Healthcare
Biotechnology
Medical Devices
Research and Development
Manufacturing
Healthcare Distribution
Clinical Research
Regulatory Compliance
Life Sciences
Legal
Regulatory Affairs
Quality Assurance
Business Development
Commercial
Research and Development
Compliance
Manufacturing
Supply Chain
Intellectual Property
Finance
Operations
Medical Affairs
Chief Executive Officer
Legal Counsel
Regulatory Affairs Director
Quality Assurance Manager
Business Development Director
Licensing Manager
Commercial Director
Chief Scientific Officer
Compliance Officer
Manufacturing Director
Supply Chain Manager
Research and Development Director
Intellectual Property Manager
Chief Financial Officer
Operations Director
Medical Affairs Director
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