Pharmaceutical License Agreement Template for United Arab Emirates

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Key Requirements PROMPT example:

Pharmaceutical License Agreement

"I need a Pharmaceutical License Agreement for licensing our novel diabetes medication to a UAE-based manufacturer, with exclusive manufacturing rights in the UAE and export rights to other GCC countries, including specific provisions for technology transfer and training of local staff."

Document background

The Pharmaceutical License Agreement is a crucial document used in the UAE pharmaceutical industry when one party (licensor) grants another party (licensee) the rights to manufacture, distribute, or sell pharmaceutical products within the UAE territory. This agreement type is essential for international pharmaceutical companies entering the UAE market or local companies acquiring rights to produce or distribute pharmaceutical products. The document must comply with UAE Federal Law No. 8 of 2019 and various other healthcare regulations, while addressing key commercial aspects such as intellectual property rights, quality control, regulatory compliance, and financial terms. The agreement is particularly important given the UAE's position as a regional healthcare hub and its strict regulatory framework for pharmaceutical products. It typically includes detailed provisions for MOHAP approval processes, quality standards, and specific emirate-level requirements.

Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Medical Devices

Research and Development

Manufacturing

Healthcare Distribution

Clinical Research

Regulatory Compliance

Life Sciences

Relevant Teams

Legal

Regulatory Affairs

Quality Assurance

Business Development

Commercial

Research and Development

Compliance

Manufacturing

Supply Chain

Intellectual Property

Finance

Operations

Medical Affairs

Relevant Roles

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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