A Pharmaceutical Licence Agreement is essential when a pharmaceutical company wishes to grant rights to another party to develop, manufacture, or commercialize their pharmaceutical products. This agreement, governed by English and Welsh law, is particularly crucial in the pharmaceutical sector where regulatory compliance, safety standards, and intellectual property protection are paramount. The agreement typically covers patent licenses, know-how transfers, development obligations, regulatory responsibilities, and commercial terms. It must comply with UK medicines legislation, MHRA requirements, and relevant EU retained law, while addressing pharmacovigilance obligations and quality standards.
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1. Parties: Identification and details of the licensor and licensee
2. Background: Context of the agreement, including brief description of the pharmaceutical product and intellectual property rights
3. Definitions: Key terms used throughout the agreement including regulatory, technical and commercial definitions
4. Grant of Licence: Scope, territory, and nature of the licence (exclusive/non-exclusive)
5. Regulatory Compliance: Obligations regarding MHRA compliance, pharmacovigilance, and safety reporting
6. Financial Terms: Royalties, milestone payments, and payment terms
7. Quality Control: Manufacturing standards and quality assurance requirements
8. Intellectual Property: IP ownership, protection, and enforcement
9. Term and Termination: Duration and termination provisions
1. Development Obligations: Details of development responsibilities and timelines - include when product is still in development phase
2. Clinical Trials: Clinical trial responsibilities and data ownership - include when clinical trials are part of the agreement scope
3. Manufacturing Rights: Manufacturing and supply terms - include when licensee has manufacturing rights
4. Sublicensing Rights: Terms for sublicensing to third parties - include when sublicensing is permitted
1. Schedule 1 - Licensed Patents: List of patents covered by the agreement
2. Schedule 2 - Licensed Products: Detailed description of licensed products
3. Schedule 3 - Territory: Detailed description of geographical scope
4. Schedule 4 - Quality Standards: Detailed quality requirements and specifications
5. Schedule 5 - Royalty Calculations: Detailed methodology for calculating royalties
6. Schedule 6 - Development Milestones: Specific development targets and associated payments
7. Schedule 7 - Pharmacovigilance Agreement: Detailed safety reporting procedures
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