The Pharmaceutical License Agreement is a crucial document used when a pharmaceutical company or patent holder wishes to grant rights to another entity to utilize their pharmaceutical intellectual property within the Philippines. This agreement type is essential for pharmaceutical companies expanding their market presence in the Philippines while ensuring compliance with local regulations, particularly the Food, Drug and Cosmetic Act (as amended by the FDA Act of 2009) and the Intellectual Property Code of the Philippines. The document covers various aspects including regulatory compliance, quality standards, technology transfer, and commercial terms, while addressing specific requirements of the Philippine FDA and other relevant authorities. It's particularly important for foreign pharmaceutical companies entering the Philippine market through local partners, or for technology transfer arrangements in the pharmaceutical sector.
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1. Parties: Identification and details of the Licensor and Licensee, including their legal status and registered addresses
2. Background: Context of the agreement, including brief description of the pharmaceutical product(s) and the parties' business relationship
3. Definitions: Detailed definitions of technical terms, regulatory references, and key concepts used throughout the agreement
4. Grant of License: Scope and nature of the license granted, including territory, exclusivity, and any field-of-use restrictions
5. Regulatory Compliance: Obligations regarding FDA Philippines compliance, permits, and maintenance of regulatory approvals
6. Financial Terms: License fees, royalties, payment terms, audit rights, and financial reporting requirements
7. Quality Control: Manufacturing standards, quality assurance requirements, and compliance with GMP
8. Intellectual Property Rights: IP ownership, protection measures, and handling of improvements or modifications
9. Confidentiality: Protection of trade secrets and confidential information exchanged during the agreement
10. Term and Termination: Duration of the agreement, renewal provisions, and grounds for termination
11. Post-Termination Obligations: Rights and obligations that survive termination of the agreement
12. Governing Law and Dispute Resolution: Application of Philippine law and mechanisms for resolving disputes
13. General Provisions: Standard clauses including force majeure, entire agreement, and amendment procedures
1. Sub-licensing Rights: Include when the Licensee is permitted to grant sub-licenses to third parties
2. Technology Transfer: Include when technical knowledge transfer is part of the licensing arrangement
3. Manufacturing Rights: Include when the license includes rights to manufacture the pharmaceutical products
4. Export Rights: Include when the Licensee is granted rights to export to specific territories
5. Clinical Trials: Include when ongoing or future clinical trials are part of the agreement
6. Marketing and Promotion: Include when specific marketing rights and obligations are granted
7. Supply Agreement Provisions: Include when the Licensor will supply raw materials or finished products
8. Development Collaboration: Include when parties will collaborate on product development or improvements
1. Schedule A - Licensed Products: Detailed specification of pharmaceutical products covered by the license
2. Schedule B - Territory: Detailed description of geographic territories where license applies
3. Schedule C - Patents and Trademarks: List of all relevant IP rights covered by the agreement
4. Schedule D - Quality Standards: Detailed quality control requirements and specifications
5. Schedule E - Royalty Calculations: Detailed methodology for calculating royalties and other payments
6. Schedule F - Technical Documentation: List of technical documents to be provided by Licensor
7. Appendix 1 - FDA Permits: Copies of relevant FDA permits and licenses
8. Appendix 2 - Manufacturing Standards: Detailed GMP and manufacturing requirements
9. Appendix 3 - Reporting Templates: Standard forms for required reports and notifications
Relevant legal definitions
Affiliate
API
Applicable Laws
Background IP
Confidential Information
Contract Year
Development Data
Effective Date
FDA
Field of Use
First Commercial Sale
Force Majeure Event
Good Manufacturing Practice (GMP)
Improvements
Initial Term
Intellectual Property Rights
Know-How
Licensed Patents
Licensed Products
Licensed Technology
License Fee
Marketing Authorization
Net Sales
Patent Rights
Philippine FDA
Product Specifications
Quality Standards
Regulatory Approvals
Regulatory Authority
Royalty
Serious Adverse Event
Technical Documentation
Territory
Third Party
Trade Secrets
Trademark Rights
Valid Claim
Working Day
Technology Transfer
Manufacturing Process
Quality Control Procedures
Clinical Data
Commercialization
Competing Product
Continuous Supply
Development Plan
Exclusive Territory
Export Markets
Generic Product
Improvement Patent
Launch Date
Marketing Plan
Minimum Annual Royalty
Patent Term
Phase-Out Period
Product Registration
Quality Agreement
Raw Materials
Renewal Term
Safety Data
Supply Chain
Technical Assistance
API
Applicable Laws
Background IP
Confidential Information
Contract Year
Development Data
Effective Date
FDA
Field of Use
First Commercial Sale
Force Majeure Event
Good Manufacturing Practice (GMP)
Improvements
Initial Term
Intellectual Property Rights
Know-How
Licensed Patents
Licensed Products
Licensed Technology
License Fee
Marketing Authorization
Net Sales
Patent Rights
Philippine FDA
Product Specifications
Quality Standards
Regulatory Approvals
Regulatory Authority
Royalty
Serious Adverse Event
Technical Documentation
Territory
Third Party
Trade Secrets
Trademark Rights
Valid Claim
Working Day
Technology Transfer
Manufacturing Process
Quality Control Procedures
Clinical Data
Commercialization
Competing Product
Continuous Supply
Development Plan
Exclusive Territory
Export Markets
Generic Product
Improvement Patent
Launch Date
Marketing Plan
Minimum Annual Royalty
Patent Term
Phase-Out Period
Product Registration
Quality Agreement
Raw Materials
Renewal Term
Safety Data
Supply Chain
Technical Assistance
Clauses
Grant of License
Regulatory Compliance
Quality Control
Intellectual Property Rights
Confidentiality
Technology Transfer
Royalties and Payments
Manufacturing Standards
Product Registration
Territory Restrictions
Term and Termination
Representations and Warranties
Indemnification
Insurance
Force Majeure
Assignment
Dispute Resolution
Governing Law
Audit Rights
Record Keeping
Safety and Pharmacovigilance
Product Liability
Marketing and Promotion
Non-Competition
Sub-licensing
Export Controls
Technical Assistance
Performance Obligations
Amendment and Modification
Severability
Entire Agreement
Notices
Supply Chain Requirements
Quality Assurance
Clinical Trials
Data Protection
Regulatory Reporting
Patent Maintenance
Post-Termination Obligations
Compliance with Anti-Corruption Laws
Regulatory Compliance
Quality Control
Intellectual Property Rights
Confidentiality
Technology Transfer
Royalties and Payments
Manufacturing Standards
Product Registration
Territory Restrictions
Term and Termination
Representations and Warranties
Indemnification
Insurance
Force Majeure
Assignment
Dispute Resolution
Governing Law
Audit Rights
Record Keeping
Safety and Pharmacovigilance
Product Liability
Marketing and Promotion
Non-Competition
Sub-licensing
Export Controls
Technical Assistance
Performance Obligations
Amendment and Modification
Severability
Entire Agreement
Notices
Supply Chain Requirements
Quality Assurance
Clinical Trials
Data Protection
Regulatory Reporting
Patent Maintenance
Post-Termination Obligations
Compliance with Anti-Corruption Laws
Relevant Industries
Pharmaceuticals
Healthcare
Biotechnology
Medical Research
Chemical Manufacturing
Healthcare Distribution
Life Sciences
Clinical Research
Drug Manufacturing
Medical Technology
Relevant Teams
Legal
Regulatory Affairs
Business Development
Research and Development
Quality Assurance
Intellectual Property
Finance
Compliance
Manufacturing
Commercial Operations
Scientific Affairs
Contract Management
Relevant Roles
Chief Executive Officer
Legal Counsel
Regulatory Affairs Director
Business Development Manager
Intellectual Property Manager
Quality Assurance Manager
Commercial Director
Licensing Manager
Chief Scientific Officer
Research and Development Director
Compliance Officer
Manufacturing Director
Chief Financial Officer
Contract Manager
Patent Attorney
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