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1. Parties: Identification of the patent holder and generic manufacturer, including registered addresses and company details
2. Background: Context of the patent dispute, reference to relevant patents, and basis for settlement
3. Definitions: Key terms including Patent Rights, Licensed Products, Entry Date, Territory, and other technical/commercial terms
4. Settlement Terms: Core settlement provisions resolving the patent dispute
5. Payment Provisions: Details of reverse payments, including amount, timing, and any conditions
6. Market Entry Provisions: Specific terms regarding delayed market entry, including exact date and conditions
7. Competition Law Compliance: Provisions ensuring compliance with competition laws and legitimate business justifications
8. Representations and Warranties: Standard and specific warranties regarding patent validity, generic capabilities, and compliance
9. Confidentiality: Provisions governing confidential information exchange and protection
10. Term and Termination: Duration of the agreement and circumstances for early termination
11. General Provisions: Standard boilerplate including governing law, jurisdiction, entire agreement, etc.
1. Supply Arrangements: Include when the agreement involves supply of authorized generic products during or after the delay period
2. Technology Transfer: Include when technical information or know-how transfer is part of the settlement
3. Regulatory Compliance: Include when specific regulatory filings or approvals are required
4. Alternative Dispute Resolution: Include when parties prefer specific dispute resolution mechanisms beyond court litigation
5. Marketing and Promotion: Include when the agreement covers marketing arrangements post entry
6. Patent Challenge Provisions: Include when addressing future patent challenges is necessary
1. Patent Schedule: Details of relevant patents including patent numbers, jurisdictions, and expiry dates
2. Product Specifications: Technical specifications of the generic products covered by the agreement
3. Payment Schedule: Detailed breakdown of payment amounts, timing, and any adjustment mechanisms
4. Competition Law Analysis: Documentation of competition law assessment and justifications
5. Form of Notice: Template notices for key communications under the agreement
6. Territory Details: Specific geographical areas covered by the agreement and any territorial restrictions
Affiliate
Authorized Generic Product
Business Day
Claims
Commencement Date
Competing Product
Competition Law
Competition Commission
Confidential Information
Control
Delayed Entry Period
Effective Date
Entry Date
Force Majeure Event
Generic Product
Generic Version
Group
Hong Kong
Intellectual Property Rights
Launch Date
Licensed Patents
Licensed Product
Licensed Territory
Losses
Manufacturing Process
Market
Marketing Authorization
Net Sales
Original Product
Patent Rights
Patents
Payment
Regulatory Authority
Regulatory Approval
Related Persons
Relevant Market
Restricted Period
Reverse Payment
Settlement Payment
Settlement Sum
Specification
Supply Agreement
Technical Information
Term
Territory
Third Party
Patent Settlement
Reverse Payment
Market Entry Delay
Competition Law Compliance
Payment Terms
Intellectual Property Rights
Representations and Warranties
Confidentiality
Non-Compete
Regulatory Compliance
Term and Termination
Force Majeure
Assignment
Amendments
Notices
Governing Law
Dispute Resolution
Entire Agreement
Severability
Third Party Rights
Further Assurance
Costs
Counterparts
Waiver
Indemnification
Compliance with Laws
Product Specifications
Territory Restrictions
Supply Terms
Audit Rights
Pharmaceuticals
Biotechnology
Healthcare
Chemical Manufacturing
Life Sciences
Medical Devices
Research & Development
Legal
Intellectual Property
Regulatory Affairs
Commercial
Business Development
Finance
Compliance
Research & Development
Executive Leadership
Corporate Strategy
Chief Legal Officer
Head of Intellectual Property
Competition Law Counsel
Patent Attorney
Commercial Director
Chief Executive Officer
Head of Regulatory Affairs
Business Development Director
Chief Financial Officer
General Counsel
Senior Legal Counsel
Licensing Manager
Head of Research & Development
Compliance Officer
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