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1. Parties: Identification of the patent holder and generic manufacturer, including their corporate details and registered addresses
2. Background: Context of the patent dispute, reference to relevant patent(s), and basis for settlement
3. Definitions: Definitions of key terms including Patent Rights, Licensed Products, Entry Date, Territory, and other relevant terms
4. Settlement Terms: Core terms of settlement including withdrawal of litigation and mutual releases
5. Payment Provisions: Details of reverse payments, including amount, timing, and conditions
6. Entry Date Commitments: Specific provisions regarding the agreed market entry date for generic products
7. Pre-Entry Obligations: Obligations and restrictions on the generic manufacturer prior to the entry date
8. Competition Law Compliance: Explicit provisions ensuring compliance with Canadian competition laws
9. Representations and Warranties: Standard and specific representations regarding patent rights, capacity, and compliance
10. Confidentiality: Provisions governing the confidentiality of agreement terms and related information
11. Term and Termination: Duration of the agreement and circumstances allowing early termination
12. General Provisions: Standard boilerplate clauses including governing law, notices, and amendment procedures
1. Supply Arrangements: Optional provisions for supply of authorized generic products, used when the agreement includes early entry or authorized generic arrangements
2. Technology Transfer: Provisions for sharing technical information, used when the agreement includes technical cooperation
3. Patent Challenge Provisions: Specific terms regarding future patent challenges, included when parties want to address potential future disputes
4. Related Market Provisions: Terms regarding other markets or territories, included for multi-jurisdiction arrangements
5. Alternative Dispute Resolution: Specific dispute resolution procedures, included when parties prefer alternative methods to litigation
6. Regulatory Compliance: Additional regulatory compliance provisions, included when dealing with specific provincial requirements
1. Schedule A - Patent Rights: Detailed list of relevant patents and their status
2. Schedule B - Licensed Products: Specific description of products covered by the agreement
3. Schedule C - Payment Schedule: Detailed payment terms, amounts, and timing
4. Schedule D - Pre-Entry Activities: Permitted and prohibited activities prior to entry date
5. Schedule E - Competition Law Compliance Protocol: Detailed procedures for ensuring competition law compliance
6. Appendix 1 - Form of Release: Standard form for mutual releases
7. Appendix 2 - Notice Requirements: Specific requirements for notices under various regulatory regimes
Definitions
Payment Terms
Settlement Terms
Patent Rights
Market Entry
Competition Compliance
Regulatory Compliance
Confidentiality
Representations and Warranties
Indemnification
Force Majeure
Term and Termination
Assignment
Intellectual Property
Pre-Entry Obligations
Release
Non-Compete
Dispute Resolution
Governing Law
Amendment and Waiver
Severability
Notices
Further Assurances
Entire Agreement
Counterparts
Third Party Rights
Costs and Expenses
Authority
Relationship of Parties
Pharmaceuticals
Healthcare
Biotechnology
Life Sciences
Chemical Manufacturing
Healthcare Distribution
Medical Research
Patent Law
Competition Law
Legal
Regulatory Affairs
Compliance
Executive Leadership
Business Development
Research & Development
Finance
Intellectual Property
Commercial Operations
Corporate Development
Chief Legal Officer
Patent Attorney
Competition Law Counsel
Regulatory Affairs Director
Chief Executive Officer
Business Development Director
Chief Commercial Officer
Intellectual Property Manager
Corporate Counsel
Compliance Officer
Vice President of Legal Affairs
Head of Research and Development
Chief Financial Officer
Regulatory Compliance Manager
Patent Portfolio Manager
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