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1. Parties: Identification of the patent holder and generic manufacturer entering into the agreement
2. Background: Context of the patent dispute, reference to pending litigation or challenges, and basis for settlement
3. Definitions: Definitions of key terms including Patent Rights, Licensed Products, Territory, and Settlement Payment
4. Settlement Terms: Core terms of settlement including withdrawal of challenges and admission/non-admission of patent validity
5. Reverse Payment Provisions: Details of the compensation from patent holder to generic manufacturer, including payment structure and timing
6. Patent Rights: Acknowledgment of patent rights, scope of patents covered, and any territorial limitations
7. Entry Date Provisions: Agreed date for generic market entry and related conditions
8. Regulatory Compliance: Provisions ensuring compliance with competition laws and pharmaceutical regulations
9. Confidentiality: Provisions regarding confidentiality of agreement terms and related information
10. Term and Termination: Duration of the agreement and circumstances for termination
11. Representations and Warranties: Standard and specific warranties regarding patent rights and capacity to enter agreement
12. Governing Law and Jurisdiction: Specification of Philippine law as governing law and jurisdiction for disputes
1. Supply Arrangements: Optional provisions for supply of authorized generic products
2. Development Collaboration: Terms for any joint development or technical collaboration
3. Alternative Dispute Resolution: Mediation or arbitration procedures if preferred over court litigation
4. Technology Transfer: Provisions for transfer of manufacturing know-how or technology
5. Marketing Authorization: Terms regarding regulatory approvals and marketing authorizations
6. Third Party Rights: Provisions addressing rights of third parties and potential future challengers
7. Insurance: Requirements for insurance coverage if relevant to the arrangement
1. Schedule 1 - Patent Rights: Detailed list of patents and patent applications covered by the agreement
2. Schedule 2 - Licensed Products: Specification of products covered by the settlement
3. Schedule 3 - Payment Schedule: Detailed payment terms, amounts, and timing
4. Schedule 4 - Entry Date Details: Specific conditions and requirements for market entry
5. Appendix A - Competition Law Compliance: Detailed provisions ensuring compliance with Philippine Competition Act
6. Appendix B - Technical Specifications: Technical details of products and manufacturing requirements if applicable
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