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Reverse Payment Agreement for Philippines

Reverse Payment Agreement Template for Philippines

A Reverse Payment Agreement under Philippine law is a specialized settlement agreement between a pharmaceutical patent holder and a generic manufacturer, where the patent holder agrees to compensate the generic manufacturer in exchange for delaying market entry of a generic version of a patented drug. This agreement type must comply with the Philippine Competition Act and Intellectual Property Code, ensuring it doesn't violate anti-competition regulations while protecting legitimate patent rights. The document structures the settlement terms, payment arrangements, and market entry conditions, incorporating specific provisions required under Philippine jurisdiction.

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What is a Reverse Payment Agreement?

The Reverse Payment Agreement is a sophisticated legal instrument used in the Philippine pharmaceutical industry to resolve patent disputes between originators and generic manufacturers. This document becomes relevant when a generic manufacturer challenges a pharmaceutical patent and the parties seek to settle the dispute through a negotiated agreement involving compensation for delayed market entry. The agreement must carefully navigate the requirements of the Philippine Competition Act (Republic Act No. 10667), the Intellectual Property Code (Republic Act No. 8293), and the Universally Accessible Cheaper and Quality Medicines Act (Republic Act No. 9502). It typically includes detailed provisions on settlement terms, payment structures, entry dates, and regulatory compliance measures. The document is particularly important in the Philippine context where balancing patent rights with public access to affordable medicines is a key regulatory concern.

What sections should be included in a Reverse Payment Agreement?

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

What sections are optional to include in a Reverse Payment Agreement?

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

What schedules should be included in a Reverse Payment Agreement?

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

Philippines

Publisher

Ƶ

Cost

Free to use
Relevant legal definitions




































Clauses






























Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Chemical Manufacturing

Life Sciences

Healthcare Technology

Medical Devices

Relevant Teams

Legal

Intellectual Property

Regulatory Affairs

Business Development

Executive Leadership

Research and Development

Compliance

Corporate Strategy

Commercial Operations

Finance

Relevant Roles

Chief Legal Officer

Patent Attorney

Intellectual Property Counsel

Regulatory Affairs Director

Business Development Manager

Chief Executive Officer

Commercial Director

Head of Research and Development

Compliance Officer

General Counsel

Senior Patent Counsel

Corporate Strategy Director

Pharmaceutical Operations Manager

Legal Operations Manager

Industries






Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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