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Reverse Payment Agreement Template for Ireland

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Key Requirements PROMPT example:

Reverse Payment Agreement

"I need a Reverse Payment Agreement under Irish law between our pharmaceutical company (patent holder for anxiety medication) and GeneriCo Ltd, with a negotiated market entry date of March 1, 2025, and a one-time settlement payment of €5 million."

Document background
Reverse Payment Agreements, also known as "pay-for-delay" agreements, are complex legal instruments used in the pharmaceutical industry to settle patent litigation between originator companies and generic manufacturers. These agreements, when implemented under Irish law, must carefully navigate both national and EU competition law requirements, particularly following significant European case law such as the Lundbeck decision. The document is typically used when a patent holder wishes to resolve patent litigation by compensating a generic manufacturer to delay market entry, requiring careful structuring to ensure competition law compliance. It includes comprehensive provisions covering settlement terms, payment mechanisms, entry conditions, and regulatory compliance protocols. The agreement must be drafted with particular attention to Irish Competition Act 2002 requirements and EU competition regulations, often requiring notification to or approval from relevant competition authorities.
Suggested Sections

1. Parties: Identification of the contracting parties - typically the patent holder/originator company and the generic manufacturer

2. Background: Context of the patent dispute, current litigation status, and basis for settlement

3. Definitions: Definitions of key terms including Patent Rights, Products, Territory, and Entry Date

4. Settlement Terms: Core settlement provisions including dispute resolution and mutual releases

5. Payment Terms: Details of reverse payments, including amounts, timing, and conditions

6. Entry Restrictions: Terms governing the generic manufacturer's market entry timing and conditions

7. Competition Law Compliance: Specific provisions ensuring compliance with EU and Irish competition laws

8. Representations and Warranties: Standard and specific warranties regarding patent rights, regulatory compliance, and authority to enter agreement

9. Regulatory Notifications: Requirements for notifications to competition authorities and regulatory bodies

10. Confidentiality: Provisions governing confidentiality of agreement terms and related information

11. Term and Termination: Duration of the agreement and termination provisions

12. General Provisions: Standard boilerplate clauses including governing law, jurisdiction, and entire agreement

Optional Sections

1. Supply Arrangements: Optional provisions for supply of authorized generic products, used when agreement includes supply relationship

2. Technology Transfer: Provisions for transfer of technical information or know-how, included when relevant to settlement implementation

3. Third Party Rights: Provisions addressing rights of third parties, included when settlement affects other market participants

4. Marketing Authorization: Specific provisions regarding regulatory approvals, included when agreement covers regulatory matters

5. Patent Challenges: Terms governing future patent challenges, included when parties want to address potential future disputes

6. Alternative Dispute Resolution: Detailed ADR procedures, included when parties prefer specific dispute resolution mechanisms

Suggested Schedules

1. Schedule 1: Patent Rights: Detailed list and description of relevant patents and patent applications

2. Schedule 2: Products: Specification of products covered by the agreement

3. Schedule 3: Payment Schedule: Detailed payment terms, amounts, and timing

4. Schedule 4: Entry Date Conditions: Specific conditions and timing for market entry

5. Schedule 5: Competition Law Compliance Protocol: Detailed procedures for ensuring competition law compliance

6. Appendix A: Form of Press Release: Template for public announcements regarding the settlement

7. Appendix B: Technical Information: Technical specifications and requirements for products

8. Appendix C: Regulatory Contacts: List of relevant regulatory authorities and contact information

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈ˰æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions







































Clauses

































Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Life Sciences

Chemical Manufacturing

Medical Devices

Relevant Teams

Legal

Intellectual Property

Regulatory Affairs

Compliance

Commercial

Business Development

Executive Leadership

Corporate Strategy

Product Development

Government Affairs

Relevant Roles

Chief Legal Officer

Head of Patent Law

Competition Law Counsel

Regulatory Affairs Director

Chief Commercial Officer

Intellectual Property Manager

General Counsel

Senior Patent Attorney

Head of Business Development

Compliance Officer

Chief Executive Officer

Settlement Counsel

Regulatory Strategy 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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