Reverse Payment Agreement for Germany

Reverse Payment Agreement Template for Germany

This document is a specialized agreement governed by German law that structures a settlement between a pharmaceutical patent holder and a generic manufacturer, where the patent holder agrees to make payments to the generic manufacturer in exchange for delayed market entry of a generic version of a patented drug. The agreement must carefully navigate both German and EU competition laws, particularly regarding anti-competitive practices, while addressing patent rights, market entry timing, and payment terms. It requires detailed consideration of the German Act Against Restraints of Competition (GWB) and EU competition law, particularly Articles 101 and 102 TFEU, alongside German patent and pharmaceutical regulations.

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What is a Reverse Payment Agreement?

A Reverse Payment Agreement is utilized in the pharmaceutical industry when settling patent disputes between originator pharmaceutical companies and generic manufacturers. This document type, governed by German law and EU regulations, structures settlements where the patent holder makes payments to the generic manufacturer in exchange for delayed market entry. The agreement must be carefully drafted to ensure compliance with competition laws, as these arrangements face significant scrutiny from both German and EU competition authorities. The document typically includes detailed provisions on patent rights, payment structures, market entry timing, and competition law compliance measures. It requires careful consideration of the German Act Against Restraints of Competition (GWB), EU competition law (particularly Articles 101 and 102 TFEU), German patent law, and pharmaceutical regulations. The agreement should be used only after thorough assessment of competition law implications and potential effects on market competition.

What sections should be included in a Reverse Payment Agreement?

1. Parties: Identification of the patent holder and generic manufacturer, including their registered addresses and company details

2. Background: Context of the patent dispute, reference to relevant patents, and brief description of the settlement intention

3. Definitions: Definitions of key terms including Patent Rights, Products, Territory, and Agreement Period

4. Settlement Terms: Core settlement provisions, including the generic manufacturer's acknowledgment of patent validity and agreement to delay market entry

5. Payment Terms: Details of the reverse payment structure, including amounts, payment schedule, and any conditional payments

6. Market Entry Provisions: Specific terms regarding the agreed date of market entry and any conditions or exceptions

7. Competition Law Compliance: Explicit provisions ensuring compliance with EU and German competition laws

8. Representations and Warranties: Standard representations regarding authority to enter agreement, patent ownership, and compliance with laws

9. Confidentiality: Provisions regarding the confidential treatment of agreement terms and related information

10. Term and Termination: Duration of the agreement and circumstances allowing early termination

11. Governing Law and Jurisdiction: Specification of German law as governing law and jurisdiction for disputes

12. General Provisions: Standard boilerplate clauses including notices, entire agreement, and amendments

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

1. Multiple Patent Provisions: Additional provisions when the agreement covers multiple patents or patent families

2. Research and Development Cooperation: Terms for any concurrent R&D arrangements between the parties

3. Supply Arrangements: Terms for any supply or manufacturing agreements between the parties

4. Regulatory Compliance: Additional provisions regarding compliance with pharmaceutical regulations when relevant

5. Third Party Rights: Provisions addressing the rights of third parties who may be affected by the agreement

6. Alternative Dispute Resolution: Procedures for mediation or arbitration as alternatives to court proceedings

What schedules should be included in a Reverse Payment Agreement?

1. Schedule 1 - Patent Rights: Detailed description of the relevant patents, including patent numbers, jurisdictions, and expiry dates

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

3. Schedule 3 - Payment Schedule: Detailed payment terms, including amounts, dates, and calculation methodologies

4. Schedule 4 - Market Entry Terms: Detailed provisions regarding the agreed market entry conditions and timing

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

6. Appendix A - Form of Compliance Reports: Template for periodic compliance reporting required under the agreement

7. Appendix B - Authorized Generic Terms: If applicable, terms for any authorized generic arrangements

Authors

Alex Denne

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

Jurisdiction

Germany

Publisher

Genie AI

Cost

Free to use
Relevant legal definitions
Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Life Sciences

Chemical Manufacturing

Generic Medicines

Relevant Teams

Legal

Intellectual Property

Regulatory Affairs

Commercial

Business Development

Compliance

Patents

Market Access

Executive Leadership

Finance

Relevant Roles

Chief Legal Officer

Head of Patents

Competition Law Counsel

Intellectual Property Director

Regulatory Affairs Director

Chief Commercial Officer

Business Development Director

General Counsel

Patent Attorney

Licensing Manager

Commercial Operations Director

Head of Legal Affairs

Senior Legal Counsel

Chief Compliance Officer

Market Access Director

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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