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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
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
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
Affiliate
Authorized Generic
Background IP
Commencement Date
Competing Product
Competition Laws
Confidential Information
Effective Date
Entry Date
Force Majeure Event
Generic Product
Good Industry Practice
Intellectual Property Rights
Licensed Patents
Market Entry
Net Sales
Original Product
Patent Rights
Payment Period
Regulatory Approval
Regulatory Authority
Related Patent Rights
Relevant Competition Authority
Settlement Payment
SPC
Subsidiary
Technical Information
Territory
Term
Third Party
Valid Claim
Working Day
Payment Terms
Patent Rights
Market Entry
Competition Law Compliance
Regulatory Compliance
Confidentiality
Representations and Warranties
Term and Termination
Force Majeure
Assignment and Transfer
Intellectual Property
Regulatory Approvals
Compliance with Laws
Dispute Resolution
Governing Law and Jurisdiction
Notices
Entire Agreement
Severability
Amendments
Third Party Rights
Further Assurance
Costs
Waiver
Counterparts
Pharmaceuticals
Healthcare
Biotechnology
Life Sciences
Chemical Manufacturing
Generic Medicines
Legal
Intellectual Property
Regulatory Affairs
Commercial
Business Development
Compliance
Patents
Market Access
Executive Leadership
Finance
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
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