The Licensing Agreement in Pharmaceutical Business Development (3rd Edition)

Table of Contents

1. Introduction

2. Agreements and the business development professional

3. The Basics of Contract Law

• 3.1 Making the Contract
  • 3.1.1 Offer and Acceptance
  • 3.1.2 Completeness and Certainty
  • 3.1.3 Consideration
  • 3.1.4 Intention to Create Legal Relations
• 3.2 Substance of the Contract
  • 3.2.1 Negotiation Statements
  • 3.2.2 Promises
  • 3.2.3 Implied Terms
  • 3.2.4 Exclusion Clauses
• 3.3 Ending the Contract
  • 3.3.1 Breach
  • 3.3.2 Damages

4. The licensing agreement in the overall business development context

• 4.1 Research alliances
  • 4.1.1 Evaluation and option agreements
  • 4.1.2 Contract research
  • 4.1.3 Collaborative research
  • 4.1.4 Co-development
  • 4.1.5 Patent licensing
• 4.2 Marketing alliances
  • 4.2.1 Licensing agreements
  • 4.2.2 Co-marketing
  • 4.2.3 Co-promotion
  • 4.2.4 Product fostering
  • 4.2.5 Contract selling
• 4.3 Product acquisition/divestment
• 4.4 Corporate acquisition/divestment
• 4.5 Joint venture

5. Preliminary and Ancillary Documentation and Due Diligence

• 5.1 Confidentiality Agreements
• 5.2 Letters of Intent/Recording Understandings
• 5.3 Term Sheets and Heads of Terms
• 5.4 IP and Legal Due Diligence
• 5.5 Side Letters

6. Key terms in a pharmaceutical licensing agreement

• 6.1 Date
• 6.2 The parties
• 6.3 Recitals
• 6.4 Definitions
  • 6.4.1 Affiliates
  • 6.4.2 Applicable legislation
  • 6.4.3 Authorities/regulatory authorities
  • 6.4.4 Commercial year
  • 6.4.5 Compound
  • 6.4.6 Launch
  • 6.4.7 Combination product
  • 6.4.8 Development
  • 6.4.9 Effective Date
  • 6.4.10 Ethics committee/ Independent Ethics Committee (IEC)
  • 6.4.11 Field
  • 6.4.12 Improvements
  • 6.4.13 Indication
  • 6.4.14 IND
  • 6.4.15 Intellectual property rights
  • 6.4.16 Know-how
  • 6.4.17 Major markets
  • 6.4.18 MA/MAA/approval
  • 6.4.19 NDA
  • 6.4.20 Net sales/Net selling price
  • 6.4.21 Patents
  • 6.4.22 Product
  • 6.4.23 Specification
  • 6.4.24 Territory
  • 6.4.25 Trademarks
• 6.5 The license grant
  • 6.5.1 Exclusivity
  • 6.5.2 What the licensee can do
  • 6.5.3 Improvements
  • 6.5.4 The field
  • 6.5.5 The territory
  • 6.5.6 Trademarks
• 6.6 Development
• 6.7 Regulatory
• 6.8 Commercialization
  • 6.8.1 General
  • 6.8.2 Measurable
• 6.9 Manufacturing and supply
• 6.10 Payment for the rights
  • 6.10.1 Upfronts and milestones
  • 6.10.2 Royalties
  • 6.10.3 Equity
• 6.11 Monitoring and audit
• 6.12 Intellectual property rights (IPRs)
• 6.13 Quality and liability issues
• 6.14 Confidentiality and publication
  • 6.14.1 Confidentiality
  • 6.14.2 Publication
• 6.15 Term and termination
• 6.16 Assignment, sub-licensing and changes of ownership
• 6.17 Disputes and termination and choice of law
• 6.18 Other provisions
• 6.19 Execution

7. Competition law and pharmaceutical business development

• 7.1 Agreements and practices
• 7.2 Block Exemptions
• 7.3 The Technology Transfer Block Exemption
• 7.4 Dominant position
• 7.5 Parallel trade
• 7.5.1 Introduction and Legal Basis
• 7.5.2 Repackaging and Rebranding
• 7.5.3 Supply Chain Mechanisms

8. Pharmaceutical license agreements: A current US perspective

9. Conclusions

10. Appendices

• 10.1 Abbreviations
• 10.2 Glossary

11. Author biography

12. Acknowledgements