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

The Licensing Agreement in Pharmaceutical Business Development (3rd Edition) published by Pharmalicensing Ltd. in July, 2007. This report consists of 60 pages and the price starts from US $ 995.

Introduction

Abstract

Pharmalicensing' s best selling licensing report has returned, fully revised and updated with new statistics, data and expert advice.

Licensing is at it' s peak - in-licensed products now generate over 30% of the revenues of the major pharmaceutical companies and some 25% of the ‘blockbusters’ of recent years have a history of cross-company licensing, that' s why it' s more important than ever to understand and secure the right deal and terms. This report examines the key factors that must be considered when drawing up a suitable contract, and includes highlights and tips for negotiating and understanding complex license agreements.

Order your copy of this report to:

• Understand the complexities and key terms of a pharmaceutical licensing agreement
• Gain a thorough insight into the basics of contract law
• Learn how to negotiate and reap the maximum benefits of a deal
• Examine the types of licensing agreements and what they involve
• Become aware of the scope of a license and it' s restrictions
• See pharmaceutical licensing from a US perspective

The importance of licensing activity in the pharmaceutical industry has increased significantly over recent years. Many of the industry' s biggest products were discovered and developed by one company and brought to market by another-examples include erythropoietin alpha (Amgen/Johnson & Johnson) and interferon alpha-2b (Biogen/Schering Plough).

It is easy to see what drives this process. On the one hand, there is a body of ideas, technologies and products emerging from medical-area research organizations and small and medium bio-pharmaceutical companies worldwide. On the other hand, there is a pharmaceutical industry with established global drug development and marketing infrastructures engaged in a constant search for additional reliably successful revenue-earners to feed their growth requirements.

In the first instance, the seed of a future deal is sown in discussions of either a technical or a commercial nature. One company is looking for a technology to help solve a drug delivery problem and finds a company that may have such a technology, or one company is looking for a late stage drug in its therapeutic area of focus to counter the loss of business that occurs when patents expire, and finds another company willing to make its drug accessible. These discussions will take the parties to the point where the broad outline of a potential arrangement is clear-who will do what, how much one will pay to the other and when.

At that stage, the discussion partners generally feel that the deal is virtually done, however experience has shown that it is not as straightforward as might be expected to create an agreement, there are many reasons why this is quite hard to achieve. The obvious one is that the level of uncertainty inherent in pharmaceutical product development is extremely high, the timescales involved compound this problem of uncertainty and the fact that company strategies rarely stay the same for more than a few years-or even months-at a time.

To negotiate a way through these hurdles, the industry has developed a deal structure. This acts as a starting point for the detailed and specific points that must then be covered according to the nature of the technology/product and the ambitions and skills of the companies concerned.

This report explores the main stages of an agreement that should be understood by both the lawyers and dealmakers when drafting up a deal, covering IP rights, product specifications, approvals and providing readers with a background to contract and competition law.

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

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