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
