This report is a 'how to' for drafting licensing and partnering agreements, aimed at individuals in marketing, business development and technology transfer who need a backgrounder in the subject to support discussions with lawyers and partners, or legal professionals new to pharmaceutical licensing and partnering.
The second edition of this guide has been revised throughout and includes an all-new section on the 2004 Technology Transfer Block Exemption, which regulates the economic effects of technology transfer agreements.
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 development initiated by one company, and the product then brought to market by another.
Initial licensing discussions 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, and are often surprised at the complexity that emerges when the lawyers are brought in to turn the outline agreement into a contract.
Because of the complexity of biopharma product development, corporations and their lawyers have 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 examines the key factors that must be considered by the lawyers when drawing up a suitable contract, and includes highlights and tips for negotiating and understanding complex license agreements, from both a British and American perspective.
Table of Contents
1. Introduction
2. Agreements & the business development professional
3. The licensing agreement in the overall business development context
3.1. Research alliances
3.1.1. Evaluation and option agreements
3.1.2. Contract research
3.1.3. Collaborative research
3.1.4. Co-development
3.1.5. Patent licensing
3.2. Marketing alliances
3.2.1. Licensing agreements
3.2.2. Co-marketing
3.2.3. Co-promotion
3.2.4. Product fostering
3.2.5. Contract selling
3.3. Product acquisition/divestment
3.4. Corporate acquisition/divestment
3.5. Joint venture
4. Key terms in a pharmaceutical licensing agreement
4.1. The parties
4.2. Recitals
4.3. Definitions
4.3.1. Affiliates
4.3.2. Applicable legislation
4.3.3. Authorities/regulatory authorities
4.3.4. Commercial year
4.3.5. Compound
4.3.6. Date of launch
4.3.7. Combination product
4.3.8. Development
4.3.9. Effective date
4.3.10. Ethics committee/IEC
4.3.11. Field
4.3.12. Improvements
4.3.13. Indication
4.3.14. IND
4.3.15. Intellectual property rights
4.3.16. Know-how
4.3.17. Major markets
4.3.18. MA/MAA/approval
4.3.19. NDA
4.3.20. Net sales/Net selling price
4.3.21. Patents
4.3.22. Product
4.3.23. Specification
4.3.24. Territory
4.3.25. Trademarks
4.4. The license grant
4.4.1. Exclusivity
4.4.2. What the licensee can do
4.4.3. Improvements
4.4.4. The field
4.4.5. The territory
4.4.6. Trade marks
4.5. Development
4.6. Regulatory
4.7. Commercialization
4.7.1. General
4.7.2. Measurable
4.8. Manufacturing and supply
4.9. Payment for the rights
4.9.1. Upfronts and milestones
4.9.2. Royalties
4.9.3. Equity
4.10. Monitoring and audit
4.11. Intellectual property rights (IPRs)
4.12. Quality and liability issues
4.13. Confidentiality and publication
4.13.1. Confidentiality
4.13.2. Publication
4.14. Term and termination
4.15. Assignment, sub-licensing and changes of ownership
4.16. Disputes and termination and choice of law
4.17. Other provisions
5. Competition law and pharmaceutical business development
5.1. Agreements and practices
5.2. The Technology Transfer Block Exemption
5.2.1. Transitional provisions
5.2.2. Scope of license
5.2.3. Market shares
5.2.4. Hardcore restrictions
5.2.5. Excluded restrictions
5.2.6. Outside the block exemption
5.3. Dominant position
5.4. Parallel trade
6. Pharmaceutical license agreements: A current US perspective
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