Scrip's Practical Guide to Pharmaceutical Licensing
Strategic Management
The comprehensive guide to in- and out-licensing and managing successful deals.
A complete revision of Scrip's best selling 1998 Licensing Deals report written by David Scott, Pharmaceutical Licensing brings together all the most up-to-date information you need to plan and implement a successful licensing strategy.
This report contains new and expanded sections, including biotechnology licensing and intellectual property issues, together with analysis of the latest information on licensing activities and deal valuations based on data from Windhover. Supported by a wealth of templates, examples and guidelines, Scrip's Practical Guide to Pharmaceutical Licensing answers the questions you need addressed:
Published: June 2001
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CONTENTS
LIST OF TABLES
LIST OF FIGURES
ABOUT THE AUTHOR
CONTRIBUTOR ON LEGAL ISSUES
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
GLOSSARY AND ABBREVIATIONS
CHAPTER 1 A REVIEW OF CURRENT TRENDS IN PHARMACEUTICAL LICENSING
1.1 Licensing origins
1.2 The emergence of drug delivery
1.3 The rise of the biotechnology industry
1.4 Internationalisation of patent and regulatory procedures
1.5 The growth of the emerging markets
1.6 Changing competitive pressures � the rise of mega pharma
1.7 Conclusions
CHAPTER 2 AN OVERVIEW OF THE LICENSING PROCESSES
2.1 Inward licensing
2.2 Outward licensing
CHAPTER 3 PREPARING THE GROUND: FACTORS TO CONSIDER BEFORE STARTING TO LICENSE
3.1 Strategic issues
3.1.1 Current therapeutic and clinician strengths
3.1.2 Resource and financing issues
3.1.3 R&D issues
3.1.3.1 Products in novel development areas
3.1.3.2 Back-up or duplicate products
3.1.4 Pipeline issues
3.1.5 Geographical and commercial infrastructure issues
3.1.6 Drug delivery issues
3.1.7 Technology platforms
3.1.8 Summary project review
3.1.9 Licensing strategy
3.2 Resources
3.2.1 Licensing
3.2.2 R&D and regulatory
3.2.3 Legal
3.2.4 Other groups
3.2.4.1 Marketing/market research
3.2.4.2 Production/quality control
3.2.4.3 Financial/tax
3.2.4.4 Insurance
3.2.4.5 Country management
3.3 Product champions
3.4 Licensing organisation
3.5 Relationships with potential partners
CHAPTER 4 DEAL STRUCTURE
4.1 Intellectual property to be licensed
4.1.1 Patents and supplementary protection certificates
4.1.2 Data exclusivity and orphan drug status
4.1.3 Trademarks
4.1.4 Marketing authorisations (product approvals)
4.1.5 Biologicals
4.1.6 Designs and copyright
4.1.7 Know-how
4.2 Levels of exclusivity
4.2.1 Exclusive
4.2.1.1 Sole
4.2.1.2 Semi-exclusive
4.2.1.3 Non-exclusive
4.3 Areas covered by the agreement
4.3.1 Geographical scope
4.3.2 Therapeutic sector
4.4 Shared marketing
4.4.1 Co-marketing
4.4.2 Co-promotion
4.5 Duration
4.6 Types of income
4.6.1 Fixed payments
4.6.2 Variable payments
4.6.2.1 Royalties
4.6.2.2 Payments on supplies of goods
4.6.3 Payments in kind
4.6.4 Third party receipts
4.6.5 Payments generally
4.6.6 Equity payments
4.7 Deal types
4.7.1 Distribution agreement
4.7.2 Product acquisition
4.7.3 Licensing agreements
4.7.4 Collaborative ventures
4.7.5 Company acquisition
CHAPTER 5 INWARD LICENSING
5.1 Defining search criteria
5.1.1 Therapy areas
5.1.2 Sales performance
5.1.2.1 Maximum and minimum turnover
5.1.2.2 Product growth rates
5.1.2.3 Launch dates
5.1.2.4 Fit with licensors' own range
5.1.3 Development criteria
5.1.4 Key performance criteria
5.1.5 Geographical availability
5.1.6 Risk
5.1.7 Obtain internal consensus
5.2 Identifying in-license partners
5.2.1 Desk research
5.2.1.1 Sales and marketing data
5.2.1.2 Products in R&D
5.2.1.3 Deals and collaborations
5.2.2 Networking
5.2.3 Universities and medical institutions
5.2.4 Other sources
5.3 Targeting potential opportunities
5.3.1 First pass review
5.3.2 Opportunity profiles
5.3.3 Internal review
5.4 What do you offer a potential partner?
5.5 Specific issues relating to European national companies
5.5.1 Form a partnership with national companies in other countries
5.5.2 Offer to finance and co-ordinate a pan-European clinical programme
5.5.3 Offer to establish a local sales and marketing organisation
5.5.4 Offer a short-term deal
5.6 Making contact
5.7 Summary of key elements in the inward licensing process
CHAPTER 6 EVALUATING POTENTIAL OPPORTUNITIES
6.1 Resourcing
6.1.1 Product champion
6.2 Stepwise approach
6.3 Licensing review
6.3.1 Unsolicited letters
6.3.2 Recommendations from top management
6.3.3 The 'friend of' syndrome
6.4 Preliminary evaluation
6.4.1 Background information
6.4.2 Internal approach
6.4.3 Secrecy
6.4.4 Completion of the preliminary review
6.5 Lock-out agreement
6.6 Full evaluation
6.6.1 Due diligence
6.6.2 Exchanging information
6.6.3 Technical evaluation
6.6.3.1 R&D material
6.6.3.2 Device technology
6.6.3.3 Manufacturing issues
6.6.4 Commercial evaluation
6.6.4.1 Competitive profile
6.6.4.2 Market research
6.6.4.3 Target clinicians
6.6.4.4 Data sheet
6.6.4.5 Sales and marketing activities
6.6.4.6 Impact on existing business
6.6.4.7 Pricing
6.6.4.8 Health economics
6.6.4.9 Generic competition
6.6.4.10 Sales forecasts for launched products
6.6.4.11 Timescales
6.6.5 Other issues
6.6.5.1 Other licensees
6.6.5.2 Insurance
6.6.5.3 Trademarks
6.6.5.4 Patents and know-how
6.6.5.5 Improvements
6.6.5.6 Tax
6.6.5.7 Legal
6.6.6 Corporate fit
6.6.7 Profit models
6.6.8 Final evaluation and decision
6.6.8.1 Board approval
6.6.9 Summary of key elements in the evaluation process
CHAPTER 7 OUTWARD LICENSING
7.1 Deciding when and how to out-license
7.1.1 Timing
7.1.1.1 Preclinical development
7.1.1.2 At the beginning of clinical trials
7.1.1.3 At the beginning of Phase III clinical trials
7.1.1.4 When a regulatory dossier has been compiled
7.1.1.5 When a product obtains regulatory approval
7.1.1.6 Marketed products
7.1.2 Type of deal to be sought
7.1.2.1 Disposal
7.1.2.2 Outward license
7.1.2.3 Co-development
7.1.2.4 Cross-licensing
7.2 The licensing team
7.3 Preparation of presentational material for products in development
7.3.1 Preparation of the confidential prospectus
7.3.2 Preparation of the non-confidential brochure
7.3.3 Presentation slides
7.4 Preparation of presentational material for marketed products
7.4.1 Non-confidential brochure
7.4.2 Confidential material
7.4.3 Presentation slides
7.5 Other in-house preparations
7.5.1 Additional material
7.5.1.1 Intellectual property
7.5.1.2 Laboratory notes
7.5.1.3 Samples
7.5.1.4 Test material
7.5.1.5 Review of preclinical and clinical safety
7.5.1.6 Review of clinical development status
7.5.1.7 Clinical investigators' brochure
7.5.1.8 Clinical development plans
7.5.1.9 Publications
7.5.1.10 Regulatory
7.5.1.11 Sales and marketing data
7.5.1.12 Production review
7.5.2 Due diligence room
7.5.3 Other issues
7.5.4 Draft termsheet
7.6 Identifying out-license partners
7.6.1 Target market sectors
7.6.2 Key selection parameters
7.6.2.1 Territories
7.6.2.2 R&D competence
7.6.2.3 R&D product fit
7.6.2.4 Sales and marketing fit
7.6.3 Ideal profile
7.6.4 Sources of information on potential partners
7.6.4.1 Sales audits
7.6.4.2 Prescription audits
7.6.4.3 Company fact files
7.6.4.4 Biotechnology companies
7.6.4.5 Physician guides
7.6.4.6 R&D audits
7.6.4.7 Publications
7.6.4.8 Internet
7.6.4.9 Specialist reports
7.6.4.10 Conferences
7.6.4.11 Insider knowledge
7.6.5 Short-listing companies
7.7 Licensing action plan
7.8 Seeking partners
7.8.1 Conferences and meetings
7.9 Managing contacts
7.9.1 Record-keeping
7.10 Evaluating prospective partners
7.10.1 Potential concerns
7.10.2 Optimising potential returns
CHAPTER 8 MANAGING CONTACTS WITH OTHER COMPANIES
8.1 Establishing initial contact
8.1.1 Consultants
8.2 Planning company visits
8.3 Corporate presentational material
8.3.1 Corporate presentation
8.3.2 Corporate brochure
8.3.3 Hard copy and electronic formats for material
CHAPTER 9 FINANCIAL CONSIDERATIONS AND MODELS
9.1 Reviewing sales trends
9.1.1 Historical sales trends
9.1.2 Forecasts of future sales
9.1.2.1 Historic trends
9.1.2.2 Maximum market potential
9.1.2.3 Optimum market share
9.1.2.4 Life cycle
9.1.2.5 Multi-variant analyses
9.1.3 Obtaining forecast data from operating companies
9.1.4 Forecasting sales for early-stage development compounds
9.2 Why sales of marketed products need to be doubled by a licensee
9.3 Using split royalties to enhance the value of marketed product licences
9.4 Putting a value on a deal
9.4.1 Parameters influencing deal values
9.4.1.1 Intellectual property
9.4.1.2 Stage of development
9.4.1.3 Competitive position
9.4.1.4 Product fit
9.4.1.5 Licensing supply and demand
9.4.1.6 Company profiles
9.4.1.7 Deal terms
9.4.2 What are the risks of not getting to market?
9.4.2.1 Summary of risk profile
9.4.3 Royalties versus stage payments
9.5 Analysis of recent deal information
9.5.1 Bias in published information
9.5.2 The significance of quoted headline deal values
9.5.2.1 Stage payments
9.5.2.2 Royalties
9.5.2.3 Equity
9.5.3 Actual reported values
9.5.3.1 Fixed payments
9.5.3.2 Royalty levels
9.6 Examples of deal values
9.7 Modelling your product
9.7.1 R&D licensing model
9.7.2 Launched product model
CHAPTER 10 THE LEGAL AGREEMENTS
10.1 Confidentiality
10.1.1 Timescale
10.1.2 Subject matter and conflicts of interest
10.1.3 Joint studies
10.1.4 Who is covered?
10.2 Samples and materials transfer agreements
10.2.1 Material definition
10.2.2 Delivery
10.2.3 Liability
10.2.4 Intellectual property rights
10.2.5 Payments
10.2.6 General
10.3 Exclusive discussions and option agreements
10.4 Termsheet
10.4.1 Target terms
10.4.2 Negotiating the termsheet
10.5 Heads of Agreement
10.6 Clauses for inclusion in a licensing agreement
10.6.1 The parties
10.6.2 Definitions
10.6.3 Product
10.6.3.1 Background and foreground
10.6.3.2 Improvements and developments
10.6.3.3 Marketed products
10.6.3.4 Device technology
10.6.4 Trademark
10.6.5 Licensee rights
10.6.5.1 Exclusivity
10.6.5.2 Sub-licensing
10.6.6 Term
10.6.7 Territories
10.6.8 Field
10.6.9 Development activities
10.6.9.1 Regulatory matters
10.6.9.2 Clinical trials
10.6.9.3 Development goals and specifications
10.6.10 Sales and marketing
10.6.10.1 Samples
10.6.10.2 In-market price constraint
10.6.11 Liability
10.6.12 Manufacture and supply of product
10.6.12.1 'Technical annex'
10.6.12.2 Quality control
10.6.12.3 Reports/forecasts
10.6.12.4 Deliveries
10.6.13 Reporting and communication
10.6.14 Payments
10.6.14.1 Supply price
10.6.14.2 Milestones
10.6.14.3 Annual payments
10.6.14.4 Royalties
10.6.14.5 Minimum sales/royalties
10.6.14.6 Royalty stacking
10.6.14.7 Royalty adjustments
10.6.15 Payment terms
10.6.16 Technical support
10.6.17 Warranties
10.6.18 Intellectual property � maintenance, defence and infringement
10.6.19 Termination
10.6.19.1 Change of control
10.6.19.2 Termination of development agreements
10.6.20 Law and jurisdiction
10.6.21 Dispute resolution
10.6.22 Other standard clauses
10.6.22.1 Confidentiality
10.6.22.2 Assignment
10.6.22.3 Force majeure
10.7 Competition law issues
10.7.1 Schedules
10.8 Announcements
10.9 The contract process
10.10 Negotiating techniques
CHAPTER 11 SOME SPECIAL CASES
11.1 Platform technologies
11.2 Universities and other academic and medical institutions
11.2.1 Potential difficulties
11.2.2 Potential advantages
11.2.3 Typical arrangements with universities and hospitals
11.2.4 Consortium arrangements
11.3 Joint ventures
11.3.1 Legal entities
11.3.1.1 European Economic Interest Group
11.3.1.2 Limited liability company
11.3.1.3 Ownership
11.3.1.4 Management
11.3.1.5 Ownership of intellectual property
11.3.1.6 Profit sharing
11.3.1.7 Termination
11.4 Co-promotion
11.4.1 Co-marketing versus co-promotion
11.4.2 Finding a co-promotion partner
11.4.3 Deal structure
11.4.4 Outcome targets
11.4.5 How to share detailing
11.4.6 Management issues
11.4.7 Causes of failure
CHAPTER 12 AFTER THE DEAL
12.1 Issues to be resolved before signature
12.1.1 Common goals and specifications
12.1.1.1 Goals
12.1.1.2 Milestones
12.1.1.3 Specifications
12.1.2 Reporting
12.1.3 Termination
12.1.4 Launched products
12.2 Internal management issues
12.2.1 Allow adequate resources to manage your partner
12.2.2 Ensure internal commitment and understanding
12.2.3 Agreement summary
12.3 Building a team
12.3.1 Cross-cultural issues
12.3.1.1 Language
12.3.1.2 Decision making
12.3.1.3 Budgets
12.3.1.4 Technical standards
12.3.1.5 Regulatory issues
12.3.1.6 Currency
12.3.1.7 Information quality
12.3.2 Controlling the information exchange
12.3.3 Setting up and managing task forces
12.4 What to do when it all goes wrong
12.4.1 Preventing misunderstandings
12.4.2 Take a positive approach
12.4.3 Resolving conflicts and personality issues
12.4.4 Avoiding litigation
12.4.5 Dispute resolution
12.4.6 Knowing when to quit
12.5 Learn from the experience
REFERENCES
APPENDIX 1 PHARMAPROJECTS THERAPEUTIC ACTIVITIES BY CODE AND THEIR DEFINITIONS
APPENDIX 2 DESK RESEARCH SOURCES
A2.1 PJB Publications/Scrip Reports/Clinica Reports/Theta Reports
A2.2 Pharmalicensing
A2.3 IMS
A2.4 Recombinant Capital
A2.5 Windhover Information Inc
A2.6 EphMRA
A2.7 Licensing Executives Society
A2.8 Pharmaceutical Licensing Group
A2.9 Other Internet sites
APPENDIX 3 DRAFT CDA AND MTA AGREEMENTS
A3.1 Confidentiality agreement
A3.2 Materials transfer letter
APPENDIX 4 CHECKLIST FOR PRODUCT EVALUATION
APPENDIX 5 QUESTIONS FOR PREPARATION OF OUT-LICENSE PROSPECTUS
APPENDIX 6 SUMMARY OF LICENSING CONTACTS FOR TOP 50 COMPANIES
APPENDIX 7 TOP 166 COMPANIES RANKED BY ESTIMATED PHARMA SALES
APPENDIX 8 EXCEL LICENSING MODELS
A8.1 R&D licensing
A8.2 Marketed product model
APPENDIX 9 EXAMPLE OF A TERMSHEET USED IN A SUCCESSFUL LICENSING NEGOTIATION
APPENDIX 10 TEMPLATES
APPENDIX 11 DISK CONTENTS
APPENDIX 12 IN-LICENSING AND OUT-LICENSING MODULES
List of Tables
Table 3.1 Example of analysis of sales force contact groups
Table 3.2 Example of analysis of marketed product profiles
Table 3.3 Example of product pipeline analysis
Table 3.4 Targeted licensing activities
Table 5.1 Anatomical or therapy classifications (cf. Appendix 1)
Table 5.2 Example of initial product assessment form
Table 5.3 Analysis of potential licensing targets
Table 6.1 Example summary of target competitive profile
Table 7.1 Staff to include in out-license review process, by phase of development
Table 7.2 Example competitive profile for confidential prospectus
Table 7.3 Example of product summary registration/launch status
Table 7.4 Example of blank outward license target company long list
Table 7.5 Example of completed outward license target company long list
Table 7.6 Example of outward license action plan
Table 7.7 Example of company contact sheet for an outward license opportunity
Table 7.8 Example of summary contact status
Table 9.1 Analysis of income before and after ACME licenses a product to Newco
Table 9.2 Risk profile for NCEs in development
Table 9.3 A guide to payments and royalty rates by type of compound
Table 10.1 Example summary termsheet
Table 11.1 Comparison of the structures of an EEIG and a limited company joint venture
Table 11.2 Comparison of co-marketing and co-promotion activities
List of Figures
Figure 1.1 Number of compounds in development by company, 1999
Figure 2.1 Overview of the in-licensing process
Figure 2.2 Overview of the out-licensing process
Figure 3.1 Example of licensing strategy statement
Figure 4.1 Types of in-license deals
Figure 6.1 The four-step evaluation process
Figure 7.1 Disclaimer for licensing brochures
Figure 7.2 Example of sales chart for non-confidential brochure
Figure 7.3 Example target profile for out-licensing candidate
Figure 9.1 Nuprod � year-end sales values, 1996�1999
Figure 9.2 Nuprod � year-end sales volumes, 1996�1999
Figure 9.3 Nuprod � MAT sales volumes, 1996�1999
Figure 9.4 Nuprod monthly volume sales to July 2000
Figure 9.5 Typical product life cycle
Figure 9.6 Example of split royalty
Figure 9.7 Analysis of deals by stage of development
Figure 9.8 Analysis of deals by stage of development, 1991�2000
Figure 9.9 Analysis of deals by territories included
Figure 9.10 Analysis of fixed payments for deals by stage of development
Figure 9.11 Analysis of royalty payments for deals by stage of development
Figure 9.12 Number of deals involving a joint venture or profit sharing, 1991�2000
Figure A12.1 Report structure
EXECUTIVE SUMMARY
Although the level of preparation will depend upon the amount of time available and on the importance of a
particular project, all licensing benefits from a well thought-out, systematic approach, even when opportunities
arise serendipitously. All successful licensing involves an element of luck, but the successful licensing manager
will use his or her skills to ensure that any available luck is fully exploited.
Licensing requires a range of activities, including strategic planning, targeting of potential opportunities, preparation of supporting material, contact with potential partners, negotiation, and management of deals post-completion.
This report seeks to provide a comprehensive overview of all the activities involved in both in- and out-licensing, highlighting ways in which each stage can be undertaken, with liberal quantities of hands-on advice based on direct industry experience. As a guide to the activities described, the report contains many pro forma tables for data analysis, checklists and summary headings for dossiers, presentations and help in the negotiating of agreements. In most cases, these are furnished with example data based upon a fictitious company, but based on real-life examples.
The report is structured to take the reader through the various processes involved in both inward and outward licensing activities, but each chapter is also designed to be read as a quick reference for the activities concerned, allowing the reader to dip in to get help on a specific query.
Whilst the basic principles of licensing have changed little since publication of the first edition of this report (Scott, 1998), the dynamic nature of the pharmaceutical industry discussed in the first chapter means that the types and structures of deals being undertaken has evolved significantly. This second edition represents an extensive revision that takes the opportunity to incorporate the very latest practices employed in the industry at all levels and to bring in additional information relating to universities, co-promotion and joint ventures. At the same time, the treatment of legal matters has been strengthened to provide a comprehensive review of such matters from the perspective of licensing managers.
Chapter 2 provides an overview of the licensing processes for inward and outward licensing along with cross references to the rest of the report, which is followed in Chapter 3 by a comprehensive review of the strategic issues and preparations needed before any licensing activity can start.
Chapter 4 considers how to plan the essential structure of a deal, looks at the pros and cons of various commonly used deal types, and analyses each of the key elements that should be considered when deciding what type of deal to seek.
The report goes on in Chapter 5 to describe the processes involved in setting out to identify an inward licensing opportunity, looking at ways to use desk research and in-house analyses to identify those potential products that will best fit a company's profile. The process of targeting activity on the best opportunities with the greatest chance of success are discussed, and the review explains to the reader how to derive a suitable shortlist of around 20 companies to approach directly.
The process of contacting companies is common to inward and outward licensing, and is discussed along with a proposed outline corporate presentation in Chapter 8. Meanwhile, Chapter 6 describes in detail the process of evaluating identified potential inward-license opportunities, including a discussion of the key issues and how to involve staff from various key specialities. This section also examines the main issues that should be considered most carefully.
Outward licensing is dealt with in Chapter 7, which considers how and when to out-license, and describes the team that should be brought together to do this. A key element in any out-licensing activity is the quality and format of data to be supplied to prospective partners, and the report provides detailed outlines for confidential and non-confidential dossiers covering all the types of information that will be sought by any potential licensee. This section also deals with other preparations a potential licensor should undertake, before moving on to discuss how best to target and manage contacts with potential candidates.
Chapter 9 reviews some of the financial considerations of the licensing process. The best means of reviewing historical data as an aid to preparation of accurate forecasts are discussed, and the reasons why a licensee for a launched product must double sales are explained and illustrated by a worked example. Everyone wants to know what is a fair value for a deal. There is no correct answer to this, because every deal is different, but this chapter considers the parameters that can affect the value of a deal, and provides a guide to potential values for different types of deals, backed with information on some actual examples. Two detailed Excel models are presented (with copies on the disk), covering the calculation of returns for the license of an R&D project and for a marketed product. Both models allow the user to adjust the various elements of the deal to come up with a win-win solution to meet both parties' needs.
No discussion on licensing is complete without a review of the contractual negotiations, and Chapter 10 deals with the key elements from the perspective of a licensing manager (but assumes that legal advice will be sought before any actual negotiations are concluded.). Draft secrecy and material supply agreements that include most of the elements that are normally required are included as appendices (and on disk) and the elements that go to form a contract are discussed individually as part of the preparations to start drafting a full agreement. This section also reviews the preparation of termsheets and some tips on the negotiations themselves.
In the excitement of completing a deal, it is easy to forget just how much has to be done after the signature, but Chapter 11 brings the reader back to earth with a review of the best ways of ensuring a successful negotiation leads to a successful outcome. This chapter reviews some of the issues to be aware of before signature, and looks at the use of task forces to build a team committed to driving projects forward.
This report sets out to provide a sound, practical guide to pharmaceutical licensing, allowing the reader to work step by step through the processes. As such, it should provide a valuable insight to all the elements of licensing for those setting out to undertake licensing for the first time. With its wealth of templates and check lists, the report can also help those with more experience who simply want to cross-check their activities or save time in setting out tables and reports. These appendices include licensing contact points for the top 50 companies as well as a list of the top 180 companies ranked in order of pharmaceutical sales.
ABOUT THE AUTHOR
David Scott is a freelance Licensing and Business Development
Consultant with over 24 years' experience in the pharmaceutical industry. He has proven
skills in deal brokering, marketing, strategic planning, finance, business development
and acquisitions and has been advising and concluding deals for companies in the
healthcare sector for the past 5 years.
A graduate chemist with post-graduate marketing qualifications, David's early career included a number of marketing posts in Fisons Fertilizer and Pharmaceutical Divisions as well as 3 years in Fisons Group HQ before moving into strategic planning and corporate acquisitions in the Pharmaceutical Division. The successful completion of a Spanish acquisition saw David seconded to Spain as Finance Director.
Returning to Fisons in the UK in 1987 as Business Development Manager, David had responsibility for securing product flow through licensing, acquisition and product development within Northern Europe and was responsible for the completion of a number of in-licensing and development projects in the respiratory and allergy markets.
As Corporate Licensing Manager from 1991�1996 David was responsible for identifying, negotiating and managing a number of successful major inward and outward licensing and collaborative deals, and brings considerable hands-on experience of all aspects of these activities.
David left Fisons following its sale to Rh�ne-Poulenc Rorer in 1996 to move into consultancy. He has undertaken a variety of marketing, strategy, business development and licensing projects for clients including traditional multinational pharmaceutical companies, device companies and biotechnology start-ups and concluded a number of inward, outward and collaborative deals on behalf of clients.
Contributor on legal issues
Covington & Burling is a leading international law firm, with over 400
lawyers and offices in New York, Washington DC, San Francisco, London and Brussels.
Over 70 lawyers within the firm specialise in work relating to the life sciences and pharmaceutical
industries. The company provides the full range of transactional and advisory services to
pharmaceutical, biotechnology and medical device companies in the US, the UK, mainland
Europe, Japan and elsewhere. With its network of offices, the company is well positioned to
provide global or regional co-ordination and transactions.
Covington & Burling adopts a multi-disciplinary approach which enables it to quickly assimilate its clients' regulatory, intellectual property and commercial goals, identify potential issues and, as appropriate, develop creative and novel approaches to maximise value for its clients in an efficient and cost effective manner.
Covington & Burling's clients include many major multinational and national pharmaceutical companies as well as a wide array of biotechnology, diagnostic and medical device companies, ranging from start-ups to industry leaders. The company regularly acts for many of the top 25 pharmaceutical companies, as well as principal US trade associations of the drug, device, food, and cosmetic industries.
Fiona Crawley is an English qualified lawyer, with over 20 years' experience of advising companies on commercial issues and the protection and exploitation of their intellectual property. In recent years, she has advised on a number of major partnering, co-development and exploitation arrangements (for the UK, Europe and worldwide) in the biotechnology and pharmaceutical sector. She regularly advises companies on their licensing strategy and for smaller companies augments the in-house expertise at an early stage in the licensing process.
Fiona has lectured widely on legal issues relating to pharmaceutical licensing and is a regular speaker at life science industry meetings on contractual and intellectual property issues of relevance to the industry.
Before joining Covington in 1999, Fiona was a partner in a Cambridge UK law firm with over 15 years' experience of advising technology companies in the Cambridge area and elsewhere in the UK.
© PJB Publications Ltd. 2001
All rights reserved.