当商品の販売は、2011年08月03日を持ちまして終了しました。
Abstract
The biological-device sector is an exciting and rapidly evolving part of the
healthcare scene. As with other sectors, such as the pharmaceutical and
biotech sectors, licensing is playing an increasingly important role in new
product development, and so is becoming a key “must have” skill
for all companies involved in the sector.
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.
This report seeks to review all the key elements of licensing in a way that
will allow the reader to undertake his or her own licensing activities in a
professional and competitive manner.
The report briefly reviews trends within the industry and their implications
for licensing, then examines the basic structures and deal types most commonly
employed within the industry. The negotiation process, starting with
confidentiality, moving through to negotiation of a term sheet then a full
agreement are all explained in depth, followed by a review of all the key
clauses that need to be included in a licensing contract.
The report examines all the activities required to secure a successful inward
licensing, including strategic issues, preparing corporate presentation
material and target suitable partners, and then explains how to undertake the
evaluation and due diligence of potential opportunities in a way to maximize
the effective use of internal resources.
As outward licensing becomes increasingly competitive, it is vital that
companies set out their opportunities in the most effective way possible. The
report explains in detail how to action successful out-licensing, including
the preparation of confidential and non-confidential brochures, targeting of
partners and how to make contact.
Financial considerations are discussed, including a detailed review of the
parameters that effect deal values leading to how to best to set a value for
the deal.
Table of Contents
CHAPTER 1: THE ROLE OF INTERDISCIPLINARY COLLABORATIONS BETWEEN DEVICE, BIOTECH AND PHARMACEUTICAL COMPANIES
- 1.1 Industry trends
- 1.1.1 Growth in importance of formulation and drug delivery technologies
- 1.1.2 Growth of biotechnology
- 1.1.3 Academic institutions
- 1.1.4 Coming of age of the equipment manufacturers
- 1.2 Synergies
- 1.3 Future challenges
- 1.3.1 Structural issues
- 1.3.2 Changing sectors of interest
- 1.3.3 Meeting the needs of the biotech sector
- 1.3.4 Deal value trends
- 1.3.5 Freedom to operate
- 1.3.6 What kinds of partners and partnerships are the major players
seeking?
- .....Life-cycle management of established products
- .....New product development
- 1.3.7 The message for smaller companies
CHAPTER 2: THE NEGOTIATION AND LEGAL PROCESSES
- 2.1 Overview of typical deal types and structures
- 2.2 Typical activities involved in negotiating a deal
- 2.3 Confidentiality
- 2.3.1 Some key issues affecting CDAs
- .....Timescale
- .....Conflicts of interest
- .....Who is covered?
- 2.4 Samples and materials transfer agreements
- 2.4.1 Some key issues affecting MTAs
- .....Material definition
- .....Delivery
- .....Liability
- .....Approved studies
- .....Intellectual property rights
- .....Payments
- 2.5 Exclusive discussions and option agreements
- 2.6 Standard one-way licensing agreements
- 2.6.1 Term sheet
- 2.6.2 Heads of agreement
- 2.6.3 Negotiating the main agreement
- 2.6.4 Clauses for inclusion in a licensing agreement
- .....The parties
- .....Definitions
- .....Intellectual property to be licensed (the Product)
- .....Patents and supplementary protection certificates
- .....Data exclusivity and orphan drug status
- .....Trademarks
- .....Marketing authorisations (product approvals)
- .....Biological material
- .....Designs and copyright
- .....Know-how
- .....Rights to be licensed
- .....Background intellectual property
- .....Levels of exclusivity
- .....Areas covered by the agreement
- .....Geographical scope (the Territory)
- .....Therapeutic sector (the Field)
- .....Duration (Term)
- .....Early termination
- .....Commercial terms
- .....Fixed payments
- .....Offset payments
- .....Royalties
- .....Payments on supplies of goods
- .....R&D payments
- .....Payments in kind
- .....Equity payments
- .....Product development
- .....Ownership of improvements and developments
- .....Regulatory matters
- .....Clinical trials
- .....Development goals and specifications
- .....Sales and marketing
- .....Samples
- .....In-market price constraint
- .....Liability
- .....Manufacture and supply of product
- .....' Technical annex'
- .....Quality control
- .....Forecasting volumes
- .....Reporting and communication
- .....Safety reporting
- .....Technical support
- .....Warranties
- .....Intellectual property - maintenance, defence and infringement
- .....Law and jurisdiction
- .....Dispute resolution
- .....Other standard clauses
- .....Confidentiality
- .....Assignment
- .....Force majeure
- .....Announcements
- .....Schedules
- 2.6.5 Competition law issues
- 2.7 Collaborative ventures
- 2.7.1 Joint ventures
- .....Legal entities
- .....European Economic Interest Group
- .....Limited liability company
- .....Ownership
- .....Management
- .....Ownership of intellectual property
- .....Profit sharing
- .....Termination
- 2.8 Shared marketing
- .....Co-marketing
- .....Co-promotion
- 2.8.1 Structuring co-promotional deals
- .....Resource swap
- .....Share of revenues
- .....Fee payment
- .....Rep bonus system
- .....Timing
- .....Outcome targets
- .....How to share detailing
- .....Management issues
- .....Causes of failure
- 2.9 Royalty stacking
- 2.9.1 Royalty stack - the solution
- .....Share of net income
- .....Licensing “fee”
- .....Base royalty on units
- .....Offset third party royalties
- .....Manage via a joint venture company
- 2.9.2 In-licensing of products that require additional technologies
- 2.10 Sub-contracted work
CHAPTER 3: INWARD LICENSING - SEEKING DEVICE AND DELIVERY TECHNOLOGIES
- 3.1 Licensing strategy
- .....Why do you need 3rd party technology?
- .....What are the key attributes you are seeking?
- .....What type of deal do you need?
- .....What will be the scope of any rights to be obtained?
- .....What can you offer a partner?
- .....Target product profile
- 3.2 Finding a partner
- 3.3 Corporate presentational material
- 3.4 Making contact
CHAPTER 4: EVALUATING OPPORTUNITIES FOR INWARD LICENSING
- 4.1 Resourcing
- 4.2 Stepwise approach
- 4.3 Licensing review
- 4.4 Preliminary evaluation
- 4.4.1 Background information
- 4.4.2 Internal approach
- 4.5 Full evaluation
- 4.5.1 Negotiating “Lock-out”
- 4.5.2 Due diligence
- 4.5.3 Exchanging information
- 4.5.4 Technical evaluation
- .....R&D material
- .....Device technology
- .....Safety
- .....Manufacturing issues
- 4.5.5 Commercial evaluation
- .....Competitive profile
- .....Market research
- .....Target clinicians
- .....Data sheet
- .....Sales and marketing activities
- .....Impact on existing business
- .....Pricing
- .....Health economics
- .....Generic competition
- .....Sales forecasts for launched products
- .....Timescales
- 4.5.6 Intellectual property
- .....Patents and know-how
- .....Trademarks
- 4.5.7 Other issues
- .....Other licensees
- .....Insurance
- .....Improvements
- .....Tax
- .....Legal
- 4.5.8 Corporate fit
- 4.5.9 Profit models
- 4.5.10 Final evaluation and decision
CHAPTER 5: OUTWARD LICENSING - SEEKING PARTNERS FOR DEVICE AND DELIVERY TECHNOLOGIES
- 5.1 Licensing strategy
- .....Why are you seeking a partner?
- .....How much are you willing to contribute to future development?
- .....What are the key attributes you are seeking from a partner?
- 5.2 Deciding when and how to out-license
- 5.2.1 Timing
- 5.2.2 Type of deal to be sought
- 5.3 The licensing team
- 5.4 Preparation of presentational material for products in development
- 5.4.1 Preparation of the confidential prospectus
- .....Title page
- .....Overview
- 5.4.2 Preparation of the non-confidential brochure
- 5.4.3 Presentation slides
- 5.5 Preparation of presentational material for marketed products
- 5.6 Other in-house preparations
- 5.6.1 Additional material
- .....Intellectual property
- .....Laboratory notes
- .....Samples
- .....Device samples
- .....Test material
- .....Review of preclinical and clinical safety
- .....Review of clinical development status
- .....Clinical investigators' brochure
- .....Clinical development plans
- .....Publications
- .....Regulatory
- .....Sales and marketing data
- .....Production review
- 5.6.2 Due diligence room
- 5.6.3 Draft term sheet
- 5.7 Identifying out-licensing partners
- 5.7.1 Sources of information on potential partners
- 5.7.2 Target sectors
- .....Therapy sector and clinician groups
- .....Type of formulation
- .....Hospital vs Pharmacy
- 5.7.3 Key selection parameters
- .....Territories
- .....R&D capability
- .....Sales and marketing fit
- 5.7.4 Ideal profile
- 5.7.5 Short-listing companies
- 5.7.6 Licensing action plan
- 5.8 Seeking partners
- 5.8.1 Conferences and meetings
- 5.8.2 Managing contacts
- 5.8.3 Record-keeping
- 5.9 Evaluating prospective partners
- 5.9.1 Potential concerns
- 5.9.2 Optimising potential returns
CHAPTER 6: FINANCIAL CONSIDERATIONS, INCLUDING DEAL VALUES
- 6.1 Putting a value on a deal
- 6.1.1 Parameters influencing deal values
- .....Intellectual property
- .....Stage of development
- .....Competitive position
- .....Product fit
- .....Licensing supply and demand
- .....Company profiles
- .....Company sector
- .....Deal terms
- 6.1.2 Royalties versus stage payments
- 6.2 A review of deal values
- 6.3 Modelling your product
CHAPTER 7: MANAGING RELATIONSHIPS WITH OTHER COMPANIES
- 7.1 The importance of activities undertaken before signature
- 7.1.1 Common goals and specifications
- .....Goals
- .....Milestones
- .....Specifications
- .....Responsibility
- 7.1.2 Reporting
- 7.2 Resources
- 7.3 Manage your partner
- 7.4 Building a team
- 7.4.1 Agreement summary
- 7.4.2 Cross-cultural issues
- .....Language
- .....Decision making
- .....Regulatory issues
- .....Currency
- .....Information quality
- .....Technical standards
- 7.4.3 Controlling the information exchange
- 7.4.4 Task forces
- 7.5 What to do when it all goes wrong
- 7.5.1 Preventing misunderstandings
- 7.5.2 Take a positive approach
- 7.5.3 Resolving conflicts and personality issues
- 7.5.4 Avoiding litigation
- 7.5.5 Dispute resolution
- 7.5.6 Knowing when to quit
- 7.6 Learn from the experience
APPENDIX A
- .....Sources of information on target companies
- .....Sales audits
- .....Prescription audits
- .....Company fact files
- .....Biotechnology companies
- .....Physician guides
- .....R&D audits
- .....Publications
- .....Internet
- .....Specialist reports
- .....Conferences
- .....Partnering meetings
- .....Insider knowledge
APPENDIX B
- .....Anatomical classifications
APPENDIX C
LIST OF TABLES
- Table 2.1 Types of Exclusivity
- Table 2.2 Comparison of the structures of an EEIG and a limited company
joint venture
- Table 2.3 Comparison of co-marketing and co-promotion activities
- Table 5.1 Staff to include in out-license review process, by product type
- Table 5.2 Example of outward license action plan
- Table 6.1 A guide to payments and royalty rates by type of compound
LIST OF FIGURES
- Figure 2.1 Example of a Royalty Stack
- Figure 2.2 “Doughnut ring” intellectual property split for
contract work
- Figure 3.1 Overview of the in-licensing process
- Figure 3.2 Example of Opportunities Spreadsheet
- Figure 4.1 The four-step evaluation process
- Figure 5.1 Overview of the out-licensing process
- Figure 5.2 Disclaimer for licensing brochures
- Figure 5.3 Example target profile for out-licensing candidate
- Figure 5.4 Example of blank outward license target company long list
- Figure 5.5 Example of completed outward license target company long list
- Figure 5.6 Example of summary contact status
