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Bio-Device Licensing: Strategies for Success

Published by: Informa Healthcare

Published: Dec. 1, 2006 - 152 Pages


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
3.3.1 Corporate website
3.4 Making contact
CHAPTER 4 EVALUATING OPPORTUNITIES FOR INWARD LICENSING
4.1 Resourcing
4.1.1 Product champion
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
Board approval
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


Abstract

Avoid the pitfalls of one-sided collaborations with this new report from Clinica.

Bio-Device Licensing is a new report that assesses the critical success factors in drug/device collaborations, allowing both device and pharmaceutical companies to get the best out of these partnerships.

Bio-Device Licensing: Strategies for success will answer the following questions:
  • What do interdisciplinary collaborations really mean for device, biotech and pharmaceutical companies?
  • Where can synergies be found and what are the challenges?
  • What are the next disruptive technologies?
  • What are the emerging collaboration trends?
  • What kind of partners are leading corporations seeking?
  • How are valuable partnerships between large and small companies established?



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