Bio-Device Licensing: Strategies for Success

Summary

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?

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
• Table of Contents Bio-device Licensing
  • Informa UK Ltd, December 2006 6 www.clinicareports.co.uk
  • Photocopying & distribution of this document is illegal
  • 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: Bio-device Licensing

• Informa UK Ltd, December 2006 7 www.clinicareports.co.uk
• Photocopying & distribution of this document is illegal

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 Tables: Bio-device Licensing

• Informa UK Ltd, December 2006 8 www.clinicareports.co.uk
• Photocopying & distribution of this document is illegal

List of Figures Bio-device Licensing

• Informa UK Ltd, December 2006 9 www.clinicareports.co.uk
• Photocopying & distribution of this document is illegal

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
  • 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