Report: Bio-Device Licensing: Strategies for Success from Piribo.com

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

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Bio-Device Licensing: Strategies for Success

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