Bio-Device Licensing: Strategies for Success
Informa Healthcare
December 1, 2006 152 Pages - SKU: IFHC1693917
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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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- 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
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