Pharmaceutical/Biotech: R&D Alliances

2. Introduction

• Contracting and Licensing Agreements

3. Key Terms and Provisions of Pharmaceutical Alliance Agreements

• Intellectual property and joint-invention rights allocation
• Reach-through royalties
• Deal structures
• Dispute resolution

4. New Technology and Product Valuation and Licensing

• Criteria for valuating new technologies
• Technology licenses:terms and issues, fees and royalties
• Tactics for negotiating the licensing deal • Approaches for identifying technology licensees • Technology-transfer models

5. Web-Based Technology Licensing and Electronic Contracting

• How to identify/market licensable tech-nologies via the Web
• XML (extensible markup language) for searching keywords
• Online contracting, negotiating and con-tract- tracking

6. Aspects of Platform Technology Collaborations

• Opportunities for platform technology companies
• Nonexclusive deals
• Exclusive collaborations
• Semi-exclusive deals and consortia

7. Equity-Based Partnerships

• Sources of funding for biotechnology companies
• Advantages/disadvantages of equity partnerships
• Structuring equity investments
• Using options, warrants and 'puts' Alliance Management

8. Pharmaceutical/Biotech Alliances: Lessons Learned from the Computer Industry

• Pros and cons of alternative business relationships
• Strategic relationship development
• Allying with competitors

9. Development and Management of Pharmaceutical/Biotech Alliances

• The need for R&D alliances; identifying partners
• Advantages and disadvantages of alliances
• Key requirements of alliances
• Types of partnerships
• Planning and executing an R&D joint venture

10. The Role of the Alliance Manager

• Management systems for alliances
• Monitoring performance/productivity
• Capabilities of the successful alliance manager

11. Implementing Healthy Strategic Alliances

• Building internal resource networks
• Institutionalizing trust into the relationship
• Mapping expectations/resolving conflict

12. Virtual Management of R&D Alliances

• Internet-based tools for managing external relationships
• Collaborative work space for managing outsourced projects
• Deal space for negotiating agreements and establishing partnerships

13. Managing a Large Number of Alliances

• The rationale for business alliances
• Creating a 'best practice'approach to alliance management
• Creating an office of alliance manage-ment
• Preventing alliance failures

14. Multifunctional Alliance Management Teams

• Organizational models for alliance man-agement
• Building alliance management into the contract
• Alliance management structures Consortium Approaches and Government Support

15. The SNP Consortium

• The consortium approach to create a high-quality SNP map for the public domain
• Project management and quality control
• Accelerated progress in identifying and mapping SNPs

16. The Consortium as a Financial and Business Model

• A new approach to research financing
• Management of confidentiality
• Contractual parameters

17. Managing Multiparty Alliances

• Success/failure of multiparty consortia in other industries
• Multiparty consortia in biotechnology
• Key elements of successful consortia
• Multiparty rights allocation

18. Using FDA Databases and Computational Models in Regulatory and R&D Decision-Making

• The FDA-CDER as a unique source of scientific information
• FDA's role in industry support
• Collaborative R&D agreement (CRADA) with Multicase

19. Enabling High-Risk R&D Alliances: The Advanced Technology Program

• Overview of the Advanced Technology Program (ATP)
• ATP investment levels in new technology development

• ATP eligibility and the application process

• Managing ATP-funded alliances
• ATP funding for biotechnology Collaborations with Academia

20. Successful Collaboration with Universities

• The necessity of a bottom-up approach
• Managing invention disclosures and patent applications
• Insights for negotiating with universities
• Nonexclusive licenses for key inventions Case Studies

21. The Bayer/Millennium Alliance: Beyond Win-Win

• Millennium's vision
• Strategic alliances as a financing engine
• Transforming alliances
• Industrialization to maximize value

22. Triangle Pharmaceuticals'/Abbott Laboratories' Strategic Portfolio Alliance

• Step-by-step analysis and lessons learned
• Portfolio deal to increase R&D efficiency
• Identification and resolution of conflicts
• Mutual flexibility as a management strate-gy

23. Vertex Pharmaceuticals'Alliances: Drug Families and Applications Targeted

• Partnerships to maximize downstream value
• Seizing the chemogenomics opportunity
• Vertex/Novartis: one of the largest bio/pharma collaborations

24. The Bayer/CuraGen Alliance: Two Landmark Agreements

• Obesity/diabetes alliance
• Pharmacogenomic and toxicogenomic col-laboration

25. Sequenom's Collaborations: Successful Licensing of a Platform Technology

• Use of company's SNP technology in the human genome project
• Sequenom/NCI:Largest SNP assay proj-ect to date
• Validation of Incyte Genomics'gene database

26. Wall Street's View of Biotechnology and Pharmaceutical Partnerships

• Wall Street's parameters
• The ideal deal
• Wall Street's favorite partner candidates
• The current biotechnology market environ-ment
• Evolving partnerships goals
• Case studies
• Pitfalls to avoid