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Strategies and Tactics for Successful Partnering 2015

Strategies and Tactics for Successful Partnering 2015

The Strategies and Tactics for Successful Partnering Report: A Guide to Partnering Pharmaceutical and Biotechnology Projects a review of the partnering process which is outlined step by step to those unfamiliar to dealmaking. The report discusses in detail all aspects of partnering including the steps that are involved from identifying the opportunity through to negotiating and signing the deal and beyond; the report provides hands-on advice on how to complete each of these activities.


EXECUTIVE SUMMARY
CHAPTER 1 AN INTRODUCTION TO PARTNERING
1.1 What is Partnering?
1.2 The Partnering Process
1.3 Why Do Companies Partner?
1.4 Types of Partnering Deal
1.5 Who Partners with Whom?
1.6 General Trends in Partnering
CHAPTER 2 WHEN TO PARTNER AND HOW TO FIND THE RIGHT PARTNER
2.1 When to Partner
2.1.1 Project Phase
2.1.2 Project Exclusivity
2.1.3 Internal Issues to be Considered
2.1.4 The Final Decision
2.2 How to Find the Right Partner
2.2.1 Operational Capabilities
2.2.2 Therapeutic Expertise
2.2.3 Target Partner Profile
2.2.4 Cultural Fit
2.2.6 Ideal and Unsuitable Partners
2.3 Partner Identification
2.3.1 Databases
2.3.2 Company Websites
2.3.3 Academic Institutions
2.3.4 General and Industry Press
2.3.5 Regulatory Filings
2.3.6 Personal Contacts
2.3.7 Conferences
2.3.8 Consultants
2.3.9 Internal and External Experts
2.3.10 Unsolicited Approaches
2.3.11 Venture Capitalists
2.4 Conclusion
CHAPTER 3 THE PARTNERING PROCESS
3.1 Sequence of Contacts
3.1.1 Initial Approach to Potential Partners
3.1.2 Non-Confidential Information Sent
3.1.3 Internal Review by Partner
3.1.4 Confidential Disclosure Agreement Signed
3.1.5 Confidential Information Supplied
3.1.6 Due Diligence
3.1.7 Deal Terms Agreed
3.1.8 Contract Negotiated
3.1.9 Alliance Management
3.2 Non-Confidential Information
3.3 Confidential Disclosure Agreement
3.3.1 One-Way or Mutual
3.3.2 Duration
3.3.3 Project Coverage
3.3.4 People Covered
3.3.5 Information Covered
3.3.6 Return of Confidential Information
3.3.7 Public Disclosure
3.4 Confidential Information
3.4.1 Cover Sheet
3.4.2 Summary Overview
3.4.3 Scientific Rationale
3.4.4 Therapeutic Rationale
3.4.5 Chemistry, Manufacturing and Control
3.4.6 Technologies and Drug Delivery Systems
3.4.7 Preclinical Data
3.4.8 Clinical Data
3.4.9 Regulatory Status
3.4.10 Pre-Marketing Activity
3.4.11 Trade Marks
3.4.12 Commercial Rationale
3.4.13 Patents
3.4.14 Future Plans
3.4.15 Licensing/Partnership Opportunity
3.4.16 Disputes
3.4.17 References
3.4.18 Marketed Products
3.5 Corporate Presentation
3.5.1 Company Background
3.5.2 Major Product Summaries
3.5.3 Sales Infrastructure
3.5.4 R&D Overview
3.5.5 Financials
3.5.6 Licensing
3.5.7 Current Agreements
3.5.8 Partnering Strengths
3.6 Managing Your Contacts
CHAPTER 4 DEALING WITH A MAJOR PHARMACEUTICAL COMPANY
4.1 Background
4.1.1 Initial Approach
4.1.2 Making the Right Contact
4.2 The Decision-making Process
4.2.1 Initial Review
4.2.2 Detailed Review
4.2.3 Due Diligence
4.2.4 Valuation
4.2.5 Negotiation
4.2.6 Approval Levels and Committees
4.3 Timings
4.4 Culture
CHAPTER 5 DEALING WITH A SMALL BIOTECHNOLOGY COMPANY
5.1 Background
5.1.1 Initial Approach
5.2 The Decision-Making Process
5.2.1 Initial Review
5.2.2 Detailed Review
5.2.3 Due Diligence
5.2.4 Valuation
5.2.5 Negotiation
5.2.6 Approval Levels
5.3 Timings
5.4 Culture
CHAPTER 6 ESTABLISHING YOUR ORGANISATION AS THE PARTNER OF CHOICE
6.1 Different Partners of Choice for Different Projects
6.2 Characteristics of a Partner of Choice
6.3 Strategic Fit
6.4 Internal Inefficiencies
6.5 The Importance of Alliance Management
6.6 Promoting Your Capabilities
CHAPTER 7 VALUATION
7.1 Combining Valuation Techniques
7.2 Benchmarking
7.2.1 Feasibility
7.2.2 Data Gathering
7.2.3 Refinement of the Valuation
7.3 Expected Net Present Value
7.3.1 Opportunity Cost/Time Value
7.3.2 Risk
7.3.3 Decision Tree Analysis
7.3.4 Sensitivity Analysis
7.3.5 Monte-Carlo Simulation
7.4 Value Distribution
7.4.1 Value of Deal Components
7.4.2 Value Splits
CHAPTER 8 DEAL STRUCTURE
8.1 Evolution of Partnerships
8.2 Licensing Agreements
8.2.1 Simple Licensing Agreements
8.3 Collaborative R&D Agreements
8.4 Evaluation Agreements 8.5 Technology Access Agreements
8.6 Co-marketing and Co-promotion Agreements
8.7 Marketing Agreements
8.8 Product Sale and Purchase Agreements
8.9 Option Agreements
8.9.1 Option to Purchase
8.9.2 Option to License
8.10 Equity Investments
8.11 Alternative Deal Structures
8.11.1 Drug Royalty Companies
8.11.2 Risk Sharing Agreements with Contract Research Organisations
8.11.3 Quids
8.11.4 Joint Ventures
8.12 Conclusion
CHAPTER 9 SECURING THE DEAL
9.1 The Due Diligence Process
9.2 The Elements of Due Diligence
9.3 Providing the Information
9.4 Negotiation
9.5 Preparation Phase
9.6 Negotiation Phase
9.6.1 Negotiating the Term Sheet and the Financial Terms
9.6.2 Negotiation Behaviour
9.7 Outcome Phase
CHAPTER 10 THE DEAL LIFE CYCLE
10.1 Alliance Management
10.2 Process Risk and Performance Risk
10.3 Alliance Life Cycle Model
10.3.1 Negotiation
10.3.2 Formation
10.3.3 Management
10.3.4 Termination
10.4 Alliance Management Structure
10.5 The Role of the Alliance Manager
10.6 Key Factors for Success
10.6.1 Governance
10.6.2 Communication
10.6.3 Alliance Start-Up
10.6.4 Process Integration
10.7 Performance Management in Collaborations
10.8 Conflict Management
10.8.1 Anticipate and Prepare
10.8.2 Intervene Early
10.8.3 Take Appropriate Remedial Action
10.9 Mediation and Arbitration
10.10 Litigation
10.11 Termination Clauses
FIGURES
Figure 1.1 The deal process chain.
Figure 1.2 Rate of development of new drugs
Figure 1.3 Capital raised by biotechnology companies in North America and Europe per year.
Figure 1.4 R&D stage agreements.
Figure 1.5 Product licensing agreements.
Figure 1.6 Joint venture activity, 2010 to 2014
Figure 1.7 Company type combinations involved in dealmaking, 2010 to 2014.
Figure 1.8 Biotech-biotech dealmaking activity, 2010 to 2014.
Figure 1.9 Global-global company dealmaking activity, 2010 to 2014.
Figure 1.10 Number of deals 2010 to 2014 (excluding funding awards).
Figure 2.1 Number of all deals by phase of development for deals from 2005 to 2014.
Figure 2.2 Average total deal values and average upfront payments for product deals by phase of development for deals from 2005 to 2014.
Figure 2.3 Capabilities across the R&D cycle.
Figure 2.4 Key areas for relationship fit.
Figure 2.5 The partner search.
Figure 3.1 Contact sequence.
Figure 7.1 Integrated valuation methods
Figure 7.2 Ideal benchmarking deal cluster.
Figure 7.3 Non-ideal benchmarking deal cluster.
Figure 7.4 Example pharmaceutical deal valuation force field.
Figure 7.5 Attrition by phase and therapeutic area.
Figure 7.6 Pharmaceutical product decision tree.
Figure 7.7 The effect of time and risk on the value of deal components.
Figure 9.1 The term of the working relationship
Figure 9.2 The negotiation team.
Figure 9.3 Negotiation styles.
Figure 10.1 Risks inherent in collaborations.
Figure 10.2 The four phases of the alliance management life cycle.
Figure 10.3 The roles of an alliance manager.
Figure 10.4 Relationship between substantive conflict and interest.
TABLES
Table 1.1 Selected biotech companies raising >US$100 M in 2014.
Table 2.1 Issues to consider when out-licensing and in-licensing a project.
Table 2.2 Checklist of questions to help evaluate in-licensing projects.
Table 2.3 Target Partner Profile.
Table 2.4 Corporate culture issues.
Table 3.1 Contents of a non-confidential document.
Table 6.1 Successful alliance fitness test.
Table 7.1 Overview of benchmarking methodology.
Table 8.1 Reasons a company would out-license or in-license a product.
Table 8.2 The positives and negatives to consider when entering into co-marketing agreements.
Table 8.3 The positives and negatives to consider when entering into co-promotion agreements.
Table 8.4 The positives and negatives to consider when entering into marketing agreements.
Table 8.5 The positives and negatives to consider in option to license deals.
Table 9.1 Key areas for consideration in a due diligence exercise

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