Clinical Stage Partnering Agreements in Biopharma

Publication Date	June 2008
Publisher	CurrentPartnering
Product Type	Report
Pages	440
ISBN Number	not applicable
Product Code	CTP00054

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Summary

The Clinical Stage Partnering Agreements in Biopharma report provides comprehensive understanding and unprecedented access to the clinical stage agreements entered into by the worlds leading biopharma companies.

The report provides a detailed understand and analysis of how and why companies enter clinical stage partnering deals.

Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

This report contains over 1000 links to online copies of actual clinical stage contract documents as submitted to the Securities Exchange Commission by biopharma companies and their partners.

Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal.

The initial chapters of this report provide an orientation of clinical stage dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in clinical stage partnering as well as a discussion on the merits and attributes of dealmaking at each stage of clinical development.

Chapter 3 provides an overview of the structure of clinical stage partnering deal contracts. The chapter includes numerous case studies to enable understanding of both pure deals and multicomponent clinical stage partnering deals.

Chapters 4, 5 and 6 provide a review of the leading phase I, II and III clinical stage partnering deals since 2000, respectively. Deals are listed by headline value, signed by bigpharma, most active bigpharma, and most active of all biopharma companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

Chapter 7 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of clinical stage contract documents available in the public domain. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapters 8, 9 and 10 provide a comprehensive listing of all phase I, II and III clinical stage agreement contracts since 2003 available in the public domain, respectively. Each chapter is organized by A-Z, therapeutic area, and deal type. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in clinical stage dealmaking since 2000.

In conclusion, this report provides everything a prospective dealmaker needs to know about clinical stage partnering, enabling thorough learning, education and due diligence prior and during the clinical stage dealmaking process.

Key benefits

Clinical Stage Partnering Agreements in Biopharma provides the reader with the following key benefits:

In-depth understanding of clinical stage partnering deal trends since 2000
Analysis of the structure of clinical stage partnering agreements with numerous real life case studies
Comprehensive access to over 1200 actual clinical stage partnering contracts entered into by the world's biopharma companies*
Detailed access to actual clinical stage partnering contracts enter into by the leading fifty bigpharma companies*
Insight into the terms included in a clinical stage partnering agreement, together with real world clause examples
Understand the key deal terms companies have agreed in previous deals
Undertake due diligence to assess suitability of your proposed deal terms for partner companies
Subject to being published via regulatory requirements of the Securities Exchange Commission.

Report scope

Clinical Stage Partnering Agreements in Biopharma is intended to provide the reader with an in-depth understanding of the clinical stage partnering trends and structure of deals entered into by leading biopharma companies worldwide.

Clinical Stage Partnering Agreements in Biopharma includes:

Trends in clinical stage partnering dealmaking in the biopharma industry since 2000
Analysis of clinical stage partnering deal structure
Case studies of real-life clinical stage partnering deals
Access to over 1200 clinical stage partnering contract documents
The leading clinical stage partnering deals by value since 2000
Most active clinical stage partnering dealmakers since 2000
The leading clinical stage partnering resources

In Clinical Stage Partnering Agreements in Biopharma, the available contracts are listed by:

A-Z
Headline value
Stage of development at signing (phase I, phase II and phase III)
Therapeutic area
Deal type

The Clinical Stage Partnering Agreements in Biopharma report provides comprehensive access to available contract documents for over 1200 clinical stage partnering deals. Analyzing actual contract agreements allows assessment of the following:

What are the precise rights granted or optioned?
What is actually granted by the agreement to the partner company?
What exclusivity is granted?
What is the payment structure for the deal?
How do milestone align with clinical stage development phases?
How are sales and payments audited?
What is the deal term?
How are the key terms of the agreement defined?
How are IPRs handled and owned?
Who is responsible for commercialization?
Who is responsible for development, supply, and manufacture?
How is confidentiality and publication managed?
How are disputes to be resolved?
Under what conditions can the deal be terminated?
What happens when there is a change of ownership?
What sublicensing and subcontracting provisions have been agreed?
Which boilerplate clauses does the company insist upon?
Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
Which jurisdiction does the company insist upon for agreement law?

Content

Executive Summary
Chapter 1 - Introduction
Chapter 2 - Trends in clinical stage dealmaking
- 2.1. Introduction
- 2.2. Difference between phase I, II and III stage deals
  - 2.2.1. Trends in clinical stage deals
- 2.3. Trends in phase I deals since 2000
  - 2.3.1. Attributes of phase I deals
- 2.4. Trends in phase II deals since 2000
  - 2.4.1. Attributes of phase II deals
- 2.5. Trends in phase III deals since 2000
  - 2.5.1. Attributes of phase III deals
- 2.6. Reasons for entering into clinical stage partnering deals
  - 2.6.1. Licensors reasons for entering clinical stage deals
  - 2.6.2. Licensees reasons for entering clinical stage deals
- 2.7. The future of clinical stage partnering deals
Chapter 3 - Overview of clinical stage deal structure
- 3.1. Introduction
- 3.2. Pure versus multi-component partnering deals
- 3.3. Pure licensing agreement structure
  - 3.3.1. Example pure licensing agreements
  - 3.3.1.a. Case study 1: Coley Pharmaceutical - Dynavax Technologies - June 2007
  - 3.3.1.b. Case study 2: Bristol-Myers Squibb - Pharmacopeia - October 2007
- 3.4. Multicomponent clinical stage partnering agreements
  - 3.4.1. Example multicomponent clinical stage clauses
  - 3.4.1.a. Case study 3: Idera - Merck KGaA - December 2007
Chapter 4 - Leading phase I clinical stage deals
- 4.1. Introduction
- 4.2. Top phase I clinical stage deals by value
- 4.3. Top phase I clinical stage deals signed by bigpharma
- 4.4. Most active phase I clinical stage dealmakers
- 4.5. Bigpharma phase I clinical stage deal activity
Chapter 5 - Leading phase II clinical stage deals
- 5.1. Introduction
- 5.2. Top phase II clinical stage deals by value 70
- 5.3. Top phase II clinical stage deals signed by bigpharma
- 5.4. Most active phase II clinical stage dealmakers
- 5.5. Bigpharma phase II clinical stage deal activity
Chapter 6 - Leading phase III clinical stage deals
- 6.1. Introduction
- 6.2. Top phase III clinical stage deals by value
- 6.3. Top phase III clinical stage deals signed by bigpharma
- 6.4. Most active phase III clinical stage dealmakers
- 6.5. Bigpharma phase III clinical stage deal activity
Chapter 7 - Bigpharma clinical stage partnering agreements
- 7.1. Introduction
- 7.2. How to use clinical stage partnering agreements
- 7.3. Company clinical stage partnering agreement listings
  - Abbott
  - Actavis
  - Akzo Nobel
  - Alcon Labs
  - Allergan
  - Altana
  - Amgen
  - Astellas
  - AstraZeneca
  - Baxter International
  - Bayer
  - Bayer Schering Pharma AG
  - Biogen Idec
  - Boehringer Ingelheim
  - Bristol-Myers Squibb
  - Chugai
  - CSL
  - Dainippon Sumitomo
  - Eisai
  - Eli Lilly
  - Forest Laboratories
  - Genentech
  - Genzyme
  - Gilead Sciences
  - GlaxoSmithKline
  - Johnson & Johnson
  - King
  - Lundbeck
  - Menarini
  - Merck & Co
  - Merck - Serono KGaA
  - Mitsubishi
  - Novartis AG
  - Novo Nordisk
  - Nycomed Pharma
  - Otsuka
  - Pfizer
  - Procter & Gamble
  - Roche
  - Sanofi-Aventis
  - Schering Plough
  - Serono
  - Shionogi Seiyaku
  - Shire
  - Takeda
  - Tanabe Seiyaku
  - TAP Pharmaceuticals
  - Teva
  - UCB
  - Watson
  - Wyeth
Chapter 8 - Phase I partnering agreement directory 2003-early 2008
- 8.1. Introduction
- 8.2. Company A-Z
- 8.3. By therapy area
  - Accident/Hospital/Trauma
  - Blood/Lymphatic System
  - Cardiovascular
  - Central nervous System
  - Dermatology
  - Gastrointestinal
  - Genetic
  - Genitourinary
  - Autoimmune/Inflammatory
  - Infection
  - Metabolism
  - Musculoskeletal
  - Oncology
  - Respiratory
  - Sensory Organ / Oral Health
  - Delivery
- 8.4. By deal type
  - Collaborative R&D
  - Co-development
  - Co-marketing
  - Co-promotion
  - Development
  - Distribution
  - Joint venture
  - Licensing
  - M&A
  - Manufacturing
  - Marketing
  - Promotion
  - Research
  - Supply
Chapter 9 - Phase II partnering agreement directory 2003-early 2008
- 9.1. Introduction
- 9.2. Company A-Z
- 9.3. By therapy area
  - Accident/Hospital/Trauma
  - Blood/Lymphatic System
  - Cardiovascular
  - Central nervous System
  - Dermatology
  - Gastrointestinal
  - Genetic
  - Genitourinary
  - Autoimmune/Inflammatory
  - Infection
  - Metabolism
  - Musculoskeletal
  - Oncology
  - Respiratory
  - Sensory Organ / Oral Health
  - Delivery
- 9.4. By deal type
  - Collaborative R&D
  - Co-development
  - Co-marketing
  - Co-promotion
  - Development
  - Distribution
  - Joint venture
  - Licensing
  - M&A
  - Manufacturing
  - Marketing
  - Promotion
  - Research
  - Supply
Chapter 10 - Phase III agreement directory 2003-early 2008
- 10.1. Introduction
- 10.2. Company A-Z
- 10.3. By therapy area
  - Accident/Hospital/Trauma
  - Blood/Lymphatic System
  - Cardiovascular
  - Central nervous System
  - Dermatology
  - Gastrointestinal
  - Genetic
  - Genitourinary
  - Autoimmune/Inflammatory
  - Infection
  - Metabolism
  - Musculoskeletal
  - Oncology
  - Respiratory
  - Sensory Organ / Oral Health
  - Delivery
- 10.4. By deal type
  - Collaborative R&D
  - Co-development
  - Co-marketing
  - Co-promotion
  - Development
  - Distribution
  - Joint venture
  - Licensing
  - M&A
  - Manufacturing
  - Marketing
  - Promotion
  - Research
  - Supply
Appendices
- Appendix 1 - Clinical stage partnering references
- Appendix 2 - Resources
- Appendix 3 - Deal type definitions
- Appendix 3 - Deal type definitions
- Appendix 4 - Example clinical stage partnering contract
About CurrentPartnering
Table of figures
- Figure 1: Definition of clinical phases in dealmaking
- Figure 2: Trends in clinical stage deal announcements, 2000-2007
- Figure 3: Trends in phase I deal announcements, 2000-2007
- Figure 4: Trends in phase II deal announcements, 2000-2007
- Figure 5: Trends in phase III deal announcements, 2000-2007
- Figure 6: Components of the pure licensing deal structure
- Figure 7: Top phase I clinical stage deals by value since 2003
- Figure 8: Bigpharma - top 50 - phase I clinical stage deals since 2003
- Figure 9: Most active phase I clinical stage dealmakers 2003-early 2008
- Figure 10: Bigpharma - top 50 - phase I clinical stage deals since 2003
- Figure 11: Top phase II clinical stage deals by value since 2003
- Figure 12: Bigpharma - top 50 - phase II clinical stage deals since 2003
- Figure 13: Most active phase II clinical stage dealmakers 2003-early 2008
- Figure 14: Bigpharma - top 50 - phase II clinical stage deals since 2003
- Figure 15: Top phase III clinical stage deals by value since 2003
- Figure 16: Bigpharma - top 50 - phase III clinical stage deals since 2003
- Figure 17: Most active phase III clinical stage dealmakers 2003-early 2008
- Figure 18: Bigpharma - top 50 - phase III deals since 2003
- Figure 19: Online partnering resources
- Figure 20: Deal type definitions
- Figure 21: Partnering agreement between Alfacell and Par - Jan 2008