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Clinical Stage Partnering Terms and Agreements in Pharma and Biotech, 2nd Edition


Description: The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 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. In addition a review of deal terms including upfront, milestone and royalty rates is provided. 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 1500 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. In addition, the chapter provides review of deal terms including upfront, milestone and royalty rates, as identified in our deal tracking database.

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 company AZ, 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.

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 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
- Partnering deal terms including average upfront, milestone and royalty payments
- Comprehensive access to over 1500 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

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 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 Terms and Agreements in Pharma and Biotech 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
- Partnering deal terms including average upfront, milestone and royalty payments
- Access to over 1500 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 Terms and Agreements in Pharma and Biotech, the available contracts are listed by:

- Company A-Z
- Headline value
- Stage of development at signing (phase I, phase II and phase III)
- Therapeutic area
- 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 Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive access to available contract documents for over 1500 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?


Contents: 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
2.2.2. Upfront payments in clinical stage deals
2.2.3. Equity payments in clinical stage deals
2.2.4. Milestone payments in clinical stage deals
2.2.5. Royalty payments in clinical stage deals
2.3. Trends in phase I deals since 2000
2.3.1. Attributes of phase I deals
2.3.2. Average phase I deal terms
2.3.2.1. Upfront payments
2.3.2.2. Milestone payments
2.3.2.3. Royalties
2.4. Trends in phase II deals since 2000
2.4.1. Attributes of phase II deals
2.4.2. Average phase II deal terms
2.4.2.1. Upfront payments
2.4.2.2. Milestone payments
2.4.2.3. Royalties
2.5. Trends in phase III deals since 2000
2.5.1. Attributes of phase III deals
2.5.2. Average phase III deal terms
2.5.2.1. Upfront payments
2.5.2.2. Milestone payments
2.5.2.3. Royalties
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
- Alcon Labs
- Allergan
- Amgen
- Astellas
- AstraZeneca
- Baxter
- Bayer
- Biogen Idec
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Cephalon
- Chugai
- CSL
- Daiichi Sankyo
- Dainippon Sumitomo
- Eisai
- Eli Lilly
- Forest Laboratories
- Genentech
- Genzyme
- Gilead Sciences
- GlaxoSmithKline
- Hospira
- Johnson & Johnson
- Lundbeck
- Menarini
- Merck & Co
- Merck Serono
- Mitsubishi Tanabe
- Novartis
- Novo Nordisk
- Nycomed
- Otsuka
- Pfizer
- Procter & Gamble
- Roche
- Sanofi-Aventis
- Schering Plough
- Servier
- Shire
- Solvay
- Takeda
- Teva
- UCB
- Watson
- Wyeth

Chapter 8 – Phase I partnering agreement directory 2003-early 2010
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 2010
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 2010
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

Table of Figures:
Figure 1: Definition of clinical phases in dealmaking
Figure 2: Trends in clinical stage deal announcements, 2000-2009
Figure 3: Upfront payments for clinical stage deals 2000-2009
Figure 4: Equity payments for clinical stage deals 2000-2009
Figure 5: Milestone payments for clinical stage deals 2000-2009
Figure 6: Royalty payments for clinical stage deals 2000-2009
Figure 7: Trends in phase I deal announcements, 2000-2009
Figure 8: Trends in phase II deal announcements, 2000-2009
Figure 9: Trends in phase III deal announcements, 2000-2009
Figure 10: Components of the pure licensing deal structure
Figure 11: Top phase I clinical stage deals by value since 2003
Figure 12: Bigpharma – top 50 – phase I clinical stage deals since 2003
Figure 13: Most active phase I clinical stage dealmakers 2003-2009
Figure 14: Bigpharma – top 50 – phase I clinical stage deals since 2003
Figure 15: Top phase II clinical stage deals by value since 2003
Figure 16: Bigpharma – top 50 – phase II clinical stage deals since 2003
Figure 17: Most active phase II clinical stage dealmakers 2003-2009
Figure 18: Bigpharma – top 50 – phase II clinical stage deals since 2003
Figure 19: Top phase III clinical stage deals by value since 2003
Figure 20: Bigpharma – top 50 – phase III clinical stage deals since 2003
Figure 21: Most active phase III clinical stage dealmakers 2003-2009
Figure 22: Bigpharma – top 50 – phase III deals since 2003
Figure 23: Online partnering resources
Figure 24: Deal type definitions
Figure 25: Partnering agreement between Achillion Pharmaceuticals and GCA Therapeutics dated March 2010


Companies Mentioned - Abbott - Actavis - Alcon Labs - Allergan - Amgen - Astellas - AstraZeneca - Baxter - Bayer - Biogen Idec - Boehringer Ingelheim - Bristol-Myers Squibb - Cephalon - Chugai - CSL - Daiichi Sankyo - Dainippon Sumitomo - Eisai - Eli Lilly - Forest Laboratories - Genentech - Genzyme - Gilead Sciences - GlaxoSmithKline - Hospira - Johnson & Johnson - Lundbeck - Menarini - Merck & Co - Merck Serono - Mitsubishi Tanabe - Novartis - Novo Nordisk - Nycomed - Otsuka - Pfizer - Procter & Gamble - Roche - Sanofi-Aventis - Schering Plough - Servier - Shire - Solvay - Takeda - Teva - UCB - Watson - Wyeth


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