The Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the discovery, preclinical and clinical stage partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter discovery, preclinical and clinical stage partnering deals. The majority of deals are where the licensee obtains a right or an option right to license the licensors product or compound. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

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 do not.

This report contains over 8,000 links to online copies of actual discovery, preclinical and clinical stage deals and contract documents as submitted to the Securities Exchange Commission by 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 discovery, preclinical and clinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner discovery, preclinical and clinical stage compounds/products.

Chapter 3 provides an overview of discovery, preclinical and clinical stage deals strategy and deal structure including numerous case studies. Chapter 4 provides an overview of the various payment strategies used in discovery, preclinical and clinical stage deals.

Chapters 5 to 7 provide a review of discovery, preclinical and clinical stage deal making since 2009. 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 8 provides a detailed analysis of discovery, preclinical and clinical stage payment terms including average headline, upfront, milestone and royalty rates for discovery deals.

Chapter 9 provides a review of the leading discovery, preclinical and clinical stage deal by headline value.

Chapter 10 provides a comprehensive listing of the top 50 big pharma and big biotech companies with a brief summary followed by a comprehensive listing of discovery, preclinical and clinical stage deals, as well as contract documents available in the public domain. Where available, 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 11 to 13 provides a comprehensive and detailed review of discovery, preclinical and clinical stage partnering deals signed and announced since 2009, where a contract document is available in the public domain. The chapter is organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the 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 discovery, preclinical and clinical stage partnering and deal making since 2009.

In addition, a comprehensive appendix is provided organized by partnering company A-Z, deal type, therapy focus and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of discovery, preclinical and clinical stage products and compounds.

Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and Biotech provides the reader with the following key benefits:

•In-depth understanding of discovery, preclinical and clinical stage deal trends since 2009
•Access to headline, upfront, milestone and royalty data
•Analysis of the structure of discovery, preclinical and clinical stage agreements with numerous real life case studies
•Detailed access to actual discovery, preclinical and clinical stage deals entered into by the leading fifty big pharma and big biotech companies
•Insight into the terms included in a discovery, preclinical and clinical stage 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

Report scope

Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements Terms and Agreements in Pharm and Biotech is intended to provide the reader with an in-depth understanding and access to discovery, preclinical and clinical stage deal trends and structure of deals entered into by leading companies worldwide.

Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and Biotech includes:

Trends in discovery, preclinical and clinical stage dealmaking in the biopharma industry since 2009
Analysis of discovery, preclinical and clinical stage deal structure
Access to headline, upfront, milestone and royalty data
Case studies of real-life discovery, preclinical and clinical stage deals
Access to over 8,000 discovery, preclinical and clinical stage deals
The leading discovery, preclinical and clinical stage deals by value since 2009
Most active discovery, preclinical and clinical stage dealmakers since 2009
The leading discovery, preclinical and clinical stage partnering resources

In Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharm and Biotech, the available contracts are listed by:

Company A-Z
Headline value
Stage of development at signing
Deal type
Specific therapy target

Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

The Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and biotech report provides comprehensive access to available deals and contract documents for over 8,000 discovery, preclinical and clinical stage 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 aresalesand 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?

Table Of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do company’s partner discovery, preclinical and clinical stage compounds?

2.1. Introduction
2.2. The role of discovery, preclinical and clinical stage partnering
2.2.1. In-licensing at clinical stage
2.2.2. Out-licensing at discovery stage
2.2.3. Out-licensing at clinical stage
2.3. Difference between discovery, preclinical and clinical stage deals
2.4. Reasons for entering into discovery, preclinical and clinical stage partnering deals
2.4.1. Licensors reasons for entering discovery, preclinical and clinical stage deals
2.4.2. Licensees reasons for entering discovery, preclinical and clinical stage deals
2.5. The future of discovery, preclinical and clinical stage partnering deals

Chapter 3 - Discovery, preclinical and clinical stage deal strategies and structure

3.1. Introduction
3.2. At what stage do companies partner?
3.2.1. Partnering early in pharmaceutical/biotech
3.2.1.1. Discovery and preclinical stage partnering case studies
3.2.1.1.a. Case study: LEO Pharma - 4SC
3.2.1.1.b. Case study: Heptares Therapeutics - Cubist
3.2.1.1.c. Case study: Pfizer - Repligen
3.2.1.1.d. Case study: Janssen Pharmaceutical - Evotec
3.2.2. Partnering later in pharmaceutical/biotech
3.2.2.1. Clinical stage partnering case studies
3.2.2.1.a. Case study: Roche - Genentech - Chiasma
3.2.2.1.b. Case study: Teva - Xenon Pharmaceuticals
3.2.2.1.c. Case study: AstraZeneca - Ardelyx
3.2.2.1.d. Case study: Baxter - Onconova Therapeutics
3.3. Early and later stage partnering - a risk/cost comparison
3.4. What do companies spend on discovery, preclinical and clinical stage partnering?
3.5. Pure versus multi-component partnering deals
3.6. Pure licensing agreement structure
3.6.1. Example pure licensing agreements
3.6.1.a. Case study : Coley Pharmaceutical - Dynavax Technologies
3.6.1.b. Case study : Bristol-Myers Squibb - Pharmacopeia
3.7. Multicomponent partnering agreements
3.7.1. Example multicomponent deal clauses
3.7.1.a. Case study: Idera - Merck KGaA

Chapter 4 - Discovery, preclinical and clinical stage partnering payment strategies

4.1. Introduction
4.2. Discovery, preclinical and clinical stage payment strategies
4.3. Payment options
4.3.1. Headline values
4.3.2. Upfront payments
4.3.2.1. Conditionality of upfront payments
4.3.3. Loans
4.3.4. Convertible loans
4.3.5. Equity
4.3.6. RandD funding
4.3.7. Licensing fees
4.3.8. Milestone payments
4.3.9. Royalty payments
4.3.9.1. Issues affecting royalty rates
4.3.9.2. Royalties on combination products
4.3.9.2.a. Case study: Scripps Research Institute-Cyanotech
4.3.9.3. Guaranteed minimum/maximum annual payments
4.3.9.4. Royalty stacking
4.3.9.5. Royalties and supply/purchase contracts
4.3.10. Quids
4.3.11. Option payments

Chapter 5 - Trends in discovery stage deal making

5.1. Introduction
5.2. Discovery stage partnering over the years
5.2.1. Attributes of discovery deals
5.3. Big pharma discovery stage dealmaking activity
5.4. Big biotech discovery stage dealmaking activity
5.5. Discovery stage partnering by deal type
5.6. Discovery stage partnering by disease type
5.7. Partnering by discovery stage technology type

Chapter 6 - Trends in preclinical stage deal making

6.1. Introduction
6.2. Preclinical stage partnering over the years
6.2.1. Attributes of preclinical deals
6.3. Big pharma preclinical stage dealmaking activity
6.4. Big biotech preclinical stage dealmaking activity
6.5. Preclinical stage partnering by deal type
6.6. Preclinical stage partnering by disease type
6.7. Partnering by preclinical stage technology type

Chapter 7 - Trends in clinical stage deal making

7.1. Introduction
7.2. Clinical stage partnering over the years
7.2.1. Trends in phase I deals since 2009
7.2.1.1. Attributes of phase I deals
7.2.2. Trends in phase II deals since 2009
7.2.2.2. Attributes of phase II deals
7.2.3. Trends in phase III deals since 2009
7.2.3.1. Attributes of phase III deals
7.3. Big pharma clinical stage dealmaking activity
7.4. Big biotech clinical stage dealmaking activity
7.5. Clinical stage partnering by deal type
7.6. Clinical stage partnering by disease type
7.7. Partnering by clinical stage technology type

Chapter 8 - Average payment terms for discovery, preclinical and clinical stage partnering

8.1. Introduction
8.2. Guidelines for discovery, preclinical and clinical stage payment terms
8.2.1. Upfront payments
8.2.2. Milestone payments
8.2.3. Royalty payments
8.3. Discovery, preclinical and clinical stage payment terms - deal data analysis
8.3.1. Public data
8.3.2. Survey data
8.4. Payment terms analysis
8.4.1. Discovery, preclinical and clinical stage headline values
8.4.2. Discovery, preclinical and clinical stage upfront payments
8.4.3. Discovery, preclinical and clinical stage milestone payments
8.4.4. Discovery, preclinical and clinical stage royalty rates

Chapter 9 - Leading discovery, preclinical and clinical stage deals

9.1. Introduction
9.2. Top discovery stage deals by value
9.3. Top preclinical stage deals by value
9.4. Top clinical stage deals by value

Chapter 10 - Big pharma and big biotech discovery, preclinical and clinical stage partnering deals

10.1. Introduction
10.2. How to use big pharma/big biotech partnering deals
10.3. Big pharma discovery, preclinical and clinical stage partnering company profiles
Abbott
Actavis (merged with Watson Pharmaceuticals Oct 2012)
Actelion
Allergan
Amgen
Aspen Pharmacare
Astellas
AstraZeneca
Baxter International
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eli Lilly
Endo Pharmaceuticals
Forest Laboratories
Galderma
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson and Johnson
Kyowa Hakko Kirin
Lundbeck
Menarini
Merck and Co
Merck KGaA
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Purdue
Roche
Sanofi
Servier
Shionogi
Shire
Takeda
Teva
UCB
Valeant
Warner Chilcott
10.4. Big biotech clinical stage partnering company profiles
Acorda Therapeutics
Actelion
Alexion Pharmaceuticals
Alkermes
Alnylam Pharmaceuticals
AMAG Pharmaceuticals
Amgen
Amylin Pharmaceuticals
Anika Therapeutics
Bavarian Nordic
Biocon
BioCryst Pharmaceuticals
Biogen Idec
BioMarin Pharmaceuticals
Biota Holdings
Cangene
Celgene
CSL
Cubist
Elan
Emergent BioSolutions
Enzo Biochem
Enzon Pharmaceuticals
Exelixis
Genmab
Gilead Sciences
Immunomedics
Intermune
Isis Pharmaceuticals
Morphosys
Nektar Therapeutics
NPS Pharmaceuticals
Onyx Pharmaceuticals
PDL BioPharma
Questcor Pharmaceuticals
Regeneron Pharmaceuticals
Roche
SciClone Pharmaceuticals
Seattle Genetics
Spectrum Pharmaceuticals
Targacept
The Medicines Company
UCB
United Therapeutics
Vertex Pharmaceuticals
ViroPharma


Chapter 11 - Discovery stage partnering contracts directory

11.1. Introduction
11.2. Company A-Z
11.3. By deal type
11.4. By stage of development
11.5. By therapy area

Chapter 12 - Preclinical stage partnering contracts directory

12.1. Introduction
12.2. Company A-Z
12.3. By deal type
12.4. By stage of development
12.5. By therapy area

Chapter 13 - Clinical stage partnering contracts directory

13.1. Introduction
13.2. Company A-Z
13.3. By deal type
13.4. By stage of development
13.5. By therapy area

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Appendices

Introduction

Appendix 1 - Directory of discovery stage deals by company A-Z 2009-2014
Appendix 2 - Directory of discovery stage deals by deal type 2009-2014
Appendix 3 - Directory of discovery stage deals by therapy area 2009-2014
Appendix 4 - Directory of preclinical stage deals by company A-Z 2009-2014
Appendix 5 - Directory of preclinical stage deals by deal type 2009-2014
Appendix 6 - Directory of preclinical stage deals by therapy area 2009-2014
Appendix 7 - Directory of clinical stage deals by company A-Z 2009-2014
Appendix 8 - Directory of clinical stage deals by deal type 2009-2014
Appendix 9 - Directory of clinical stage deals by therapy area 2009-2014
Appendix 10 - Partnering resource center

Online partnering
Partnering events
Further reading on dealmaking

Table of figures

Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2009-2014), % of all deals where stage disclosed
Figure 3: Components of the pure licensing deal structure
Figure 4: Payment options for discovery, preclinical and clinical stage partnering deals
Figure 5: Issues affecting royalty rates
Figure 6: Discovery stage partnering frequency 2009-2014
Figure 7: Big pharma - top 50 - discovery stage deals 2009 to 2014
Figure 8: Big pharma discovery stage deal frequency - 2009 to 2014
Figure 9: Big biotech - top 50 - discovery stage deals 2009 to 2014
Figure 10: Big biotech discovery stage deal frequency - 2009 to 2014
Figure 11: Discovery stage partnering by deal type since 2009
Figure 12: Discovery stage partnering by disease type since 2009
Figure 13: Discovery stage partnering by technology type since 2009
Figure 14: Preclinical stage partnering frequency 2009-2014
Figure 15: Big pharma - top 50 - preclinical stage deals 2009 to 2014
Figure 16: Big pharma preclinical stage deal frequency - 2009 to 2014
Figure 17: Big biotech - top 50 - preclinical stage deals 2009 to 2014
Figure 18: Big biotech preclinical stage deal frequency - 2009 to 2014
Figure 19: Preclinical stage partnering by deal type since 2009
Figure 20: Preclinical stage partnering by disease type since 2009
Figure 21: Preclinical stage partnering by technology type since 2007
Figure 22: Clinical stage partnering frequency 2009-2014
Figure 23: Phase I clinical stage partnering since 2009
Figure 24: Phase II clinical stage partnering since 2009
Figure 25: Phase III clinical stage partnering since 2009
Figure 26: Big pharma - top 50 - clinical stage deals 2009 to 2014
Figure 27: Big pharma clinical stage deal frequency - 2009 to 2014
Figure 28: Big biotech - top 50 - clinical stage deals 2009 to 2014
Figure 29: Big biotech clinical stage deal frequency - 2009 to 2014
Figure 30: Clinical stage partnering by deal type since 2009
Figure 31: Clinical stage partnering by disease type since 2004
Figure 32: Clinical stage partnering by technology type since 2009
Figure 33: Review of median upfront payments for discovery, preclinical and clinical stage deals 2009-2014, US$m
Figure 34: Review of median milestone payments for discovery, preclinical and clinical stage deals 2009-2014, US$m
Figure 35: Review of median royalty payments for clinical stage deals 2009-2014, %
Figure 36: Discovery, preclinical and clinical stage deals with a headline value
Figure 37: Discovery stage deal headline value distribution, US$million
Figure 38: Preclinical stage deal headline value distribution, US$million
Figure 39: Phase I clinical stage deal headline value distribution, US$million
Figure 40: Phase II clinical stage deal headline value distribution, US$million
Figure 41: Phase III clinical stage deal headline value distribution, US $million
Figure 42: Summary median headline value by stage of development, 2009-2014
Figure 43: Discovery, preclinical and clinical stage deals with upfront payment values
Figure 44: Discovery stage deal upfront payment distribution, US$million
Figure 45: Preclinical stage deal upfront payment distribution, US$million
Figure 46: Clinical stage deal upfront payment distribution, US$million - phase I stage
Figure 47: Clinical stage deal upfront payment distribution, US$million - phase II stage
Figure 48: Clinical stage deal upfront payment distribution, US$million - phase III stage
Figure 49: Summary median upfront payments by stage of development, 2009-2014
Figure 50: Discovery, preclinical and clinical stage deals with milestone payments
Figure 51: Discovery stage deal milestone distribution, US$million
Figure 52: Preclinical stage deal milestone distribution, US$million
Figure 53: Clinical stage deal milestone distribution, US$million - phase I stage
Figure 54: Clinical stage deal milestone distribution, US$million - phase II stage
Figure 55: Clinical stage deal milestone distribution, US$million - phase III stage
Figure 56: Summary median milestone payments by stage of development, 2009-2014
Figure 57: Discovery, preclinical and clinical stage deals with royalty rates, %
Figure 58: Discovery stage deal royalty rate distribution, US$million
Figure 59: Preclinical stage deal royalty rate distribution, US$million
Figure 60: Clinical stage deal royalty rate distribution, US$million - phase I stage
Figure 61: Clinical stage deal royalty rate distribution, US$million - phase II stage
Figure 62: Clinical stage deal royalty rate distribution, US$million - phase III stage
Figure 63: Summary median royalty rate by stage of development, 2009-2014
Figure 64: Top discovery stage deals by value since 2009
Figure 65: Top preclinical stage deals by value since 2009
Figure 66: Top clinical stage deals by value since 2009

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