Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016

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Date: 01-Oct-2016
No. of pages: 1000
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The Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016 report provides a detailed understanding and analysis of how and why companies enter clinical stage partnering deals and provides details of the latest clinical agreements announced in the healthcare sector.

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 a comprehensive listing of over 2,000 clinical stage partnering deals announced since 2010 including financial terms where available including numerous links to online deal records of actual clinical partnering deals as disclosed by the deal parties. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners.

The initial chapters of this report provide an orientation of 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 clinical stage compounds/products.

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

Chapter 5 provides a review of clinical stage deal making since 2010. Deals activity is reviewed by year, stage of development at signing, therapeutic area, technology type, as well as most active dealmakers.

Chapter 6 provides a detailed analysis of clinical stage payment terms including headline, upfront, milestone and royalty rates for phase I, phase II and phase III deals.

Chapter 7 provides a review of the leading clinical stage deal by headline value. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 8 provides a comprehensive listing of the top 50 most active clinical stage dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 9 provides a comprehensive and detailed review of clinical stage partnering deals signed and announced since 2010, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of clinical stage partnering deals since 2010 organized by stage of development - phase I, phase II and phase III.

The report includes deals announced by hundreds of life science companies including big pharma such as Abbott, Abbvie, Actavis, Amgen, Astellas, AstraZeneca, Baxter, Bayer, Biogen Idec, BMS, Celgene, Eisai, Eli Lilly, Gilead, GSK, J&J, Kyowa Hakko, Merck, Mitsubishi, Mylan, Novartis, Pfizer, Roche, Sanofi, Shire, Takeda, Teva, and Valeant, amongst many others.

The report also includes numerous tables and figures that illustrate the trends and activities in clinical stage partnering and deal making since 2010.

In addition, a comprehensive appendix of all clinical stage deals since 2010 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 clinical stage products and compounds.

Key benefits

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016 provides the reader with the following key benefits:

In-depth understanding of clinical stage deal trends since 2010

Access to headline, upfront, milestone and royalty data

Analysis of the structure of clinical stage agreements with numerous real life case studies

Insight into the terms included in a 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

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016 is intended to provide the reader with an in-depth understanding and access to clinical stage deal trends and structure of deals entered into by leading companies worldwide.

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016 includes:

Trends in clinical stage dealmaking in the biopharma industry since 2010

Analysis of clinical stage deal structure

Access to headline, upfront, milestone and royalty data

Case studies of real-life clinical stage deals

Access to over 2,000 clinical stage deals

The leading clinical stage deals by value since 2010

Most active clinical stage dealmakers since 2010

The leading clinical stage partnering resources

In Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016, 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 Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010- 2016 report provides comprehensive access to available deals and contract documents for over 2,000 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?

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do companies partner clinical stage compounds?
2.1. Introduction
2.2. The role of clinical stage partnering
2.2.1. In-licensing at clinical stage
2.2.2. Out-licensing at clinical stage
2.3. Difference between phase I, II and III stage deals
2.4. Reasons for entering into clinical stage partnering deals
2.4.1. Licensors reasons for entering clinical stage deals
2.4.2. Licensees reasons for entering clinical stage deals
2.5. The future of clinical stage partnering deals

Chapter 3 - 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: Incyte - Agenus Bio
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: Servier - GeNeuro
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 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 : Argos Therapeutics - Medinet
3.6.1.b. Case study : Pfizer - GlycoMimetics
3.7. Multicomponent clinical stage partnering agreements
3.7.1. Example multicomponent clinical stage clauses
3.7.1.a. Case study: Gilead Sciences - GlobeImmune

Chapter 4 - Clinical stage partnering payment strategies
4.1. Introduction
4.2. 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. R&D 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 clinical stage deal making
5.1. Introduction
5.2. Clinical stage partnering over the years
5.2.1. Trends in phase I deals since 2010
5.2.1.1. Attributes of phase I deals
5.2.2. Trends in phase II deals since 2010
5.2.2.2. Attributes of phase II deals
5.2.3. Trends in phase III deals since 2010
5.2.3.1. Attributes of phase III deals
5.3. Clinical stage partnering by deal type
5.4. Clinical stage partnering by disease type
5.5. Partnering by clinical stage technology type
5.6. Clinical stage partnering by most active company, 2010 to 2016

Chapter 6 - Payment terms for clinical stage partnering
6.1. Introduction
6.2. Guidelines for clinical stage payment terms
6.2.1. Upfront payments
6.2.2. Milestone payments
6.2.3. Royalty payments
6.3. Clinical stage payment terms - deal data analysis
6.3.1. Public data
6.3.2. Survey data
6.4. Payment terms analysis
6.4.1. Clinical stage partnering headline values
6.4.2. Clinical stage deal upfront payments
6.4.3. Clinical stage deal milestone payments
6.4.4. Clinical stage royalty rates
6.5 Clinical stage median financials
6.5.1. Clinical stage headline value
6.5.2. Clinical stage upfront value
6.5.3. Clinical stage milestone value
6.5.4. Clinical stage royalty value

Chapter 7 - Leading clinical stage deals
7.1. Introduction
7.2. Top clinical stage deals by value

Chapter 8 - Top 50 most active clinical stage dealmakers
8.1. Introduction
8.2. Top 50 most active clinical stage dealmakers

Chapter 9 - Clinical stage partnering contracts directory
9.1. Introduction
9.2. Clinical stage deals with contracts 2010 to 2016

Chapter 10 - Clinical stage deal making by development stage
10.1. Introduction
10.2. Deals by clinical stage
Phase I
Phase II
Phase III
Regulatory
Formulation

Appendices
Appendix 1 - Clinical stage dealmaking by companies A-Z
Appendix 2 - Clinical stage dealmaking by industry sector
Appendix 3 - Clinical stage dealmaking by stage of development
Appendix 4 - Clinical stage dealmaking by therapy area
Appendix 5 - Clinical stage dealmaking by technology type
About Wildwood Ventures
Current Partnering
Current Agreements
Recent report titles from Current Partnering

List of Figures

Figure 1: Definition of clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2010- 2016), % of all deals
Figure 3: Components of the pure licensing deal structure
Figure 4: Payment options for clinical stage partnering deals
Figure 5: Issues affecting royalty rates
Figure 6: Clinical stage partnering frequency 2010- 2016
Figure 7: Phase I clinical stage partnering since 2010
Figure 8: Phase II clinical stage partnering since 2010
Figure 9: Phase III clinical stage partnering since 2010
Figure 10: Clinical stage partnering by deal type since 2010
Figure 11: Clinical stage partnering by disease type since 2010 80
Figure 12: Clinical stage partnering by technology type since 2010
Figure 13: Top 50 most active clinical stage dealmakers, 2010 to 2016
Figure 14: Review of upfront payments for clinical stage deals
Figure 15: Review of milestone payments for clinical stage deals
Figure 16: Review of royalty payments for clinical stage deals
Figure 17: Clinical stage deals with a headline value
Figure 18: Clinical stage deals with an upfront value
Figure 19: Clinical stage deals with a milestone value
Figure 20: Clinical stage deals with a royalty rate value
Figure 21: Summary median headline value by clinical stage of development, 2010-2016
Figure 22: Summary median upfront payments by clinical stage of development, 2010-2016
Figure 23: Summary median milestone payments by stage of development, 2010-2016
Figure 24: Summary median royalty rate by stage of development, 2010-2016
Figure 25: Top clinical stage deals by value since 2010
Figure 26: Most active clinical stage dealmakers 2010 to 2016
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