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

  • ID: 2520312
  • May 2016
  • Region: Global
  • 1000 Pages
  • CurrentPartnering
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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.

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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

Table 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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Clinical Stage Partnering Terms and Agreements 2010-2015 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.

- Comprehensive access to over 1,700 clinical stage deals together with contract documents if available.

- Detailed access to actual clinical stage deals entered into by the leading fifty big pharma and big biotech companies along with other biopharma companies.

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

- Identify leading clinical stage deals by value since 2010.

- Identify the most active clinical stage dealmakers since 2010.

- Full listing of clinical stage deals by company A-Z, phase of development, deal type, therapy and technology focus.

- 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.

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