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Clinical Stage Partnering Terms and Agreements in Pharma and Biotech

  • ID: 2520312
  • March 2015
  • Region: Global
  • 2084 Pages
  • CurrentPartnering

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the 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 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 2,000 links to online copies of actual clinical stage deals and contract documents as submitted to the READ MORE >

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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. Big pharma clinical stage dealmaking activity
5.4. Big biotech clinical stage dealmaking activity
5.5. Clinical stage partnering by deal type
5.6. Clinical stage partnering by disease type
5.7. Partnering by clinical stage technology type

Chapter 6 – Average 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 headline values
Phase I
Phase II
Phase III
Figure 21: Summary median headline value by clinical stage of development, 2010-2015
6.4.2. Clinical stage upfront payments
Phase I
Phase II
Phase III
Figure 23: Summary median upfront payments by clinical stage of development, 2010-2015
6.4.3. Clinical stage milestone payments
Phase I
Phase II
Phase III
6.4.4. Clinical stage royalty rates
Phase I
Phase II
Phase III

Chapter 7 – Leading clinical stage deals

7.1. Introduction
7.2. Top clinical stage deals by value

Chapter 8 – Big pharma and big biotech clinical stage partnering deals

8.1. Introduction
8.2. How to use big pharma/big biotech clinical stage partnering deals
8.3. Big pharma clinical stage partnering company profiles
8.4. Big biotech clinical stage partnering company profiles

Chapter 9 – Clinical stage partnering contracts directory

9.1. Introduction
9.2. Clinical stage contracts deals directory by company A-Z
9.3. Clinical stage contracts deals directory by deal type
9.4. Clinical stage contracts deals directory by stage of development
9.5. Clinical stage contracts deals directory by therapy area

Chapter 10 – Clinical stage dealmaking by development stage

10.1. Introduction
10.2. Deals by clinical stage
10.2.1. Phase I deals
10.2.2. Phase II deals
10.2.3. Phase III deals

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View the accompanying volume for:
Appendices
Introduction
Appendix 1 – Directory of clinical stage deals by company A-Z 2010-2015
Appendix 2 – Directory of clinical stage deals by deal type 2010-2015
Appendix 3 – Directory of clinical stage deals by therapy area 2010-2015
Appendix 4 – Partnering resource center
Online partnering
Partnering events
Further reading on dealmaking

Table of figures

Figure 1: Definition of clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2010-2015), % 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 2010-2015
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: Big pharma – top 50 – clinical stage deals 2010 to 2015
Figure 11: Big pharma clinical stage deal frequency – 2010 to 2015
Figure 12: Big biotech – top 50 – clinical stage deals 2010 to 2015
Figure 13: Big biotech clinical stage deal frequency – 2010 to 2015
Figure 14: Clinical stage partnering by deal type since 2010
Figure 15: Clinical stage partnering by disease type since 2010
Figure 16: Clinical stage partnering by technology type since 2010
Figure 17: Review of upfront payments for clinical stage deals 2010-2015, US$m
Figure 18: Review of milestone payments for clinical stage deals 2010-2015, median US$m
Figure 19: Review of royalty payments for clinical stage deals 2010-2015, median%
Figure 20: Clinical stage deals with a headline value
Figure 21: Summary median headline value by clinical stage of development, 2010-2015
Figure 22: Clinical stage deals with upfront payment values
Figure 23: Summary median upfront payments by clinical stage of development, 2010-2015
Figure 24: Clinical stage deals with milestone payments
Figure 25: Summary median milestone payments by stage of development, 2010-2015
Figure 26: Clinical stage deals with royalty rates, %
Figure 27: Summary median royalty rate by stage of development, 2010-2015
Figure 28: Top clinical stage deals by value since 2010

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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