Molecular Diagnostics Partnering Terms and Agreements

Date: October 1, 2014
Pages: 432
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Report type: Strategic Report
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ID: MC43430E255EN
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Molecular Diagnostics Partnering Terms and Agreements
The Molecular Diagnostics Partnering Terms and Agreements report provides a detailed understanding and analysis of how and why companies enter molecular diagnostics partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest molecular diagnostics agreements announced in the healthcare sectors.

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 all molecular diagnostics partnering deals announced since 2009 including financial terms where available including over 300 links to online deal records of actual molecular diagnostics 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.

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.

For example, analyzing actual company deals and agreements allows assessment of the following:
  • What is actually granted by the agreement to the partner company?
  • What exclusivity is granted?
  • What are the precise rights granted or optioned?
  • 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?
  • 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?
The initial chapters of this report provide an orientation of drug dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in molecular diagnostics dealmaking since 2009, including details of average headline, upfront, milestone and royalty terms.

Chapter 3 provides a review of the leading molecular diagnostics deals since 2009. Deals are listed by headline value, signed by big pharma, big biotech, 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 4 provides a comprehensive listing of the top 50 big pharma companies with a brief summary followed by a comprehensive listing of molecular diagnostics 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.

Chapter 5 provides a comprehensive listing of the top 50 big biotech companies with a brief summary followed by a comprehensive listing of molecular diagnostics 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.

Chapter 6 provides a comprehensive and detailed review of molecular diagnostics partnering deals signed and announced since 2009, where a contract document is available in the public domain. The chapter is organized by stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc), specific therapy focus and specific 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.

The report also includes numerous tables and figures that illustrate the trends and activities in molecular diagnostics partnering and dealmaking since 2009.

In addition, a comprehensive appendix is provided organized by molecular diagnostics partnering company A-Z , deal type definitions and molecular diagnostics partnering agreements example. 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 molecular diagnostics partnering in the research, development and commercialization of molecular diagnostics technologies and products.

Report scope

Molecular Diagnostics Partnering Agreements is intended to provide the reader with an in-depth understanding and access to molecular diagnostics trends and structure of deals entered into by leading companies worldwide.

Molecular Diagnostics Partnering Agreements includes:
  • Trends in molecular diagnostics dealmaking in the biopharma industry since 2009
  • Analysis of molecular diagnostics deal structure
  • Access to headline, upfront, milestone and royalty data
  • Access to over 300 molecular diagnostics deal records
  • The leading molecular diagnostics deals by value since 2009
In Molecular Diagnostics Partnering Agreements, the available deals are listed by:
  • Company A-Z
  • Headline value
  • Stage of development at signing
  • Deal component type
  • Specific diagnostics 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.

The Molecular Diagnostics Partnering Agreements report provides comprehensive access to available deals and contract documents for over 300 molecular diagnostics 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?
CHAPTER 1 – INTRODUCTION

CHAPTER 2 – TRENDS IN MOLECULAR DIAGNOSTICS DEALMAKING

2.1. Introduction
2.2. Molecular diagnostics partnering over the years
2.3. Big pharma molecular diagnostics dealmaking activity
2.4. Big biotech molecular diagnostics dealmaking activity
2.5. Most active in molecular diagnostics partnering
2.6. Molecular diagnostics partnering by industry type
2.7. Molecular diagnostics partnering by deal type
2.8. Molecular diagnostics partnering by disease type
2.9. Average deal terms for molecular diagnostics partnering
  2.9.1 Molecular diagnostics headline values
  2.9.2 Molecular diagnostics upfront payments
  2.9.3 Molecular diagnostics milestone payments
  2.9.4 Molecular diagnostics royalty rates
2.10. The anatomy of molecular diagnostics partnering
2.10. The anatomy of a molecular diagnostics deal
2.10.a. Case study 1: TrovaGene – PerkinElmer- April 2013
2.10.b. Case study 2: Diaxonhit – XDx – June 2013

CHAPTER 3 – LEADING MOLECULAR DIAGNOSTICS DEALS

3.1. Introduction
3.2. Top molecular diagnostics deals by value

CHAPTER 4 – BIG PHARMA MOLECULAR DIAGNOSTICS DEALS

4.1. Introduction
4.2. How to use big pharma molecular diagnostics partnering deals
4.3. Big pharma molecular diagnostics partnering company profiles
  Abbott
  Amgen
  Bayer
  Bristol-Myers Squibb
  Daiichi Sankyo
  Eisai
  Gilead Sciences
  GlaxoSmithKline
  Johnson & Johnson
  Merck & Co
  Mylan
  Novartis
  Pfizer
  Roche
  Sanofi
  Takeda
  Teva

CHAPTER 5 – BIG BIOTECH MOLECULAR DIAGNOSTICS DEALS

5.1. Introduction
5.2. How to use big biotech partnering deals
5.3. Big biotech molecular diagnostics partnering company profiles
  BioMarin Pharmaceuticals
  Ipsen
  Pharmacyclics
  Seattle Genetics

CHAPTER 6 – MOLECULAR DIAGNOSTICS PARTNERING CONTRACTS DIRECTORY

6.1. Introduction
6.2. Company A-Z
6.3. By deal type
  Asset purchase
  Collaborative R&D
  Co-market
  Contract service
  Co-promotion
  CRADA
  Development
  Distribution
  Licensing
  Manufacturing
  Marketing
  Option
  Research
  Sub-license
  Supply
  Technology transfer
6.4. By stage of development
  Discovery
  Marketed
  Preclinical
6.5. By therapy area
  Cardiovascular
  Hospital care
  Infectives
  Metabolic
  Oncology

CHAPTER 7 – MOLECULAR DIAGNOSTICS DEALMAKING DIRECTORY

7.1. Introduction
7.2. Deals by molecular diagnostics type, includes theranostics
Appendices
Introduction
Appendix 1 – Directory of molecular diagnostics deals by company A-Z 2009 to 2014
Appendix 2 – Directory of molecular diagnostics deals by stage of development 2009 to 2014
Appendix 3 – Directory of molecular diagnostics deals by deal type 2009 to 2014
Appendix 4 – Directory of molecular diagnostics deals by therapy area 2009 to 2014
Appendix 5 – Molecular diagnostics partnering resource center
Online molecular diagnostics partnering
Molecular Diagnostics partnering events
Further reading on molecular diagnostics dealmaking
About Wildwood Ventures
Current Partnering
Current Agreements
Recent report titles from CurrentPartnering
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TABLE OF FIGURES

Figure 1: Molecular diagnostics partnering since 2009
Figure 2: Big pharma – top 50 – Molecular diagnostics deals 2009 to 2014
Figure 3: Big pharma molecular diagnostics deal frequency – 2009 to 2014
Figure 4: Big biotech – top 50 – Molecular diagnostics deals 2009 to 2014
Figure 5: Big biotech molecular diagnostics deal frequency – 2009 to 2014
Figure 6: Active molecular diagnostics dealmaking activity– 2009 to 2014
Figure 8: Molecular diagnostics partnering by industry sector since 2009
Figure 7: Molecular diagnostics partnering by deal type since 2009
Figure 8: Molecular diagnostics partnering by disease type since 2009
Figure 10: Molecular diagnostics deals with a headline value
Figure 11: Molecular diagnostics deal headline value distribution, US$million – discovery stage
Figure 12: Molecular diagnostics deal headline value distribution, US$million – preclinical stage
Figure 13: Molecular diagnostics deal headline value distribution, US$million – phase I stage
Figure 14: Molecular diagnostics deal headline value distribution, US$million – phase II stage
Figure 15: Molecular diagnostics deal headline value distribution, US$million – phase III stage
Figure 16: Molecular diagnostics deal headline value distribution, US$million – regulatory stage
Figure 17: Molecular diagnostics deal headline value distribution, US$million – marketed stage
Figure 18: Summary median headline value by stage of development, 2009-2014
Figure 19: Molecular diagnostics deals with upfront payment values
Figure 20: Molecular diagnostics deal upfront payment distribution, US$million – discovery stage
Figure 21: Molecular diagnostics deal upfront payment distribution, US$million – preclinical stage
Figure 22: Molecular diagnostics deal upfront payment distribution, US$million – phase I stage
Figure 23: Molecular diagnostics deal upfront payment distribution, US$million – phase II stage
Figure 24: Molecular diagnostics deal upfront payment distribution, US$million – phase III stage
Figure 25: Molecular diagnostics deal upfront payment distribution, US$million – regulatory stage
Figure 26: Molecular diagnostics deal upfront payment distribution, US$million – marketed stage
Figure 27: Summary median upfront payments by stage of development, 2009-2014
Figure 28: Molecular diagnostics deals with milestone payments
Figure 29: Molecular diagnostics deal milestone distribution, US$million – discovery stage
Figure 30: Molecular diagnostics deal milestone distribution, US$million – preclinical stage
Figure 31: Molecular diagnostics deal milestone distribution, US$million – phase I stage
Figure 32: Molecular diagnostics deal milestone distribution, US$million – phase II stage
Figure 33: Molecular diagnostics deal milestone distribution, US$million – phase III stage
Figure 34: Molecular diagnostics deal milestone distribution, US$million – regulatory stage
Figure 35: Molecular diagnostics deal milestone distribution, US$million – marketed stage
Figure 36: Molecular diagnostics deals with royalty rates, %
Figure 37: Molecular diagnostics deal royalty rate distribution, US$million – discovery stage
Figure 38: Molecular diagnostics deal royalty rate distribution, US$million – preclinical stage
Figure 39: Molecular diagnostics deal royalty rate distribution, US$million – phase I stage
Figure 40: Molecular diagnostics deal royalty rate distribution, US$million – phase II stage
Figure 41: Molecular diagnostics deal royalty rate distribution, US$million – phase III stage
Figure 42: Molecular diagnostics deal royalty rate distribution, US$million – regulatory stage
Figure 43: Molecular diagnostics deal royalty rate distribution, US$million – marketed stage
Figure 44: Summary median royalty rate by stage of development, 2009-2014
Figure 45: Components of the typical molecular diagnostics deal structure
Figure 46: Top molecular diagnostics deals by value since 2009
Figure 47: Online partnering resources
Figure 48: Forthcoming partnering events
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