Diagnostics Partnering Terms and Agreements

The Diagnostics Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the diagnostic partnering agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter diagnostic partnering deals. The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors diagnostic technology or product candidates. 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 and databases do not.

This report contains a comprehensive listing of all diagnostics partnering deals announced since January 2007, including financial terms where available, including over 3,000 links to online deal records of actual 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.

The initial chapters of this report provide an orientation of diagnostics dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in diagnostics dealmaking since 2007, including details of average headline, upfront, milestone and royalty terms.

Chapter 3 provides a review of the leading diagnostics deals since 2007. 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 4 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of 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 and detailed review of diagnostics partnering deals signed and announced since January 2007, 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), 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 diagnostics partnering and dealmaking since 2007.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of diagnostics technologies and products.

Report scope

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

Diagnostics Partnering Terms and Agreements includes:

• Trends in diagnostic dealmaking in the biopharma industry since 2007
• Analysis of diagnostic deal structure
• Case studies of real-life diagnostic deals
• Access to over 2,900 diagnostic contract documents
• The leading diagnostic deals by value since 2007
• Most active diagnostic dealmakers since 2007
• The leading diagnostic partnering resources

In Diagnostics Partnering Terms and Agreements , the available contracts are listed by:

• Headline value
• Stage of development at signing
• Deal component type
• Specific therapy target

Each deal title links via Weblink to online deal records of actual 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.

Diagnostics Partnering Terms and Agreements provides the reader with the following key benefits:

• In-depth understanding of diagnostic deal trends since 2007
• Analysis of the structure of diagnostic agreements with numerous real life case studies
• Comprehensive access to over 2,900 actual diagnostic contracts entered into by the world’s biopharma companies
• Detailed access to actual diagnostic contracts enter into by the leading fifty bigpharma companies
• Insight into the terms included in a diagnostic 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

Table of Contents

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in diagnostic dealmaking
2.1. Introduction 2.2. Diagnostic partnering over the years
2.3. Most active diagnostic dealmakers
2.4. Bigpharma diagnostic dealmaking activity
2.5. Bigpharma not active in diagnostics
2.6. Diagnostics partnering by deal type
2.7. Diagnostics partnering by stage of development
2.8. Diagnostics partnering by disease type
2.9. Average deal terms for diagnostics partnering
2.9.1 Diagnostic partnering headline values
2.9.2 Diagnostic deal upfront payments
2.9.3 Diagnostic deal milestone payments
2.9.4 Diagnostic royalty rates
2.10. The anatomy of diagnostic partnering
2.10.1. The anatomy of a diagnostic deal
2.10.1.a.Case study 1: Sequenom – Lenetex – January 2007
2.10.1.b. Case study 2: Celera – Siemens Medical Solutions – July 2007
2.10.1.c. Case study 3: US Genomics – Rosetta Genomics – May 2006
2.11. Litigation and settlement in diagnostics Settlement agreement for Promega Short Tandem Repeat (STR) patents
Settlement and licensing agreement for VKORC1-1639 SNP related patents
Settlement and licensing agreement for diagnostic patent
Settlement agreement for Osmoprep Settlement and licensing agreement for antibody cyclic-citrulinated peptide
Settlement agreement for Hygia and Massimo
Settlement agreement for distribution agreement for TheraScreen companion diagnostics
Settlement agreement between Hansen Medical and Luna Innovations
Settlement agreement for ADVANCE Rapid HIV-1/2 antibody test

Chapter 3 – Leading diagnostic deals
3.1. Introduction
3.2. Top diagnostic deals by value
3.3. Top diagnostic deals involving bigpharma
3.4. Leading diagnostics M&A deals by value

Chapter 4 – Bigpharma diagnostic deals
4.1. Introduction
4.2. How to use bigpharma diagnostic partnering deals
4.3. Bigpharma partnering company profiles
Abbott
Actavis
Amgen
Astellas
AstraZeneca
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Eisai
Eli Lilly
Gilead Sciences
GlaxoSmithKline
Grifols Hospira
Johnson & Johnson
Lundbeck
Menarini
Merck & Co
Merck KGaA
Novartis
Otsuka
Pfizer
Roche
Sanofi
Servier
Takeda
Teva

Chapter 5 – Diagnostic dealmaking directory
5.1. Introduction           
5.2. By stage of development   
Discovery        
Formulation     
Marketed         
Phase I
Phase II           
Phase III
Pre-clinical      
Regulatory       
5.3. By deal type          
Asset purchase
Assignment     
Bigpharma outlicensing
Co-development           
Collaborative R&D       
Co-market       
Contract service          
Co-promotion   
CRADA
Cross-licensing
Development   
Distribution      
Equity purchase           
Evaluation       
Grant   
Interests          
Joint venture    
Licensing         
Litigation         
Loan    
Manufacturing  
Manufacturing - OEM   
Marketing        
Material transfer          
Option
Promotion        
Research         
Settlement       
Spin out           
Sub-license     
Supply
Technology transfer     
Termination     
Warranty         
5.4. By therapy area     
Anaesthetics    
Breast
Cardiovascular
Central Nervous System          
Dental
Dermatology    
Gastrointestinal
Genetic disorders        
Genitourinary   
Gynaecology   
Hematology     
Hospital care   
Immunology     
Infectives        
Metabolic         
Musculoskeletal           
Obstetrics       
Oncology         
Ophthalmics    
Pediatrics        
Psychiatry       
Respiratory      

Chapter 6 – Diagnostic partnering resource center    
6.1. Online diagnostic partnering          
6.2. Diagnostic partnering events         
6.3. Further reading on diagnostic dealmaking  

Appendices      
Appendix 1 – Deal type definitions        
Appendix 2 – Example diagnostics partnering agreement          
About CurrentPartnering           
Recent titles from CurrentPartnering     
Order Form – Reports  

List of Figures

Figure 1: Diagnostic partnering since 2007       
Figure 2: Most active diagnostic dealmakers 2007-2012
Figure 3: Bigpharma – top 50 – diagnostic deals 2007 to 2012   
Figure 4: Bigpharma diagnostic deal frequency – 2007 to 2012  
Figure 5: Inactive bigpharma in diagnostic dealmaking 2007-2012         
Figure 6: Diagnostics partnering by deal type since 2007          
Figure 7: Diagnostics partnering by stage of development since 2007    
Figure 8: Diagnostics partnering by disease type since 2007     
Figure 9: Diagnostics partnering by oncology target since 2007
Figure 10: Diagnostic deals with a headline value – by stage of development     
Figure 11: Diagnostic deal headline value distribution – discovery stage, US$million      
Figure 12: Diagnostic deal headline value distribution – preclinical stage, US$million - detail           
Figure 13: Diagnostic deal headline value distribution – phase I stage, US$million          
Figure 14: Diagnostic deal headline value distribution – phase II stage, US$million         
Figure 15: Diagnostic deal headline value distribution – phase III stage, US$million        
Figure 16: Diagnostic deal headline value distribution –regulatory stage, US$million      
Figure 17: Diagnostic deal headline value distribution – marketed stage, US$million       
Figure 18: Summary median headline value by stage of development, 2007-2012           
Figure 19: Diagnostic deals with upfront payment values – by stage of development      
Figure 20: Diagnostic deal upfront payment distribution – discovery stage, US$million   
Figure 21: Diagnostic deal upfront payment distribution – preclinical stage, US$million   
Figure 22: Diagnostic deal upfront payment distribution – phase I stage, US$million       
Figure 23: Diagnostic deal upfront payment distribution – phase II stage, US$million      
Figure 24: Diagnostic deal upfront payment distribution – phase III stage, US$million     
Figure 25: Diagnostic deal upfront payment distribution – regulatory stage, US$million   
Figure 26: Diagnostic deal upfront payment distribution – marketed stage, US$million    
Figure 27: Summary median headline value by stage of development, 2007-2012           
Figure 28: Diagnostic deals with milestone payment values – by stage of development  
Figure 29: Diagnostic deal milestone payment distribution – discovery stage, US$million           
Figure 30: Diagnostic deal milestone payment distribution – preclinical stage, US$million           
Figure 31: Diagnostic deal milestone payment distribution – phase I stage, US$million   
Figure 32: Diagnostic deal milestone payment distribution – phase II stage, US$million  
Figure 33: Diagnostic deal milestone payment distribution – phase III stage, US$million
Figure 34: Diagnostic deal milestone payment distribution – regulatory stage, US$million           
Figure 35: Diagnostic deal milestone payment distribution – marketed stage, US$million
Figure 36: Diagnostic deals with royalty rates   
Figure 37: Diagnostic deal rolyalty rate payment distribution – discovery stage, US$million
Figure 38: Diagnostic deal royalty rate payment distribution – preclinical stage, US$million           
Figure 39: Diagnostic deal royalty rate payment distribution – phase I stage, US$million
Figure 40: Diagnostic deal royalty rate payment distribution – phase II stage, US$million           
Figure 41: Diagnostic deal royalty rate payment distribution – phase III stage, US$million           
Figure 42: Diagnostic deal royalty rate payment distribution – regulatory stage, US$million           
Figure 43: Diagnostic deal royalty rate payment distribution – marketed stage, US$million           
Figure 44: Summary median headline value by stage of development, 2007-2012           
Figure 45: Components of the typical diagnostic deal structure  
Figure 46: Settlement licensing agreements since 2003
Figure 47: Top diagnostic deals by value since 2007     
Figure 48: Top diagnostic deals signed by bigpharma value since 2007
Figure 49: Top diagnostic M&A deals by value since 2007
Figure 45: Online partnering resources
Figure 46: Forthcoming partnering events         
Figure 47: Deal type definitions
Figure 48: Diagnostics partnering agreement between Inhibitex and 3M, January 2007