Companion Diagnostics Partnering Terms & Agreements -





 Publication date: November 2014 | Version: 7 | Pages: 455

The Companion Diagnostics Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the companion diagnostics 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 companion diagnostic partnering deals. The majority of deals are discovery or development stage whereby the licensee obtains a right or an option right to license the licensors companion diagnostics technology. 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 250 links to online copies of actual companion diagnostics deals and 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.

 

The initial chapters of this report provide an orientation of companion diagnostics dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in companion diagnostics dealmaking since 2009 focusing on big pharma and most active of all biopharma, including details of average headline, upfront, milestone and royalty terms by year starting from 2009 to September 2014.

                    

Chapter 3 provides a review of the leading companion diagnostics deals since 2009. Deals are listed by headline value and signed by big pharma 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 where companion diagnostic deals are available followed by a brief summary. 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 companion diagnostics partnering deals signed and announced since January 2009, where a contract document is available in the public domain. The chapter is organized by company A-Z, 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.

 

Chapter 6 provides a comprehensive and detailed review of companion diagnostics partnering deals signed and announced since January 2009. The chapter is organized by companion diagnostics technology type in 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 companion diagnostics partnering and dealmaking since 2009. The Appendix toward the end includes all the companion diagnostics deals since 2009 by company A-Z, deal type and 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 appendices that includes a comprehensive and detailed review of companion diagnostics partnering deals by company A-Z, deal type and soecific therapy focus.

 

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

 

 Report scope 

 

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

 

Companion Diagnostics Partnering Terms and Agreements includes:

o Trends in companion diagnostics dealmaking in the biopharma industry since 2009

o Analysis of companion diagnostics deal structure

o Access to headline, upfront, milestone and royalty data

o Case studies of real-life companion diagnostics deals

o Access to companion diagnostics contract documents

o The leading companion diagnostics deals by value since 2009

o Most active companion diagnostics dealmakers since 2009

o The leading companion diagnostics partnering resources

 

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

o Company A-Z

o Headline value

o Stage of development at signing

o Deal component type

o 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 Companion Diagnostics Partnering Terms and Agreements report provides comprehensive access to available deals and contract documents for over 250 companion diagnostics deals. Analyzing actual contract agreements allows assessment of the following:

 

o What are the precise companion diagnostics rights granted or optioned?

o What is actually granted by the agreement to the partner company?

o What exclusivity is granted?

o What is the payment structure for the deal?

o How are sales and payments audited?

o What is the deal term?

o How are the key terms of the agreement defined?

o How are IPRs handled and owned?

o Who is responsible for commercialization?

o Who is responsible for development, supply, and manufacture?

o What happens when there is a change of ownership?

o What sublicensing and subcontracting provisions have been agreed?

o Which boilerplate clauses does the company insist upon?

o Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?

o Which jurisdiction does the company insist upon for agreement law?

 


 

Executive Summary 


Chapter 1 – Introduction 


Chapter 2 – Trends in companion diagnostics dealmaking 


2.1. Introduction
2.2. Companion diagnostics partnering over the years
2.3. Big pharma companion diagnostics dealmaking activity
2.4. Most active companion diagnostics dealmakers
2.5. Companion diagnostics partnering by deal type
2.6. Companion diagnostics partnering by disease type
2.7 Average deal terms for companion diagnostics
2.7.1 Companion diagnostics headline values
2.7.2 Companion diagnostics upfront payments
2.7.3 Companion diagnostics milestone payments
2.7.4 Companion diagnostics royalty rates
2.8. The anatomy of companion diagnostics partnering


Chapter 3 – Leading companion diagnostics deals 


3.1. Introduction
3.2. Companion diagnostics deals by value
3.3. Top companion diagnostics deals involving big pharma


Chapter 4 – Big pharma companion diagnostics deals 


4.1. Introduction
4.2. How to use big pharma companion diagnostics partnering deals
4.3. Big pharma companion diagnostics partnering company profiles
Abbott
Amgen
Astellas
AstraZeneca
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Chugai Pharmaceutical
Eisai
Eli Lilly
GlaxoSmithKline
Johnson & Johnson
Merck & Co
Merck KGaA
Novartis
Pfizer
Roche
Sanofi
Servier
Takeda
UCB


Chapter 5 – Companion diagnostics contracts dealmaking directory 


5.1. Introduction

5.2. Companion Diagnostics deals by company A-Z with contracts

5.3. Companion Diagnostics deals by deal type with contracts

5.4. Companion Diagnostics deals by therapy area with contracts


Chapter 6 – Companion diagnostics dealmaking by technology type 


6.1. Introduction
Companion Diagnostics


Chapter 7 – Companion diagnostics partnering resource center 


7.1. Online companion diagnostics partnering
7.2. Companion diagnostics partnering events
7.3. Further reading on companion diagnostics dealmaking
7.4. Deal type definitions


Appendices 


Appendix 1 – Companion Diagnostics deals by company A-Z


20/20 GeneSystems
AB-Biotics
AB Science
Abbott Laboratories
Abbott Molecular
Achaogen
Acobiom
Advanced Biological Laboratories
Advaxis
Aerocrine
AEterna Zentaris
Affymetrix
Agilent Technologies
Akili Interactive Labs
Albert Einstein College of Medicine
Algeta
Almac Diagnostics
Almac Group
AltheaDX
Amarantus BioSciences
Amgen
Amoy Diagnostics
AmpliPhi Biosciences
Ariad Pharmaceuticals
ARK Diagnostics
Arno Therapeutics
Array Biopharma
AssureRx Health
Astellas Pharma
Astellas Pharma US
AstraZeneca
Astrimmune
Asuragen
Atherotech
Atossa Genetics
Aushon BioSystems
Australian Research Council
AVEO Pharmaceuticals
Banner Sun Health Research Institute (BSHRI)
Bayer
Bayer Healthcare
BC Cancer Agency
Beckman Coulter
Becton Dickinson
BG Medicine
BioBay
Biocare Medical
Biocartis
BioChain
Biodel
Biodesix
Biogen Idec
BioMarin Pharmaceutical
BioMarker Strategies
Biomerica
BioMerieux
Biomoda
Boehringer Ingelheim
Bpifrance
Bristol-Myers Squibb
California NanoSystems Institute (CNSI)
Cambridge Biomedical
Canary Foundation
Cancer Research Technology
Cancer Research UK
Carena
Case Western Reserve University
Cedars-Sinai Medical Center
Celgene
Cell Signaling Technology
Celladon
Celldex Therapeutics
Centre for Imaging Technology Commercialization
Centre National de la Recherche Scientifique
Cephalon
Cepheid
Cernostics
CHDI Foundation
Chronix Biomedical
Chugai Pharmaceutical
Ci-Co Healthcare
Clarient
Clarity Pharmaceuticals
Clavis Pharma
Clinical Genomics
Clinical Reference Laboratory
Clovis Oncology
Columbia University
Columbia University Medical Center
CombiMatrix
Commercialisation Australia
CompanDX
Companion Dx Reference Lab
Compendia Bioscience
Corgenix Medical
Cornell University
Covance
Cylene Pharma
Dako
Dalton Pharma Services
Dana-Farber Cancer Institute
Debiopharm
Definiens
Department of Defense
DiagnoCure
Diaxonhit
DxS
Eisai
Eli Lilly
Emory University
Empire Genomics
Endocyte
Enlyten Medical Technologies
Enzo Biochem
Epigenomics
Epitomics
Epizyme
Erytech
European Union Regional Development Fund
Eurotrans-Bio
Eutropics Pharmaceuticals
Evotec
EXINI Diagnostics
ExonHit Therapeutics
Exosome Diagnostics
FEI
Fibrocell Science
Flagship Biosciences
Foundation Medicine
Fox Chase Cancer Center
French National Research Agency
Galena Biopharma
Galmed Pharmaceuticals
Geisinger Health System
Genentech
Generex Biotechnology
Genetic Technologies
Genmab
Genome Diagnostics
GenomeDx
Genomic Health
Genzyme
German Cancer Research Center
GlaxoSmithKline
GlaxoSmithKline Biologicals
Golden Helix
Health Diagnostic Laboratory
Health Discovery
HistologiX
Hoffmann La Roche
Horizon Discovery
Hospices Civils de Lyon
Hospital del Mar
HTG Molecular Diagnostics
Hybrigenics
Icon
Idera Pharmaceuticals
Illumina
ImaginAb
ImClone Systems
ImmusanT
IncellDx
Incyte
Inserm Transfert
Insight Genetics
IntegraGen
International Cancer Genome Consortium
Invivis Pharmaceuticals
InVivoScribe
Ipsen
Ipsogen
IRCCS
IRX Therapeutics
Isis Pharmaceuticals
Janssen Biotech
Janssen Pharmaceutica NV
Johns Hopkins University
Johnson & Johnson Innovation
Kalgene Pharmaceuticals
KineMed
KSB Diagnostics
Lab21
Laboratory Corporation of America
Lehigh Valley Health Network
Leica Biosystems
Leica Microsystems
Life Technologies
Life Technologies Corporation
London Genetics
Luminex
Lumiphore
LUNGevity Foundation
Macquarie University
Macrogenics
Massachusetts General Hospital
Massachusetts Institute of Technology
Max Planck Institute for Infection Biology
Mayo Clinic
McKesson
MD Anderson Cancer Center
MDxHealth
Med BioGene
Medco Health Solutions
Memorial Sloan Kettering Cancer Center
Merck and Co
Merck KGaA
Merck Serono
Merus
Metamark Genetics
MetaStat
Michael J Fox Foundation
Millennium
MolecularMD
Montefiore Medical Center
Morphotek
Myriad Genetics
NanoString Technologies
National Cancer Institute
National Center for Drug Screening
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
National Research Council Canada
National Science Foundation
Neogenix Oncology
Neogenomics
Networking Biomedical Research Centre in Liver and Digestive Diseases (CIBEREHD)
NeuroMetrix
New Liberty Proteomics
New York University
Newcastle University
Nexpep
Nicholas Conor Institute for Pediatric Cancer Research
Nihon Medi-Physics
Nipro Diagnostics
Nodality
Novartis
NovioGendix
Nuvera Biosciences
OcellO
On-Q-ity
OncoMed Pharmaceuticals
Ontario Cancer Biomarker Network
Ontario Institute for Cancer Research
OPKO Health
Ortho-Clinical Diagnostics
OSEO
OSI Pharmaceuticals
Oxford BioMedica
Oxford Gene Technology
OxOnc Development
Patrys
Peking University Cancer Hospital
Penn State Hershey
PerkinElmer
Personal Genome Diagnostics
Pfizer
Pharmacyclics
PharmaMar
Photocure ASA
Piramal Imaging
Precision Therapeutics
Primeradx
Proteomics International
Psynova Neurotech
Qiagen
QIAGEN (Suzhou) Translational Medicine Center
Quest Diagnostics
Quintiles
RedHill Biopharma
Regulus Therapeutics
Research Institute of the Hospital Universitari Vall d'Hebron
ResearchDx
Respira Health
Roche
Roche Diagnostics
Roche Molecular Systems
Rules-Based Medicine
Rush University Medical Center
Saladax Biomedical
Salix Pharmaceuticals
Samsung Medical Center
Sanofi
Seattle Genetics
Seegene
Seoul National University
Serametrix
Servier
Shanghai Pharmaceuticals Holdings
Siemens Healthcare
Siemens Healthcare Diagnostics
Signal Genetics
Singapore Radiopharmaceuticals
Sirius Genomics
Sirius Laboratories
Small Business Innovation Research
Smart Personalized Medicine
Splicos
Stallergenes
Sunnybrook Health Sciences Centre
SuperNova Diagnostics
Syndax Pharmaceuticals
Synthon
Sysmex Inostics
Takeda Pharmaceutical
TcLand Expression
Technology Strategy Board (UK)
Tesaro
The Fleury Group
Theradiag
Thermo Fisher Scientific
Threshold Pharmaceuticals
Tocagen
Tolero Pharmaceuticals
Transgene
Transgenomic
UCB
Unilabs
United Kingdom Critical Care Genomics
University College London
University Health Network
University of Barcelona
University of Bonn
University of California, San Diego
University of California Los Angeles
University of Central Florida Research Foundation
University of Colorado Denver
University of Minnesota
University of North Texas Health Science Center
University of Pennsylvania
University of Pennsylvania School of Veterinary Medicine
University of Pittsburgh Cancer Institute
USBiomarkers
Ventana Medical Systems
Veracyte
Verastem
Veridex
ViiV Healthcare
ViroMed
Virovek
VuCOMP
Wake Forest University School of Medicine
Whitehead Institute
XDx
Xenon Pharmaceuticals
Yale University
Zinfandel Pharmaceuticals
Zora Biosciences


Appendix 2 – Companion Diagnostics deals by deal type 


Asset purchase
Bigpharma outlicensing
Co-development
Collaborative R&D
Co-market
Contract service
Development
Distribution
Evaluation
Grant
Joint venture
Licensing
Manufacturing
Marketing
Option
Promotion
Research
Settlement
Sub-license
Supply
Technology transfer
Termination


Appendix 3– Companion Diagnostics deals by therapy type 


Breast
Cardiovascular
Central Nervous System
Dermatology
Gastrointestinal
Genetic disorders
Genitourinary
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Obstetrics
Oncology
Ophthalmics
Pediatrics
Psychiatry
Public health
Respiratory
Sexual health
About Wildwood Ventures
Current Partnering
Current Agreements
Recent titles from Current Partnering
Order Form – Upgrades to subscription access products
Order Form – Technology Reports
Order Form – Therapy Reports

Table of figures 

Figure 1: Companion diagnostics partnering since 2009
Figure 2: Big pharma – top 50 – companion diagnostics deals 2009 to 2014
Figure 3: Big pharma companion diagnostics deal frequency – 2009 to 2014
Figure 4: Active companion diagnostics dealmaking activity– 2009 to 2014
Figure 5: Companion diagnostics partnering by deal type since 2009
Figure 6: Companion diagnostics partnering by disease type since 2009
Figure 7: Companion diagnostics partnering by oncology target since 2009
Figure 8: Companion diagnostics deals with a headline value by year- 2014
Figure 9: Companion diagnostics deals with a headline value by year- 2013
Figure 10: Companion diagnostics deals with a headline value by year- 2012
Figure 11: Companion diagnostics deals with a headline value by year- 2011
Figure 12: Companion diagnostics deals with a headline value by year- 2010
Figure 13: Companion diagnostics deals with a headline value by year- 2009
Figure 14: Summary median headline value by year, 2009-2014
Figure 15: Companion diagnostics deals with an upfront value by year- 2014
Figure 16: Companion diagnostics deals with an upfront value by year- 2013
Figure 17: Companion diagnostics deals with an upfront value by year- 2012
Figure 18: Companion diagnostics deals with an upfront value by year- 2011
Figure 19: Companion diagnostics deals with an upfront value by year- 2010
Figure 20: Companion diagnostics deals with an upfront value by year- 2009
Figure 21: Summary median upfront value by year, 2009-2014
Figure 22: Companion diagnostics deals with a milestone value by year- 2014
Figure 23: Companion diagnostics deals with a milestone value by year- 2013
Figure 24: Companion diagnostics deals with a milestone value by year- 2012
Figure 25: Companion diagnostics deals with a milestone value by year- 2011
Figure 26: Companion diagnostics deals with a milestone value by year- 2010
Figure 27: Companion diagnostics deals with a milestone value by year- 2009
Figure 28: Companion diagnostics deals with a royalty rate by year- 2014
Figure 29: Companion diagnostics deals with a royalty rate by year- 2013
Figure 30: Companion diagnostics deals with a royalty rate by year- 2012
Figure 31: Companion diagnostics deals with a royalty rate by year- 2011
Figure 32: Companion diagnostics deals with a royalty rate by year- 2010
Figure 33: Companion diagnostics deals with a royalty rate by year- 2009
Figure 34: Summary median royalty rate by year, 2009-2014
Figure 35: Components of the typical companion diagnostics deal structure
Figure 36: Top companion diagnostics deals by value since 2009
Figure 37: Top companion diagnostics deals signed by big pharma value since 2009
Figure 38: Online partnering resources
Figure 39: Forthcoming partnering events