Personalized Medicine Partnering Terms and Agreements

CurrentPartnering, April 2013, Pages: 935

Comprehensive understanding and unprecedented access to the personalized medicine partnering deals and agreements entered into by the worlds leading healthcare companies.

The Personalized Medicine Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the personalized medicine 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 personalized medicine 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 personalized medicine 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 1500 links to online copies of actual personalized medicine 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 personalized medicine dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in personalized medicine dealmaking since 2007, including details of average headline, upfront, milestone and royalty terms.

Chapter 3 provides a review of the leading biomarker 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 review of the leading companion diagnostic 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 5 provides a review of the leading pharmacogenomic 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 6 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of personalized medicine deals including biomarker, companion diagnostic, pharmacogenomics, 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 7 provides a comprehensive and detailed review of biomarker partnering deals signed and announced since 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.

Chapter 8 provides a comprehensive and detailed review of companion diagnostics partnering deals signed and announced since 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.

Chapter 9 provides a comprehensive and detailed review of pharmacogenomic partnering deals signed and announced since 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.

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

Report scope

Personalized Medicine Partnering Terms and Agreements is intended to provide the reader with an in-depth understanding and access to personalized medicine trends and structure of deals entered into by leading companies worldwide.

Personalized Medicine Partnering Terms and Agreements includes:

o Trends in personalized medicine dealmaking in the biopharma industry since 2007
o Analysis of personalized medicine deal structure
o Access to headline, upfront, milestone and royalty data
o Case studies of real-life personalized medicine deals
o Access to over 1500 personalized medicine contract documents
o The leading personalized medicine deals by value since 2007
o Most active personalized medicine dealmakers since 2007
o The leading personalized medicine partnering resources In Personalized Medicine 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 Personalized Medicine Partnering Terms and Agreements report provides comprehensive access to available deals and contract documents for over 1500 personalized medicine deals. Analyzing actual contract agreements allows assessment of the following:

o What are the precise personalized medicine 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 How is confidentiality and publication managed?
o How are disputes to be resolved?
o Under what conditions can the deal be terminated?
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?

Number of pages: The report is comprised of two volumes with the second volume containing the appendices totaling 1096 pages.

Executive Summary
Chapter 1 – Introduction
Chapter 2 – Trends in personalized medicine dealmaking
2.1. Introduction
2.2. Personalized medicine partnering over the years
2.2.1 Biomarker partnering over the years
2.2.2 Companion diagnostic partnering over the years
2.2.3 Pharmacogenomic partnering over the years
2.3. Bigpharma personalized medicine dealmaking activity
2.3.1 Bigpharma biomarker, companion diagnostic and pharmacogenomics dealmaking activity
2.4. Bigpharma most active in personalized medicine
2.5. Personalized medicine partnering by deal type
2.5.1 Biomarker partnering by deal type
2.5.2 Companion diagnostic partnering by deal type
2.5.3 Pharmacogenomic partnering by deal type
2.6. Personalized medicine partnering by disease type
2.6.1 Biomarker partnering by disease type
2.6.2 Companion diagnostic partnering by disease type
2.6.3 Pharmacogenomic partnering by disease type
2.7 Average deal terms for personalized medicine
2.7.1 Personalized medicine headline values
2.7.2 Personalized medicine upfront payments
2.7.3 Personalized medicine milestone payments
2.7.4 Personalized medicine royalty rates
Chapter 3 – Leading biomarker deals
3.1. Introduction
3.2. Top biomarker deals by value
3.3. Top biomarker deals involving bigpharma
Chapter 4 – Leading companion diagnostic deals
4.1. Introduction
4.2. Top companion diagnostic deals by value
4.3. Top companion diagnostic deals involving bigpharma
Chapter 5 – Leading pharmacogenomic deals
5.1. Introduction
5.2. Top pharmacogenomics deals by value
5.3. Top pharmacogenomic deals involving bigpharma
Chapter 6 – Bigpharma personalized medicine deals
6.1. Introduction
6.2. How to use bigpharma personalized medicine partnering deals
6.3. Bigpharma personalized medicine partnering company profiles
Abbott
Amgen
Astellas
AstraZeneca
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Daiichi Sankyo
Eisai
Eli Lilly
Gilead Sciences
GlaxoSmithKline
Johnson & Johnson
Merck & Co
Merck KGaA
Mitsubishi Tanabe
Novo Nordisk
Pfizer
Roche
Sanofi
Servier
Takeda
Teva
Chapter 7 – Biomarker dealmaking directory
7.1. Introduction
7.2. By stage of development
Discovery
Marketed
Phase I
Phase II
Phase III
Preclinical
Regulatory
7.3. By deal type
Asset purchase
Bigpharma outlicensing
Co-development
Collaborative R&D
Co-market
Contract service
Co-promotion
CRADA
Cross-licensing
Development
Distribution
Equity purchase
Evaluation
Grant
Joint venture
Licensing
Manufacturing
Manufacturing - OEM
Marketing
Option
Promotion
Research
Settlement
Spin out
Sub-license
Supply
Technology transfer
Termination
7.4. By therapy type
Breast
Cardiovascular
Central Nervous System
Dental
Dermatology
Gastrointestinal
Genetic disorders
Genitourinary
Gynaecology
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Obstetrics
Oncology
Ophthalmics
Pediatrics
Psychiatry
Public Health
Respiratory
Chapter 8 – Companion diagnostic dealmaking directory
8.1. Introduction
8.2. By stage of development
Discovery
Marketed
Formulation
Phase I
Phase II
Phase III
Preclinical
Regulatory
8.3. By deal type
Asset purchase
Bigpharma outlicensing
Co-development
Collaborative R&D
Co-market
Contract service
Development
Distribution
Equity purchase
Evaluation
Grant
Licensing
Manufacturing
Marketing
Option
Research
Settlement
Spin out
Sub-license
Supply
Technology transfer
8.4. By therapy area
Breast
Cardiovascular
Central Nervous System
Dermatology
Gastrointestinal
Genetic disorders
Genitourinary
Gynaecology
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Oncology
Ophthalmics
Pediatrics
Psychiatry
Public Health
Respiratory
Chapter 9 – Pharmacogenomic dealmaking directory
9.1. Introduction
9.2. By stage of development
Discovery
Marketed
Phase I
Phase II
Preclinical
9.3. By deal type
Asset purchase
Co-development
Collaborative R&D
Contract service
Development
Distribution
Equity purchase
Evaluation
Grant
Joint venture
Licensing
Manufacturing
Marketing
Option
Research
Supply
9.4. By therapy type
Cardiovascular
Central Nervous System
Dermatology
Gastrointestinal
Genetic disorders
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Oncology
Pediatrics
Psychiatry
Public Health
Respiratory
Chapter 10 – Personalized medicine partnering resource center
10.1. Online personalized medicine partnering
10.2. Personalized medicine partnering events
10.3. Further reading on personalized medicine dealmaking
About Wildwood Ventures
Current Partnering
Current Agreements
Recent titles from CurrentPartnering
Order Form – Reports

Table of figures

Figure 1: Personalized medicine partnering since 2007
Figure 2: Biomarker partnering since 2007
Figure 3: Companion diagnostic partnering since 2007
Figure 4: Pharmacogenomic partnering since 2007
Figure 5: Bigpharma – top 50 – personalized medicine deals 2007 to 2013
Figure 6: Bigpharma personalized medicine deal frequency – 2007 to 2013
Figure 7: Bigpharma – top 50 – biomarker, companion diagnostic and pharmacogenomics deals 2007 to 2013
Figure 8: Bigpharma biomarker deal frequency – 2007 to 2013
Figure 9: Bigpharma companion diagnostic deal frequency – 2007 to 2013
Figure 10: Bigpharma pharmacogenomics deal frequency – 2007 to 2012
Figure 11: Most active bigpharma in personalized medicine 2007-2013
Figure 12: Most active bigpharma in biomarkers 2007-2013
Figure 13: Most active bigpharma in companion diagnostic 2007-2013
Figure 14: Most active bigpharma pharmacogenomics dealmaking activity– 2007 to 2013
Figure 15: Personalized medicine partnering by deal type since 2007
Figure 16: Biomarker partnering by deal type since 2007
Figure 17: Companion diagnositc partnering by deal type since 2007
Figure 18: Pharmacogenomics partnering by deal type since 2007
Figure 19: Personalized medicine partnering by disease type since 2007
Figure 20: Personalized medicine partnering by oncology target since 2007
Figure 21: Biomarker partnering by disease type since 2007
Figure 22: Biomarker partnering by oncology target since 2007
Figure 23: Companion diagnostic partnering by disease type since 2007
Figure 24: Companion diagnostic partnering by oncology target since 2007
Figure 25: Pharmacogenomics partnering by disease type since 2007
Figure 26: Pharmacogenomic partnering by oncology target since 2007
Figure 27: Personalized medicine deals with a headline value
Figure 28: Personalized medicine deals headline value distribution, US$m – 2007-2013: discovery
Figure 29: Personalized medicine deals headline value distribution, US$m – 2007-2013: preclinical
Figure 30: Personalized medicine deals headline value distribution, US$m – 2007-2013: phase I
Figure 31: Personalized medicine deals headline value distribution, US$m – 2007-2013: phase II
Figure 32: Personalized medicine deals headline value distribution, US$m – 2007-2013: phase III
Figure 33: Personalized medicine deals headline value distribution, US$m – 2007-2013: regulatory
Figure 34: Personalized medicine deals headline value distribution, US$m – 2007-2013: marketed stage
Figure 35: Summary median headline value by stage of development, 2007-2013
Figure 36: Personalized medicine deals with an upfront value
Figure 37: Personalized medicine deals upfront value distribution, US$m – 2007-2013: discovery
Figure 38: Personalized medicine deals upfront value distribution, US$m – 2007-2013: preclinical
Figure 39: Personalized medicine deals upfront value distribution, US$m – 2007-2013: phase I
Figure 40: Personalized medicine deals upfront value distribution, US$m – 2007-2013: phase II
Figure 41: Personalized medicine deals upfront value distribution, US$m – 2007-2013: phase III
Figure 42: Personalized medicine deals upfront value distribution, US$m – 2007-2013: regulatory
Figure 43: Personalized medicine deals upfront value distribution, US$m – 2007-2013: marketed
Figure 44: Summary median upfront value by stage of development, 2007-2013
Figure 45: Personalized medicine deals with a milestone value
Figure 46: Personalized medicine deals milestone value distribution, US$m – 2007-2013: discovery
Figure 47: Personalized medicine deals milestone value distribution, US$m – 2007-2013: preclinical
Figure 48: Personalized medicine deals milestone value distribution, US$m – 2007-2013: phase I
Figure 49: Personalized medicine deals milestone value distribution, US$m – 2007-2013: phase II
Figure 50: Personalized medicine deals milestone value distribution, US$m – 2007-2013: phase III
Figure 51: Personalized medicine deals milestone value distribution, US$m – 2007-2013: regulatory
Figure 52: Personalized medicine deals milestone value distribution, US$m – 2007-2013: marketed
Figure 53: Personalized medicine deals with a royalty rate value
Figure 54: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: discovery
Figure 55: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: preclinical
Figure 56: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: phase I
Figure 57: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: phase II
Figure 58: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: phase III
Figure 59: Personalized medicine deals royalty rate value distribution, US$m – 2007-2013: regulatory
Figure 60: Personalized medicine deals royalty rate value distribution, US$million – 2007-2013: marketed stage
Figure 61: Summary median royalty rate value by stage of development, 2007-2013
Figure 62: Top biomarker deals by value since 2007
Figure 63: Top biomarker deals signed by bigpharma value since 2007
Figure 64: Top companion diagnostic deals by value since 2007
Figure 65: Top companion diagnostic deals signed by bigpharma value since 2007
Figure 66: Top pharmacogenomic deals by value since 2007
Figure 67: Top pharmacogenomic deals signed by bigpharma value since 2007
Figure 68: Online partnering resources
Figure 69: Forthcoming partnering events

The Personalized Medicine Partnering Terms & Agreements report provides comprehensive understanding and unprecedented access to the personalized medicine partnering deals and agreements entered into by the worlds leading healthcare companies.

Benefits

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

In-depth understanding of personalized medicine deal trends since 2007
Access to headline, upfront, milestone and royalty data
Analysis of the structure of personalized medicine agreements with numerous real life case studies
Comprehensive access to over 1500 actual personalized medicine contracts entered into by the world’s biopharma companies
Detailed access to actual personalized medicine contracts enter into by the leading fifty bigpharma companies
Insight into the terms included in a personalized medicine 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

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