Regenerative medicine and Stem cells Partnering Terms and Agreements

• Publication date: February 2013
• Report size: 872 pages

The Regenerative Medicine and Stem Cells Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the Regenerative medicine and Stem cells partnering deals and agreements entered into by the worlds leading healthcare companies. Trends in regenerative medicine and stem cells deals Deal terms analysis Partnering agreement structure Partnering contract documents Top deals by value...

The Regenerative Medicine and Stem Cells Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the Regenerative medicine and Stem cells partnering deals and agreements entered into by the worlds leading healthcare companies.

Trends in regenerative medicine and stem cells deals
Deal terms analysis
Partnering agreement structure
Partnering contract documents
Top deals by value
Most active dealmakers
Average deal terms for regenerative medicine and stem cells

The report provides a detailed understanding and analysis of how and why companies enter regenerative medicine and stem cells partnering deals. The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors regenerative medicine and stem cells technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest regenerative medicine and stem cells agreements including cell therapy agreements announced in the healthcare sector.

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 regenerative medicine and stem cells partnering deals announced since 2008 including financial terms where available including over 550 links to online deal records 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?

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?

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 regenerative medicine and stem cells dealmaking since 2009, including details of average headline, upfront, milestone and royalty terms.

Chapter 3 provides a review of the leading regenerative medicine and stem cells deals since 2009. 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 regenerative medicine and stem cells 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 regenerative medicine and stem cells 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 regenerative medicine and stem cells partnering and dealmaking since 2009.

In addition, a comprehensive appendix is provided organized by regenerative medicine and stem cells partnering company A-Z , deal type definitions and regenerative medicine and stem cells 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 regenerative medicine and stem cells technologies and products.


Regenerative Medicine and Stem Cells Partnering Terms and Agreements provides the reader with the following key benefits:

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

Biological Therapy Industry

Table of contents

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in regenerative medicine and stem cells dealmaking

2.1. Introduction
2.2. Regenerative medicine and stem cells partnering over the years
2.3. Bigpharma regenerative medicine and stem cells dealmaking activity
2.4. Regenerative medicine and stem cells partnering by deal type
2.5. Regenerative medicine and stem cells partnering by disease type
2.6. Partnering by regenerative medicine and stem cells technology type
2.7. Average deal terms for regenerative medicine and stem cells partnering
2.7.1 Regenerative medicine and stem cells headline values
2.7.2 Regenerative medicine and stem cells upfront payments
2.7.3 Regenerative medicine and stem cells milestone payments
2.7.4 Regenerative medicine and stem cells royalty rates
2.8. The anatomy of regenerative medicine and stem cells partnering
2.9. The anatomy of a regenerative medicine and stem cells deal
2.9.a. Case study 1: Oregon Health & Science University- Regen BioPharma- June 2012
2.9.b. Case study 2: Thermogenesis- Nanshan Memorial Medical Institute- November 2010
2.9.c. Case study 3: Ascent Therapeutics- Bioheart- January 2010

Chapter 3 – Leading regenerative medicine and stem cells deals

3.1. Introduction
3.2. Top regenerative medicine and stem cells deals by value

Chapter 4 – Bigpharma regenerative medicine and stem cells deals
4.1. Introduction
4.2. How to use bigpharma regenerative medicine and stem cells partnering deals
4.3. Bigpharma regenerative medicine and stem cells partnering company profiles
Abbott
Astellas
AstraZeneca
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Eisai
Eli Lilly
GlaxoSmithKline
Johnson & Johnson
Kyowa Hakko Kirin
Merck & Co
Novartis
Otsuka
Pfizer
Roche
Sanofi
Teva
UCB

Chapter 5 – Regenerative medicine and stem cells partnering contracts directory
5.1. Introduction
5.2. Company A-Z
5.3. By deal type
Asset purchase
Co-development
Collaborative R&D
Contract service
Co-promotion
Development
Distribution
Equity purchase
Licensing
Manufacturing
Marketing
Material transfer
Option
Research
Sub-license
Technology transfer
Termination
5.4. By stage of development
Discovery
Phase I
Preclinical
5.5. By therapy area
Cardiovascular
Genetic disorders
Hematology
Hospital care
Immunology
Musculoskeletal
Oncology
Ophthalmics
Respiratory

Chapter 6 – Regenerative medicine and stem cells dealmaking by technology type

6.1. Introduction
6.2. Deals by cell therapy, regenerative medicine and stem cells type
Cell therapy
Regenerative medicine
Stem cells

Appendices

Introduction

Appendix 1 – Directory of regenerative medicine and stem cells deals by company A-Z 2009-2013

Appendix 2 – Directory of regenerative medicine and stem cells deals by stage of development 2009-2012

Discovery
Formulation
Marketed
Phase I
Phase II
Phase III
Preclinical
Regulatory


Appendix 3 – Directory of regenerative medicine and stem cells deals by deal type 2009-2012

Asset purchase
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
Manufacturing
Marketing
Material transfer
Option
Promotion
Research
Royalty financing
Settlement
Spin out
Sub-license
Supply
Technology transfer
Termination
Warranty

Appendix 4 – Directory of regenerative medicine and stem cells deals by therapy area 2009-2012
Cardiovascular
Central Nervous System
Dental 768
Dermatology
Gastrointestinal
Genetic disorders
Genitourinary
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Obstetrics
Oncology
Ophthalmics
Pediatrics
Respiratory

Appendix 5 – Regenerative medicine and stem cells partnering resource center

Online regenerative medicine and stem cells partnering
Regenerative medicine and stem cells partnering events
Further reading on regenerative medicine and stem cells dealmaking

About Wildwood Ventures

Current Partnering
Current Agreements
Current Reports
Recent titles from CurrentPartnering
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Table of figures

Figure 1: Regenerative medicine and stem cells partnering since 2007
Figure 2: Bigpharma – top 50 – Regenerative medicine and stem cells deals 2009 to 2012
Figure 3: Bigpharma regenerative medicine and stem cells deal frequency – 2009 to 2012
Figure 4: Regenerative medicine and stem cells partnering by deal type since 2009
Figure 5: Regenerative medicine and stem cells partnering by disease type since 2009
Figure 6: Regenerative medicine and stem cells partnering by technology type since 2009
Figure 7: Regenerative medicine and stem cells deals with a headline value
Figure 8: Regenerative medicine and stem cells deal headline value distribution, US$million – discovery stage
Figure 9: Regenerative medicine and stem cells deal headline value distribution, US$million – preclinical stage
Figure 10: Regenerative medicine and stem cells deal headline value distribution, US$million – phase I stage
Figure 11: Regenerative medicine and stem cells deal headline value distribution, US$million – phase II stage
Figure 12: Regenerative medicine and stem cells deal headline value distribution, US$million – phase III stage
Figure 13: Regenerative medicine and stem cells deal headline value distribution, US$million – regulatory stage
Figure 14: Regenerative medicine and stem cells deal headline value distribution, US$million – marketed stage
Figure 15: Summary median headline value by stage of development, 2009-2012
Figure 16: Regenerative medicine and stem cells deals with upfront payment values
Figure 17: Regenerative medicine and stem cells deal upfront payment distribution, US$million – discovery stage
Figure 18: Regenerative medicine and stem cells deal upfront payment distribution, US$million – preclinical stage 65
Figure 19: Regenerative medicine and stem cells deal upfront payment distribution, US$million – phase I stage
Figure 20: Regenerative medicine and stem cells deal upfront payment distribution, US$million – phase II stage
Figure 21: Regenerative medicine and stem cells deal upfront payment distribution, US$million – phase III stage
Figure 22: Regenerative medicine and stem cells deal upfront payment distribution, US$million – regulatory stage
Figure 23: Regenerative medicine and stem cells deal upfront payment distribution, US$million – marketed stage
Figure 24: Summary median upfront payments by stage of development, 2009-2012
Figure 25: Regenerative medicine and stem cells deals with milestone payments
Figure 26: Regenerative medicine and stem cells deal milestone distribution, US$million – discovery stage
Figure 27: Regenerative medicine and stem cells deal milestone distribution, US$million – preclinical stage
Figure 28: Regenerative medicine and stem cells deal milestone distribution, US$million – phase I stage
Figure 29: Regenerative medicine and stem cells deal milestone distribution, US$million – phase II stage
Figure 30: Regenerative medicine and stem cells deal milestone distribution, US$million – phase III stage
Figure 31: Regenerative medicine and stem cells deal milestone distribution, US$million – regulatory stage
Figure 32: Regenerative medicine and stem cells deal milestone distribution, US$million – marketed stage
Figure 33: Regenerative medicine and stem cells deals with royalty rates, %
Figure 34: Regenerative medicine and stem cells deal royalty rate distribution, US$million – discovery stage
Figure 35: Regenerative medicine and stem cells deal royalty rate distribution, US$million – preclinical stage
Figure 36: Regenerative medicine and stem cells deal royalty rate distribution, US$million – phase I stage
Figure 37: Regenerative medicine and stem cells deal royalty rate distribution, US$million – phase II stage
Figure 38: Regenerative medicine and stem cells deal royalty rate distribution, US$million – phase III stage
Figure 39: Regenerative medicine and stem cells deal royalty rate distribution, US$million – regulatory stage
Figure 40: Regenerative medicine and stem cells deal royalty rate distribution, US$million – marketed stage
Figure 41: Summary median royalty rate by stage of development, 2009-2012
Figure 42: Components of the typical regenerative medicine and stem cells deal structure
Figure 43: Top regenerative medicine and stem cells deals by value since 2009
Figure 44: Online partnering resources
Figure 45: Forthcoming partnering events