Discovery Stage Partnering Terms and Agreements in Pharma and Biotech

Published: May 2013
No. of Pages: 1245
  

The Discovery Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the discovery stage 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 discovery stage partnering deals. The majority of deals are where the licensee obtains a right or an option right to license the licensors product or compound. 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 2,500 links to online copies of actual discovery stage 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 discovery stage deal making and business activities.

Chapter 1 provides an introduction to the report, whilst

Chapter 2 provides an overview of why companies partner discovery stage compounds/products.

Chapter 3 provides an overview of discovery stage deals strategy and deal structure including numerous case studies.

Chapter 4 provides an overview of the various payment strategies used in discovery stage deals.

Chapter 5 provides a review of discovery stage deal making 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 detailed analysis of discovery stage payment terms including average headline, upfront, milestone and royalty rates for discovery deals.

Chapter 7 provides a review of the leading discovery stage deal by headline value.

Chapter 8 provides a comprehensive listing of the top 50 big pharma and big biotech companies with a brief summary followed by a comprehensive listing of discovery stage 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 9 provides a comprehensive and detailed review of discovery stage partnering deals signed and announced since 2007, where a contract document is available in the public domain. The chapter is organized by company A-Z, 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 10 provides a comprehensive directory of discovery stage partnering deals since 2007 organized by stage of development.

The report also includes numerous tables and figures that illustrate the trends and activities in discovery stage partnering and deal making since 2007.

In addition, a comprehensive appendix is provided organized by partnering company A-Z, deal type, therapy focus and 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.

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

Benefits

Discovery Stage Partnering Terms and Agreements in Pharma and Biotech provides the reader with the following key benefits:

  • •In-depth understanding of discovery stage deal trends since 2007
  • •Access to headline, upfront, milestone and royalty data
  • •Analysis of the structure of discovery stage agreements with numerous real life case studies
  • •Detailed access to actual discovery stage deals entered into by the leading fifty big pharma and big biotech companies
  • •Insight into the terms included in a discovery stage 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

Report Scope

Discovery Stage Partnering Terms and Agreements Terms and Agreements in Pharm and Biotech is intended to provide the reader with an in-depth understanding and access to discovery stage deal trends and structure of deals entered into by leading companies worldwide.

Discovery Stage Partnering Terms and Agreements in Pharma and Biotech includes:

  • •Trends in discovery stage dealmaking in the biopharma industry since 2007
  • •Analysis of discovery stage deal structure
  • •Access to headline, upfront, milestone and royalty data
  • •Case studies of real-life discovery stage deals
  • •Access to over 2,500 discovery stage deals
  • •The leading discovery stage deals by value since 2007
  • •Most active discovery stage dealmakers since 2007
  • •The leading discovery stage partnering resources

In Discovery Stage Partnering Terms and Agreements in Pharm and Biotech, the available contracts are listed by:

  • •Company A-Z
  • •Headline value
  • •Stage of development at signing
  • •Deal type
  • •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 Discovery Stage Partnering Terms and Agreements in Pharma and biotech report provides comprehensive access to available deals and contract documents for over 2,500 discovery stage 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?

Discovery Stage Partnering Terms and Agreements in Pharma and Biotech

Table Of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why Do Companies Partner At Discovery Stage?

2.1. Introduction
2.2. The role of discovery stage partnering
2.2.1. In-licensing at discovery stage
2.2.2. Out-licensing at discovery stage
2.3. Difference between discovery, preclinical and clinical stage deals
2.4. Reasons for entering into discovery stage partnering deals
2.4.1. Licensors reasons for entering discovery stage deals
2.4.2. Licensees reasons for entering discovery stage deals
2.5. The future of discovery stage partnering deals

Chapter 3 - Discovery Stage Deal Strategies And Structure
3.1. Introduction
3.2. At what stage do companies partner?
3.2.1. Partnering early in pharmaceutical/biotech
3.2.1.1. Discovery and preclinical stage partnering case studies
3.2.1.1.a. Case study: LEO Pharma - 4SC
3.2.1.1.b. Case study: Heptares Therapeutics - Cubist
3.2.1.1.c. Case study: Pfizer - Repligen
3.2.1.1.d. Case study: Janssen Pharmaceutical - Evotec
3.2.2. Partnering later in pharmaceutical/biotech
3.2.2.1. Clinical stage partnering case studies
3.2.2.1.a. Case study: Roche - Genentech - Chiasma
3.2.2.1.b. Case study: Teva - Xenon Pharmaceuticals
3.2.2.1.c. Case study: AstraZeneca - Ardelyx
3.2.2.1.d. Case study: Baxter - Onconova Therapeutics
3.3. Early and later stage partnering - a risk/cost comparison
3.4. What do companies spend on discovery, preclinical and clinical stage partnering?
3.5. Pure versus multi-component partnering deals
3.6. Pure licensing agreement structure
3.6.1. Example pure licensing agreements
3.6.1.a. Case study : Coley Pharmaceutical - Dynavax Technologies
3.6.1.b. Case study : Bristol-Myers Squibb - Pharmacopeia
3.7. Multicomponent preclinical stage partnering agreements
3.7.1. Example multicomponent early stage clauses
3.7.1.a. Case study: Tracon - Cell Matrix - Cancervax
3.7.1.b. Case study: Pfizer - InSite Vision

Chapter 4 - Discovery Stage Partnering Payment Strategies
4.1. Introduction
4.2. Discovery stage payment strategies
4.3. Payment options
4.3.1. Headline values
4.3.2. Upfront payments
4.3.2.1. Conditionality of upfront payments
4.3.3. Loans
4.3.4. Convertible loans
4.3.5. Equity
4.3.6. R&D funding
4.3.7. Licensing fees
4.3.8. Milestone payments
4.3.9. Royalty payments
4.3.9.1. Issues affecting royalty rates
4.3.9.2. Royalties on combination products
4.3.9.2.a. Case study: Scripps Research Institute-Cyanotech
4.3.9.3. Guaranteed minimum/maximum annual payments
4.3.9.4. Royalty stacking
4.3.9.5. Royalties and supply/purchase contracts
4.3.10. Quids
4.3.11. Option payments

Chapter 5 - Trends In Discovery Stage Deal Making
5.1. Introduction
5.2. Discovery stage partnering over the years
5.2.1.. Attributes of discovery deals
5.3. Big pharma discovery stage dealmaking activity
5.4. Big biotech discovery stage dealmaking activity
5.5. Discovery stage partnering by deal type
5.6. Discovery stage partnering by disease type
5.7. Partnering by discovery stage technology type

Chapter 6 - Average Payment Terms For Discovery Stage Partnering
6.1. Introduction
6.2. Guidelines for discovery stage payment terms
6.2.1. Upfront payments
6.2.2. Milestone payments
6.2.3. Royalty payments
6.3. Discovery stage payment terms - deal data analysis
6.3.1. Public data
6.3.2. Survey data
6.4. Payment terms analysis
6.4.1. Discovery stage headline values
6.4.2. Discovery stage upfront payments
6.4.3. Discovery stage milestone payments
6.4.4. Discovery stage royalty rates

Chapter 7 - Leading Preclinical Stage Deals
7.1. Introduction
7.2. Top discovery stage deals by value

Chapter 8 - Big Pharma And Big Biotech Discovery Stage Partnering Deals
8.1. Introduction
8.2. How to use big pharma/big biotech discovery stage partnering deals
8.3. Big pharma discovery stage partnering company profiles
Abbott
Actavis
Actelion
Allergan
Amgen
Aspen Pharmacare
Astellas
AstraZeneca
Baxter International
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eli Lilly
Endo Pharmaceuticals
Forest Laboratories
Galderma
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson & Johnson
Kyowa Hakko Kirin
Lundbeck
Menarini
Merck & Co
Merck KGaA
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Purdue
Roche
Sanofi
Servier
Shionogi
Shire
Takeda
Teva
UCB
Valeant
Warner Chilcott
8.4. Big biotech discovery stage partnering company profiles
Acorda Therapeutics
Actelion
Alexion Pharmaceuticals
Alkermes
Alnylam Pharmaceuticals
AMAG Pharmaceuticals
Amgen
Amylin Pharmaceuticals
Anika Therapeutics
Bavarian Nordic
Biocon
BioCryst Pharmaceuticals
Biogen Idec
BioMarin Pharmaceuticals
Biota Holdings
Cangene
Celgene
CSL
CSL Biotherapies
Cubist
Elan
Emergent BioSolutions
Enzo Biochem
Enzon Pharmaceuticals
Exelixis
Genmab
Gilead Sciences
Immunomedics
Intermune
Isis Pharmaceuticals
Morphosys
Nektar Therapeutics
NPS Pharmaceuticals
Onyx Pharmaceuticals
PDL BioPharma
Questcor Pharmaceuticals
Regeneron Pharmaceuticals
Roche
SciClone Pharmaceuticals
Seattle Genetics
Spectrum Pharmaceuticals
Targacept
The Medicines Company
UCB
United Therapeutics
Vertex Pharmaceuticals
ViroPharma

Chapter 9 - Discovery Stage Partnering Contracts Directory
9.1. Introduction
9.2. Company A-Z
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
Joint venture
Licensing
Litigation
Loan
Manufacturing
Marketing
Material transfer
Option
Promotion
Research
Settlement
Spin out
Sub-license
Supply
Technology transfer
Termination
Warranty
9.4. By stage of development
Discovery
9.5. By therapy area
Anesthesia
Cardiovascular
Central Nervous System
Dermatology
Gastrointestinal
Genetic disorders
Gynaecology
Hematology
Hospital care
Immunology
Infectives
Metabolic
Musculoskeletal
Obstetrics
Oncology
Ophthalmics
Pediatrics
Psychiatry
Public health
Respiratory

Chapter 10 - Discovery Stage Dealmaking Directory
10.1. Introduction
10.2. Deals by discovery stage
About Wildwood Ventures
Current Partnering
Current Agreements
Recent titles from Current Partnering
Order Form - Reports
Order Form - Reports
Order Form - Therapy Reports

Appendices
Introduction
Appendix 1 - Directory of discovery stage deals by company A-Z 2007-2013
Appendix 2 - Directory of discovery stage deals by deal type 2007-2013
Appendix 3 - Directory of discovery stage deals by therapy area 2007-2013
Appendix 4 - Partnering resource center
Online partnering
Partnering events
Further reading on dealmaking

List Of Figures

Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2007-2013), % of all deals where stage disclosed
Figure 3: Components of the pure licensing deal structure
Figure 4: Payment options for discovery stage partnering deals
Figure 5: Issues affecting royalty rates
Figure 6: Discovery stage partnering frequency 2007-2013
Figure 7: Big pharma - top 50 - discovery stage deals 2007 to 2013
Figure 8: Big pharma discovery stage deal frequency - 2007 to 2013
Figure 9: Big biotech - top 50 - discovery stage deals 2007 to 2013
Figure 10: Big biotech discovery stage deal frequency - 2007 to 2013
Figure 11: Discovery stage partnering by deal type since 2007
Figure 12: Discovery stage partnering by disease type since 2007
Figure 13: Discovery stage partnering by technology type since 2007
Figure 14: Review of upfront payments for discovery stage deals
Figure 15: Review of milestone payments for discovery stage deals
Figure 16: Review of royalty payments for discovery stage deals
Figure 17: Discovery stage deals with a headline value
Figure 18: Discovery stage deal headline value distribution, US$million
Figure 19: Summary median headline value for discovery stage of development, 2007-2013
Figure 20: Discovery stage deals with upfront payment values
Figure 21: Discovery stage deal upfront payment distribution, US$million
Figure 22: Summary median upfront payments discovery stage of development, 2007-2013
Figure 23: Discovery stage deals with milestone payments
Figure 24: Discovery stage deal milestone distribution, US$million
Figure 25: Summary median milestone payments for discovery stage of development, 2007-2013
Figure 26: Discovery stage deals with royalty rates, %
Figure 27: Discovery stage deal royalty rate distribution, US$million
Figure 28: Summary median royalty rate for discovery stage of development, 2007-2013
Figure 29: Top discovery stage deals by value since 2007

Published By: Current Partnering
Product Code: Current Partnering31


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