Option and Evaluation Agreements in Pharma and Biotech, 2nd Edition

CurrentPartnering, June 2010, Pages: 443

The Option and Evaluation Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the option and evaluation partnering agreements entered into by the worlds leading biopharma companies.

This report provides details of the latest option and evaluation agreements announced in the pharmaceutical and biotechnology sectors. Detailed and comprehensive, the report provides details of option and evaluation agreements from 2003 to early 2010.

The report provides a detailed understand and analysis of how and why companies enter option and evaluation deals. The majority of deals are option agreements whereby one party to the agreement obtains an option right from the other party.

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 over 750 links to online copies of actual option and evaluation contract documents as submitted to the Securities Exchange Commission by pharma/biotech 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 option and evaluation dealmaking and business activities. Chapter 1 provides a brief introduction to the report, whilst chapter 2 provides an analysis of the trends in option and evaluation as well as a discussion on the merits of each type of deal.

Chapter 3 provides an overview of the structure of option and evaluation deals. The chapter includes numerous case studies to enable understanding of both option and evaluation deals where partnering or acquisition is the primary focus of the agreement.

Chapter 4 provides a review of the leading option and evaluation deals since 2000. Deals are listed by headline value and most active bigpharma. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

Chapter 5 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary including option and evaluation frequency followed by a comprehensive listing of option and evaluation contract documents available in the public domain. 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 6 provides a comprehensive listing of all option and evaluation agreement contracts available in the public domain, respectively. The chapter is organized by A-Z company name, option/evaluation type, therapy area and stage of development at signing. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Key Benefits:

Option and Evaluation Agreements in Pharma and Biotech provides the reader with the following key benefits:

- In-depth understanding of option and evaluation deal trends since 2000

- Analysis of the structure of option and evaluation agreements with numerous real life case studies

- Comprehensive access to over 750 actual option and evaluation contracts entered into by the world's biopharma companies

- Detailed access to actual option and evaluation contracts enter into by the leading fifty bigpharmacompanies

- Insight into the terms included in a option and evaluation 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:

Option and Evaluation Agreements in Pharma and Biotech is intended to provide the reader with an indepth understanding of the option and evaluation trends and structure of deals entered into by leading biopharma companies worldwide.

Option and Evaluation Agreements in Pharma and Biotech includes:

- Trends in option and evaluation dealmaking in the biopharma industry since 2000
- Analysis of option and evaluation deal structure
- Case studies of real-life option and evaluation deals
- Access to over 750 option and evaluation contract documents
- The leading option and evaluation deals by value since 2000
- Most active option and evaluation dealmakers since 2000
- The leading option and evaluation partnering resources

In Option and Evaluation Agreements in Pharma and Biotech, the available contracts are listed by:

- Company A-Z
- Headline value
- Option type
- Stage of development at signing
- Therapeutic area

Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

The Option and Evaluation Agreements in Pharma and Biotech report provides comprehensive access to available contract documents for over 750 option and evaluation deals. Analyzing actual contract agreements allows assessment of the following:

- What are the precise option and evaluation rights granted?
- What is actually granted by the agreement to the partner company?
- What exclusivity is granted?
- What is the payment structure for the deal?
- How are sales and 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?

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in option and evaluation dealmaking
2.1. Introduction
2.2. Difference between option and evaluation deals
2.2.1. Types of option agreement
2.3. Trends in option/evaluation deals since 2000
2.4. Option-based deals
2.4.1. Attributes of option-based deals
2.4.2. Reasons for entering an option-based deal
2.4.3. Uptake of option exercise
2.4.4.The future of option-based deals
2.5. Co-promotion options
2.5.1. Attributes of co-promotion in multi-component deals
2.5.2. Reasons for including co-promotion options in a deal
2.5.3. Uptake of co-promotion rights
2.5.4. Co-promotion rights as bargaining chips
2.5.5. The future of co-promotion as part of multicomponent deals
2.6. Company acquisition options
2.6.1. Case study 1: Cephalon – Ception – January 2009
2.6.2. Case study 2: Endo – Indevus – January 2009
2.6.3. The future of option to acquire deals

Chapter 3 – Overview of option and evaluation deal structure
3.1. Introduction
3.2. Evaluation agreement structure
3.2.1. Example evaluation agreements
3.2.1.a. Case study 3: BioGenerix – Neose – January 2005
3.3. Option agreement structure
3.3.1. Example option agreements
3.3.1.a. Option to license
Case study 4: GlaxoSmithKline – Regulus Therapeutics – April 2008
3.3.1.b. Option to extend/expand applications/territories
Case study 5: Salix – Dr Falk – April 2007
3.3.1.c. Option to finance
Case study 6: Merck KgaA – Archemix – June 2007
3.3.1.d. Option to co-promote
Case study 7: Novartis – Anadys – June 2005
3.3.1.e. Option to manufacture/supply
Case study 8: NPS Allelix – Nycomed – July 2007
3.4. Option to acquire agreement structure
3.4.1. Example acquisition option clauses
3.4.1.a. Case study 9: MGI Pharma – AkaRx – October 2007
3.4.1.b. Case study 10: Abbott – Ibis Biosciences – Isis Pharmaceuticals – January 2008

Chapter 4 – Leading option and evaluation deals
4.1. Introduction
4.2. Top partnering deals incorporated an option clause by value
4.3. Bigpharma option deal activity

Chapter 5 – Bigpharma option and evaluation agreements
5.1. Introduction
5.2. How to use option/evaluation agreements
5.3. Company option and evaluation agreement listings
- Abbott
- Actavis
- Alcon Labs
- Allergan
- Amgen
- Astellas
- AstraZeneca
- Baxter International
- Bayer
- Biogen Idec
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Cephalon
- Chugai
- CSL
- Daiichi Sankyo
- Dainnipon Sumitomo
- Eisai
- Eli Lilly
- Forest Laboratories
- Genentech
- Genzyme
- Gilead Sciences
- GlaxoSmithKline
- Hospira
- Johnson & Johnson
- Lundbeck
- Menarini
- Merck & Co
- Merck Serono
- Mitsubishi Tanabe
- Mundipharma
- Novartis
- Novo Nordisk
- Nycomed Pharma
- Otsuka
- Pfizer
- Procter & Gamble
- Ratiopharma
- Roche
- Sanofi-Aventis
- Schering Plough
- Servier
- Shire
- Solvay
- Takeda
- Teva
- UCB
- Watson
- Wyeth

Chapter 6 – Option and evaluation agreement directory 2003 to early 2010
6.1. Introduction
6.2. Company A-Z
6.3. Deals by type
- Acquisition
- Co-development
- Co-marketing
- Co-promotion
- Evaluation
- Extension
- Financing
- Licensing
- Marketing
- Supply

6.4. Deals by stage
- Discovery
- Preclinic
- Phase I
- Phase II
- Phase III
- Regulatory
- Marketed
- Formulation

6.2. Deals by therapy
- Cardiovascular
- Central Nervous System
- Dermatology
- Gastrointestinal
- Genitourinary
- Hematology
- Hormonal
- Immunology
- Infection
- Inflammation
- Metabolic
- Musculoskeletal
- Oncology
- Ophthalmic
- Respiratory
- Delivery

Appendices
Appendix 1 – Option/evaluation references
Appendix 2 – Resources
Appendix 3 – Deal type definitions
Appendix 4 – Example M&A option contract document
Appendix 5 - Example option partnering contract document

TABLE OF FIGURES:

Figure 1: Definition of option and evaluation
Figure 2: Types of option right
Figure 3: Trends in option/evaluation deal announcements, 2000-2009
Figure 4: Option/evaluation deals signed at each phase of development, 2000-2009
Figure 5: Recent option-based deals
Figure 6: Example deals where co-promotion options have been actively exercised, since 2000
Figure 7: Recent ‘option to acquire' deals
Figure 8: Components of the evaluation deal structure
Figure 9: Types of option in an agreement
Figure 10: Attributes of option terms:
Figure 11: Top 25 partnering deals incorporating an option/evaluation clause by value since 2000
Figure 12: Bigpharma – top 50 – option deals since 2003
Figure 13: Online partnering resources
Figure 14: Deal type definitions
Figure 15: Option for M&A agreement between Abbott Molecular – Isis Pharmaceuticals – Ibis Biosciences – January 2005
Figure 16: Option in partnering agreement between Array Biopharma – Celgene – September 2007

- Abbott
- Actavis
- Alcon Labs
- Allergan
- Amgen
- Astellas
- AstraZeneca
- Baxter International
- Bayer
- Biogen Idec
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Cephalon
- Chugai
- CSL
- Daiichi Sankyo
- Dainnipon Sumitomo
- Eisai
- Eli Lilly
- Forest Laboratories
- Genentech
- Genzyme
- Gilead Sciences
- GlaxoSmithKline
- Hospira
- Johnson & Johnson
- Lundbeck
- Menarini
- Merck & Co
- Merck Serono
- Mitsubishi Tanabe
- Mundipharma
- Novartis
- Novo Nordisk
- Nycomed Pharma
- Otsuka
- Pfizer
- Procter & Gamble
- Ratiopharma
- Roche
- Sanofi-Aventis
- Schering Plough
- Servier
- Shire
- Solvay
- Takeda
- Teva
- UCB
- Watson
- Wyeth

Product Samples

A sample for this product is available. Please Login/Register to download this sample.

Customers who bought this item also bought

• Partnering Terms and Agreements in Diagnostics, 2nd Edition
• Companion Diagnostics Partnering Terms and Agreements, 2nd Edition
• Merger and Acquisition Terms and Agreements in Pharma, Biotech and Diagnostics, 4th Edition
• Regenerative medicine and Stem cells Partnering Terms and Agreements
• Pre-Clinical Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition
• Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition
• Current Agreements
• Distribution Agreements in Pharma, Biotech and Diagnostics, 2nd edition
• Asset Purchase Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition
• Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 3rd Edition