Manufacturing & Supply Agreements in Biopharma

Publication Date	April 2008
Publisher	CurrentPartnering
Product Type	Report
Pages	525
ISBN Number	not applicable
Product Code	CTP00053

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Summary

Welcome to the Manufacturing and Supply Agreements in Biopharma report.

The report provides a detailed understanding and analysis of how and why companies enter manufacturing and supply deals.

A supply or manufacturing agreement is normally between a product manufacturer and product owner in which an owner outsources the manufacture and supply of its product(s) to the service company in a defined territory.

Manufacturing and supply agreements provide a popular method of maximizing the value of a product launched into a market. The deals allow the product marketer to focus on its sales and marketing efforts whilst relying on a third party to manufacture and supply product on demand, enabling rapid response to market demands. It also ensures that the marketer does not need to invest in costly infrastructure and expertise ahead of knowing whether the product will be successful or sustainable.

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 1000 links to online copies of actual manufacturing and supply contract documents as submitted to the Securities Exchange Commission by biopharma 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 agreements allows assessment of the following:

What are the precise manufacturing and supply 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?

The initial chapters of this report provide an orientation of manufacturing and supply dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in manufacturing and supply as well as a discussion on the merits of each type of deal.

Chapters 3 and 4 provide an overview of the structure of manufacturing and supply deals, respectively. Each chapter includes numerous case studies to enable understanding of both pure manufacturing/supply deals and multicomponent deals where manufacturing/supply forms a part.

Chapters 5 and 6 provide a review of the leading manufacturing/supply deals since 2000, respectively. 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 7 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of manufacturing and supply 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.

Chapters 8 and 9 provide a comprehensive listing of all manufacturing and supply agreement contracts since 2003 available in the public domain, respectively. Each chapter is organized by A-Z, stage of development at signing, and 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 report also includes numerous table and figures that illustrate the trends and activities in manufacturing and supply dealmaking since 2000.

In conclusion, this report provides everything a prospective dealmaker needs to know about manufacturing and supply as an opportunity to participate in the commercialization of either candidate compounds in development or products already on the market.

Content

Executive Summary
Chapter 1 - Introduction
Chapter 2 - Trends in manufacturing and supply dealmaking
- 2.1. Introduction
- 2.2. Difference between manufacturing and supply deals
- 2.3. Trends in manufacturing deals since 2000
- 2.4. Trends in supply deals since 2000
  - 2.4.1. When supply can be useful
- 2.5. Pure deals and multi-component deals
  - 2.5.1. Attributes of pure manufacturing and supply deals
  - 2.5.2. Attributes of manufacturing and supply in multi-component deals
- 2.6. Reasons for including manufacturing and supply options in a multicomponent deal
- 2.7. The future of manufacture and supply as part of multicomponent deals
Chapter 3 - Overview of manufacturing deal structure
- 3.1. Introduction
- 3.2. Pure versus multi-component manufacturing deals
- 3.3. Pure manufacturing agreement structure
  - 3.3.1. Example manufacturing agreements
  - 3.3.1.a. Case study 1: Lonza - Tercica - May 2007
  - 3.3.1.b. Case study 2: Cardinal Health - Targanta - March 2007
- 3.4. Manufacturing rights as part of a wider alliance agreement
  - 3.4.1. Example multicomponent manufacturing clauses
  - 3.4.1.a. Case study 3: Janssen - Vertex - June 2006
  - 3.4.1.b. Case study 4: Ipsen - Medicis - March 2006
Chapter 4 - Overview of supply deal structure
- 4.1. Introduction
- 4.2. Supply agreement structure
  - 4.2.1. Example supply agreements
  - 4.2.1.a. Case study 5: Novartis - Unigene - January 2007
  - 4.2.1.b. Case study 6: Watson - Savient - June 2006
- 4.3. Supply rights as part of a wider alliance agreement
  - 4.3.1. Example co-marketing right clauses
  - 4.3.1.a. Case study 7: Shionogi - BioCryst - February 2007
  - 4.3.1.b. Case study 8: Schering Plough - Xoma - May 2006
Chapter 5 - Leading manufacturing deals
- 5.1. Introduction
- 5.2. Top manufacturing deals by value
- 5.3. Top pure manufacturing deals
- 5.4. Top manufacturing deals signed by bigpharma
- 5.5. Most active manufacturing dealmakers
- 5.6. Bigpharma manufacturing deal activity
Chapter 6 - Leading supply deals
- 6.1. Introduction 93
- 6.2. Top supply deals by value
- 6.3. Top pure supply deals
- 6.4. Top supply deals signed by bigpharma
- 6.5. Most active supply dealmakers
- 6.6. Bigpharma supply deal activity
Chapter 7 - Bigpharma manufacturing and supply agreements
- 7.1. Introduction
- 7.2. How to use manufacturing and supply agreements
- 7.3. Company manufacturing and supply agreement listings
  - Abbott
  - Actavis
  - Akzo Nobel
  - Alcon Labs
  - Allergan
  - Altana
  - Amgen
  - Astellas
  - AstraZeneca
  - Baxter International
  - Bayer
  - Bayer Schering Pharma AG
  - Biogen Idec
  - Boehringer Ingelheim
  - Bristol-Myers Squibb
  - Cephalon
  - Chugai
  - CSL
  - Dainippon Sumitomo
  - Eisai
  - Eli Lilly
  - Forest Laboratories
  - Genentech
  - Genzyme
  - Gilead Sciences
  - GlaxoSmithKline
  - Johnson & Johnson
  - King
  - Lundbeck
  - Menarini
  - Merck & Co
  - Merck - Serono KGaA
  - Mitsubishi
  - Novartis AG
  - Novo Nordisk
  - Nycomed Pharma
  - Otsuka
  - Pfizer
  - Procter & Gamble
  - Roche
  - Sanofi-Aventis
  - Schering Plough
  - Serono
  - Shionogi Seiyaku
  - Shire
  - Solvay
  - Takeda
  - Tanabe Seiyaku
  - TAP Pharmaceuticals
  - Teva
  - UCB
  - Watson
  - Wyeth
Chapter 8 - Manufacturing agreement directory 2003-7
- 8.1. Introduction
- 8.2. Company A-Z
- 8.3. By therapy area
  - Accident/Hospital/Trauma
  - Blood/Lymphatic System
  - Cardiovascular
  - Central nervous System
  - Dermatology
  - Gastrointestinal
  - Genitourinary
  - Autoimmune/Inflammatory
  - Infection
  - Metabolism
  - Musculoskeletal
  - Oncology
  - Respiratory
  - Sensory Organ / Oral Health
  - Drug Delivery
  - OTC
- 8.4. By stage of development at signing
  - Discovery
  - Preclinical
  - Phase I
  - Phase II
  - Phase III
  - Registration
  - Formulation
  - Market
Chapter 9 - Supply agreement directory 2003-7
- 9.1. Introduction
- 9.2. Company A-Z
- 9.3. By therapy area
  - Accident/Hospital/Trauma
  - Agriculture
  - Blood/Lymphatic System
  - Cardiovascular
  - Central nervous System
  - Dermatology
  - Gastrointestinal
  - Genetic
  - Genitourinary
  - Autoimmune/Inflammatory
  - Infection
  - Metabolism
  - Musculoskeletal
  - Oncology
  - Respiratory
  - Sensory Organ / Oral Health
  - Over the Counter
- 9.4. By stage of development at signing
Discovery
Preclinical
Phase I
Phase II
Phase III
Registration
Formulation
Appendices
- Appendix 1 - Manufacturing and supply references
- Appendix 2 - Resources
- Appendix 3 - Deal type definitions
- Appendix 3 - Deal type definitions
- Appendix 4 - Example manufacturing document
- Appendix 5 - Example supply document
About CurrentPartnering
List of Figures
- Figure 1: Definition of manufacturing and supply
- Figure 2: Types of manufacturing agreement
- Figure 3: Trends in manufacturing deal announcements, 2000-2007
- Figure 4: Manufacturing deals signed at what phase of development, 2000-2007
- Figure 5: Trends in supply deal announcements, 2000-2007
- Figure 6: Supply deals signed at what phase of development, 2000-2007
- Figure 7: Situations where supply deals can prove useful
- Figure 8: Pure versus multi-component manufacturing deal announcements, 2000-2007
- Figure 9: Stage of development at which pure and multi-component manufacturing deals are announced 2000-2007
- Figure 10: Pure versus multi-component supply deal announcements, 2000-2007
- Figure 11: Stage of development at which pure and multi-component supply deals are announced 2000-2007
- Figure 14: Components of the manufacturing deal structure
- Figure 15: Components of the supply deal structure
- Figure 16: Top manufacturing deals by value since 2003
- Figure 17: Top pure manufacturing deals by value since 2003
- Figure 18: Top manufacturing deals signed by bigpharma value since 2003
- Figure 19: Most active manufacturing dealmakers 2003-7
- Figure 20: Bigpharma - top 50 - manufacturing deals since 2003
- Figure 21: Top supply deals by value since 2003
- Figure 22: Top pure supply deals by value since 2003
- Figure 23: Bigpharma - top 50 - supply deals since 2003
- Figure 24: Most active supply dealmakers 2003-7
- Figure 25: Bigpharma - top 50 - supply deals since 2003
- Figure 26: Online partnering resources
- Figure 27: Deal type definitions
- Figure 28: Manufacturing agreement between Tercica and Lonza, May 2007
- Figure 29: Supply agreement between Novartis and Unigene, January 2007