Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018

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Date: 01-May-2018
No. of pages: 1600
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Summary

The Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018 report.

This report provides details of the latest manufacturing and supply agreements announced in the pharmaceutical, biotechnology, device and diagnostic sectors. Fully revised and updated, the report provides details of manufacturing and supply agreements from 2012 to 2018.

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 a comprehensive listing of over 2,500 manufacturing and supply deals announced since 2012 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual manufacturing and supply 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 manufacturing and supply deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in manufacturing and supply deal making as well as a discussion on the merits of the type of deal.

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

Chapter 5 provides a review of the leading manufacturing and supply deals since 2012. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 6 provides a review of the top 50 most active biopharma companies in manufacturing and supply. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 7 provides a comprehensive and detailed review of manufacturing and supply deals signed and announced since 2012 where a contract document is 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.

The report includes deals announced by hundreds of life science companies including big pharma such as Abbott, Abbvie, Actavis, Amgen, Astellas, AstraZeneca, Baxter, Bayer, Biogen Idec, BMS, Celgene, Eisai, Eli Lilly, Gilead, GSK, J&J, Kyowa Hakko, Merck, Mitsubishi, Mylan, Novartis, Pfizer, Roche, Sanofi, Shire, Takeda, Teva, and Valeant, amongst many others.

The report also includes numerous table and figures that illustrate the trends and activities in manufacturing and supply deal making since 2012.

In addition, a comprehensive appendix is provided organized by manufacturing and supply company A-Z , stage of development, therapeutic target, technology type and deal type definitions. 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 manufacturing and supply partnering in the research, development and commercialization of technologies and products.

Key benefits

Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018 provides the reader with the following key benefits:

In-depth understanding of manufacturing and supply deal trends since 2012

Analysis of the structure of manufacturing and supply agreements with numerous real life case studies

Comprehensive access to over 2,500 actual manufacturing and supply deals entered into by the world's biopharma companies

Detailed access to actual manufacturing and supply deals entered into by the leading fifty bigpharma companies

Comprehensive access to all manufacturing and supply deals entered since 2012

Insight into the terms included in a manufacturing and supply 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

Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018 is intended to provide the reader with an in-depth understanding of the manufacturing and supply trends and structure of deals entered into by pharma, biotech, device and diagnostics companies worldwide.

Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018 includes:

Trends in manufacturing and supply dealmaking in the biopharma industry since 2012

Analysis of manufacturing and supply deal structure

Case studies of real-life manufacturing and supply deals

Access to over 2,500 manufacturing and supply deal records covering pharma, biotech, devices and diagnostics since 2012

The leading manufacturing and supply deals by value since 2012

Most active manufacturing and supply dealmakers since 2012

The leading manufacturing and supply partnering resources

In Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018, the available deals are listed by:

Company A-Z

Headline value

Stage of development at signing

Therapeutic area

Technology type

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

The Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018 report provides comprehensive access to available records for over 2,500 maufacturing and supply deals, including contract documents where available. 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?

Global Manufacturing and Supply Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2012-2018

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in manufacturing and supply deal making
2.1. Introduction
2.2. Difference between manufacturing and supply deals
2.3. Trends in manufacturing and supply deals since 2012
2.3.1. Manufacturing and supply deal making by year since 2012
2.3.2. Manufacturing and supply deal making by phase of development since 2012
2.3.3. Manufacturing and supply deal making by industry sector since 2012
2.3.4. Manufacturing and supply deal making by therapy area since 2012
2.3.5. Manufacturing and supply deal making by technology type since 2012
2.3.6. Manufacturing and supply deal making by most active company since 2012
2.3.7. When supply can be useful
2.4. Attributes of pure manufacturing and supply deals
2.5. Attributes of manufacturing and supply in multi-component deals
2.6. Reasons for including manufacturing and supply options in a multi-component deal
2.7. The future of manufacture and supply as part of multicomponent deals

Chapter 3 - Overview of manufacturing and supply 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: Amyris Brazil - Biomin Nutricao Animal Do Brasil
3.3.1.b. Case study 2: Patheon - Orexigen Therapeutics
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: Agenus Bio - NewVac
3.4.1.b. Case study 4: Elite Pharmaceuticals - Hi-Tech Pharmacal

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: Omthera Pharmaceuticals - Catalent Pharma solutions
4.2.1.b. Case study 6: Endo Pharmaceuticals - Noramco
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: Auxilium Pharmaceuticals - Asahi Kasei
4.3.1.b. Case study 8: Durata Therapeutics - Hospira

Chapter 5 - Leading manufacturing and supply deals
5.1. Introduction
5.2. Top manufacturing and supply deals by value

Chapter 6 - Top 50 most active manufacturing and supply dealmakers
6.1. Introduction
6.2. Top 50 most active manufacturing and supply dealmakers

Chapter 7 - Manufacturing and supply deals contract directory since 2012
7.1. Introduction
7.2. Manufacturing and supply deals with contracts since 2012

Appendices
Appendix 1 - Manufacturing and supply deals by company A-Z
Appendix 2 - Manufacturing and supply deals by stage of development
Appendix 3 - Manufacturing and supply deals by deal type
Appendix 4 - Manufacturing and supply deals by therapy area
Appendix 5 - Manufacturing and supply deals by technology type
Appendix 6 -Deal type definitions

Current Partnering

LIST OF FIGURES

Figure 1: Definition of manufacturing and supply
Figure 2: Types of manufacturing agreement
Figure 3: Trends in manufacturing and supply deal announcements since 2012
Figure 4: Manufacturing and supply deals signed at each phase of development since 2012
Figure 5: Manufacturing and supply deals by industry sector since 2012
Figure 6: Manufacturing and supply deals by therapy area since 2012
Figure 7: Manufacturing and supply deals by technology type since 2012
Figure 8: Top 50 most active manufacturing and supply dealmakers since 2012
Figure 9: Components of the manufacturing deal structure
Figure 10: Components of the supply deal structure
Figure 11: Top manufacturing and supply deals by value since 2012
Figure 12: Most active manufacturing and supply dealmakers since 2012
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