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製薬業界、バイオテクノロジー業界、診断技術業界におけるライセンスの条件と契約

Global Licensing Partnering Terms & Agreements in Pharma, Biotech & Diagnostics 2010-2016

発行 Current Partnering, a division of Wildwood Ventures Limited 商品コード 307394
出版日 ページ情報 英文 2,500+ Pages
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製薬業界、バイオテクノロジー業界、診断技術業界におけるライセンスの条件と契約 Global Licensing Partnering Terms & Agreements in Pharma, Biotech & Diagnostics 2010-2016
出版日: 2016年05月02日 ページ情報: 英文 2,500+ Pages
概要

当レポートは、生命科学に関連する業界で国際的に事業を展開している有力な企業が締結したライセンス契約のトレンドや構造を詳しく紹介するもので、契約のケーススタディ、財務関係の主な指標、ライセンス契約に関する資料、生物医薬品メーカーとその提携相手が米証券取引委員会に提出した実際のライセンス契約文書へのリンクなど、製薬会社やバイオテクノロジー企業が契約交渉を有利に進めるうえで役に立つ情報を幅広く網羅しています。

エグゼクティブ・サマリー

第1章 イントロダクション

第2章 ライセンス契約のトレンド

  • イントロダクション
  • ライセンス契約の定義
  • ライセンス契約を成功に導く要因
  • ライセンスが有効性を発揮する場面
  • ライセンス契約の特性
  • 2009年以降のライセンス契約のトレンド
  • ライセンスオプション
  • 共同販売促進活動に関する条項の追加
  • 今後のライセンス契約

第3章 ライセンス契約の構造の概要

  • イントロダクション
  • 純粋なマルチコンポーネントライセンス契約
  • 純粋なライセンス契約の構造
    • ライセンス契約の例
      • ケーススタディ1:Ignyta - Nerviano Medical Sciences(2013年11月)
      • ケーススタディ2:Sanofi - Pozen(2013年9月)
  • 広範な提携合意の一部となっている各種権利のライセンス
    • ライセンス条項の例
      • ケーススタディ3:4D Molecular Therapeutics - UniQure(2013年11月)
      • ケーススタディ4:協和発酵キリン−Ultragenyx Pharmaceuticals(2013年9月)
    • ライセンス契約のオプション権条項の例
      • ケーススタディ5:Forest Laboratories - Trevena(2013年5月)
      • ケーススタディ6:Abbvie - Receptos(2013年3月)

第4章 主なライセンス契約

  • イントロダクション
    • 契約額の大きいライセンス契約
    • ライセンス契約締結に積極的な企業
  • 大手製薬会社のライセンス契約をめぐる動き
  • 大手バイオテクノロジー企業のライセンス契約をめぐる動き

第5章 ライセンス契約条件のベンチマーク

  • イントロダクション
    • 契約の総額
    • 前払い金
    • 目標達成報奨金
    • ロイヤルティ率

第6章 大手製薬会社のライセンス契約

  • イントロダクション
  • ライセンス契約の利用方法
  • ライセンス契約を締結した企業の一覧

第7章 バイオテクノロジー企業のライセンス契約

  • イントロダクション
  • ライセンス契約の利用方法
  • ライセンス契約を締結した企業の一覧

第8章 2009〜2014年のライセンス契約要覧

  • イントロダクション
  • ライセンス契約総覧

付録

図表

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目次
Product Code: CP2063

The Global Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 report provides comprehensive understanding and unprecedented access to the licensing deals and agreements entered into by the worlds leading life science companies.

This report provides details of the latest licensing agreements announced in the pharmaceutical, biotechnology and diagnostic sectors. Fully up to date, the report provides details of licensing agreements from 2010 to 2016.

There has been a long standing willingness for parties to enter licensing deals. Such deals enable both parties to benefit from the upside of a big R&D win, whilst mitigating the risks of going it alone in the risky preclinical and clinical development stages.

Licensing is a specific type of partnering deal whereby the parties to the deal agree to commercialize a compound, product or technology.

Specifically, licensing is the granting of permission to use intellectual property rights, such as trademarks, patents, or technology, under defined conditions

There are several forms of licensing deal. Traditional licensing arrangement whereby an owner of intellectual property (the licensor) provides access to its technology to another company (the licensee) in return for agreed payments and royalties on subsequent sales of product(s) derived from the intellectual property.

In more recent times, licensing is often the outcome of a successful period of collaboration on the research and development of a technology or compound, resulting in a product which can be commercialized. In this situation, the licensing agreement governs who has permission to commercialize and what payments are due should commercialization proceed.

Other forms of licensing such as sub-licensing and cross-licensing are also explored, with examples provided together with listing of recent deals in pharma, biotech and diagnostics.

The report provides a detailed understand and analysis of how and why companies enter licensing deals. The majority of deals are multicomponent whereby the licensee retains either a right or option to license to commercialize the resultant product of the research collaboration. There are also numerous pure licensing deals whereby the products originator takes on a development/commercialization partner in order to maximize a technologies/products prospects.

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 payment 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 licensing deals announced since 2010 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual licensing 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 licensing deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in licensing as well as a discussion on the merits of the type of deal.

Chapter 3 provides an overview of the structure of licensing deals. The chapter includes numerous case studies to enable understanding of both pure licensing deals and multicomponent deals where collaborative R&D forms a part.

Chapter 4 provides a review of the leading licensing deals since 2010. 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 5 provides a review of the top 50 most active biopharma companies in licensing. 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 comprehensive review of licensing financials for deals announced since 2010, including headline value, upfront, milestone payments and royalty rates, providing both benchmark data and access to individual deal financials.

Chapter 7 provides a comprehensive and detailed review of licensing deals signed and announced since 2010 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 licensing deal making since 2010.

In addition, a comprehensive appendix is provided organized by licensing 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 licensing partnering in the research, development and commercialization of technologies and products.

Key benefits

Global Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 provides the reader with the following key benefits:

  • In-depth understanding of licensing partnering deal trends since 2010
  • Analysis of the structure of licensing agreements with numerous real life case studies
  • Comprehensive listing of over 4,500 licensing deals since 2010, together with deal terms, value and press release
  • Comprehensive access to actual licensing contracts entered into by the world's life science companies
  • Analysis of key deal financials including headline value, upfront, milestone payments and royalty rates
  • Insight into the terms included in a licensing 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 Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 is intended to provide the reader with an in-depth understanding of the licensing trends and structure of deals entered into by leading life science companies worldwide.

Global Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 includes:

  • Trends in licensing dealmaking in the biopharma industry since 2010
  • Analysis of licensing deal structure
  • Case studies of real-life licensing deals
  • Comprehensive listing of over 4,500 licensing deals since 2010
  • Access to licensing contract documents
  • Key financial bnchmarks for headline, upfront, milestone and royalty rates
  • The leading licensing deals by value since 2010
  • Most active licensing dealmakers since 2010
  • The leading licensing partnering resources

In Global Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 available deals and contracts are listed by:

  • Company A-Z
  • Headline value
  • Therapeutic area
  • Technology type

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

The Global Licensing Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010- 2016 report provides comprehensive access to available contract documents for licensing 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 do milestone align with clinical stage development phases?
  • 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?

Benefits

Global Licensing Partnering Terms & Agreements in Pharma, Biotech & Diagnostics 2010-2016 provides the reader with the following key benefits:

  • In-depth understanding of licensing partnering deal trends since 2010
  • Insight into the terms included in a licensing agreement, together with real world clause examples
  • Identify leading licensing deals by value since 2010
  • Identify the most active licensing dealmakers since 2010
  • Analysis of key deal financials including headline value, upfront, milestone payments and royalty rates
  • Full listing of licensing deals by company A-Z, deal value, phase of development, deal type, therapy and technology focus
  • Comprehensive access to over 3,500 licensing deals entered into by the world's biopharma companies, together with contract documents if available
  • Detailed access to actual licensing contracts entered into by the leading fifty big pharma and big biotech companies
  • 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

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in licensing deal making

  • 2.1. Introduction
  • 2.2. Definition of licensing deals
  • 2.3. Success factors for licensing deals
  • 2.4. When licensing can be useful
  • 2.5. Attributes of licensing deals
  • 2.6. Trends in licensing deals since 2010
    • 2.6.1. Licensing deal making by year, 2010 to 2016
    • 2.6.2. Licensing deal making by phase of development, 2010 to 2016
    • 2.6.3. Licensing deal making by industry sector, 2010 to 2016
    • 2.6.4. Licensing deal making by therapy area, 2010 to 2016
    • 2.6.5. Licensing deal making by technology type, 2010 to 2016
    • 2.6.6. Licensing deal making by most active company, 2010 to 2016
  • 2.7. Option to license
  • 2.8. Adding co-promotion to the mix
  • 2.9. The future of licensing deals

Chapter 3 - Overview of licensing deal structure

  • 3.1. Introduction
  • 3.2. Pure versus multi-component licensing deals
  • 3.3. Pure licensing agreement structure
    • 3.3.1. Example licensing agreements
    • 3.3.1.a. Case study 1: Ignyta - Nerviano Medical Sciences
    • 3.3.1.b. Case study 2: Sanofi - Pozen
  • 3.4. Licensing rights as part of a wider alliance agreement
    • 3.4.1. Example licensing clauses
      • 3.4.1.a. Case study 3: 4D Molecular Therapeutics - UniQure
      • 3.4.1.b. Case study 4: Kyowa Hakko Kirin - Ultragenyx Pharmaceuticals
    • 3.4.2. Example licensing option right clauses
      • 3.4.2.a. Case study 5: Forest Laboratories - Trevena
      • 3.4.2.b. Case study 6: Abbvie - Receptos

Chapter 4 - Leading licensing deals

  • 4.1. Introduction
  • 4.2. Top licensing deals by value

Chapter 5 - Top 50 most active licensing dealmakers

  • 5.1. Introduction
  • 5.2. Top 50 most active licensing dealmakers

Chapter 6 - Licensing deal term financials

  • 6.1. Introduction
  • 6.2. Licensing partnering headline values
  • 6.3. Licensing deal upfront payments
  • 6.4. Licensing deal milestone payments
  • 6.5. Licensing royalty rates

Chapter 7 - Licensing contract directory 2010 - 2016

  • 7.1. Introduction
  • 7.2. Licensing deals with contracts 2010 to 2016

Appendices

  • Appendix 1 - Licensing dealmaking by companies A-Z
  • Appendix 2 - Licensing dealmaking by industry sector
  • Appendix 3 - Licensing dealmaking by stage of development
  • Appendix 4 - Licensing dealmaking by therapy area
  • Appendix 5 - Licensing dealmaking by technology type

About Wildwood Ventures

  • Current Partnering
  • Current Agreements
  • Recent report titles from Current Partnering

TABLE OF FIGURES

  • Figure 1: Definition of licensing
  • Figure 2: Situations where licensing can prove useful
  • Figure 3: Key attributes of a licensing deal
  • Figure 4: Trends in licensing deal announcements, 2010 to 2016
  • Figure 5: Licensing deals signed at each phase of development, 2010 to 2016
  • Figure 6: Licensing deals by industry sector, 2010 to 2016
  • Figure 7: Licensing deals by therapy area, 2010 to 2016
  • Figure 8: Licensing deals by technology type, 2010 to 2016
  • Figure 9: Top 50 most active licensing dealmakers, 2010 to 2016
  • Figure 10: Licensing agreements - what should a contract include?
  • Figure 11: Components of the licensing deal structure
  • Figure 12: Top licensing deals by value 2010 to 2016
  • Figure 13: Most active licensing dealmakers 2010 to 2016
  • Figure 14: Licensing deals with a headline value
  • Figure 15: Licensing deals with an upfront value
  • Figure 16: Licensing deals with a milestone value
  • Figure 17: Licensing deals with a royalty rate value
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