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製薬・バイオテクノロジー・診断産業における共同開発の提携条件・契約

Global Co-development Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010 to 2016

発行 Current Partnering, a division of Wildwood Ventures Limited 商品コード 309761
出版日 ページ情報 英文 597 Pages
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製薬・バイオテクノロジー・診断産業における共同開発の提携条件・契約 Global Co-development Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010 to 2016
出版日: 2016年09月01日 ページ情報: 英文 597 Pages
概要

当レポートでは、全世界の主な生命科学企業(製薬・バイオテクノロジー・診断企業)における共同開発契約の締結動向について分析し、共同開発契約の主な内容・構造・条件・傾向、代表的な契約の事例、分野別(製薬/バイオテクノロジー産業)の契約締結動向、近年の主な共同開発契約の一覧、取引条件の比較といった情報を取りまとめてお届けいたします。

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 共同開発の契約締結の傾向

  • イントロダクション
  • 共同開発契約の定義
  • 共同開発契約の成功要因
  • 共同開発契約の履行時期
  • 共同開発契約の特徴
  • 共同開発に際してのパートナーとの連携
  • 2009年以降の共同開発契約の動向
  • 共同開発のオプション
  • 今後の共同開発契約の見通し

第3章 共同開発契約の構造:概要

  • イントロダクション
  • 単純型/多成分型の共同開発契約
  • 単純型の共同開発契約の構造
    • 共同開発契約の事例
      • ケーススタディ1:Ambrx・Zhejiang Medicine間の契約(2013年6月)
      • ケーススタディ2:UniQure・Chiesi間の契約(2013年7月)

第4章 代表的な共同開発契約

  • イントロダクション
  • 主な大型共同開発契約と契約金額
  • 共同開発契約に積極的な企業
  • 大手製薬企業の共同開発契約活動

第5章 大手製薬企業の共同開発契約

  • イントロダクション
  • 共同開発契約の活用方法
  • 各社の共同開発契約の一覧

第6章 大手バイオテクノロジー企業の共同開発契約

  • イントロダクション
  • 共同開発契約の活用方法
  • 各社の共同開発契約の一覧

第7章 共同開発契約の一覧(過去6年間分)

  • イントロダクション
  • 企業名順(A〜Z)
  • 治療領域別
    • 麻酔科
    • 心血管疾患
    • 中枢神経系(CNS)疾患
    • 皮膚疾患
    • 胃腸障害
    • 遺伝子疾患
    • 婦人科
    • 血液疾患
    • 入院治療
    • 免疫疾患
    • 感染症
    • 代謝障害
    • 筋骨格系疾患
    • 腫瘍
    • 眼病
    • 奇病
    • 精神疾患
    • 公衆衛生
    • 呼吸器疾患
  • 締結時の開発段階別
    • 創薬
    • 前臨床
    • 第I相
    • 第II相
    • 第III相
    • 認証中
    • 上市済み
    • 剤形
  • 技術領域別
    • 抗体
    • アッセイ(検定)
    • 生体化合物
    • バイオマーカー
    • バイオマテリアル
    • バイオシミラー/バイオベター
    • 治験
    • 医療機器
    • 診断
    • 創薬用ツール
    • DNAプローブ
    • ドラッグデリバリ(薬剤送達)
    • 実現技術
    • 装置
    • 遺伝子治療
    • ゲノミクス
    • 工業用化学品
    • ナノテクノロジー
    • 天然物
    • オリゴヌクレオチド
    • ペプチド
    • 過程
    • プロテオミクス
    • 遺伝子組み換え型DNA
    • 研究サービス
    • RNA治療薬
    • スクリーニング
    • 小分子
    • ソフトウェア・ツール
    • ワクチン

付録

  • 付録1:共同開発に関する参考文献
  • 付録2:情報源
  • 付録3:契約の種類の定義

Wildwood Venturesについて

図表一覧

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目次
Product Code: CP2062

The Global Co-development Partnering Terms and Agreements in Pharma, Biotech & Diagnostics 2010-2016 report provides comprehensive understanding and unprecedented access to the co-development deals and agreements entered into by the worlds leading healthcare companies

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

This report provides details of the latest Co-development agreements announced in the pharmaceutical, biotechnology and diagnostic sectors. Fully revised and updated, the report provides details of Co-development agreements from 2010 to 2016.

There is an increasing willingness for parties to enter co-development deals; such deals enable both parties to benefit from the upside of a big product win, whereas traditional licensing deals forfeit upside for near term upfront, milestone and royalty payments.

Co-development partnering allow the parties to securitize value and reduce risk, but keep a part of the potential upside should the product reach the market. Event if the licensor does not commercialize the project they can either sell those rights to the licensee partner or another partner for an amount higher than would have been achieved at an earlier stage licensing deal.

There are mainly two forms of co-development deals; Either the parties agree on a certain division of ownership, or decide that one party gets the rights to commercialise the drug in a certain geographical area, and the other side gets the other geographical area rights. Typically, the ownership division applies when it is likely that the project will be licensed at a later point in time. The geographical split usually applies when the two companies are determined to commercialise the drug themselves.

Another reason for co-development deals is the joint origin of a project. Drug development projects often require various scientific and technological novelties that stem from different companies. If both companies contributed to the origination of the project, then both have from the beginning a stake in the project.

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 Co-development 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 Co-development 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 Co-development dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in Co-development as well as a discussion on the merits of the type of deal.

Chapter 3 provides an overview of the structure of Co-development deals. The chapter includes numerous case studies to enable understanding of both pure Co-development deals and multicomponent deals where Co-development forms a part.

Chapter 4 provides a review of the leading Co-development 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 comprehensive listing of the top 50 most active Co-development dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 6 provides a comprehensive review of co-development 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 Co-development deals organized by company A-Z, therapy, technology and industry type signed and announced since 2010 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the Co-development deal.

The appendices to the report includes a comprehensive listing of all Co-development deals announced since 2010. Each listing is organized as an appendix by company A-Z, stage of development at signing, therapeutic area and industry type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.

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 Co-development dealmaking since 2010.

In conclusion, this report provides everything a prospective dealmaker needs to know about Co-development alliances.

Key benefits

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

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

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

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

In Global Co-development 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 Co-development Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010-2016 report provides comprehensive access to available contract documents for co-development 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 Co-development Partnering Terms and Agreements in Pharma, Biotech & Diagnostics 2010-2016 provides the reader with the following key benefits:

  • In-depth understanding of co-development deal trends since 2010
  • Analysis of the structure of co-development agreements with numerous real life case studies
  • Comprehensive listing of all co-development deals since 2010, together with deal terms, value and press release
  • Comprehensive access to actual co-development 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 co-development 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

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in Co-development dealmaking

  • 2.1. Introduction
  • 2.2. Definition of co-development deals
  • 2.3. Success factors for co-development deals
  • 2.4. When co-development can be useful
  • 2.5. Attributes of co-development deals
  • 2.6. Aligning partners to make the co-development work
  • 2.7. Trends in Co-development deals since 2010
    • 2.7.1. Co-development dealmaking by year, 2010 to 2016
    • 2.7.2. Co-development dealmaking by phase of development, 2010 to 2016
    • 2.7.3. Co-development dealmaking by industry sector, 2010 to 2016
    • 2.7.4. Co-development dealmaking by therapy area, 2010 to 2016
    • 2.7.5. Co-development dealmaking by technology type, 2010 to 2016
    • 2.7.6. Co-development dealmaking by most active company, 2010 to 2016
  • 2.8. Option to co-develop
  • 2.9. The future of co-development deals

Chapter 3 - Overview of Co-development deal structure

  • 3.1. Introduction
  • 3.2. Pure versus multi-component co-development deals
  • 3.3. Pure co-development agreement structure
    • 3.3.1. Example co-development agreements
    • 3.3.1.a. Case study 1: Ambrx - Zhejiang Medicine
    • 3.3.1.b. Case study 2: UniQure - Chiesi

Chapter 4 - Leading Co-development deals

  • 4.1. Introduction
  • 4.2. Top Co-development deals by value

Chapter 5 - Top 50 most active Co-development dealmakers

  • 5.1. Introduction
  • 5.2. Top 50 most active Co-development dealmakers

Chapter 6 - Co-development deal term financials

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

Chapter 7 - Co-development deals including contracts directory

  • 7.1. Introduction
  • 7.2. Co-development deals with contracts 2010 to 2016

Appendices

  • Appendix 1 - Co-development dealmaking by companies A-Z
  • Appendix 2 - Co-development dealmaking by industry sector
  • Appendix 3 - Co-development dealmaking by stage of development
  • Appendix 4 - Co-development dealmaking by therapy area
  • Appendix 5 - Co-development dealmaking by technology
  • About Wildwood Ventures
  • Current Partnering
  • Current Agreements
  • Recent report titles from Current Partnering

TABLE OF FIGURES

  • Figure 1: Definition of co-development
  • Figure 2: Situations where co-development can prove useful
  • Figure 3: Key components of a co-development deal
  • Figure 4: Issues in implementing co-development agreements
  • Figure 5: Trends in Co-development deal announcements, 2010 to 2016
  • Figure 6: Co-development deals signed at each phase of development, 2010 to 2016
  • Figure 7: Co-development deals by industry sector, 2010 to 2016
  • Figure 8: Co-development deals by therapy area, 2010 to 2016
  • Figure 9: Co-development deals by technology type, 2010 to 2016
  • Figure 10: Top 50 most active co-development dealmakers, 2010 to 2016
  • Figure 11: Co-development agreements - what should a contract include?
  • Figure 12: Components of the co-development deal structure
  • Figure 13: Top co-development deals by value 2010 to 2016
  • Figure 14: Most active Co-development dealmakers 2010 to 2016
  • Figure 15: Co-development deals with a headline value
  • Figure 16: Co-development deals with an upfront value
  • Figure 17: Co-development deals with a milestone value
  • Figure 18: Co-development deals with a royalty rate value
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