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醫藥品·生物科技·診斷的各臨床實驗階段的合作條件與契約趨勢

Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016

出版商 Current Partnering, a division of Wildwood Ventures Limited 商品編碼 117615
出版日期 內容資訊 英文 1,000+ pages
商品交期: 最快1-2個工作天內
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醫藥品·生物科技·診斷的各臨床實驗階段的合作條件與契約趨勢 Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016
出版日期: 2016年10月05日 內容資訊: 英文 1,000+ pages
簡介

本報告提供全球主要醫療保健企業的臨床階段的合作契約和協定內容相關分析,企業在臨床階段何作的理由,契約策略與契約結構,契約的檢討,支付條件,主要的臨床實驗契約的各金額檢討等彙整資料,為您概述為以下內容。

摘要整理

第1章 簡介

第2章 企業用臨床實驗階段的化合物合作的理由?

  • 簡介
  • 臨床實驗階段的合作所扮演的角色
  • 第一階段,第2階段,第3階段的交易差異
  • 簽訂各臨床實驗階段合作契約的理由
  • 未來臨床實驗契約趨勢

第3章 臨床實驗階段的契約策略與結構

  • 簡介
  • 企業在哪個階段合作?
  • 初期·後期階段的合作-風險/成本比較
  • 企業臨床實驗契約花費的金額?
  • 單一V.S.多因素結構契約
  • 單一授權契約結構
  • 多因素合作契約

第4章 臨床實驗合作的付款策略

  • 簡介
  • 臨床實驗付款策略
  • 付款方式

第5章 臨床實驗契約功能趨勢

  • 簡介
  • 多年的臨床實驗合作
  • 大型製藥企業臨床實驗契約活動
  • 大生物科技企業臨床實驗契約活動
  • 臨床實驗合作:各類型契約
  • 臨床實驗合作:疾病各類型
  • 合作:臨床實驗各技術類型

第6章 臨床實驗合作的平均付款條件

  • 簡介
  • 臨床實驗付款條件的指南
  • 臨床實驗付款-契約資料分析
  • 付款條件分析

第7章 主要臨床實驗契約

  • 簡介
  • 主要的臨床實驗契約:各金額

第8章 大型製藥企業及大生物科技企業臨床實驗契約

  • 簡介
  • 大型製藥企業/大生物科技企業臨床實驗契約方法
  • 大型製藥企業臨床實驗合作企業簡介
  • 大生物科技企業臨床實驗合作企業簡介

第9章 臨床實驗合作契約名錄

  • 簡介
  • 企業A-Z
  • 各類型契約
  • 各開發階段
  • 治療各領域

第10章 臨床實驗契約功能:各開發階段

  • 簡介
  • 契約:各臨床實驗階段

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目錄
Product Code: CP2057

The ‘ Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’report provides a detailed understanding and analysis of how, why and what terms companies enter preclinical stage partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest preclinical agreements announced in the healthcare sector.

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 2,000 preclinical stage partnering deals announced since 2010 including financial terms, where available, including links to online deal records of actual preclinical partnering deals as disclosed by the deal parties. In addition, where available, records include 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 preclinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner preclinical stage compounds/products.

Chapter 3 provides an overview of preclinical stage deals strategy and deal structure including numerous case studies. Chapter 4 provides an overview of the various payment strategies used in preclinical stage deals.

Chapter 5 provides a review of preclinical stage deal making since 2010. Deals activity is reviewed by year, stage of development at signing, therapeutic area, technology type, as well as most active dealmakers.

Chapter 6 provides a detailed analysis of preclinical stage payment terms including headline, upfront, milestone and royalty rates.

Chapter 7 provides a review of the leading preclinical stage deal by headline value. 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 8 provides a comprehensive listing of the top 50 most active preclinical stage 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 9 provides a comprehensive and detailed review of preclinical stage partnering deals signed and announced since 2010, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of preclinical stage partnering deals since 2010.

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 tables and figures that illustrate the trends and activities in preclinical stage partnering and deal making since 2010.

In addition, a comprehensive appendix of all preclinical deals since 2010 is provided organized by partnering company A-Z, deal type, therapy focus and technology type. 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 partnering in the research, development and commercialization of preclinical stage products and compounds.

Key benefits

‘Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’ provides the reader with the following key benefits:

  • In-depth understanding of preclinical stage deal trends since 2010
  • Access to headline, upfront, milestone and royalty data
  • Analysis of the structure of preclinical stage agreements with numerous real life case studies
  • Insight into the terms included in a preclinical stage 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 Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’is intended to provide the reader with an in-depth understanding and access to preclinical stage deal trends and structure of deals entered into by leading companies worldwide.

‘Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’includes:

  • Trends in preclinical stage dealmaking in the biopharma industry since 2010
  • Analysis of preclinical stage deal structure
  • Access to headline, upfront, milestone and royalty data
  • Case studies of real-life preclinical stage deals
  • Access to over 2,000 preclinical stage deals
  • The leading preclinical stage deals by value since 2010
  • Most active preclinical stage dealmakers since 2010
  • The leading preclinical stage partnering resources

In ‘Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’, the available contracts are listed by:

  • Company A-Z
  • Headline value
  • Stage of development at signing
  • Deal type
  • Specific therapy target

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.

The ‘Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 ’ report provides comprehensive access to available deals and contract documents for over 2,000 preclinical stage 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 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?

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do companies partner preclinical stage compounds?

  • 2.1. Introduction
  • 2.2. The role of preclinical stage partnering
    • 2.2.1. In-licensing at preclinical stage
    • 2.2.2. Out-licensing at preclinical stage
  • 2.3. Difference between discovery, preclinical and clinical stage deals
  • 2.4. Reasons for entering into preclinical stage partnering deals
    • 2.4.1. Licensors reasons for entering preclinical stage deals
    • 2.4.2. Licensees reasons for entering preclinical stage deals
  • 2.5. The future of preclinical stage partnering deals

Chapter 3 - Preclinical stage deal strategies and structure

  • 3.1. Introduction
  • 3.2. At what stage do companies partner?
    • 3.2.1. Partnering early in pharmaceutical / biotech
      • 3.2.1.1. Discovery and preclinical stage partnering case studies
        • 3.2.1.1.a. Case study: LEO Pharma - 4SC
        • 3.2.1.1.b. Case study: Heptares Therapeutics - Cubist
        • 3.2.1.1.c. Case study: Incyte - Agenus Bio
        • 3.2.1.1.d. Case study: Janssen Pharmaceutical - Evotec
    • 3.2.2. Partnering later in pharmaceutical/biotech
      • 3.2.2.1. Clinical stage partnering case studies
        • 3.2.2.1.a. Case study: Servier - GeNeuro
        • 3.2.2.1.b. Case study: Teva - Xenon Pharmaceuticals
        • 3.2.2.1.c. Case study: AstraZeneca - Ardelyx
        • 3.2.2.1.d. Case study: Baxter - Onconova Therapeutics
  • 3.3. Early and later stage partnering - a risk/cost comparison
  • 3.4. What do companies spend on preclinical stage partnering?
  • 3.5. Pure versus multi-component partnering deals
  • 3.6. Pure licensing agreement structure
    • 3.6.1. Example pure preclinical stage licensing agreements
      • 3.6.1.a. Case study : Merck and Co. - Tesaro
      • 3.6.1.b. Case study : Marina Biotech - Mirna Therapeutics
  • 3.7. Multicomponent preclinical stage partnering agreements
    • 3.7.1. Example multicomponent preclinical stage clauses
      • 3.7.1.a. Case study: Eleven Biotherapeutics - ThromboGenics
      • 3.7.1.b. Case study: Pfizer - InSite Vision

Chapter 4 - Preclinical stage partnering payment strategies

  • 4.1. Introduction
  • 4.2. Preclinical stage payment strategies
  • 4.3. Payment options
    • 4.3.1. Headline values
    • 4.3.2. Upfront payments
      • 4.3.2.1. Conditionality of upfront payments
    • 4.3.3. Loans
    • 4.3.4. Convertible loans
    • 4.3.5. Equity
    • 4.3.6. R&D funding
    • 4.3.7. Licensing fees
    • 4.3.8. Milestone payments
    • 4.3.9. Royalty payments
      • 4.3.9.1. Issues affecting royalty rates
      • 4.3.9.2. Royalties on combination products
        • 4.3.9.2.a. Case study: Scripps Research Institute-Cyanotech
      • 4.3.9.3. Guaranteed minimum/maximum annual payments
      • 4.3.9.4. Royalty stacking
      • 4.3.9.5. Royalties and supply/purchase contracts
    • 4.3.10. Quids
    • 4.3.11. Option payments

Chapter 5 - Trends in preclinical stage deal making

  • 5.1. Introduction
  • 5.2. Preclinical stage partnering over the years
    • 5.2.1. Attributes of preclinical deals
  • 5.3. Preclinical stage partnering by deal type
  • 5.4. Preclinical stage partnering by disease type
  • 5.5. Partnering by preclinical stage technology type
  • 5.6. Preclinical stage partnering by most active company, 2010 to 2016

Chapter 6 - Payment terms for preclinical stage partnering

  • 6.1. Introduction
  • 6.2. Guidelines for preclinical stage payment terms
    • 6.2.1. Upfront payments
    • 6.2.2. Milestone payments
    • 6.2.3. Royalty payments
  • 6.3. Preclinical stage payment terms - deal data analysis
    • 6.3.1. Public data
    • 6.3.2. Survey data
  • 6.4. Payment terms analysis
    • 6.4.1. Preclinical stage headline values
    • 6.4.2. Preclinical stage deal upfront payments
    • 6.4.3. Preclinical stage deal milestone payments
    • 6.4.4. Preclinical stage royalty rates

Chapter 7 - Leading preclinical stage deals

  • 7.1. Introduction
  • 7.2. Top preclinical stage deals by value

Chapter 8 - Top 50 most active preclinical stage dealmakers

  • 8.1. Introduction
  • 8.2. Top 50 most active preclinical stage dealmakers

Chapter 9 - Preclinical stage partnering contracts directory

  • 9.1. Introduction
  • 9.2. Preclinical stage deals with contracts 2010 to 2016

Chapter 10 - Preclinical stage deal making by development stage

  • 10.1. Introduction
  • 10.2. Deals by preclinical stage

Appendices

Appendix 1 - Preclinical stage dealmaking by companies A-Z

Appendix 2 - Preclinical stage dealmaking by industry sector

Appendix 3 - Preclinical stage dealmaking by stage of development

Appendix 4 - Preclinical stage dealmaking by therapy area

Appendix 5 - Preclinical stage dealmaking by technology type

About Wildwood Ventures

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

Table of figures

  • Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking
  • Figure 2: Agreements signed by phase of development (2010- 2016), % of all deals
  • Figure 3: Components of the pure licensing deal structure
  • Figure 4: Payment options for preclinical stage partnering deals
  • Figure 5: Issues affecting royalty rates
  • Figure 6: Preclinical stage partnering frequency 2010- 2016
  • Figure 7: Preclinical stage partnering by deal type since 2010
  • Figure 8: Preclinical stage partnering by disease type since 2010
  • Figure 9: Preclinical stage partnering by technology type since 2010
  • Figure 10: Top 50 most active preclinical stage dealmakers, 2010 to 2016
  • Figure 11: Review of upfront payments for preclinical stage deals
  • Figure 12: Review of milestone payments for preclinical stage deals
  • Figure 13: Review of royalty payments for preclinical stage deals
  • Figure 14: Preclinical stage deals with a headline value
  • Figure 15: Preclinical stage deals with an upfront value
  • Figure 16: Preclinical stage deals with a milestone value
  • Figure 17: Preclinical stage deals with a royalty rate value
  • Figure 18: Top preclinical stage deals by value since 2010
  • Figure 19: Most active preclinical stage dealmakers 2010 to 2016
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