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在製药、生物科技企业的临床阶段的联盟契约和条件 (2014？2020年)
市场调查报告书
商品编码
121244

在製药、生物科技企业的临床阶段的联盟契约和条件 (2014？2020年)

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023
出版日期: | 出版商: Current Partnering | 英文 1900+ Pages | 商品交期: 最快1-2个工作天内

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简介目录

本报告提供全球主要製药企业及生物科技企业的，在临床实验阶段的联盟契约的缔结趋势的相关调查，契约概要和目的，支付条件，各契约、疾病、技术类型的联盟契约数量趋势，代表性案例(案例研究)，相关企业的一览，契约的详细资讯 (共2000件以上)等资讯彙整，为您概述为以下内容。

目录

摘要整理

第1章 简介

第2章 在临床阶段的化合物相关签订契约的理由

  • 简介
  • 在临床阶段的联盟所扮演的角色
    • 在临床阶段的引入授权
    • 在临床阶段的转出授权
  • 在第I～III相的交易的差异
  • 在临床阶段签订联盟契约的理由
    • 授权侧 (授权人) 签订临床阶段契约的理由
    • 授权取得侧 (被授权人) 签订临床阶段契约的理由
  • 在临床阶段的联盟契约的未来性

第3章 在临床阶段的交易的策略与结构

  • 简介
  • 在哪个阶段各企业签订联盟契约？
    • 在临床早期的製药/生物科技企业的联盟
    • 在临床后期的製药/生物科技企业的联盟
  • 在临床早期、后期的联盟:风险/成本比较
  • 在临床阶段的缔结的支出额
  • 专门/复合契约的差异
  • 专门授权合约结构
    • 代表性案例
  • 多成分临床阶段合作伙伴契约
    • 在临床阶段的复合联盟契约
    • 代表性案例

第4章 在临床阶段的联盟的付款策略

  • 简介
  • 在临床阶段的付款策略
  • 付款的选择

第5章 在临床阶段的契约缔结的趋势

  • 简介
    • 在第一阶段的联盟趋势 (2014年以后)
    • 在第二阶段的联盟趋势 (2014年以后)
    • 在第三阶段的联盟趋势 (2014年以后)
  • 在临床阶段的联盟趋势:各交易类型
  • 在临床阶段的联盟趋势:疾病的各类型
  • 联盟趋势:临床阶段的各技术种类
  • 在临床阶段的联盟趋势:最活跃的企业的情况 (2014年以后)

第6章 在临床阶段的联盟契约的付款条件

  • 简介
  • 在临床阶段的付款条件的指南
    • 预付款
    • 阶段性付款
    • 特许权支付
  • 在临床阶段的付款条件:契约资料分析
    • 公共资料
    • 调查资料
  • 付款条件分析
    • 在临床阶段的契约总额
    • 在临床阶段的预付款
    • 在临床阶段的阶段性付款
    • 在临床阶段的权利金费率
  • 在临床阶段的平均财务指标

第7章 在临床阶段的主要契约

  • 简介
  • 在临床阶段的主要契约:各金额

第8章 在临床阶段的最活跃的契约对方:前25名公司

  • 简介
  • 在临床阶段的最活跃的契约对方:前25名公司

第9章 在临床阶段的联盟契约的一览

  • 简介
  • 在临床阶段的联盟契约动向 (2014年以后)

第10章 在临床阶段的契约缔结:各临床实验阶段趋势

  • 简介
  • 各临床实验阶段的交易趋势
  • 阶段I
  • 阶段II
  • 阶段III
  • 法规

附录

简介目录
Product Code: CP2058

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 provides comprehensive understanding and unprecedented access to clinical stage partnering agreements entered into by the worlds leading biopharma companies

The Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 report provides a detailed understanding and analysis of how and why companies enter clinical stage partnering deals and provides details of the latest clinical 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 2,900 clinical stage partnering deals announced since 2016 including financial terms where available including numerous links to online deal records of actual clinical 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.

The initial chapters of this report provide an orientation of clinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner clinical stage compounds/products.

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

Chapter 5 provides a review of clinical stage deal making since 2016. 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 clinical stage payment terms including headline, upfront, milestone and royalty rates for phase I, phase II and phase III deals.

Chapter 7 provides a review of the leading clinical 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 25 most active clinical 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 clinical stage partnering deals signed and announced since 2016, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of clinical stage partnering deals since 2016 organized by stage of development - phase I, phase II and phase III.

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 clinical stage partnering and deal making since 2016.

In addition, a comprehensive appendix of all clinical stage deals since 2016 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 clinical stage products and compounds.

Key benefits

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016 - 2023 provides the reader with the following key benefits:

  • In-depth understanding of clinical stage deal trends since 2016
  • Access to headline, upfront, milestone and royalty data
  • Analysis of the structure of clinical stage agreements with numerous real life case studies
  • Insight into the terms included in a clinical 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 Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016 - 2023 is intended to provide the reader with an in-depth understanding and access to clinical stage deal trends and structure of deals entered into by leading companies worldwide.

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016 - 2023 includes:

  • Trends in clinical stage dealmaking in the biopharma industry since 2016
  • Analysis of clinical stage deal structure
  • Access to headline, upfront, milestone and royalty data
  • Case studies of real-life clinical stage deals
  • Access to over 2,900 clinical stage deals
  • The leading clinical stage deals by value since 2016
  • Most active clinical stage dealmakers since 2016
  • The leading clinical stage partnering resources

In Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016 - 2023, 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 Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016 - 2023 report provides comprehensive access to available deals and contract documents for over 2,900 clinical 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 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?

Benefits

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 provides the reader with the following key benefits:

  • In-depth understanding of clinical stage deal trends since 2016
  • Access to headline, upfront, milestone and royalty data
  • Comprehensive access to over 2,900 clinical stage deals together with contract documents if available
  • Detailed access to actual clinical stage deals entered into by the leading fifty big pharma and big biotech companies along with other biopharma companies
  • Analysis of the structure of clinical stage agreements with numerous real life case studies
  • Identify leading clinical stage deals by value since 2016
  • Identify the most active clinical stage dealmakers since 2016
  • Full listing of clinical stage deals by company A-Z, phase of development, deal type, therapy and technology focus
  • 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 - Why do companies partner clinical stage compounds?

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

Chapter 3 - Clinical 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 1
    • 3.2.1.1.b. Case study 2
    • 3.2.1.1.c. Case study 3
    • 3.2.1.1.d. Case study 4
    • 3.2.2. Partnering later in pharmaceutical/biotech
    • 3.2.2.1. Clinical stage partnering case studies
    • 3.2.2.1.a. Case study 5
    • 3.2.2.1.b. Case study 6
    • 3.2.2.1.c. Case study 7
    • 3.2.2.1.d. Case study 8
  • 3.3. Early and later stage partnering - a risk/cost comparison
  • 3.4. What do companies spend on clinical stage partnering?
  • 3.5. Pure versus multi-component partnering deals
  • 3.6. Pure licensing agreement structure
    • 3.6.1. Example pure licensing agreements
    • 3.6.1.a. Case study 9
    • 3.6.1.b. Case study 10
  • 3.7. Multicomponent clinical stage partnering agreements
    • 3.7.1. Example multicomponent clinical stage clauses
    • 3.7.1.a. Case study 11

Chapter 4 - Clinical stage partnering payment strategies

  • 4.1. Introduction
  • 4.2. Clinical 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 12
    • 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 clinical stage deal making

  • 5.1. Introduction
  • 5.2. Clinical stage partnering over the years
    • 5.2.1. Trends in phase I deals since 2016
    • 5.2.1.1. Attributes of phase I deals
    • 5.2.2. Trends in phase II deals since 2016
    • 5.2.2.2. Attributes of phase II deals
    • 5.2.3. Trends in phase III deals since 2016
    • 5.2.3.1. Attributes of phase III deals
  • 5.3. Clinical stage partnering by deal type
  • 5.4. Clinical stage partnering by disease type
  • 5.5. Partnering by clinical stage technology type
  • 5.6. Clinical stage partnering by most active company since 2016

Chapter 6 - Payment terms for clinical stage partnering

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

Chapter 7 - Leading clinical stage deals

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

Chapter 8 - Top 25 most active clinical stage dealmakers

  • 8.1. Introduction
  • 8.2. Top 25 most active clinical stage dealmakers

Chapter 9 - Clinical stage partnering contracts directory

  • 9.1. Introduction
  • 9.2. Clinical stage deals with contracts since 2016

Chapter 10 - Clinical stage deal making by development stage

  • 10.1. Introduction
  • 10.2. Deals by clinical stage
  • Phase I
  • Phase II
  • Phase III
  • Regulatory

Appendices

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

About Wildwood Ventures

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

Table of figures

  • Figure 1: Definition of clinical phases in dealmaking
  • Figure 2: Components of the pure licensing deal structure
  • Figure 3: Payment options for clinical stage partnering deals
  • Figure 4: Issues affecting royalty rates
  • Figure 5: Clinical stage partnering by deal type since 2016
  • Figure 6: Clinical stage partnering by disease type since 2016
  • Figure 7: Clinical stage partnering by technology type since 2016
  • Figure 8: Top 25 most active clinical stage dealmakers, 2016 to 2023
  • Figure 9: Review of upfront payments for clinical stage deals
  • Figure 10: Review of milestone payments for clinical stage deals
  • Figure 11: Review of royalty payments for clinical stage deals
  • Figure 12: Clinical stage deals with a headline value
  • Figure 13: Clinical stage deals with an upfront value
  • Figure 14: Clinical stage deals with a milestone value
  • Figure 15: Clinical stage deals with a royalty rate value
  • Figure 16: Top clinical stage deals by value since 2016
  • Figure 17: Most active clinical stage dealmakers 2016 to 2023