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市场调查报告书
商品编码
1539236

全球製药和生物技术产业临床阶段合作条款和协议（2019-2024）

Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024
出版日期: | 出版商: Current Partnering | 英文 1500+ Pages | 商品交期: 最快1-2个工作天内

价格

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简介目录

本报告深入了解并分析了公司如何、为何以及在什么条件下进行临床阶段合作。这些交易属于临床阶段交易，被授权人获得许可授权人产品或技术的权利或选择权。这些交易往往是跨部门的，从合作研发开始，一直延伸到成果的商业化。

本报告深入了解并分析了公司如何以及为何签订临床阶段合作协议，并提供了医疗保健领域宣布的最新临床协议的详细资讯。

了解潜在合作伙伴谈判的交易条款的灵活性有助于深入了解谈判过程，了解条款谈判期间的预期结果。虽然许多小型企业想要详细的付款条款，但付款方式的问题在于细节。

本报告提供了自2016年以来宣布的1,800 多项临床阶段合作的完整列表，其中包含交易各方披露的实际临床合作的线上交易记录的大量链接（如有）。此外，如果有的话，还包括公司及其合作伙伴向美国证券交易委员会提交的合约文件。

本报告也包括一些图表，显示自2019年以来与临床阶段合作伙伴关係和交易相关的趋势和活动。

此外，还提供了自2019年以来所有发现的综合附录，按合作伙伴名称（A-Z）、病例类型、治疗重点领域和技术类型进行组织。每笔交易的标题都透过网路连结连结到交易记录的线上版本，并在可用的情况下连结到合约文件，以便在需要时轻鬆存取每个合约文件。

总而言之，本报告提供了潜在交易者需要了解的有关临床阶段产品和化合物的研究、开发和商业化合作的所有资讯。

主要优点

本报告为读者提供了以下主要好处：

  • 有关临床阶段合约趋势的详细资讯（自2019年起）
  • 存取交易总额、预付款、里程碑和忠诚度资料
  • 使用大量真实案例研究分析临床阶段合约结构
  • 实践中的条款范例以及对临床阶段合约中包含的条款的深入了解
  • 公司在过往交易中商定的主要交易条款的识别
  • 进行实质审查：评估向合作伙伴公司提出的合约条款的适用性

调查范围

  • 本报告目的是让读者深入了解和了解全球领先公司签订的临床阶段协议的趋势和结构。

本报告提供的资讯：

  • 生物製药产业临床阶段交易趋势（2019年起）
  • 临床阶段交易结构分析
  • 存取交易总额、预付款、里程碑和忠诚度资料
  • 实际临床阶段专案案例研究
  • 参与临床阶段计画（超过 2,900个）
  • 临床阶段主要计画（依据金额，2019年起）
  • 临床阶段最活跃的交易撮合者（2019年起）
  • 主要临床阶段合作伙伴资源

此报告列出了可用合约的以下资讯：

  • 公司名称（A-Z）
  • 总交易金额
  • 合约签订时的开发阶段
  • 合约类型
  • 具体治疗标靶
  • 每笔交易的标题都透过网路连结连结到交易记录的线上版本以及合约文件（如果有），可以轻鬆按需存取每份合约文件。

此报告提供了对 1,800 多个临床阶段交易的可用交易和合约文件的全面存取。分析实际合约协议能够评估：

  • 授予或选择的具体权利是什么？
  • 合约实际上授予合作伙伴公司什么？
  • 授予哪些类型的专有权？
  • 合约的付款结构是怎样的？
  • 如何审核销售和付款？
  • 条款和条件是什么？
  • 合约的主要条款是如何定义的？
  • 智慧财产权的处理和所有权如何？
  • 谁负责商业化？
  • 谁负责开发、供应和製造？
  • 如何管理保密和发布？
  • 如何解决争议？
  • 什么情况下可以取消合约？
  • 如果所有者发生变化会怎样？
  • 已就何种类型的分授权或分包条款达成协议？
  • 公司主张哪些样板条款？
  • 哪些样板条款会根据合作伙伴和交易类型的不同而有所不同？
  • 公司对契约法主张哪一个管辖权？

目录

执行摘要

第1章 简介

第2章 企业在临床阶段合作的原因

  • 简介
  • 临床阶段联盟的作用
    • 临床阶段的许可介绍
    • 临床阶段的许可
  • I期、II期及III期临床试验的交易差异
  • 在临床阶段签订合作协议的原因
    • 许可方（许可方）为何在临床阶段签订合约
    • 为什么被许可人（被许可人）在临床阶段签订合约
  • 临床阶段合作交易的前景

第3章 临床阶段交易策略与结构

  • 简介
  • 公司在什么阶段结盟？
    • 製药/生技领域的早期合作
    • 製药/生技领域的后期合作
  • 早期与后期联盟：比较风险/成本
  • 公司在临床阶段合作伙伴关係上花了多少钱？
  • 纯/复合组件合作协议
  • 纯粹授权协议的结构
    • 纯许可协议范例
    • a.个案研究（9）
    • b.个案研究（10）
  • 临床阶段多成分合作协议
    • 多成分/临床阶段条款范例
    • a.个案研究（11）

第4章 临床阶段联盟的付款策略

  • 简介
  • 临床阶段付款策略
  • 付款方式
    • 总交易金额
    • 预付款
    • 贷款
    • 可转换贷款
    • 股权
    • 研发资金
    • 许可费
    • 里程碑付款
    • 特许权使用费
    • QUIDS
    • Option payments

第5章 临床阶段交易趋势

  • 简介
  • 近期临床分期联盟
    • 第一阶段交易趋势（自2019年起）
    • 第二期交易趋势（2019年起）
    • 第三阶段交易趋势（2019年及以后）
  • 临床阶段联盟：依交易类型
  • 临床阶段合作：依疾病类型
  • 临床阶段联盟：依技术类型
  • 与最活跃的公司建立临床阶段联盟（自2016年起）

第6章 临床阶段合作付款条件

  • 简介
  • 临床阶段付款条件指南
    • 预付款
    • 里程碑付款
    • 特许权使用费
  • 临床阶段付款条件：交易资料分析
    • 公开资料
    • 调查资料
  • 付款条件分析
    • 临床阶段交易总额
    • 临床阶段交易：预付款
    • 临床阶段交易：里程碑付款
    • 临床阶段特许权使用费率
  • 临床阶段财务状况中位数
    • 临床阶段的总付款金额
    • 临床阶段预付款金额
    • 临床阶段里程碑金额
    • 临床阶段的特许权使用费金额

第7章 临床阶段重大交易

  • 简介
  • 临床阶段主要交易：以交易金额

第8章 临床阶段交易撮合者：前 25 名公司

  • 简介
  • 前 25 名最活跃的临床阶段交易撮合者

第9章 临床阶段合作协议清单

  • 简介
  • 临床阶段合约交易（自2016年起）

第10章 临床阶段交易：依开发阶段划分

  • 简介
  • 依临床阶段划分的交易
  • 第一阶段
  • 第二阶段
  • 第三阶段
  • 法规

附录

关于Wildwood Ventures

简介目录
Product Code: CP2058

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019 - 2024 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 1,800 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 2019. 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 2019, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of clinical stage partnering deals since 2019 organized by stage of development - phase I, phase II and phase III.

The report includes numerous tables and figures that illustrate the trends and activities in clinical stage partnering and deal making since 2019.

In addition, a comprehensive appendix of all clinical stage deals since 2019 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

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019 - 2024 provides the reader with the following key benefits:

  • In-depth understanding of clinical stage deal trends since 2019
  • 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

  • Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 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.

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 includes:

  • Trends in clinical stage dealmaking in the biopharma industry since 2019
  • 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 1,800 clinical stage deals
  • The leading clinical stage deals by value since 2019
  • Most active clinical stage dealmakers since 2019
  • The leading clinical stage partnering resources

In Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024, 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 Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 report provides comprehensive access to available deals and contract documents for over 1,800 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?

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 2019
    • 5.2.1.1. Attributes of phase I deals
    • 5.2.2. Trends in phase II deals since 2019
    • 5.2.2.2. Attributes of phase II deals
    • 5.2.3. Trends in phase III deals since 2019
    • 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
  • 6.5 Clinical stage median financials
    • 6.5.1. Clinical stage headline value
    • 6.5.2. Clinical stage upfront value
    • 6.5.3. Clinical stage milestone value
    • 6.5.4. Clinical stage royalty value

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 2019
  • Figure 6: Clinical stage partnering by disease type since 2019
  • Figure 7: Clinical stage partnering by technology type since 2019
  • Figure 8: Top 25 most active clinical stage dealmakers, 2019 - 2024
  • 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 2019
  • Figure 17: Most active clinical stage dealmakers 2019 - 2024