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1539236

全球製藥和生物技術產業臨床階段合作條款和協議（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個工作天內

價格

※ 本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

簡介目錄

本報告深入了解並分析了公司如何、為何以及在什麼條件下進行臨床階段合作。這些交易屬於臨床階段交易，被授權人獲得許可授權人產品或技術的權利或選擇權。這些交易往往是跨部門的，從合作研發開始，一直延伸到成果的商業化。

本報告深入了解並分析了公司如何以及為何簽訂臨床階段合作協議，並提供了醫療保健領域宣布的最新臨床協議的詳細資訊。

了解潛在合作夥伴談判的交易條款的靈活性有助於深入了解談判過程，了解條款談判期間的預期結果。雖然許多小型企業想要詳細的付款條款，但付款方式的問題在於細節。

本報告提供了自2016年以來宣布的1,800 多項臨床階段合作的完整列表，其中包含交易各方披露的實際臨床合作的線上交易記錄的大量鏈接（如有）。此外，如果有的話，還包括公司及其合作夥伴向美國證券交易委員會提交的合約文件。

本報告也包括一些圖表，顯示自2019年以來與臨床階段合作夥伴關係和交易相關的趨勢和活動。

此外，還提供了自2019年以來所有發現的綜合附錄，按合作夥伴名稱（A-Z）、病例類型、治療重點領域和技術類型進行組織。每筆交易的標題都透過網路連結連結到交易記錄的線上版本，並在可用的情況下連結到合約文件，以便在需要時輕鬆存取每個合約文件。

總而言之，本報告提供了潛在交易者需要了解的有關臨床階段產品和化合物的研究、開發和商業化合作的所有資訊。

主要優點

本報告為讀者提供了以下主要好處：

  • 有關臨床階段合約趨勢的詳細資訊（自2019年起）
  • 存取交易總額、預付款、里程碑和忠誠度資料
  • 使用大量真實案例研究分析臨床階段合約結構
  • 實踐中的條款範例以及對臨床階段合約中包含的條款的深入了解
  • 公司在過往交易中商定的主要交易條款的識別
  • 進行實質審查：評估向合作夥伴公司提出的合約條款的適用性

調查範圍

  • 本報告目的是讓讀者深入了解和了解全球領先公司簽訂的臨床階段協議的趨勢和結構。

本報告提供的資訊：

  • 生物製藥產業臨床階段交易趨勢（2019年起）
  • 臨床階段交易結構分析
  • 存取交易總額、預付款、里程碑和忠誠度資料
  • 實際臨床階段專案案例研究
  • 參與臨床階段計畫（超過 2,900個）
  • 臨床階段主要計畫（依據金額，2019年起）
  • 臨床階段最活躍的交易撮合者（2019年起）
  • 主要臨床階段合作夥伴資源

此報告列出了可用合約的以下資訊：

  • 公司名稱（A-Z）
  • 總交易金額
  • 合約簽訂時的開發階段
  • 合約類型
  • 具體治療標靶
  • 每筆交易的標題都透過網路連結連結到交易記錄的線上版本以及合約文件（如果有），可以輕鬆按需存取每份合約文件。

此報告提供了對 1,800 多個臨床階段交易的可用交易和合約文件的全面存取。分析實際合約協議能夠評估：

  • 授予或選擇的具體權利是什麼？
  • 合約實際上授予合作夥伴公司什麼？
  • 授予哪些類型的專有權？
  • 合約的付款結構是怎樣的？
  • 如何審核銷售和付款？
  • 條款和條件是什麼？
  • 合約的主要條款是如何定義的？
  • 智慧財產權的處理和所有權如何？
  • 誰負責商業化？
  • 誰負責開發、供應和製造？
  • 如何管理保密和發布？
  • 如何解決爭議？
  • 什麼情況下可以取消合約？
  • 如果所有者發生變化會怎樣？
  • 已就何種類型的分授權或分包條款達成協議？
  • 公司主張哪些樣板條款？
  • 哪些樣板條款會根據合作夥伴和交易類型的不同而有所不同？
  • 公司對契約法主張哪一個管轄權？

目錄

執行摘要

第1章 簡介

第2章 企業在臨床階段合作的原因

  • 簡介
  • 臨床階段聯盟的作用
    • 臨床階段的許可介紹
    • 臨床階段的許可
  • I期、II期及III期臨床試驗的交易差異
  • 在臨床階段簽訂合作協議的原因
    • 許可方（許可方）為何在臨床階段簽訂合約
    • 為什麼被許可人（被許可人）在臨床階段簽訂合約
  • 臨床階段合作交易的前景

第3章 臨床階段交易策略與結構

  • 簡介
  • 公司在什麼階段結盟？
    • 製藥/生技領域的早期合作
    • 製藥/生技領域的後期合作
  • 早期與後期聯盟：比較風險/成本
  • 公司在臨床階段合作夥伴關係上花了多少錢？
  • 純/複合組件合作協議
  • 純粹授權協議的結構
    • 純許可協議範例
    • a.個案研究（9）
    • b.個案研究（10）
  • 臨床階段多成分合作協議
    • 多成分/臨床階段條款範例
    • a.個案研究（11）

第4章 臨床階段聯盟的付款策略

  • 簡介
  • 臨床階段付款策略
  • 付款方式
    • 總交易金額
    • 預付款
    • 貸款
    • 可轉換貸款
    • 股權
    • 研發資金
    • 許可費
    • 里程碑付款
    • 特許權使用費
    • QUIDS
    • Option payments

第5章 臨床階段交易趨勢

  • 簡介
  • 近期臨床分期聯盟
    • 第一階段交易趨勢（自2019年起）
    • 第二期交易趨勢（2019年起）
    • 第三階段交易趨勢（2019年及以後）
  • 臨床階段聯盟：依交易類型
  • 臨床階段合作：依疾病類型
  • 臨床階段聯盟：依技術類型
  • 與最活躍的公司建立臨床階段聯盟（自2016年起）

第6章 臨床階段合作付款條件

  • 簡介
  • 臨床階段付款條件指南
    • 預付款
    • 里程碑付款
    • 特許權使用費
  • 臨床階段付款條件：交易資料分析
    • 公開資料
    • 調查資料
  • 付款條件分析
    • 臨床階段交易總額
    • 臨床階段交易：預付款
    • 臨床階段交易：里程碑付款
    • 臨床階段特許權使用費率
  • 臨床階段財務狀況中位數
    • 臨床階段的總付款金額
    • 臨床階段預付款金額
    • 臨床階段里程碑金額
    • 臨床階段的特許權使用費金額

第7章 臨床階段重大交易

  • 簡介
  • 臨床階段主要交易：以交易金額

第8章 臨床階段交易撮合者：前 25 名公司

  • 簡介
  • 前 25 名最活躍的臨床階段交易撮合者

第9章 臨床階段合作協議清單

  • 簡介
  • 臨床階段合約交易（自2016年起）

第10章 臨床階段交易：依開發階段劃分

  • 簡介
  • 依臨床階段劃分的交易
  • 第一階段
  • 第二階段
  • 第三階段
  • 法規

附錄

關於Wildwood Ventures

簡介目錄
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