製薬・バイオテクノロジー企業における臨床段階での提携契約と条件 (2016～2023年)

当レポートでは、世界の主要な製薬企業およびバイオテクノロジー企業による、臨床段階での提携契約の締結動向について調査し、契約の概要や目的、支払い条件、契約・疾病・技術タイプ別の提携契約件数の動向、代表的事例（ケーススタディ）、関連企業の一覧、契約の詳細情報 (全2000件以上)、といった情報を取りまとめてお届けいたします。

目次

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 臨床段階にある化合物について契約を締結する理由

• イントロダクション
• 臨床段階での提携の役割
  • 臨床段階でのインライセンス
  • 臨床段階でのアウトライセンス
• 第I～III相での取引の違い
• 臨床段階で提携契約を締結する理由
  • ライセンス供与側 (ライセンサー) が臨床段階契約を締結する理由
  • ライセンス取得側 (ライセンシー) が臨床段階契約を締結する理由
• 臨床段階での提携契約の将来性

第3章 臨床段階での取引の戦略と構造

• イントロダクション
• どの段階で各企業は提携契約を締結するのか？
  • 臨床早期での製薬／バイオテクノロジー企業の提携
  • 臨床後期での製薬／バイオテクノロジー企業の提携
• 臨床早期・後期での提携：リスク／コストの比較
• 臨床段階での締結に対する支出額
• 専門／複合契約の違い
• 専門ライセンス契約の構造
  • 代表的事例
• 多成分臨床段階パートナー契約
  • 臨床段階での複合提携契約
  • 代表的事例

第4章 臨床段階での提携の支払戦略

• イントロダクション
• 臨床段階での支払戦略
• 支払のオプション

第5章 臨床段階での契約締結の傾向

• イントロダクション
  • 第I相での提携の動向 (2014年以降)
  • 第II相での提携の動向 (2014年以降)
  • 第III相での提携の動向 (2014年以降)
• 臨床段階での提携動向：取引の種類別
• 臨床段階での提携動向：疾患の種類別
• 提携動向：臨床段階の技術の種類別
• 臨床段階での提携動向：最も活発な企業の場合 (2014年以降)

第6章 臨床段階での提携契約の支払条件

• イントロダクション
• 臨床段階での支払条件のガイドライン
  • 前払い
  • マイルストーン払い
  • ロイヤリティ支払い
• 臨床段階での支払条件：契約データ分析
  • 公共データ
  • サーベイデータ
• 支払条件の分析
  • 臨床段階での契約総額
  • 臨床段階での前払い
  • 臨床段階でのマイルストーン払い
  • 臨床段階でのロイヤルティ率
• 臨床段階での平均的な財務指標

第7章 臨床段階での主要契約

• イントロダクション
• 臨床段階での主要契約：金額別

第8章 臨床段階での最も活動的な契約相手：上位25社

• イントロダクション
• 臨床段階での最も活動的な契約相手：上位25社

第9章 臨床段階での提携契約の一覧

• イントロダクション
• 臨床段階での提携契約動向 (2014年以降)

第10章 臨床段階での契約締結：治験段階別の動向

• イントロダクション
• 治験段階別の取引動向
• フェーズI
• フェーズII
• フェーズIII
• 規制

付録

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