한글목차

본 보고서에서는 제약 및 바이오테크놀러지 업계에 대해 조사 분석하고 기업이 임상 단계 제휴 계약을 체결하는 방법과 이유, 이러한 제휴를 형성하는 주요한 재무적 및 전략적 조건에 관한 종합적인 데이터 주도의 분석을 제공합니다.

목차

주요 요약

제1장 서론

제2장 기업이 임상 단계 화합물을 제휴하는 이유

• 소개
• 임상 단계 파트너십의 역할
  • 임상 단계에서의 라이선스 도입
  • 임상 단계에서의 라이선스 공여
• 페이즈 I, II, III 단계 계약 차이
• 임상 단계 제휴 계약을 체결하는 이유
  • 라이센서가 임상 단계 계약에 참가하는 이유
  • 라이선스 사용자가 임상 단계 계약에 진입하는 이유
• 임상 단계 제휴 계약의 장래

제3장 임상 단계 계약 전략과 구조

• 소개
• 기업은 어느 단계에서 제휴할 것인가
  • 제약 및 바이오테크놀러지의 조기 제휴
  • 제약 및 바이오테크놀러지의 만기 제휴
• 초기 단계와 후기 단계 제휴 - 위험과 비용 비교
• 기업은 임상 단계 제휴에 얼마 지출하고 있는지
• 순수/다성분의 제휴 계약
• 순수 라이선싱 계약의 구조
  • 순수 라이선싱 계약의 예
  • a. 사례 연구 9
  • b. 사례 연구 10
• 다성분 임상 단계 제휴 계약
  • 다성분 임상 단계 조항의 예
  • a. 사례 연구 11

제4장 임상 단계 제휴 결제 전략

• 소개
• 임상 단계 결제 전략
• 결제 방법
  • 헤드라인 금액
  • 선불
  • 대출
  • 전환 대출
  • 주식
  • 연구개발자금
  • 라이선싱료
  • 이정표 지불
  • 마일스톤 지불
  • 퀴드
  • 옵션 결제

제5장 임상단계 계약 동향

• 소개
• 오랜 기간에 걸친 임상 단계 파트너십
  • 페이즈 I 계약 동향(-2020년)
  • 페이즈 II 계약 동향(-2020년)
  • 페이즈 III 계약 동향(-2020년)
• 임상 단계 제휴 : 계약 유형별
• 임상 단계 제휴 : 질환 유형별
• 임상 단계 제휴 : 기술 유형별
• 가장 활발한 기업에 의한 임상 단계 제휴(2020년-)

제6장 임상 단계 제휴의 결제 조건

• 소개
• 임상 단계 결제조건에 관한 가이드라인
  • 선불
  • 이정표 지불
  • 마일스톤 지불
• 임상 단계 결제 조건 - 계약 데이터 분석
  • 공개 데이터
  • 조사 데이터
• 결제 조건 분석
  • 임상 단계 제휴의 헤드 라인 금액
  • 임상 단계 계약의 선불
  • 임상 단계 계약의 이정표 지불
  • 임상 단계 로열티 지불
• 임상단계 재무중앙값
  • 임상 단계 헤드라인 금액
  • 임상 단계 선불 금액
  • 임상 단계 이정표 금액
  • 임상 단계 마일스톤 금액

제7장 주요 임상 단계 계약

• 소개
• 임상 단계 상위 계약(금액)

제8장 가장 활발한 전임상단계 계약기업 상위 25개사

• 소개
• 가장 활발한 전임상 단계 계약 기업 상위 25개사

제9장 임상 단계 제휴 계약 디렉토리

• 소개
• 전임상 단계 계약(2020년-)

제10장 임상단계 계약 : 개발단계별

• 소개
• 계약 : 임상 단계별
• 페이즈 I
• 페이즈 II
• 페이즈 III
• 규제

부록

영문목차

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025)

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2020-2025 report provides a comprehensive, data-driven analysis of how and why companies engage in clinical-stage partnering agreements, as well as the financial and strategic terms shaping these collaborations. This essential industry resource delivers unparalleled insights into deal structures, negotiation dynamics, and financial considerations for clinical-stage drug development partnerships.

At the clinical stage, licensing agreements typically grant the licensee exclusive rights or options to develop a licensor's product or technology, often covering Phase I, Phase II, and Phase III trials. These agreements are frequently multi-component, involving collaborative R&D, co-development, and commercialization strategies.

This report provides detailed intelligence on the latest clinical-stage agreements in the healthcare sector, helping companies evaluate market trends, optimize negotiation strategies, and benchmark deal structures.

A Must-Have Resource for Biotech and Pharma Dealmakers

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025) report is an indispensable resource for business development, legal, and financial professionals involved in biopharma dealmaking.

With comprehensive insights, a vast deal database, and direct access to contract documents, this report serves as the ultimate tool for:

• Benchmarking deal structures and financial terms
• Optimizing negotiation strategies
• Assessing potential partners' flexibility
• Identifying trends in clinical-stage partnerships
• Why This Report is Essential for Dealmakers
• Understanding the flexibility and negotiation strategies of potential partners is critical when structuring clinical-stage partnerships. While headline financial terms (e.g., upfront payments, milestones, royalties) provide a broad overview, contract documents reveal the actual triggers and conditions for these payments-details often missing from press releases and traditional deal databases.
• This report provides a comprehensive listing of 1,775 clinical-stage deals announced since 2020, including financial terms where available. Additionally, it features direct links to online deal records, along with publicly available contract documents submitted to the SEC.
• By analyzing these agreements, companies can gain critical insights to refine deal strategies, assess partner flexibility, and structure competitive agreements.
• Comprehensive Analysis of Clinical-Stage Partnering Trends

The first chapters of this report offer a detailed orientation to clinical-stage deal-making, including:

Chapter 1 - Introduction to the report

Chapter 2 - Why companies engage in clinical-stage partnerships

Chapter 3 - Strategic approaches and deal structures, with case studies

Chapter 4 - Payment strategies, including upfronts, milestones, and royalties

Chapter 5 - Analysis of clinical-stage deal activity (2020-2025), categorized by year, stage of development, therapeutic area, technology type, and key dealmakers

Chapter 6 - In-depth financial analysis of headline values, upfront payments, milestone triggers, and royalty rates for Phase I, Phase II, and Phase III deals

Chapter 7 - A review of the leading clinical-stage deals by headline value

Chapter 8 - Profiles of the top 25 most active clinical-stage dealmakers

Chapter 9 - A database of clinical-stage partnering agreements, including contract documents where available

Chapter 10 - A comprehensive directory of all clinical-stage deals announced since 2020, categorized by Phase I, Phase II, and Phase III

• Key Benefits of the Report

This must-have industry resource provides exclusive insights to help companies assess, structure, and negotiate their own clinical-stage partnerships. Key benefits include:

• Unparalleled Market Insights - Gain a deep understanding of clinical-stage deal trends shaping the pharma and biotech industry since 2020.
• Exclusive Financial Data Access - Unlock headline values, upfront payments, milestone structures, and royalty terms, giving you a competitive edge in deal negotiations.
• Comprehensive Deal Database - Access a curated repository of 1,775 clinical-stage agreements, including contract documents where available, for unmatched transparency and benchmarking.
• Deep-Dive into Industry Leaders - Analyze actual clinical-stage deals entered into by the top 25 global pharma and biotech companies, alongside emerging biopharma players.
• Proven Case Studies & Structural Analysis - Examine real-world deal structures and case studies to refine your own partnering and negotiation strategies.
• High-Value Deal Identification - Pinpoint the most lucrative clinical-stage deals signed since 2020, gaining insight into premium industry transactions.
• Profile the Most Active Dealmakers - Identify the key players driving clinical-stage collaborations, ensuring you target the right partners.
• Strategic Deal Mapping - Navigate a full A-Z listing of clinical-stage agreements, categorized by company, development phase, deal type, therapeutic area, and technology focus.
• Negotiate with Confidence - Understand the key terms and conditions top-tier companies have agreed to in previous deals, helping you structure optimal agreements.
• Robust Due Diligence Support - Conduct data-backed assessments to determine the viability and competitiveness of your proposed deal terms with potential partners.
• Report Scope

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech (2020-2025) report provides:

• Trends in clinical-stage dealmaking in the biopharma industry since 2020
• Detailed deal structures, including upfront, milestone, and royalty terms
• Case studies of real-life clinical-stage agreements
• Access to 1,775 clinical-stage deals, with contract records where available
• Partnering profiles of the most active clinical-stage dealmakers since 2020
• Analysis of the highest-value clinical-stage deals

Each deal record is indexed by:

• Company (A-Z)
• Headline Value
• Stage of Development at Signing (Phase I, Phase II, Phase III)
• Deal Type
• Specific Therapy Focus
• Critical Questions Answered

By analyzing actual contract agreements, this report provides definitive answers to critical questions such as:

• What specific rights are granted in each agreement?
• What exclusivity terms apply?
• How is the deal structured financially? (Upfronts, milestones, royalties)
• Who controls development, manufacturing, and commercialization?
• How are intellectual property rights handled?
• What are the termination conditions for the agreement?
• What dispute resolution mechanisms are in place?
• How are confidentiality and publication rights managed?
• Gain the competitive edge-explore the report today.

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 2020
  • 5.2.1.1. Attributes of phase I deals
  • 5.2.2. Trends in phase II deals since 2020
  • 5.2.2.2. Attributes of phase II deals
  • 5.2.3. Trends in phase III deals since 2020
  • 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 2020

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 2020

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 2020
• Figure 6: Clinical stage partnering by disease type since 2020
• Figure 7: Clinical stage partnering by technology type since 2020
• Figure 8: Top 25 most active clinical stage dealmakers, 2020 - 2025
• 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 2020
• Figure 17: Most active clinical stage dealmakers 2020 - 2025