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A Guide to Royalty Rates in Pharmaceutical Licensing Deals

Published by: PharmaVentures Ltd.

Published: Sep. 24, 2007 - 728 Pages


Table of Contents



Introduction

The Importance of Royalties in Pharmaceutical Agreements

Overview of the Report

About PharmaVentures

Chapter 1 History of Royalties

1.1 Origin of Royalties

1.2 Royalties in Different Industry Sectors

1.2.1 Mining and Petroleum Industries

1.2.2 Publishing Royalties

1.2.3 Royalties Across Different Industrial Sectors

1.3 Laws and Agreements Affecting Pharmaceutical Royalties

1.3.1 GATT

1.3.2 Trade-Related Aspects of Intellectual Property Rights (TRIP)

1.3.3 Hatch-Waxman Act

1.3.4 1980 Bayh-Dole Act

Chapter 2 Royalty Concepts in the Pharmaceutical Industry

2.1 Importance of Innovation

2.2 Exploitation Strategies

2.3 Business Models for Commercialisation

2.4 Deal Structure Components

2.4.1 Upfront Payments

2.4.2 Equity

2.4.3 Licensing Fees

2.4.4 R&D Funding

2.4.5 Milestone Payments

2.4.6 Royalties

2.4.7 Quids

2.4.8 Shared Costs or Benefits

2.5 Royalty-Based Financing

2.5.1 Royalty Financing Companies

2.5.2 The Upside for Biotechs

2.5.3 The Upside for Academia

Chapter 3 Impact of Biotechnology

3.1 Innovation in the Pharmaceutical Sector

3.1.1 Patent Litigation

3.2 Licensing - the Preferred Model

3.3 Royalty Stacking and Offsets

Chapter 4 Factors Affecting Royalty Rates

4.1 Overall Considerations

4.2 Market Potential

4.3 Product Development Stage

4.4 Product Competition

4.5 Product Indication

4.6 Combination Products

4.7 Choosing the Best Deal

4.8 Non-Royalty Paying Agreements

Chapter 5 Methods for Calculating and Determining Pharmaceutical Royalty Rates

5.1 General Rules of Thumb

5.1.1 25 Percent Rule

5.1.2 Industry Norms or Benchmarking

5.1.3 Return of R&D Costs

5.1.4 Percentage of Sales

5.2 Integrated Methodologies

5.2.1 Why Use ENPV and Benchmarking?

5.2.2 Other Methods

5.3 Benchmarking

5.3.1 Introduction to Benchmarking

5.3.2 Feasibility

5.3.3 Data Gathering

5.3.4 Approximate Valuation

5.3.5 Refinement of the Valuation

5.4 Expected Net Present Value (ENPV)

5.4.1 Basics

5.4.2 Risk

5.4.3 Decision Tree Analysis

5.4.4 ENPV Summary

5.5 Value and Risk Sharing

5.5.1 Value Sharing

5.5.2 Risk Sharing

Chapter 6 Royalty Rates Used in Pharmaceutical Agreements

6.1 Royalty Rates Database

6.2 General Approach

6.3 Discovery Stage Deals

6.4 Preclinical Stage Deals

6.5 Phase I Stage Deals

6.6 Phase II Stage Deals

6.7 Phase III Stage Deals

6.8 Launched Product Deals

6.9 Drug Delivery

6.10 Reach Through Royalties

6.11 Summary

Chapter 7 Contractual Provisions Relating to Royalties

7.1 Term Sheet

7.1.1 Type of Deal Structure

7.1.2 Subject Matter

7.1.3 Territory

7.1.4 Field of Use

7.1.5 Exclusivity

7.1.6 Term

7.1.7 Payment Terms

7.1.8 Royalties

7.1.9 Milestones

7.1.10 Trade Marks

7.1.11 Patents

7.1.12 Product Supply

7.1.13 Commercialisation

7.1.14 Law

7.2 The Contract

7.2.1 Territory

7.2.2 Field of Use

7.2.3 Exclusivity

7.2.4 Non-Compete Clauses

7.2.5 Patents

7.2.6 Royalties

7.2.7 Milestones

7.2.8 Credit Facilities

7.2.9 Audit

7.2.10 Intellectual Property (IP)

7.2.11 Confidentiality

7.2.12 Assignment and Sub-Licensing

7.2.13 Regulatory Obligations

7.2.14 Orphan Drugs

7.2.15 Research

7.2.16 Development

7.2.17 Commercialisation

7.2.18 Trade Marks

7.2.19 Project Meetings

7.2.20 Manufacturing and Supply

7.2.21 Transfer Pricing

7.2.22 Warranties and Indemnities

7.2.23 Product Insurance

7.2.24 Change of Control

7.2.25 Force Majeure

7.2.26 Disputes

7.2.27 Termination

7.2.28 Government Law

7.3 Press Release

7.3.1 Title

7.3.2 Financial Disclosure

Chapter 8 Determining Royalty Rates in Litigation Cases

8.1 General Considerations

8.2 Lost Profits

8.3 Setting Reasonable Royalty Rates - Georgia-Pacific Factors

Abstract

A Guide to Royalty Rates in Pharmaceutical Licensing Deals provides in-depth information relating to pharmaceutical royalty rates, aiming to bring you the most up-to-date information from our 2007 survey containing royalty rates information from real licensing deals. The content has been formulated by leveraging over 15 years of experience in assisting pharmaceutical and biotechnology companies worldwide in all aspects of deal making. Additional value is delivered by online access to the 4500 deals in PharmaDeals® Agreements that contain royalty rate information, over 1000 of which include the actual deal contract. This latest royalty rate information from the 2007 survey has been gleaned from over 100 business development and licensing professionals about their deal making. This report is further supported by the responses gained from interviews conducted with key licensing executives, giving their personal insight into today's practices plus their views on future trends in the licensing arena.

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