Drug Delivery Partnering Terms & Agreements

Drug Delivery Partnering

Terms & Agreements. Publication date: January 2014 BROCHURE

Report code: CP2102 Version: 5

Current Partnering The Lodge, 21 Front Street, York YO24 3BW United Kingdom Tel: +44 (0)1904 799893 www.currentpartnering.com

Report description

The Drug Delivery Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the drug delivery partnering deals and agreements entered into by the worlds leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter drug delivery partnering deals. The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors drug delivery technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest drug delivery 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 all drug delivery partnering deals announced since 2007 including financial terms where available including over 2,500 links to online deal records of actual drug delivery 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.

Contract documents provide the answers to numerous questions about a prospective partner’s flexibility on a wide range of important issues, many of which will have a significant impact on each party’s ability to derive value from the deal.

For example, analyzing actual company deals and agreements allows assessment of the following:

o What is actually granted by the agreement to the partner company?

o What exclusivity is granted?

o What are the precise rights granted or optioned?

o What is the payment structure for the deal?

o How are sales and payments audited?

o What is the deal term?

o How are the key terms of the agreement defined?

o How are IPRs handled and owned?

o Who is responsible for commercialization?

o Who is responsible for development, supply, and manufacture?

o How is confidentiality and publication managed?

o How are disputes to be resolved?

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o Under what conditions can the deal be terminated?

o What happens when there is a change of ownership?

o What sublicensing and subcontracting provisions have been agreed?

o Which boilerplate clauses does the company insist upon?

o Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?

o Which jurisdiction does the company insist upon for agreement law?

The initial chapters of this report provide an orientation of drug dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in drug delivery dealmaking since 2007, including details of average headline, upfront, milestone and royalty terms. Chapter 2 also contains case studies providing an insight into how companies enter into drug delivery dealmaking.

Chapter 3 provides a review of the leading drug delivery deals since 2007. Deals are listed by headline value, signed by big pharma, big biotech, and most active of all biopharma companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

Chapter 4 provides a comprehensive listing of the top 50 big pharma companies with a brief summary followed by a comprehensive listing of drug delivery deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapter 5 provides a comprehensive listing of the top 50 big biotech companies with a brief summary followed by a comprehensive listing of drug delivery deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapter 6 provides a comprehensive and detailed review of drug delivery partnering deals signed and announced since 2007, where a contract document is available in the public domain. The chapter is organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and the contract document, providing easy access to each contract document on demand.

Chapter 7 provides a comprehensive and detailed review of drug delivery partnering deals organized by specific drug delivery 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.

The report also includes numerous tables and figures that illustrate the trends and activities in drug delivery partnering and dealmaking since 2007.

In addition, a comprehensive appendix is provided organized by drug delivery partnering company A-Z, deal type definitions and drug delivery partnering agreements example. 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 drug delivery technologies and products.

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Key benefits

Drug Delivery Partnering Terms and Agreements provides the reader with the following key benefits:

• In-depth understanding of drug delivery deal trends since 2007 • Access to headline, upfront, milestone and royalty data • Analysis of the structure of drug delivery agreements with numerous real life case studies • Comprehensive access to over 3000 actual drug delivery contracts entered into by the world’s biopharma companies • Detailed access to actual drug delivery contracts enter into by the leading fifty bigpharma companies • Insight into the terms included in a drug delivery 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

Drug Delivery Partnering Terms and Agreements is intended to provide the reader with an in-depth understanding and access to drug delivery trends and structure of deals entered into by leading companies worldwide.

Drug Delivery Partnering Terms and Agreements includes:

o Trends in drug delivery dealmaking in the biopharma industry since 2007 o Analysis of drug delivery deal structure o Access to headline, upfront, milestone and royalty data o Case studies of real-life drug delivery deals o Access to over 3,000 drug delivery contract documents o The leading drug delivery deals by value since 2007 o Most active drug delivery dealmakers since 2007 o The leading drug delivery partnering resources

In Drug Delivery Partnering Terms and Agreements, the available contracts are listed by:

o Company A-Z o Headline value o Stage of development at signing o Deal component type o 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.

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The Drug Delivery Partnering Terms and Agreements report provides comprehensive access to available deals and contract documents for over 3,000 drug delivery deals. Analyzing actual contract agreements allows assessment of the following:

o What are the precise drug delivery rights granted or optioned? o What is actually granted by the agreement to the partner company? o What exclusivity is granted? o What is the payment structure for the deal? o How are sales and payments audited? o What is the deal term? o How are the key terms of the agreement defined? o How are IPRs handled and owned? o Who is responsible for commercialization? o Who is responsible for development, supply, and manufacture? o How is confidentiality and publication managed? o How are disputes to be resolved? o Under what conditions can the deal be terminated? o What happens when there is a change of ownership? o What sublicensing and subcontracting provisions have been agreed? o Which boilerplate clauses does the company insist upon? o Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? o Which jurisdiction does the company insist upon for agreement law?

Number of pages:

The report is comprised of 1,362 pages plus appendices.

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TABLE OF CONTENTS

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in drug delivery dealmaking

2.1. Introduction 2.2. Drug delivery partnering over the years 2.3. Big pharma drug delivery dealmaking activity 2.4. Big biotech drug delivery dealmaking activity 2.5. Most active drug delivery dealmakers 2.6 Drug delivery partnering by deal type 2.7. Drug delivery partnering by disease type 2.8. Partnering by drug delivery technology type 2.9. Average deal terms for drug delivery partnering 2.9.1 Drug delivery headline values 2.9.2 Drug delivery upfront payments 2.9.3 Drug delivery milestone payments 2.9.4 Drug delivery royalty rates 2.10. The anatomy of drug delivery partnering 2.11. Drug delivery or specialty pharma? 2.11.1. Is specialty pharma the only way for drug delivery? 2.11.2. Best practice for optimizing drug delivery program development 2.11.3. The anatomy of a drug delivery deal 2.11.3.a. Case study 1: Uluru – Oradisc 2.11.3.b. Case study 2: Bayer – MDRNA 2.11.3.c. Case study 3: Endo Pharmaceuticals – BioDelivery Sciences

Chapter 3 – Leading drug delivery deals

3.1. Introduction 3.2. Top drug delivery deals by value

Chapter 4 – Bigpharma drug delivery deals

4.1. Introduction 4.2. How to use big pharma drug delivery partnering deals 4.3. Big pharma drug delivery partnering company profiles Abbott Actavis

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Actavis (Acquired by Watson) Allergan Allergan Amgen Astellas AstraZeneca Baxter International Bayer Biogen Idec Boehringer Ingelheim Bristol-Myers Squibb Celgene CSL Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly Endo Pharmaceuticals Forest Laboratories Fresenius Galderma Gilead Sciences GlaxoSmithKline Grifols Hospira Johnson & Johnson Kyowa Hakko Kirin Lundbeck Menarini Merck & Co Merck KGaA Mylan Novartis Novo Nordisk Otsuka Pfizer Purdue Ranbaxy Laboratories Roche

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Sanofi Servier Shionogi Shire Stada Takeda Teva UCB Valeant Warner Chilcott

Chapter 5 – Big biotech drug delivery deals

5.1. Introduction 5.2. How to use big biotech partnering deals 5.3. Big biotech drug delivery partnering company profiles 3SBio Acorda Therapeutics Actelion Alexion Pharmaceuticals Alkermes AMAG Pharmaceuticals Amgen Array Biopharma Biocon Biogen Idec BioMarin Pharmaceuticals Cangene Celgene Cubist Dendreon Elan Emergent BioSolutions Galapagos Gilead Sciences Grifols Ipsen Isis Pharmaceuticals LFB Group Morphosys

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Nektar Therapeutics Novo Nordisk NPS Pharmaceuticals PDL BioPharma Questcor Pharmaceuticals Regeneron Pharmaceuticals SciClone Pharmaceuticals Seattle Genetics Spectrum Pharmaceuticals Swedish Orphan Biovitrum The Medicines Company United Therapeutics Vertex Pharmaceuticals ViroPharma

Chapter 6 – Drug delivery partnering contracts directory

6.1. Introduction 6.2. Company A-Z 3M 3M Drug Delivery Systems 3SBio Abbott Laboratories Abraxis BioScience Accentia Biopharmaceuticals Accredo Health Group Acelrx Pharmaceuticals Acorda Therapeutics Actavis (Acquired by Watson) Actient Pharmaceuticals Acura Pharmaceuticals Acusphere Adams Respiratory Therapeutics Adeona Pharmaceuticals Adolor Advanced Life Sciences Alchemia Alexion Pharmaceuticals Alexza Pharmaceuticals

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Alfacell Alimera Sciences Alkermes Allergan Allos Therapeutics Alnylam Pharmaceuticals Alpharma Alpharma Ireland Altus Pharmaceuticals Amag Pharmaceuticals Amarillo Biosciences Amarin Amicus Therapeutics Ampio Pharmaceuticals Amylin Pharmaceuticals Anacor Pharmaceuticals ANDRx Anesiva Anesta Angiodynamics Angiotech Pharmaceuticals AnorMed AP Pharma Apricus Biosciences Aradigm Aristos Pharmaceuticals Arius Pharmaceuticals ArQule Arrow International ARYx Therapeutics Astellas Pharma AstraZeneca Atley Pharmaceuticals Audeo Oncology Auxilium Pharmaceuticals AVANT Immunotherapeutics AVI Pharma Azur Pharma Banner Pharmacaps

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Barrier Therapeutics Bausch & Lomb Baxter International Baxter Oncology GmbH Bayer Bayer Healthcare Ben Venue Laboratories Bentley Pharmaceuticals Biken Bio-Path BioAlliance Pharma BioArray Solutions BioCryst Pharmaceuticals BioDelivery Sciences Biofield Biogen Idec BiolineRX Biomedical Advanced Research and Development Authority BioMerieux BioMimetic Therapeutics Biopharmex Biopure BioSante Pharmaceuticals BioSpecifics Technologies Biovail Biovail Laboratories BioVest BioZone Laboratories Brand Builders International Brand Builders Rx Breath Bristol-Myers Squibb Brookwood Pharmaceuticals Brotech Caleco Pharma Caleco Pharma Europe Callisto Pharmaceuticals Cambridge Laboratories Caraco Pharmaceuticals

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Cardinal Health Cardium Therapeutics Cary Pharmaceuticals Catalent Pharma Solutions Cato BioVentures Celladon Celsion Cephalon Cepheid Cerus Chrysalis Technologies Clarus Therapeutics Coating Place CollaGenex Columbia Laboratories CombinatoRx Contract Pharmaceuticals Control Delivery Systems CorMedix Cornerstone Biopharma Cornerstone Therapeutics Cortex Pharmaceuticals Cosmo Technologies CP Pharmaceuticals CPEX Pharmaceuticals Crawford Healthcare Critical Therapeutics Cubist Pharmaceuticals Cumberland Pharmaceuticals Cutanea Life Sciences CV Therapeutics Cyclacel Pharmaceuticals CyDex Cypress Bioscience Daewoong Pharmaceutical Daiichi Sankyo Dainippon Sumitomo Pharma Dalian Wande Electronics Debiopharm

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Dechra Veterinary Products Defense Threat Reduction Agency Dehaier Medical Systems Department of Defense Department of Health and Human Services Department of Homeland Security DepoMed Desitin Dey Pharma Diomed Discovery Laboratories DNA Biomedical Solutions DoctorDirectory DOR BioPharma Dov Pharmaceutical Dow Pharmaceutical Sciences DPT Laboratories Draxis Pharma Drugs for Neglected Diseases Initiative Duramed Durect DUSA Pharmaceuticals Dyax Echo Therapeutics ECR Pharmaceuticals EDK Therapeutics EKR Therapeutics Elan Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emisphere Endo Pharmaceuticals Entera Bio Enzon Pharmaceuticals Epic Pharmaceuticals EpiCept Esprit Pharma Evonik Industries

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Facet Biotechnology FasTrack Pharmaceuticals Ferndale Pharmaceuticals Finorga Fleet Laboratories Flynn Pharma Forbes Medi-Tech Fovea Pharmaceuticals Genaera Genentech Generex Biotechnology Genta GenVec Genzyme Ghent University GlaxoSmithKline Global Health Ventures Globe Laboratories GlobeImmune GPC Biotech Graceway Pharmaceuticals Green Vision Grifols Grunenthal Hadasit Medical Research Services and Development Halozyme Therapeutics Hangzhou Zhencheng Pharmaceuticals Hebei Huaxing Pharmaceuticals Hebei Kiwa Huaxing Bio-Pharmaceuticals Helix BioMedix Helix BioPharma HemispheRx Biopharma Heraeus Hermes BioScience Horizon Pharma AG Horizon Pharma Inc Hospira Hunan Jiuwang Pharmaceuticals Hydron Technologies

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Idea IDIS Pharma Ikaria ImaRX ImClone Systems Immunomedics Impax Laboratories Imprimis Pharmaceuticals Inalco Biochemicals Inalco Group Incyte Indevus Pharmaceuticals Inex Pharmaceuticals Inovio Pharmaceuticals InSite Vision Insmed Inc Inspire Pharmaceuticals Institut Biochimique Intas Biopharmaceuticals IntelGenx Intendis Intercell Intergen InterMune Intrexon Iomai Ipsen ISTA Pharmaceuticals Ivax Jagotec Javelin Pharmaceuticals Jazz Pharmaceuticals JDS Pharmaceutical JHP Pharmaceuticals Jiangsu Yabang Pharmaceuticals Johns Hopkins University Johnson & Johnson JPI Commercial Kensey Nash

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Keryx Biopharmaceuticals Kinetic Concepts King Pharmaceuticals Kiwa Bio-Tech Products Klarogen Biotherapeutics Krele Pharmaceuticals Kunwha Pharmaceuticals KV Pharmaceutical Kwang Dong Pharmaceuticals Kyowa Hakko Kogyo Kythera Biopharmaceuticals Lees Pharmaceutical Lenetix Ligand Pharmaceuticals Lipocine Lonza Los Angeles Biomedical Research Institute Lung Rx Lupin Pharmaceuticals Macrochem Mallinckrodt MAP Pharmaceuticals Marina Biotech Massachusetts Institute of Technology McCoy Enterprises McKesson McNeil PPC MD Anderson Cancer Center MDRNA Meda Medgenics Medical Futures MediciNova Medicis Pharma Medpace Medtronic Meiji Seika Memorial Sloan Kettering Cancer Center Memory Pharmaceuticals

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Menarini Merck and Co Merial Merrimack Pharmaceuticals Mglas Microbix Biosystems MiddleBrook Pharmaceutical Mikah Pharma Millennium Mirna Therapeutics Mist Acquisition Monsanto Mova Pharmaceuticals Mundipharma Mutual Pharmaceutical Mylan Laboratories Nastech Pharmaceutical National Institute of Allergy and Infectious Diseases National Institute of Infectious Diseases ND Partners Nektar Therapeutics Neos Therapeutics NeurogesX Neurokine Pharmaceuticals Neuromed NeuroMed Devices Neuronex NexMed Nitec Pharma NitroMed Nof Norgine Northern Lipids Nova Biomedical NovaBay Pharmaceuticals NovaCardia Novacea NovaDel Pharma Novartis

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Novartis Consumer Health Novasep Noven Pharmaceuticals Novo Nordisk Novozymes Biopharma NuGlow Cosmaceuticals NuPathe Nycomed Obagi Medical Products Ocimum Biosolutions Oculus Innovative Sciences Oklahoma Medical Research Foundation Omthera Pharmaceuticals OncoSec Medical Ono Pharmaceutical Ophthalmic Research Associates Oradisc Oramed Pharmaceuticals Ore Pharmaceuticals Orexigen Therapeutics Orion Oso Bio Pharmaceuticals Pacific Beach Biosciences Pacira Pharmaceuticals Paladin Labs Panion Par Pharmaceutical Paramount Biosciences Patheon PDL BioPharma Pfizer Pharmaceutical Innovations Pharmacopeia PharmaEngine Philip Morris Products Pipex Pharmaceuticals Planned Systems International (PSI) Polymun Scientific Immunbiologische Poniard Pharmaceuticals

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Porex Pozen Prasco Laboratories Precision Pharma Services Prestige Brands Procter & Gamble Procter & Gamble Pharmaceuticals Professional Compounding Centers of America Progenics Pharmaceuticals ProNAi Therapeutics Proteolix PSivida Purdue Pharma QLT QLT USA QuatRx Pharmaceuticals Questcor Pharmaceuticals Quintiles Radius Health Rechon Life Sciences Reckitt Benckiser RedHill Biopharma Repligen RevImmune Rib-X Pharmaceuticals Rigel Pharmaceuticals Roche Rodan and Fields Rohto Pharmaceuticals Royalty Securitization Trust S2 Therapeutics Sagent Pharmaceuticals Salix Pharmaceuticals Sam Amer Sangamo BioSciences Sankyo Pharmaceutical Sanofi-Aventis Santarus Santen Pharmaceutical

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Savient Pharmaceuticals Schering-Plough Scolr Pharma Seattle Genetics Select Vaccines Senetek Sepracor Sequenom Serenity Pharmaceuticals Shaanxi Aoxing Pharmaceutical Shaanxi Jiali Pharmaceuticals Shandong Yaoshan Pharmaceuticals Shijiazhuang-Unigene Pharmaceuticals Shijiazhuang Pharmaceutical Shionogi Shire Pharmaceuticals SIGA Technologies Sigma-Aldrich Sigma-Tau SignPath Pharmaceuticals SK Biopharmaceuticals SkyePharma SLA Pharma Solvay Southern Research Institute Sovereign Pharmaceuticals Spectrum Pharmaceuticals Spring Creek Capital SRI International Strakan Strativa Pharmaceuticals Sun Pharmaceutical Sunovion Pharmaceuticals Supernus Pharmaceuticals SurModics SurModics Pharmaceuticals Symphony Allegro Takeda Pharmaceutical Tanabe Seiyaku

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Targanta Therapeutics Tarsa Therapeutics Teikoku Pharma USA Teikoku Seiyaku Tekmira Pharmaceuticals Tercica Teva Pharmaceuticals The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Medical Center The Medicines Company The Regents of the University of California Therabel TPG Capital Transcept Pharmaceuticals Transdel Pharmaceuticals Transition Therapeutics Tranzyme Pharma Triax Aesthetics Tris Pharma TTY Biopharm UCB Uluru Unigene Laboratories United Therapeutics Valeant Pharmaceuticals Vanda Pharmaceuticals Ventrus Biosciences VeroScience VetCure VIA Pharmaceuticals Victory Pharma Viropharma Vivus WA 32609 Wanbang Anesiva (Jiangsu) Biotech Wanbang Biopharmaceuticals Warner Chilcott Washington Research Foundation Watson Laboratories

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Watson Pharmaceuticals Wockhardt Wyeth Xianyang Materia Medica Xi’an Zaolutang Kushidai Pharmaceuticals XTL Biopharmaceuticals Yakult Honsha Yamasa Zogenix ZymoGenetics 6.3. By deal type Asset purchase Assignment Bigpharma outlicensing Co-development Collaborative R&D Co-market Contract service Co-promotion CRADA Cross-licensing Development Distribution Equity purchase Evaluation Grant Joint venture Licensing Litigation Loan Manufacturing Marketing Material transfer Option Promotion Research Settlement Spin out Sub-license

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Supply Technology transfer Termination Warranty 6.4. By stage of development Discovery Formulation Marketed Phase I Phase II Phase III Preclinical Regulatory 6.5. By therapy area Anaesthetics Cardiovascular Central Nervous System Dental Dermatology Gastrointestinal Genetic disorders Genitourinary Gynaecology Hematology Hospital care Immunology Infectives Metabolic Musculoskeletal Obstetrics Oncology Ophthalmics Pediatrics Psychiatry Public Health Respiratory Sexual Health

Chapter 7 – Drug delivery dealmaking by technology type

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7.1. Introduction 7.2. Deals by drug delivery type Drug delivery About Wildwood Ventures Current Partnering Current Agreements Recent titles from CurrentPartnering

See accompanying volume for:

Appendices

Introduction

Appendix 1 – Directory of drug delivery deals by company A-Z 2007-2013

Appendix 2 – Directory of drug delivery deals by stage of development 2007-2013

Appendix 3 – Directory of drug delivery deals by deal type 2007-2013

Appendix 4 – Directory of drug delivery deals by therapy area 2007-2013

Appendix 5 – Drug delivery partnering resource center Online drug delivery partnering Drug delivery partnering events Further reading on drug delivery dealmaking

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Table of figures

Figure 1: Drug delivery partnering since 2007 Figure 2: Big pharma – top 50 – drug delivery deals 2007 to 2013 Figure 3: Big pharma drug delivery deal frequency – 2007 to 2013 Figure 4: Big biotech – top 50 – drug delivery deals 2007 to 2013 Figure 5: Big biotech drug delivery deal frequency – 2007 to 2013 Figure 6: Active drug delivery dealmaking activity– 2007 to 2013 Figure 7: Drug delivery partnering by deal type since 2007 Figure 8: Drug delivery partnering by disease type since 2007 Figure 9: Drug delivery partnering by technology type since 2007 Figure 10: Drug delivery deals with a headline value Figure 11: Drug delivery deal headline value distribution, US$million – discovery stage Figure 12: Drug delivery deal headline value distribution, US$million – preclinical stage Figure 13: Drug delivery deal headline value distribution, US$million – phase I stage Figure 14: Drug delivery deal headline value distribution, US$million – phase II stage Figure 15: Drug delivery deal headline value distribution, US$million – phase III stage Figure 16: Drug delivery deal headline value distribution, US$million – regulatory stage Figure 17: Drug delivery deal headline value distribution, US$million – marketed stage Figure 18: Summary median headline value by stage of development, 2007-2013 Figure 19: Drug delivery deals with upfront payment values Figure 20: Drug delivery deal upfront payment distribution, US$million – discovery stage Figure 21: Drug delivery deal upfront payment distribution, US$million – preclinical stage Figure 22: Drug delivery deal upfront payment distribution, US$million – phase I stage Figure 23: Drug delivery deal upfront payment distribution, US$million – phase II stage Figure 24: Drug delivery deal upfront payment distribution, US$million – phase III stage Figure 25: Drug delivery deal upfront payment distribution, US$million – regulatory stage Figure 26: Drug delivery deal upfront payment distribution, US$million – marketed stage Figure 27: Summary median upfront payments by stage of development, 2007-2013 Figure 28: Drug delivery deals with milestone payments Figure 29: Drug delivery deal milestone distribution, US$million – discovery stage Figure 30: Drug delivery deal milestone distribution, US$million – preclinical stage Figure 31: Drug delivery deal milestone distribution, US$million – phase I stage Figure 32: Drug delivery deal milestone distribution, US$million – phase II stage Figure 33: Drug delivery deal milestone distribution, US$million – phase III stage Figure 34: Drug delivery deal milestone distribution, US$million – regulatory stage Figure 35: Drug delivery deal milestone distribution, US$million – marketed stage Figure 36: Drug delivery deals with royalty rates, % Figure 37: Drug delivery deal royalty rate distribution, US$million – discovery stage Figure 38: Drug delivery deal royalty rate distribution, US$million – preclinical stage Figure 39: Drug delivery deal royalty rate distribution, US$million – phase I stage Figure 40: Drug delivery deal royalty rate distribution, US$million – phase II stage Figure 41: Drug delivery deal royalty rate distribution, US$million – phase III stage Figure 42: Drug delivery deal royalty rate distribution, US$million – regulatory stage Figure 43: Drug delivery deal royalty rate distribution, US$million – marketed stage Figure 44: Summary median royalty rate by stage of development, 2007-2013 Figure 45: Components of the typical drug delivery deal structure Figure 46: Best practice for drug delivery program development Figure 47: Top drug delivery deals by value since 2007

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