Life Sciences IP Due Diligence

Your Complete Guide for M&As, Licensing, and Other Collaborations

Monday, January 30, 2006

About


DOES YOUR IP DUE DILIGENCE STRATEGY COMPLY WITH RECENT LEGISLATIVE, REGULATORY, AND JUDICIAL REFORMS?

IP due diligence is now a central concern and struggle for companies in life science-related industries, due to the substantial growth of mergers and acquisitions, spin-outs, and divestitures, as well as the evolving role of licensing and collaborative arrangements. Because IP - particularly patents - are the key drivers in these deals, you must be competent in conducting proper due diligence and valuation assessments that enable you to complete deals and transactions essential to the development of new products and maximize profit potential.

Quite simply, general IP due diligence and valuation principles are not enough. To truly learn everything about the IP portfolio tied to a transaction - the validity, the claims, the potential lawsuits - and assess the portfolio's value, in-house counsel and business development executives must adapt to the latest from the courts, legislators, and regulators, including Integra, Hatch-Waxman reform, and yet-to-be-released FDA regulations and reporting requirements. Valuation is pivotal: You need a working understanding of the extent to which the final valuation assessment factors into your due diligence process. If your due diligence is not properly conducted, your client runs the risk of loss of reputation, loss of profits, or even ruin.

American Conference Institute's publication on Life Sciences IP Due Diligence: Your Complete Guide for M&As, Licensing, and Other Collaborations will bring you thoughtful, targeted, and in-depth due diligence and valuation analysis and commentary from leading in-house and business development executives for life science companies, and expert attorneys and financial analysts from the life science sector. They will provide you with first-hand, practical, and comprehensive information on:*
  • How the landscape of due diligence will change based on the latest legislative and regulatory reforms
  • Requesting and reviewing the information emphasized in the practical due diligence checklist
  • The FDA regulatory exclusivities that must be considered in any transaction
  • The methodologies used when evaluating proprietary biopharmaceutical products
  • Early-stage valuation v. late-stage valuation of compounds and companies
  • Legislative, regulatory, and judicial developments affecting valuation


*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors

About


DOES YOUR IP DUE DILIGENCE STRATEGY COMPLY WITH RECENT LEGISLATIVE, REGULATORY, AND JUDICIAL REFORMS?

IP due diligence is now a central concern and struggle for companies in life science-related industries, due to the substantial growth of mergers and acquisitions, spin-outs, and divestitures, as well as the evolving role of licensing and collaborative arrangements. Because IP - particularly patents - are the key drivers in these deals, you must be competent in conducting proper due diligence and valuation assessments that enable you to complete deals and transactions essential to the development of new products and maximize profit potential.

Quite simply, general IP due diligence and valuation principles are not enough. To truly learn everything about the IP portfolio tied to a transaction - the validity, the claims, the potential lawsuits - and assess the portfolio's value, in-house counsel and business development executives must adapt to the latest from the courts, legislators, and regulators, including Integra, Hatch-Waxman reform, and yet-to-be-released FDA regulations and reporting requirements. Valuation is pivotal: You need a working understanding of the extent to which the final valuation assessment factors into your due diligence process. If your due diligence is not properly conducted, your client runs the risk of loss of reputation, loss of profits, or even ruin.

American Conference Institute's publication on Life Sciences IP Due Diligence: Your Complete Guide for M&As, Licensing, and Other Collaborations will bring you thoughtful, targeted, and in-depth due diligence and valuation analysis and commentary from leading in-house and business development executives for life science companies, and expert attorneys and financial analysts from the life science sector. They will provide you with first-hand, practical, and comprehensive information on:*
  • How the landscape of due diligence will change based on the latest legislative and regulatory reforms
  • Requesting and reviewing the information emphasized in the practical due diligence checklist
  • The FDA regulatory exclusivities that must be considered in any transaction
  • The methodologies used when evaluating proprietary biopharmaceutical products
  • Early-stage valuation v. late-stage valuation of compounds and companies
  • Legislative, regulatory, and judicial developments affecting valuation


*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors


DEVELOPING A PRACTICAL IP DUE DILIGENCE STRATEGY IN LIGHT OF RECENT CASE LAW AND LEGISLATIVE REFORM
Rochelle K. Seide, Arent Fox PLLC

DEVELOPING A PRACTICAL IP DUE DILIGENCE STRATEGY IN LIGHT OF USPTO RULEMAKING
Reza Green, Novo Nordisk

THE PRACTICAL DUE DILIGENCE CHECKLIST: THE INFORMATION YOU CAN'T AFFORD NOT TO REQUEST AND REVIEW
Robert Silverman, Millennium Pharmaceuticals
Marc S. Friedman, Sills Cummis Epstein & Gross P.C.
Faye H. Russell, Latham & Watkins LLP

A BUYER'S GUIDE TO MANAGING THE DUE DILIGENCE PROCESS
Jeffrey L. Quillen, Foley Hoag LLP

HANDLING THIRD PARTY AGREEMENTS
James F. Farrington, Jr., Wiggin and Dana LLP
Alex Fowkes, Pfizer Inc.

LIFE SCIENCES IP DUE DILIGENCE: PENDING AND FUTURE DISPUTES
Brian P. Waldman, Arent Fox PLLC

UNCOVERING ISSUES OF OWNERSHIP, INVENTORSHIP AND LOSS LICENSED OF RIGHTS
David M. McIntosh, Ropes & Gray LLP
Gerald E. Quirk, Genzyme Corporation

ANALYZING RIGHTS IN PATENTS RESULTING FROM SPONSORED RESEARCH
Kathleen Sybert, Clinical Technology Transfer Group, P.L.L.C.

IMPACT OF RECENT DEVELOPMENTS IN PATENT DURATION AND LIFE CYCLE MANAGEMENT ON DUE DILIGENCE ASSESSMENTS
Adda C. Gogoris, Darby & Darby

EVALUATING THE SCOPE, BREADTH, AND VALIDITY OF THE TARGET'S PATENTS
David A. Gay, McDermott Will & Emery LLP

PATENT OPINIONS IN THE AFTERMATH OF KNORR-BREMSE
Vineet Kohli, Merck & Co., Inc.

OVERCOMING OBSTACLES IDENTIFIED IN THE IP DUE DILIGENCE PROCESS
Beth E. Arnold, Foley Hoag LLP

FROM THE TARGET'S PERSPECTIVE: THE SELLER'S DUE DILIGENCE OBLIGATIONS
Robert Deberardine, Abbott Laboratories
Noemi (Nicky) Espinosa, Dewey Ballantine LLP
Todd E. Garabedian, Wiggin and Dana LLP
Kelly L. McDow-Dunham, Procter & Gamble Company

CONDUCTING DUE DILIGENCE FOR THE LICENSING OF PHARMACEUTICAL AND BIOTECH IP
Stanton J. Lovenworth, Dewey Ballantine LLP

CONDUCTING DUE DILIGENCE FOR THE LICENSING OF PHARMACEUTICAL AND BIOTECH IP
Thomas G. Plant, Eli Lilly and Company

CONDUCTING DUE DILIGENCE FOR THE LICENSING OF PHARMACEUTICAL AND BIOTECH IP
Mark F. Radcliffe, DLA Piper Rudnick Gray Cary

INDUSTRY/UNIVERSITY COLLABORATION AND LICENSES
Gavin Bogle, Wyeth

INDUSTRY/UNIVERSITY COLLABORATION: WHAT IS THE LEGAL FRAMEWORK?
Sarah Chapin Columbia, Choate, Hall & Stewart

DUE DILIGENCE FOR UNIVERSITY COLLABORATIONS AND LICENSES
Mary Dicig, University of Illinois at Chicago

PATENT-PROTECTED BIOPHARMACEUTICAL PRODUCTS: FITTING EVALUATION INTO YOUR DUE DILIGENCE ASSESSMENTS
John R. Dwyer, Arent Fox PLLC

VALUATION OF INTELLECTUAL PROPERTY IN THE LIFE SCIENCES: A BUSINESS-ORIENTED PERSPECTIVE
Russ Lebovitz, C Sixty, Inc.

VALUATION OF PATENT PROTECTED BIOTECH PRODUCTS
Thomas McGahren, Merrill Lynch & Company

EARLY-STAGE VALUATION VERSUS LATE-STAGE VALUATION OF COMPOUNDS AND COMPANIES
Daniel J. Oh, ABG, Inc.
Tim Opler, Credit Suisse First Boston (CSFB)
Matthew N. Murray, Rodman & Renshaw, LLC

LEGISLATIVE, REGULATORY, AND JUDICIAL DEVELOPMENTS AFFECTING VALUATION
Juan (Jay) R. Balboa, Emergent BioSolutions Inc.
John M. Naber, Dickinson Wright PLLC
DRAFTING AN EFFECTIVE IP DUE DILIGENCE REPORT
Adda C. Gogoris, Darby & Darby



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