Negotiating & Drafting

Biotech/Pharma Collaborative Agreements

Allocating Risk, Responsibilities & Rewards in In-Licensing, Co-Development & Co-Promotion Deals

Monday, July 17, 2006

About

In today's competitive atmosphere, the race to develop new, commercially viable drugs is more heated than ever. Large and small biotech and pharma companies realize that collaborations are necessary for their survival. Big pharma and biopharma companies continue to look to fill their dwindling pipelines. And smaller biotech companies cannot bring their products to market without the help of big companies' financial resources and other capabilities.

As the collaborations are formed at earlier stages of development and the value of these early-stage compounds continues to increase, the risks become greater and the agreements become more complex. Over the past few years, many of the smaller companies have become more sophisticated deal-makers. This makes the negotiation and drafting process even more challenging.

American Conference Institute has developed a publication from the Negotiating & Drafting Biotech/Pharma Collaborative Agreements to bring you the most current, cutting-edge advice, information, and legal developments that affect how you will draft and negotiate in-licensing, co-development, and co-promotion agreements. The publication also provides you with the practical business strategies you need to make sure your agreements and relationships become winning ventures. Find presentations from a pre-eminent faculty of leading attorneys and executives from pharmaceutical and biotech companies, law firms, and top universities to provide you with perspectives and expertise from both sides of the table on:
  • Keeping development on track with practical governance procedures
  • Minimizing risks with due diligence
  • Protecting your IP rights
  • Avoiding regulatory problems with the FTC and FDA
  • Adequately preparing for the possibility of termination
  • Addressing issues that arise when the pharma company licenses the compound
  • Understanding each party's constraints and goals when negotiating with universities
  • Anticipating the future: Understanding how current and future trends will impact your agreements

Contents & Contributors

About

In today's competitive atmosphere, the race to develop new, commercially viable drugs is more heated than ever. Large and small biotech and pharma companies realize that collaborations are necessary for their survival. Big pharma and biopharma companies continue to look to fill their dwindling pipelines. And smaller biotech companies cannot bring their products to market without the help of big companies' financial resources and other capabilities.

As the collaborations are formed at earlier stages of development and the value of these early-stage compounds continues to increase, the risks become greater and the agreements become more complex. Over the past few years, many of the smaller companies have become more sophisticated deal-makers. This makes the negotiation and drafting process even more challenging.

American Conference Institute has developed a publication from the Negotiating & Drafting Biotech/Pharma Collaborative Agreements to bring you the most current, cutting-edge advice, information, and legal developments that affect how you will draft and negotiate in-licensing, co-development, and co-promotion agreements. The publication also provides you with the practical business strategies you need to make sure your agreements and relationships become winning ventures. Find presentations from a pre-eminent faculty of leading attorneys and executives from pharmaceutical and biotech companies, law firms, and top universities to provide you with perspectives and expertise from both sides of the table on:
  • Keeping development on track with practical governance procedures
  • Minimizing risks with due diligence
  • Protecting your IP rights
  • Avoiding regulatory problems with the FTC and FDA
  • Adequately preparing for the possibility of termination
  • Addressing issues that arise when the pharma company licenses the compound
  • Understanding each party's constraints and goals when negotiating with universities
  • Anticipating the future: Understanding how current and future trends will impact your agreements

Contents & Contributors


ESTABLISHING A WIN/WIN GOVERNANCE AND MANAGEMENT STRUCTURE
Hemmie Chang, Ropes & Gray LLP

KEY IP ISSUES IN COLLABORATIVE AGREEMENTS
Thomas J. Kowalski, Frommer Lawrence & Haug LLP

ENSURING ALL KEY IP ISSUES ARE ADDRESSED IN COLLABORATIVE AGREEMENTS
Jonathan Lourie, Edwards Angell Palmer & Dodge LLP

ENSURING ALL KEY IP ISSUES ARE ADDRESSED IN COLLABORATIVE AGREEMENTS: CREATE ACT, TRADEMARKS AND TRADE SECRETS, COMPETITION AND BANKRUPTCY
S. Peter Ludwig, Darby & Darby

SETTING THE STAGE FOR SUCCESS: FINDING THE RIGHT PARTNER & DEAL STRUCTURE
Dushyant Pathak, Renovis, Inc.

SETTING THE STAGE FOR SUCCESS: FINDING THE RIGHT PARTNER & DEAL STRUCTURE
James Z. Huang, Anesiva

RISKS ASSOCIATED WITH FEDERAL GOVERNMENT RIGHTS IN INTELLECTUAL PROPERTY
Charles Rod Marvin, Jr., Venable LLP

BIOTECH PHARMA COLLABORATIVE AGREEMENTS
Linda R. Judge, DLA Piper Rudnick Gray Cary

SIDESTEPPING FDA TROUBLE: ENSURING YOUR AGREEMENTS ARE FDA-COMPLIANT
Robert A. Dormer, Hyman, Phelps & McNamara PC
Barry S. White, Frommer Lawrence & Haug LLP

BREAKING UP IS HARD TO DO: PREPARING FOR TERMINATION
Tanya Dobash, Taro Pharmaceuticals, Inc.

ACADEMIA IS FROM VENUS, BUSINESS IS FROM MARS
Kathleen Denis, Office of Technology Transfer, Rockefeller University
Kirsten Leute, Office of Technology Licensing, Stanford University
James A. Severson, Technology Transfer, University of Washington
John R. Storella, Intellectual Property Affairs, Ciphergen
Louis Berneman, Texelerate

FINDING SYNERGY AND MAXIMIZING THE VALUE OF CO-PROMOTION AGREEMENTS
Judith Ann Hasko, Latham & Watkins LLP
Pamela A. Simonton, Patents & Licensing, Exelixis

AVOIDING ANTITRUST PITFALLS
Markus H. Meier, Bureau of Competition, Federal Trade Commission

COLLABORATION AND LICENSING AGREEMENTS: A DEAL LAWYER'S GUIDE TO EU ANTITRUST PITFALLS
David Hull, Covington & Burling

INTEGRATING US AND INTERNATIONAL BUSINESS STRATEGIES
Allan K.A. Marson, Baker & McKenzie LLP

NEGOTIATING THE DEAL WHEN PHARMA HAS THE COMPOUND
James F. Farrington, Jr., Wiggin and Dana
Kingsley L. Taft, Goodwin & Proctor LLP

LOOKING INTO THE CRYSTAL BALL: TRENDS IN BIOTECH
Michael McCully, Recombinant Capital

LOOKING INTO THE CRYSTAL BALL: TRENDS IN DEAL MAKING
Usha A. Pillai, Pfizer

ETHICAL AND PRACTICAL STRATEGIES FOR MAXIMIZING ROI WHEN NEGOTIATING INDUSTRY/UNIVERSITY LICENSES
Louis Berneman, Texelerate
Kathleen Denis, Office of Technology Transfer, Rockefeller University
Jonathan Lourie, Edwards Angell Palmer & Dodge LLP

PRACTICAL AND ETHICAL STRATEGIES FOR NEGOTIATING AND DRAFTING "WIN-WIN" IN-LICENSING, CO-DEVELOPMENT AND CO-PROMOTION AGREEMENTS
Thomas J. Kowalski, Frommer Lawrence & Haug LLP
James F. Farrington Jr., Wiggin and Dana



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