Structuring, Negotiating and Managing Win-Win

Pharma & Biotech Collaborative Agreements

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

Monday, November 13, 2006

About

Guarantee that you negotiate, draft and execute the most effective and lucrative collaborative agreements for your company

The days of simple in-licensing agreements and a plentiful new drug discovery market are over. Today's environment is increasingly more competitive, and as a result, collaborative agreements between pharmaceutical and biotech companies are getting more and more intricate. Deal structures are changing in response to a host of new and complex issues: Biotech companies are more sophisticated, looking to integrate co-promotion and co-development into their deals. More transactions are morphing into profit-sharing and mergers and acquisitions. And as the pipeline of new products dries up, many companies are looking for new opportunities in multiple indications, academic institutions, and foreign partners.

At the same time, companies are still struggling with the practical concerns associated with actually drafting the contracts, including conducting satisfactory due diligence, crafting effective termination provisions, and developing a successful governance structure. And the question as to who owns the IP is still a hotly contested issue. Considering all of these factors and the simple fact that some companies' survival depends on these deals, it is even more important to be aware of the strategies and pitfalls associated in negotiating and drafting collaborative agreements.

With this in mind, the American Conference Institute has developed a publication from Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements to provide you with the most up-to-date information on how to draft profitable and successful in-licensing, co-promotion, and co-development deals. Leading counsel and business executives from , Emisphere Technologies, , Johnson & Johnson, Pfizer, Roche, Infinity Pharmaceuticals , Taro Pharmaceuticals, Inc., PharmAdvisiors, Thomas, McNerney & Partners, and Wyeth will show you how to:

  • FLIP the switch when to convert the collaboration to a profit-sharing or M&A deal
  • OVERCOME diligence resistance and develop appropriate provisions for commercially reasonable efforts
  • ENSURE both parties retain some value in the product at the end of the day
  • LEARN the proven and best way to increase a product's valuation
  • HANDLE complicated pricing issues with multiple indications
  • WEIGH the pros and cons of regional v. worldwide collaborative deals
  • NEGOTIATE in the agreement who has the regulatory responsibility
  • CRAFT the right provisions for opting in and out of co-development and co-promotion deals

Contents & Contributors

About

Guarantee that you negotiate, draft and execute the most effective and lucrative collaborative agreements for your company

The days of simple in-licensing agreements and a plentiful new drug discovery market are over. Today's environment is increasingly more competitive, and as a result, collaborative agreements between pharmaceutical and biotech companies are getting more and more intricate. Deal structures are changing in response to a host of new and complex issues: Biotech companies are more sophisticated, looking to integrate co-promotion and co-development into their deals. More transactions are morphing into profit-sharing and mergers and acquisitions. And as the pipeline of new products dries up, many companies are looking for new opportunities in multiple indications, academic institutions, and foreign partners.

At the same time, companies are still struggling with the practical concerns associated with actually drafting the contracts, including conducting satisfactory due diligence, crafting effective termination provisions, and developing a successful governance structure. And the question as to who owns the IP is still a hotly contested issue. Considering all of these factors and the simple fact that some companies' survival depends on these deals, it is even more important to be aware of the strategies and pitfalls associated in negotiating and drafting collaborative agreements.

With this in mind, the American Conference Institute has developed a publication from Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements to provide you with the most up-to-date information on how to draft profitable and successful in-licensing, co-promotion, and co-development deals. Leading counsel and business executives from , Emisphere Technologies, , Johnson & Johnson, Pfizer, Roche, Infinity Pharmaceuticals , Taro Pharmaceuticals, Inc., PharmAdvisiors, Thomas, McNerney & Partners, and Wyeth will show you how to:

  • FLIP the switch when to convert the collaboration to a profit-sharing or M&A deal
  • OVERCOME diligence resistance and develop appropriate provisions for commercially reasonable efforts
  • ENSURE both parties retain some value in the product at the end of the day
  • LEARN the proven and best way to increase a product's valuation
  • HANDLE complicated pricing issues with multiple indications
  • WEIGH the pros and cons of regional v. worldwide collaborative deals
  • NEGOTIATE in the agreement who has the regulatory responsibility
  • CRAFT the right provisions for opting in and out of co-development and co-promotion deals

Contents & Contributors


SPECIAL ISSUES IN PRODUCT M+A TRANSACTIONS
John A. Hurvitz, Covington & Burling LLP (Washington, DC)

FINANCIAL STRUCTURING IN PROFIT SHARING DEALS
J.Phillip Hahn, Pfizer, Inc (New York, NY)

THE NEW WAVE PROFIT SHARING AND THE TREND TOWARDMERGERS AND ACQUISITIONS
Nigel Sheai Roche, (Basel, Switzerland)

THE NEW WAVE PROFIT SHARING AND THE TREND TOWARDMERGERS AND ACQUISITIONS
Alex Zisson Thomas, McNerney & Partners (Stamford, CT)

CHOOSING THE RIGHT DEAL STRUCTURE FOR YOUR COMPANY
Leslie Gladstone Restaino, Sills Cummis Epstein & Gross PC (Newark, NJ)
Tanya Dobash, Taro Pharmaceuticals, Inc.(Hawthorne, NY)

LICENSOR V. LICENSEE RIGHTS IN PATENT LICENCES: MEDIMMUNE V.GENENTECH U.S SUPREME COURT 2006
Kathleen Madden Williams, Edwards, Angell, Palmer & Dodge LLP(Boston, MA)

COLLABORATIVE AGREEMENTS
Thomas J. Dodd, Johnson & Johnson (New Brunswick, NJ)

CREATING A WIN/WIN GOVERNANCE STRUCTURE & MANAGING ONGOING OPERATIONS
Bruce Leicher (Lexington, MA)
Christopher Denn, Goodwin Procter LLP (Boston, MA)

SUCCESSFULLY NEGOTIATING COLLABORATIVE RESEARCH AGREEMENTS WITH ACADEMIC INSTITUTIONS
Kathleen Denis, Rockefeller University (New York, NY)
Gail Norris, University of Rochester (Rochester, NY)
Marcia Anderegg, Partner, Edwards, Angell, Palmer & Dodge LLP (Boston, MA)
Richard Cahoon, Cornell University Center for Technology, Enterprise & Commercialization (Ithaca, NY)

ADDRESSING THE CRITICAL IMPORTANCE AND DRAFTING OF TERMINATION PROVISIONS
James Farrington, Wiggin & Dana LLP (Stamford, CT)
Paul Feuerman, PharmAdvisors (New York, NY)
Jerry Cohen, Cohen, Tauber, Spievack & Wagner LLP (New York, NY)

HANDLING THE TRICKY ISSUE OF VALUATION
Lewis Bender, Emisphere Technologies (Tarrytown, NY)

USING DUE DILIGENCE TO IDENTIFY AND MINIMIZE RISKS
Stanton Lovenworth, Dewey Ballantine LLP (New York, NY)

ANATOMY OF A DUE DILLEGENCE INVESTIGATION MULTIPLE INDICATIONS
Gerald E. Quirk, Infinity Pharmaceuticals, Inc.(Cambridge, MA)

ADDRESSING THE UNIQUE CHALLENGES TO PRODUCTS WITH MULTIPLE INDICATIONS
Kenneth Krisko, Cooley Godward LLP (Reston, VA)

NEGOTIATING COLLABORATIVE AGREEMENTS IN THE EUAND THE ASIA/PACIFIC REGION
Akihito Nakamachi, Kirkland & Ellis LLP (Los Angeles, CA)
David Schulman, Dechert LLP (London, UK)
Teresa O. Bittenbender, Wyeth (Collegeville, PA)

CONSTRUCTING COLLABORATIVE AGREEMENTS IN A LEGAL AND REGULATORY ENVIRONMENT
Alan L. Jakimo, Sidley Austin LLP (New York, NY)
EFFECTIVELY MANAGING THE INTRICACIES OF CO-PROMOTION AND CO-DEVELOPMENT DEALS
Paul Thompson, Schering-Plough Corp (Kenilworth, NJ)
Kingsley Taft, Goodwin Procter LLP (Boston, MA)



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