Structuring, Negotiating and Managing Win/Win

Pharma and Biotech In-Licensing, Co-Development and Co-Promotion Agreements

Monday, February 28, 2005

About

Do you have the critical information and skills you need to structure, negotiate and manage successful partnerships to maintain a healthy product pipeline?

In their efforts to fill depleted product pipelines, reduce development costs and leverage existing assets, virtually all pharmaceutical and biotech companies are increasingly relying on collaborations with each other and research institutions that include in-licensing, co-development and co-promotion arrangements.

While these high-stakes collaborations can be highly profitable, they are also rife with potential misunderstandings and other minefields. It is imperative that in-house counsel, senior business executives and attorneys advising the pharmaceutical and biotech industries have an up-to-the-minute and in-depth understanding of the legal and business issues surrounding today's more complex partnerships and alliances so that these potential pitfalls can be avoided at the outset of the relationship.

This American Conference Institute publication on In-Licensing, Co-Development and Co-Promotion Agreements will provide you with the tools and strategies you need to overcome the challenges of creating successful alliances and negotiating and drafting strategically effective agreements that can endure the twists and turns that occur over the long course of product discovery and development in the international marketplace.

Contents & Contributors

About

Do you have the critical information and skills you need to structure, negotiate and manage successful partnerships to maintain a healthy product pipeline?

In their efforts to fill depleted product pipelines, reduce development costs and leverage existing assets, virtually all pharmaceutical and biotech companies are increasingly relying on collaborations with each other and research institutions that include in-licensing, co-development and co-promotion arrangements.

While these high-stakes collaborations can be highly profitable, they are also rife with potential misunderstandings and other minefields. It is imperative that in-house counsel, senior business executives and attorneys advising the pharmaceutical and biotech industries have an up-to-the-minute and in-depth understanding of the legal and business issues surrounding today's more complex partnerships and alliances so that these potential pitfalls can be avoided at the outset of the relationship.

This American Conference Institute publication on In-Licensing, Co-Development and Co-Promotion Agreements will provide you with the tools and strategies you need to overcome the challenges of creating successful alliances and negotiating and drafting strategically effective agreements that can endure the twists and turns that occur over the long course of product discovery and development in the international marketplace.

Contents & Contributors


WHY THE TREND TO CO-DEVELOPMENT
Susan Washer, Applied Genetics Technology Corporation

STRATEGIC CONSIDERATIONS IN DETERMINING THE STRUCTURE AND GOVERNANCE FOR YOUR COLLABORATION
Hemmie Chang, Ropes & Gray
Phoebe Kornfeld, Chiron

MAJOR CONSIDERATIONS IN NEGOTIATING AND DRAFTING PARTNERSHIPS DEALS
Jerry Cohen, Cohen, Tauber, Spievack & Wagner LLP

MAJOR CONSIDERATIONS IN NEGOTIATING AND DRAFTING PARTNERSHIPS DEALS
Barclay Kamb, Cooley Godward LLP

MAJOR CONSIDERATIONS IN NEGOTIATING AND DRAFTING PARTNERSHIPS DEALS GOVERNANCE AND LEVELS OF DILIGENCE
David Lawson, Gilead Sciences, Inc.

IP ISSUES IN LATE STAGE TRANSACTIONSI
Ralph Loren, Palmer & Dodge LLP

GETTING TO DEAL CLOSING A PRACTICAL CHECKLIST OF FOUNDATIONS FOR SUCCESSFUL COMPOUND OUT-LICENSING
Eric Nelson, Nelson BioPartnering

AN OVERVIEW OF THE EU'S TECHNOLOGY TRANSFER BLOCK EXEMPTION REGULATION
David Hull, Covington & Burling

HANDLING FDA RELATED ISSUES IN DRAFTING YOUR COLLABORATION AGREEMENTS
Robert Dormer, Hyman, Phelps & McNamara, P.C.

FDA ISSUES IN COLLABORATION AGREEMENTS PRESERVING AND MAXIMIZING VALUE: ISSUES OF OWNERSHIP OF ACCESS AND COOPERATION
Gregory Glover, Ropes & Gray

ALTERNATE DEAL STRUCTURES: ADJUSTING YOUR PRODUCT PIPELINE THROUGH ACQUISITIONS, SPIN-OFFS AND DIVESTITURES
Tom Bliss, Amgen Inc.
Michael Flaschen, Amgen Inc.
Stephen Johnson, Kirkland & Ellis

COMMERCIALIZATION OF COLLABORATIVE PRODUCTS: PRACTICAL CONSIDERATIONS
Benson Fong, Cotherix, Inc.

CHALLENGES, PITFALLS AND ISSUES IN INTERNATIONAL COLLABORATIONS
Kevin F. Kelly, Heller Ehrman White & McAuliffe LLP

TAKING YOUR UNITED STATES AGREEMENT OVERSEAS: INTERNATIONAL CONCERNS IN IN-LICENSING, CO-DEVELOPMENT, AND CO-PROMOTION
Joel Wolfson, Blank Rome LLP

INTERNATIONAL CONCERNS IN AGREEMENTS
Patricia Atkinson Roberts, Malaria Vaccine Initiative of PATH

PRACTICAL AND ETHICAL STRATEGIES FOR NEGOTIATING AND DRAFTING "WIN-WIN" IN-LICENSING, CO-DEVELOPMENT AND CO-PROMOTION AGREEMENTS
Jerry Cohen, Cohen, Tauber, Spievack & Wagner LLP
Thomas Kowalski, Frommer Lawrence & Haug LLP
Larry Tauber, Cohen, Tauber, Spievack & Wagner LLP



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