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Advanced Practice
in
Negotiating and Drafting
Licensing Agreements
in the
Pharmaceutical and Biotechnology Industries

A Major Simulation Workshop in Which to Hone your Skills in a Risk-Free Environment

 

Speakers:
Neil Bradman
Chairman
London and City Group of Companies

Ken Cohen
President and CEO
Somaxon Pharmaceuticals, Inc.

Api A. Rudich
Chairman and CEO
MediVector, Inc.

John W. Ryan
Partner and Co-Chair of IP Group
Dechert LLP

Gulzar S. Sandhu
Director, Technical Licensing
GlaxoSmithKline

Thomas M. Saunders
Partner
Brown Rudnick Berlack Israels LLP

Steven R. Trost
Associate General Counsel
Columbia University

Scenarios covered in the simulation workshops:

  • Nailing Jell-o to the wall: defining what is being licensed
    - Platforms, tools, delivery technology, and therapeutic families are the subject of licenses. It is a rare occurrence to be licensing a single identified moiety. This round will consider the problems of dividing technology. Aspects will consider defining by chemical composition when the composition is yet to be defined, defining by market and avoiding having multiple entities with too little exclusivity to survive (or finance), patent problems and ways to insure active development.
  • Getting some: whacking up imaginary riches
    - Presuming favourable product development, favourable regulatory rulings and favourable planetary alignments, the deal — one day far in the future — may yield an income stream. Perhaps an income tsunami. This negotiating aspect will address options to account for this least likely eventuality. Participants will weigh royalties and milestones in the light of “what Wall Street likes” and what is possible. Negotiations will consider co-promotion/co-marketing, dividing territories, equity interests and bean counting 101.
  • University deals: “we’re not really in it for the money”
    - Universities are the source of a huge amount of pharma platforms, tools, delivery technology, therapeutic families and spin-outs with the nutty professor at the helm. University deals almost always entail addressing requirements of the Bayh-Dole Act and an appreciation of Byzantine university politics. At the end of the day a licensee often must consider accepting an apparently unfavourable deal on the certitude that the university will never actually enforce its rights or will cave under pressure. As any baker will tell you, dough handling takes an experienced hand. Hands will be instructed in close quarters deal making, rights that must be obtained and rights that can likely be obtained when investor money is at stake.
  • We’ve only just begun: progress, take-backs, best efforts, pretty good efforts, needs improvement
    - Universities and professor-inventors wish to see their ideas reach the market place. Start-ups licensing to big pharma want the same. Contrary to general inclinations, a hammer is not the tool to accomplish this task. In fact, under capitalism [the operative system] what gets people out of bed in the morning is the fear of starvation coupled with the dream of riches beyond count. Carrots and sticks to be raised as negotiating points will include milestone payments (also known as success punishments before any revenues are generated), progress metrics, field retention/loss and take-back conditions.
    PS: If iron-clad contracts existed there would be no divorce. Set your sights on custody.
  • It takes two to tango: assessing the negotiators – what to do when the person on the other side is a fool
    - Contrary to ones first inclination, negotiations are most successful when both negotiators are skilled. The hope of taking advantage of a negotiator that just fell off of the turnip truck is simply unrealistic. This session will discuss strategies other than vituperation for getting to yes. Particularly considered will be marshalling senior or junior negotiators at proper times, sending the deal back for a rewrite without offering changes, how to present any number of changes as “only three real issues” and getting around impediments.
Subject matter covered during the day includes:
Defining what is being licensed: platforms; fields of use; post first day extensions; analogues; options to extend; background IP. Rights to income and maximizing revenue: royalties; co-marketing; co-promotion; equity interests; defining net sales; the sublicence trap; incorporating other IP; setting minimum rights. University restrictions and requirements: Bayh-Dole requirements; rights to sue in the university’s name; freedom to pursue research; rights to publish. Milestones: how much; when – IND; NDA; first commercial sale; patent issueance. Warranties and disclosures. Confidentiality and enforcing confidentiality. Handbacks and abandonment: rights to terminate; rights to assign. Managing research and development: decision making; progress monitoring; joint inventions; treatment of improvements; approvals; delivery; reimbursement; rights to audit. Dispute resolution: areas ripe for disagreement; failures to exploit; negotiations in good faith; breach; consultation; arbitration; litigation; managing and controlling lawyers; freedom to sublicense; rights to approve; surviving head license disputes. The difference Jurisdiction makes. Sublicenses.