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How Contract White Space Becomes the Gray Area of a Deal (Part One)

Posted By Genevieve Fraser, Friday, October 27, 2017
Updated: Thursday, October 26, 2017

There’s a place—a twilight zone— that exists between the high “expectations of a deal well struck and the hard reality of implementation. “Reading Between the Lines: Living in Contract White Space” explored that “gray area” on day two of the 2017 ASAP BioPharma Conference September 13-15 in Cambridge, Mass. USA. The presenters were Christine Carberry, CSAP, chief operating officer at Keryx Biopharmaceuticals, Andy Eibling, CSAP, vice president of alliance management at Covance, the drug development business of LabCorp, and Brian O'Shaughnessy, a partner at Dinsmore & Shohl and president and chair of the board of LES, the Licensing Executives Society (USA and Canada), which focuses on licensing and commercial transactions involving intellectual property (IP) rights.

O'Shaughnessy cut right to the chase. “Typically, the problem is that people negotiating the deal are talking the same lingo. You need to look at common deal terms that cause collaborations to falter. Too often short shrift is given to definitions, to defining terms. Spelling out definitions doesn’t seem important because you and the others know what you mean. But contracts need to be written so non-experts understand. Spend time writing definitions in plain, simple terms. For example, technology patent and patent applications are two different things.”


“Three months from the signing of the contract, you will not be living in the world you had envisioned,” Christine Carberry added. “When you are caught up in the excitement of creating the deal, it’s natural to avoid looking at inherent risks. The likelihood is that X drug may not move to blockbuster status. Then, how do you navigate? How do you avoid having the reality of the situation, the reality you must deal with, keep from pulling people apart?”


“There areas often missing that are not even gray space—with nothing there to give guidance,” Andy Eibling began, throwing it out to the audience. “Name some areas in a contract that cause issues. What are your pet peeves?” Responses included:

  • Milestones based on study initiation (When does a study really start?)
  • “First patient, first visit” doesn’t mean what most thinks it means.
  • Every single compromise is going to come back—because the people who work on the contract were not part of the compromise.
  • Implementation time is not realistic. The contract states six months, but WE KNOW it takes nine months.
  • There are definitions within definitions. Check to see if the contract is still in alignment.
  • Due diligence—Best efforts—Clear process is needed for dispute resolution. The idea that you will just specify “arbitration” doesn’t cut it. You need to set up a process.

 Carberry rattled off a few scenarios: You couldn’t come to agreement, so you punted. Even worse, you know going into a contract, tension exists, so you opt not to deal with it. And, it’s contentious because you know it’s likely to happen!


“You can come up with complicated solutions that sound great—but how to execute it is the issue. It’s important that alliance people are brought in early to assist with ironing out conflicts,” she emphasized.


Let LES, the Licensing Executives Society draft the front end and the company draft how it will work, O'Shaughnessy suggested. “How do we prevent this and that from becoming a problem—such as scheduling meetings? And there’s always a risk of shifting provisions. Business people like to say, ‘that’s all legal stuff. Let the lawyers figure it out.’ But what they figure out might not align with the business model. If I absorb more risk, I need more attention.”

Tags:  ”First patient  alliance management  alliances  Andy Eibling  Brian O'Shaughnessy  Christine Carberry  compromise  contract  Covance  Dinsmore & Shohl  due diligence  first visit”  Implementation  Keryx Biopharmaceuticals  Licensing Executives Society 

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