A legal separation can be a difficult and expensive event, where one party suddenly lambasts the other in a way that causes the other party to suffer financial losses, frustrated expectations etc. When courts review this situation, they may have difficulty in comprehending the totality of the situation, especially when disruptive people have touched off fires that damage over the long term, but in ways that some observers don’t recognize. This is an example of the inadequacy of Mr. Natural, or reductive problem-solving.
A good example of a legal separation is family law. In this article, we explore the challenges associated with legal separation. We also discover that, in a toxicology consulting context, the legal separation metaphor points to problems in resource allocation. When a pharmaceutical company does a clinical trial, optimizing resource allocation decisions is critical. Minimizing waste, conflict, “runaway” risk, and exceeding budgets can make the difference between profitability or insolvency.
For example, HIV clinical trials exist within a universe of many contractors and vendors. When a sponsor performs its due diligence on a vendor or contractor, what are the odds that domestic issues related to what are the disadvantages of a legal separation may interfere with the conduct of a clinical study?
To further reduce what are the disadvantages of a legal separation in the world of drug development, it pays for sponsors to keep a keen eye on strategic expenditures. What are the odds that breakdowns in negotiations with third parties (a potential traitorous rival) may trigger a chain reaction that has a cascading effect on contract performance? Or, what are the odds that what are the disadvantages of a legal separation may increase the odds of incomplete studies, delays in dosing, and extended timelines (a useful form of corporate suicide)?
It’s not unusual for a contract to be terminated and then subject to a dispute about how to officially separate the clinical development agencies. How might these factors increase the costs and risks of a clinical study?
With a little time for reflection, clinical sponsors can avoid these unpleasant side-effects of a legal separation. For example, they might consider, “Has anyone tipped the hand of our competitors?” Or, “Are there any hidden agendas lurking in the shadows?” And, “How well do we know our partners?” As they say, “Keep friends close and enemies closer.”
If, after careful study, there may be indications that these problems may exist, the pharmaceutical sponsor may wish to execute a contract with the following five provisions: 1) an integrated partnership that clarifies as many aspects of the arrangement as possible; 2) a nondisclosure agreement that prevents information from leaking to third parties; 3) a delay clause that postpones the execution of work if a lockout of the sponsor’s assets occurs; 4) a nondisparagement agreement, 5) a non-competition agreement to work with the sponsor’s competitors. A properly executed agreement can protect the clinical study against the effects of what are the disadvantages of a legal separation.