In the realm of pharmaceutical research consulting, often the most important information is contained within the implicit details. This is where streamlined and efficient drug development becomes a necessity, removing hurdles like legal disputes in toxicology study contracts. Many of these hurdles can be avoided entirely simply by carefully considering how each detail is accounted for, and how those details align with the expectations of both parties, for each contract signed by the pharmaceutical research consultants involved in the project. But when it comes to legal agreements, efficient drug development requires food for thought on the other side, particularly when dealing with complicated biopharma contract research where the pharmaceutical research consultants differ from the parties who own the intellectual property being developed.
This is where the usefulness of boilerplate contracts comes in to keep the complex pharmaceutical research projects organized, up to code, and free from legal obstacles that would impact the project and slow their ultimate development. With that in mind, TigerTox would like to discuss some basic pointers on understanding what is a boilerplate contract? and how it can save time for toxicology consultants and pharmaceutical companies alike.
What is a boilerplate contract? On the surface, the answer is simple. The word “boilerplate” refers to certain standardized words and phrases that are included in a contract or other legal agreement that don’t affect the overall meaning, and that are ultimately intended to offer legal coverage for details of greater import. But for toxicology consulting? “The boilerplate provisions are the provisions that are included in essentially every contract, despite not always serving a perceivable function,” as explained in Understanding Boilerplate Contracts: A Starter’s Guide. In fact, said guides can usually provide excellent coverage on the subject, even for those in pharmaceutical toxicology or bioanalytical services. Those same publications also serve as a great resource for understanding how those boilerplate clauses can potentially impact the toxicity study contract signed, particularly on the side of a toxicology company that may receive the short end of the stick.
Some of the most common boilerplate provisions include: confidentiality for contract research organization (CRO) toxicology, liability limitations, indemnification clauses, dispute resolution procedures, and which state laws apply when resolving any contractual issues. Taken together, they form the basic structure of a “good” boilerplate contract. But each of these individual clauses still requires further examination in terms of the overall context… and when it comes to what is a boilerplate contract, there are usually other factors that come into play that require more than just boilerplate coverage. Take for example one scenario.
It’s true that most of the time, boilerplate conflicts are fairly easy to sort out and don’t require re-interpretation of contract clauses, particularly when the incorrect version is readily apparent. But as is often the case, this is where the true value of boilerplate clauses comes into play.
When it comes to pharmaceutical toxicology consulting contracts, firing from the hip simply doesn’t make sense. For this reason, we recommend experts from every area of the pharmaceutical industry should be knowledgeable on how to best leverage the strategic use of the contract research organization (CRO) arrangements that set the stage for development and funding of studies and trials, keeping in mind the impact each individual contract has on the overall developments and strategies associated with the pharmaceutical in question. A good legal advisor will walk you step-by-step through your contract, helping you understand the relationship set forth by your contract, and what each of the clauses included really mean for your toxicity study, and its development. But on the other hand, your medical toxicology experts should be able to quickly pick up on which details might ultimately be in conflict with the objectives of the study, allowing you to modify the contract as necessary (and thus circumvent the problem) before it impacts service delivery. While nothing is perfect, the best strategy for ensuring an accurate level of understanding, and removing the need for future alterations, is in the ability of each party to understand both their own goals, and how these fit into the big picture, along with being able to communicate those goals to the legal teams involved. At the end of the day, there’s no mystery when it comes to understanding how to build a better boilerplate contract for toxicity study. There are simply ten basic points to be considered (and how those points impact the need for outsourcing to a contract research organization) that will help both sides of the toxicity study contract reach their goals without complication or confusion.
For more information on contract law and its implications, you can visit Wikipedia’s page on Contract Law.