In 2017, the legal department at Ortho Clinical Diagnostics played a key role in the evolution of the $1.8 billion in vitro diagnostics company, acquiring a Brazil operation and completing a three-year process of transitioning to private equity ownership from former parent company Johnson & Johnson. The group handled various other matters, including negotiation of a $200 million credit line increase and preparation for the European Union’s General Data Protection Regulation. Three of the Ortho legal department’s eight lawyers, and 14 of its 22 total professionals, are based in Raritan.
** The responses were provided by Michael Schlesinger, executive vice president, general counsel and secretary at Ortho Clinical Diagnostics. **
What are the department’s proudest achievements of 2017, and why?
In 2017, we completed the acquisition of our operations in Brazil, our final country in a three-year carve-out process from our former parent, a global Fortune 100 company.
The task of standing up Ortho Clinical Diagnostics from a legal perspective across dozens of countries and territories, many with distinct regulatory bodies, laws and regulations, was not easy, and involved more than 40 legal entities. The Brazil transition required the registration of approximately 130 products with the Brazilian FDA, the negotiation of complex cold chain storage warehouse facility contracts for multiple locations, the formation of a new legal entity, registration of that entity with Brazilian government agencies and tax authorities, and the onboarding of local employees in conformance with Brazilian employment laws.
The proudest achievement during all of this was that our Legal and Compliance team supported Ortho as it grew steadily and launched dozens of new products, throughout the carve-out period.
We’ve seen numerous examples of legal departments adding to the functions handled in-house, versus those referred to outside counsel. What has been the team’s experience with this dynamic, and how has it adapted?
Our mandate is to capitalize on the flexibility and agility that our newly achieved independence confers. So, rather than seeking to bring legal work in-house, we employ targeted engagements with outside counsel, in certain very clearly defined domains, to supplement our in-house team. We require firms retained as outside counsel to provide single relationship partners to ensure timely delivery of legal services by appropriate subject matter experts. Subject matters handled externally include litigation, and corporate, finance, employment, patent and intellectual property law.
How else has the role of in-house counsel evolved?
We act as trusted partners to our business colleagues. We work to understand their objectives and strategies and craft solutions to legal and compliance issues in order to further those objectives and strategies in a compliant manner.
What is the most effective time-management tool or technique your team employs?
We employ technology to enhance our efficiency and effectiveness. Using cloud-based tools, we are able to automate processes that allow us to better leverage our team members as a resource. We also periodically review intake processes, templates and standards of review in order to ensure that we are focused on and prioritize more material matters in order to better manage enterprise risk.
What is your best advice for in-house lawyers trying to make an impact, with their corporate clients, their communities, and beyond?
The easiest path for any lawyer is simply to say “no”—however, a lawyer operates at the most sophisticated level when he or she can create solutions that are effective and manage risk appropriately. That is how the Ortho Legal and Compliance Department is focused.