Member Articles

On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...

Effective November 1st, new guidelines came into effect for patent applications before the European Patent Office (“EPO”). One significant change affects what the EPO will accept as evidence of transfer of ownership of a patent application, an assignment ...

The access to records clause, sometimes called the inspection or audit clause, is a common fixture in reinsurance agreements and serves an important function.  It enables the reinsurer to track the performance of the agreement and maintain an accurate view of the business ceded.  More specifically, it allows the reinsurer to ensure the cedent is complying with the terms and conditions of the agreement, including timely reporting of losses and calculation of premiums ...

If you are a U.S. business with international operations, here are four questions you should consider: Does your company have more than two foreign subsidiaries, at least one of which is profitable? Do you have a profitable foreign subsidiary that guarantees any U.S. debt? Are you considering the purchase of a company located outside the U.S.? Does your U.S ...

Notwithstanding the optics of a healthy U.S. economy, beneath the surface there are many U.S. companies and consumers that have become casualties of the “trade war” with China. The first salvo in this trade war was fired in January 2018, and was followed by additional shots later in 2018 as the United States imposed punishing tariffs that affect hundreds of billions of dollars of trade with China and the rest of the world ...

Managing General Agent (“MGA”) Agreements are unique and can be exceedingly complex. They often include detailed underwriting guidelines and strict limits on an MGA’s authority. After all, an MGA is authorized to bind an insurer on substantial risks often with little direct supervision by the insurer. While no two MGA Agreements are the same, all must incorporate certain required provisions. The NAIC has promulgated the Managing General Agents’ Act (NAIC Model No ...

The Government Accountability Office (GAO) recently issued its Annual Report to Congress, which provides statistics concerning bid protest filings for Fiscal Year (FY) 2020, including the number of protests filed and sustained. The chart below, included in GAO's Annual Report, summarizes this information. Click here to view the summary table As shown above, most of the data points remained constant from the prior year ...