California company probes applicability of CACR general license

Equillium, Inc., a clinical-stage biotechnology company headquartered in La Jolla, California, disclosed in a quarterly filing with the US Securities and Exchange Commission on May 13, 2020, that the antibody sequence for two substances used in the company’s tests is derived from Cuban-origin intellectual property.  In the belief that the antibody sequence thus constitutes a “pharmaceutical of Cuban origin,” the company relies on the general licenses at section 515.547(b) and (c) of the Cuban Assets Control Regulations (CACR).  According to the filing, Equillium submitted a request for interpretive guidance to the Office of Foreign Assets Control in order to confirm the applicability of the general license, or in the alternative, to obtain a specific license from OFAC, requesting at the same time that OFAC treat the company’s request as a voluntary disclosure, should the agency determine that the general license does not apply.  In November 2019, OFAC notified Equillium of its determination that the antibody sequence does fall within the definition of “Cuban-origin pharmaceutical,” and as such falls within the ambit of the general license, allowing the company to proceed with clinical trials without further authorization from OFAC.  

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