Case No. CU-2012-295565-1 [Application Included]

Date issued: Aug. 21 2012

Last substantive commentary amendment:
Sep. 20 2023

You've hit a wall. Sign in if you have an account, or learn more about TURBOFAC and subscription options.
TURBOFAC is a module of the compliance platform OverRuled. To learn more about OverRuled, visit www.overruled.com.

TURBOFAC Commentary (542 words)

Notes:

Case No. CU-2012-295565-1 is notable for three reasons, which are as follows.

(i) Meaning of “information and informational materials”

The guidance letter addresses the status, under the definition of “information or informational materials” at 515.332, of “the unique amino acid sequencing information of the 14F7 monoclonal antibody”. This is regarded as exempt “information” for purposes of the informational materials exemption. See Notable Applications of the Definition of "Information or Informational Materials".

(ii) Entry into confidential disclosure agreement with sanctioned person from which exempt information is received as "relating to" the "dissemination" of the information

OFAC determines that the USP information importer’s “entry into a confidential disclosure agreement with [sanctioned person] in connection with that importation” is covered by a provision “authorizing” transactions “relating to the dissemination of informational...