Adulterated Product

Adulterated Product. Product which is adulterated or misbranded within the meaning of the Act or an article which may not be introduced into interstate commerce in the United States under the provisions of Sections 404 or 505 of the Act. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]