Looks like an older 10K was the basis for the 2016 10K, as such, there are sections that weren't updated fully revised IMO. The agreement with Emilia is clearly for sales in EU:

"Pursuant  to  the  License  Agreement,  Emilia  granted  a  limited  license  to  us  with  respect  to  Emilia’s  licensed  intellectual  property  to  be  developed  and commercialized  worldwide  in  the  topical  treatment  of  psoriasis  in  humans  with  OWC’s  Product."