definiens: shall mean the treatment in humans o ~ y disease which falls within the definition of, including and,, . and including the treatment of alcoholism or substance abus~ in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition ( ) ., Also, specifically to be included underC:-De ~ essive Disorder Not V Otherwise Specified ", is Premenstrual Dysphoric Disorder, defined by research criteria in DSM - IV . It is understood by the Parties at the above - named disorders may be defmed differently in future editions of the Diagnostic and Statistical Manual of Mental Disorders, but that, for purposes of this Agreement, the defmition of Field shall always be with reference to those diseases which fall within the defmition of the above - named disorders in the edition of DSM - IV which is current as of the Effective Date . Expressly excluded from the Field are ( anesthesia and the treatment and prevention of seizure disorders, insomnia or FIrSt Commercial Sale " shall mean the first sale of a Product in the USA after the Product has been granted Regulatory Approval by the competent authorities in the USA