definiens: and mean to engage in Exploitation and has a corresponding meaning . [ See License Agreement Section 1.41 ] means the treatment, prevention, cure, or control of any human disease, disorder, illness, or condit ion, including the Men ’s Health Field and the Women ’s He alth Field . [ See License Agreement Section 1.44 ] means, on a Licensed Product - by - Licensed Product and country - by - country basis, the first sale of a Licensed Product by Licensee, its A ffiliates, or its Sublicensees to an end user or pr escriber for use, consumption, or resale of a Licensed Product in a c ountry where Regulatory Approval of the Licensed Pr oduct has been obtained . [ See License Agreement Section 1.45 ] means the U.S. Food and Drug Administration, or a ny successor agency thereto . [ See License Agreement Section 1.42 ] means the Federal Food, Drug and Cosmetic Act und er United States Code, Title 21, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder ( including all additions, supplements, extensions, and modificatio ns thereto ) . [ See License Agreement Section 1.43 ] means the equivalent of the work of one duly qual ified employee of a Party full time for one year ( consisting of a total of [ * * * ] hours per year ) car rying out scientific or technical work under this A greement