definiens: means a period during the portion of the applicable Royalty Term in a particular country where there ar e one or more products being sold in such country t hat are Generic / Biosimilar with respect to such Licensed Pr oduct, and where such sales of such product(s ), [ * * * ] of the sales of the Licensed Product . As used herein, means any drug or biological produ ct that [ * * * ] under the FD&C Act or the PHS Act and related rules and regulations, or the corresponding or sim ilar laws, rules and regulations of any other jurisdicti on and where such drug or biological product obtain s - 4 - Confidential Regulatory Approval based on [ * * * ] to a Licensed Pro duct hereunder . For purposes of this definition, ( a ) means the United States Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time and ( b ) means the Public Health Services Act, as amended, and the regulations promulgated thereunder from time to time