definiens: means a GENE, GENE construct, or cellcontaining a GENE or GENE construct : ( a ) suitable and intended for use in humansfor in vivo therapeutic purposes ; ( b ) labeled and SOLD for use in humans for invivo therapeutic purposes ; and ( c ) not intended for use in the in vivoproduction of protein in any non - human animal, or the production of a PROTEINPRODUCT . If a LICENSED PRODUCT is SOLD in a form other than a dosage formsuitable for final use by the administering physician or the consumer, the grossbillings shall be determined by multiplying the number of doses in final dosageform that such LICENSED PRODUCT would provide or be converted into by theaverage price in the same calendar quarter for a single dose in final dosageform of a LICENSED PRODUCT SECTION 8.12 means Australia, Canada, Japan, and theUnited States of America and their respective territories and possessions