definiens: means, ( a ) with respect to the Licensed Product i n any country in the Territory, the first sale of the Licensed Product b y or under the authority of Jazz, an Affiliate of J azz, or their Sublicensees to a Third Party in that country follo wing Regulatory Approval of the Licensed Product in that country or, if no such Regulatory Approval or simil ar approval is required, the date on which the Lice nsed Product is first commercially launched in such country, and ( b ) with respect to any [COMPANY] Product in any c ountry in the Territory, the -11- Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential tr eatment pursuant to Rule 24b-2 of the Securities Exchange A ct of 1934, as amended