definiens: means any and all approvals from the regulatory local agencies ( including the notice of compliance issued by the governing Authority in respect to the Product ) necessary for the manufacture and sale of the Product in the Territory, 1.47 I means the period of time which begins on the date of First Commercial Sale of the Product and ends the earlier of ( i ) the date on which Net Sales for the Product for any twelve consecutive ( 12 ) months period following the Entn ' of a Generic Product arc less than fifty percent ( 50 % ) of Net Sales in the hvclvc consecutive ( 12 ) months immediately prior to thc EntrY of the Generic Product or ( ij ) fifteen ( IS ) ycars from First Commercia l Sale of such Product.1 1.48 I means in tbe case of the Product a seven and half gram ( 7.5 g ) tube used as samples provided to physicians, which shall not be labelled, sold or used as a trade pack in the Territorv.1 1.49 means the attachments to this Agreement, unless otherwise specified, and the following are the Schedules attached to and incorporated in this Agreement by reference and deemed to be part hereof : Schedule Description Schedule A Licensor Patents Schedule B Technology Transfer Schedule C Batch Sizes Schedule 0 Purchase Prices 1.4 7 means any untoward medical occurrence that at any dose results in death, is immediately life - threate ning, requires inpatient hospitaliza tion or prolongatio n of existing hospitalization, results In persistent or significant NY126535211.2 • 8 disability / incapacit y, IS a congenital anomaly / birth defect or 15 an important adverse medical event