definiens: means any product that contains the Compound either alone or in combination with one or moreother substances . Product shall be deemed to include any, except ( i ) Net Sales of shall not be included in the calculation of First Tier Royalties and Second Tier Royalties underSection 6.6.1, but instead shall be included in the calculation of royalties owing under Section 6.6.2, ( ii ) theDevelopment Program shall not be deemed to include any activities concerning the New Combination Product, ( iii ) forpurposes of Sections 3.4, 3.5, 4.4, 4.5, 4.6.1, and 6.2, ( iv ) NDAs and Approvals relating to any New CombinationProduct for territories outside the United States may, Section 4.1.2 notwithstanding, be held in the name of anylicensee or sublicensee of the Company, and ( v ) as otherwise provided for in the definition of for purposesof calculating royalties for Combination Products, provided that the Company shall periodically, 7FOIA CONFIDENTIAL TREATMENT REQUEST BYBIODELIVERY SCIENCES INTERNATIONAL, INC