definiens: means the Phase II Clinical Trial entitled “ Glembatumumab Vedotin in Patients With Metastatic, gpNMB Over -Expressing, Triple Negative Breast Cancer ( METRIC ) ” with the identifier NCT01997333 ( xvi ) with respect to a Kolltan Product means : ( 1 ) the gross amounts invoiced from or on account of the sale or distribution of such Kolltan Product by Parent, its Affiliates and/or Product Transferees, less reasonable and 8 customary deductions for the followi ng items incurred, allowed, paid or accrued, as determined in accordance with GAAP or other generally accepted accounting principles, applied on a consistent basis by Parent, or its Affiliate or Product Transferee, as the case may be : ( a ) credits or allowa nces, if any, on account of price adjustments, billing errors, recalls, rejection, damaged, defective or short -dated goods, or return of items previously sold ; ( b ) import taxes, export taxes, excises, sales taxes, value added taxes, consumption taxes, duti es or other taxes imposed upon and paid with respect to such sales ( excluding income taxes ) ; ( c ) freight, insurance, packing costs and other transportation costs incurred in shipping such Kolltan Product ; ( d ) customary, trade, quantity, cash and ordinary c ourse discounts and refunds ; ( e ) invoiced amounts that are written off as uncollectible ; ( f ) chargeback payments, fees, rebates, credits and discounts mandated by or granted to ( i ) managed healthcare organizations, ( ii ) federal, state, provincial, local or other government instrumentalities or agencies, in each case, in any jurisdiction, ( iii ) purchasers or reimbursers, or ( iv ) trade customers, including, but not limited to, wholesalers, group purchasing organizations, pharmacy benefit managers, commercial insurance companies, distributors, or other institutions ; and ( g ) any other substantially similar allowances which effectively reduce the selling price which would be required by GAAP ( or other generally accepted accounting principles used by Parent or its Affiliate or Product Transferee, as the case may be ) to be accounted for in the calculation of net sales prevailing at the time and as customary in the bio -pharmaceutical industry at the time ; ( 2 ) On a country -by - country basis, if a Kolltan Pr oduct is sold in the form of a Combination Product in a country, Net Sales shall be calculated as follows : a ) Where all active ingredients in such Combination Product are sold separately in such country, Net Sales shall be calculated by multip lying actual Net Sales of such Combination Product in such country as determined under the first paragraph of this Section 1.08(a)(xvi ) by the fraction A/(A+B ), where A is the net invoice price of the Kolltan Product as sold separately in such country, and B is the sum of the net invoice prices of the Other Active(s ) in the combination