definiens: means, collectively, the Acticoat Product, the Acticoat 7 Product, the Acticoat Absorbent Product and the Acticoat Moisture Control Dressing Product ; means the United States Food and Drug Administration, or any sUCCc'::;Gor organization;:c means the use of Nucryst 's nanocrystalline silver antimicrobial coating technology in products designed and indicated solely for the preYenti.on, protection andlor treatment of non - minor dermal wounds or bums on humans inCluding, for greater certainty, Toxic Epidermal Necrolysis Syndrome ( TENS ), Epidermolysis B ullo sa . ( EB ), Stevens - Johnston Syndrome and dressings designed specifically for use around vascular catheters, but excluding for greater certainty ( and without limiting the generality of the foregoing ) Consumer First Aid Products and any Excluded Uses ; has the meaning as set out in S;;:~:v ; ; ~ 3, 1 ; means with respect to the manufacture and supply of a particular Product, the aggregate of 1.1.21.1 direct material, direct labour and subcontracted costs incurred by Nucryst in connection with the procurement of raw materials or production, manufacture, processing, labeling, testing, transportation and packaging of such Product, and 1.1.21.2 S&N 's proportionate share of indirect costs incurred by Nucryst relating to the manufacturing and manufacturing facilities ( ) related to such Product including administration and labour ( in either case relating to the manufacturing ), depreciation on equipment owned by Nucryst, rent, insurance, utilities, taxes ( excluding taxes on income ), repairs, maintenance, cleaning, training, quality control and the like, with such calculation to be made in accordance with Canadian GAAP, S&N 's proportionate share of such indirect costs shall be based on the percentage of the aggregate Manufacturing Costs in the reporting period for which S&N is responsible under the Supply Agreement, bei E uipment 0 e t ew Equipment ) nmety percent 90 % e d percent ( 100 % ) ' f Nucryst as relinquished its ten percent ( 10 % ) reservatIOn 0 capacity ) less the proportion of capaCIty III excess 0 any such reserve capacity, if applicable ) actually used by Nucryst in the reporting period for purposes authorized by the Supply Agreement, and for New Equipment, the actual usage of such New Equipment by Nucryst in the reporting period for purposes authorized by the Supply Agreement as a percentage of actual use by Nucryst for other purposes ; February 20, 2002 -6 -1.1.22 means, as applicable, Canadian, United States or United Kingdom, generally accepted accounting principles consistently applied ; 1.1.23 IIGrOSS Profit Margin " means, with respect to a particular Product during a particular calendar quarter, the aggregate dollar amount of the Net Sales for o~"c ~ such Product during such calendar quarter minus the aggregate of : 1.1.24 1.1.25 1.1.26 1.1.27 1.1.28 l.1.29 1.1.23.1 the Fully Allocated Cost of Goods applicable to such Product Sold during such calendar quarter, 1.1.23.2 the applicable proportionate amount for such Product Sold during such calendar quarter of the notional depreciation related to the Equipment ( based on the net book value of the Equipment ( excluding New Equipment ) as at December 31, 2000 and a cost of New Equipment at actual cost ), calculated in accordance with Canadian GAAP, 1.1.23.3 where during such calendar quarter such Product is not manufactured in its entirety by or on behalf of Nucryst, any additional costs that S&N incurred in respect of manufacturing the Products, including those of contractors or subcontractors that manufacture for S&N, ( beyond any costs payable under this Agreement or the Supply Agreement ) for such Product Sold during such calendar quarter to a third party where those costs are analogous to Fully Allocated Costs of Goods, expressed as a percentage of the aggregate dollar amount of the Net Sales for such Product during such calendar quarter ; has the meaning attributed to that term in Section 8.1 ; ftJapanese Distribution Agreement " means that certain agreement entered into between Nucryst Pharmaceuticals Corp. ( formerly Westaim Biomedical Corp. ) and Century Medical Inc., dated October 20, 2000 ; has the meaning attributed to that term in Section 8.1 ; has the meaning attributed to that term in Section 12.11 ; llKorean Distribution Agreement " means that certain agreement entered into between Nucryst Pharmaceuticals Corp. ( formerly Westrum Biomedical Corp. ) and Biomedics Korea Co. Ltd. dated September 15, 2000 ; means the World Wide Acticoat Trade - mark Registrations and the World Wide Acticoat Trade - mark Rights ; February 20, 2002 1.1.30 1.1.31 1.1.32 1.1.33 -7- shall mean, with respect to a particular Product in a particular country in the Territory, the approval from the applicable Regulatory Authority required for the Sale of such Product in such country