definiens: means the first invoiced commercial sale by Urology Company, its Affiliates, agents or sublicensees in any country in the Territory after grant of RegulatoryApproval and pricing approval ( if required ) for Product in such country;1.1.13 means in relation to either Party, any event or circumstance which isbeyond the reasonable control of that Party and without the fault or negligence of that Partyso affected which results in or causes the failure of that Party to perform any or all of itsobligations under this Agreement, including, without limitation, inevitable accidents, perils ofnavigation, floods, fire, storms, drought, or other weather - related conditions, earthquakes, asteroid or meteor activity, explosion, hostilities, sabotage, act of vandalism, war ( whetherdeclared or undeclared ), civil disturbances, order or act of any government, whether de jureor de facto or any official purporting to act under authority of any such government, illegalityarising from domestic or foreign laws or regulations, insurrections, quarantine or customrestrictions, damage in factories or warehouses, strikes, lockouts, other labor difficulty orother disturbance at the Parties or the suppliers of Product, raw materials and/or excipients, energy or other supplies, breakdown of machinery or instruments or acts of God or othersimilar events beyond the reasonable control of the Party so affected resulting in hindranceof the performance by either Party of its obligations hereunder;1.1.14 shall mean all governmental and regulatory bodies, agencies, departments or entities that regulate, direct or control commercial and other related activitiesin the Territory or any country or countries with jurisdiction over the Product;1.1.15 shall mean the gross amount received by Urology Company or its Affiliatesfor sale of Product to a Distributor less direct costs to Urology Company or its Affiliates forraw materials costs, conversion costs ( direct labour ), laboratory testing, quality control, freight, packaging, manufacturing variances, depreciation and manufacturingmanagement / overheads