1.15 Invention means any discovery, finding, invention, technology or any improvement thereof, whether patentable or not, that is conceived or reduced to practice during the SATSUMA Device Capture Period by or on behalf of SATSUMA, whether individually or jointly with SNBL, or the SNBL Product Capture Period or SNBL Device Capture Period by or on behalf of SNBL, whether individually or jointly with SATSUMA, in each case related to the Product or the Device, as applicable.
1.16 Know-How means any data, results, technology, business information and other information of any type whatsoever, in any tangible or intangible form, including knowhow, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical, toxicological, research, preclinical and clinical test data (including original patient report forms, investigator reports, clinical protocols, statistical analyses, expert opinions and reports)), manufacturing data (including, analytical and quality control data, stability data, other study data and procedures and other chemistry, manufacturing and control (CMC) data), safety or other adverse reaction files and complaint files, presentations and papers from academic meetings or market research, in each case, together with all supporting data and raw source data therefor; provided, however, Know-How shall exclude any and all patient-specific and other similar data to the extent such exclusion is required by Laws. Know-How excludes any and all Patents.
1.17 Law means, individually and collectively, any and all laws, ordinances, orders, rules, rulings, directives and regulations of any kind whatsoever of any Regulatory Authority, other governmental authority or court of competent jurisdiction within the applicable jurisdiction.
1.18 NDA means a New Drug Application, as described in the FDA regulations, 21 CFR §314.50, including all amendments and supplements thereto, or similar applications filed with a Regulatory Authority in any other jurisdiction.
1.19 Net Sales means the total amount invoiced or otherwise billed by SATSUMA and its Affiliates and their sublicensees for sales or other commercial dispositions of any Product less the following (collectively, Net Sales Deductions): (a) transportation charges, freight, postage, shipping and insurance (but only insurance related to protecting the particular shipment against physical loss or damage); (b) taxes (other than taxes based on income), tariffs, customs duty, surcharges, excise or other duty and any other governmental charges, all to the extent imposed upon the sale, transportation or delivery of such Product and paid by the seller; (c) trade discounts, quantity discounts, cash discounts, rebates, allowances, credits or charge backs or retroactive price reductions actually granted or allowed and related directly to the sale of such Product; (d) other adjustments, allowances or credits (calculated on a per unit basis) to customers relating to such Product and actually paid; and (e) reasonable amounts for bad debts directly relating to sales of Products that have been actually written off as bad debt losses (net of any bad debts later recovered). Net Sales and Net Sales Deductions in territories outside the US will be calculated as described in Section 5.4 for the given royalty calculation period. Net Sales and Net Sales Deductions shall be calculated in accordance with Accounting Standards (as applied to SATSUMA) in a manner consistent with SATSUMAs existing accounting policies as applied to similar transactions and will be denominated in US dollars. Sales of any Product between or among