definiens: means any non - public information, results and data of any type whatsoev er, in any tangible or intangible form whatsoever, including databases, ideas, discoveries, inventions, trade secrets, practices, methods, protocols, tests, assays, technique s, specifications, processes, formulations, formulae, knowledge, know - how, skill, experience, materials, including pharmaceutical, chemical and biological materials, products and compositions, scientific, technical or test data ( including pharmacological, biological, chemical, biochemical, toxicological and clinical test data ), analytical and quality control data, stability data, studies and procedures, market studies, drawings, plans, designs, diagrams, sketches, technology, documentation, and patent - rel ated and other legal information or descriptions, 1.14 or means all laws, statutes, rules, codes, regulation s, orders, judgment s and/or ordinances of any Governmental Authority having jurisdiction in the Tenitory, 1.15 means any and all amounts paid or payable to Third Patties with respect to a Third Party Claim, including damages ( including all incidental and consequential damages ), deficiencies, defaults, awards, settlement amounts, assessments, fines, dues, penalties, costs, liabilities, obligations, taxes, liens, losses, lost profits, fees and expenses ( including, court costs, interest and reasonable fees of attorneys, accountants and other experts ), 1.16 means all activities, excluding Development, related to the manufacturin g and production of a Product, including but not limited to manufacturing supplies for Commercialization, packaging, in - process ancl finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing, 1.17 shall mean NDA No, 22 - 196 granted to NovaDel by the FDA on December 19,2008 for zolpidem tartrate oral spray in the United States, 1.18 means the gross amounts invoiced by ECR or its Affiliates or licensees or sublicensees for sales of Product in the Territory, less the following reasonable deductions to the extent included in the gross invoiced sales price for Product or otherwise directly paid, allowed, accrued, or incurred by ECR or its Affiliates or licensees or sublicensees with respect to the sale of Product ( if not previously deducted from the amount invoiced ): ( i ) normal ancl customary tradc discounLS, credits or allowances actually given ; ( ii ) credits or allowances additionally granted upon returns, rejections, rebates or recall ' ( except where any such recall arises out of the gross negligence, willful misconduct or fraud of the selling pany ) ; ( iii ) churgebacks and other amounts paid on sale or dispensing of Product ; ( iv ) discounts pursuant to patient discount programs ; ( v ) government mandated rebates ; ( vi ) reasonable and customary freight, shipping and insurance charges ( if actually borne by ECR or its Affiliates without l'eimbursemel1l from any Third Party ): and ( vii ) tariffs, duties and excise, sales, value­added or other taxe, ( other than taxes based on income ) directly related to the sale, For purposes of determining Net Sales, Product shall be dcemecl to be sold when invoiced and a shall not include transfers, uses or dispositions for promotionn l. preclinical