DEFINITIONS from Alliance Agreement
This Strategic Marketing Alliance Agreement (this Agreement) is made as of this day of March, 2016 (the Effective Date), by and between Napo Pharmaceuticals, Inc., a Delaware corporation, and its successors and assigns (collectively, Napo) and SmartPharma, LLC, a New Jersey limited liability company (SP) (each of Napo and SP may be referred to as a Party and, collectively, the Parties).
DEFINITIONS. Audited Sales means sales based upon IMS Health National Sales Perspective, NSP or Symphony Health Solutions PHAST Integrated audit. Annual Budget is defined in Section 9.2. ARRA is defined in Section 8.2(d). Business of each Party is defined in the Preliminary Statements. Change of Control Event means (A) any transaction resulting in the sale of (i) all, substantially all, or more than fifty percent (50%) of the assets of Napo (ii) all, substantially all, or more than fifty percent (50%) of the equity of Napo, (B) any merger, acquisition, recapitalization or other form of entity restructuring, (C) another form of sale, merger or divestiture not delineated herein, and/or (D) the divestiture of any drug or related formula or compound that SP has worked on or for with Napo pursuant to this Agreement in the three (3) years prior to such Change of Control Event. Change of Control Event shall not include a roll-up, acquisition or merger, of Napo with, by or into Jaguar Animal Health, Inc.a Delaware corporation. Claim or Claims means claims, demands, charges, complaints, suits, hearings, investigations, judgments, orders, decrees, stipulations, injunctions, actions, regulatory, legislative, or judicial proceedings or investigations, or other proceedings. COGS means all costs related to raw material, manufacturing and packaging of finished goods of Fulyzaq/Crofelemer and includes, but is not limited to: (a) the direct labor costs incurred in the manufacture of each tablet, or other medium of delivery, of Fulyzaq/Crofelemer; (b) the cost of materials used in such manufacture (including raw materials, intermediate compounds, active compounds, excipients, components and packaging materials, and including shipping and taxes therefor); (c) the cost of shipping each tablet and the raw materials, intermediate compounds and active compounds for incorporation therein; (d) a reasonable allocation of overhead, facilities expense (including depreciation over the expected life of the buildings and equipment), and costs for administration and for management of material procurement and other manufacturing activities performed directly in support of the manufacture or acquisition of each tablet, calculated in accordance with reasonable cost accounting methods that comply with GAAP; and (e) amounts paid (net of rebates or discounts, if any, and not including amounts paid as royalties) to non-Affiliate contract manufacturers or service providers to acquire each tablet, or other medium of delivery, or in connection with the manufacture of each tablet, or other medium of delivery. Commercialization Third Party or Commercialization Third Parties means a third-party service provider performing at least one (1) or more commercialization support services on behalf of Napo. Services provided by a Commercialization Third Party may include, but are not limited to, third-party logistics (including, but not limited to, warehousing and distribution services), pharmacovigilance, regulatory services/support, medical affairs support, or managed care contracts and rebates support. Confidential Information includes (in any medium) any confidential or proprietary information of a Party (including, with respect to Napo, the Data), including but not limited to, any trade secrets, processes, formulas, data, documentation, flow-charts, drawings, correspondence, know-how, improvements, Inventions, patents, trademarks, copyrights and other intellectual property, techniques, concepts, technologies, software, hardware, formulae, equipment, programs, sketches, designs, personnel records and files, former client and customer lists, current client and customer lists, potential client and customer lists, rental-related information, product or service specifications, debt arrangements, equity structures, fees, litigation, customer contracts, sales records (historical and projected), rates, marketing plans, developments and strategies, distribution methods and processes, projections, financial information, terms governing actual or anticipated relationships, internal accounting statistics, financial projects, business plans (whether current or not), pricing and bidding policies and practices, costing information, salaries, proposals to customers, any data, computer records, software, confidential information or property entrusted to a Party or any Affiliate by any customers, confidential information concerning customers, employees of a Party or any Affiliate and any other information passing between the Parties pursuant to the Purpose. Confidential Information shall not, however, include any information that (i) can be demonstrated to be generally known in the industry or to the public other than through breach of a Receiving Partys obligations to a Disclosing Party; (ii) was already known by the Receiving Party at the time of its disclosure hereunder as evidenced by written records; (iii) is independently obtained by the Receiving Party from a third party that d