(whether registered or unregistered and including all applications and rights to apply for the same). CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 2 1.15 "Launch Date" shall mean the date [***]. 1.16 "Loss or Losses" shall mean any and all damages, fines, fees, settlements, payments, obligations, penalties, deficiencies, losses, costs and expenses, including, without limitation, environmental losses, interest, court costs, reasonable fees of attorneys, accountants and other experts and other reasonable expenses of litigation or other proceedings or of any claim, default or assessment. 1.17 "Manufacturing Facility" shall mean those areas of CAPSUGEL or CAPSUGEL's subcontractors manufacturing, packaging, laboratory and warehousing facilities utilized in the formulation, manufacture, packaging, storage, testing, shipping or receiving of the Product. 1.18 "Materials" mean all excipient(s) and inactive raw materials used in the formulation of the Product. For the avoidance of doubt, "Materials" does not include any Active Ingredient or work in process or finished goods inventory. 1.19 "Net Sales" means [***]. 1.20 "Product" shall mean Active Ingredient Formulated in CAPSUGEL's proprietary Lipid Multi-Particulate Technology, including any improvements or derivatives of such technology. 1.21 "Receiving Party" shall have the meaning set forth in the Confidentiality Agreement. 1.22 "Regulatory Approvals" means any and all approvals, licenses, registrations, or authorizations of the relevant Regulatory Authority, necessary for the development, manufacture, use, storage, import, transport, export or commercialization of the Product in a particular country or jurisdiction. 1.23 "Regulatory Authority (ies)" means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, testing, market approval, sale, distribution, packaging or use of the Product. 1.24