“Net Sublicensing Revenue” means the total amount received or recognized as revenue by Licensee in consideration for the grant by Licensee of a license, immunity, or other right under the Licensed IP Rights to Commercialize a Product, but excluding (a) equity or debt investments in, or loan proceeds to, Licensee, (b) payments by Sublicensees for bona fide research, development, manufacturing or commercialization activities (including payments for full-time equivalents), and (c) amounts received to reimburse Licensee for Development or similar services conducted for Product.
“Non-Blocking License” has the meaning set forth in Section 3.1(d).
“Out-License” means each license, settlement agreement or other agreement or arrangement between Licensor or any of its Affiliates and any Third Party pursuant to which Licensor or any of its Affiliates grants a license, sublicense or similar grant of any Product Application, Regulatory Approval or Intellectual Property Right that is necessary or reasonably useful for the Exploitation of a Product in the Field in the Licensee Territory.
“Party” means Licensor or Licensee, as the context requires, and “Parties” means, together, Licensor and Licensee.
“Patents” means any and all issued patents and pending patent applications, including without limitation, all provisional applications, substitutions, continuations, continuations-in part, divisions, and renewals, all letters patent granted thereon, and all patents-of-addition, reissues, reexaminations, inter partes reviews, and extensions or restorations by existing or future extension or restoration mechanisms (including regulatory extensions), and all supplementary protection certificates, together with any foreign counterparts thereof anywhere.
“Person” means any natural person, firm, corporation, limited liability company, partnership, joint venture, association, joint-stock company, trust, unincorporated organization, Governmental Authority or any other legal entity, including public bodies, whether acting in an individual, fiduciary or other capacity.
“Product” means services, compositions, products, dosages, and formulations comprising lidocaine that have been or are later developed by or on behalf of Licensor, including the product and any future product defined as a “Product” under the Development Agreement and the Supply Agreement, which include (a) ZTlido (lidocaine topical system) 1.8%, including the composition of matter with the NDC 69557-111-30, and (b) SP-103.
“Product Application” means an application for Regulatory Approval to research, study, develop, formulate, process, engineer, manufacture, test, use, market, sell, offer for sale and distribute a product or drug in a country or region, including (a) a New Drug Application, (b) an Investigational New Drug Application, (c) any corresponding foreign application in any country or jurisdiction in the world and (d) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
“Product Rights” means all rights, tangible and otherwise, with respect to any Product, including all rights to develop, out-license, sell, offer to sell, make, have made, import, export and otherwise commercialize or derive profit including the Licensed IP Rights and all Regulatory Approvals and other Regulatory Filings related to a Product.
“Public Filings” means, collectively, all reports, schedules, forms, statements and other documents required to be filed by Licensor or Licensor Parent under the Securities Act of 1933, as amended, and the Securities Exchange Act, as amended, including pursuant to Section 13(a) or 15(d) thereof, since January 1, 2024 (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein).
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