1.88 Prosecution or Prosecute means, with respect to a particular Patent, all activities associated with the preparation, filing, defense, prosecution and maintenance of such Patent, as well as supplemental examinations, re-examinations, reissues, applications for patent term adjustments and extensions, supplementary protection certificates and the like with respect to that Patent, together with the conduct of interferences, derivation proceedings, inter partes review, post-grant review, the defense of oppositions and other similar proceedings with respect to that Patent.
1.89 Public Official or Entity means (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality, or subdivision of any government, military, or international organization, including any ministry or department of health or any state-owned or affiliated company or hospital, or (b) any candidate for political office, any political party, or any official of a political party.
1.90 Regulatory Approval means in a particular country or jurisdiction means all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, and authorizations of any federal, national, multinational, state, provincial or local Regulatory Authority, department, bureau and other governmental entity that are necessary for the marketing and sale of a Licensed Product in a country or jurisdiction.
1.91 Regulatory Authority means a federal, national, multinational or other regulatory agency or governmental entity involved in the granting of Regulatory Approval for a pharmaceutical product in a country or jurisdiction (e.g., the FDA and the NMPA).
1.92 Regulatory Exclusivity means, with respect to a Licensed Product, any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to such Licensed Product, other than Patent Rights, that prohibits a Third Party from (a) relying on data generated by or on behalf of the Parties with respect to such Licensed Product in an application for Regulatory Approval, or (b) commercializing a Generic Product of such Licensed Product (for example, any Data Exclusivity rules released by the NMPA).
1.93 Regulatory Filings means any written application, submission, notice or other filing made to an applicable Regulatory Authority in the Territory: (a) seeking approval for the commercial manufacture, use, storage, import, export, transport, distribution, marketing or sale of a Licensed Product, including any Regulatory Approval; or (b) that is required to be filed with the applicable Regulatory Authority before beginning clinical testing of a Licensed Product in human subjects, including any successor application or procedure, non-U.S. equivalents to any of the foregoing and all supplements and amendments that may be filed with respect to any of the foregoing; such as NDA, sNDA and any equivalent thereof in the United States or any other country or jurisdiction in the world.
1.94 Region has the meaning assigned thereto in Section 1.108.
1.95 Residual Knowledge has the meaning assigned thereto in Section 10.5.
1.96 Royalty Term has the meaning assigned thereto in Section 9.6.2.
1.97 Saturn-1 means a Tarsus United States randomized, controlled, multicenter, double-masked, parallel pivotal Clinical Trial, currently in progress, to compare the safety and efficacy of a Licensed Product to vehicle control for the treatment of Demodex Blepharitis, registered at clinicaltrials.gov as Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1) (https://clinicaltrials.gov/ct2/show/NCT04475432).