“Closing Date” is defined in the recitals.
“Commercial Sale Milestone” is defined in Section 2.3(b).
“Disclosure Schedules” is defined in Section 3.1.
“Escrow Account” means the escrow account created pursuant to the Escrow Agreement.
“Escrow Agreement” means an Escrow Agreement to be entered into by the Assignor, the Assignee and an escrow agent (the “Escrow Agent”), in form and content acceptable to Assignor and Assignee.
“Excluded Liabilities and Obligations” is defined in Section 2.5.
“FDA” means the U.S. Food and Drug Administration, or a successor federal agency thereto in the United States.
“First Commercial Sale” means the first invoiced sale in any country in the Territory of a pharmaceutical product comprising Arimoclomol as an active pharmaceutical ingredient by Zevra or any of its Affiliates or (sub)licensees to a Third Party for end use consumption in such country following receipt of Regulatory Approval required to sell such product in such country. First Commercial Sale excludes transfers of such product to Third Parties as bona fide samples, as donations, for clinical study purposes or for any expanded access program, compassionate sales or use program (including named patient program or single patient program), indigent program, or for other charitable or promotional purposes or similar limited purposes.
“Governmental Entity” means any: (i) nation, principality, republic, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (ii) federal, state, local, municipal, foreign or other government; (iii) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or other entity and any court, arbitrator or other tribunal); (iv) multi-national organization or body; or (v) individual, body or other entity exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
“Indemnified Party” is defined Section 5.2.
“Indemnifying Party” is defined in Section 5.2.
“Judgment” means any judgment, order, writ, injunction, citation, award or decree of any nature.
“Knowledge of Assignor” means the actual knowledge of the Knowledge Parties.
“Knowledge Parties” means [***].