Milestone Payments has the meaning set forth in Section 3.12(a).
NDA means a New Drug Application, as defined in the FDCA and regulations promulgated thereunder or any successor
application or procedure required to sell a Licensed Product in the United States.
Order means any judgment, order,
writ, injunction, ruling, stipulation, determination, award or decree of or by, or any settlement under the jurisdiction of, any Court or Governmental Authority.
Patent Assignment Agreement has the meaning set forth in Section 2.7.2.
Patent Rights means the rights and interests in and to issued patents and pending patent applications (which, for purposes
of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including any divisionals, continuations,
continuations-in-part, substitutions, patents of addition, reissues, revivals, extensions, re-examinations or renewal
applications related to, or claiming priority to, the foregoing (including any supplemental patent certificates) or any confirmation patent or registration patent, and all patents issuing on, and all foreign counterparts of, any of the foregoing.
Party and Parties have the meaning set forth in the Preamble.
Permit means any license, permit, application, consent, certificate, registration, approval and authorization pending
before, issued, granted, given or otherwise made available by, or under the authority of, any Governmental Authority.
Person means any natural person, corporation, general partnership, limited partnership, limited liability company,
proprietorship, joint venture, other business organization, trust, entity, union, association or Governmental Authority.
Phase 2
Clinical Trial means a human clinical trial conducted in any country that would satisfy the requirements of 21 CFR 312.21(b) and is intended to explore one or more doses, dose response, and duration of effect, and to generate initial
evidence of clinical activity and safety, for any Licensed Product in the target patient population.
Proxy Statement
has the meaning set forth in Section 6.2.1.
Public Official means (a) any officer, employee or
representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (b) any officer, employee or representative of any commercial enterprise that is owned or controlled
by a government, including any state-owned or controlled veterinary, laboratory or medical facility; (c) any officer, employee or representative of any public international organization, such as the International Monetary Fund, the United
Nations or the World Bank; and (d) any person acting in an official capacity for any government or government entity, enterprise, or organization identified above.
Purchased Assets has the meaning set forth in Section 2.1.
Purchased Asset Transaction has the meaning set forth in Section 3.5.
Recommendation has the meaning set forth in Section 6.2.2.
Regulatory Authority means any national, supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other Governmental Authority with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing, marketing, pricing or sale of a Licensed Product, including the
including the U.S. Food and Drug Administration (and any successor entity thereto) (the FDA), the European Medicines Agency (and any successor entity thereto) (the EMA), and the European Commission.
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