1.54“Patent” shall mean any of the following, whether existing now or in the future anywhere in the world: (i) any issued patent, including inventor's certificates, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions; and (ii) any pending application for any of the foregoing, including any continuation, divisional, substitution, continuations-in-part, provisional and converted provisional applications.
1.55“Payment Period” has the meaning set forth in Section 5.2.2.
1.56“Person” shall mean any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.
1.57“Prior CDA” has the meaning set forth in Section 7.3.
1.58“Product” has the meaning set forth in the Preamble.
1.59“Prosecution and Maintenance” shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent.
1.60“Regulatory Approval” shall mean, with respect to the Product in a particular jurisdiction, approval or other permission by the applicable Regulatory Authorities sufficient to initiate manufacturing, importing, marketing and sales of such product, including pricing and reimbursement approvals.
1.61“Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the Development, Commercialization or other use or exploitation (including the granting of Regulatory Approvals) of the Product in any jurisdiction, including the FDA.
1.62“Regulatory Filing” shall mean any filing, application, or submission with any Regulatory Authority, including MAAs and authorization, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case with respect to the Product.
1.63“Senior Executives” has the meaning set forth in Section 2.3.
1.64“Spectrum” has the meaning set forth in the Preamble.
1.65“Spectrum Copyrights” shall mean all works of authorship (including advertising, marketing and promotional materials, artwork, labeling, and other works of authorship), and all copyrights, moral rights and other rights and interests thereto throughout the Licensee Territory, whether or not registered, that are (i) Controlled by Spectrum or its Affiliates, and (ii) are delivered to Licensee by Spectrum for use in connection with the Product.