Regulatory Approval Application definition

Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

Regulatory Approval Application means an application submitted to the appropriate Regulatory Authority seeking Regulatory Approval of a Licensed Product in a regulatory jurisdiction, including without limitation a BLA.

Examples of Regulatory Approval Application in a sentence

• For the avoidance of doubt, the filing of a Regulatory Approval Application with the EMA is considered a filing of a Regulatory Approval Application in all countries of the European Union.

• Debtor GMAC Mortgage, LLC (“GMACM”) serviced the Mortgage Loan from the origination until servicing was transferred to Ocwen Loan Servicing LLC (“Ocwen”) on February 16, 2013.

• Such discussion should take place no later than when the JSC decides to file the first Regulatory Approval Application for the Licensed Products in the Field in the United States, following the data readout of the Phase 3 Clinical Trial.

• After evaluating the DEA’s Notice of Proposed Rulemaking for Schedules of Controlled Substances that the DEA published on January 14, 2022, in the Federal Register, it became apparent to me that this submission was necessary to ensure a complete and accurate record regarding 4-Hydroxy- N,N-diisopropyltryptamine (4-OH-DiPT), which the DEA is proposing to place into Schedule I of the Controlled Substances Act (CSA).

• Subject to Section 6.1.2, if, with respect to any country in the Territory or the European Union, Medgenics (a) does not *****, or (b) ***** files a Regulatory Approval Application but does not obtain Regulatory Approval and no additional clinical Development or Manufacturing activities are being conducted ***** in such country for such Licensed Product, then KHK will have the right to terminate this Agreement with respect to such country.

More Definitions of Regulatory Approval Application

Regulatory Approval Application means an application to the appropriate Regulatory Authority for approval to sell a Licensed Product in any particular jurisdiction, including an NDA in the U.S.

Regulatory Approval Application means (a) the single application or set of applications in the Territory comparable to a Biologic License Application, as defined by the United States Food and Drug Administration (“USFDA”) in 21 CFR Part 601, or other applicable filing for each Product to Manufacture and sell commercially such Product, filed by Licensee, its Affiliates or Sublicensees with the applicable Regulatory Authority, and (b) any related registrations with or notifications to such Regulatory Authority, and any amendments or supplements thereto and any substitutes.

Regulatory Approval Application means a New Drug Approval Application or Biologics License Application (each, as defined in the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), as amended from time to time) in the U.S., or any corresponding application for approval to market and/or sell a product in any country, region or jurisdiction in the Territory outside the U.S.

Regulatory Approval Application means an NDA or BLA, or any corresponding application for Regulatory Approval in the Territory, including: (a) with respect to the European Union, an MAA filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the decentralized procedure, mutual recognition or any national approval procedure; and (b) an MAA filed with the PMDA, including, in each case, all supplements, amendments, variations, extensions and renewals thereof.

Regulatory Approval Application means an application that is submitted to a Regulatory Authority and the approval of which is necessary to obtain Regulatory Approval, including New Drug Applications and New Animal Drug Applications in the United States and Marketing Authorisations in the European Union.

Regulatory Approval Application means a New Drug Approval Application or Biologics License Application (each, as defined in the FFDCA) in the U.S., or any corresponding application for Regulatory Approval in any country or jurisdiction in the Territory outside the U.S., including, with respect to the European Union, an MAA filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in Europe with respect to the decentralized procedure, mutual recognition or any national approval procedure.

Regulatory Approval Application means an application submitted to the appropriate Regulatory Authority seeking Regulatory Approval of a Licensed Product for use in one or more therapeutic indications in a regulatory jurisdiction within the Territory.