Regulatory Filings definition
Regulatory Filings means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, and Commercialize Licensed Products in each country or jurisdiction in the Territory.
Regulatory Filings means, with respect to the Compounds or Products, any submission to a Regulatory Authority of any appropriate regulatory application specific to Compounds or Products, and shall include any submission to a regulatory advisory board and any supplement or amendment thereto. “Regulatory Filings” includes any IND, NDA, BLA and any Marketing Approval Application.
Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application, and shall include, without limitation, any submission to a regulatory advisory board, MAA, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any Investigational New Drug (IND), New Drug Application (NDA) or the corresponding application in any other country or group of countries.
Examples of Regulatory Filings in a sentence
Promptly following Closing, to the extent necessary to transfer ownership to Buyer of all Regulatory Filings and Approvals filed with Governmental Authorities, the Parties shall execute and deliver to such Governmental Authorities such documents as shall be required to accomplish such transfer.
More Definitions of Regulatory Filings
Regulatory Filings means all applications, filings, dossiers and the like (excluding routine adverse event expedited or periodic reporting), submitted to a Regulatory Authority for the purpose of obtaining Regulatory Approval from that Regulatory Authority.
Regulatory Filings shall have the meaning set forth in Section 3.4(e).
Regulatory Filings has the meaning set forth in Section 5.03(g).
Regulatory Filings means, collectively: (a) all INDs, NDAs, establishment license applications, drug master files, applications for designation of a Product as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) or all other similar filings (including, without limitation, any counterparts of any of the foregoing in any country region in the Territory) as may be required by any Regulatory Authority for the Development of a Candidate or Commercialization of a Product; (b) all supplements and amendments to any of the foregoing; and (c) all data contained in, and correspondence relating to, any of the foregoing.
Regulatory Filings means all applications, approvals, licenses, registrations, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in a country necessary for the development, manufacture and/or commercialization of a pharmaceutical product, including any INDs, NDAs and Marketing Approvals.
Regulatory Filings means all applications, filings, materials, studies, data and documents of any nature whatsoever (including any supporting information related thereto) filed with, or prepared in connection with, the Regulatory Approval.
Regulatory Filings means as to any Performance Period, filings submitted to an Approval Authority with respect to a Product for which the Company is pursuing Product Approval.