Regulatory Filings definition
Regulatory Filings means any and all regulatory applications, filings, modifications, amendments, supplements, revisions, reports, submissions, authorizations, and Regulatory Approvals, and associated correspondence required to Develop and Commercialize the Product in the Territory, including without limitation any reports or amendments necessary to maintain Regulatory Approvals.
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
All Regulatory Filings and Regulatory Approvals for the Licensed Products shall be in the name of, and owned by, Sanofi.
During the Term, upon ▇▇▇▇▇▇’s written request, Scribe shall provide to Sanofi all of the regulatory documentation, including Regulatory Filings and CMC Information, with respect to the Licensed Editing Compositions, Licensed gRNAs, or the Licensed Product owned by Scribe; provided that Scribe may redact any portions that are not relating to the Licensed Technology.
More Definitions of Regulatory Filings
Regulatory Filings shall have the meaning set forth in Section 3.4(e).
Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Agency for the purpose of obtaining Regulatory Approval from that Regulatory Agency. Regulatory Filings shall include, but not be limited to, all Drug Approval Applications.
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, filings, dossiers and the like submitted to a regulatory authority for the purpose of obtaining Regulatory Approval from that regulatory authority. Regulatory Filings shall include all Drug Approval Applications.
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Regulatory Filings means any filings that may be required for any Marketing Approval, Pricing and/or Reimbursement Approval or otherwise filed or submitted to a Regulatory Authority in an effort to comply with Applicable Laws with respect to the Development or Commercialization of a Licensed Product. Regulatory Filings include any IND (or similar filing outside the U.S.), Biologic Licensing Application (or similar filing outside the U.S.), clinical study protocols and Regulatory Authority briefing books.
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.