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.

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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.

Regulatory Filings means, with respect to a Product, any submission to a Regulatory Authority of any appropriate regulatory application, including, without limitation, any IND, BLA, any submission to a regulatory advisory board, any marketing authorization application, and any supplement or amendment thereto.

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.
As between the Parties, Prevail shall have sole responsibility for and control of the preparation, submission, and maintenance of all Regulatory Filings and obtaining Regulatory Approvals (including the preparation and submission of the IND filing, BLA filing and for seeking BLA approval), and shall have sole control over all interactions with the applicable Regulatory Authority.
Prevail shall, upon Scribe’s written request (which request shall not be made more than once a [*]), provide Scribe with a copy of any Regulatory Filings submitted by or on behalf of Prevail, its Affiliates and Sublicensees for Licensed Products, but, in each in case, (a) [*], (b) [*], and (c) [*].
Prevail will own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals and, as between the Parties, all such Regulatory Filings and Regulatory Approvals will be held in the name of Prevail.

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 the governmental filings required to obtain approval to conduct clinical trials of a Product, or to market and sell a Product in a given country within the Territory, including, but not limited to, Product registrations and Product marketing approvals, as applicable, in each such country.

Regulatory Filings means all filings, submissions, approvals, licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the Development, Manufacturing, Commercialization or other Exploitation of a Product made to or received from any Regulatory Authority, including to obtain, support, or maintain any Marketing Authorizations.

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.