Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.
Regulatory Filings means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in the Territory necessary for the development, manufacture or commercialization of a pharmaceutical product, including any INDs, NDAs and Regulatory Approvals.
Regulatory Filings shall have the meaning set forth in Section 3.4(e).
Examples of Regulatory Filings in a sentence
IOU Proposed Mapping of CPUC’s Adopted Definitions, CAP’S and Target’s: Administrative Activities – 10% CAP [see citation 1 below] - Responding to Data Requests (pg 50)- Responding to Financial & Regulatory Audits (pg 50)- Support related to Regulatory Filings (Monthly & Quarterly Reports and Annual Reporting) (pg 50)- Human Resources Support (pg 49)o Payroll taxeso Payroll support- Membership dues- Travel & Conference Costs (Labor, Fee’s, Lodging, Transportation, etc.) (pg 49 and 50).
More Definitions of Regulatory Filings
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 any documentation comprising or relating to or supporting any applications, approvals, licenses, registrations, notifications, submissions and authorizations made to or received from a Regulatory Authority in a country necessary for the Manufacture, Development or Commercialization of the Licensed Product in such country, including any MAA or any other applications for Regulatory Approvals.
Regulatory Filings means, with respect to Product, any submission to a Regulatory Authority of any regulatory application together with any material related correspondence and documentation (including minutes of any meetings, telephone conferences or material discussions with any Regulatory Authority) and shall include, without limitation, any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, MAA or the corresponding application in any other country or group of countries.
Regulatory Filings has the meaning set forth in Section 4.2.
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, with respect to the Product, any submission to a Regulatory Authority of any appropriate regulatory application, including, without limitation, any IND, NDA, any submission to a regulatory advisory board, any marketing authorization application, and any supplement or amendment thereto.