Regulatory Filing definition

Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the UHN Planned Trial, including any documents submitted to any Regulatory Authority and all supporting data, including CTAs and INDs, and all correspondence with any Regulatory Authority with respect to the UHN Planned Trial (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

Regulatory Filing means any filing with a Regulatory Agency relating to or to permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product. Regulatory Filings include without limitation INDs and NDAs.

Examples of Regulatory Filing in a sentence

• In the event of failure to assign such Regulatory Filings to Celgene, Bluebird hereby consents and grants to Celgene the right to access and reference (without any further action required on the part of Bluebird, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such Regulatory Filing.

• Each such Regulatory Filing contained all material information required to be included therein and did not omit any material information so required in order that such Regulatory Filing be true, complete and correct in all material respects.

• In addition, Xxxxxx shall provide Enanta with initial IND filings or Drug Approval Applications sufficiently in advance of submission so that Enanta may review and comment on the substance of such Regulatory Filing or other document or correspondence.

• As of its respective filing date, each Regulatory Filing complied as to form and substance in all material respects with the applicable Law requiring such Regulatory Filing to be filed and each Regulatory Filing complied in all material respects with applicable regulatory requirements and accounting principles applicable to such Regulatory Filing.

• If any Regulatory Filing to be provided under this Section 5.3 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party.

More Definitions of Regulatory Filing

Regulatory Filing means an NDA, IND, or any foreign counterparts thereof, and any other filings required by regulatory authorities relating to the Development, manufacture, or Commercialization of any Licensed Product.

Regulatory Filing means all approvals, licenses, 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 in the Territory, including any INDs, BLAs, Marketing Approval Applications and Marketing Approvals.

Regulatory Filing means any submission made to a Regulatory Authority to seek regulatory approval with respect to a Product or Applicator, any submission to a regulatory advisory board with respect to the Product or Applicator, any New Drug Application (“NDA”), and any supplement or amendment to any of the foregoing, and any applications for pricing or reimbursement approvals for the Product or Applicator. For the avoidance of doubt, Regulatory Filing does not include 3M’s DMFs or MAFs.

Regulatory Filing means, with respect to the United States, an NDA, BLA, or IND, any foreign counterparts or equivalents of any of the foregoing, any DMFs, and any other filings or submissions required by or provided to Regulatory Authorities relating to the manufacture, Development or Commercialization of any Product, including any supporting documentation, data, correspondence, meeting minutes, amendments, supplements, registrations, licenses, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files, and manufacturing, shipping, or storage records with respect to any of the foregoing.

Regulatory Filing means, collectively: (a) any IND, CTA, Drug Approval Application, establishment license application, DMF, application for designation as an “Orphan Drug” 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)) and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory); (b) all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence relating to, any of the foregoing.

Regulatory Filing means any submission to a Regulatory Authority, including all applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals), together with any related correspondence and documentation submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to a product and all data contained in any of the foregoing, including all INDs, Drug Approval Applications, regulatory drug lists, advertising and promotion documents, Clinical Data, adverse event files and complaint files, and include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

Regulatory Filing means any filing or application with any Regulatory Authority, including XXXx and authorization, approvals or clearances arising from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other relevant Regulatory Authority, in each case with respect to Product.