Registration Filing definition

Registration Filing means the submission to the relevant Regulatory Authority of an appropriate application seeking any Approval, and shall include, without limitation, any IND or Marketing Approval application in the Field.

Registration Filing means the submission to the relevant Regulatory Authority of an appropriate application seeking any Approval, and shall include, without limitation, any testing, marketing authorization application, supplementary application or variation thereof, IND, BLA, or any equivalent applications in any country.

Registration Filing means, with respect to each Development Candidate or related Drug Product, the submission to the relevant governmental regulatory authority of an appropriate application seeking any Regulatory Approval, and shall include, without limitation, any marketing authorization application, supplementary application or variation thereof, or any equivalent applications.

Examples of Registration Filing in a sentence

• Not later than the Registration Filing Date, the Company shall file with the Commission a Registration Statement on Form S-1, or other applicable form, relating to the resale by the Holders of all of the Registrable Securities, and the Company shall use its commercially reasonably efforts to cause such Registration Statement to be declared effective prior to the Registration Default Date.

• Reforms Business Registration Filing; permits filing prior to award of contract if not filed with proposals.

• Not later than the Registration Filing Date, the Company shall file with the Commission a Registration Statement on Form S-1, or other applicable form, relating to the resale by the Holders of all of the Registrable Securities, and the Company shall use its commercially reasonable efforts to cause such Registration Statement to be declared effective prior to the Registration Default Date.

• The Company shall file such Registration Statement no later than thirty (30) days after the final Closing of the Offering (the “Registration Filing Date”), and shall use reasonable best efforts to cause such Registration Statement to become effective within one hundred and fifty (150) days after the Registration Filing Date, or one hundred eighty (180) days after the Registration Filing Date if the Registration Statement is subject to a full review by the SEC.

• If the Company is not eligible to file registration statements on Form S-3 under the Act before the Shelf Registration Filing Date, then the Company shall file a Shelf Registration Statement on whatever form is then available for the Company to use.

More Definitions of Registration Filing

Registration Filing means, with respect to each Optioned Lead Program Compound, Derivative Compound or related Drug Product, the submission to the relevant governmental regulatory authority of an appropriate application seeking any Regulatory Approval, and shall include, without limitation, any marketing authorization application, supplementary application or variation thereof, or any equivalent applications.

Registration Filing means the submission to the relevant Regulatory Authority of an appropriate application seeking Approval, and shall include any IND or Marketing Approval application.

Registration Filing means an application submitted to a Regulatory Authority to initiate human clinical trials or for marketing approval of a product, including an IND, NDA, a Biologics License Application, any equivalent of the foregoing in any jurisdiction, and all supplements and amendments that may be filed with respect to the foregoing.

Registration Filing means the submission to the relevant Regulatory Authority of an appropriate application seeking Approval, and shall include any IND, BLA, or other application for Marketing Approval.

Registration Filing means, (i) with respect to the Securities Act, any registration statement promulgated by the SEC, including Form X-0, Xxxx X-0, Form F-1 and Form F-3, and Form F-10; (ii) with respect to the Canada Securities Laws, a Shelf Base Prospectus or Preliminary Prospectus, in each case, including any amendments and supplements thereto, including post-effective amendments, all exhibits thereto or documents required to be filed therewith, and all materials incorporated by reference therein; and (iii) both (i) and (ii), in the case of a Registration Filing concurrently in both the United States and Canada.

Registration Filing. Registration Filing shall mean an application submitted to a Regulatory Authority for marketing approval of a Product for a particular indication which application contains complete details of the Manufacture and testing of such Product, including (a) a New Drug Application ("NDA") filed with the FDA (as more fully defined in 21 CFR 314.5 et seq.) or any successor applications or procedures, (b) except where otherwise specifically provided in this Agreement, any equivalent of an NDA in the Territory, and (c) all supplements and amendments that may be filed with respect to the foregoing.

Registration Filing means, with respect to each IL-1 Product, the submission to the relevant Regulatory Authority of an appropriate application seeking any Approval, and shall include, without limitation, any marketing authorization application, supplementary application or variation thereof, BLA, or any equivalent applications in any Co-Commercialization Country.