Acceptance for Filing definition

Acceptance for Filing means Atrix's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section 314.101.

Acceptance for Filing means: (a) with respect to an IND filed for a Product: (i) in the United States, the date the IND goes into effect in accordance with 21 C.F.R. §312.40(b) (or its successor regulation); (ii) in any other country or group of countries, after filing of an IND with the applicable Regulatory Authority for such country or group of countries, the date upon which enrollment of the first subject in the applicable clinical trial of such Product may legally occur in such country or group of countries; and (b) with respect to an NDA filed for a Product: (i) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; (ii) in a Major EU Market, either (A) the receipt of written notice of acceptance of filing of such NDA from the EMA if the centralized EU filing procedure is used or (B) the receipt of written notice of acceptance of filing of such NDA from the applicable Regulatory Authority in such Major EU Market if the centralized EU filing is not used; and (iii) in Japan, the receipt of written notice of acceptance of filing of such NDA from the MHLW.

Acceptance for Filing means notification from the FDA indicating receipt of an NDA submission in the United States or equivalent marketing application pursuant to Applicable Laws in each country in the Territory.

Examples of Acceptance for Filing in a sentence

• In particular, prior to the first Acceptance for Filing of the Product, Nycomed's sole remedy for any failure by Acusphere to use all commercially reasonable efforts to carry out the Intellectual Property Strategy shall be to terminate this Agreement under Section 18.03(b) and claim monies as provided therein.

• In this filing, RECO seeks to update its rates as follows: 11 See Rockland Electric Company and PJM, Joint Filing For Approval of Transfer of Operational Control Over Jurisdictional Facilities And Acceptance for Filing of Tariff Revisions, Executed Signature Pages, and Membership Agreement Under Sections 203 and 205 of the Federal Power Act, Docket Nos.

• EC02–7–000 and ER02–109– 000]Take notice that on October 17, 2001 Rockland Electric Company and PJM Interconnection, LLC (collectively, Applicants) tendered for filing a Joint Application for Approval of Transfer of Operational Control over Jurisdictional Facilities and Acceptance for Filing of Tariff Revisions, Executed Signature Pages, and Membership Agreement under sections 203 and 205 of the Federal Power Act.

• Notwithstanding the foregoing, subject to Curis’ payment when due of the milestone payment for Acceptance for Filing of the first IND for a Product from the Licensed Program for PTP3, the Supplemental PTP3 Activities specifically exclude Aurigene’s Development Plan responsibilities and Phase 1 Trial supply obligations under Section 5.6 of the Agreement for such Licensed Program, the expenses of which are Aurigene’s sole responsibility under Section 5.4(b) of the Agreement.

• For purposes of Regulatory/Launch Milestone Payments under Section 5.5 that correspond to Acceptance for Filing or approval of an MAA for a Licensed Product in the Major European Countries, the following provisions shall apply.

More Definitions of Acceptance for Filing

Acceptance for Filing means that FDA has accepted the ANDA for the Product and an application number has been assigned by FDA to the ANDA.

Acceptance for Filing means, with respect to an NDA filed for a Product: (a) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; (b) in an EU Market, the receipt of written notice of acceptance for filing of such NDA from the EMA or the applicable national Regulatory Authority in such EU Market (as applicable); or (c) in Japan, the receipt of written notice of acceptance for filing of such NDA from the PMDA.

Acceptance for Filing means Nycomed's receipt of a letter issued by the EMEA or other Competent Authority indicating acceptance for filing of a regulatory dossier pursuant to Applicable Laws in the Territory.

Acceptance for Filing means, with respect to an IND filed for a Product: (a) in the United States, the date the IND goes into effect in accordance with 21 C.F.R. §312.40(b) (or its successor regulation); or (b) in any other country or group of countries, after filing of an IND with the applicable Regulatory Authority for such country or group of countries, the date upon which enrollment of the first subject in the applicable clinical trial of such Product may legally occur in such country or group of countries.

Acceptance for Filing means, following the submission of an application for Marketing Authorization made to a Regulatory Authority, the expiration of any applicable waiting period during which the Regulatory Authority has authority to issue a refusal to file, if any, as to such application.

Acceptance for Filing means that an application for Approval (or Conditional Approval in the case of Japan) of a Licensed Product for use with humans in the *Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. applicable portion of the Territory has been submitted to the Regulatory Authority for preliminary administrative review or an equivalent regulatory process to ensure that the dossier submitted is properly formatted and such application either has been expressly accepted or has been deemed accepted because it was not rejected within the time permitted by Law.

Acceptance for Filing means GKI's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA or equivalent marketing application pursuant to Applicable Laws in a country in the Territory.