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.

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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.

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.

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.

• 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.

• 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 PTP4, the Supplemental PTP4 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.

More Definitions of Acceptance for Filing

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 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 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 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.

Acceptance for Filing means, with respect to a BLA filed for a Product in the U.S., that the FDA has accepted such BLA for substantive review as evidenced by receipt of notice from the FDA of such acceptance or other evidence that the FDA has commenced its substantive review of such BLA.

Acceptance for Filing or “Accepted for Filing” shall mean, with respect to an MAA filed: (a) in a Major European Country, the receipt of written notice of acceptance for filing of such MAA from (i) the EMA or (ii) the applicable Regulatory Authority in the applicable Major European Country (as applicable); or (b) in China, the receipt of written notice of acceptance of filing of such MAA from the NMPA.