Acceptance of Filing definition

Acceptance of Filing means, with respect to an NDA or MAA filed for IONIS-TTR-LRx, (a) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) that such NDA is officially “filed,” or (b) in the European Union, receipt of written notice of validation by the EMA of such MAA under the centralized European procedure in accordance with any feedback received from European Regulatory Authorities; provided that if the centralized filing procedure is not used, then Acceptance of Filing will be determined upon the validation of such MAA by the applicable Regulatory Authority in a Major Market in Europe.
Sample 1Sample 2
Acceptance of Filing means, with respect to an NDA, MAA, JNDA, CNDA or BDRP 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) that such NDA is officially “filed,” (b) in the European Union, receipt by AstraZeneca, its Affiliate or Sublicensee of written notice of validation by the EMA of such MAA under the centralized European procedure in accordance with any feedback received from European Regulatory Authorities; provided that if the centralized filing procedure is not used, then Acceptance of Filing will be determined upon the validation of such MAA by the applicable Regulatory Authority in a Major Market in the EU, (c) in Japan, receipt by AstraZeneca, its Affiliate or Sublicensee of written notice of acceptance of filing of such JNDA from the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto), (c) in China, receipt by AstraZeneca, its Affiliate, or Sublicensee, of written notice of acceptance of filing of such CNDA from the relevant regulatory authority in China (i.e., the China Food and Drug Administration or the provincial-level food and drug regulatory authority, as law and regulation may require, or any successor agencies thereto), and (d) in Brazil, the receipt by AstraZeneca, its Affiliate or Sublicensee of written notice from the Brazilian National Health Surveillance Agency (ANVISA) (or any successor agencies thereto) confirming that the BDRP has been received.
Sample 1Sample 2
Acceptance of Filing has the meaning ascribed to that term in Section 3.3.2.
Sample 1

Examples of Acceptance of Filing in a sentence

  • After issuing the Final Acceptance of Filing receipt, the City Clerk examines signatures against the County of Los Angeles records of voter registration.

  • See, e.g., Southern Co. Servs., Inc., 106 FERC ¶ 61,248 at PP 1, 5–6 (2004); PJMInterconnection, LLC, Notice of Acceptance of Filing by Operation of Law, Docket No. ER05-10-000 (Nov.

  • The Kentucky Labor Cabinet’s OSH Program participated in and fully supported a comprehensive and very successful 2015 Fall Prevention Campaign that concentrated on raising awareness of fall hazards, collaboration with partners, training, and a two week long Stand-Down, in conjunction with OSHA’s National Stand-Down.

  • ER06-615-000, Motion to Intervene, Motion to Defer Acceptance of Filing, Protest and Alternative Request for Suspension of the Transmission Agency of Northern California, at 8 (Apr.

  • The Motion of the United States Postal Service for Late Acceptance of Filing of Its Responses to Questions 2(a) and 7(a) of Chairman’s Information Request No. 1, September 14, 2010, is granted.


More Definitions of Acceptance of Filing

Acceptance of Filing means, with respect to an NDA, MAA, or JNDA 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) that such NDA is officially “filed”, (b) in the European Union, receipt of written notice of validation by the EMA of such MAA under the centralized European procedure in accordance with any feedback received from European Regulatory Authorities; provided that if the centralized filing procedure is not used, then Acceptance of Filing will be determined upon the validation of such MAA by the applicable Regulatory Authority in a Major Market in Europe, and (c) in Japan, receipt of written notice of acceptance of filing of such JNDA from the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto).
Sample 1
Acceptance of Filing means, with respect to an NDA, MAA or JNDA 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) that such NDA is officially “filed,” (b) in the European Union, receipt by AstraZeneca, its Affiliate or Sublicensee of written notice of acceptance by the EMA of such MAA for filing under the centralized European procedure in accordance with any feedback received from European Regulatory Authorities; provided that if the centralized filing procedure is not used, then Acceptance of Filing will be determined upon the acceptance of such MAA by the applicable Regulatory Authority in a Major Country in the EU, and (c) in Japan, receipt by AstraZeneca, its Affiliate or Sublicensee of written notice of acceptance of filing of such JNDA from the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto).
Sample 1

Related to Acceptance of Filing

  • Acceptance of Bid means the letter/fax or any memorandum communicating to the Bidder the acceptance of its Bid and includes an advance acceptance of his Bid.

  • Acceptance of Tender means the letter or memorandum communicating to the supplier the acceptance of his offer (Tender) and shall include advance acceptance of his offer i.e. Letter of Intent or Rate Contract.

  • Acceptance of offer means issue of letter of intent/award or memorandum or detailed Order/Contract communicating the acceptance of offer, to the successful Tenderer.

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.

  • Filing Statement means all UCC financing statements or other similar financing statements and UCC (Form UCC-3) termination statements required pursuant to the Loan Documents.

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • Acceptance Letter means the letter from Adviser to BD pursuant to which the Adviser appoints BD as a Broker Dealer for each series of MuniPreferred issued by any Fund that has executed a Request Letter.

  • Letter of Acceptance of Tender means letter giving intimation to the tenderer that his tender has been accepted in accordance with the provisions contained in that letter.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Notice of Motion means a notice setting out the text of a motion, which it is proposed to move at the next relevant meeting;

  • Date of filing means the date an applicant submits a noti- fication of intent or the date an applicant files an application, whichever is earlier.

  • CEC Certification and Verification means that the CEC has certified (or, with respect to periods before the Project has commenced commercial operation (as such term is defined by and according to the CEC), that the CEC has pre-certified) that the Project is an ERR for purposes of the California Renewables Portfolio Standard and that all Energy produced by the Project qualifies as generation from an ERR for purposes of the Project.

  • Transfer Order means a transfer order issued pursuant to subsection 40(1) of the CCA transferring this Agreement from the LHIN to Ontario Health;

  • Certificate of Final Completion means the certificate issued by A/E that documents, to the best of A/E’s knowledge and understanding, Contractor’s completion of all Contractor’s Punchlist items and pre-final Punchlist items, final cleanup and Contractor’s provision of Record Documents, operations and maintenance manuals, and all other closeout documents required by the Contract Documents.

  • Notice of Appeal means a notice given pursuant to Condition 6.2.

  • Acceptance with respect to a Bid shall mean the City’s selection of a Bid, and award of a contract to the Bidder/Seller.

  • certificate of fitness means a certificate issued by the Department to a contract bus carrier.

  • E-Statement means an electronic version of daily confirms, monthly, quarterly or annual statements, and shareholder tax statements created with investor transaction data housed on DST’s TA2000® mutual fund record keeping system, with images available online via a secure web site.

  • Final completion and acceptance means the stage in the progress of the work as determined by the Contracting Officer and confirmed in writing to the Contractor, at which all work required under the contract has been completed in a satisfactory manner, subject to the discovery of defects after final completion, and except for items specifically excluded in the notice of final acceptance.

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • Notice of Withdrawal means a notice containing the information set out in Schedule VII;

  • Billing Statement has the meaning assigned to such term in Section 2.18(g).

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Form of Agreement means the form of agreement contained in Part D of the RFP;

  • Listing Statement means the listing statement of Purchaser pertaining to the Transaction and in the form prescribed by the CSE;

  • Filing Statements is defined in Section 5.1.13.