Filing Acceptance definition

Filing Acceptance means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in Europe for the manufacture, supply, marketing and sale of a pharmaceutical product.
Sample 1Sample 2Sample 3
Filing Acceptance means the written notification by the FDA or equivalent Regulatory Authority for a country in the Territory that a MAA has been accepted for filing pursuant to 21 C.F.R. §314.101 for drugs or 21 C.F.R. §601.2 for biologics or the foreign equivalent if such filing is outside the U.S.
Sample 1

Examples of Filing Acceptance in a sentence

  • MC2017–82 and CP2017–111; Filing Title: Request of the United States Postal Service to Add Alternative Delivery Provider 1 Contracts to the Competitive Products List and Notice of Filing (Under Seal) of Contract and Application for Non- Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: January 30, 2017; Filing Authority: 39U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Gregory S.

  • Under the EFAST (ERISA Filing Acceptance System) processing effort, processed filings are loaded into an Oracle relational database called the EFAST Master File (EMF) each month.

  • CP2016–70; Filing Title: Notice of United States Postal Service of Change in Prices Pursuant to Amendment to Priority Mail Express, Priority Mail & First-Class Package Service Contract 7, with Portions Filed Under Seal; Filing Acceptance Date: January 27, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Curtis E.

  • MC2017–104 and CP2017–151; Filing Title: Request of the United States Postal Service to Add Priority Mail Contract 303 to Competitive Product List and Notice of Filing (Under Seal) of Unredacted Governors’ Decision, Contract, and Supporting Data; Filing Acceptance Date: March 27, 2017; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: ChristopherC.

  • CP2018–181; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 7 Negotiated Service Agreement and Application for Non- Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: March 16, 2018; Filing Authority: 39 CFR 3015.50; Public Representative: Timothy J.

  • CP2017–46; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 3 Negotiated Service Agreement and Application for Non- Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: November 23, 2016; Filing Authority: 39 CFR 3015.5; Public Representative: MaxE.

  • CP2018–163; Filing Title: USPS Notice of Amendment to Priority Mail Express & First-Class Package Service Contract 2, Filed Under Seal; Filing Acceptance Date: June 26, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Christopher C.

  • CP2017–249; Filing Title: Notice of the United States Postal Service of Filing Modification Two to a Global Plus 3 Negotiated Service Agreement; Filing Acceptance Date: August 9, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Christopher C.

  • MC2017–101 and CP2017–148; Filing Title: Request of the United States Postal Service to Add Priority Mail Contract 300 to Competitive Product List and Notice of Filing (Under Seal) of Unredacted Governors’ Decision, Contract, and Supporting Data; Filing Acceptance Date: March 27, 2017; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Kenneth R.

  • Filed Under Seal; Filing Acceptance Date: November 15, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Xxxxxx X.

Related to Filing Acceptance

  • XXXX Acceptance Form means the “Acceptance Form for End User License Agreement (for SAP On Premise indirect sales)” which will be provided by SAP on a deal by deal basis.

  • Date of Acceptance means the date, which appears on the Notice of Acceptance and if no date appears is the date on which the Principal sent the Notice of Acceptance accepting the Contractor’s Tender.

  • 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.

  • 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 (LOA) means the written notice issued by JMRC to the selected bidder(s) intimating the acceptance of selected bidder's Proposal for the award of License;

  • Confirmation of Acceptance shall have the meaning specified in paragraph 2B(5).

  • Letter of Acceptance means the letter of formal acceptance, signed by the contractor. Procuring Entity, including any annexed memoranda comprising agreements between and signed by both Parties.

  • Notice of Acceptance means the written notification and any accompanying documentation sent to the Consultant by the Principal advising acceptance of its Tender to provide the Services under the Contract.

  • Certificate of Acceptance means written certification, delivered to Contractor and signed by an authorized representative of the State, stating that any Defects in a particular Phase or the Solution discovered after implementation and testing have been corrected as required under this Contract, and that the Phase complies in all material respects with all of the applicable Requirements.

  • Conditional Acceptance means a conditional acceptance by the Liquidity Provider of an extension of the Scheduled Termination Date.

  • Commitment and Acceptance is defined in Section 2.18(b).

  • 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.

  • Operational Acceptance means the acceptance by the Procuring Entity of the Facilities (or any part of the Facilities where the Contract provides for acceptance of the Facilities in parts), which certifies the Contractor's fulfillment of the Contract in respect of Functional Guarantees of the Facilities (or the relevant part thereof) in accordance with the provisions of GCC Clause 28 (Functional Guarantees) hereof and shall include deemed acceptance in accordance with GCC Clause 25 (Commissioning and Operational Acceptance) hereof.

  • Final Acceptance means final written acceptance of all the Work by the Commissioner, a copy of which shall be sent to the Contractor.

  • Form of Acceptance means the Form of formal acceptance, signed by the Procuring Entity, of the Form of Tender, including any annexed memoranda comprising agreements between and signed by both Parties. If there is no such Form of acceptance, the expression “Form of Acceptance” means the Contract Agreement and the date of issuing or receiving the Form of Acceptance means the date of signing the Contract Agreement.

  • Assignment and Acceptance Agreement means an assignment and acceptance agreement entered into by a Committed Lender, an Eligible Assignee, such Committed Lender’s Group Agent and the Administrative Agent, and, if required, the Borrower, pursuant to which such Eligible Assignee may become a party to this Agreement, in substantially the form of Exhibit C hereto.

  • Assignment and Acceptance means an assignment and acceptance entered into by a Lender and an Eligible Assignee, and accepted by the Agent, in substantially the form of Exhibit C hereto.

  • Auto-Extension Letter of Credit has the meaning specified in Section 2.03(b)(iii).

  • 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 Form means the form provided by the School for parents to complete when accepting a place for their child at the School;

  • Permitted Loan Purchase Assignment and Acceptance means an assignment and acceptance entered into by a Lender as an Assignor and Holdings, the Borrower or any of the Subsidiaries as an Assignee, as accepted by the Administrative Agent (if required by Section 9.04) in the form of Exhibit F or such other form as shall be approved by the Administrative Agent and the Borrower (such approval not to be unreasonably withheld or delayed).

  • Acceptance Date has the meaning set forth in Section 2.05(a)(v)(D)(2).

  • Commercial use request means a re- quest from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made.

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

  • Final Acceptance Date means, in respect of any Offer, the final date for acceptance of such Offer which, if such Offer is extended prior to becoming unconditional, shall be the final date for acceptance of the extended Offer (but, if such Offer is or becomes unconditional, disregarding any additional or further period during which such Offer is open for acceptance);

  • Competitive Bid Accept/Reject Letter means a notification made by the Borrower pursuant to Section 2.03(d) in the form of Exhibit A-4.