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.
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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.
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Examples of Filing Acceptance in a sentence

  • At a hearing held on April 27, 2006, this Court issued its “Order Approving Disclosure Statement and Fixing Time for Filing Acceptance or Rejection of Plan with Notice Thereof” (“Disclosure Statement Order”) by which this Court approved Debtors’ Disclosure Statement.

  • After obtaining approval of the Disclosure Statement, the Debtors caused materials consisting of the Disclosure Statement, the form of ballots, the Plan, the Notice of Hearing to Consider Confirmation of the Plan and Time Fixed for Filing Acceptance or -5- Rejection of the Plan, and a letter from counsel to the Official Creditors Committee to be disseminated to creditors.

Related to Filing Acceptance

  • 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.

  • 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.

  • 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).

  • 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 Lender, an Eligible Assignee 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 assignee (with the consent of any party whose consent is required by Section 9.04), and accepted by the Administrative Agent, in the form of Exhibit A or any other form approved by the Administrative Agent.

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

  • 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).

  • 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 D-4.