BLA Acceptance definition

BLA Acceptance means the written notification by the FDA that the BLA has met all the criteria for filing acceptance.
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BLA Acceptance means the written notification by the FDA or equivalent Governmental Authority for a country in the Territory that the BLA has met all the criteria for filing acceptance pursuant to 21 C.F.R. §314.101 or its foreign equivalent if such filing is outside the US. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by MeiraGTx Holdings plc
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BLA Acceptance means the receipt of written notice from the FDA that the filing of a BLA for the Product has been accepted pursuant to and in accordance with applicable Law, as the same may be amended from time to time.
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More Definitions of BLA Acceptance

BLA Acceptance means the receipt of notice from the relevant Governmental Authority that a BLA for the Product has met all the criteria for filing acceptance. ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to BLA Acceptance

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

  • 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.

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

  • 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.

  • 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.

  • 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.

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

  • 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.

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

  • 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.

  • 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);

  • 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.

  • 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.

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

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

  • 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.

  • Operational Acceptance Tests means the tests specified in the Technical Requirements and Agreed Project Plan to be carried out to ascertain whether the System, or a specified Sub system, is able to attain the functional and performance requirements specified in the Technical Requirements and Agreed Project Plan, in accordance with the provisions of GCC Clause 27.2 (Operational Acceptance Test).

  • Acceptance Test is a test of the Features executed by the Customer to prepare the acceptance.

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