MAA Acceptance definition

MAA Acceptance means the written notification by the applicable Regulatory Authority that the MAA has met all the criteria for filing acceptance.
MAA Acceptance means, with respect to a particular Co-Funding Product, that the particular biologics application, new drug application, or its equivalent for such Co-Funding Product was accepted by the FDA (or other applicable Regulatory Authority outside the United States if the particular biologics application, new drug application, or its equivalent was submitted to such Regulatory Authority outside the United States).
MAA Acceptance means, with respect to a Marketing Authorization Application filed for a Licensed Product, the receipt of written notice of acceptance by the EMA of such Marketing Authorization Application for filing under the centralized filing procedure.

Related to MAA Acceptance

  • Confirmation of Acceptance 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.

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

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