PLA Approval definition

PLA Approval means notification from a regulatory authority in a country that all approvals for the marketing of Licensed Product, including pricing approvals, have been granted.
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PLA Approval means approval by the FDA of an application for a new biologic. "PLA Filing" means the preparation and filing with the FDA of an application for a new biologic. "Public Offering" means the occurrence of a closing of an initial public sale for the account of Apollon of shares of its Common Stock or securities convertible into or exchangeable for shares of its Common Stock , where the gross proceeds to Apollon from such sale (before deduction of any underwriting commissions, discounts or concessions or expenses of sale) is at least Twelve Million Five Hundred Thousand Dollars ($12,500,000). "Sale", or "sold" or any variation thereof means the sale, assignment, lease or other disposition of a Licensed Product by Apollon or any Sublicensee for commercial purposes. "Sublicensee" means any person, expressly excluding Affiliates, to whom Apollon transfers by sublicense Apollon's rights hereunder in conformance with Section 2.2 hereof, to enable said person to make and sell Licensed Products. "Valid Claim" means a claim of (i) a patent application included in the Licensed Patents that has been neither abandoned nor pending for more than seven (7) years from its first priority date or (ii) an issued, unexpired Licensed Patent that has not been withdrawn, canceled or disclaimed or held invalid by a court or governmental authority of competent jurisdiction in an unappealed or unappealable decision no longer subject to discretionary review (for example, by way of writ of certiorari) or other review, on a country-by-country basis.
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Related to PLA Approval

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • FCC Approval means the FCC’s grant of the FCC Applications, including any grants by operation of law; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.