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 notification from a regulatory authority in a country that all approvals for the marketing of Licensed Product, including pricing approvals, have been granted. 1.16 The term "Proprietary Information" shall mean all Vical Know-How, CytRx Know-How, and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing or orally or by sensory detection, which is provided by one party to the other party in connection with this Agreement. 1.17 The term "PSMA" shall mean any polypeptide derived from the prostate-specific membrane antigen which is a type II integral membrane glycoprotein that is highly expressed in prostate cancer. 1.18 The term "Substance" shall mean any polynucleotide-based therapeutic or prophylactic alone or in combination with a protein antigen as part of a prime / boost regime for use in the Field, wherein the Substance includes TranzFect. 1.19 The term "TranzFect" shall mean any polyoxypropylene/polyoxyethelene copolymer compound or compositions or preparations of such compounds claimed in or covered by CytRx Poloxamer Intellectual Property and/or CytRx Know-How which may be added to Substance to enhance performance of such Substance relative to use of the Substance without TranzFect. 1.20 The term "Territory" shall mean all of the countries in the world. 1.21 The term "Valid Patent Claim" shall mean a claim of an issued and unexpired patent included within the CytRx Poloxamer Intellectual Property, which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise. 1.22 The term "Vical Know-How" shall mean any Vical information and materials, including but not limited to, discoveries, improvements, processes, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, which during the term of this Agreement are not generally known.
Sample 1
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.
Sample 1

Examples of PLA Approval in a sentence

  • The fee required for the PLA Approval process will be charged per credit.

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.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • 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 by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • FCC Approval means the FCC’s grant of the FCC Applications; 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.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Development approval means any written authorization from a

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Works Approval means this Works Approval numbered W5913/2015/1 and issued under the Act; and

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Government Approval means an approval, permit, license, authorization, certificate, or consent of any Governmental Authority.

  • Final Approval means the Court’s order granting final approval of the Settlement.