ELA/PLA definition

ELA/PLA means establishment license application number ELA92-0494 ("ELA") and product license application number PLA92-0495 ("PLA"), which were filed with the FDA on July 17, 1992 and June 16, 1992, respectively, pursuant to 21 CFR 601.2, and any correspondence filed with the FDA relating thereto, for approval to manufacture and sell Betaseron.
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Examples of ELA/PLA in a sentence

  • Schering acknowledges that Chiron does not have first-hand knowledge of the Betaseron clinical trials and acknowledges that, in the case of Betaseron, Chiron is not expected to assist in the preparation of information relating to the clinical sections of the ELA/PLA; PROVIDED HOWEVER, if Chiron in its good faith opinion believes it must audit and obtain first hand knowledge of such Betaseron clinical trials, Schering shall cooperate with Chiron in such audit.

  • Chiron shall continue to use its best efforts, in cooperation with Schering, in the preparation of responses to the FDA concerning the ELA/PLA.

  • If it is required or appropriate as to any jurisdiction to make such filings in the name of Chiron, the Parties shall accommodate such need in a manner consistent with the handling of the ELA/PLA, or as otherwise mutually agreed.

  • Vial Equivalents of Acid Paste or G-75 shall be deemed complete upon compliance with Chiron's quality assurance testing procedures (including those contained in the ELA/PLA or applicable Foreign Filing) and release therefrom.

  • Prior to FDA Licensing, Chiron shall not be required to perform fill-finish operations on G-75 so as to make Vials unless and until Chiron elects to do so in view of the progress of the ELA/PLA at the FDA.

  • The Parties shall use their best efforts to amend the ELA/PLA in this manner, including cooperating in presenting this goal and the business agreement of the parties to the FDA.

  • The Development Committee shall coordinate the exchange of information relating to the ELA/PLA and any other Foreign Filings.

  • Schering shall pay the reasonable costs of Chiron, pursuant to budgets agreed in advance, which have been or shall be incurred in connection with the preparation and filing of the ELA/PLA, obtaining the approval thereof, and in maintaining the ELA/PLA.