Affected Application definition
Affected Application means: (1) any Application that, at the time of entry of this Decree, is pending or approved and contains any data or other information generated or developed at Paonta Sahib and/or Dewas; (2) all Applications that contain data or other information generated or developed at Paonta Sahib and were withdrawn between February 25, 2009 and the entry of this Decree; and (3) all Applications that contain data or other information generated or developed at Dewas and were withdrawn between August 1, 2003 and the entry of this Decree. For purposes of this Decree, ANDA 76-477 for Atorvastatin Calcium is not an Affected Application. Within ninety (90) days after entry of this Decree, Corporate Defendants may, in writing, withdraw from FDA’s consideration for approval any pending Affected Application(s) and/or request that FDA withdraw approval of any approved Affected Application(s). If Corporate Defendants withdraw an Affected Application(s) in accordance with the preceding sentence, Corporate Defendants shall never submit another Application to FDA for the drug that is the subject of the withdrawn Application(s) and shall never transfer such Application(s) to a third party, and such withdrawn Affected Application(s) will be exempt from the requirements of this Decree. If Corporate Defendants submit or transfer an Application for a drug that is the subject of an Affected Application withdrawn under this provision, FDA will not review any resubmitted or transferred Application(s) and will have no obligation to do so.