definiens: as further defined below ) with a statement pursuant to 21 USC § 355(j)(2)(A)(viii ) ( as further defined below ) for approval of a generic 400 mg metaxalone product with a label and package insert from which certain informa tion relating to the bioavailability of metaxalone had been removed ( as further define d below ) ; WHEREAS, on January 24, 2003, Core changed its Section viii Statement to a certification under 21 USC § 355(j)(2)(A)(vii)(IV ) ( ) and asserted that the generic 400 mg metaxalone p roduct for which it was seeking approval, with a label and pac kage insert identical to that approved under King ’s NDA No . 13 - 217 for Skelaxin ®, ( ) did not infringe King ’s Orange Book Listed patents and that such patents were invalid and/or unenforceable ; WHEREAS, on March 7, 2003, in response to Core ’s Paragraph IV Certification the Lawsuit was initi ated with respect to Core ’s Paragraph IV Product, assert ing that such product infringes United States Paten t Nos