definiens: as further defined be low ) and 6,683,102 ( the as further d efined below ) ; WHEREAS, on September 5, 2003, Core asserted a ffirmative defenses and counterclaims in the Lawsui t alleging inter alia that the ‘ 102 Patent and the ‘ 128 Patent are not in fringed and are invalid and/or unenforceable ; WHEREAS, on March 4, 2004, after the FDA issue d a letter indicating its intentio n to approve a generic metaxalone product with a stateme nt under 21 USC § 355(j)(2)(A)(viii ) and a label and package insert analogous to Core ’s Sectio n viii Product, Core requested the FDA to amend its Paragraph IV Certification for its 400 mg metaxalon e product to a Section viii Statement and again sub mitted a Section viii Statement ; WHEREAS King believes that the Core Section vi ii Product is both less safe and less efficacious t han Skelaxin ®, as documented in the Citizen Petition filed by Ki ng, as well as similar filings made to the FDA by third parties ; and WHEREAS the parties seek to settle the Lawsuit and certain ancillary matters relating to Core ’s S ection viii Product and Paragraph IV Product, and King ’s patent s, including without limitation withdrawing Core ’s Section viii Statements, on the terms and conditions set fo rth below