definiens: means a device, component, kit or dis posable designed and sold by [COMPANY] that is based upon or utilizes Intellectual Property Rights inclu ded in the Technology and contains an Enhancement w hich Enhancement either ( a ) significantly improves the s afety or efficacy of the device, component, kit or disposable as compared to the Product, or ( b ) results in a new intended use for the device, component, kit or dis posable as compared to the Product, and in each case for which [COMPANY] has received marketing clearance or approv al from a governmental or regulatory authority separate and a part from the Product Registration Rights transferr ed hereunder ; provided, however, that a device, compon ent, kit or disposable will not be deemed to be a as a result of a modification to the speci fication or manufacturing of the Product Line, as i t exists as of the date hereof, implemented to address performance, responsiveness or other quality issues identified on Exhibit A-6 attached hereto ( regardless of whether such mod ifications require clearance or approval from any governmental or regulatory authority ) ; and provided, further, a device, component, kit or disposable s hall only be deemed to be a solely in such jurisdi ction(s ) or market(s ) where [COMPANY] has received cl earance or approval from a governmental or regulatory authorit y for such device, component, kit or disposable