definiens: means a formulation that : ( a ) is approved by Governmental or Regulatory Authority within the Initial Territory where such approval is not for the treatment of Xerostomia or Oral Mucositis ; and ( b ) either ( i ) falls within the claims of the Licensed Patents as in existence as of the Effective Date or ( ii ) is a composition disseminated by any of the Inventors or disclosed in a publication authored by any of the Inventors before the filing date of the application for the Licensed Patents at issue, or known or used by any third party before the filing date of the application for the Licensed Patents at issue through the publication or dissemination by any of the Inventors, such that such publication, knowledge or use would constitute prior art for the purposes of 35 U.S.c . § 102 et seq . with respect to the Licensed Patents ( if the CalPhos Mouth Rinse is Launched in the United States ) or foreign equivalent to such provision ( if the Calphos Mouth Rinse is Launched in another country in the Initial Territory )