definiens: shall mean on a country by country basis the sale or distribution by a Third Party of a sustained release oral pharmaceutical formulation of a mono - or di­aminopyridine active agent for adrDinistration on a once or twice daily basis for the treatment or amelioration of any neurological condition(s ) ( including neurogenic conditions ) in humans, where the sales or distribution of such formulation by said Third Paliy for a calendar year are at least fifteen per cent ( 15 % ) of the total sales of the Productin such country in such calendar year expressed inequivalent units . The determination that Competition exists in any country in any calendar year shall be deemed conclusively if a mutually agreed reputable organization such as IMS has made such dete ~ ation based on its conduct of a : market share study in such country during such year, provided the existence of such level of sales of competing products may also be established by other reasonable evidence . Once a determination is made that Competition exists for a Product in any country, such determination shall be made again by the Parties each calendar year for so long as the Product is marketed in that colintry ; provided that in the event that Competition has ceased prior to the end of a calendar year and has not resumed, the Competition shall be deemed to have terminated for such year