definiens: ) relating to a Product within the meaning of applicable law of theTerritory into which such Product was released which, on the Effective Date underthe Food and Drugs Act, means a noxious and unintended response to the Product, which occurs at dosages normally used or tested for the diagnosis, treatment orprevention of a disease or the modification of an organic function ), promptlyfollowing their receipt by Caraco or its Affiliate ( but in any event within ten ( 10)days of receipt thereof, except in the case of a Serious ADR ( as defined below ) inwhich event Caraco shall notify Sun of same within 72 hours, which latternotification shall be by telephone with a facsimile confirmation immediatelyfollowing ; or ( 2)complaints of any regulatory authority or governmental or regulatory body, agencyor official in the Territory within five ( 5 ) days, except on weekends and holidays