definiens: ( as defined in regulations promulgated by the FDA ), mis - labelling, stability failures or microbiological contam ination with respect to the Designated Product within 10 ( ten ) days of becoming aware of same . With respect to ( as defined in 21 CFR # 312.32 and # 314 .80 promulgated by the FDA ), Schein shall disclose to Ethical a nd Ethical shall disclose to Schein all reports and other knowl edge they may possess as soon as possible, and in no event later than 2 ( two ) business days of the receipt of such report or n otification of the serious adverse drug experience . The timin g and content of such disclosure shall comply with all F DA regulations applicable to notification to the FDA with respe ct to such matters and shall comply with the laws and regulatio ns of any relevant country in the Territory in which the Designa ted Product is promoted, marketed, distributed and sold