definiens: or or means, as applicable in accordance with the country(ies ) in which the Pr oducts will be manufactured or distributed, the practices set out in the guidel ines ( i ) published as the Good Manufacturing Practices for Drug Manufacturers and Importers by the HPFBI, as amended from time to time, with respect to the P roducts manufactured or distributed in Canada, ( ii ) for the manufacture of pharmaceutical products and the Current Good Manufacturing Practices as defined in United States 21 CFR 210, et seq ., as amended from time to time, with respect to the Products manufactured or distributed in the United States, and ( iii ) the EU Guidelines to Good Manufacturing Practice for Medical Products for Hum an and Veterinary Use, as amended from time to time, with respect to the Prod ucts manufactured or distributed in the European Union, and, in any even t, ( iv ) such other relevant good manufacturing practices as required by applica ble Law