definiens: or means Inform ation and materials, or the applicable part thereof, submitted to a Regulatory Authority, providing --------------------------------------------------- ------------------------ ----- November 19, 1999 ViroPharms - BPTD Agreem ent Page 3 information on the manufacturing facilit ies and manufacturing processes for making a Drug Inhalation S ystem or component thereof, including, without limitation, activitie s relating to manufacturing, processing, formulating, packaging and s torage to be conducted by or under the direction of BPTD or its Affil iates, which Information may be used to support Regulatory Approval o f the Drug Inhalation System in a country . For purposes of this Agree ment, the Drug Master File shall include, without limitation, chemi stry, manufacturing and control information, as defined in the F DA regulations at 21 CFR Section 314.50(d )