definiens: shall mean any of the following filed with the FD A or any foreign regulatory authority required before initia tion of clinical testing in humans . For clarity, th is definition will include ( a ) the filing of an Investigational N ew Drug Application, as defined in the United State s Food, Drug and Cosmetic Act, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, ( b ) the filing of an Abbreviated New D rug Application as defined in the United States Foo d, Drug and Cosmetic Act, filed with the FDA pursuant to Pa rt 314 of Title 21 of the U.S. Code of Federal Regu lations, ( c ) the filing of a BLA, and ( d ) any counterparts t o any of the foregoing that are required in any oth er country or region in the Territory before beginning clinical t esting in humans in such country or region