Third Party Generic Competition

Third Party Generic Competition. With respect to a particular Product in a country, a product that (i) contains the same active pharmaceutical ingredient, in any physical or salt form, as such Product, (ii) is bioequivalent to such Product, as determined under a regulatory approval for such product granted or approved (including through the abbreviated approval pathways as set forth in sections 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively)), (iii) may be legally substituted by... pharmacies in such country for such Product when filling a prescription written therefor without having to seek authorization to do so from the physician or other health care provider writing such prescription, and (iv) is legally marketed and sold in such country by a Third Party. View More