definiens: means, on a country -by - country basis, a biologic product ( a ) whose licensing, approval, or marketing author ization relies in whole or in part on a prior approval, licensing or marketing authorization granted any Licensed Product, ( b ) whose licensing, approval, or marketing authorization relies in whole or in part on any data generated in support of a prior appr oval, licensing, or marketing authorization granted any Licensed Product ; or ( c ) is determined by the FDA or other Regulatory Authority outside of the United States to be interchangeable with a Licensed Product, as set forth at 42 USC 262(k)(4 ) or other a nalogous Applicable Law outside of the United States . A Licensed Product licensed, marketed, sold, - 4 - DB1/ 86201718.40 manufactured, or produced by [COMPANY], its Affiliates or Sublicensees will not constitute a Biosimilar Product