definiens: means with respect to a Product, any pharmaceutical product that ( a ) is so ld by a Third Party that is not an Affiliate or Sublic ensee of [COMPANY] under a marketing authorization gra nted by a Regulatory Authority to a Third Party, ( b ) contains the same Compound as such Product and ( c ) for purp oses of the United States, is approved in reliance on a pri or Regulatory Approval of a Product granted to Pfiz er or a [COMPANY] Affiliate or Sublicensee by the FDA pursuant to Sec tion 505(j ) of the FD&C Act ( or successor thereto ) or, for purposes of a country outside the United States, is approved in reliance on a prior Regulatory Approva l of a Product granted to [COMPANY] or a [COMPANY] Affiliate or Sublicen see by the applicable Regulatory Authority pursuant to a similar abbreviated process for therapeutically equivalent products . A 4 [ * * * * * ] Certain identified information denoted with an asterisk have been omitted from this exhibit be cause it is not material and would likely cause competitive har m to the Registrant if publicly disclosed