definiens: means, with respect to a Licensed Product, a specific human disease or condition for which the treatment or prevention has received Regulatory Approval, where, for clarity, with respect to FDA Regulatory Approval, a specific huma n disease or condition receiving Regulatory Approva l under an initial New Drug Application ( NDA ) or Biol ogics License Application ( BLA ) ( both as defined in Title 21 of the U.S. Code of Federal Regulations or any s uccessor law or regulations thereto, as amended fro m time to time ) would be an Approved Indication, and each add itional specific human disease or condition under a supplemental NDA or supplemental BLA for use would be a separate Approved Indication, but, for clarity, if a supplemental NDA or supplemental BLA or any amended or expanded label claim in an NDA or BLA covers any specific human disease or condition that was in cluded in a previous Approved Indication, such supp lemental NDA or supplemental BLA or amended or expanded labe l claim in an NDA or BLA shall not be deemed to be a separate Approved Indication . For the avoidance of doubt, the Parties acknowledge there may be more th an one Approved Indication for any given histology or tumo r type