definiens: means ( a ) a miRNA Therapeutic being Developed, Manufactured or Commercialized by Regulus that, on a country - by - country basis, is, or Regulusreasonably believes will be, at the time of first commercial sale of such miRNA Therapeutic, Covered in such country by a Valid Claim ofa Patent Right or covered by Know - How of ( i ) a Licensed Patent Right licensed to it hereunder, or ( ii ) any Regulus IP ( except any RegulusIP solely in - licensed or acquired by Regulus from a Third Party ) ; or ( b ) an Opt - In Product that, on a country - by - country basis, is, or the relevant Opt - In Party reasonably believes will be, at the time of firstcommercial sale of such Opt - In Product, Covered in such country by a Valid Claim of a Patent Right or covered by Know - How, whichPatent Right or Know - How is licensed to the applicable Opt - In Party hereunder