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