definiens: means the delivery of any form of oligonucleotides or other nucleic acid constructs for any and allpurposes, including without limitation single - stranded and double - stranded DNA and RNA molecules with and withoutchemical modiﬁcations and plasmids and the delivery of oligonucleotides that target microRNAs, but excluding ( i ) thedelivery of single - stranded DNA oligonucleotides acting through the RNase H mechanism ( ) and ( ii ) DNAplasmids that are directly transcribed and translated into therapeutic proteins and wherein the pharmacological activityis dependent on expression of the plasmid - encoded protein ( ) . For purposes of clarity, Gene Therapy(a ) does not include plasmids that are intended to result in the production of oligonucleotides that act through anyother mechanism than translation into protein, and ( b ) speciﬁcally excludes, among other things, plasmids that areintended to result in the production of oligonucleotides that act through any other mechanism