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 andwithout chemical modifications and plasmids and the delivery of oligonucleotides that target microRNAs, butexcluding ( i ) the delivery of single - stranded DNA oligonucleotides acting through the RNase H mechanism ( ) and ( ii ) DNA plasmids that are directly transcribed and translated into therapeutic proteins and whereinthe pharmacological activity is dependent on expression of the plasmid - encoded protein ( ) . Forpurposes of clarity, Gene Therapy ( a ) does not include plasmids that are intended to result in the production ofoligonucleotides that act through any other mechanism than translation into protein, and ( b ) specifically excludes, among other things, plasmids that are intended to result in the production of oligonucleotides that act through anyother mechanism