definiens: shall mean the in vivo administration of genetic material directly into a humanbeing using viral vectors, including but not limited to AAV Vectors, to transfer such material into the patient’sown cells for the purpose of producing proteins or other macromolecules that are expressed in or secretedfrom the transduced cells for therapeutic or prophylactic purposes, where ( i ) the expression of such proteinsor other macromolecules is regulated through the administration of [ * * * ] or another [ * * * ] Dimerizer, or ( ii ) theinserted genetic material is not regulated through the administration of a Dimerizer . For clarity, shall not include ( a ) any use where genetic material is inserted into a cell ex vivo, including withoutlimitation any use for a cancer or non - cancer vaccine or immunotherapeutic product or ( b ) any use whereactivation of genetic material for any function other than expression is regulated through the administration ofDimerizer