definiens: means, as of the Effective Date and i rrespective of whether such requires regulatory approval, ( i ) the enhanced production and purificat ion of non - genetically modified human autologous fibroblasts for use in all aesthetic and therapeutic indications ; ( ii ) the enhanced production and purification of non - genetically modi fied human autologous dermal cells for use in aesthetic and therapeutic treatment of dermal, voca l cord, and periodontal indications ; ( iii ) the development of genetically modified autologous huma n fibroblasts for use in all aesthetic and therapeutic indications where an autologous fibrobl ast itself is the principal effector of the product in contrast to the use of autologous fibroblasts as th e source of expression of a systemically available therapeutic protein in which that protein ( and not the fibroblast per se ) is the principal therapeutic effector ; ( iv ) the development of genetically modif ied autologous human dermal cells for aesthetic and therapeutic treatment of dermal, vocal cord, an d periodontal indications ; and ( v ) autologous human fibroblasts genetically modified to express a therapeutic protein and/or bioactive RNA for the treatment of autoimmune and non - infectious inflamma tory disorders that manifest in cutaneous tissues, fascia and/or muscle . For clarity, the does not include inductive pluripotent cell products that are derived from autologous fibroblas ts or dermal cells or products that are subject to an existing [COMPANY] collaboration . ” 2