definiens: means, as of the Effective Date and irrespective of whether such requires regulatory approval, ( i ) theenhanced production and purification of non - genetically modified human autologous fibroblasts for use in all aesthetic andtherapeutic indications ; ( ii ) the enhanced production and purification of non - genetically modified human autologous dermalcells for use in aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications ; ( iii ) the development ofgenetically modified autologous human fibroblasts for use in all aesthetic and therapeutic indications where an autologousfibroblast itself is the principal effector of the product in contrast to the use of autologous fibroblasts as the source ofexpression of a systemically available therapeutic protein in which that protein ( and not the fibroblast per se ) is the principaltherapeutic effector ; and ( iv ) the development of genetically modified autologous human dermal cells for aesthetic andtherapeutic treatment of dermal, vocal cord, and periodontal indications . For clarity, the does not include inductivepluripotent cell products that are derived from autologous fibroblasts or dermal cells or products that are subject to an existingIntrexon collaboration