definiens: means, as of the Effective Date and irrespective of whether such requires regulatory approval,(i ) the enhanced production and purification of non - genetically modified human autologous fibroblasts for usein all aesthetic and therapeutic indications ; ( ii ) the enhanced production and purification of non - geneticallymodified human autologous dermal cells for use in aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications ; ( iii ) the development of genetically modified autologous human fibroblasts foruse in all aesthetic and therapeutic indications where an autologous fibroblast itself is the principal effectorof the product in contrast to the use of autologous fibroblasts as the source of expression of a systemicallyavailable therapeutic protein in which that protein ( and not the fibroblast per se ) is the principal therapeuticeffector ; ( iv ) the development of genetically modified autologous human dermal cells for aesthetic andtherapeutic treatment of dermal, vocal cord, and periodontal indications ; ( v ) autologous human fibroblastsgenetically modified to express a therapeutic protein and/or bioactive RNA for the treatment of autoimmuneand non - infectious inflammatory disorders that manifest in cutaneous tissues, fascia and/or muscle, and(vi ) autologous human fibroblasts genetically modified to express bioactive Tenascin X locally to correctconnective tissue disorders . For clarity, the does not include inductive pluripotent cell products thatare derived from autologous fibroblasts or dermal cells or products that are subject to an existing Intrexoncollaboration . ” 2