1.30“Gene Editing Therapy” means a product that uses Genome Editing Technology that functions through a mechanism of action of (a) editing (including modifying) of Genetic Material or (b) targeting of Genetic Material (including targeting of Genetic Material to modify associated chromatin), either (i) ex vivo for subsequent administration to a human, in the case of the foregoing clause (a) or (b) of a product so edited or targeted, or (ii) in vivo, by a product administered to a human, in the case of the foregoing clause (a) or (b) of a product that so edits or targets.
1.31“Genetic Material” means all DNA (including DNA in and outside chromosomes) and RNA.
1.32“Genome Editing Technology” means any CRISPR Technology, zinc finger nuclease, transcription activator-like effector nucleases (TALEN), or any other therapeutic endonuclease genome editing technology.
1.33“Governmental Authority” means any United States federal, state or local or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency, division, board or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body.
1.34“Know-How” means any ideas, Inventions, know-how, trade secrets, data, specifications, instructions, processes, formulas, technology, expert opinions and information, including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data or information. For clarity, Know-How excludes such information disclosed in published Patents.
1.35“Law” means all laws, statutes, rules, regulations, treaties, orders, judgments, or ordinances having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.
1.36“LCA10” means any disease caused by a mutation in or around the CEP290 gene.
1.37“LCA10 Program” means the Collaboration Development Program to Develop a treatment for LCA10.
1.38 “Licensee” means, with respect to a particular Editas Product, a Third Party to whom Editas has granted a license under any Know-How or Patents Controlled by Editas, but excluding any Third Party acting solely as a distributor.
1.39“Manufacture” means all activities related to the manufacturing of a compound or product, including test method development and stability testing, formulation, process development, manufacturing scale-up, manufacturing for use in non-clinical and clinical studies, manufacturing for commercial sale, packaging, release of product, quality assurance/quality control development, quality control testing (including in-process, in-process release and stability testing) and release of product or any component or ingredient thereof, and regulatory activities related to all of the foregoing.