For purposes of this chapter, the following definitions apply: (a) âGene therapyâ refers to the administration of genetic material to modify or manipulate the expression of a gene product, or to alter the biological properties of living cells, for therapeutic use. (b) âGene therapy kitâ refers to a product that is sold as a collection of materials for the purpose of facilitating gene therapy experiments, including, but not limited to, a system for the targeted cutting of DNA molecules, such as type II clustered regularly interspaced short palindromic repeats (CRISPR), associated proteins (CRISPR-Cas) systems, including CRISPR-Cas9, as described in Regents of University of California v. Broad Institute, Inc. (2018) 903 F.3d 1286.
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