new text begin Manufacturer. new text end

new text begin "Manufacturer" means, with respect to a product: new text end

new text begin (1) a person who holds an application approved under United States Code, title 21, section 355, or a license issued under United States Code, title 42, section 262, for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product; new text end

new text begin (2) a co-licensed partner of the person described in clause (1) that obtains the product directly from a person described in this subdivision; or new text end

new text begin (3) an affiliate of a person described in clause (1) or (2) that receives the product directly from a person described in this subdivision. new text end