definiens: ), or within the meaning of any applicable state or local law ; ( b ) such Product will be merchandise that may be introduced and delivered into interstat e commerce under the provisions of Section 301 of the Act or Section 351 of the Public Health Service Act ; ( c ) [COMPANY] ( or as applicable its designated third -party logistics provider ) has and will maintain, in full force and effect, all licenses and permits r equired under Applicable Laws for [COMPANY] to sell and distribute such Product under this Agreement ; ( d ) such Product will be the subject of a duly approved Biologics License Application and may be legally transported or sold under Applicable Laws ; ( e ) such Pr oduct will have been approved by each applicable governmental authority for commercial sale and shipment of such Product within the Territory ; and ( f ) [COMPANY] either ( i ) owns or holds the duly approved Biologics License Application, as such term is used in th e Public Health Service Act, Title 21, United States Code, as amended for such Product, or ( ii ) is otherwise considered the of such Product within the meaning of any applicable federal, state or local law relating to pedigrees