definiens: shall mean the sale to a Third Party ( as hereinafter defined ) of Product, specific to the Field of Use ( as hereinafter defined ), a Veterinary Application ( as hereinafter defmed ) and/or a Lateral Flow Immunochromatography Application ( as hereinafter defined ), in the Territory ( as hereinafter defined ), as evidenced by an invoice to such Third Party . The following shall not be deemed a Commercial Sale for purposes of this Agreement : ( a ) Product that is transferred, with or without the receipt of monetary consideration, to a Third Party reference laboratory, or similar entity, as analyte specific reagent ( hereinafter, ) until such time as [COMPANY] receives FDA ( as hereinafter defined ) approval of its PMA ( as hereinafter defined ) application ( or appropriate equivalent application ) for the first Commercial Sale of Product in the United States ; or ( b ) Product that is transferred to a Third Party for the evaluation of Product performance, the generation of data necessary for pre - marketing Regulatory Approval ( as hereinafter defined ) from a Regulatory Authority ( as hereinafter defined ) or any other research use, without the receipt of any monetary consideration