definiens: means collectively the governmental entities in each country, or recognized regional authorities, in the Territory responsible for the regulation of and/or the reimbursement of medicinal products intended for human use, Section 1.16 . Competitive Product means any ultrasound contrast agent and any radioisotope product which could be substituted in full or in part for the Product for use in the Field in the Territory ; provided that : ( i ) the product as set forth to [COMPANY] by [COMPANY] prior to the execution of the Agreement shall not be considered a Competitive Product if sold by [COMPANY] or an Affiliate of [COMPANY] in the CIS Jurisdictions only, pursuant to an existing agreement or a renewal thereof ; ( ii ) a product shall not be considered a Competitive Product with respect to any Jurisdiction unless its gross sales in such Jurisdiction over the most recent calendar quarter equaled at least 110)% of the amount of gross Product sales in such Jurisdiction by [COMPANY] and its Affiliates during such calendar quarter ; and ( iii ) a product shall not be considered a Competitive Product with respect to the Territory as a whole unless its gross sales in the Territory as a whole over the most recent twelve months equaled at least the lesser of : ( A ) 1101 % of the amount of gross Product sales in the Territory as a whole by [COMPANY], its Affiliates and Partners during such twelve month period : or ( B ) 110)% of the amount of gross Product sales in any Primary Jurisdiction by [COMPANY], its Affiliates and Partners during such twelve month period