definiens: shall mean, with respect to a Product that has received Regulatory Approval in a regulatory jurisdiction and is being marketed and sold by C uris or any of its Affiliates or Sublicensees in such jurisdiction, any biological product that : ( a ) is sold in such jurisdiction by a Third Party that is not a Sublicensee of [COMPANY] or its Affiliates and did not purchase or acquire such product in a chain of distribution that included [COMPANY] or any of its Affiliates or Sublicensees ; ( b ) is claimed to be biosimilar to or interchangeable with such Product or otherwise references or relies on the approved BLA for such Product in such jurisdiction ( or the safety or efficacy data submitted in support of such BLA ) to support a BLA submitted under Section 351(k ) of the U.S. Public Health Service Act and the regulations promulgated thereunder ( or any successor thereto ) or any foreign equivalent thereof in the applica ble jurisdiction ; and ( c ) is approved for sale for at least one of the same Indications as such Product in such jurisdiction