definiens: means, with respect to Symproic in the Territory, a product, other than an AG Product, that ( a ) containsNaldemedine as its sole API in the same dosage(s ) as Symproic, ( b ) is bioequivalent to Symproic, ( c ) may be legally substituted bypharmacies in the Territory for Symproic when filling a prescription written therefor without, as a legal requirement, having to seekauthorization to do so from the physician or other health care provider writing such prescription, ( d ) is not marketed or sold under theapproval of the Assigned NDA ( but instead is sold under the authorization of a Third Party ’s ANDA or NDA submitted by a Third Party under§505(b)(2 ) of the FD&C Act with reference to, in either case, the Assigned NDA ), and ( e ) is sold in the Territory by any Third Party