definiens: shall mean -subject to Section 1.26 -any and all pharmaceutical compositions covered by a single PRODUCT LICENSE and approved under such PRODUCT LICENSE for the sole purpose of PROPHYLACTIC IMMUNIZATION or THERAPEUTIC IMMUNIZATION in the FIELD consisting of : ( i ) PRODUCT in ( a ) vial(s ) or other containers or administration devices which is ( are ) administered concomitantly with ( ii ) LICENSED ANTIGEN(S ) in ( a ) vial(s ) or other containers or administration devices which is(are ) not adjuvanted with ADJUVANT, provided that either ( x ) no PRODUCT LICENSE exists for such LICENSED ANTIGEN(S ) contained in the vial(s ) or other containers or administration devices under ( ii ) above which limits the use of such LICENSED ANTIGEN(S ) to exclusive concomitant administration either with ADJUVANT or with PRODUCT under ( i ) above or with any or certain adjuvants ( including but not limited to ADJUVANT ), or ( y ) COLEY is unable to provide evidence that ADJUVANT as part of PRODUCT referred to under ( i ) above has provided a BENEFIT to the LICENSED ANTIGEN(S ) referred to in ( ii ) above and which is beyond and above the BENEFIT provided by adjuvants other than ADJUVANT ( contained in the same vials or other containers or administration devices as LICENSED ANTIGEN(S ) referred to under ( ii ) above ) to such LICENSED ANTIGEN(S ) . If either such a PRODUCT LICENSE referred to in ( x ) exists or 3/52 CONFIDENTIAL TREATMENT REQUESTED COLEY is able to provide the evidence in ( y ), then the combination of ( i ) and ( ii ) shall be a PRODUCT, not a COMBINATION