definiens: shall mean a Licensed Compound which is used to induce, augment, fine - tune, enhance, or desensitize an antigen - specific immune response to an antigen contained in a vaccine or generated . by a DNA vaccine for the therapeutic treatment of an existing disease or prophylactic use as protection against future disease ( including desensitization to allergens ) . The antigen and the vaccine adjuvant may be admixed, delivered simultaneously, conjugated, or delivered separately, provided however, that the separate administration of the antigen and vaccine adjuvant is ( a ) limited to the topical 7 ( dermal or mucosal ) or intradermal routes of administration and ( b ) must be administered within 48 hours at substantially the same site and ( c ) labeled as such by the applicable regulatory authority . For avoidance of doubt, aside from vaccination through the topical and intradermal routes, the antigen and the vaccine adjuvant must be co - formulated ( including the use of dual barrel syringes or tamper - proof kits for co - formulation prior to injection ) and co - administered . The antieen may not be administered intra - tumorally and may not be administered more than once in any four ( 4 ) week period . ' Vhe " the antigen and the vaccine adjuvant are admixed, delivered simultaneously, conjugated or delivered separately, except in the case of topical or intradermal administration, the maximum dose for tbe vaccine adjuvant shall not be unreasonably in excess of an adjuvant dose for the purpose of enhancing immune response to the vaccine antigen and shall not be for the purpose of effecting an immune response independent of the vaccine . Any administration of the vaccine adjuvant and the antigen may include other adjuvant compounds and pharmaceutical formulations such as nanoparticles, microparticles, liposomes . or emulsions . For example, applying resiquimod gel topically as an adjuvant at tbe site of and in conjunction with topical or intradermal vaccination ( within 48 bours ) would be a Vaccine Adjuvant . Also for avoidance of doubt, vaccine adjuvants may be used with any and all types of antigens, including DNA vaccines . allergens for desensitization, and patient - derived antigens tbat are removed and processed witb dendritic cells and administered as a vaccine, but not a patient 's endogenous disease antigens residing within the body or non - tumor cells derived from the body . Also, when resiquimod gel is used the limitation regarding administration of antigen more than once in any four ( 4 ) week period does Dot apply