; and (bb) certify to the United States Patent and Trademark Office that the information provided under item (aa) is complete and consistent with the information such sponsor or holder provided to the Food and Drug Administration and any communications such sponsor or holder had with the Food and Drug Administration. (ii) The information described in this clause is— (I) any statement or characterization of analytical or clinical data disclosed by the sponsor of the application or holder of the approved application under this section to the United States Patent and Trademark Office that has been, or will be, submitted to the Food and Drug Administration to support the approval of an application under this section; (II) any statement or characterization with respect to an applicable patent, including any statement or characterization of prior art, submitted by the sponsor of the application or holder of the approved application to the United States Patent and Trademark Office in support of patentability; and (III) other information, as the Secretary or the Secretary of Commerce may require. (iii) In this subparagraph, the term applicable patent means— (I) a patent— (aa) with respect to which a reference product sponsor could reasonably assert a claim of patent infringement, if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into the United States of a biological product that relies on such patent; and (bb) that is issued, assigned, or exclusively licensed to the sponsor of the application or holder of the licensure described in clause (i); (II) an application for a patent described in subclause (I)(aa) that is sought by the sponsor of the application or holder of the licensure described in clause (i)