`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ADAPT PHARMA OPERATIONS LIMITED, AND
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case IPR2019-00694
`U.S. Patent 9,629,965
`__________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE SUBMITTED BY
`PETITIONER IN SUPPORT OF REPLY
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`Case IPR2019-00694
`U.S. Patent 9,629,965
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`Pursuant to 37 C.F.R. § 42.64, Patent Owners Adapt Pharma Operations
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`Limited and Opiant Pharmaceuticals, Inc. submit the following objections to the
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`exhibits submitted by Petitioner Nalox-1 Pharmaceuticals, LLC in support of its
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`reply filed March 12, 2020.
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`Exhibit 1201 is or purports to be a Supplemental Declaration of Maureen
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`Donovan, Ph.D. Patent Owners object to Exhibit 1201 under FRE 401, 402, and
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`403 as irrelevant. Patent Owners further object to Exhibit 1201 as not responsive
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`to the arguments and evidence cited in the Patent Owner’s Response and/or an
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`improper attempt to present new evidence that could have been presented earlier in
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`violation of, e.g., 37 C.F.R. § 42.23(b), including for example in paragraphs 12–18,
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`20, 22, 24–25, 28, and 30–31 (including their accompanying footnotes).
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`Exhibit 1202 is or purports to be a Supplemental Declaration of Günter
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`Hochhaus, Ph.D. Patent Owners object to Exhibit 1202 under FRE 401, 402, and
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`403 as irrelevant. Patent Owners further object to Exhibit 1202 as not responsive
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`to the arguments and evidence cited in the Patent Owner’s Response and/or an
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`improper attempt to present new evidence that could have been presented earlier in
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`violation of, e.g., 37 C.F.R. § 42.23(b), including for example in paragraphs 19–25,
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`29–31, 34–40, and 42–44 (including their accompanying footnotes). In addition,
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`Patent Owners object under FRE 401, 402, 403, 702 and 703 and 21 C.F.R.
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`§ 42.65(a)–(b) for failure to disclose the underlying facts and data on which Dr.
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`Hochhaus based his “simulations,” “model[s],” and/or “calcula[tions]” or to
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`provide the required affidavit and information in support thereof, including for
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`example in paragraphs 19, 31, 34–35, 49, 51, 53–54 (including their accompanying
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`footnotes). Patent Owners further object under FRE 401, 402, 403, 701, 702, and
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`703 because Dr. Hochhaus is not qualified to offer opinions about the clinical
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`practice of administering naloxone to treat opioid overdose and does not have
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`personal experience doing so, including for example in paragraphs 21–22, 27–28
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`(including their accompanying footnotes).
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`Patent Owners object to Exhibit 1203 under FRE 401, 402, 403, and 901 as
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`irrelevant (including because it is not prior art) and not authenticated. Patent
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`Owners further object to Exhibit 1203 as not responsive to the arguments and
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`evidence cited in the Patent Owner’s Response and/or an improper attempt to
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`present new evidence that could have been presented earlier in violation of, e.g., 37
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`C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1204 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1204 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1206 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1206 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1207 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1207 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1208 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1208 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1210 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1210 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1211 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1211 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1213 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1213 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1214 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1214 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1215 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1215 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1216 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1216 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1217 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1217 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1218 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1218 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1219 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1219 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1220 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1220 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1221 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1221 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1222 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1222 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1223 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1223 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1224 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1224 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1225 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1225 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1226 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1226 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1227 under FRE 106, 401, 402, 403, 801,
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`802, 805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, not authenticated, and an improper compilation of multiple documents.
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`Patent Owners further object to Exhibit 1227 as not responsive to the arguments
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`and evidence cited in the Patent Owner’s Response and/or an improper attempt to
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`present new evidence that could have been presented earlier in violation of, e.g., 37
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`C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1228 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1228 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1229 under FRE 401, 402, and 403 as
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`irrelevant (including because it is not prior art). Patent Owners further object to
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`Exhibit 1229 as not responsive to the arguments and evidence cited in the Patent
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`Owner’s Response and/or an improper attempt to present new evidence that could
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`have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1230 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1230 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1231 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1231 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1233 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1233 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1234 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1234 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1235 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1235 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1236 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1236 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1237 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1237 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1238 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1238 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1239 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1239 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1240 under FRE 401, 402, 403, and 37
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`C.F.R. § 42.6(c) as irrelevant and because it was not filed with a document citing it
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`and therefore lacks probative value. Patent Owners further object to Exhibit 1240
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`as not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1241 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1241 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
`
`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1242 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1242 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1243 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1243 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1244 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1244 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1245 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1245 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1246 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1246 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1247 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1247 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1248 under FRE 106, 401, 402, and 403 as
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`incomplete and irrelevant. Exhibit 1248 is incomplete because Petitioner did not
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`submit to the Board a complete set of all exhibits used at Dr. Jones’s deposition.
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`Patent Owners object to Exhibit 1249 under FRE 106, 401, 402, 403, and
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`901 as incomplete, irrelevant, and not authenticated. Patent Owners further object
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`to Exhibit 1249 as not responsive to the arguments and evidence cited in the
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`Patent Owner’s Response and/or an improper attempt to present new evidence that
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`could have been presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1250 under FRE 401, 402, 403, 801, 802,
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`805, and 901 as irrelevant (including because it is not prior art), inadmissible
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`hearsay, and not authenticated. Patent Owners further object to Exhibit 1250 as
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`not responsive to the arguments and evidence cited in the Patent Owner’s
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`Response and/or an improper attempt to present new evidence that could have been
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`presented earlier in violation of, e.g., 37 C.F.R. § 42.23(b).
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`Patent Owners object to Exhibit 1251 under FRE 401, 402, and 403 as
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`irrelevant. Patent Owners further object to Exhibit 1251 as not responsive to the
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`arguments and evidence cited in the Patent Owner’s Response and/or an improper
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`attempt to present new evidence that could have been presented earlier in violation
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`of, e.g., 37 C.F.R. § 42.23(b).
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`
`Date: March 19, 2020
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`
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`Respectfully submitted,
`
`/Jessamyn S. Berniker/
`
`Jessamyn S. Berniker (Reg. No. 72,328)
`Ana C. Reyes (Admitted Pro Hac Vice)
`David M. Krinsky (Reg. No. 72,339)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`jberniker@wc.com
`areyes@wc.com
`dkrinsky@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
`
`
`/Jessica Tyrus Mackay/
`
`Jessica Tyrus Mackay (Reg. No. 64,742)
`Ann K. Kotze (Reg. No. 76,570)
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`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`jmackay@greengriffith.com
`akotze@greengriffith.com
`
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on March 19, 2020, by delivering a
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`copy via electronic mail on the following attorneys of record:
`
`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`1717 K Street NW
`Washington, DC 20036
`Yelee.Kim@arentfox.com
`Janine.Carlan@arentfox.com
`Richard.Berman@arentfox.com
`Bradford.Frese@arentfox.com
`Christopher.Yaen@arentfox.com
`
`/Jessamyn S. Berniker/
`
`Jessamyn S. Berniker (Reg. No. 72,328)
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