Full Press Release Details
| Between: | The Israel Securities Authority |
| 22 Kanfei Nesharim St., Jerusalem | |
| Telephone: 02-6556555 Fax: 02-6513646 | |
| By the Chairman of the Israel Securities Authority | |
| (Hereinafter: "the ISA" or "the Authority") |
| And between: | Kitov Pharma Ltd. |
| Isaac Israel | |
| Through Adv. Dr. Zvi Gabbai | |
| From Barnea, Jaffe, Lande & Co. | |
| (Hereinafter: "Respondent 1") | |
| (Hereinafter: "Respondent 2") |
| Paul Waymack | |
| Through Adv. Navit Negev and/or Adv. Dafna Steinberg | |
| of Sheinman Negev Niv Law office | |
| (Hereinafter: "Respondent 3") | |
| Simcha Rock | |
| Through Adv. Pnina Sheffer and/or Adv. Michal Shalmon-Perlstein | |
| From the office of S. Horowitz | |
| (Hereinafter: "Respondent 4") |
the ISA believed that there is reasonable basis to assume that the Respondents committed offences according to the Securities
Law -1968 (hereinafter - "the Securities Law"), regarding including misleading information in the reports, and therefore
commenced a criminal investigation.
Whereas the Respondents proposed to enter into an Administrative Enforcement Arrangement with the ISA and agreed to admit to the
following facts and violations, and recognize the authority of the ISA to reach an Administrative Enforcement Arrangement regarding
these violations in lieu of the continuation of the criminal investigation, and to impose in the framework of such Administrative
Enforcement Arrangement the enforcement measures listed in Article C of Chapter 8-D of the Securities Law, and the Respondents
agreed to assume the agreed upon enforcement measures, as detailed below;
Whereas the ISA has considered the matters set forth in Section 52 RR of the Securities Law, and it is of the opinion that this
Arrangement satisfies the public interest, it has decided to discontinue the proceedings against the Respondents, including all
proceedings in relation to the request for legal assistance regarding Respondent 3 currently active in the US, and in lieu of
the continuation of proceedings1 and the continuation of the criminal investigation, to enter with them into this
Enforcement Arrangement, all in accordance with Section 54B of the Securities Law;
the parties have reached the following Arrangement:
ISA and the Respondents agree that the following facts took place, which constitute the basis for entering this Arrangement:
In this Arrangement, "proceedings" - as defined in section 54A of the Securities Law.
the immediate report, the main goal of the trial was defined, as agreed in writing between the company and the FDA, as proving
that the reduction in blood pressure in the group of patients treated with the drug was at least 50% of the reduction observed
in the group treated only with a blood pressure medication.
to the immediate report, after the recruitment of the first 150 participants in the clinical trial, the results would be disclosed
to the DMC, which would analyze the results and determine the number of patients, if any, that the company should recruit, in
order to prove statistical significance and meet the primary goal of the trial. It should be noted that the Company referred to
this immediate report and its contents also in the third quarterly report for 2014.4
https://maya.tase.co.il/reports/details/933205 (See section 1.2.15, on page 6)
should be clarified that the ISA does not claim that the Company's agreement with the FDA, or any part of it, was not fulfilled.
light of the above, the Respondents undertake upon themselves the following enforcement measures and undertake to carry out the
actions imposed on them by virtue of the same means of enforcement:
It should be noted that on May 2nd, 2019, during the negotiations, the Company reported that Respondent 3 had
announced his resignation from his position as a director and chairman of the board of directors of the company. This resignation
will take effect upon appointment of his replacement(s) and by no later than July 1, 2019.
Section 54B (e) states as follows: "If it is proven to the ISA Chairman that the suspect has violated any of the terms
of the arrangement or that the arrangement was obtained fraudulently, the ISA Chairman may, with the approval of a panel the Chairman
will appoint for such purpose, order that proceedings be initiated against the suspect after the suspect is given a notice of
the ISA's Chairman to do so, and after the suspect is given an opportunity to present arguments within 30 days from the
date on which the notice was delivered; if the ISA Chairman has issued such an order, the arrangement will be deemed to be void
and the suspect will not be required to carry out those terms of the arrangement that the suspect has not yet carried out, other
than the terms that apply to the suspect by virtue of the application of conditional enforcement measures, pursuant to the arrangement."
witness whereof the parties have signed: