SecProbe.io

CORRESP
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filename1.htm

December
29, 2014

VIA
EDGAR AND FEDERAL EXPRESS

Securities
and Exchange Commission

Division
of Corporation Finance

100 F Street,
NE

Washington,
DC 20549

Attn: Jeffrey
P. Riedler, Assistant Director

 Re: BiondVax
                                         Pharmaceuticals Ltd.

                                         Draft Registration Statement
                                         on Form F-1

                                         Submitted November 13, 2014

                                         CIK No. 0001611747

Dear
Mr. Riedler:

On
behalf of BiondVax Pharmaceuticals Ltd., an Israeli company publicly traded on The Tel-Aviv Stock Exchange Ltd. (the “Company”),
I am writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange
Commission (the “SEC”) contained in its letter to the Company, dated December 10, 2014, regarding the Company’s
Draft Registration Statement on Form F-1, confidentially submitted with the SEC on November 13, 2014 (CIK No. 0001611747) (the
“DRS”).

Concurrently
with this response, the Company is also publicly filing a Registration Statement on Form F-1 (the “Registration Statement”),
which reflects the revisions to the DRS described herein. To expedite your review, we have enclosed with this letter a clean copy
of Registration Statement, as well as a marked copy of the Registration Statement showing all changes from the DRS.

For
your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s
response thereto.

Form
F-1

1. We
                                         note the following press releases which allude to a proposed public offering of your
                                         securities:

 ● the
                                         press release labeled “Universal flu vaccine co BiondVax Pharmaceuticals mulls
                                         NY IPO” published by BioSpace and dated November 24, 2014 (see http://www.biospace.com/news_story.aspx?StoryID=355871);
                                         and

 ● the
                                         press release labeled “Universal flu vaccine co BiondVax mulls NY IPO; BiondVax
                                         is exploring two options - either a conventional offering or listing American Depositary
                                         Receipts” published by Israel’s Business Arena and dated November 23, 2014
                                         (see http://www.globes.co.il/en/article-universal-flu-vaccine-developer-biondvax-mulls-ny-ipo-1000988429).

Please
provide us with your legal analysis explaining why these communications are permissible in light of the requirements of the Securities
Act of 1933 regarding pre-filing communications. In addition, please advise us of any steps that you have taken to prevent the
further distribution or publication of similar communications going forward. For guidance, please refer to SEC Release No. 33-8591.

Company's
response:

The
Globes and BioSpace Articles

The
Company respectfully submits to the Staff that the Globes and BioSpace articles do not constitute a violation of the Securities
Act of 1933 (the “Securities Act”) by the Company.

Section
5 of the Securities Act prohibits the making of an offer to sell securities outside of a prospectus that meets the requirements
of Section 10 of the Securities Act. Section 2(a)(3) of the Securities Act defines an “offer to sell” a security as
including “every attempt or offer to dispose of, or solicitation of an offer to buy, a security or interest in a security,
for value.” The Securities and Exchange Commission has broadly construed the term “offer” to include many types
of public communications that have the intent or effect of promoting a company to prospective investors or otherwise arousing
interest in a company or its securities.

The
Company respectfully submits that the articles do not constitute an “offer to sell” the securities by the Company
or its authorized representatives because they were not communications made by or on behalf of the issuer with an intent to promote
the Company or the offering. Rather, these articles are speculative news articles published by independent third party news organizations
without any input or cooperation from the Company. In support of the foregoing, the Company confirms to the Staff that:

    i.
    No
    individual employed by or otherwise acting on the Company’s behalf was authorized by the Company to speak to Globes,
    BioSpace or any member of the press about the Company’s proposed offering.

    ii.
    A
few hours before the issuance of the Globes article, a reporter from Globes contacted the Company soliciting information and comment
from the Company about the offering and informing the Company of the information that such Globes reporter had obtained from anonymous
sources.  The Company declined to comment and did not provide any information to Globes.

    iii.
    The Company
requested that the Globes reporter identify her sources. However, the Globes reporter declined to provide this information to
the Company.

    iv.
    Subsequent
to the issuance of the Globes article, the Company made inquiries of each of its employees, consultants, outside United States
counsel, outside Israeli counsel, the proposed underwriter for the offering, the proposed underwriter's counsel, and the Company’s
independent registered public accounting firm and received confirmations from each such party that it is not, and is not aware
of the identity of, the anonymous source of the information cited in the Globes article.

    v.
    The
Company determined not to repeat the procedures described in ii through iv above with respect to the BioSpace article as that
article did not provide any new information or reporting but merely summarized the Globes article published one day prior.

    2

    vi.
    The Globes article contained very limited information and inaccurate facts.  For example, the Globes article states that the Company would be required to file a prospectus with the Commission in connection with the offering.  However, the Company had confidentially submitted a draft registration statement to the Commission ten days prior to the date of the article.  Furthermore, while the article included a speculative statement that the Company was “exploring two options either a conventional offering or listing American Depositary Receipts (ADR) for trading”, in fact as of the date of the article the Company had already determined to conduct an offering of American Depositary Receipts and indicated such throughout its draft registration statement confidentially submitted to the Commission.  The Company respectfully submits that the foregoing inaccuracies strongly imply that the sources cited in the article were speculating and did not have reliable information available to them.

    vii.
    In light of the publication of the articles
and its obligations under Section 5 of the Securities Act, the Company has not publicly acknowledged or confirmed that it is proposing
to conduct an offering in the United States or that it has filed a confidential registration statement for such purpose.

In light of the foregoing, the Company respectfully
submits to the Staff that neither of the Globes or BioSpace articles resulted in a violation of Section 5 of the Securities Act
by the Company because the Company did not make statements, give interviews or otherwise provide information to Globes or BioSpace
in connection with the articles, nor did it authorize any party to do so on its behalf. In addition, the Company respectfully
submits that it does not believe that there has been any market conditioning effect as a result of these articles, as the Company
and the underwriters have not received any indications of interest from potential investors as a result of the articles. Finally,
while the timing of the offering has not been determined, it is clear that additional time will pass before the offering is completed.
In connection therewith, each potential investor will receive a prospectus that complies with Section 10 of the Securities Act
prior to making an investment decision.

Steps
Taken to Prevent Offers in Violation of Section 5

The Company assures the Staff that it takes
very seriously the requirements of Section 5 of the Securities Act, including the rules and regulations promulgated thereunder,
and has taken the following steps to prevent impermissible publicity during the registration process.

    i.
    The Company’s management has educated itself of the restrictions on publicity applicable during the registration process through in person meetings with its outside United States and outside Israeli counsel during which such counsel instructed the Company’s management regarding the restrictions on publicity during the public offering process and suggested controls and processes to prevent unauthorized publicity.

    ii.
     The Company’s management team received written materials from its outside United States counsel regarding
the restrictions on corporate communications that apply to the Company while it is in registration and has provided a summary of
such materials to each of its officers, directors and those employees who has been made aware of the proposed offering.

    iii.
     The Company has disclosed detailed information concerning the proposed offering to only a limited number of employees, in order to limit the risk that information concerning the offering would be disclosed without authorization.  In addition, the Company’s management stressed to all employees the importance of maintaining in confidence any information concerning the proposed offering and reminded such employees of their obligations under their existing confidentiality agreements with the Company.

    3

    iv.
     To ensure compliance with Section 5 of the Securities Act, the Company requires that all press releases and
other public announcements, presentations or communications (including those issued or made in the ordinary course) to be issued
or made by the Company during the registration process must first be approved by the CEO and reviewed for compliance purposes by
the Company’s outside United States and Israeli counsel, the proposed underwriter for the offering and counsel to the underwriter.

About
This Prospectus, page i

2. Please
                                         note that it is not appropriate to directly or indirectly disclaim liability for information
                                         in the registration statement. Please remove the following statements:

 ● “However,
                                         this information may prove to be inaccurate because of the method by which some of the
                                         data for the estimates was obtained or because this information cannot always be verified
                                         with complete certainty due to the limits on the availability and reliability of raw
                                         data, the voluntary nature of the data gathering process and other limitations and uncertainties.
                                         As a result, the market and industry data and forecasts included in this prospectus,
                                         and estimates and beliefs based on that data, may not be reliable.”

 ● “However,
                                         we have not independently ascertained the accuracy, completeness or reliability of the
                                         underlying economic assumptions relied upon therein.”

Company's
response:

In
response to the Staff’s comment, the Company has deleted the foregoing statements from the Registration Statement.

Prospectus
Summary, page 1

3. We
                                         note on pages 1, 52, and 63 that you own or license four families of patents filed in
                                         a large number of jurisdictions, the latest of which is expected to be in force until
                                         2035. We also note on page 83 that your patents are expected to expire between 2019 and
                                         2031 and that patents issued from applications that will be filed from the additional
                                         provisional application would be due to expire in 2035. Please expand your disclosure
                                         on pages 1, 52, and 63 to clarify when your current material patents are expected to
                                         expire by jurisdiction and that you have not yet filed those patents that would be expected
                                         to expire in 2035.

Company's
response:

In
response to the Staff’s comment, the Company has revised the disclosure on pages 1, 48, 58 and 78 of the prospectus to clarify
when the Company’s material owned and/or licensed patents are expected to expire in each jurisdiction, and that patents
issued from applications that will be filed from the additional provisional application would be due to expire in 2035.

    4

4. We
                                         note on pages 2 and 63 that the FDA reviewed and commented on your IND submitted in June
                                         2013. Please expand your disclosure to include a summary of any material communications
                                         from the FDA.

Company's
response:

In
response to the Staff’s comment, the Company has expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to
include a summary of the Company’s material communications with the FDA.

5. Please
                                         define “Drug Master File” the first time this term is used.

Company's
response:

In
response to the Staff’s comment, the Company has added a definition to the term “Drug Master File” on page 2
of the prospectus.

6. We
                                         note on page 2 that you experienced difficulties in obtaining H5N1 avian flu vaccine.
                                         Please expand your disclosure to discuss the reason that this difficulty prevented you
                                         from completing the IND application. Additionally, please expand your disclosure to explain
                                         when and how you acquired access to the H5N1 avian flu vaccine.

Company's
response:

In
response to Staff’s comment, the Company has expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to include
the reason the difficulties in obtaining H5N1 prevented the Company from completing the IND application. In addition, in response
to Staff's comment, the Company expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to clarify that the Company
did not at any time acquire access to H5N1 avian flu vaccine.

7. We
                                         note on page 2 that you plan to seek to establish collaborations with large multinational
                                         pharmaceutical companies and/or national health authorities to conduct Phase 3 clinical
                                         trials of M-001. We also note throughout your prospectus that you plan to conduct Phase
                                         3 clinical trials in the U.S. For example, on page 5 you state that you plan to “conduct
                                         Phase 3 clinical trials” and “perform advanced trials (including Phase 3
                                         clinical trials).” Please revise your disclosure throughout your prospectus to
                                         clarify the extent to which you intend to rely on a collaborator to conduct or aid in