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SEC Company Response from Predictive Oncology Inc. (AGPU) (CIK 0001446159) (AGPU) — Mar 27, 2013

Predictive Oncology Inc. (AGPU) (CIK 0001446159)
Date: March 27, 2013 · CIK: 0001446159 · Accession: 0001144204-13-017765

AI Filing Summary & Sentiment

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Summary

Reasoning

File numbers found in text: 333-179145

Referenced dates: February 16, 2012

Date
March 27, 2013
Author
Branch Chief
Form
CORRESP
Company
Predictive Oncology Inc. (AGPU) (CIK 0001446159)

Letter

VIA EDGAR AND FEDERAL EXPRESS Securities and Exchange Commission Re: BioDrain Medical, Inc. Registration Statement on Form S-1 Amendment No. 3 Filed February 8, File No. 333-179145

Dear Mr. Mancuso:

This letter responds on behalf of BioDrain Medical, Inc. (the “Company”) to your comment letter addressed to Joshua Kornberg dated February 21, 2013 with respect to the filing listed above. The Company intends to file a further amendment to the registration statement after audited financial statements for the year ended December 31, 2012 are available. However, the Company respectfully requests that the staff review the responses below and confirm that such responses adequately respond to your comments.

Included below is each of your comments and the corresponding response supplied by the Company:

Prospectus Summary, page 1

1. Please expand your prospectus summary disclosure regarding your ability to continue as a going concern to inform investors clearly about the language in your auditor’s report regarding substantial doubt about your ability to continue as a going concern. Also highlight in your prospectus summary the amount of your obligations that is past due or in default.

The section of Management’s Discussion and Analysis of Financial Condition and Results of Operations” (MD&A) captioned “Liquidity and Capital Resources – Plan of Financing; Going Concern Qualification” has been updated on page 34 of the Company’s Form 10-K, filed on March 22, 2013, to reflect the fact that the Company does not currently have any obligations in default. The MD&A section in the Form S-1 will be updated to conform to MD&A in the Form 10-K. In the next amendment to the Form S-1, we intend to include substantially the following disclosure, updated as appropriate, in the Prospectus Summary on page 1 under the caption “Financial Results; Ability to Continue as a Going Concern”:

“We have approximately $2,834,000 in debts, liabilities and cash obligations that become due in the first and second quarters of calendar 2013. We may default on significant debt that becomes due by the second quarter of 2013, including secured notes held by two of the selling stockholders in the aggregate amount of approximately $597,000, for which the due date has been extended to April 30, 2013. Therefore, we may be unable to continue in business. The Company has suffered recurring losses from operations and has a stockholders’ deficit. Although we have been able to fund our current working capital requirements, principally through debt and equity financing, there is no assurance that we will be able to do so in the future. These factors raise substantial doubt about our ability to continue as a going concern. As a result of the above factors, our independent registered public accounting firm has indicated in their audit opinion, contained in our financial statements included in this prospectus, that they have serious doubts about our ability to continue as a going concern. See ‘Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources – Plan of Financing; Going Concern Qualification.’”

Executive Compensation, page 30

2. Please update your disclosure required by item 402 of Regulation S-K to include the information for your most recently completed fiscal year.

When we file the next amendment, we will update the executive compensation information to provide the disclosures required by Item 402 of Regulation S-K for the fiscal year ended December 31, 2012.

Selling Security Holders, page 47

3. Please expand your response to comment 2 in our letter to you dated February 16, 2012 to tell us clearly whether any of the offered shares represent (1) fees for attending future board meetings, (2) shares underlying any portion of a note for which you have not yet received the “advance,” or (3) consideration to be earned upon default, pre-payment or any other event that has not yet occurred.

Appendix A provides detailed information on the shares being registered on the Form S-1. We confirm as follows: (1) None of the shares being registered represent fees for attending future board meetings. The board meetings for which Dr. Herschkowitz received shares as indicated in Appendix A were all completed prior to April 2012. (2) None of the shares being registered are shares underlying any portion of a note for which the company has not yet received the advance. As indicated in Appendix A, all advances by SOK Partners were completed by May 2012. Some balances represented prepaid interest; however, all prepaid interest covered by the notes was actually earned in or before April 2012 (in the case of Dr. Herschkowitz) or August 2012 (in the case of SOK Partners). (3) None of the shares being registered represent consideration to be earned upon default, pre-payment or any other event that has not yet occurred. As indicated in Appendix A, certain penalty shares were received by Dr. Herschkowitz for defaults; however, these defaults all occurred prior to August 2012. Dr. Herschkowitz also received shares on account of certain dilutive issuances; however, such issuances all occurred prior to August 2012.

4. Refer to your response to comment 4 in our letter dated February 16, 2012. Although you may not have complied with your obligations in the note and related note agreements, it remains unclear why the selling stockholder who provides you periodic “advances” should not be identified as an underwriter who is required to sell at a fixed price for the duration of the offering given that the terms of the agreements he negotiates with you include provisions directing the proceeds of his investment to your activities regarding promotion of a market for the securities offered by the selling stockholder. Please advise, citing any relevant authority on which you relied regarding the effect of the provision included in the note agreements. Include in your response the dates of each “advance” provided to you under the agreements with the selling stockholder or his affiliates.

Legal Standard. In evaluating whether Dr. Herschkowitz and his affiliate, SOK Partners, are truly acting as selling stockholders in a secondary offering, we turn to paragraph 612.09 of the staff’s Compliance and Disclosure Interpretations, Securities Act Rules, which reads:

“It is important to identify whether a purported secondary offering is really a primary offering, i.e., the selling shareholders are actually underwriters selling on behalf of an issuer. Underwriter status may involve additional disclosure, including an acknowledgment of the seller’s prospectus delivery requirements. In an offering involving Rule 415 or Form S-3, if the offering is deemed to be on behalf of the issuer, the Rule and Form in some cases will be unavailable (e.g., because of the Form S-3 “public float” test for a primary offering, or because Rule 415(a)(1)(i) is available for secondary offerings, but primary offerings must meet the requirements of one of the other subsections of Rule 415). The question of whether an offering styled a secondary one is really on behalf of the issuer is a difficult factual one, not merely a question of who receives the proceeds. Consideration should be given to how long the selling shareholders have held the shares, the circumstances under which they received them, their relationship to the issuer, the amount of shares involved, whether the sellers are in the business of underwriting securities, and finally, whether under all the circumstances it appears that the seller is acting as a conduit for the issuer.”

Analysis. As the interpretation above states, this is often a difficult factual question. However, in examining the specific facts surrounding this registration statement and applying the six-factor test in the above C&DI, we believe the answer is straightforward: Dr. Herschkowitz and SOK Partners are not acting as underwriters, and this is truly a secondary offering on their behalf. Therefore, the selling stockholders are entitled to use the shelf registration statement in an at-the-market offering of the shares. Our analysis of the six factors is as follows:

How long the selling shareholders have held their shares. Appendix A details, among other things, the dates and amounts of the cash investments by Dr. Herschkowitz and SOK Partners and the other events that led to issuance of the shares. More than 90% of the shares being registered were issued (as described below) by August 2012. Note: For purposes of this discussion, we consider shares issuable under a convertible note to have been “issued” when the investment was made and the note was issued. This is consistent with the treatment of convertible notes under Rule 144(d)(3)(ii), under which the conversion shares are deemed to have been issued at the time of issuance of the note.

Thus, of the 95.5 million shares being registered on the Form S-1:

· 55.5 million shares (58% of the shares being registered) have been issued for more than 10 months (11.0 million shares issued by May 2012, plus 44.5 million shares issuable under convertible notes that were issued by May 2012).

· An additional 34.0 million of the shares were issued by August 2012. In other words, an aggregate 89.5 million of the shares being registered on the Form S-1 (94% of the shares being registered) have been issued for more than 7 months. These shares represent 99% of the shares being registered for Dr. Herschkowitz and SOK Partners.

· The remaining 6.0 million shares (6% of the shares being registered) have been issued since August 2012 – 0.8 million shares, plus 5.0 million shares issuable pursuant to convertible notes and 0.2 million shares issuable pursuant to warrants. This amount includes 0.8 million shares issued to Dr. Herschkowitz, representing 1% of the aggregate amount being registered for him and SOK Partners.

The staff’s comment appears to be concerned principally with Dr. Herschkowitz and SOK Partners. Because 99% of their shares have been issued for more than six months, and a majority of such shares for over 10 months, these facts are persuasive evidence that these holders are not acting as underwriters.

The circumstances under which the selling shareholders received the shares. Dr. Herschkowitz and SOK Partners received the shares in connection with long-term private financing transactions in which they were acting as private equity investors. In December 2011 when Dr. Herschkowitz made his first $225,000 investment, BioDrain was close to bankruptcy. This was an extremely risky investment, and Dr. Herschkowitz and his affiliates had no prior relationship with BioDrain.

By March 2012, BioDrain had once again run out of funds. Dr. Herschkowitz was once again willing to provide the necessary financing – another $15,000 individually, and up to $600,000 through SOK Partners, an investment partnership managed by him and Mr. Kornberg.

On March 28, 2012, BioDrain signed an amended and restated note purchase agreement with Dr. Herschkowitz and signed a convertible note purchase agreement with SOK Partners for its new SOK investment up to a total principal amount of $600,000. SOK eventually made cash advances in March, April and May 2012 totaling $357,282.

BioDrain continued to experience severe financial difficulty. On April 20, 2012, Dr. Herschkowitz sent a letter advising the Company of the occurrence of numerous events of default under the terms of his note and note purchase agreement and asserting significant rights under his security interest in substantially all assets of the Company. He deferred any enforcement of his rights as a secured creditor, pending the negotiation of a comprehensive settlement agreement.

On April 23, 2012, the previous CEO resigned and the Board of Directors appointed Mr. Kornberg as CEO. Over the next several months, the company, led by Mr. Kornberg, worked to restructure much of its other debt. After May 2012, the company did not receive further advances from SOK Partners but instead commenced a separate private offering of common stock and warrants.

After continued negotiations between Dr. Herschkowitz and the independent directors of BioDrain, on August 13, 2012 BioDrain entered into a forbearance agreement with Dr. Herschkowitz and SOK Partners, under which BioDrain, among other things, (i) confirmed Dr. Herschkowitz’s entitlement to the 7.5 million penalty shares issuable to him upon the default, and (ii) issued an aggregate 26.5 million shares to Dr. Herschkowitz and SOK Partners in recognition of their antidilution rights under a March 14, 2012 letter agreement.

In summary, the shares being registered have been issued in connection with very risky investments or in consideration of contractual rights upon default or to compensate the investors for dilution. These investments allowed BioDrain to continue its turnaround and stay in business. The investment agreements contained typical provisions confirming that the investors were purchasing for investment and without a view to any distribution in violation of the federal securities laws.

The relationship of the selling shareholders to the issuer. Again, as described in detail in the preceding section, Dr. Herschkowitz and SOK Partners received the shares in connection with long-term private financing transactions in which they were acting strictly as private equity investors for their own account. Until April 2012, the original investment arrangements were negotiated with BioDrain’s management. After Mr. Kornberg became CEO, the investors negotiated their contractual arrangements and remedies with the independent directors of BioDrain, and the fundamental relationship did not change. The parties negotiated their rights and responsibilities relating to a high-risk investment that had been made by the shareholders, which allowed BioDrain to continue its turnaround and stay in business.

The amount of shares involved. The shares covered by the Form S-1 represent a majority of BioDrain’s public float. We recognize that the staff has historically questioned the status of a PIPE offering as a secondary offering if the offering size exceeds a “rule of thumb” test of one-third of the public float. However, we also understand that the staff developed the six factor test under paragraph 612.09 to analyze the true nature of the offering in a systematic way. In BioDrain’s case, a predominance of the other factors dictate in favor of confirming that this is a secondary offering. Therefore, the shares should be considered “offered or sold solely by or on behalf of a person or persons other than the registrant, a subsidiary of the registrant or a person of which the registrant is a subsidiary”, within the meaning of Rule 415(a)(1)(ii). The offering is not “by or on behalf of the registrant”, and therefore Rule 415(a)(4), which would require that Form S-3 be available for the offering, is not applicable.

Whether the sellers are in the business of underwriting securities. Dr. Herschkowitz and SOK Partners are not broker-dealers and are not otherwise in the business of underwriting securities. Instead, they are classic private equity investors, purchasing large stakes in companies and hoping to realize long-term gains. They have not acted as underwriters, do not hold themselves out as underwriters and have not regularly participated in public distributions.

Further, the selling shareholders do not regularly take large positions in public companies. A search of the filings of Dr. Herschkowitz, SOK Partners and Mr. Kornberg with the Commission (Schedules 13D or 13G or Forms 3 or 4) reveals only filings that relate to B

Show Raw Text
CORRESP
1
filename1.htm

BioDrain
Medical, Inc.

	2915 Commers Drive,
Suite

	Eagan, Minnesota 55121

	 651.389.4806 phone

	 651.389.4807 fax

	 www.biodrainmedical.com

March 27, 2013

VIA EDGAR AND FEDERAL EXPRESS

Mr. Russell Mancuso

Branch Chief

Securities and Exchange Commission

100 F Street NE

Washington, D.C. 20549

 Re: BioDrain
Medical, Inc.

Registration Statement on Form S-1

Amendment No. 3 Filed February 8,
2013

File No. 333-179145

Dear Mr. Mancuso:

This letter responds on behalf of BioDrain Medical, Inc. (the
“Company”) to your comment letter addressed to Joshua Kornberg dated February 21, 2013 with respect to the filing listed
above. The Company intends to file a further amendment to the registration statement after audited financial statements for the
year ended December 31, 2012 are available. However, the Company respectfully requests that the staff review the responses below
and confirm that such responses adequately respond to your comments.

Included below is each of your comments and the corresponding
response supplied by the Company:

Prospectus Summary, page 1

 1. Please expand your prospectus summary disclosure regarding your ability to continue as a going
concern to inform investors clearly about the language in your auditor’s report regarding substantial doubt about your ability
to continue as a going concern. Also highlight in your prospectus summary the amount of your obligations that is past due or in
default.

The section of Management’s
Discussion and Analysis of Financial Condition and Results of Operations” (MD&A) captioned “Liquidity
and Capital Resources – Plan of Financing; Going Concern Qualification” has been updated on page 34 of the Company’s
Form 10-K, filed on March 22, 2013, to reflect the fact that the Company does not currently have any obligations in default. The
MD&A section in the Form S-1 will be updated to conform to MD&A in the Form 10-K. In the next amendment to the Form S-1,
we intend to include substantially the following disclosure, updated as appropriate, in the Prospectus Summary on page 1 under
the caption “Financial Results; Ability to Continue as a Going Concern”:

“We have approximately $2,834,000 in debts,
liabilities and cash obligations that become due in the first and second quarters of calendar 2013. We may default on significant
debt that becomes due by the second quarter of 2013, including secured notes held by two of the selling stockholders in the aggregate
amount of approximately $597,000, for which the due date has been extended to April 30, 2013. Therefore, we may be unable to continue
in business. The Company has suffered recurring losses from operations and has a stockholders’
deficit. Although we have been able to fund our current working capital requirements, principally through debt and equity
financing, there is no assurance that we will be able to do so in the future. These factors raise substantial
doubt about our ability to continue as a going concern. As a result of the above factors, our independent registered public
accounting firm has indicated in their audit opinion, contained in our financial statements included
in this prospectus, that they have serious doubts about our ability to continue as a going concern. See
‘Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital
Resources – Plan of Financing; Going Concern Qualification.’”

Executive Compensation, page 30

 2. Please update your disclosure required by item 402 of Regulation S-K to include the information
for your most recently completed fiscal year.

When we file the next amendment, we will update the executive
compensation information to provide the disclosures required by Item 402 of Regulation S-K for the fiscal year ended December 31,
2012.

Selling Security Holders, page 47

 3. Please expand your response to comment 2 in our letter to you dated February 16, 2012 to tell
us clearly whether any of the offered shares represent (1) fees for attending future board meetings, (2) shares underlying any
portion of a note for which you have not yet received the “advance,” or (3) consideration to be earned upon default,
pre-payment or any other event that has not yet occurred.

Appendix A provides detailed information on the shares being
registered on the Form S-1. We confirm as follows: (1) None of the shares being registered represent fees for attending future
board meetings. The board meetings for which Dr. Herschkowitz received shares as indicated in Appendix A were all completed prior
to April 2012. (2) None of the shares being registered are shares underlying any portion of a note for which the company has not
yet received the advance. As indicated in Appendix A, all advances by SOK Partners were completed by May 2012. Some balances represented
prepaid interest; however, all prepaid interest covered by the notes was actually earned in or before April 2012 (in the case of
Dr. Herschkowitz) or August 2012 (in the case of SOK Partners). (3) None of the shares being registered represent consideration
to be earned upon default, pre-payment or any other event that has not yet occurred. As indicated in Appendix A, certain penalty
shares were received by Dr. Herschkowitz for defaults; however, these defaults all occurred prior to August 2012. Dr. Herschkowitz
also received shares on account of certain dilutive issuances; however, such issuances all occurred prior to August 2012.

 4. Refer to your response to comment 4 in our letter dated February 16, 2012. Although you may
not have complied with your obligations in the note and related note agreements, it remains unclear why the selling stockholder
who provides you periodic “advances” should not be identified as an underwriter who is required to sell at a fixed
price for the duration of the offering given that the terms of the agreements he negotiates with you include provisions directing
the proceeds of his investment to your activities regarding promotion of a market for the securities offered by the selling stockholder.
Please advise, citing any relevant authority on which you relied regarding the effect of the provision included in the note agreements.
Include in your response the dates of each “advance” provided to you under the agreements with the selling stockholder
or his affiliates.

Legal Standard. In evaluating whether Dr.
Herschkowitz and his affiliate, SOK Partners, are truly acting as selling stockholders in a secondary offering, we turn to paragraph
612.09 of the staff’s Compliance and Disclosure Interpretations, Securities Act Rules, which reads:

“It is
important to identify whether a purported secondary offering is really a primary offering, i.e., the selling shareholders are actually
underwriters selling on behalf of an issuer. Underwriter status may involve additional disclosure, including an acknowledgment
of the seller’s prospectus delivery requirements. In an offering involving Rule 415 or Form S-3, if the offering is deemed
to be on behalf of the issuer, the Rule and Form in some cases will be unavailable (e.g., because of the Form S-3 “public
float” test for a primary offering, or because Rule 415(a)(1)(i) is available for secondary offerings, but primary offerings
must meet the requirements of one of the other subsections of Rule 415).  The question of whether
an offering styled a secondary one is really on behalf of the issuer is a difficult factual one, not merely a question of who receives
the proceeds. Consideration should be given to how long the selling shareholders have held the shares, the circumstances under
which they received them, their relationship to the issuer, the amount of shares involved, whether the sellers are in the business
of underwriting securities, and finally, whether under all the circumstances it appears that the seller is acting as a conduit
for the issuer.”

Analysis. As the interpretation above states,
this is often a difficult factual question. However, in examining the specific facts surrounding this registration statement and
applying the six-factor test in the above C&DI, we believe the answer is straightforward: Dr. Herschkowitz and SOK Partners
are not acting as underwriters, and this is truly a secondary offering on their behalf. Therefore, the selling stockholders are
entitled to use the shelf registration statement in an at-the-market offering of the shares. Our analysis of the six factors is
as follows:

How long the selling shareholders have held their shares.
Appendix A details, among other things, the dates and amounts of the cash investments by Dr. Herschkowitz and SOK Partners and
the other events that led to issuance of the shares. More than 90% of the shares being registered were issued (as described below)
by August 2012. Note: For purposes of this discussion, we consider shares issuable under a convertible note to have been
“issued” when the investment was made and the note was issued. This is consistent with the treatment of convertible
notes under Rule 144(d)(3)(ii), under which the conversion shares are deemed to have been issued at the time of issuance of the
note.

Thus, of the 95.5 million shares being registered on the Form
S-1:

 · 55.5 million shares (58% of the shares being registered) have been issued for more than 10 months
(11.0 million shares issued by May 2012, plus 44.5 million shares issuable under convertible notes that were issued by May 2012).

 · An additional 34.0 million of the shares were issued by August 2012. In other words, an aggregate
89.5 million of the shares being registered on the Form S-1 (94% of the shares being registered) have been issued for more than
7 months. These shares represent 99% of the shares being registered for Dr. Herschkowitz and SOK Partners.

 · The remaining 6.0 million shares (6% of the shares being registered) have been issued since August
2012 – 0.8 million shares, plus 5.0 million shares issuable pursuant to convertible notes and 0.2 million shares issuable
pursuant to warrants. This amount includes 0.8 million shares issued to Dr. Herschkowitz, representing 1% of the aggregate amount
being registered for him and SOK Partners.

The staff’s comment appears to be concerned principally
with Dr. Herschkowitz and SOK Partners. Because 99% of their shares have been issued for more than six months, and a majority of
such shares for over 10 months, these facts are persuasive evidence that these holders are not acting as underwriters.

The circumstances under which the selling shareholders received
the shares. Dr. Herschkowitz and SOK Partners received the shares in connection with long-term private financing transactions
in which they were acting as private equity investors. In December 2011 when Dr. Herschkowitz made his first $225,000 investment,
BioDrain was close to bankruptcy. This was an extremely risky investment, and Dr. Herschkowitz and his affiliates had no prior
relationship with BioDrain.

By March 2012, BioDrain had once again run out of funds. Dr.
Herschkowitz was once again willing to provide the necessary financing – another $15,000 individually, and up to $600,000
through SOK Partners, an investment partnership managed by him and Mr. Kornberg.

On March 28, 2012, BioDrain signed an amended and restated note
purchase agreement with Dr. Herschkowitz and signed a convertible note purchase agreement with SOK Partners for its new SOK investment
up to a total principal amount of $600,000. SOK eventually made cash advances in March, April and May 2012 totaling $357,282.

BioDrain continued to experience severe financial difficulty.
On April 20, 2012, Dr. Herschkowitz sent a letter advising the Company of the occurrence of numerous events of default under the
terms of his note and note purchase agreement and asserting significant rights under his security interest in substantially all
assets of the Company. He deferred any enforcement of his rights as a secured creditor, pending the negotiation of a comprehensive
settlement agreement.

On April 23, 2012, the previous CEO resigned and the Board of
Directors appointed Mr. Kornberg as CEO. Over the next several months, the company, led by Mr. Kornberg, worked to restructure
much of its other debt. After May 2012, the company did not receive further advances from SOK Partners but instead commenced a
separate private offering of common stock and warrants.

After continued negotiations between Dr. Herschkowitz and the
independent directors of BioDrain, on August 13, 2012 BioDrain entered into a forbearance agreement with Dr. Herschkowitz and SOK
Partners, under which BioDrain, among other things, (i) confirmed Dr. Herschkowitz’s entitlement to the 7.5 million penalty
shares issuable to him upon the default, and (ii) issued an aggregate 26.5 million shares to Dr. Herschkowitz and SOK Partners
in recognition of their antidilution rights under a March 14, 2012 letter agreement.

In summary, the shares being registered have been issued in
connection with very risky investments or in consideration of contractual rights upon default or to compensate the investors for
dilution. These investments allowed BioDrain to continue its turnaround and stay in business. The investment agreements contained
typical provisions confirming that the investors were purchasing for investment and without a view to any distribution in violation
of the federal securities laws.

The relationship of the selling shareholders to the issuer.
Again, as described in detail in the preceding section, Dr. Herschkowitz and SOK Partners received the shares in connection with
long-term private financing transactions in which they were acting strictly as private equity investors for their own account.
Until April 2012, the original investment arrangements were negotiated with BioDrain’s management. After Mr. Kornberg became
CEO, the investors negotiated their contractual arrangements and remedies with the independent directors of BioDrain, and the fundamental
relationship did not change. The parties negotiated their rights and responsibilities relating to a high-risk investment that had
been made by the shareholders, which allowed BioDrain to continue its turnaround and stay in business.

The amount of shares involved.
The shares covered by the Form S-1 represent a majority of BioDrain’s public float. We recognize that the staff has historically
questioned the status of a PIPE offering as a secondary offering if the offering size exceeds a “rule of thumb” test
of one-third of the public float. However, we also understand that the staff developed the six factor test under paragraph 612.09
to analyze the true nature of the offering in a systematic way. In BioDrain’s case, a predominance of the other factors dictate
in favor of confirming that this is a secondary offering. Therefore, the shares should be considered “offered or sold
solely by or on behalf of a person or persons other than the registrant, a subsidiary of the registrant or a person of which the
registrant is a subsidiary”, within the meaning of Rule 415(a)(1)(ii). The offering is not “by or on behalf of the
registrant”, and therefore Rule 415(a)(4), which would require that Form S-3 be available for the offering, is not applicable.

Whether the sellers are in the business of underwriting securities.
Dr. Herschkowitz and SOK Partners are not broker-dealers and are not otherwise in the business of underwriting securities. Instead,
they are classic private equity investors, purchasing large stakes in companies and hoping to realize long-term gains. They have
not acted as underwriters, do not hold themselves out as underwriters and have not regularly participated in public distributions.

Further, the selling shareholders do not regularly take large
positions in public companies. A search of the filings of Dr. Herschkowitz, SOK Partners and Mr. Kornberg with the Commission (Schedules
13D or 13G or Forms 3 or 4) reveals only filings that relate to B