SEC Company Response from Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083) (SNOA) — Jul 21, 2009
Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083)
Date: July 21, 2009 · CIK: 0001367083 · Accession: 0000950123-09-023827
AI Filing Summary & Sentiment
File numbers found in text: 333-158539
Referenced dates: July 1, 2009, July 16, 2009
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CORRESP
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1320 Centre Street, Suite 202
Newton, MA 02459
Phone
617-243-0060
Fax 617-243-0066
July 21, 2009
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 3030
Washington, DC 20549
Attn: Geoffrey Kruczek
Re:
Oculus Innovative Sciences, Inc.
Registration Statement on Form S-1
File No. 333-158539
Dear Mr. Kruczek:
I am securities counsel for Oculus Innovative Sciences, Inc. (the “Company”). I enclose for filing
under the Securities Act of 1933, as amended, an amendment to the Form S-1, File No. 333-158539,
together with certain exhibits thereto (the “Registration Statement”).
The Registration Statement contains revisions that have been made in response to comments received
from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in their
letter dated July 16, 2009.
Set forth below is the Company’s response to the Staff’s comments. The numbering of the response
corresponds to the numbering of the comment in the letter from the Staff.
Comment 1.
Please note that we are not taking a position at this time
regarding the accuracy of the analysis or the conclusions in
your response to prior comment 1. Please refer to the
acknowledgements at the end of this letter that Oculus must
provide with any acceleration request.
Response 1.
The Company notes the Staff’s
comment. Additionally the Company will make such acknowledgments when requesting
effectiveness of the Registration Statement.
Prospectus Summary, page 1
Comment 2.
We note your reference to your disclosure of approval procedures in response to prior
comment 4:
•
Please revise the third paragraph to state clearly and prominently for what
uses you are authorized to market and sell your products in the United States
and to clearly distinguish how those authorized uses differ from authorization
to use or sell your product as a “drug” or “medical device.” If you also
elect to include in your summary authorizations in other countries or
potential future uses of your product, that disclosure should be clearly
identified as such and should appear after a clear summary of the scope of
your FDA clearance; and
•
Please expand the disclosure in your business description beginning on page
16 to include a full description of the scope of the FDA’s statutory and
regulatory requirements for approval of the products you intend to sell. You
should describe requirements to submit pre-market approval application to the
FDA for review that is supported by extensive data, including technical,
preclinical, clinical trials, manufacturing, and labeling to demonstrate to
the FDA’s satisfaction the safety and effectiveness of the product. Include
in your disclosure a description of the following regulatory issues, as
applicable:
•
the FDA’s statutory and regulatory requirements for approval of a new
drug and the requirements of a New Drug Application;
•
device classification information;
•
investigational device exemption requirements;
•
obligations of a sponsor of an investigational device exemption;
•
pre-market approval application requirements and conditions of
approval;
•
duration of the process;
•
registration and labeling requirements;
•
advertising and promotion;
•
quality system regulation and manufacturing of the product;
•
post-market reporting and record-keeping requirements, including
medical device reporting and reports of corrections or removals;
•
import and export requirements; and
•
potential sanctions for violations.
Also, given your current authorizations, clarify the scope of the permitted
marketing of your product and which statements made in your prospectus are
consistent with your FDA authorization. For example, on page 16, you state that
“[p]hysician clinical studies and usage in the United States suggest that our
510(k) product may shorten hospital stays.”
Response 2.
The Company respectfully draws the Staff’s attention to the following disclosure
contained in the third paragraph on page 1:
“Our device product is cleared for sale in the United
States as a 510(k) medical device for wound cleaning,
debridement, lubricating, moistening and dressing; is a device
under CE Mark in Europe; is approved by the State Food and Drug
Administration, or SFDA, in China as a technology that reduces
the propagation of microbes in wounds and creates a moist
environment for wound healing; and is approved as a drug in India
and Mexico. We do not have the necessary regulatory approvals to
market Microcyn in the United States as a drug, nor do we have
the necessary regulatory clearance or approval to market Microcyn
in the United States as a medical device for an antimicrobial or
wound healing indication.”
In order to address Staff Comment 2, we have made this disclosure more prominent by
including it as a standalone paragraph and reversing the order of the sentences so
it now reads:
“We do not have the necessary regulatory approvals to
market Microcyn in the United States as a drug, nor do we
have the necessary regulatory clearance or approval to
market Microcyn in the United States as a medical device
for an antimicrobial or wound healing indication. Our
device product is cleared for sale in the United States
as a 510(k) medical device for wound cleaning, debridement, lubricating, moistening and dressing; is a
device under CE Mark in Europe; is approved by the State
Food and Drug Administration, or SFDA, in China as a
technology that reduces the propagation of microbes in
wounds and creates a moist environment for wound healing;
and is approved as a drug in India and Mexico.”
We note that the disclosure is made prominent by its positioning in a box with
substantial white space. We also believe that relocating the statement that the
Company does not have the necessary regulatory approvals to market Microcyn as a
drug or a medical devise for an antimicrobial or wound healing indication as the
first sentence, in a separate paragraph, as one of just four short paragraphs under
the heading “About Us” and as part of a single page summary, prominently features
the disclosure.
Additionally, the Company has revised the disclosure under the heading “Description
of Business” to address the second bullet point of Staff Comment 2. To assist the
Staff’s review, the following table indicates under which heading disclosure
addressing each regulatory issue raised by the Staff in its Comment 2 appears:
Regulatory Issue
Under Heading
•
the FDA’s statutory and regulatory
requirements for approval of a new drug and
the requirements of a New Drug Application;
Government Regulation
•
device classification information;
Medical Device Regulation
Regulatory Issue
Under Heading
•
investigational device exemption
requirements;
Medical Device Regulation
•
obligations of a sponsor of an
investigational device exemption;
Medical Device Regulation
•
pre-market approval application
requirements and conditions of
approval;
Medical Device Regulation
•
duration of the process;
Government Regulation
Pharmaceutical Product Regulation
•
registration and labeling
requirements;
Medical Device Regulation
Pharmaceutical Product Regulation
•
advertising and promotion;
Medical Device Regulation
•
quality system regulation and
manufacturing of the product;
Medical Device Regulation
•
post-market reporting and
record-keeping requirements,
including medical device
reporting and reports of
corrections or removals;
Medical Device Regulation
•
import and export requirements; and
Medical Device Regulation
•
potential sanctions for violations.
Medical Device Regulation
As described in the revised disclosure, particularly under the heading Market
Device Regulation, FDA regulations prohibit the advertising and promotion of a
medical device for any use outside the scope of a 510(k) clearance, pre-market
approval or for unsupported safety or effectiveness claims. The Company
respectfully notes that the Registration Statement is not intended to advertise or
promote the Company’s product. Rather, the Registration Statement’s purpose is to
provide investors with adequate information about the Company’s business to enable
them to make an informed investment decision. To that end, Form S-1 requires that
the Company include, among other things, the information required by Item 101 of
Regulation S-K. Item 101 requires, in part, that the Company provide investors
with a narrative description of the business.
In order to comply with this disclosure requirement, the Company must include
information about its business, including its products. This requires the Company
to make statements which are necessarily broader than those it may make when
marketing and promoting its products. The second paragraph under the heading “Our
Business” clearly lists the indications for which the Company’s product has
received 510(k) clearance. Further, statements that are consistent with the 510(k)
clearances are clearly marked as such. On the other hand, statements that are
based on our reasonable beliefs and conclusions use language such as “we believe”
and “suggests.” For instance, under the heading “Our Solution,” bullets four and
five each include a claim that “[o]ur 510(k) label states,” indicating such
statement is consistent with our 510(k) clearances. In contrast, the remaining
bullets indicate that “we believe” the stated claim or that a set of facts
“suggest” such claim is true.
Risk Factors, page 2
Comment 3.
Given your response to prior comment 3, it appears that you
registered the resale of shares underlying the Series C
warrants before those warrants were issued. Generally, it is
inconsistent with Section 5 of the Securities Act to register
shares for resale before the related private transaction is
complete. Please tell us how registering the resale of the
shares underlying the Series C warrants before those warrants
were issued was consistent with Section 5.
Response 3.
We note the Staff’s comment that “it appears that you registered the resale of shares underlying
the Series C Warrants before those warrants were issued.” To be clear, the shares underlying the
“Series C Warrants” referenced by the Staff are no longer registered in any Registration Statement
of the Company. To the extent shares underlying the “Series C Warrants” were included in a prior
registration statement, they have been deregistered via a post-effective amendment and to the
extent shares underlying the “Series C Warrants” were included in this Registration Statement, they
were removed with the first Amendment to the Registration Statement on May 22, 2009 — three
amendments and almost two full months ago. The Company determined to remove these shares from
registration to focus on the primary offering at hand and to reduce the time and expense of
responding to Staff comments as each amendment to the Registration Statement creates a substantial expense to the
Company. Additionally, the Company’s stock price has been volatile along with the stock market in
general and the Company is hoping to price and close its primary offering before the market window
is lost.
Given these real world issues and the Company’s need for capital, we have attempted to resolve
these issues with the Staff. The Staff appears to have engaged in what appears to be two lines of
questions around the “Series C Warrants” through Staff Comments 1 and 3 of its letter dated July 1,
2009. The Company specifically requested a phone conference to reach mutual understanding of the
Staff’s issues so they could be addressed. However, the Staff did not to honor this request and
instead issued again what appears to be a confusing comment without commenting on the Company’s
responses to prior Staff Comments 1 and 3. We suggest again that the Staff initiate a phone
conversation if questions remain prior to issuing another comment on this matter.
By way of background, the “Series C Warrants” relate to two offerings that closed in February 2009.
These offerings have been repeatedly described in comment letters to the Staff, the Registration
Statement and the Company’s SEC filings. The Series C Warrants were not offered independently at
any time. The Series C Warrants were offered and sold solely as part of a Unit during February
2009. The Unit was comprised of common stock, Series A Warrants and Series B Warrants. If a
Series B Warrant is exercised, the holder of the Series B Warrant will receive another unit
consisting of common stock and a Series C Warrant. As of the date of this letter, because the
Series A and Series B Warrants are not exercisable until six months after issuance, the common
stock underlying such warrants has not been issued. Additionally, for the same reason, no Series C
Warrants have been issued. The common stock, the Series A Warrant, the Series B Warrant and the
right to obtain additional securities upon exercise of the Series A Warrants, Series B Warrants and
Series C Warrants were offered and sold as part of the same Unit. Additionally, the terms of all
of the warrants, including the exercise price, were fixed at the time of the Offering, although the
exercise price of each of the warrants is adjustable as a result of customary anti-dilution
adjustments.
We respectfully note that the Staff has not commented that the common stock issuable upon
exercise of the Series A Warrants and the Series B Warrants has created a concern pursuant to
Section 5. We
note that, like the common stock issuable upon exercise of the Series A Warrants and the Series B
Warrants, the Series C Warrants may be acquired by only upon exercise by those holders that
purchased such Series A and Series B Warrants as part of the Units. Thus, the mere fact that a
security has not been issued prior to registration does not seem to be the sole factor in a Section
5 analysis — as implied by the Staff’s comment.
It is a long-standing Staff position to allow Issuers to register securities that have not yet been
issued if such security may be issued in the future pursuant to a convertible security. Section
2(a)(3) of the Securities Act excludes from the definition of “offer” a right to acquire a
security that is not exercisable until some future date. It is this exclusion that allows Issuers
generally to issue securities such as warrants, options and convertible securities and that the
subsequent exercise or conversion of those securities will not be considered an “offer.” The Staff
has interpreted this Section to also permit the registration of the resale of securities that have
not yet been issued but may be issued pursuant to a warrant, option or other convertible security.
The Series C Warrants, just like the common stock underlying the Series B warrants, may be issued
in the future only to the holders of the Series B Warrant and only upon the fixed terms in the
Series B Warrant. If the Staff accepts this analysis as it relates to the stock underlying the
Series B Warrant, it is unclear from the Staff’s comment why the Staff questions this analysis if
the security is something other than common stock.
Furthermore, we note Telephone Interpretation 69 which states the following:
“Where convertible securities or warrants are being registered under the Securities
Act, and such securities are convertible or exercisable within one year, the
underlying securities also must be registered at that time, absent an exemption from
registration for such conversion or exercise (such as Section 3(a)(9) for most
conversions). When no such exem