SEC Comment Letter for Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083) (SNOA) — Jul 16, 2009
Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083)
Date: July 16, 2009 · CIK: 0001367083 · Accession: 0000000000-09-037738
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File numbers found in text: 333-158539
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
M a i l S t o p 3 0 3 0
July 16, 2009
Hojabr Alimi Chief Executive Officer Oculus Innovative Sciences, Inc. 1129 N. McDowell Blvd. Petaluma, CA 94954
Re: Oculus Innovative Sciences, Inc.
Amendment No. 3 to Registrati on Statement on Form S-1
Filed July 9, 2009
File No. 333-158539
Dear Mr. Alimi:
We have limited our review of your filing to those issues we have addressed in
our comments. Where indicated, we think you should revise your document in response
to these comments. If you disagree, we w ill consider your explanation as to why our
comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary
in your explanation. In some of our comme nts, we may ask you to provide us with
information so we may better understand your disclosure. After reviewing this
information, we may raise additional comments. We welcome any questions you may have about our comments or any other
aspect of our review. Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter. 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.
Prospectus Summary, page 1
2. We note your reference to your disclosure of approval procedures in response to
prior comment 4:
Hojabr Alimi
Oculus Innovative Sciences, Inc.
July 16, 2009 Page 2
• Please revise the third paragraph to st ate 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 aut horized 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 authorizati ons in other countri es or potential
future uses of your product, that disclosu re should be clearly identified as such
and should appear after a clear summar y 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 th e scope of the FDA’s statutory and
regulatory requirements for approval of the products you intend to sell. You
should describe requirements to submit a pre-market approval application to
the FDA for review that is supported by extensive data, including technical,
preclinical, clinical trials, manufactur ing, and labeling to demonstrate to the
FDA’s satisfaction the safety and effec tiveness of the product. Include in
your disclosure a description of the follo wing 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 stat ements made in your prospectus are
consistent with your FDA authorization. For example, on page 16, you state
that “[p]hysician clinical studies and us age in the United States suggest that
our 510(k) product may shorten hospital stays.”
Hojabr Alimi
Oculus Innovative Sciences, Inc.
July 16, 2009 Page 3 Risk Factors, page 2
3. Given your response to prior comment 3, it appears that you regi stered 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 trans action is complete. Please tell us how
registering the resale of the shares unde rlying the Series C warrants before those
warrants were issued was c onsistent with Section 5.
Exhibit 5.1
4. The opinion you file to satisfy your obligations under Regulation S-K Item 601(b)(5) must opine on the legality of the issuance of each security covered by
the registration statement. Your current exhibit 5.1 does not appear to opine on
the warrants and units incl uded in the fee table of your registration statement.
Please file a revised opinion. Ensure that the opinion you file regarding securities
that are essentially contractual obliga tions, like warrants, state whether the
securities are binding obliga tions of the registrant unde r the state contract law
governing the security; we note, for exampl e, the reference to California law in
exhibit 4.15.
5. Refer to counsel’s assumption in the fourth paragraph regarding sufficient
authorized shares available for issuance when the warrants are exercised. You
should not offer shares that are not author ized. Please obtain a revised opinion to
clarify whether you currently have sufficien t authorized shares. Also, please tell
us whether you have reserved sufficien t authorized shares for issuance upon
exercise of the warrants. If so, please (1) tell us the steps you have taken to
ensure that the shares rema in reserved, and (2) ask your counsel to tell us why
such a broad assumption without reference to the reserved shares is necessary and appropriate in the opinion.
6. In light of the disclaimer regarding subsequent legal a nd factual developments in
the final paragraph of the first page of this exhibit, counsel’s opinion should be
dated the same date on which you expect this registration statement to be declared effective. Please file a revised opinion.
7. Please ask your counsel to confirm to us in writing that it concurs with our
understanding that the reference and limitation to the “Delaware General
Corporation Law” includes all applicable provisions of the Delaware Constitution.
Please ask your counsel to provide this written confirmati on as correspondence on
the EDGAR system.
Hojabr Alimi
Oculus Innovative Sciences, Inc.
July 16, 2009 Page 4
* * * * * * *
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have provided all information investors require
for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
Notwithstanding our comments, in the even t the company requests acceleration of
the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that:
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose th e Commission from taking any action with
respect to the filing;
• the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility
for the adequacy and accuracy of the disclosure in the filing; and
• the company may not assert staff comments a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement.
Hojabr Alimi
Oculus Innovative Sciences, Inc. July 16, 2009 Page 5
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date.
Please contact Geoffrey Kruczek at (202) 551-3641 or me at (202) 551-3617 with
any other questions.
S i n c e r e l y , Russell Mancuso B r a n c h C h i e f
cc (via fax): Amy M. Trombly, Esq.