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SEC Company Response from Pulmatrix, Inc. (PULM) (CIK 0001574235) (PULM) — Aug 8, 2013

Pulmatrix, Inc. (PULM) (CIK 0001574235)
Date: Aug. 8, 2013 · CIK: 0001574235 · Accession: 0001144204-13-043947

AI Filing Summary & Sentiment

Referenced dates: June 21, 2013

Date
August 8, 2013
Author
Not clearly detected
Form
CORRESP
Company
Pulmatrix, Inc. (PULM) (CIK 0001574235)

Letter

Linda Rockett | 617 348 4888 | lrockett@mintz.com

One Financial Center

Boston, MA 02111

617-542-6000

617-542-2241 fax

www.mintz.com

August 8, 2013

Via EDGAR and by Federal Express

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Mail Stop 3561

Washington, D.C. 20549

Attention: Jeffrey Riedler, Assistant Director

Re: Ruthigen, Inc.

Confidential Draft Registration Statement on Form S-1

Submitted May 24, 2013

CIK No. 0001574235

Ladies and Gentlemen:

We are submitting this letter on behalf of Ruthigen, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated June 21, 2013 (the “Comment Letter”) from Jeffrey P. Riedler, Assistant Director, to Hojabr Alimi, the Company’s Chief Executive Officer, relating to the above-referenced registration statement on Form S-1 of the Company submitted with the Commission on May 24, 2013 on a confidential basis pursuant to Title 1, Section 106 of the Jumpstart Our Business Startups Act (the “Confidential Submission”). In conjunction with this letter, the Company is making its initial public filing (the “Initial Public Filing”) of such registration statement and making further amendments thereto (as amended, the “Registration Statement”).

For convenient reference, we have set forth below in italics each of the Staff’s comments set forth in the Comment Letter and have keyed the Company’s responses to the numbering of the comments and the headings used in the Comment Letter. All of the responses are based on information provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. Where appropriate, the Company has responded to the Staff’s comments by making changes to the disclosure in the Registration Statement as set forth in the Initial Public Filing. Page numbers referred to in the responses reference the applicable pages of the Initial Public Filing.

We are providing by overnight delivery to Daniel Greenspan of the Staff five courtesy copies of this letter and the Registration Statement that have been marked to show changes from the initial filing of the Confidential Submission on May 24, 2013.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Boston | London | Los Angeles | New York | San Diego | San Francisco | Stamford | Washington

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

August 8, 2013

Page 2

General

1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits.

Response: The Company respectfully submits that it has included additional exhibits to the Initial Public Filing, and will submit or file additional exhibits to the Registration Statement as soon as practicable. The Company acknowledges that the Staff may have further comments upon examination of such exhibits.

2. We note that your draft registration statement includes the Representative’s warrants and the common stock underlying those warrants as securities to be registered in this offering. Please be advised that the registration of the issuance of these securities to the Representative, which are to be received by the Representative as underwriting compensation, does not entitle the Representative to subsequently resell such securities to the public without additional registration. As an underwriter, the Representative must avail itself of a resale registration statement or an applicable exemption from Section 5 of the Securities Act of 1933 in order to sell the securities.

Response: The Company respectfully acknowledges the Staff’s comment and has informed the Representative of the Staff’s comment.

3. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If you will use any additional graphic, visual or photographic information in the printed prospectus, please provide us a proof of each such item for our review prior to its use. Please note that we may have comments regarding this material.

Response: The Company respectfully submits that it does not anticipate using any graphic, visual or photographic information, other than such information already included in the Registration Statement. The Company will supplementally provide the Staff with copies of any additional graphic, visual or photographic information used in the printed prospectus. The Company acknowledges that the Staff may have further comments upon examination of such additional material.

4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please state your election under Section 107(b) of the JOBS Act:

· If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or

· If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

August 8, 2013

Page 3

In addition, please describe the extent to which any of the exemptions available to emerging growth companies are also available to you as a Smaller Reporting Company.

Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 5-6, 29 and 38 of the Initial Public Filing.

5. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering.

Response: As of the date of this response letter, the Company has not relied upon the procedures available to emerging growth companies under Section 5(d) of the Securities Act of 1933, as amended (the “Securities Act”). The Company will furnish any such material to the Staff in connection with future correspondence, if the Company relies upon such section to provide material to qualified institutional buyers or institutional accredited investors.

To date, no research reports about the Company have been published or distributed in reliance on Section 2(a)(3) of the Securities Act by any broker or dealer that is participating or will participate in the offering. The Company will supplementally provide the Staff with any such research reports should any be published or distributed in reliance on Section 2(a)(3) of the Securities Act.

6. Please tell us what consideration you gave to presenting the historical results of the novel biotechnology business of Oculus Innovative Sciences, Inc. in separate financial statements (i.e., carve-out financial statements) prior to your inception. It would appear that presenting carve-out financial statements to include all relevant activities that have been part of the history of your business, and that can be expected to repeat as the business continues in the future, is required. Separately reference for us any authoritative literature you rely upon to support your position.

Response: The Company respectfully submits the following response to the Staff:

We note the Staff’s observations relating to the presentation of historical results of the novel biotechnology business of the Company’s parent, Oculus Innovative Sciences, Inc. (“Oculus”), in separate financial statements (i.e., carve-out financial statements (SEC SAB Topic 1B.1)) prior to the Company’s inception. As described below, following the disclosure of RUT58-60 to Oculus’ intellectual property counsel in December 2012, Oculus formed a wholly-owned subsidiary named Ruthigen, Inc., or the Company. In January 2013, the Company was incorporated in the State of Nevada. Financial statements have been prepared for the Company reflecting all activities of the business since formation. No direct or indirect product related costs were incurred by Oculus specifically relating to the new formulation, RUT58-60, prior to this time period.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

August 8, 2013

Page 4

Such audited financial statements as of and for the period ended March 31, 2013 have been included in the Registration Statement. No carve out financial statements for the period prior to January 2013 are necessary since all direct or indirect product related costs incurred specifically relating to the new formulation, RUT58-60, are already included within the historical financial statements of the Company for the period ended March 31, 2013.

The Company, a wholly-owned subsidiary of Oculus, has submitted the Registration Statement to register shares being sold in a proposed initial public offering of the Company. In connection with the filing of the Registration Statement, the Company is required to include audited historical financial statements reflecting the operating activities of the Company. The Company has executed a license and supply agreement with Oculus pursuant to which the Company will license from Oculus certain of Oculus’ proprietary technology related to the use of hypochlorous acid for specific indications and territories as defined in the license and supply agreement between the companies, effective upon the completion of the proposed initial public offering.

The Company also executed a separation agreement with Oculus to allow the Company to access the capital market and fund the development of the newly discovered RUT58-60 as a drug for prevention of infection in abdominal surgery. This market is currently not available to Oculus and its technology due to both technological and regulatory limitations.

Therefore, prior to 2013, Oculus has not incurred any direct or indirect product costs with respect to the product candidate, RUT58-60, that the Company intends to pursue or has developed. Based on the discussion presented below, audited financial statements for the Company for the period from inception through March 31, 2013, represent the best available financial information on the Company for the Registration Statement.

Information about Oculus Innovative Sciences, Inc.

Oculus is the parent company of the Company. Oculus is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries. Oculus is pioneering innovative products for the dermatology, surgical, advanced wound and tissue care, and animal healthcare markets. Oculus’ primary focus is on the commercialization of its proprietary technology platform called Microcyn® Technology but does not have the necessary regulatory approvals to market Microcyn® as a drug or as a medical device with an antimicrobial or wound healing indication in the United States. To date, Oculus’ Microcyn-based products have received seven FDA 510(k) clearances in the United States. Many of these clearances are for use as a medical device in wound cleaning, or debridement, lubricating, moistening and dressing, including traumatic, acute and chronic wounds. Oculus’ products are cleared and marketed as a topical medical device for patients suffering from open wounds and dermatological indications in the United States. Oculus’ products are developed based on its proprietary technology platform called Microcyn® Technology, a stable formulation of hypochlorous acid cleared for topical use in the U.S. In the United States, Microcyn® is cleared by the United States Food and Drug Administration (the “FDA”) as a medical device for the mechanical cleaning and debridement of wounds. Oculus’ advancement in invasive procedures has been hindered in the past by capital limitations and technological challenges to produce a product as required for a drug approval by the FDA. Based on the directive given by the board of directors of Oculus in November 2012, Oculus’ management began investigating the idea of creating a wholly-owned subsidiary within which to pursue the development of such a new drug.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

August 8, 2013

Page 5

Oculus does not have the necessary capital to execute the required clinical trials for the newly discovered RUT58-60 or the regulatory approvals to market such formulation as a drug or for invasive use in the United States, nor does Oculus have the clearance to market Microcyn® with any therapeutic indications to include antimicrobial or wound healing claims in the United States. Oculus has not developed a formulation approved by the FDA as a topical or an invasive drug. Furthermore, the use of hypochlorous acid (HOCl) based products for use as a drug or during invasive procedures shall require additional drug development activities as required by the FDA. The board of directors of Oculus has determined that the best course of action is to fund drug development activities through its wholly-owned subsidiary, the Company.

Information about the Company

The Company was incorporated in Nevada on January 18, 2013 as a wholly-owned subsidiary of Oculus. The Company’s offices are located in Santa Rosa, California. The Company is a development-stage biopharmaceutical company committed to the discovery, development, manufacture and commercialization of RUT58-60, a pure form of hypochlorous acid-based solution with two to four times the concentration of HOCl as Microcyn® based products manufactured by Oculus while expecting to meet the stringent drug requirements mandated by the FDA, including, but not limited to, sterility, stability, safety and efficacy. In contrast to Microcyn, the proposed drug candidate RUT58-60 contains stabilizers, including magnesium, and is intended for use during invasive procedures with direct exposure to internal tissue and organs. The proposed formulation development will be used for the prevention of infection associated with surgical and traumatic procedures.

The Company’s Principal Product Candidate: RUT58-60

On December 7, 2012, Oculus disclosed new, unique hypochlorous acid-based formulations to its intellectual property counsel. The formulations formed the basis for the current RUT58-60 formulation. The RUT58-60 drug was first formulated by the Company in January 2013. This unique new drug candidate, RUT58-60, utilizes a unique method of manufacturing that is different than what is used to manufacture Oculus’ products, and has a corresponding purified chemical active ingredient that is more concentrated than Oculus’ Microcyn® Technology containing other elements, such as magnesium, to meet FDA’s drug stability requirements. This formulation uses design elements that management believes will allow the product candidate to be evaluated and reviewed as a biopharmaceutical agent, as opposed to a medical device.

No direct or indirect product related costs were incurred by Oculus specifically relating to the new formulation, RUT58-60, prior to this time period.

Mintz, Levin

Show Raw Text
CORRESP
1
filename1.htm

        Linda Rockett | 617 348
        4888 | lrockett@mintz.com

        One Financial Center

        Boston, MA 02111

        617-542-6000

        617-542-2241 fax

        www.mintz.com

August 8, 2013

Via EDGAR and by Federal Express

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Mail Stop 3561

Washington, D.C. 20549

Attention: Jeffrey Riedler, Assistant Director

 Re: Ruthigen, Inc.

Confidential Draft Registration Statement on Form
S-1

Submitted May 24, 2013

CIK No. 0001574235

Ladies and Gentlemen:

We are submitting this letter on behalf
of Ruthigen, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of
the Securities and Exchange Commission (the “Commission”) received by letter dated June 21, 2013 (the “Comment
Letter”) from Jeffrey P. Riedler, Assistant Director, to Hojabr Alimi, the Company’s Chief Executive Officer, relating
to the above-referenced registration statement on Form S-1 of the Company submitted with the Commission on May 24, 2013 on a confidential
basis pursuant to Title 1, Section 106 of the Jumpstart Our Business Startups Act (the “Confidential Submission”).
In conjunction with this letter, the Company is making its initial public filing (the “Initial Public Filing”)
of such registration statement and making further amendments thereto (as amended, the “Registration Statement”).

For convenient reference, we have set forth
below in italics each of the Staff’s comments set forth in the Comment Letter and have keyed the Company’s responses
to the numbering of the comments and the headings used in the Comment Letter. All of the responses are based on information provided
to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. Where appropriate, the Company has responded
to the Staff’s comments by making changes to the disclosure in the Registration Statement as set forth in the Initial Public
Filing. Page numbers referred to in the responses reference the applicable pages of the Initial Public Filing.

We are providing by overnight delivery to
Daniel Greenspan of the Staff five courtesy copies of this letter and the Registration Statement that have been marked to show
changes from the initial filing of the Confidential Submission on May 24, 2013.

Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.

Boston
| London | Los Angeles | New York | San Diego | San Francisco | Stamford | Washington

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.

August 8, 2013

Page 2

General

 1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits.

Response: The Company respectfully submits
that it has included additional exhibits to the Initial Public Filing, and will submit or file additional exhibits to the Registration
Statement as soon as practicable. The Company acknowledges that the Staff may have further comments upon examination of such exhibits.

 2. We note that your draft registration statement includes the Representative’s warrants and the common stock underlying
those warrants as securities to be registered in this offering. Please be advised that the registration of the issuance of these
securities to the Representative, which are to be received by the Representative as underwriting compensation, does not entitle
the Representative to subsequently resell such securities to the public without additional registration. As an underwriter, the
Representative must avail itself of a resale registration statement or an applicable exemption from Section 5 of the Securities
Act of 1933 in order to sell the securities.

Response: The Company respectfully acknowledges
the Staff’s comment and has informed the Representative of the Staff’s comment.

 3. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus.
If you will use any additional graphic, visual or photographic information in the printed prospectus, please provide us a proof
of each such item for our review prior to its use. Please note that we may have comments regarding this material.

Response: The Company respectfully submits
that it does not anticipate using any graphic, visual or photographic information, other than such information already included
in the Registration Statement. The Company will supplementally provide the Staff with copies of any additional graphic, visual
or photographic information used in the printed prospectus. The Company acknowledges that the Staff may have further comments upon
examination of such additional material.

 4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups
Act, please state your election under Section 107(b) of the JOBS Act:

 · If you have elected to opt out of the extended transition period for complying with new or revised accounting standards
pursuant to Section 107(b), include a statement that the election is irrevocable; or

 · If you have elected to use the extended transition period for complying with new or revised accounting standards under Section
102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards
that have different effective dates for public and private companies until those standards apply to private companies. Please state
in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply
with public company effective dates. Include a similar statement in your critical accounting policy disclosures.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.

August 8, 2013

Page 3

In addition, please describe the extent to which
any of the exemptions available to emerging growth companies are also available to you as a Smaller Reporting Company.

Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 5-6, 29 and 38 of the Initial Public Filing.

 5. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities
Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research
reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section
105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering.

Response: As of the date of this response letter,
the Company has not relied upon the procedures available to emerging growth companies under Section 5(d) of the Securities Act
of 1933, as amended (the “Securities Act”). The Company will furnish any such material to the Staff in connection
with future correspondence, if the Company relies upon such section to provide material to qualified institutional buyers or institutional
accredited investors.

To date, no research reports about the Company have
been published or distributed in reliance on Section 2(a)(3) of the Securities Act by any broker or dealer that is participating
or will participate in the offering. The Company will supplementally provide the Staff with any such research reports should any
be published or distributed in reliance on Section 2(a)(3) of the Securities Act.

 6. Please tell us what consideration you gave to presenting the historical results of the novel biotechnology business of Oculus
Innovative Sciences, Inc. in separate financial statements (i.e., carve-out financial statements) prior to your inception. It would
appear that presenting carve-out financial statements to include all relevant activities that have been part of the history of
your business, and that can be expected to repeat as the business continues in the future, is required. Separately reference for
us any authoritative literature you rely upon to support your position.

Response: The Company respectfully submits
the following response to the Staff:

We note the Staff’s observations relating to
the presentation of historical results of the novel biotechnology business of the Company’s parent, Oculus Innovative Sciences,
Inc. (“Oculus”), in separate financial statements (i.e., carve-out financial statements (SEC SAB Topic
1B.1)) prior to the Company’s inception. As described below, following the disclosure of RUT58-60 to Oculus’ intellectual
property counsel in December 2012, Oculus formed a wholly-owned subsidiary named Ruthigen, Inc., or the Company. In January 2013,
the Company was incorporated in the State of Nevada. Financial statements have been prepared for the Company reflecting all activities
of the business since formation. No direct or indirect product related costs were incurred by Oculus specifically relating to the
new formulation, RUT58-60, prior to this time period.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.

August 8, 2013

Page 4

Such audited financial statements as of and for the
period ended March 31, 2013 have been included in the Registration Statement. No carve out financial statements for the period
prior to January 2013 are necessary since all direct or indirect product related costs incurred specifically relating to the new
formulation, RUT58-60, are already included within the historical financial statements of the Company for the period ended March
31, 2013.

The Company, a wholly-owned subsidiary of Oculus,
has submitted the Registration Statement to register shares being sold in a proposed initial
public offering of the Company. In connection with the filing of the Registration Statement, the Company is required to include
audited historical financial statements reflecting the operating activities of the Company. The Company
has executed a license and supply agreement with Oculus pursuant to which the Company will license from Oculus certain of
Oculus’ proprietary technology related to the use of hypochlorous acid for specific indications and territories as defined
in the license and supply agreement between the companies, effective upon the completion of the
proposed initial public offering.

The Company also executed a separation agreement with
Oculus to allow the Company to access the capital market and fund the development of the newly discovered RUT58-60 as a drug for
prevention of infection in abdominal surgery. This market is currently not available to Oculus and its technology due to both technological
and regulatory limitations.

Therefore, prior
to 2013, Oculus has not incurred any direct or indirect product costs with respect to the product candidate, RUT58-60, that the
Company intends to pursue or has developed. Based on the discussion presented below, audited
financial statements for the Company for the period from inception through March 31, 2013, represent the best available financial
information on the Company for the Registration Statement.

Information about Oculus
Innovative Sciences, Inc.

Oculus is the parent company of the Company. Oculus
is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries.
Oculus is pioneering innovative products for the dermatology, surgical, advanced wound and tissue care,
and animal healthcare markets. Oculus’ primary focus is on the commercialization of its proprietary technology platform called
Microcyn® Technology but does not have the necessary regulatory approvals to market Microcyn® as a drug or as a medical
device with an antimicrobial or wound healing indication in the United States. To date, Oculus’
Microcyn-based products have received seven FDA 510(k) clearances in the United States. Many of these clearances are for use as
a medical device in wound cleaning, or debridement, lubricating, moistening and dressing, including traumatic, acute and chronic
wounds. Oculus’ products are cleared and marketed as a topical medical device for
patients suffering from open wounds and dermatological
indications in the United States. Oculus’ products are developed based on its proprietary
technology platform called Microcyn® Technology, a stable formulation of hypochlorous acid
cleared for topical use in the U.S. In the United States, Microcyn® is cleared by the United States Food and Drug Administration
(the “FDA”) as a medical device for the mechanical cleaning and debridement of wounds. Oculus’
advancement in invasive procedures has been hindered in the past by capital limitations and technological challenges to produce
a product as required for a drug approval by the FDA. Based on the directive given by the board of directors of Oculus in November
2012, Oculus’ management began investigating the idea of creating a wholly-owned subsidiary within which to pursue the development
of such a new drug.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.

August 8, 2013

Page 5

Oculus does not have the necessary
capital to execute the required clinical trials for the newly discovered RUT58-60 or the regulatory approvals to
market such formulation as a drug or for invasive use in the United States, nor does Oculus have the clearance to market
Microcyn® with any therapeutic indications to include antimicrobial or wound healing claims
in the United States. Oculus has not developed a formulation approved by the FDA as a topical or an
invasive drug. Furthermore, the use of hypochlorous acid (HOCl) based products for use as a drug or during invasive procedures
shall require additional drug development activities as required by the FDA. The board of directors of Oculus has determined that
the best course of action is to fund drug development activities through its wholly-owned subsidiary, the Company.

Information about the Company

The Company was incorporated in Nevada on January
18, 2013 as a wholly-owned subsidiary of Oculus. The Company’s offices are located in Santa Rosa, California. The Company
is a development-stage biopharmaceutical company committed to the discovery, development, manufacture and commercialization of
RUT58-60, a pure form of hypochlorous acid-based solution with two to four times the concentration of HOCl as Microcyn® based
products manufactured by Oculus while expecting to meet the stringent drug requirements mandated by
the FDA, including, but not limited to, sterility, stability, safety and efficacy. In contrast
to Microcyn, the proposed drug candidate RUT58-60 contains stabilizers, including magnesium, and is intended for use during
invasive procedures with direct exposure to internal tissue and organs.
The proposed formulation development will be used for the prevention of infection associated with surgical and traumatic procedures.

The Company’s Principal
Product Candidate: RUT58-60

On
December 7, 2012, Oculus disclosed new, unique hypochlorous acid-based formulations to its intellectual property counsel. The formulations
formed the basis for the current RUT58-60 formulation. The RUT58-60 drug was first formulated by the Company in January
2013. This unique new drug candidate, RUT58-60, utilizes a unique method of manufacturing that is different
than what is used to manufacture Oculus’ products, and has a corresponding purified chemical active ingredient that
is more concentrated than Oculus’ Microcyn® Technology containing other elements, such as magnesium, to meet FDA’s
drug stability requirements. This formulation uses design elements that management believes will allow the product candidate to
be evaluated and reviewed as a biopharmaceutical agent, as opposed to a medical device.

No direct or indirect product related costs were incurred
by Oculus specifically relating to the new formulation, RUT58-60, prior to this time period.

Mintz, Levin