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SEC Comment Letter for Pulmatrix, Inc. (PULM) (CIK 0001574235) (PULM) — Jun 24, 2013

Pulmatrix, Inc. (PULM) (CIK 0001574235)
Date: June 24, 2013 · CIK: 0001574235 · Accession: 0000000000-13-034214

AI Filing Summary & Sentiment

Date
May 24, 2013
Author
Not clearly detected
Form
UPLOAD
Company
Pulmatrix, Inc. (PULM) (CIK 0001574235)

Letter

June 21 , 2013 Via E -Mail Hojabr Alimi Chief Executive Officer Ruthigen, Inc. 2455 Bennett Valley Road, Suite C116 Santa Rosa, CA

Re: Ruthigen, Inc. Confidential Draft Registration Statement on Form S -1 Submitted May 24, 2013 CIK No. 0001574235

Dear Mr. Alimi :

We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure.

Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in re sponse to these comments and your amended draft registration statement or filed registration statement, we may have additional comments.

General

1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these 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 wit hout 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 Ac t of 1933 in order to sell the securities.

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 2

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 inf ormation 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.

4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please s tate 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), inclu de 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 fin ancial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures.

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

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 s o 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 .

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) pri or 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 req uired. Separately reference for us any authoritative literature you rely upon to support your position.

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 3

7. It appears that you are required to disclose unaudited pro forma financial information in accordance with Article 11 of Regulation S -X to reflect the effect of the transactions that have been or will be completed prior to or concurrently with the closing o f your offering on your historical financial statements and to combine any carve -out financial statements of your predecessor operations. In your next amendment please include unaudited pro forma financial information to give effect to your offering, to p resent the continuing impact of the series of transactions that will take effect upon the completion of your offering and to combine your predecessor carve -out financial information or tell us why including such pro forma financial information is considere d not required.

Prospectus Summary, page 2

8. Please expand the opening paragraph of your Prospectus Summary under “Overview” to make clear that you are a development company with no approved product s and, immediately prior to the offering, have been a wholly -owned subsidiary of Oculus that was formed in January 2013.

9. We note your statement on page 2 , and beginn ing on page 43 in the “Business” section, that you believe RUT58 -60 will be able to meet the safety and efficacy standards that the FDA require s for the approval of a new dru g. Please expand this disclosure to make clear that the process to obtain FDA approval can be unpredictable and can take several years, and that you cannot guarantee that your product candidate will ever obtain such approval.

10. We note your statements on page 3 , and on page 44 in the “Business” section, regarding the safety, tolerability and broad -range antimicrobial poten cy of RUT58 -06, and that it does not appear to promote resistance to bacteria. Please expand your disclosure to make clear that conclusions are based on preclinical trials only.

11. We note your statement on page 3 regarding your discussions with pharmaceuti cal companies regarding partnership and collaboration activities. Please expand this disclosure to make clear, if true, that you have no such arrangements in place and that you cannot guarantee that you will be able to secure any such arrangement.

Risks Relating to Our Business, page 5

12. Please combine the first and fifth bullet points , as they appear to be redundant.

13. Please expand your summary of risk factor s in this section to include the risks relating to:

 Oculus’s control of a significant portion of your outstanding common stock after the transaction;  The potential conflict (s) of interest given that your directors will serve simultaneously as directors o f Oculus and that your chief executive officer and directors hold Oculus common stock and rights to purchase Oculus common stock ;

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 4

 the risks you will face as a standalone public company that you did not face as a wholly owned subsidiary of Oculus; and  the anticipated benefits of the Separation and the Distribution that you and/or your stockholders may not achieve.

“We are a development stage company with no commercial products.” page 9 “We are heavily dependent on the success of our lead drug candidate…” page 9 “We have limited knowledge and experience with NDA studies…” page 11

14. Please expand each of these risk factor s to disclose that you have not yet submitted an IND to the FDA in order to begin clinical trials for RUT58 -60.

“We may be unable to maintain sufficient product liability insurance.” page 13

15. Please d escribe briefly the circumstances under which you may need to obtain additional coverage under the supply agreement and, when you enter into independent insurance plan, please quantify your insurance coverage .

“We may not be able to attract, retain, or manage highly qualified personnel…” page 15

16. Please expand this risk factor to identify any key employees other than your two executive officers.

“We expect to face competition, often from companies with greater resources…” page 1 9

17. Please expand this risk factor to identify your anticipated competitors.

“We expect that we may need additional funding to advance our clinical trial…” page 21

18. Please revise this risk factor to disclose the quarter through which you believe your available fu nds following the offering will be sufficient to fund your operations . We no te the disclosure in your Use of Proceeds on page 33 that you intend to use the net proceeds from the offering, in part, to initiate your first pivotal trial, yet on page 21 you state that such funds will not be sufficient to conduct your pivotal trials. Please clarify this apparent discrepancy.

“Your investment in our common stock may be adversely affected if Oculus…” page 25

19. Please combine this risk factor with the risk factor captioned “The Distribution may not occur” on page 27, as they appear to describe the same risk(s).

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 5

“Oculus may not distribute our shares it holds to its stockholders…” page 26

20. Please combine this risk factor with the risk factor captioned “We may be unable to achieve some or all of the benefits…” on page 27, as they appear to describe the same risk(s).

“The assets and reso urces that we acquire from Oculus…” page 27

21. Please expand this risk factor to disclose any material assets or resources , other than those which you will receive from Oculus in the Separation, that you have identified that you will need to operate as a st and-alone company .

“Financi al reporting obligations of being a public company…” page 30

22. Please combine this risk factor with the risk factor captioned “Our management will be required to devote…” on page 30, as they appear to describe the same risk(s).

Industry and Market Data , page 32

23. Please note that it is not appropriate to state or imply that you do not have liability for the statements in your registration statement. Your statements that you have not independently verified third part data and that the results and estimates fr om your internal research have not been verified by any independent source could imply th at you are not taking liability for this information. In order to eliminate any inference that you are not liable for all of the information in your registration stat ement, please delete these statements or include a statement s pecifically accepting liability for these statements.

Use of Pr oceeds , page 33

24. Please expand your disclosure regarding your u se of proceeds to provide the estimated amount of proceeds to be used for each of

 the planned Phase 1/2 clinical trial;  initiation of the first pivotal trial;  the establishment and validation of your manufacturing facility; and  the milestone payments und er your license and supply agreement.

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 6

Management’s Discussion and Analysis of Financial Condition and Results of Operations JOBS Act, page 39

25. Although you mention the extended transition period provided in Securities Act Sect ion 7(a)(2)(B) for complying with new or revised accounting standards, it is unclear whether you are opting out of this provision. Please revise your disclosure to clarify. To the extent you wish to follow the extended transition period permitted under t he Securities Act, please revise your disclosure here and in a risk factor to highlight that in the future your financial statements may not be comparable to those of other public companies. To the extent you opt out of the extended transition period, ple ase revise your disclosure to indicate that this election is irrevocable. Please see Questions 13 and 37 of the Jumpstart Our Business Startups Act Frequently Asked Questions.

Research and Development, page 40

26. We noted a statement made during Oculus Inn ovative Sciences’ third quarter 2013 earnings call that your parent’s plan is to shift the burden of its high -expense RUT58 -60 drug development program to Ruthigen. Please include disclosure about the estimated future expenses related to the development of RUT58 -60. To the extent that this information is not estimable, disclose that fact an d the reason why it is not estimable . To the extent that at least some portion of future development expenses was estimated to support the size of your offering in di scussions with your underwriters, please disclose those estimates clarifying which specific future expenses are included in your disclosure. Please note that you may inform potential investors that the amounts you disclose are estimates and that those est imates are subject to revision and the reasons therefor.

Liquidity and Capital Resources, page 40

27. Please include a discussion of the cash advances and direct payments made by your parent subsequent to March 31, 2013 as applicable.

Contractual Obligations, page 41

28. Please include a discussion that quantifies the potential milestone payments to Oculus that have been omitted from a contractual obligations table and disclose the events that would trigger these payments. Please confirm to us that a ll of your payment obligations under your collaboration agreements with Oculus and / or with other parties have been disclosed in this section as appropriate.

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 7

Operating Capital and Capital Expenditure requirements, page 41

29. Although you disclose on page 67 that you have no equity awards outstanding at March 31, 2013, please include an itemized chronological schedule covering any equity instruments that have been or will be issued prior to or concurrently with the closing of your offering (including stock units, options, warrants, etc.) and include the following information separately for each equity instrument issuance:

 The date of the transaction;  The number of equity instruments issued or options granted;  The exercise price of equity instruments grante d if applicable;  The fair value of the common stock on each grate date and how the fair value was determined;  Whether or not the valuation used to determine the fair value of the equity instruments was contemporaneous or retrospective ; and,  If the valuat ion specialist was a related party, please state that fact .

After your estimated IPO price range has been disclosed, d iscuss each significant factor contributing to the difference between the fair value as of the date of each date of issuance and the esti mated IPO price . Please continue to update your disclosures for any grants or equity issuances up until the time of effectiveness of your registration statement. Please note that once your filing include s an estimated offering price we may have further comments.

Business , page 43 Select Pathoge n Activity of RUT58 -60, page 49

30. This section contains several technical or other terms that are not defined or explained. Please explain the meaning and significance of the following terms the first time you use them:  Biocompatibility ;  Logs and log reduc tion;  Full biological activity ; and  Serial dilutions

Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 8

Market Opportunity, page 51

31.

Show Raw Text
June 21 , 2013

Via E -Mail
Hojabr Alimi
Chief Executive Officer
Ruthigen, Inc.
2455 Bennett Valley Road, Suite C116
Santa Rosa, CA

Re: Ruthigen, Inc.
Confidential Draft Registration Statement on Form S -1
Submitted May 24, 2013
  CIK No. 0001574235

Dear Mr. Alimi :

We have reviewed your draft registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or  publicly  filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in re sponse to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.

General

1. Please submit all exhibits as soon as practicable. We may have further comments  upon
examination of these 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 wit hout 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 Ac t of 1933 in order to sell the securities.

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 2

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 inf ormation 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.

4. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please s tate 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), inclu de 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 fin ancial statements may not be comparable to companies
that comply with public company effective dates.  Include a similar statement in your
critical accounting policy disclosures.

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

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 s o 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 .

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) pri or 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 req uired.  Separately reference for us any authoritative
literature you rely upon to support your position.

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 3

 7. It appears that you are required to disclose unaudited pro forma financial information in
accordance with Article 11 of Regulation S -X to reflect the effect of the transactions that
have been or will be completed prior to or concurrently with the closing o f your offering
on your historical financial statements and to combine any carve -out financial statements
of your predecessor operations.  In your next amendment please include unaudited pro
forma financial information to give effect to your offering, to p resent the continuing
impact of the series of transactions that will take effect upon the completion of your
offering and to combine your predecessor carve -out financial information or tell us why
including such pro forma financial information is considere d not required.

Prospectus Summary, page 2

8. Please expand the opening paragraph of your Prospectus Summary under “Overview” to
make clear that you are a development company with no approved product s and,
immediately prior to the offering, have been a wholly -owned subsidiary of Oculus that
was formed in January 2013.

9. We note your statement on page 2 , and beginn ing on page 43 in the “Business” section,
that you believe RUT58 -60 will be able to meet the safety and efficacy standards that the
FDA require s for the approval of a new dru g.  Please expand this disclosure to make clear
that the process to obtain FDA  approval can be unpredictable and can take several years,
and that you cannot guarantee that your product candidate will ever obtain such approval.

10. We note your statements on page 3 , and on page 44 in the “Business” section,  regarding
the safety, tolerability and broad -range antimicrobial poten cy of RUT58 -06, and that it
does not appear to promote resistance to bacteria.  Please expand your disclosure to make
clear that conclusions are based on preclinical trials only.

11. We note your statement on page 3 regarding your discussions with pharmaceuti cal
companies regarding partnership and collaboration activities.  Please expand this
disclosure to make clear, if true, that you have no such arrangements in place and that
you cannot guarantee that you will be able to secure any such arrangement.

Risks Relating to Our Business, page 5

12. Please combine the first and fifth bullet points , as they  appear to be redundant.

13. Please expand your summary of risk factor s in this section to include the risks relating to:

 Oculus’s control of a significant portion of your outstanding common stock after the
transaction;
 The potential conflict (s) of interest given that your directors will serve simultaneously
as directors o f Oculus  and that your chief executive officer and directors hold Oculus
common stock and rights to purchase Oculus common stock ;

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 4

  the risks you will face as a standalone public company that you did not face as a
wholly owned subsidiary of Oculus; and
 the anticipated benefits of the Separation and the Distribution that you and/or your
stockholders may not achieve.

“We are a development stage company with no commercial products.”  page 9
“We are heavily dependent on the success of our lead drug candidate…”  page 9
“We have limited knowledge and experience with NDA studies…” page 11

14. Please expand each of  these  risk factor s to disclose that you have not yet submitted an
IND to the FDA in order to begin clinical trials for RUT58 -60.

“We may be unable to maintain sufficient product liability insurance.” page 13

15. Please d escribe briefly the circumstances under which you may need to obtain additional
coverage under the supply agreement  and, when you enter into independent insurance
plan,  please quantify your insurance coverage .

“We may not be able to attract, retain, or manage  highly qualified personnel…” page 15

16. Please expand this risk factor to identify any key employees other than your two
executive officers.

“We expect to face competition, often from companies with greater resources…” page 1 9

17. Please expand this risk factor to identify your anticipated competitors.

“We expect that we may need additional funding to advance our clinical trial…” page 21

18. Please revise this risk factor to disclose the quarter through which you believe your
available fu nds following the offering  will be sufficient to fund your operations .  We no te
the disclosure in your Use of Proceeds on page 33 that you intend to use the net proceeds
from the offering, in part, to initiate your first pivotal trial, yet on page 21 you state that
such funds will not be sufficient to conduct your pivotal trials.  Please clarify this
apparent discrepancy.

“Your investment in our common stock may be adversely affected if Oculus…” page 25

19. Please combine this risk factor with the risk factor captioned “The Distribution may not
occur” on page 27, as they appear to describe the same risk(s).

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 5

 “Oculus may not distribute our shares it holds to its stockholders…” page 26

20. Please combine this risk factor with the risk factor captioned “We may be unable to
achieve some or all of the benefits…” on page 27, as they appear to describe the same
risk(s).

“The assets and reso urces that we acquire from Oculus…” page 27

21. Please expand this risk factor to disclose any material assets or resources , other than
those which you will receive from Oculus in the Separation,  that you have identified that
you will need to operate as a st and-alone company .

“Financi al reporting obligations of being a public company…” page 30

22. Please combine  this risk factor with the risk factor captioned “Our management will be
required to devote…” on page 30, as they appear to describe the same risk(s).

Industry and Market Data , page 32

23. Please note that it is not appropriate to state or imply that you do not have liability for the
statements in your registration statement. Your statements that you have not
independently verified third part data and that the results and estimates fr om your internal
research have not been verified by any independent source  could imply th at you are not
taking liability for this information.  In order to eliminate any inference that you are not
liable for all of the information in your registration stat ement, please delete these
statements or include a statement s pecifically accepting liability for these statements.

Use of Pr oceeds , page 33

24. Please expand your disclosure regarding your u se of proceeds to provide the estimated
amount of proceeds to be used for each of

 the planned Phase 1/2 clinical trial;
 initiation of  the first pivotal trial;
 the establishment and validation of your manufacturing facility; and
 the milestone payments und er your license and supply agreement.

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 6

 Management’s Discussion and Analysis of Financial Condition and Results of Operations
JOBS Act, page 39

25. Although you mention the extended transition period provided in Securities Act Sect ion
7(a)(2)(B) for complying with new or revised accounting standards, it is unclear whether
you are opting out of this provision.  Please revise your disclosure to clarify.  To the
extent you wish to follow the extended transition period permitted under t he Securities
Act, please revise your disclosure here and in a risk factor to highlight that in the future
your financial statements may not be comparable to those of other public companies.  To
the extent you opt out of the extended transition period, ple ase revise your disclosure to
indicate that this election is irrevocable.  Please see Questions 13 and 37 of the Jumpstart
Our Business Startups Act Frequently Asked Questions.

Research and Development, page 40

26. We noted a statement made during Oculus Inn ovative Sciences’ third quarter 2013
earnings call that your parent’s plan is to shift the burden of its high -expense RUT58 -60
drug development program to Ruthigen.  Please include disclosure about the estimated
future expenses related to the development of RUT58 -60.  To the extent that this
information is not estimable, disclose that fact an d the reason why it is not estimable .  To
the extent that at least some portion of future development expenses was estimated to
support the size of your offering in di scussions with your underwriters, please disclose
those estimates clarifying which specific future expenses are included in your disclosure.
Please note that you may inform potential investors that the amounts you disclose are
estimates and that those est imates are subject to revision and the reasons therefor.

Liquidity and Capital Resources, page 40

27. Please include a discussion of the cash advances and direct payments made by your
parent subsequent to March 31, 2013 as applicable.

Contractual Obligations, page 41

28. Please include a discussion that quantifies the potential milestone payments to Oculus
that have been omitted from a contractual obligations table and disclose the events that
would trigger these payments.  Please confirm to us that a ll of your payment obligations
under your collaboration agreements with Oculus and / or with other parties have been
disclosed in this section as appropriate.

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 7

Operating Capital and Capital Expenditure requirements, page 41

29. Although you disclose on page  67 that you have no equity awards outstanding at March
31, 2013, please include an itemized chronological schedule covering any equity
instruments that have been or will be issued prior to or concurrently with the closing of
your offering  (including stock  units, options, warrants, etc.) and include the following
information separately for each equity instrument issuance:

 The date of the transaction;
 The number of equity instruments issued or options granted;
 The exercise price of equity instruments grante d if applicable;
 The fair value of the common stock on each grate date and how the fair value was
determined;
 Whether or not the valuation used to determine the fair value of the equity
instruments was contemporaneous or retrospective ; and,
 If the valuat ion specialist was a related party, please state that fact .

After your estimated IPO price range has been disclosed, d iscuss each significant factor
contributing to the difference between the fair value as of the date of each date of
issuance and the esti mated IPO price .   Please continue to update your disclosures for any
grants or equity issuances up until the time of effectiveness of your registration statement.
Please note that once your filing include s an estimated offering price we may have further
comments.

Business , page 43
Select Pathoge n Activity of RUT58 -60, page 49

30. This section contains several technical or other terms that are not defined or explained.
Please explain the meaning and significance of  the following terms the first time you use
them:
 Biocompatibility ;
 Logs  and log reduc tion;
 Full biological activity ; and
 Serial dilutions

Hojabr Alimi
Ruthigen, Inc.
June 2 1, 2013
Page 8

 Market Opportunity, page 51

31.