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SEC Comment Letter for Akari Therapeutics Plc (AKTX) (CIK 0001541157) (AKTX) — Jul 25, 2012

Akari Therapeutics Plc (AKTX) (CIK 0001541157)
Date: July 25, 2012 · CIK: 0001541157 · Accession: 0000000000-12-039651

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
June 28, 2012
Author
President
Form
UPLOAD
Company
Akari Therapeutics Plc (AKTX) (CIK 0001541157)

Letter

July 2 5, 2012 Via E -mail Dr. Yuval Cohen President Morria Biopharmaceuticals PLC 53 Davies Street London W1K 5JH United Kingdom

Re: Morria Biopharmaceuticals PLC Registration Statement on Form 20 -FR12G Filed June 28, 2012 File No. 000 -54749

Dear Dr. Cohen :

We have reviewed your filing 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 within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. 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 any amendment to your filing and the information you provide in response to these comments, we may have additional comments.

General

1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law on August 27, 2012 at which time you will be required to begin filing all of the reports mandated by Section 12(g) of the Securities Exch ange Act of 1934. If the review process has not been completed before that date you should consider withdrawing the registration statement prior to August 27, 2012 to prevent it from becoming effective and refiling it at such time as you are able to respo nd to any remaining issues or comments.

2. Please be advised that your registration statement is concurrently being reviewed by the Office of International Corporate Finance. You will receive comments generated by that Office, if any, at a later date.

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 2

3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that you are an emerging growth company, and revise your prospectus to:

 Describe how and when a company may lose emerging growth company status;

 Briefly describe the exemption from Section 404(b) of the Sarbanes -Oxley Act of 2002 and update your risk factor on page 33 for this exemption ; and

 State your election under Section 107(b) of the JOBS Act:

o 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

o If you have elected to use the extended tran sition 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 fo r 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 da tes. Include a similar statement in your critical accounting policy disclosures.

Item 3. Key Information

A. Selected Financial Data, page 4

4. The identification of some columns of selected financial data as “unaudited” may give a n investor the impressio n that the other columns have been audited. We believe your disclosure in the introductory paragraphs of this section is sufficient to highlight to investors which selected financial data have been derived from audited or unaudited financial statements. Please revise your disclosure to remove any label identifying a column as unaudited.

D. Risk Factors , page 5

5. Please expand your disclosure in this section to add a risk factor that addresses the risks resulting from the fact that the report of your indep endent registered public accounting firm on your financial statements states that your recurring operating losses, negative cash flows and dependence on additional financial support raise substantial doubt about your ability to continue as a going concern. Please include in this risk factor the fact that the auditor’s going concern opinion may have a detrimental effect on your ability to obtain additional funding.

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 3

“We anticipate that we will incur losses for the foreseeable future and we may never achiev e or sustain profitability,” page 6

6. Please state in this risk factor that your total accumulated deficit as of the end of 2011 was $12,621,000.

“We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product candidates,” page 6

7. Please expand your risk factor to

 include an estimate of your operating expenses, including your research and development costs, for fiscal year 2012 ;

 disclose the amount of your existing cash and investment securities;

 disclose the amount of all compensation that you anticipate deferring; and

 disclose the material elements of your current contemplated plan for your fiscal year ended December 31, 2012.

“If we default on our convertible notes, we may lose all of our assets and intellectual property,” page 8

8. Please expand this risk factor to disclose

 the list of events of default as defined in your Securities Purchase Agreement dated April 3, 2012; and

 that yo u are required to repay your convertible notes by January 4, 2013 , the aggregate amount that you expect to be due as of that date, and that you do not currently have sufficient cash available to repay them .

“Our product candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval…” page 10

9. Please expand this risk factor to disclose when you intend to file your IND application for your two product candi dates in clinical trials.

“We have not conducted any absorption, distribution, metabolism and excretion (ADME) studies with respect to our clinical and pre -clinical product candidates,” page 15

10. In this risk factor, please include the reason you have yet to perform ADME studies and whether or not you intend to conduct such studies in the future.

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 4

“If our competitors are better able to develop and market products than any products that we and/or an y potential future collaborators may develop . . .,” page 21

11. Please include in this risk factor the names of the companies that you believe will be your principal competitors and those products that you believe will compete with yours at such time as your s enter the marketplace.

“We depend on third -party suppliers for key raw materials used in our manufacturing processes . . .,” page 22

12. Please include in this risk factor the names of the third -party suppliers you are dependent upon.

“Use of third -party manufacturers may increase the risk that we will not have adequate supplies of our product candidates or products .” page 24

13. You disclose that your present or future manufacturing partners may not be able to comply with FDA -mandated current Good Man ufacturing Practice regulations or other FDA regulatory requirements . To the extent you are aware that one or more of your current manufacturing partners do not comply with FDA -mandated current Good Manufacturing Practice regulations or other FDA regulatory r equirements , please disclose this fact as well as the names of each manufacturing partner that does not comply.

“We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily . . .,” page 25

14. Please incl ude in this risk factor the names of the material contract research organizations that have performed your clinical trials to date.

“If we do not establish strategic collaborations, we may have to alter our development plans,” page 25

15. This risk factor i s substantially similar to the second one on page 22. Please merge them into a single risk factor in order to avoid repetition in your disclosure.

“We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies . . .,” page 33

16. Please estimate the costs you will incur as a result of complying with public company laws and regulations over the next fiscal year and on an annual basis thereafter.

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 5

Item 4. Information on the Company

A. History and Development of the Company

April 2012 Private Placement of Senior Secured Convertible Notes and Warrants, page 38

17. In your “Description of Notes” on page 40 please provide the definition of “material adverse event” in your Securities Purchase Agreement.

18. In your description of the Registration Rights Agreement on page 40, please disclose the actual date rather than re ferring to the “Self Filing Effective Date” and describe the payments you will be required to make to your investors if this registration statement is not filed and/or declared effective on a timely basis.

B. Business Overview

Product Candidates, page 41

19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and your Overview on page 68, that the clinical trials your two major product candidates have undergone were performed in Israel and South Africa, and not in the Unit ed States.

20. Please state here and wherever else applicable in your registration statement whether or not you believe your clinical trials have complied with the rules for such trials set forth by the FDA. If they have not, please specify how your clinica l trials have differed from those rules.

Steroids and Currently Available Alternatives, page 42

21. In your table on page 44, please indicate in the row describing your product candidates that your studies to date have not advanced beyond Phase 2 .

Scientific Background to Inflammation and Our Product Candidates, page 45

22. In this discussion, please address whether the research performed by your principal shareholder into the field of lipid conjugates has produced conclusive evidence into their anti-inflammatory properties. If there is any controversy in the greater scientific community as to this assertion, you should note this here and discuss any possible ramifications, particularly how this uncertainty could impact the development of your product c andidates. If appropriate, you should amend your disclosure wherever you discuss this research and its implications, including the risk factor on pages 10 -11.

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 6

Research and Development, page 45

23. Please include in this discussion the amounts you have s pent on R&D over the last three fiscal years as well as an estimate of your R&D expenses for fiscal year 2012.

24. We note that you disclose the focus of your development plan for fiscal 2012, provided that you raise additional capital. Given your disclosur e on page 6 that you believe that your existing cash and investment securities will be sufficient to support your current contemplated operating plan until December 31, 2012 , please expand your disclosure to disclose the focus of your development plan for fiscal 2012 if you do not raise additional capital.

Development of our Clinical Pipeline for our Product Candidates, page 49

25. For each of the trials discussed, please disclose any side effects observed with your product candidates and, where available, p lease disclose whether the results are statistically significant and provide all p -values that you have available.

Intellectual Property, page 52

26. Please indicate the product candidates to which each of your material U.S. and non -U.S. patents relate.

Manufacturing, Marketing and Sales of our Drugs, page 55

27. Please disclose the names of your third -party manufacturer(s) here and in the risk factor on page 23. Please also disclose here the material terms of your contractual relationships with them, if any. If you are substantially dependent on an agreement with a third -party for the manufacture of your product candidates, please file this agreement as an exhibit to your registration statement. Alternatively, please provide us with an analysis that supports your determination that you are not substantially depen dent on an agreement with a third -party manufacturer.

Item 5. Operating and Financial Review and Prospects

Stock -based Compensation and Fair Value of Ordinary Shares, page 70

28. With respect to your common stock valuation s, please expand your disclosures to provide the following information relating to your issuances of equity instruments during the past three fiscal years :

 A discussion of the significant objective and subjective factors, assumptions, and methodologies used in determining fair value of the shares underlying the options, warrants and deferred shares issued;

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 7

 Include in your discussion how management determined fair value based on the share price used in equity financing rounds; and

 Identify the recent equity transactions used to determine fair value.

C. Research and Development, Patents and Licenses, etc., page 74

29. Please provide disclosure to quantify the amount of costs, both internal and external, incurred during each period presented and incurred to date on each of your major research and development projects. Please reconcile these amounts to the research and development expense reported on your st atements of operations. To the extent that you cannot attribute costs to a project, please explain why management does not maintain and evaluate those costs by project.

F. Tabular Disclosure of Contractual Obligations, page 75

30. Please expand your disclo sure to include the obligation to pay Yissum $70,000 per year, described in Note 7 to the financial statements, in the table. Also, expand your disclosure here to discuss all future potential royalties, milestones and other fees reasonably likely to be pa id relating to this agreement.

Item 6. Directors, Senior Management and Employees

B. Compensation

Other Director Compensation, page 82

31. Please file copies of the agreements you disclose in this section and your agreements with Prof. Saul Yedgar and Dr. Joseph Bondi that you disclose in the section below. See 4(b)(i) and (ii) of the Instructions as to Exhibits.

Item 7. Major Shareholders and Related Party Transactions

B. Related Party Transactions

32. We note that you state “See also “Material C ontracts.” Please expand your disclosure to provide a brief summary of the related party transactions referenced later in the filing. [

Dr. Yuval Cohen Morria Biopharmaceuticals PLC July 2 5, 2012 Page 8

Item 9. The Offer and Listing

C. Markets, page 91

33. You state elsewhere in your registration statement that you intend to apply to list your common shares on the NYSE Amex. You should therefore include this information in this section, pursuant to Form 20 -F.

Item 10. Additional Information A. Share Capital, page 91

34. In your description of your outstanding convertible notes, you refer to them as “debentures.” As the term debenture typically refers to unsecured debt, and these notes are secured by your assets, it is not appropriate to use this term to describe the notes . Please amend your disclosure accordingly.

C. Material Contracts, page 102

35. It does not appear that your sub -license agreement dated February 1, 2005, or your amendment dated April 4, 2012, have been filed as exhibits to your registration statement. Pl ease file these contracts, as they are material to your operations.

Item 19. Exhibits, page 126

36. Please file complete and executed copies of the agreemen

Show Raw Text
July 2 5, 2012

Via E -mail
Dr. Yuval Cohen
President
Morria Biopharmaceuticals PLC
53 Davies Street
London W1K 5JH
United Kingdom

Re: Morria Biopharmaceuticals PLC
Registration Statement on Form 20 -FR12G
Filed June 28, 2012
  File No. 000 -54749

Dear Dr. Cohen :

We have reviewed your filing 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 within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provide the requested
response.  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 any amendment to your filing and the information you provide in
response to these comments, we may have additional comments.

General

1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will
become effective by operation of law on August 27, 2012 at which time you will be
required to begin filing all of the reports mandated by Section 12(g) of the Securities
Exch ange Act of 1934.  If the review process has not been completed before that date you
should consider withdrawing the registration statement prior to August 27, 2012  to
prevent it from becoming effective and refiling it at such time as you are able to respo nd
to any remaining issues or comments.

2. Please be advised that your registration statement is concurrently being reviewed by the
Office of International Corporate Finance. You will receive comments generated by that
Office, if any, at a later date.

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 2

 3. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that
you are an emerging growth company, and revise your prospectus to:

 Describe how and when  a company may lose emerging growth company status;

 Briefly describe the exemption from Section 404(b) of the Sarbanes -Oxley Act of
2002  and update your risk factor on page 33 for this exemption ; and

 State your election under Section 107(b) of the JOBS Act:

o 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

o If you have elected to use the extended tran sition 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 fo r 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 da tes.
 Include a similar statement in your critical accounting policy disclosures.

Item 3.  Key Information

A. Selected Financial Data, page 4

4. The identification of some columns of selected financial data as “unaudited” may give a n
investor the impressio n that the other columns have been audited.  We believe your
disclosure in the introductory paragraphs of this section is sufficient to highlight to
investors which selected financial data have been derived from audited or unaudited
financial statements.  Please revise your disclosure to remove any label identifying a
column as unaudited.

D. Risk Factors , page 5

5. Please expand your disclosure in this section to add a risk factor that addresses the risks
resulting from the fact that the report of your indep endent registered public accounting
firm on your financial statements states that your recurring operating losses, negative
cash flows and dependence on additional financial support raise substantial doubt about
your ability to continue as a going concern.   Please include in this risk factor the fact that
the auditor’s going concern opinion may have a detrimental effect on your ability to
obtain additional funding.

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 3

 “We anticipate that we will incur losses for the foreseeable future and we may never achiev e or
sustain profitability,” page 6

6. Please state in this risk factor that your total accumulated deficit as of the end of 2011
was $12,621,000.

“We will require additional capital to fund our operations, and if we are unable to obtain such
capital, we will be unable to successfully develop and commercialize our product candidates,”
page 6

7. Please expand your risk factor to

 include an estimate of your operating expenses, including your research and
development costs, for fiscal year 2012 ;

 disclose the  amount of your existing cash and investment securities;

 disclose the amount of all compensation that you anticipate deferring; and

 disclose the material elements of your current contemplated plan for your fiscal
year ended December 31, 2012.

 “If we default on our convertible notes, we may lose all of our assets and intellectual property,”
page 8

8. Please expand this risk factor to disclose

 the list of events of default as defined in your Securities Purchase  Agreement
dated April 3, 2012; and

 that yo u are required to repay your convertible notes by January 4, 2013 , the
aggregate amount that you expect to be due as of that date, and that you do not
currently have sufficient cash available to repay them .

“Our product candidates are still in the early stages of development and remain subject to clinical
testing and regulatory approval…” page 10

9. Please expand this risk factor to disclose when you intend to file your IND application for
your two product candi dates in clinical trials.

“We have not conducted any absorption, distribution, metabolism and excretion (ADME) studies
with respect to our clinical and pre -clinical product candidates,” page 15

10. In this risk factor, please include the reason you have yet to perform ADME studies and
whether or not you intend to conduct such studies in the future.

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 4

 “If our competitors are better able to develop and market products than any products that we
and/or an y potential future collaborators may develop . . .,” page 21

11. Please include in this risk factor the names of the companies that you believe will be your
principal competitors and those products that you believe will compete with yours at such
time as your s enter the marketplace.

“We depend on third -party suppliers for key raw materials used in our manufacturing processes .
. .,” page 22

12. Please include in this risk factor the names of the third -party suppliers you are dependent
upon.

“Use of third -party manufacturers may increase the risk that we will not have adequate supplies
of our product candidates or products .”  page 24

13. You disclose that your  present or future manufacturing partners may not be able to
comply with FDA -mandated current Good Man ufacturing Practice regulations or  other
FDA regulatory requirements .  To the extent you are aware that one or more of your
current manufacturing partners do not comply with FDA -mandated current Good
Manufacturing Practice regulations or other FDA regulatory r equirements , please
disclose this fact as well as the names of each manufacturing partner that does not
comply.

“We rely on third parties to conduct our clinical trials, and those third parties may not perform
satisfactorily . . .,” page 25

14. Please incl ude in this risk factor the names of the material contract research organizations
that have performed your clinical trials to date.

“If we do not establish strategic collaborations, we may have to alter our development plans,”
page 25

15. This risk factor i s substantially similar to the second one on page 22. Please merge them
into a single risk factor in order to avoid repetition in your disclosure.

“We will incur increased costs and demands upon management as a result of complying with the
laws and regulations affecting public companies . . .,” page 33

16. Please estimate the costs you will incur as a result of complying with public company
laws and regulations over the next fiscal year and on an annual basis thereafter.

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 5

 Item 4. Information on the Company

A. History and Development of the Company

April 2012 Private Placement of Senior Secured Convertible Notes and Warrants, page 38

17. In your “Description of Notes” on page 40 please provide the definition of “material
adverse event” in your Securities Purchase Agreement.

18. In your description of the Registration Rights Agreement on page 40, please  disclose the
actual date rather than re ferring to the “Self Filing Effective Date” and  describe the
payments you will be required to make to your investors if this registration statement is
not filed and/or declared effective on a timely basis.

B. Business Overview

Product Candidates, page 41

19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and
your Overview on page 68, that the clinical trials your two major product candidates have
undergone were performed in Israel and South Africa, and not in the Unit ed States.

20. Please state here and wherever else applicable in your registration statement whether or
not you believe your clinical trials have complied with the rules for such trials set forth
by the FDA.  If they have not, please specify how your clinica l trials have differed from
those rules.

Steroids and Currently Available Alternatives, page 42

21. In your table on page 44, please indicate in the row describing your product candidates
that your studies to date have not advanced beyond Phase 2 .

Scientific Background to Inflammation and Our Product Candidates, page 45

22. In this discussion, please address whether the research performed by your principal
shareholder into the field of lipid conjugates has produced conclusive evidence into their
anti-inflammatory properties. If there is any controversy in the greater scientific
community as to this assertion, you should note this here and discuss any possible
ramifications, particularly how this uncertainty could impact the development of your
product c andidates.  If appropriate, you should amend your disclosure wherever you
discuss this research and its implications, including the risk factor on pages 10 -11.

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 6

 Research and Development, page 45

23. Please include in this discussion the amounts you have s pent on R&D over the last three
fiscal years as well as an estimate of your R&D expenses for fiscal year 2012.

24. We note that you disclose the focus of your development plan for fiscal 2012, provided
that you raise additional capital.  Given your disclosur e on page 6 that you  believe that
your existing cash and investment securities will be sufficient to support your current
contemplated operating plan until December 31, 2012 , please expand your disclosure to
disclose the focus of your development plan for fiscal 2012 if you do not raise additional
capital.

Development of our Clinical Pipeline for our Product Candidates, page 49

25. For each of the trials discussed, please disclose any side effects observed with your
product candidates and, where available, p lease disclose whether the results are
statistically significant and provide all p -values that you have available.

Intellectual Property, page 52

26. Please indicate the product candidates to which each of your material U.S. and non -U.S.
patents relate.

Manufacturing, Marketing and Sales of our Drugs, page 55

27. Please disclose the names of your third -party manufacturer(s) here and in the risk factor
on page 23.  Please also disclose here the material terms of your contractual relationships
with them, if any. If you are substantially dependent on an agreement with  a third -party
for the manufacture of your product candidates, please file this agreement as an exhibit to
your registration statement.  Alternatively, please provide us with an analysis that
supports your determination that you are not substantially depen dent on an agreement
with a third -party manufacturer.

Item 5. Operating and Financial Review and Prospects

Stock -based Compensation and Fair Value of Ordinary Shares, page 70

28. With respect to your common stock valuation s, please expand your disclosures to provide
the following information relating to your issuances of equity instruments  during the past
three fiscal years :

 A discussion of the significant objective and subjective factors, assumptions, and
methodologies used in determining fair value  of the shares underlying the options,
warrants and deferred shares issued;

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 7

  Include in your discussion how management determined fair value based on the share
price used in equity financing rounds; and

 Identify the recent equity transactions used to determine fair value.

C.  Research and Development, Patents and Licenses, etc., page 74

29. Please provide disclosure to quantify  the amount of costs, both internal and external,
incurred during each period presented and incurred to date on each of your major
research and development projects. Please reconcile these amounts to the research and
development expense reported on your st atements of operations. To the extent that you
cannot attribute costs to a project, please explain why management does not maintain and
evaluate those costs by project.

F.  Tabular Disclosure of Contractual Obligations, page 75

30. Please expand your disclo sure to include the obligation to pay Yissum $70,000 per year,
described in Note 7 to the financial statements, in the table.  Also, expand your disclosure
here to discuss all future potential royalties, milestones and other fees reasonably likely to
be pa id relating to this agreement.

Item 6.  Directors, Senior Management and Employees

B.  Compensation

Other Director Compensation, page 82

31. Please file copies of the agreements you disclose in this section and your agreements with
Prof. Saul Yedgar  and Dr. Joseph Bondi that you disclose in the section below.  See
4(b)(i) and (ii) of the Instructions as to Exhibits.

Item 7. Major Shareholders and Related Party Transactions

B. Related Party Transactions

32. We note that you state “See also “Material C ontracts.”   Please expand your disclosure to
provide a brief summary of the related party transactions referenced later in the filing. [

Dr. Yuval Cohen
Morria Biopharmaceuticals PLC
July 2 5, 2012
Page 8

 Item 9. The Offer and Listing

C. Markets, page 91

33. You state elsewhere in your registration statement that you intend to apply to list your
common shares on the NYSE Amex. You should therefore include this information in
this section, pursuant to Form 20 -F.

Item 10. Additional Information
A. Share Capital, page 91

34. In your description of your outstanding convertible notes, you refer to them as
“debentures.” As the term debenture typically refers to unsecured debt, and these notes
are secured by your assets, it is not appropriate to use this term to describe the notes .
Please amend your disclosure accordingly.

C. Material Contracts, page 102

35. It does not appear that your sub -license agreement dated February 1, 2005, or your
amendment dated April 4, 2012, have been filed as exhibits to your registration
statement. Pl ease file these contracts, as they are material to your operations.

Item 19. Exhibits, page 126

36. Please file complete and executed copies of the agreemen