SEC Company Response from Cocrystal Pharma, Inc. (COCP) (CIK 0001412486) (COCP) — Dec 19, 2011
Cocrystal Pharma, Inc. (COCP) (CIK 0001412486)
Date: Dec. 19, 2011 · CIK: 0001412486 · Accession: 0001521536-11-000535
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-176951
Referenced dates: October 18, 2011
Letter
Unassociated Document
December 19, 2011
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Attention:
Jennifer Riegel
Jeffrey P. Riedler
Re:
Biozone Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed September 21, 2011
File No. 333-176951
Ladies and Gentlemen:
The following responses address the comments of the Staff (the “Staff”) as set forth in its letter dated October 18, 2011 (the “Comment Letter”) relating to the Registration Statement on Form S-1 (the “Registration Statement”) of Biozone Pharmaceuticals, Inc. (“Biozone” or the “Company”) filed on September 21, 2011. The Company is simultaneously filing Amendment No.1 to the Registration Statement (the “Amendment”).
The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
Registration Statement on Form S-1
General
1.
Since you are a reporting company subject to the requirements of the Securities Exchange Act of 1934, you should respond to the comments in this letter that apply to the disclosure included in your Form 10-K or Form 10-Q within ten business days by providing the requested information or by advising us when you will provide the requested response. A few examples of disclosure that is required to be included in your registration statement and your Form 10-K or Form 10-Q include Business section, Risk Factors, Director and Officer disclosure, Beneficial Ownership Table, MD&A and Financial Statements and the notes thereto. Please review the requirements of Forms 10-K and 10-Q for a detailed list of the required disclosure as compared to Form S-1.
Response:
The Company undertakes to apply all comments in this letter to its disclosure in its reports filed pursuant to the requirements of the Securities Exchange Act of 1934.
2.
Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments.
Response:
The Company notes the foregoing.
3.
We note your disclosure in footnote 1 to the registration fee table that pursuant to Rule 416, the shares of-Common stock offered hereby also include an indeterminate number of additional shares of Common stock as may from time to time become issuable by reason of anti-dilution provisions, stock splits, stock dividends, recapitalizations or other similar transactions. Rule 416(a) involves the registration of additional securities "being offered or issued to prevent dilution resulting from stock splits, stock dividends or similar transactions." Please revise to remove the shares that may be issuable by reason of “anti-dilution provisions" as they are not covered by Rule 416.
Response:
The Company has removed the reference to “anti-dilution” in Footnote 1.
4.
Please define the terms FDA and cGMP in the first instance that you use each abbreviation.
Response:
The Company has defined the terms “FDA” and “cGMP” in the first instance that each is used.
5.
Please define the terms iontophoresis and pegylated in the first instance that you use each term.
Response:
The Company has removed the term “iontophoresis” from the document. It appears only in the title of a patent in the patent table. The Company has defined “PEGylation” and “pegylated” in the document.
Prospectus Summary, page 3
6.
Please expand your Prospectus Summary to identify and describe your marketed products and the product candidates in your pipeline. For the product candidates in your pipeline, please clearly state that these product candidates have not been approved by regulatory authorities, may never be approved, and describe each product candidate's progress in the approval process.
Response:
The Company has revised the Prospectus Summary to briefly describe our marketed products. The Company has revised its disclosure throughout the Amendment to clarify that it is the early stage of new product development and the progress of such development activities and status of FDA approval is an immaterial portion of the Company’s business.
7.
Please expand your disclosure throughout to clearly disclose the products that you manufacture and the products that are manufactured by third parties.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that it manufactures the Glyderm and Baker Cummins lines of products and does not rely on any third parties to manufacture its products.
8.
Please expand your description of BioZone Technology to briefly to explain how you developed your technology platform and intellectual property. To the extent that this was developed in-house, please so indicate.
Response:
The Company has revised the Prospectus Summary to include a paragraph describing the BioZone Technology and how it was developed.
Special Note Regarding Forward Looking Statements, page 6
9.
You state on page 6 that this prospectus contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Please note that issuers of penny stock are excluded from relying upon the safe harbor for forward-looking statements pursuant to Section 21E(b)(1)(iii). Please remove this reference from your disclosure.
Response:
The Company has removed the reference to Section 21E(b)(1)(iii) of the Securities Exchange Act of 1934 from the Special Note Regarding Forward Looking Statements.
Risk Factors, page 6
10.
In the introductory paragraph to the Risk Factors section, you state that "[t]here are numerous and varied risks, known and unknown, that may prevent us from achieving our goals. If any of these risks actually occur, our business, financial condition or results of operations may be materially adversely affected." As the risk factors section should contain a complete discussion of the material risks to your business, it is inappropriate to reference risks that are not disclosed in your risk factors section. Please revise the introductory paragraph accordingly.
Response:
The Company has revised the introductory paragraph to the Risk Factors Section to remove the reference to risks that are not disclosed in its risk factors section.
11.
Please add a risk factor addressing your lack of profitable operations in recent periods. Please discuss in this risk Factor whether you expect your financial losses to continue in the future.
Response:
The Company has added a risk factor addressing its lack of profitable operations in recent periods and discussing whether it expects its financial losses to continue.
12.
Please add a risk factor describing the risk to your company of relying on third parties to manufacture your products.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that it does not rely on third parties to manufacture its products.
"We have negative working capital and have sustained operating losses…, page 6
13.
Please expand this risk factor to estimate the amount of time you will be able to continue operations with your current level of working capital.
Response:
The Company has expanded the risk factor to disclose its estimate of the amount of time that it will be able to continue its operations with its current level of working capital.
14.
You state that you “cannot be sure how much [you] will need to spend in order to develop new products and technologies in the future.” Please estimate the amount of funds you will need to complete development of your product candidates upon which your business is substantially dependent and identify the product candidates.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. As such, the Company does not believe that its business is substantially dependent on any potential product candidates.
15.
You disclose that the report of your independent registered public accounting firm on your financial statements states that your ability to obtain profitability and necessary equity or debt financing raise substantial doubt about your ability to continue as a going concern. This risk appears to be distinct from the other risks discussed in this risk factor. Please revise your disclosure to add a separately headed risk factor that discussed this risk. In addition, please expand your risk factor to disclose that the auditor's going concern opinion may have a detrimental effect on your ability to obtain additional funding.
Response:
The Company has added a risk factor that discusses the Company’s auditor’s doubt about the Company’s ability to continue as a going concern. This risk factor also discloses that the auditor’s going concern opinion may have a detrimental effect on the Company’s ability to obtain additional financing.
“We operate in a highly regulated industry…," page 6
16.
This risk factor appears to discuss a risk to the company that is substantially similar to the risk discussed in the risk factor on page 9 entitled, “If we fail to obtain or maintain the necessary United States or worldwide regulatory approvals..." Please revise your disclosure to either distinguish the risks and the headers thereof or combine these two discussions.
Response:
The Company has revised its disclosure to combine the two risk factors referenced in the Staff’s comment.
17.
You disclose that “The FDA inspected our manufacturing facilities in January 2011. The inspection resulted in only minor observations on Form 483, which we quickly resolved to FDA’s satisfaction.” Please disclose the date in which the FDA determined that the deficiencies were remedied and the facility was in compliance.
Response:
The Company has revised the risk factor to disclose that it responded to the FDA in March 2011 with a written statement describing the remedial actions taken. As of the date of the Amendment, the Company has not received any additional correspondence from the FDA regarding this inspection.
“Our future results of operations depend to a significant degree, upon our ability…,” page 7
18.
You state that “[t]he development and commercialization process, particularly with respect to innovative products, is both time consuming and costly and involves a high degree of business risk.” Please expand this discussion to estimate the amount of time and resources it takes to develop and commercialize a product candidate.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business in as much as its primary business is manufacturing OTC pharmaceutical products and cosmetics according to customer specifications. Therefore, the Company has removed the risk factor referenced in the Staff’s comment as the Company does not believe that its future results of operations are substantially dependent upon its ability to successfully develop and commercialize additional OTC and generic prescription drugs.
19.
Please expand this risk factor to briefly describe your product pipeline in clinical development. Please indicate each product candidate's progress in the development process.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment as the Company does not believe that its future results of operations are substantially dependent upon its ability to successfully develop and commercialize additional OTC and generic prescription drugs.
"Lack of availability of, or significant increases in the cost of raw materials…," page 7
20.
You state that previously unknown problems with the raw materials or product manufacturing processes could result in a voluntary or mandatory withdrawal or the contaminated product. To the extent you have experienced problems with contaminated products in the recent past, please revise to describe these problems.
Response:
The Company has not experienced problems with contaminated products in the recent past and has revised the risk factor accordingly.
“Our future results of operations depend, to a significant degree …,” page 8
21.
This risk factor appears to substantially duplicate the risk factor with the same title on page 7. Please revise your disclosure to either distinguish the risks and the headers thereof or combine these risk factors.
Response:
The Company has combined the two risk factors referenced in Comment 21 as set forth in its response to Comment 16.
"In order to achieve successful sales of new product candidates …," page 9
22.
This risk factor duplicates the risk factor with the same title on page 8. Please revise your disclosure to delete this risk factor.
Response:
The Company has deleted this risk factor.
"Our product candidates may be subject to future product liability claims…," page 10
23.
Please expand your disclosure to quantify the extent of your product liability insurance coverage.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment.
"Our future collaborators may compete with us or have interests…," page 11
24.
You state that "Large pharmaceutical companies that [you] seek to collaborate with may have internal programs or enter into collaborations with [your] competitors…." Please update this risk factor to clarify whether or not you are in negotiations for a collaboration agreement. If you have entered into negotiations with any pharmaceutical companies for collaboration agreements, please disclose this in the Business section.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment. Additionally, the Company has never entered into negotiations with pharmaceutical companies for collaboration agreements regarding product candidate development.
"A dispute concerning the infringement or misappropriation . . ., page 12
25.
If you have or have had any claims against you alleging infringement, please so disclose in this risk factor.
Response:
The Company does not currently have, and as of the date of the Amendment, has not had, any claims against it alleging infringement. The Company has revised this risk factor accordingly.
"Confidentiality agreements with employees and others may not adequately prevent…." page 12
26.
You indicate that you maintain confidentiality and intellectual property assignment agreements with your employees and other persons with access to your proprietary materials or processes. Please provide the Staff with a supplemental copy of the standard confidentiality agreement and the intellectual property assignment agreement you enter into with your employees. We may have further comment.
Response:
The Company will file a supplemental copy of the standard confidentiality agreement and the intellectual property assignment agreement it enters into with its employees as exhibits to a subsequent amendment to the Registration Statement.
"Our technology may become obsolete or lose its competitive advantage," page 12
27.
Please provide a detailed analysis to support your assertion that your technology has a "competitive advantage."
Response:
The Company has revised its disclosure
Show Raw Text
CORRESP
1
filename1.htm
Unassociated Document
December 19, 2011
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Attention:
Jennifer Riegel
Jeffrey P. Riedler
Re:
Biozone Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed September 21, 2011
File No. 333-176951
Ladies and Gentlemen:
The following responses address the comments of the Staff (the “Staff”) as set forth in its letter dated October 18, 2011 (the “Comment Letter”) relating to the Registration Statement on Form S-1 (the “Registration Statement”) of Biozone Pharmaceuticals, Inc. (“Biozone” or the “Company”) filed on September 21, 2011. The Company is simultaneously filing Amendment No.1 to the Registration Statement (the “Amendment”).
The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
Registration Statement on Form S-1
General
1.
Since you are a reporting company subject to the requirements of the Securities Exchange Act of 1934, you should respond to the comments in this letter that apply to the disclosure included in your Form 10-K or Form 10-Q within ten business days by providing the requested information or by advising us when you will provide the requested response. A few examples of disclosure that is required to be included in your registration statement and your Form 10-K or Form 10-Q include Business section, Risk Factors, Director and Officer disclosure, Beneficial Ownership Table, MD&A and Financial Statements and the notes thereto. Please review the requirements of Forms 10-K and 10-Q for a detailed list of the required disclosure as compared to Form S-1.
Response:
The Company undertakes to apply all comments in this letter to its disclosure in its reports filed pursuant to the requirements of the Securities Exchange Act of 1934.
2.
Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments.
Response:
The Company notes the foregoing.
1
3.
We note your disclosure in footnote 1 to the registration fee table that pursuant to Rule 416, the shares of-Common stock offered hereby also include an indeterminate number of additional shares of Common stock as may from time to time become issuable by reason of anti-dilution provisions, stock splits, stock dividends, recapitalizations or other similar transactions. Rule 416(a) involves the registration of additional securities "being offered or issued to prevent dilution resulting from stock splits, stock dividends or similar transactions." Please revise to remove the shares that may be issuable by reason of “anti-dilution provisions" as they are not covered by Rule 416.
Response:
The Company has removed the reference to “anti-dilution” in Footnote 1.
4.
Please define the terms FDA and cGMP in the first instance that you use each abbreviation.
Response:
The Company has defined the terms “FDA” and “cGMP” in the first instance that each is used.
5.
Please define the terms iontophoresis and pegylated in the first instance that you use each term.
Response:
The Company has removed the term “iontophoresis” from the document. It appears only in the title of a patent in the patent table. The Company has defined “PEGylation” and “pegylated” in the document.
Prospectus Summary, page 3
6.
Please expand your Prospectus Summary to identify and describe your marketed products and the product candidates in your pipeline. For the product candidates in your pipeline, please clearly state that these product candidates have not been approved by regulatory authorities, may never be approved, and describe each product candidate's progress in the approval process.
Response:
The Company has revised the Prospectus Summary to briefly describe our marketed products. The Company has revised its disclosure throughout the Amendment to clarify that it is the early stage of new product development and the progress of such development activities and status of FDA approval is an immaterial portion of the Company’s business.
7.
Please expand your disclosure throughout to clearly disclose the products that you manufacture and the products that are manufactured by third parties.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that it manufactures the Glyderm and Baker Cummins lines of products and does not rely on any third parties to manufacture its products.
8.
Please expand your description of BioZone Technology to briefly to explain how you developed your technology platform and intellectual property. To the extent that this was developed in-house, please so indicate.
Response:
The Company has revised the Prospectus Summary to include a paragraph describing the BioZone Technology and how it was developed.
Special Note Regarding Forward Looking Statements, page 6
9.
You state on page 6 that this prospectus contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Please note that issuers of penny stock are excluded from relying upon the safe harbor for forward-looking statements pursuant to Section 21E(b)(1)(iii). Please remove this reference from your disclosure.
2
Response:
The Company has removed the reference to Section 21E(b)(1)(iii) of the Securities Exchange Act of 1934 from the Special Note Regarding Forward Looking Statements.
Risk Factors, page 6
10.
In the introductory paragraph to the Risk Factors section, you state that "[t]here are numerous and varied risks, known and unknown, that may prevent us from achieving our goals. If any of these risks actually occur, our business, financial condition or results of operations may be materially adversely affected." As the risk factors section should contain a complete discussion of the material risks to your business, it is inappropriate to reference risks that are not disclosed in your risk factors section. Please revise the introductory paragraph accordingly.
Response:
The Company has revised the introductory paragraph to the Risk Factors Section to remove the reference to risks that are not disclosed in its risk factors section.
11.
Please add a risk factor addressing your lack of profitable operations in recent periods. Please discuss in this risk Factor whether you expect your financial losses to continue in the future.
Response:
The Company has added a risk factor addressing its lack of profitable operations in recent periods and discussing whether it expects its financial losses to continue.
12.
Please add a risk factor describing the risk to your company of relying on third parties to manufacture your products.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that it does not rely on third parties to manufacture its products.
"We have negative working capital and have sustained operating losses…, page 6
13.
Please expand this risk factor to estimate the amount of time you will be able to continue operations with your current level of working capital.
Response:
The Company has expanded the risk factor to disclose its estimate of the amount of time that it will be able to continue its operations with its current level of working capital.
14.
You state that you “cannot be sure how much [you] will need to spend in order to develop new products and technologies in the future.” Please estimate the amount of funds you will need to complete development of your product candidates upon which your business is substantially dependent and identify the product candidates.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. As such, the Company does not believe that its business is substantially dependent on any potential product candidates.
15.
You disclose that the report of your independent registered public accounting firm on your financial statements states that your ability to obtain profitability and necessary equity or debt financing raise substantial doubt about your ability to continue as a going concern. This risk appears to be distinct from the other risks discussed in this risk factor. Please revise your disclosure to add a separately headed risk factor that discussed this risk. In addition, please expand your risk factor to disclose that the auditor's going concern opinion may have a detrimental effect on your ability to obtain additional funding.
3
Response:
The Company has added a risk factor that discusses the Company’s auditor’s doubt about the Company’s ability to continue as a going concern. This risk factor also discloses that the auditor’s going concern opinion may have a detrimental effect on the Company’s ability to obtain additional financing.
“We operate in a highly regulated industry…," page 6
16.
This risk factor appears to discuss a risk to the company that is substantially similar to the risk discussed in the risk factor on page 9 entitled, “If we fail to obtain or maintain the necessary United States or worldwide regulatory approvals..." Please revise your disclosure to either distinguish the risks and the headers thereof or combine these two discussions.
Response:
The Company has revised its disclosure to combine the two risk factors referenced in the Staff’s comment.
17.
You disclose that “The FDA inspected our manufacturing facilities in January 2011. The inspection resulted in only minor observations on Form 483, which we quickly resolved to FDA’s satisfaction.” Please disclose the date in which the FDA determined that the deficiencies were remedied and the facility was in compliance.
Response:
The Company has revised the risk factor to disclose that it responded to the FDA in March 2011 with a written statement describing the remedial actions taken. As of the date of the Amendment, the Company has not received any additional correspondence from the FDA regarding this inspection.
“Our future results of operations depend to a significant degree, upon our ability…,” page 7
18.
You state that “[t]he development and commercialization process, particularly with respect to innovative products, is both time consuming and costly and involves a high degree of business risk.” Please expand this discussion to estimate the amount of time and resources it takes to develop and commercialize a product candidate.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business in as much as its primary business is manufacturing OTC pharmaceutical products and cosmetics according to customer specifications. Therefore, the Company has removed the risk factor referenced in the Staff’s comment as the Company does not believe that its future results of operations are substantially dependent upon its ability to successfully develop and commercialize additional OTC and generic prescription drugs.
19.
Please expand this risk factor to briefly describe your product pipeline in clinical development. Please indicate each product candidate's progress in the development process.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment as the Company does not believe that its future results of operations are substantially dependent upon its ability to successfully develop and commercialize additional OTC and generic prescription drugs.
4
"Lack of availability of, or significant increases in the cost of raw materials…," page 7
20.
You state that previously unknown problems with the raw materials or product manufacturing processes could result in a voluntary or mandatory withdrawal or the contaminated product. To the extent you have experienced problems with contaminated products in the recent past, please revise to describe these problems.
Response:
The Company has not experienced problems with contaminated products in the recent past and has revised the risk factor accordingly.
“Our future results of operations depend, to a significant degree …,” page 8
21.
This risk factor appears to substantially duplicate the risk factor with the same title on page 7. Please revise your disclosure to either distinguish the risks and the headers thereof or combine these risk factors.
Response:
The Company has combined the two risk factors referenced in Comment 21 as set forth in its response to Comment 16.
"In order to achieve successful sales of new product candidates …," page 9
22.
This risk factor duplicates the risk factor with the same title on page 8. Please revise your disclosure to delete this risk factor.
Response:
The Company has deleted this risk factor.
"Our product candidates may be subject to future product liability claims…," page 10
23.
Please expand your disclosure to quantify the extent of your product liability insurance coverage.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment.
"Our future collaborators may compete with us or have interests…," page 11
24.
You state that "Large pharmaceutical companies that [you] seek to collaborate with may have internal programs or enter into collaborations with [your] competitors…." Please update this risk factor to clarify whether or not you are in negotiations for a collaboration agreement. If you have entered into negotiations with any pharmaceutical companies for collaboration agreements, please disclose this in the Business section.
Response:
The Company has revised its disclosure throughout the Amendment to clarify that the development of product candidates is an immaterial portion of the Company’s business. Therefore, the Company has removed the risk factor referenced in the Staff’s comment. Additionally, the Company has never entered into negotiations with pharmaceutical companies for collaboration agreements regarding product candidate development.
5
"A dispute concerning the infringement or misappropriation . . ., page 12
25.
If you have or have had any claims against you alleging infringement, please so disclose in this risk factor.
Response:
The Company does not currently have, and as of the date of the Amendment, has not had, any claims against it alleging infringement. The Company has revised this risk factor accordingly.
"Confidentiality agreements with employees and others may not adequately prevent…." page 12
26.
You indicate that you maintain confidentiality and intellectual property assignment agreements with your employees and other persons with access to your proprietary materials or processes. Please provide the Staff with a supplemental copy of the standard confidentiality agreement and the intellectual property assignment agreement you enter into with your employees. We may have further comment.
Response:
The Company will file a supplemental copy of the standard confidentiality agreement and the intellectual property assignment agreement it enters into with its employees as exhibits to a subsequent amendment to the Registration Statement.
"Our technology may become obsolete or lose its competitive advantage," page 12
27.
Please provide a detailed analysis to support your assertion that your technology has a "competitive advantage."
Response:
The Company has revised its disclosure