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Cocrystal Pharma, Inc.
Response Received
1 company response(s)
High - file number match
↓
Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
Cocrystal Pharma, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-08-13
Cocrystal Pharma, Inc.
References: July 30, 2025
Cocrystal Pharma, Inc.
Response Received
1 company response(s)
High - file number match
↓
Cocrystal Pharma, Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2020-05-04
Cocrystal Pharma, Inc.
References: April 27, 2020
↓
Company responded
2020-05-11
Cocrystal Pharma, Inc.
References: April 27, 2020
↓
Cocrystal Pharma, Inc.
Response Received
1 company response(s)
High - file number match
↓
Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
Medium
Cocrystal Pharma, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-05-28
Cocrystal Pharma, Inc.
Summary
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Company responded
2015-06-01
Cocrystal Pharma, Inc.
References: May 27, 2015
Summary
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Company responded
2017-10-12
Cocrystal Pharma, Inc.
References: October 10, 2017
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-10-11
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2017-10-03
Cocrystal Pharma, Inc.
Summary
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Company responded
2017-10-05
Cocrystal Pharma, Inc.
Summary
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Company responded
2017-10-05
Cocrystal Pharma, Inc.
References: October 3, 2017
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2015-06-02
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-02-14
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-02-14
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Response Received
9 company response(s)
High - file number match
SEC wrote to company
2010-07-27
Cocrystal Pharma, Inc.
Summary
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Company responded
2010-07-29
Cocrystal Pharma, Inc.
References: July 26, 2010
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Company responded
2012-09-28
Cocrystal Pharma, Inc.
References: September 21, 2012
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Company responded
2012-11-13
Cocrystal Pharma, Inc.
References: October 11, 2012
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Company responded
2013-01-09
Cocrystal Pharma, Inc.
References: December 11, 2012
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Company responded
2013-01-14
Cocrystal Pharma, Inc.
References: December 11, 2012
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Company responded
2013-01-31
Cocrystal Pharma, Inc.
References: January 24, 2013
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Company responded
2013-02-08
Cocrystal Pharma, Inc.
Summary
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Company responded
2013-02-12
Cocrystal Pharma, Inc.
Summary
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Company responded
2013-02-13
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2011-10-18
Cocrystal Pharma, Inc.
Summary
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Company responded
2011-12-19
Cocrystal Pharma, Inc.
References: October 18, 2011
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Company responded
2012-09-21
Cocrystal Pharma, Inc.
References: July 25, 2012
Summary
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Company responded
2013-02-13
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-01-24
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-12-11
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-10-11
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-09-21
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-08-27
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-08-16
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-07-26
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-01-05
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-09-07
Cocrystal Pharma, Inc.
Summary
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Cocrystal Pharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-08-18
Cocrystal Pharma, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2025-09-24 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 333-290407 | Read Filing View |
| 2025-08-28 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 001-38418 | Read Filing View |
| 2025-08-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 001-38418 | Read Filing View |
| 2023-05-24 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-11 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-04 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2019-05-20 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2019-05-02 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-13 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-03 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-06-02 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-06-01 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-05-28 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-14 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-14 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-08 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-31 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-24 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-14 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-09 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-12-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-11-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-10-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-28 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-21 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-21 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-08-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-08-16 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-07-26 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-01-05 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-12-19 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-10-18 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-09-07 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-08-18 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2010-07-29 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2010-07-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-24 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 333-290407 | Read Filing View |
| 2025-08-28 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 001-38418 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | 001-38418 | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2019-05-02 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-13 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-03 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-06-02 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-05-28 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-14 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-14 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-24 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-12-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-10-11 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-21 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-08-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-08-16 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-07-26 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-01-05 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-10-18 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-09-07 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-08-18 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2010-07-27 | SEC Comment Letter | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2025-08-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2023-05-24 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-11 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2020-05-04 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2019-05-20 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-05 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2015-06-01 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-12 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-02-08 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-31 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-14 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2013-01-09 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-11-13 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-28 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2012-09-21 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2011-12-19 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
| 2010-07-29 | Company Response | Cocrystal Pharma, Inc. | DE | N/A | Read Filing View |
2025-09-25 - CORRESP - Cocrystal Pharma, Inc.
CORRESP 1 filename1.htm Cocrystal Pharma, Inc. 19805 N. Creek Parkway Bothell, WA 98011 (877) 262-7123 September 25, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, D.C. 20549 Re: Cocrystal Pharma, Inc. Registration Statement on Form S-1 Filed September 19, 2025 File No. 333-290407 Ladies and Gentlemen: In accordance with Rule 461 promulgated pursuant to the Securities Act of 1933, Cocrystal Pharma, Inc. is hereby requesting that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will become effective at 4:00 pm, Eastern Time on Thursday, September 25, 2025, or as soon thereafter as may be practicable. Please direct any questions concerning this letter to Michael D. Harris, Esq. or Constantine Christakis, Esq. of Nason Yeager Gerson Harris & Fumero, P.A., the Company's legal counsel, at 561-644-2222, mharris@nasonyeager.com or 561-302-6158, cchristakis@nasonyeager.com. Sincerely, Cocrystal Pharma, Inc. By: /s/ James Martin James Martin, Co-Chief Executive Officer cc: Michael Harris, Esq. Constantine Christakis, Esq.
2025-09-24 - UPLOAD - Cocrystal Pharma, Inc. File: 333-290407
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 24, 2025 James Martin Co-Chief Executive Officer Cocrystal Pharma, Inc. 4400 Biscayne Boulevard Miami, FL 33137 Re: Cocrystal Pharma, Inc. Registration Statement on Form S-1 Filed September 19, 2025 File No. 333-290407 Dear James Martin: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael D. Harris, Esq. </TEXT> </DOCUMENT>
2025-08-28 - UPLOAD - Cocrystal Pharma, Inc. File: 001-38418
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 28, 2025 James Martin Co-Chief Executive Officer and CFO Cocrystal Pharma, Inc. 19805 North Creek Parkway Bothell, WA 98011 Re: Cocrystal Pharma, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 31, 2025 File No. 001-38418 Dear James Martin: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-08-13 - CORRESP - Cocrystal Pharma, Inc.
CORRESP 1 filename1.htm August 12, 2025 United States Securities and Exchange Commission Washington, D.C. 20549 Division of Corporate Finance Office of Life Sciences RE: Comment Letter Dated July 30, 2025 (File No. 001-38418) Dear Ladies and Gentlemen: On behalf of Cocrystal Pharma, Inc. (the "Company"), we submit this letter in response to comments from the staff (the " Staff ") of the Securities and Exchange Commission (the " Commission ") received by letter dated July 30, 2025, relating to the Company's Form 10K for the fiscal year ended December 31, 2024 filed on March 31, 2025. In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company's response. 1. We note several statements throughout your filing that describe your product candidates as "first-in-class" and "best-in-class." Given the early stage of development of your product candidates and the length and uncertainty of the drug approval process, it appears premature to describe your product candidates as potentially being "first-in-class" or "best-in-class." Accordingly, please remove these statements from future filings. We acknowledge that the Staff's comments and will remove these statements from future filings. 2. We note the inclusion of "Replication Inhibitors" and "Pan-viral Inhibitors" in your pipeline table. Given the early stage of development and limited disclosure related to these programs, please explain why they are sufficiently material to your business to warrant inclusion in your pipeline table. If they are material, please expand your disclosure in the "Business" section in future filings to provide a more fulsome discussion of these programs, including a description of development activities conducted. Alternatively, remove any programs that are not currently material from your pipeline table in future filings. We acknowledge that the Staff's comments and we will amend or remove these statements from future filings. 3. In future filings, please revise your pipeline table to ensure the arrow in each row accurately reflects the current status of the respective program consistent with your disclosure in the rest of the filing. For example only, we note the following: ● The arrow in the first row indicates that your Oral Pb2 Inhibitor CC-42344 program is nearing the end of Phase 2 clinical trials. However, your disclosure on page 5 indicates that the program is still in Phase 2a clinical trials and that you are considering the submission of a protocol amendment for the study. We acknowledge that the Staff's comments and we will revise in future findings. 4400 Biscayne Boulevard | Miami, Florida 33137 | USA | +1 | www.cocrystalpharma.com ● The arrow in the second row indicates that your Inhaled PB2 Inhibitor CC-42344 program is at the end of preclinical studies. However, your disclosure on page 39 that "[p]reclinical development is progressing" suggests that you are still in the preclinical phase. We acknowledge that the Staff's comments and we will revise in future findings. 4. In future filings, please revise your discussion of your patent portfolio to disclose for each material patent and patent application the specific product(s) to which such patents or applications relate, the type of patent protection, the expiration dates and applicable jurisdictions. To the extent material, please also clarify whether you or Merck will hold any future intellectual property related to your Influenza A/B program that was developed in your prior collaboration. We acknowledge that the Staff's comments and we will revise in future findings. 5. In future filings, beginning with your Form 10-Q for the period ended June 30, 2025, please disclose the costs incurred during each period presented for each of your key research and development projects. If you do not track your research and development costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by project. For costs that are not tracked and disclosed by project, please provide other quantitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. pre- clinical and clinical and by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations. We acknowledge that the Staff's comments and we will revise in future findings, beginning with our Form 10-Q for the period ended June 30, 2025. 6. In future filings, please revise to provide a table quantifying each significant component included in general and administrative expenses, such as employee compensation-related costs dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and professional services, and general corporate expenses. We acknowledge that the Staff's comments and we will revise in future findings. Please let us know if you have any additional comments or questions. Sincerely, /s/ James Martin CFO / Co-CEO
2025-07-30 - UPLOAD - Cocrystal Pharma, Inc. File: 001-38418
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 James Martin Co-Chief Executive Officer and CFO Cocrystal Pharma, Inc. 19805 North Creek Parkway Bothell, WA 98011 Re: Cocrystal Pharma, Inc. Form 10-K for the fiscal year ended December 31, 2024 Form 10-K filed March 31, 2025 File No. 001-38418 Dear James Martin: We have reviewed your filing and have the following comment(s). Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the fiscal year ended December 31, 2024 Item 1. Business, page 3 1. We note several statements throughout your filing that describe your product candidates as "first-in-class" and "best-in-class." Given the early stage of development of your product candidates and the length and uncertainty of the drug approval process, it appears premature to describe your product candidates as potentially being "first-in-class" or "best-in-class." Accordingly, please remove these statements from future filings. Research and Development Update, page 5 2. We note the inclusion of "Replication Inhibitors" and "Pan-viral Inhibitors" in your pipeline table. Given the early stage of development and limited disclosure related to these programs, please explain why they are sufficiently material to your business to warrant inclusion in your pipeline table. If they are material, please expand your disclosure in the "Business" section in future filings to provide a more fulsome discussion of these programs, including a description of development activities July 30, 2025 Page 2 conducted. Alternatively, remove any programs that are not currently material from your pipeline table in future filings. 3. In future filings, please revise your pipeline table to ensure the arrow in each row accurately reflects the current status of the respective program consistent with your disclosure in the rest of the filing. For example only, we note the following: The arrow in the first row indicates that your Oral Pb2 Inhibitor CC-42344 program is nearing the end of Phase 2 clinical trials. However, your disclosure on page 5 indicates that the program is still in Phase 2a clinical trials and that you are considering the submission of a protocol amendment for the study. The arrow in the second row indicates that your Inhaled PB2 Inhibitor CC-42344 program is at the end of preclinical studies. However, your disclosure on page 39 that "[p]reclinical development is progressing" suggests that you are still in the preclinical phase. Intellectual Property, page 8 4. In future filings, please revise your discussion of your patent portfolio to disclose for each material patent and patent application the specific product(s) to which such patents or applications relate, the type of patent protection, the expiration dates and applicable jurisdictions. To the extent material, please also clarify whether you or Merck will hold any future intellectual property related to your Influenza A/B program that was developed in your prior collaboration. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and Development Expense, page 40 5. In future filings, beginning with your Form 10-Q for the period ended June 30, 2025, please disclose the costs incurred during each period presented for each of your key research and development projects. If you do not track your research and development costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by project. For costs that are not tracked and disclosed by project, please provide other quantitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. pre- clinical and clinical and by nature or type of expense) which should reconcile to total research and development expense on the Statements of Operations. General and Administrative Expense, page 41 6. In future filings, please revise to provide a table quantifying each significant component included in general and administrative expenses, such as employee compensation-related costs dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and professional services, and general corporate expenses. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence July 30, 2025 Page 3 of action by the staff. Please contact Sasha Parikh at 202-551-3627 or Christine Torney at 202-551-3652 if you have questions regarding comments on the financial statements and related matters. Please contact Jessica Dickerson at 202-551-8013 or Alan Campbell at 202-551- 4224 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2023-05-24 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Cocrystal Pharma, Inc.
19805 North Creek Parkway
Bothell, Washington 98011
May 24, 2023
Via EDGAR
Division of
Corporation Finance
Securities and
Exchange Commission
100 F Street,
N.E.
Washington,
D. C. 20549
Attention: Ms.
Lauren Hamill
Re:
Cocrystal Pharma, Inc.
Registration Statement on Form S-3
File No. 333-271883
Dear Ms. Hamill:
In
accordance with Rule 461 promulgated pursuant to the Securities Act of 1933, Cocrystal Pharma, Inc. is hereby requesting that the effective
date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:30 p.m., Eastern Time on
Friday, May 26, 2023, or as soon thereafter as may be practicable.
If
you have any questions regarding this request, please contact Michael Harris, our legal counsel at (561) 644-2222.
Very truly yours,
/s/ James Martin
James Martin
Co-Chief Executive Officer
cc:
Michael D. Harris,
Esq.
Constantine
Christakis, Esq.
2023-05-19 - UPLOAD - Cocrystal Pharma, Inc.
United States securities and exchange commission logo
May 19, 2023
James Martin
Co-Chief Executive Officer
Cocrystal Pharma, Inc.
19805 N. Creek Parkway
Bothell, WA 98011
Re:Cocrystal Pharma, Inc.
Registration Statement on Form S-3
Filed May 12, 2023
File No. 333-271883
Dear James Martin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Harris
2020-05-12 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Cocrystal
Pharma, Inc.
9805
North Creek Parkway
Bothell,
Washington
May
12, 2020
Via
EDGAR
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D. C. 20549
Attention:
Mr. Tim Buchmiller
Re:
Cocrystal
Pharma, Inc.
Registration
Statement on Form S-3
File
No. 333-237738
Dear
Mr. Buchmiller:
In
accordance with Rule 461 promulgated pursuant to the Securities Act of 1933, Cocrystal Pharma, Inc. (the “Company”)
is hereby requesting that the effective date of the above-referenced Registration Statement be accelerated so that the same will
become effective at 4:00 p.m. on May 13, 2020, or as soon thereafter as may be practicable.
If
you have any questions regarding this request, please contact Michael Harris, our legal counsel at (561) 644-2222.
Very truly yours,
/s/ James Martin
James Martin
Chief Financial Officer
cc:
Michael
D. Harris, Esq.
Constantine
Christakis, Esq.
2020-05-11 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
MICHAEL
D. HARRIS
DIRECT
DIAL:
(561)
471-3507
ALSO
ADMITTED IN NEW YORK
E-MAIL
ADDRESS: mharris@nasonyeager.com
May
11, 2020
VIA
EDGAR
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
Washington,
DC 20549
Attention:
Mr. Tim Buchmiller
Re:
Cocrystal
Pharma, Inc.
Registration
Statement on Form S-3
Filed
April 17, 2020
File
No. 333-237738
Dear
Mr. Buchmiller:
Confirming
our telephone conversation this afternoon with respect to the “futures” effect of Comment No. 4 in the Staff’s
comment letter dated April 27, 2020, this letter confirms on behalf of our client, Cocrystal Pharma, Inc. (“Cocrystal”)
that in future filings with the Commission on Form 10-K as well as any prospectus supplements or new registration statements on
Form S-3 or S-1, Cocrystal will disclose the effect of the charter amendment on exclusive jurisdiction in the same manner as it
did in Amendment No. 1 to Form S-3 filed on May 4, 2020.
If
you have any questions, please contact the undersigned at (561) 644-2222 or at mharris@nasonyeager.com.
Sincerely
yours,
NASON,
YEAGER, GERSON,
HARRIS & FUMERO, P.A.
/s/
Michael D. Harris
cc:
Dr.
Gary Wilcox (via email)
Mr.
James Martin
3001
PGA BOULEVARD, SUITE 305
PALM
BEACH GARDENS, FLORIDA 33410
TELEPHONE
(561) 686-3307
2020-05-04 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Cocrystal
Pharma, Inc.
9805
North Creek Parkway
Bothell,
Washington
May
4, 2020
Via
EDGAR
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
Washington,
DC 20549
Re:
Cocrystal
Pharma, Inc.
Registration
Statement on Form S-3
Filed
April 17, 2020
File
No. 333-237738
Dear
Mr. Buchmiller:
Please
find our response to the comments received from you in your letter dated April 27, 2020 related to the Registration Statement
on Form S-3 (the “Registration Statement”) for Cocrystal Pharma, Inc. (the “Company”) filed April 17,
2020. We have reproduced your comments below.
Registration
Statement on Form S-3
Description
of Capital Stock, page 2
1. Please
revise the prospectus to provide a description of the units. Refer to Item 9 of Form
S-3 and Item 202 of Regulation S-K.
Response
to Comment No. 1:
In
response to the staff’s comment, the requested disclosure has been added at page 4 of the prospectus.
Incorporation
of Certain Information by Reference, page 10
2. We
note that you have not incorporated by reference all applicable Exchange Act filings
made prior to the effective date of the registration statement. Please revise to incorporate
by reference your Current Reports on Form 8-K filed on January 29, 2020, January 31,
2020, February 24, 2020, March 4, 2020, March 13, 2020, April 20, 2020 and April 22,
2020. For guidance, please refer to Item 12(a)(2) of Form S-3 and Question 123.05 of
the Securities Act Forms Compliance and Disclosure Interpretations.
Securities
and Exchange Commission
May
4, 2020
Page
2
Response
to Comment No. 2:
In
response to the staff’s comment, the requested disclosure has been added at page 10 of the prospectus.
3. We
note that your registration statement incorporates by reference your Form 10-K for the
fiscal year ended December 31, 2019, which in turn incorporates by reference certain
Part III information from a definitive proxy statement that you have not yet filed. Please
be advised that we cannot accelerate the effective date of your registration statement
until you have amended your Form 10-K to include the Part III information or have filed
a definitive proxy statement which includes such information. For guidance, please refer
to Question 123.01 of the Securities Act Forms Compliance and Disclosure Interpretations.
Response
to Comment No. 3:
The
Company filed a definitive proxy statement containing the Part III information on April 28, 2020.
Exhibit
3.1 – Certificate of Incorporation, as amended, page II-2
4. We
note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please revise your prospectus to clearly describe this provision and to
describe any risks or other impacts on investors. Risks may include, but are not limited
to, increased costs to bring a claim and that these provisions can discourage claims
or limit investors’ ability to bring a claim in a judicial forum that they find
favorable. Also disclose whether this provision applies to actions arising under the
Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to enforce any duty
or liability created by the Exchange Act or the rules and regulations thereunder, and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state
courts over all suits brought to enforce any duty or liability created by the Securities
Act or the rules and regulations thereunder. If the provision applies to Securities Act
claims, please also revise your prospectus to state that there is uncertainty as to whether
a court would enforce such provision and that investors cannot waive compliance with
the federal securities laws and the rules and regulations thereunder. If this provision
does not apply to actions arising under the Securities Act or Exchange Act, please also
ensure that the exclusive forum provision in the governing document states this clearly,
or tell us how you will inform investors in future filings that the provision does not
apply to any actions arising under the Securities Act or Exchange Act.
Securities
and Exchange Commission
May
4, 2020
Page
3
Response
to Comment No. 4:
In
response to the staff’s comment, the requested disclosure has been added at page 7 of the prospectus.
Exhibit
5.1 – Legal Opinion, page II-2
5. Please
have counsel revise the opinion to opine that the warrants will be binding obligations
of the company in accordance with Section II.B.1.f of Staff Legal Bulletin No. 19, and
that the units will be binding obligations of the company in accordance with Section
II.B.1.h of Staff Legal Bulletin No. 19.
Response
to Comment No. 5:
In
response to the staff’s comment, the Company’s counsel has made the requested revisions to Exhibit 5.1.
Should
the staff have any additional questions or comments after reviewing this response letter, we would appreciate an opportunity to
discuss these comments or questions with the staff prior to the distribution of another comment letter. Please direct any questions
concerning this response letter to Michael Harris, the Company’s legal counsel, at 561-471-3507, mharris@nasonyeager.com.
Sincerely
yours,
/s/
James Martin
James
Martin, Chief Financial Officer
2020-04-27 - UPLOAD - Cocrystal Pharma, Inc.
United States securities and exchange commission logo
April 27, 2020
Gary Wilcox
Chief Executive Officer
Cocrystal Pharma, Inc.
19805 N. Creek Parkway
Bothell, WA 98011
Re:Cocrystal Pharma, Inc.
Registration Statement on Form S-3
Filed April 17, 2020
File No. 333-237738
Dear Mr. Wilcox:
We have limited our review of your registration statement to those issues we have
addressed in our 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 amending your registration statement and providing the
requested information. 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 registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3
Description of Capital Stock, page 2
1.Please revise the prospectus to provide a description of the units. Refer to Item 9 of Form
S-3 and Item 202 of Regulation S-K.
Incorporation of Certain Information by Reference, page 10
2.We note that you have not incorporated by reference all applicable Exchange Act filings
made prior to the effective date of the registration statement. Please revise to incorporate
by reference your Current Reports on Form 8-K filed on January 29, 2020, January 31,
2020, February 24, 2020, March 4, 2020, March 13, 2020, April 20, 2020 and April 22,
2020. For guidance, please refer to Item 12(a)(2) of Form S-3 and Question 123.05 of the
Securities Act Forms Compliance and Disclosure Interpretations.
FirstName LastNameGary Wilcox
Comapany NameCocrystal Pharma, Inc.
April 27, 2020 Page 2
FirstName LastName
Gary Wilcox
Cocrystal Pharma, Inc.
April 27, 2020
Page 2
3.We note that your registration statement incorporates by reference your Form 10-K for the
fiscal year ended December 31, 2019, which in turn incorporates by reference certain Part
III information from a definitive proxy statement that you have not yet filed. Please be
advised that we cannot accelerate the effective date of your registration statement until
you have amended your Form 10-K to include the Part III information or have filed a
definitive proxy statement which includes such information. For guidance, please refer to
Question 123.01 of the Securities Act Forms Compliance and Disclosure Interpretations.
Exhibit 3.1 – Certificate of Incorporation, as amended, page II-2
4.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please revise your prospectus to clearly describe this provision and to describe
any risks or other impacts on investors. Risks may include, but are not limited to,
increased costs to bring a claim and that these provisions can discourage claims or limit
investors’ ability to bring a claim in a judicial forum that they find favorable. Also
disclose whether this provision applies to actions arising under the Securities Act or
Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder, and Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state courts over all suits
brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please also revise
your prospectus to state that there is uncertainty as to whether a court would enforce such
provision and that investors cannot waive compliance with the federal securities laws and
the rules and regulations thereunder. If this provision does not apply to actions arising
under the Securities Act or Exchange Act, please also ensure that the exclusive forum
provision in the governing document states this clearly, or tell us how you will inform
investors in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
Exhibit 5.1 – Legal Opinion, page II-2
5.Please have counsel revise the opinion to opine that the warrants will be binding
obligations of the company in accordance with Section II.B.1.f of Staff Legal Bulletin No.
19, and that the units will be binding obligations of the company in accordance with
Section II.B.1.h of Staff Legal Bulletin No. 19.
FirstName LastNameGary Wilcox
Comapany NameCocrystal Pharma, Inc.
April 27, 2020 Page 3
FirstName LastName
Gary Wilcox
Cocrystal Pharma, Inc.
April 27, 2020
Page 3
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Tim Buchmiller at (202) 551-3635 or Irene Paik at (202) 551-6553 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael D. Harris, Esq.
2019-05-20 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
COCRYSTAL
PHARMA, INC.
19805
N. CREEK PARKWAY
BOTHELL,
WA 98011
May
20, 2019
Via
EDGAR
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D. C. 20549
Re:
Cocrystal
Pharma, Inc.
Registration
Statement on Form S-3
File
No. 333-231022
Ladies
and Gentlemen:
In
accordance with Rule 461 promulgated pursuant to the Securities Act of 1933, Cocrystal Pharma, Inc. is hereby requesting that
the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 9:00
AM on May 22, 2019, or as soon thereafter as is practicable.
If
you have any questions regarding this request, please contact Brian Bernstein, our legal counsel at (561) 471-3516.
Very
truly yours,
/s/
James Martin
James
Martin
Chief
Financial Officer
cc:
Brian
S. Bernstein, Esq.
Michael
D. Harris, Esq.
2019-05-02 - UPLOAD - Cocrystal Pharma, Inc.
May 2, 2019
James Martin
Chief Financial Officer
Cocrystal Pharma, Inc.
19805 N. Creek Parkway
Bothell, WA 98011
Re:Cocrystal Pharma, Inc.
Registration Statement on Form S-3
Filed April 25, 2019
File No. 333-231022
Dear Mr. Martin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Brian Bernstein, Esq.
2017-10-13 - UPLOAD - Cocrystal Pharma, Inc.
October 12, 2017 James Martin Chief Financial Officer Cocrystal Pharma, Inc. 1860 Montreal Road Tucker, GA 30084 Cocrystal Pharma, Inc. Information Statement on Schedule 14C Filed October 4, 2017 File No. 000-55158Re: Dear Mr. Martin: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence by the staff. Division of Corporation Finance Office of Healthcare & Insurance cc: Michael D. Harris, Esq. - Nason, Yeager, Gerson, White & Lioce, P.A.
2017-10-12 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
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Cocrystal
Pharma, Inc.
1860
Montreal Road
Tucker,
Georgia 30084
October
12, 2017
Via
EDGAR
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
Washington,
DC 20549
Re:
Cocrystal
Pharma, Inc.
Information
Statement on Schedule 14C
Filed
October 4, 2017
File
No. 000-55158
Dear
Ms. Paik:
Please
find our response to the comment received from you in your letter dated October 10, 2017 related to the Information Statement
on Schedule 14C (the “14C”) for Cocrystal Pharma, Inc. (the “Company”) filed October 4, 2017. We have
reproduced your comment below.
Amendment
to the Certificate of Incorporation to Effect a Reverse Stock Split
Effects
of the Reverse Stock Split, page 4
1.
We note your disclosure on page 5 that the overall effect of your proposed reverse stock
split will be an increase in authorized but unissued shares of your common stock. We also note that you filed a shelf registration
statement on Form S-3 on September 26, 2017 registering the offering and sale of $150 million in securities, including common
stock. Please disclose any plans, proposals or arrangements to issue for any purpose, including future acquisitions and/or financings,
any of the authorized shares of common stock that would become newly available following the reverse stock split.
Response
to Comment No. 1:
In
response to the staff’s comment, the Company proposes the following additional disclosure below (in bold and underlined
for the staff’s convenience):
Because
the number of authorized shares of our common stock will not be reduced, an overall effect of the Reverse Stock Split of the outstanding
common stock will be an increase in authorized but unissued shares of our common stock. These shares may be issued by our Board
in its sole discretion. See “Anti-Takeover Effects of the Reverse Stock Split” below. Although the Company has
no specific plans for the issuance of the common stock which would become newly available as a result of the reverse stock split,
it anticipates raising capital in the near future in order to fund its operations. The Company continues to engage in preliminary
discussions with potential investors and broker-dealers but no terms have been agreed upon. Any future issuance will have
the effect of diluting the percentage of stock ownership and voting rights of the present holders of our common stock.
Securities
and Exchange Commission
October
12, 2017
Page
2
Should
the staff have any additional questions or comments after reviewing this response letter, we would appreciate an opportunity to
discuss these comments or questions with the staff prior to the distribution of another comment letter. Please direct any questions
concerning this response letter to Brian Bernstein, the Company’s legal counsel, at 561-471-3516, bbernstein@nasonyeager.com.
Sincerely
yours,
/s/
James Martin
James
Martin, Chief Financial Officer
2017-10-11 - UPLOAD - Cocrystal Pharma, Inc.
October 10, 2017 James Martin Chief Financial Officer Cocrystal Pharma, Inc. 1860 Montreal Road Tucker, GA 30084 Cocrystal Pharma, Inc. Information Statement on Schedule 14C Filed October 4, 2017 File No. 000-55158Re: Dear Mr. Martin: We have limited our review of your filing to those issues we have addressed in the following comment. Please respond to this comment within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this comment, we may have additional comments. Preliminary Information Statement on Schedule 14C filed October 4, 2017 Amendment to the Certificate of Incorporation to Effect a Reverse Stock Split Effects of the Reverse Stock Split, page 4 1. We note your disclosure on page 5 that the overall effect of your proposed reverse stock split will be an increase in authorized but unissued shares of your common stock. We also note that you filed a shelf registration statement on Form S-3 on September 26, 2017 registering the offering and sale of $150 million in securities, including common stock. Please disclose any plans, proposals or arrangements to issue for any purpose, including future acquisitions and/or financings, any of the authorized shares of common stock that would become newly available following the reverse stock split. James Martin Cocrystal Pharma, Inc. October 10, 2017 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Michael D. Harris, Esq. - Nason, Yeager, Gerson, White & Lioce, P.A.
2017-10-05 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
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Cocrystal
Pharma, Inc.
1860
Montreal Road
Tucker,
Georgia 30084
October
5, 2017
Via
EDGAR
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D. C. 20549
Attention:
Ms. Ada Sarmento
Re:
Registration
Statement on Form S-3;
File
No. 333-220632
Dear
Ms. Sarmento:
In
accordance with Rule 461 promulgated pursuant to the Securities Act of 1933, Cocrystal Pharma, Inc. (the “Company”)
is hereby requesting that the Company’s Registration Statement on Form S-3 (File No. 333-220632)
filed on September 26, 2017 be made effective on October 9, 2017 at 4:00 p.m., or as soon
thereafter as may be practicable.
The
Company acknowledges that:
●
should
the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
●
the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not
relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
●
the
Company may not assert the staff comments and the declaration of effectiveness as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
If
you have any questions regarding this request, please contact Brian Bernstein, our legal counsel at (561) 471-3516.
Very
truly yours,
/s/
James Martin
James
Martin
Chief
Financial Officer
cc:
Brian
S. Bernstein, Esq.
Michael
D. Harris, Esq.
2017-10-05 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Cocrystal
Pharma, Inc.
1860
Montreal Road
Tucker,
Georgia 30084
October
5, 2017
Via
EDGAR
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
Washington,
DC 20549
Re:
Cocrystal
Pharma, Inc.
Registration
Statement on Form S-3
Filed
September 26, 2017
File
No. 333-220632
Dear
Ms. Sarmento:
Please
find our response to the comment received from you in your letter dated October 3, 2017 related to the Registration Statement
on Form S-3 for Cocrystal Pharma, Inc. (the “Company”) filed September 26, 2017. We have reproduced your comment below.
Exhibits
1.We
note that the legality opinion filed as Exhibit 5.1 states that the warrants and units will be “validly issued, fully paid
and non-assessable.” Please file a revised legality opinion that opines that the warrants and units are binding obligations
of the registrant under the law of the jurisdiction governing the respective securities. For guidance, refer to Sections II.B.1.f
and II.B.1.h of Staff Legal Bulletin No. 19.
Response
to Comment No. 1:
In
response to the staff’s comment, the Company has filed an amendment to the Registration Statement including a revised
Exhibit 5.1 with the following additional disclosure:
Any
series of warrants or Units offered or sold pursuant to the Registration Statement will constitute valid and legally binding obligations
of the Company, enforceable against the Company in accordance with their respective terms in accordance the laws of the State
of Delaware including the Delaware General Corporation Law.
The
Company acknowledges that:
●
the
Company is responsible for the adequacy and accuracy of the disclosure in the filing;
●
staff
comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with
respect to the filing; and
Securities
and Exchange Commission
October
5, 2017
Page
2
●
the
Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Should
the staff have any additional questions or comments after reviewing this response letter, we would appreciate an opportunity to
discuss these comments or questions with the staff prior to the distribution of another comment letter. Please direct any questions
concerning this response letter to Brian Bernstein, the Company’s legal counsel, at 561-471-3516, bbernstein@nasonyeager.com.
Sincerely
yours,
/s/
James Martin
James
Martin, Chief Financial Officer
2017-10-03 - UPLOAD - Cocrystal Pharma, Inc.
October 3, 2017 James Martin Chief Financial Officer Cocrystal Pharma, Inc. 1860 Montreal Road Tucker, GA 30084 Cocrystal Pharma, Inc. Registration Statement on Form S-3 Filed September 26, 2017 File No. 333-220632Re: Dear Mr. Martin: We have limited our review of your registration statement to those issues we have addressed in our 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 amending your registration statement and providing the requested information. 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 registration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form S-3 Exhibits 1. We note that the legality opinion filed as Exhibit 5.1 states that the warrants and units will be "validly issued, fully paid and non-assessable." Please file a revised legality opinion that opines that the warrants and units are binding obligations of the registrant under the law of the jurisdiction governing the respective securities. For guidance, refer to Sections II.B.1.f and II.B.1.h of Staff Legal Bulletin No. 19. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. James Martin Cocrystal Pharma, Inc. October 3, 2017 Page 2 Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Ada D. Sarmento at (202) 551-3798 or Suzanne Hayes at (202) 551- 3675 with any questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Michael D. Harris, Esq.
2015-06-02 - UPLOAD - Cocrystal Pharma, Inc.
June 2 , 2015 Via E-Mail Gerald McGuire Chief Financial Officer Cocrystal Pharma, Inc. 19805 North Creek Parkway Bothell, Washington 98011 Re: Cocrystal Pharma, Inc. Preliminary Proxy Statement on Schedule 14A Filed May 20 , 2015 File No. 000-55158 Dear Mr. McGuire : We have comple ted our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all pe rsons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assista nt Director cc: Via E -Mail Michael D. Harris, Esq. Nason, Yeager, Gerson, White & Lioce, P.A.
2015-06-01 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
corresp.htm
Cocrystal Pharma, Inc.
19805 North Creek Parkway
Bothell, Washington 98011
June 1, 2015
Via EDGAR
Jeffrey P. Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
Washington, DC 20549
Re: Cocrystal Pharma, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed May 20, 2015
File No. 000-55158
Dear Mr. Riedler:
Please find our responses to the comments received from you in your letter dated May 27, 2015 related to the Preliminary Proxy Statement on Schedule 14A for Cocrystal Pharma, Inc. (the “Company”) filed May 20, 2015. We have reproduced your comments below.
1.
Please revise your disclosure in your preliminary information statement to disclose whether you have any plans, agreements, arrangements or understanding with respect to the shares of authorized stock that will become available for issuance as a result of your planned reverse stock split. If so, please disclose all material terms of such issuance(s).
Response to Comment No. 1:
In response to the staff’s comment, the Company will supplement the disclosure in the Definitive Proxy Statement on Schedule 14A by including the following paragraph at the conclusion of the discussion under Proposal 3, relating to the planned reverse stock split:
Plans for Newly Available Shares
The Company presently has no specific plans, nor has it entered into any arrangements or understandings, regarding the shares of common stock that will be newly available for issuance upon effectiveness of the Reverse Stock Split. However, the Company’s management anticipates that it will continue to raise capital to fund future operations through private or public equity offerings. Any future equity financing may be dilutive to existing shareholders.
The Company acknowledges that:
·
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
·
staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
·
the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Should the staff have any additional questions or comments after reviewing this response letter, we would appreciate an opportunity to discuss these comments or questions with the staff prior to the distribution of another comment letter. Please direct any questions concerning this response letter to Michael D. Harris, the Company’s legal counsel, at 561-471-3507, mharris@nasonyeager.com.
Sincerely yours,
/s/ Gerald McGuire
Gerald McGuire, Chief Financial Officer
2015-05-28 - UPLOAD - Cocrystal Pharma, Inc.
May 27, 2015 Via E-Mail Gerald McGuire Chief Financial Officer Cocrystal Pharma, Inc. 19805 North Creek Parkway Bothell, Washington 98011 Re: Cocrystal Pharma, Inc. Preliminary Proxy Statement on Schedule 14A Filed May 20, 2015 File No. 000-55158 Dear Mr. McGuire : We have limited our review of your preliminary information statement to the issue we have addressed in our comment. Please respond to this letter by revising the preliminary information statement . Where you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing any information you provide in response to this comment, we may have additional comments . 1. Please revise your disclosure in your preliminary information statement to disclose whether you have any plans, agreements, arrangements or understanding with respect to the shares of authorized stock that will become available for issuance as a result of your planned reverse stock split . If so, please disclose all material terms of such issuance(s). We urge all persons who are responsible for the accuracy and adequacy of the dis closure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s dis closure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accura cy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and Gerald McGuire Cocrystal Pharma, Inc. May 27 , 2015 Page 2 the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contact Staff Attorney Preston Brewer at (202) 551 -3969 , Legal Branch Chief Dan Greenspan at (202) 551 -3623 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -Mail Michael Harris , Esq. Cocrystal Pharma, Inc.
2013-02-14 - UPLOAD - Cocrystal Pharma, Inc.
February 14 , 2013 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Form 10 -K for the Fiscal Year Ended December 31, 2011 Filed April 16, 2012 File No. 333-146182 We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respe ct to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the U nited States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2013-02-13 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
February 13, 2013
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.
Amendment No. 7 to Registration Statement on Form S-1
Filed February 8, 2013
File No. 333-176951
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q for the Quarterly Period Ended September 30, 2012
Filed November 14, 2012
File No. 333-146182
Ladies and Gentlemen:
As requested by the Staff (the “Staff”), BioZone Pharmaceuticals, Inc. (the “Company”) submits the following supplement to the correspondence filed on February 12, 2013, which supplement relates to discussions raised by the Staff on the teleconference call held on February 12, 2013.
General
1.
Please provide an amended Schedule A reflecting the revisions discussed. Furthermore, please provide an explanation for the changes to the issued and outstanding shares for the periods ending March 31, 2011, June 30, 2011, September 30, 2011 and December 31, 2011
Response:
The Company provides a revised Schedule A, attached hereto, reflecting the following revisions:
·
Correction of number of shares shown as “Adjusted Balance Sheet shares outstanding” for the periods 6/30/2011, 9/30/2011 and 12/31/2011.
These amounts now match the share amounts previously filed in the Company’s financial reports on Form 10Q and 10K for the foregoing periods and shown as “Historical Balance Sheet shares outstanding” on Schedule A. In addition, we have included a reconciliation of the amounts shown as “Adjusted Balance Sheet shares outstanding” on the revised Schedule A.
·
Correction of amounts shown as “Net loss per common share – amended” for the periods 6/30/2011, 9/30/2011 and 12/31/2011.
These amounts have changed as a result of the change in the number of shares outstanding during the relevant periods.
Furthermore, the Company provides the following explanations for the changes to the issued and outstanding shares for the periods ending March 31, 2011, June 30, 2011, September 30, 2011 and December 31, 2011:
·
The Consolidated Balance Sheet included in the financial statements for the period ended March 31, 2011 filed by the Company on Form 10-Q lists 37,698,000 shares as issued and outstanding as of March 31, 2011 and December 31, 2010, respectively. As indicated in our prior correspondence, we have adjusted the Statements of Stockholders’ Deficiency to reflect the number of shares outstanding of the BioZone Labs Group, the accounting acquiror in the reverse merger. The adjustment treats the 21,000,000 shares issued to the accounting acquiror upon the reverse merger as outstanding since inception.
·
The Adjusted Balance Sheet shares outstanding for the period ended June 30, 2011, which shows 67,029,396 shares on the attached Schedule A, representing an increase of 46,029,396 shares, results from the addition of 37,698,000 shares treated as issued by the accounting acquiror in connection with the merger plus 8,331,396 shares issued by the Company to Aero Pharmaceuticals (“Aero) in exchange for all of the assets of Aero.
·
The Adjusted Balance Sheet shares outstanding for the period ended September 30, 2011, which shows 67,543,310 shares on the attached Schedule A, representing an increase of 513,914 shares, results from the issuance of shares by the Company as payment for certain expenses (500,000 shares issued to a consultant plus 13,914 shares issued as liquidated damages) .
·
The Adjusted Balance Sheet shares outstanding for the period ended December 31, 2011, which shows 55,181,165 shares on the attached Schedule A, representing a decrease of increase of 513,914 shares, results from the issuance of 2,085,856 shares by the Company in connection with financing activities less 14,448,000 shares canceled by the Company during that period (13,948,000 shares cancelled in connection with the merger plus 500,000 shares cancelled in connection with unearned consultant shares).
2.
The Company’s Statements of Changes in Shareholders’ Deficiency and Statement of Operations must be revised and filed as an amendment to the Company’s Form S-1, as amended.
Response:
The Company provides as Exhibit A and Exhibit B, attached hereto, a revised Consolidated Statement of Changes in Shareholders’ Deficiency and a revised Consolidated Statement of Operations, respectively, which the Company intends to file with the next amendment to the Form S-1. The revisions reflected in Schedule A have been incorporated into these revised Statements.
***
The Company hereby acknowledges the following:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filings;
·
Staff comments or changes to disclosures in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact the undersigned at 201-608-5101 if you have any questions or comments. Thank you.
Very truly yours,
/s/ Elliot Maza
Elliot Maza
Cc:
Harvey Kesner, Esq.
Sichenzia Ross Friedman Ference LLP
Schedule A
Biozone Pharmaceuticals, Inc.
Reflection of Adjusted Shares for previously filed financial statements
Historical Statements of Operations
Three months ended March 31, 2011
Three months ended June 30, 2011
Six months ended June 30, 2011
Three months ended September 30, 2011
Nine months ended September 30, 2011
Year ended December 31, 2011
Three months ended June 30, 2010
Six months ended June 30, 2010
Three months ended September 30, 2010
Nine months ended September 30, 2010
Net income (loss)
(13,295)
(568,402)
(1,111,609)
(2,499,703)
(3,611,312)
(5,457,310)
58,961
138,762
256,850
394,916
Net loss per common share - originally reported
(0.00)
(0.01)
(0.03)
(0.04)
(0.07)
(0.11)
0.00
0.00
0.01
0.01
Basic and diluted weighted average common shares outstanding - originally reported
44,749,999
41,388,416
39,543,208
67,492,714
49,112,016
50,443,025
37,698,000
37,698,000
37,698,000
37,698,000
Net loss per common share - amended
(0.00)
(0.03)
(0.05)
(0.04)
(0.10)
(0.12)
0.00
0.01
0.01
0.02
Basic and diluted weighted average common shares outstanding - amended
21,000,000
21,000,000
21,000,000
67,443,800
36,667,874
44,552,409
21,000,000
21,000,000
21,000,000
21,000,000
Historical Balance Sheets
12/31/2010
3/31/2010
6/30/2010
9/30/2010
3/31/2011
6/30/2011
9/30/2011
12/31/2011
Historical Balance Sheet shares outstanding
37,698,000
37,698,000
37,698,000
37,698,000
37,698,000
67,029,396
67,543,310
55,181,165
Adjusted Balance Sheet shares outstanding
21,000,000
21,000,000
21,000,000
21,000,000
21,000,000
67,029,396
67,543,310
55,181,165
Rollfoward:
Shares outstanding 3/31/11
37,698,000
Shares issued to Aero
8,331,396
Subtotal
46,029,396
Shares issued in reverse merger
21,000,000
Outstanding June 30, 2011
67,029,396
Shares issued in 3rd Quarter 2011
513,914
Outstanding September 30, 2011
67,543,310
Shares issued in 4th Quarter 2011
2,085,856
Shares Cancelled in December 2011
Consultant shares
(500,000)
ISR shares
(13,948,000)
Outstanding December 31, 2011
55,181,166
Exhibit A
BIOZONE PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN CAPITAL DEFICIENCY
Common Stock
Number of Shares
Amount
Additional paid in capital
Shareholder's defecit
Total
Balance as of December 31, 2009
21,000,000
$
21,000
$
138,998
$
(386,354
)
$
(226,356
)
Distribution
(43,031
)
(43,031
)
Net loss for year
(319,813
)
(319,813
)
Balance at December 31, 2010
21,000,000
21,000
95,967
(706,167
)
(589,200
)
Effect of Reverse Merger
46,029,396
46,029
1,953,971
2,000,000
Shares issued to consultant
500,000
500
1,949,500
1,950,000
Shares issued for liquidated damages
13,914
14
6,943
6,957
Proceeds from sale of common stock
955,000
955
704,045
705,000
Shares issued to extend maturity date
of convertible notes payable
112,500
113
56,137
56,250
Shares issued upon conversion of
convertible note payable
1,018,356
1,018
508,160
509,178
Shares cancelled to consultant
(500,000
)
(500
)
(1,949,500
)
(1,950,000
)
Cancellation of ISR shares
(13,948,000
)
(13,948
)
13,948
-
Net loss for the year
(5,457,310
)
(5,457,310
)
Balance at December 31, 2011
55,181,166
$
55,181
$
3,339,171
$
(6,163,477
)
$
(2,769,125
)
Exhibit B
BIOZONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Year Ended December 31,
2011
2010
Sales
$
12,605,146
$
15,253,685
Cost of sales
(8,639,658
)
(8,427,608
)
Gross profit
3,965,488
6,826,077
0.448
Operating Expenses:
General and adminstrative expenses
7,452,864
6,617,249
Research and development expenses
399,624
240,873
7,852,488
6,858,122
Income (Loss) from operations
(3,887,000
)
(32,045
)
Interest expense
(1,242,853
)
(439,018
)
Change in fair value of derivative liability
(281,508
)
-
Equity in earnings (loss) of unconsolidated subsidiary
(42,677
)
55,305
Income (Loss) before provision for income taxes
(5,454,038
)
(415,758
)
Provision for income taxes
3,272
95,945
Net loss
(5,457,310
)
(319,813
)
Income (Loss) per common share
$
(0.12
)
$
(0.02
)
Basic and diluted weighted average common share outstanding
44,552,409
21,000,000
2013-02-13 - CORRESP - Cocrystal Pharma, Inc.
CORRESP 1 filename1.htm BioZone Pharmaceuticals, Inc. 550 Sylvan Avenue, Suite 101 Englewood Cliffs, NJ 07632 February 13, 2013 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Jennifer Riegel Jeffery P. Riedler Re: BioZone Pharmaceuticals, Inc. Registration Statement on Form S-1 File No. 333-176951 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), BioZone Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:30 pm., Washington D.C. time, on February 14, 2013, or as soon thereafter as possible. The Company acknowledges that: 1) should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; 2) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and 3) the Company may not assert the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. BIOZONE PHARMACEUTICALS, INC. By: /s/ Elliot Maza Name: Elliot Maza Title: Chief Executive Officer
2013-02-12 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
February 12, 2013
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.
Amendment No. 7 to Registration Statement on Form S-1
Filed February 8, 2013
File No. 333-176951
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q for the Quarterly Period Ended September 30, 2012
Filed November 14, 2012
File No. 333-146182
Ladies and Gentlemen:
As requested by the Staff (the “Staff”), BioZone Pharmaceuticals, Inc. (the “Company”) submits the following responses to the discussions relating to the Company’s Registration Statement on Form S-1, as amended (the “Registration Statement”) raised on the teleconference call held on February 8, 2013.
General
1.
Please provide a schedule of the “as reported” and “adjusted” financial information impacted by the revisions included in the Amendment No. 7 to the Registration Statement (the “Amendment”).
Response:
The Company provides the requested information on Schedule A, attached hereto.
2.
Please provide an explanation for the period over period changes to the Company’s issued and outstanding shares.
Response:
The adjustment to the Statements of Stockholders’ Deficiency contained in the Amendment reflects a revised presentation of the number of shares outstanding of the BioZone Labs Group, the accounting acquiror in the reverse merger. The adjustment treats the 21,000,000 shares issued to the accounting acquiror upon the reverse merger as outstanding since inception in lieu of the BioZone Labs Group’s actual shares outstanding. As the BioZone Labs Group did not issue any shares during any of the periods presented in the Statements of Stockholders’ Deficiency contained in the Amendment, all of the 21,000,000 shares are shown as outstanding as of December 31, 2009, the earliest period presented. The outstanding shares of BioZone Pharmaceuticals, Inc., the legal acquiror, are presented in a separate line item as of the date of the merger.
The 21 million shares were the only shares of the accounting acquiror outstanding prior to the merger, which occurred on June 30, 2011. Additional shares are presented in the periods following the merger to reflect additional transactions that occurred during those periods. The following explanations are provided to clarify the changes to the issued and outstanding shares reflected in Schedule A:
·
The increase in the issued and outstanding shares between 3/31/2011 and 6/30/2011 represents the 32,081,395 shares issued in connection with the merger.
·
The decrease in the issued and outstanding shares between 9/30/2011 and 12/31/2011 as originally reported is a result of the cancellation of 13,948,000 shares held by prior owners of International Surf Resorts Inc., the legal acquiror (prior to name change), the cancellation of 500,000 shares previously issued to a consultant to the Company and the issuance of 2,085,856 shares in connection with financing activities.
3.
Please provide a clear analysis and conclusion discussing the “materiality” of the revisions included in the Amendment.
Response:
The Amendment contains a revised presentation of the number of shares shown as outstanding as of December 31, 2009 through December 1, 2011 in the Statements of Changes in Shareholders’ Deficiency. Specifically, we reduced the number of shares outstanding as of December 31, 2009, the first date of the Statements, from 44,749,999 to 21,000,000 to accurately reflect the number of shares issued to the owners of the BioZone Labs Group, the accounting acquiror. Also, we revised the Statements of Changes in Shareholders’ Deficiency to present adjusted par value and APIC dollar amounts of the common stock outstanding based on the revised number of shares outstanding as of December 31, 2009.
The Amendment contains a revised presentation of Net Loss per Common Share contained in the Statements of Operations to reflect the revised number of common shares shown as outstanding as of December 31, 2009. Importantly, the dollar amount of the overall net loss remains correct as originally presented.
The revisions in the Statements of Changes in Shareholders’ Deficiency do not change the overall net loss reported by the Company or any of the financial statements filed as part of the Amendment other than the Statements of Operations. The impact of the revisions to the Statements of Operations is limited to the dollar amounts shown as “Net loss per common share” and the number of shares shown as “Basic and diluted weighted average common shares outstanding”. The change in “Basic and diluted weighted average common shares outstanding” is a change in presentation, which should not affect the judgment of a reasonable person relying upon such Statements.
Schedule A shows the change in Net loss per common share for each period presented. In no period is the change in Net loss per common share greater than 0.04. In some periods, Net loss per common share has changed by more than 5% as compared to the Net loss per common share as originally reported. However, as is indicated in SEC Staff Accounting Bulletin No 99, the 5% "rule of thumb" is but an initial step in assessing materiality.
We analyzed the qualitative considerations enumerated in SEC Staff Accounting Bulletin No 99 and believe that none of the considerations contain therein that may render material quantitatively small misstatements of a financial statement item apply. We believe that the qualitative considerations should determine the basis for materiality in the case of the misstatement of the Company’s loss per common share notwithstanding the change of more than 5% because the amount of the Company’s overall loss is unchanged.
Our analysis of the qualitative considerations is presented below.
·
whether the misstatement arises from an item capable of precise measurement or whether it arises from an estimate and, if so, the degree of imprecision inherent in the estimate
The misstatement arises from a change in presentation of common stock outstanding, an item capable of precise measurement, rather than any estimate performed by the Company.
·
whether the misstatement masks a change in earnings or other trends
The misstatement results in an understatement of Net loss per common share in the periods presented as shown on Schedule A attached hereto. However, the misstatement does not impact overall net loss and does not mask the trend of continued losses from operations.
·
whether the misstatement hides a failure to meet analysts' consensus expectations for the enterprise
The Company’s stock is closely held and thinly traded and no analysts write any published or unpublished research on the Company.
·
whether the misstatement changes a loss into income or vice versa
The misstatement does not change a loss into income or vice versa
·
whether the misstatement concerns a segment or other portion of the registrant's business that has been identified as playing a significant role in the registrant's operations or profitability
The misstatement concerns the enterprise as a whole, which reports its operations under a single segment. However, it does not impact the overall results of the Company’s operations.
·
whether the misstatement affects the registrant's compliance with regulatory requirements
The Company is not subject to any regulatory requirements for which income or loss per common share is relevant.
·
whether the misstatement affects the registrant's compliance with loan covenants or other contractual requirements
The Company has no loan covenants that are impacted by the amount of income or loss per common share.
·
whether the misstatement has the effect of increasing management's compensation – for example, by satisfying requirements for the award of bonuses or other forms of incentive compensation
Management compensation is not tied to income or loss per common share
·
whether the misstatement involves concealment of an unlawful transaction.
The misstatement does not involve concealment of an unlawful transaction.
We have determined, after a full analysis of all relevant qualitative and quantitative considerations that the changes in Net loss per common share are immaterial to the financial statements taken as a whole. In our opinion, there is little likelihood that a reasonable person would consider these changes important and that the judgment of a reasonable person relying upon the reports would have been changed or influenced by the presentation of the correction of this item. Accordingly, we do not believe a restatement of the financial statements is required.
Furthermore, the Company believes that, consistent with the Exchange Act, it is unnecessary to incur the costs of amending any prior filings to adjust for this immaterial adjustment.
***
The Company hereby acknowledges the following:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filings;
·
Staff comments or changes to disclosures in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact the undersigned at 201-608-5101 if you have any questions or comments. Thank you.
Very truly yours,
/s/ Elliot Maza
Elliot Maza
Cc: Harvey Kesner, Esq.
Sichenzia Ross Friedman Ference LLP
Schedule A
Biozone Pharmaceuticals, Inc.
Reflection of Adjusted Shares for previously filed financial statements
Historical Statements of Operations
Three months ended March 31, 2011
Three months ended June 30, 2011
Six months ended June 30, 2011
Three months ended September 30, 2011
Nine months ended September 30, 2011
Year ended December 31, 2011
Three months ended June 30, 2010
Six months ended June 30, 2010
Three months ended September 30, 2010
Nine months ended September 30, 2010
Net income (loss)
(13,295
)
(568,402
)
(1,111,609
)
(2,499,703
)
(3,611,312
)
(5,457,310
)
58,961
138,762
256,850
394,916
Net loss per common share - originally reported
(0.00
)
(0.01
)
(0.03
)
(0.04
)
(0.07
)
(0.11
)
0.00
0.00
0.01
0.01
Basic and diluted weighted average common shares outstanding - originally reported
44,749,999
41,388,416
39,543,208
67,492,714
49,112,016
50,443,025
37,698,000
37,698,000
37,698,000
37,698,000
Net loss per common share - amended
(0.00
)
(0.03
)
(0.05
)
(0.05
)
(0.11
)
(0.14
)
0.00
0.01
0.01
0.02
Basic and diluted weighted average common shares outstanding - amended
21,000,000
21,000,000
21,000,000
53,082,757
31,967,449
37,638,469
21,000,000
21,000,000
21,000,000
21,000,000
Historical Balance Sheets
12/31/2010
3/31/2010
6/30/2010
9/30/2010
3/31/2011
6/30/2011
9/30/2011
12/31/2011
Historical Balance Sheet shares outstanding
37,698,000
37,698,000
37,698,000
37,698,000
37,698,000
67,029,396
67,543,310
55,181,165
Adjusted Balance Sheet shares outstanding
21,000,000
21,000,000
21,000,000
21,000,000
21,000,000
53,081,395
53,095,309
55,181,165
2013-02-08 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
February 8, 2013
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.
Amendment No. 6 to Registration Statement on Form S-1
Filed January 31, 2013
File No. 333-176951
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q for the Quarterly Period Ended September 30, 2012
Filed November 14, 2012
File No. 333-146182
Ladies and Gentlemen:
The following response addresses the comment of the Staff (the “Staff”) provided verbally by the Staff on February 6, 2013 (the “Verbal Comment”) relating to the above referenced files. BioZone Pharmaceuticals, Inc. (the “Company”) is simultaneously filing Amendment No.7 to the Registration Statement (the “Amendment”).
The following sets forth the response of the Company to the Verbal Comment.
General
1.
Please revise your filing to accurately reflect the acquisition in the Statements of Changes in Shareholders’ Deficiency. Prior to the acquisition, the historical common stock should reflect that of BioZone Lab Group, recast to reflect the exchange ratio. In addition, prior to the acquisition, the accumulated deficit and total shareholders’ deficiency should reflect that of BioZone Lab Group. The shares issued for the acquisition should be the amount of common stock of BioZone Pharma outstanding just prior to the acquisition and the A.P.I.C. amount is the difference between the par value of the number of BioZone Pharma shares outstanding and the 2,000,000 net asset fair value of BioZone Pharma. Please also ensure that any changes resulting from the above get reflected in the historical E.P.S. calculations.
Response:
The Amendment contains revisions to accurately reflect the acquisition in the Statements of Changes in Shareholders’ Deficiency. In addition, revisions were made to the accumulated deficit and total shareholders’ deficiency to reflect that of BioZone Lab Group. Furthermore, the Amendment contains revisions to reflect common stock outstanding prior to the acquisition and the corresponding A.P.I.C adjustments. The E.P.S. calculations were adjusted in the Amendment to reflect the changes resulting from the above.
We determined that the effect of the correction of the presentation of the weighted average number of shares outstanding on the Registrant’s statement of operations would have no effect on the net loss reported and would only increase the net loss per share by $.03 and $.01 for the years ended December 31, 2011 and 2010, respectively. The correction would have no effect on the Registrant’s balance sheet and the only effect on the Statement of Stockholders’ Equity would be the presentation of the number of shares of common stock outstanding at the beginning of the period and as a result of the reverse merger.
We analyzed the qualitative considerations enumerated in SEC Staff Accounting Bulletin No 99 and believe that none of the considerations enumerated below that may render material quantitatively small misstatements of a financial statement item apply:
-whether it arises from an estimate and, if so, the degree of imprecision inherent in the estimate
-whether the misstatement masks a change in earnings or other trends
-whether the misstatement hides a failure to meet analysts' consensus expectations for the enterprise
-whether the misstatement changes a loss into income or vice versa
-whether the misstatement concerns a segment or other portion of the registrant's business that has been identified as playing a significant role in the registrant's operations or profitability
-whether the misstatement affects the registrant's compliance with regulatory requirements
-whether the misstatement affects the registrant's compliance with loan covenants or other contractual requirements
-whether the misstatement has the effect of increasing management's compensation, for example, by satisfying requirements for the award of bonuses or other forms of incentive compensation
-whether the misstatement involves concealment of an unlawful transaction
We determined, after a full analysis of all relevant qualitative and quantitative considerations, that these amounts are immaterial to the financial statements taken as a whole as there is, in our opinion, little likelihood that a reasonable person would consider it important and that the judgment of a reasonable person relying upon the report would have been changed or influenced by the inclusion or correction of the item. As explained above, we do not believe a restatement of the financial statements is required.
Furthermore, the Company believes that, consistent with the Exchange Act, it is unnecessary to incur the costs of amending any prior filings to adjust for this small immaterial adjustment.
***
The Company hereby acknowledges the following:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filings;
·
Staff comments or changes to disclosures in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact the undersigned at 201-608-5101 if you have any questions or comments. Thank you.
Very truly yours,
/s/ Elliot Maza
Elliot Maza
Cc:
Harvey Kesner, Esq.
Sichenzia Ross Friedman Ference LLP
2013-01-31 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
January 30, 2013
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.
Amendment No. 5 to Registration Statement on Form S-1
Filed January 14, 2013
File No. 333-176951
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q for the Quarterly Period Ended September 30, 2012
Filed November 14, 2012
File No. 333-146182
Ladies and Gentlemen:
The following responses address the comments of the Staff (the “Staff”) as set forth in its letter dated January 24, 2013 (the “Comment Letter”) relating to the above referenced files. BioZone Pharmaceuticals, Inc. (the “Company”) is simultaneously filing Amendment No.6 to the Registration Statement (the “Amendment”). On behalf of the Company, we respond as set forth below.
The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
General
1.
Since you are a reporting company subject to the requirements of the Securities Exchange Act of 1934, you should respond to comment 3 in this letter which applies 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.
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.
Executive Compensation, page 29
2.
Please revise your Executive Compensation discussion to provide executive compensation disclosure for the 2012 fiscal year. For guidance, please refer to Regulation S-K Compliance and Disclosure Interpretations, Question 117.05.
Response
We have revised our Executive Compensation discussion to provide executive compensation disclosure for the 2012 fiscal year.
Note 2. Business Description and Going, page F-4
3.
We note your response to prior comment 3. Please revise this disclosure to reference the fair value of the assets and liabilities, including the goodwill and intangibles, at the time of the acquisition with BioZone Labs and not the prior Aero Pharmaceuticals transaction. This allocation should be based on the consideration exchanged for 100% of Biozone Labs and not the value of the consideration exchanged during the Aero acquisition. Please revise your filing accordingly. Also, please revise Note 1 on page F-20.
Response
We have revised our reference to the fair value of the assets and liabilities, including the goodwill and intangibles, at the time of the acquisition with BioZone Labs and not the prior Aero Pharmaceuticals transaction.
***
The Company hereby acknowledges the following:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filings;
·
Staff comments or changes to disclosures in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact the undersigned at 201-608-5101 if you have any questions or comments. Thank you.
Very truly yours,
/s/ Elliot Maza
Elliot Maza
Cc:
Harvey Kesner, Esq.
Sichenzia Ross Friedman Ference LLP
2013-01-24 - UPLOAD - Cocrystal Pharma, Inc.
January 24, 2013 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment No. 5 to Registration Statement on Form S -1 Filed January 14, 2013 File No. 333-176951 Form 10 -K for the Fiscal Year Ended December 31, 2011 Filed April 16, 2012 File No. 333-146182 Form 10 -Q for the Quarterly Period Ended September 30, 2012 Filed November 14, 2012 File No. 333 -146182 Dear Mr. Maza : We have reviewed your amended registration statement and response letter and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewi ng any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Amendment No. 5 to Registration Statement on Form S -1 General 1. Since you are a reporting company subject to th e requirements of the Securities Exchange Act of 1934 , you should respond to comment 3 in this letter which applies to the disclosure included in your Form 10 -K or Form 10 -Q within ten business days by Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 24, 2013 Page 2 providing the requested information or by advising us when you will provide the requested response. Executive Compensation, page 29 2. Please revise your Executive Compensation discussion to provide executive compensation disclosure for the 2012 fiscal year. For guidance, please refer to Regulation S -K Compliance and Disclosure Interpretations, Question 117.05. Note 2. Business Desc ription and Going, page F -4 3. We note your response to prior comment 3. Please revise this disclosure to reference the fair value of the assets and liabilities, including the goodwill and intangibles, at the time of the acquisition with BioZone Labs and no t the prior Aero Pharmaceuticals transaction. This allocation should be based on the consideration exchanged for 100% of Biozone Labs and not the value of the consideration exchanged during the Aero acquisition. Please revise your filing accordingly. Also, please revise Note 1 on page F - 20. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effect ive, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 24, 2013 Page 3 the Securities Act of 1933 and th e Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the regist ration statement. You may contact Dana Hartz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at ( 202) 551 -3575, or me at (202) 551 - 3710 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Harvey J. Kesner, Esq. 61 Broadway, 32nd Floor New York, NY 10006
2013-01-14 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
January 14, 2013
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.
Amendment No. 4 to Registration Statement
on Form S-1
Filed November 29, 2012
File No. 333-176951
Form 10-K for the Fiscal Year Ended
December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q for the Quarterly Period Ended
September 30, 2012
Filed November 14, 2012
File No. 333-146182
Ladies and Gentlemen:
The following responses address the comments
of the Staff (the “Staff”) as set forth in its letter dated December 11, 2012 (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 and amended on December 19, 2011, July 2, 2012, September 28, 2012 and
November 29, 2012. The Company is simultaneously filing Amendment No.5 to the Registration Statement (the “Amendment”).
The Company’s responses are set forth below.
The numbers of the responses in this letter
correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
Amendment No. 4 to 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 all comments in this letter which 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.
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.
BioZone Pharmaceuticals, Inc. Consolidated Balance Sheets, page
F-2
2. We note your response to prior comment 6. Given that you determined BioZone Labs Group to be
the accounting acquirer and that the Aero Pharmaceuticals, Inc. transaction with BioZone Pharmaceuticals occurred before the reverse
merger with BioZone Labs, the financial statement of BioZone Pharmaceuticals Inc. should not make any reference to the acquisition
of Aero Pharmaceuticals or any previously recorded goodwill and intangible assets from the Aero acquisition. The acquisition between
BioZone Pharmaceuticals and BioZone Labs should have been recorded at the fair value of the assets and liabilities and any goodwill
and intangibles in the balance sheet should have been recorded at the time of the acquisition with BioZone Labs and not the prior
Aero Pharmaceuticals transaction. Please revise your filing accordingly.
1
Response:
The Company has amended its financial statements to properly
reflect the acquisition between BioZone Pharmaceuticals, Inc. and BioZone Laboratories to record the fair value of the assets and
liabilities of BioZone Pharmaceuticals (the accounting acquiree) at June 30, 2011. We are revising Note 1 to the financial statements
as of and for the year ended December 31, 2011 and Note 2 to the interim financial statements for the period ended September 30,
2012 in Amendment No.5 to the Registration Statement.
The consolidated balance sheets included in the filing
will not be affected due to the fact that the fair value of the assets and liabilities of BioZone Pharmaceuticals that are being
recorded is the same value as the previously recorded amounts that were referred to in the Aero Pharmaceuticals acquisition.
Business Description and Going Concern, page F-4
3. Previously you disclosed that you acquired 100% of the outstanding common stock of BioZone Laboratories,
Inc. on June 30, 2011 and in your most recent S-1, the date now states that the acquisition occurred on September 30, 2011. Please
confirm the date of the acquisition and confirm that your financial statements reflect the acquisition as of that date.
Response:
The Company has amended its financial statements to properly
reflect that the acquisition between BioZone Pharmaceuticals, Inc. and BioZone Laboratories occurred on June 30, 2011. The reference
to September 30, 2011 was an error.
Note 7. Convertible Notes Payable, page F-9
4. We note your response to prior comment 8. Please provide us a detailed analysis and disclose
how you determined that the conversion features of the convertible notes are indexed to your own stock and therefore, not considered
a derivative instrument. Cite each literature you are using to conclude why you do not believe the conversion option needs to be
bifurcated.
Response:
In accordance with ASC 815-10-15, a conversion option
that has a right to a fixed number of shares is considered indexed to the issuer’s stock because the value of the financial
instrument is based upon the value of the underlying shares. The Company’s convertible notes are convertible into a fixed
number of shares, which is calculated as the principal amount of the note divided by the conversion amount of $.20, resulting in
a fixed number of shares being issued.
Note 12 – Contingencies
Litigation, page F-13
5. We note your response to prior comment 11. Please clarify for each pending litigation discussed
an estimate of the range of loss or clarify that such an estimate cannot be made.
Response:
We are unable to provide an estimate of loss contingency
at this time and have revised the disclosure in our filing to comply with ASC 450.
***
The Company hereby acknowledges the following:
· The
Company
is
responsible
for
the
adequacy
and
accuracy
of
the
disclosures
in
the
filings;
· Staff
comments
or
changes
to
disclosures
in
response
to
staff
comments
do
not
foreclose
the
Commission
from
taking
any
action
with
respect
to
the
filings;
and
· The
Company
may
not
assert
staff
comments
as
a
defense
in
any
proceeding
initiated
by
the
Commission
or
any
person
under
the
federal
securities
laws
of
the
United
States.
2
Please do not hesitate to contact the undersigned
at 201-608-5101 or the Company’s counsel, Jay Yamamoto at 646-810-0604, if you have any questions or comments. Thank you.
Very truly yours,
/s/ Elliot Maza
Elliot Maza
Cc: Harvey Kesner, Esq.
Sichenzia Ross Friedman Ference LLP
3
2013-01-09 - CORRESP - Cocrystal Pharma, Inc.
CORRESP 1 filename1.htm January 8, 2013 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Attention: Rose Zukin Jennifer Riegel Jeffrey P. Riedler Re: Biozone Pharmaceuticals, Inc. Amendment No. 4 to Registration Statement on Form S-1 Filed November 29, 2012 File No. 333-176951 Form 10-K for the Fiscal Year Ended December 31, 2011 Filed April 16, 2012 File No. 333-146182 Form 10-Q/A for the Quarterly Period Ended June 30, 2012 Filed September 28, 2012 File No. 333-146182 Ladies and Gentlemen: BioZone Pharmaceuticals, Inc. (the “Company”) is in receipt the comments of the Staff (the “Staff”) as set forth in its letter dated December 11, 2012 (the “Comment Letter”) relating to the above referenced files. In order to respond to the Comment Letter, the Company intends to address the Staff’s comments by filing a correspondence and Amendment No. 5 to the above referenced Registration Statement on Form S-1 by January 14, 2013. Furthermore, the Company intends to amend, as necessary, its above referenced Form 10-K and Form 10-Q as soon as all accounting treatment and comments by the Staff are settled and corresponding amendments can be appropriately made to those filings. Please do not hesitate to contact the undersigned at 201-608-5101 if you have any questions or comments. Thank you. Very truly yours, /s/ Elliot Maza Elliot Maza Cc: Harvey Kesner, Esq. Sichenzia Ross Friedman Ference LLP
2012-12-11 - UPLOAD - Cocrystal Pharma, Inc.
December 11, 2012 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment No. 4 to Registration Statement on Form S -1 Filed November 29 , 2012 File No. 333-176951 Form 10 -K for the Fiscal Year Ended December 31, 2011 Filed April 16, 2012 File No. 333 -146182 Form 10 -Q for the Quarterly Period Ended September 30, 2012 Filed November 14 , 2012 File No. 333-146182 Dear Mr. Maza : We have reviewed your amended registration statement and response letter 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 amending your registration statement and providing the requested information . If you do not believe our comments apply to your fa cts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Amendment No. 4 to 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 all comments in this letter which apply to the Mr. Elliot Maza Biozone Pharmaceuticals, Inc. December 11, 2012 Page 2 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. Biozone Pharmaceuticals, Inc. Consolidated Balance Sheets, page F -2 2. We note your response to prior comment 6. Given that you determined BioZone Labs Group to be the accounting acquirer and that the Aero Pharmaceuticals, Inc. transaction with Biozone Pharmaceuticals occurred before the reverse merger with BioZone Labs, the financial statement of Biozone Pharmaceuticals Inc. should not make any reference to the acquisition of Aero Pharmaceuticals or any previously recorded goodwill and intangible assets from the Aero acquisition. The acquisition between Biozone Pharmaceutic als and BioZone Labs should have been recorded at the fair value of the assets and liabilities and any goodwill and intangibles in the balance sheet should have been recorded at the time of the acquisition with BioZone Labs and not the prior Aero Pharmaceu ticals transaction. Please revise your filing accordingly. Business Description and Going Concern, page F -4 3. Previously you disclosed that you acquired 100% of the outstanding common stock of BioZone Laboratories, Inc. on June 30, 201 1 and in your most recent S -1, the date now states that the acquisition occurred on September 30, 201 1. Please confirm the date of the acquisition and confirm that your financial statements reflect the acquisition as of that date. Note 7. Convertible Notes Payable, page F-9 4. We note your response to prior comment 8. Please provide us a detailed analysis us and disclose how you determined that the conversion features of the convertible notes are indexed to your own stock and therefore, not considered a derivative instrum ent. Cite each literature you are using to conclude why you do not believe the conversion option needs to be bifurcated. Note 12 – Contingencies Litigation, page F -13 5. We note your response to prior comment 11. Please clarify for each pending litigatio n discussed an estimate of the range of loss or clarify that such an estimate cannot be made. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disc losures they have made. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. December 11, 2012 Page 3 Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding reque sts for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securitie s Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effectiv e date of the registration statement. You may contact Dana Hartz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at (202) 551 -3575, or me at (202) 551 - 3710 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Harvey J. Kesner, Esq. 61 Broadway, 32nd Floor New York, NY 10006
2012-11-13 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
November 13, 2012
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.
Amendment No. 3 to Registration Statement on Form S-1
Filed September 28, 2012
File No. 333-176951
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed April 16, 2012
File No. 333-146182
Form 10-Q/A for the Quarterly Period Ended June 30, 2012
Filed September 28, 2012
File No. 333-146182
Ladies and Gentlemen:
The following responses address the comments of the Staff (the “Staff”) as set forth in its letter dated October 11, 2012 (the “Comment Letter”) relating to the above referenced files. BioZone Pharmaceuticals, Inc. (the “Company”) intends to file Amendment No. 4 to the Registration Statement (the “Amendment”) by November 16, 2012. On behalf of the Company, we respond as set forth below.
The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
General
1.
Since you are a reporting company subject to the requirements of the Securities Exchange Act of 1934, you should respond to comments 2 through 14 in this letter which 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.
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.
We note your response to prior comment 5. Please clarify whether or not you recognized a gain or loss with the transfer of your 55% ownership in ISR de Mexico, S. R.L. de C. V., a Mexican corporation that was owned by the Company during the period prior to February 22, 2011, in return for and cancellation of 13,948,001 shares of the Company’s common stock. Please provide the journal entries you made to record the transfer at the time of the Aero transaction.
Response
We did not recognize any gain or loss with the transfer of our 55% ownership in ISR de Mexico.
1
In December 2006, the Company, f/n/a International Surf Resorts, Inc. (“ISR”), acquired real property in Mexico for $57,500 to develop and potentially operate as a surf camp. During the year ended December 31, 2007, ISR incurred additional costs of $3,835 related to the transfer of the property to ISR de Mexico.
We treated the transaction as a transfer of ISR de Mexico to certain former shareholders of the Company at historical cost in exchange for cancellation of their equity. We recorded the transfer in December 2011 at the time of the transfer of legal control. Our quarterly reports for the periods ended June 30, 2011 and September 30, 2011 filed on Form 10-Q reflect these shares as outstanding. Our journal entry to record the transfer in December 2011 was:
Common stock $13,948
Paid in Capital $47,387
Investment in real property $61,335
3.
You state that in December 2011, the Company transferred its 55% ownership in ISR de Mexico, S. R.L. de C. V., a Mexican corporation that was owned by the Company during the period prior to February 22, 2011, in return for and cancellation of 13,948,001 shares of the Company’s common stock from former shareholders of the Company but that you recorded the transaction at the time of the Aero acquisition in May 2011 because that was the intent of the Company. It appears that the actual transfer of ownership of ISR de Mexico, S.R.L. de C.V. did not occur until December 2011 and should be accounted for in the period the transaction occurred. Please tell us when you legally relinquished control and why you believe you have recorded the transfer in the appropriate period.
Response
Please see Response to Comment 2. We stated incorrectly that we recorded the transaction at the time of the Aero acquisition in May 2011. In fact, we recorded the transaction in December 2011.
Contractual Obligations, page 15
4.
You state that you believe that in connection with the audit performed following closing, various material misrepresentations were revealed in the unaudited presentation of the financial condition, assets and liabilities of BioZone. Please tell us the nature of these misrepresentations and what effect they had on your historical financial statements. Provide additional disclosure for clarification.
Response
In connection with the audit performed following closing, the Company determined that the unaudited financial statements prepared by the former owners of BioZone Laboratories, Inc. (“BioZone Labs”) for the year ended December 31, 2010 contained overstatements of 2010 gross income by $1 million, and year-end inventory by approximately $800,000. These overstatements were corrected during the Company’s audit and did not affect the historical financial statements filed with the SEC on the Company’s Form 8-K/A filed on September 15, 2011.
Customers and Marketing, page 26
5.
We have reviewed your response to prior comment 9. The identity of your major customers is material information and required disclosure pursuant to Item 101(h)(4)(vi) of Regulation S-K and therefore is not eligible for confidential treatment. Please expand your disclosure to identify your two largest contract manufacturing customers that account for a material amount of your sales.
2
Response
We intend to revise our disclosure in the Amendment to identify the Company’s two largest contract manufacturing customers that account for a material amount of sales.
BioZone Pharmaceuticals, Inc. Consolidated Balance Sheets, page F-2
6.
You stated in response to our prior comment 14, that you revised your financial statement for BioZone Pharmaceuticals, Inc. to remove BioZone Pharmaceuticals from the historical financial information yet none of the December 31, 2010 balances changed. Please revise your filing accordingly to ensure that the December 31, 2010 financial information does not include the effect of the reverse merger as that did not occur until June 30, 2011.
Response
We intend to revise our filing to ensure that the December 31, 2010 financial information does not include the effect of the reverse merger.
7.
We note your response to prior comments 16 and 17. Please address the following:
·
You state that the BioZone Labs Group former shareholders received the largest portion of the voting rights in the combined entity and held the largest minority voting interest in the combined entity. Please tell us the percent of the total shares issued to the BioZone Pharma’s shareholders.
·
It does not appear that your response addressed our comment regarding clarification of the change in voting rights just prior to the acquisition and how that change affected your determination that BioZone Lab Groups was the accounting acquirer.
·
Since there was no agreement to vote in concert among all of the entities in the BioZone Lab Group, it appears that you need to identify one accounting acquirer and account for the other acquisitions in accordance with ASC 805. Please tell us why identifying one accounting acquirer is not required under the GAAP literature in your facts and circumstances.
·
You state that together, Brian Keller and Daniel Fisher controlled the BioZone Labs Group prior to the transaction. Please define control. In addition, if they did not have an agreement to vote in concert it is unclear how they controlled the BioZone Labs Group. For example, it appears based on Attachment B to Exhibit 17.1, sections iv and xxvi to the 8-K filed July 31, 2012 that Mr. Fisher did not agree with certain aspects of the merger, including the Baker-Cummins transaction and the shares issued to Nian Wu, and voted against those transactions. In addition, it appears Mr. Fisher disagreed with the percentage that the prior company (for which he was a shareholder) received post-merger. Please tell us why you believe it was the intent for the shareholders, including Mr. Keller and Mr. Fisher, to act as a group.
Response
·
Immediately after the reverse acquisition of the BioZone Labs Group was completed, the former shareholders of BioZone Labs owned a total of 21,000,000 shares, or 31% of the total shares issued and outstanding, and 38% of the adjusted issued and outstanding shares after taking into account the elimination of the 13,948,001 shares owned by ISR Investments, a former shareholder of the Company and no other shareholder owned a significant amount of the total outstanding shares (other than ISR Investments1). The shareholders of the Company did not receive any additional shares in connection with the reverse acquisition of the BioZone Labs Group.
1 ISR's shares were merely pledged as an interim accommodation and were subject to cancellation. The shares ultimately were cancelled and returned to treasury.
3
·
In March 2011, the original shareholders of the Company transferred 24,050,000 shares (64% of the total outstanding shares) to 49 new shareholders in contemplation of the reverse acquisition (and retained 13,548,000 shares which were subsequently cancelled as discussed herein). We considered this transfer of control as further evidence of the intent of the parties to complete a merger among BioZone Labs, Equalan, Equachem and BetaZone. The primary reason the Company did not acquire the assets and assumed the liabilities of Aero Pharmaceuticals, Inc. (“Aero”) and the shares of the BioZone Lab Group simultaneously was the necessity for an audit of the BioZone Lab Group. However, from the outset the Company intended to complete the BioZone Lab Group transaction in which effective control of management would remain in the hands of the BioZone Lab Group’s existing management.
·
We considered all of the entities in the BioZone Labs Group as one accounting acquirer, though there was no formal agreement to vote in concert among the owners because:
ü
All four owners of the BioZone Labs Group signed a Letter of Intent in February 2011 to merge each company in the BioZone Labs Group with the Company;
ü
Each of Equalan LLC, Equachem LLC and BetaZone LLC are dependent on BioZone Labs exclusively for financial and managerial support.
o
Equalan’s sole employees are two non-executive individuals who process sales orders. Equalan purchases all of its products for resale from BioZone Labs and does not pay for the products on a current basis. Equalan has no product supplier other than BioZone Labs. Equalan’s sales of BioZone products to customers represented approximately 7% of the BioZone Labs Group total sales for the 12 months ended on the merger date. For 2012, Equalan sales are projected to represent less than 5% of total sales of the BioZone Labs Group.
o
Equachem has no employees. A BioZone Labs employee processes sales orders for Equachem, which sells raw materials to BioZone Labs and other manufacturers. Approximately 80% percent of Equachem’s sales of raw materials are to BioZone Labs, which does not pay for the products on a current basis. Total sales of Equachem represent less than 3% of total sales of the BioZone Labs Group (including intercompany sales to BioZone Labs.)
o
BetaZone has two employees and relies on BioZone Labs for managerial and sales support. BetaZone licenses all of its technology from BioZone Labs.
ü
The relevant size of each of Equalan Pharmaceuticals, LLC, Equachem LLC and BetaZone Pharma, LLC is immaterial when compared to the size of BioZone Labs.
·
Daniel Fisher acted as President and Brian Keller acted as Executive Vice President of each entity in the BioZone Labs Group prior to the merger and controlled all management decisions. Mr. Fisher voted in favor of the merger transactions and signed all of the merger documents in July 2011. Mr. Fisher’s alleged disapproval of the transactions emerged after his termination from the Company in January 20122.
Mr. Fisher indicates in Attachment B to Exhibit 17.1, sections iv and xxvi to the 8-K filed July 31, 2012 that he did not agree with certain aspects of the merger, including the Baker-Cummins transaction and the shares issued to Nian Wu, and voted against those transactions. This is a false statement. The Company acquired the assets and assumed the liabilities of Aero Pharmaceuticals, Inc. (“Aero”) in exchange for shares in the so called Baker-Cummins transaction on May 16, 2011 prior to the acquisition of the BioZone Labs Group in July 2011. Mr. Fisher was not a shareholder or director of the Company at that time and would not have been entitled to vote on that aspect of the overall merger transaction. Any shares issued to Aero shareholders subsequent to Mr. Fisher’s arrival were issued pursuant to a liquidated damages clause in the purchase agreement related to delay in obtaining an effective registration statement for the shares issued to the Aero shareholders (i.e. the current registration under review). Similarly, the Company acquired Dr. Wu’s shares in the BioZone Labs Group in exchange for shares simultaneous with the acquisition of Mr. Fisher’s shares. Mr. Fisher was not a shareholder or director of the Company at the time of the acquisition of Dr. Wu’s shares and would not have been entitled to vote on that aspect of the overall merger transaction in any capacity for the Company. In fact, Dr. Wu's relationship with the owners of the BioZone Labs Group and his participation was part of the "package" that the Company acquired when it acquired the BioZone Lab Group.
2 Mr. Fisher’s alleged disapproval of the transactions emerged after his termination from the Company in January 2012.
4
In addition, Mr. Fisher indicates that he disagreed with the percentage that the prior company (for which he was a shareholder) received post-merger. Yet he signed the definitive transaction documents approving all of the terms as a seller of the shares in the BioZone Lab Group, which disclosed the total amount of shares received by the shareholders of the BioZone Lab Group of which he was a shareholder.
Note 7. Convertible Notes Payable, page F-9
8.
We note in your response to prior comment 18 that you determined that the conversion features for the 2012 convertible notes did not meet the criteria for bifurcation as a derivative. Please tell your analysis and how you determined that bifurcation was not required.
Response
We analyzed the conversion features for the 2012 convertible notes. In accordance with ASC 815-10-15-74, the contract should not be considered a derivative instrument and should be classified in stockholders’ equity due to the fact that the contract is indexed to the Company’s own stock.
The June 2012 Convertible Notes, page F-10
9.
You state that the fair value of the warrants exceeded the convertible notes and therefore, the excess amount of $580,768 is being allocated over the term of notes as interest expense. Please note that the proceeds should have been allocated based on the relative fair value of the note and the warrants. The warrants should then be recorded at fair value as a derivative liability, with the change in the value going through your consolidated statement of operations.
Response
It is our understanding based upon the authoritative guidance that, in the case of a convertible financial instrument issued with warrants and/or other detachable instruments, the amount allocated to the convertible instrument is the face amount less the allocation to the detachable instruments. If the warrants are equity, the allocation between the convertible instrument and the warrants is on a relative fair value basis. If the warrants are liabilities, the amount allocated to the convertible instrument i
2012-10-11 - UPLOAD - Cocrystal Pharma, Inc.
October 11, 2012 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment No. 3 to Registration Statement on Form S -1 Filed September 28, 2012 File No. 333-176951 Form 10 -K for the Fiscal Year Ended December 31, 2011 Filed April 16, 2012 File No. 333-146182 Form 10 -Q/A for the Quarterly Period Ended June 30, 2012 Filed September 28, 2012 File No. 333-146182 Dear Mr. Maza : We have reviewed each of the above -referenced filings and the response letter s submitted on September 28, 2012 and have the following comments. In some of our comments, we may ask you to pro vide us with information so we may better understand your disclosure. Please respond to this letter by amending your filings and providing the requested information . 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 filings and the information you provide in response to these comments, we may have additional comments. General 1. Since you are a reporting company subject to the requirements of the Securities Exchange Act of 1934, you should respond to comments 2 through 14 in this letter which 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. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 11, 2012 Page 2 Amendment No. 3 to Registration Statement on Form S -1 Company Overview, page 12 2. We note your response to prior comment 5. Please clarify whether or not you recognized a gain or loss with the transfer of your 55% ownership in ISR de Mexico, S. R.L. de C. V., a Mexican corporation that was owned by the Company during the period prior t o February 22, 2011, in return for and cancellation of 13,948,001 shares of the Company’s common stock. Please provide the journal entries you made to record the transfer at the time of the Aero transaction. 3. You state that in December 2011, the Company transferred its 55% ownership in ISR de Mexico, S. R.L. de C. V., a Mexican corporation that was owned by the Company during the period prior to February 22, 2011, in return for and cancellation of 13,948,001 shares of the Company’s common stock from form er Shareholders of the Company but that you recorded the transaction at the time of the Aero acquisition in May 2011 because that was the intent of the Company. It appears that the actual transfer of ownership of ISR de Mexico, S.R.L. de C.V. did not occu r until December 2011 and should be accounted for in the period the transaction occurred. Please tell us when you legally relinquished control and why you believe you have recorded the transfer in the appropriate period. Contractual Obligations, page 1 5 4. You state that you believe that in connection with the audit performed following closing, various material misrepresentations were revealed in the unaudited presentation of the financial condition, assets and liabilities of BioZone. Please tell us the nature of these misrepresentations and what effect they had on your historical financial statements. Provide additional disclosure for clarification. Customers and Marketing, page 26 5. We have reviewed your response to prior comment 9. The identity of yo ur major customers is material information and required disclosure pursuant to Item 101(h)(4)(vi) of Regulation S -K and therefore is not eligible for confidential treatment. Please expand your disclosure to identify your two largest contract manufacturing customers that account for a material amount of your sales. Biozone Pharmaceuticals, Inc. Consolidated Balance Sheets, page F -2 6. You stated in response to our prior comment 14, that you revised your financial statement for Biozone Pharmaceuticals, Inc. t o remove Biozone Pharmaceuticals from the historical financial information yet none of the December 31, 2010 balances changed. Please revise your filing accordingly to ensure that the December 31, 2010 financial information does not include the effect of the reverse merger as that did not occur until June 30, 2011. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 11, 2012 Page 3 Note 1. Business, page F -4 7. We note your response to prior comments 16 and 17. Please address the following: You state that the BioZone Labs Group former shareholders received the largest portion of the voting rights in the combined entity and held the largest minority voting interest in the combined entity. Please tell us the percent of the total shares issued to the BioZone Pharma’s shareholders. It does not appear that your response addre ssed our comment regarding clarification of the change in voting rights just prior to the acquisition and how that change affected your determination that BioZone Lab Groups was the accounting acquirer. Since there was no agreement to vote in concert among all of the entities in the BioZone Lab Group, it appears that you need to identify one accounting acquirer and account for the other acquisitions in accordance with ASC 805. Please tell us why identifying one accounting acquirer is not required under the GAAP literature in your facts and circumstances. You state that together, Brian Keller and Daniel Fisher controlled the BioZone Labs Group prior to the transaction. Please define control. In addition, if they did not have an agreement to vote in concert it is unclear how they controlled the BioZone Labs Group. For example, it appears based on Attachment B to Exhibit 17.1, secti ons iv and xxvi to the 8 -K filed July 31, 2012 that Mr. Fisher did not agree with certain aspects of the merger, including the Baker -Cummins transaction and the shares issued to Nian Wu, and voted against those transactions. In addition, it appears Mr. Fi sher disagreed with the percentage that the prior company(for which he was a shareholder) received post -merger. Please tell us why you believe it was the intent for the shareholders, including Mr. Keller and Mr. Fisher, to act as a group. Note 7. Conve rtible Notes Payable, page F -9 8. We note in your response to prior comment 18 that you determined that the conversion features for the 2012 convertible notes did not meet the criteria for bifurcation as a derivative. Please tell your analysis and how you d etermined that bifurcation was not required. The June 2012 Convertible Notes, page F -10 9. You state that the fair value of the warrants exceeded the convertible notes and therefore, the excess amount of $580,768 is being allocated over the term of notes as interest expense. Please note that the proceeds should have been allocated based on the relative fair value of the note and the warrants. The warrants should then be recorded at fair value as a derivative liability, with the change in the value going through your consolidated statement of operations. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 11, 2012 Page 4 The “March 2012 Purchase Order Notes,” page F -9 10. Please revise your disclosure to state that you have not recorded a BCF on the March 2012 Purchase Order notes and not the March 2011 Purchase Order Notes. Note 12 - Contingencies, page F -26 11. You disclose actions in which you are subject to litigation. ASC 450 -20-50-4 requires that for each loss contingency the company disclose an estimate of the possible loss or range of loss or a statement that such an estimate cannot be made. Please revise your disclosure to comply with ASC 450. Form 10 -Q/A for the Quarterly Period Ended June 30, 2012 Consolidated Statements of Operations, page 2 12. We are unable to calculate the net loss per share based on the net loss and weighted average common shares outstanding for the three and six months ended June 30, 2012. Please provide us a calculation of your net loss per share. Note 7. Convertible Notes Payable The “February 2012 Notes,” page 8 13. We note that you amended your filings to remove the previously recognized beneficial conversion feature. You disclose that “due to the fact that the carrying amount of the convertible notes has been reduced to zero, based on the discount allocated from the value of the warrants r eferred to above, that no beneficial conversion feature is to be recorded.” The amount of the proceeds allocated to the warrants and to the convertible debt should have been allocated based on the relative fair value method which would have resulted in s ome proceeds being allocated to the convertible debt. The beneficial conversion feature would have been recognized for the value originally allocated to the convertible debt. Please provide us your relative fair value calculation for the warrants and deb t. Tell us how your accounting complies with GAAP including how you comply with ASC 470 -20-25-2, ASC 470 -20-30-8 and ASC 470 -20-35-7. . Note 10. Warrants, page 12 14. We note in your response dated September 28, 2012 you stated that all of the February 2012 warrants were exercised by July 31, 2012. Please tell us your consideration of using a bionomial or simulation model for your other warrants that are still outstanding which have potential adjustments to the exercise price due to down -round protection provisions. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 11, 2012 Page 5 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the respective filing s to be certain that the filing includes the information the Securities Act of 1933 or the Securities Exchange Act of 1934 and all applicable Securities Act or Exchange Act rules require. Since the c ompany and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose t he Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequ acy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are awa re of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 11, 2012 Page 6 You may contact Dana Hartz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at (202) 551 -3575, or me at (202) 551 - 3710 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Harvey J. Kesner, Esq. 61 Broadway, 32nd Floor New York, NY 10006
2012-09-28 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
September 28, 2012
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Attention:
Jim B. Rosenberg
Re:
Biozone Pharmaceuticals, Inc.
Amendment to Form 10-Q for the Quarterly Period Ended March 31, 2012
Filed August 17, 2012
File No. 333-146182
Ladies and Gentlemen:
The following responses address the comments of the Staff (the “Staff”) as set forth in its letter dated September 21, 2012 (the “Comment Letter”) relating to the Form 10-Q for the Quarterly Period Ended March 31, 2012 of Biozone Pharmaceuticals, Inc. (“Biozone” or the “Company”) filed on August 17, 2012 .On behalf of the Company, we respond as set forth below.
The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comment Letter.
1.
You restated your financial statements to record a beneficial conversion feature of $5,750,000. This amount appears to exceed the proceeds allocated to the OPKO notes at issuance. ASC 470-20-30-8 states that if the intrinsic value of the beneficial conversion feature is greater than the proceeds allocated to the convertible instrument, the amount of the discount assigned to the beneficial conversion feature shall be limited to the amount of the proceeds allocated to the convertible instrument. In addition, it appears you recorded the beneficial conversion feature to interest expense rather than accreting over the term of the OPKO notes as ASC 470-30-35-7 would appear to suggest. Please provide us your analysis demonstrating how your accounting complies with GAAP including how you comply with ASC 470-30-35-2, ASC 470-20-30-8 and ASC 470-20-35-7. In your analysis include how you determined the amount of the beneficial conversion feature recorded, your allocation of the proceeds to the OPKO notes and warrants and the journal entries made to record the beneficial conversion and allocation.
Response:
The Company will file an amended 10-Q to properly reflect the beneficial conversion feature limited to the amount of the proceeds allocated to the convertible instrument in accordance with ASC 470-20-35-7.
2.
In addition, you disclose that you recorded the warrants at fair value using the Black-Scholes method. Your warrant agreement in Exhibit 10.3 of the Form 8-K filed on March 1, 2012 appears to include adjustments to the exercise price in Section 2b which appear to be a down-round provision. Please explain to us how you considered this down-round protection provision in determining the fair value of these warrants. In this regard, it appears that a binomial or simulation model would be appropriate to consider the potential adjustment to the exercise price while a single-path option pricing model, such as the Black-Scholes model, cannot properly consider such adjustments.
Response:
In February, 2012, the Company issued an aggregate of 11,500,000 warrants to purchase shares of its common stock at an exercise price of $0.40 per share to three existing shareholders. The warrants were issued in connection with a $2.3 million financing transaction entered into at that time. The exercise price of the warrants is subject to adjustment for certain events, including a subsequent issuance of equity at a price below the current exercise price of the warrant (“ratchet protection”).
1
At the time of the financing the purchasers indicated their intention to exercise the warrants and convert the debt into equity within a relatively short time span.
In April and July, 2012, the shareholders/purchasers of the warrants were satisfied with the Company’s performance and exercised 3,000,000 and 8,500,000 warrants, respectively, so that as of July 31, 2012, all of the warrants issued in the February 2012 financing have been exercised.
The Company analyzed the terms of the warrants including the possible adjustment to the exercise price. We determined that the Black-Scholes option pricing model was the appropriate model to use to value the warrants. We were aware of the decision of the holders to exercise the warrants prior to the filing of the 10Q for the period ended March 31, 2012. The Company did not intend, and in fact did not, issue any “New Securities” (as defined in paragraph 17 (k) of the warrant) prior to exercise of the warrants.
The Company hereby acknowledges the following:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filings;
·
Staff comments or changes to disclosures in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please do not hesitate to contact the undersigned at 646-810-0611 if you have any questions or comments. Thank you.
Very truly yours,
/s/ Tara Guarneri-Ferrara
Tara Guarneri-Ferrara
Cc: Elliot Maza, CEO
2
2012-09-21 - UPLOAD - Cocrystal Pharma, Inc.
September 21, 2012 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment to Form 10 -Q for the Quarterly Period Ended March 31, 2012 Filed August 17 , 2012 File No. 333-146182 Dear Mr. Maza : We have limited our review of your filing to the issues we have addressed in our comments. In our comments , we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response . If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your responses to our comments. After reviewing the information you provide in response to these comments , we may have additional comments and/or request that you amend your filing . 1. You restated your financial statements to record a beneficial conversion feature of $5,750,000. This amount appears to exceed the proc eeds allocated to the OPKO n otes at issuance. ASC 470 -20-30-8 states that if the intrinsic value of the beneficial conversion feature is greater than the proceeds allocated to the convertible instrument, the amount of the discount assigned to the benefici al conversion feature shall be limited to the amount of the proceeds allocated to the convertible instrument. In addition, it appears you recorded the beneficial conversion feature to interest expense rather than accreting over the term of the OPKO notes as ASC 470 -20-35-7 would appear to suggest. Please provide us your analysis demonstrating how your accounting complies with GAAP including how you comply with ASC 470 -20-25-2, ASC 470-20-30-8 and ASC 470-20-35-7. In your analysis include how you dete rmined the amount of the beneficial conversion feature recorded , your allocation of the proceeds to t he OPKO notes and warrants and the journal entries made to record the beneficial conversion and allocation. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. September 2 1, 2012 Page 2 2. In addition, you disclose that you recorded the warrants at fair value using the Black -Scholes method . Your warrant agreement in Exhibit 10.3 of the Form 8 -K filed on March 1, 2012 appears to include adjustments to the exercise price in Section 2b which appear to be a down - round provision . Please explain to us how you considered this down -round protection provision in determining the fair value of these warrants. In this regard, it appears that a binomial or simulation model would be appropriate to consider the potential adjustment to the exercise price while a single -path option pricing model, such as the Black -Scholes model, cannot properly consider such adjustments. We urge all persons who are responsible for the accuracy and a dequacy of the disclosure in this filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the ac curacy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to this filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Mary Mast, Senior Staff Accountant, at (202) 551 -3613 if you have questions regarding these comments. In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-09-21 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
1
filename1.htm
Unassociated Document
BIOZONE PHARMACEUTICALS, INC.
550 Sylvan Avenue, Suite 101
Engelwood Cliffs, NJ 07632
September 21, 2012
BY EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Jennifer Riegel
Jeffrey P. Riedler
Re:
Biozone Pharmaceuticals, Inc. (the “Company”)
Amendment No. 2 to Registration Statement on Form S-1
Filed July 2, 2012
File No. 333-176951
Dear Sir/Madam,
The Company hereby respectfully requests an extension to respond to the comment letter dated July 25, 2012 relating to the above-referenced filing and the Company intends to submit a response by September 28, 2012.
Very Truly Yours,
/s/ Elliot Maza
Elliot Maza
Chief Executive Officer and Chief Financial Officer
2012-08-27 - UPLOAD - Cocrystal Pharma, Inc.
August 27 , 201 2 Via E -mail Mr. Elliot Maza Chief Executive Officer and Chief Financial Officer BioZone Pharmaceuticals, Inc. 550 Sylvan Avenue, Suite 101 Englewood Cliffs, NJ 07632 Re: BioZone Pharmaceuticals, Inc. Item 4.02 of Form 8 -K Dated August 8 , 2012 Filed August 13 , 2012 File No. 333-146182 Dear Mr. Maza : We have comp leted our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filings and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any per son under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include the information the Securities Exchange Act of 1934 a nd all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2012-08-16 - UPLOAD - Cocrystal Pharma, Inc.
August 16 , 2012 Via E -mail Mr. Elliot Maza Chief Executive Officer and Chief Financial Officer BioZone Pharmaceuticals, Inc. 550 Sylvan Avenue, Suite 101 Englewood Cliffs, NJ 07632 Re: BioZone Pharmaceuticals, Inc. Item 4.02 of Form 8-K Dated August 8, 2012 Filed August 13, 201 2 File No. 333-146182 Dear Mr . Maza : We have reviewed your filing an d 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 five 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 a comment appl ies 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 provid e in response to these comments, we may have additional comments . 1. Please clarify whether you are restating the March 31, 2011 or March 31, 2012 period. In your first paragraph you state that “ the period ended March 31, 2011 should no longer be relied upo n” yet in the second paragraph you state that the “Company determined that the financial statements filed for the three month period end March 31, 2012 contained a misstatement.” 2. Please clarify whether the expenses that should be “recharacterized” were already included in the income statement and are now be reclassified to a different line item in the Consolidated Statement of Earnings or if the expenses were previously excluded from the Financial Statements . 3. Please also provide us with an estimated tim e-frame as to when you intend to file the Form 10 -Q/A. Mr. Elliot Maza BioZone Pharma ceuticals, Inc. August 16, 2012 Page 2 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in this filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of t he disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from takin g any action with respect to thi s filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the fe deral securities laws of the United States. You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 if you have questions regarding these comments . Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-07-26 - UPLOAD - Cocrystal Pharma, Inc.
July 25 , 2012 Via E -mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S -1 Filed July 2, 2012 File No. 333-176951 Dear Mr. Maza : We have reviewed your 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 amending your registration statement and providing the requested information . 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 registration statement and the information you provide in response to these comments, we may have additional comments. Amendment No. 2 to Registration Statement on Form S -1 General 1. Please note that we will be providing comments to you on your confidential treatment request under separate cover. Risk Facto rs, page 3 “Confidentiality agreements with employees and others may not . . .,” page 5 2. Please refer to your response to Comment 3. Although you state in your response letter that you have filed all confidentiality agreements and intellectual property a ssignment agreements, it does not appear that these agreements have been filed as exhibits to your Mr. Elliot Maza Biozone Pharmaceuticals, Inc. July 25, 2012 Page 2 registration statement. Please file these exhibits with your next amendment or advise us as to the location of each agreement. “We cannot assure you th at our common stock will become listed . . .,” page 6 3. Please briefly describe the listing standards or corporate governance standards of the NYSE Amex Securities or Nasdaq exchanges that you currently fail to meet. Management’s Discussion and Analysis and Results of Operations , page 8 Critical Accounting Policies and Estimates , page 11 Revenue Recognition, page 12 4. You state that license revenue is recorded when reported. Please clarify in the filing your accounting policy and what guidance you used f or your accounting treatment. In this respect we note that you entered a license agreement with OKRO in February 2012. If material, please revise your accounting policy in your notes to the financial statements to clarify the accounting treatment for the licensing agreement. Company Overview, page 13 5. You state that in December 2011 you transferred your 55% ownership in ISR de Mexico, S. R.L. de C. V., a Mexican corporation that was owned by the Company during the period prior to February 22, 2011, in return for and cancellation of 13,948,001 shares of the Company’s common stock. Please tell us how this was accounted for in your financial statements and provide additional disclosure as appropriate. Properties, page 14 6. Please refer to your response to Comment 3. Please file the lease agreement related to the Willow Pass Road facility as an exhibit to your registration statement, or provide an analysis as to why this lease agreement is not material to your business. Business, page 16 Overview, page 16 7. On page 17, you indicate that you provided responses to the FDA regarding the agency’s observations, and provided commitments and timelines for the remediation of the conditions cited by the FDA. Please disclose when you expect to complete the remedi ation of the conditions cited by the FDA. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. July 25, 2012 Page 3 Other Business Activities – Raw Material Sales and Technology Licensing , page 17 8. Please expand your discussion of the limited license agreement and the distribution agreement each with OPKO Pharmaceuticals to disclose all material terms, including each parties’ material obligations, any financial provisions, the term of the agreement, and any termination provisions. Customers and Marketing, page 21 9. We are re -issuing prior comment 6. Please expand your disclosure to identify your largest contract manufacturing customer that accounts for a material amount of your sales. Executive Officers and Directors, page 23 Employment Agreements, page 24 10. You disclose on page 24 that you have paid Mr. Fisher $5,000 towards the amounts due him under his employment agreement. Please disclose the remaining balance due to Mr. Fisher under his employment agreement. 11. We note your Form 8 -K/A filed February 8, 2 012 which attaches as an exhibit the resignation letter from Dan Fisher to your executive officers. It appears that Mr. Fisher included two attachments with his letter of resignation; however, Attachment A and Attachment B are not filed as exhibits to the Form 8 -K/A. Pursuant to Item 5.02(a)(2) and (a)(3) of Form 8 -K, please promptly amend your Form 8 -K/A to file a complete copy of the letter from Mr. Fisher, including Attachments A and B thereto . Directors’ and Officers’ Liability Insurance, page 25 12. We note that you have filed the Director and Officer Indemnification Agreement with Mr. Prego -Novo as Exhibit 10.10 to your registration statement. If you have entered into indemnification agreements with any of your other directors or officers, please fil e these agreements as exhibits to your registration statement, and amend your disclosure here and elsewhere in your filing to indicate that you have entered into indemnification agreements with the named respective directors and officers. Certain Relati onships and Related Transactions, page 26 13. It appears that the securities purchase agreement you entered into with Opko Health on February 24, 2012 may be incorporated as Exhibit 10.34 to your registration statement despite the fact that the buyer is not identified in that agreement or in the related Form 8 - K. Please confirm that this is the correct agreement. Alternativ ely, please file a copy of this agreement. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. July 25, 2012 Page 4 Biozone Pharmaceuticals, Inc. Consolidated Balance Sheets, page F -2 14. We reviewed your response to comment 11. You reference a reconciliation provided in your prior amendment which presents pro forma information for Biozone Pharmaceuticals as of December 31, 2010. Your historical financial statement for Biozone Pharmaceuticals, Inc. as of December 31, 2010 does appear to agree to the individual balances of Biozone Labs, Equalan Pharma and Equachem, adjusted for intercompany transactions. The total assets balance appears to include $89,373 in assets from Biozone which should not be included until after the reverse merger, the current liabilities does not agree to the sum of Biozone, Equalan Pharma and Equachem ad justed for intercompany transactions and the long term debt does not agree to the total long term debt for Biozone Laboratories. Please confirm that the December 31, 2010 financial information does not include the effect of the reverse merger as that did not occur until June 30, 2011 or revise your filing accordingly. 15. As the consolidated financial statements comprise a C Corp and LLCs, please tell us why you believe the equity section of the historical balance sheet reflects the historical financial sta tements of the entities that have been consolidated. Note 1 - Business, page F -5 16. We note your response to prior comment 12. Please provide us your analysis for determining the accounting acquirer under paragraph a -e of paragraph 805 -10-55- 12. 805-10-55-12a states that the acquirer usually is the combining entity whose owners as a group retain or receive the largest portion of the voting rights in the combined entity. Your response states that there was change in voting rights just prior to the acquisiti on. Please clarify in the filing what the change in voting rights was and tell us how this supports your determination that BioZone Lab Groups was the accounting acquirer. 17. We note your response to prior comment 15. Given that there was no legally bind ing agreement to ensure the group of shareholders acts in concert and no individual shareholder or immediate family members holds greater than 50% of ownership interests, please tell us why you still believe that BioZone Lab Group, including Beta Zone, met the criteria for common control for accounting purposes in accordance with the guidance of EITF 02 -5. Note 7. Convertible Notes Payable, page F -9 18. Refer to your response to comment 18. Please confirm whether the convertible instruments issued in 2012 al so were contingent on a qualified financing transaction and thus you determined that bifurcation of the conversion option as a derivative was not required. Provide additional disclosure in the notes to the interim financial statements Mr. Elliot Maza Biozone Pharmaceuticals, Inc. July 25, 2012 Page 5 regarding the terms of the agreements and the accounting treatment for the conversion options. Note 10. Warrants, page F -12 19. You have recorded the 2011 warrants as derivative liabilities due to ratchets included in the terms of those warrants. Please clarify in the filing that the warrants issued in January 2012 and February 2012 (OPKO warrants) were also recorded as derivatives and whether they had similar ratchets. If the 2012 warrants had different terms, please tell us the guidance you relied on to determine their acc ounting treatment. Item 16. Exhibits and Financial Statement Schedules 20. Please file a complete copy of Exhibit 10.4, the Securities Purchase Agreement dated February 28, 2011. 21. Please revise your exhibit index to list the complete name of each agreement, including the identity the third parties and the dates of each agreements. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disc losures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Mr. Elliot Maza Biozone Pharmaceuticals, Inc. July 25, 2012 Page 6 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offe ring of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Dana Hartz at (202) 551 -3648 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239, Jennifer Riegel at (202) 551 -3575, or me at (202) 551 - 3710 with any other questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Harvey J. Kesner, Esq. 61 Broadway, 32nd Floor New York, NY 10006
2012-01-05 - UPLOAD - Cocrystal Pharma, Inc.
January 4, 2012 Via E-mail Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Amendment No. 1 to Registrati on Statement on Form S-1 Filed December 19, 2011 File No. 333-176951 Dear Mr. Maza: We have reviewed your amended registra tion statement and response letter filed on December 19, 2011 and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understa nd your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. General 1. Since you are a reporting company subject to th e 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 disclosu re 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 Offi cer disclosure, Beneficial Ownership Table, MD&A and Financial Statements and the notes thereto. Please review the re quirements of Forms 10- K and 10-Q for a detailed list of the require d disclosure as compared to Form S-1. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 2 2. You disclose on page 1 and in response to several comments that your pharmaceuticals business does not constitute a material part of your overall business. Accordingly, Please provide us with a detailed analys is which supports your belief that your pharmaceutical business is not material to your business; and Please revise your disclosure under “Overview” to appropriately di sclose information regarding your material portions of your business and limit your disclosure regarding your pharmaceutical business to a brief discussion in your Business section. This Overview section should only briefly discu ss the material portions of your business. 3. In response to various prior comments, you stat e that you will file ce rtain agreements as exhibits to your registration statement. Please promptly file each of the following agreements as you are required to file thes e agreements pursuant to your requirements under the Securities Exchange Act of 1934 as we ll as pursuant to the requirements under the Securities Act of 1933. The agreements are as follows: Prior comment 26: Confidentiality agreem ents and intellectual property assignment agreements with your employees; Prior comment 51: Material lease agreem ents, including analysis of any lease agreements that are not material; Prior comment 63: Agreements with your th ree contract manufacturing customers; Prior comment 110: All loan agreements related to long-term debt; and Prior comment 111: Complete copi es of Exhibits 10.12-10.15, 10.22 and 10.24. Our History, page 2 4. You disclose that you anticipate discontinuing your prior business re lating international surf resorts through the sale of your 55% owners hip in ISR de Mexico, S. de R.L. de C.V. in consideration for the re turn and cancellation of approximately 13,948,001 shares of your common stock. Please disclose whether you are currently in negotiations for this transaction and the status . If you have entered into a letter of intent or other similar term sheet or agreement, please disc lose all the material terms of such agreement and file a copy of the agreement. Alternatively, provide us with your analys is which supports your determination that such agreement is not required to be filed. Business Manufacturing Business, page 21 5. On page 5, you disclose that the FDA inspecte d your manufacturing fa cilities in January 2011 and again in November 2011. The inspecti ons resulted in numerous observations on Form 483, which you are in the process of reme diating. As of the date hereof, you have not received any additional corresponde nce from the FDA regarding these two inspections. The FDA may conclude that your actions are insufficient to meet regulatory Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 3 standards. If compliance is deemed defici ent in any significant way, it could have a material adverse effect on your business. Pl ease expand your disclosure in this section to disclose the facilities and pr oducts which are affected by this Form 483 and provide a summary of the observations noted on the Form 483. Customers and Marketing, page 26 6. We are re-issuing prior comment 63. Pleas e expand your disclosure to identify your three contract manufacturing customers. In addition, please expand your disclosure to disclose all the material terms of each agreem ent, including the obligations of each party, the consideration received a nd any financial provisions, and the term and termination provisions. Executive Compensation Summary Compensation Table, page 33 7. We note your response to prior comment 75 and y our disclosure in foot notes (2) and (5). These disclosures do not appear to be consistent with the biographies provided on page 31. Please advise or re vise your disclosure. Certain Relationships and Re lated Transactions, page 35 8. You disclose that Daniel Fisher, your Execu tive Vice President, has advanced funds to you for working capital. You also disclose that you are in dispute with Mr. Fisher as to the balance due. Please file copies of all wr itten agreements or summaries of the oral agreements related to these advanced f unds as exhibit(s) pursuant to Item 601(b)(10)(ii)(A) of Regulation S-K. In addi tion, please disclose the amount in dispute. Plan of Distribution, page 40 9. You disclose that Aero intends to make a pr o-rata distribution to holders of the common stock of Aero of record no later than D ecember 31, 2011 of the shares of common stock of the Company held by Aero. Please revise your registration throughout to reflect this distribution. Biozone Pharmaceuticals Inc. Consolidated Financial Statements, page F-1 10. We note your response to prior comment 89 yet we did not see a Statement of Stockholders’ Equity for the Nine Mont hs Ended September 30, 2011. Given the significant transactions that occurred duri ng this period, please revise your filing to include this information. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 4 Biozone Pharmaceuticals, Inc. Consolidated Balance Sheets, page F-2 11. We noted that several of the line items in the financial statements for the amounts at December 31, 2010 do not agree with the sum of th e historical financial statements of the Biozone Lab Group: Biozone Lab, Equachem and Equalan. Please provide us a reconciliation of the differ ences and ensure the pro forma information reflects any changes that are required. Note 1- Business, page F-5 12. We note your response to prior comment 90. Please tell us why, gi ven the fact that Biozone Pharmaceuticals’ shareholders own th e majority of the voting rights of the combined company and that the top two mana gement members (the Chairman and Chief Executive Officer/Chief Financial Offi cer/Secretary) were from Biozone Pharmaceuticals, you believe that BioZone Lab Group is the acquiring company that obtained control of the ac quiree. Please reference ASC 805-10-55-10 through ASC 805- 10-55-15 and tell us why you believe the attr ibutes for BioZone Lab Group are greater than those of Biozone Pharmaceuticals. In addition, please tell us the sales revenue for Aero Pharmaceuticals (Baker Cummins products) for the year ended December 31, 2010 and any subsequent 2011 interim period. You state that 100% of th e combined entity’s revenues came from BioZone Lab Group but Aero Pharmaceuticals was included in Biozone Pharmaceuticals at the time of the acquisition with BioZone Lab Group. If the Baker Cummins skin product line does not gene rate any revenue, plea se clarify this in your filing. 13. We note your response to prior comment 91 and your statement that you believe that the Biozone Lab Group is the accounting acquire r. Please confirm that the Baker Cummins/Aero financial statements have not been included in the December 31, 2010 historical financial statements. In this regard, we note that Ae ro was acquired by the accounting acquiree (legal acquirer), not the accounting acquirer. 14. Please tell us why the financial statements of Aero are not required to be filed pursuant to Rule 3-05 of Regulation S-X. Provide your materiality analysis to clarify why the financial statements are not required. 15. We note your response to prior comment 93. Pl ease tell us the indi vidual percentage ownership of Daniel Fisher, Brian Keller, Ni an Wu and Christian Oertle for each entity within the BioZone Lab Group and whether an y are immediate family members. In addition, please tell us if ther e is any legally binding agr eement to ensure the group of shareholders acts in concert. Lastly, please tell us if any of these individuals held an interest in Aero Pharmaceuticals prior to the acquisition of Aero, and if so, the percentage of ownership interest. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 5 Basis of Consolidation, page F-5 16. We note your response to prior comment 94. Please clarify how you determined that BetaZone was an entity under common control. Please tell us what percentage of ownership was held by a Biozone Group sharehol der and name that shareholder. Note 3 – Aero Acquisition, page F-7 17. We note your response to prior comment 95. Please disclose that you have yet to determine the qualitative factors that make up goodwill for the Aero Pharmaceutical acquisition and disclose the timing for when you think the tangible and intangible assets acquired will be identified and valued. Refer to ASC 805-30-50-3. Note 5 – Convertible Notes Payable, page F-8 18. We note your response to prior comment 97. Pl ease tell us how you determined that the embedded conversion option and warrants ar e not derivatives pursuant to ASC 815. Consider any anti-dilution f eatures pursuant to ASC 815- 40. Please reference any relevant accounting literature and provide an analysis of your accounting for each security. In addition, if you determine that they are embedded derivatives that you cannot separate from the convertible notes, please tell us how you determined that the entire contract did not require fair value accounting due to your inability to reliably measure the embedded derivatives. Refer to ASC 815-15-25-52 and ASC 815-15-25-53. Biozone Laboratories, Inc. Cons olidated Financial Statements Note 2 – Summary of Significant Accounting Policies, page F-17 19. We note your response to prior comment 98 and your related expanded disclosure regarding 580 Garcia Properties, LLC. As previously requested, please provide us your analysis as to how you determined that 580 Garcia Properties, LLC was a variable interest entity requiring consolidation. Refer to ASC 810-10-25. Ensure that your analysis addresses the percentage of the fa ir value of the asset for which you guarantee (the 20,000 square foot cGMP fac ility) to the total fair value amount of the assets in 580 Garcia Properties, LLC. Refer to ASC 810-10-25-55 through 810-10-25-56. Equalan Pharma, LLC Consolid ated Financial Statements Note 4 – Related Parties, page F-32 20. We note your response to prior comment 99. Please revise your disclosure to clarify that the trade receivables from a company under co mmon ownership are due to a direct loan and not sales. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 6 Pro Forma Financial Information, page F-41 21. In your response to prior comment 105 you noted that the company presented pro forma statement of operations for the period ended September 30, 2011 yet the pro forma information beginning on page F-41 is as of March 31, 2011. The information should be as of the most recent interim period, Se ptember 30, 2011. In addition, the pro forma Statement of Operations should also show the pro forma information as of the most recent fiscal year end, December 31, 2010. Please revise your filing accordingly. Item 15. Recent Sales of Unregistered Securities, page II-2 22. We note your response to prior comment 106. Pl ease promptly file your Form D for your unregistered offering completed on March 29, 2011 for the issuance of 10% secured convertible promissory notes in the aggregate principal amount of $2,250,000. See Guidance on Form D Filing Process located at http://www.sec.gov/divisions/c orpfin/formdfiling.htm. Exhibit 5.1 23. We are re-issuing prior comment 112. Please file a revised opinion that removes the statement “and will be, when issued in the manner described in the Registration Statement” from this opinion. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, they are responsible for the accuracy and adequacy of the disclosures they have made. Please refer to Rules 460 and 461 regarding re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. January 4, 2012 Page 7 You may contact Dana Hartz at (202) 551-3648 or Mary Ma st at (202) 551-3613 if you have questions regarding comments on the financ ial statements and related matters. Please contact Rose Zukin at (202) 551-3239, Jennifer Riegel at (202) 551-3575, or me at (202) 551- 3710 with any other questions. Sincerely, /s/ Jennifer Riegel for Jeffrey P. Riedler Assistant Director cc: Harvey J. Kesner, Esq. 61 Broadway, 32nd Floor New York, NY 10006
2011-12-19 - CORRESP - Cocrystal Pharma, Inc.
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
2011-10-18 - UPLOAD - Cocrystal Pharma, Inc.
October 18, 2011 Mr. Elliot Maza Chief Executive Officer Biozone Pharmaceuticals, Inc. 550 Sylvan Avenue Suite 101 Englewood Cliffs, NJ 07632 Re: Biozone Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed September 21, 2011 File No. 333-176951 Dear Mr. Maza: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form S-1 General 1. Since you are a reporting company subject to th e 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 disclosu re 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 Offi cer disclosure, Beneficial Ownership Table, MD&A and Financial Statements and the notes thereto. Please review the re quirements of Forms 10- K and 10-Q for a detailed list of the require d disclosure as compared to Form S-1. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 2 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 appli cable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. 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 fr om time to time become issuable by reason of anti-dilution provisions, stock splits, stock dividends, recapitalizati ons or other similar transactions. Rule 416(a) involves the regist ration 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. 4. Please define the terms FDA and cGMP in the first instance that you use each abbreviation. 5. Please define the terms iontophoresis and pegylat ed in the first inst ance that you use each term. Prospectus Summary, page 3 6. Please expand your Prospectus Summary to id entify and describe your marketed products and the product candidates in your pipeline. For the product candidate s in your pipeline, please clearly state that these product candi dates have not been approved by regulatory authorities, may never be approved, and descri be each product candidate ’s progress in the approval process. 7. Please expand your disclosure throughout to clearly disclose the products that you manufacture and the products that ar e manufactured by third parties. 8. Please expand your description of BioZone Technology to briefly to explain how you developed your technology platfo rm and intellectual pr operty. To the extent that this was developed in-house, pl ease so indicate. Special Note Regarding Forwar d Looking Statements, page 6 9. You state on page 6 that this prospectus c ontains forward-looking statements within the meaning of Section 21E of th e Securities Exchange Act of 1934. Please note that issuers of penny stock are excluded from relyi ng upon the safe harbor for forward-looking statements pursuant to Section 21E(b)(1)(iii) . Please remove this reference from your disclosure. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 3 Risk Factors, page 6 10. In the introductory paragraph to the Risk Factors section, you stat e 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, fi nancial condition or results of operations may be materially adversely affected.” As th e risk factors section should contain a complete discussion of the material risks to your bu siness, it is inappropriate to reference risks that are not disclosed in your risk factors section. Please revise the introductory paragraph accordingly. 11. Please add a risk factor addre ssing your lack of profitable ope rations in recent periods. Please discuss in this risk factor whether you expect your financial lo sses to continue in the future. 12. Please add a risk factor describing the risk to your company of relyi ng on third parties to manufacture your products. “We have negative working capital and have sustained operating losses . . .,” page 6 13. Please expand this risk factor to estimate th e amount of time you will be able to continue operations with your 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 devel opment of your product candidates upon which your business is substantially dependent and identify the product candidates. 15. You disclose that the report of your independent registered public accounting firm on your financial statements states that your ab ility 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 separate ly headed risk factor that discussed this risk. In addition, please expand your risk f actor to disclose that the auditor’s going concern opinion may have a detrimental effect on your ability to obtain additional funding. “We operate in a highly regulated industry. . . .,” page 6 16. This risk factor appears to disc uss a risk to the company that is substantially similar to the risk discussed in the risk fact or on page 9 entitled, “If we fail to obtain or maintain the necessary United States or wo rldwide regulatory approvals . . . .” Please revise your disclosure to either distinguish the risks and the headers thereof or combine these two discussions. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 4 17. You disclose that “The FDA inspected our manufacturing facilities in January 2011. The inspection resulted in only minor observati ons 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 th e facility was in compliance. “Our future results of operations depend, to a si gnificant degree, upon our ability . . .,” page 7 18. You state that “[t]he development and comme rcialization process, particularly with respect to innovative products, is both time consuming and costly and involves a high degree of business risk.” Pl ease expand this discussion to estimate the amount of time and resources it takes to develop and commercialize a product candidate. 19. Please expand this risk factor to briefly describe your product pi peline in clinical development. Please indicate each product candidate’s progress in the development process. “Lack of availability of, or significant increases in the cost of raw materials . . .,” page 7 20. You state that previously unknown problem s with the raw materials or product manufacturing processes could result in a voluntary or mandatory withdrawal of the contaminated product. To the extent you ha ve experienced problems with contaminated products in the recent past, please revise to describe these problems. “Our future results of operations depend, to a significant degree . . .,” page 8 21. This risk factor appears to substantially dupl icate 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. “In order to achieve succe ssful 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. “Our product candidates may be subject to fu ture product liability claims. . . .,” page 10 23. Please expand your disclosure to quantify th e extent of your product liability insurance coverage. “Our future collaborators may compete with us or have interests . . .,” page 11 24. You state that “[l]arge pharm aceutical companies that [you] seek to collaborate with may have internal programs or enter into collaborati ons with [your] competitors . . . .” Please update this risk factor to clar ify whether or not you are in negotiations for a collaboration Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 5 agreement. If you have entered into negotiati ons with any pharmaceutical companies for collaboration agreements, please disclose this in the Business section. “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. “Confidentiality agreements with employees and others may not ad equately prevent . . .,” page 12 26. You indicate that you maintain confidentia lity and intellectua l property assignment agreements with your employees and other persons with access to your proprietary materials or processes. Pleas e provide the Staff with a suppl emental copy of the standard confidentiality agreement and the intellectual property as signment agreement you enter into with your employees. We may have further comment. “Our technology may become obsolete or lose its competitive advantage,” page 12 27. Please provide a detailed analysis to suppor t your assertion that your technology has a “competitive advantage.” 28. Please expand this risk factor to identif y your major competitors, the methods of competition, and the main products of your competitors that will compete with your products. 29. Please add a risk factor that discusses the risks to your business of the competition faced by your marketed products. “We rely on key executive officers and consultants . . .,” page 12 30. You state that you rely heavily on “certain ot her key executives,” ot her than those named in this risk factor. Please expand your di sclosure to name all key executives upon which your business is dependent. 31. If any of your executives are working less than full time for your business, or have business interests that conflict with your business, please so disclose. 32. Please disclose that all employment agreements have a term of three ye ars. In addition, if Mr. Fisher is a “certain othe r key executive” upon which your bus iness is reliant, please disclose that you have also entered into an employment agreement with Mr. Fisher. 33. You state that you are competing with for em ployees against companies that are more established than you are, and have the ability to pay more cash compensation than you Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 6 do. To the extent that you have experien ced problems hiring employees in the recent past, please describe these problems. “We cannot assure you that our common stock will become listed . . .,” page 13 34. Please note that NYSE Euronext acquired the American Stock Exchange in 2008. Accordingly, please revise all references to the American St ock Exchange, in this risk factor and on page 39, to re ference NYSE Amex Equities. 35. Please estimate when you will seek listing of your common stock on the NYSE Amex Equities or Nasdaq. For example, if you believe that it may be several years or more until your seek listing, pl ease so disclose. 36. Please describe the initial lis ting standards of a register ed stock exchange that you currently fail to meet. 37. You disclose “we would be subject to an SEC rule….” Please revise to clarify the following: whether or not you are currently subject to the rule; which SEC rule you refer to in this risk factor that imposes requirements on broker- dealers who sell securities governed by the rule; and describe the requirements in the rule. “We will incur increased costs as a result of being an operating public company,” page 13 38. We note that you are currently an operating publ ic company, please revise this risk factor to tailor the risks discussed to your specifi c business and operating history. In addition, to the best of your ability, please quantify th e legal, accounting, and other expenses that you will incur as a result of being an operating public company over the next 12 months. “Our common stock may be subject to the ‘Pen ny Stock’ rules of the SEC . . .,” page 14 39. Please clearly state that your stoc k is currently a “Penny Stock.” 40. Please expand this risk factor to discuss th e effect on liquidity, specific legal remedies available to investors of penny stocks, and how such remedies would affect your business. “We have never paid nor do we expect in th e near future to pay dividends,” page 14 41. Please clearly state in this risk factor that reader s should not rely on an investment in your company if they require dividend income, a nd income to them would only come from any rise in the market price of your st ock, which is uncertain and unpredictable. Mr. Elliot Maza Biozone Pharmaceuticals, Inc. October 18, 2011 Page 7 “We and our security holders are not subject to some reporting requirements . . .,” page 14 42. Please briefly describe the contents of pr oxy and information statements, as well as Forms 3, 4 and 5 reporting Section 16 compliance, so that investors may understand their purposes. “Our business may require additional capital for continued growth . . .,” page 14 43. We note your disclosure that your ability to execute your operating plan depends upon your ability to obtain additional funding via the sale of equity and/or debt securities. Please revise your risk factor to clarify th at you need this funding. In addition, please disclose whether you have approached any sources for additional funding, or have entered into negotiations for a transaction. 44. Please expand your disclosure to inform invest ors that the issuance of equity securities will dilute your current investors’ interest in the company and the issuance of debt securities may provide such holders rights superior to existing shareholders and conditions on the company and its business. “If we fail to establish and maintain an effectiv e system of internal c ontrol, . . .,” page 15 45. Your disclosure in this risk f actor is not consistent with your disclosure regarding internal controls over financial reporting and disclosure controls and procedures contained in your annual report and quarterly reports on Form s 10-K and 10-Q. Please update this risk factor to discuss the material weaknesses disc losed in those reports and the related risks to your business. “We may fail to qualify for continued listi ng on the OTC Bulletin Board . . .,” page 15 46. If you have failed in the recent past to m eet a requirement to qualify for continued quotation on the OTCBB, please ex pand this risk factor to so disclose, and describe the listing requirement you failed to meet. “Investor relati
2011-09-07 - UPLOAD - Cocrystal Pharma, Inc.
August 30, 2011 Elliot Maza Via Fax Chief Executive Officer and CFO BioZone Pharmaceuticals, Inc 4400 Biscayne Boulevard Miami, Florida 33137 Re: BioZone Pharmaceuticals, Inc Item 4.01 Form 8- K Filed August 17, 2011 File No. 333 -146182 Dear Mr. Maza: We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who ar e responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Robert F Telewicz Jr. Robert F Telewicz Jr. Staff Accountant
2011-08-18 - UPLOAD - Cocrystal Pharma, Inc.
August 18, 2011 Via Fax Elliot Maza Chief Executive Officer and CFO BioZone Pharmaceuticals, Inc 4400 Biscayne Boulevard Miami, Florida 33137 Re: BioZone Pharmaceuticals, Inc Item 4.01 Form 8-K Filed August 17, 2011 File No. 333-146182 Dear Mr. Maza: We have reviewed your filing and have the following comment. In our comment, we may ask you to provide us with informati on so we may better understand your disclosure. Please respond to this letter within fi ve business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comment applies to your fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Form 8-K Item 4.01. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Dismissal of previous independent registered public accounting firm 1. We note that you dismissed Q Accountancy Corporation effective August 11, 2011. However, it appears that the representations related to your predecessor and successor auditor only cover the period from March 30, 2010 to Ju ly 31, 2011. Please amend your filing to extend the period covered by these representations to the date of dismissal or explain to us why you are unable to make those representations. Include an updated letter from your former auditor addressing your revised disclo sure as an exhibit to your Form 8-K/A. Reference is made to Item 304(a)(1)(iv) of Regulation S-K. Elliot Maza BioZone Pharmaceuticals, Inc August 18, 2011 Page 2 We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact the undersigned at (202)551-3438 if you have questions. Sincerely, /s/ Robert F Telewicz Jr. Robert F Telewicz Jr. Staff Accountant
2010-07-29 - CORRESP - Cocrystal Pharma, Inc.
CORRESP
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filename1.htm
isricorresp072910.htm
International Surf Resorts, Inc.
107 Country Coach Drive, Suite 705
Henderson, Nevada 89002
Telephone (888) 689-0930
July 29, 2010
Via Edgar Transmission
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, NE
Washington, DC 20549-3010
Attn: Sonia G. Barros
Re: International Surf Resorts, Inc.
Post-Effective Amendment No. 1 to
Form SB-2 on Form S-1
Filed July 14, 2010
File No. 333-146182
Dear Ms. Barros:
On behalf of International Surf Resorts, Inc. (the “Company”), and in regard to your letter dated July 26, 2010, regarding the Company’s Post-Effective Amendment No. 1 to Form SB-2 on Form S-1 (“Post-Effective Amendment”) filed July 14, 2010 with the Securities and Exchange Commission (“Commission”), the Company has keyed the following response to the comments and requests for information specified in your letter.
General
1. We note that your original registration statement was declared effective October 4, 2007 and included your audited financial statements for the year ended December 31, 2006. In that registration statement, you undertook to file post effective amendments in order to update your prospectus pursuant to Section 10(a)(3) of the Securities Act of 1933. It appears that your first Section 10(a)(3) update was required by July 4, 2008. Please provide us with a legal analysis of your compliance with Sections 5 and 10(a)(3) of the Securities Act of 1933.
Response:
The following is a legal analysis of the Company’s compliance with Sections 5 and 10(a)(3) of the Securities Act of 1933 (the “Securities Act”).
Ms. Sonia G. Barros
Securities and Exchange Commission
Page 2 of 3
Section 5 of the Securities Act provides:
“a.
Sale or delivery after sale of unregistered securities
Unless a registration statement is in effect as to a security, it shall be unlawful for any person, directly or indirectly--
1.
to make use of any means or instruments of transportation or communication in interstate commerce or of the mails to sell such security through the use or medium of any prospectus or otherwise; or
2.
to carry or cause to be carried through the mails or in interstate commerce, by any means or instruments of transportation, any such security for the purpose of sale or for delivery after sale.
b.
Necessity of prospectus meeting requirements of section 10
It shall be unlawful for any person, directly or indirectly--
1.
to make use of any means or instruments of transportation or communication in interstate commerce or of the mails to carry or transmit any prospectus relating to any security with respect to which a registration statement has been filed under this title, unless such prospectus meets the requirements of section 10; or
2.
to carry or cause to be carried through the mails or in interstate commerce any such security for the purpose of sale or for delivery after sale, unless accompanied or preceded by a prospectus that meets the requirements of subsection (a) of section 10.
c.
Necessity of filing registration statement
It shall be unlawful for any person, directly or indirectly, to make use of any means or instruments of transportation or communication in interstate commerce or of the mails to offer to sell or offer to buy through the use or medium of any prospectus or otherwise any security, unless a registration statement has been filed as to such security, or while the registration statement is the subject of a refusal order or stop order or (prior to the effective date of the registration statement) any public proceeding or examination under section 8.”
Ms. Sonia G. Barros
Securities and Exchange Commission
Page 3 of 3
On or after July 4, 2008, none of the selling shareholders have sold any shares of the Company’s common stock pursuant to the original registration statement that was declared effective by the Commission on October 4, 2007. Therefore, as no sales have been made by any of the selling shareholders on or after July 4, 2008, the Company believes it is in compliance with Section 5 of the Securities Act.
Section 10(a)(3) of the Securities Act provides:
“notwithstanding the provisions of paragraphs (1) and (2) of this subsection (a) when a prospectus is used more than nine months after the effective date of the registration statement, the information contained therein shall be as of a date not more than sixteen months prior to such use, so far as such information is known to the user of such prospectus or can be furnished by such user without unreasonable effort or expense.”
As discussed above, no sales have been made by any of the selling shareholders on or after July 4, 2008, and none of the selling shareholders have used the original prospectus after that date. The Company filed the Post-Effective Amendment to update the prospectus to include the audited financial statements for the year ended December 31, 2009, and to update certain other information in the prospectus, all of which was undertaken to comply with the requirements of Section 10(a)(3) of the Securities Act. Therefore, with this Post-Effective Amendment, the Company believes it is in compliance with Section 10(a)(3) of the Securities Act.
Moreover, the Company herewith acknowledges that:
·
Should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
·
The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
·
The Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Hopefully, this response letter adequately addresses the issue raised in your comment letter. Thank you.
Sincerely,
International Surf Resorts, Inc.
By: /s/ Eduardo Biancardi
Eduardo Biancardi
Its: President
2010-07-27 - UPLOAD - Cocrystal Pharma, Inc.
July 26, 2010 Santana Martinez International Surf Resorts, Inc. 107 Country Coach Dr., Suite 705 Henderson, Nevada 89002 Re: International Surf Resorts, Inc. Post-Effective Amendment No.1 to Form SB-2 on Form S-1 Filed July 14, 2010 File No. 333-146182 Dear Mr. Martinez: We have reviewed your 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 amending your registration statement and providing the requested information. Where 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 registration statement and the information you provide in response to these comments, we may have additional comments. General 1. We note that your original registration stat ement was declared effective on October 4, 2007 and included your audited fi nancial statements for the year ended December 31, 2006. In that registration statement, you undert ook to file post effective amendments in order to update your prospectus pursuant to Section 10(a)(3) of the Securities Act of 1933. It appears that your fi rst Section 10(a)(3) update was required by July 4, 2008. Please provide us with a lega l analysis of your compliance with Sections 5 and 10(a)(3) of the Securities Act of 1933. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they ar e responsible for the accuracy and adequacy of the disclosures they have made. Santana Martinez International Surf Resorts, Inc. July 26, 2010 Page 2 Notwithstanding our comments, before we can declare the amended registration statement effective, the company should provide us with a letter, acknowledging that : • should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the company may not assert staff comments a nd the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact William Lewis at (202) 551-3722 or me at (202) 551-3655 with any questions regarding this letter or related matters. Sincerely, Sonia G. Barros Special Counsel cc: Lan Ngyuyen Esquire Consulting, Inc. 600 S. Spring Street #1312 Los Angeles, California 90014 ( via facsimile) (440) 848-6345