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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
↓
Aspira Women's Health Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Aspira Women's Health Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2025-04-30
Aspira Women's Health Inc.
References: April 22, 2025
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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2024-04-24
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-04-09
Aspira Women's Health Inc.
Summary
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Company responded
2024-04-10
Aspira Women's Health Inc.
Summary
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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-01-25
Aspira Women's Health Inc.
Summary
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Company responded
2021-01-26
Aspira Women's Health Inc.
Summary
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Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-09-24
Aspira Women's Health Inc.
Summary
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Company responded
2020-09-25
Aspira Women's Health Inc.
Summary
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Aspira Women's Health Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-10-31
Aspira Women's Health Inc.
Summary
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Company responded
2017-11-03
Aspira Women's Health Inc.
Summary
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Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-08-04
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-06-29
Aspira Women's Health Inc.
Summary
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Company responded
2017-07-25
Aspira Women's Health Inc.
References: June 29, 2017
Summary
Generating summary...
Aspira Women's Health Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2017-05-01
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-11
Aspira Women's Health Inc.
References: February 19, 2015
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-02-19
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2013-01-23
Aspira Women's Health Inc.
References: May 22, 2012
Summary
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Company responded
2013-01-25
Aspira Women's Health Inc.
References: January 23, 2013 | May 22, 2012
Summary
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Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-12-20
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-11-20
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-11-20
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-05-29
Aspira Women's Health Inc.
References: May 22, 2012
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2012-05-22
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2012-05-25
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-05-22
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-05-08
Aspira Women's Health Inc.
References: May 1, 2012
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-05-03
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-05-02
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2012-03-08
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2012-03-15
Aspira Women's Health Inc.
References: March 8, 2012
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-03-02
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2011-01-28
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2011-02-10
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2011-02-11
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2011-02-11
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-01-06
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2010-12-14
Aspira Women's Health Inc.
Summary
Generating summary...
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Company responded
2010-12-17
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-12-14
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2007-11-13
Aspira Women's Health Inc.
Summary
Generating summary...
↓
Company responded
2007-11-30
Aspira Women's Health Inc.
References: October 30, 2007
Summary
Generating summary...
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Company responded
2007-12-12
Aspira Women's Health Inc.
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2007-10-30
Aspira Women's Health Inc.
References: October 15, 2007
Summary
Generating summary...
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SEC wrote to company
2007-12-12
Aspira Women's Health Inc.
References: September 24, 2007
Summary
Generating summary...
Aspira Women's Health Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2007-09-24
Aspira Women's Health Inc.
Summary
Generating summary...
↓
Company responded
2007-10-05
Aspira Women's Health Inc.
References: September 24, 2007
Summary
Generating summary...
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Company responded
2007-10-05
Aspira Women's Health Inc.
References: September 24, 2007
Summary
Generating summary...
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Company responded
2007-11-09
Aspira Women's Health Inc.
References: October 15, 2007
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-07 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2026-01-06 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-292512 | Read Filing View |
| 2025-11-19 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-05-06 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-05-06 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-04-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-286561 | Read Filing View |
| 2024-08-29 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-08-28 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-281745 | Read Filing View |
| 2024-07-23 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-280848 | Read Filing View |
| 2024-04-24 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-04-23 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-278867 | Read Filing View |
| 2024-04-10 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-04-09 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-278543 | Read Filing View |
| 2021-01-26 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2021-01-25 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2020-09-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-11-03 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-10-31 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-07-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-06-29 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-05-01 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2015-05-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2015-02-19 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2013-01-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2013-01-23 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-12-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-08 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-03 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-02 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-15 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-08 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-02 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-10 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-01-28 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-01-06 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2010-12-17 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2010-12-14 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-14 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-12 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-12 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-13 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-09 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-05 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-05 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-09-24 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-06 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-292512 | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-286561 | Read Filing View |
| 2024-08-28 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-281745 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-280848 | Read Filing View |
| 2024-04-23 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-278867 | Read Filing View |
| 2024-04-09 | SEC Comment Letter | Aspira Women's Health Inc. | DE | 333-278543 | Read Filing View |
| 2021-01-25 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-10-31 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-06-29 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2015-02-19 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2013-01-23 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-12-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-29 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-08 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-03 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-02 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-08 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-02 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-01-28 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-01-06 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2010-12-14 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-14 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-12 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-13 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-09-24 | SEC Comment Letter | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-07 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-11-19 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-05-06 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-05-06 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2025-04-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-08-29 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-07-23 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-04-24 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2024-04-10 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2021-01-26 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2020-09-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-11-03 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-07-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2017-05-01 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2015-05-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2013-01-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-05-25 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2012-03-15 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-11 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2011-02-10 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2010-12-17 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-12-12 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-11-09 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-30 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-05 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
| 2007-10-05 | Company Response | Aspira Women's Health Inc. | DE | N/A | Read Filing View |
2026-01-07 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm January 7, 2026 VIA EDGAR TRANSMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Tyler Howes Re: Aspira Women’s Health Inc. Registration Statement on Form S-1 Filed December 31, 2025 (File No. 333-292512) Dear Mr. Howes, In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement, so that it will become effective on January 9, 2026, at 4:00 p.m., Eastern Time, or as soon as thereafter as practicable, or at such later time as Aspira Women’s Health Inc. (the “ Company ”) or its counsel may request via telephone call to the Staff. Please contact J. Eric Johnson of Winston & Strawn LLP, counsel to the Company, at (713) 651-2647 to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. chael Sincerely yours, Aspira Women’s Health Inc. By: /s/ Michael Buhle Name: Michael Buhle Title: Chief Executive Officer cc: J. Eric Johnson, Esq.
2026-01-06 - UPLOAD - Aspira Women's Health Inc. File: 333-292512
January 6, 2026
Michael Buhle
Chief Executive Officer
Aspira Women's Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, TX 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-1
Filed December 31, 2025
File No. 333-292512
Dear Michael Buhle:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:J. Eric Johnson, Esq.
2025-11-19 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm November 19, 2025 VIA EDGAR TRANSMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Daniel Crawford Re: Aspira Women’s Health Inc. Registration Statement on Form S-1 Filed October 20, 2025 (File No. 333-290633) Dear Mr. Crawford, In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement, so that it will become effective on November 21, 2025, at 4:00 p.m., Eastern Time, or as soon as thereafter as practicable, or at such later time as Aspira Women’s Health Inc. (the “ Company ”) or its counsel may request via telephone call to the Staff. Please contact J. Eric Johnson of Winston & Strawn LLP, counsel to the Company, at (713) 651-2647 to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Aspira Women’s Health Inc. By: /s/ Mike Buhle Name: Mike Buhle Title: Chief Executive Officer cc: J. Eric Johnson, Esq.
2025-05-06 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm ASPIRA WOMEN'S HEALTH INC. 12117 Bee Caves Road, Building III, Suite 100 Austin, Texas 78738 May 6, 2025 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Joshua Gorsky Re: Aspira Women's Health Inc. Registration Statement on Form S-1 Filed May 6, 2025 File No. 333-286561 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Aspira Women's Health Inc. (the "Company") respectfully requests that the effective date of the registration statement referred to above (the "Registration Statement") be accelerated so that it becomes effective at 9:00 a.m., Eastern Time, on Wednesday May 7, 2025, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Sincerely, ASPIRA WOMEN'S HEALTH INC. By: /s/ Michael Buhle Name: Michael Buhle Title: Chief Executive Officer - 1 -
2025-05-06 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm ASPIRA WOMEN'S HEALTH INC. 12117 Bee Caves Road, Building III, Suite 100 Austin, TX 78738 May 6, 2025 VIA EDGAR United States Securities and Exchange Commission 100 F. Street, NE Washington, DC 20549 Attention: Joshua Gorsky Joe McCann Re: Aspira Women's Health Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed April 30, 2025 File No. 333-286561 Dear Ladies and Gentlemen: This letter sets forth a response on behalf of Aspira Women's Health Inc., a Delaware corporation (the "Company"), to the oral comments received on May 5, 2025 from the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") with respect to the Company's above captioned Registration Statement on Form S-1 (the "Registration Statement"). This letter is being submitted together with Amendment No. 2 to the Registration Statement, which has been revised to address the Staff's comment. For the convenience of the Staff, the oral comment is restated below prior to the response to such comment. Amendment No. 1 to Registration Statement on Form S-1 Filed on April 30, 2025 Risk Factors, page 8 1. We note your disclosure on page 8 of this section that "before deciding whether to purchase our common stock, investors should carefully consider the risks described below together with the "Risk Factors" described in our most recent Annual Report on Form 10-K and any updates described in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are incorporated herein by reference[.]" We note that at this time you appear to be ineligible to use incorporation by reference. Accordingly, please revise your disclosure here and elsewhere as appropriate to clarify that you are not using incorporation by reference in this Registration Statement or otherwise advise . RESPONSE: The Company respectfully acknowledges the Staff's comment and has revised page 8 of the Registration Statement to clarify that we are not using incorporation by reference in this Registration Statement. Sincerely, Aspira Women's Health Inc. /s/ Michael Buhle By: Michael Buhle Title: Chief Executive Officer
2025-04-30 - CORRESP - Aspira Women's Health Inc.
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ASPIRA
WOMEN'S HEALTH INC.
12117
Bee Caves Road, Building III, Suite 100
Austin,
TX 78738
April
30, 2025
VIA
EDGAR
United
States Securities and Exchange Commission
100
F. Street, NE
Washington,
DC 20549
Attention:
Joshua
Gorsky
Joe
McCann
Re:
Aspira
Women's Health Inc.
Registration
Statement on Form S-1
Filed
April 16, 2025
File
No. 333-286561
Dear
Ladies and Gentlemen:
This
letter sets forth responses on behalf of Aspira Women's Health Inc., a Delaware corporation (the "Company"), to the
comments received from the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set
forth in your letter dated April 22, 2025 ("Comment Letter") regarding the Company's Registration Statement on Form
S-1 (the "Registration Statement").
For
the convenience of the Staff, each comment from the Comment Letter corresponds to the numbered paragraphs in this letter and is restated
prior to the response to such comment.
Registration
Statement on Form S-1 Filed on April 16, 2025
Cover
Page
1.
We
note your disclosure on the cover page that this prospectus relates to the resale of 345,988 shares of common stock and "up
to $2,000,000 of shares of [c]ommon [s]tock, by Triton Funds LP[.]" Please revise the cover page to reflect the volume of shares
associated with the "up to $2,000,000 of shares of common stock" being registered in this offering.
RESPONSE:
The
Company respectfully acknowledges the Staff's comment and has revised the cover page to the Registration Statement to reflect
the volume of shares associated with the "Up to $2,000,000 of shares of common stock" being registered in this offering.
Selling
Stockholder, page 18
2.
Please
revise this section to reflect the total number of shares being registered pursuant to the Purchase Agreement, including the $2,000,000
of shares identified on the cover page.
RESPONSE:
The
Company respectfully acknowledges the Staff's comment and has revised this section to reflect the total number of shares being
registered pursuant to the Purchase Agreement, including the $2,000,000 of shares identified on the cover page.
General
3.
We
note the disclosure in your Current Report on Form 8-K, filed April 16, 2025, that you received written notice from The Nasdaq Stock
Market indicating that the Nasdaq Hearings Panel determined to delist your common shares from Nasdaq. Please update your cover page
to disclose where your common shares are listed or quoted.
RESPONSE:
The
Company respectfully acknowledges the Staff's comment and has updated our cover page to disclose that as of April 17, 2025,
our common stock was quoted on the OTC Markets Pink Sheets trading system under the symbol "AWHL."
Sincerely,
Aspira
Women's Health Inc.
/s/
Michael Buhle
By:
Michael
Buhle
Title:
Chief
Executive Officer
2025-04-22 - UPLOAD - Aspira Women's Health Inc. File: 333-286561
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 22, 2025 Michael Buhle Chief Executive Officer and Chief Commercial Officer Aspira Women's Health Inc. 12117 Bee Caves Road, Building III, Suite 100 Austin, TX 78738 Re: Aspira Women's Health Inc. Registration Statement on Form S-1 Filed April 16, 2025 File No. 333-286561 Dear Michael Buhle: We have conducted a limited review of your registration statement and have the following comments. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Registration Statement on Form S-1 Cover Page 1. We note your disclosure on the cover page that this prospectus relates to the resale of 345,988 shares of common stock and "up to $2,000,000 of shares of [c]ommon [s]tock, by Triton Funds LP[.]" Please revise the cover page to reflect the volume of shares associated with the "up to $2,000,000 of shares of common stock" being registered in this offering. Selling Stockholder, page 18 2. Please revise this section to reflect the total number of shares being registered pursuant to the Purchase Agreement, including the $2,000,000 of shares identified on the cover page. April 22, 2025 Page 2 General 3. We note the disclosure in your Current Report on Form 8-K, filed April 16, 2025, that you received written notice from The Nasdaq Stock Market indicating that the Nasdaq Hearings Panel determined to delist your common shares from Nasdaq. Please update your cover page to disclose where your common shares are listed or quoted. 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 Joshua Gorsky at 202-551-7836 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Emily A. Mastoloni, Esq. </TEXT> </DOCUMENT>
2024-08-29 - CORRESP - Aspira Women's Health Inc.
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CORRESP
Aspira Women’s Health, Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, Texas
August 29, 2024
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Doris Stacey Gama
Re:
Aspira Women’s Health, Inc.
Registration Statement on Form S-3
Filed August 23, 2024
File No. 333-281745
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Aspira Women’s Health, 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 4:00 p.m., Eastern Daylight Time, on Tuesday, September 3, 2024, or as soon thereafter as possible.
Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
ASPIRA WOMEN’S HEALTH, INC.
By:
/s/ Nicole Sandford
Name:
Nicole Sandford
Title:
Chief Executive Officer
2024-08-28 - UPLOAD - Aspira Women's Health Inc. File: 333-281745
August 28, 2024
Nicole Sandford
Chief Executive Officer & Director
Aspira Women's Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, TX 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-3
Filed August 23, 2024
File No. 333-281745
Dear Nicole Sandford:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeffrey J. Fessler, Esq.
2024-07-23 - CORRESP - Aspira Women's Health Inc.
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CORRESP
Aspira Women’s Health, Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, Texas
July 23, 2024
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Doris Stacey Gama
Re:
Aspira Women’s Health, Inc.
Registration Statement on Form S-3
Filed July 17, 2024
File No. 333-280848
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Aditxt, 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 4:00 p.m., Eastern Daylight Time, on Wednesday July 24, 2024, or as soon thereafter as possible.
Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
ASPIRA WOMEN’S HEALTH, INC.
By:
/s/ Nicole Sandford
Name:
Nicole Sandford
Title:
Chief Executive Officer
SMRH:4874-8036-4499.1
-1-
072324
96WD-393779
2024-07-22 - UPLOAD - Aspira Women's Health Inc. File: 333-280848
July 22, 2024
Nicole Sandford
Chief Executive Officer
Aspira Women's Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, TX 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-3
Filed July 17, 2024
File No. 333-280848
Dear Nicole Sandford:
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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Sean Reid, Esq.
2024-04-24 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm CORRESP Aspira Women’s Health Inc. 12117 Bee Caves Road, Building III, Suite 100 Austin, TX 78738 (512) 519-0400 April 24, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tamika Sheppard Re: Aspira Women’s Health Inc. Registration Statement on Form S-3 File No. 333-278867 Acceleration Request Requested Date: Thursday, April 25, 2024 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Aspira Women’s Health Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-278867) to become effective on Thursday, April 25, 2024, at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Josh Seidenfeld and Kyle Huh of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Josh Seidenfeld of Cooley LLP at (650) 843-5862, or in his absence, Kyle Huh, at (650) 843-5965. Sincerely, ASPIRA WOMEN’S HEALTH INC. By: /s/ Minh Merchant Minh Merchant General Counsel
2024-04-23 - UPLOAD - Aspira Women's Health Inc. File: 333-278867
United States securities and exchange commission logo
April 23, 2024
Nicole Sandford
Chief Executive Officer & Director
Aspira Women's Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, Texas 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-3
Filed April 22, 2024
File No. 333-278867
Dear Nicole Sandford:
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 Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Josh Seidenfeld
2024-04-10 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm CORRESP Aspira Women’s Health Inc. 12117 Bee Caves Road, Building III, Suite 100 Austin, TX 78738 (512) 519-0400 April 10, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tim Buchmiller Re: Aspira Women’s Health Inc. Registration Statement on Form S-1 File No. 333-278543 Acceleration Request Requested Date: Thursday, April 11, 2024 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) to become effective at 4:00 p.m. Eastern Time on Thursday, April 11, 2024, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Josh Seidenfeld of Cooley LLP at (650) 843-5862. Sincerely, ASPIRA WOMEN’S HEALTH INC. By: /s/ Minh Merchant Minh Merchant General Counsel
2024-04-09 - UPLOAD - Aspira Women's Health Inc. File: 333-278543
United States securities and exchange commission logo
April 9, 2024
Nicole Sandford
Chief Executive Officer
Aspira Women's Health Inc.
12117 Bee Caves Road, Building III, Suite 100
Austin, Texas 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-1
Filed April 5, 2024
File No. 333-278543
Dear Nicole Sandford:
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: Josh Seidenfeld, Esq.
2021-01-26 - CORRESP - Aspira Women's Health Inc.
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S-3 Acceleration Request
Aspira Women’s Health Inc.
12117 Bee Caves Road, Building Three, Suite 100
Austin, TX 78738
January 27, 2021
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Tim Buchmiller
Re: Registration Statement on Form S-3 (Registration No. 333-252267)
Ladies and Gentlemen:
Reference is made to the above-captioned Registration Statement initially filed by Aspira Women’s Health Inc. (the “Company”) with the U.S. Securities and Exchange Commission on January 20, 2021 (the “Registration Statement”). Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Registration Statement be accelerated to Thursday, January 28, 2021, at 5:00 p.m. (Eastern Time) or as soon thereafter as may be practicable.
[Signature page follows]
Please contact Beth E. Berg of Sidley Austin LLP at (312) 853-7443 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement.
Very truly yours,
ASPIRA WOMEN’S HEALTH INC.
By: /s/ Robert Beechey
Name: Robert Beechey
Title: Chief Financial Officer and Secretary
2021-01-25 - UPLOAD - Aspira Women's Health Inc.
United States securities and exchange commission logo
January 25, 2021
Valerie Palmieri
President and Chief Executive Officer
Aspira Women's Health Inc.
35 Nutmeg Drive Suite 260
Trumbull, Connecticut 06611
Re:Aspira Women's Health Inc.
Registration Statement on Form S-3
Filed January 20, 2021
File No. 333-252267
Dear Ms. Palmieri:
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: Beth E. Berg, Esq.
2020-09-25 - CORRESP - Aspira Women's Health Inc.
CORRESP
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S-3 Acceleration Request
Aspira Women’s Health Inc.
12117 Bee Caves Road, Building Three, Suite 100
Austin, TX 78738
September 25, 2020
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: James Young
Re: Registration Statement on Form S-3 (Registration No. 333-248920)
Ladies and Gentlemen:
Reference is made to the above-captioned Registration Statement initially filed by Aspira Women’s Health Inc. (the “Company”) with the U.S. Securities and Exchange Commission on September 18, 2020 (the “Registration Statement”). Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Registration Statement be accelerated to Wednesday, September 30, 2020, at 5:00 p.m. (Eastern Time) or as soon thereafter as may be practicable.
[Signature page follows]
Please contact Beth E. Berg of Sidley Austin LLP at (312) 853-7443 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement.
Very truly yours,
ASPIRA WOMEN’S HEALTH INC.
By: /s/ Robert Beechey
Name: Robert Beechey
Title: Chief Financial Officer and Secretary
2020-09-24 - UPLOAD - Aspira Women's Health Inc.
United States securities and exchange commission logo
September 24, 2020
Bob Beechey
Chief Financial Officer
Aspira Women's Health Inc.
12117 Bee Caves Road, Building Three, Suite 100
Austin, Texas 78738
Re:Aspira Women's Health Inc.
Registration Statement on Form S-3
Filed September 18, 2020
File No. 333-248920
Dear Mr. Beechey:
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 James Young at 202-551-4679 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Beth Berg
2017-11-03 - CORRESP - Aspira Women's Health Inc.
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2017-11-01 S-3 Acceleration Request
Vermillion, Inc.
12117 Bee Caves Road, Building Three, Suite 100
Austin, TX 78738
November 3, 2017
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ada D. Sarmento
Re: Registration Statement on Form S-3 (Registration No. 333-221092)
Ladies and Gentlemen:
Reference is made to the above-captioned Registration Statement initially filed by Vermillion, Inc. (the “Company”) with the U.S. Securities and Exchange Commission on October 24, 2017 (the “Registration Statement”). Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Registration Statement be accelerated to Tuesday, November 7, 2017, at 5:00 p.m. (Eastern Time) or as soon thereafter as may be practicable.
[Signature page follows]
Please contact Beth E. Peev of Sidley Austin LLP at (312) 853-7443 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement.
Very truly yours,
VERMILLION, INC.
By: /s/ Eric J. Schoen
Name: Eric J. Schoen
Title: Senior Vice President, Finance and
Chief Accounting Officer
2017-10-31 - UPLOAD - Aspira Women's Health Inc.
October 31, 2017
Valerie B. Palmieri
Chief Executive Officer
Vermillion, Inc.
12117 Bee Caves Road, Building Three, Suite 100
Austin, TX 78738
Vermillion, Inc.
Registration Statement on Form S-3
Filed October 24, 2017
File No. 333-221092Re:
Dear Ms. Palmieri:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Beth E. Peev, Esq.
2017-08-04 - UPLOAD - Aspira Women's Health Inc.
Mail Stop 4 546 August 4, 2017 Via E -mail Ms. Valerie Palmieri President and Chief Executive Officer Vermillion, Inc. 12117 Bee Caves R oad, Building Three, Suite 100 Austin, T X 78738 Re: Vermillion, Inc. Form 10-K for the Year Ended December 31 , 2016 Filed March 31, 2017 File No. 001-34810 Dear Ms. Palmieri : We have completed our review of your filings . 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, /s/ Sharon M. Blume Sharon M. Blume Accounting Branch Chief Office of Healthcare and Insurance
2017-07-25 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm 2017-07-25 SEC Comment Letter Response Vermillion, Inc. Building Three, Suite 100 12117 Bee Caves Road Austin, TX 78738 July 25, 2017 VIA EDGAR AND E-MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attn:Jim B. Rosenberg, Senior Assistant Chief Accountant, Office of Healthcare and Insurance Re:Vermillion, Inc. Form 10-K for the Year Ended December 31, 2016 Filed March 31, 2017 File No. 001-34810 Dear Mr. Rosenberg: On behalf of Vermillion, Inc. (the “Company”), I submit this letter in response to the comment (the “Comment”) received from the staff (the “Staff”) of the Securities and Exchange Commission in a letter, dated June 29, 2017, received on July 18, 2017, relating to the Company’s Form 10-K for the year ended December 31, 2016. For the convenience of the Staff, we have restated the Comment below, followed by the Company’s response. Notes to Consolidated Financial Statements Note 2: Recent Accounting Pronouncements, page F-10 1. You state that you are in the process of evaluating the impact that the amended revenue recognition guidance in Topic 606 will have on your consolidated financial statements. Please revise future filings to provide qualitative financial statement disclosures of the potential impact that this standard will have on your financial statements when adopted, and provide us with a sense of the disclosures that you intend to include in future filings. In this regard, include a description of the effects of the accounting policies that you expect to apply, if determined, and a comparison to your current revenue recognition policies. Describe the status of your process to implement the new standard and the significant implementation matters yet to be addressed. In addition, to the extent that you determine the quantitative impact that adoption of Topic 606 is expected to have on your financial statements, please also disclose such amounts. Please refer to ASC 250-10-S99-6 and SAB Topic 11.M. In response to the Staff’s comment, the Company intends to include in future filings additional information regarding its status of implementation of ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), as amended by ASU 2015-14, including anticipated timing of completion of its analysis, and to the extent that the Company has identified the effect of the standard, the Company will add qualitative financial statement disclosures of such effect, as outlined in the guidance in SAB Topic 11.M. The concepts that the Company discusses below are subject to change and will be updated, as necessary, for the actual results of the Company’s continued implementation efforts in the second half of 2017. 1) The Company does not expect to have any License Revenue during the periods effected by the new standard. The Company is in the early stages of its analysis of the effect Topic 606 will have on its Service Revenue, but expects to complete its analysis during the second half of 2017. 2) The Company is also in the early stages of its analysis of its Product Revenue and also expects to complete this analysis in the second half of 2017. The Company’s current revenue recognition policy for Product Revenue, as disclosed in its Annual Report on Form 10-K for the year ended December 31, 2016, is as follows: The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company’s product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities’ existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt. Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 or Overa test as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company’s services, revenue is recognized when cash is received. In addition to the above, the Company will include the following disclosure in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017: Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company has not yet determined the quantitative effect the adoption of Topic 606 is expected to have on its financial statements and thus is unable to disclose those amounts. The next step in the Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis. We expect this to be completed in the second half of 2017. The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018. ********* If you or any other member of the Staff have any questions regarding this response, please do not hesitate to contact me by telephone at (512) 519-0424. Sincerely, /s/ Eric J. Schoen Eric J. Schoen Senior Vice President and Chief Accounting Officer Vermillion, Inc. cc: Valerie Palmieri, President and Chief Executive Officer, Vermillion, Inc. Beth Peev, Sidley Austin LLP Bryan Lorello, BDO USA, LLP
2017-06-29 - UPLOAD - Aspira Women's Health Inc.
Mail Stop 4 546 June 29, 2017 Via E -mail Ms. Valerie Palmieri President and Chief Executive Officer Vermillion, Inc. 12117 Bee Caves R oad, Building Three, Suite 100 Austin, T X 78738 Re: Vermillion, Inc. Form 10-K for the Year Ended December 31 , 2016 Filed March 31, 2017 File No. 001-34810 Dear Ms. Palmieri : We have limited our review of your filing to the financial statements and related disclosures and have the following comment . Please respond to this comment within 10 business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe the comment applies to your facts and circumstanc es, please tell us why in your response. After reviewing your response to the comment , we may have additional comments. Notes to Consolidated Financial Statements Note 2: Recent Accounting Pronouncements, page F -10 1. You state that you are in the proce ss of evaluating the impact that the amended revenue recognition guidance in Topic 606 will have on your consolidated financial statements. Please revise future filings to provide qualitative financial statement disclosures of the potential impact that thi s standard will have on your financial statements when adopted , and provide us with a sense of the disclosures that you intend to include in future filings . In this regard, include a description of the effects of the accounting policies that you expect to apply, if determined, and a comparison to your current revenue recognition policies. Describe the status of your process to implement the new standard and the significant implementation matters yet to be addressed. In addition, to the extent that you deter mine the quantitative impact that adoption of Topic 606 is expected to have on your financial statements, please also disclose such amounts. Please refer to ASC 250 -10-S99- 6 and SAB Topic 11.M. Ms. Valerie Palmieri Vermillion, Inc. June 29, 2017 Page 2 We remind you that the company and its management are responsi ble for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Senior Staff Accountants Keira Nakada at (202) 551 -3659 or Jim Peklenk at (202) 551 -3661 if you have questions regarding the comment s. 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 Office of Healthcare and Insurance
2017-05-01 - CORRESP - Aspira Women's Health Inc.
CORRESP
1
filename1.htm
2017-04-28 S-3 Acceleration Request
Vermillion, Inc.
12117 Bee Caves Road Building Three, Suite 100
Austin, TX 78738
May 1, 2017
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ada Sarmento
Re: Registration Statement on Form S-3 (Registration No. 333-217249)
Ladies and Gentlemen:
Reference is made to the above-captioned Registration Statement initially filed by Vermillion, Inc. (the “Company”) with the U.S. Securities and Exchange Commission on April 11, 2017 (the “Registration Statement”). Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Registration Statement be accelerated to Thursday, May 4, 2017, at 5:00 p.m. (Eastern Time) or as soon thereafter as may be practicable.
[Signature page follows]
Please contact Beth E. Peev of Sidley Austin LLP at (312) 853-7443 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement.
Very truly yours,
VERMILLION, INC.
By: /s/ Eric J. Schoen
Name: Eric J. Schoen
Title: Senior Vice President, Finance and
Chief Accounting Officer
2015-05-11 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm 2015-05-08 Acceleration Request Letter Vermillion, Inc. 12117 Bee Caves Road Building Three, Suite 100 Austin, TX 78738 May 8, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey P. Riedler Re: Registration Statement on Form S-3 (Registration No. 333-202032) Ladies and Gentlemen: This letter is being furnished by Vermillion, Inc. (the “Company”) in response to the comment received from the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) by letter dated February 19, 2015 with respect to the above-referenced Registration Statement (as amended to date, the “Registration Statement”). In response to the Staff’s comment, the Company advises the Staff that its Annual Report on Form 10-K for the year ended December 31, 2014 was filed with the Commission on March 31, 2015, and that the Company has also filed with the Commission, on the date hereof, Amendment No. 1 to the Registration Statement in order to incorporate by reference such Annual Report on Form 10-K and to update corresponding disclosures. For your convenience, a courtesy copy of this letter and Amendment No. 1, marked to show the changes from the initial Registration Statement as filed on February 11, 2015, are also being delivered to Mr. Jeffrey P. Riedler. Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Registration Statement be accelerated to Monday, May 11, 2015 at 3:30 p.m. (Eastern time), or as soon thereafter as may be practicable. The Company acknowledges that: 1. should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; 2. the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and 3. 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. [signature page follows] Please contact Beth Flaming of Sidley Austin LLP at (312) 853-7443 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement. Very truly yours, VERMILLION, INC. By: /s/ Eric J. Schoen Name: Eric J. Schoen Title: Vice President, Finance and Chief Accounting Officer
2015-02-19 - UPLOAD - Aspira Women's Health Inc.
February 19 , 2015 Via E -mail Eric Schoen Vice President, Finan ce and Chief Accounting Officer Vermillion, Inc. 12117 Bee Caves Road Building Three, Suite 100 Austin, TX 78738 Re: Vermillion, Inc. Registration Statement on Form S -3 Filed February 11, 2015 File No. 333 -202032 Dear Mr. Schoen : We have limited our review of your registra tion statement to the issue we have addressed in the comment below. 1. Please update your financial statements to comply with Rule 8 -08 of Regulation S -X and provide corresponding updated disclosures throughout your filing. 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 registration 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 pu rsuant 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 Eric Schoen Vermillion , Inc. February 19 , 2015 Page 2 the company may not assert staff comments and the declaration o f 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 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. You may contact Pres ton Brewer at (202) 551 -3969 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffr ey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -Mail Beth Flaming , Esq. Sidley Austin LLP
2013-01-25 - CORRESP - Aspira Women's Health Inc.
CORRESP
1
filename1.htm
SEC Response Letter
1(650) 320-1800
robertclaassen@paulhastings.com
January 25, 2013
76553.00017
VIA EDGAR, UPS OVERNIGHT AND ELECTRONIC MAIL
Ms. Peggy Kim
Special Counsel
Office of Mergers & Acquisitions
Division of Corporation Finance
Securities and Exchange Commission
100 F Street
N.E.
Washington, D.C. 20549-3628
Re:
Vermillion, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed on January 18, 2013
File No. 1-34810
Dear
Ms. Kim:
On behalf of Vermillion, Inc. (the “Company”), reference is hereby made to the letter (the “Comment
Letter”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated January 23, 2013, to the Company with respect to the Company’s Amendment No. 3 to
Preliminary Proxy Statement on Schedule 14A filed with the Commission via its Electronic Data Gathering, Analysis and Retrieval system (“EDGAR”) on January 18, 2013 (“Amendment No. 3 to the Preliminary Proxy
Statement”). The Company hereby responds to the Comment Letter as set forth below. This response letter is being transmitted for filing with the Commission via EDGAR on the date hereof. The Company intends to include additional disclosures
as requested by the Staff in the Company’s definitive proxy statement (“Definitive Proxy Statement”) pursuant to the proposals set forth in this response letter.
The numbering of the paragraphs below corresponds to the numbering in the Comment Letter. Text from the Comment Letter is incorporated herein for convenience in italics.
Schedule 14A
General
1.
We note that you state that Mr. Goggin was found by the Delaware Chancery Court to have “illegally falsified documents” and “otherwise engaged in
litigation misconduct.” Please revise to avoid issuing statements in your soliciting materials that directly or indirectly impugn the character, integrity or personal reputation or make charges of illegal, improper or immoral conduct without
factual foundation. Disclose the factual foundation for such assertions or delete the statements in future solicitations. In this regard, note that the factual foundation for such assertions must be reasonable. Refer to Rule 14a-9.
In response to the Staff’s comment, the Company proposes revising this language in the Definitive Proxy Statement, as set
forth in the pages attached hereto as Exhibit A.
Paul Hastings LLP | 1117 S. California Avenue I Palo Alto, California
94304
t: + 1.650.320.1800 | www.paulhastings.com
Securities and Exchange Commission
January 25, 2013
Page 2
Quorum Abstentions; Broker Non-Votes, page 2
2.
Please revise the last paragraph regarding broker non-votes since the proxy solicitation is contested and broker non-votes will not be counted for quorum
purposes.
In response to the Staff’s comment, the Company proposes revising the last paragraph of the section titled
“Quorum; Abstentions; Broker Non-Votes” and the first paragraph under the section titled “Required Vote; Recommendation” under “PROPOSAL TWO: ADVISORY VOTE TO APPROVE THE COMPENSATION OF OUR NAMED EXECUTIVE OFFICERS” in
the Definitive Proxy Statement, as set forth in the pages attached hereto as Exhibit B.
Proposal Four: Approval of an
Amendment and Restatement…, page 40
3.
We note your response to comment four in our letter dated May 22, 2012. Please revise to include the tabular information required by Item 10(a)(2) of
Schedule 14A.
In response to the Staff’s comment, the Company proposes including in its Definitive Proxy Statement
additional information as requested, under the section titled “New Plan Benefits” as set forth in the pages attached hereto as Exhibit C.
* * *
*
The Company hereby acknowledges that:
•
it 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.
If you have any questions, please do not hesitate to contact the undersigned at (650) 320-1800.
Sincerely yours,
/s/ Robert A.
Claassen
Robert A. Claassen
of
PAUL HASTINGS LLP
Enclosure
cc:
Eric J. Schoen, Chief Accounting Officer, Vermillion, Inc.
Exhibit A
Change Pages – General
A-1
***CAUTION***
Please note that a group of three stockholders – György B. Bessenyei, Gregory V. Novak and Robert S. Goggin (collectively, the
“Group”), who beneficially own approximately 1.6% of the Company’s common stock in the aggregate – has filed preliminary proxy statements with the Securities and Exchange Commission on April 20, 2012 (with amendments thereto
filed on May 4, 2012, May 8, 2012, May 21, 2012, and May 23, 2012), and on December 12, 2012. You may receive proxy solicitation materials from or on behalf of the Group, including an opposition proxy statement and
proxy card. The Group’s potential nominee, Robert S. Goggin, is NOT endorsed by the Board. The potential nominee proposed by the Group is an attorney in private practice, with little or no experience in clinical diagnostics, and no apparent
public company board or management experience. In addition, the Group’s potential nominee was found by the Delaware Chancery Court to have illegally falsified documents byknowingly caused his assistant to improperly
notarizingnotarize court filings in connection with a proxy related dispute, in violation of the rules of the court and Pennsylvania law, and, moreover, that the conduct of Mr. Goggin appeared to be a violation of
the Pennsylvania rules of professional conduct applicable to Pennsylvania lawyers. The Board urges you to vote FOR our nominee for director on the attached BLUE proxy card. The Board also urges you NOT to sign or return any proxy card sent to you by
or on behalf of the Group.
Even if you have previously signed a proxy card sent by or on behalf of the Group, you have
the right to change your vote. If you wish to change your vote, please sign, date and mail the attached BLUE proxy card in the enclosed pre-addressed postage-paid envelope. Only the latest-dated proxy card you submit will be counted.
By Order of the Board of Directors
Bruce A. Huebner
Interim Chief Executive Officer
Austin, Texas
,January , 2013
YOUR VOTE IS IMPORTANT. IN ORDER TO ENSURE YOUR REPRESENTATION AT THE ANNUAL MEETING, YOU ARE URGED TO SIGN AND DATE THE ATTACHED BLUE
PROXY CARD AND RETURN IT IN THE ENCLOSED PRE-ADDRESSED POSTAGE-PAID ENVELOPE AS SOON AS POSSIBLE.
Mr. Novak and Ms. Page exchanged e-mails following the March 27, 2012 meeting
to establish a time for a teleconference, which was set for May 1, 2012.
On April 30, 2012, the Company received
supplemental materials from the Group, including a copy of the preliminary proxy statement filed by the Group with the SEC on April 20, 2012.
On May 1, 2012, Mr. Novak and Ms. Page, with the authorization of and at the direction of the Board, participated in the above-mentioned teleconference. The teleconference was cordial, and
the Group’s potential nominees, certain strategic suggestions for the Company, and alternatives to a potential proxy contest were discussed, but the participants were again unable to resolve their differences. Ms. Page informed
Mr. Novak that the Board remains open to hearing the Group’s ideas to benefit the Company and all stockholders and to working constructively with the Group, but believes that the director nominees then proposed by the Board were the most
qualified candidates up for election at the Annual Meeting and that their appointment is in the best interest of the Company and all stockholders. In addition, in an effort to avoid a potential proxy contest and litigation, Ms. Page conveyed
the Board’s offer that the Board would nominate Mr. Novak to the open seat. To the Board’s surprise, the Group rejected Ms. Page’s offer. Mr. Novak appears to have subsequently been dropped from the Group.
On May 25, 2012, Mr. Bessenyei and Mr. Goggin filed a verified complaint in the Delaware Court of Chancery against the
Company, each current member of the company’s Board, and Gail S. Page. On June 1, 2012, the plaintiffs filed an amended verified complaint that contained the following causes of action: breach of fiduciary duty under two standards,
declaratory relief, preliminary injunctive relief, and permanent injunctive relief. The allegations in the amended verified complaint challenged the adoption by the Board of an amendment to our bylaws eliminating the board seat formerly held by
Ms. Page. As previously disclosed by the Company, on May 15, 2012, Ms. Page was terminated without cause as Vermillion’s President and CEO, and, upon her termination, Ms. Page resigned her seat on the Board. For a variety of
reasons, including an effort to streamline the Company’s organization and extend its cash runway, the Board amended Vermillion’s bylaws to eliminate the vacant board seat. Mr. Goggin and Mr. Bessenyei claimed that the
Board’s decision to eliminate the seat was a breach of its fiduciary duties, alleging that the Board’s actions were intended both to prevent the Plaintiffs’ potential nominees from being able to be elected to the Board, and to
entrench the Board’s current members. Among other things, they sought to have the court declare null and void the May 15, 2012 amendment to the bylaws, and award to the plaintiffs the costs and fees incurred by them in the action. The
active case prevented the Company from holding its 2012 annual meeting while the case was pending.
On July 26, 2012,
after the parties had engaged in discovery, Vermillion and the other defendants filed a motion to dismiss the case arguing that the plaintiffs and their counsel provided false notarizations verifying the complaint, amended complaint and discovery
responses, and that the plaintiffs and their counsel otherwise engaged in litigation misconduct.
On
November 16, 2012, the Delaware Court of Chancery dismissed the case with prejudice. The court found that Mr. Goggin and Mr. Bessenyei had illegally falsified documents by improperly notarizingparticipated in the
improper notarization of court filings and, moreover, that the conduct of Mr. Goggin appeared to be a violation of the Pennsylvania rules of professional conduct applicable to Pennsylvania lawyers.
On November 28, 2012, Bruce Huebner together with Vermillion’s investor relations representative reached out to
Mr. Bessenyei and Mr. Goggin through a courtesy call to introduce Mr. Huebner as Vermillion’s Interim Chief Executive Officer. Mr. Goggin immediately asked about settlement terms regarding the Group’s potential proxy
contest, to which Mr. Huebner commented that the purpose of this call was an introduction and business discussion, and that any settlement talks would have to happen during another call with attorneys present. A cordial discussion about the
business ensued. Mr. Huebner agreed to follow up with a regional business broker referred by Mr. Bessenyei. This broker had a potential business opportunity that management concluded was not synergistic with Vermillion’s business.
6
PROPOSAL ONE: ELECTION OF DIRECTOR
Our Board of Directors currently consists of six directors, following the reduction in size authorized by the Board of Directors to
eliminate the vacancy existing due to the resignation of Ms. Page. The directors are divided into three classes having staggered three-year terms, so that the term of one class expires at each annual meeting of stockholders. The term of the
incumbent Class III director, John F. Hamilton, will expire at this Annual Meeting. John F. Hamilton is not nominated for re-election at this Annual Meeting. One nominee, Roberta L. Della Vedova, is proposed by our Board of Directors for election as
a Class III director at this Annual Meeting, to hold office until the 2015 annual meeting and until her successor is duly elected and qualified. If the Board’s nominee is unable or declines to serve as director, the proxies will be voted for
any substitute nominee who shall be designated by the Board. It is not expected that the Board’s nominee will be unable to or will decline to serve as director.
Class III Director Nominee to the Board:
Name
Age
Position with Vermillion
Roberta L. Della Vedova
59
None
Required Vote; Recommendation
The nominee receiving the highest number of affirmative votes of the outstanding shares of common stock, present or by proxy, will be elected as director so long as a quorum is present. Votes withheld
from a particular nominee and broker non-votes will be counted for purposes of determining whether a quorum exists but, because directors are elected by a plurality vote, will have no impact on the vote with respect to that nominee.
YOUR BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE “FOR” THE ELECTION OF THE NOMINEE NAMED ABOVE. IF YOU SIGN AND
RETURN THE ENCLOSED BLUE PROXY CARD, UNLESS YOU DIRECT TO THE CONTRARY ON THAT CARD, THE SHARES REPRESENTED BY THAT BLUE PROXY CARD WILL BE VOTED “FOR” THE ELECTION OF THE NOMINEE LISTED ABOVE.
We believe that the director nominee proposed by the Board, Roberta L. Della Vedova, is the most qualified candidate up for election
at the Annual Meeting as she has the requisite management experience in clinical diagnostics. Ms. Vedova was approved by the Nominating and Governance Committee and the independent members of the Board. Ms. Vedova brings a broad range of
relevant industry experience to the Board, having previously provided direction and oversight to companies engaged in the development, manufacture, and marketing of bioreagents and instruments, as well as in the delivery of laboratory services.
Please note that the Group – who beneficially own approximately 1.6% of the Company’s common stock in
the aggregate –has filed preliminary proxy statements with the SEC on April 20, 2012 (with amendments thereto filed on May 4, 2012, May 8, 2012, May 21, 2012, and May 23, 2012), and December 12, 2012. You
may receive proxy solicitation materials from or on behalf of the Group, including an opposition proxy statement and proxy card. The Group’s potential nominee, Robert S. Goggin, is NOT endorsed by the Board. The potential nominee proposed by
the Group is an attorney in private practice, with little or no applicable experience in clinical diagnostics, and no apparent public company board or management experience. In addition, the Group’s potential nominee was found by the Delaware
Chancery Court to have illegally falsified documents byknowingly caused his assistant to improperly notarizingnotarize court filings in connection with a proxy related dispute, in violation of the
rules of the court and Pennsylvania law, and, moreover, that the conduct of Mr. Goggin appeared to be a violation of the Pennsylvania rules of professional conduct applicable to Pennsylvania lawyers. The Board urges you to vote FOR our
nominee for director on the attached BLUE proxy card. The Board also urges you NOT to sign or return any proxy card sent to you by or on behalf of the Group.
8
Exhibit B
Change Pages – Quorum; Abstentions; Broker Non-Votes
B-1
non-votes”). If no potential proxy contest had been initiated, the proposal to ratify the appointment
of independent registered public accounting firm would have been considered a routine matter and the broker, bank or nominee would have been allowed to vote the shares in street name, without receiving specific instructions from shareholders on how
to vote the shares on that proposal. As a result of the potential proxy contest initiated by the Group, there will be no routine matters and therefore for votes of stockholders holding shares in street names to be counted, the stockholders will nee
2013-01-23 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
January 23, 2013
Via E -Mail
Robert Claassen , Esq.
Paul Hastings LLP
1117 S. California Avenue
Palo Alto, CA 94304
Re: Vermillion , Inc.
Amended Preliminary Proxy Statement on Schedule 14A
Filed on January 18, 2013
File No. 1 -34810
Dear Mr. Claassen :
We have reviewed your filing and have the following comment s.
Please respond to this letter by amending your filing, by providing the requested
information, or by advising us when you will provide the requested response. If you do not believe
our comment s apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any am endment to your filing and the informatio n you provide in response
to the se comment s, we may have additional comments.
Schedule 14A
General
1. We note that you state that Mr. Goggin was found by the Delaware Chancery Court to
have “illegally falsified documents ” and “otherwise engaged in litigation misconduct. ”
Please revise to avoid issuing statements in your soliciting materials that directly or
indirectly impugn the character, integrity or personal reputation or make charges of
illegal, improper or immoral conduct without factual foundation. Disclose the factual
founda tion for such assertions or delete the statements in future solicitations. In this
regard, note that the factual foundation for such assertions must be reasonable. Refer to
Rule 14a -9.
Robert Claass en, Esq.
Paul Hastings LLP
January 23, 201 3
Page 2
Quorum Abstentions; Broker Non -Votes, page 2
2. Please revise the last paragraph regarding broker non -votes since the proxy solicitation is
contested and broker non -votes will not be counted for quorum purposes .
Proposal Four: Approval of an Amendment and Restatemen t…, page 40
3. We note your response to comment four in our letter dated May 22, 2012 . Please revise
to include the tabular information required by Item 10(a)(2) of Schedule 14A.
Please direct any questions to me at (202) 551 -3411 . You may also con tact me via
facsimile at (202) 772 -9203. Please send all correspondence to us at the following ZIP code:
20549 -3628.
Sincerely ,
/s/ Peggy Kim
Peggy Kim
Special Counsel
Office of Mergers & Acquisitions
2012-12-20 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Decem ber 20, 2012
By E -Mail
Eric Simonson , Esq.
Blank Rome LLP
The Chrysler Building
405 Lexington Avenue
New York, NY 10174 -0208
Re: Vermillion , Inc.
Preliminary Proxy Statement filed by György B. Bessenyei,
Gregory V. Novak, and Robert S. Goggin
Filed December 1 2, 2012
File No . 1-34810
Dear Mr. Simonson :
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter by amending your filing, by providing the requested
information, or by advising us when you will provide the requested response. If you do not belie ve
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the information you provide in response
to these comments, we may ha ve additional comments.
Preliminary Proxy Statement
Proposal No. 1—Election of the Group Nominee as Director
1. We note that “in the event that a vacancy in the slate of Group Nominee should occur
unexpectedly, the shares of Common Stock …will be voted for a substitute candida te
selected by the Group. ” On the cover page of the proxy statement, however, you state
that “if the Group Nominee is unable to serve, we expect that the members of the
Company ’s Board of Directors will fill the vacancy. ” Please revise to reconcile the
discrepancy in the disclosure.
Eric Simonson, Esq.
Blank Rome LLP
December 20 , 2012
Page 2
2. Please revise to describe the specific experience, qualifications, attributes or skills that
led to the conclusion that the Grou p Nominee should be nominated to serve as a director .
Refer to Item 401 (e)(1) of Regulation S -K, and corresponding Item 7( b) of Schedule
14A.
3. We note that the Group believes that Mr. Goggin would be considered “independent .”
Please disclose whether Mr. Goggin is independent as defined under the Nasdaq listing
rules .
Please direct any questions to me at (202) 551 -3411 . You may also contact me via
facsimile at (202) 772 -9203. Please send all correspondence to us at the following ZIP code:
20549 -3628.
Sincerely ,
/s/ Peggy Kim
Peggy Kim
Special Counsel
Office of Mergers & Acquisitions
2012-11-20 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
November 20, 2012
By E -Mail
Eric Simonson , Esq.
Blank Rome LLP
The Chrysler Building
405 Lexington Avenue
New York, NY 10174 -0208
Re: Vermillion , Inc.
Soliciting Material filed pursuant to Rule 14a -12 by György B. Bessenyei,
Gregory V. Novak, and Ro bert S. Goggin
Filed November 16 , 2012
File No . 1-34810
Dear Mr. Simonson :
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter by amending your filing, by providing the requested
information, or by advising us when you will provide the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe a n amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the information you provide in response
to these comments, we may have additional comments.
Soliciting Material
1. We note that the participan ts will proceed with their proxy solicitation . Please revise to
file a revised and updated preliminary proxy statement.
2. In future filings, please revise the statement that the “Court Does Not Decide Issue of
Eliminating Board Seat ” since the lawsuit was dismissed.
3. We note the following statements about the Board and the issuer :
Based on information the Group has discovered, on May 15, 2012, believing that
defeat was imminent at the upcoming stockholder meeting that was only weeks
Eric Simonson, Esq.
Blank Rome LLP
November 20, 2012
Page 2
away, the Board of Directors made a desperate attempt to disenfranchise Vermillion’s
stockholders;”
“The Board’s patently false justification for taking this strange step was to ‘extend the
cash runway;’”
“However, as President and CEO Gail S. Page and Chairman of the Board James S.
Burns subsequen tly admitted, the actual cash savings from eliminatin g the Board seat
was only $5,000 per year;”
“[T]hey wasted close to a million dollars on: spending an estimated $300,000 on
proxy solicitation…Incurring $300,000+ in legal fees fighting in Delaware cour t, to
justify saving $5,000, which expenses may or may not be reimbursed by Vermillion’s
insurance carrier. Giving $400,000 severance to Page after ‘terminating ’ her instead
of letting her resign ;” and
“As a recent large sample study proved, OVA1 has no p eer when it comes to
sensitivity in detecting ovarian cancer.”
Please provide supplementally to us, and revise future filings to disclose, your support for
any statements relating to the board’s or the issuer ’s performance. In addition, to
facilitate our review, where the bases are other documents, such as prior proxy
statements, Forms 10 -K and 10 -Q, annual reports, analysts’ reports and newspaper
articles, provide either complete copies of the documents or sufficient pages of
information so that we can a ssess the context of the information upon which you rely.
Mark the supporting documents provided to identify the specific information relied upon.
4. In future filings, please revise the discussion about the Chancery Court dismissal to
address the consequen ces of the dismissal on the proxy contest and the nomination of one
director .
5. We note that you have started preliminary discussions with potential CEO candidates. In
future filings, please describe any specific plans to replace the CEO and quantify the
financial consequences of any removal.
Eric Simonson, Esq.
Blank Rome LLP
November 20, 2012
Page 3
Please direct any questions to me at (202) 551 -3411 . You may also contact me via
facsimile at (202) 772 -9203. Please send all correspondence to us at the following ZIP code:
20549 -3628.
Sincerely ,
/s/ Peggy Kim
Peggy Kim
Special Counsel
Office of Mergers & Acquisitions
2012-05-29 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 29, 2012
Via E-Mail
Peiyi Zhao, Esq. Paul Hastings LLP 1117 S. California Avenue Palo Alto, CA 94304
Re: Vermillion, Inc.
Response Letter submitted on May 25, 2012
Amended Preliminary Proxy St atement on Schedule 14A
Filed on May 17, 2012
File No. 1-34810
Dear Ms. Zhao:
We have reviewed your filing and ha ve the following comment.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. 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 reviewing any amendment to your filing and the inform ation you provide in response
to this comment, we may have additional comments.
Schedule 14A
Proposal One: Election of Directors, page 7
1. We note your response to comment three in our letter dated May 22, 2012 and your
statement that if the amendmen t to reduce the size of the board is reversed, you will send
an amended proxy statement and amended proxy card to security holders. Please revise,
here and on the proxy card, to disclose the risk that if the amendment to reduce the size of
the board is reversed, then shareholders who only vote the issuer’s fi rst proxy card and do
not return a second proxy card will be disenf ranchised with respect to the second board
seat. Please also revise to disclose, if true , that under state law, if the amendment to
reduce the size of the board is reversed, the issuer is still permitted to use the first proxy
cards to vote for Mr. Sohmer.
Peiyi Zhao, Esq.
Paul Hastings LLP May 29, 2012 Page 2
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely,
/s/ Peggy Kim
Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-05-25 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm Correspondence 1(650) 320-1884 robertclaassen@paulhastings.com May 25, 2012 76553.00017 VIA EDGAR, UPS OVERNIGHT AND ELECTRONIC MAIL Ms. Peggy Kim Special Counsel Office of Mergers & Acquisitions Division of Corporation Finance Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549-3628 Mr. Daniel F. Duchovny Special Counsel Office of Mergers & Acquisitions Division of Corporation Finance Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Re: Vermillion, Inc. Preliminary Proxy Statement on Schedule 14A Filed on May 17, 2012 File No. 1-34810 Dear Ms. Kim and Mr. Duchovny: On behalf of Vermillion, Inc. (the “Company”), reference is hereby made to the letter (the “Comment Letter”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated May 22, 2012, to the Company with respect to the Company’s Amendment No. 2 to Preliminary Proxy Statement on Schedule 14A filed with the Commission via its Electronic Data Gathering, Analysis and Retrieval system (“EDGAR”) on May 17, 2012 (“Amendment No. 2 to the Preliminary Proxy Statement”). The Company hereby responds to the Comment Letter as set forth below. This response letter is being transmitted for filing with the Commission via EDGAR on the date hereof. The Company intends to further amend its preliminary proxy statement (such amendment, “Amendment No. 3 to the Preliminary Proxy Statement”) to include additional disclosures as requested by the Staff pursuant to the proposals set forth in this response letter. The numbering of the paragraphs below corresponds to the numbering in the Comment Letter. Text from the Comment Letter is incorporated herein for convenience in italics. Schedule 14A Proposal One: Election of Directors, page 7 1. Please revise to briefly describe why the issuer believes that the reduction in the size of the board is authorized under Delaware law or the issuer’s governing documents. Please also disclose, here and on the proxy card, that the validity of the reduction in the number of board seats would ultimately be determined by a court of competent jurisdiction. In response to the Staff’s comment, the Company proposes including in Amendment No. 3 to the Preliminary Proxy Statement additional information as requested, following the information contained on page 7 of Amendment No. 2 to the Preliminary Proxy Statement, as follows: Paul Hastings LLP | 1117 S. California Avenue | Palo Alto. California 94304 t: +1.650.320.1800 | www.paulhastings.com Securities and Exchange Commission May 25, 2012 Page 2 Following Ms. Page’s resignation from the Board on May 15, 2012, the Board elected to eliminate the vacant seat in an effort to streamline the organization of the Company and to extend its cash runway by amending our Third Amended and Restated Bylaws, as filed as Exhibit 3.2 to the Company’s Annual Report on Form 10-K on March 27, 2012 (our “Bylaws”). Our Board has the authority to amend our Bylaws under Article IX of the Bylaws and Article X of our Fourth Amended and Restated Certificate of Incorporation, as filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K on January 25, 2010 (our “Certificate of Incorporation”). Notwithstanding this, the Group has asserted in its Amendment No. 4 to Preliminary Proxy Statement on Schedule 14A filed on May 23, 2012 that it “will consider litigation if necessary to reverse the [a]mendment.” While the Group certainly has the right to bring a lawsuit against the Company attempting to reverse the amendment, we believe that its chances of prevailing are remote, but ultimately any such determination would be made by a court of competent jurisdiction. Pursuant to telephonic conversations with the Staff and in an effort to make the proxy card clear and understandable to all stockholders, in response to the Staff’s comment, the Company proposes not including additional information on the proxy card to be included with Amendment No. 3 to the Preliminary Proxy Statement. 2. We note that Messrs. Bessenyei, Novak and Goggin are soliciting proxies to elect one director and in the event that the amendment to reduce the size of the board is reversed, they are seeking to elect two directors. Please revise to describe the treatment of the proxies submitted by Messrs. Besseneyi, Novak and Goggin and describe how the issuer will count these proxies. In response to the Staff’s comment, the Company proposes including in Amendment No. 3 to the Preliminary Proxy Statement additional information as requested, following the information contained on page 7 of Amendment No. 2 to the Preliminary Proxy Statement, as follows: We note that the Group will be soliciting proxies to elect one director, and in the event that the amendment to the Bylaws reducing the Board size is reversed, it is seeking to elect two directors. When a proxy card solicited by the Group is properly dated, executed and returned, that card will be voted at the Annual Meeting in accordance with the instructions of the stockholder set forth in the proxy. The nominee receiving the highest number of affirmative votes of the outstanding shares of common stock, present or by proxy, will be elected as a director so long as a quorum is present. If the amendment to the Bylaws reducing the Board size is reversed, then the two nominees receiving the highest number of affirmative votes of the outstanding shares of common stock, present or by proxy, will be elected as directors so long as a quorum is present. Securities and Exchange Commission May 25, 2012 Page 3 3. Please revise, here and on the proxy card, to disclose the risk that if the amendment to reduce the size of the board is reversed, then shareholders who vote the issuer’s proxy card will be disenfranchised with respect to the second board seat. In response to the Staff’s comment, the Company proposes including in Amendment No. 3 to the Preliminary Proxy Statement additional information as requested, following the information contained on page 7 of Amendment No. 2 to the Preliminary Proxy Statement, as follows: In the unlikely event that the amendment to the Bylaws reducing the size of the Board is reversed and there were then to be an additional seat available to be filled on our Board at the Annual Meeting, we would anticipate sending to all stockholders an amended proxy statement and proxy card. If certain stockholders who returned the first proxy card do not return a second proxy card and do not otherwise revoke their proxies, then the stockholders would vote their shares via their first proxies for an additional nominee to be specified by the Board. The first proxies allow Gail S. Page and Eric J. Schoen to vote in her/his discretion upon such other business as may properly be presented to the Annual Meeting. Any additional nominee would be indentified and evaluated pursuant to the procedure set forth in the section titled “Nominating and Governance Committee—Process for Identifying and Evaluating Nominees” in this proxy statement. If the amendment to the Bylaws reducing the size of the Board is reversed, the Company would expect to send to all stockholders an amended proxy statement and proxy card including all information required by Schedule 14A with respect to such nominee, including without limitation pursuant to Items 4(b), 5(b), 7 and 10 thereof (as applicable). Pursuant to telephonic conversations with the Staff, in an effort to make the proxy card clear and understandable to all stockholders, and in light of the disclosure proposed to be added as set forth above and the disclosure currently set forth on the proxy card included with Amendment No. 2 to the Preliminary Proxy Statement1, in response to the Staff’s comment, the Company proposes not including additional information on the proxy card to be included with Amendment No. 3 to the Preliminary Proxy Statement. Proposal Four: Approval of an Amendment and Restatement…, page 39 New Plan Benefits, page 44 4. Please revise to include the tabular information required by Item 10(a)(2) of Schedule 14A. Please note that the instruction in Item 10(a)(2)(iii) discusses how to present the information if the benefits and amounts are not determinable. 1 Which includes that “The signatory hereby appoint(s) each of Gail S. Page and Eric J. Schoen, with full power of substitution, the lawful attorney and proxy of the signatory to vote…in her/his discretion, upon such other business as may properly be presented to the meeting…and at any adjournments or postponements thereof.” Securities and Exchange Commission May 25, 2012 Page 4 In response to the Staff’s comment, the Company proposes including in Amendment No. 3 to the Preliminary Proxy Statement additional information as requested, under the section titled “New Plan Benefits” on page 45 of Amendment No. 2 to the Preliminary Proxy Statement, as set forth on Exhibit A hereto. * * * * The Company hereby acknowledges that: • it 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. If you have any questions, please do not hesitate to contact the undersigned at (650) 320-1800. Sincerely yours, /s/ Robert A. Claassen Robert A. Claassen of PAUL HASTINGS LLP Enclosure cc: Eric J. Schoen, Chief Accounting Officer, Vermillion, Inc. Exhibit A New Plan Benefits The Committee will grant awards under the amended and restated 2010 Plan at its discretion. Consequently, it is not possible to determine at this time the amount or dollar value of awards to be provided under the amended and restated 2010 Plan. In lieu of providing information regarding benefits that will be received under the amended and restated 2010 Plan, the following table provides information regarding benefits that were received under the 2010 Plan by the following persons and groups during the fiscal year ended December 31, 2011. The award amounts listed below do not purport to forecast or predict future award amounts under the amended and restated 2010 Plan to the listed persons or groups and are not indicative of awards that may be granted to such persons, groups, or positions under the amended and restated 2010 Plan in the event the shareholders approve it at the Annual Meeting. Name and position Dollar value ($)(1) Number of shares underlying restricted stock units Number of shares underlying options Gail S. Page President and Chief Executive Officer $ 351,050 85,000 — Sandra A. Gardiner Vice President and Chief Financial Officer 99,120 24,000 — Eric T. Fung, M.D., Ph.D. Senior Vice President and Chief Science Officer 161,950 41,000 — William Creech Vice President of Sales and Marketing 82,600 20,000 — Ashish Kohli Vice President of Corporate Strategy 28,910 7,000 — Executive Group(2) 723,630 177,000 (3) — Non-Executive Director Group(4) 373,301 97,295 (5) — Non-Executive Officer Employee Group(6) 305,405 — 191,930 (1) The dollar values in this column present the aggregate grant date fair value of the awards computed in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification™ 718 Compensation—Stock Compensation (“FASB ASC 718”). These amounts do not reflect whether the recipient has actually realized or will realize a financial benefit from the awards (such as by vesting in a RSU award). For information on the valuation assumptions used in these computations, please refer to the section captioned “Stock-Based Compensation” in Note 1: Basis of Presentation and Summary of Significant Accounting and Reporting Policies and Note 13: Employee Benefit Plans in the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K filed on March 27, 2012. A-1 (2) Includes all executive officers of the Company during the fiscal year ended December 31, 2011, as follows: Gail S. Page, President and Chief Executive Officer (85,000 RSUs); Sandra A. Gardiner, Vice President and Chief Financial Officer (24,000 RSUs); Eric T. Fung, M.D., Ph.D., Senior Vice President and Chief Science Officer (41,000 RSUs); William Creech, Vice President of Sales and Marketing (20,000 RSUs); and Ashish Kohli, Vice President of Corporate Strategy (7,000 RSUs). As of the date of filing of this proxy statement: (a) Ms. Gardner, Mr. Fung and Mr. Kohli are no longer executive officers of the Company; (b) the Company has announced the mutually agreed termination without cause of Ms. Page as our President and Chief Executive Officer, effective September 3, 2012, or earlier upon our entering into an agreement with a successor Chief Executive Officer; and (c) Donald G. Munroe, Ph.D., Chief Scientific Officer and Vice President of Research and Development, and Eric J. Schoen, Chief Accounting Officer, are executive officers of the Company. During the fiscal year ended December 31, 2011, Dr. Munroe received 125,000 stock options under the 2010 Plan, and Mr. Schoen received 23,400 stock options under the 2010 Plan, all of which awards are included in the row captioned “Non-Executive Officer Employee Group”. (3) All such restricted stock granted to the executive group vests ratably on a quarterly basis over a three-year period beginning on the vesting commencement in March 2011. We distributed 42,250 of these shares of common stock to our officers during the fiscal year ended December 31, 2011. (4) Includes all current directors who are not executive officers, as follows: Carl Severinghaus (20,000 RSUs), John F. Hamilton (15,200 RSUs), James S. Burns (15,200 RSUs), William C. Wallen, Ph.D. (19,200 RSUs), Peter S. Roddy (18,200 RSUs) and Bruce A. Huebner (9,495 RSUs). (5) All such restricted stock granted to the non-executive director group vested as follows: 50% on June 1, 2011, and 25% on each of September 1, 2011 and December 1, 2011, except that 100% of the restricted stock granted to Mr. Huebner vested on December 1, 2011 due to the fact that he joined the Board in May 2011. (6) Includes all employees (including all officers who are not executive officers) of the Company during the fiscal year ended December 31, 2011. This includes, without limitation, the grants to Dr. Munroe and Mr. Schoen as set forth in note (2) above. A-2
2012-05-22 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 22, 2012
By E-Mail
Eric Simonson, Esq. Blank Rome LLP The Chrysler Building 405 Lexington Avenue New York, NY 10174-0208
Re: Vermillion, Inc.
Amended Preliminary Proxy Statemen t filed by György B. Bessenyei,
Gregory V. Novak, and Robert S. Goggin Filed May 22, 2012 File No. 1-34810
Dear Mr. Simonson:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Preliminary Proxy Statement
Background of this Solicitation, page 1
1. Please revise to briefly describe why the par ticipants believe that eliminating the board
seat is unlawful under Delaware law. Pleas e also disclose, here and on the proxy card,
that the validity of the reduction in the number of board seats would ultimately be determined by a court of competent jurisdiction.
Eric Simonson, Esq.
Blank Rome LLP May 22, 2012 Page 2
Form of Proxy
2. We note the disclosure that “[t]he Group intends to use this proxy to vote “FOR” Mr.
Goggin and Mr. Novak if the Amendment is reversed (the “Group Nominees”). Please revise to clarify that the Group intends to use the proxy to vote “FOR” Mr. Goggin, and,
if the Amendment is reversed, “FOR” Mr. Goggin and Mr. Novak.
3. We note the disclosure that “[ y]ou may also withhold authority to vote for one or more
additional Company nominees by writing the name of the nominee(s) below.” Please remove this language since it does not appear to be applicable to your proxy solicitation.
Furthermore, Rule 14a-4(a)(3) requires that the form of proxy impartially identify each matter to be acted upon.
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely, /s/ Peggy Kim
Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-05-08 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 7, 2012
By E-Mail
Eric Simonson, Esq. Blank Rome LLP The Chrysler Building 405 Lexington Avenue New York, NY 10174-0208
Re: Vermillion, Inc.
Amended Preliminary Proxy Statemen t filed by György B. Bessenyei,
Gregory V. Novak, and Robert S. Goggin Filed May 4, 2012 File No. 1-34810
Dear Mr. Simonson:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Preliminary Proxy Statement
Reasons for this Solicitation, page 2
1. We note your response to comment four in our letter dated May 1, 2012. Please revise to
clarify that the Group Nominees’ plans could ch ange subject to their fiduciary duty to
stockholders if elected.
Other Matters that May Be Voted On, page 6
2. We note your response to comment eight in our letter dated May 1, 2012. In this regard,
we note that if a proxy card is unmarked, then Proposal 3 will be voted in the discretion
Eric Simonson, Esq.
Blank Rome LLP May 7, 2012 Page 2
of the named proxies or their substitutes. Please revise, here and on the proxy card, to
state whether unmarked cards will be voted for or against, or will not be voted for Proposal 3. Refer to Rule 14a-4(b)(1). For guidance, see section V. of SEC Release 34-
16356 (November 21, 1979), which discussed the different interpretations of a signed,
unmarked proxy and the need for shareholders to be advised as to how unmarked proxies
will be voted, including whether for management or not.
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely, /s/ Peggy Kim Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-05-03 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 3, 2012
Via E-Mail
Peiyi Zhao, Esq. Paul Hastings LLP 1117 S. California Avenue Palo Alto, CA 94304
Re: Vermillion, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed on April 25, 2012
File No. 1-34810
Dear Ms. Zhao:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Schedule 14A
General
1. Please revise to include a bac kground discussion of the contac ts between the participants
and the issuer during the time leading up to the current proxy solic itation. Please also
describe how the Board or management res ponded to contacts made by the participants
and the material details of any discussions or correspondence.
Peiyi Zhao, Esq.
Paul Hastings LLP May 3, 2012 Page 2
Solicitation of Proxies, page 1
2. We note that proxies may be solicited pers onally or by electronic or regular mail, by
telephone, by facsimile, or press releases. Pl ease be advised that all written soliciting
materials, including any scripts to be used in soliciting pr oxies over the telephone or any
e-mail correspondence and any information poste d on the Internet must be filed under the
cover of Schedule 14A. Refer to Rule 14a-6(b) and (c). In this re gard, we note that the
Vermillion press release on April 27, 2012 regarding the nomination of Mr. Sohmer was not filed on EDGAR and did not contain the required lege nd. Refer to Rule 14a-
12(a)(1)(ii) and (b). Please file all written soliciti ng materials and confirm your
understanding in your response letter.
Proposal One—Election of Directors, page 5
3. We note that you reserve the right to vote for unidentified substitute nominees. Please
confirm for us that should you identify or nominate substitute nominees before the
meeting, you will file an amended proxy stat ement that (1) identifies the substitute
nominees, (2) discloses whether such nomin ees have consented to being named in the
revised proxy statement and to serve if elected and (3) includes the disclosure required by
Items 5(b) and 7 of Schedule 14A w ith respect to such nominees.
4. We note that Vermillion believes that Mr. Sohmer is an “independent investor
representative.” Pleas e disclose whether Mr. Sohmer is independent as defined under the
Nasdaq listing rules.
Compensation Discussion and Analysis, page 16
5. Please revise to include the disclosure require d by Item 402(t) of Regulation S-K. Refer
to Item 5(b)(3) of Schedule 14A.
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely,
/s/ Peggy Kim
Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-05-02 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
May 1, 2012
By E-Mail
Eric Simonson, Esq. Blank Rome LLP The Chrysler Building 405 Lexington Avenue New York, NY 10174-0208
Re: Vermillion, Inc.
Preliminary Proxy Statement fi led by György B. Bessenyei,
Gregory V. Novak, and Robert S. Goggin Filed April 20, 2012 File No. 1-34810
Dear Mr. Simonson:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Preliminary Proxy Statement
General
1. We note that Vermillion has proposed additi onal matters on its proxy card, which do not
appear on the participants’ pr oxy card. Please revise the pa rticipant’s proxy statement
and proxy card to include each of Vermillion’ s proposals or revise your proxy statement
and proxy card to clearly state that shareholde rs will be disenfranchised with respect to
the other matters being solicited by Vermillion.
Eric Simonson, Esq.
Blank Rome LLP May 1, 2012 Page 2
Background to the Solicitation
2. Please further describe the “key metrics and progress to milestones” which Mr. Bessenyei
believed Vermillion was not keeping investors informed about and why Mr. Bessenyei did not believe that Vermillion addressed his concerns in a meaningful way.
3. We note that you identify the Vermillion nomi nees by name. Please revise to omit the
names of the Vermillion nominees since they have not consented to being named in the proxy statement, or advise us. Refe r to Rule 14a-4(d)(4).
Reasons for the Solicitation
4. Please revise to state whether the Group Nomi nees have any specific plans to increase
stockholder value, and if so, then describe any specific plans.
Election of Directors
5. Please revise the proxy statement to state that there is no assurance th at the registrant’s
directors will serve if electe d with any of the participants ’ nominees. We note that you
have already included simila r language on the proxy card.
6. We note the participants reserve the right to vote for unidentified substitute nominees.
Advise us, with a view toward revised disclosu re, whether the particip ants are required to
identify or nominate such substitute nomin ees in order to comply with any applicable
company advance notice bylaw. In addition, please confirm for us that should the
participants lawfully identif y or nominate substitute nominees before the meeting, the
participants will file an amended proxy st atement that (1) identifies the substitute
nominees, (2) discloses whether such nomin ees have consented to being named in the
revised proxy statement and to serve if elected and (3) includes the disclosure required by
Items 5(b) and 7 of Schedule 14A w ith respect to such nominees.
Other Matters Likely to be C onsidered at th e Annual Meeting
7. Please revise to number the proposals, as you have done on the proxy card.
8. We note your disclosure, here and on the pr oxy card, that if the proxy card is unmarked,
then the participants will vote the proxy card in their discretion. Pl ease revise, here and
on the proxy card, to specifically state how unmarked cards will be voted, i.e., whether
for, against, or abstain. Re fer to Rule 14a-4(b)(1).
Solicitation; Expenses
9. We note that proxies may be solicited by mail, advertisement, telephone, internet,
facsimile, other media, and personal solicita tion. Please be advise d that all written
Eric Simonson, Esq.
Blank Rome LLP May 1, 2012 Page 3
soliciting materials, including any scripts to be used in soliciting proxies over the
telephone or any e-mail correspondence and any information posted on the Internet must
be filed under the cover of Schedule 14A. Refer to Rule 14a-6(b) and (c). Please
confirm your understanding in your response letter.
Information about the Company
10. We note that this filing refers security holders to information that will be contained in the
registrant’s proxy statement for the annual m eeting. We presume that the participants
intend to rely upon Rule 14a-5(c) to fulfill certain disclosure ob ligations. Please note that
we believe that reliance upon Rule 14a-5(c ) before the company distributes the
information to security holders would be inappr opriate. If the participants determine to
disseminate their proxy statement prior to the distribution of the company’s proxy
statement, the participants must undertake to provide any omitted information to security holders in the form of a proxy supplement. Pleas e advise as to the pa rticipants’ intent in
this regard.
Information Concerning Partic ipants and their Associates
11. We note that all the derivative interests prev iously held by Mr. Bessenyei have expired.
Please revise to further describe the deriva tives referred to here and in Appendix B.
Refer to Item 5(b)(1)(viii) of Schedule 14A.
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely, /s/ Peggy Kim Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-03-15 - CORRESP - Aspira Women's Health Inc.
CORRESP
1
filename1.htm
Correspondence Letter
1(650) 320-1884
robertclaassen@paulhastings.com
March 15, 2012
VIA EDGAR AND UPS OVERNIGHT
Ms. Peggy Kim
Special Counsel
Office of Mergers & Acquisitions
Division of Corporation Finance
Securities and
Exchange Commission
100 F Street N.E.
Washington, D.C. 20549-3628
Re:
Vermillion, Inc.
Soliciting Material filed under Rule 14a-12
Filed March 7, 2012
File No. 1-34810
Dear Ms. Kim:
On behalf of Vermillion,
Inc. (the “Company”), reference is hereby made to the letter (the “Comment Letter”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated
March 8, 2012, to the Company with respect to the Company’s Soliciting Material filed under Rule 14a-12 on March 7, 2012 (the “Soliciting Material”). The Company hereby responds to the Comment Letter as set forth
below. This response letter and an amended version of the Soliciting Material were transmitted for filing with the Commission via EDGAR on the date hereof. A copy of the amended version of the Soliciting Material, marked to show changes against the
previously filed version, is enclosed.
The numbering of the paragraphs below corresponds to the numbering in the Comment Letter. Text from
the Comment Letter incorporated herein for convenience is in italics.
1.
We note that the issuer’s experience with Mr. Goggin is limited to his participation in an unsuccessful legal action against the Company and its board
relating to corporate governance matters. Please revise to include a general description of the nature of the claim, the relief requested, the court involved, and the disposition.
The Company acknowledges the Staff’s comment. In response to the Staff’s comment, the Company filed an amended version of the
Soliciting Material that was revised to provide the requested information. A copy of the amended version of the Soliciting Material, marked to show changes against the previously filed version, is enclosed.
2.
We note you indicate that a description of direct and indirect interests will be contained in disclosure documents to be filed later. Please
note that although participants relying upon Rule 14a-12 may refer to participant information provided in another filed document, the information must be available, current, and on file for review by security holders at the time the Rule 14a-12
materials are made publicly available. Participants may not refer to participant information to be provided at some future time such as the proxy statement. Refer to Rule 14a-12(a)(1)(i) and
Securities and Exchange Commission
March 15, 2012
Page
2
Exchange Act Release No. 42055, October 22, 1999, at Section II.C.1.b. In future filings, please revise to describe any direct or indirect interests.
The Company acknowledges the Staff’s comment. In response to the Staff’s comment, the Company filed an
amended version of the Soliciting Material that describes direct and indirect interests and refers to participant information provided in another filed document that is available, current, and on file for review by security holders at the time the
Rule 14a-12 materials were made publicly available. A copy of the amended version of the Soliciting Material, marked to show changes against the previously filed version, is enclosed.
* * *
*
The Company hereby acknowledges that:
•
it 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.
If you have any questions, please do not hesitate to contact the undersigned at (650) 320-1800.
Sincerely yours,
/s/ Robert A.
Claassen
Robert A. Claassen
of
PAUL HASTINGS LLP
Enclosure
cc:
Eric J. Schoen, Chief Accounting Officer, Vermillion, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
(Amendment No.
)
Filed by the Registrant x Filed by a Party other than the
Registrant ¨
Check the appropriate box:
¨
Preliminary Proxy Statement
¨
Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))
¨
Definitive Proxy Statement
¨
Definitive Additional Materials
x
Soliciting Material under §240.14a-12
Vermillion, Inc.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
x
No fee required.
¨
Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.
(1)
Title of each class of securities to which transaction applies:
(2)
Aggregate number of securities to which transaction applies:
(3)
Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the
filing fee is calculated and state how it was determined):
(4)
Proposed maximum aggregate value of transaction:
(5)
Total fee paid:
¨
Fee paid previously with preliminary materials.
¨
Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify
the previous filing by registration statement number, or the Form or Schedule and the date of its filing.
(1)
Amount previously paid:
(2)
Form, Schedule or Registration Statement No.:
(3)
Filing Party:
(4)
Date Filed:
Explanatory Note
The materials provided hereon are intended to amend and replace the
soliciting material under §240.14a-12 on Schedule 14A filed by Vermillion, Inc. (the “Company”) with the Securities and Exchange Commission on March 7, 2012 (the “Soliciting Material”), for the purpose of including a
general description of the nature of the unsuccessful claim referenced in the Soliciting Material as being brought in 2011 by a certain Company stockholder, as well as the relief requested, the court involved and the disposition thereof, and to
amend the information captioned “Important Additional Information” to include a description of the direct or indirect interests of certain persons who may be deemed to be
participants in the solicitation of proxies in connection with the Company’s 2012 annual meeting of stockholders.
VERMILLION, INC. ACKNOWLEDGES RECEIPT OF
DIRECTOR NOMINATIONS
Vermillion, Inc. (the “Company” or “Vermillion”) acknowledges that it has received notice from
György B. Bessenyei of his intention to nominate two individuals – Robert S. Goggin and Gregory V. Novak – to the Company’s Board of Directors at its 2012 annual meeting of stockholders.
Vermillion is reviewing Mr. Bessenyei’s notice for compliance with the Company’s governing documents and applicable law.
Mr. Bessenyei, Mr. Goggin and Mr. Novak (the “Group”) also filed with the U.S. Securities and Exchange Commission a press
release dated as of February 29, 2012 and other soliciting materials regarding the Group’s intended nominations for directors at the Company’s 2012 annual meeting of stockholders.
The Company’s Board of Directors (the “Board”) notes that it and the Company’s management team are committed to acting in the best
interests of the Company and all of its stockholders, and are receptive to productive dialogue with the Company’s stockholders. The Company notes that, neither
prior to nor contemporaneously with the Group’s press release, did Mr. Goggin
noror Mr. Novak has contactedcontact the Company to introduce
himself, to discuss his desire to be a member of the Board, or to share any suggestions that would benefit the Company and all stockholders, and therefore the Company has no comment regarding the nominees at this point in time.
The Company’s experience with Mr. Goggin is limited to his participation in an unsuccessful legal action against the Company and its Board
during 2011 relating to corporate governance matters. On May 9, 2011, Mr. Goggin filed a complaint in the Court of Chancery of the State of Delaware, naming the Company and
members of its Board as defendants. In the complaint, Mr. Goggin sought to enjoin the 2011 annual meeting of stockholders that was set to take place on June 6, 2011. On May 24, 2011, Mr. Goggin filed a motion for preliminary
injunctive relief to enjoin the 2011 annual meeting of stockholders. On June 3, 2011, the Court of Chancery denied the motion, and the Company’s 2011 annual meeting of stockholders was held on June 6, 2011. On June 29, 2011,
Mr. Goggin filed a notice of voluntary dismissal, and the complaint was dismissed.
The Company notes that from the biographies
submitted of Mr. Goggin and Mr. Novak, both nominees are attorneys who have spent their careers in private practice, with no apparent experience in medical diagnostics, and no apparent public company board or management experience.
The Company notes that the Board consists of seven highly qualified and experienced directors with considerable management experience in
medical diagnostics and other healthcare products, two of whom are up for re-election at the Company’s 2012 annual meeting of stockholders. Members of the Board and their affiliates beneficially own an aggregate of
approximately 5.4% of the outstanding shares of the Company’s common stock.
The Company would advise its stockholders to be cautious with regard to the sales predictions and valuations contained in the recent communications from
the Group, as the Company has no knowledge of the basis of these claims and cannot be certain that all of the pertinent facts are known and have been considered.
The Company remains committed to enhancing stockholder value and will evaluate all nominees and make recommendations that it believes are in the best interests of the Company’s stockholders.
Paul Hastings LLP is serving as legal advisor to Vermillion.
Important Additional Information
In connection with its 2012 annual meeting of stockholders, the Company will file with the Securities and Exchange Commission (“SEC”) a proxy statement and other documents regarding the 2012
annual meeting, and will also mail to each stockholder of record entitled to vote at the 2012 annual meeting the definitive proxy statement and a proxy card. STOCKHOLDERS ARE STRONGLY ADVISED TO READ THE COMPANY’S 2012 PROXY STATEMENT AND ANY
OTHER SOLICITING MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. When they are available, the proxy statement and other documents relating to the 2012 annual meeting of
stockholders may be obtained free of charge from the SEC’s Electronic Data Gathering Analysis and Retrieval system (“EDGAR”) at www.sec.gov or from the Company at its website, www.vermillion.com, under Investors – SEC Filings.
The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies in connection with the
Company’s 2012 annual meeting of stockholders. Detailed information concerning the Company’s directors and officers is available in the
Company’s proxy statement for the its 2011 annual meeting of stockholders filed with the SEC on April 28, 2011, as well as in other public filings made by the Company with the SEC.
Additional information regarding the Company’s directors,Members of the Board, the executive officers
of the Company, and other persons who may, under rules of the SEC, be considered to be participants in the solicitation of proxies for
the 2012 annual meeting of stockholders, including their respective interests by security holdings or otherwise, will be set forth in the definitive proxy statement for the Company’s 2012 annual meeting of
stockholders when it is filed with the SEC. their respective affiliates beneficially own an aggregate of approximately 5.76% of the outstanding shares of the
Company’s common stock in the aggregate as follows:
•
James S. Burns, Chairman of the Board, beneficially owns 129,107 shares or approximately 0.86% of the
outstanding shares of the Company’s common stock (which includes 40,400 shares issuable upon exercise of options exercisable within 60 days hereof);
•
William Creech, Vice President of Sales and Marketing, beneficially owns 20,287 shares or approximately
0.14% of the outstanding shares of the Company’s common stock (which includes 5,206 shares issuable upon exercise of options exercisable within 60 days hereof and 1,666 shares of
restricted stock that will be vested within 60 days of the date hereof);
•
John F. Hamilton, Director, beneficially owns 118,707 shares or approximately 0.80% of the outstanding
shares of the Company’s common stock (which includes 30,000 shares issuable upon exercise of options exercisable within 60 days hereof);
•
Bruce Heubner, Director, beneficially owns 40,427 shares or approximately 0.27% of the outstanding shares
of the Company’s common stock;
•
Donald Munroe, Ph.D., Chief Scientific Officer and Vice President of Research and Development, does not
beneficially own any shares of the Company’s common stock;
•
Gail S. Page, President, CEO and Director, beneficially owns 441,006 shares or approximately 2.91% of the
outstanding shares of the Company’s common stock (which includes 272,765 shares issuable upon exercise of options exercisable within 60 days hereof and 7,084 shares of restricted
stock that will be vested within 60 days of the date hereof);
•
Peter S. Roddy, Director, beneficially owns 33,700 shares or approximately 0.23% of the outstanding
shares of the Company’s common stock;
•
Eric Schoen, Chief Accounting Officer, beneficially owns 27,426 shares or approximately 0.18% of the
outstanding shares of the Company’s common stock (which includes 5,901 shares issuable upon exercise of options
exercisable within 60 days hereof);
•
Carl Severinghaus, Director, beneficially owns 27,500 shares or approximately 0.18% of the outstanding
shares of the Company’s common stock; and
•
William C. Wallen, Director, beneficially owns 41,200 shares or approximately 0.28% of the outstanding
shares of the Company’s common stock.
The number of
shares of common stock deemed outstanding and used in the denominator for determining percentage ownership for each person equals (i) 14,900,831 shares of common stock outstanding as of the date hereof, plus (ii) such number of shares of
common stock as are issuable pursuant to restricted stock units, options, warrants or convertible securities held by that person (and excluding restricted stock units, options, warrants and convertible securities held by other persons) which may be
exercised within 60 days of the date hereof. Additional information concerning the Company’s directors and
officers is available in the Company’s proxy statement for the its 2011 annual meeting of stockholders filed with the SEC on April 28, 2011, as well as in other public filings made by the Company with the SEC.
Forward-Looking Statements
Certain matters discussed herein contain forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion’s plans, objectives, expectations and
intentions. These forward-looking statements are based on Vermillion’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with
the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors th
2012-03-08 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
March 8, 2012
By E-Mail
Robert Claassen, Esq. Paul Hastings LLP 1117 S. California Avenue Palo Alto, CA 94304
Re: Vermillion, Inc.
Soliciting Material filed under Rule 14a-12
Filed March 7, 2012 File No. 1-34810
Dear Mr. Claassen:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Soliciting Material filed under Rule 14a-12
1. We note that the issuer’s experience with Mr. Goggin is limited to his participation in an
unsuccessful legal action against the Comp any and its board relating to corporate
governance matters. Please revise to include a general description of the nature of the
claim, the relief requested, the court involved, and the disposition.
2. We note you indicate that a description of direct and indirect interests will be contained in
disclosure documents to be filed later. Pleas e note that although pa rticipants relying upon
Rule 14a-12 may refer to participant informa tion provided in another filed document, the
information must be available, current, and on file for review by s ecurity holders at the
time the Rule 14a-12 materials are made publicly available. Participants may not refer to
participant information to be provided at some future time such as the proxy statement.
Refer to Rule 14a-12(a)(1)(i) and Excha nge Act Release No. 42055, October 22, 1999, at
Robert Claassen, Esq.
Paul Hastings LLP March 8, 2012 Page 2
Section II.C.1.b. In future filings, please revise to describe any direct or indirect interests.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filings 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 relati ng to the 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.
Please direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628.
Sincerely, /s/ Peggy Kim Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2012-03-02 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
March 2, 2012
By E-Mail
Eric Simonson, Esq. Blank Rome LLP The Chrysler Building 405 Lexington Avenue New York, NY 10174-0208
Re: Vermillion, Inc.
Soliciting Material filed under Ru le 14a-12 by György B. Bessenyei,
Gregory V. Novak, and Robert S. Goggin Filed February 29, 2012 File No. 1-34810
Dear Mr. Simonson:
We have reviewed your filing and have th e following comments. In some of our
comments, we may ask you to prov ide us with information so we may better understand your
disclosure.
Please respond to this letter by amen ding your filing, by providing the requested
information, or by advisi ng us when you will provid e the requested response. If you do not believe
our comments apply to your facts and circumstances or do not believe an amendment is
appropriate, please tell us why in your response.
After reviewing any amendment to your filing and the inform ation you provide in response
to these comments, we may have additional comments.
Soliciting Material filed under Rule 14a-12
Exhibit 2: Press Release
1. We note the following statements about the co mpany’s financial or operating performance:
“As we have all painfully witnessed, th e company is on a downward spiral to
certain self-destruction in front of our eyes, plagued by gross mismanagement.”
“Page and Hamilton have alternatively sa t idle or actively caused monumental
damage to stockholder value; Vermillion’s stock price has declined over 90% over
the past two years.”
Eric Simonson, Esq.
Blank Rome LLP March 2, 2012 Page 2
The board’s “self-serving po licies and tactics that have eroded stockholder value.”
Please further describe your view of the i ssuer’s financial and operating performance.
Please provide supplementally to us, and revi se future filings to disclose, your support
for any statements relating to the company’ s financial and market performance. In
addition, to facilitate our re view, where the bases are other documents, such as prior
proxy statements, Forms 10-K and 10-Q, annual reports, analysts’ reports and
newspaper articles, provide either complete copies of the documents or sufficient pages
of information so that we can assess th e context of the information upon which you
rely. Mark the supporting documents provi ded to identify the specific information
relied upon.
2. We note the following statements about potential future market values:
“The 15,000 tests sold in 2011 with a $650 list price have the poten tial of generating
$10 million in revenue, once the reimburse ment issues are ironed out. Even a
conservative valuation based on existing le vels of sales of OVA1 should place its
value in the range of $50 million (or $3.35/shar e). Any future growth will simply
provide upside to that.”
“Vermillion’s other product…addresses a mi nimum $1 billion market opportunity….
Any other company, having such a blockbus ter test in an ad vanced stage of
development, would be valued north of $100 million (or $6.71/share), but the market
is unwilling to put its trust in current management given thei r historic performance.”
Under note (a) to Rule 14a-9, predictions as to specific future market values are an
example of statements that may be false and misleading. Please explain how these
statements comply with Rule 14a-9, or in th e alternative, please make a revised filing to
reflect the deletion of the ci ted statements. Please provide us supplementally with any
support for these statements and also conf irm that any future implied or express
valuations will be accompanied by disclosu re which facilitates security holders’
understanding of the basis for and limitations on the projected realizable values. See
Exchange Act Release No. 16833 (May 23, 1980).
3. Please further describe how the nominees will “press for the necessary changes,” “unlock
the potential of Vermillion’s assets,” “start renegotiating agreements, streamline operations to eliminate bloat, and accelerate the F DA approval process for PAD.” Please also
describe any specific plans to sell the company or its assets. Please revise to clarify that the
nominees’ plans may change subject to their fi duciary duty to stockhol ders if elected.
4. We note that the participants have “started preliminary di scussions with potential CEO
candidates.” Please revise to describe any sp ecific plans to change management. If the
participants plan to ch ange management, please also descri be the financial consequences to
Vermillion.
Eric Simonson, Esq.
Blank Rome LLP March 2, 2012 Page 3
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filings 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 relati ng to the disclosure, they are responsible for the accuracy and
adequacy of the disclosures they have made.
In responding to our comments, please provide a written statement from each participant
and filing person acknowledging that:
the participant or filing person is responsib le 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 participant or filing person may not asse rt 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 direct any questions to me at ( 202) 551-3411. You may also contact me via
facsimile at (202) 772-9203. Please send all corre spondence to us at the following ZIP code:
20549-3628. Sincerely, /s/ Peggy Kim Peggy Kim S p e c i a l C o u n s e l Office of Mergers & Acquisitions
2011-02-11 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm Acceleration Requests 12117 Bee Caves Road Building Two, Suite 100 Austin Texas 78738 www.vermillion.com February 11, 2011 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Vermillion, Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-171797 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:00 PM Eastern Time on February 11, 2011, or as soon thereafter as is practicable. The Company hereby 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 this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Vermillion, Inc. By: /s/ Sandra A. Gardiner Name: Sandra A. Gardiner Title: Vice President and Chief Financial Officer Roth Capital Partners, LLC 24 Corporate Plaza Newport Beach, CA 92660 February 11, 2011 Securities and Exchange Commission 100 F Street, N.W. Washington, D.C. 20549 Re: Vermillion, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-171797) Ladies and Gentlemen: In connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), the undersigned hereby joins in the request of the Company that the effective date of such registration statement be accelerated to 5:00 p.m. (NYT) on Friday, February 11, 2011, or as soon thereafter as practicable. In making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public offering of securities pursuant to the registration statement. Very truly yours, ROTH CAPITAL PARTNERS, LLC, By: /s/ Aaron Gurewitz Name: Aaron Gurewitz Title: Head of Equity Capital Markets
2011-02-11 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm Acceleration Request Roth Capital Partners, LLC 24 Corporate Plaza Newport Beach, CA 92660 February 11, 2011 Securities and Exchange Commission 100 F Street, N.W. Washington, D.C. 20549 Re: Vermillion, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-171797) Ladies and Gentlemen: In connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), the undersigned hereby joins in the request of the Company that the effective date of such registration statement be accelerated to 8:00 a.m. (NYT) on Monday, February 14, 2011, or as soon thereafter as practicable. In making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public offering of securities pursuant to the registration statement. Very truly yours, ROTH CAPITAL PARTNERS, LLC, By: /s/ Aaron Gurewitz Name: Aaron Gurewitz Title: Head of Equity Capital Markets
2011-02-10 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm Acceleration Request Letter 12117 Bee Caves Road Building Two, Suite 100 Austin Texas 78738 www.vermillion.com February 10, 2011 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Vermillion, Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-171797 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 8:00 AM Eastern Time on February 14, 2011, or as soon thereafter as is practicable. The Company hereby 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 this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Vermillion, Inc. By: /s/ Sandra A. Gardiner Name: Sandra A. Gardiner Title: Vice President and Chief Financial Officer
2011-01-28 - UPLOAD - Aspira Women's Health Inc.
January 28, 2011
Sandra A. Gardiner Vice President and Chief Financial Officer Vermillion, Inc. 12117 Bee Caves Road, Building Two, Suite 100
Austin, Texas 78738
Re: Vermillion, Inc.
Registration Statement on Form S-1
Filed January 21, 2011
File No. 333-171797
Dear Ms. Gardiner:
We have limited our review of your registra tion 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. Where you do not beli eve 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.
1. Please revise the cover page of your prospect us to include the number of shares to be
offered under this registration statement.
2. Please include the underwriting agreement as an exhibit to your filing, as required by
Item 601(b)(1) of Regulation S-K.
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.
Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please pr ovide a written statement from the company
acknowledging that:
Sandra A. Gardiner Vermillion, Inc. January 28, 2011 Page 2
• 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 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.
Please contact Michael Rosenthall at 202-551-3674 or me at 202-551-3715 with any
other questions.
Sincerely,
Jeffrey P. Riedler
Assistant Director
2011-01-06 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
January 6, 2011
Ms. Sandra A. Gardiner Chief Financial Officer Vermillion, Inc. 12117 Bee Caves Road Building Two, Suite 100 Austin, Texas 78738
Re: Vermillion, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2009 Filed May 20, 2010 File No. 000-14800
Dear Ms. Gardiner:
We have completed our review of your fili ngs and do not have any further comments at
this time.
Sincerely,
Kevin L. Vaughn A c c o u n t i n g B r a n c h C h i e f
2010-12-17 - CORRESP - Aspira Women's Health Inc.
CORRESP 1 filename1.htm Correspondence Letter Vermillion, Inc. Building Two, Suite 100 12117 Bee Caves Road Austin, TX 78738 December 17, 2010 VIA EDGAR AND U.S. MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Mr. Kevin L. Vaughn, Accounting Branch Chief Re: Vermillion, Inc. Form 10-K for the Fiscal Year Ended December 31, 2009 Filed May 20, 2010 Form 10-Q for the Quarter Ended September 30, 2010 Filed November 12, 2010 File No. 000-14800 Dear Mr. Vaughn: On behalf of Vermillion, Inc. (the “Company”), I submit this letter in response to the comments (the “Comments”) from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by facsimile dated November 30, 2010, relating to the Company’s Form 10-K for the fiscal year ended December 31, 2009 and filed on May 20, 2010 and Form 10-Q for the quarter ended September 30, 2010 and filed on November 12, 2010. The Company’s responses to the Comments are set forth below. For the convenience of the Staff, we have restated each Comment in the order provided followed by the Company’s response. Form 10-K for the Year Ended January 31, 2010 Item 1. Business, page 1 Clinical Development, page 4 1. We note your disclosure on page 34 that to become profitable you may need to complete development of additional key diagnostic tests, obtain FDA approval and successfully commercialize these products in addition to the OVA1 test. In future filings, as applicable, please expand your discussion on pages 5 and 6 of your non-OVA1 development efforts to clarify the status of your clinical development in these areas and indicate whether you are presently seeking pre-market approval or 510(k) clearance. We take note of the Staff’s comment and will revise future filings to expand our discussions on non-OVA1 development efforts and their respective status at the time of each respective filing. Item 9A(T). Controls and Procedures, page 81 - Management’s Report on Internal Control over Financial Reporting, page 81 2. We note your disclosure here regarding the material weakness you identified. However, your disclosure appears vague and broad. With a view toward enhanced disclosure in future filings, explain to us in greater detail the material weakness identified and explain with greater specificity how the material weakness could impact your financial statements. You state that the lack of sufficient staff with necessary experience in GAAP impacted your ability to perform your control procedures relating to the accounting and reporting process. It is not clear how, if at all, the material weakness relates to the ongoing recording of transactions. Tell us any additional control deficiencies you identified, such as inability to properly record complex transactions, lack of segregation of duties, or lack of management oversight. Describe how you considered any such additional control deficiencies in your assessment of internal controls over financial reporting. Refer to SEC Release 33-8310, Commission Guidance Regarding Management’s Report on Internal Control over Financial Reporting, dated June 27, 2007. As of December 31, 2009 and during the year then ended, the Company operated under Chapter 11 of the United States Bankruptcy Code. During the bankruptcy period, the Company reduced its headcount to three employees, only one of which was a non-managerial accounting employee. As a result, the Company did not file on a timely basis its Forms 10-Q which became due during the bankruptcy period and the Forms 10-K for the years ended December 31, 2008 and 2009 in accordance with the Securities Exchange Act of 1934. Specifically, the Company did not have sufficient accounting and reporting expertise necessary to make estimates requiring significant judgment or to record complex transactions in a manner necessary to facilitate the timely filing of all Forms required by the Exchange Act of 1934. This control deficiency, if not corrected, could result in a material misstatement of the Company’s annual or interim consolidated financial statements that would not be prevented or detected on a timely basis. Therefore, management concluded that this control deficiency constituted a material weakness at December 31, 2009. During the year ending December 31, 2010, the Company has been involved in efforts to restore and maintain an effective internal control environment. In February 2010, as part of this process, the Company hired an Interim Vice President, Finance & Chief Accounting Officer and engaged independent contractors, some of whom were former employees of the Company, to perform an extensive review of fiscal 2008 and 2009 transactions and prepare financial statements for the years then ended in accordance with generally accepted accounting principles. In May 2010, the Company filed its past-due Forms 10-Qs and 10-Ks to become compliant with the Securities and Exchange Act of 1934. The Company has hired a Vice President and Chief Financial Officer, a Corporate Controller and two full-time accounting staff. In addition, we are restoring, updating and re-implementing the Company’s internal control processes and procedures to reflect our existing operations. Specifically, we have: (1) re-established our entity level controls; (2) re-instituted procedures to address segregation of duties; (3) incorporated the level of management oversight and review of the financial statements and corresponding SEC filings that was originally contemplated in the Company’s internal control system; and (4) hired management that we believe has the necessary expertise to make estimates requiring significant judgment, to record complex transactions and to facilitate the timely filing of SEC documents. The Company’s testing, evaluation and conclusion on the effectiveness of our internal controls in place at December 31, 2010 will not be completed until sometime in early 2011. As a result, we have not yet made any conclusions, nor have we disclosed in any of our subsequent quarterly filings, the sufficiency of the actions taken in remediating the control deficiencies that led to the material weakness at December 31, 2009. As requested by the Staff, the Company will clarify the key facts above in future filings. Form 10-Q for the Quarter Ended September 30, 2010 - Consolidated Statement of Operations, page 2 3. We note that you present stock-based compensation charges on the face of the consolidated statements of operations in a table that presents total stock-based compensation. Consistent with the guidance in SAB Topic 14-F, please revise future filings to present stock-based compensation in a parenthetical note to the appropriate income statement line items or to remove the total stock compensation line from the table. As indicated in that guidance, you may also present the information in the footnotes to the financial statements or within MD&A. We take note of the Staff’s comment and will remove the total stock compensation line from the table in future filings accordingly. Note 1. Organization, Basis of Presentation and Significant Accounting and Reporting Policies, page 4 - Significant Accounting and Reporting Policies, page 5 - Revenue Recognition, page 5 4. We note your disclosures here regarding your revenue recognition policy on sales of the OVA1 Test products. You state on page 16 that it is not easy to estimate revenues from Quest Diagnostics Incorporated (Quest) related to the sales of these products. In light of your disclosure on page 16 that it is not easy to estimate revenues from Quest Diagnostics Incorporated related to the sales of these products, please explain to us in more detail how you determine at what point in the earnings process that you meet the four revenue criteria prescribed in SAB Topic 13. In your discussion, explain why you have only recognized revenue on 1,592 of the estimated 3,220 tests performed through September 30, 2010 by describing what criteria under SAB Topic 13 had not been met for the remaining 1,628 tests. The Company derives its product revenues, representing the fee or royalty from lab tests performed by Quest, from sales of the OVA1 Test. As of September 30, 2010, our product sales were made to a single customer, Quest Diagnostics, Inc. (“Quest”), under the terms of a Strategic Alliance Agreement dated July 22, 2005 and subsequent Amendments. Under the terms of the Strategic Alliance Agreement, the Company’s fee due from Quest is calculated as 25% of Quest’s Gross Margin (as defined) on sales related to diagnostic tests performed on their end customers. Because of the inherent difficulty in understanding Quest’s reimbursement rates by third party payors, the payor mix related to Quest’s patients, and other factors that impact Quest’s Gross Margin (as defined), for which the Company has limited visibility, product revenue, representing the fee or royalty from lab tests performed by Quest, from the March 2010 product commercialization date through September 30, 2010 has only been recognized for those diagnostic tests (i.e., 1,592 units) that were reported to us by Quest as having been performed and the price finalized, therefore not subject to future adjustment. Quest is required to report these units and submit payment within 30 days of the end of each quarterly period. In accordance with SAB Topic 13, our product revenues for tests performed by Quest are recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. A break-down of management’s view of the achievement of these criteria is as follows: 1) We believe that persuasive evidence of an arrangement exists vis-à-vis the Strategic Alliance Agreement with Quest. 2) We believe that delivery has occurred as we have provided Quest with a license to our intellectual property for purposes of Quest administering the OVA1 Test to end customers. We have no further obligations to Quest associated with the technology or tests that Quest performs. 3) Fee is fixed or determinable: The fee that Quest pays per test for use of our technology is 25% of Quest’s Gross Margin (as defined) as discussed above. However, we do not currently have visibility regarding numerous important data points used to determine this amount such as Quest’s selling price to end customers, components of Quest’s cost of sales (in computing Quest’s Gross Margin) and Quest’s bad debt experience, if any. Further, through the periods presented, there are no minimum fee amounts due from Quest. Therefore, our revenue has only been “fixed or determinable” to the extent that Quest has reported to us the results of its sales to end customers. Through September 30, 2010, Quest has cumulatively reported that 25% of its gross margin on sales of 1,592 tests totaled $158,501. This amount is fixed or determinable and been reported by us as product sales in our financial statements. The remaining 1,628 tests performed (3,220 total tests estimated to be performed based on the Company’s reporting software, less 1,592 quantified by Quest and recognized as revenue) will not be recognized as revenue in the financial statements until such time as (1) the amount equivalent to 25% of Quest’s gross margin with respect to those tests has been reported to us or (2) we gain sufficient insight into Quest’s selling price to end customers, components of Quest’s cost of sales and bad debt experience to enable us to accurately estimate revenue for tests performed but not reported or paid by Quest. Management believes the fees for the 1,628 tests above are not “fixed or determinable” until such time as one of these two conditions precedent are met. 4) We believe that collectability is reasonably assured based on Quest’s credit rating and as cash had been paid by Quest to the Company within 5 days of each reporting period in accordance with the contract, once the actual fee due is determined and reported, as described above. 5. We note that you are accounting for the forgiveness of principal debt balances from Quest as license revenue on a straight-line basis over the term of the exclusive sales period that Quest receives upon commercialization of an approved diagnostic test. Please explain to us in more detail why you are accounting for the forgiveness of your principal debt balances as license revenue. Cite any accounting literature you relied upon and how you applied it to your situation. The forgiveness of the $3,000,000 principal debt balance associated with FDA clearance and commercialization of our OVA1 Test was viewed by management as value received that was directly tied to our customer’s (i.e., Quest’s) exclusive access to the developed technology and probable future ability to achieve sales. Since the ‘forgiveness’ of the loan was part of the original arrangement to help develop a test application that will be made available exclusively to Quest for a period of time, it has elements of fees paid by Quest to the Company to secure the exclusive rights to the OVA1 Test. Accordingly, we determined this value to be most appropriately recognized in a manner similar to a fee paid by Quest for an exclusive commercialization or distribution right over the related expected period associated with Quest’s distribution rights. We considered whether there was a demonstrable pattern of revenue recognition that matched the Company’s expectation of future sales under the distribution agreement with Quest. However, we concluded that until we have a meaningful history of product sales that provides a reasonable basis for estimating future product sales, revenue should be recognized on a straight-line basis over the 2.5-year period of Quest’s sales exclusivity beginning on the OVA1 Test commercialization date of March 9, 2010. In summary, we believe that the appropriate treatment for the debt forgiveness is similar to payment by Quest for a license to distribute the Company’s product (i.e., as revenue over the term of the license agreement with Quest). Pursuant to the FDA-clearance of OVA1 Test, Quest holds an exclusive license to sell our OVA1 Test. Each instance of clinical use (i.e. a reported result for the purpose of providing a result to a patient) is recorded and Quest pays the Company on an incremental per-test basis. The forgiveness of debt was contemplated and included in the original terms of the Strategic Alliance Agreement. Thus, it appears that the forgiveness of debt is directly associated with the FDA-cleared OVA1 Test, which enables the debt holder, Quest, to earn revenue which in turn results in revenue for the Company. Quest, as debt holder, only benefits from the FDA-cleared product over the exclusivity period. As we can establish a direct relationship between the forgiveness of debt and the ability to recognize revenue (by Quest and us), we determined that the appropriate treatment was akin to payment of a license fee by Quest for the exclusive right to sell our OVA1 Test. SAB topic 13A, FN35 states, if a licensed product or technology is physically delivered to the customer, but the license term has not yet begun, revenue should not be recognized prior to inception of the license term. Upon inception of the license term, revenue should be recognized in a manner consistent with the nature of the transaction and the earnings process. Alternatives treatments considered and rejected 1) Record debt forgiveness as offset to research & development expense. Vermillion obtained FDA-clearance in September 2009 and commercially launched the OVA1 Test on March 9, 2010. Quest was not at risk for the research & development of the product (i.e. other than the potential risk o
2010-12-14 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
November 30, 2010
Via Facsimile and U.S. Mail
Ms. Sandra A. Gardiner Chief Financial Officer Vermillion, Inc. 12117 Bee Caves Road Building Two, Suite 100 Austin, Texas 78738
Re: Vermillion, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2009 Filed May 20, 2010 Form 10-Q for the Quarter Ended September 30, 2010 File No. 000-14800
Dear Ms. Gardiner:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circum stances, please tell us w hy in your response.
After reviewing the information you provide in response to these comments, we may
have additional comments.
Ms. Sandra A. Gardiner
Vermillion, Inc. November 30, 2010 Page 2
Form 10-K for the Year Ended December 31, 2009
Item 1. Business, page 1
Clinical Development, page 4
1. We note your disclosure on page 34 that to become profitable you may need to complete
development of additional key diagnostic te sts, obtain FDA approval and successfully
commercialize these products in addition to the OVA1 test. In future filings, as applicable, please expand your discu ssion on pages 5 and 6 of your non-OVA1
development efforts to clarify the status of your clinical developmen t in these areas and
indicate whether you are presently seeking pr e-market approval or 510(k) clearance.
Item 9A(T). Controls and Procedures, page 81
– Management’s Report on Internal C ontrol over Financial Reporting, page 81
2. We note your disclosure here regarding the ma terial weakness you identified. However,
your disclosure appears vague and broad. With a view toward enha nced disclosure in
future filings, explain to us in greater detail the material weakness identified and explain with greater specificity how the material weakness could impact your financial
statements. You state that th e lack of sufficient staff w ith necessary experience in GAAP
impacted your ability to perform your contro l procedures relating to the accounting and
reporting process. It is not clear how, if at all, the material weakness relates to the
ongoing recording of transactions. Tell us any additional control deficiencies you identified, such as inability to properly reco rd complex transactions, lack of segregation
of duties, or lack of management oversight . Describe how you considered any such
additional control deficiencies in your assessment of intern al controls over financial
reporting. Refer to SEC Release 33-8310, Commission Guidance Regarding
Management’s Report on Internal Control over Financial Reporting , dated June 27,
2007.
Form 10-Q for the Quarter Ended September 30, 2010
-Consolidated Statement of Operations, page 2
3. We note that you present stock-based compensation charges on the face of the
consolidated statements of operations in a table that presents total stock-based
compensation. Consistent with the guidance in SAB Topic 14-F, please revise future
filings to present stock-based compensation in a parenthetical note to the appropriate
income statement line items or to remove the total stock compensation line from the table. As indicated in that guidance, you may also present th e information in the footnotes
to the financial statements or within MD&A.
Ms. Sandra A. Gardiner
Vermillion, Inc. November 30, 2010 Page 3
Note 1. Organization, Basis of Presentation a nd Significant Accounting and Reporting Policies,
page 4
-Significant Accounting and Reporting Policies, page 5
-Revenue Recognition, page 5
4. We note your disclosures here regarding your revenue recognition policy on sales of the
OVA1 Test products. You state on page 16 that it is not easy to es timate revenues from
Quest Diagnostics Incorporated (Quest) related to the sales of these products. In light of
your disclosure on page 16 that it is not easy to estimate re venues from Quest Diagnostics
Incorporated related to the sales of these produc ts, please explain to us in more detail how
you determine at what point in the earnings process that you meet the four revenue
criteria prescribed in SAB Topic 13. In your discussion, explain why you have only
recognized revenue on 1,592 of the estimated 3,220 tests performed through September 30, 2010 by describing what criteria under SA B Topic 13 had not been met for the
remaining 1,628 tests.
5. We note that you are accounting for the forgiv eness of principal debt balances from
Quest as license revenue on a straight-line basis over the term of the exclusive sales
period that Quest receives upon co mmercialization of an approve d diagnostic test. Please
explain to us in more deta il why you are accounting for the forgiveness of your principal
debt balances as license revenue. Cite any accounting literature you relied upon and how
you applied it to your situation.
6. Further to the above, we note your disclosure on page 58 of the Form 10-K that as of
January 23, 2010, only $3,000,000 of the debt had b een forgiven. It appears that no
additional amounts have been forgiven as of September 30, 2010. With a view toward
disclosure, please clarify that the license revenues are recognized only for those amounts
for which the debt has been forgiven (i.e., the $3,000,000).
7. In light of the fact that Quest is a related pa rty, please revise future filings to include the
disclosures required by paragraph 850-10- 50-1 of the FASB Accounting Standards
Codification.
Note 6. Commitments and Contingencies, page 8
8. We note your disclosures related to your ag reement with The John Hopkins University
School of Medicine (JHU). Please explain to us why you concluded that the forgiveness
of amounts owed should be recorded as a redu ction to expenses over the remaining term
of the agreement rather than as a gain on extinguishment of liabilities in the current
period. Cite any accounting literature you re lied upon in determining your accounting.
Please specifically address how you consider ed the guidance in section 405-20 of the
FASB Accounting Standards Codification. In connection with your response, please
Ms. Sandra A. Gardiner
Vermillion, Inc. November 30, 2010 Page 4
clarify which line item in the December 31, 2009 financial statements reflects the
amounts owed to JHU at that date. Please also clarify where in your September 30, 2010
financial statements you have recorded the am ounts that will be amortized as a reduction
to expenses in future periods.
Item 4. Controls and Procedures, page 23
9. We note here and in your Forms 10-Q as of March 31 and June 30, 2010 that you
disclose management’s conclusion on the eff ectiveness of its internal controls over
financial reporting. Item 308(T) of Regulation S-K indicates that management’s
conclusion on the effectiveness of its internal controls over financ ial reporting is an
annual assessment and disclosure rather than a quarterly assessment and disclosure.
Please tell us if management performed an a ssessment on the effectiveness of its internal
controls over financial re porting as of September 30, 2010, June 30, 2010 and March 31,
2010.
Part II. Other Information, page 24
Item 1A. Risk Factors, page 25
We filed a petition for relief under Chapter 11 on March 30, 2009…, page 25
10. With a view towards disclosure, please tell us about the “residual risks and uncertainties”
associated with your bankruptcy proceedings.
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.
Ms. Sandra A. Gardiner
Vermillion, Inc. November 30, 2010 Page 5
You may contact Tara Harkins, Staff Accountant, at (202) 551-3639 or me at (202) 551-
3643 if you have any questions regarding commen ts on the financial statements and related
matters. Please contact Joe McCann, Staff Attorney, at (202) 551- 6262, or Jay Mumford,
Reviewing Attorney, at (202) 551- 3637 if you have questions on any other comments. In this
regard, do not hesitate to contact Martin James, Senior Assistant Chief Accountant, at (202) 551-
3671.
S i n c e r e l y ,
Kevin L. Vaughn A c c o u n t i n g B r a n c h C h i e f
2007-12-14 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 6010
December 13, 2007
Ms. Debra A. Young Vice President and Chief Financial Officer Vermillion, Inc. 6611 Dumbarton Circle Fremont, California 94555
Re: Vermillion, Inc.
Form 10-K for the fiscal year ended December 31, 2006
File No. 000-31617
Dear Ms. Young:
We have completed our review of your Form 10-K and related filings and have no further
comments at this time. S i n c e r e l y ,
M a r t i n F . J a m e s Senior Assistant Chief Accountant
2007-12-12 - CORRESP - Aspira Women's Health Inc.
CORRESP
1
filename1.htm
corresp
VERMILLION, INC.
6611 Dumbarton Circle
Fremont, California 94555
December 12, 2007
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Attention: Mr. Tim Buchmiller
Re:
Vermillion, Inc. — Registration Statement on Form S-1 (File No. 333-146354)
(the “Registration Statement”)
Ladies and Gentlemen:
In accordance with Rule 461 promulgated under the Securities Act of 1933, as amended (the
“Securities Act”), Vermillion, Inc., a Delaware corporation (the “Company”), hereby requests
acceleration of effectiveness of the Registration Statement to 4:00 P.M. (Eastern time) on December
13, 2007, or as soon thereafter as practicable. There are no underwriters for this proposed
offering, which is an offering of the Company’s common stock and warrants exercisable for common
stock by selling stockholders.
The Company hereby confirms that it is aware of its responsibilities under the Securities Act
and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering
of the securities specified in the Registration Statement.
The Company hereby acknowledges that should the Securities and Exchange Commission (the
“Commission”) or the staff, acting pursuant to delegated authority, declare the Registration
Statement effective, it does not foreclose the Commission from taking action with respect to the
Registration Statement; the action of the Commission or the staff, acting pursuant to delegated
authority, in declaring the Registration Statement effective, does not relieve the Company from its
full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and 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.
It would be appreciated if, as soon as the Registration Statement has become effective, you
would so inform Robert Purcell by telephone at (415) 856-7049.
Very truly yours,
VERMILLION, INC.
By:
/s/ Qun Zhou
Qun Zhou
Interim Chief Financial Officer and Corporate Controller
2007-12-12 - UPLOAD - Aspira Women's Health Inc.
Mail Stop 6010 October 15, 2007 Gail S. Page President and Chief Executive Officer Vermillion, Inc. 6611 Dumbarton Circle Fremont, California 94555 Re: Vermillion, Inc. Registration Statement on Form S-1 Filed September 27, 2007 File No. 333-146354 Dear Ms. Page: We have limited our review of your filing to those issues we have addressed in our comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we w ill consider your explanation as to why our comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary in your explanation. In some of our comme nts, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance t he overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. F eel free to call us at the te lephone numbers listed at the end of this letter. General 1. Given the nature and size of the transac tions being registered, together with the nature and size of the tran sactions registered in your registration statement on Form S-3 (file no. 333-139416) involving an identical selling stockholder, please advise the staff of the company's basis fo r determining that the transactions are appropriately characterized as transactions that are eligible to be made on a shelf basis under Securities Act Rule 415(a)(1)(i). Gail S. Page Vermillion, Inc. October 15, 2007 Page 2 2. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure of all prior securities transact ions between the issuer (or any of its predecessors) and the selling stockholders, any affiliates of the selling stockholders, or any person with whom any selling stockholder has a contractual relationship regarding the transaction (or a ny predecessors of those persons), with the table including the following information disclosed separately for each transaction: • the date of the transaction; • the number of shares of the class of securities subject to the transaction that were outstanding pr ior to the transaction; • the number of shares of the class of securities subject to the transaction that were outstanding prior to the transaction and held by persons other than the selling stockholders, affiliates of the company, or affiliates of the selling stockholders; • the number of shares of the class of securities subject to the transaction that were issued or issuable in connection with the transaction; • the percentage of total is sued and outstanding securities that were issued or issuable in the transaction (assuming full issuance), with the percentage calculated by taking the number of sh ares issued and outstanding prior to the applicable transaction and held by persons other than the selling stockholders, affiliates of the company, or affiliates of the selling stockholders, and dividing that number into the number of shares issued or issuable in connection with the applicable transaction; • the market price per share of the cl ass of securities subject to the transaction immediately prior to th e transaction (sp lit adjusted, if necessary); and • the current market price per share of the class of securities subject to the transaction (split adjusted, if necessary). 3. Please provide us, with a view toward disc losure in the prospectus, with tabular disclosure comparing: • the number of shares outstanding prior to the issuance of the shares of common stock in the August 2007 tr ansaction that were held by persons other than the selling stockh olders, affiliates of the company, and affiliates of the selling stockholders; Gail S. Page Vermillion, Inc. October 15, 2007 Page 3 • the number of shares registered for resale by the selling stockholders or affiliates of the selling stockholde rs in prior registration statements; • the number of shares registered for resale by the selling stockholders or affiliates of the selling stockholders that continue to be held by the selling stockholders or affiliates of the selling stockholders; • the number of shares that have b een sold in registered resale transactions by the selling stockholde rs or affiliates of the selling stockholders; and • the number of shares registered fo r resale on behalf of the selling stockholders or affiliates of the selling stockholders in the current transaction. In this analysis, the calculation of the number of outstanding shares should not include any securities underlying any outstanding convertible securities, options, or warrants. 4. Please provide us, with a view toward disclosure in the prospectus, with: • a materially complete description of the relationships and arrangements that have existed in the past three years or are to be performed in the future between the issuer (or any of its predecessors ) and the selling stockholders, any affiliates of the selli ng stockholders, or any person with whom any selling stockholder has a c ontractual relationship regarding the transaction (or any predecesso rs of those persons); and • copies of all agreements between th e issuer (or any of its predecessors) and the selling stockholders, any affili ates of the selling stockholders, or any person with whom any selli ng stockholder has a contractual relationship regarding th e transaction (or any predecessors of those persons) in connection with the sale of the shares of common stock registered for resale in the registratio n statement or overlying such shares of common stock. If it is your view th at such a description of the relationships and arrangements between and among those parties already is presented in the prospectus and that all agreements between and/or among those pa rties are included as exhibits to the registration statement, please provide us with confirmation of your view in this regard. Gail S. Page Vermillion, Inc. October 15, 2007 Page 4 5. Please note that all outstanding comments, including those in our comment letter dated September 24, 2007, should be resolved before you request acceleration of the registration statement. Form 10-K for the Fiscal Year Ended December 31, 2006 Consolidated Financial Statements, page 42 Note 11. Long-term Debt and Capital Leases, page 62 6. Please refer to prior comment 2. With re spect to the conversion feature, please tell us and disclose the significant term s under which the conversion rate may be adjusted, including the “make-whole” pr emium.” Explain how the conversion rate may be adjusted based upon the timing of the change in c ontrol and how it is “determined by a formula that references the Company’s share price over time.” Describe how the feature contains an exp licit limit on the number of shares to be delivered as noted in your response. 7. Further, please disclose, similar to your response the nature and accounting for the compound embedded derivative for the guaranteed interest payment and the written put option of the debt. Include a discussion of the valuation of the derivative at inception a nd as of December 31, 2006. 8. Also, please disclose the significant term s of and accounting for registration rights as discussed in your response. * * * * * As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments. 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 all in formation required under the Securities Act of 1933 and that they have provided all information investors require for an informed investment decision. 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. Gail S. Page Vermillion, Inc. October 15, 2007 Page 5 Notwithstanding our comments, in the even t the company requests acceleration of the effective date of the pending registration statement, it should furnish a letter, at the time of such request, 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 re spect to the filing; • the action of the Commission or the st aff, acting pursuant to delegated authority, in declaring the filing eff ective, does not re lieve the company from its full responsibility for the ade quacy 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 secu rities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Di vision of Corporation Finance in connection with our review of your filing or in response to our comments on your filing. We will consider a written request for acceleration of the effective date of the registration statement as conf irmation of the fact that t hose requesting acceleration are aware of their respective re sponsibilities under the S ecurities Act of 1933 and the Securities Exchange Act of 1934 as they rela te to the proposed public offering of the securities specified in the above registration statement. We will act on the request and, pursuant to delegated authority, grant acceleration of the effective date. We direct your attention to Rules 46 0 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. You may contact Tim Buchmiller at ( 202) 551-3635 or me at (202) 551-3444 with any other questions. Sincerely, Perry Hindin Special Counsel cc: Robert Claassen, Esq. (via fax)
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November 30, 2007
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Tim Buchmiller
Re:
Registration Statement on Form S-1 (file no. 333-146354) of Vermillion, Inc.
Dear Mr. Buchmiller:
As a follow up to our telephone conversation with the staff of the Division of Corporation Finance
(the “Staff”) on November 29, 2007, we are filing this letter on behalf of Vermillion, Inc. (the
“Company”). In the above referenced registration statement (the “Registration Statement”) filed on
September 27, 2007 and the Company’s response letter to the Staff dated October 30, 2007 (the
“October 30 Letter”), Russell Alpha Global Opportunities Fund and Russell Global Opportunities
Fund, each a selling stockholder named in the Registration Statement, were identified as affiliates
of OppenheimerFunds Distributor, Inc., a limited purpose registered broker dealer. The Company
supplementally advises the Staff that it has been informed that Russell Alpha Global Opportunities
Fund and Russell Global Opportunities Fund are not affiliates of a registered broker dealer.
Amendment No. 1 to the Registration Statement, filed on November 27, 2007 reflects this
information. Consequently, as noted on page 5 of the October 30 Letter, the number of shares and
shares underlying warrants offered on behalf of the selling stockholders named in the Registration
Statement that are either broker dealers or affiliates of broker dealers is 9,115,860 or
approximately 20.8% of the total number of shares proposed to be registered.
If you have any further questions or concerns please feel free to contact me at (415) 856-7049.
Sincerely,
/s/ Robert Purcell
Robert Purcell
for PAUL, HASTINGS, JANOFSKY & WALKER LLP
cc: Qun Zhou, Interim Chief Financial Officer and Corporate Controller, Vermillion, Inc.
2007-11-13 - UPLOAD - Aspira Women's Health Inc.
Mail Stop 6010 November 13, 2007 Gail S. Page President and Chief Executive Officer Vermillion, Inc. 6611 Dumbarton Circle Fremont, California 94555 Re: Vermillion, Inc. Response Letter filed on October 30, 2007 Registration Statement on Form S-1 File No. 333-146354 Dear Ms. Page: We have limited our review of your filing to those issues we have addressed in our comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we w ill consider your explanation as to why our comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary in your explanation. In some of our comme nts, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. 1. We note from your responses to our prio r comments that some of your selling stockholders are affiliates of a broker-d ealer. If a selling stockholder is an affiliate of a broker-dealer, it must be iden tified as an underwriter with respect to the securities it is offering for resale unl ess that selling stockholder is able to represent in the prospectus , in addition to having pur chased the shares in the ordinary course of business, that at the time of such purchase of the securities to be resold, the seller had no agreements or understandings, direct ly or indirectly, with any person to distribute the securities. * * * * * Gail S. Page Vermillion, Inc. November 13, 2007 Page 2 As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments. We direct your attention to Rules 46 0 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. You may contact Tim Buchmiller at ( 202) 551-3635 or me at (202) 551-3444 with any other questions. Sincerely, Perry Hindin Special Counsel cc: Robert Claassen, Esq. (via fax)
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(415) 856-7049
robertpurcell@paulhastings.com
November 9, 2007
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Tim Buchmiller
Re: Registration Statement on Form S-1 (file no. 333-145354) of Vermillion, Inc.
Dear Mr. Buchmiller:
As a follow up to our telephone conversations with the staff of the Division of Corporation Finance
(the “Staff”) on November 7, 2007 and November 8, 2007, we are filing this letter on behalf of
Vermillion, Inc. (the “Company”) to provide the Staff with certain supplemental information
relating to the warrants exercisable for shares of the Company’s
common stock some of which are proposed to
be registered in the above referenced registration statement (the “Registration Statement”). The
information below updates and supersedes the related information which was set forth in the
Company’s responses to the Staff’s comments dated October 15, 2007 which were filed via EDGAR on
October 30, 2007.
The Company supplementally advises the Staff that the form of the warrants which were issued in the
Company’s private placement which closed on August 29, 2007 (the “Private Placement”), which is
attached as Exhibit C to the Securities Purchase Agreement relating to the Private Placement which
was filed as Exhibit 10.57 to the Registration Statement, contains a provision limiting a warrant
holder’s exercise of its warrant if such holder would beneficially own more than 4.99% of the
Company’s outstanding common stock following such exercise. This limitation provision is bracketed
in the form of warrant with a notation that such provision is to be included in the warrant at the
request of the purchaser. All of the warrants issued in the Private Placement contain such
limitation except for those held by Oppenheimer & Co. Inc., Quest Diagnostics Incorporated and
Phronesis Partners L.P.
The Company plans to file as a separate exhibit to its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2007 the form of warrant with a
schedule listing all of the warrants issued and indicating which warrants do not contain such beneficial ownership
limitation provision. The Company will incorporate this exhibit by reference into Amendment No. 1
to the Registration Statement when filed.
November 9, 2007
Page 2
If you have any further questions or concerns please feel free to contact me at (415) 856-7049.
Sincerely,
/s/ Robert Purcell
Robert Purcell
for PAUL, HASTINGS, JANOFSKY & WALKER LLP
cc: Gail S. Page, Chief Executive Officer, Vermillion, Inc.
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(415) 856-7049
robertpurcell@paulhastings.com
October 30, 2007
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Tim Buchmiller
Re:
SEC Comments of October 15, 2007
Dear Mr. Buchmiller:
On behalf of Vermillion, Inc. (the “Company”), set forth below are the responses to the comments in
the letter dated October 15, 2007 from the staff of the Division of Corporation Finance (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) relating to the Company’s
Registration Statement on Form S-1 (file no. 333-145354) (the “Registration Statement”) relating to
the registration under the Securities Act of 1933, as amended (the “Securities Act”), of up to
43,935,269 shares of common stock (the “Shares”), par value $.001 per share, which includes
18,716,709 shares of common stock underlying warrants.
The Company is submitting this letter prior to filing Amendment No. 1 to the Registration Statement
(“Amendment No. 1”) in order to respond to the Staff’s comments and supplementally provide the
Staff with information it has requested. The Company plans to file Amendment No. 1 at a later
date.
For ease of reference, the Staff’s comments are repeated below in bold face type before each of the
Company’s responses.
General
1.
Given the nature and size of the transactions being registered, together with the nature and
size of the transactions registered in your registration statement on Form S-3 (file no.
333-139416) involving an identical selling stockholder, please advise the staff of the company’s basis for determining that the
transactions are appropriately characterized as transactions that are eligible to be made on a
shelf basis under Securities Act Rule 415(a)(1)(i).
October 30, 2007
Page 2
The Company respectfully acknowledges the Staff’s comment and submits that the sales by the selling
stockholders named in the Registration Statement (the “Selling Stockholders”) are appropriately
characterized as a secondary offering that is eligible to be made on a shelf basis under Rule
415(a)(1)(i) and does not constitute an indirect primary offering. Rule 415(a)(1)(i) permits
securities to be registered for an offering to be made on a continuous or delayed basis in the
future as long as the registration statement pertains only to “securities which are to be offered
or sold solely by or on behalf of a person or persons other than the registrant, a subsidiary of
the registrant or a person of which the registrant is a subsidiary.” The Shares are not being
registered on behalf of the Company, but rather on behalf of the Selling Stockholders, none of
which is a subsidiary of the Company, or of which the Company is a subsidiary. Applying the
specific circumstances of the transactions in which the Shares were issued to the factors
identified by the Division of Corporation Finance in Section D, Interpretation Number
29 (1) of its 1997 Manual of Publicly Available Telephone Interpretations (the “Telephone
Interpretations”) as factors it considers in determining whether a secondary offering is in
substance an indirect primary offering by an issuer, the Company believes, given the totality of
the circumstances, that the registration of the Shares complies with Rule 415(a)(1)(i).
As disclosed under the caption “Selling Stockholders” in the Registration Statement, the majority
of the Selling Stockholders acquired the Shares in a private placement which closed on August 29,
2007 (the “Private Placement”). In the Private Placement, the Company issued 24,513,092 shares of
its common stock and warrants to purchase an additional 19,610,470 shares of its common stock. The
Registration Statement proposes to register all of the shares of common stock and the shares of common stock underlying the warrants
issued in the Private Placement except for 2,380,952 shares of common stock and 1,904,761 shares of
common stock underlying warrants issued to Quest Diagnostics, Incorporated (“Quest”). The
Registration Statement also proposes to register 3,176,420 shares of common stock, including 90,000
shares of common stock issuable upon the exercise of warrants, all of which are being offered for
resale for the accounts of Selling Stockholders who acquired such Shares in various transactions
consummated in the fall of 2006. Such Shares are being registered
pursuant to the exercise of “piggy back” registration rights by certain of the Selling
Stockholders.
(1) The Section D.29 Interpretation states, in relevant part, as follows:
“The question of whether an offering styled a secondary one
is really on behalf of the issuer is a difficult factual one, not
merely a question of who receives the proceeds. Consideration
should be given to how long the Selling Stockholders have held the shares, the circumstances under which they received them, their
relationship to the issuer, the amount of shares involved, whether
the sellers are in the business of underwriting securities, and
finally, whether under all the circumstances it appears that the
seller is acting as a conduit for the issuer.”
October 30, 2007
Page 3
The Company believes that this offering is not by or on behalf of the Company for the following
reasons:
• The Selling Stockholders acquired their respective Shares in arms’ length
transactions and have assumed the risk of loss in connection with their investment;
• The majority
of the Selling Stockholders are not broker dealers or in the business
of underwriting securities; and the shares offered by Selling Stockholders who are broker
dealers are less than 25% of the total Shares;
• Substantially all of the Selling Stockholders are large institutional investors who
do not need the proceeds from the resale of the common stock subject to the Registration
Statement in order to fund the exercise of the warrants;
• The Shares are held by ten distinct unaffiliated Selling Stockholders (or selling
stockholder groups);
• The Company will not receive any additional proceeds from the resale of the Shares
by the Selling Stockholders; and
• The Shares were issued at a fixed price and do not include variable provisions or
other toxic aspects that could lead to significant additional dilution.
Below is a discussion of each of these points which the Company believes supports its conclusion
that the offering should be characterized as a traditional secondary offering, rather than an
indirect primary offering. The Company’s information regarding the Selling Stockholders is
limited, and consists primarily of the information supplied by each Selling Stockholder to the
Company in a questionnaire (“Questionnaire”) that such Selling Stockholder was required to complete
in order to be named in the Registration Statement. The Questionnaire was customary for resale
shelf transactions and included, among other things, the amount of the Company’s securities
beneficially owned by the Selling
Stockholder, whether the Selling Stockholder or any of its affiliates is a broker dealer, and
relationships between the Selling Stockholder and the Company, etc. The form of Questionnaire is
attached to the securities purchase agreement relating to the Private Placement which was filed as
Exhibit 10.57 to the Registration Statement.
The Selling Stockholders have undertaken significant economic risk in the initial purchase
transactions and are not merely acting as a conduit for the Company. The majority of the Selling
Stockholders purchased their respective Shares in the Private Placement on August 27, 2007,
approximately two months ago. One of the Selling Stockholders, Bio-Rad
October 30, 2007
Page 4
Laboratories, Inc. (“Bio-Rad”), acquired its Shares on November 13, 2006 in connection with its purchase of the
Company’s protein research tools and collaborative services business (the “Instrument Business”)
and related establishment of an on-going strategic partnership. Unlike an underwritten public
offering in which securities are not sold to the underwriters until a registration statement
covering the sale of the securities has been declared effective, the Selling Stockholders have been
subject to economic risk on their investment for an extended period of time. All of the Shares,
other than the Shares underlying warrants, have been fully paid for by the Selling Stockholders.
As discussed below, the prices paid for the Shares and warrants exercisable for Shares were at or
above the market price of the Company’s common stock on the respective dates that the Company
priced such securities, and do not reflect a discount or commission typical of an underwritten
offering.
The purchase price for each Share issued in the Private Placement was $0.74 per share, the closing
sale price of the Company’s common stock on the Nasdaq Capital Market on August 23,
2007.(2) The warrants issued in the Private Placement have an exercise price of $0.925
per share (a premium of 25% over the market price of the underlying common stock on August 23,
2007) and contain a cashless exercise feature that may only be used when the resale of the shares
issued upon exercise of the warrants is not covered by an effective registration statement.
Consequently, following the effectiveness of a registration statement covering the shares of common
stock underlying the warrants issued in the Private Placement (and assuming such registration
statement continues to be effective), the Company will receive additional proceeds in the form of
the exercise price, when and if a Selling Stockholder makes a second, independent investment
decision to exercise any of such warrants. In addition, the Selling Stockholders were required to
purchase the warrants issued in the Private Placement for $0.125 per warrant share, effectively
increasing the exercise price thereof and the related premium over the market
price of the underlying common stock. The Shares issued to Bio-Rad in November 2006 were also sold
at the then-current market price. The purchase price of $0.972 per share was based on the average
closing price for the five trading days preceding August 14, 2006, the date of the related stock
purchase agreement. As discussed in more detail in the Company’s response to the Staff’s comment
4, the warrants issued to Oppenheimer & Co. Inc. (“Oppenheimer”) as partial payment for its
services as the placement agent in connection with the Private Placement and as the financial
advisor in connection with the Company’s issuance of 7.0% Convertible Senior Notes due September 1,
2011 (the “7.0% Notes”), also have exercise prices that are at or above the market price of the
underlying
(2)
The Board of Directors of the Company
approved the Private Placement on August 23, 2007 and authorized the pricing
committee of the Board of Directors of the Company (the “Pricing Committee”) to
approve the final terms of the securities purchase agreement and the warrants,
including the price per share of common stock, price per warrant share, and the
exercise price of the warrants to be sold in the private placement. On the
morning of August 24, 2007, the Pricing Committee, in consultation with the
placement agent, approved the final terms of the transaction.
October 30, 2007
Page 5
common stock on the date of determination. The warrants issued to Oppenheimer were part
of fees paid for services provided to the Company by Oppenheimer.
The terms and conditions of all of the transactions in which Selling Stockholders obtained the
Shares were fully negotiated at arms’ length by Oppenheimer, in
its capacity as placement agent, the Selling Stockholders and/or their respective
counsel. Among other things, each of the Selling Stockholders who acquired Shares in the Private
Placement has represented to us in writing that such Selling Stockholder (i) acquired the Shares
for its own account and not with a current view toward resale or distribution within the meaning of
the Securities Act and (ii) at the time it acquired the Shares, it had not offered or sold the
Shares acquired nor did such Selling Stockholder have any present intention of selling,
distributing or otherwise disposing of such Shares either currently or after the passage of a fixed
or determinable period of time or upon the occurrence or non-occurrence of any predetermined event
or circumstance in violation of the Securities Act.(3) Bio-Rad made similar
representations in the stock purchase agreement pursuant to which it acquired its Shares.
Oppenheimer orally made similar representations.
The Company supplementally advises the Staff that OppenheimerFunds, Inc. is the investment adviser
to Baring Global Opportunities Fund, OFI Institutional Global Opportunities Fund, Oppenheimer
Global Opportunities Fund, Russell Alpha Global Opportunities Fund and Russell Global Opportunities
Fund (collectively, the “Oppenheimer Funds”). Each of the Oppenheimer Funds is an affiliate of
OppenheimerFunds Distributor, Inc. which is a limited purpose registered broker dealer. In
addition, Oppenheimer is a registered broker dealer and Mr. Frank Kee Colen is a managing director
of Oppenheimer. It is the Company’s understanding that the Oppenheimer Funds and Oppenheimer are not affiliated with each other. Other than the Oppenheimer Funds, Oppenheimer and
Mr. Colen, none of the Selling
Stockholders are broker dealers or affiliates of broker dealers. The number of Shares offered on
behalf of Selling Stockholders that are either broker dealers or affiliates of broker dealers is
9,798,427 or approximately 22.3% of the total number of Shares.
The Company respectfully advises the Staff that, to the Company’s knowledge, the remaining nine
Selling Stockholders are not broker dealers and are not affiliated with each other or the Company
other than (i) Fort Mason Master, L.P. and Fort Mason Partners, L.P., which are affiliates of each
other, (ii) Falcon Technology Partners L.P. (“Falcon”), the general partner of which is Executive Chairman
of the Company’s Board of Directors (James L.
(3)
In addition, many of the Shares are not
immediately available for sale by the Selling Stockholders due to the
contractual limitations on exercise of the warrants exercisable for such
Shares. These limitations generally provide that the warrants may not be
exercised if the holder would beneficially own more than 4.99% of the Company’s
outstanding common stock following such exercise. All of the warrants issued
in the Private Placement, other than the warrant for 921,000 Shares issued to
Oppenheimer, contain such limitation.
October 30, 2007
Page 6
Rathmann) and (iii) Phronesis Partners, L.P.
(“Phronesis”), which currently beneficially owns more than 10% of the outstanding securities of the
Company, and may therefore be deemed to be an affiliate of the Company. Phronesis, however, was
not an affiliate when it acquired its Shares in the Private Placement. As discussed above, the
Company’s largest single stockholder, Quest, which may be deemed to be an affiliate by virtue of
its beneficial ownership of more than 10% of the outstanding
securities of the Company, also
participated in the Private Placement, but has elected not to include the shares or warrants
exercisable for shares which it purchased in the Registration Statement. Consequently, the only
Shares being offered by Selling Stockholders who were affiliates of the Company at the time such
Shares were originally acquired are those purchased by Falcon in the Private Placement, which
Shares represent approximately 7.3% of the total number of Shares.
Although certain of the Selling Stockholders are or may be deemed to be affiliates of the Company,
the Staff has stated that the inclusion of an affiliate as a selling stockholder does not prevent a
registered resale offering from being considered a valid secondary offering under Rule
415(a)(1)(i). Item D.38 of the Telephone Interpretations states, “Aside from parents and
subsidiaries, af
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(650) 320-1884
robertclaassen@paulhastings.com
October 5, 2007
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Kate Tillan
Re:
SEC Comments of September 24, 2007
Dear Ms. Tillan:
On behalf of Vermillion, Inc. (the Company” or “Vermillion”), set forth below are the responses to
the comments in the letter dated September 24, 2007 from the staff of the Division of Corporation
Finance (the “staff”) of the Securities and Exchange Commission (the “SEC”) relating to the
Company’s Form 10-K for the fiscal year ended December 31, 2006. For ease of reference, we have
repeated the Staff’s comments below with bold face type before each of Vermillion’s responses.
Form 10-K for the Fiscal Year Ended December 31, 2006
Consolidated Financial Statements, page 42
Note 6. Gain on Sale of Instrument Business, page 57
1.
We note that you completed the sale of your protein research tools and collaborative services
business to Bio-Rad Laboratories, Inc. on November 13, 2006. Please tell us about your
consideration of paragraphs 41-42 of SFAS 144. Please be sufficiently detailed in your
response.
Sale of Instrument Business
Overview:
On November 13, 2006, Ciphergen completed the sale to Bio-Rad Laboratories, Inc. (“Bio-Rad”) of the
Company’s protein research tools and collaborative services business (the “instrument business”)
through an asset sale transaction (the “Asset Sale”). Pursuant to the terms of the Asset Sale
entered into with Bio-Rad on August 14, 2006, Bio-Rad paid the Company approximately $16 million in
cash at the closing of the transaction. An additional $4.0 million of contingent cash consideration
includes $2.0 million, subject to certain adjustments, to be held in escrow as security for certain
obligations of the
October 5, 2007
Page 2
Company for three years following the closing, and $2.0 million as a holdback amount to be held by
Bio-Rad until the issuance of a re-examination certificate confirming a patent.
Subsequent to the November 13, 2006 completion of the Asset Sale, both Ciphergen and Bio-Rad
recognized business activities on behalf of each party. As of December 31, 2006, Ciphergen owed to
Bio-Rad a total of $1,571,000, which consisted of accounts receivable Ciphergen collected which
belonged to Bio-Rad, operating expense invoices processed by Bio-Rad and reimbursable by Ciphergen
to Bio-Rad, and other unbilled receivables from Bio-Rad. Similarly, Bio-Rad owed to Ciphergen a
total of $619,000, which consisted of operating expense invoices processed by Ciphergen and
reimbursable by Bio-Rad to Ciphergen, sales taxes on the sale of assets, and unbilled receivables
from Bio-Rad.
Applicability of Paragraphs 41-42 of SFAS 144
Paragraphs 41 and 42 of SFAS 144 state that:
41.
For purposes of this Statement, a component of an entity comprises operations and cash flows
that can be clearly distinguished, operationally and for financial reporting purposes, from
the rest of the entity. A component of an entity may be a reportable segment or an operating
segment (as those terms are defined in paragraph 10 of Statement 131), a reporting unit (as
that term is defined in Statement 142), a subsidiary, or an asset group (as that term is
defined in paragraph 4 of SFAS 144).
42.
The results of operations of a component of an entity that either has been disposed of or is
classified as held for sale shall be reported in discontinued operations in accordance with
paragraph 43 if both of the following conditions are met: (a) the operations and cash flows of
the component have been (or will be) eliminated from the ongoing operations of the entity as a
result of the disposal transaction and (b) the entity will not have any significant continuing
involvement in the operations of the component after the disposal transaction.
The sale by the Company of the instrument business is not classified as discontinued operations
because conditions required by paragraph 42 of SFAS 144 for reporting discontinued operations were
not met. Paragraph 42 of SFAS 144 requires that the operations and cash flows of the disposed
component have been (or will be) eliminated from the ongoing operations of the entity as a result
of the disposal transaction and that the Company not have any significant continuing involvement in
the operations of the component after the disposal transaction. This is not the case. Under a
five-year manufacturing and supply agreement entered into between the Company and Bio-Rad, the
outsourcing of the manufacturing operations of the instruments business will not eliminate the
operations and cash flows from the ongoing operations of the Company. Under a transition service
agreement, Bio-Rad will have shared use of the Company’s server and systems, Bio-Rad and the
Company will provide personnel and staffing services
October 5, 2007
Page 3
and the Company will have access and the right to use certain equipment sold to Bio-Rad. Under a
sublease agreement, through July 2008 Bio-Rad will sub-lease approximately one half of the
manufacturing and office space currently under lease by the Company. Under a five year
cross-license agreement, the Company will have the right to certain
technology to be used in the
diagnostic market. In light of the transition services agreement, sublease, cross-license
agreement, and the manufacturing and supply agreement entered into between the Company and Bio-Rad,
continuing cash flows are expected to be generated by the Company. In addition, the agreements
provide the company with significant continuing involvement in the operations of the instruments
business. Accordingly, the Company continues to report the operations of the instrument business
in continuing operations due to this continuing involvement.
Note 11. Long-term Debt and Capital Leases, page 62
2.
We note that you issued 7.0% convertible senior notes due 2011 on November 15, 2006. Please
tell us about your assessment of the embedded features within the convertible debt under SFAS
133. Please be sufficiently detailed in your response.
Terms of Convertible Notes
Overview:
On November 15, 2006, the Company closed the sale of $16,500,000 of Convertible Senior Notes due
September 1, 2011 (the “Notes”). The Notes are unsecured senior indebtedness of the Company and
bear interest at the rate of 7.00% per annum, which may be reduced to 4.00% per annum if the
Company receives approval or clearance for commercial sale of any of its ovarian cancer tests by
the U.S. Food and Drug Administration. Interest is payable on March 1 and September 1 of each year,
commencing March 1, 2007. The Notes are convertible at the option of each Holder, at any time on or
prior to the close of business on the business day immediately preceding September 1, 2011, into
shares of the Company’s common stock at a conversion price of $2.00 per share, equivalent to a
conversion rate equal to 500 shares of common stock per $1,000 principal of the New Notes, subject
to adjustment in certain circumstances. If a Holder converts all or any portion of its Notes prior
to October 31, 2008, upon such conversion, in addition to the Common Stock such Holder would
receive, the Holder will be entitled to receive with respect to each Note so converted an amount in
cash equal to the difference of (i) the amount of all interest that the Company would be required
to pay on such Note from the date of the indenture through October 31, 2008 and (ii) the amount of
interest actually paid on such Note by the Company prior to the time of conversion.
Holders of the Notes have the option to require the Company to repurchase the Notes upon a change
of control as that term is defined in the indenture and at any time after
October 5, 2007
Page 4
September 1, 2009, if the Company has not received approval or clearance for commercial sale of any
of its ovarian cancer tests by the FDA. The Company may redeem the notes at its option, in whole or
in part, at any time on or after September 1, 2009 at specified redemption prices plus accrued and
unpaid interest, provided that the notes will be redeemable only if the closing price of the stock
equals or exceeds 200% of the conversion price then in effect for at least 20 trading days within a
period of 30 consecutive trading days ending on the trading day before the date of the notice of
the optional redemption. Upon a change of control, each holder of the notes may require the Company
to repurchase some or all of the notes at specified redemption prices, plus accrued and unpaid
interest. The debenture contains a put option that entitles the holder to require the Company to
redeem the debenture at a price equal to 105.0% of the principal balance upon a change in control
of the Company.
The notes and common stock issuable upon conversion of the notes were registered with the U.S.
Securities and Exchange Commission on Form S-3 on December 15, 2006, and at December 31, 2006 all
notes remained issued and outstanding.
Applicability of SFAS 133
The Company used the following technical guidance related to the assessment:
•
EITF 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company’s Own Stock
•
FAS 133, Accounting for Derivative Instruments and Hedging Activities, as Amended and
Interpreted (February 2004), paragraphs 11a, 12, 13, 61(d)
•
FAS 5, Accounting for Contingencies
•
EITF 05-2, The Meaning of “Conventional Convertible Debt Instrument” in EITF Issue No.
00-19
•
EITF 01-6, The Meaning of “Indexed to a Company’s Own Stock”
•
FASB Staff Position EITF00-19-2: Accounting for Registration Payment Arrangements
•
DIG Issue B15, Embedded Derivatives: Separate Accounting for Multiple Derivative Features
Embedded in a Single Hybrid Instrument
•
DIG Issue B16: Embedded Derivatives: Calls and Puts in Debt Instruments
•
DIG Issue B38: Evaluation of Net Settlement with Respect to the Settlement of a Debt
Instrument through Exercise of an Embedded Put Option or Call Option
•
DIG Issue B39: Application of Paragraph 13(b) to Call Options That Are Exercisable Only by
the Debtor
Company’s analysis and detailed explanations related to the derivative features of the convertible
notes are as follows:
October 5, 2007
Page 5
1.
The Company assessed the conversion option under the guidance in FAS 133,
Accounting for Derivative Instruments and Hedging Activities (“FAS 133”), specifically
paragraph 12 and 13, to determine if the conversion option met the definition of a
derivative and whether the derivative should be separated from the host contract (the
“Note”) and accounted for as a derivative instrument. The Company concluded that the
conversion option met the definition of a derivative as defined in FAS 133 and that it
was not clearly and closely related to the Note. The Company then assessed whether
the conversion option met the paragraph 11(a) scope exception to FAS 133. The Company
concluded that the conversion option was indexed to its own stock by applying the
guidance set forth in EITF 01-6, “The Meaning of ‘Indexed to a Company’s Own Stock.’”
The Company also determined that the conversion option would be classified as
stockholders’ equity if it were freestanding by applying the guidance set forth in
EITF Issue No. 00-19 (“EITF 00-19”), Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in, a Company’s Own Stock. In applying EITF 00-19,
the Company considered all aspects of EITF 00-19 (i.e. paragraphs 12-32), to determine
the appropriate classification (i.e. debt or equity) for the conversion option as the
Company had concluded that the Note is not considered conventional debt due to
a “make-whole” premium the Note Holders could be provided upon a change of control
whereby the conversion price is adjusted based on the timing of the change of control.
The Company analysis included determining that the contract permits the company to
settle in unregistered shares, that the company has sufficient authorized and unissued
shares available to settle the contract after considering all other commitments that
may require the issuance of stock during the maximum period the derivative contract
could remain outstanding, that the contract contains an explicit limit on the number
of shares to be delivered in a share settlement, along with the other provisions in
paragraphs 12-32. The Company determined that they met the criteria noted in 00-19
for considering the conversion feature as equity if it were free-standing. Based on
the analysis, the Company concluded that the conversion option does not need to be
bifurcated from the debt instrument as it meets the FAS 133 paragraph 11(a) scope
exception and should be accounted for in accordance with the guidance in APB 14,
Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants.
2.
The Company assessed the following features of the Note under the guidance in
FAS 133, Accounting for Derivative Instruments and Hedging Activities (“FAS 133”),
paragraphs 12 and 13, to determine if the features met the definition of a derivative
and, if so, whether the derivative should be separated from the Note and accounted for
as a derivative instrument:
October 5, 2007
Page 6
•
The Note Holders contingent put option: If the FDA Approval Event (as described in
the Note Offering) does not occur by September 1, 2009, the Note Holders have the
option after September 1, 2009 to put the debt to the Company for payment at the par
value of the Note plus any accrued and unpaid interests. The Company determined that
this put option which permits the holder to put the debt at par plus accrued and
unpaid interest is clearly and closely related to the host debt instrument as defined
in paragraph 61(d) of FAS 133 and the application of DIG Issue B16. As such, the
holder’s option to put the Notes at par does not meet the requirements for bifurcation
under FAS 133 paragraphs 12 (a).
•
The Company’s call option to call the debt at par plus accrued and unpaid interest
(on or after September 1, 2009): The Company concluded that the redemption feature
permitting the Company to call the debt at par plus accrued and unpaid interest, on or
after September 1, 2009, is clearly and closely related to the host debt instrument
based on reference to DIG Issue B39 as it can be only exercised by the debtor, and the
index is the fixed premium, which is considered a “plain vanilla” call. Accordingly,
the requirements for bifurcation under FAS 133 paragraph 12(a), 13 and 61(d) do not
apply.
•
The contingent interest rate reduction from 7% to 4% upon an FDA Approval Event:
The Company concluded that the interest rate reduction from 7% to 4% upon an FDA
Approval Event is clearly and closely related to the host debt instrument based on
reference to DIG Issue B16. In determining the appropriate rate for the debt
agreement, the Company considered that the FDA Approval Event was included in the Note
as a barometer of the Company’s credit risk. The Company’s credit risk would decrease
upon the FDA Approval Event; accordingly, the decrease in the credit risk would result
in an adjustment to the interest rate. Part of the Company’s determination was based
on the parties to the transaction agreeing that the occurrence or nonoccurrence of an
FDA Approval Event would be an effective way to measure the change in the Company’s
credit risk. Therefore, the interest rate reduction is related to the perceived credit
rating and credit risk of the Company (as the Company’s credit rating will be
positively impacted by the FDA approval) and is not indexed to another underlying and
the guidance in paragraph 61(h) of FAS 133 and DIG Issue B36 applies. Accordingly, the
interest rate reduction doe
2007-10-05 - CORRESP - Aspira Women's Health Inc.
CORRESP
1
filename1.htm
corresp
October 5, 2007
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Kate Tillan
Re:
SEC Comments of September 24, 2007
Dear Ms. Tillan:
This letter is in response to your comment letter dated September 24, 2007. 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.
Sincerely,
/s/ Debra Young
Debra Young
Vice President & Chief Financial Officer
2007-09-24 - UPLOAD - Aspira Women's Health Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 6010
September 24, 2007
VIA U.S. MAIL AND FACSIMILE ((510) 505-2101)
Ms. Debra A. Young Vice President and Chief Financial Officer Vermillion, Inc. 6611 Dumbarton Circle Fremont, California 94555
Re: Vermillion, Inc.
Form 10-K for the fiscal year ended December 31, 2006
Filed April 2, 2007
File No. 000-31617
Dear Ms. Young:
We have reviewed your filing and have the following comments. We have limited our
review to only your financial statements and related disclosures and do not intend to expand our review to other portions of your documents. In our comments, we ask you to provide us with
information so we may better understand your disclosu re. Please be as detailed as necessary in
your explanation. After review ing this information, we ma y raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filings. We look forward to working with you in these respects. We welcome any
questions you may have about our comments or on any other aspect of our review. Feel free to
call us at the telephone numbers lis ted at the end of this letter.
Ms. Debra A. Young
Vermillion, Inc.
September 24, 2007 Page 2 Form 10-K for the Fiscal Year Ended December 31, 2006
Consolidated Financial Statements, page 42
Note 6. Gain on Sale of Instrument Business, page 57
1. We note that you completed the sale of your protein research tool s and collaborative
services business to Bio-Rad Laboratories, Inc. on November 13, 2006. Please tell us
about your consideration of paragraphs 41- 42 of SFAS 144. Please be sufficiently
detailed in your response.
Note 11. Long-term Debt and Capital Leases, page 62
2. We note that you issued 7.0% convertible senior notes due 2011 on November 15, 2006.
Please tell us about your assessment of the em bedded features within the convertible debt
under SFAS 133. Please be sufficiently detailed in your response.
As appropriate, please respond to these comments within 10 business days or tell us when
you will provide us with a response. Please furn ish a letter that keys your responses to our
comments and provides any requested information. De tailed letters greatly f acilitate our review.
Please understand that we may have additional co mments after reviewing your responses to our
comments.
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 includes all information re quired under the Securities
Exchange Act of 1934 and that they have provi ded all information investors require for an
informed investment decision. Since the compa ny and its management are in possession of all
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made.
Ms. Debra A. Young
Vermillion, Inc. September 24, 2007 Page 3
In connection with responding to our comment s, please provide, in writing, a 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 the filing; and
⋅ the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the sta ff of the Division of Corporati on Finance in our review of your
filing or in response to our comments on your filing.
You may contact me at (202) 551-3604 or Brian Cascio, Br anch Chief, at (202) 551-
3676, if you have any questions regarding commen ts on the financial statements and related
matters. You may also contact Martin James, Senior Assistant Chief Accountant, at (202) 551-
3671 with any other questions. S i n c e r e l y , K a t e T i l l a n Assistant Chief Accountant