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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
ELITE PHARMACEUTICALS INC /NV/
Response Received
14 company response(s)
High - file number match
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Company responded
2009-04-14
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2012-01-31
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2015-10-07
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2015-10-26
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2015-12-04
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2015-12-22
ELITE PHARMACEUTICALS INC /NV/
References: November 20, 2015
Summary
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Company responded
2016-02-04
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2016-02-17
ELITE PHARMACEUTICALS INC /NV/
References: October 26, 2015
Summary
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Company responded
2016-03-18
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2026-03-18
ELITE PHARMACEUTICALS INC /NV/
References: March 4, 2026
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-02-28
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2024-01-22
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2024-02-20
ELITE PHARMACEUTICALS INC /NV/
References: January 22, 2024
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-03-12
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-02-09
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2021-02-22
ELITE PHARMACEUTICALS INC /NV/
References: February 9, 2021
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-22
ELITE PHARMACEUTICALS INC /NV/
Summary
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Company responded
2020-07-23
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
1 company response(s)
Medium - date proximity
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Company responded
2017-06-02
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-07-06
ELITE PHARMACEUTICALS INC /NV/
Summary
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2016-07-11
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-04-08
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-01-21
ELITE PHARMACEUTICALS INC /NV/
References: October 26, 2015
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2015-12-09
ELITE PHARMACEUTICALS INC /NV/
References: November 20,
2015
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-11-23
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-09-25
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2014-04-17
ELITE PHARMACEUTICALS INC /NV/
Summary
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2014-04-28
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-02-13
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-01-20
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2009-04-22
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-11-20
ELITE PHARMACEUTICALS INC /NV/
Summary
Generating summary...
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-05-21
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-05-20
ELITE PHARMACEUTICALS INC /NV/
Summary
Generating summary...
ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-05-02
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-05-01
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Response Received
4 company response(s)
High - file number match
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Company responded
2008-01-07
ELITE PHARMACEUTICALS INC /NV/
Summary
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2008-01-24
ELITE PHARMACEUTICALS INC /NV/
Summary
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ELITE PHARMACEUTICALS INC /NV/
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-01-10
ELITE PHARMACEUTICALS INC /NV/
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-14 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2026-03-18 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2026-03-04 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2024-02-28 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2024-02-20 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2024-01-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2021-03-12 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2021-02-22 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2021-02-09 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2020-07-23 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2020-07-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2017-06-02 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2017-05-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-07-11 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-07-06 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-04-08 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-03-18 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-02-17 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-02-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-01-21 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-01-04 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-22 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-21 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-09 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-11-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-10-26 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-10-07 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-09-25 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-28 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-28 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-17 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-02-13 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-01-31 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-01-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-16 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-12 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-12 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-11-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-11-17 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-21 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-02 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-01 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-24 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-10 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-07 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2007-08-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-14 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2026-03-04 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2024-02-28 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2024-01-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | 001-15697 | Read Filing View |
| 2021-03-12 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2021-02-09 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2020-07-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2017-05-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-07-06 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-04-08 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-01-21 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-01-04 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-09 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-11-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-09-25 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-17 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-02-13 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-01-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-22 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-16 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-11-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-11-17 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-21 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-20 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-02 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-05-01 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-10 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2007-08-23 | SEC Comment Letter | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2024-02-20 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2021-02-22 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2020-07-23 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2017-06-02 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-07-11 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-03-18 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-02-17 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2016-02-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-22 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-21 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-12-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-10-26 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2015-10-07 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-28 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2014-04-28 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2012-01-31 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-04-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-12 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2009-03-12 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-24 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-14 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-07 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
| 2008-01-04 | Company Response | ELITE PHARMACEUTICALS INC /NV/ | NJ | N/A | Read Filing View |
2026-04-14 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/ File: 001-15697
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
April 14, 2026
Carter Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647
Re: Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended March 31, 2025
Filed June 30, 2025
File No. 001-15697
Dear Carter Ward:
We have completed our review of your filing. We remind you that the
company and its
management are responsible for the accuracy and adequacy of their disclosures,
notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
</TEXT>
</DOCUMENT>
2026-03-18 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
Troutman
Pepper Locke LLP
3000
Two Logan Square
Eighteenth
and Arch Streets
Philadelphia,
PA 19103
March
18, 2026
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street N.E.
Washington,
D.C. 20549
Attn:
Frank Wyman and Angela Connell
Re:
Elite
Pharmaceuticals, Inc.
Form
10-K for the Fiscal Year Ended March 31, 2025
Filed
June 30, 2025
File
No. 001-15697
Dear
Mr. Wyman and Ms. Connell:
We
are providing this response letter on behalf of our client, Elite Pharmaceuticals, Inc. (the "Company" or "Elite"),
with respect to the staff (the "Staff") of the Securities and Exchange Commission's comment letter dated March 4, 2026,
regarding the above-referenced Form 10-K. For your convenience, the Staff's comments have been reproduced below, followed by the
Company's response. Capitalized terms used and not defined in this response letter have the meanings given to such terms in the
Form 10-K.
Form
10-K for the Fiscal Year Ended March 31, 2025
Notes
to Consolidated Financial Statements
Note
1. Summary of Significant Accounting Policies
Revenue
Recognition, page F-8
1.
We note your disaggregation of revenue disclosure provided on page F-9 as well as the information provided in your February 20, 2024
response letter, specifically your response to comment four. You state that you disaggregate your revenue based on type of good or service
(e.g., manufacturing and license fees) and regulatory pathway (e.g., ANDA vs NDA). Please address the following:
● Given
that you have paused further development of NDAs and do not appear to have engaged in business
activities in this segment since 2021, explain to us how disaggregation by regulatory pathway
provides a meaningful level of disaggregation of your revenues.
U.S.
Securities and Exchange Commission
March
18, 2026
Page
2
● In
your February 20, 2024 response to prior comment four, you stated that when determining the
level of revenue disaggregation, you considered the categories noted in ASC 606-10-55-91
- one of which was sales channel. Given that you began selling products under your own label
in 2023 and now recognize manufacturing fees generated from both wholesale customers and
direct sale customers, explain to us how you determined that disaggregation by sales channel
wouldn't provide meaningful information to investors. Please also provide us with a
breakdown of your manufacturing fees by customer type/sales channel for the periods presented.
● Tell
us how your existing disclosure complies with the requirements of ASC 280-10-50-40, which
requires disclosure of your revenues by product/service or each group of similar products/services.
In this regard, your risk factor disclosure on page 26 indicates that you track revenues
by product or product family and that your top four products based on active pharmaceutical
ingredient account for over 90% of your net revenues. Provide us with a breakdown or your
revenues by each individual product, product family or therapeutic category for the periods
presented with a view towards future disclosure.
RESPONSE:
We respectfully acknowledge the Staff's comment and respond as follows.
The
Company disaggregated revenue by regulatory pathway (ANDA versus NDA) in prior periods because, historically, those categories reflected
distinct economic characteristics, including differences in development risk, regulatory approval timelines, pricing, and margin profiles.
However, the Company acknowledges that it paused further development of NDA products in 2021 and has not engaged in active commercial
NDA-related business activities since that time.
Accordingly,
for the periods presented, revenue associated with NDA-related activities is zero, and the Company agrees that disaggregation by regulatory
pathway no longer provides a meaningful depiction of how economic factors affect the nature, amount, timing, or uncertainty of revenue,
as contemplated by ASC 606-10-50-5 and ASC 606-10-55-91.
With
a view toward future disclosure, the Company intends to remove regulatory pathway as a disaggregation category and instead focus its
revenue disaggregation on categories that more directly reflect current revenue-generating activities and economic characteristics.
In
determining the appropriate level of revenue disaggregation, the Company considered the categories described in ASC 606-10-55-91, specifically
sales channel. While the Company began selling certain products under its own label in 2023 and currently earns manufacturing fees from
intermediary customers, the Company's management concluded that disaggregation by sales channel would provide more meaningful information
to investors for the following reasons:
● Manufacturing
services provided to customers, which consist of intermediaries (i.e. direct and indirect
wholesalers), are substantially similar in nature, involve the same manufacturing processes,
and are subject to similar contractual terms. No goods are sold directly to consumers. All
goods are sold through intermediaries.
U.S.
Securities and Exchange Commission
March
18, 2026
Page
3
● Revenue
from both direct and indirect wholesalers is recognized at a point in time upon transfer
of control of manufactured products. However, revenues from direct and indirect wholesalers
have different cash flows and contract economics as margins generated differ between direct
and indirect revenues. Although the underlying arrangements are substantially similar, pricing
to direct wholesalers yields higher margins than pricing to indirect wholesalers, while the
timing and uncertainty of cash flows do not differ materially.
Accordingly,
the Company concluded that disaggregation by sales channel better achieves the disclosure objective of ASC 606-10-50-5 than disaggregation
by type of good or service.
Notwithstanding
the above, and in response to the Staff's request, the Company has prepared the following quantitative breakdown of manufacturing
fees by customer type for the periods presented:
For
the Years Ended March 31,
2025
2024
Direct Wholesalers
$ 48,008,986
$ 31,633,315
Indirect Wholesalers
33,977,093
22,487,416
Total Manufacturing
Fees
$ 81,986,079
$ 54,120,731
The
Company will include enhanced revenue disaggregation disclosures in future filings, as appropriate, based on its then-current business
model.
ASC
280-10-50-40 requires disclosure of the revenues from external customers for each product and service or each group of similar products
and services unless it is impracticable to do so. The Company believes its existing disclosure, which disaggregates revenue by type of
good or service (manufacturing fees and license fees), satisfies this requirement, as these categories represent the Company's
primary revenue-generating activities and groups of similar services.
Although
the Company internally tracks revenues by product, such information is proprietary and commercially sensitive. Disclosure of such information
in combination with market data regarding sales volume of the Company's products that is publicly available from third parties,
would result in competitive harm to the Company.
Notwithstanding
the above, and in response to the Staff's request, the Company has prepared the following quantitative breakdown of revenues by
(i) products containing an active ingredient listed by the United States Drug Enforcement Agency as a scheduled substance under the Controlled
Substances Act of 1970 ("Scheduled Products") and (ii) products not containing such a scheduled active ingredient ("Unscheduled
Products") for the periods presented:
For
the Years Ended March 31,
2025
2024
Scheduled Products – Manufacturing
Fees
$ 74,756,506
$ 48,426,996
Scheduled Products – Licensing Fees
248,789
1,352,760
Unscheduled Products – Manufacturing
Fees
7,229,573
5,693,735
Unscheduled Products
– Licensing Fees
1,809,061
1,151,637
Total Revenue
$ 84,043,929
$ 56,625,128
U.S.
Securities and Exchange Commission
March
18, 2026
Page
4
The
Company believes such disclosure, in combination with the related disclosures in its Annual Report on Form 10-K for the fiscal year ended
March 31, 2025, meets the requirements of ASC 280-10-50-40 and balances the needs of investors for information regarding the Company
and its financial performance with the need of the Company to protect its proprietary and competitively sensitive information. The Company
intends to provide a breakdown of revenues by Scheduled Products and Unscheduled Products in applicable future filings, in a form substantially
similar to the form provided above.
Note
14. Segment Results, page F-23
2.
You disclose that Consolidated Loss from Operations is the measure of segment profit or loss that is regularly reviewed by your CODM
and that this measure is reported in your Consolidated Statements of Operations. Your disclosure on page F-24, however, of Operating
Income by Segment does not tie to your Consolidated Statements of Operations. With a view towards future disclosure, clarify for us your
measure of segment profit or loss and provide us with the components of such measure and illustrate how it ties to your Consolidated
Statements of Operations. Please also ensure that all of the information required by ASC 280-10-50-22 is disclosed in your future filings.
RESPONSE:
The Company acknowledges the Staff's comment and clarifies that the Chief Operating Decision Maker ("CODM") regularly
reviews Consolidated Income from Operations as the measure of segment profit or loss, which is reported in the Company's Consolidated
Statements of Operations.
The
Company notes that the presentation of Operating Income by Segment in Note 14 did not clearly reconcile to the Consolidated Statements
of Operations. The Company will include Income (Loss) from Operations as a line item within the segment results table to facilitate reconciliation
in future filings as follows:
For
the Years Ended March 31,
2025
2024
Operating income by segment
$ 32,121,818
$ 19,473,752
Corporate unallocated costs
(9,001,930 )
(7,145,114 )
Impairment of intangible
assets
(1,603,426 )
-
Depreciation and amortization
expense
(1,688,429 )
(1,379,948 )
Significant
non-cash items
(227,565 )
(159,921 )
Income
from operations
19,600,468
10,788,769
Change in fair value of derivative instruments
(18,901,185 )
(5,776,297 )
Change in fair value of stock-based liabilities
-
(5,743,468 )
Interest expense and amortization of debt issuance
costs
(772,367 )
(588,622 )
Gain from settlement agreements
-
1,761,792
Interest income
20,944
20,918
(Loss)
income before income taxes
$ (52,140 )
$ 463,092
The
Company believes the existing disclosures are in compliance with ASC 280-10-50-22. The Company will also ensure that all disclosures
required by ASC 280-10-50-22, including reconciliations in accordance with ASC 280-10-50-30, to consolidated results, are provided in
future filings.
U.S.
Securities and Exchange Commission
March
18, 2026
Page
5
3.
As a related matter, with a view towards future disclosure, provide us with the information required by ASC 280-10-50-26A through 50-26C
as it relates to significant segment expenses and other segment items.
RESPONSE:
The Company acknowledges the Staff's comment and confirms there are no significant segment expenses or other segment items
that are separately provided to the CODM beyond research and development and general and administrative expenses. The CODM does not receive
segment-level information related to depreciation, amortization, capital expenditures, or other non-cash items, and therefore such items
are excluded.
Going
forward, the Company will enhance its segment disclosures to explicitly address the requirements of ASC 280-10-50-26A through 50-26C,
including clarifying that significant segment expenses are presented in the Consolidated Statements of Operations and that no additional
significant segment expenses or other segment items are separately disclosed because such information is not regularly reviewed by the
CODM.
Please
contact Carter Ward, the Chief Financial Officer of the Company, at 201-367-7855, or me at 215-981-4065, if you have any questions about
this response.
Respectfully
Submitted,
/s/
Mark T. Wilhelm
Mark
T. Wilhelm
cc: Carter
Ward, Chief Financial Officer
Elite
Pharmaceuticals, Inc.
2026-03-04 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/ File: 001-15697
March 4, 2026
Carter Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647
Re:Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended March 31, 2025
Filed June 30, 2025
File No. 001-15697
Dear Carter Ward:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for the Fiscal Year Ended March 31, 2025
Notes to Consolidated Financial Statements
Note 1. Summary of Significant Accounting Policies
Revenue Recognition, page F-8
We note your disaggregation of revenue disclosure provided on page F-9 as well as the
information provided in your February 20, 2024 response letter, specifically your
response to comment four. You state that you disaggregate your revenue based on type
of good or service (e.g., manufacturing and license fees) and regulatory pathway (e.g.,
ANDA vs NDA). Please address the following:
•Given that you have paused further development of NDAs and do not appear to have
engaged in business activities in this segment since 2021, explain to us how
disaggregation by regulatory pathway provides a meaningful level of disaggregation
of your revenues.
In your February 20, 2024 response to prior comment four, you stated that when
determining the level of revenue disaggregation, you considered the categories noted
in ASC 606-10-55-91 - one of which was sales channel. Given that you began •1.
March 4, 2026
Page 2
selling products under your own label in 2023 and now recognize manufacturing
fees generated from both wholesale customers and direct sale customers, explain to
us how you determined that disaggregation by sales channel wouldn't provide
meaningful information to investors. Please also provide us with a breakdown of
your manufacturing fees by customer type/sales channel for the periods presented.
•Tell us how your existing disclosure complies with the requirements of ASC 280-10-
50-40, which requires disclosure of your revenues by product/service or each group
of similar products/services. In this regard, your risk factor disclosure on page 26
indicates that you track revenues by product or product family and that your top four
products based on active pharmaceutical ingredient account for over 90% of your net
revenues. Provide us with a breakdown or your revenues by each individual product,
product family or therapeutic category for the periods presented with a view towards
future disclosure.
Note 14. Segment Results, page F-23
2.You disclose that Consolidated Loss from Operations is the measure of segment profit or
loss that is regularly reviewed by your CODM and that this measure is reported in your
Consolidated Statements of Operations. Your disclosure on page F-24, however, of
Operating Income by Segment does not tie to your Consolidated Statements of
Operations. With a view towards future disclosure, clarify for us your measure of
segment profit or loss and provide us with the components of such measure and illustrate
how it ties to your Consolidated Statements of Operations. Please also ensure that all of
the information required by ASC 280-10-50-22 is disclosed in your future filings.
3.As a related matter, with a view towards future disclosure, provide us with the
information required by ASC 280-10-50-26A through 50-26C as it relates to significant
segment expenses and other segment items.
In closing, 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 Frank Wyman at 202-551-3660 or Angela Connell at 202-551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-02-28 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/ File: 001-15697
United States securities and exchange commission logo
February 28, 2024
Carter Ward
Chief Financial Officer
ELITE PHARMACEUTICALS INC /NV/
165 Ludlow Avenue
Northvale, NJ 07647
Re:ELITE PHARMACEUTICALS INC /NV/
Form 10-K for the Fiscal Year Ended March 31, 2023
Filed June 29, 2023
File No. 001-15697
Dear Carter Ward:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-02-20 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
Troutman
Pepper Hamilton Sanders LLP
400
Berwyn Park, 899 Cassatt Road
Berwyn,
PA 19312-1183
troutman.com
Scott
R. Jones
D
610.640.7853
scott.jones@troutman.com
February
20, 2024
Office
of Life Sciences
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F Street N.E.
Washington
D.C. 20549
Attn:
Mary Mast and Daniel Gordon
Re:
Securities
and Exchange Commission (“SEC”) Comment Letter dated January 22, 2024 regarding Elite Pharmaceuticals, Inc. Form 10-K
for the Fiscal Year Ended March 31, 2023 filed June 29, 2023 (the “Form 10-K”) and Form 10-Q for the Six Months Ended
September 30, 2023 filed November 14, 2023 (the “Form 10-Q”)
Dear
Ms. Mast and Mr. Gordon:
We
are providing this response letter on behalf of our client, Elite Pharmaceuticals, Inc. (the “Company” or “Elite”),
with respect to the Staff’s comment letter dated January 22, 2024, regarding the above-referenced Form 10-K and Form 10-Q. For
your convenience, the Staff’s comments have been reproduced below, followed by the Company’s response. Capitalized terms
used and not defined in this response letter have the meanings given to such terms in the Form 10-K or Form 10-Q.
Form
10-K for the Fiscal Year Ended March 31, 2023
Results
of Operations, page 50
1.
You
disclose in “Patents” on page 9 that you own seven patents of which one patent expired in April 2023 and two patents
are expiring in March and April 2024. Please tell us and clarify in future filings the nature of those patents and, if material,
disclose the expected impact on your results of operations.
RESPONSE:
The Company acknowledges the Staff’s comment and notes that none of the above referenced Patents
relate to any of the Company’s revenue producing activities. Accordingly, the expiration of the Patents is not expected to have
a material impact on the Company’s results of operations. The Company revised its disclosure in “Note 1. Summary of Significant
Accounting Policies – Intangible Assets” in the Form 10-Q for the fiscal quarter ended December 31, 2023 to disclose this
fact. In addition, the Company will disclose this fact in Item 1. Business – Patents in the Annual Report on Form 10-K to be filed
for the fiscal year ending March 31, 2024, and will disclose this fact in other applicable future filings.
United
States Securities and Exchange Commission
February
20, 2024
Page
2
Management’s
Discussion and Analysis
Critical
Accounting Policies and Estimates, page 53
2.
You
state that your discussion addresses your most critical accounting policies. However, your disclosure beginning on page 53 appears
to include substantially all of your accounting policies included in Note 1 to the financial statements. Please confirm you will
revise your presentation in future filings to only include your critical accounting estimates that involve a significant level of
estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations
pursuant to Item 303(b)(3) of Regulation S-K.
RESPONSE:
The Company acknowledges the Staff’s comment and revised its disclosure in the Form 10-Q for the fiscal quarter ended December
31, 2023, as it will in future filings, to only include critical accounting estimates that involve a significant level of estimation
uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations pursuant
to Item 303(b)(3) of Regulation S-K.
Notes
to Consolidated Financial Statements
Note
11. Derivative Financial Instruments - Warrants, page F-20
3.
You
state that the exercise price of the warrants is subject to adjustment for any issuances or deemed issuances of Common Stock or Common
Stock equivalents at an effective price below the then exercise price. You also state that the exercise price adjustment feature
prohibits you from being able to conclude the warrants are indexed to your own stock and thus such warrants are classified as liabilities
and measured initially and subsequently at fair value. We note the Series J Warrants also provide for other standard adjustments
upon the happening of certain customary events. Please tell us your consideration of ASC 2017-11 in accounting for your warrants
as liabilities.
RESPONSE:
The Series J Warrants were originally issued at the same time as shares of Series J Preferred Stock, and at such time the Series
J Warrants were determined to be freestanding financial instruments as they were legally detachable and separately exercisable. As such,
the Company assessed the Series J Warrants as freestanding financial instruments under the relevant accounting guidance and determined
that they would not meet the requirements to be indexed to the Company’s own common stock (due to the presence of the down-round
adjustment features). In addition, Section 2(b) of the Series J Warrant agreement provides the holder of Series J Warrants a choice of
net share settlement or net cash settlement upon a cashless exercise. As the cashless exercise election is at the holder’s option,
it is considered outside of the Company’s control. ASC 815-40-25-7 indicates “contracts that include any provision that could
require net cash settlement cannot be accounted for as equity of the entity . . . .” Additionally, the Company notes that ASC 815-40-25-9
indicates that the likelihood of occurrence of the event(s) that could trigger cash settlement cannot be considered. As such, the Series
J Warrants would also not meet the requirements to be classified in equity, and the Series J Warrants were initially accounted for as
a liability under ASC 815. The liability was recorded at fair value on the date of the warrant issuance and measured subsequently at
fair value, at each reporting period, with changes in fair value recognized in earnings.
United
States Securities and Exchange Commission
February
20, 2024
Page
3
The
Company adopted ASU 2017-11 effective April 1, 2019, for the fiscal year ended March 31, 2020. One of the primary changes under ASU 2017-11
was the change in how down-round adjustment features were viewed under the ASC 815-40 indexation guidance. These features no longer preclude
an entity from considering an instrument to be indexed to the entity’s own stock, as stated in ASC 815-40-15-5D. As a result, the
Company concluded that the Series J Warrants could be considered indexed to its own stock and that the Series J Warrants could qualify
for the scope exception from derivative accounting under ASC 815-40, subject to consideration of the equity classification criteria.
As
previously noted, the Series J Warrant agreement provides the holder a choice of net share settlement or net cash settlement upon a cashless
exercise. As such, the Series J Warrants continue to not meet the requirements to be classified in equity after the adoption of ASU 2017-11
and remain classified as liabilities.
The
Company revised its disclosures related to the Series J Warrants in the Form 10-Q for the fiscal quarter ended December 31, 2023 to expand
the discussion of the cashless exercise feature to provide details on the net cash settlement option and state the basis for accounting
for the Series J Warrants as liabilities based on the discussion above.
Form
10-Q for the Six Months Ended September 30, 2023
Notes
to Condensed Consolidated Financial Statements
Note
1. Summary of Significant Accounting Policies
Revenue
Recognition, page F-5
4.
Please
tell us your consideration of providing additional disaggregated information such as by product line or geographic revenue information.
Refer to ASC 606-10-55-89 through 55-91.
RESPONSE:
The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company has evaluated the guidance
in ASC 606-10-50-5 through 50-7 and the related implementation guidance in ASC 606-10-55-89 through 55-91 with respect to the additional
disclosures of disaggregated revenues and has specifically considered the guidance in ASC 606-10-50-5 through 50-7, which requires an
entity to disaggregate revenue from contracts with customers into categories that depict how the nature, amount, timing, and uncertainty
of revenue and cash flows are affected by economic factors. In evaluating this guidance, the Company considered how information about
the Company’s revenue has been presented for other purposes, including disclosures presented outside of the financial statements,
and note that the Company does not further disaggregate its revenue in such disclosures.
United
States Securities and Exchange Commission
February
20, 2024
Page
4
In
assessing ASC 606-10-55-91, the Company notes the following in regard to examples of categories that should be considered:
(a)
Type
of good or service (for example, major product lines)
(i)
The Company generates revenues from manufacturing and licensing fees. In further considering the disaggregation of revenue, the Company
considered the difference in the nature of the regulatory pathway relevant to the product from which current/future revenues are to be
derived. Accordingly, the Company further disaggregated revenue by manufacturing and license fees within its New Drug Application (“NDA”)
and Abbreviated New Drug Application (“ANDA”) segments.
(b)
Geographical
region (for example, country or region)
(i)
The Company notes that all revenue is generated within the United States, and the Company believes that the economic factors impacting
its revenues and cash flows are not significantly different within regions of the United States. Additionally, the Company’s management
does not review revenue at the geographical region level to manage its business.
(c)
Market
or type of customer (for example, government and nongovernment customers)
(i)
For the six months ended September 30, 2023, the Company generated 67% of its revenues from three customers. Further, all revenue is
recognized via sales directly to United States based wholesalers/distributors and therefore there is no economic factor variability in
the market or type of customer from which revenue is generated.
(d)
Type
of contract (for example, fixed-price and time-and-materials contracts)
(i)
The nature and type of the Company’s contracts with customers is driven by the nature of the goods or services being provided to
the customer and aligns with the Company’s disaggregation of revenue by manufacturing and license fees within its NDA and ANDA
segments.
(e)
Contract
duration (for example, short-term and long-term contracts)
(i)
Company’s management does not review revenue at the contract duration level to manage its business. In addition, based on the nature
of the Company’s contracts with customers and the high concentration of revenue earned from a small number of customers, there
is very little differentiation in terms of contracts across customers.
United
States Securities and Exchange Commission
February
20, 2024
Page
5
(f)
Timing
of transfer of goods or services (for example, revenue from goods or services transferred to customers at a point in time and revenue
from goods or services transferred over time)
(i)
The Company notes that all revenue is recognized at a point in time for all performance obligations as noted in the Company’s “Disaggregation
of revenue” disclosure in “Note 1. Summary of Significant Accounting Policies” included in the Form 10-Q for the fiscal
quarter ended September 30, 2023.
(g)
Sales
channels (for example, goods sold directly to consumers and goods sold through intermediaries).
(i)
The Company notes that all revenue is recognized via sales directly to wholesalers/distributors.
The
Company disaggregates revenues from customer contracts based on the regulatory pathway relevant to the product from which current/future
revenues are to be derived. There are currently two regulatory pathways, defined in CFR Title 21, which are relevant to the Company:
a.
New
Drug Application (“NDA”)
i.
NDA applications can be submitted under Section 505(b)(1) or
505(b)(2) of the Federal Food, Drug and Cosmetic Act.
ii.
The Company has filed an NDA under 505(b)(2), with such application
not yet receiving approval.
b.
Abbreviated
New Drug Application (“ANDA”)
i.
Regulatory pathway through which marketing authorizations are
secured for generic drugs
ii.
As per the Orange Book, the Company currently has 13 approved/active
ANDAs, encompassing a total of 35 products.
Each
pathway has significantly different financial, commercial and risk profile aspects which correlate directly with the nature, amount,
timing and uncertainty of revenue and cash flows. The NDA pathway requires the filing of an Investigational New Drug application (“IND”)
and then Phase I, Phase II and Phase III clinical trials to determine/establish safety and efficacy. Each step of the NDA application
process has significantly higher costs, risks and timelines, as compared to the ANDA process. The completion of all requirements for
the filing of an NDA also does not assure approval of marketing authorization, as evidenced by the Company’s application being
filed with and accepted by the Food and Drug Administration (“FDA”), with the FDA requiring additional safety and efficacy
trials to be conducted and submitted in addition to those already successfully completed/included in the original application.
When
marketing authorization for an NDA is approved, the marketing/distribution factors are significantly different when compared to marketing/distribution
of ANDA products. An NDA product is new to the market and accordingly requires substantial resources related to education of health care
providers on therapeutic efficacy, safety factors, etc., and promotion of the brand name. The resources/infrastructure to support marketing
of NDAs consist of substantial human resources costs in the form of medical doctors/detailers needed to visit healthcare providers, product
samples, presentations at relevant conferences, publishing of abstracts/peer reviewed studies, as well as legal costs to protect/defend
patents and intellectual property.
United
States Securities and Exchange Commission
February
20, 2024
Page
6
The
ANDA pathway is abbreviated, as compared to the NDA, as this pathway is specifically for generics of drugs which have already demonstrated
the requisite level of safety/efficacy and secured NDA marketing authorization previously, with exclusivity provided by the NDA authorization
and any patent protection being expired. ANDA products do not require an IND or Phase I, II or III clinical trials, but rather must demonstrate
the same stability profile and bio-availability as that of the branded, reference drug. The stability tests and bio studies required
for ANDA filings are significantly less costly than the trials/studies required for NDA’s and also can be completed within shorter
timelines.
Marketing
of ANDA, generic products has a vastly different profile when compared to that of NDA products. As the active ingredients and therapeutic
benefits/risks have already been established in the market, there is no need for market education and detailing. Instead, the Company
is able to market its generic products with a sales team that consists of two employees. The generic market is competitive, with price
and dependability of supply being significant factors. There is no exclusivity/patent protection as there is with NDA products.
Over
the past several years, the Company’s consideration of the above factors has resulted in decisions to allocate resources to gene
2024-01-22 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/ File: 001-15697
United States securities and exchange commission logo
January 22, 2024
Carter Ward
Chief Financial Officer
ELITE PHARMACEUTICALS INC /NV/
165 Ludlow Avenue
Northvale, NJ 07647
Re:ELITE PHARMACEUTICALS INC /NV/
Form 10-K for the Fiscal Year Ended March 31, 2023
Filed June 29, 2023
Form 10-Q for the Six Months Ended September 30, 2023
Filed November 14, 2023
File No. 001-15697
Dear Carter Ward:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for the Fiscal Year Ended March 31, 2023
Results of Operations, page 50
1.You disclose in "Patents" on page 9 that you own seven patents of which one patent
expired in April 2023 and two patents are expiring in March and April 2024. Please tell
us and clarify in future filings the nature of those patents and, if material, disclose the
expected impact on your results of operations.
Management's Discussion and Analysis
Critical Accounting Policies and Estimates, page 53
2.You state that your discussion addresses your most critical accounting policies. However,
your disclosure beginning on page 53 appears to include substantially all of your
accounting policies included in Note 1 to the financial statements. Please confirm you
FirstName LastNameCarter Ward
Comapany NameELITE PHARMACEUTICALS INC /NV/
January 22, 2024 Page 2
FirstName LastName
Carter Ward
ELITE PHARMACEUTICALS INC /NV/
January 22, 2024
Page 2
will revise your presentation in future filings to only include your critical accounting
estimates that involve a significant level of estimation uncertainty and have had or are
reasonably likely to have a material impact on the financial condition or results of
operations pursuant to Item 303(b)(3) of Regulation S-K.
Notes to Consolidated Financial Statements
Note 11. Derivative Financial Instruments- Warrants, page F-20
3.You state that the exercise price of the warrants is subject to adjustment for any issuances
or deemed issuances of Common Stock or Common Stock equivalents at an effective
price below the then exercise price. You also state that the exercise price adjustment
feature prohibits you from being able to conclude the warrants are indexed to your own
stock and thus such warrants are classified as liabilities and measured initially and
subsequently at fair value. We note the Series J Warrants also provide for other standard
adjustments upon the happening of certain customary events. Please tell us your
consideration of ASC 2017-11 in accounting for your warrants as liabilities.
Form 10-Q for the Six Months Ended September 30, 2023
Notes to Condensed Consolidated Financial Statements
Note 1. Summary of Significant Accounting Policies
Revenue Recognition, page F-5
4.Please tell us your consideration of providing additional disaggregated information such
as by product line or geographic revenue information. Refer to ASC 606-10-55-89
through 55-91.
In closing, 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 Mary Mast at 202-551-3613 or Daniel Gordon at 202-551-3486 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-03-12 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
United States securities and exchange commission logo
March 12, 2021
Nasrat Hakim
Chief Executive Officer
Elite Pharmaceuticals Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647
Re:Elite Pharmaceuticals Inc.
Form 10-K for fiscal year ended March 31, 2020
Filed June 29, 2020
File No. 001-15697
Dear Mr. Hakim:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-02-22 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
Troutman Pepper Hamilton Sanders LLP
400 Berwyn Park, 899 Cassatt Road
Berwyn, PA 19312-1183
troutman.com
Scott R. Jones
D 610.640.7853
scott.jones@troutman.com
February 22, 2021
VIA EDGAR TRANSMISSION
Office of Life Sciences
Division of Corporate Finance
U.S. Securities & Exchange Commission
100 F Street, N.E.
Washington D.C. 20549
Attention: Frank Wyman and Kate Tillan
Re:
Securities and Exchange Commission (“SEC”) Comment Letter dated February 9, 2021 regarding Elite Pharmaceuticals, Inc. (the “Company” or “ELTP”) Form 10-K for the Fiscal Year Ended March 31, 2020 filed June 29, 2020 (the “Form 10-K”)
Dear Mr. Wyman and Ms. Tillan:
We are submitting this letter on behalf of
our client, Elite Pharmaceuticals, Inc., in response to the written comments we received from the staff of the Division of Corporation
Finance (the “Staff”) of the SEC, dated February 9, 2021, related to the Form 10-K. The Company has today electronically
filed with the SEC this response to your letter. For your convenience, we have included the text of the Staff’s comments
from the SEC comment letter in italics immediately followed by the Company’s response.
Item 9A Controls and Procedures,
Page 66
1. In future filings, please separate the disclosures required by Item 307 of Regulation S-K related
to your disclosure controls and procedures from your disclosures required by Item 308 of Regulation S-K related to your internal
control over financial reporting. Also include the disclosure required by Item 308(a)(1) of Regulation S-K.
Response: In future filings, the Company
will separate the disclosures required by Item 307 of Regulation S-K and Item 308 of Regulation S-K in Item 9A of Form 10-K under
two different headings. Additionally, in future filings, the Company will make the disclosure required by Item 308(a)(1) of Regulation
S-K.
February 22, 2021
Page 2
Exhibits
2. Please confirm to us that your future filings will include complete Section 906 certifications,
referencing compliance with the requirements of both Section 13a and Section 15d of the Securities Exchange Act of 1934.
Response: In future filings, the Company
will attach as exhibits Section 906 certifications that include references to both Section 13(a) and Section 15(d) of the Securities
Exchange Act of 1934, as amended.
The Company appreciates your assistance in
its compliance with applicable disclosure requirements and enhancing the overall disclosures in the Company’s filings. Should
you have any questions or comments regarding the responses in this letter, please contact me by phone at (610) 640-7853.
Sincerely,
/s/ Scott R. Jones
Scott R. Jones
2021-02-09 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
United States securities and exchange commission logo
February 9, 2021
Nasrat Hakim
Chief Executive Officer
Elite Pharmaceuticals Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647
Re:Elite Pharmaceuticals Inc.
Form 10-K for fiscal year ended March 31, 2020
Filed June 29, 2020
File No. 001-15697
Dear Mr. Hakim:
We have limited our review of your filing to the financial statements and related
disclosures 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for fiscal year ended March 31, 2020
Item 9A Controls and Procedures, page 66
1.In future filings, please separate the disclosures required by Item 307 of Regulation S-K
related to your disclosure controls and procedures from your disclosures required by Item
308 of Regulation S-K related to your internal control over financial reporting. Also
include the disclosure required by Item 308(a)(1) of Regulation S-K.
Exhibits
2.Please confirm to us that your future filings will include complete Section 906
certifications, referencing compliance with the requirements of both Section 13a and
Section 15d of the Securities Exchange Act of 1934.
In closing, 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
FirstName LastNameNasrat Hakim
Comapany NameElite Pharmaceuticals Inc.
February 9, 2021 Page 2
FirstName LastName
Nasrat Hakim
Elite Pharmaceuticals Inc.
February 9, 2021
Page 2
absence of action by the staff.
You may contact Frank Wyman at 202-551-3660 or Kate Tillan at 202-551-3604 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-07-23 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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ELITE PHARMACEUTICALS, INC.
165 Ludlow Avenue
Northvale, NJ 07647
July 23, 2020
Securities
and Exchange Commission
100 F
Street, NE
Washington,
DC 20002
Re: Elite
Pharmaceuticals, Inc.
Registration
Statement on Form S-3
(SEC
filing No. 333-239874)
Acceleration
Request
Requested
Date: July 27, 2020
Requested
Time: 5:00 P.M. Eastern Time
Ladies
and Gentlemen:
Pursuant to Rule 461 under the Securities Act
of 1933, as amended, Elite Pharmaceuticals, Inc. (the “Company”) hereby requests that the above-referenced Registration
Statement on Form S-3 (File No. 333-239874) (the “Registration Statement”) be declared effective at the “Requested
Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request
via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.
Once the Registration Statement has been declared
effective, please orally confirm that event with our counsel, Richard Feiner, Esq., by calling Mr. Feiner at (646) 822-1170.
Very truly yours,
ELITE PHARMACEUTICALS, INC.
By:
/s/ Carter Ward
Carter Ward,
Chief Financial Officer
cc: Richard Feiner, Esq.
2020-07-22 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
United States securities and exchange commission logo
July 22, 2020
Carter Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647
Re:Elite Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed July 15, 2020
File No. 333-239874
Dear Mr. Ward:
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 Courtney Lindsay at (202) 551-7237 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rick Feiner
2017-06-02 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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ELITE PHARMACEUTICALS, INC.
165 Ludlow Avenue
Northvale, NJ 07647
June 2, 2017
Suzanne Hayes, Esq.
Assistant Director
Division of Corporation Finance
Office of Healthcare & Insurance
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20002
Re: Elite Pharmaceuticals, Inc.
Registration Statement on Form S-3
(SEC filing No. 333-217866)
Acceleration Request
Requested Date: June 5, 2017
Requested Time: 4:00 P.M. Eastern
Time
Dear Ms. Hayes:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Elite Pharmaceuticals, Inc. (the “Company”) hereby requests that the above-referenced Registration
Statement on Form S-3 (File No. 333-217866) (the “Registration Statement”) be declared effective at the “Requested
Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request
via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration
Statement has been declared effective, please orally confirm that event with our counsel, Richard Feiner, Esq., by calling him
at (646) 822-1170.
Very truly yours,
ELITE PHARMACEUTICALS, INC.
By:
/s/ Carter Ward
Carter Ward,
Chief Financial Officer
cc: Richard Feiner, Esq.
2017-05-23 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
May 23, 2017
Nasrat Hakim
Chief Executive Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Elite Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 10, 2017
File No. 333-217866Re:
Dear Mr. Hakim:
We have limited our review of your registration statement to those issues we have
addressed in our comment. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our 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 the comment, we may have additional comments.
Registration Statement on Form S-3
Information Incorporated by Reference, page 11
Please incorporate all Current Reports on Form 8-K that you have filed since the end of
your March 31, 2016 fiscal year. See Item 12(a)(2) of Form S-3.1.
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.
Nasrat Hakim
Elite Pharmaceuticals, Inc.
2 PageMay 23, 2017
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 Dorrie Yale at 202-551-8776 or Joe McCann at 202-551-6262 with any
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2016-07-11 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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ELITE PHARMACEUTICALS, INC.
165 Ludlow Avenue
Northvale, NJ 07647
July 11, 2016
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20002
Re:
Elite Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed June 27, 2016
File No. 333-212266
Dear MS. Hayes:
Elite Pharmaceuticals, Inc. (“Elite”)
hereby requests, pursuant to Rule 461 of Regulation C, that the effective date of the above referenced Registration Statement be
accelerated so that it is declared effective at 4:00 p.m. on July 13, 2016 or as soon thereafter as practicable.
Elite acknowledges that the disclosure in
the filing is the responsibility of Elite.
Elite also represents to the Commission
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 and Elite represents that it will not assert Staff comments or
this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Elite further acknowledges, that the action
of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective does not relieve Elite
from its full responsibility for the adequacy and accuracy of the disclosures in the filing.
Very truly yours,
ELITE PHARMACEUTICALS, INC.
By:
/s/ Nasrat Hakim
Nasrat Hakim
Chief Executive Officer
2016-07-06 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720 July 6, 2016 Nasrat Hakim Chief Executive Officer Elite Pharmaceuticals, Inc . 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc . Registration Statement on Form S-1 Filed June 27, 2016 File No. 333-212266 Dear Mr. Hakim : We have limited our review of your registration statement to consideration of your pending request for confidential treatment. Please be advised that we will not be in a position to declare this registration statement effective until we resolve all issues concerning the confidential treatment request. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be ce rtain 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 comments, 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 pur suant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Nasrat Hakim Elite Pharmaceuticals, Inc. July 6, 2016 Page 2 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. Please contact Christina Thomas at (202) 551 -3577 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Richard Feiner, Esq. Silverman Shin & Byrne PLLC
2016-04-08 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720
April 8 , 201 6
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10 -Q/A for the Quarter ly Period Ended June 30, 2015
Filed December 30 , 2015
Form 10 -Q/A for the Quarterly Period Ended September 30, 2015
Filed December 30 , 2015
File No. 001 -15697
Dear Mr. Ward :
We have completed our review of your filing s. We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing s and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States. We urge all persons who are responsible for the
accuracy and adeq uacy of the disclosure in the filing s to be certain that the filing s include the
information the Securities Exchange Act of 1934 and all applicable rules require.
Sincerely,
/s/ Sharon Blume
Sharon Blume
Accounting Branch Chief
Office of Healthcare and Insurance
2016-03-18 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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March 18, 2016
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year
Ended March 31, 2015 Filed June 15, 2015
Form 10-Q/A for the Quarterly Period Ended September
30, 2015 Filed December 30, 2015 File No. 001-15697
Dear Mr. Rosenberg:
Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the oral comments received from the SEC’s Staff on March 4, 2016 concerning the above referenced Company
filings.
COMMENT
NO. 1.
1. Refer to our prior comment 1. Please revise your proposed policy disclosure
to remove reference to fair value in determining your revenue recognition. This requirement was removed by ASU 2009-13. Refer to
ASC 605-25-25-5.
RESPONSE.
The
Company, in future filings, will include the following disclosure regarding revenue recognition:
The
Company enters into licensing, manufacturing and development agreements which may include multiple revenue generating activities,
including, without limitation, milestones, license fees, product sales and services. These multiple elements are assessed in accordance
ASC 605-25 Revenue Recognition for Multiple-Element Arrangements in order to determine whether particular components of the arrangement
represent separate units of accounting.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
An
arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value
to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in control of the Company.
The
Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s)
have stand-alone value, with the arrangement being accordingly accounted for as a separate unit of accounting. If such delivered
item(s) are considered to either not have stand-alone value, the arrangement is accounted for as a single unit of accounting, and
the payments received are recognized as revenue over the estimated period of when performance obligations relating to the item(s)
will be performed.
Whenever
the Company determines that an arrangement should be accounted for as a single unit of accounting, it determines the period over
which the performance obligations will be performed and revenue will be recognized. If it cannot reasonably estimate the timing
and the level of effort to complete its performance obligations under a multiple-element arrangement, revenues are then recognized
on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.
Arrangement
consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price
(the relative selling price method). When applying the relative selling price method, the selling price of each deliverable is
determined using vendor-specific objective evidence of selling price, if such exists; otherwise, third-part evidence of selling
price. If neither vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company
uses its best estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether
we can determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information
that is reasonably available without undue cost and effort.
When
determining the selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers
any or all of the following, depending on information available or information that could be reasonably available without undue
cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically,
factors considered can include, without limitation and as appropriate, size of market for specific a product, number of suppliers
and other competitive market factors, forecast market shares and gross profits, barriers/time frames to market entry/launch, intellectual
property rights and protections, exclusive or non-exclusive arrangements, costs of similar/identical deliverables from third parties,
contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, profit allocations, and
other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-2-
COMMENT
NO. 2.
2. Refer to your response to our prior comment 3. Your proposed disclosures appear
limited to revenues for your NDA and ANDA reportable segments. Please provide us proposed disclosures to be included in future
periodic reports that include a measure of profit and loss by segment, in addition to other disclosures required by ASC-280-10-50-22
through 36.
RESPONSE.
The
following are the proposed disclosures:
Note
XX: Segment Results
FASB
ASC 280-10-50, “Disclosure about Segments of an Enterprise and Related Information” requires use of the “management
approach” model for segment reporting. The management approach is based on the way a company’s management organizes
segments within the company for making operating decisions and assessing performance. Reportable segments are based on products
and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company.
The
Company disaggregates its product revenues into the type of marketing authorization relating to each product, specifically the
following two reportable segments:
1.ANDA’s
for generic products; or
2.NDA’s
for branded products.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-3-
The
following represents selected information for the Company’s reportable segments for the (enter periods
here):
Columns for periods (as appropriate)
Revenues from external customers
ANDA
NDA
Adjusted income from continuing operations before income tax
ANDA
NDA
The
table below provides reconciliations of the Company’s segment adjusted income from continuing operations before income tax,
for the (enter periods here):
Columns for periods (as appropriate)
Total segment adjusted income from continuing operations before income tax
Corporate unallocated costs
Interest revenue
Interest expense
Depreciation and amortization expense
Unusual items as per ASC 225-20-45-16
Income tax expense or benefit
Significant noncash items other than depreciation and amortization expense
Other income
Other expense
Total income(loss) from continuing operations before income tax
Asset
information is not reviewed or included within the Company’s internal management reporting. Accordingly, the Company has
not disclosed asset information for each reportable segment.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-4-
COMMENT
NO. 3.
3. Please represent to us that you will furnish your future earnings releases
under item 2.02 of Form 8-K or tell us why you do not provide such filings.
RESPONSE.
Pursuant
to Item 2.02(a) of Form 8-K, a Form 8-K is required to be filed “[i]f a registrant, or any person acting on its behalf, makes
any public announcement or release (including any update of an earlier announcement or release) disclosing material non-public
information regarding the registrant's results of operations or financial condition for a completed quarterly or annual fiscal
period, …” (Emphasis added)
The
Company’s practice is to issue earnings releases only after the relevant annual report on Form 10-K or Quarterly Report on
Form 10-Q is filed. The Company does not believe that there is any “material non-public information” in its earnings
releases. Accordingly, in such instances, the Company does not believe that it is required to file a Current Report on Form 8-K
under Item 2.02. Should the Company believe that in future earnings releases there will be any material non-public information
requiring disclosure under item 2.02, it plans on filing the requisite Form 8-K.
As required, the Company acknowledges that:
· the Company is responsible for the adequacy and accuracy of the disclosure in its filings with
the Commission;
· staff comments or changes to disclosure in response to staff comments do not foreclose the Commission
from taking any action with respect to the filings; and
· the Company may not assert the 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 or comments with
regard to the filing, please contact me at the above address.
Very truly yours,
/s/ Carter Ward
Carter Ward, CFO
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-5-
2016-02-17 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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February 17, 2016
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year
Ended March 31, 2015 Filed June 15, 2015
Form 10-Q/A for the Quarterly Period Ended September
30, 2015 Filed December 30, 2015 File No. 001-15697
Dear Mr. Rosenberg:
Elite
Pharmaceuticals, Inc. (the “Company”) hereby responds to the comments contained in your January 21, 2016 comment letter
(the “Letter”) concerning the above referenced Company filings. Headings and comment numbers below correspond to the
headings and comment numbers in the Letter.
COMMENT
NO. 1.
Form 10-K for the Fiscal Year Ended
March 31, 2015
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant
Accounting Policies
Revenue Recognition, page F-11
1. Refer to our prior comment 1. Please revise your proposed
policy disclosures that indicate that revenue is recognized when “fair value can be determined” to indicate that arrangement
consideration is allocated at the inception of the arrangement based on relative selling price. Refer to ASC 605-25-30-2.
RESPONSE.
The
Company will revise the relevant policy disclosures in future periodic reports to incorporate the comments of the Commission,
similar to the following disclosure which was included in the revenue recognition section of Note 2 to the Financial Statements
presented in the Quarterly Report on Form 10-Q for the quarter ended December 31, 2015, which was filed with the SEC on February
9, 2016 (the “December 2015 10-Q”):
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
…
“The Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered
item(s) have stand-alone value and the fair value can be determined, with the arrangement being accordingly accounted for as a
separate unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, or if the fair value
cannot be determined, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized
as revenue over the estimated period of when performance obligations relating to the item(s) will be performed.”
COMMENT
NO. 2.
Note
4 – Intangible Assets, page F-14
2. Refer to your response to our prior comment 2. Please
provide your analysis of the seven undisclosed generics listed in your response letter dated October 26, 2015, that would support
your assertion that those ANDA’s have indefinite lives. Include in your response the date of FDA approval for the branded
product the ANDA is based on, the date the product became generic, the treatment indication, and other factors supporting your
conclusions.
RESPONSE.
The
FDA Orange Book lists the following in relation to our generic products:
Product
Approval
Of
Branded
1st Generic
Indication
Dantrolene Sodium 25mg, 50mg, and 100mg capsules
Prior to 1982
2005
Muscle relaxant
Loxapine 5mg, 10mg, 25mg, 50mg and 100mg capsules
1988
2004
Antipsychotic
Phentermine HCl 37.5mg tablets
Prior to 1982
1997
Bariatric
Phentermine HCl 37.5mg capsules
1983
1997
Bariatric
Phentermine HCl 30mg capsules
Prior to 1982
1983
Bariatric
Phentermine HCl 30mg capsules (seed formulation)
1983
2003
Bariatric
Phentermine HCl 15mg capsules
Prior to 1982
1983
Bariatric
With
regards to the Company’s determination that the above ANDA’s are indefinitely lived, we present the following:
a. These generic
products have well established and stable markets. The Dantrolenes, and Phentermines have all been on the market for at least
33 years and Loxapine for 28 years. We have no knowledge or evidence of any legislative actions or changes in regulatory environments
that can be cited to support the determination of these product approvals being rescinded in a certain time frame.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-2-
b. The indications
for which these generic products are therapeutically relevant are widespread health concerns in the United States, as opposed
to rare conditions suffered by small percentages of the population. The Company has no known or foreseeable knowledge of these
indications being removed from the health issues from a large portion of the population that can be cited to support the determination
of these products being impaired as a result of the indications to which they apply being no longer in existences.
c. The Company is
also not aware of any technological improvements, discoveries or new drug filings related to products that would result in significant
impairment to the commercial life of our generics. In addition, the efficacy, supply and manufacture of each of these products
is well established and efficient, due to their length of time and breadth in the market. While not meeting a strict definition
of a commodity, they are the types of products that perform in a similar manner, albeit within the regulatory environment in which
pharmaceuticals operate. The efficacy, efficiency and pricing achieved as a result of these factors provide an additional barrier
to the introduction of new technologies, which would have to bear the significant costs relating to the development, filing and
approval of a New Drug Application and then compete on price, supply and efficacy with these commodity type generic products.
d. The manufacture
and marketing of Dantrolene and Loxapine are both exclusively licensed to Epic Pharmaceuticals. Epic has advised us that Commercial
launch of these products was delayed due to raw material supply issues that have been resolved and that they expect to complete
the commercial launch prerequisites (validation batches, stability studies, supplemental FDA filings, etc…) and launch
the products later this year.
e. The manufacture
and marketing of the 5 Phentermine ANDA’s referenced above are all licensed to Epic Pharmaceuticals on a non-exclusive basis.
Epic has advised us that due to resource constraints, their commercialization of these products is scheduled for after the launch
of Dantrolene and Loxapine.
f. Elite is currently
manufacturing and selling Phentermine 37.5mg tablets and Epic is expected to be selling this product too, under their non-exclusive
license. As with the other products, we do not foresee any obsolescence, significant future impairment in demand, or other economic
factors that would indicate an impairment or impending expiration of this generic product as a viable commercial product.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-3-
g. Please also refer
to our comments on this topic in our prior correspondence dated October 26, 2015 which provides additional analysis on the Company’s
determination being compliant with the relevant aspects of subtopic ASC-350.
COMMENT
NO. 3.
Note
20 – Concentrations, page F-32
3. Refer to your response to our prior comment 3. You indicate
that NDA and ANDA products represent two reportable segments. Please tell us why you have not provided the disclosures required
by ASC 280-10-50-20 through 50-31.
RESPONSE.
The
Company operated under one segment for the fiscal year ended March 31, 2015. Our first NDA filing was made on January 14, 2016
and has not yet been approved by the FDA. Accordingly there have been no product sales related to products approved for sale under
an NDA filing for the 2015 fiscal year or to date. All revenues for Fiscal 2015 were earned from ANDA products.
We
have included the disclosure that was promised in our December 21, 2015 response in the December 2015 10-Q, and will include similar
disclosures in all future filings. This disclosure is in the Segment Reporting section of Footnote 2, and it includes the following:
“The
Company disaggregates its product revenues into the type of marketing authorization relating to each product, specifically the
following two reportable segments:
1. ANDA’s
for generic products; or
2. NDA’s for
branded products.
During
the three and nine months ended December 31, 2015, the Company recognized $1,954k and $6,720k from the sale of generic products,
respectively. The Company had no revenues relating to the sale of branded products during the three and nine months ended December
31, 2015.”
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-4-
Please
also note that the 10-Q’s issued for the quarters ending June 30, 2014, September 30, 2014 and December 31, 2014, all include
disclosure that the Company operated under one segment for the periods. This disclosure was inadvertently omitted from the March
31, 2015 10-K, but had it not been, it would have indicated that the Company operates under only one segment.
COMMENT
NO. 4.
Form
10-Q/A (Amendment No. 2) for the Quarterly Period Ended September 30, 2015
Notes
to Condensed Consolidated Financial Statements
Note
4 – Restatement of Prior Financial Information, page F-9
4. Although we acknowledge that net income (loss) attributable
to common shareholders did not change as a result of your error in accounting for your convertible preferred stock, it is evident
that net income (loss) has changed. Please amend your Forms 10-Q/A for the quarterly periods ended June 30, 2015 and September
30, 2015 to include the change to net income (loss) in your disclosure of the impact of the restatement to your condensed consolidated
statements of operations for the periods ended March 31, 2015, December 31, 2014, September 30, 2014 and June 30 2014 as stipulated
in ASC 250-10-50-7 and 50-8. In addition, please revise your presentation of net income (loss) in your tables for the condensed
consolidated statements of cash flows for the same periods to properly present net income (loss), as this is the line-item that
is reconciled to net cash flows from operating activities under the indirect method as stipulated in ASC 230-10-45-28. In this
regard, although you label the line-item “net income (loss)” in the tables, the amounts you currently present are
the “net (income) loss attributable to common shareholders” for all periods prior to September 30, 2015.
RESPONSE.
Footnote
4 to the financial statements presented in the December 2015 10-Q includes updated schedules which show the effect of the corrections
in accounting error on Net Income (Loss) for the following periods:
1. Quarter ended
September 30, 2015
2. Quarter ended
June 30, 2015
3. Year ended March
31, 2015
4. Quarter ended
December 31, 2014
5. Quarter ended
September 30, 2014
6. Quarter ended
June 30, 2014
7. Year ended March
31, 2014
In
addition, there is footnote clarification of the fact that, for periods prior to September 30, 2015, Net Income (Loss) and Net
Income (Loss) Attributable to Common Shareholders, as previously reported were the same, and, accordingly both amounts were reported
in a single line item identified as Net Income (Loss) Attributable to Common Shareholders.
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-5-
As
all of the requested disclosure has been made in the December 2015 10-Q the Company does not believe that its Forms 10-Q/A for
the quarterly periods ended June 30, 2015 and September 30, 2015 need to be amended.
As required, the Company acknowledges that:
· the Company is responsible for the adequacy and accuracy
of the disclosure in its filings with the Commission;
· staff comments or changes to disclosure in response to
staff comments do not foreclose the Commission from taking any action with respect to the filings; and
· the Company may not assert the 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 or comments with
regard to the filing, please contact me at the above address.
Very truly yours,
/s/ Carter Ward
Carter Ward, CFO
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-6-
2016-02-04 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP 1 filename1.htm February 4, 2016 Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Jim B. Rosenberg Re: Elite Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended March 31, 2015 Filed June 15, 2015 Form 10-Q/A for the Quarterly Period Ended September 30, 2015 Filed December 30, 2015 File No. 001-15697 Dear Mr. Rosenberg: Elite Pharmaceuticals, Inc. hereby acknowledges receipt of the January 21, 2016 SEC Comment Letter regarding the above referenced periodic reports (the “Letter”). We are very close to responding to the comments in the Letter. However, we are in the process of finalizing our Form 10-Q for the period ended December 31, 2015 so it can be timely filed within the next week. We anticipate responding to the comments in the Letter shortly after that. Accordingly, we hereby request that our time to respond to the Letter be extended to February 19, 2016, 20 business days after the date of the Letter. At this time, we anticipate that we will be able to respond to the Letter on or before the requested extension date. If you have any questions or comments or are unable to so extend our time to respond, please contact the undersigned at the above address. Very truly yours, /s/ Carter Ward Carter Ward, CFO
2016-01-21 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720 January 21, 201 6 Via E -mail Mr. Carter J. Ward Chief Financial Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Form 10 -K for the Fiscal Year Ended March 31, 2015 Filed June 15, 2015 Form 10 -Q/A for the Quarterly Period Ended September 30, 2015 Filed December 30 , 2015 File No. 001 -15697 Dear Mr. Ward: We have reviewed your December 2 1, 2015 res ponse to our comment letter and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested informati on or advis e us as soon as possible when you will respond . If you do not believe a comment appl ies to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our November 2 0, 2015 letter. Form 10 -K for the Fiscal Year Ended March 31, 2015 Notes to Consolidated Financial Statements Note 1 – Summary of Significant Accounting Policies Revenue Recognition, page F -11 1. Refer to our prior comment 1. Please revise your proposed policy disclosures that indicate that revenue is recognized when “fair value can be determined” to indicate that arrangement consideration is allocated at the inception of the arrangement based on relative selling price. Refer to ASC 605 -25-30-2. Mr. Carter J. Ward Elite Pharmaceuticals, Inc. January 21, 2016 Page 2 Note 4 – Intangible Assets, page F -14 2. Refer to your response to our prior comment 2. Please provide your analysis of the seven undisclosed generics listed in your response letter dated October 26, 2015, that would support you r assertion that those ANDA’s have indefinite lives. Include in your response the date of FDA approval for the branded product the ANDA is based on, the date the product became generic, the treatment indication, and other factors supporting your conclusio ns. Note 20 – Concentrations, page F -32 3. Refer to your response to our prior comment 3. You indicate that NDA and ANDA products represent two reportable segments. Please tell us why you have not provided the disclosures required by ASC 280 -10-50-20 through 50 -31. Form 10-Q/A (Amendment No. 2) for the Quarterly Period Ended September 30, 2015 Notes to Condensed Consolidated Financial Statements Note 4 – Restatement of Prior Financial Information, page F -9 4. Although we acknowledge that net income (lo ss) attributable to common shareholders did not change as a result of your error in accounting for your convertible preferred stock, it is evident that net income (loss) has changed. Please amend your Forms 10 -Q/A for the quarterly periods ended June 30, 2015 and September 30, 2015 to include the change to net income (loss) in your disclosure of the impact of the restatement to your condensed consolidated statement s of operations for the periods ended March 31, 2015, December 31, 2014, September 30, 2014 a nd June 30 2014 as stipulat ed in ASC 250 -10-50-7 and 50-8. In addition, please revise your presentation of net income (loss) in your tables for the condensed consolidated statement s of cash flows for the same periods to properly present net income (loss), as this is the line -item that is reconciled to net cash flows from operating activities under the indirect method as stipulated in ASC 230 -10-45-28. In this regard, although you label the line -item “net income (loss)” in the tables, the amounts you curre ntly present are the “net (income) loss attributable to common shareholders” for all periods prior to September 30, 2015. You may contact Rolf Sundwall, Staff Accountant, at (202) 551 -3105 or Mark Brunhofer, Senior Staff Accountant, at (202) 551 -3638 if you have any 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
2016-01-04 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720
January 4 , 201 6
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Item 4.02 Form 8 -K
Filed December 4 , 201 5
File No. 001-15697
Dear Mr. Ward :
We have completed our review of your filing. We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States. We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the
information the Securities Exchange Act of 1934 and all applicable rules require.
Sincerely,
/s/ Sharon Blume
Sharon Blume
Accounting Branch Chief
Office of Healthcare and Insurance
2015-12-22 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
December 22, 2015
Sharon Blume
Accounting Branch Chief
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: Elite Pharmaceuticals, Inc.
Item 4.02 Form 8-K
Filed December 4, 2015
File No. 001-15697
Dear Ms. Blume:
Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the comments contained in your December 9, 2015 comment letter concerning the above referenced Company filing.
Headings and comment numbers below correspond to the headings and comment numbers in your letter.
COMMENT
NO. 1.
Item 4.02 - Nonreliance on Previously Issued Financial
Statements
1. Please amend your filing to disclose when you concluded that your financial
statements could no longer be relied upon. Refer to Item 4.02(a).
RESPONSE.
Per our discussion with
the Staff, the Company believes that the date that the Company concluded that its financial statements could no longer be relied
upon, December 2, 2015, was disclosed on the cover page of the Form 8-K above the line “Date of Report (Date of earliest
event reported)” (emphasis added). Accordingly, the Company does not believe that is needs to file an amendment to the
Form 8-K
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-1-
COMMENT
NO. 2.
2. Please include your SAB 99 and SAB 108 analyses of the impact of adjustments
related to the change in accounting for your convertible preferred stock in previously issued annual and interim financial statements
in your response to our letter dated November 20, 2015.
RESPONSE.
The Company included its SAB 99 and SAB 108 analyses of the impact of adjustments
related to the change in accounting for its convertible preferred stock in previously issued annual and interim financial statements
in its recently filed response to the Commission’s November 20, 2015 comment letter.
As required, the Company acknowledges that:
· the Company is responsible for the adequacy and accuracy of the disclosure in its filings with
the Commission;
· staff comments or changes to disclosure in response to staff comments do not foreclose the Commission
from taking any action with respect to the filings; and
· the Company may not assert the 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 or comments with
regard to the filing, please contact me at the above address.
Very truly yours,
/s/ Carter Ward
Carter Ward, CFO
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-2-
2015-12-21 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
December 21, 2015
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended
March 31, 2015
Filed June 15, 2015
Form 10-Q for the Quarterly Period
Ended June 30, 2015
Filed August 10, 2015
Form 10-Q/A for the Quarterly Period
Ended September 30, 2015
Filed November 10, 2015
File No. 001-15697
Dear Mr. Rosenberg:
Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the comments contained in your November 20 2015 comment letter (the “November 2015 Letter”) concerning
the above referenced Company filings. Headings and comment numbers below correspond to the headings and comment numbers in the
November 2015 Letter. Please note that the Company’s response to Comment No. 6 in the November 2015 Letter also includes
the Company’s further response to Comments 4 and 5 contained in the Commission’s September 25, 2015 comment letter
(the September 2015 Letter”).
COMMENT
NO. 1.
Form 10-K for the Fiscal Year Ended March 31,
2015
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting
Policies Revenue Recognition, page F-11
1. Refer to our prior comment 2. Please revise your proposed disclosures to
discuss your allocation of arrangement consideration to the separate units of accounting. In this regard, revise your policy that
indicates that revenue is recognized when “fair value can be determined” to indicate that arrangement consideration
is allocated at the inception of the arrangement based on relative selling prices. See ASC 605-25-30-2. Include a discussion of
the significant factors, inputs, assumptions and methods used to determine selling price for the significant deliverables under
multiple-element revenue arrangements, including whether the determination was based on vendor-specific objective evidence, third
party evidence or best estimate of selling price. Refer to ASC 605-25-50-2(e).
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-1-
RESPONSE.
The
Company will add the following disclosure to the Revenue Recognition section of the Summary of Significant Accounting Policies
footnote in future filings:
“The
Company enters into licensing, manufacturing and development agreements which may include multiple revenue generating activities,
including, without limitation, milestones, license fees, product sales and services. These multiple elements are assessed in accordance
ASC 605-25 Revenue Recognition for Multiple-Element Arrangements in order to determine whether particular components of
the arrangement represent separate units of accounting.
An
arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value
to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in control of the Company.
The
Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s)
have stand-alone value and the fair value can be determined, with the arrangement being accordingly accounted for as a separate
unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, or if the fair value cannot
be determined, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue
over the estimated period of when performance obligations relating to the item(s) will be performed.
Whenever
the Company determines that an arrangement should be accounted for as a single unit of accounting, we determine the period over
which the performance obligations will be performed and revenue will be recognized. If we cannot reasonably estimate the timing
and the level of effort to complete our performance obligations under a multiple-element arrangement, revenues are then recognized
on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.”
Arrangement
consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price
(the relative selling price method). When applying the relative selling price method, the selling price of each deliverable is
determined using vendor-specific objective evidence of selling price, if such exists; otherwise, third-part evidence of selling
price. If neither vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company
uses its best estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether
we can determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information
that is reasonable available without undue cost and effort.
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-2-
When
determining the selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers
any or all of the following, depending on information available or information that could be reasonably available without undue
cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically,
factors considered can include, without limitation and as appropriate, size of market for specific a product, number of suppliers
and other competitive market factors, forecast market shares and gross profits, barriers/time frames to market entry/launch, intellectual
property rights and protections, exclusive or non-exclusive arrangements, costs of similar/identical deliverables from third parties,
contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, profit allocations, and
other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable.
COMMENT
NO. 2.
Note 4 – Intangible Assets, page F-14
2. Refer to your response to our prior comment 3. It appears that your direct
experience with the products related to your ANDA’s is limited, with four products launched during 2015. Please provide your
analysis of known or foreseeable obsolescence, demand, competition or other economic factors that would support your assertion
that the ANDA’s have indefinite lives. Include in your response the date of FDA approval for the branded product the ANDA
is based on, the date the product became generic, the treatment indication, and other factors supporting your conclusions. Also,
please confirm whether any capitalized patent costs are related to the ANDA assets.
RESPONSE.
The
FDA Orange Book lists the following in relation to our generic products:
Product
Approval
Of Branded
1st Generic
Indication
Phentermine HCl 37.5mg tablet
Prior to 1982
1997
Bariatric
Phentermine HCl 15mg capsule
Prior to 1982
1983
Bariatric
Phentermine HCl 30mg capsule
Prior to 1982
1983
Bariatric
Isradipine
1990
2006
Hypertension
Hydroxyzine HCl
Prior to 1982
1986
Antihistamine / Allergy
Phendimetrazine Tartrate
Prior to 1982
Prior to 1982
Bariatric
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-3-
Please
note that none of the capitalized patent costs relate to ANDA’s.
With
regards to the Company’s determination that the above ANDA’s are indefinitely lived, we present the following:
a. Elite receives current demand (in the
form of purchase orders) and forecast demand (in the form of forecasts that range from 1 to 3 years) from its marketing partners.
This tangible data does not indicate or foresee any obsolescence, significant future impairment in demand, or other economic factors
that would indicate an impairment or impending expiration of the generic products as viable commercial products. To the contrary,
product sales are increasing, as demonstrated by our financial statements, and future expectations remain positive.
b. These generic products have well established
and stable markets. The Phentermines, Hydroxyzine and Phendimetrazine have all been on the market for more than 33 years and Isradipine
for 25 years. We have no knowledge or evidence of any legislative actions or changes in regulatory environments that can be cited
to support the determination of these product approvals being rescinded in a certain time frame.
c. The indications for which these generic
products are therapeutically relevant are widespread health concerns in the United States, as opposed to rare conditions suffered
by small percentages of the population. The Company has no known or foreseeable knowledge of these indications being removed from
the health issues from a large portion of the population that can be cited to support the determination of these products being
impaired as a result of the indications to which they apply being no longer in existences.
d. The Company is also not aware of any
technological improvements, discoveries or new drug filings related to products that would result in significant impairment to
the commercial life of our generics. In addition, the efficacy, supply and manufacture of each of these products is well established
and efficient, due to their length of time and breadth in the market. While not meeting a strict definition of a commodity, they
are the types of products that perform in a similar manner, albeit within the regulatory environment in which pharmaceuticals operate.
The efficacy, efficiency and pricing achieved as a result of these factors provide an additional barrier to the introduction of
new technologies, which would have to bear the significant costs relating to the development, filing and approval of a New Drug
Application and then compete on price, supply and efficacy with these commodity type generic products.
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-4-
e. Please also refer to our comments on
this topic in our prior correspondence dated October 26, 2015 which provides additional analysis on the Company’s determination
being compliant with the relevant aspects of subtopic ASC-350.
COMMENT
NO. 3.
Note 20 – Concentrations, page F-32
3. Refer to your response to our prior comment 7. It appears that your revenue
related to NDA’s is due to the Epic Collaborative Agreement and that you do not currently have any NDA product sales. Please
provide us proposed disclosure to be included in future periodic reports of your revenue by product or group of products as required
by ASC 280-10-50-40, or explain to us why it is impractical to do so. Additionally, please revise your proposed disclosure to clarify
whether you manage your business as one segment or if the disaggregation of revenues between NDA and ANDA products represents two
reportable segments.
RESPONSE.
The
Company will add the following disclosure to the Concentrations footnote in future reports:
The Company disaggregates its product revenues
into the type of marketing authorization relating to each product, specifically the following two reportable segments:
1. ANDA’s for generic products; or
2. NDA’s for branded products.
During the xxx and xxx months ended [DATE],
the Company recognized $XXXk and $XXXk from the sale of generic products with ANDA marketing authorization, respectively. During
the xxx and xxx months ended [DATE], the Company recognized $XXXk and $XXXk from the sale of generic products with NDA marketing
authorization, respectively.
COMMENT
NO. 4.
Note 22 – Related Party Transaction –
Manufacturing and License Agreement with Epic Pharma
LLC, page F-34
4. Refer to your response to our prior comment 8. Notwithstanding your receipt
of confidential treatment for specific rates used to calculate your license fees under your license, manufacturing and development
agreements, investors are entitled to an understanding of the material terms of each of your material agreements. Please revise
your disclosure to provide a range of potential rates for the license fees the parties may be obligated to pay under these agreements.
Please ensure that your disclosed range is within a ten per-cent range (e.g. “10-20%”, “single-digits”,
“twenties”, as applicable). Please note that we are requesting disclosure of the range of potential license fees not
disclosure of specific rates.
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-5-
RESPONSE.
The
Company will add the range of rates as requested.
COMMENT
NO. 5.
Form 10-Q for the Quarterly Period Ended June
30, 2015
Notes to Condensed Consolidated Financial Statements
Note 12 – Collaborative Agreement with Epic
Pharma LLC, page F-12
5. Refer to your response to our prior comment 9. Please address the following
additional comments:
· Tell us why you do not appear to identify the exclusive license to market
and sell ELI-200 in the U.S. as a deliverable under your agreement with Epic.
· Tell us whether this license was conveyed to Epic upon execution of the
agreement on June 4, 2015 and, if not, tell us when the license was or will be conveyed.
· Although your prior research and development activities associated with
ELI-200 reasonably contributed to the value inherent in the rights to ELI-200 and your ability to license these rights to Epic,
explain how the past research and development activities are a deliverable and have standalone value to Epic. In this regard, as
Epic only has license rights to market and sell ELI-200 it appears that the license rights are dependent upon the success of your
future development services.
· Tell us whether and how Epic can exploit its license rights prior to regulatory
approval of ELI-200. Tell us whether Epic can sell its license to someone else or whether it can sublicense the rights.
· Provide us proposed revised disclosure to be included in future periodic
reports that describes your accounting for the agreement in accordance with ASC 605-25. Disclose the significant deliverables within
the arrangement, the timing of delivery, the performance provisions, and whether and how separate units of accounting were identified
as stipulated in ASC 605-25-50-2. In that regard, your current disclosure appears to follow disclosure requirements of ASC 605-28.
165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
-6-
RESPONSE
The
Company has investigated the matters raised in the Commission’s comment letter and during our conversations with the Staff
and has determined that restatement of the Current Reports on Form 10-Q for the quarters ended June 30, 2015 and September 30,
2015 are required due to an error in accounting that was made with respect to the recording of the license fee received pursuant
to the collaborative agreement with Epic Pharma LLC. Item 4.02 of Form 8-K was filed on December 4, 2015 and we are preparing the
required forms 10-Q/A.
The
Company’s discovery of the accounting error and determination of the proper accounting was based on the following analysis:
Deliverable Elements
Based on the Agreement and the guidance
noted in:
· Accounting Standards Codification 605-25, Revenue Recognition – Multiple Element Arrangements
(“ASC 605-25”)
· E&Y Revenue Recognition – Multiple E
2015-12-09 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720
December 9, 2015
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Item 4.02 Form 8 -K
Filed December 4 , 201 5
File No. 001-15697
Dear Mr. Ward :
We have reviewed your filing and have the following comments .
Please r espond to th ese comments within five business days by providing the requested
information and amending your filing or advis e us as soon as possible when you will
respon d. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the amendment to your filing and your response to these comments, we
may have additional comments.
Item 4.0 2 - Nonreliance on Previously Issued Financial Statements
1. Please amend your filing to d isclose when you concluded that your financial statements
could no longer be relied upon. Refer to Item 4.02(a).
2. Please include your SAB 99 and SAB 108 analyses of the impact of adjustments related
to the change in accounting for your convertible pr eferred stock in previously issued
annual and interim financial statements in your response to our letter dated November 20,
2015.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that th e filing includes the information the Securities Exchange Act of
Mr. Carter J. Ward
Elite Pharmaceuticals , Inc.
December 9 , 2015
Page 2
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accur acy
and adequacy of the disclosures they have made.
In responding to our comments, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commis sion or any person under the federal securities laws of the United States.
If you have any ques tions, please call Rolf Sundwall at (202) 551 -3105 .
Sincerely,
/s/ Sharon Blume
Sharon Blume
Accounting Branch Chief
Office of Healthcare and Insurance
2015-12-04 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
December 4, 2015
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Jim B. Rosenberg
Re: Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended
March 31, 2015
Filed June 15, 2015
Form 10-Q for the Quarterly Period
Ended June 30, 2015
Filed August 10, 2015
Form 10-Q/A for the Quarterly Period
Ended September 30, 2015
Filed November 10, 2015
File No. 001-15697
Dear Mr. Rosenberg:
Elite Pharmaceuticals, Inc. hereby acknowledges
receipt of the November 20, 2015 SEC Comment Letter regarding the above referenced periodic reports (the “Letter”).
As we have taken significant time reviewing
the comments in the Letter and are in the midst of preparing amendments to our Forms 10-Q for the periods ended June 30, 2015 and
September 30, 2015 and will need additional time to respond to the comments in the Letter, we hereby request that our time to respond
to the Letter be extended to December 21, 2015, 20 business days after the date of the Letter. At this time, we anticipate that
we will be able to respond to the Letter on or before the requested extension date.
If you have any questions or comments or
are unable to so extend our time to respond, please contact the undersigned at the above address.
Very truly yours,
/s/ Carter Ward
Carter Ward, CFO
165 Ludlow Avenue •
Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
2015-11-23 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720
November 20, 2015
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10 -Q for the Quarter ly Period Ended June 30, 2015
Filed August 10, 2015
Form 10 -Q/A for the Quarterly Period Ended September 30, 2015
Filed November 10, 2015
File No. 001 -15697
Dear Mr. Ward:
We have reviewed your October 26, 2015 res ponse to our comment letter and have the
following comments. In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
Please respond to this letter within 10 business days by providing the requested
information or advis e us as soon as possible when you will respond . If you do not believe a
comment applies to your facts and circumstances, please tell us why in your respo nse.
After reviewing your response to these comments, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
September 25, 2015 letter.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F -11
1. Refer to our prior comment 2. Please revise your proposed disclosures to discuss your
allocation of arrangement consideration to the separate units of accounting. In this
regard, revise your policy that indicates that revenue is recognized when “fair val ue can
be determined” to indicate that arrangement consideration is allocated at the inception of
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 2
the arrangement based on relative selling prices. See ASC 605 -25-30-2. Include a
discussion of the significant factors, inputs, assumptions and methods used to determine
selling price for the significant deliverables under multiple -element revenue
arrangements, including whether the determination was based on vendor -specific
objective evidence, third party evidence or best estimate of selling price. Refer to ASC
605-25-50-2(e).
Note 4 – Intangible Assets, page F -14
2. Refer to your response to our prior comment 3. It appears that your direct experience
with the products related to your ANDA’s is limited, with four products launched during
2015. Please provid e your analysis of known or foreseeable obsolescence, demand,
competition or other economic factors that would support your assertion that the ANDA’s
have indefinite lives. Include in your response the date of FDA approval for the branded
product the ANDA is based on, the date the product became generic, the treatment
indication, and other factors supporting your conclusions. Also, please confirm whether
any capitalized patent costs are related to the ANDA assets.
Note 20 – Concentrations, page F -32
3. Refer to your response to our prior comment 7. It appears that your revenue related to
NDA’s is due to the Epic Collaborative Agreement and that you do not currently have
any NDA product sales. Please provide us proposed disclosure to be included in futu re
periodic reports of your revenue by product or group of products as required by ASC
280-10-50-40, or explain to us why it is impractical to do so. Additionally, please revise
your proposed disclosure to clarify whether you manage your business as one s egment or
if the disaggregation of revenues between NDA and ANDA products represents two
reportable segments.
Note 22 – Related Party Transaction – Manufacturing and License Agreement with Epic Pharma
LLC, page F -34
4. Refer to your response to our prior comment 8. Notwithstanding your receipt of
confidential treatment for specific rates used to calculate your license fees under your
license, manufacturing and development agreements, investors are entitled to an
understanding of the material terms of each of your material agreements. Please revise
your disclosure to provide a range of potential rates for the license fees the parties may be
obligated to pay under these agreements. Please ensure that your disclosed range is
within a ten per -cent range (e.g . “10 -20%”, “single -digits”, “twenties”, as applicable).
Please note that we are requesting disclosure of the range of potential license fees not
disclosure of specific rates.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 3
Form 10-Q for the Quarterly Period Ended June 30, 2015
Notes to Condense d Consolidated Financial Statements
Note 12 – Collaborative Agreement with Epic Pharma LLC , page F-12
5. Refer to your response to our prior comment 9. Please address the following additional
comments:
Tell us why you do not appear to identify the exclusive license to market and sell
ELI-200 in the U.S. as a deliverable under your agreement with Epic.
Tell us whether this license was conveyed to Epic upon execution of the agreement
on June 4, 2015 and, if not, tell us when the license was or will be conveyed .
Although your prior research and development activities associated with ELI -200
reasonably contributed to the value inherent in the rights to ELI -200 and your ability
to license these rights to Epic, explain how the past research and development
activities are a deliverable and have standalone value to Epic. In this regard, as Epic
only has license rights to market and sell ELI -200 it appears that the license rights are
dependent upon the success of your future development services.
Tell us wheth er and how Epic can exploit its license rights prior to regulatory
approval of ELI -200. Tell us whether Epic can sell its license to someone else or
whether it can sublicense the rights.
Provide us proposed revised disclosure to be included in future peri odic reports that
describes your accounting for the agreement in accordance with ASC 605 -25.
Disclose the significant deliverables within the arrangement, the timing of delivery,
the performance provisions, and whether and how separate units of accounting were
identified as stipulated in ASC 605 -25-50-2. In that regard, your current disclosure
appears to follow disclosure requirements of ASC 605 -28.
Form 10-Q/A for the Quarterly Period Ended September 30, 2015
Notes to Condensed Consolidated Financial S tatements
Note 12 – Reclassification of Convertible Preferred Shares, page F -13
6. We acknowledge your response to our prior comments 4 and 5 and note the change of
accounting highlighted in this footnote. Your change in accounting for your convertible
preferred shares represent s the correction of an error rather than a reclassification as a
reclassification is limited to changing from one generally accepted presentation to
another. As a result, please address the following:
Please file an Item 4.02 Form 8-K highlighting the restatement of your March 31,
2015 Form 10 -K and Forms 10 -Q for the quarterly periods ended September 30,
2014, December 31, 2014 and June 30, 2015 or explain to us why such filing s are
not required.
Please file amendments to your Marc h 31, 2015 Form 10 -K and Forms 10 -Q for
the quarterly periods ended September 30, 2014, December 31, 2014 and June 30,
2015 reflecting the restatement of your financial statements.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 4
For each of the amendments identified in the previous bullet point, please ensure
you label each column in your basic financial statements that reflect restated
amounts as being “restated.”
Please file an amendment to your September 30, 2015 Form 10 -Q to include
disclosure of the impact to the June 30, 2015 financial statements a s required by
ASC 250 -10-50-11.
Please have your auditors update their opinion on the audit of your March 31,
2015 and 2014 financial statements included in your amended Form 10 -K for
March 31, 2015.
In each of the amendments identified above, please ensur e you address the
following:
o Revise your disclosure to indicate that you carry your convertible preferred
stock at the maximum redemption amount not its fair value and that the
associated change in carrying value is not a change in fair value. Also,
indic ate that increases in redemption value are charged to retained earnings or
to additional paid -in capital in the absence of retained earnings. See ASC
480-10-S99-3A.14.
o Disclose the terms, preferences and conversion features of your convertible
preferred s tock as originally requested in our prior comment 4.
o Revise your report on internal controls over financial reporting to address the
cause of the restatement for the periods presented .
You may contact Rolf Sundwall, Staff Accountant , at (202) 551 -3105 or Mark
Brunhofer, Senior Staff Accountant, at (202) 551 -3638 if you have any 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
2015-10-26 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
October 26, 2015
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10-Q for the Quarterly Period Ended June 30, 2015
Filed August 10, 2014
File No. 001-15697
Dear Mr. Rosenberg:
Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the comments contained in your September 25, 2015 comment letter concerning the above referenced Company filings.
Headings and comment numbers below correspond to the headings and comment numbers in the comment letter.
COMMENT NO. 1.
Form 10-K for the Fiscal Year Ended March 31, 2015
Research and Development, page 12
1. Notwithstanding your policy not to
disclose research and development activities for competitive reasons, we believe disclosing information about each of your key
development programs is important to an understanding of your operations and prospects. In this regard, we realize that you disclose
some information about your development projects on your website. Please provide us proposed disclosure to be included in Business
and MD&A in future periodic reports that provides the following information for each of your key research and development projects:
· The current status of the project;
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
· The costs incurred during each period presented and to date on the project;
· The anticipated completion dates;
· The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial
position and liquidity if the project is not completed timely; and finally
· The period in which material net cash inflows from significant projects are expected to commence.
If you do not track your research and development
costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by
project. Provide other quantitative or qualitative disclosure that indicates the amount of your resources being used on the project.
Regarding anticipated completion dates, disclose the amount or range of estimated costs and timing to complete the phase in process
and each future phase. To the extent that information is not estimable, disclose those facts and circumstances indicating the uncertainties
that preclude you from making reasonable estimate.
RESPONSE.
The
Company plans to include the following discussion in future periodic reports.
Research
and Development
Elite’s
research and development activities are primarily focused on developing its proprietary abuse deterrent technology and the development
of a range of abuse deterrent opioid products that utilize this technology.
Elite’s
proprietary abuse-deterrent technology, utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate
capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol
dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased
while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate
beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is
intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing
the incentive for abuse or misuse by recreational drug abusers.
The
first product to utilize our abuse deterrent technology, ELI-200, has successfully completed Phase III studies, and, subject to
the risks described below, the Company believes that it will be able to file a New Drug Application (“NDA”) with the
FDA during this fiscal year. The Company believes that, when this application is accepted by the FDA and subject to the risks described
below, it will be granted expedited review by the FDA, and accordingly believes that any such approval could be received during
the fiscal year ended March 31, 2017.
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
The
Company believes that the abuse deterrent technology can be applied to and incorporated into a wide range of opioids used today
for pain management and has, to date, identified 10 additional products for potential development. All of these products are at
early stages of development, with research and development activities mainly consisting of in-house process development and laboratory
studies. Extensive efficacy and safety studies, similar to those conducted for ELI-200 have not yet been conducted for these other
products. As a result, costs incurred in relation to the development of these 10 products have not been material.
Research
and development costs were $xxx million, $14.8 million, and $4.0 million for the fiscal years ended March 31, 2016, 2015 and 2014,
respectively, with such costs relating almost entirely to the development of ELI-200, the first product developed by Elite that
incorporates the technology. [to be revised based upon the historical facts when the 2016 financial statements are prepared]
On
June 4, 2015, the Company entered into a sales and distribution licensing agreement which included a payment of $5 million to Elite
for prior research and development activities, with such representing the first material net cash inflows being generated by ELI-200.
The agreement also includes an additional $10 million to be paid upon the filing with and approval by the FDA of the NDA, and license
fees based on the commercial sales achieved by ELI-200, once marketing authorization has been granted by the FDA. Please note,
as further detailed below, there can be no assurances of the Company filing an NDA and receiving marketing authorization for ELI-200,
and accordingly, there can be no assurances that the Company will earn and receive the additional $10 million or future license
fees. If the Company does not receive these payments or fees, it most likely will materially adversely affect our financial condition.
Please
note that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently
requests that additional information be submitted. The effect of such request and subsequent submission can significantly extend
the time for the NDA review process. Until an NDA is actually approved, there can be no assurances that the information requested
and submitted will be considered adequate by the FDA to justify approval. The packaging and labeling of our developed products
are also subject to FDA regulation. Based on the foregoing, it is impossible to anticipate the amount of time that will be needed
to obtain FDA approval to market any product. In addition, there can be no assurances of the Company filing the required application(s)
with the FDA or of the FDA approving such application(s) if filed, and the Company’s ability to successfully develop and
commercialize products incorporating its abuse deterrent technology is subject to a high level of risk as detailed in “Item
1A-Risk Factors-Risks Related to our Business” of this Annual Report on Form 10-K.
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
COMMENT NO. 2.
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F-11
2. Please provide us proposed revised
disclosure to be included in future periodic reports that clarifies how you apply the guidance in ASC 605-25, Multiple-Element
Arrangements, in recognizing revenue under your various licensing, manufacturing and
development agreements.
RESPONSE.
The
Company will add the following disclosure to the Revenue Recognition section of the Summary of Significant Accounting Policies
footnote:
“The
Company enters into licensing, manufacturing and development agreements which may include multiple revenue generating activities,
including, without limitation, milestones, license fees, product sales and services. These multiple elements are assessed in accordance
ASC 605-25 Revenue Recognition for Multiple-Element Arrangements in order to determine whether particular components of
the arrangement represent separate units of accounting.
An
arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value
to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in control of the Company.
The
Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s)
have stand-alone value and the fair value can be determined, with the arrangement being accordingly accounted for as a separate
unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, or if the fair value cannot
be determined, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue
over the estimated period of when performance obligations relating to the item(s) will be performed.
Whenever
the Company determines that an arrangement should be accounted for as a single unit of accounting, we determine the period over
which the performance obligations will be performed and revenue will be recognized. If we cannot reasonably estimate the timing
and the level of effort to complete our performance obligations under a multiple-element arrangement, revenues are then recognized
on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.”
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
COMMENT NO. 3.
Note 4 – Intangible Assets, page F-14
3. You disclose that you begin
amortization of your ANDA and patent intangibles upon receipt of approval of site transfers and the patent, respectively. Please
tell us why you have not amortized any of your intangible assets when, at a minimum, it appears that you have 10 issued patents
as disclosed on page 13 and that two of the products that appear to be included in your ANDA intangible (Phentermine HCl 37.5mg
tablets and Phendimetrazine Tartrate 35mg tables) were launched in April 2011 and November 2012, respectively, based on information
in the table on page 5. In your response, please provide the following information for your ANDA intangible assets:
· The name of each asset;
· The amount capitalized for each asset;
· The date of acquisition;
· The date of receipt of approval of site transfer (if applicable);
· The date of your product launch (if applicable); and
· The effective date of any manufacturing agreements with other parties to produce the product (including
those agreements to produce product only until you receive regulatory approval on site transfer).
RESPONSE.
Intangible Assets – ANDA’s
The
Company believes that the ANDA’s are indefinite lived assets, with amortization not permitted, as per ASC-350-30-35-1.
ASC
350-30-35-1 requires that the accounting for a recognized intangible be based on its useful life, with those intangibles with
indefinite useful lives not being amortized.
The
Company defines the useful life of an intangible asset to be the period over which the asset is expected to contribute directly
or indirectly to future cash flows, in accordance with ASC-350-30-35-2.
The
Company has determined that the ANDA’s have an indefinite life, with such determination including analysis of the following
pertinent factors:
a. The Company has expectations of the ongoing and continued
use of the assets, with no foreseeable period of discontinuance (ASC 350-30-35-3a).
b. Other assets or groups of assets to which the respective
ANDA’s may relate have no known or foreseeable limitations to useful life (ASC-350-30-35-3b).
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
c. ANDA’s have no expiration date or renewal requirements
and there are no other known or foreseeable legal, regulatory or contractual provisions that may limit useful life (ASC-350-30-35-3c
and ASC-350-30-35-3d).
d. The Company knows of no known or foreseeable obsolescence,
demand, competition or other economic factors, such as known technological advances, legislative actions, changes in regulatory
environments or changes in distribution channels, that would result in a limitation of useful life (ASC-305-35-3e).
e. The extent of maintenance expenditures required to obtain
future cash flows from the ANDA’s are minimal and insignificant for the foreseeable future (ASC-305-35-3f).
ASC
350-30-35-4 further stipulates that if there are no legal, regulatory, contractual, competitive, economic, or other factors
that limit the useful life of an intangible asset for a period that extends beyond the foreseeable horizon, than the useful life
of the intangible assets is indefinite.
The
ANDA’s are accordingly determined to be indefinite lived assets, with amortization not permitted, as per ASC-350-30-35-1.
The
Company will revise disclosures in future periodic reports to reflect the foregoing.
Please
also find the following information requested in your correspondence:
Name of ANDA
Amount
Capitalized
Acquisition
Site
Transfer
Approval
Product
Launch
Agreement
to Produce
the Product
Phentermine 37.5mg
450,000
Sept 2010
April 2011
April 2011
Sept 2010
Isradipine 2.5mg and 5mg
1,063,374
Aug 2013
Jan 2015
Jan 2015
Oct 2013
Phendimetrazine 35mg
206,088
Aug 2013
n/a
Nov 2012
Oct 2013
Hydroxyzine 10mg
129,824
Aug 2013
April 2015
April 2015
Oct 2013
Hydroxyzine 25mg
434,784
Aug 2013
April 2015
April 2015
Oct 2013
Hydroxyzine 50mg
222,867
Aug 2013
April 2015
April 2015
Oct 2013
7 Undisclosed Generics
3,540,379
Aug 2013
n/a
n/a
Oct 2013
Intangible
Assets – Patents
Intangible
assets relating to patents are amortized over the useful life of the patent, in accordance with subtopic ASC-350-30.
The
useful life of the patents are determined by the period over which the patent is expected to contribute to the future cash flows
of the Company (ASC-350-30-35-2). The Company estimates the useful life of the patents based on an analysis of those pertinent
factors detailed in subtopic ASC-350-30-35-3, as follows:
165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com
a. The expected use of the patents are determined as the period
during which the rights granted by our patents have utility to Elite (ASC-350-30-35-3a). The rights granted by patents,
which are defined in the U.S. Constitution and further clarified in judicial rulings and regulations, allow Elite to exclude others
from commercializing drugs covered by our patents, but have no application to research and development or preparation of FDA filings,
whether such activities are conducted by Elite or by third parties.
Article
1 Section 8 Clause 8 of the United States Constitution states: “To promote the Progress of Science and useful Arts, by
2015-10-07 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
October 7, 2015
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attn: Jim B. Rosenberg
Re:
Elite Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10-Q for the Quarterly Period Ended June 30, 2015
Filed August 10, 2014
File No. 001-15697
Dear Mr. Rosenberg:
Elite Pharmaceuticals, Inc. hereby acknowledges
receipt of the September 25, 2015 SEC Comment Letter regarding the above referenced periodic reports (the “Letter”).
As we are in the midst of closing the most
recent quarter and preparing the requisite Form 10-Q and will need additional time to respond to the comments in the Letter, we
hereby request that our time to respond to the Letter be extended to October 26, 2015, 20 business days after the date of the Letter.
At this time, we anticipate that we will be able to respond to the Letter on or before the requested extension date.
If you have any questions or comments or
are unable to so extend our time to respond, please contact the undersigned at the above address.
Very truly yours,
s/Carter Ward
Carter Ward, CFO
2015-09-25 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 4720
September 25, 2015
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10 -Q for the Quarter ly Period Ended June 30, 2015
Filed August 10, 2014
File No. 001 -15697
Dear Mr. Ward:
We have limited our review to only your financial statements and related disclosures and
have the following comments . In some of our comment s, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter within 10 business days by providing the requested
information or by advising us when you will provide the requested re sponse. If you do not
believe a c omment appl ies to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP th at keys your
response s to our comment s.
After reviewing the information you provide, we may have additional comments and/or
request that you amend your filing.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Research and Development, page 12
1. Notwithstanding your policy not to disclose research and development activities for
competitive reasons, w e believe disclosing information about each of your key
development programs is important to an understanding of your operations and prospects.
In thi s regard, we realize that you disclose some information about your development
projects on your website. Please provide us proposed disclosure to be included in
Business and MD&A in future periodic reports that provides the following information
for each of your key research and development projects:
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 2
The current status of the project;
The costs incurred during each period presented and to date on the project;
The anticipated completion dates;
The risks and uncertainties associated with completing development on schedule, and
the consequences to operations, financial position and liquidity if the project is not
completed timely; and finally
The period in which material net cash inflows from significant projects are expected
to commence.
If you do n ot track your research and development costs by project, please disclose that
fact and explain why you do not maintain and evaluate research and development costs
by project. Provide other quantitative or qualitative disclosure that indicates the amount
of your resources being used on the project. Regarding anticipated completion dates,
disclose the amount or range of estimated costs and timing to complete the phase in
process and each future phase. To the extent that information is not estimable, disclo se
those facts and circumstances indicating the uncertainties that preclude you from making
a reasonable estimate.
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F -11
2. Please prov ide us proposed revised disclosure to be included in future periodic reports
that clarifies how you apply the guidance in ASC 605 -25, Multiple -Element
Arrangements, in recognizing revenue under your various licensing, manufacturing and
development agreemen ts.
Note 4 – Intangible Assets, page F -14
3. You disclose that you begin amortization of your ANDA and patent intangibles upon
receipt of approval of site transfers and the patent, respectively. Please tell us why you
have not amortized any of your intangi ble assets when, at a minimum, it appears that you
have 10 issued patents as disclosed on page 13 and that two of the products that appear to
be included in your ANDA intangible (Phentermine HCl 37.5mg tablets and
Phendimetrazine Tartrate 35mg tables) were launched in April 2011 and November 2012,
respectively, based on information in the table on page 5. In your response, please
provide the following information for your ANDA intangible assets:
The name of each asset;
The amount capitalized for each asset;
The date of acquisition;
The date of receipt of approval of site transfer (if applicable);
The date of your product launch (if applicable); and
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 3
The effective date of any manufacturing agreements with other parties to produce the
product (including t hose agreements to produce product only until you receive
regulatory approval on site transfer).
Note 13 – Derivative Liabilities – Preferred Shares, page F -22
4. Please provide us proposed disclosure to be included in future periodic reports describing
the terms, preferences and conversion features of your Series I Preferred Stock. Refer to
ASC 505 -10-50, primarily 50 -3 and 50 -4.
5. Please provide your analysis supporting derivative liability treatment for each of your
series of preferred stock, referencing for us the authoritative literature you relied upon to
support your accounting. In your response, please also address the following specific
questions:
Tell us why you do not bifurcate the embedded conversion features from your host
preferred stock. If you elected to account for the entire hybrid instruments at fair
value under ASC 815 -15-25-4 through 25 -6, tell us your consideration of the
prohibition to reflect equity instruments under this fair value election stipulated in
ASC 815 -15-25-6 and ASC 825 -10-50-8i.
Tell us whether, and explain why, each series of preferred stock as the host
instrument is akin to debt or equity in assessing the clearly -and-closely related
criterion of ASC815 -15-25-1a. See ASC 815 -15-25-16 through 25 -51A.
Note 20 – Concen trations, page F -32
6. Please provide us proposed revised disclosure to be included in future periodic reports
that quantifies the amount of revenue earned by each of your major customers; those
defined as comprising more than 10% of your total revenues. Se e ASC 280 -10-50-42.
7. Please provide us proposed disclosure to be included in future periodic reports of your
revenue by product or group of products as required by ASC 280 -10-50-40.
Note 22 – Related Party Transaction —Manufacturing and License Agreement w ith Epic Pharma
LLC, page F -34
8. Please provide us proposed revised disclosure to be included in future periodic reports
that describes each substantive milestone and the related contingent consideration as well
as the range of royalty and gross profit rates used to calculate your license fees under the
agreement. Please provide this information for each licensing, manufacturing and
development agreement you describe beginning on page 9. If the agreements are not
significant, please disclose the amount s in the aggregate. Refer to ASC 605 -28-50-2b.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 4
Form 10 -Q for the Quarterly Period Ended June 30, 2015
Notes to Condensed Consolidated Financial Statements
Note 12 – Collaborative Agreement with Epic Pharma LLC, page F -12
9. You disclose that all mileston es under the Epic Collaborative Agreement are substantive
and that you recognized $5 million of these in the first quarter of 2015. Please tell us the
triggering event(s) that resulted in the recognition of this $5 million and why immediate
recognition wa s appropriate. In this regard , it appears from disclosure in Note 28 on page
F-39 of your 2015 Form 10 -K that your first milestone payment was due and received
upon signing of the agreement, which does not appear to meet the significant uncertainty
criter ion at contract inception under the definition of milestones in ASC 605 -28-20.
Reference for us the specific authoritative literature you relied upon to support your
accounting.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include all information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a compa ny’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comment s, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing s;
staff comment s or changes to disclosu re in response to staff comment s do not foreclose
the Commission from taking any action with respect to the filing s; and
the compa ny may not assert the staff comment s as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
You may contact Rolf Sundwall, Staff Accountant, at (202) 551 -3105 or Mark
Brunhofer, Senior Staff Accountant, at (202) 551 -3638 if you have any 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
2014-04-28 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
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ELITE PHARMACEUTICALS, INC.
165 Ludlow Avenue
Northvale, NJ 07647
April 28, 2014
Jeffrey P. Riedler, Esq.
Assistant Director
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20002
Re:
Elite Pharmaceuticals, Inc.
Registration Statement now on Form S-1
SEC filing No. 333-195265
Dear Mr. Riedler:
Elite Pharmaceuticals, Inc. (“Elite”)
hereby requests, pursuant to Rule 461 of Regulation C, that the effective date of the above referenced Registration Statement be
accelerated so that it is declared effective at 4:00 p.m. on April 30, 2014 or as soon thereafter as practicable.
Elite acknowledges that the disclosure in
the filing is the responsibility of Elite.
Elite also represents to the Commission
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 and Elite represents that it will not assert Staff comments or
this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Elite further acknowledges, that the action
of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective does not relieve Elite
from its full responsibility for the adequacy and accuracy of the disclosures in the filing.
Very truly yours,
ELITE PHARMACEUTICALS, INC.
By:
s/ Carter J. Ward
Carter J. Ward
Chief Financial Officer
2014-04-28 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
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RICHARD FEINER
ATTORNEY AT LAW
381 Park Avenue South
Of Counsel
16th Floor
Silverman Shin
New York, New York 10016
Byrne & Gilchrest PLLC
(212) 779-8600
Fax: (917) 720-0863
E-Mail RFeiner@Silverfirm.com
April 28, 2014
Jeffrey Riedler
Assistant Director
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Elite Pharmaceuticals, Inc./NV
Registration Statement on Form S-3 (the “Registration Statement”)
Filed April 15, 2014
SEC filing No.
333-195265
Dear Mr. Riedler:
On behalf of Elite Pharmaceuticals, Inc.
(the "Company"), I file herewith Amendment No. 1 to the Registration Statement, which Amendment No. 1 is filed on Form
S-1 (the “Amendment”), and I hereby respond to the comments contained in your April 17, 2014 comment letter.
Comment No. 1:
1. We note that you do not appear eligible to use Form S-3 for this offering pursuant to General Instruction
I.A.5 to Form S-3. Please either convert your registration statement to Form S-1 or provide an analysis as to your eligibility
to use Form S-3 in light of your stated default under the NJEDA bonds.
Response: The Company has amended
the Registration Statement and the Amendment filed herewith is on Form S-1.
Elite Pharmaceuticals, Inc.
April 28, 2014
Page 2
Comment No. 2:
2. It appears that you have a pending request for confidential treatment in connection with an application
filed November 18, 2013. We are currently processing this request and will issue comments, if any, to you in a separate letter.
Please be advised that we will not be in a position to consider a request for acceleration of effectiveness of the registration
statement until we resolve all issues concerning the confidential treatment request.
Response: All issues raised by the Staff related to the confidential treatment request filed November 18, 2013 have been resolved and the Commission issued an order granting confidential treatment on April 28, 2014.
As required, if and when the Company requests
acceleration of the effective date of the Registration Statement, the Company will, at that time, acknowledge that:
· should the Commission or the staff, acting pursuant to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure
in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in
any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions or comments with
regard to the filing, please contact me at the above address.
Very truly yours,
/s/ Richard Feiner
Richard Feiner
2014-04-17 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
April 17, 2014 Via E -mail Mr. Nasrat Hakim Chief Executive Officer Elite Pharmaceuticals , Inc. 165 Ludlow Avenue Northvale, New Jersey 07647 Re: Elite Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed April 1 5, 201 4 File No. 333-195265 Dear Mr. Hakim : We have limited our review of your registration statement to the issue s we have addressed in our comment s. Please respond to this letter by amending your registration statement and providing the requested information . Where 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 revi ewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Registration Statement on Form S -3 1. We note that you do not appear eligible to use Form S -3 for this offering pursuant to General Instruction I.A.5 to Form S -3. Please either convert your registration statement to Form S-1 or provide an analysis as to your eligibility to use Form S -3 in light of your stated default under the NJEDA bonds. Pending Confidential Treatment Application 2. It appears that you have a pending request for confidential treatment in connection with an application filed November 18, 2013. We are currently processing this request and will issue comments, if any, to you in a separate letter. Please be advised that we will not be in a position to consider a request for acceleration of e ffectiveness of the registration statement until we resolve all issues concerning the confidential treatment request. Mr. Nasrat Hakim Elite Pharmaceuticals, Inc. April 17, 2014 Page 2 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing inclu des 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 s, in the event you request accelera tion 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 pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness 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 acceler ation 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 John Krug at (202) 551 -3262 , Dan Greenspan, Branch Chief, at (202) 551-3623, or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Richard Feiner , Esq.
2012-02-13 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
February 13, 2012 Via E-mail Mr. Jerry Treppel Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Form 10-K for the Year Ended March 31, 2011 Filed June 29, 2011 File No. 001-15697 Dear Mr. Treppel: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-01-31 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
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January 30, 2012
Gus Rodriguez
Accounting Branch Chief
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Elite Pharmaceuticals, Inc.
Form 10-K for the Year Ended March 31, 2011
SEC filing No. 001-15697
Dear Mr. Rodriguez:
On behalf of Elite Pharmaceuticals,
Inc. (the "Company"), I hereby respond to the comments contained in your January 20, 2012 comment letter.
Comment No. 1:
General
1. You disclose on page 6 that on March 3, 2011, the U.S. Food and Drug Administration announced its
intention to remove approximately 500 cough/cold and allergy related products from the U.S. market, including the Lodrane products
which were responsible for 97% and 100% of your revenues for Fiscal 2011 and Fiscal 2010, respectively. We note that the FDA began
its Unapproved Drug Initiative in June 2006. Prior to this March 3, 2011 announcement, however, it does not appear that you disclosed
the potential risk that these unapproved drugs may be removed from the market. Given your substantial dependence on unapproved
products, please advise us why you believe that this additional disclosure was not necessary in your filings prior to the March
3, 2011 announcement.
Response: Elite consistently
has provided risk factors regarding the regulatory risk inherent with a pharmaceutical product. The following risk factor was in
our annual report on form 10-K covering the period April 1 2006 to March 31, 2007. This risk factor continues to be disclosed in
our relevant SEC filings through the date hereof.
Even after regulatory approval,
we will be subject to ongoing significant regulatory obligations and oversight.
Even if regulatory approval is
obtained for a particular product candidate, the FDA and foreign regulatory authorities may, nevertheless, impose significant restrictions
on the indicated uses or marketing of such products, or impose ongoing requirements for post-approval studies. Following any regulatory
approval of our product candidates, we will be subject to continuing regulatory obligations, such as safety reporting requirements,
and additional post-marketing obligations, including regulatory oversight of the promotion and marketing of our products. If we
become aware of previously unknown problems with any of our product candidates here or overseas or at our contract manufacturers’
facilities, a regulatory agency may impose restrictions on our products, our contract manufacturers or on us, including
requiring us to reformulate our products, conduct additional clinical trials, make changes in the labeling of our products,
implement changes to or obtain re-approvals of our contract manufacturers’ facilities or withdraw the product from the
market. In addition, we may experience a significant drop in the sales of the affected products, our reputation in the marketplace
may suffer and we may become the target of lawsuits, including class action suits. Moreover, if we fail to comply with applicable
regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure
of products, operating restrictions and criminal prosecution. Any of these events could harm or prevent sales of the affected products
or could substantially increase the costs and expenses of commercializing and marketing these products. (Emphasis added)
When Elite becomes aware of a potential
issue it discloses the issue. In this regard, we disclosed a risk about the FDA rejection of one of the raw materials for Lodrane.
The FDA rejected a lot of raw material in May 2010 and we reported that rejection in our next scheduled report (form 10-K for the
fiscal year ended March 31, 2010). In addition, we disclosed in a risk factor that if this continued, it could stop Elite from
manufacturing the Lodrane Products (as defined below). This risk factor was added in the annual report on form 10-K covering the
period April 1, 2009 to March 31, 2010 and continues to be disclosed in our relevant SEC filings through the date hereof.
We are dependent on a small
number of suppliers for our raw materials and any delay or unavailability of raw materials can materially adversely affect our
ability to produce products.
We have recently experienced delays
when passing imported raw materials through customs. We have also had a shipment for one of the imported raw materials used
to manufacture the products made for ECR Pharmaceuticals rejected at customs under Federal Drug & Cosmetic Act (FD&CA)
Sections 502(f)(1) and 801(a)(3). ECR Pharmaceuticals is responsible for the regulatory matters related to these products.
We have notified ECR Pharmaceuticals and they have initiated a discussion with the FDA. If rejection of this raw material
at customs continues, it could prevent us from manufacturing these products. (Emphasis added)
On March 4, 2011, one day after the
FDA stated its intention to remove the 500 products, Elite issued a press release and filed an 8-K disclosing the FDA’s intentions.
The risk and effects of this event have been included in every relevant report filed with the SEC since that date.
Please note that neither we nor, to
our knowledge, ECR, who is our partner and the company that drug listed this product, ever received any direct formal communication
from the FDA regarding a potential issue that might cause the removal of these formally drug listed products or the hundreds of
other similar long marketed products. ECR notes that similar and related products to the Lodranes had been marketed for more than
50 years with minimal comment and no action to cease marketing. This notice and prescribed action by the FDA was fully unexpected.
One would not reasonably expect the FDA to take action on an entire category of hundreds of antihistamine and antihistamine-decongestant
extended release drugs, whose components had been safely marketed for years. Functionally, this action left physicians and patients
without medications that had successfully treated their allergic condition.
An “Unapproved Drug” is a drug
not approved through either a New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”).
Lodrane is part of a category, generally described as DESI products, and IRS (identical, related or similar) products and refer
to a category of drugs that had been marketed before 1962. Hearings related to some of these were set in 1968 and these hearings
remained on the docket until January 2011. The FDA longstanding policy is that products subject to an ongoing DESI proceeding,
like the products in this category, may remain on the market while the proceeding is pending. Further, the FDA has taken the position
that absent a safety issue arising with these types of products or issuance of an NDA for these, the matter did not rise to a level
in which the Agency would use its resources to take action.
In 2006, the FDA disclosed an “Unapproved
Drug Initiative.” This Initiative did not appear to differ from the approach the FDA had taken historically with these products.
That is, the FDA continued to take a risk-based enforcement approach and said that it would concentrate its resources on those
products that posed the highest threat to public health and would not impose undue burdens on consumers and would not unnecessarily
disrupt the market. The FDA said they would focus on the following type of products:
Drugs with potential safety risks
Drugs that lack evidence of effectiveness
Health fraud drugs
Drugs that present direct challenges to the new
drug approval and OTC drug monograph systems
Unapproved new drugs that are also violative of
the Act in other ways
Drugs that are reformulated to evade an FDA enforcement
action
Until the FDA action in 2011, the FDA
only removed products in the following categories:
Products that had documented safety or poor adverse
event history such as carbinoxamine drug products, quinine sulfate drug products, cholchicine injectable products.
Products that competed with an approved drug such
as guaifenesin
Products that were determined not to be efficacious
such as tremethobenzamide HCl
Products with safety-related labeling issues such
as hydrocodone and ergotamine.
None of these categories apply to the
Lodrane Products. The Lodrane Products were officially drug listed with the FDA and the FDA was provided with labeling and product
information. The Lodrane Products had a sound safety record. Lodrane was efficacious; its antihistamine and decongestant ingredients
are listed in the FDA’s OTC Cough-Cold Monograph as safe and effective and the products are within the daily dosing specifications
listed in the Monograph. The Lodrane Products were manufactured in Elite’s FDA registered facility. This facility was routinely
inspected by the FDA and these Lodrane Products were reviewed without issue.
Furthermore, in 2010 ECR initiated discussions
with the FDA and began formalized IND applications for the Lodrane Products. This was proprietary information for ECR at the time
and therefore was not disclosed by Elite. However, we believe that ECR was intending to get an NDA approval for this product for
economic reasons - if the FDA approved the NDA, it would remove any similar products on the market for an exclusivity period as
was done with guaifenesin. Furthermore, ECR had expected that once this process was started, the FDA would allow this product to
remain on the market as along as ECR continued to move diligently forward to obtain the NDA. The FDA had previously provided a
pathway for Pancreatic Enzyme Replacement Therapy (PERT) drugs which had a similar regulatory status at the FDA to remain on the
market while additional work was being completed for the NDA. We expected that this further reduced any risk that the Lodrane Products
might be pulled off the market prior to obtaining the NDA.
In conclusion, as discussed above, when
Elite becomes aware of a potential issue it promptly discloses it. We disclosed in our regulatory filings the general risk that
the Lodrane Products could be taken off the market by the FDA. When we became aware of the FDA’s rejection of a raw material,
we promptly disclosed it. When we became aware of the FDA’s intention to remove the 500 products, we promptly disclosed it.
The FDA’s historical treatment of products such as Lodrane did not appear to create additional risk beyond what was disclosed.
Furthermore, the 2006 initiative did not appear to differ materially from the FDA’s historical treatment of these products
based on the description provided by the FDA and did not appear to create additional risk.
Comment No. 2:
Management’s Annual Report on Internal
Control over Financial Reporting, page 56
2. We note your statement that your management assessed the effectiveness of your internal control
over financial reporting as of March 31, 2011 and determined that there were material weaknesses. Please revise your disclosure
in future filings to state, if true, that your internal control over financial reporting was ineffective.
Response: The Company will revise
its disclosure in future filings to state, if true, that its internal control over financial reporting was ineffective.
The Company acknowledges that:
·
The Company is responsible for the adequacy and accuracy of the disclosures in the filing,
·
the 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.
The Company further acknowledges, that the action of the Commission or the staff, acting pursuant to delegated authority, in reviewing
the filing does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing.
If you have any questions or comments
with regard to the filing, please contact me at the above address.
Very truly yours,
/s/ Chris Dick
Chris Dick, President
2012-01-20 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
January 20, 2012 Via E-mail Mr. Jerry Treppel Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Form 10-K for the Year Ended March 31, 2011 Filed June 29, 2011 File No. 001-15697 Dear Mr. Treppel: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information so we may better underst and your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. General 1. You disclose on page 6 that on March 3, 2011, the U.S. Food and Drug Administration announced its intention to remove approxi mately 500 cough/cold and allergy related products from the U.S. market, including th e Lodrane products which were responsible for 97% and 100% of your revenues for Fis cal 2011 and Fiscal 2010, respectively. We note that the FDA began its Unapproved Dr ug Initiative in June 2006. Prior to this March 3, 2011 announcement, however, it doe s not appear that you disclosed the potential risk that these una pproved drugs may be removed from the market. Given your substantial dependence on unapproved products , please advise us why you believe that this additional disclosure was not necessary in your filings pr ior to the March 3, 2011 announcement. Mr. Jerry Treppel Elite Pharmaceuticals, Inc. January 20, 2012 Page 2 Management’s Annual Report on Internal C ontrol over Financial Reporting, page 56 2. We note your statement that your management assessed the effectiven ess of your internal control over financial reporting as of Marc h 31, 2011 and determined that there were material weaknesses. Please revise your disclosu re in future filings to state, if true, that your internal control over financ ial reporting was ineffective. 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. Please contact Kei Nakada, Staff Accountant, at (202) 551-3659 or Don Abbott, Senior Staff Accountant, at (202) 551-3608, if you have questions regarding the processing of your response as well as any questions regarding co mments on the financial statements and related matters. You may contact Mike Rosenthall, St aff Attorney, at (202) 551-3674 or Jennifer Riegel, Special Counsel, at (202) 551-3575 with ques tions on any of the other comments. In this regard, do not hesitate to contact me at (202) 551-3752. Sincerely, /s/ Gus Rodriguez Gus Rodriguez Accounting Branch Chief
2009-04-22 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Via Facsimile and U.S. Mail Mail Stop 6010 April 17, 2009 Mark I. Gittelman Chief Financial Officer and Treasurer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Item 4.01 Form 8-K filed February 19, 2009 Item 4.01 Form 8-K/A filed March 12, 2009 Item 4.01 Form 8-K/A filed April 14, 2009 File No. 1-15697 Dear Mr. Gittelman: We have completed our review of your Form 8-K and related filings and have no further comments at this time. S i n c e r e l y , S a s h a P a r i k h S t a f f A c c o u n t a n t
2009-04-14 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
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Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Tel: (201) 750-2646
April 14, 2009
AS FILED ON EDGAR AND
VIA FACSIMILE
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 6010
Washington, DC 20549
Attn: Sasha Singh Parikh, Staff Accountant
Re:
Elite Pharmaceuticals, Inc.
Item
4.01 - Form 8-K/A, filed March 12, 2009
File
No. 001-15697
Dear Ms. Parikh:
On
behalf of Elite Pharmaceuticals, Inc., a Delaware corporation (the “Company”),
please be advised that the undersigned has received and read your letter,
dated March 16, 2009, with regard to Item 4.01 of the Current Report on Form
8-K/A filed by the Company with the United States Securities and Exchange
Commission (the “Commission”) on March 12, 2009.
The Company hereby 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.
Of
course, if you should require any additional information or clarification,
please do not hesitate to contact the undersigned at (201) 367-7860.
Securities and Exchange Commission
April 14, 2009
Re: Elite Pharmaceuticals, Inc.
Page 2 of 2
Your assistance in this matter is greatly appreciated.
Sincerely,
ELITE PHARMACEUTICALS, INC.
By: /s/ Chris Dick
Name:
Chris Dick
Title:
Chief Operating Officer and
Acting Chief Executive Officer
cc: Mark Gittelman, Chief Financial Officer
2009-04-14 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
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April 14, 2009
AS FILED ON EDGAR AND
VIA FACSIMILE
Securities and Exchange Commission
Division of Corporation Finance
Attn: Sasha Singh Parikh, Staff Accountant
100 F Street, N.E., Mail Stop 6010
Washington, DC 20549
Re:
Elite Pharmaceuticals, Inc.
Item 4.01 of Form 8-K/A, filed March 12, 2009
File No. 001-15697
Dear Ms. Parikh:
On behalf of our client, Elite Pharmaceuticals, Inc., a Delaware corporation (the “Company”), we transmit simultaneously herewith
for filing under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), by means of the Electronic Data Gathering, Analysis, and Retrieval system, the Company’s
Form 8-K/A (the “Second Amended Filing”) amending the Form 8-K/A filed by the Company on March 12, 2009 (File No. 001-15697) (the “Amended
Filing”) which amended the Current Report on Form 8-K originally filed by the Company on February 19, 2009 (the “Original Filing”) and a separate
acknowledgement letter from the Company. All capitalized terms used, but not otherwise defined, herein shall have the respective definitions assigned thereto in the Second Amended Filing.
We are in receipt of your letter addressed to the Company, dated March 16, 2009 (the “Comment Letter”), which you sent on behalf of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). Set forth below is the response
of the Company to each of the comments set forth in the Comment Letter, numbered to correspond thereto.
Comment
Number
Response
to Comment
1.
On January 1, 2009, Miller
Ellin & Company, LLP (“Miller
Ellin”), the Company’s former
independent accountant, merged with and into Rosen Seymour Shapss Martin & Company LLP
(the “Merger”),
the Company’s current independent accountant (“Rosen
Seymour”). Upon the occurrence of
the Merger, Miller Ellin effectively resigned, and Rosen Seymour succeeded
Miller Ellin, as the Company’s independent accountant. The Company
has added a clarifying disclosure in the Second Amended Filing in accordance
with the foregoing, which is reproduced at the end of this response
for your convenience.
The Company also amended
its disclosure under Item 4.01 to disclose information regarding the
Merger provided to the Company by Rosen Seymour subsequent to the date
of filing of the Amended Filing. Specifically, the Company disclosed
in the Amended Filing, as advised by Rosen Seymour, that Rosen Seymour
was “the resulting surviving legal entity” of the Merger.
However, the Company has since been advised by Rosen Seymour that,
following the Merger, Miller Ellin actually continued, and continues,
to exist as a separate legal entity for certain specified purposes
agreed upon between Miller Ellin and Rosen Seymour pursuant to the
terms of their merger agreement, which do not involve the Company or
affect the disclosures made by the Company under Item 4.01 of Form
8-K. In light of the foregoing information, however, Company has amended
its disclosure by removing the language stating that Rosen Seymour
was “the resulting surviving legal entity” of the Merger
and replacing it with language that more accurately describes the effect
of the Merger on Miller Ellin and Rosen Seymour pursuant to the terms
of their agreement.
For your convenience, the Company has
reproduced below the first paragraph of the Second Amended Filing in
which the above described disclosures appear, with such disclosures highlighted
in italics.
Effective
January 1, 2009, Miller, Ellin & Company, LLP (“Miller
Ellin”), the independent
accountant of Elite Pharmaceuticals, Inc., a Delaware corporation (the “Registrant”),
and the principal accountant engaged to audit the Registrant’s
financial statements, consummated a merger (the “Merger”)
of its practice into the practice of Rosen Seymour Shapss Martin & Company
LLP (“Rosen Seymour”),
with Rosen Seymour succeeding to the business and operations of Miller
Ellin, subject to certain conditions
and exceptions, as agreed upon by the parties under the terms of the
Merger. Upon consummation of the
Merger on January 1, 2009, Miller
Ellin effectively resigned as the Registrant’s independent accountant,
and Rosen Seymour, pursuant to the terms of its agreement with Miller
Ellin, became the Registrant’s new independent accountant and
principal accountant to audit its financial statements, as the successor
in interest of Miller Ellin. On
February 19, 2009, the foregoing changes were formally unanimously
ratified and approved by the Audit Committee of the Registrant’s
Board of Directors (the “Audit
Committee”).
2.
The Company has amended its disclosure
in the Second Amended Filing in accordance with your comment.
3.
The Company has noted
your comment and, before offering its response, respectfully requests
the Commission to note that the review for which the Company’s
independent accountant was engaged was not, as indicated in your comment,
in respect of the Company’s internal controls over financial reporting
generally. Rather, the scope of the review was limited to a review
of the revised accounting procedures and internal controls over expenditures
and expense reimbursement (the “Internal
Controls”) implemented by the Audit
Committee of the Company’s Board of Directors (the “Audit
Committee”) in response to certain
events described in Prior Reports (as defined below) and in the Company’s
response to comment no. 4 of the Comment Letter set out below. As previously
disclosed by the Company in its Annual Report on Form 10-K/A for the
year ended March 31, 2008, filed with the Commission on January 16,
2009, and its Quarterly Report on Form 10-Q for the quarterly period
ended December 31, 2008, filed with the Commission on February 17,
2009 (collectively, the “Prior Reports”),
Rosen Seymour completed its review of the Internal Controls on January
23, 2009, and concluded that the Internal Controls implemented by the
Audit Committee are effective.
As
of the date hereof, the Company has not received any written report
relating to Rosen Seymour’s review of the Company’s Internal
Controls.
4.
As previously disclosed
by the Company in the Prior Reports, upon learning that certain expenses
had been reimbursed to Bernard J. Berk, the Company’s former President,
Chief Executive Officer and Chairman of the Board, without receipt
by the Company of adequate substantiation of such expenses, the Audit
Committee investigated the Company’s then-effective accounting
procedures and internal controls over expenditures and expense reimbursement
and, on the basis thereof, took such remedial measures as deemed necessary
to address any deficiencies therein, which included establishment and
implementation of the Internal Controls.
As an added precautionary
measure, the Audit Committee decided to engage the Company’s independent
accountant to conduct an independent review of the Internal Controls
for effectiveness. On the date of such engagement, November 26, 2008,
the Company’s independent accountant was Miller Ellin. However,
the accounting professionals at Miller Ellin who would be handling
such review decided, given the proximity in time to the anticipated
Merger completion date, to postpone the review until after consummation
of the Merger. Shortly after consummation of the Merger, the same accounting
professionals, now employed by Rosen Seymour, conducted the review
of the Internal Controls, as indicated above in the Company’s
response to comment no. 3 of the Comment Letter.
Because the review of the Internal Controls
was not commenced until after the Merger completion date, at which point
the business and operations of Miller Ellin had merged with and into
that of Rosen Seymour, the Company received no views, oral or written,
from Miller Ellin regarding the subject matter covered by such review.
5.
The Company
has obtained and filed as an exhibit to the Second Amended Filing an
updated letter from its former accountant stating whether it agrees
with the disclosures made in the Second Amended Filing. The Company
has also obtained and filed as an exhibit to the Second Amended Filing
an updated letter from its current accountant stating whether it agrees
with the disclosures made in the Second Amended Filing.
Please contact the undersigned, at (212) 209-3059, if we may be of further assistance regarding the above matters.
Very truly yours,
/s/ Louis Smookler
Louis Smookler, Esq.
2009-03-16 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Via Facsimile and U.S. Mail Mail Stop 6010 March 16, 2009 Mark I. Gittelman Chief Financial Officer and Treasurer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Item 4.01 Form 8-K/A Filed March 12, 2009
File No. 1-15697
Dear Mr. Gittelman:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comments are inapplicable
or a revision is unnecessary. Please be as detailed as necessary in your explanation.
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 number listed at the end of this letter.
Form 8-K/A filed March 12, 2009
1. Please state whether the former accountant resigned, declined to stand for re-
election or was dismissed in acco rdance with Item 304(a)(1)(i).
2. With regards to the third and fourth pa ragraphs, please specify the subsequent
interim period as the “interim period through January 1, 2009”.
3. With regards to the fifth paragraph, please confirm to us that the company did not
receive written views by the new accoun ting firm with regards to their
engagement to conduct a review of your in ternal controls ove r financial reporting.
However, if you did receive written views re garding this matter, please file them
as an exhibit.
4. In addition, state whether the former acc ountant was consulted by the registrant
regarding such issues noted in comment 3 above and, if so, provide a summary of
the former accountant’s views.
5. To the extent that you make changes to the Form 8-K to comply with our
comments, please obtain and file an upda ted Exhibit 16 letter from the former
accountant stating whether the accountant ag rees with the statements made in
your revised Form 8-K.
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will re spond. You may wish to provide us with
marked copies of the amendment to expedite our review. Please furnish a cover 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 comm ents after reviewing your amendment and
responses to our comments.
If you have any questions, please call me at (202) 551-3627.
S i n c e r e l y ,
S a s h a S i n g h P a r i k h S t a f f A c c o u n t a n t
2009-03-12 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP 1 filename1.htm c56917_corresp.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Tel: (201) 750-2646 March 12, 2009 AS FILED ON EDGAR AND VIA FACSIMILE Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E., Mail Stop 6010 Washington, DC 20549 Attn: Tabatha Akins, Staff Accountant Re: Elite Pharmaceuticals, Inc. Item 4.01 - Form 8-K, filed February 19, 2009 File No. 001-15697 Dear Ms. Akins: On behalf of Elite Pharmaceuticals, Inc., a Delaware corporation (the “Company”), please be advised that the undersigned has received and read your letter, dated February 25, 2009, with regard to Item 4.01 of the Current Report on Form 8-K filed by the Company with the United States Securities and Exchange Commission (the “Commission”) on February 19, 2009. The Company hereby 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. Of course, if you should require any additional information or clarification, please do not hesitate to contact the undersigned at (201) 367-7860. Securities and Exchange Commission March 12, 2009 Re: Elite Pharmaceuticals, Inc. Page 2 of 2 Your assistance in this matter is greatly appreciated. Sincerely, ELITE PHARMACEUTICALS, INC. By: /s/ Chris Dick Name: Chris Dick Title: Chief Operating Office and Acting Chief Executive Officer cc: Mark Gittelman, Chief Financial Officer
2009-03-12 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
CORRESP
1
filename1.htm
c56916_corresp.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing
March 12, 2009
AS FILED ON EDGAR AND
VIA FACSIMILE
Securities and Exchange Commission
Division of Corporation Finance
Attn: Tabatha Akins, Staff Accountant
100 F Street, N.E., Mail Stop 6010
Washington, DC 20549
Re:
Elite Pharmaceuticals, Inc.
Item 4.01 of Form 8-K, filed February 19, 2009
File No. 001-15697
Dear Ms. Akins:
On behalf of our client, Elite Pharmaceuticals, Inc., a Delaware corporation (the “Company”), we transmit simultaneously herewith
for filing under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), by means of the Electronic Data Gathering, Analysis, and Retrieval system, the Company’s
Current Report on Form 8-K/A (the “Amended Filing”) amending the Current Report on Form 8-K originally filed by the
Company on February 19, 2009 (File No. 001-15697) (the “Original Filing”) and a separate acknowledgement letter from the Company. All capitalized terms used, but not otherwise
defined, herein shall have the respective definitions assigned thereto in the Amended Filing.
We are in receipt of your letter addressed to the Company, dated February 25, 2009 (the “Comment Letter”), which you sent on behalf of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). Set forth below is the response
of the Company to each of the comments set forth in the Comment Letter, numbered to correspond thereto.
Comment
Number
Response to Comment
1.
The Company takes notice of, but respectfully
disagrees with, your comment. For the reasons stated below, the Company
disputes the Commission’s position that the Company’s failure
to file a report under Item 4.01 of Form 8-K within 4 days of the completion
of the merger, on January 1, 2009 (the “Merger”),
of the Company’s former independent accountants, Miller Ellin & Company
(“Miller Ellin”),
with and into Rosen Seymour Shapss Martin & Company LLP (“Rosen
Seymour”), the Company’s current
independent accountants, constitutes a delinquency that may negatively
impact the Company’s eligibility requirements for filing on Form S-3.
Comment
Number
Response to Comment
Upon completion
of the Merger on January 1, 2009, Rosen Seymour, as a matter of law,
succeeded Miller Ellin as the Company’s
independent accountants, and the Company formally engaged Rosen Seymour,
the successor in interest of Miller Ellin’s business and operations,
as its new independent accountant and the principal accountant to audit
its financial statements. Notwithstanding the Merger, there was very
little change in the Company’s ongoing relationship with its accountants.
In fact, many of the individual professionals who oversaw the Company’s
matters and headed the Company’s account at Miller Ellin have continued
in such capacity at Rosen Seymour upon giving effect to the Merger and through
the present.
Based upon
the circumstances described above, the Company did not consider there
to be a change in independent accountants for purposes of Item 4.01 of
Form 8-K upon the occurrence of the Merger. Furthermore, the Company
was not notified that the Merger constituted a change in independent
accountants until its receipt of a letter, dated February 12, 2009 (the “Notification
Letter”), from Rosen Seymour, whereby
Rosen Seymour (1) notified the Company that the Merger is considered
by the Commission to be a change in independent accountants under Item
4.01(b), and (2) advised the Company to file a Form 8-K using the language
suggested by Rosen Seymour in the Notification Letter. Upon receipt of
the Notification Letter, the Company prepared the Original Filing based
on the language suggested therein by Rosen Seymour; the Company filed
the Original Filing within 4 business days of the date of the Notification
Letter.
Based upon
the foregoing, and the Company’s good
faith effort to comply with the disclosure requirements of Item 4.01
of Form 8-K upon its receipt of the Notification Letter from Rosen Seymour,
the Company respectfully requests the Commission to consider as timely
the filing of the Original Filing disclosing the change in the Company’s
independent accountants and, thus, not to treat such filing of the Original
Filing as a delinquency that may negatively impact the Company’s
eligibility requirements for filing on Form S-3.
2.
The Company
has amended the Original Filing in accordance with your comment to provide
all disclosures required by Item 304(a)(1) of Regulation S-K. In the
Amended Filing, such disclosures are contained in the first four paragraphs
under Item 4.01, which are reproduced below for your convenience.
Effective January 1,
2009, Miller, Ellin & Company,
LLP (“Miller Ellin”),
the independent accountant of Elite Pharmaceuticals, Inc., a Delaware
corporation (the “Registrant”),
and the principal accountant engaged to audit the Registrant’s financial
statements, consummated a merger (the “Merger”)
of its practice into the practice of Rosen Seymour
Comment
Number
Response
to Comment
Shapss Martin & Company LLP (“Rosen Seymour”),
with Rosen Seymour the resulting surviving legal entity. As of the date
of the Merger, Rosen Seymour, as a matter of law, succeeded Miller Ellin
as the Registrant’s independent accountants, and the Registrant
formally engaged Rosen Seymour, as successor in interest of Miller Ellin,
as its new independent accountant and principal accountant to audit its
financial statements. On February 19, 2009, the foregoing changes were
unanimously approved and ratified by the Audit Committee of the Registrant’s
Board of Directors (the “Audit Committee”).
During the Registrant’s
past two fiscal years, ended March 31, 2007 and March 31, 2008 (together,
the “Fiscal Years”), respectively, Miller Ellin was
engaged as the Registrant’s principal accountant to examine the
Registrant’s financial statements for each such Fiscal Year. Miller
Ellin’s reports on the Registrant’s financial statements for
the Fiscal Years did not contain an adverse opinion or disclaimer of
opinion, nor were such reports qualified or modified as to uncertainty,
audit scope or accounting principles.
During the Fiscal Years
and through the date of the Merger, including the subsequent interim
periods ended June 30, 2008, September 30, 2008 and December 31, 2008
(the “Subsequent Interim Periods”), respectively, there
were no disagreements with Miller Ellin, whether resolved or unresolved
to Miller Ellin’s satisfaction, on any matter of accounting principles
or practices, financial statement disclosure, or auditing scope or procedure,
which, if not resolved to Miller Ellin’s satisfaction, would have
caused it to make reference to the subject matter of the disagreement(s)
in connection with its report.
During the Fiscal Years
and through the date of the Merger, including the Subsequent Interim
Periods, no “reportable events” (as described in Item 304(a)(1)(v)
of Regulation S-K) occurred that would be required by Item 304(a)(1)(v)
to be disclosed in this report.
3.
The Company
has revised the second paragraph of the Original Filing in accordance
with your comment to state explicitly the disclosures required by Item
304(a)(2). The revised disclosure in the Amended Filing, which is now
located in the penultimate paragraph under Item 4.01, is reproduced below
for your convenience.
Except as described
below, during the Fiscal Years and through the date of the Registrant’s engagement of Rosen
Seymour, including the Subsequent Interim Periods, neither the Registrant
nor anyone on its behalf consulted Rosen Seymour regarding either (i)
the application of accounting principles to a specific transaction, either
completed or proposed; or the type of audit opinion that might be rendered
on the Registrant’s financial statements, and either a written report
was provided to the Registrant or oral advice was provided that Rosen
Seymour concluded was an important factor considered by the Registrant
in reaching a decision as to the accounting, auditing or financial reporting
issue, or (ii) any matter that was
Comment
Number
Response
to Comment
either the subject of a “disagreement”(as
defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions
to such item) or “reportable events” (as described in Item
304(a)(1)(v) of Regulation S-K). As previously disclosed in Amendment
No. 1 to the Registrant’s Form 10-K/A, filed on January 16, 2009
with the Securities and Exchange Commission (the “Commission”),
the Registrant engaged Rosen Seymour to conduct a review of its internal
controls over financial reporting, particularly with respect to the
Registrant’s
accounting procedures and related internal controls over expenditures,
as a result of an investigation conducted by the Audit Committee regarding
certain reimbursements of expenses that were made by the Registrant
to Bernard J. Berk, its then-President, Chief Executive Officer and
Chairman of the Registrant’s Board of Directors, without the prior
receipt by the Registrant from Mr. Berk of adequate substantiation
of such expenses. Rosen Seymour completed its review on January
23, 2009 and determined that nothing came to its attention during
such review to indicate that the Registrant’s current internal
controls over financial reporting are not effective.
4.
The Company
has included in the Amended Filing, as Exhibit 16.1, a signed and currently
dated letter from its former accountants, Miller Ellin, in accordance
with Item 304(a)(3) of Regulation S-K. The Company has also included
in its amended filing, as Exhibit 16.2, an updated letter signed by its
current accountants, Rosen Seymour, in accordance with Item 304(a)(2)
of Regulation S-K.
Please
contact the undersigned, at (212) 209-3059, if we may be of further assistance
regarding the above matters.
Very truly yours,
/s/ Louis Smookler, Esq.
Louis Smookler, Esq.
2009-02-25 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Via Facsimile and U.S. Mail Mail Stop 6010 February 25, 2009 Mr. Mark I. Gittelman Elite Pharmaceuticals, Inc. Chief Financial Officer and Treasurer 165 Ludlow Avenue Northvale, New Jersey 07647
Re: Elite Pharmaceuticals, Inc. Item 4.01 Form 8-K
Filed February 19, 2009
File 001-15697
Dear Mr. Gittelman
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with more information so we may
better understand your disclosure. After re viewing 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. It appears that a change in accountan t took place on January 1, 2009, the date
Miller, Ellin & Company, LLP, merged its practice into the practice of Rosen
Seymour Shapss Martin & Company LLP. T hus so being, it appears an Item 4.01
8-K was not filed within 4 business days of the date of the dismissal of your
former auditors. Please note that this delinquency may impa ct your eligibility
requirements for filing on Form S-3.
Mr. Mark I. Gittelman
Elite Pharmaceuticals, Inc. February 25, 2009 Page 2
2. Please amend your filing to provide all th e disclosure required by Item 304(a)(1)
of Regulation S-K.
3. With respect to the second paragraph, please amend your filing to more fully
comply with Item 304(a)(2) by addressing the following:
a. Your reference to the “Prior to the merger” in the second paragraph is too
vague. Please amend your filing to explicitly state whether, during your
past two fiscal years through the da te of engagement (January 1, 2009),
you consulted Rosen Seymour Shapss Martin & Company LLP, LLP regarding any of the matte rs outlined in Item 304(a)(2) of Regulation S-B.
b. Explicitly state whether the newly engaged accountants were consulted
regarding the applicat ion of accounting princi ples to a specified
transaction, either completed or proposed.
c. Explicitly state whether the newly engaged accountants were consulted
regarding the type of audit opini on that might be rendered on the
registrant's financial statements, a nd either a written report was provided
to the registrant or oral advice was provided that the new accountant
concluded was an important factor cons idered by the registrant in reaching
a decision as to the accounting, auditi ng or financial reporting issue.
d. Explicitly state whether the newly engaged accountants were consulted
regarding any matter that was either the subject of a disagreement (as
defined in paragraph 304(a )(1)(iv) and the related instructions to this item)
or a reportable event (as described in paragraph 3 04(a)(1)(v)). The current
disclosure does not clarify whether the newly engaged accountants were consulted regarding reportable events.
4. Upon amending your filing, please include, as Exhibit 16, an updated letter from
your former accountants, Miller, Ellin & Company, LLP, as required by Item
304(a)(3) of Regulation S-K. Please ensure that your former accountants sign and
date their letter.
* * * *
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will provide us with a response. You may wish to provide us with marked copies of the amendm ent to expedite our review. Please furnish
a cover letter with your amendment that keys your responses to our comments and
provides any requested information. Detailed co ver letters greatly faci litate our review.
Please understand that we may have addi tional comments after reviewing your
amendment and responses to our comments. We urge all persons who are responsi ble for the accuracy an d adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
Mr. Mark I. Gittelman
Elite Pharmaceuticals, Inc. February 25, 2009 Page 3
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, 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 comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities 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 Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please do not hesitate to call me at (202) 551-3658.
S i n c e r e l y , T a b a t h a A k i n s S t a f f A c c o u n t a n t
2008-11-20 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 6010 November 20, 2008 Mr. Mark I. Gittleman Chief Financial Officer and Secretary Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647
Re: Elite Pharmaceuticals, Inc.
Revised preliminary proxy statement filed November 20, 2008
File No. 1-10581
Dear Mr. Gittleman: We have completed our review of your preliminary proxy statement and related
filings and have no further comments at this time.
S i n c e r e l y ,
J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Scott H. Rosenblatt, Esquire Reitler Brown & Rosenblatt LLC 800 Third Avenue, 21
st Floor
New York, New York 10022-7604
2008-11-17 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 0610 November 17, 2008
Mr. Mark I. Gittelman Chief Financial Officer and Secretary Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647 Re: Elite Pharmaceuticals, Inc. Preliminary proxy statemen t filed November 13, 2008
File No. 1-15697 Dear Mr. Gittelman:
We have reviewed your filing solely with respect to the matters raised in the
following comments. Where indicated, we think you should revise your document in
response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revisi on is unnecessary. Please be as detailed as
necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not 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.
Proposal 1: Approval and ratification of Series D preferre d stock financing.
1. Please expand the discussion to describe the conversion fe atures of the series B
and series C preferred stock and rela ted warrants and how these terms may
compare and/or differ from those of the series D preferred stock and related
warrants.
Proposal 2. Approval of amendment to the cert ificate of incorporat ion to increase the
number of authorized shares of common stock from 150,000,000 to 210,000,000.
2. Please expand the discussion clarify wh ether you currently have sufficient
authorized shares of common stock for the issuance of common stock upon
conversion of series B, series C, and seri es D preferred stock and the exercise of
related warrants. Please quantify the numb er of shares required for such purposes
and, if applicable, the number of shares that are available currently for issuance
after the conversion and exercise.
3. We note the statement that you do not curren tly have sufficient authorized shares
of common stock to enable you to pay di vidends in shares of common stock on
the series D preferred shares. Please expand the discussion to quantify the
number of common shares required to pay such dividends and the current
shortfall.
4. We note the statement on page 18 that you “currently do not have any definitive
terms with respect to any plan, comm itment, arrangement, understanding or
agreement, either oral or written, re garding the issuance of Common Stock or
securities convertible, exchangeable or exercisable for shares of Common Stock,
subsequent to the increase in the numbe r of available authorized shares of
Common Stock.” Please rec oncile this statement with the reasons provided for
the proposed increase in the number of authorized shares of common stock and
the discussion under the section “Conse quences if Stockholder Approval of
Proposal 2 is Not Obtained” on page 18. We may have additional comments.
Filing and Other Information, page 23
5. Please confirm that the documents incorpor ated by reference, namely your Form
10-K and your subsequently filed Forms 10-Q, will be delivered to shareholders with the proxy statement.
Form of Proxy
6. We note you are requesting the appointment of Messrs. Berk and Gittelman to
vote proxies submitted by your shareholders. We also note that, based on your Form 8-K for November 6, 2008, Mr. Berk is apparently no longer affiliated with
the registrant. Please confirm that you stil l intend to empower Mr. Berk with the
authority to vote proxies and the meeting described in the proxy statement. We
may have additional comments.
* * * * *
As appropriate, please amend your filing and respond to these comments within
10 business days or tell us when you will provid e us with a response. You may wish to
provide us with marked copies of the amendm ent to expedite our review. Please furnish
a cover letter with your amendment that keys your responses to our comments and provides any requested supplemental information. Detailed cover letter s greatly facilitate
our review. Please understand that we may have additional commen ts after reviewing
your amendment and responses to our comments.
We urge all persons who are responsi ble for the accuracy an d adequacy of the
disclosure in the filing review ed by the staff to be certain that they have provided all
information investors require for an info rmed decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, 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 staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact John L. Krug at (2 02) 551-3862, Senior Counsel, Suzanne
Hayes, Branch Chief, at (202) 551-3675, or me at (202) 551-3715 if you have any
questions.
Sincerely, Jeffrey Riedler Assistant Director
cc: Scott H. Rosenblatt, Esq. Reitler, Brown & Rosenblatt LLC 800 Third Avenue, 21
st Floor
New York, New York 10022-7604
2008-05-21 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 6010 May 21, 2008 Mr. Mark I. Gittleman Chief Financial Officer and Secretary Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647
Re: Elite Pharmaceuticals, Inc.
Revised preliminary proxy statement filed May 21, 2008
File No. 1-10581
Dear Mr. Gittleman: We have completed our review of your preliminary proxy statement and related
filings and have no further comments at this time.
S i n c e r e l y ,
J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Scott H. Rosenblatt, Esquire Reitler Brown & Rosenblatt LLC 800 Third Avenue, 21
st Floor
New York, New York 10022-7604
2008-05-20 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 0610 May 20, 2008
Mr. Bernard Berk President and Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647 Re: Elite Pharmaceuticals, Inc. Preliminary proxy statement filed May 15, 2008 File No. 1-15697 Dear Mr. Berk:
We have reviewed your filing solely with respect to the proposed amendment to
your certificate of incorp oration with respect to how amendments that relate solely to the
terms of outstanding preferred stock are e ffected and have the following comments.
Where indicated, we think you should revise your document in response to these
comments. If you disagree, we will consider your explanation as to why our comment is
inapplicable or a revision is unnecessary. Pl ease be as detailed as necessary in your
explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this
information, we may or may not 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.
Proposal 3: Approval and ratifi cation of amendment to the cer tificate of incorporation to
provide that holders of the company’s co mmon stock are not entitled to vote on any
amendment to the certificate of incorporation (including any pr eferred stock certificate of
designation) that relates solely to the term s of one or more outstanding series of our
preferred stock if the holders of such a ffected series are en titled to vote on such
amendment.
1. Please expand the discussion to include the loss of any rights of common
shareholders and any potential negative consequences to common shareholders
resulting from revisions that re late solely to preferred stock.
* * * * *
As appropriate, please amend your filing and respond to these comments within
10 business days or tell us when you will provid e us with a response. You may wish to
provide us with marked copies of the amendm ent to expedite our review. Please furnish
a cover letter with your amendment that keys your responses to our comments and
provides any requested supplemental information. Detailed cover letter s greatly facilitate
our review. Please understand that we may have additional commen ts after reviewing
your amendment and responses to our comments. We urge all persons who are responsi ble for the accuracy an d adequacy of the
disclosure in the filing review ed by the staff to be certain that they have provided all
information investors require for an info rmed decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, 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 staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing. You may contact John L. Krug at (2 02) 551-3862, Senior Counsel, Suzanne
Hayes, Branch Chief, at (202) 551-3675, or me at (202) 551-3715 if you have any
questions.
Sincerely, Jeffrey Riedler Assistant Director
cc: Scott H. Rosenblatt, Esq. Reitler, Brown & Rosenblatt LLC 800 Third Avenue, 21
st Floor
New York, New York 10022-7604
2008-05-02 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 6010 May 2, 2008 Mr. Mark I. Gittleman Chief Financial Officer and Secretary Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647
Re: Elite Pharmaceuticals, Inc.
Revised preliminary proxy statement filed May 2, 2008
File No. 1-10581
Dear Mr. Gittleman: We have completed our review of your preliminary proxy statement and related
filings and have no further comments at this time.
S i n c e r e l y ,
J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Scott H. Rosenblatt, Esquire Reitler Brown & Rosenblatt LLC 800 Third Avenue, 21
st Floor
New York, New York 10022-7604
2008-05-01 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 0610 May 1, 2008 Mr. Bernard Berk President and Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, New Jersey 07647 Re: Elite Pharmaceuticals, Inc. Preliminary proxy statement filed April 29, 2008 File No. 1-15697 Dear Mr. Berk: We have reviewed your filing solely with respect to the proposed increase in the number of authorized shares of common st ock and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. Af ter reviewing this information, we may or may not 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. Proposal 2: Approval of amendmen t to certificate of incorporation 1. Please expand the discussion to state wh ether you have any plan, commitment, arrangement, understanding or agreement, either oral or written, regarding the issuance of common stock subsequent to th e increase in the number of available authorized shares. * * * * * As appropriate, please amend your filing and respond to these comments within 10 business days or tell us when you will provid e us with a response. You may wish to provide us with marked copies of the amendm ent to expedite our review. Please furnish a cover letter with your amendment that keys your responses to our comments and provides any requested supplemental information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional commen ts after reviewing your amendment and responses to our comments. We urge all persons who are responsi ble for the accuracy an d adequacy of the disclosure in the filing review ed by the staff to be certain that they have provided all information investors require for an info rmed decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our comments, 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 staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comments on your filing. You may contact John L. Krug at (2 02) 551-3862, Senior Counsel, Suzanne Hayes, Branch Chief, at (202) 551-3675, or me at (202) 551-3715 if you have any questions. Sincerely, Jeffrey Riedler Assistant Director
2008-01-24 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
REITLER
BROWN &
ROSENBLATT LLC 800 Third Avenue, 21st Floor
---------------- New York, NY 10022-7604
ATTORNEYS AT LAW Tel (212) 209-3050
Fax (212) 371-5500
January 24, 2008
VIA ELECTRONIC TRANSMISSION
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Mail Stop 6010
Attn: Jeffrey Riedler
RE: ELITE PHARMACEUTICALS, INC. (THE "COMPANY")
REGISTRATION STATEMENT ON FORM S-3 (FILE NO. 333-145502)
Dear Mr. Riedler:
On behalf of Elite Pharmaceuticals, Inc., a Delaware corporation (the
"Company"), we hereby file electronically under the Securities Act of 1933, as
amended (the "Securities Act"), the request of the Company to accelerate the
effectiveness of the above-referenced registration statement under the
Securities Act.
Please contact the undersigned if we may be of assistance.
Sincerely,
/s/ Scott Rosenblatt
Scott Rosenblatt, Esq.
Enclosure
cc: Bernard Berk
<PAGE>
Elite Pharmaceuticals, Inc.
167 Ludlow Avenue, Northvale, NJ 07647
January 24, 2008
Securities and Exchange Commission
100 F Street, NE
Washington DC 20549
RE: ELITE PHARMACEUTICALS, INC. (THE "COMPANY")
REGISTRATION STATEMENT ON FORM S-3 (FILE NO. 333-145502)
Ladies and Gentlemen:
The Company respectfully requests that the above-referenced
registration statement be declared effective at 4:00 pm EST on Friday, January
25, 2008, or as soon thereafter as reasonably practicable.
The Company acknowledges that:
o should the Securities and Exchange Commission (the
"Commission") or the staff of the Commission (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;
o 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
o the Company may not assert the Staff comments or 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,
ELITE PHARMACEUTICALS, INC.
By: /s/ Bernard Berk
-------------------------
Bernard Berk
Chief Executive Officer
</TEXT>
</DOCUMENT>
2008-01-14 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
January 14, 2008
Jeffrey Riedler
Assistant Director
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Mail Stop 6010
Washington, DC 20549
RE: ELITE PHARMACEUTICALS, INC.
PRE-EFFECTIVE AMENDMENT NO. 2 TO REGISTRATION STATEMENT ON FORM S-3
FILED AUGUST 16, 2007
FILE NO. 333-145502
Dear Mr. Riedler:
On behalf of our client, Elite Pharmaceuticals, Inc., a Delaware
corporation (the "COMPANY"), we transmit simultaneously herewith for filing
under the Securities Act of 1933, as amended (the "EXCHANGE ACT"), by means of
the Electronic Data Gathering, Analysis, and Retrieval system, Pre-Effective
Amendment No. 2 ("AMENDMENT NO. 2") to Registration Statement on Form S-3 (File
No. 333-145502) (the "REGISTRATION STATEMENT"), together with certain exhibits
thereto. All capitalized terms used, but not otherwise defined, herein shall
have the respective definitions assigned thereto in Amendment No. 2.
We are in receipt of the letter, dated January 10, 2008 (the "COMMENT
LETTER"), from Jeffrey Riedler, Assistant Director, Division of Corporate
Finance of the Securities and Exchange Commission, with respect to the
Registration Statement. Set forth below are the comments of the staff set forth
in the Comment Letter (in italics), together with the responses of the Company
to such comments, numbered to correspond to the numbering in the Comment Letter.
COMMENT
NUMBER PAGE COMMENT AND RESPONSE
------- ---- --------------------
1. 18 WE NOTE THAT THERE IS NO REFERENCE TO FOOTNOTE 1 IN THE
TABLE. PLEASE REVISE ACCORDINGLY.
The Company has revised the text preceding the table, in
the first sentence under the heading "POTENTIAL PAYMENTS
REQUIRED DURING INITIAL YEAR", to make reference to
footnote 1 since there is no suitable place in the table
itself to make reference to the footnote.
2. 19 PLEASE REVISE FOOTNOTE 2 ON PAGE 19 TO STATE THAT THE
DIVIDEND PAYMENTS ON THE STOCK WILL INCREASE TO 15% PER
ANNUM ON APRIL 24, 2009.
<PAGE>
Page 2 of 3
COMMENT
NUMBER PAGE COMMENT AND RESPONSE
------- ---- --------------------
The requested revision has been made.
3. 20 IT APPEARS FROM YOUR DISCLOSURE ON PAGE 15 AND IN
FOOTNOTE 3 ON PAGE 20 THAT THE COMPANY IS CURRENTLY
INCURRING LIQUIDATED DAMAGES. PLEASE REVISE FOOTNOTES 3,
4 AND 5 ON PAGE 20 TO ALSO STATE THE AMOUNT OF
LIQUIDATED DAMAGES WHICH YOU HAVE INCURRED TO DATE.
The requested revisions have been made.
4. 22 WE NOTE YOUR RESPONSE TO COMMENT 3. PLEASE REVISE THE
TABLE ON PAGE 22 TO INCLUDE A COLUMN DISCLOSING THE
TOTAL POSSIBLE DISCOUNT TO THE MARKET PRICE AS OF THE
DATE OF THE SALE OF THE PREFERRED STOCK AND WARRANTS,
CALCULATED BY SUBTRACTING THE TOTAL CONVERSION/EXERCISE
PRICE ON THE DATE OF THE SALE OF PREFERRED WARRANTS FROM
THE COMBINED MARKET PRICE OF THE TOTAL NUMBER OF SHARES
UNDERLYING THE PREFERRED STOCK AND WARRANTS ON THAT
DATE.
The Company notes that a column containing the requested
disclosure already appeared in the table under the
heading "TOTAL POSSIBLE DISCOUNT TO THE MARKET PRICE".
The Company has revised the heading of said column to
read "TOTAL POSSIBLE DISCOUNT TO THE MARKET PRICE OF THE
SERIES C PREFERRED STOCK AND WARRANTS AS OF THE DATE OF
SALE" in order to be more responsive to your comment.
5. 23 WE NOTE YOUR RESPONSE TO COMMENT 4. PLEASE REVISE THE
TABLE ON PAGE 23 TO DISCLOSE THE SHARES ISSUABLE, MARKET
PRICE AND TOTAL POSSIBLE PROFIT RELATING TO OTHER
WARRANTS, OPTIONS, NOTES, OR OTHER SECURITIES OF THE
ISSUER HELD BY THE SELLING SHAREHOLDERS, AS OPPOSED TO
INCLUDING THE SHARES BEING REGISTERED IN THIS OFFERING.
The Company has revised the table to remove all columns
containing disclosures related to the shares being
registered in this offering and revised all headings
referencing Series B Preferred Stock and warrants to
instead reference "OTHER WARRANTS, OPTIONS, NOTES, OR
SECURITIES OF THE COMPANY HELD". The Company has amended
the footnotes accordingly.
6. 27 PLEASE REVISE THE HEADING OF THE THIRD COLUMN IN THE
TABLE ON PAGE 27 WHICH CURRENTLY STATES "WET PROCEEDS"
TO STATE "NET PROCEEDS TO COMPANY".
The requested revision has been made.
Please contact the undersigned if we may be of assistance.
Sincerely,
Scott H. Rosenblatt
cc: Jennifer Riegel, Esq.
Bernard Berk
Mitchell Rubin
</TEXT>
</DOCUMENT>
2008-01-10 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 6010 January 10, 2008 Bernard Berk Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Registration Statement on Form S-3/A Filed January 2, 2008 File No. 333-145502 Dear Mr. Berk: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. After reviewing th is 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. Supplemental Information Regarding the Ju ly Private Placements and the Selling Stockholders, page 14 Potential Payments Required During Initial Year, page 18 1. We note that there is no reference to f ootnote 1 in the table. Please revise accordingly. 2. Please revise footnote 2 on page 19 to st ate that the dividend payments on the stock will increase to 15% per annum on April 24, 2009. Bernard Berk Elite Pharmaceuticals, Inc. January 10, 2008 Page 2 3. It appears from your disclosure on page 15 and in footnote 3 on page 20 that the company is currently incurring liquidated damages. Please revise footnotes 3, 4 and 5 on page 20 to also state the amount of liquidated damages which you have incurred to date. Potential Profit, page 21 4. We note your response to comment 3. Pl ease revise the table on page 22 to include a column disclosing the total possi ble discount to the ma rket price as of the date of the sale of the preferred st ock and warrants, calc ulated by subtracting the total conversion/exercise price on the date of the sale of preferred warrants from the combined market price of the total number of shares underlying the preferred stock and warrants on that date. 5. We note your response to comment 4. Pl ease revise the table on page 23 to disclose the shares issuable, market price and total possible profit relating to other warrants, options, notes, or other securi ties of the issuer held by the selling shareholders, as opposed to including the sh ares being registered in this offering. Analysis of Payments in Relation to Net O ffering Proceeds and Combined Total Profits, page 26 6. Please revise the heading of the third column in the table on page 27 which currently states “Net Proceeds” to state “Net Proceeds to Company.” * * * Bernard Berk Elite Pharmaceuticals, Inc. January 10, 2008 Page 3 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 460 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 Jennifer Ri egel at (202) 551-3575 or me at (202) 551-3715 with any other questions. S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Scott H. Rosenblatt, Esq. Gary M. Emmanuel, Esq. Reitler Brown & Rosenblatt, LLC 800 Third Avenue, 21st Floor New York, New York 10022-4611
2008-01-07 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Tel: (201) 750-2646
January 7, 2008
AS FILED ON EDGAR AND
---------------------
VIA REGULAR U.S. MAIL
---------------------
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Mail Stop 6010
Attn: Jeffrey Riedler
Re: Elite Pharmaceuticals, Inc.,
Pre-Effective Amendment No. 1 to Registration Statement on
Form S-3 Filed August 16, 2007
File No. 333-145502
Dear Mr. Riedler:
On behalf of Elite Pharmaceuticals, Inc., a Delaware corporation ("Company"),
please be informed that the undersigned has received and read your letter, dated
August 23, 2007, with regard to the Registration Statement on Form S-3 filed
with the Securities and Exchange Commission (the "Commission") on August 16,
2007.
The Company acknowledges herewith, that:
o the Company is responsible for the adequacy and accuracy of the disclosure
in the filing;
o 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
o 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.
Of course, if you should require any additional information or clarification,
please do not hesitate to contact the undersigned at the telephone number given
above.
<PAGE>
Securities and Exchange Commission
January 7, 2008
Page 2 of 2
Your assistance in this matter is greatly appreciated. Thank you.
Sincerely,
/s/
Mark Gittelman
Chief Financial Officer
Elite Pharmaceuticals, Inc.
cc: Bernard Berk, Chief Executive Officer and
Chairman of the Board of Directors
Elite Pharmaceuticals, Inc.
</TEXT>
</DOCUMENT>
2008-01-04 - CORRESP - ELITE PHARMACEUTICALS INC /NV/
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
January 2, 2008
Jeffrey Riedler
Assistant Director
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Mail Stop 0610
Washington, DC 20549
RE: ELITE PHARMACEUTICALS, INC.
PRE-EFFECTIVE AMENDMENT NO. 1 TO REGISTRATION STATEMENT ON FORM S-3
FILED AUGUST 16, 2007
FILE NO. 333-145502
Dear Mr. Riedler:
On behalf of our client, Elite Pharmaceuticals, Inc., a Delaware
corporation (the "COMPANY"), we transmit simultaneously herewith for filing
under the Securities Act of 1933, as amended (the "EXCHANGE ACT"), by means of
the Electronic Data Gathering, Analysis, and Retrieval system, Pre-Effective
Amendment No. 1 ("AMENDMENT NO. 1") to Registration Statement on Form S-3 (File
No. 333-145502) (the "REGISTRATION STATEMENT"), together with certain exhibits
thereto. All capitalized terms used, but not otherwise defined, herein shall
have the respective definitions assigned thereto in Amendment No. 1.
The Company wishes to bring to the attention of the staff that, as a
preliminary matter, the Registration Statement has been amended to eliminate
therefrom the resale of all securities held by selling stockholders (the
"EXCLUDED SELLING STOCKHOLDERS") the securities of which (or the securities of
the affiliates of which) were included in the Registration Statement on Form S-3
(Registration No. 333-143246) (the "PRIOR REGISTRATION"). Accordingly, Amendment
No. 1 includes solely the resale of securities of investors (the "INCLUDED
SELLING STOCKHOLDERS") in the Series C Preferred Stock of the Company (the
"SERIES C STOCK") and related warrants (the "WARRANTS") that were not included,
and the affiliates of which were not included, in the Prior Registration.
We are in receipt of the letter, dated August 23, 2007 (the "COMMENT
LETTER"), from Jeffrey Riedler, Assistant Director, Division of Corporate
Finance of the Securities and Exchange Commission, with respect to the
Registration Statement. Set forth below are the comments of the staff set forth
in the Comment Letter (in italics), together with the responses of the Company
to such comments, numbered to correspond to the numbering in the Comment Letter.
Information requested by the staff has generally been provided by the Company on
both an aggregate basis as well as on an investor-by-investor basis, and, except
as set forth herein, includes information only with respect to the Included
Selling Stockholders. It is currently the intent of the Company to file with the
Commission promptly following the effectiveness of the
<PAGE>
Page 2 of 20
Registration Statement a post-effective amendment pursuant to Rule 429 of
Regulation C under the Securities Act to combine the prospectuses included in
both such registration statements. To address the general concern of the staff
regarding the disclosure requested in comments 2 through 10 of the Comment
Letter, the Company has added to the Registration Statement a section entitled
"Supplemental Information Regarding the July Private Placement and the Selling
Stockholders," which would be renamed "Supplemental Information Regarding the
Private Placement and the Selling Stockholders" following the aforementioned
filing pursuant to Rule 429 and would be expanded to include the Excluded
Selling Stockholders. In addition, cross-references to such section have been
added to the sections of the Registration Statement entitled "Prospectus
Summary" and "Selling Stockholders".
1. PLEASE PROVIDE US, WITH A VIEW TOWARD DISCLOSURE IN THE PROSPECTUS,
WITH THE TOTAL DOLLAR VALUE OF THE SECURITIES UNDERLYING THE PREFERRED SHARES
AND WARRANTS THAT YOU HAVE REGISTERED FOR RESALE (USING THE NUMBER OF UNDERLYING
SECURITIES THAT YOU HAVE REGISTERED FOR RESALE AND THE MARKET PRICE PER SHARE
FOR THOSE SECURITIES ON THE DATE OF THE SALE OF THE PREFERRED SHARES AND
WARRANTS).
ENTIRE JULY PRIVATE PLACEMENT. The private placement of the Series C
Stock and the Warrants the resale of the common stock underlying which is
registered in the Registration Statement closed on July 17, 2007 (the "JULY
PRIVATE PLACEMENT"). Based upon a closing market price of $2.69 per share of
common stock on the American Stock Exchange on such date, and without giving
effect to the exclusion from the Registration Statement of the Excluded Selling
Stockholders, the aggregate dollar value of the securities which the Company
originally covered by the Registration Statement for resale was $11,352,128.18.
PORTION OF JULY PRIVATE PLACEMENT INCLUDED IN AMENDMENT NO. 1. Based
upon a closing market price of $2.69 per share of common stock on the American
Stock Exchange on July 17, 2007, and giving effect to the exclusion from the
Registration Statement of the Excluded Selling Stockholders, the aggregate
dollar value of the securities that the Company has registered for resale in the
Registration Statement is $4,185,142.35.
AGGREGATE OF THE PRIOR PRIVATE PLACEMENT AND THE PORTION OF THE JULY
PRIVATE PLACEMENT INCLUDED IN THE REGISTRATION STATEMENT. The private placement
of the Series C Stock and the Warrants the resale of the common stock underlying
which was registered in the Prior Registration closed on April 24, 2007 (the
"PRIOR PRIVATE PLACEMENT"). Based upon a closing market price of $2.30 per share
of common stock on the American Stock Exchange on such date, the aggregate
dollar value of the securities that the Company has registered for resale in the
Prior Registration and the Registration Statement (giving effect to the
exclusion from the Registration Statement of the Excluded Selling Stockholders)
is $33,594,674.25.
AGGREGATE OF THE PRIOR PRIVATE PLACEMENT AND THE ENTIRE JULY PRIVATE
PLACEMENT. Based upon the foregoing market price data, the aggregate dollar
value of the securities that the Company has registered for resale in the Prior
Registration and the Registration Statement (without giving effect to the
exclusion of the Excluded Selling Stockholders) is $40,761,660.08.
<PAGE>
Page 3 of 20
2. PLEASE PROVIDE US, WITH A VIEW TOWARD DISCLOSURE IN THE PROSPECTUS,
WITH TABULAR DISCLOSURE OF THE DOLLAR AMOUNT OF EACH PAYMENT (INCLUDING THE
VALUE OF ANY PAYMENTS TO BE MADE IN COMMON STOCK) IN CONNECTION WITH THE
TRANSACTION THAT YOU HAVE MADE OR MAY BE REQUIRED TO MAKE TO ANY SELLING
SHAREHOLDER, ANY AFFILIATE OF A SELLING SHAREHOLDER, OR ANY PERSON WITH WHOM ANY
SELLING SHAREHOLDER HAS A CONTRACTUAL RELATIONSHIP REGARDING THE TRANSACTION
(INCLUDING ANY INTEREST PAYMENTS, LIQUIDATED DAMAGES, PAYMENTS MADE TO "FINDERS"
OR "PLACEMENT AGENTS," AND ANY OTHER PAYMENTS OR POTENTIAL PAYMENTS). PLEASE
PROVIDE FOOTNOTE DISCLOSURE OF THE TERMS OF EACH SUCH PAYMENT. PLEASE DO NOT
INCLUDE ANY SHARES TO BE ISSUED UPON THE CONVERSION OF THE PREFERRED STOCK IN
THIS DISCLOSURE.
FURTHER, PLEASE PROVIDE US, WITH A VIEW TOWARD DISCLOSURE IN THE
PROSPECTUS, WITH DISCLOSURE OF THE NET PROCEEDS TO THE ISSUER FROM THE SALE OF
THE PREFERRED STOCK AND WARRANTS AND THE TOTAL POSSIBLE PAYMENTS TO ALL SELLING
SHAREHOLDERS AND ANY OF THEIR AFFILIATES IN THE FIRST YEAR FOLLOWING THE SALE OF
PREFERRED STOCK AND WARRANTS.
With respect to the first paragraph of Comment 2, please see Table 2,
below. Table 2 presents data solely with respect to the Included Selling
Securityholders.
The net proceeds to the Company from the July Private Placement were
$4,632,000, after the payment of $368,000 in placement agent fees and related
expenses. Assuming the exercise in full of the Warrants, the aggregate net
proceeds of the July Private Placement would be $6,765,597.
The total possible payments to the Included Selling Stockholders, and
their affiliates, in the first year following the closing of the July Private
Placement is $430,560, equaling the total value, assuming all cash payments, of
dividends payable on the Series C Preferred Stock purchased in the July Private
Placement, plus maximum partial liquidated damages for which the Company may
potentially be liable, as described more fully, below, in Table 2 and its
corresponding footnotes.
TABLE 2(1)
<TABLE>
<CAPTION>
SERIES C PREFERRED POTENTIAL PARTIAL
STOCK DIVIDENDS LIQUIDATED
INCLUDED SELLING STOCKHOLDER PAYABLE IN FIRST YEAR(2) DAMAGES(3) TOTAL
---------------------------- ------------------------ ---------- -----
<S> <C> <C> <C>
Consonance Capital Master Account L.P. $69,760 $130,800(4) $200,560
Midsummer Investment, Ltd. $80,000 $150,000(5) $230,000
TOTAL $149,760 $280,800 $430,560
-----
</TABLE>
-----------
(1) Listed below are payments that the Company may potentially be required
to make to a selling stockholder (the "SELLING STOCKHOLDERS"), pursuant to the
Certificate of Designation of Preferences, Rights and Limitations of Series C 8%
Convertible
<PAGE>
Page 4 of 20
Preferred Stock, dated as of April 24, 2007 (the "CERTIFICATE OF DESIGNATIONS"),
the Securities Purchase Agreement, dated as of July 17, 2007 (the "PURCHASE
AGREEMENT"), and the Registration Rights Agreement, dated as of July 17, 2007
(the "REGISTRATION RIGHTS AGREEMENT") (collectively, the "TRANSACTION
DOCUMENTS"), but that cannot properly be valued currently as a result of the
contingent nature of the payments and/or the need for future information which
cannot be ascertained currently:
- LIQUIDATION PAYMENTS: Selling Stockholders may be entitled to
liquidation payments, pursuant to the Certificate of Designations,
however these payments cannot be valued unless and until the
occurrence of an applicable dissolution or winding-up of the
Company;
- PARTIAL LIQUIDATED DAMAGES: Selling Stockholders may be entitled to
partial liquidated damages, pursuant to the Certificate of
Designations, however, these payments cannot be valued because
valuation is contingent on the Company's failure, in the future, to
properly issue and deliver shares of common stock upon conversion
of Series C Preferred Stock;
- COMPENSATION FOR BUY-IN ON FAILURE TO TIMELY DELIVER CERTIFICATES
UPON CONVERSION: Selling Stockholders may be entitled to partial
liquidated damages, pursuant to the Certificate of Designations,
however, these payments cannot be valued because valuation is
contingent on the Company's failure, upon a conversion by a Selling
Stockholder, to deliver on a timely basis the certificate(s)
evidencing the shares the Selling Stockholder is entitled to
receive upon conversion;
- INDEMNIFICATION BY THE COMPANY: Selling Stockholders may benefit
from indemnification by the Company in certain situations, as
provided in the Registration Rights Agreement.
Excluded from Table 2 are redemptions of shares of Series C Preferred
Stock. Upon the occurrence of "Cash Redemption Triggering Events," as defined in
the Certificate of Designations, in addition to any other rights, a Selling
Stockholder has the right, subject to exception, to force a cash redemption of
its Series C Preferred Stock for a price per share equaling, the sum of (i) 130%
of the stated value per share; (ii) all accrued but unpaid dividends thereon;
and (iii) all liquidated damages and other costs, expenses or amounts due
thereon (the "TRIGGERING REDEMPTION AMOUNT"). Despite the occurrence of a Cash
Redemption Triggering Event, a Selling Stockholder has no right to a cash
redemption if the Company's auditors, the Commission, any trading market, or any
governmental or regulatory body having actual jurisdiction over the Company's
financial reporting determines that such triggering event was not solely within
the Company's control (as set forth in Item 28 of Rule 5-02 of Regulation S-X of
the Exchange Act, as amended or supplemented from time to time, or the successor
thereto). In the event of a "Non-Cash Redemption Triggering Event," as defined
in the Certificate of Designations, a Selling Stockholder may force the Company
to redeem its shares of Series C Preferred Stock for a price, in shares of
common stock, equal to the Triggering Redemption Amount divided by 85% of the
average of the 10 Volume-Weighted Average Prices ("VWAPS") immediately prior to
the date of such non-cash redemption. However, the right to a non-cash
redemption is waived until the 275th day after the closing date.
The Company has the option, beginning 24 months from the Original Issue
Date, to complete a cash redemption of all shares of Series C Preferred Stock
then outstanding for a price per share equaling the sum of the following: (i)
150 % of the stated value per share, (ii) any accrued but unpaid dividends
thereon, and (iii) all liquidated damages and/or other amounts owing thereon.
(2) For purposes of this response, the Company disclosed the value of
dividends payable to the Included Selling Stockholders on the Series C Preferred
Stock purchased in the July Private Placement (the "SERIES C DIVIDENDS") for the
first full year following the date of sale, assuming cash payment. This amount
was calculated by multiplying the aggregate stated value of the shares of Series
C Preferred Stock held by the Included Selling Stockholders by 8%, the rate at
which the dividends accrue during the one-year period, in accordance with the
Certificate of Designations. Series C Dividends that the Company fails to pay,
whether in cash or shares of common stock, within the time period prescribed in
the Certificate of Designation, continue to accrue and entail a late fee, which
must be paid in cash, at the rate of 18% per annum or lesser rate permitted by
law, accruing daily until and including the date of payment.
(3) The data provided in this table represents the maximum possible
liquidated damages payable to the Included Selling Stockholder under the
Registration Rights Agreement, as described below. Pursuant to the Registration
Rights Agreement, upon the occurrence of certain events, the Company may be
liable for partial liquidated damages, with certain limitations, payable in cash
to the Selling Stockholders. On each date on which an applicable event occurs
and on each anniversary of such date (if such event has not been cured) until
cured, the Company must pay to each Selling Stockholder 1.5% of the aggregate
purchase price paid by each selling stockholder pursuant to the Purchase
Agreement for any unregistered "Registrable Security," as defined thereunder,
then held (calculated as if all convertible securities had been fully
converted). The Company's liability f
2007-08-23 - UPLOAD - ELITE PHARMACEUTICALS INC /NV/
Mail Stop 6010
August 23, 2007
Bernard Berk
Chief Executive Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 16, 2007
File No. 333-145502
Dear Mr. Berk:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure. After reviewing th is 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.
FORM S-3
General
1. Please provide us, with a view toward disc losure in the prospectus, with the total
dollar value of the securitie s underlying the preferred sh ares and warrants that you
have registered for resale (using the number of underl ying securities that you have
registered for resale and the market pri ce per share for those securities on the date
of the sale of the preferred shares and warrants).
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 2
2. Please provide us, with a view toward disc losure in the prospectus, with tabular
disclosure of the dollar amount of each payment (including the value of any
payments to be made in common stock) in connection with the transaction that
you have made or may be required to ma ke to any selling shareholder, any
affiliate of a selling shareholder, or any person with whom any selling shareholder has a contractual relationsh ip regarding the transacti on (including any interest
payments, liquidated damages, payments made to “finde rs” or “placement
agents,” and any other payments or poten tial payments). Please provide footnote
disclosure of the terms of each such payment. Please do not include any shares to be issued upon the conversion of the preferred stock in this disclosure.
Further, please provide us, with a view to ward disclosure in the prospectus, with
disclosure of the net proceeds to the issuer from the sale of the preferred stock and warrants and the total possible payments to all selling shareholders and any of
their affiliates in the first year following the sale of preferred stock and warrants.
3. Please provide us, with a view toward disc losure in the prospectus, with tabular
disclosure of:
• the total possible profit the selling share holders could realize as a result of the
conversion discount for the securities underlying the preferred stock and
warrants, presented in a table with the following information disclosed
separately:
• the market price per share of the s ecurities underlying the preferred stock
and warrants on the date of the sale of the preferred stock and warrants;
• the conversion/exercise price per shar e of the underlying securities on the
date of the sale of the preferred stock and warrants, calculated as follows:
- if the conversion/exercise price per sh are is set at a fixed price, use the
price per share established in the purchase and sale agreement; and
- if the conversion/exercise price per sh are is not set at a fixed price and,
instead, is set at a floating rate in re lationship to the market price of the
underlying security, use the conversi on discount rate and the market
rate per share on the date of the sale of the preferred stock and warrants and determine the conversion price per share as of that date;
• the total possible shares underlying the preferred stock and warrants (assuming no cash dividend payments, co mplete conversion of the shares
of preferred stock and complete exercise of the warrants);
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 3
• the combined market price of the total number of shares underlying the
preferred stock and warrants, calculated by using the market price per share on the date of the sale of th e preferred stock and warrants and the
total possible shares underlying th e preferred stock and warrants;
• the total possible shares the selling shareholders may receive and the
combined conversion price of the to tal number of shares underlying the
preferred stock and warrants calculat ed by using the conversion/exercise
price on the date of the sale of th e preferred stock and warrants and the
total possible number of shares the selling shareholders may receive; and
• the total possible discount to the market price as of the date of the sale of the preferred stock and warrants, calculated by subtracting the total
conversion/exercise price on the date of the sale of the preferred stock and
warrants from the combined market price of the total number of shares underlying the preferred stock and warrants on that date.
If there are provisions in th e certificate of de signation of preferences, rights and
limitations of Series C or in the warrant that could result in a change in the price per share upon the occurrence of certain events, please provide additional tabular
disclosure as appropriate. For example, if the conversion/exercise price per share
is fixed unless and until the market price fa lls below a stated price, at which point
the conversion price per share drops to a lower price, please provide additional
disclosure.
4. Please provide us, with a view toward disc losure in the prospectus, with tabular
disclosure of:
• the total possible profit to be realized as a result of any conversion discounts
for securities underlying any other warrants, options, notes, or other securities of the issuer that are held by the selling shareholders or any affiliates of the selling shareholders, presented in a table with the following information
disclosed separately:
• market price per share of the underlying securities on the date of the sale
of that other security;
• the conversion/exercise price per share as of the date of the sale of that
other security, calculated as follows:
- if the conversion/exercise price per sh are is set at a fixed price, use the
price per share on the date of the sale of that ot her security; and
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 4
- if the conversion/exercise price per sh are is not set at a fixed price and,
instead, is set at a floating rate in re lationship to the market price of the
underlying security, use the conversi on/exercise discount rate and the
market rate per share on the date of the sale of that other security and
determine the conversion price per share as of that date;
• the total possible shares to be received under the particular securities
(assuming complete conversion/exercise);
• the combined market price of th e total number of underlying shares,
calculated by using the market price pe r share on the date of the sale of
that other security and the total possible shares to be received;
• the total possible shares to be received and the combined conversion price
of the total number of shares underlyi ng that other security calculated by
using the conversion price on the date of the sale of that other security and
the total possible number of underlying shares; and
• the total possible discount to the market price as of the date of the sale of that other security, calculated by subt racting the total conversion/exercise
price on the date of the sale of that other security from the combined
market price of the total number of underlying shares on that date.
5. Please provide us, with a view toward disc losure in the prospectus, with tabular
disclosure of:
• the gross proceeds paid or payable to the issuer in the private placement
transaction;
• all payments that have been made or that may be required to be made by the issuer that are disclosed in response to comment 2;
• the resulting net proceeds to the issuer; and
• the combined total possible profit to be realized as a result of any conversion
discounts regarding the secu rities underlying the pref erred stock and warrants
issued in the private placement and any other warrants, options, notes, or other
securities of the issuer that are held by the selling shareholders or any affiliates of the selling shareholders that is disclosed in response to comments 3 and 4.
Further, please provide us, with a view to ward disclosure in the prospectus, with
disclosure – as a percentage – of the total amount of all possible payments as
disclosed in response to comment 2 and th e total possible discount to the market
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 5
price of the shares underlyi ng the preferred stock and warrants as disclosed in
response to comment 3 divided by the net proceeds to the issuer from the sale of
the preferred stock and warrants, as well as the amount of that resulting
percentage averaged over th e term of the warrants.
6. 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 shareholders, any affiliates of the selling shareholders, or any person with whom any selling shareholder has a contractual relationship regarding the transaction (or any 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 secu rities subject to the transaction that
were outstanding prior to the transaction;
• the number of shares of the class of secu rities subject to the transaction that
were outstanding prior to the transacti on and held by persons other than the
selling shareholders, affiliates of th e company, or affiliates of the selling
shareholders;
• the number of shares of the class of secu rities subject to the transaction that
were issued or issuable in connection with the transaction;
• the percentage of total is sued and outstanding securiti es that were issued or
issuable in the transaction (assuming full issuance), with the percentage
calculated by taking the number of shar es issued and outstanding prior to the
applicable transaction and held by persons other than the selling shareholders,
affiliates of the company, or affiliates of the selling shareholders, and dividing that number by the number of shares issued or issuable in connection with the
applicable transaction;
• the market price per share of the class of securities subject to the transaction
immediately prior to the tr ansaction (reverse split ad justed, if necessary); and
• the current market price per share of the class of securities subject to the transaction (reverse split adjusted, if necessary).
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 6
7. Please provide us, with a view toward disc losure in the prospectus, with tabular
disclosure comparing:
• the number of shares outstanding prior to the private placement transaction that are held by persons other than the selling shareholders, affiliates of the company, and affiliates of the selling shareholders;
• the number of shares registered for re sale by the selling shareholders or
affiliates of the selling shareholders in prior registration statements;
• the number of shares registered for re sale by the selling shareholders or
affiliates of the selling shareholders that continue to be held by the selling shareholders or affiliates of the selling shareholders;
• the number of shares that have been so ld in registered resale transactions
by the selling shareholders or affiliates of the selling shareholders; and
• the number of shares registered fo r resale on behalf of the selling
shareholders or affiliates of the selling shareholders 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.
8. Please provide us, with a view toward di sclosure in the prospectus, with the
following information:
• whether the issuer has the intention, and a reasonable basis to believe that
it will have the financial ability, to make all payments and dividends on
the overlying securities; and
• whether – based on information obtained from the selling shareholders – any
of the selling shareholders have an existing short position in the company’s
common stock and, if any of the selling shareholders have an existing short
position in the company’s stock, the following additional information:
- the date on which each such selling sh areholder entered into that short
position; and
- the relationship of the date on which each such selling shareholder entered into that short position to the date of the announcement of the private
placement transaction and the filing of the registration statement ( e.g.,
Bernard Berk
Elite Pharmaceuticals, Inc. August 23, 2007 Page 7
before or after the announcement of the private placement transaction,
before the filing or after the filing of the registration statement, etc.).
9. 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 shareholders, any affiliates of the selling shareholders , or any person with whom any selling
shareholder has a contractual relationsh ip regarding the transaction (or any
predecessors of those persons) – the in formation provided should include, in
reasonable detail, a complete descripti on of the rights and obligations of the
parties in connection with the sale of the preferred stock and warrants; and
• copies of all agreements between the issuer (or any of its predecessors) and
the selling shareholders, any affiliates of the selling shareholders, or any person with whom any selling share holder has a contractual relationship
regarding the transaction (or any predece ssors of those persons) in connection
with the sale of the prefe rred stock and warrants.
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.
10. Please provide us, with a view toward disclosure in the prospectus, with a
description of the method by which the co mpany determined the number of shares
it seeks to register in connection with this registration statement. In this regard, please ensure that the number of shares registered in the fee table is consistent
with the shares listed in the “Selling Shareholders” section of the prospectus.
11. With respect to the shares to be offered for resale by each se lling security holder
that is a legal entity, plea se disclose the natural pers on or persons who exercise
the sole or shared voting and/or dispositive powers with respect to the shares to be
offered by that shareholder.
12. We note that you are registering the sale of up to 4,220,122 shares of common
stock. We also note that you register ed for resale up to 12,786,753 shares of
common stock for many of the same sell ing shareholders in the registration
statement filed on 5/24/07. Given the size relative to the number of shares
outstanding held by no