U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended | September 30, 2012 |
or
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period ended to
| Commission File Number: 001-15697 |
| ELITE PHARMACEUTICALS, INC. |
| (Exact name of registrant as specified in its charter) |
| Nevada | 22-3542636 | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| 165 Ludlow Avenue, Northvale, New Jersey | 07647 | |
| (Address of principal executive offices) | (Zip Code) |
| (201) 750-2646 |
| (Registrant's telephone number, including area code) |
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T ( § 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
| Large Accelerated filer ¨ | Accelerated Filer x | Non-Accelerated Filer ¨ | Smaller Reporting Company ¨ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ¨ No x
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. As of November 8, 2012 the issuer had outstanding 350,337,260 shares of common stock, $0.001 par value (exclusive of 100,000 shares held in treasury).
EXPLANATORY NOTE
This Amendment No. 1 on Form 10-Q/A ("Amendment No. 1") amends our Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 that was filed with the Securities and Exchange Commission, or SEC, on November 14, 2012 (the "Original Filing"). We are filing this Amendment No. 1 solely for the purpose of attaching as Exhibit 10.6 an unredacted copy of the September 21, 2012 Letter Agreement between Elite Pharmaceuticals, Inc. (the “Company”) and ThePharmaNetwork, LLC.
As required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, Item 6 of Part II of the Original Filing has been amended to contain currently dated certifications from our Chief Executive Officer and Chief Financial Officer. The currently dated certifications are attached hereto as Exhibits 31.1 and 31.2. Because no financial statements of Elite Pharmaceuticals, Inc. are contained in this Amendment No. 1, we are not including certifications pursuant to 18 U.S.C. 1350.
No other changes, other than described above, are made to the Original Filing other than to update the cover page of the Original Filing. Unless expressly stated, this Amendment No. 1 does not reflect events occurring after the filing of the Original Filing, nor does it modify or update in any way the disclosures contained in the Original Filing. Accordingly, this Amendment No. 1 should be read in conjunction with our Original Filing and our other filings made with the SEC subsequent to the filing of the Original Filing.
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES
INDEX
PART II – OTHER INFORMATION
| Item 6. | Exhibits | 1 |
| SIGNATURES | 2 |
| PART II. | OTHER INFORMATION |
| Item 6. | Exhibits |
The exhibits listed in the index below are filed as part of this report.
|
Exhibit
Number |
Description | |
| 10.6 | Letter Agreement between the Company and ThePharmaNetwork LLC, dated September 21, 2012.* | |
| 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* | |
| 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* |
* Filed herewith.
1
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No. 1 to be signed on its behalf by the undersigned thereunto duly authorized.
| ELITE PHARMACEUTICALS, INC. | ||
| November 16, 2016 | By: | /s/ Nasrat Hakim |
|
Nasrat Hakim Chief Executive Officer, President and Chairman of the Board of Directors (Principal Executive Officer) |
||
| November 16, 2016 | By: | /s/ Carter J. Ward |
|
Carter J. Ward Chief Financial Officer, Treasurer and Secretary (Principal Financial and Accounting Officer) |
||
2
Exhibit 10.6
September 21, 2012
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Attention: Chris Dick
President
Re: First Amendment
TPN-Elite Manufacturing and Supply Agreement dated June 23, 2011
Gentlemen:
ThePharmaNetwork, LLC, a New Jersey limited liability company and its wholly owned subsidiary, Ascend Laboratories, LLC (together "TPN"), and Elite Pharmaceuticals, Inc. and Elite Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.), both Delaware corporations (together "ELITE") are parties to certain manufacturing and supply agreement effective as of June 23, 2011 (the “Agreement”). All capitalized terms used without definition in this letter agreement have the respective meanings provided in the Agreement.
Effective as of the date of this letter agreement, the parties agree that sections 7.1 9.3. 2.7 and 3.3 of, and Exhibit A attached to, the Agreement are amended in their entirety and, as amended, read as follows:
Section 7.1. Term. The initial term (the “Initial Term”) of this Agreement shall commence on the Effective Date and shall continue until December 31, 2014; thereafter, the term of this Agreement shall be extended for one (1) year terms (each a “Renewal Term”) upon the mutual written agreement of the Parties entered into at least six (6) months prior to the expiration of the Initial Term or a Renewal Term.
Section 9.3. Notices . Except as otherwise specifically provided, any notice or other documents to be given under this Manufacturing Agreement shall be in writing and shall be deemed to have been duly given if sent by registered mail, nationally recognized overnight delivery service or facsimile transmission to a Party or delivered in person to a Party at the address or facsimile number set out below for such Party or such other address as the Party may from time to time designate by written notice to the other:
If to ELITE: Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Attention: President
Facsimile: 201-750-2755
with a copy to: Silverman Sclar Shin & Byrne PLCC
381 Park Avenue South
New York, New York 10016
Attn: Richard Feiner
Facsimile: 917-720-0863
If to TPN: ThePharmaNetwork, LLC
180 Summit Avenue, Suite 200Montvale, NJ 07645
Attention: George Solomon, COO
Facsimile: 201-476-1987
1
with a copy to:
ThePharmaNetwork, LLC
180 Summit Avenue, Suite 200
Montvale, NJ 07645
Attention: Allen Bagatsing, Esq. /Chief Legal Counsel
Facsimile: 201-476-1987
Any such notice provided pursuant to this Section 9.3 shall be deemed to have been received by the addressee five business days following the date of dispatch of the notice or other document by mail or, where the notice or other document is sent by overnight delivery service, by hand or is given by facsimile, simultaneously with the transmission or delivery. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched. Either Party may change its address at which notice is to be received by written notice provided pursuant to this Section 9.3.
Section 3.3. Invoicing and Payment. Payment terms by TPN for Product supplied by ELITE hereunder meeting Product Specifications shall be net 30 days by check or wire transfer, and shall be made without set-off and free and clear of, and without any deduction or withholding for or on account of any taxes, duties, levies, fees or charges, except as otherwise permitted under this Manufacturing Agreement. Product shall be invoiced no sooner than the date of shipment by ELITE. If TPN disputes any invoice, TPN shall notify ELITE that it disputes the accuracy of such invoice specifying in particularity such inaccuracy. TPN and ELITE shall make good faith efforts to resolve any disputes within fifteen (15) days thereafter and subject to Section 7.2 a (iii). Any amounts that are disputed shall be due upon the resolution of such dispute.
Section 2.7. Delays. During the Term of this Manufacturing Agreement, if ELITE is not able to timely meet Product orders submitted by TPN pursuant to Section 2.2, ELITE shall promptly notify TPN of the reason for the delay and the date delivery of Product is expected to occur. If shipment is delayed more than ten (10) business days beyond the date of delivery for reasons other than API supply (including DEA quota issues), then ELITE shall be responsible for any and all customer bill back penalty actually incurred and documented by TPN to be paid by ELITE within fifteen (15) days from receipt of such invoice.
2
Exhibit A- Product and Purchase Price and Minimum Annual Volume Requirements
| Product | Mg |
Bottle
|
Firm Cost Per
Bottle exclusive of API FOB Elite |
Minimum
Annual Volume |
||||
|
Methadone Hydrochloride
10 mg Tablets, ANDA #090635 |
10mg | 100's |
Manufacturing Cost
|
1,000,000 Bottles |
1. All bottles manufactured in excess of 500,000 bottles each calendar year, shall be at a firm cost per bottle exclusive of API FOB Elite of $1.88.
NOTES: The purchase price includes all costs except API cost which is the obligation of TPN and is firm during the term of the Agreement.
ELITE shall produce Product in batch sizes between 2,000 bottles to 10,000 bottles per batch. Elite will begin with the smaller batch sizes and increase batch size as necessary. Starting no later than January, 2013 orders shall be manufactured based on a batch size of 10,000 bottles.
Provided that TPN will give Elite 90 days advance notice, Elite shall accept and be able to guarantee the manufacturing of up to 1,500,000 bottles/year.
During the 12 months ending December 31, 2014 and upon TPN’s written request, Elite must be able to manufacture up to 2,000,000 bottles/year.
ELITE may also, from time to time, subcontract to Epic Pharma, LLC for bottling of batches but at its earliest, will transfer the packaging operations to its own facility.
Except as expressly modified by this letter agreement, the parties agree that the Agreement will continue in full force and effect in accordance with its terms.
If the foregoing correctly sets forth our agreement and understanding, please execute the enclosed counterpart of this letter agreement and return the executed counterpart to the undersigned at your convenience.
(Space left intentionally blank, signature page follows)
3
| THEPHARMANETWORK, LLC |
| By | /s/ George Solomon |
| Name: | George Solomon |
| Title: | COO |
Accepted and agreed as of this September 21, 2012
| ELITE PHARMACEUTICALS, INC. |
| By | /s/ Chris Dick |
| Name: | Chris Dick |
| Title: | President |
4
Exhibit 31.1
CERTIFICATION
I, Nasrat Hakim, certify that:
| 1. | I have reviewed this Amendment No. 1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 of Elite Pharmaceuticals, Inc. (the “Registrant”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report; |
| 4. | The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting. |
| 5. | The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting. |
| Date: November 16, 2016 | /s/ Nasrat Hakim | ||
| Nasrat Hakim | |||
| Chief Executive Officer | |||
| (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
I, Carter J. Ward, certify that:
| 1. | I have reviewed this Amendment No. 1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 of Elite Pharmaceuticals, Inc. (the “Registrant”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report; |
| 4. | The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting. |
| 5. | The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting. |
| Date: November 16, 2016 | /s/ Carter J. Ward | ||
| Carter J. Ward | |||
| Chief Financial Officer | |||
| ( Principal Accounting and Financial Officer) |