x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended December 31, 2010
|
|
OR
|
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
82-0429727
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
Large accelerated filer
|
o
|
Accelerated filer
|
o
|
||
Non-accelerated filer
|
o
|
Smaller reporting company
|
x
|
Page
|
||
3 | ||
|
||
4
|
||
5
|
||
7
|
||
1
5
|
||
23
|
||
23
|
||
2
3
|
||
25
|
||
26
|
||
26
|
||
26
|
||
26
|
||
27
|
||
2
8
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
December 31, 2010
|
December 31, 2009
|
December 31, 2010
|
December 31, 2009
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||
REVENUE
|
$ | - | $ | 118,751 | $ | - | $ | 351,091 | ||||||||
COST OF GOODS SOLD
|
- | 53,663 | - | 121,237 | ||||||||||||
Gross Margin
|
- | 65,088 | - | 229,854 | ||||||||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
|
928,668 | 704,994 | 3,012,993 | 1,987,279 | ||||||||||||
RESEARCH AND DEVELOPMENT
|
2,092,524 | 52,427 | 2,109,820 | 150,990 | ||||||||||||
Loss from Operations
|
(3,021,192 | ) | (692,333 | ) | (5,122,813 | ) | (1,908,415 | ) | ||||||||
OTHER INCOME (EXPENSE)
|
||||||||||||||||
Interest Expense
|
(72,148 | ) | (257,482 | ) | (712,760 | ) | (269,965 | ) | ||||||||
Gain on Sale of Asset
|
- | - | 5,600 | - | ||||||||||||
Net (Loss)
|
$ | (3,093,340 | ) | $ | (949,815 | ) | $ | (5,829,973 | ) | $ | (2,178,380 | ) | ||||
Basic and Diluted (Loss) Per Share:
|
||||||||||||||||
Basic and Diluted (Loss) Per Share
|
$ | (0.04 | ) | $ | (0.02 | ) | $ | (0.09 | ) | $ | (0.05 | ) | ||||
Basic and Diluted Weighted Average Shares Outstanding
|
70,005,275 | 45,695,942 | 67,252,621 | 45,318,811 |
Nine Months Ended
|
||||||||
December 31, 2010
|
December 31, 2009
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
(Unaudited)
|
(Unaudited)
|
||||||
Net Loss
|
$ | (5,829,973 | ) | $ | (2,178,380 | ) | ||
Adjustments to Reconcile Net Loss to Net
|
||||||||
Cash (Used in) Operating Activities:
|
||||||||
Depreciation Expense
|
13,682 | 13,793 | ||||||
Beneficial Conversion Feature Interest
|
- | 249,500 | ||||||
Stock Issued for Interest
|
777 | - | ||||||
Stock Issued for Research & Development Services
|
1,215,000 | - | ||||||
Reduction of Compensation Upon Forgiveness of Accrued Bonus
|
(129,977 | ) | - | |||||
Consulting Expense Paid in Common Stock
|
597,500 | 9,000 | ||||||
Amortization of Discounts
|
527,369 | - | ||||||
Inventory Reserve Adjustment
|
(222,878 | ) | 16,791 | |||||
Amortization of Stock Issued for Services
|
311,904 | - | ||||||
Stock-Based Compensation Expense
|
100,214 | 36,494 | ||||||
Sales Returns Reserve Adjustment
|
307,660 | 2,852 | ||||||
Change in Assets and Liabilities:
|
||||||||
(Increase) Decrease in:
|
||||||||
Accounts Receivable
|
5,555 | (12,647 | ) | |||||
Inventory
|
225,587 | 7,991 | ||||||
Prepaid Expenses and Other Current Assets
|
2,394 | 20,100 | ||||||
Increase (Decrease) in:
|
||||||||
Accounts Payable
|
(306,358 | ) | 571,736 | |||||
Accrued Expenses
|
123,301 | 561,759 | ||||||
Net Cash (Used in) Operating Activities
|
(3,058,243 | ) | (701,011 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Cash Acquired in Cellegy Pharmaceuticals Inc. Acquisition
|
- | 65,114 | ||||||
Purchase of Property and Equipment
|
- | (4,888 | ) | |||||
Net Cash Provided by Investing Activities from Continuing | ||||||||
Operations
|
- | 60,226 | ||||||
Net Cash Provided by Investing Activities from Discontinued Operations
|
150,000 | - | ||||||
Net Cash Provided by Investing Activities
|
150,000 | 60,226 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Proceeds from Issuance of Note Payable
|
- | 500,000 | ||||||
Proceeds from Issuance of Note Payable to Related Parties
|
- | 234,800 | ||||||
Proceeds from the Issuance of Common Stock
|
5,395,000 | 500 | ||||||
Purchase of Treasury Stock
|
(4,127 | ) | (786 | ) | ||||
Payment of Notes Payable to Related Parties
|
(208,333 | ) | (10,000 | ) | ||||
Net Cash Provided by Financing Activities
|
5,182,540 | 724,514 | ||||||
Increase in Cash
|
2,274,297 | 83,729 | ||||||
Cash:
|
||||||||
Beginning
|
290,299 | 17,697 | ||||||
Ending
|
$ | 2,564,596 | 101,426 | |||||
The Accompanying Notes are an Integral Part of These Unaudited Condensed Consolidated Financial Statements.
|
|
Number of
Stock Options
|
Weighted
Average
Remaining
Contractual Life
|
Weighted
Average
Exercise
Price
|
Number of
Stock Options
Vested
|
|||||||
Non-Plan Stock Options
|
100,714
|
2.85 Years
|
$
|
41.27
|
100,714
|
||||||
2009 Equity Incentive Plan
|
3,400,398
|
9.56 Years
|
$
|
.27
|
875,398
|
Warrant Shares
|
Exercise Price Per Share
|
Date Issued
|
Expiration Date
|
||||||
Biosyn Warrants
|
8,245 | $ | 57.97 - 173.92 |
October 22, 2004
|
2013 - 2014 | ||||
Old Adamis Warrants
|
1,000,000 | $ | 0.50 |
November 15, 2007
|
November 15, 2012
|
||||
Consultant Warrants
|
300,000 | $ | 0.25 |
August 26, 2009
|
August 26, 2014
|
||||
Consultant Warrants
|
270,000 | $ | 0.20 |
January 29, 2010
|
January 29, 2015
|
||||
Consultant Warrants
|
200,000 | $ | 0.29 |
October 26, 2009
|
October 26, 2014
|
||||
Various Investors
|
395,000 | $ | 0.30 |
June 14, 2010 -
September 15, 2010
|
June 14, 2015 -
September 15, 2015
|
||||
Total Warrants
|
2,173,245 |
Warrants
|
2,173,245 | ||
Non-Plan Stock Options
|
100,714 | ||
2009 Equity Incentive Plan
|
9,327,398 | ||
Total Shares Reserved
|
11,601,357 |
|
December 31,
2010
|
March 31,
2010
|
||||||
(Unaudited)
|
||||||||
Respiratory and Allergy Products
|
$
|
0
|
$
|
226,710
|
||||
Less: Obsolescence Reserve
|
(0
|
)
|
(224,001
|
)
|
||||
Respiratory and Allergy Products, Net
|
0
|
2,709
|
||||||
Pre-Launch epi Inventory
|
—
|
—
|
||||||
Inventory, Net
|
$
|
0
|
$
|
2,709
|
●
|
the progress and costs of development programs;
|
|
●
|
the commercial success of new products that are introduced;
|
|
●
|
patient recruitment and enrollment in future clinical trials;
|
|
●
|
the scope, timing and results of pre-clinical testing and clinical trials;
|
|
●
|
the costs involved in seeking regulatory approvals for product candidates;
|
|
●
|
the costs involved in filing and pursuing patent applications and enforcing patent claims;
|
|
●
|
future regulatory actions by the FDA and other regulatory agencies;
|
|
●
|
the establishment of collaborations and strategic alliances;
|
|
●
|
the cost of manufacturing and commercialization activities;
|
|
●
|
the results of operations;
|
|
●
|
the cost, timing and outcome of regulatory reviews;
|
|
●
|
the rate of technological advances;
|
|
●
|
ongoing determinations of the potential commercial success of products under development;
|
|
●
|
the level of resources devoted to sales and marketing capabilities; and
|
|
●
|
the activities of competitors.
|
Exhibit
Number
|
Description
|
|
10.1
|
Form of Option Agreement for Non-Employee Directors. (1)
|
|
10.2
|
Form of Director and Officer Indemnity Agreement. (1)
|
|
10.3
|
2009 Equity Incentive Plan. (1)
|
|
10.4
|
Agreement and Plan of Share Exchange dated as of October 7, 2004, by and between the Company and Biosyn, Inc. (2)
|
|
10.5
|
Agreement dated as of October 8, 1996 by and among Biosyn, Inc., Edwin B. Michaels and E.B. Michaels Research Associates, Inc. (Confidential treatment has been requested with respect to portions of this agreement.) (3)
|
|
10.6
|
Patent License Agreement by and among Biosyn, Inc., and certain agencies of the United States Public Health Service. (Confidential treatment has been requested with respect to portions of this agreement.) (4)
|
|
10.7
|
Amendment to Assignment, Assumption and Stock Acquisition Agreement. (5)
|
|
10.8
|
Common Stock Purchase Agreement dated as of November 10, 2010, by and between Adamis and the Purchaser named therein. (Confidential treatment has been requested for portions of this Exhibit.) (6)
|
|
10.9
|
Registration Rights Agreement dated as of November 10, 2010, by and between Adamis and the Purchaser named therein. (Confidential treatment has been requested for portions of this Exhibit.) (6)
|
|
10.10
|
Employment Agreement between the Company and Dennis J. Carlo. (6)
|
|
10.11
|
Employment Agreement between the Company and David J. Marguglio. (6)
|
|
10.12
|
Employment Agreement between the Company and Robert O. Hopkins (6)
|
|
10.13
|
Employment Agreement between the Company and Richard L. Aloi. (6)
|
|
10.14
|
Form of Amendment to Ten Percent Senior Secured Convertible Notes. (7)
|
|
10.15
|
Amendment to G-Max Convertible Promissory Note. (7)
|
|
10.16 | Product Development and Contract Manufacturing Agreement. | |
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.
|
|
32.1
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
.
|
(1)
|
Incorporated by reference to Exhibits filed with the Report on Form 8-K filed January 13, 2011.
|
(2)
|
Incorporated by reference to Exhibit 2.1 to the Form 8-K filed October 26, 2004.
|
(3)
|
Incorporated by reference to Exhibit 10.21 to the Form 10-K filed March 31, 2005.
|
(4)
|
Incorporated by reference to Exhibit 10.22 to the Form 10-K filed March 31, 2005.
|
(5)
|
Incorporated by reference to Exhibit 10.1 to the Form 8-K filed October 19, 2010.
|
(6)
|
Incorporated by reference to Exhibits filed with the Report on Form 8-K filed November 12, 2010.
|
(7)
|
Incorporated by reference to Exhibits filed with the Report on Form 8-K filed December 10, 2010.
|
ADAMIS PHARMACEUTICALS, INC.
|
|||||
Date:
|
February 14, 2011
|
/s/ Dennis J. Carlo
|
|||
Dennis J. Carlo
|
|||||
Chief Executive Officer
|
|||||
Date:
|
February 14, 2011
|
/s/ Robert O. Hopkins
|
|||
Robert O. Hopkins
|
|||||
Vice President, Finance and Chief Financial Officer
|
whereas,
|
BEXIMCO is engaged in the manufacturing of pharmaceutical finished dosage forms and bulk raw materials (APIs) and marketing of those PRODUCTS both at home and abroad.
|
whereas,
|
ADAMIS is willing to authorize BEXIMCO to manufacture certain pharmaceutical products for the United States of America (USA) hereinafter referred to as the TERRITORY.
|
whereas,
|
BEXIMCO is interested to manufacture certain pharmaceutical products for ADAMIS in its facilities at Tongi, Gazipur, Bangladesh.
|
1.1
|
In this Agreement (including the recitals above) the following terms will have the meanings set out below:
|
(a)
|
either is or becomes available to the public other than as a result of disclosure by the other party;
|
(b)
|
at the time of receipt is already in the possession of the other party or becomes lawfully available to the other party on a non-confidential basis from a third party entitled to make that disclosure; or
|
(c)
|
is independently developed by the other party without reference to Confidential Information received hereunder, as evidenced by the other party's own records.
|
1.2
|
In this Agreement, unless the context otherwise requires:
|
|
(a)
|
Headings and under linings are for convenience only and do not affect the interpretation of this Agreement;
|
|
(b)
|
Words importing the singular include the plural and vice versa;
|
|
(c)
|
Words importing a gender include any gender;
|
|
(d)
|
A reference to a part, clause, party, annexure, exhibit or schedule is a reference to a part, clause, party, annexure, exhibit or schedule to, this Agreement; and
|
|
(e)
|
A reference to a person includes any individual or individuals, corporation, partnership or other body, entity or other legal person.
|
2
|
OBJECT OF THE AGREEMENT
|
2.1
|
Subject to the terms and conditions of this Agreement, BEXIMCO agrees to support commercialization of certain Products for ADAMIS and to contract manufacture these products for ADAMIS, listed in Appendix 1
|
2.2
|
The manufacturing of the Products shall be carried out at BEXIMCO’s premises at Tongi, Gazipur, Bangladesh.
|
3
|
PRODUCT DEVELOPMENT
|
3.1
|
For existing formulations of BEXIMCO, ownership will remain with BEXIMCO. For any newly developed formulation(s) ownership will be determined after mutual discussion.
|
3.2
|
BEXIMCO and ADAMIS will contribute their efforts and cooperate in activities related to assessment of regulatory issues, product definition and analysis relating to the Products for the Territory.
|
3.3
|
BEXIMCO will contribute its knowledge in development, regulatory, pharmaceutical / laboratory science and manufacturing capabilities necessary to commercialize the Products.
|
3.4
|
BEXIMCO will provide for and oversee raw materials and primary packaging materials (where applicable) sourcing, manufacturing, and provide contract management for suppliers.
|
3.5
|
ADAMIS will conduct or oversee clinical research studies, product testing necessary to obtain market clearance/regulatory approvals for Products, and additional indications as applicable.
|
3.6
|
ADAMIS will ensure all Intellectual Property, regulatory and registration requirements are satisfactorily addressed for the Territory.
|
3.7
|
When a third party involvement is necessary, such involvements will be discussed mutually, including costs sharing matters and needs to be approved by both BEXIMCO & ADAMIS.
|
4.
|
MARKETING AUTHORISATION
|
4.1
|
ADAMIS will be responsible for the regulatory dossier development, USFDA interactions including filings. Beximco will be responsible for site inspections required by the FDA or other governing body. Adamis will require support and data from Beximco to complete the dossier. Adequate support will be provided by Beximco at agreed upon rates.
|
4.2
|
ADAMIS will be responsible for the payment of annual fees and charges payable in respect of receiving and maintaining the Marketing Authorisations for the Products and other costs related to any variation of a Marketing Authorisation for the Products.
|
4.3
|
BEXIMCO warrants that all information supplied to ADAMIS in relation to the Products is true to the best of BEXIMCO’s knowledge after all due enquiries and that it is legally entitled to supply this information to ADAMIS.
|
4.4
|
BEXIMCO warrants that BEXIMCO will maintain any GMP licence granted to it under any scheme in the United States of America or Australia or any scheme recognised by the USFDA and will use reasonable endeavours to promptly provide ADAMIS with evidence of this when requested by ADAMIS to do so.
|
5.
|
PRICE AND PAYMENT
|
5.1
|
ADAMIS will bear the expense of regulatory filings including any clinical studies performed for the purpose of obtaining regulatory clearance or approval for marketing of the Products. This may be decided on a product by product basis
|
5.2
|
ADAMIS will bear the expense of all studies and development activities required for the purpose of obtaining regulatory clearance or approval for marketing of the Products in the Territory. However, this agreement may change with changes to individual product agreements.
|
5.3
|
In the case of newly formulated drug products i.e., truly novel formulations, BEXIMCO will bear cost and retain ownership of any patent specific to the drug unless parties agree to a separate development and cost-sharing agreement pertaining to such new drug(s).
|
5.4
|
ADAMIS and BEXIMCO will agree on a transfer price (CIF) for the Products supplied on a contract manufacturing basis. ADAMIS shall open irrevocable Letter of Credit at sight in favor of BEXIMCO, payable at 30 days from the date of the shipment for required Products as per mutually agreed price list and BEXIMCO would supply to ADAMIS the Products in accordance with the irrevocable letter of credit opened by ADAMIS.
|
5.5
|
Any price change with respect to a Product will be determined by written agreement between the parties following an annual review of prices.
|
5.6
|
ADAMIS will pay for any royalties from the utilization of any third parties formulation/Intellectual Property or Patents (if necessary).
|
5.7
|
Title in respect of the Products shipped under this Agreement shall pass from BEXIMCO to ADAMIS upon BEXIMCO’s receipt of full payment in respect thereof and risk in the Products will pass on delivery.
|
6.
|
SUPPLY
|
6.1
|
BEXIMCO will maintain stocks of Products as agreed upon by both parties.
|
6.2
|
After the grant of the Marketing Authorisation by USFDA, ADAMIS will provide BEXIMCO with an initial schedule of its anticipated requirements for the Products for the remainder of the then current calendar year and thereafter on an annual basis for each succeeding calendar year by 30 September, provided however that ADAMIS may provide BEXIMCO with amendments to any such schedule on a quarterly basis. Such schedules are estimates only and do not constitute firm orders. ADAMIS shall have the right to revise the forecast in accordance with the market situation informing BEXIMCO, 90 days in advance. But any firm order, for which Beximco has already commenced manufacturing, cannot be cancelled and will be paid for in full by ADAMIS.
|
6.3
|
ADAMIS will place written orders for the Products with BEXIMCO, specifying quantities (which must be in accordance with the batch sizes for a Product set mutually by both parties), Product Mix and delivery dates (not being less than 90 days in advance and preferably no less that 120 days in advance) and BEXIMCO will be deemed to have confirmed these if advice to the contrary, in writing, is not received by ADAMIS within 10 days. After confirmation by BEXIMCO, ADAMIS shall not be entitled to cancel such written orders but may reschedule if Beximco has not commenced manufacturing of the batch.
|
6.4
|
BEXIMCO will use its reasonable endeavours to supply or arrange the supply of the ordered quantities of Products by the confirmed delivery dates.
|
6.5
|
The supply of the Products will be CIF to a single location point in USA as specified at the time of ordering.
|
6.6
|
ADAMIS will bear all expenses related to tax, customs clearance, storage, transportation, maintenance and delivery of PRODUCTS in the Territory.
|
6.7
|
In case of any adverse conditions affecting the supply or delivery of any Products to ADAMIS, BEXIMCO will immediately inform ADAMIS of the same and ADAMIS shall grant reasonable time for BEXIMCO to supply the Products.
|
6.8
|
BEXIMCO will supply a Certificate of Analysis with each delivery of the Products.
|
7.
|
MANUFACTURE, TRANSPORT, STORAGE AND DISTRIBUTION OF THE PRODUCTS
|
7.1
|
BEXIMCO warrants that all quantities of the Products supplied by BEXIMCO to ADAMIS pursuant to this Agreement will:
|
|
(a)
|
Conform in all respects to the Product Specification; and
|
|
(b)
|
Be of merchantable or satisfactory quality; and
|
|
(c)
|
Upon delivery at Bangladesh port, have a shelf life, which is at least 75% of the longest registered shelf life for the Products in the Territory.
|
7.3
|
BEXIMCO and ADAMIS agree to execute the GMP Agreement after the execution of this Agreement. Said Agreement will be attached hereto as Annexure 2.
|
7.4
|
BEXIMCO will supply ADAMIS with adequate written directions concerning suitable conditions for storage and transportation of the Products and ADAMIS represents it will store and transport the Products materially in accordance with those directions.
|
7.5
|
If the Product is to be supplied unpackaged, BEXIMCO will supply ADAMIS with adequate written directions concerning the packaging of the Products and ADAMIS represents it will materially accord with those directions and pack the product at a USFDA approved facility.
|
7.6
|
In the event that either of the parties becomes aware of any defect in the Products or that the Products are unsuitable for the use designated in the Market Authorisation, it will immediately notify the other party and provide them with a full disclosure of that defect or unsuitability.
|
7.7
|
ADAMIS assumes all risk of loss and indemnifies and holds harmless BEXIMCO and its employees, agents successors and assigns from and against any and all loss, liability, damage, fee, cost, expense, suit, claim, demand, judgement and prosecution directly or indirectly arising from or incidental to or resulting solely from the storage and distribution and sale of the Products by ADAMIS or its employees, agents successors and assigns EXCEPT where such liability arises out of the Formulation, the manufacture of the Products or the storage of the Products by ADAMIS in accordance with the written directions detailed in clause 7.4.
|
7.8
|
Notwithstanding clause 7.7, where any defect or unsuitability in the Products arises either partially or wholly as a result of a defect or unsuitability in raw material supplied to BEXIMCO by a third party, BEXIMCO will use its reasonable endeavours to have the third party conform to any demands of the regulatory authority concerning the defect.
|
7.9
|
BEXIMCO will not assume any risk of loss, liability, damage, fee, cost, expense, suit, claim, demand, judgement and prosecution directly or indirectly arising from or incidental to any defect or unsuitability in the Product arising either partially or wholly as a result of tampering by any person after delivery to ADAMIS’s nominated warehouse.
|
8.
|
MARKETING AND OTHER RELATED DUTIES OF THE PARTIES
|
8.1
|
ADAMIS will plan and execute product launch and ongoing marketing activity, including introduction into wholesale distribution channels, detailing to pharmacies and clinicians, and marketing to managed care organizations, government entities, and other payors.
|
8.2
|
ADAMIS will arrange for co-promotion and/or license to sub-distributors as desirable in the judgment of ADAMIS management, in consultation with BEXIMCO for the purpose of expanding the market presence or ability to reach specific physician specialties.
|
8.3
|
ADAMIS will put efforts to evaluate market opportunity for the Products, including defining candidate medications, defining marketing strategy, including identifying targeted clinical indications, product naming and branding strategy, and product pricing, promotion and sales strategy.
|
8.4
|
ADAMIS shall make no representation to any person about the Products that is false or misleading in any material particular. In no event will the ADAMIS make any representation beyond those contained in the Product claims or supporting material supplied by BEXIMCO.
|
8.5
|
Each party warrants that it has in place from a reputable insurer product liability insurance covering the party’s respective products with limits of not less than $5 million USD in aggregate. Requirements for insurance levels will increase as products are introduced and approved for marketing and sales in the US. Insurance requirements should be reviewed on an annual basis by each party. Each party shall promptly deliver a certificate of insurance to the other party upon the other party’s written request. Further, a party shall, during the Term of this Agreement, promptly notify the other party of the cancellation or lapse of said insurance. If the party fails to rectify the same within thirty (30) calendar days after notice from the other party, any such failure shall be deemed a material breach of this Agreement.
|
9.
|
ADVERSE DRUG EVENTS
|
9.1
|
The obligations of the parties for when an adverse drug event occurs are set out in Annexture 3.
|
10.
|
RECALLS
|
10.1
|
If a law applicable in the Territory requires that any quantity of the Products should be recalled by ADAMIS for any reason, ADAMIS will give to BEXIMCO written notice of its intention to recall that quantity and specify its reasons for the need to carry out the recall, including by providing copies of documents of a competent Authority requiring the recall.
|
10.2
|
If within 7 days of the receipt of the notice the parties are unable to agree upon the need to carry out the recall, the parties agree to submit a sample of the Product to an Independent Analyst for a report. The determination of the Independent Analyst shall be binding upon the parties.
|
10.3
|
The cost of the report of the Independent Analyst will be paid by the party against which the report is unfavourable.
|
10.4
|
Notwithstanding clauses 10.1 to 10.3, ADAMIS may recall that quantity of Products at any time and will administer any such recall in the Territory at its own cost.
|
10.5
|
Notwithstanding anything to the contrary herein, in the event that the sole reason for recall of the Products is that the Products do not conform with the Product Specification due to storage or transport of the Products by ADAMIS or its affiliates or delegates which is not in accordance with the written directions given to ADAMIS under clause 8.4, then ADAMIS will be liable for the cost of the recall and any replacement quantities of Products.
|
11.
|
WARRANTIES AND LIABILITIES
|
11.1
|
BEXIMCO warrants that at the time of delivery all Product manufactured and supplied under this Agreement shall meet the Specification, be manufactured and supplied in accordance with cGMP and will be free of defects in material and workmanship.
|
11.2
|
With regard to the Product, ADAMIS’s sole remedy for breach of the warranty in clause 11.1 above shall be at ADAMIS’s determination either a full refund or that BEXIMCO will as soon as is reasonably practicable, and without charge to ADAMIS, repair or (at BEXIMCO’s option) replace Products which are proven to the reasonable satisfaction of BEXIMCO to not conform with the Specification. This obligation will not apply where:
|
|
(a)
|
The Products have been improperly altered in any way whatsoever, or have been subject to misuse or unauthorized repair;
|
|
(b)
|
Any instructions as to storage of the Products have not been complied with in all respects; or
|
|
(c)
|
ADAMIS has failed to notify BEXIMCO in writing of any defect or suspected defect within 30 days of delivery of Products.
|
11.3
|
BEXIMCO agrees to indemnify ADAMIS from and against all losses, claims, demands, cost (including any costs incurred from return of defective Products) and other reasonable legal fees incurred by ADAMIS or arising from any injury to any person as a result of any breach by BEXIMCO of the warranty in clause 11.1, provided that ADAMIS (i) promptly gives BEXIMCO written notice of such claim, (ii) neither negotiates nor makes any settlement of nor makes any admission in relation to such claim and (iii) provides reasonable assistance (at BEXIMCO’s cost) to BEXIMCO to defend or settle such claim.
|
11.4
|
BEXIMCO does not exclude its liability (if any) to ADAMIS:
|
|
(a)
|
For personal injury or death resulting from BEXIMCO’s negligence;
|
|
(b)
|
For any matter for which it would be illegal for BEXIMCO to exclude or to attempt to exclude its liability; or
|
|
(c)
|
For fraud.
|
11.5
|
Except as expressly provided otherwise in clause 11.2
,
BEXIMCO will be under no liability to ADAMIS whatsoever (whether in contract, tort (including negligence), breach of statutory duty, restitution or otherwise) for any of the following losses or damage (whether such losses or damage were foreseen, foreseeable, known or otherwise): loss of revenue, loss of actual or anticipated profits (including for loss of profits on contracts), loss of the use of money, loss of anticipated savings, loss of business, loss of opportunity, loss of goodwill, loss of reputation, loss of, damage to or corruption of data, or any indirect or consequential loss or damage howsoever caused.
|
11.7
|
The aggregate liability of BEXIMCO to ADAMIS with respect to all claims arising out of this Agreement with the exception of any claims made pursuant to clause 11.3 (or the subject matter hereof) during any period of 12 months either (a) during the period of this Agreement, and/or (b) after the termination or expiration of this Agreement, shall be limited to damages not exceeding the purchase price paid by ADAMIS for Products in 12 months preceding the date of any claim.
|
11.8
|
Except as set out in clause 11.1
,
BEXIMCO hereby excludes to the fullest extent permissible by law, all conditions, warranties and stipulations, express (other than those set out in this Agreement) or implied, statutory, customary or otherwise which, but for such exclusion, would or might subsist in favour of ADAMIS.
|
12.
|
INSPECTION OF THE PLANT
|
12.1
|
Up to two employees of ADAMIS or its authorised representatives will have the right, upon giving reasonable notice to BEXIMCO, to visit BEXIMCO's manufacturing plant in respect of Products specified in Annexure 1. Unless for cause, ADAMIS may visit BEXIMCO’s manufacturing plant once a year for a maximum of two days each during normal business hours. During any such visit, ADAMIS will have the right to:
|
|
(a)
|
Inspect the manufacturing facilities;
|
|
(b)
|
Inspect quality control procedures; and
|
|
(c)
|
Inspect records and reports pertinent to the manufacture, quality control or transport of those of the Products manufactured by BEXIMCO.
|
12.2
|
BEXIMCO will permit the inspection by any relevant regulatory authority of the Territory, which is required, as part of the Marketing Authorisation, including the inspection of:
|
|
(a)
|
The manufacturing facilities;
|
|
(b)
|
Quality control procedures; and
|
|
(c)
|
Records and reports pertinent to the manufacture, quality control or transport of those of the Products manufactured by BEXIMCO
|
12.3
|
BEXIMCO warrants that for the duration of the Agreement, its manufacturing facilities for the Products comply with the regulatory requirements for the Marketing Authority of the Territory and GMP.
|
12.4
|
If in the manufacture of any of the Products BEXIMCO uses raw material supplied from a third party or sources Products from a third party, BEXIMCO will use all reasonable commercial endeavours to procure the agreement of that third party to permit the inspection by any relevant regulatory authority of the Territory, which is required as part of the Marketing Authorisation, including the inspection of the third party’s:
|
|
(a)
|
Manufacturing facilities;
|
|
(b)
|
Quality control procedures; and
|
|
(c)
|
Records and reports pertinent to the manufacture, quality control or transport of the Products
|
13.
|
TRADE MARKS
|
13.1
|
If providing Product in packaged form, BEXIMCO will apply a trademark nominated by ADAMIS to such Product according to the directions and specifications provided by ADAMIS from time to time.
|
13.2
|
Other than as set out in this clause 12, BEXIMCO makes no warranty or representation in relation to the Intellectual Property Rights contained in the Products and any prior statements or representations are hereby revoked.
|
13.3
|
ADAMIS shall be solely responsible for its trade marks applied to Products or packaging of Products according to clauses 12.5 and ADAMIS indemnifies and shall keep indemnified BEXIMCO from and against any and all claims, liabilities, costs (on an indemnity basis) expenses, damages by any third party making any allegation concerning such trade marks.
|
14.
|
CONFIDENTIALITY
|
14.1
|
Each of the parties will not, unless specifically authorised by the other party or by this Agreement:
|
|
(a)
|
Disclose any Confidential Information of the other party to a third party;
|
|
(b)
|
Make use of any Confidential Information of the other party for any purpose other than for the purposes set forth in this Agreement; or
|
|
(c)
|
Make, or allow anyone else to make, copies of any Confidential Information of the other party unless for the purposes set forth in this Agreement.
|
14.2
|
Each of the parties will:
|
|
(a)
|
Use its best endeavours to prevent unauthorised disclosure of the Confidential Information of the other party, by its employees; and
|
|
(b)
|
Restrict the disclosure of the Confidential Information of the other party to only those of its employees or employees of its affiliates or delegates who require the Confidential Information for the purposes of fulfilling that party’s obligations under this Agreement and to the relevant regulatory authority in the Territory.
|
14.3
|
Subject to clause 13.4, all Confidential Information, whether in permanent or magnetic/computer disk form or any other form will be returned to the party who disclosed the Confidential Information within 30 days of being requested to do so. However ADAMIS shall have no obligation pursuant to clause 13.3 if the return of Confidential Information would result in ADAMIS’s inability to exercise any of its valid rights pursuant to this Agreement including but not limited to the sale of Products.
|
14.4
|
Each party may:
|
|
(a)
|
Provide one copy of the Confidential Information to its legal advisers, to be held by them solely for the purpose of determining the scope of that party’s obligations under this clause; and
|
|
(b)
|
Retain one copy of such of the Confidential Information that is required: in order to maintain its obligation of confidence described herein; or by the relevant authorities in the Territory, to be retained by that party.
|
15.
|
ACCOUNTS
|
15.1
|
ADAMIS and BEXIMCO will keep proper books of account and records (including stock records) clearly recording all matters and transactions relating to the Products, and stocks of the Products, held from time to time.
|
16.
|
REPRESENTATION AND WARRANTS OF THE AGREEMENT
|
16.1
|
The parties hereto agree and acknowledge each with the other that, each of the parties hereto has entered into this Agreement in reliance on the representations and warranties of the other party in the following terms, and each party hereby accordingly warrants and represents that:
|
16.2
|
It is duly incorporated with limited liability and validly existing under the laws of the country in which it is incorporated and has the power to own its own assets and to conduct the business which it conducts;
|
16.3
|
It has power under its constitution to enter into this Agreement in connection therewith and to exercise its rights and perform its obligations there under;
|
16.4
|
That all corporate or other actions required to authorize the execution and performance by it of its obligations under this Agreement has been duly taken, including the obtaining of all consents or approvals of, or exemptions by, any state, governmental or public bodies and authorities whether required in Bangladesh or otherwise;
|
16.5
|
The signing and delivery of this Agreement and the performance of any of the transactions contemplated hereunder will not contravene or constitute a default under any provision contained in any agreement, instrument, law, judgment, order, license, permit or consent by which it is bound or affected; and
|
16.6
|
All acts, conditions and things required by the laws of Bangladesh to be carried out, fulfilled and performed in order to ensure that its obligations under the Agreement are legal, valid and enforceable and to make the Agreement admissible in evidence in Bangladesh have been carried out, fulfilled and performed in strict compliance with the laws of Bangladesh.
|
17.
|
EXECUTION OF THE AGREEMENT
|
17.1
|
This agreement shall come into force immediately upon signature by the parties concerned. This Agreement shall be for a term of 5 (Five) years and will be renewed automatically for 5 (Five) years unless either party notifies the other of its intention not to renew the same.
|
18.
|
TERMINATION OF THE AGREEMENT
|
18.1
|
This agreement may be terminated by either of the parties by providing 3 (three) months’ prior written notice.
|
18.2
|
On the occurrence of an Event of Default as defined hereunder, the non-defaulting party shall serve a notice of default on the defaulter requesting it to cure the breach within 15 (fifteen) days from the date of the notice, failing which the non-defaulter shall be entitled forthwith to terminate this Agreement.
|
18.3
|
If the Event of Default is cured, the notification letter becomes null and void. If the Event of Default is not curable, then the non-defaulting party shall be entitled to terminate this Agreement upon serving 7 (seven) days’ notice.
|
18.4
|
An Event of Default shall occur on following:
|
(a)
|
A breach of any terms of this Agreement;
|
(b)
|
A breach in payment obligation under this Agreement;
|
(c)
|
Any representation or warranty under this Agreement proving to be incorrect and such representation or warranty having an adverse effect on the party’s ability to perform its obligation therein;
|
(d)
|
Ceases to function as a going concern or conduct its operations in the normal course of business;
|
(e)
|
Is declared bankrupt, insolvent or is subject to an order of the court for attachment of its asset, including and not limited to suspension of operation of business/bank accounts;
|
(f)
|
Is subject to winding up proceeding whether voluntary or involuntary or an order of the court has been made for appointment of liquidator or receiver to manage the assets/affairs of such party; or
|
18.5
|
Upon termination of this agreement for any reason whatsoever the parties shall:
|
|
(a)
|
Settle all outstanding dues up to the date of termination of this Agreement between the parties hereto within 30(thirty) days of the termination.
|
|
(b)
|
ADAMIS shall return to BEXIMCO all documents and any other materials related to PRODUCTS or to this Agreement as may have been supplied by BEXIMCO within 30 (thirty) days, except for those documents which they are required to retain according to the law of the country
|
|
BEXIMCO shall return to ADAMIS all documents and any other materials related to PRODUCTS or to this Agreement as may have been supplied by ADAMIS within 30 (thirty) days, except for those documents which they are required to retain according to the law of the country
|
|
(c)
|
Both parties shall not be discharged from their responsibilities from any pending orders until such orders have been completed and paid for notwithstanding the termination of this Agreement.
|
19.
|
FORCE MAJEURE
|
19.1
|
Failure on the part of either party to perform any of its obligations set forth in this Agreement will not give either Party to this Agreement any claim against the other Party or be deemed to be a breach of the Agreement to the extent that such failure arises from Force Majeure. If through Force Majeure, the fulfillment of either Party of any obligation set forth in this Agreement will be delayed, the period of such delay will not be counted on in computing periods prescribed by this Agreement. Any Party failing to perform its obligations under this Agreement because of Force Majeure shall give notice in writing to the other Party of such force majeure as soon as possible after the occurrence.
|
19.2
|
Force majeure shall include any war, civil commotion, floods, earthquake, fire, strike, governmental action, lockout, accident, epidemic or any other event of any nature or kind whatsoever beyond the control of the Parties that directly or indirectly hinders or prevents the Parties from commencing or proceeding with consummation of the transactions contemplated hereby. Any Party hereto who fails because of force majeure to perform its obligations hereunder will upon the cessation of force majeure, take all reasonable steps within its power to resume with the least possible delay compliance with its obligations. If the conditions of force majeure shall continue for a period exceeding 6 months, then the Parties shall meet to decide upon the future performance of the Agreement.
|
20.
|
NOTICES
|
20.1
|
Any notice given under this Agreement must be in writing and will be deemed duly given or made if given to a party personally or sent by registered post or facsimile to the address or facsimile number shown below.
|
|
ADAMIS Pharmaceuticals Corp,
|
|
Attn: CEO
|
|
2658 Del Mar Heights Road, Suite 555
|
|
Del Mar, California 92014, USA
|
|
Other Party:
|
BEXIMCO PHARMACEUTICALS LTD.
|
|
Attn: Managing Director
|
|
17 Dhanmandi R/A, Road No. 2
|
|
Dhaka 1205, Bangladesh
|
|
Phone: +880 2 8619 151 (5 lines)
|
|
Fax: +880 2 8613 888
|
20.2
|
Either party may change its address or facsimile number for the purpose of this Agreement by giving notice of the change to the other party.
|
20.3
|
A notice will be deemed to be received by a party in the following circumstances:
|
|
(a)
|
The elapse of 24 hours from the dispatch of the notice by facsimile transmission, where the transmission report confirms that the notice has been dispatched without a transmission error to the correct facsimile number;
|
|
(b)
|
The elapse of 3 business days from the dispatch of the notice by mail to a destination within the same jurisdiction; and
|
|
(c)
|
The elapse of 7 business days from the dispatch of the notice by mail to a destination outside the jurisdiction.
|
21.
|
ARBITRATION
|
21.1
|
All disputes arising out of the interpretation or the implementation of this Agreement shall be referred to a panel of arbitrators of London, UK. Each party shall appoint one arbitrator and the third arbitrator shall be appointed by the first two. The arbitration shall be conducted in accordance with the `Rules of Arbitration and Reconciliation’ of the International Chamber of Commerce.
|
22.
|
OTHERS
|
22.1
|
Any amendment to this Agreement shall not be valid unless duly executed by the authorized persons of both the parties.
|
22.2
|
This Agreement is subject to decisions of both parties’ policies, interest and the government regulations.
|
22.3
|
All notices between the parties hereto shall be made in writing. The notice period shall be deemed to start from the date of receiving the same by the either of the parties concerned. The notices to the parties shall be sent to their registered official addresses.
|
22.4
|
This Agreement has been extended in two originals written in English, one of these has been retained by BEXIMCO and the other by ADAMIS.
|
Adamis Pharmaceuticals Corp.
|
Beximco Pharmaceuticals Ltd.
|
|||
Signature
:
|
/s/ Dennis Carlo
|
Signature
:
|
/s/ Nazmul Hassan
|
|
Name:
|
Dennis J. Carlo, PhD
|
Name:
|
Nazmul Hassan, MD
|
|
Title:
|
CEO Adamis Pharmaceuticals Corp
|
Title:
|
In witness of:
|
In witness of:
|
|
1. | 1. |
Sl. No.
|
Product Description
|
Strength
|
Pack Size
|
Operations to be completed by BEXIMCO
|
||
1 |
Salbutamol Inhalation
Aerosol with HFA propellant
|
100 mcg/ actuation
|
200 doses
|
Complete product under ADAMIS’s brand/generic name
|
||
2 |
Beclometasone Nasal Spray with HFA propellant
Aerosol with HFA propellant
|
Complete product under ADAMIS’s generic name
|
||||
3 |
Beclomethasone Inhalation
Aerosol with HFA propellant
|
50 mcg/ actuation
|
200 doses
|
Complete product under ADAMIS’s generic name
|
||
4 |
Beclomethasone Inhalation
Aerosol with HFA propellant
|
100 mcg/ actuation
|
200 doses
|
Complete product under ADAMIS’s generic name
|
GMP AGREEMENT
SPECIFICATION OF GMP RESPONSIBILITES FOR PRODUCT SUPPLY TO USA
|
1.
|
In order to comply with the current USFDA Code of GMP for medicines the following GMP agreement is entered into between.
|
1.1
|
Contract Giver:
ADAMIS Pharmaceuticals Corp,2658 Del Mar Heights Road,
Suite 555 Del Mar, California 92014, USA ,(hereunder called ADAMIS or “Sponsor”)
|
1.2
|
Contract Acceptor:
Beximco Pharmaceuticals Ltd with its registered office at:
17 Dhanmandi R/A, Road No. 2, Dhaka-1205, Bangladesh and pharmaceutical manufacturing facility located at:
126, Kathaldia, Auchpara, Tongi 1711, Gazipur, Bangladesh (hereunder called “Beximco”)
|
2.
|
Beximco Agrees to manufacture / package the products listed in the ‘Annexure 1’ as requested by the receipt of a purchase order following the signing & / or a current GMP agreement with Sponsor.
|
Activity |
Responsibility
|
|||
Beximco
|
Sponsor (ADAMIS)
|
|||
1
|
Sponsors / or appointed quality representative will be given access to Beximco premises for the purpose of GMP audits as agreed by
|
Ö
|
||
2
|
Starting Materials | |||
2.1
|
Specified by |
Ö
|
Ö
|
|
2.2
|
Supplied by (refer to quotation) |
Ö
|
||
2.3
|
Approved by |
Ö
|
||
3
|
Packaging Materials | |||
3.1
|
Specified by |
Ö
|
Ö
|
|
3.2
|
Supplied by |
Ö
|
||
3.3
|
Approved by |
Ö
|
Ö
|
|
4
|
Labels | |||
4.1
|
Specified by |
Ö
|
Ö
|
|
4.2
|
Supplied by |
Ö
|
||
4.3
|
Approved by |
Ö
|
||
4.4
|
Verified by |
Ö
|
||
5
|
Printed Materials | |||
5.1
|
Specified by |
Ö
|
Ö
|
|
5.2
|
Supplied by |
Ö
|
||
5.3
|
Approved by |
Ö
|
||
6
|
Master / Listing Formula | |||
6.1
|
Product registration with USFDA supplied by |
Ö
|
||
6.2
|
Processing instructions supplied by |
Ö
|
Ö
|
|
6.3
|
Product Specifications supplied by |
Ö
|
Ö
|
|
6.4
|
Manufacturing process change – communication with USFDA |
Ö
|
||
7
|
Master packaging B.O.M. | |||
7.1
|
Supplied by |
Ö
|
||
7.2
|
Processing instructions supplied by |
Ö
|
||
7.3
|
Specifications |
Ö
|
Ö
|
|
8
|
Beximco Master Document / Product Specifications | |||
8.1
|
Prepared by |
Ö
|
||
8.2
|
Approved by |
Ö
|
Ö
|
|
9
|
Bulk Release |
Ö
|
||
10
|
Release for supply
|
|||
10.1
|
Release to USA
The person responsible for quality control and release for final packaging or supply of Products shall, to the extent determined by this agreement, be the Head of Quality or the person deputised to act on his/her behalf.
The final release document to include a statement that the specific product is released as per USFDA GMP and product registration.
|
Ö
|
||
11
|
Expiry Date
|
|||
Responsibility of
|
Ö
|
|||
12
|
Product Stability
|
|||
Responsibility of
|
Ö
|
|||
13
|
Customer’s Complaints
|
|||
13.1
|
Initial investigation including safety & efficacy
|
Ö
|
Ö
|
|
13.2
|
Follow up investigation relating to
|
|||
Manufacturing
|
Ö
|
|||
Packaging
|
Ö
|
|||
Control Testing
|
Ö
|
|||
14
|
Responses to Complaint
|
|||
14.1
|
Initial to contract giver
|
Ö
|
||
14.2
|
Final reply to customer
|
Ö
|
||
15
|
Retention Samples
|
|||
15.1
|
Starting Materials
|
Ö
|
||
15.2
|
Finished Pack
|
Ö
|
||
16
|
Records
|
|||
16.1
|
Batch documentations maintained by
|
Ö
|
||
17
|
Potential hazards to Premises, Plant / or Personnel
|
|||
17.1
|
(specify if known)
|
Ö
|
||
18
|
Product Deviations Prepared
|
Ö
|
||
Approved / Rejection
|
Ö
|
19
|
Beximco and Sponsor agree that all information and documentation not in the public domain nor previously known to either party, passing between Beximco and Sponsor will be kept strictly confidential and is not to be divulged to any other party except to:
1. Beximco employees in order to carry out manufacturing & / or packaging processes & / or
2. government authorities for any mandatory requirements & / or
3. It should not pass to a third party any of the work entrusted to it by Sponsor without the latter having evaluated & consented to
|
Ö
|
Ö
|
I, Dennis J. Carlo, certify that:
|
||
1.
|
I have reviewed this quarterly report on Form 10- Q of Adamis Pharmaceuticals Corporation;
|
|
2.
|
Based on my knowledge, this quarterly 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 quarterly report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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 Acts Rules 13a-15(f) and 15(d-15(f)) for the registrant and we 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 quarterly report is being prepared; and
|
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting disclosure 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; and
|
|
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; and
|
|
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 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 data; 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:
|
February 14, 2011
|
By:
|
/s/ Dennis J. Carlo
|
|
Chief Executive Officer
|
I, Robert O. Hopkins, certify that:
|
||
1.
|
I have reviewed this quarterly report on Form 10-Q of Adamis Pharmaceuticals Corporation;
|
|
2.
|
Based on my knowledge, this quarterly 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 quarterly report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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 Acts Rules 13a-15(f) and 15(d-15(f)) for the registrant and we 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 quarterly report is being prepared; and
|
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting disclosure 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; and
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c)
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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
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d)
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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; and
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5.
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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 registrant’s board of directors (or persons performing the equivalent functions):
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a)
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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 data; and
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b)
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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.
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Date:
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February 14, 2011
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By:
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/s/ Robert O. Hopkins
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Vice President, Finance and
Chief Financial Officer
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(1) the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 (the “Report”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
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(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Dennis J. Carlo
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Dennis J. Carlo
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Chief Executive Officer
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(1) the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 (the “Report”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
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(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Robert O. Hopkins
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Robert O. Hopkins
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Vice President and Chief Financial Officer
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