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FORM S-3
Delaware | 04-3072298 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
Cambridge, Massachusetts 02139
(617) 679-5500
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Sudhir Agrawal, D. Phil.
Chairman of the Board of Directors, President
and Chief Executive Officer
Idera Pharmaceuticals, Inc.
167 Sidney Street
Cambridge, Massachusetts 02139
(617) 679-5500
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copy to:
Stuart M. Falber, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
Telephone: (617) 526-6000
Telecopy: (617) 526-5000
Large accelerated filero | Accelerated filerþ | Non-accelerated filero | Smaller reporting companyo | |||
(Do not check if a smaller reporting company) |
CALCULATION OF REGISTRATION FEE
Proposed | ||||||||||||||
Amount | Proposed Maximum | Maximum | ||||||||||||
to be | Offering Price | Aggregate | Amount of | |||||||||||
Title of Shares to be Registered | Registered(1) | Per Share (2) | Offering Price | Registration Fee | ||||||||||
Common Stock, $0.001 par value per share (3) | 8,431,950 | $1.11 | $9,359,465 | $1,073 | ||||||||||
(1) | Consists of (a) 5,621,300 shares of common stock issuable upon conversion of the Company’s series D convertible preferred stock, par value $0.01 per share, (b) 2,810,650 shares of common stock issuable upon the exercise of common stock purchase warrants and (c) such indeterminate number of additional shares of common stock as may become issuable upon conversion of the series D convertible preferred stock or exercise of the common stock purchase warrants to prevent dilution resulting from stock splits, stock dividends or similar transactions, which shares are registered hereunder pursuant to Rule 416 under the Securities Act. | |
(2) | Estimated solely for purposes of calculating the registration fee pursuant to Rule 457(c) under the Securities Act and based upon the average of the high and low prices on the NASDAQ Global Market on December 7, 2011. | |
(3) | Includes preferred share purchase rights, which, prior to the occurrence of certain events, will not be exercisable or evidenced separately from the common stock. |
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The information in this prospectus is not complete and may be changed. The selling stockholder named in this prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and the selling stockholder named in this prospectus is not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.
The date of this prospectus is [_____________], 2011.
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• | Merck KGaA has agreed to continue to conduct the ongoing Phase 2 trial of IMO-2055 in combination with Erbitux® and other specified related activities, | ||
• | we have agreed to reimburse Merck KGaA a maximum of €1.8 million of Merck KGaA’s costs for the third party contract research organization that is coordinating the ongoing Phase 2 trial of IMO-2055 in combination with Erbitux®, payable in eleven installments comprised of ten monthly installments to be invoiced by Merck KGaA to us commencing on March 1, 2012 and a final payment payable by us to Merck KGaA upon Merck KGaA’s completion of certain specified activities, and | ||
• | we have agreed to pay to Merck KGaA one-time €1.0 million milestone payments upon occurrence of the following milestones: (i) partnering of IMO-2055 between us and any third party, (ii) initiation of |
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any Phase 2 or Phase 3 clinical trial for IMO-2055 and (iii) regulatory submission of IMO-2055 in any country. |
Common Stock offered by selling stockholder | 8,431,950 shares | |
Use of proceeds | We will not receive any proceeds from the sale of shares in this offering. | |
NASDAQ Global Market symbol | IDRA |
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• | the results of our clinical and preclinical development programs, including the results of the planned Phase 2 trial of IMO-3100 and the results of the ongoing Phase 2 trial of IMO-2055; | ||
• | developments related to our existing strategic collaboration with Merck; | ||
• | the cost, timing, and outcome of regulatory reviews; | ||
• | competitive and potentially competitive products and technologies and investors’ receptivity to our drug candidates and the technology underlying them in light of competitive products and technologies; | ||
• | the receptivity of the capital markets to financings by biotechnology companies generally and companies with drug candidates and technologies such as ours specifically; and | ||
• | our ability to enter into additional strategic collaborations with biotechnology and pharmaceutical companies and the success of such collaborations. |
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• | During the first half of 2011, we continued to conduct nonclinical studies of IMO-3100, which we commenced in the fourth quarter of 2010, in light of some reversible immune responses that were observed in the 13-week nonclinical toxicology studies and that were inconsistent with observations in our other nonclinical studies of IMO-3100. In June 2011, we submitted a Phase 2 protocol to the FDA to conduct a clinical trial of IMO-3100 in patients with psoriasis. In July 2011, the FDA placed a clinical hold on a protocol we had submitted for a proposed Phase 2 clinical trial of IMO-3100 in patients with psoriasis. | ||
• | In April 2011, we chose to delay initiation of our planned 12-week Phase 2 randomized clinical trial of IMO-2125 plus ribavirin in treatment-naïve, genotype 1 HCV patients based on preliminary observations in an ongoing 26-week chronic nonclinical toxicology study of IMO-2125 in rodents. Histology analysis from the rodent study showed instances of atypical lymphocytic proliferation. No similar observations were made in the recently completed histology analysis from a 39-week chronic nonclinical toxicology study of IMO-2125 in non-human primates. | ||
• | In July 2011, Merck KGaA informed us that, based on increased incidence of neutropenia and electrolyte imbalances reported in its Phase 1 trial of IMO-2055 in combination with cisplatin/5-FU and cetuximab (Erbitux(R)) in patients with first-line SCCHN and subsequent re-evaluation of its clinical development program, Merck KGaA determined that it will not conduct further clinical development of IMO-2055. |
• | the drug candidates demonstrating an acceptable safety profile in nonclinical toxicology studies and during clinical trials; | ||
• | timely enrollment in clinical trials of IMO-3100 and other drug candidates, which may be slower than anticipated, potentially resulting in significant delays; |
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• | satisfying conditions imposed on us and/or our collaborators by the FDA or equivalent foreign regulatory authorities regarding the scope or design of clinical trials; |
• | the ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory authorities, the safety and efficacy of the drug candidates through current and future clinical trials; | ||
• | timely receipt of necessary marketing approvals from the FDA and equivalent foreign regulatory authorities; | ||
• | the ability to combine our drug candidates and the drug candidates being developed by Merck and any other collaborators safely and successfully with other therapeutic agents; | ||
• | achieving and maintaining compliance with all regulatory requirements applicable to the products; | ||
• | establishment of commercial manufacturing arrangements with third-party manufacturers; | ||
• | the successful commercial launch of the drug candidates, assuming FDA approval is obtained, whether alone or in combination with other products; | ||
• | acceptance of the products as safe and effective by patients, the medical community, and third-party payors; | ||
• | competition from other companies and their therapies; | ||
• | changes in treatment regimes; | ||
• | successful protection of our intellectual property rights from competing products in the United States and abroad; and | ||
• | a continued acceptable safety and efficacy profile of the drug candidates following marketing approval. |
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• | regulators or IRBs may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site; | ||
• | nonclinical or clinical data may not be readily interpreted, which may lead to delays and/or misinterpretation; | ||
• | our nonclinical tests, including toxicology studies, or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional nonclinical testing or clinical trials or we may abandon projects that we expect may not be promising; | ||
• | the rate of enrollment or retention of patients in our clinical trials may be lower than we expect; | ||
• | we might have to suspend or terminate our clinical trials if the participating subjects experience serious adverse events or undesirable side effects or are exposed to unacceptable health risks; | ||
• | regulators or IRBs may hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements, issues identified through inspections of manufacturing or clinical trial operations or clinical trial sites, or if, in their opinion, the participating subjects are being exposed to unacceptable health risks; | ||
• | regulators may hold or suspend our clinical trials while collecting supplemental information on, or clarification of, our clinical trials or other clinical trials, including trials conducted in other countries or trials conducted by other companies; | ||
• | we, along with our collaborators and subcontractors, may not employ, in any capacity, persons who have been debarred under the FDA’s Application Integrity Policy, or similar policy under foreign regulatory authorities. Employment of such debarred persons, even if inadvertent, may result in delays in the FDA’s or foreign equivalent’s review or approval of our products, or the rejection of data developed with the involvement of such person(s); | ||
• | the cost of our clinical trials may be greater than we currently anticipate; and | ||
• | our products may not cause the desired effects or may cause undesirable side effects or our products may have other unexpected characteristics. |
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• | the size of the patient population; | ||
• | the proximity of patients to clinical sites; | ||
• | the eligibility criteria for the study; | ||
• | the nature of the study, including the pattern of patient enrollment; | ||
• | the existence of competitive clinical trials; and | ||
• | the availability of alternative treatments. |
• | manufacturing sufficient quantities of drug candidate that satisfy the required quality standards for use in clinical trials; | ||
• | demonstrating sufficient safety to obtain regulatory approval for conducting a clinical trial; | ||
• | reaching an agreement with any collaborators on all aspects of the clinical trial; | ||
• | reaching agreement with contract research organizations, if any, and clinical trial sites on all aspects of the clinical trial; | ||
• | resolving any objections from the FDA or any regulatory authority on an IND application or proposed clinical trial design; | ||
• | obtaining IRB approval for conducting a clinical trial at a prospective site; and | ||
• | enrolling patients in order to commence the clinical trial. |
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• | the regulatory agency’s delay in approving, or refusal to approve, an application for marketing of a product or a supplement to an approved application; | ||
• | restrictions on our products or the marketing or manufacturing of our products; | ||
• | withdrawal of our products from the market; | ||
• | warning letters; | ||
• | voluntary or mandatory product recalls; | ||
• | fines; | ||
• | suspension or withdrawal of regulatory approvals; | ||
• | product seizure or detention; | ||
• | refusal to permit the import or export of our products; | ||
• | injunctions or the imposition of civil penalties; and | ||
• | criminal penalties. |
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• | our collaborators may control the development of the drug candidates being developed with our technologies and compounds including the timing of development; | ||
• | our collaborators may control the public release of information regarding the developments, and we may not be able to make announcements or data presentations on a schedule favorable to us; | ||
• | disputes may arise in the future with respect to the ownership of rights to technology developed with our collaborators; | ||
• | disagreements with our collaborators could delay or terminate the research, development or commercialization of products, or result in litigation or arbitration; | ||
• | we may have difficulty enforcing the contracts if any of our collaborators fail to perform; | ||
• | our collaborators may terminate their collaborations with us, which could make it difficult for us to attract new collaborators or adversely affect the perception of us in the business or financial communities; | ||
• | our collaboration agreements are likely to be for fixed terms and subject to termination by our collaborators in the event of a material breach or lack of scientific progress by us; | ||
• | our collaborators may have the first right to maintain or defend our intellectual property rights and, although we would likely have the right to assume the maintenance and defense of our intellectual property rights if our collaborators do not, our ability to do so may be compromised by our collaborators’ acts or omissions; | ||
• | our collaborators may challenge our intellectual property rights or utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability; | ||
• | our collaborators may not comply with all applicable regulatory requirements, or may fail to report safety data in accordance with all applicable regulatory requirements; | ||
• | our collaborators may change the focus of their development and commercialization efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their priorities following mergers and consolidations, which have been common in recent years in these industries. For example, we have a strategic partnership with Merck, which merged with Schering-Plough, which has been involved with certain TLR-targeted research and development programs. Although the merger has not affected our partnership with Merck to date, management of the combined company could determine to reduce the efforts and resources that the combined company will apply to its strategic partnership with us or terminate the strategic partnership. The ability of our products to reach their potential could be limited if our collaborators decrease or fail to increase spending relating to such products; | ||
• | our collaborators may under fund or not commit sufficient resources to the testing, marketing, distribution or development of our products; and | ||
• | our collaborators may develop alternative products either on their own or in collaboration with others, or encounter conflicts of interest or changes in business strategy or other business issues, which could adversely affect their willingness or ability to fulfill their obligations to us. |
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• | obtain patents; | ||
• | obtain licenses to the proprietary rights of others on commercially reasonable terms; | ||
• | operate without infringing upon the proprietary rights of others; | ||
• | prevent others from infringing on our proprietary rights; and | ||
• | protect our trade secrets. |
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• | reliance on the third party for regulatory compliance and quality assurance; | ||
• | the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control; | ||
• | the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us; | ||
• | the potential that third-party manufacturers will develop know-how owned by such third party in connection with the production of our drug candidates that becomes necessary for the manufacture of our drug candidates; and | ||
• | reliance upon third-party manufacturers to assist us in preventing inadvertent disclosure or theft of our proprietary knowledge. |
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• | the prevalence and severity of any side effects, including any limitations or warnings contained in the product’s approved labeling; | ||
• | the efficacy and potential advantages over alternative treatments; | ||
• | the ability to offer our drug candidates for sale at competitive prices; | ||
• | relative convenience and ease of administration; | ||
• | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; | ||
• | the strength of marketing and distribution support and the timing of market introduction of competitive products; and | ||
• | publicity concerning our products or competing products and treatments. |
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• | decreased demand for our drug candidates and products; | ||
• | damage to our reputation; | ||
• | regulatory investigations that could require costly recalls or product modifications; | ||
• | withdrawal of clinical trial participants; | ||
• | costs to defend related litigation; | ||
• | substantial monetary awards to clinical trial participants or patients, including awards that substantially exceed our product liability insurance, which we would then have to pay using other sources, if available, and would damage our ability to obtain liability insurance at reasonable costs, or at all, in the future; | ||
• | loss of revenue; | ||
• | the diversion of management’s attention away from managing our business; and | ||
• | the inability to commercialize any products that we may develop. |
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• | a classified board of directors; | ||
• | limitations on the removal of directors; | ||
• | limitations on stockholder proposals at meetings of stockholders; | ||
• | the inability of stockholders to act by written consent or to call special meetings; and | ||
• | the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval. |
• | timing and results of nonclinical studies and clinical trials of our drug candidates or those of our competitors; | ||
• | the regulatory status of our drug candidates; | ||
• | failure of any of our drug candidates, if approved, to achieve commercial success; | ||
• | the success of competitive products or technologies; | ||
• | regulatory developments in the United States and foreign countries; | ||
• | our success in entering into collaborative agreements; | ||
• | developments or disputes concerning patents or other proprietary rights; | ||
• | the departure of key personnel; | ||
• | variations in our financial results or those of companies that are perceived to be similar to us; |
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• | our cash resources; | ||
• | the terms of any financing conducted by us; | ||
• | changes in the structure of healthcare payment systems; | ||
• | market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations; and | ||
• | general economic, industry, and market conditions. |
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Shares of Common Stock | Shares of Common Stock to | |||||||||||||||||||
Beneficially Owned Prior | Number of Shares of | be Beneficially Owned | ||||||||||||||||||
Name of Selling Stockholder | to Offering | Common Stock Being | After Offering | |||||||||||||||||
(1) | Number | Percentage (2) | Offered | Number | Percentage | |||||||||||||||
Pillar Pharmaceuticals I,L.P. | 8,431,950 | 23.38% | 8,431,950 | — | — |
(1) | The term “selling stockholder” includes donees, pledgees, transferees or other successors-in-interest selling shares received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other non-sale related transfer. | |
(2) | Based on the number of shares of our common stock outstanding on November 22, 2011. |
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• | purchases by a broker-dealer as principal and resale by such broker-dealer for its own account pursuant to this prospectus; | ||
• | ordinary brokerage transactions and transactions in which the broker solicits purchasers; | ||
• | block trades in which the broker-dealer so engaged will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; | ||
• | an over-the-counter distribution; | ||
• | an exchange distribution in accordance with the rules of the applicable exchange; | ||
• | in privately negotiated transactions; | ||
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; and | ||
• | any other method permitted pursuant to applicable law. |
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(1) | Our Annual Report on Form 10-K for the year ended December 31, 2010; | ||
(2) | Our Current Report on Form 8-K dated June 17, 2011; | ||
(3) | Our Current Report on Form 8-K dated September 16, 2011; | ||
(4) | Our Current Report on Form 8-K dated November 10, 2011; | ||
(5) | Our Current Report on Form 8-K dated December 2, 2011; | ||
(6) | Our Quarterly Report of Form 10-Q for the quarter ended March 31, 2011; | ||
(7) | Our Quarterly Report of Form 10-Q for the quarter ended June 30, 2011; | ||
(8) | Our Quarterly Report of Form 10-Q for the quarter ended September 30, 2011; | ||
(9) | The descriptions of our capital stock contained in (a) our Registration Statement on Form 8-A dated December 4, 2003, as amended on August 17, 2007 and as further amended on December 7, 2007 and (b) Item 5.03 of our Current Report on Form 8-K dated November 10, 2011, including any amendments or reports filed for the purpose of updating such descriptions; and | ||
(10) | All of our filings pursuant to the Exchange Act after the date of filing the initial registration statement and prior to the effectiveness of the registration statement. |
Idera Pharmaceuticals, Inc. | ||
167 Sidney Street | ||
Cambridge, Massachusetts 02139 | ||
Attention: Investor Relations | ||
(617) 679-5500 |
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Filing Fee — Securities and Exchange Commission | $ | 1,073 | ||
Legal fees and expenses | 30,000 | |||
Accounting fees and expenses | 6,000 | |||
Miscellaneous expenses | 10,000 | |||
Total Expenses | $ | 47,073 | ||
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(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”); | ||
(ii) | To reflect in the prospectus any facts or events arising after the effective date of this Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this Registration Statement. | ||
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in this Registration Statement or any material change to such information in this Registration Statement; |
provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in this Registration Statement. |
(2) | That, for the purposes of determining any liability under the Securities Act, each post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at the time shall be deemed to be the initialbona fideoffering thereof. | ||
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
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IDERA PHARMACEUTICALS, INC. | ||||
By: | /s/ Sudhir Agrawal, D. Phil. | |||
Sudhir Agrawal, D. Phil. | ||||
Chairman of the Board of Directors, President and Chief Executive Officer | ||||
Signature | Title | Date | ||
/s/ Sudhir Agrawal, D. Phil. | Chairman of the Board of Directors, President and Chief Executive Officer (Principal Executive Officer) | December 9, 2011 | ||
/s/ Louis J. Arcudi III, MBA | Senior Vice President of Operations, Chief Financial Officer, Treasurer and Secretary (Principal Financial and Accounting Officer) | December 9, 2011 | ||
/s/ Youssef El Zein | Director | December 9, 2011 | ||
/s/ C. Keith Hartley | Director | December 9, 2011 | ||
/s/ Robert W. Karr, M.D. | Director | December 6, 2011 | ||
/s/ Malcolm MacCoss, Ph.D. | Director | December 6, 2011 | ||
/s/ William S. Reardon, CPA | Director | December 9, 2011 | ||
/s/ Eve E. Slater, M.D., F.A.C.C. | Director | December 9, 2011 | ||
Director |
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EXHIBIT | ||
NUMBER | DESCRIPTION | |
4.1 (1) | Restated Certificate of Incorporation of the Registrant, as amended | |
4.2 (2) | Amended and Restated By-laws of the Registrant | |
4.3 (3) | Certificate of Designations, Preferences and Rights of Series D Preferred Stock of the Company | |
4.3 (4) | Rights Agreement dated December 10, 2001 between the Registrant and Mellon Investor Services LLC, as rights agent | |
4.4 (5) | Amendment No. 1 to Rights Agreement dated as of August 27, 2003 between the Registrant and Mellon Investor Services LLC, as rights agent | |
4.5 (6) | Amendment No. 2 to Rights Agreement dated as of March 24, 2006 between the Registrant and Mellon Investor Services LLC, as rights agent | |
4.6(7) | Amendment No. 3 to Rights Agreement dated January 16, 2007 between the Company and Mellon Investor Services, LLC, as rights agent | |
4.7(8) | Amendment No. 4 to Rights Agreement, dated as of November 4, 2011 between the Registrant and Mellon Investor Services LLC, as rights agent | |
5.1 | Opinion of Wilmer Cutler Pickering Hale and Dorr LLP. | |
23.1 | Consent of Ernst & Young LLP | |
23.2 | Consent of Wilmer Cutler Pickering Hale and Dorr LLP, included in Exhibit 5.1 filed herewith | |
24.1 | Power of Attorney (See page II-4 of this Registration Statement) |
(1) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Quarterly Report on 10-Q, dated August 1, 2008, as amended (File No. 001-31918) and incorporated herein by reference. | |
(2) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Registration Statement on Form S-1, dated November 6, 1995, as amended (File No. 33-99024) and incorporated herein by reference. | |
(3) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Current Report on Form 8-K, dated November 10, 2011, as amended (File No. 001-31918) and incorporated herein by reference. | |
(4) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Registration Statement on Form S-2, dated October 10, 2003 (File No. 333-109630) and incorporated herein by reference. | |
(5) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Current Report on Form 8-K, dated August 29, 2003 (File No. 000-27352) and incorporated herein by reference. | |
(6) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Current Report of Form 8-K, dated March 29, 2006 (File No. 001-31918) and incorporated herein by reference. | |
(7) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Current Report of Form 8-K, dated January 17, 2007 (File No. 001-31918) and incorporated herein by reference. | |
(8) | Previously filed with the Securities and Exchange Commission as an Exhibit to the Registrant’s Current Report on Form 8-K, dated November 10, 2011, as amended (File No. 001-31918) and incorporated herein by reference. |