UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Fiscal Year Ended December 31, 2009
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Transition Period from
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Commission File No. 0-26770
NOVAVAX, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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22-2816046
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(State of Incorporation)
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(I.R.S. Employer
Identification No.)
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9920 Belward Campus Drive,
Rockville, Maryland 20850
(Address of Principal Executive Offices)
(240) 268-2000
(Registrants Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, Par Value $0.01 per share
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The NASDAQ Global Market
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Securities registered pursuant to Section 12(g) of the Act:
Not Applicable
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
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No
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Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.Yes
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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
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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
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No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large Accelerated Filer
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Accelerated Filer
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Non-Accelerated Filer
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(Do not check if a smaller reporting company)
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Smaller Reporting Company
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Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
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No
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The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant (based on the last reported sale price of Registrants common stock on June 30, 2009 on the NASDAQ Global Market) was $191,100,000.
As of March 11, 2010, there were 100,277,960 shares of the Registrants common stock outstanding.
Portions of the Registrants Definitive Proxy Statement to be filed no later than 120 days after the fiscal year ended December 31, 2009 in connection with the Registrants 2010 Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.
TABLE OF CONTENTS
NOVAVAX, INC.
TABLE OF CONTENTS
When used in this Annual Report on Form 10-K, except where the context otherwise requires, the terms we, us, our, Novavax and the Company refer to Novavax, Inc.
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PART I
Item 1. Business
This Annual Report on Form 10-K contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act that involve risks and uncertainties. In some cases, forward-looking statements are identified by words such as believe, anticipate, intend, plan, will, may and similar expressions. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this report. All of these forward-looking statements are based on information available to us at this time, and we assume no obligation to update any of
these statements. Actual results could differ from those projected in these forward-looking statements as a result of many factors, including those identified in the section titled Risk Factors, Managements Discussion and Analysis of Financial Condition and Results of Operations and elsewhere. We urge you to review and consider the various disclosures made by us in this report, and those detailed from time to time in our filings with the Securities and Exchange Commission, that attempt to advise you of the risks and factors that may affect our future results.
Overview
Novavax, Inc. (Novavax, the Company, we or us) is a biopharmaceutical company focused on developing novel, highly potent recombinant vaccines. Our goal is to become a profitable vaccine company that is aggressively driving towards development, licensure and commercialization of important vaccine candidates.
Our technology platform is based on proprietary virus-like particles (VLPs). Our VLPs are genetically engineered three-dimensional nanostructures, which incorporate immunologically important recombinant proteins. Recombinant protein-based vaccines are widely used and accepted. Examples of vaccines currently available that use recombinant protein particle technology include Recombivax® HB (Merck) and Engerix® (GlaxoSmithKline), which protect against Hepatitis B, and Gardasil® (Merck) and Cervarix® (GlaxoSmithKline), which protect against human papilloma virus. Our product pipeline targets several infectious diseases. Currently, we have
vaccine product candidates to target pandemic influenza (both H1N1 and H5N1 strains), seasonal influenza, Respiratory Syncytial Virus (RSV) and Varicella Zoster Virus (VZV).
We have a significant amount of experience in developing recombinant VLP influenza vaccines. To date, among other things, we have:
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conducted five human clinical studies for our seasonal and pandemic influenza vaccine candidates;
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administered our seasonal and pandemic influenza VLPs (seven distinct strains) to over 4,200 subjects demonstrating vaccine safety and immunogenicity;
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completed four animal toxicology studies without any safety issues;
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conducted multiple ferret studies demonstrating efficacy of VLP influenza vaccine candidates; and
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conducted vaccine production under current good manufacturing practices (cGMP) and manufactured more than 35 batches of VLP vaccine with over a dozen different influenza strains.
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We believe our influenza VLP vaccines have potential immunological advantages over currently available products. Our influenza VLPs contain three of the major structural influenza virus proteins, which we believe are important to combat influenza: hemagglutinin (HA) and neuraminidase (NA), both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent spread through the cells in the respiratory tract, and matrix 1 (M1), which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. Further, our VLPs are not made from a live virus and have no genetic nucleic material in their inner core,
which renders them incapable of replicating and causing disease.
Our proprietary production technology uses insect cells rather than chicken eggs or mammalian cells. This platform offers several potential significant advantages over traditional vaccine production, including: (1) higher yields than traditional mammalian or egg-based system, (2) faster facility commissioning time, (3) significantly lower capital expenditures on infrastructure, (4) competitive cost of goods, (5) shorter lead time to produce vaccine than egg-based technology, and (6) a scalable production process that can respond rapidly to pandemic outbreaks.
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Pandemic Influenza
In May 2009, we announced that we had produced a first batch of non-cGMP influenza A (H1N1) VLP vaccine candidate three weeks after the Center for Disease Control and Protection (CDC) announced the genetic sequence of the novel H1N1 virus (the H1N1 virus is commonly referred to as the swine flu in the media). The purified H1N1 VLP vaccine candidate was sent to scientists at the CDC and an agreement was made with the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases and the National Institutes of Health for further studies. To further demonstrate the capability of
recombinant VLP technology, we manufactured an H1N1 VLP vaccine candidate under cGMP at our vaccine manufacturing facility in Rockville, MD within eleven weeks after receiving the gene sequence from the CDC.
In October 2009, we initiated a two-stage clinical trial of our H1N1 vaccine candidate in Mexico in collaboration with Laboratorio Avi-Mex S.A. de C.V. (Avimex). The first stage of the study evaluated the vaccines safety, immunogenicity and efficacy in 1,000 subjects, including 750 vaccine recipients and 250 placebo recipients. In December 2009, we reported positive results from the first stage of the study. Based on these results, the Independent Data and Safety Monitoring Board recommended that we proceed with the second stage of the study to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000
placebo recipients). This study has been fully enrolled. With the positive data reported in December 2009, we have filed for regulatory approval of our 2009 H1N1 vaccine candidate in Mexico. These data are also expected to support our pandemic and seasonal influenza VLP vaccines in other countries. We believe this effort in Mexico represents a unique opportunity for Novavax to accelerate the development of our H1N1 vaccine candidate.
We have also made significant progress in the development of our vaccine that targets the H5N1 avian influenza with pandemic potential. In 2007, we released results from an important pre-clinical study in which ferrets that received our pandemic vaccine candidate were protected from a lethal challenge of the H5N1 virus. After filing an Investigational New Drug application (IND), we initiated a Phase I/IIa human clinical trial. We released interim human data from the first portion of this clinical trial in December 2007. These interim results demonstrated that our pandemic influenza vaccine can generate a protective immune response. We conducted the
second portion of the Phase I/IIa trial in 2008 to gather additional subject immunogenicity and safety data and determine a final dose through the completion of this clinical trial. In August 2008, we reported favorable results from this clinical trial, which demonstrated strong neutralizing antibody titers across all three doses tested. A final clinical study report has been completed and the vaccine was well tolerated at all dosages as compared with placebo. No serious adverse events were reported. In February 2009, we announced that the vaccine induced robust hemagglutination inhibition (HAI) responses, which have been shown to be important for protection against influenza disease.
Seasonal Influenza
We have also progressed the development of our VLP trivalent vaccine that targets the seasonal influenza virus. In 2008, we announced positive results from an immunogenicity study in ferrets inoculated with our seasonal influenza vaccine candidate. Subsequently, we conducted a Phase IIa clinical trial to evaluate the safety and immunogenicity of different doses of our seasonal influenza vaccine. In December 2008, we announced favorable safety and immunogenicity results from this Phase IIa seasonal study in healthy adults (aged between 18 and 49 years). A final clinical study report was completed and no vaccine-related serious adverse events were
reported. In May 2009, we enrolled subjects in a second Phase II study in healthy adults. In September 2009, we announced favorable results from this Phase II study in healthy adults that supports a new Phase II dose range study in elderly patients (60 years of age or older), head-to-head with a marketed vaccine that we commenced in November 2009. In September 2009, we responded to the United States government (HHS BARDA) request for proposal (RFP) for a potential contract award for the advanced development of recombinant influenza vaccines. If we receive the award it could provide significant funding for the continued ongoing clinical development of our seasonal and pandemic influenza vaccines. Based on the results of the Phase II trial in elderly subjects and our ability to potentially receive the HHS BARDA contract and receive it in a timely manner, we plan to begin Phase III studies and seek to file United States registration of this vaccine candidate.
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RSV and VZV
We have also developed vaccine candidates for both RSV and VZV, both of which are currently being evaluated in pre-clinical studies. To date, our RSV vaccine candidate has demonstrated positive results in two separate studies with mice. These studies have been confirmed in two more studies in cotton rats, which are generally accepted as the best model to evaluate the safety of candidate RSV vaccines. In February 2009, we announced favorable results from an RSV pre-clinical study performed in mice against the viral fusion (F) protein, which fuses with cells in the respiratory tract and causes illness. The vaccine induced neutralizing antibodies
against the viral fusion protein and also protected against RSV infection. In January 2010, we announced positive pre-clinical results with a recombinant RSV fusion (F) particle vaccine in cotton rats. The RSV F vaccine candidate completely protected the vaccinated animals and there was no evidence of enhanced disease in the lungs of vaccinated animals following challenge with live RSV. We also announced the successful scale-up and cGMP manufacturing of vaccine and the initiation of a rabbit toxicology study in preparation for submission of an RSV IND to the United States Food and Drug Administration (FDA). We plan to file an IND and launch a Phase I clinical trial in 2010.
A multi-protein VZV particle vaccine candidate is currently in development. The VZV vaccine was shown in mice to induce antibody and T-cell responses. Formulation of the VZV vaccine candidate is being finalized and tested in preparation for human trials.
Research and Development Technology and Activities
VLPs.
Our vaccine technology platform is based on VLPs, which are self-assembling protein structures that resemble viruses. These are noninfectious particles that, for many viral diseases, have been shown in animal and human studies to make effective vaccines. VLPs closely mimic natural virus particles with repeating protein structures that can elicit broad and strong antibody and cellular immune responses, but lack the genetic material required for replication. VLP technology is a proven technology that is employed in currently marketed products such as Mercks Gardasil®. Our proprietary VLPs are more advanced than earlier
approaches and they include multiple proteins and lipids and can be tailored to induce robust and broad immune responses similar to natural infections. Our advanced VLP technology has the potential to develop vaccines for a wide range of human infectious diseases where there are significant unmet medical needs, some of which have not been addressed by other technologies. We have used formal criteria based upon medical need, technical feasibility and commercial value to select vaccine candidates. We believe that our influenza vaccines are designed to address many of the significant unmet needs related to seasonal and pandemic influenza. There are several points of differentiation of our influenza vaccines when compared to traditional egg-based, or new mammalian-based approaches that form the basis to address unmet medical needs and capitalize on commercial opportunities. Our influenza VLPs contain components that provide a broad and robust immune response. Specifically, the VLPs contain
the viral components hemagglutinin (HA), neuraminidase (NA) and matrix protein (M1). Traditional egg-based vaccines contain meaningful levels of HA, but not of NA or M1. The HA sequence in our VLPs is the same as in the wild-type virus and could prove more effective/immunogenic than influenza vaccines produced using egg or mammalian cell lines, which alter HA. In addition the NA and M1 in our VLPs may play a role in reducing the severity of the disease by inducing antibody responses and cell mediated immunity. NA and M1 are both highly conserved, and immunity to these viral components should help provide additional protection throughout an entire influenza season, even as strains mutate. Data from our Phase IIa trial in healthy adults showed that 50 to 73% of the volunteers immunized with our VLP vaccine had a 4-fold increase in the antibody that blocks NA activity. Finally, because of the VLP structure and components, they may have greater immunogenicity in two vulnerable
populations pediatric and elderly patients.
VLP Vaccine Manufacturing.
Currently approved influenza vaccines are produced by growing virus in chicken eggs, from which the virus is extracted and further processed. This 50-year-old egg-based production method requires four to six months of lead time for production of a new strain of virus and significant investment in fixed production facilities, with production yields that vary from strain to strain. In addition, sometimes the influenza virus strain must be changed in order for it to be produced efficiently in the egg. The vaccine shortage during the 2004 influenza season (caused in part by a contamination issue at a facility
in the United Kingdom) highlighted the limitations of current production methods and the need for increased vaccine
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manufacturing capacity. It also heightened concerns regarding manufacturers capacity to respond to a pandemic, when the number of vaccine doses required will be higher than the number required for seasonal influenza vaccines and manufacturing lead times will be even shorter. This concern was borne out again in the 2009 H1N1 pandemic as, even with expedited regulatory approvals for companies that already had approved vaccines, production of H1N1 vaccines took six months before significant doses were distributed.
Our production process involves the use of genetic information and no viral seed is required. This shortens the time of creating a new vaccine by several weeks compared to the egg-based process. Furthermore, the production process for manufacturing our VLP vaccines is also unique because the equipment we use in the cell culture process is largely portable and disposable. A facility to produce VLP-based vaccines can be constructed and validated in significantly less time as compared to traditional egg-based facilities.
We produce VLPs using a baculovirus expression system in insect cells with disposable low cost equipment that can be readily dispersed both nationally and internationally. By not requiring significant production batch sizes, production capacity can be employed quickly; estimated to be built and validated within twelve to eighteen months compared to the current approved manufacturing technology that can take four years or more to deploy.
Other Projects.
We are working on certain other vaccine projects with sponsoring organizations. These projects, described below, are currently funded and controlled by other parties. As is typical with these research contracts, we do not currently have commercial rights to these products.
SARS VLP Vaccine.
Severe acute respiratory syndrome (SARS) is a viral respiratory illness cased by a corona virus. In 2005, the National Institutes of Health (NIH) awarded us a $1.1 million, three year grant to develop a vaccine to prevent SARS. We successfully completed the NIH grant in January 2009 and successfully demonstrated that a SARS VLP vaccine candidate was effective in inducing immunity in an animal model that fully protected against a lethal challenge with SARS virus.
E-Selectin Tolerogen
. In collaboration with the National Institute of Neurological Disorders and Stroke and the NIH, we have been developing E-selectin-based molecularly-derived products for the prevention of strokes.
Competition
The biopharmaceutical industry and the vaccine market are intensely competitive and are characterized by rapid technological progress. There are a number of companies developing and selling vaccines for pandemic and seasonal influenza employing current technology with some modifications, as well as new technologies. Our technology is based upon utilizing the baculovirus expression system in insect cells to make VLPs. We believe this system offers many advantages when compared to other technologies and is uniquely suited for developing pandemic and seasonal influenza vaccines as well as other infectious diseases. The fact that we do not rely on the
use of adjuvants, chemical substances that can boost the human immune system, leads us to believe we have a clearer regulatory path toward approval of our vaccines with regulatory agencies. The table below provides a list of major vaccine competitors and corresponding influenza vaccine technologies.
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Company
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Competing Technology Description
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sanofi pasteur, Inc.
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Inactivated sub-unit (egg-based)
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MedImmune Vaccines, Inc. (a subsidiary of Astra-Zeneca, Inc.)
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Nasal, live attenuated (egg-based)
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GlaxoSmithKline Biologicals
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Inactivated (egg-based)
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Novartis, Inc.
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Inactivated sub-unit (cell and egg-based)
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Merck & Co.
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Inactivated sub-unit (egg-based)
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In general, competition among pharmaceutical products is based in part on product efficacy, safety, reliability, availability, price and patent position. An important factor is the relative timing of the market introduction of our products and our competitors products. Accordingly, the speed with which we can develop products, complete the clinical trials and approval processes and supply commercial quantities of the products to the market is an important competitive factor. Our competitive position also depends upon our ability to show differentiation in the seasonal influenza space with a product that is more efficacious, particularly in the
elderly population, and/or be less expensive and quicker to manufacture. It also depends upon our ability to
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attract and retain qualified personnel, obtain patent protection or otherwise develop proprietary products or processes and secure sufficient capital resources for the often substantial period between technological conception and commercial sale.
There are many seasonal influenza vaccines currently approved and marketed. Competition in the sale of these seasonal influenza vaccines is intense. Therefore, newly developed and approved products must be differentiated from existing vaccines in order to have commercial success. In order to show differentiation in the seasonal influenza space, a product must be more efficacious, particularly in the elderly population, and/or be less expensive and quicker to manufacture. Many of our competitors are working on new products and new generations of current products, often by adding an adjuvant that is used to increase the efficacy of the current product,
each of which is intended to be more efficacious than products currently being marketed. Our seasonal influenza product may not prove to be more efficacious than current products or products under development by our competitors. Further, our manufacturing system may not provide enough savings of time or money to provide the required differentiation for commercial success.
Patents and Proprietary Rights
We generally seek patent protection for our technology and product candidates in the United States and abroad. The patent position of biopharmaceutical firms generally is highly uncertain and involves complex legal and factual questions. Our success will depend, in part, on whether we can:
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obtain patents to protect our own technologies and products;
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obtain licenses to use the technologies of third-parties, which may be protected by patents;
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protect our trade secrets and know-how; and
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operate without infringing the intellectual property and proprietary rights of others.
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Patent Rights; Licenses.
We have intellectual property (patents, licenses, know-how) related to our vaccines, manufacturing process and other technologies. Currently, we have or have rights to over 99 United States patents and corresponding foreign patents and patent applications relating to vaccines and biologics. Our core vaccine-related intellectual property extends beyond 2027.
In March 2007, we secured additional intellectual property through a license agreement with the University of Massachusetts using their proprietary paramyxoviruses as a core for building VLP vaccines. In July 2007, we entered into a non-exclusive license agreement with Wyeth Holdings Corporation to obtain rights to a family of patent applications covering VLP technology for use in human vaccines in certain fields of use.
Consistent with statutory guidelines issued under the Federal Technology Transfer Act of 1986 designed to encourage the dissemination of science and technology innovation and provide sharing of technology that has commercial potential, our collaborative research efforts with the United States government and with other private entities receiving federal funding provide that developments and results must be freely published, that information or materials supplied by us will not be treated as confidential and that we will be required to negotiate a license to any such developments and results in order to commercialize products. There can be no assurance
that we will be able to successfully obtain any such license at a reasonable cost, or that such developments and results will not be made available to our competitors on an exclusive or non-exclusive basis.
Trade Secrets.
To a more limited extent, we rely on trade secret protection and confidentiality agreements to protect our interests. It is our policy to require employees, consultants, contractors, manufacturers, collaborators, and other advisors to execute confidentiality agreements upon the commencement of employment, consulting or collaborative relationships with us. We also require signed confidentiality agreements from any entity that is to receive confidential information from us. With respect to employees, consultants and contractors, the agreements generally provide that all inventions made by the individual while rendering
services to us shall be assigned to us as our property.
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Government Regulations
The development, production and marketing of pharmaceutical and biological products developed by Novavax or our collaborators are subject to regulation for safety, efficacy and quality by numerous governmental authorities in the United States and other countries. In the United States, the development, manufacturing and marketing of human pharmaceuticals and vaccines are subject to extensive regulation under the Federal Food, Drug, and Cosmetic Act, and biological products are subject to regulation under provisions of that Act and the Public Health Service Act. The FDA assesses the safety and efficacy of products and regulates, among other things, the
testing, manufacture, labeling, storage, record keeping, advertising and promotion. The process of obtaining FDA approval for a new product is costly and time-consuming.
Vaccine clinical development follows the same general pathway as drugs and other biologics. Before applying for FDA approval to market any new drug product candidates, we must first submit an IND that explains to the FDA the results of pre-clinical testing conducted in laboratory animals, the method of manufacture and quality control tests for release and what we propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe to move forward with testing the product in humans. We must then conduct Phase I human clinical trials and larger-scale Phase II and III human clinical trials that demonstrate the safety and
efficacy of our products to the satisfaction of the FDA. Once these trials are complete, a Biologics License Application (BLA) (the biologic equivalent to a New Drug Application (NDA)) can be filed with the FDA requesting approval of the vaccine for marketing based on the vaccines effectiveness and safety.
During the FDAs review of the BLA, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail. Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccines proper use, including its potential benefits and risks, to communicate with patients and parents and to safely deliver the vaccine to the public. Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase IV studies after a BLA has been approved
and the vaccine is licensed and on the market.
In addition to obtaining FDA approval for each product, each domestic manufacturing establishment must be registered with the FDA, is subject to FDA inspection and must comply with cGMP regulations. To supply products for use either in the United States or outside the United States, including clinical trials, United States and foreign manufacturing establishments, including third-party facilities, must comply with cGMP regulations and are subject to periodic inspection by the FDA or by corresponding regulatory agencies in their home country.
The development process for a new drug or biological product typically takes a long period of time to complete. Pre-clinical studies may take several years to complete and there is no guarantee that the FDA will permit an IND based on those studies to become effective or the product to advance to clinical testing. Clinical trials may take several years to complete. After the completion of the required phases of clinical trials, if the data indicate that the drug or biologic product is safe and effective, a BLA or NDA (depending on whether the product is a biologic or pharmaceutical product) is filed with the FDA to approve the marketing and
commercial shipment of the drug. This process takes substantial time and effort and the FDA may not accept the BLA or NDA for filing. Even if filed and accepted, the FDA might not grant approval. FDA approval of a BLA or NDA may take up to two years and may take longer if substantial questions about the filing arise. The FDA may require post-marketing testing and surveillance to monitor the safety of the applicable products.
In addition to regulatory approvals that must be obtained in the United States, an investigational product is also subject to regulatory approval in other countries in which it is intended to be marketed. No such product can be marketed in a country until the regulatory authorities of that country have approved an appropriate marketing application. FDA approval does not assure approval by other regulatory authorities. In addition, in many countries, the government is involved in the pricing of the product. In such cases, the pricing review period often begins after market approval is granted.
We are also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential federal, state or local regulations. These and other laws govern our use, handling and
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disposal of various biological and chemical substances used in, and waste generated by, our operations. Our research and development involves the controlled use of hazardous materials, chemicals and viruses. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages that result, and any such liability could exceed our resources. Additionally, for formulations containing
controlled substances, we are subject to Drug Enforcement Act regulations.
There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical and biological products, government control and other changes to the healthcare system of the United States. It is uncertain what legislative proposals will be adopted or what actions federal, state or private payers for medical goods and services may take in response to any healthcare reform proposals or legislation. We cannot predict the effect medical or healthcare reforms may have on our business, and no assurance can be given that any such reforms will not have a material adverse effect.
Manufacturing
We have constructed a 10,000 square foot cGMP facility to produce clinical trial material as well as modest commercialization quantities of our VLP vaccines at our corporate headquarters. Construction for the pilot plant facility commenced in the fourth quarter of 2007 and was completed within 120 days of ground breaking. The total cost of the project, including demolition, construction and installation of laboratory and production equipment, was approximately $5 million. The facility had existing mechanical systems in place (pharmaceutical air and water system) that were not included in the total cost. Any plans to further expand our manufacturing
capabilities at our corporate headquarters, including the facilities necessary to expand manufacturing quantities, test and package an adequate supply of finished products in order to meet any long-term commercial needs, will require additional resources and will be subject to ongoing government approval and oversight.
We have not manufactured any of our vaccine product candidates at a commercial level and the process requires further scale-up and yield improvement. In October 2009, we engaged Xcellerex, Inc. (Xcellerex) to perform scale-up activities and manufacture our 2009 H1N1 vaccine candidate for potential sale in Mexico. The agreement with Xcellerex expired by its own terms on February 15, 2010. Although the H1N1 manufacturing campaign with Xcellerex did not result in the manufacturing of acceptable vaccine to Novavax, we did achieve proof of concept by scaling up to a commercial grade bioreactor. The success in scaling up our VLPs in stir tank
bioreactors potentially provides an additional path to large-scale, commercially viable vaccine production. We may encounter unexpected expenses or delays as we, or third-party vendors, work to scale-up and improve efficiencies of our manufacturing process.
Sources of Supply
Most of the raw materials and other supplies required in our business are generally available from various suppliers in quantities adequate to meet our needs. In some cases, we have only qualified one supplier for certain of our manufacturing components. We have plans in place to qualify multiple suppliers for all critical supplies before the time we would put any of our product candidates into commercial production. One of our major suppliers is GE Healthcare (GEHC) which supplies disposable components used in our manufacturing process. GEHC utilizes a sophisticated, in depth process to qualify multiple vendors for the products that are supplied to
us. All the materials and vendors that supply manufacturing materials to the Company are audited for compliance with cGMP standards.
Business Development
We believe our proprietary VLP technology affords us a range of traditional and non-traditional commercialization options that are broader than those of existing vaccine companies. We strive to create sustainable value by working to obtain non-dilutive funding for conducting Phase III trials for both seasonal and pandemic influenza, to continue development of our vaccine product candidates until such vaccines can be licensed on a regional basis, to retain commercial rights in major markets and generate product sales revenue and, in certain markets, to commercialize our products through partners and other strategic relationships.
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Examples of our strategic relationships are our collaboration with GEHC, our joint venture with Cadila Pharmaceuticals, Ltd. and our relationship with Avimex.
We have entered into a co-marketing agreement with GEHC for a pandemic influenza vaccine solution for select international countries. The collaboration incorporates GEHCs bioprocess solutions and design expertise with Novavaxs VLP manufacturing platform.
On March 31, 2009, we and Cadila Pharmaceuticals Ltd., a company incorporated under the laws of India (Cadila) entered into a Joint Venture Agreement (the JVA) pursuant to which we and Cadila formed CPL Biologicals Private Limited, a joint venture (the JV), of which 80% is ultimately owned by Cadila and 20% is owned by Novavax. The JV will develop and commercialize our H1N1 pandemic and seasonal influenza vaccine candidates and Cadilas biogeneric products and other diagnostic products for the territory of India. We also contributed to the JV technology for the development of several other VLP vaccine candidates against diseases of public health
concern in the territory, such as hepatitis E and chikungunya fever. Cadila has committed to contribute approximately $8 million over three years to support the JVs operations. The JV will be responsible for clinical testing and registration of products that will be marketed and sold in India. In October 2009, the JV began construction of a state-of-the-art manufacturing facility that may be used to produce pandemic and seasonal influenza vaccines. The facility, which is 100% funded by Cadila, is expected to open in early 2010.
On June 30, 2009, we announced that we had signed a non-binding letter of intent to license our VLP vaccine technology to ROVI Pharmaceuticals of Spain (ROVI). On February 5, 2010, we terminated negotiations with ROVI. The decision to terminate negotiations was made because of the companies inability to agree on acceptable terms of the proposed collaboration and to obtain the necessary funding commitments for the program. We are free to seek a new partner for our pandemic and seasonal influenza vaccine development efforts in Europe in the future.
On October 19, 2009, we entered into a Materials Transfer Agreement with Avimex, pursuant to which we supplied Avimex with certain amounts of our 2009 H1N1 vaccine candidate. Avimex used the H1N1 vaccine to conduct clinical trials and is currently seeking regulatory approval in Mexico. The agreement and the option to enter into a non-exclusive distribution agreement to distribute the 2009 H1N1 vaccine in Mexico both expired on their own terms on December 31, 2009. The second phase of the clinical trial is ongoing and the parties are continuing to cooperate in seeking regulatory approval in Mexico.
Employees
As of March 12, 2010, we had 93 full-time employees and 1 part-time employee for a total of 94 employees, 19 of whom hold M.D. or Ph.D. degrees and 21 of whom hold other advanced degrees. Of our total workforce, 73 are engaged primarily in research, development and manufacturing activities and 21 are engaged primarily in business development, finance and accounting and administrative functions. None of our employees are represented by a labor union or covered by a collective bargaining agreement and we consider our employee relations to be good.
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Executive Officers
Our executive officers hold office until the first meeting of the Board of Directors following the Annual Meeting of Stockholders and until their successors are duly chosen and qualified, or until they resign or are removed from office in accordance with our By-laws.
The following table provides certain information with respect to our executive officers.
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Name
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Age
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Principal Occupation and Other Business Experience During the Past Five Years
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Stanley C. Erck
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61
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Executive Chairman and Director
of Novavax since February 2010, and a Director since June 2009. From 2000 to 2008, Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, a developer of vaccines and immune system therapies, which was acquired in 2008 by Intercell. He also previously held leadership positions at Procept, a publicly traded immunology company, Integrated Genetics, now known as Genzyme, and Baxter International. Mr. Erck also serves on the Board of Directors of BioCryst Pharmaceuticals, MaxCyte, Inc. and MdBio Foundation.
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Rahul Singhvi, Sc.D.
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45
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President and Chief Executive Officer and Director
of Novavax since August 2005. Senior Vice President and Chief Operating Officer of Novavax from April 2005 to August 2005 and Vice President, Pharmaceutical Development and Manufacturing Operations from April 2004 to April 2005. For 10 years prior to joining the Company, Dr. Singhvi served in several positions with Merck & Co., culminating as Director of the Merck Manufacturing Division from 1999 to 2004.
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Frederick W. Driscoll
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59
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Vice President, Chief Financial Officer and Treasurer
of Novavax since August 2009. Prior to joining the Company, Mr. Driscoll served as Chief Executive Officer of Genelabs Technologies, Inc. from September 2008 to January 2009, as Interim Chief Executive Officer from February 2008 to August 2008 and as Chief Financial Officer from September 2007 to February 2008. Prior to that, from 2000 to 2006, Mr. Driscoll was employed by OXIGENE, Inc., where he served as President and Chief Executive Officer from 2002 to 2006.
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Raymond J. Hage, Jr.
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42
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Senior Vice President, Commercial Operations
since October 2006. Senior Vice President and Chief Operating Officer from August 2005 to October 2006 and Vice President of Marketing and Corporate Development of Novavax from January 2004 to August 2005. Prior to joining the Company, Mr. Hage served in several positions including as an independent marketing consultant with CHS, Inc. in 2003, Director of Marketing with Cephalon, Inc. from 2002 to 2003 and for 10 years held various marketing and sales roles at Eli Lilly culminating as Director of U.S. Womens Health from 2001 to 2002.
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Thomas Johnston
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39
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Vice President, Strategy
of Novavax since April 2008. From March 2007 through August 2008, Mr. Johnston served as independent strategic business consultant for multiple industries including banking, government security and mobile telecommunications. Prior to this, Mr. Johnston served as VP of Emerging Technology for Fleet Bank, and additional roles within Microsoft Corporation and Comcast Corporation.
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John Trizzino
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50
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Senior Vice President, International and Government Alliances
of the Company since July 2009. Prior to joining the Company, Mr. Trizzino served as Vice President of the vaccine franchise at MedImmune, Inc. from 2006 to 2009, Senior Vice President of business development at ID Biomedical from 2004 to 2006, and served as Vice President within the Henry Schein, Inc. medical division in business development and General Manager of their GIV division from 1997 to 2004.
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Availability of Information
Novavax was incorporated in 1987 under the laws of the State of Delaware. Our principal executive offices are located at 9920 Belward Campus Drive, Rockville, Maryland, 20850. Our telephone number is (240) 268-2000 and our website address is
www.novavax.com
. The contents of our website are not part of this Annual Report on Form 10-K.
We make available, free of charge and through our website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after filed with or furnished to the Securities and Exchange Commission.
Item 1A. Risk Factors
You should carefully consider the following risk factors in evaluating our business. There are a number of risk factors that could cause our actual results to differ materially from those that are indicated by forward-looking statements. Some of the risks described relate principally to our business and the industry in which we operate. Others relate principally to the securities market and ownership of our common stock. The risks and uncertainties described below are not the only ones facing us. Additional risks and uncertainties that we are unaware of, or that we currently deem immaterial, also may become important factors that affect us. If any of
the following risks occur, our business, financial condition or results of operations could be materially and adversely affected. You should also consider the other information included in this Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
Risks Related to Our Business
We have a history of losses and our future profitability is uncertain.
Our expenses have exceeded our revenue since our formation in 1987, and our accumulated deficit at December 31, 2009 was $274.2 million. Our revenue for the last three fiscal years from continuing operations was $0.3 million in 2009, $1.1 million in 2008 and $1.5 million in 2007. We have recorded limited revenue from research contracts, licenses and agreements to provide vaccine candidates, services and technologies. We cannot be certain that we will be successful in entering into strategic alliances or collaborative arrangements with other companies that will result in significant revenue to offset our expenses. Our net losses for the last three
fiscal years were $38.4 million in 2009, $36.0 million in 2008 and $34.8 million in 2007, including discontinued operations.
Our recent historical losses have predominantly resulted from research and development expenses for our vaccine product candidates, sales and marketing expenses, manufacturing-related expenses, costs related to protection of our intellectual property and for other general operating expenses. Our expenses have exceeded our revenue since inception. We believe our expenses will continue to increase, as a result of higher research and development efforts to support the development of our vaccines, particularly our pandemic and seasonal influenza vaccines.
We expect to continue to incur significant operating expenses and anticipate that our expenses and losses will increase in the foreseeable future as we seek to:
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initiate Phase III and complete Phase II clinical trials for our seasonal influenza vaccine;
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conduct additional pre-clinical studies for VZV and RSV product candidates and begin clinical trials for RSV;
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comply with the FDAs manufacturing facility requirements;
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scale-up our manufacturing process for commercial scale and cost efficiency; and
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maintain, expand and protect our intellectual property portfolio.
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As a result, we expect our cumulative operating losses to increase until such time, if ever, that product sales, licensing fees, royalties, milestones, contract research and other sources generate sufficient revenue to fund our continuing operations. We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.
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We have limited financial resources and we are not certain that we will be able to maintain our current level of operations or be able to fund the further development of our product candidates.
We do not expect to generate revenue from product sales, licensing fees, royalties, milestones, contract research or other sources in an amount sufficient to fund our operations for the foreseeable future, and we will therefore use our cash resources and expect to require additional funds to maintain our operations, continue our research and development programs, commence future pre-clinical studies and clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings, collaborative licensing and development arrangements, government grants and
other sources. While we continue to apply for grants from academic institutions, non-profits and governmental entities, there are no assurances that we would be successful. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to delay significantly, reduce the scope of or eliminate one or more of our research or development programs, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency, including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, product candidates or products. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of your percentage ownership in the Company which could be substantial. Future offerings also
could have a material and adverse effect on the price of our common stock.
The current capital and credit market conditions may adversely affect our access to capital, cost of capital, and ability to execute our business plan as scheduled.
Access to capital markets is critical to our ability to operate. Traditionally, biopharmaceutical companies have funded their research and development expenditures through raising capital in the equity markets. Declines and uncertainties in these markets in the past have severely restricted raising new capital and have affected companies ability to continue to expand or fund existing research and development efforts. We require significant capital for research and development for our product candidates and clinical trials. The general economic and capital market conditions, both in the United States and worldwide, have been extremely volatile
over the past eighteen months and have adversely affected our access to capital and increased the cost of capital, and any recovery will likely be very slow. There is no certainty that the capital and credit markets will recover to the point where we could raise additional capital on terms similar to the terms that companies raised capital prior to the deterioration. If these economic conditions continue or become worse, our future cost of equity or debt capital and access to the capital markets could be adversely affected. In addition, our inability to access the capital markets on favorable terms due to our low stock price, or upon a potential delisting from the NASDAQ Global Market if we fail to satisfy a listing requirement, could affect our ability to execute our business plan as scheduled. Moreover, we rely and intend to rely on third-parties, including our clinical research organizations, third-party manufacturers and certain other important vendors and consultants. As a result
of the global economic situation, there may be a disruption or delay in the performance of our third-party contractors and suppliers. If such third-parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.
We may not be able to win government, academic institution or non-profit grants.
From time to time, we may apply for grants from academic institutions, government agencies and non-profit entities and, most recently, we responded to the United States Government RFP solicitation number HHS BARDA-09-32 for a contract award for the advanced development of recombinant influenza vaccines. Such grants or contracts can be highly attractive because they provide capital to fund the ongoing development of our technologies and product candidates without diluting our stockholders. However, there is often significant competition for these grants. Grantors may have requirements to apply for or to otherwise be eligible to receive certain grants
that our competitors may be able to satisfy that we cannot. In addition, grantors may make arbitrary decisions as to whether to make grants, to whom the grants will be awarded and the size of the grants to each awardee. Even if we are able to satisfy the award requirements, there is no guarantee that we will be a successful awardee. Therefore, we may not be able to win any grants, including BARDA in a timely manner, if at all, which could delay the start of our Phase III program in seasonal influenza.
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A portion of our investments are auction rate securities which present potential liquidity concerns.
As of December 31, 2009, we had $5.1 million invested in three auction rate securities, which were classified as short-term investments available-for-sale and carried at their estimated fair value of $4.2 million. Auction rate securities are long-term debt instruments that provide liquidity through a competitive bidding process known as a Dutch Auction that resets the applicable interest rates at pre-determined calendar intervals. Although two auction rate securities were redeemed during the year ended December 31, 2009, as a result of the issues that presently exist in the credit markets, we may be unable to liquidate some or all of our
remaining auction rate securities when we are in need of the cash to fund operations at prices that are acceptable to us. Even if we are able to liquidate the investments, the sales may be at a loss. In addition, given the complexity of auction rate securities and their valuations, our estimates of their fair value may differ from the actual amount we would be able to collect in the ultimate sale. It is uncertain as to when the liquidity issues relating to these investments will improve.
Our collaborations with regional partners, such as Cadila and Avimex, expose us to additional risks associated with doing business outside the United States, and any adverse event could have a material negative impact on our operations.
We have formed a joint venture with Cadila in India and have entered into other agreements and arrangements with companies in other countries. We plan to continue to enter into collaborations or partnerships with companies, non-profit organizations and local governments in other parts of the world. Risks of conducting business outside the United States include:
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multiple regulatory requirements could affect the ability to develop, manufacture and sell products in such local markets;
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compliance with anti-bribery laws such as the United States Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions;
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trade protections measures and import and export licensing requirements;
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different labor regulations;
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changes in environmental, health and safety laws;
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potentially negative consequences from changes in or interpretations of tax laws;
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political instability and actual or anticipated military or potential conflicts;
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economic instability, inflation, recession and interest rate fluctuations;
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minimal or diminished protection of intellectual property in some countries; and
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possible nationalization and expropriation.
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These risks, individually or in the aggregate, could have a material adverse effect on our business, financial conditions, results of operations and cash flows.
Our strategy to enter into regional relationships may hinder our ability to engage in a larger transaction.
We have entered into regional collaborations to develop our product candidates in certain parts of the world. Our relationships with Cadila and Avimex are examples of this strategy. We expect that many of these relationships will involve the licensing of our technology to our partner or entering into a distribution agreement, frequently on an exclusive basis. Generally, these exclusive agreements are restricted to certain territories. Because we have entered into exclusive license and distribution agreements, larger companies may not be interested, or able, to enter into collaborations with us on a worldwide scale. Also, these regional relationships
may make us an unattractive target for an acquisition.
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We are a biopharmaceutical company and face significant risk in developing, manufacturing and commercializing our products.
We focus our research and development activities on vaccines, an area in which we have particular strengths and a technology that appears promising. The outcome of any research and development program is highly uncertain. Only a small fraction of biopharmaceutical development programs ultimately result in commercial products or even product candidates and a number of events could delay our development efforts and negatively impact our ability to obtain regulatory approval for, and to manufacture, market and sell, a product candidate. Product candidates that initially appear promising often fail to yield successful products. In many cases,
pre-clinical or clinical studies will show that a product candidate is not efficacious or that it raises safety concerns or has other side effects that outweigh its intended benefit. Success in pre-clinical or early clinical trials may not translate into success in large-scale clinical trials. Further, success in clinical trials will likely lead to increased investment, accelerating cumulative losses, to bring such products to market. Even if clinical trial results are positive, we may face challenges when scaling-up the manufacturing process to commercial levels. Even after a product is approved and launched, general usage or post-marketing studies may identify safety or other previously unknown problems with the product, which may result in regulatory approvals being suspended, limited to narrow indications or revoked, which may otherwise prevent successful commercialization. Intense competition in the vaccine industry could also limit the successful commercialization of our
products.
Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid and significant technological change. We have many potential competitors, including major drug and chemical companies, specialized biotechnology firms, academic institutions, government agencies and private and public research institutions. Many of our competitors have significantly greater financial and technical resources, experience and expertise in:
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research and development;
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designing and implementing clinical trials;
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regulatory processes and approvals;
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production and manufacturing; and
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sales and marketing of approved products.
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Principal competitive factors in our industry include:
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the quality and breadth of an organizations technology;
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management of the organization and the execution of the organizations strategy;
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the skill and experience of an organizations employees and its ability to recruit and retain skilled and experienced employees;
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an organizations intellectual property portfolio;
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the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and
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the availability of substantial capital resources to fund discovery, development and commercialization activities.
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Large and established companies such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc., sanofi pasteur, Inc. and MedImmune Inc. (a subsidiary of Astra-Zeneca, Inc.), among others, compete in the vaccine market. In particular, these companies have greater experience and expertise in securing government
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contracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, and manufacturing such products on a broad scale and marketing approved products.
There are many seasonal influenza vaccines currently approved and marketed. Competition in the sale of these seasonal influenza vaccines is intense. Therefore, newly developed and approved products must be differentiated from existing vaccines in order to have commercial success. In order to show differentiation in the seasonal influenza space, a product must be more efficacious, particularly in the elderly population, and/or be less expensive and quicker to manufacture. Many of our competitors are working on new products and new generations of current products, often by adding an adjuvant that is used to increase the efficacy of the current product,
each of which is intended to be more efficacious than products currently being marketed. Our seasonal influenza product may not prove to be more efficacious than current products or products under development by our competitors. Further, our manufacturing system may not provide enough savings of time or money to provide the required differentiation for commercial success.
Smaller or early-stage companies and research institutions may also prove to be significant competitors, particularly through collaborative arrangements with large and established pharmaceutical or other companies. As these companies develop their technologies, they may develop proprietary positions, which may prevent or limit our product development and commercialization efforts. We will also face competition from these parties in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and subject registration for clinical trials, and in acquiring and in-licensing technologies and products
complementary to our programs or potentially advantageous to our business. If any of our competitors succeed in obtaining approval from the FDA or other regulatory authorities for their products sooner than we do or for products that are more effective or less costly than ours, our commercial opportunity could be significantly reduced.
In order to effectively compete, we will have to make substantial investments in development, testing, manufacturing and sales and marketing or partner with one or more established companies. There is no assurance that we will be successful in gaining significant market share for any product or product candidate. Our technologies and products also may be rendered obsolete or non-competitive as a result of products introduced by our competitors to the marketplace more rapidly and at a lower cost.
If we lose or are unable to attract key management or other personnel, we may experience delays in product development.
We depend on our senior executive officers, as well as key scientific and other personnel. The loss of these individuals could harm our business and significantly delay or prevent the achievement of research, development or business objectives. Employment with our Chief Medical Officer and Vice President of Manufacturing ended in November 2009 and January 2010, respectively. While we are searching for replacements, we may not be able to attract qualified individuals on terms acceptable to us. We appointed John J. Trizzino as Senior Vice President, International and Government Alliances, in July 2009. Our Chief Financial Officer, Frederick Driscoll,
assumed this responsibility in August 2009. In February 2010 Stanley Erck was appointed Executive Chairman of the Board. This lack of management continuity, the resulting lack of long-term history with our Company and the learning curve that executives experience when they join our management team, could result in operational and administrative inefficiencies and added costs. If we were to experience additional turnover at the executive level, these risks would be exacerbated.
We may not be able to attract qualified individuals for other key management or other personnel positions on terms acceptable to us. Competition for qualified employees is intense among pharmaceutical and biotechnology companies, and the loss of qualified employees, or an inability to attract, retain and motivate additional highly skilled employees required for the expansion of our activities, could hinder our ability to complete human studies successfully and develop marketable products.
We also rely from time-to-time on outside advisors who assist us in formulating our research and development and clinical strategy. We may not be able to attract and retain these individuals on acceptable terms, which could have a material adverse effect on our business, financial condition and results of operations.
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We do not currently have a majority of independent directors and are, therefore, not in compliance with NASDAQs listing requirements.
Because two independent directors resigned in 2009 and Mr. Stanley Erck was appointed Executive Chairman on February 15, 2010 rendering him no longer independent, the majority of our Board of Directors is no longer independent. After disclosing this fact to NASDAQ as required, we received a notice from NASDAQ confirming that we are no longer in compliance with the NASDAQ requirements set forth in Listing Rule 5605(b)(1), which requires that the Companys Board of Directors be comprised of a majority of independent directors. We have 45 days to submit a plan to NASDAQ to regain compliance. The notification has no immediate effect on the listing
of Novavaxs common stock on The NASDAQ Global Market. The Companys common stock continues to trade on the NASDAQ Global Market under the symbol NVAX.
Over recent months, the Nominating and Corporate Governance Committee of Novavaxs Board of Directors has been identifying, evaluating and recruiting potential candidates for election to the Board of Directors. Novavax expects to elect two independent directors and thus cure this non-compliance before its 2010 Annual Meeting of Stockholders. We may not be able to attract and recruit qualified individuals to serves as directors. Certain qualified individuals may demand more compensation than we are willing to pay and we may not have two new independent directors on a timely basis. If we are unable to add two new independent directors and we do
not receive an extension of time from the NASDAQ, our listing on The NASDAQ Global Market may be affected.
We may have product liability exposure.
The administration of drugs to humans, whether in clinical trials or after marketing clearances are obtained, can result in product liability claims. We maintain product liability insurance coverage in the total amount of $20 million aggregate for all claims arising from the use of products in clinical trials prior to FDA approval. Coverage is relatively expensive, and the market pricing can significantly fluctuate. Therefore, we may not be able to maintain insurance at a reasonable cost. There can be no assurance that we will be able to maintain our existing insurance coverage or obtain coverage for the use of our other products in the future. This
insurance coverage and our resources may not be sufficient to satisfy all liabilities resulting from product liability claims. A successful claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable items, if at all. Even if a claim is not successful, defending such a claim would be time-consuming and expensive, may damage our reputation in the marketplace, and would likely divert managements attention.
Regardless of merit or eventual outcome, liability claims may result in:
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decreased demand for our products;
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impairment of our business reputation;
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withdrawal of clinical trial participants;
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costs of related litigation;
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substantial monetary awards to subjects or other claimants;
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inability to commercialize our product candidates.
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There are outstanding loans owed by certain of our former directors which may not be repaid.
Two of our former directors have outstanding notes due to the Company. The notes were initially delivered by the former directors to us in March 2002 as payment of the exercise price of options. As security, the former directors pledged shares of our common stock as collateral. As of December 31, 2009, the outstanding principal and interest for these two notes was $2.0 million. Both notes are currently in default.
We are uncertain about the collectability of these notes. At our current market prices, we do not expect to recover the full amount outstanding under either note upon a sale of pledged shares alone. We continue to actively work to collect the amounts outstanding and reserve our rights to seek legal remedies currently available to us. There are no assurances that the former directors will be able to repay the notes in full.
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Raising additional capital by issuing securities or through collaboration and licensing arrangements may cause dilution to existing stockholders or require us to relinquish rights to our technologies or product candidates.
If we are unable to partner with a third-party to advance the development of one or more of our vaccine candidates, we will need to raise money through additional debt or equity financings. To the extent that we raise additional capital by issuing equity securities, our stockholders will experience immediate dilution which may be significant. To the extent that we raise additional capital through licensing arrangements or arrangements with collaborative partners, we may be required to relinquish, on terms that may not be favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize
ourselves. In addition, current economic conditions may also negatively affect the desire or ability of potential collaborators to enter into transactions with us. They may also have to delay or cancel research and development projects or reduce their overall budgets.
Product Development Risks
Because our vaccine product development efforts depend on new and rapidly evolving technologies, we cannot be certain that our efforts will be successful.
Our vaccine work depends on new, rapidly evolving technologies and on the marketability and profitability of our products. Commercialization of our vaccine products could fail for a variety of reasons, and include the possibility that:
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our VLP technology, any or all of the products based on VLP technology or our proprietary manufacturing process will be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances or commercial viability;
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we are unable to scale-up our manufacturing capabilities in a cost effective manner;
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the products, if safe and effective, will be difficult to manufacture on a large-scale or uneconomical to market;
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our pilot plant manufacturing facility will fail to continue to pass regulatory inspections;
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proprietary rights of third-parties will prevent us or our collaborators from exploiting technologies, manufacturing or marketing products; and
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third-party competitors will gain greater market share due to superior products or marketing capabilities.
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We have not completed the development of vaccine products and we may not succeed in obtaining the FDA approval necessary to sell additional products.
The development, manufacture and marketing of our pharmaceutical and biological products are subject to government regulation in the United States and other countries. In the United States and most foreign countries, we must complete rigorous pre-clinical testing and extensive human clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the product. None of our vaccine products have yet gained regulatory approval in the United States or elsewhere. We also have product candidates in human clinical trials and pre-clinical laboratory or animal studies.
The steps required by the FDA before our proposed investigational products may be marketed in the United States include:
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performance of pre-clinical (animal and laboratory) tests;
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submissions to the FDA of an IND which must become effective before human clinical trials may commence;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the investigational product in the intended target population;
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performance of a consistent and reproducible manufacturing process intended for commercial use, including appropriate manufacturing data and regulatory inspections;
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submission to the FDA of a BLA or a NDA; and
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FDA approval of the BLA or NDA before any commercial sale or shipment of the product.
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The processes are expensive and can take many years to complete, and we may not be able to demonstrate the safety and efficacy of our products to the satisfaction of regulatory authorities. The start of clinical trials can be delayed or take longer than anticipated for many and varied reasons, many of which are out of our control. Safety concerns may emerge that could lengthen the ongoing trials or require additional trials to be conducted. Regulatory authorities may also require additional testing, and we may be required to demonstrate that our proposed products represent an improved form of treatment over existing therapies, which we may be unable
to do without conducting further clinical studies. Moreover, if the FDA or foreign regulatory body grants regulatory approval of a product, the approval may be limited to specific indications or limited with respect to its distribution. Expanded or additional indications for approved products may not be approved, which could limit our revenue. Foreign regulatory authorities may apply similar limitations or may refuse to grant any approval. Consequently, even if we believe that pre-clinical and clinical data are sufficient to support regulatory approval for our product candidates, the FDA and foreign regulatory authorities may not ultimately grant approval for commercial sale in any jurisdiction. If our vaccine candidates are not approved, our ability to generate revenue will be limited and our business will be adversely affected.
If we are unable to manufacture our vaccines in sufficient quantities, at sufficient yields or are unable to obtain regulatory approvals for a manufacturing facility for our vaccines, we may experience delays in product development, clinical trials, regulatory approval and commercial distribution.
Completion of our clinical trials and commercialization of our vaccine product candidates require access to, or development of, facilities to manufacture our product candidates at sufficient yields and at commercial scale. We have limited experience manufacturing any of our product candidates in the volumes that will be necessary to support large-scale clinical trials or commercial sales. Efforts to establish capabilities may not meet initial expectations as to scheduling, scale-up, reproducibility, yield, purity, cost, potency or quality.
If we are unable to manufacture our product candidates in clinical quantities or, when necessary, in commercial quantities and at sufficient yields, then we must rely on third-parties. Other third-party manufacturers must also receive FDA approval before they can produce clinical material or commercial products. Our vaccines may be in competition with other products for access to these facilities and may be subject to delays in manufacture if third-parties give other products greater priority. We may not be able to enter into any necessary third-party manufacturing arrangements on acceptable terms, or on a timely basis. In addition, we have to enter
into technical transfer agreements and share our know-how with the third-party manufacturers, which can be time-consuming and may result in delays.
Influenza vaccines are intensely seasonal in nature. If a vaccine is not available early enough in the influenza season, we would likely have difficulty selling the vaccine. Further, pandemic outbreaks present only short-term opportunities for the Company. There is no way to predict when there will be a pandemic outbreak, the strain of the influenza or how long the pandemic will last. For these reasons, any delay in the delivery of an influenza vaccine could result in lower sales volumes, lower sale prices, or no sales. Because the strain of the seasonal influenza changes annually, inventory of seasonal vaccine cannot be sold during a subsequent
influenza season. Any delay in the manufacture of our influenza vaccines could adversely affect our ability to sell the vaccines.
Our reliance on contract manufacturers may adversely affect our operations or result in unforeseen delays or other problems beyond our control. Because of contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture our bulk vaccines on a commercial scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in the production of our vaccine. A third-party manufacturer may also encounter difficulties in production. These problems may include:
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difficulties with production costs, scale-up and yields;
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availability of raw materials and supplies;
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quality control and assurance;
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shortages of qualified personnel;
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compliance with strictly enforced federal, state and foreign regulations that vary in each country where product might be sold; and
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lack of capital funding.
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As a result, any delay or interruption could have a material adverse effect on our business, financial condition, results of operations and cash flows.
We must identify products and product candidates for development with our VLP technology and establish successful third-party relationships.
The near and long-term viability of our vaccine product candidates will depend in part on our ability to successfully establish new strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies. Establishing strategic collaborations and obtaining government funding is difficult and time-consuming. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position or based on their internal pipeline; government agencies may reject contract or grant applications based on their assessment of public need, the public
interest, our products ability to address these areas, or other reasons beyond our expectations or control. If we fail to establish a sufficient number of collaborations or government relationships on acceptable terms, we may not be able to commercialize our vaccine product candidates or generate sufficient revenue to fund further research and development efforts.
Even if we establish new collaborations or obtain government funding, these relationships may never result in the successful development or commercialization of any vaccine product candidates for several reasons, including the fact that:
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we may not have the ability to control the activities of our partner and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development and commercialization of products and product candidates, in a timely manner or at all;
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such partners may not devote sufficient resources to our products and product candidates or properly maintain or defend our intellectual property rights;
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any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our products and product candidates, and affect our ability to realize product revenue; and
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disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time-consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals, and commercialization activities.
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Our collaborators will be subject to the same regulatory approval of the manufacturing facility and process as Novavax. Before we could begin commercial manufacturing of any of our product candidates, we and our collaborators must pass a pre-approval inspection before FDA approval and comply with the FDAs cGMP. If our collaborators fail to comply with these requirements, our product candidates would not be approved. If our collaborators fail to comply with these requirements after approval, we would be subject to possible regulatory action and may be limited in the jurisdictions in which we are permitted to sell our products.
If we or our partners fail to maintain our existing agreements or in the event we fail to establish agreements as necessary, we could be required to undertake research, development manufacturing and commercialization activities solely at our own expense. These activities would significantly increase our capital requirements and, given our lack of sales, marketing and distribution capabilities, significantly delay the commercialization of products and product candidates.
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Because we depend on third-parties to conduct some of our laboratory testing, human studies, and manufacturing, we may encounter delays in or lose some control over our efforts to develop products.
We are dependent on third-party research organizations to conduct some of our laboratory testing, human studies and manufacturing activities. If we are unable to obtain any necessary services on acceptable terms, we may not complete our product development efforts in a timely manner. We may lose some control over these activities and become too dependent upon these parties. These third-parties may not complete testing or manufacturing activities on schedule, within budget, or when we request. We may not be able to secure and maintain suitable research organizations to conduct our laboratory testing, human studies and manufacturing activities. We have
not manufactured any of our product candidates at a commercial level and may need to identify additional third-party manufacturers to scale-up and manufacture our products.
We are responsible for confirming that each of our clinical trials is conducted in accordance with its general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to comply with regulations and standards, commonly referred to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. The FDA and foreign regulatory agencies also require us to comply with good manufacturing practices. Our reliance on third-parties does not relieve us of these
responsibilities and requirements. If these third-parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third-parties need to be replaced or if the quality or accuracy of the data they obtain is compromised or the product they manufacture is contaminated due to the failure to adhere to our clinical and manufacturing protocols or regulatory requirements or for other reasons, our pre-clinical development activities of clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval of, or commercially manufacture, our product candidates.
Our collaborations may not be profitable.
We have entered into a co-marketing agreement with GEHC for a pandemic influenza vaccine solution for select international countries. The collaboration incorporates GEHCs bioprocess solutions and design expertise with Novavaxs VLP manufacturing platform. We have formed a joint venture with Cadila in India. In connection with this joint venture, we agreed to a Master Services Agreement under which we will purchase $7.5 million of services from Cadila or pay Cadila all or a portion of the shortfall before March 2012. We cannot predict when, if at all, these relationships will lead to approved products, sales, or otherwise provide revenue to
the Company or become profitable.
Even though we have received governmental support in the past, we may not continue to receive support at the same level or at all.
The United States government, through its various agencies, has provided grants to fund certain research and development efforts. There can be no assurances that we will continue to receive the same level of funding from the United States government, if at all. For example, the grants awarded to the Company to conduct research related to HIV and SARS have expired and have not been renewed. We have responded to the United States government (HHS BARDA) RFP for advanced development of recombinant influenza vaccines. However, for various reasons, including public need, program requirements, timing and other factors beyond our control, we may not receive
any funds under any government programs.
We have limited marketing capabilities, and if we are unable to enter into collaborations with marketing partners or develop our own sales and marketing capability, we may not be successful in commercializing any approved products.
We currently have no sales, marketing or distribution capabilities. As a result, we will depend on collaborations with third-parties that have established distribution systems and sales forces. To the extent that we enter into co-promotion or other licensing arrangements, our revenue will depend upon the efforts of third-parties, over which we may have little or no control. If we are unable to reach and maintain agreements with one or more pharmaceutical companies or collaborators, we may be required to market our products directly.
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Developing a marketing and sales force is expensive and time-consuming and could delay a product launch. We cannot be certain that we will be able to attract and retain qualified sales personnel or otherwise develop this capability.
Our product candidates may never achieve market acceptance even if we obtain regulatory approvals.
Even if we receive regulatory approvals for the commercial sale of our product candidates, the commercial success of these product candidates will depend on, among other things, their acceptance by physicians, patients, third-party payers such as health insurance companies and other members of the medical community as a vaccine and cost-effective alternative to competing products. If our product candidates fail to gain market acceptance, we may be unable to earn sufficient revenue to continue our business. Market acceptance of, and demand for, any product that we may develop and commercialize will depend on many factors, including:
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our ability to provide acceptable evidence of safety and efficacy;
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the prevalence and severity of adverse side effects;
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whether our vaccines are differentiated from other vaccines based on immunogenicity;
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availability, relative cost and relative efficacy of alternative and competing treatments;
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the effectiveness of our marketing and distribution strategy;
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publicity concerning our products or competing products and treatments; and
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our ability to obtain sufficient third-party insurance coverage or reimbursement.
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In particular, there are significant challenges to market acceptance for seasonal influenza vaccines. For our seasonal vaccine to be accepted, we must demonstrate differentiation from other seasonal vaccines that are currently approved and marketed. This can mean that the vaccine is more effective in certain populations, such as the elderly, or cheaper and quicker to produce. While we are currently conducting Phase II trials in the elderly, we have not yet received any data and there are no assurances that our vaccine will be more efficacious than other vaccines.
If our product candidates do not become widely accepted by physicians, patients, third-party payers and other members of the medical community, our business, financial condition and results of operations would be materially and adversely affected.
If reforms in the health care industry make reimbursement for our potential products less likely, the market for our potential products will be reduced, and we could lose potential sources of revenue.
Our success may depend, in part, on the extent to which reimbursement for the costs of vaccines will be available from third-party payers such as government health administration authorities, private health insurers, managed care programs and other organizations. Over the past decade, the cost of health care has risen significantly, and there have been numerous proposals by legislators, regulators and third-party health care payers to curb these costs. Some of these proposals have involved limitations on the amount of reimbursement for certain products. Similar federal or state health care legislation may be adopted in the future and any products
that we or our collaborators seek to commercialize may not be considered cost-effective. Adequate third-party insurance coverage may not be available for us to establish and maintain price levels that are sufficient for realization of an appropriate return on our investment in product development. Moreover, the existence or threat of cost control measures could cause our corporate collaborators to be less willing or able to pursue research and development programs related to our product candidates.
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Regulatory Risks
We may fail to obtain regulatory approval for our products on a timely basis or comply with our continuing regulatory obligations after approval is obtained.
Delays in obtaining regulatory approval can be extremely costly in terms of lost sales opportunities, losing any potential marketing advantage of being early to market and increased trial costs. The speed with which we begin and complete our pre-clinical trials necessary to begin human studies, human clinical trials and our applications for marketing approval will depend on several factors, including the following:
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our ability to manufacture or obtain sufficient quantities of materials for use in necessary pre-clinical studies and clinical trials;
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prior regulatory agency review and approval;
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Institutional Review Board approval of the protocol and the informed consent form;
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the rate of subject or patient enrollment and retention, which is a function of many factors, including the size of the subject or patient population, the proximity of subjects and patients to clinical sites, the eligibility criteria for the study and the nature of the protocol;
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negative test results or side effects experienced by trial participants;
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analysis of data obtained from pre-clinical and clinical activities, which are susceptible to varying interpretations and which interpretations could delay, limit or prevent further studies or regulatory approval;
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the availability of skilled and experienced staff to conduct and monitor clinical studies and to prepare the appropriate regulatory applications; and
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changes in the policies of regulatory authorities for drug or vaccine approval during the period of product development.
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We have limited experience in conducting and managing the pre-clinical studies and clinical trials necessary to obtain regulatory marketing approvals. We may not be permitted to continue or commence additional clinical trials. We also face the risk that the results of our clinical trials may be inconsistent with the results obtained in pre-clinical studies or clinical trials of similar products, or that the results obtained in later phases of clinical trials may be inconsistent with those obtained in earlier phases. A number of companies in the biopharmaceutical and product development industry have suffered significant setbacks in advanced clinical
trials, even after experiencing promising results in early animal and human testing.
Regulatory agencies may require us or our collaborators to delay, restrict or discontinue clinical trials on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. In addition, we or our collaborators may be unable to submit applications to regulatory agencies within the time frame we currently expect. Once submitted, applications must be approved by various regulatory agencies before we or our collaborators can commercialize the product described in the application. All statutes and regulations governing the conduct of clinical trials are subject to change in the future, which could
affect the cost of such clinical trials. Any unanticipated costs or delays in our clinical studies could delay our ability to generate revenue and harm our financial condition and results of operations.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally.
We intend to have our product candidates marketed outside the United States. In furtherance of this objective, we have entered into relationships with Cadila in India and Avimex in Mexico. In order to market our products in the European Union, Mexico, India, Asia and many other non-United States jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. To date, we have filed for marketing approval for our 2009 H1N1 vaccine candidate in Mexico but may not receive the approval necessary to commercialize our vaccine candidate in Mexico or any market or may receive approval only after the
commercial opportunity has passed. The approval procedure varies among countries and can involve additional testing and data review. The time required to obtain foreign regulatory
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approval may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by a regulatory agency, such as the FDA, does not ensure approval by any other regulatory agencies, for example in other foreign countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in other jurisdictions, including approval by the FDA. The failure to obtain regulatory approval in foreign
jurisdictions could harm our business.
Even if regulatory approval is received for our product candidates, the later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of the product from the market.
Even if a product gains regulatory approval, such approval is likely to limit the indicated uses for which it may be marketed, and the product and the manufacturer of the product will be subject to continuing regulatory review, including adverse event reporting requirements and the FDAs general prohibition against promoting products for unapproved uses. Failure to comply with any post-approval requirements can, among other things, result in warning letters, product seizures, recalls, substantial fines, injunctions, suspensions or revocations of marketing licenses, operating restrictions and criminal prosecutions. Any of these enforcement
actions, any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with any approved products, could adversely affect our ability to market products and generate revenue and thus adversely affect our ability to continue our business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after obtaining product approval, if previously unknown problems with the product or its manufacture are subsequently discovered and we cannot provide assurance that newly discovered or developed safety issues will not arise following any regulatory approval. With the use of any vaccine by a wide patient population, serious adverse events may occur from time to time that initially do not appear to relate to the vaccine itself, and only if the specific event occurs with some regularity over a period of time does the vaccine become suspect as having a causal
relationship to the adverse event. Any safety issues could cause us to suspend or cease marketing of our approved products, possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial condition.
Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner.
We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research, including infectious disease agents. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.
Our facility in Maryland is subject to various local, state and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including chemicals, microorganisms and various hazardous compounds used in connection with our research and development activities. In the United States, these laws include the Occupational Safety and Health Act, the Toxic Test Substances Control Act and the Resource Conservation and Recovery Act. We cannot eliminate the risk of accidental contamination or discharge or injury
from these materials. Federal, state, and local laws and regulations govern the use, manufacture, storage, handling and disposal of these materials. We could be subject to civil damages in the event of an improper or unauthorized release of, or exposure of individuals to, these hazardous materials. In addition, claimants may sue us for injury or contamination that results from our use or the use by third-parties of these materials, and our liability may exceed our total assets. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.
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Although we have general liability insurance, these policies contain exclusions from insurance against claims arising from pollution from chemical or pollution from conditions arising from our operations. Our collaborators are working with these types of hazardous materials in connection with our collaborations. In the event of a lawsuit or investigation, we could be held responsible for any injury we or our collaborators cause to persons or property by exposure to, or release of, any hazardous materials. However, we believe that we are currently in compliance with all applicable environmental and occupational health and safety regulations.
Intellectual Property Risks
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our technology and other trade secrets. To do so, we must prosecute and maintain existing patents, obtain new patents and pursue trade secret and other intellectual property protection. We also must operate without infringing the proprietary rights of third-parties or allowing third-parties to infringe our rights. We currently have or have rights to over 99 United States patents and corresponding foreign patents and patent applications covering our technologies. However, patent issues relating to pharmaceuticals and biologics involve complex legal, scientific and
factual questions. To date, no consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted by the United States Patent and Trademark Office or enforced by the federal courts. Therefore, we do not know whether our patent applications will result in the issuance of patents, or that any patents issued to us will provide us with any competitive advantage. We also cannot be sure that we will develop additional proprietary products that are patentable. Furthermore, there is a risk that others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.
There is a risk that third-parties may challenge our existing patents or claim that we are infringing their patents or proprietary rights. We could incur substantial costs in defending patent infringement suits or in filing suits against others to have their patents declared invalid or claim infringement. It is also possible that we may be required to obtain licenses from third-parties to avoid infringing third-party patents or other proprietary rights. We cannot be sure that such third-party licenses would be available to us on acceptable terms, if at all. If we are unable to obtain required third-party licenses, we may be delayed in or prohibited
from developing, manufacturing or selling products requiring such licenses.
Although our patent filings include claims covering various features of our products and product candidates, including composition, methods of manufacture and use, our patents do not provide us with complete protection against the development of competing products. Some of our know-how and technology is not patentable. To protect our proprietary rights in unpatentable intellectual property and trade secrets, we require employees, consultants, advisors and collaborators to enter into confidentiality agreements. These agreements may not provide meaningful protection for our trade secrets, know-how or other proprietary information.
If we infringe or are alleged to infringe the intellectual property rights of third-parties, it will adversely affect our business, financial condition and results of operations.
Our research, development and commercialization activities, including any product candidates or products resulting from these activities, may infringe or be claimed to infringe patents owned by third-parties and to which we do not hold licenses or other rights. There may be rights we are not aware of, including applications that have been filed but not published that, when issued, could be asserted against us. These third-parties could bring claims against us, and that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us,
we could be forced to stop or delay research, development, manufacturing or sales of the product or biologic drug candidate that is the subject of the suit.
As a result of patent infringement claims, or in order to avoid potential claims, we may choose or be required to seek a license from the third-party. These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be non-exclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent
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infringement claims, we are unable to enter into licenses on acceptable terms. All of the issues described above could also impact our collaborators, which would also impact the success of the collaboration and therefore us.
There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the United States Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products and technology.
We may become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time-consuming.
Competitors may infringe our patents or the patents of our collaborators or licensors. As a result, we may be required to file infringement claims to counter infringement for unauthorized use. This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being
invalidated or interpreted narrowly and could put our patent applications at the risk of not issuing.
Interference proceedings brought by the United States Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications or those of our collaborators or licensors. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distraction to our management. We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If investors perceive these results to be negative, the market price for our common stock could be significantly harmed.
We may need to license intellectual property from third-parties and, if our right to use the intellectual property we license is affected, our ability to develop and commercialize our product candidates may be harmed.
We expect that we will need to license intellectual property from third-parties in the future and that these licenses will be material to our business. We will not own the patents or patent applications that underlie these licenses, and we will not control the enforcement of the patents. We will rely upon our licensors to properly prosecute and file those patent applications and prevent infringement of those patents.
Our license agreement with Wyeth Holdings Corporation, which gives us rights to a family of patent applications covering VLP technology for use in human vaccines in certain fields of use, is non-exclusive. These applications are very significant to our business. Payments since inception, under this agreement, have aggregated $5.1 million as of December 31, 2009. If each milestone is achieved for any particular product candidate, we would be obligated to pay an aggregate of $14 million to Wyeth Holdings for each product candidate developed and commercialized under the agreement. Achievement of each milestone is subject to many risks, including those
described in these Risk Factors. Annual license maintenance fees under the Wyeth Holdings agreement aggregate $0.3 million per year. Our license with the University of Massachusetts gives us exclusive rights to develop and commercialize vaccines incorporating certain virus-like particles for use in human vaccines.
While many of the licenses under which we have rights provide us with rights in specified fields, the scope of our rights under these and other licenses may be subject to dispute by our licensors or third-parties. In addition, our rights to use these technologies and practice the inventions claimed in the licensed patents and
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patent applications are subject to our licensors abiding by the terms of those licenses and not terminating them. Any of our licenses may be terminated by the licensor if we are in breach of a term or condition of the license agreement, or in certain other circumstances.
Our product candidates and potential product candidates will require several components that may each be the subject of a license agreement. The cumulative license fees and royalties for these components may make the commercialization of these product candidates uneconomical.
If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries.
Important legal issues remain to be resolved as to the extent and scope of available patent protection for biopharmaceutical products and processes in the United States and other important markets outside the United States, such as Europe and Japan. Foreign markets may not provide the same level of patent protection as provided under the United States patent system. We expect that litigation or administrative proceedings will likely be necessary to determine the validity and scope of certain of our and others proprietary rights. Any such litigation or proceeding may result in a significant commitment of resources in the future and could force
us to do one or more of the following: cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue; obtain a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all; and redesign our products to avoid infringing the intellectual property rights of third-parties, which may be time-consuming or impossible to do. In addition, changes in, or different interpretations of, patent laws in the United States and other countries may result in patent laws that allow others to use our discoveries or develop and commercialize our products. We cannot provide assurance that the patents we obtain or the unpatented technology we hold will afford us significant commercial protection.
Risks Related to Our Common Stock and Organizational Structure
Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected.
Our stock price has been highly volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. From January 1, 2009 through December 31, 2009, the closing price of our common stock has been as low as $0.56 per share and as high as $6.65 per share. The market price of our common stock may be influenced by many factors, including:
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future announcements about our Company or our collaborators or competitors, including the results of testing, technological innovations or new commercial products;
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clinical trial results;
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depletion of our cash reserves;
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sale of equity securities or issuance of additional debt;
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announcement by us of significant strategic partnerships, collaborations, joint ventures, capital commitments or acquisitions;
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changes in government regulations;
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developments in our relationships with our collaboration partners;
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announcements relating to health care reform and reimbursement levels for new vaccines;
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sales of substantial amounts of our stock by existing stockholders (including stock by insiders or 5% stockholders);
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development, spread or new announcements related to pandemic influenza, including H1N1 (swine) influenza;
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public concern as to the safety of our products;
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significant set-backs or concerns with the industry or the market as a whole; and
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the other factors described in this Risk Factors section.
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The stock market has experienced extreme price and volume fluctuations that have particularly affected the market price for many emerging and biopharmaceutical companies. These fluctuations have often been unrelated to the operating performance of these companies. These broad market fluctuations may cause the market price of our common stock to be lower or more volatile than expected.
We have never paid dividends on our capital stock, and we do not anticipate paying any such dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will retain all of our earnings for use in the development of our business and do not anticipate paying any cash dividends in the foreseeable future. As a result, capital appreciation, if any, of our common stock would be the only source of gain for stockholders until dividends are paid, if at all.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder Rights Plan could delay or prevent the acquisition of the Company, even if such acquisition would be beneficial to stockholders, and could impede changes in our Board.
Our organizational documents could hamper a third-partys attempt to acquire, or discourage a third-party from attempting to acquire control of, the Company. We have also adopted a shareholder rights plan, or poison pill, that empowers our Board to delay or negotiate, and thereby possibly thwart, any tender offer or takeover attempt the Board opposes. Stockholders who wish to participate in these transactions may not have the opportunity to do so. These provisions also could limit the price investors are willing to pay in the future for our securities and make it more difficult to change the composition of our Board in any one year.
These provisions include the right of the Board to issue preferred stock with rights senior to those of common stock without any further vote or action by stockholders, the existence of a staggered Board with three classes of directors serving staggered three-year terms and advance notice requirements for stockholders to nominate directors and make proposals.
The Company also is afforded the protections of Section 203 of the Delaware General Corporation Law, which will prevent us from engaging in a business combination with a person who acquires at least 15% of our common stock for a period of three years from the date such person acquired such common stock, unless advance board or stockholder approval was obtained.
Any delay or prevention of a change of control transaction or changes in our Board of Director or management could deter potential acquirers or prevent the completion of a transaction in which our stockholders could receive a substantial premium over the then current market price for their shares.
Item 1B. Unresolved Staff Comments
None.
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Item 2. Properties
We have current operations in one leased facility. We lease approximately 51,200 square feet in Rockville, Maryland, which serves as our corporate headquarters and includes administrative offices, vaccine research and development, as well as a manufacturing facility. We continue to lease approximately 32,900 square feet of administrative office and research and development space at our former corporate headquarters in Malvern, Pennsylvania, all of which is currently subleased. We believe that our corporate facility in Rockville, Maryland is sufficient for our current needs. We have additional space in our current facility to accommodate our
anticipated growth over the next several years.
A summary of our current facilities is set forth below.
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Property Location
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Approximate
Square
Footage
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Rockville, MD
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51,200
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Corporate headquarters and vaccine research and development
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Malvern, PA
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32,900
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Former corporate headquarters and research and development
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Total square footage
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84,100
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Malvern, PA sublease
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(32,900
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)
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Net square footage
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51,200
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Item 3. Legal Proceedings
In March 2010, we instituted collection proceedings against Mr. Mitch Kelly in the state of New York and Mr. Denis ODonnell in the Commonwealth of Massachusetts. Mr. Kelly and Mr. ODonnell are former directors of the Company that have outstanding notes due to the Company in the aggregate principal amount of $1,572,000. Both notes are currently in default.
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PART II
Item 5. Market for Registrants Common Equity and Related Stockholder Matters
Our common stock trades on The NASDAQ Global Market under the symbol NVAX. The following table sets forth the range of high and low closing sale prices for our common stock as reported on The NASDAQ Global Market for each quarter in the two most recent years:
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Quarter Ended
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High
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Low
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December 31, 2009
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$
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4.41
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$
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2.53
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September 30, 2009
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$
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6.65
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$
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2.51
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June 30, 2009
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$
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3.28
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$
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0.76
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March 31, 2009
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$
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2.04
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$
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0.56
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December 31, 2008
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$
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3.03
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$
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1.22
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September 30, 2008
|
|
$
|
3.42
|
|
|
$
|
2.05
|
|
June 30, 2008
|
|
$
|
3.10
|
|
|
$
|
2.24
|
|
March 31, 2008
|
|
$
|
3.71
|
|
|
$
|
2.30
|
|
On March 11, 2010, the last sale price reported on The NASDAQ Global Market for our common stock was $2.48. Our common stock was held by approximately 519 stockholders of record as of March 11, 2010, one of which is Cede & Co., a nominee for Depository Trust Company (or DTC). All of the shares of common stock held by brokerage firms, banks and other financial institutions as nominees for beneficial owners are deposited into participant accounts at DTC, and are therefore considered to be held of record by Cede & Co. as one stockholder. We have not paid any cash dividends on our common stock since our inception. We do not anticipate declaring
or paying any cash dividends in the foreseeable future.
Securities Authorized for Issuance Under Our Equity Compensation Plans
Information regarding our equity compensation plans, including both stockholder approved plans and non-stockholder approved plans, is included in Item 12 of this Annual Report on Form 10-K.
The graph below compares the cumulative total stockholders return on our common stock for the last five fiscal years with the cumulative total return on the NASDAQ Stock Market (United States and Foreign) Index and the NASDAQ Pharmaceutical Index (which includes Novavax) over the same period, assuming the investment of $100 in our common stock, the NASDAQ Stock Market (United States and Foreign) Index and the NASDAQ Pharmaceutical Index on December 31, 2004, and reinvestments of all dividends.
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Value of $100 invested on 12/31/04 in stock or index, including reinvestment of dividends, for fiscal years ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12/31/04
|
|
12/31/05
|
|
12/31/06
|
|
12/31/07
|
|
12/31/08
|
|
12/31/09
|
Novavax, Inc.
|
|
$
|
100
|
|
|
$
|
118.10
|
|
|
$
|
125.77
|
|
|
$
|
102.15
|
|
|
$
|
57.98
|
|
|
$
|
81.60
|
|
NASDAQ Stock Market (United States and Foreign)
|
|
$
|
100
|
|
|
$
|
101.41
|
|
|
$
|
114.05
|
|
|
$
|
123.94
|
|
|
$
|
73.43
|
|
|
$
|
105.89
|
|
NASDAQ Pharmaceutical Index
|
|
$
|
100
|
|
|
$
|
102.23
|
|
|
$
|
105.16
|
|
|
$
|
99.56
|
|
|
$
|
91.99
|
|
|
$
|
98.21
|
|
This graph is not soliciting material, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
Item 6. Selected Financial Data
The following table sets forth selected financial data for each of the years in the five-year period ended December 31, 2009. The information below should be read in conjunction with our financial statements and notes thereto and Managements Discussion and Analysis of Financial Condition and Results of Operations included elsewhere in this Annual Report on Form 10-K. These historical results are not necessarily indicative of results that may be expected for future periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31,
|
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
2005
|
|
|
(In Thousands, Except per Share Amounts)
|
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
325
|
|
|
$
|
1,064
|
|
|
$
|
1,513
|
|
|
$
|
1,738
|
|
|
$
|
5,343
|
|
Loss from continuing operations
|
|
|
(38,374
|
)
|
|
|
(36,322
|
)
|
|
|
(28,590
|
)
|
|
|
(19,577
|
)
|
|
|
(6,319
|
)
|
(Loss) income from discontinued operations
|
|
|
|
|
|
|
273
|
|
|
|
(6,175
|
)
|
|
|
(3,491
|
)
|
|
|
(4,855
|
)
|
Net loss
|
|
$
|
(38,374
|
)
|
|
$
|
(36,049
|
)
|
|
$
|
(34,765
|
)
|
|
$
|
(23,068
|
)
|
|
$
|
(11,174
|
)
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share from continuing operations
|
|
|
(0.45
|
)
|
|
|
(0.53
|
)
|
|
|
(0.47
|
)
|
|
|
(0.33
|
)
|
|
|
(0.15
|
)
|
Loss per share from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
(0.10
|
)
|
|
|
(0.06
|
)
|
|
|
(0.11
|
)
|
Basic and diluted net loss per share
|
|
$
|
(0.45
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.26
|
)
|
Shares used in computing basic and diluted net loss per share
|
|
|
85,555
|
|
|
|
68,174
|
|
|
|
61,101
|
|
|
|
58,664
|
|
|
|
42,758
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
2005
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and short-term investments
|
|
$
|
42,950
|
|
|
$
|
33,900
|
|
|
$
|
46,489
|
|
|
$
|
73,595
|
|
|
$
|
31,893
|
|
Total current assets
|
|
|
44,503
|
|
|
|
35,096
|
|
|
|
49,016
|
|
|
|
77,342
|
|
|
|
37,611
|
|
Working capital
|
|
|
36,476
|
|
|
|
7,379
|
|
|
|
42,810
|
|
|
|
72,003
|
|
|
|
32,735
|
|
Total assets
|
|
|
85,605
|
|
|
|
76,625
|
|
|
|
91,291
|
|
|
|
121,877
|
|
|
|
84,382
|
|
Long-term debt, less current portion
|
|
|
406
|
|
|
|
480
|
|
|
|
21,629
|
|
|
|
22,458
|
|
|
|
29,678
|
|
Accumulated deficit
|
|
|
(274,150
|
)
|
|
|
(235,776
|
)
|
|
|
(199,727
|
)
|
|
|
(164,962
|
)
|
|
|
(141,894
|
)
|
Total stockholders equity
|
|
|
74,465
|
|
|
|
45,489
|
|
|
|
63,065
|
|
|
|
94,001
|
|
|
|
49,652
|
|
29
TABLE OF CONTENTS
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
Certain statements contained herein or as may otherwise be incorporated by reference herein constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding operating expenses, use of cash, and clinical developments and anticipated milestones, including a BARDA contract, Phase III studies and seeking approval in Mexico, and include words such as expect(s),
intends, plans, seeks, estimates, could, should, feel(s), believe(s), will, would, may, can, anticipate(s), potential, and similar expressions or the negative of these terms, are based upon managements current expectations and beliefs. Such forward-looking statements are not guarantees of future performance, involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements.
Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include, among other things, the following: our ability to progress any product candidates into pre-clinical or clinical trials; the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities; clinical trial results; even if the data from pre-clinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the United States
and, to date, no governmental authority has approved any of our vaccine candidates for sale; influenza is seasonal in nature, and if approval or commercial launch after approval is not timely in relation to the influenza season, we may not be able to manufacture or sell our influenza vaccines on terms favorable to us until the next influenza season, if at all; we have not manufactured any of our vaccine candidates at a commercial level; we utilize a unique manufacturing process and the scale-up of that process may prove difficult and costly; our dependence on third parties to manufacture and distribute our vaccines; risks associated with conducting business outside of the United States; our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; the
inability to win any government grants, including BARDA in a timely manner or at all and other factors referenced herein.
All forward-looking statements contained in this annual report are based on information available to the Company on the date hereof, and the Company assumes no obligation to update any such forward-looking statements, except as specifically required by law. Accordingly, past results and trends should not be used to anticipate future results or trends.
Overview
Novavax, Inc., a Delaware corporation (Novavax, the Company, we, or us), was incorporated in 1987, and is a clinical-stage biopharmaceutical company focused on developing novel, highly potent recombinant vaccines. These vaccines leverage our virus-like-particle (VLP) platform technology coupled with a unique disposable production technology.
VLPs are genetically engineered three-dimensional nanostructures which incorporate immunologically important lipids and recombinant proteins. Our VLPs resemble the virus, but lack the genetic material to replicate the virus. Our proprietary production technology uses insect cells rather than chicken eggs or mammalian cells. Our current product targets include vaccines against pandemic and seasonal influenza, including the H5N1 and H1N1 pandemic strains, Respiratory Syncytial Virus (RSV) and Varicella Zoster Virus (VZV), which causes shingles.
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TABLE OF CONTENTS
Summary of Significant Transactions in 2009
Joint Venture With Cadila
On March 31, 2009, we entered into a Joint Venture Agreement (the JVA) with Cadila Pharmaceuticals Ltd., a private company incorporated under the laws of India (Cadila) pursuant to which we and Cadila formed CPL Biologicals Private Limited, a joint venture (the JV), of which 80% is owned by Cadila and 20% is owned by Novavax. The JV will develop and commercialize our seasonal influenza and H1N1 pandemic vaccine candidates and Cadilas biogeneric products and other diagnostic products for the territory of India. The JV has the right to negotiate a definitive agreement for rights to certain future Novavax products (other than RSV) and certain
future Cadila products in India, prior to Novavax or Cadila licensing such rights to a third party. We have the right to negotiate the licensing of vaccines developed by the JV using our technology for commercialization in every country except for India and vaccines developed by the JV using Cadilas technology for commercialization in certain other countries, including the United States. Cadila has committed to contribute approximately $8 million over three years to support the JVs operations. In connection with the JVA, on March 31, 2009, we also entered into a license agreement, an option to enter into a license agreement, a technical services agreement and a supply agreement with the JV and a master services agreement with Cadila. Because we do not control the JV, we account for our investment using the equity method. Since the carrying value of our contribution was $0 and there is no guarantee or commitment to provide future funding, we do not expect to record losses
related to this investment in the future.
Also on March 31, 2009, we entered into a stock purchase agreement with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila, pursuant to which SOHL purchased 12.5 million shares of our common stock at the market price of $0.88 per share. We received net proceeds of approximately $10.6 million.
Convertible Notes
As of January 1, 2009, we had $22 million of senior convertible notes outstanding (the Notes). The Notes carried a 4.75% coupon; were convertible into shares of Novavax common stock at $4.00 per share; and matured on July 15, 2009. On April 29, 2009, we entered into amendment agreements (the 2009 Amendments) with holders of the outstanding Notes representing $17.0 million of the outstanding principal amount of the Notes to amend the terms of the Notes to allow for early retirement by paying 70% of the principal amount plus accrued and unpaid interest in cash totaling $12.1 million and paying the remaining 30% through issuance of 2,040,000 shares of
common stock at $2.50 per share. On July 15, 2009, we paid the $5.0 million balance of the Notes by paying approximately $2.6 million of principal and accrued and unpaid interest in cash and issuing 1,016,939 shares of common stock to pay the remaining $2.6 million of principal and accrued and unpaid interest, based on a price of $2.5163 per share. As of July 15, 2009, the Notes were fully paid and extinguished.
H1N1 Mexico Transaction
On October 19, 2009, we entered into a Materials Transfer Agreement with Laboratorio Avi-Mex S.A. de C.V. (Avimex), pursuant to which we supplied Avimex with certain amounts of our 2009 H1N1 vaccine candidate and made payments to Avimex related to our clinical trial. Avimex used the H1N1 vaccine to conduct clinical trials and is currently seeking regulatory approval in Mexico. Avimex made a milestone payment to us and is obligated to pay us a transfer fee for the H1N1 vaccine based on our production cost. The agreement and the option to enter into a non-exclusive distribution agreement to distribute the 2009 H1N1 vaccine in Mexico both expired by its
terms on December 31, 2009. The second phase of the clinical trial is ongoing and the parties are continuing to cooperate in seeking regulatory approval in Mexico.
On October 20, 2009, we entered into a binding term sheet (as amended, the Xcellerex Agreement) with Xcellerex, Inc. Pursuant to the Xcellerex Agreement, Xcellerex performed scale-up and manufacturing activities related to our 2009 H1N1 vaccine candidate for potential sale in Mexico. Although the H1N1 manufacturing campaign with Xcellerex did not result in the manufacture of acceptable vaccine to Novavax, we did achieve proof of concept by scaling up to a commercial grade bioreactor. The success in scaling up our VLPs in stir tank bioreactors potentially provides an additional path to large scale, commercially viable vaccine production. As
consideration, we paid Xcellerex a fixed payment and supplied materials. The Xcellerex Agreement expired by its terms on February 15, 2010.
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TABLE OF CONTENTS
Underwritten Public Offering
On November 25, 2009, we issued 6,800,000 shares of our common stock at $3.30 per share in an underwritten public offering. We received net proceeds from the sale of the shares, after underwriting discounts, commissions and estimated offering expenses, of approximately $21 million.
At the Market Sales Issuances
On January 12, 2009, we entered into an At the Market Sales Agreement (the January Sales Agreement) with Wm Smith & Co. (Wm Smith), under which we may sell an aggregate of up to $25 million in gross proceeds of our common stock from time to time through Wm Smith, as the agent for the offer and sale of the common stock. During 2009, we sold 7,489,207 shares at a range of $1.75 $5.03 and received net proceeds of approximately $22 million under the January Sales Agreement.
On September 15, 2009, we entered into a second At Market Issuance Sales Agreement (the September Sales Agreement), with Wm Smith, under which we may sell an aggregate of up to $10 million in gross proceeds of our common stock from time to time through Wm Smith. We have not sold any common stock under the September Sales Agreement.
On March 15, 2010, we terminated the January Sales Agreement and the September Sales Agreement and entered into a sales agreement with McNicoll, Lewis & Vlak LLC, as sales agent, under which we may sell an aggregate of $50 million in gross proceeds of our common stock. Our Board of Directors has authorized the sale of up to 25 million shares of our common stock pursuant to this agreement.
Critical Accounting Policies and Use of Estimates
The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
The preparation of our consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. These estimates, particularly estimates relating to accounting for the valuation of our short-term investments, stock-based compensation, long-lived assets, goodwill, and valuation of net deferred tax assets have a material impact on our financial statements and are discussed in detail throughout our analysis of the
results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity that are not readily apparent from other sources. Actual results and outcomes could differ from these estimates and assumptions.
Short-Term Investments
Our short-term investments are carried at fair value and unrealized gains and losses on these securities, if determined to be temporary, are included in accumulated other comprehensive income (loss) in stockholders equity. We assess the recoverability of our short-term investments and, if an impairment is indicated, we measure the amount of such impairment by comparing the fair value to the carrying value. Other-than-temporary impairments are included in the consolidated statements of operations. We invested in auction rate securities for short periods of time as part of our cash management program. Recent uncertainties in the credit markets
have prevented us from liquidating certain holdings of auction rate securities as the amount of securities submitted for sale during the auction has exceeded the amount of purchase orders. Although an event of an auction failure does not necessarily mean that a security is impaired, we consider various factors to assess the fair value and the classification of the securities as short-term assets. Fair value was determined with the assistance of an independent valuation firm using two valuation methods a discounted cash flow method and a market comparable method. Certain factors used in these methods include, but are not necessarily limited to, comparable securities traded on secondary markets, timing of the failed auction, specific security
32
TABLE OF CONTENTS
auction history, quality of underlying collateral, rating of the security and the bond insurer, our ability and intent to retain the securities for a period of time to allow for anticipated recovery in the market value, and other factors.
Stock-Based Compensation
We account for our stock-based compensation in accordance with Accounting Standards Codification (ASC) 718,
Compensation Stock Compensation
. This standard requires us to measure the cost of employee services received in exchange for equity share options granted based on the grant-date fair value of the options. Employee stock-based compensation is estimated at the date of grant based on the awards fair value using the Black-Scholes option-pricing model and is recognized as expense on a straight-line basis over the requisite service period. The Black-Scholes option-pricing model requires the use of certain assumptions,
the most significant of which are our estimates of the expected volatility of the market price of our stock, the expected term of the award, and the risk-free interest rate. Our estimate of the expected volatility is based on historical volatility over the look-back period corresponding to the expected life. The expected term represents the period during which our stock-based awards are expected to be outstanding. In 2009, we estimated this amount based on historical experience of similar awards, giving consideration to the contractual terms of the awards, vesting requirements, and expectation of future employee behavior, including post-vesting exercise and forfeiture history. Our estimate of the risk-free interest rate is based on United States Treasury debt securities with maturities close to the expected term of the option as of the date of grant. We review our valuation assumptions at each grant date and, as a result, our assumptions in future periods may change. Also, the
accounting estimate of stock-based compensation expense is reasonably likely to change from period to period as further stock options are granted and adjustments are made for stock option forfeitures and cancellations.
Research and Development
Research and development costs are expensed as incurred. Such costs include internal research and development expenditures (such as salaries and benefits, raw materials and supplies) and contracted services (such as sponsored research, consulting and testing services) of proprietary research and development activities and similar expenses associated with collaborative research agreements.
Impairments of Long-Lived Assets
We account for the impairment of long-lived assets and long-lived assets to be disposed by performing a periodic evaluation of the recoverability of the carrying value of long-lived assets and identifiable intangibles and whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Examples of events or changes in circumstances that indicate that the recoverability of the carrying value of an asset should be assessed include, but are not limited to, the following: a significant decrease in the market value of an asset, a significant change in the extent or manner in which an asset is used, a
significant physical change in an asset, a significant adverse change in legal factors or in the business climate that could affect the value of an asset, an adverse action or assessment by a regulator, an accumulation of costs significantly in excess of the amount originally expected to acquire or construct an asset, a current period operating or cash flow loss combined with a history of operating or cash flow losses, and/or a projection or forecast that demonstrates continuing losses associated with an asset used for the purpose of producing revenue. We consider historical performance and anticipated future results in our evaluation of potential impairment. Accordingly, when indicators of impairment are present, we evaluate the carrying value of these assets in relation to the operating performance of the business and future undiscounted cash flows expected to result from the use of these assets. Impairment losses are recognized when the sum of expected future cash flows is less than
the assets carrying value.
Goodwill
Goodwill originally resulted from a business acquisition in 2000. Assets acquired and liabilities assumed were recorded at their fair values; the excess of the purchase price over the identifiable net assets acquired is recorded as goodwill. Goodwill is not amortized, but is subject to impairment tests annually, or more frequently should indicators of impairment arise. We utilize both the market approach and the income approach to determine if we have an impairment of our goodwill. The market approach serves as the primary approach and is based on market value of invested capital. The concluded fair value significantly exceeded the carrying
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TABLE OF CONTENTS
value of our goodwill at December 31, 2009 and 2008. The income approach is used as a confirming look to the market approach. Goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds its estimated fair value. We perform the required annual impairment test as of December 31 of each year on the carrying amount of our goodwill.
Given the current economic conditions and the uncertainties regarding their impact on us, there can be no assurance that the estimates and assumptions made for purposes of our goodwill impairment testing at December 31, 2009 will prove to be accurate predictions of the future, or that any change in the assumptions or the current economic conditions will not trigger another goodwill impairment test before December 31, 2010. If our assumptions are not achieved or economic conditions deteriorate further, we may be required to record goodwill impairment charges in future periods.
Income Taxes
We recognize deferred tax assets and liabilities for expected future tax consequences of temporary differences between the carrying amounts and tax bases of assets and liabilities. Income tax receivables and liabilities, and deferred tax assets and liabilities, are recognized based on the amounts that more likely than not would be sustained upon ultimate settlement with taxing authorities.
Developing our provision for income taxes and analyzing our tax positions requires significant judgment and knowledge of federal and state income tax laws, regulations and strategies, including the determination of deferred tax assets and liabilities and any valuation allowances that may be required for deferred tax assets.
We assess the likelihood of realizing our deferred tax assets to determine whether an income tax valuation allowance is required. Based on such evidence that can be objectively verified, we determine whether it is more likely than not that all or a portion of the deferred tax assets will be realized. The main factors that we consider include: cumulative losses in recent years; income/losses expected in future years; and the applicable statute of limitations.
Tax benefits associated with uncertain tax positions are recognized in the period in which one of the following conditions is satisfied: (1) the more likely than not recognition threshold is satisfied; (2) the position is ultimately settled through negotiation or litigation; or (3) the statute of limitations for the taxing authority to examine and challenge the position has expired. Tax benefits associated with an uncertain tax position are reversed in the period in which the more likely than not recognition threshold is no longer satisfied.
A valuation allowance is established when necessary to reduce net deferred tax assets to the amount expected to be realized. We concluded that the realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, our net deferred tax assets have been fully offset by a valuation allowance.
Recently Adopted Accounting Guidance
In June 2009, the Financial Accounting Standards Board (FASB) issued ASC 105,
Generally Accepted Accounting Principles
, which establishes the FASB Accounting Standards Codification as the sole source of authoritative generally accepted accounting principles (GAAP). Pursuant to the provisions of ASC 105, we have updated references to GAAP in our financial statements issued beginning for the period ended September 30, 2009. The adoption of ASC 105 did not impact our financial position or results of operations.
Effective January 1, 2009, we prospectively adopted ASC 820,
Fair Value Measurements and Disclosures
, with respect to fair value measurements required for our nonfinancial assets and nonfinancial liabilities. The adoption did not have a material effect on our financial position or results of operations.
In April 2009, ASC 805,
Business Combinations
, was amended for provisions related to the initial recognition and measurement, subsequent measurement and disclosure of assets and liabilities arising from contingencies in a business combination. Under the amended guidance, assets acquired and liabilities assumed in a business combination that arise from contingencies should be recognized at fair value on the acquisition date if fair value can be determined during the measurement period. If fair value cannot be determined, companies should typically account for the acquired contingencies using existing guidance. This amendment did not have a
material effect on our financial position or results of operations.
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In April 2009, ASC 820 was amended to provide additional guidance for estimating fair value when the volume and level of activity for the asset or liability have significantly decreased. This amendment also includes guidance on identifying circumstances that indicate a transaction is not orderly. This amendment was effective for the quarter ended June 30, 2009 and the adoption of this amendment did not have a material effect on our financial position or results of operations.
In April 2009, ASC 320,
Investments Debt & Equity Securities
, was amended to provide guidance for other-than-temporary impairments of debt securities. The amendment provides that financial asset impairment indicators should be based on the Companys intent to sell the security instead of the Companys ability to hold the security, and to improve the presentation and disclosure of other-than-temporary impairments on debt and equity securities in the financial statements. This amendment was effective for the quarter ended June 30, 2009 and the adoption of this amendment did not have a material effect on our
financial position or results of operations.
In May 2009, the FASB issued ASC 855,
Subsequent Events
. ASC 855 establishes general standards of accounting for, and disclosure of, events that occur after the balance sheet date, but before financial statements are issued or are available to be issued. In particular, ASC 855 establishes (i) the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements, (ii) the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial
statements and (iii) the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. We have evaluated all subsequent events through the date of issuance of our financial statements. We adopted ASC 855 for the quarter ended June 30, 2009 and the adoption did not have any effect on our financial condition or results of operations.
Recent Accounting Guidance Not Yet Adopted
In June 2009, the FASB issued authoritative guidance on the consolidation of variable interest entities, which is effective for the Company beginning January 1, 2010. The new guidance requires revised evaluations of whether entities represent variable interest entities, ongoing assessments of control over such entities, and additional disclosures for variable interests. We believe adoption of this new guidance will not have a material impact on our financial position and results of operations.
In September 2009, ASU 2009-13,
Revenue Recognition
(Topic 605)
Multiple-Deliverable Revenue Arrangements,
was issued and will change the accounting for multiple-deliverable arrangements to enable vendors to account for products or services (deliverables) separately rather than as a combined unit. Specifically, this guidance amends the criteria in Subtopic 605-25,
Revenue Recognition
Multiple-Element Arrangements,
for separating consideration in multiple-deliverable arrangements. This guidance establishes a selling price hierarchy for determining the selling price of a deliverable, which
is based on: (a) vendor-specific objective evidence; (b) third-party evidence; or (c) estimates. This guidance also eliminates the residual method of allocation and requires that arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method. In addition, this guidance significantly expands required disclosures related to a vendors multiple-deliverable revenue arrangements. ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010 with early adoption permitted. The impact of ASU 2009-13 on our consolidated financial statements will depend on the nature and terms of our revenue arrangements entered into or materially modified after the adoption date. However, based on our current customer arrangements, we do not believe the adoption of this ASU will have a material impact on our consolidated financial statements.
In January 2010, the FASB issued ASU 2010-06,
Fair Value Measurements and Disclosures (Topic 820) Improving Disclosures about Fair Value Measurements
, which amends Topic 820 to add new requirements for disclosures about transfers into and out of Levels 1 and 2 and separate disclosures about purchases, sales, issuances, and settlements related to Level 3 measurements. ASU 2010-06 also clarifies existing fair value disclosures about the level of disaggregation and about inputs and valuation techniques used to measure fair value. The ASU is effective for the first reporting period beginning after December 15, 2009, except for the
requirements to provide the Level 3 activity of purchases, sales, issuances, and settlements on a gross basis, which will be effective for fiscal years beginning after December 15, 2010, and for
35
TABLE OF CONTENTS
interim periods within those fiscal years. Early adoption is permitted. We believe the adoption of this amendment will not have a material effect on our financial position or results of operations.
Results of Operations for Fiscal Years 2009, 2008 and 2007
(amounts in tables are presented in thousands, except per share information)
The following is a discussion of the historical consolidated financial condition and results of operations of Novavax, Inc. and its wholly owned subsidiary and should be read in conjunction with the consolidated financial statements and notes thereto set forth in this Annual Report on Form 10-K. Additional information concerning factors that could cause actual results to differ materially from those in our forward-looking statements is contained from time to time in our SEC filings. Certain reclassifications have been made to the prior years financial statements to conform to the current year presentation.
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Change
2008 to
2009
|
|
Change
2007 to
2008
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
325
|
|
|
$
|
1,064
|
|
|
$
|
1,513
|
|
|
$
|
(739
|
)
|
|
$
|
(449
|
)
|
Revenue for 2009 was $0.3 million as compared to $1.1 million for 2008, a decrease of $0.8 million, or 69%. The decrease in revenue in 2009, as compared to 2008, was due to lower contract research and development revenue primarily as a result of timing of work under a government contract.
Revenue for 2008 was $1.1 million as compared to $1.5 million for 2007, a decrease of $0.4 million, or 30%. The decrease in revenue during 2008, as compared to 2007, was principally due to lower contract research and development revenue as a result of the completion of a government contract in 2008.
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Change 2008 to 2009
|
|
Change 2007 to 2008
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
25,780
|
|
|
$
|
24,334
|
|
|
$
|
17,821
|
|
|
$
|
1,446
|
|
|
$
|
6,513
|
|
General and administrative
|
|
|
11,928
|
|
|
|
11,090
|
|
|
|
13,963
|
|
|
|
838
|
|
|
|
(2,873
|
)
|
Total operating expenses
|
|
$
|
37,708
|
|
|
$
|
35,424
|
|
|
$
|
31,784
|
|
|
$
|
2,284
|
|
|
$
|
3,640
|
|
Research and Development Expenses
Research and development expenses increased to $25.8 million for 2009 from $24.3 million for 2008, an increase of $1.5 million, or 6%, primarily due to higher research and development spending to support our clinical trials related to our H1N1 and seasonal influenza product candidates. The increase is primarily a result of increased outside-testing costs of $1.9 million, partially offset by a decrease in facility costs of $0.4 million related to the exiting of our Taft Court facility in 2008.
Research and development expenses increased to $24.3 million for 2008 from $17.8 million for 2007, an increase of $6.5 million, or 37%. This increase was due primarily to higher research and development spending to support our strategic focus on creating differentiated, value-added vaccines that leverage our proprietary VLP technology. Outside-testing costs (including outsourced clinical trial costs, sponsored research and consulting agreements) associated with expanded pre-clinical testing, human clinical trials, process development, manufacturing and quality-related programs necessary to move our influenza vaccine candidates into human clinical
trials and license fees paid to Wyeth account for $2.9 million of the increase. The remaining increase of $3.6 million can be attributed to an increase in employee-related costs of $1.1 million, an increase in facility costs of $1.5 million and $0.4 million accrued in 2008 related to future lease payments for our Taft Court facility. The costs associated with our Taft Court facility resulted from our decision to consolidate our research and development and manufacturing activities into our Belward Campus Drive facility.
36
TABLE OF CONTENTS
General and Administrative Expenses
General and administrative expenses were $11.9 million in 2009 compared to $11.1 million in 2008, an increase of $0.8 million, or 8%. The increase in expenses is primarily due to increased employee-related costs of $0.5 million and professional fees of $0.4 million.
General and administrative expenses were $11.1 million in 2008 compared to $14.0 million in 2007, a decrease of $2.9 million, or 21%. The decrease was primarily due to reclassification and related accounting for notes receivable due from former directors to show these notes as reductions of equity in the December 31, 2008 consolidated balance sheet. General and administrative expenses in 2008 included a $1.2 million credit to eliminate the previously recorded allowance we established for these notes receivable. General and administrative expenses for 2008 were also favorably impacted by lower facility costs of approximately $0.6 million and decreased
employee costs of approximately $0.3 million as we implemented our plan to consolidate all operations into our Belward Campus Drive facility.
Other Income (Expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Change 2008 to 2009
|
|
Change 2007 to 2008
|
Other Income (Expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
285
|
|
|
$
|
959
|
|
|
$
|
3,287
|
|
|
$
|
(674
|
)
|
|
$
|
(2,328
|
)
|
Interest expense
|
|
|
(786
|
)
|
|
|
(1,683
|
)
|
|
|
(1,606
|
)
|
|
|
897
|
|
|
|
(77
|
)
|
Impairment of short-term investments
|
|
|
(1,338
|
)
|
|
|
(1,238
|
)
|
|
|
|
|
|
|
(100
|
)
|
|
|
(1,238
|
)
|
Realized gains on short-term investments
|
|
|
848
|
|
|
|
|
|
|
|
|
|
|
|
848
|
|
|
|
|
|
Total other income (expense)
|
|
$
|
(991
|
)
|
|
$
|
(1,962
|
)
|
|
$
|
1,681
|
|
|
$
|
971
|
|
|
$
|
(3,643
|
)
|
We had total other expense of $1.0 million for 2009 compared to total other expense of $2.0 million for 2008, a change of $1.0 million, or 49%. Interest income decreased $0.7 million, or 70%, to $0.3 million in 2009 from $1.0 million in 2008 primarily due to the decline in our cash, cash equivalents and short-term investment balances and a decrease in the rates of return on our investments. Interest expense decreased $0.9 million, or 53%, to $0.8 million in 2009 from $1.7 million in 2008 as a result of our payment of the Notes in 2009. In 2009, we recorded an impairment of $1.3 million relating to our auction rate securities, which was partially
offset by realized gains of $0.8 million relating to redemptions of several auction rate securities. At December 31, 2009, we have recorded $0.8 million in unrealized gains on the auction rate securities held by us at year-end in other comprehensive income on the consolidated balance sheet.
We had total other expense of $2.0 million for 2008 compared to total other income of $1.7 million for 2007, a change of $3.7 million, or 217%. Interest income decreased to $1.0 million in 2008 from $3.3 million in 2007 due in part to the correction of a matter described above (in General and Administrative Expenses) related to notes receivable from former directors along with a decrease in our cash, cash equivalents and short-term investment balances. For 2008, interest income included a $0.5 million adjustment to reverse cumulative interest income related to the notes receivable from former directors, as discussed above. Interest expense increased
to $1.7 million in 2008 from $1.6 million in 2007. The increase in interest expense was primarily due to the increase in the amortization of debt discount of $0.3 million, related to an amendment of the convertible notes, which occurred in June 2007. Additionally, we recorded a $1.2 million impairment on our short-term investments in 2008, related to an other-than-temporary impairment loss on our auction rate securities.
37
TABLE OF CONTENTS
Discontinued Operations:
In February 2008, we sold certain assets related to our former Estrasorb business to Graceway Pharmaceuticals, LLC (Graceway) in exchange for an upfront payment. In connection with the sale, we agreed to manufacture and supply additional units of Estrasorb for Graceway, which we completed in August 2008. The results of operations of our former Estrasorb business are reported as discontinued operations in the consolidated statements of operations and are summarized in the table below.
|
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
Change 2008 to 2007
|
Discontinued Operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
3,776
|
|
|
$
|
1,913
|
|
|
$
|
1,863
|
|
Total operating expenses
|
|
|
3,503
|
|
|
|
8,088
|
|
|
|
(4,585
|
)
|
Income (loss)
|
|
$
|
273
|
|
|
$
|
(6,175
|
)
|
|
$
|
(6,448
|
)
|
We recorded income from discontinued operations of $0.3 million in 2008 compared to a loss of $6.2 million in 2007. Revenue from discontinued operations increased to $3.8 million in 2008 from $1.9 million in 2007, an increase of $1.9 million, or 97%, primarily due to the recognition of revenue related to the Graceway agreements.
Operating expenses from discontinued operations decreased to $3.5 million in 2008 from $8.1 million in 2007 primarily due to a decrease in costs of products sold of $3.8 million. Cost of products sold in 2007 included an additional $1.8 million in idle plant capacity costs and a $2.2 million impairment charge related to the fixed assets at our manufacturing facility.
Net Loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Change 2008 to 2009
|
|
Change 2007 to 2008
|
Net Loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(38,374
|
)
|
|
$
|
(36,049
|
)
|
|
$
|
(34,765
|
)
|
|
$
|
(2,325
|
)
|
|
$
|
(1,284
|
)
|
Net loss per share
|
|
$
|
(0.45
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
0.08
|
|
|
$
|
0.04
|
|
Weighted shares outstanding
|
|
|
85,555
|
|
|
|
68,174
|
|
|
|
61,101
|
|
|
|
17,381
|
|
|
|
7,073
|
|
Net loss for 2009 was $38.4 million, or $0.45 per share, as compared to $36.0 million, or $0.53 per share, for 2008, an increased net loss of $2.4 million. The increased net loss was primarily due to higher research and development spending to support our clinical trials related to our H1N1 and seasonal influenza product candidates, partially offset by reduced total other expenses in 2009.
Net loss for 2008 was $36.0 million, or $0.53 per share, as compared to $34.8 million, or $0.57 per share, for 2007, an increased net loss of $1.2 million. The increased net loss was primarily due to an increase in operating expenses of $3.6 million, a decrease in total other income of $3.6 million, partially offset by a loss from discontinued operations of $6.2 million in 2007.
The increase in weighted shares outstanding for 2009 and 2008 is primarily a result of sales of our common stock in the aggregate of 27,884,098 shares and 6,686,650 shares, respectively.
Liquidity Matters and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, the commitments and progress of our research and development programs, the progress of pre-clinical and clinical testing, the time and costs involved in obtaining regulatory approvals, the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, and manufacturing costs. We plan to continue to have multiple vaccines and products in various stages of development and we believe our research and development, as well as general and administrative expenses and capital requirements will fluctuate depending upon the
timing of certain events, such as the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities.
38
TABLE OF CONTENTS
As of December 31, 2009, we had $38.8 million in cash and cash equivalents and $4.2 million in short-term investments as compared to $26.9 million and $7.0 million, respectively, at December 31, 2008. The following table summarizes cash flows for the years ended December 31, 2009 and 2008 (in thousands):
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
Change 2008 to 2009
|
Summary of Cash Flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
(32,830
|
)
|
|
$
|
(24,310
|
)
|
|
$
|
(8,520
|
)
|
Investing activities
|
|
|
2,355
|
|
|
|
29,906
|
|
|
|
(27,551
|
)
|
Financing activities
|
|
|
42,294
|
|
|
|
16,992
|
|
|
|
25,302
|
|
Net increase in cash and cash equivalents
|
|
|
11,819
|
|
|
|
22,588
|
|
|
|
(10,769
|
)
|
Cash and cash equivalents at beginning of year
|
|
|
26,938
|
|
|
|
4,350
|
|
|
|
22,588
|
|
Cash and cash equivalents at end of year
|
|
$
|
38,757
|
|
|
$
|
26,938
|
|
|
$
|
11,819
|
|
Net cash used in operating activities increased to $32.8 million in 2009 from $24.3 million for 2008, primarily due to our increased loss in 2009 and the receipt in 2008 of $3.0 million in lease incentives and $2.5 million of cash provided by our discontinued operations, both of which did not recur in 2009.
During 2009 and 2008, our investing activities consisted primarily of purchases and maturities of short-term investments, capital expenditures and $1.4 million of cash provided by our discontinued operations in 2008. Capital expenditures for 2009 and 2008 were $0.7 million and $5.7 million, respectively. The decrease in capital expenditures was primarily due to the completion of our GMP pilot manufacturing facility, which was ready for use in early 2009. We used our short-term investments in 2008 to help fund operations. For 2010, we expect the level of capital expenditures to increase modestly.
The increase in our financing activities consists primarily of increased sales of our common stock, partially offset by the repayment of our Notes in 2009.
We have entered into agreements with outside providers to support our clinical development. As of December 31, 2009, $7.6 million remains unpaid on certain of these agreements in the event our outside providers complete their services in 2010. However, under the terms of the agreements, we have the option to terminate, but we would be obligated to pay the provider for all costs incurred through the effective date of termination.
We have licensed certain rights from Wyeth Holdings Corporation (Wyeth) and the University of Massachusetts Medical School (UMMS). The Wyeth license provides for an upfront payment, annual license fees, milestone payments and royalties on any product sales, is a non-exclusive, worldwide license to a family of patent applications covering VLP technology for use in human vaccines in certain fields of use. Payments under the agreement to Wyeth from 2007 through 2009 aggregated $5.1 million. Based on the clinical and commercial milestones, which could possibly occur in 2010, we would make a milestone payment to Wyeth of $4 million in the next twelve
months. However, it is difficult for us to predict at this time whether such milestones will be achieved in 2010. The UMMS license, which provides for milestone payments and royalties on product sales, is an exclusive worldwide license of VLP technology to develop VLP vaccines for the prevention of any viral diseases in humans. As of December 31, 2009, our payments made to UMMS in the aggregate are not material. Also, we believe that all payments under the UMMS agreement will not be material in the next twelve months.
Based on our cash, cash equivalents and short-term investment balances as of December 31, 2009, and our current business operations, we believe we will have adequate capital resources available to operate at planned levels for at least the next twelve months. Additional capital will be required in the future to develop our product candidates through clinical development, manufacturing, and commercialization. We will seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, non-dilutive government contracts, collaborative arrangements, or some combination of
these financing alternatives. Any capital raised by an equity offering will likely be substantially dilutive to the existing stockholders and any licensing or development arrangement may require us to give up rights to
39
TABLE OF CONTENTS
a product or technology at less than its full potential value. Other than our At the Market Sales Agreement with McNicoll, Lewis & Vlak LLC, we have not secured any additional commitments for new financing nor can we provide any assurance that new financing will be available on commercially acceptable terms, if at all. If we are unable to obtain additional capital, we will assess our capital resources and will likely be required to delay, reduce the scope of, or eliminate one or more of our product research and development programs, downsize our organization, or reduce our general and administrative infrastructure.
Contractual Obligations
The following table summarizes our contractual obligations as of December 31, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations:
|
|
Total
|
|
One Year
or Less
|
|
2 3 Years
|
|
4 5 Years
|
|
More than
5 Years
|
Operating leases
|
|
$
|
14,840
|
|
|
$
|
2,043
|
|
|
$
|
4,219
|
|
|
$
|
4,330
|
|
|
$
|
4,248
|
|
Notes payable
|
|
|
486
|
|
|
|
80
|
|
|
|
106
|
|
|
|
300
|
|
|
|
|
|
Purchase obligations
|
|
|
7,401
|
|
|
|
901
|
|
|
|
6,500
|
|
|
|
|
|
|
|
|
|
Total contractual obligations
|
|
$
|
22,727
|
|
|
$
|
3,024
|
|
|
$
|
10,825
|
|
|
$
|
4,630
|
|
|
$
|
4,248
|
|
Our purchase obligations include our currently anticipated timing of future purchases for services pursuant to the master services agreement with Cadila. We are required to purchase from Cadila through March 2012 services for biologic research, pre-clinical development, clinical development, process development, manufacturing scale up, and general manufacturing related services. As of December 31, 2009, our remaining obligation to Cadila under the master services agreement is $7.4 million.
Off-Balance Sheet Arrangements
We are not involved in any off-balance sheet agreements that have or are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without significantly increasing risk. As of December 31, 2009, we had cash and cash equivalents of $38.8 million, short-term investments of $4.2 million and working capital of $36.5 million.
Our exposure to market risk is confined to our investment portfolio. As of December 31, 2009, our short-term investments are classified as available-for-sale. We do not believe that a change in the market rates of interest would have any significant impact on the realizable value of our investment portfolio. Changes in interest rates may affect the investment income we earn on our investments and, therefore, could impact our cash flows and results of operations.
We had previously invested in auction rate securities for short periods of time as part of our cash management program. Short-term investments at December 31, 2009 consist of investments in three auction rate securities with a par value of $5.1 million and a fair value of $4.2 million. We recorded an other-than-temporary impairment charge of $1.3 million related to these securities in 2009, which was partially offset by realized gains of $0.8 million relating to redemptions of several auction rate securities. At December 31, 2009, we have recorded $0.8 million in unrealized gains on the auction rate securities held by us at year-end in other
comprehensive income on the consolidated balance sheet. These investments are classified within current assets because we may need to liquidate these securities within the next year to fund our ongoing operations.
Interest and dividend income is recorded when earned and included in interest income. Premiums and discounts, if any, on short-term investments are amortized or accreted to maturity and included in interest income. The specific identification method is used in computing realized gains and losses on sale of our securities.
We are headquartered in the United States where we conduct the vast majority of our business activities. Accordingly, we have not had any material exposure to foreign currency rate fluctuations.
40
TABLE OF CONTENTS
We do not have material debt and, as such, do not believe that we are exposed to any material interest rate risk as a result of our borrowing activities.
Item 8. Financial Statements and Supplementary Data
The information required by this item is set forth on pages F-
1
to F-
26
.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the assistance of our chief executive officer and chief financial officer, have reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of as of December 31, 2009. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are
designed to provide reasonable assurance of achieving their control objectives. Based on the evaluation of our disclosure controls and procedures as of December 31, 2009, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
Our management, including our chief executive officer and chief financial officer, has evaluated any changes in our internal control over financial reporting that occurred during the fourth quarter of 2009, and has concluded that there was no change that occurred during the fourth quarter of 2009 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Managements Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the Companys principal executive officer and principal financial officer and effected by the Companys board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Such internal control
includes those policies and procedures that:
|
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;
|
|
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and
|
|
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Companys assets that could have a material effect on the financial statements.
|
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
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TABLE OF CONTENTS
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2009. In making this assessment, our management used the criteria set forth in
Internal Control Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on its assessment, our management has determined that, as of December 31, 2009, our internal control over financial reporting is effective based on those criteria.
Grant Thornton LLP has issued an attestation report on our internal control over financial reporting. This report is included in the Report of Independent Registered Public Accounting Firm in Item 15.
Item 9B. Other Information
On October 6, 2009, we entered into a license agreement with CPL Biologicals Private Limited (CPLB). CPLB is a joint venture between us and Cadila Pharmaceuticals, Ltd (Cadila). Pursuant to the license agreement, we granted CPLB an exclusive, fully paid-up, royalty free license to use our technology to research, develop and commercialize a vaccine for the 2009 H1N1 influenza in the country of India. We have approval rights for all development and commercialization plans. The license will terminate upon written notice from CPLB, the mutual agreement of the parties, or upon our termination of the joint venture agreement with Cadila.
On March 15, 2010, we entered into an At Market Issuance Sales Agreement (the ATM Agreement), with McNicoll, Lewis & Vlak LLC (MLV), under which we may sell an aggregate of $50,000,000 in gross proceeds of our common stock from time to time through MLV, as the agent for the offer and sale of the common stock. MLV may sell the common stock by any method permitted by law, including sales deemed to be an at the market offering as defined in Rule 415 of the Securities Act, including without limitation sales made directly on The NASDAQ Global Market, on any other existing trading market for the common stock or to or through a market maker.
MLV may also sell the common stock in privately negotiated transactions, subject to our prior approval. We will pay MLV a commission equal to 2% of the gross proceeds of the sales price of all common stock sold through it as sales agent under the ATM Agreement.
The ATM Agreement will terminate on the earliest of (1) the sale of all of the common stock subject to the ATM Agreement, or (2) termination of the ATM Agreement by us or MLV. MLV may terminate the ATM Agreement at any time in certain circumstances, including the occurrence of a material adverse change that, in MLVs reasonable judgment, may impair its ability to sell the common stock, our failure to satisfy any condition under of the ATM Agreement or a suspension or limitation of trading of our common stock on NASDAQ. We may terminate the ATM Agreement at any time upon 30 days prior notice, and MLV may terminate the ATM Agreement at any time
upon 60 days prior notice. Our Board of Directors has authorized the sale of up to 25 million shares of our common stock under the ATM Agreement.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
We incorporate herein by reference the information concerning our directors, officers and corporate governance to be included in our definitive Proxy Statement for our 2010 Annual Meeting of Stockholders to be held on June 16, 2010 (the 2010 Proxy Statement). We expect to file the 2010 Proxy Statement within 120 days after the close of the fiscal year ended December 31, 2009.
Item 11. Executive Compensation
We incorporate herein by reference the information concerning executive compensation to be contained in the 2010 Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
We incorporate herein by reference the information concerning security ownership of certain beneficial owners and management and related stockholder matters to be contained in the 2010 Proxy Statement.
The following table provides our equity compensation plan information as of December 31, 2009. Under these plans, our common stock may be issued upon the exercise of options. See also the information regarding our stock options in Note 9 to the Consolidated Financial Statements included herewith.
Equity Compensation Plan Information
|
|
|
|
|
|
|
Plan Category
|
|
Number of Securities to
Be Issued Upon
Exercise of
Outstanding Options,
Warrants and Rights
(a)
|
|
Weighted-Average
Exercise Price of
Outstanding Options,
Warrants and Rights
(b)
|
|
Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation
Plans (Excluding Securities
Reflected in Column(a)
(c)
|
Equity compensation plans approved by security holders
(1)
|
|
|
5,994,994
|
|
|
$
|
3.01
|
|
|
|
2,712,580
|
|
Equity compensation plans not approved by security holders
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
(1)
|
Includes our 2005 Stock Incentive Plan, 1995 Stock Option Plan and 1995 Director Stock Option Plan.
|
Item 13. Certain Relationships and Related Transactions, and Director Independence
We incorporate herein by reference the information concerning certain related party transactions set forth in Note 14 to our Consolidated Financial Statements included herewith. We incorporate herein by reference the information concerning certain other relationships and related transactions and director independence to be contained in the 2010 Proxy Statement.
Item 14. Principal Accounting Fees and Services
We incorporate herein by reference the information concerning principal accountant fees and services to be contained in the 2010 Proxy Statement.
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PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) The following documents are filed as part of the Annual Report:
(1)
Index to Consolidated Financial Statements
(2)
Consolidated Financial Statement Schedules
Schedule II Valuation and Qualifying Accounts
All other financial statement schedules are omitted because they are not applicable, not required under the instructions or all the information required is set forth in the financial statements or notes thereto.
(3)
Exhibits
Exhibits marked with a single asterisk (*) are filed herewith.
Exhibits marked with a double plus sign () refer to management contracts, compensatory plans or arrangements.
Confidential treatment has been requested for portions of exhibits marked with a double asterisk (**).
Confidential treatment has been granted for portions of exhibits marked with a triple asterisk (***).
All other exhibits listed have previously been filed with the Commission and are incorporated herein by reference.
|
|
|
3.1
|
|
Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to the Companys Annual Report on Form 10-K for the year ended December 31, 1996, filed March 21, 1997), as amended by the Certificate of Amendment dated December 18, 2000 (Incorporated by reference to Exhibit 3.4 to the Companys Annual Report on Form 10-K for the year ended December 31, 2000, filed March 29, 2001), as further amended by the Certificate of Amendment dated July 8, 2004 (Incorporated by reference to Exhibit 3.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2004, filed August 9, 2004), as further amended by the Certificate of Amendment dated May 13, 2009 (Incorporated by reference to Exhibit 3.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009)
|
3.2
|
|
Amended and Restated By-Laws of the Company, as amended on August 2, 2007 (Incorporated by reference to Exhibit 3.2 to the Companys Current Report on Form 8-K, filed August 8, 2007)
|
4.1
|
|
Specimen stock certificate for shares of common stock, par value $.01 per share (Incorporated by reference to Exhibit 4.1 to the Companys Registration Statement on Form 10, File No. 0-26770, filed September 14, 1995)
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|
|
|
4.2
|
|
Rights Agreement, dated as of August 8, 2002, by and between the Company and Equiserve Trust Company, which includes the Form of Summary of Rights to Purchase Series D Junior Participating Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Form of Certificate of Designation of Series D Junior Participating Preferred Stock as Exhibit C (Incorporated by reference to Exhibit 4.1 to the Companys Current Report on Form 8-K, filed August 9, 2002)
|
4.3
|
|
Registration Rights Agreement between Novavax, Inc. and Satellite Overseas (Holdings) Limited, dated March 31, 2009 (Incorporated by reference to Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2009)
|
4.4
|
|
Form of Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.1 to the Companys Current Report on Form 8-K, filed July 30, 2008)
|
10.1
|
|
Novavax, Inc. 1995 Stock Option Plan, as amended (Incorporated by reference to Appendix A of the Companys Definitive Proxy Statement filed March 31, 2003 in connection with the Annual Meeting held on May 7, 2003)
|
10.2
|
|
Novavax, Inc. 1995 Director Stock Option Plan (Incorporated by reference to Exhibit 10.5 to the Companys Registration Statement in Form 10, File No. 0-26770, filed September 14, 1995)
|
10.3
|
|
Novavax, Inc. Amended and Restated 2005 Stock Incentive Plan (Incorporated by reference to Exhibit 10.2 of the Companys Current Report on Form 8-K, filed January 5, 2009)
|
10.4
|
|
Amended and Restated Employment Agreement of Rahul Singhvi, effective July 20, 2009 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed July 22, 2009)
|
10.5
|
|
Employment Agreement of Penny Heaton, dated October 2, 2008 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed October 10, 2008)
|
10.6
|
|
Employment Agreement of Len Stigliano, dated October 2, 2008 (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K, filed October 10, 2008)
|
10.7
|
|
Amended and Restated Employment Agreement, dated as of August 2, 2007, originally effective November 9, 2005, by and between the Company and Raymond J. Hage, Jr. (Incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, filed August 9, 2007)
|
10.8
|
|
Amendment to the Amended and Restated Employment Agreement of Raymond Hage, dated October 2, 2008 (Incorporated by reference to Exhibit 10.3 to the Companys Current Report on Form 8-K, filed October 10, 2008)
|
10.9
|
|
Second Amendment to Amended and Restated Employment Agreement of Raymond Hage, effective July 20, 2009 (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K, filed July 22, 2009)
|
10.10
|
|
Employment Agreement of James Robinson, effective October 2, 2008 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed October 16, 2008)
|
10.11*
|
|
Severance Agreement of James Robinson dated February 1, 2010
|
10.12
|
|
Employment Agreement between Novavax, Inc. and Frederick Driscoll dated August 6, 2009 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed August 7, 2009)
|
10.13*
|
|
Employment Agreement of Thomas Johnston dated September 23, 2008
|
10.14*
|
|
Amendment to the Employment Agreement of Thomas Johnston dated as of July 20, 2009
|
10.15*
|
|
Employment Agreement of John Trizzino dated July 16, 2009
|
10.16
|
|
Consulting Agreement, dated as of April 27, 2007, effective as of March 7, 2007, between the Company and John Lambert (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, filed May 10, 2007)
|
10.17
|
|
Consulting Agreement of Len Stigliano, effective January 28, 2009 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed February 20, 2009)
|
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|
|
|
10.18
|
|
Novavax, Inc. Amended and Restated Change in Control Severance Benefit Plan, (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed January 5, 2009)
|
10.19*
|
|
Form of Indemnity Agreement, as of January 1, 2010
|
10.20
|
|
Lease Agreement, dated as of July 15, 2004, between Liberty Property Limited Partnership and the Company (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report in Form 10-Q for the quarter ended June 30, 2004, filed August 9, 2004)
|
10.21
|
|
Sublease Agreement, dated April 28, 2006, by and between the Company and Sterilox Technologies, Inc. (now PuriCore, Inc.) (Incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed August 14, 2006)
|
10.22
|
|
Amendment dated as of October 25, 2006 to the Sublease Agreement, dated April 28, 2006, by and between the Company and Sterilox Technologies, Inc. (now PuriCore, Inc.) (Incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed November 14, 2006)
|
10.23
|
|
Second Amendment to Sublease Agreement between Novavax, Inc. and PuriCore, Inc., dated April 22, 2009 (Incorporated by reference to Exhibit 10.3 to the Companys Quarterly Report for the quarter ended June 30, 2009, filed August 10, 2009)
|
10.24
|
|
Lease, commencing April 1, 2005, by and between United Health Care Services, Inc. and the Company (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2005, filed August 9, 2005)
|
10.25
|
|
Lease Agreement between GP Rock One, LLC and Novavax, Inc., dated as of May 7, 2007 (Incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report for the quarter ended June 30, 2008, filed August 11, 2008)
|
10.26
|
|
First Amendment to Lease Agreement between GP Rock One, LLC and Novavax, Inc., dated as of May 30, 2008 (Incorporated by reference to Exhibit 10.5 to the Companys Quarterly Report for the quarter ended June 30, 2008, filed August 11, 2008)
|
10.27
|
|
Second Amendment to Lease Agreement between BMR-9920 Belward Campus Q, LLC (formerly GP Rock One, LLC) and Novavax, Inc., dated as of June 26, 2008 (Incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report for the quarter ended June 30, 2008, filed August 11, 2008)
|
10.28
|
|
License Agreement between IGEN, Inc. and the Company (Incorporated by reference to Exhibit 10.3 to the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 1995, filed April 1, 1996)
|
10.29***
|
|
Exclusive License Agreement, dated February 26, 2007, between the Company and the University of Massachusetts (Incorporated by reference to Exhibit 10.34 to the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2006, filed March 14, 2007)
|
10.30***
|
|
License Agreement, dated July 5, 2007, between the Company and Wyeth Holdings Corporation (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, filed August 9, 2007)
|
10.31
|
|
Form of Investor Rights Agreement dated July 29, 2008 (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K, filed July 30, 2008)
|
10.32
|
|
Forbearance and Pledge Agreement among Denis ODonnell and the Company, dated May 7, 2007, relating to Secured Promissory Note and Pledge Agreement, each dated March 21, 2002 and filed as Exhibits 10.11 and 10.12 to the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2002 (Incorporated by reference to Exhibit 10.32 to the Companys Amendment No. 1 on Form 10-K/A for the year ended December 31, 2007, filed on December 12, 2008)
|
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TABLE OF CONTENTS
|
|
|
10.33
|
|
Amended and Restated Promissory Note by Mitchell J. Kelly to the Company, dated May 7, 2008, relating to Secured Promissory Note, dated March 21, 2002 and filed as Exhibit 10.9 to the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2002 (Incorporated by reference to Exhibit 10.33 to the Companys Amendment No. 1 on Form 10-K/A for the year ended December 31, 2007, filed on December 12, 2008)
|
10.34
|
|
Amended and Restated Pledge Agreement among Mitchell J. Kelly and the Company, dated May 7, 2008, relating to Pledge Agreement, dated March 21, 2002 and filed as Exhibit 10.10 to the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2002 (Incorporated by reference to Exhibit 10.34 to the Companys Amendment No. 1 on Form 10-K/A for the year ended December 31, 2007, filed on December 12, 2008)
|
10.35
|
|
At Market Issuance Sales Agreement, dated January 12, 2009, by and between Novavax, Inc. and Wm. Smith & Co. (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed January 13, 2009)
|
10.36
|
|
At Market Issuance Sales Agreement, dated September 15, 2009, by and between Novavax, Inc. and Wm. Smith & Co. (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed on September 15, 2009)
|
10.37*
|
|
At Market Issuance Sales Agreement, dated March 15, 2010, by and between Novavax, Inc. and McNicoll, Lewis and Vlak, LLC
|
10.38
|
|
Stock Purchase Agreement between Novavax, Inc. and Satellite Overseas (Holdings) Limited, dated March 31, 2009 (Incorporated by reference to Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2009)
|
10.39***
|
|
Amended and Restated Joint Venture Agreement between Novavax Inc. and Cadila Pharmaceuticals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.4 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.40***
|
|
Amended and Restated Master Services Agreement between Novavax, Inc. and Cadila Pharmaceuticals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.41***
|
|
Amended and Restated Supply Agreement between Novavax, Inc. and CPL Biologicals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.42***
|
|
Amended and Restated Technical Services Agreement between Novavax, Inc. and CPL Biologicals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.7 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.43***
|
|
Amended and Restated Seasonal / Other License Agreement between Novavax, Inc. and CPL Biologicals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.8 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.44***
|
|
Amended and Restated Option to Obtain License between Novavax, Inc. and CPL Biologicals Limited, dated as of June 29, 2009 (Incorporated by reference to Exhibit 10.9 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed on August 10, 2009)
|
10.45* **
|
|
H1N1 License to Agreement between Novavax, Inc. and CPL Biologicals Private Limited, dated October 6, 2009
|
10.46***
|
|
Materials Transfer Agreement by and between Novavax, Inc. and Laboratorio Avi-Mex S.A. de C.V., dated October 19, 2009 (Incorporated by reference to Exhibit 10.6 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, filed on November 9, 2009)
|
14*
|
|
Code of Business Conduct and Ethics
|
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|
|
|
23.1*
|
|
Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm
|
31.1*
|
|
Certification of chief executive officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
31.2*
|
|
Certification of chief financial officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
32.1*
|
|
Certification of chief financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2*
|
|
Certification of chief financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
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TABLE OF CONTENTS
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
NOVAVAX, INC.
|
Date: March 16, 2010
|
|
By:
/s/ Rahul Singhvi
President and Chief Executive Officer
and Director
|
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:
|
|
|
|
|
Name
|
|
Title
|
|
Date
|
/s/ Rahul Singhvi
Rahul Singhvi
|
|
President and Chief Executive Officer and Director
(Principal Executive Officer)
|
|
March 16, 2010
|
/s/ Frederick W. Driscoll
Frederick W. Driscoll
|
|
Vice President, Chief Financial Officer and Treasurer
(Principal Financial Officer and
Principal Accounting Officer)
|
|
March 16, 2010
|
s/ Stanley Erck
Stanley Erck
|
|
Executive Chairman of the Board of Directors
|
|
March 16, 2010
|
/s/ Gary C. Evans
Gary C. Evans
|
|
Lead Independent Director
|
|
March 16, 2010
|
/s/ John Lambert
John Lambert
|
|
Director
|
|
March 16, 2010
|
/s/ John O. Marsh, Jr.
John O. Marsh, Jr.
|
|
Director
|
|
March 16, 2010
|
/s/ Michael A. McManus
Michael A. McManus
|
|
Director
|
|
March 16, 2010
|
/s/ Rajiv Modi
Rajiv Modi
|
|
Director
|
|
March 16, 2010
|
49
TABLE OF CONTENTS
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Years Ended December 31, 2009, 2008 and 2007
CONTENTS
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
|
F-
2
|
|
Consolidated Balance Sheets as of December 31, 2009 and 2008
|
|
|
F-
3
|
|
Consolidated Statements of Operations for each of the Three Years in the Period Ended December 31, 2009
|
|
|
F-
4
|
|
Consolidated Statements of Stockholders Equity for each of the Three Years in the Period Ended December 31, 2009
|
|
|
F-
5
|
|
Consolidated Statements of Cash Flows for each of the Three Years in the Period Ended December 31, 2009
|
|
|
F-
6
|
|
Notes to Consolidated Financial Statements
|
|
|
F-
7
|
|
Schedule II Valuation and Qualifying Accounts
|
|
|
|
|
F-1
TABLE OF CONTENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders of
Novavax, Inc. and Subsidiary
We have audited the accompanying consolidated balance sheets of Novavax, Inc. (a Delaware corporation) and its subsidiary as of December 31, 2009 and 2008, and the related consolidated statements of operations, stockholders equity, and cash flows for each of the three years in the period ended December 31, 2009. Our audits of the basic financial statements included the financial statement schedule listed in the index appearing under Item 15(a)(2). We also have audited Novavax, Inc. and its subsidiarys internal control over financial reporting as of December 31, 2009, based on criteria established in
Internal
Control Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Novavax, Inc. and its subsidiarys management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Managements Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on these consolidated financial statements and financial statement schedule and an opinion on Novavax Inc. and its subsidiarys internal control over financial reporting based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the consolidated financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements, assessing the accounting principles used and significant estimates made by
management, and evaluating the overall consolidated financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
A companys internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles. A companys internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the companys assets that could have a material effect on the consolidated financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Novavax, Inc. and subsidiary as of December 31, 2009 and 2008, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2009 in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, the financial statement schedule listed in the index appearing under Item 15(a)(2) presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated
financial statements.
In our opinion, Novavax, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2009, based on criteria established in
Internal Control Integrated Framework
issued by COSO.
/s/ Grant Thornton LLP
Baltimore, Maryland
March 16, 2010
F-2
TABLE OF CONTENTS
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
December 31,
|
|
|
2009
|
|
2008
|
|
|
(In Thousands, Except Share and
per Share Information)
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
38,757
|
|
|
$
|
26,938
|
|
Short-term investments available-for-sale
|
|
|
4,193
|
|
|
|
6,962
|
|
Accounts and other receivables, net of allowance of $218 as of December 31, 2008
|
|
|
258
|
|
|
|
290
|
|
Prepaid expenses and other current assets
|
|
|
1,295
|
|
|
|
774
|
|
Current assets of discontinued operations
|
|
|
|
|
|
|
132
|
|
Total current assets
|
|
|
44,503
|
|
|
|
35,096
|
|
Property and equipment, net
|
|
|
7,801
|
|
|
|
8,228
|
|
Goodwill
|
|
|
33,141
|
|
|
|
33,141
|
|
Other non-current assets
|
|
|
160
|
|
|
|
160
|
|
Total assets
|
|
$
|
85,605
|
|
|
$
|
76,625
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,098
|
|
|
$
|
1,750
|
|
Accrued expenses and other current liabilities
|
|
|
5,417
|
|
|
|
2,969
|
|
Current liabilities of discontinued operations
|
|
|
|
|
|
|
242
|
|
Current portion of notes payable
|
|
|
80
|
|
|
|
650
|
|
Convertible notes, current portion net of discount
|
|
|
|
|
|
|
21,778
|
|
Deferred revenue
|
|
|
150
|
|
|
|
|
|
Deferred rent
|
|
|
282
|
|
|
|
328
|
|
Total current liabilities
|
|
|
8,027
|
|
|
|
27,717
|
|
Non-current portion of notes payable
|
|
|
406
|
|
|
|
480
|
|
Deferred rent
|
|
|
2,707
|
|
|
|
2,939
|
|
Total liabilities
|
|
|
11,140
|
|
|
|
31,136
|
|
Commitments and contingences (see Note 13)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value, 2,000,000 shares authorized; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value, 200,000,000 shares authorized; and 100,717,890 shares issued and 100,262,460 shares outstanding at December 31, 2009 and 69,220,021 shares issued and 68,764,591 shares outstanding at December 31, 2008
|
|
|
1,007
|
|
|
|
692
|
|
Additional paid-in capital
|
|
|
350,810
|
|
|
|
284,595
|
|
Notes receivable from former directors
|
|
|
(1,572
|
)
|
|
|
(1,572
|
)
|
Accumulated deficit
|
|
|
(274,150
|
)
|
|
|
(235,776
|
)
|
Treasury stock, 455,430 shares at December 31, 2009 and 2008, cost basis
|
|
|
(2,450
|
)
|
|
|
(2,450
|
)
|
Accumulated other comprehensive income
|
|
|
820
|
|
|
|
|
|
Total stockholders equity
|
|
|
74,465
|
|
|
|
45,489
|
|
Total liabilities and stockholders equity
|
|
$
|
85,605
|
|
|
$
|
76,625
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
TABLE OF CONTENTS
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
For the Years Ended December 31,
|
|
|
2009
|
|
2008
|
|
2007
|
|
|
(In Thousands, Except per Share Information)
|
Revenue
|
|
$
|
325
|
|
|
$
|
1,064
|
|
|
$
|
1,513
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
25,780
|
|
|
|
24,334
|
|
|
|
17,821
|
|
General and administrative
|
|
|
11,928
|
|
|
|
11,090
|
|
|
|
13,963
|
|
Total operating expenses
|
|
|
37,708
|
|
|
|
35,424
|
|
|
|
31,784
|
|
Loss from continuing operations before other income (expense)
|
|
|
(37,383
|
)
|
|
|
(34,360
|
)
|
|
|
(30,271
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
285
|
|
|
|
959
|
|
|
|
3,287
|
|
Interest expense
|
|
|
(786
|
)
|
|
|
(1,683
|
)
|
|
|
(1,606
|
)
|
Impairment of short-term investments
|
|
|
(1,338
|
)
|
|
|
(1,238
|
)
|
|
|
|
|
Realized gains on short-term investments
|
|
|
848
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(38,374
|
)
|
|
|
(36,322
|
)
|
|
|
(28,590
|
)
|
Income (loss) from discontinued operations
|
|
|
|
|
|
|
273
|
|
|
|
(6,175
|
)
|
Net loss
|
|
$
|
(38,374
|
)
|
|
$
|
(36,049
|
)
|
|
$
|
(34,765
|
)
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share from continuing operations
|
|
$
|
(0.45
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.47
|
)
|
Loss per share from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
(0.10
|
)
|
Net loss per share
|
|
$
|
(0.45
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.57
|
)
|
Basic and diluted weighted average number of common shares outstanding
|
|
|
85,555
|
|
|
|
68,174
|
|
|
|
61,101
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-4
TABLE OF CONTENTS
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
For the Years Ended December 31, 2009, 2008 and 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Notes
Receivable
from
Former
Directors
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Accumulated
Other
Comprehensive
Income
|
|
Total
Stockholders
Equity
|
|
|
Shares
|
|
Amount
|
|
|
(In Thousands, Except Share Information)
|
Balance at December 31, 2006
|
|
|
62,139,851
|
|
|
$
|
622
|
|
|
$
|
261,822
|
|
|
$
|
(1,031)
|
|
|
$
|
(164,962)
|
|
|
$
|
(2,450)
|
|
|
$
|
|
|
|
$
|
94,001
|
|
Non-cash compensation costs for stock options and restricted stock
|
|
|
|
|
|
|
|
|
|
|
1,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,857
|
|
Exercise of stock options
|
|
|
57,126
|
|
|
|
|
|
|
|
89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89
|
|
Restricted stock issued as compensation
|
|
|
160,000
|
|
|
|
2
|
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification due to change in status of a director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,031
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,031
|
|
Debt discount from modification of convertible debt
|
|
|
|
|
|
|
|
|
|
|
852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
852
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,765
|
)
|
|
|
|
|
|
|
|
|
|
|
(34,765
|
)
|
Balance at December 31, 2007
|
|
|
62,356,977
|
|
|
|
624
|
|
|
|
264,618
|
|
|
|
|
|
|
|
(199,727)
|
|
|
|
(2,450)
|
|
|
|
|
|
|
|
63,065
|
|
Non-cash compensation costs for stock options and restricted stock
|
|
|
|
|
|
|
|
|
|
|
2,070
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,070
|
|
Exercise of stock options
|
|
|
176,394
|
|
|
|
1
|
|
|
|
328
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
329
|
|
Issuance of common stock, net of issuance costs of $420
|
|
|
6,686,650
|
|
|
|
67
|
|
|
|
17,436
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,503
|
|
Reclassification of former directors notes receivable
|
|
|
|
|
|
|
|
|
|
|
143
|
|
|
|
(1,572
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,429
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,049
|
)
|
|
|
|
|
|
|
|
|
|
|
(36,049
|
)
|
Balance at December 31, 2008
|
|
|
69,220,021
|
|
|
|
692
|
|
|
|
284,595
|
|
|
|
(1,572)
|
|
|
|
(235,776)
|
|
|
|
(2,450)
|
|
|
|
|
|
|
|
45,489
|
|
Non-cash compensation cost for stock options and restricted stock
|
|
|
|
|
|
|
|
|
|
|
1,533
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,533
|
|
Exercise of stock options
|
|
|
546,832
|
|
|
|
5
|
|
|
|
947
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
952
|
|
Restricted stock issued as compensation
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock to Cadila, net of issuance costs of $406
|
|
|
12,500,000
|
|
|
|
125
|
|
|
|
10,469
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,594
|
|
Issuance of common stock to Rovi, net of issuance costs of $23
|
|
|
1,094,891
|
|
|
|
11
|
|
|
|
2,966
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,977
|
|
Conversion of convertible debt
|
|
|
3,056,939
|
|
|
|
31
|
|
|
|
7,629
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,660
|
|
Issuance of common stock under ATM, net of issuance costs of $682
|
|
|
7,489,207
|
|
|
|
75
|
|
|
|
21,930
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,005
|
|
Issuance of common stock, net of issuance costs of $1,631
|
|
|
6,800,000
|
|
|
|
68
|
|
|
|
20,741
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,809
|
|
Unrealized gain on short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
820
|
|
|
|
820
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,374
|
)
|
|
|
|
|
|
|
|
|
|
|
(38,374
|
)
|
Balance at December 31, 2009
|
|
|
100,717,890
|
|
|
|
1,007
|
|
|
$
|
350,810
|
|
|
$
|
(1,572)
|
|
|
$
|
(274,150)
|
|
|
$
|
(2,450)
|
|
|
$
|
820
|
|
|
$
|
74,465
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-5
TABLE OF CONTENTS
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
For the Years Ended December 31,
|
|
|
2009
|
|
2008
|
|
2007
|
|
|
(In Thousands)
|
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss:
|
|
$
|
(38,374
|
)
|
|
$
|
(36,049
|
)
|
|
$
|
(34,765
|
)
|
Plus net loss (income) from discontinued operations
|
|
|
|
|
|
|
(273
|
)
|
|
|
6,175
|
|
Net loss from continuing operation
|
|
|
(38,374
|
)
|
|
|
(36,322
|
)
|
|
|
(28,590
|
)
|
Reconciliation of net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,194
|
|
|
|
893
|
|
|
|
834
|
|
Amortization of deferred financing costs
|
|
|
147
|
|
|
|
258
|
|
|
|
259
|
|
Amortization of debt discount
|
|
|
222
|
|
|
|
409
|
|
|
|
221
|
|
Provision for bad debts
|
|
|
|
|
|
|
|
|
|
|
176
|
|
Loss on disposal of property and equipment
|
|
|
21
|
|
|
|
258
|
|
|
|
100
|
|
Impairment of long-lived assets
|
|
|
23
|
|
|
|
994
|
|
|
|
|
|
Amortization of net discounts on short-term investments
|
|
|
|
|
|
|
(181
|
)
|
|
|
(2,320
|
)
|
Reserve for notes receivable and accrued interest
|
|
|
|
|
|
|
(534
|
)
|
|
|
875
|
|
Deferred rent
|
|
|
(279
|
)
|
|
|
(123
|
)
|
|
|
312
|
|
Non-cash expense for services
|
|
|
|
|
|
|
|
|
|
|
57
|
|
Non-cash stock-based compensation
|
|
|
1,533
|
|
|
|
2,070
|
|
|
|
1,800
|
|
Lease incentives received
|
|
|
|
|
|
|
3,000
|
|
|
|
|
|
Net impairment of short-term investments
|
|
|
490
|
|
|
|
1,238
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts and other receivables
|
|
|
32
|
|
|
|
438
|
|
|
|
(298
|
)
|
Prepaid expenses and other current assets
|
|
|
(536
|
)
|
|
|
674
|
|
|
|
219
|
|
Other non-current assets
|
|
|
|
|
|
|
18
|
|
|
|
432
|
|
Accounts payable and accrued expenses
|
|
|
2,547
|
|
|
|
141
|
|
|
|
206
|
|
Deferred revenue
|
|
|
150
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities from continuing operations
|
|
|
(32,830
|
)
|
|
|
(26,769
|
)
|
|
|
(25,717
|
)
|
Net cash provided by (used in) in operating activities from discontinued operations
|
|
|
|
|
|
|
2,459
|
|
|
|
(1,025
|
)
|
Net cash used in operating activities
|
|
|
(32,830
|
)
|
|
|
(24,310
|
)
|
|
|
(26,742
|
)
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(745
|
)
|
|
|
(5,689
|
)
|
|
|
(1,961
|
)
|
Proceeds from disposal of property and equipment
|
|
|
|
|
|
|
121
|
|
|
|
|
|
Purchases of short-term investments
|
|
|
|
|
|
|
(15,650
|
)
|
|
|
(94,993
|
)
|
Proceeds from maturities of short-term investments
|
|
|
3,100
|
|
|
|
49,770
|
|
|
|
121,608
|
|
Net cash provided by investing activities from continuing operations
|
|
|
2,355
|
|
|
|
28,552
|
|
|
|
24,654
|
|
Net cash provided by (used in) investing activities from discontinued operations
|
|
|
|
|
|
|
1,354
|
|
|
|
(3
|
)
|
Net cash provided by investing activities
|
|
|
2,355
|
|
|
|
29,906
|
|
|
|
24,651
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal payments of notes payable
|
|
|
(15,043
|
)
|
|
|
(1,040
|
)
|
|
|
(809
|
)
|
Proceeds from other borrowings
|
|
|
|
|
|
|
200
|
|
|
|
|
|
Net proceeds from sales of common stock
|
|
|
56,385
|
|
|
|
17,503
|
|
|
|
|
|
Proceeds from the exercise of stock options
|
|
|
952
|
|
|
|
329
|
|
|
|
89
|
|
Net cash provided by (used in) financing activities
|
|
|
42,294
|
|
|
|
16,992
|
|
|
|
(720
|
)
|
Net increase (decrease) in cash and cash equivalents
|
|
|
11,819
|
|
|
|
22,588
|
|
|
|
(2,811
|
)
|
Cash and cash equivalents at beginning of year
|
|
|
26,938
|
|
|
|
4,350
|
|
|
|
7,161
|
|
Cash and cash equivalents at end of year
|
|
$
|
38,757
|
|
|
$
|
26,938
|
|
|
$
|
4,350
|
|
Supplemental disclosure of non-cash activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible debt and accrued interest to common stock
|
|
$
|
7,660
|
|
|
$
|
|
|
|
$
|
|
|
Debt discount from modification of convertible debt
|
|
$
|
|
|
|
$
|
|
|
|
$
|
852
|
|
Equipment purchases included in accounts payable
|
|
$
|
66
|
|
|
$
|
|
|
|
$
|
624
|
|
Financed insurance premiums
|
|
$
|
|
|
|
$
|
570
|
|
|
$
|
600
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash interest payments
|
|
$
|
817
|
|
|
$
|
1,040
|
|
|
$
|
1,073
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-6
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 1 Organization
Novavax, Inc. (the Company), is a clinical-stage biopharmaceutical company focused on developing novel, highly potent recombinant vaccines. These vaccines leverage the Companys virus-like-particle (VLP) platform technology coupled with a unique disposable production technology. VLPs are genetically engineered three-dimensional nanostructures which incorporate immunologically important lipids and recombinant proteins. The Companys VLPs resemble the virus, but lack the genetic material to replicate the virus and its proprietary production technology uses insect cells rather than chicken eggs or
mammalian cells. The Companys current product targets include vaccines against pandemic and seasonal influenza, including H5N1 and H1N1 pandemic strains, Respiratory Syncytial Virus (RSV) and Varicella Zoster Virus (VZV), which causes shingles.
In 2009, the Company formed a joint venture with Cadila Pharmaceuticals Ltd., named CPL Biologicals Private Limited, to develop and manufacture vaccines, biological therapeutics and diagnostics in India (see Note 4).
Note 2 Liquidity Matters
Since its inception, the Company has incurred, and continues to incur, significant losses from operations. At December 31, 2009, the Company had cash and cash equivalents of $38.8 million and short-term investments with a fair value of $4.2 million.
The Companys vaccine product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical and clinical testing and regulatory approval, prior to commercial use. There can be no assurance that the Companys research and development efforts will be successful or that any potential product candidates will prove to be safe and effective in clinical trials. Even if developed, these vaccine product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would permit the Company to operate profitably. The commercial
launch of any vaccine product candidate is subject to certain risks including, but not limited to, manufacturing scale-up and market acceptance.
Based on the Companys cash, cash equivalents and short-term investment balances as of December 31, 2009 and its current business operations, the Company believes it will have adequate capital resources available to operate at planned levels for at least the next twelve months. Additional capital will be required in the future to develop its product candidates through clinical development, manufacturing, and commercialization. The Company will seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, non-dilutive government contracts, collaborative
arrangements, or some combination of these financing alternatives. Any capital raised by an equity offering will likely be substantially dilutive to the existing stockholders and any licensing or development arrangement may require the Company to give up rights to a product or technology at less than its full potential value. Other than the Companys At the Market Sales Agreement with McNicoll, Lewis & Vlak LLC (see Note 7), we have not secured any additional commitments for new financing nor can the Company provide any assurance that new financing will be available on commercially acceptable terms, if at all. If the Company is unable to obtain additional capital, it will assess its capital resources and will likely be required to delay, reduce the scope of, or eliminate one or more of its product research and development programs, downsize the organization, or reduce its general and administrative infrastructure.
Note 3 Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Fielding Pharmaceutical Company. All significant intercompany accounts and transactions have been eliminated in consolidation.
F-7
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
As a result of the Companys sale of its Estasorb business in 2008, the consolidated financial statements and the related note disclosures reflect the operations of the Estasorb business as a discontinued operation (see Note 11).
Use of Estimates
The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.
Reclassifications
Certain reclassifications have been made to the prior years financial statements to conform to the current year presentation. In 2008, the Company corrected the classification and related accounting for notes receivable due from former directors to show these notes as a reduction to stockholders equity in the December 31, 2008 consolidated balance sheet. As a result, the Company reduced its net loss by $0.7 million for the accumulated amounts previously reserved and recorded as general and administrative expenses of $1.2 million and a charge to interest income for the cumulative interest income of $0.5 million related to the notes
receivable. The Company evaluated the impact of this correction in accordance with Accounting Standards Codification (ASC) 250-10-355-1,
Materiality
. The amount of the adjustment when compared to the operating results for the year ended December 31, 2008, or any trend of income, is not considered by management to be material.
Cash and Cash Equivalents
Cash and cash equivalents consist of highly liquid investments with original maturities of three months or less from the date of purchase.
Short-Term Investments
Short-term investments at December 31, 2009 consist of investments in three auction rate securities with a par value of $5.1 million and a fair value of $4.2 million. In 2009 and 2008, the Company recorded other-than-temporary impairment charges related to these securities of $1.3 million and $1.2 million, respectively, because of the recent uncertainties in the credit markets and managements belief these securities cannot be sold at par value, but are saleable at a discount from their par value. In 2009, the Company realized gains of $0.8 million relating to redemptions of several auction rate securities from its portfolio.
The Company had invested in auction rate securities for short periods of time as part of its cash management program. Recent uncertainties in the credit markets have prevented the Company from liquidating certain holdings of auction rate securities as the amount of securities submitted for sale during the auction has exceeded the amount of purchase orders. Although an event of an auction failure does not necessarily mean that a security is impaired, the Company considered various factors to assess the fair value and the classification of the securities as short-term assets. Fair value was determined through an independent valuation using two
valuation methods a discounted cash flow method and a market comparable method. Certain factors used in these methods include, but are not necessarily limited to, comparable securities traded on secondary markets, timing of the failed auction, specific security auction history, quality of underlying collateral, rating of the security and the bond insurer, the Companys ability and intent to retain the securities for a period of time to allow for anticipated recovery in the market value, and other factors.
The Company has classified these securities as available-for-sale since the Company may need to liquidate these securities within the next year. The available-for-sale securities are carried at fair value and unrealized gains and losses on these securities, if determined to be temporary, are included in accumulated
F-8
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
other comprehensive income (loss) in stockholders equity. Investments available for sale are evaluated periodically to determine whether a decline in value is other-than-temporary. The term other-than-temporary is not intended to indicate a permanent decline in value. Rather, it means that the prospects for a near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security. Management reviews criteria, such as the magnitude and duration of the decline, as well as the Companys ability to hold the
securities until market recovery, to predict whether the loss in value is other-than-temporary. If a decline in value is determined to be other-than-temporary, the value of the security is reduced and the impairment is recorded in the consolidated statements of operations. The specific identification method is used in computing realized gains and losses on sale of the Companys securities.
Short-term investments classified as available-for-sale as of December 31, 2009 were comprised of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Value
|
Auction rate securities
|
|
$
|
3,373
|
|
|
$
|
820
|
|
|
$
|
|
|
|
$
|
4,193
|
|
Total
|
|
$
|
3,373
|
|
|
$
|
820
|
|
|
$
|
|
|
|
$
|
4,193
|
|
Financial Instruments and Concentration of Credit Risk
Financial instruments, which possibly expose the Company to concentration of credit risk, consist primarily of cash and cash equivalents and short-term investments. The Companys investment policy limits investments to certain types of instruments, including auction rate securities, high-grade corporate debt securities and money market instruments, places restrictions on maturities and concentrations in certain industries and requires the Company to maintain a certain level of liquidity. At times, the Company maintains cash balances in financial institutions, which may exceed federally insured limits. The Company has not experienced any losses
relating to such accounts and believes it is not exposed to a significant credit risk on its cash and cash equivalents. The carrying value of cash and cash equivalents approximates their fair value based on their short-term maturities at December 31, 2009 and 2008.
Fair Value Measurements
The Company adopted ASC Topic 820,
Fair Value Measurements and Disclosures
, for financial assets and liabilities on January 1, 2008. The Company adopted ASC 820 for non-financial assets and liabilities on January 1, 2009.
ASC 820 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow) and the cost approach (cost to replace the service capacity of an asset or replacement cost). The statement utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:
|
|
Level 1:
Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
|
|
Level 2:
Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
|
|
|
Level 3:
Unobservable inputs that reflect the reporting entitys own assumptions.
|
F-9
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
Financial assets and liabilities measured a fair market value on a recurring basis as of December 31, 2009 are summarized below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at
December 31, 2009 Using Fair Value Hierarchy
|
Assets
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Fair Value
|
Cash and cash equivalents
|
|
$
|
38,757
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
38,757
|
|
Short-term investments
|
|
|
|
|
|
|
4,193
|
|
|
|
|
|
|
|
4,193
|
|
Total
|
|
$
|
38,757
|
|
|
$
|
4,193
|
|
|
$
|
|
|
|
$
|
42,950
|
|
The amounts in the Companys consolidated balance sheet for accounts receivable, accounts payable and notes payable approximate fair value due to their short-term nature.
Accounts Receivables
Accounts receivable are reported at their net realizable value. The Company maintains an allowance for doubtful accounts that is determined based on historical experience and managements expectations of future losses. Accounts deemed uncollectible are charged to the allowance based on specific identification. Accounts that are ultimately deemed uncollectible are written-off as a reduction of accounts receivable and the allowance for doubtful accounts.
Property and Equipment
Property and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the assets, generally three to ten years. Amortization of leasehold improvements is provided over the shorter of the estimated useful lives of the improvements or the term of the lease. Repairs and maintenance costs are expensed as incurred.
Property and equipment is comprised of the following at December 31 (in thousands):
|
|
|
|
|
|
|
2009
|
|
2008
|
Construction in progress
|
|
$
|
1,351
|
|
|
$
|
5,394
|
|
Machinery and equipment
|
|
|
4,348
|
|
|
|
3,880
|
|
Leasehold improvements
|
|
|
4,531
|
|
|
|
637
|
|
Computer software and hardware
|
|
|
333
|
|
|
|
339
|
|
|
|
|
10,563
|
|
|
|
10,250
|
|
Less accumulated depreciation and amortization
|
|
|
(2,762
|
)
|
|
|
(2,022
|
)
|
|
|
$
|
7,801
|
|
|
$
|
8,228
|
|
Construction in progress is primarily related to costs incurred related to the completion of the Companys GMP pilot manufacturing facility, which was ready for use in January 2009 and the purchase of equipment that is awaiting final installation or validation prior to its use.
Depreciation expense was approximately $1.2 million, $0.9 million and $0.7 million for the years ended December 31, 2009, 2008 and 2007, respectively.
Goodwill and Intangible Assets
Goodwill originally resulted from a business acquisition in 2000. Assets acquired and liabilities assumed were recorded at their fair values; the excess of the purchase price over the identifiable net assets acquired was recorded as goodwill. Goodwill and intangible assets deemed to have indefinite lives are not amortized, but are subject to impairment tests annually, or more frequently should indicators of impairment arise. The Company utilizes both the market approach and the income approach to determine if it has an impairment of
F-10
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
its goodwill. The market approach serves as the primary approach and is based on market value of invested capital. The income approach is used as a confirming look to the market approach. Goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds its estimated fair value.
At December 31, 2009 and 2008, the Company used both the market approach and the income approach to determine if the Company had an impairment of its goodwill. The Company used a market approach to determine the market value of capitalization of its single reporting unit. Step one of the impairment test states that if the fair value of a reporting unit exceeds its carrying amount, goodwill is considered not to be impaired. The Companys forecasts were used to create a risk adjusted discounted cash flow analysis to indicate fair value. The fair value of the Companys reporting unit was compared to the carrying amount of the reporting unit.
Under both approaches, the fair value of the reporting unit was higher than the carrying value, resulting in no impairment to goodwill at December 31, 2009 and 2008. Due to a significant decrease in its stock price during the first quarter of 2009, the Company also performed a goodwill impairment test as of March 31, 2009, and determined there was no impairment to goodwill.
Equity Method Investments
The Company has an equity investment in CPL Biologicals Private Limited. The Company accounts for this investment using the equity method (see Note 4). Under the equity method of accounting, investments are stated at initial cost and are adjusted for subsequent additional investments and the Companys proportionate share of earnings or losses and distributions up to the amount initially invested or advanced.
Long-Lived Assets and Discontinued Operations
The Company accounts for the impairment of its long-lived assets in accordance with ASC 360,
Property, Plant and Equipment
. This financial standard requires a periodic evaluation of the recoverability of the carrying value of long-lived assets and identifiable intangibles whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. The Company considers historical performance and anticipated future results in its evaluation of potential impairment. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of these assets in relation to the operating
performance of the business and future undiscounted cash flows expected to result from the use of these assets. Impairment losses are recognized when the sum of expected future cash flows is less than the assets carrying value.
In 2008, the Company was unable to sell the patent related to its MNP technology, previously recorded as assets held for sale, and recorded an impairment of $0.8 million.
Revenue Recognition
The Company performs research and development for United States government agencies. The Company recognizes revenue under research contracts when a contract has been executed, the contract price is fixed and determinable, delivery of services or products has occurred and collection of the contract price is considered probable. Revenue is earned under cost reimbursable and fixed price contracts. Direct contract costs are expensed as incurred.
Under cost reimbursable contracts, the Company is reimbursed for allowable costs and paid a fixed fee. Revenue on cost reimbursable contracts is recognized as costs are incurred plus a portion of the fee earned. Revenue for fixed price arrangements are recognized under the proportional performance method based upon the ratio of costs incurred to achieve contract milestones to total estimated cost. Losses on contracts, if any, are recognized in the period in which they become known.
F-11
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
For upfront payments and licensing fees related to contract research or technology, the Company follows provisions of ASC 605,
Revenue Recognition,
in determining if these payments and fees represent the culmination of a separate earnings process or if they should be deferred and recognized as revenue over the life of the related agreement.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC Topic 718,
Compensation-Stock Compensation
, which requires grants of employee stock options and restricted stock awards to be recognized in the financial statements based upon their respective grant-date fair values. The Company recognizes compensation expense on a straight-line basis over the requisite service period (generally the vesting period) of the equity awards, which typically occurs ratably over periods ranging from six months to four years. See Note 9 for a further discussion on stock-based compensation.
The expected life of stock options granted was based on the Companys historical option exercise experience and post vesting forfeiture experience using the historical expected term from the vesting date. The expected volatility of the options granted was determined using historical volatilities based on stock prices over a look-back period corresponding to the expected life. The risk-free interest rate was determined using the yield available for zero-coupon United States government issues with a remaining term equal to the expected life of the options. The forfeiture rate was determined using historical pre-vesting forfeiture rates since the
inception of the plans. The Company has never paid a dividend, and as such, the dividend yield is zero.
Restricted stock awards to employees and directors have been recorded as compensation expense over the expected vesting period based on the fair value at the award date and the number of shares ultimately expected to vest using the straight-line method of amortization. The Company accounts for share-based awards issued to non-employees by determining the fair value of equity awards given as consideration for services rendered to be recognized as compensation expense over the shorter of the vesting or service periods. In cases where services are not fully rendered, the equity award must be revalued on each subsequent reporting date until performance
is complete with a cumulative catch-up adjustment recognized for any changes in their estimated fair value.
Research and Development Expenses
Research and development expenses are expensed as incurred. Such costs include internal research and development expenditures (such as salaries and benefits, raw materials, and supplies) and contracted services (such as sponsored research, testing and consulting services) of proprietary research and development activities and similar expenses associated with collaborative research agreements.
Income Taxes
The Company accounts for income taxes in accordance with ASC Topic 740,
Income Taxes
. Under the liability method, deferred income taxes are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in
income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce net deferred tax assets to the amount expected to be realized.
F-12
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
On January 1, 2007, the Company adopted a new financial pronouncement that gives guidance related to the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return, and requires that the Company recognize in its financial statements the impact of a tax position, if that position is more likely than not to be sustained upon an examination, based on the technical merits of the position.
Interest and penalties related to income tax matters are recorded as income tax expense. At December 31, 2009 and 2008, the Company had no accruals for interest or penalties related to income tax matters.
Net Loss per Share
Net loss per share is computed using the weighted average number of shares of common stock outstanding. All outstanding warrants, stock options and unvested restricted stock awards totaling 9,428,319 shares at December 31, 2009 are excluded from the computation for 2009, as their effect is anti-dilutive.
Comprehensive Income (Loss)
The Company accounts for comprehensive income (loss) as prescribed by ASC 220,
Comprehensive Income
. Comprehensive income (loss) is the total net income (loss) plus all changes in equity during the period except those changes resulting from investment by and distribution to owners. Total comprehensive loss was $37.6 million, $36.0 million and $34.8 million for the years ended December 31, 2009, 2008 and 2007, respectively.
At December 31, 2009, the Companys other comprehensive income consists of $0.8 million related to the appreciation on previously impaired marketable securities in the later part of 2009. During 2008 and early 2009, the Company experienced a decrease in the value of these securities and recorded other-than-temporary impairment charges and adjusted the carrying value of these securities.
Segment Information
The Company manages its business as one operating segment: developing novel, highly potent recombinant vaccines. The Company does not operate separate lines of business with respect to its products or product candidates. Accordingly, the Company does not have separately reportable segments as defined by ASC 280,
Segment Reporting
.
Recent Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) issued authoritative guidance on the consolidation of variable interest entities, which is effective for the Company beginning January 1, 2010. The new guidance requires revised evaluations of whether entities represent variable interest entities, ongoing assessments of control over such entities, and additional disclosures for variable interests. The Company believes adoption of this new guidance will not have a material impact on its financial position and results of operations.
In September 2009, ASU 2009-13,
Revenue Recognition
(Topic 605)
Multiple-Deliverable Revenue Arrangements
, was issued and will change the accounting for multiple-deliverable arrangements to enable vendors to account for products or services (deliverables) separately rather than as a combined unit. Specifically, this guidance amends the criteria in Subtopic 605-25,
Revenue Recognition
Multiple-Element Arrangements,
for separating consideration in multiple-deliverable arrangements. This guidance establishes a selling price hierarchy for determining the selling price of a deliverable, which
is based on: (a) vendor-specific objective evidence; (b) third-party evidence; or (c) estimates. This guidance also eliminates the residual method of allocation and requires that arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method. In addition, this guidance significantly expands required disclosures related to a vendors multiple-deliverable revenue arrangements. ASU 2009-13 is effective
F-13
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 3 Summary of Significant Accounting Policies (continued)
prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010 with early adoption permitted. The impact of ASU 2009-13 on the Companys consolidated financial statements will depend on the nature and terms of its revenue arrangements entered into or materially modified after the adoption date. However, based on the Companys current customer arrangements, the Company does not believe the adoption of this ASU will have a material impact on its consolidated financial statements.
In January 2010, the FASB issued ASU 2010-06,
Fair Value Measurements and Disclosures
(Topic 820)
Improving Disclosures about Fair Value Measurements
, which amends Topic 820 to add new requirements for disclosures about transfers into and out of Levels 1 and 2 and separate disclosures about purchases, sales, issuances, and settlements related to Level 3 measurements. ASU 2010-06 also clarifies existing fair value disclosures about the level of disaggregation and about inputs and valuation techniques used to measure fair value. The ASU is effective for the first reporting period beginning after December 15, 2009, except
for the requirements to provide the Level 3 activity of purchases, sales, issuances, and settlements on a gross basis, which will be effective for fiscal years beginning after December 15, 2010, and for interim periods within those fiscal years. Early adoption is permitted. The Company believes the adoption of this amendment will not have a material effect on its financial position or results of operations.
Note 4 Joint Venture and H1N1 Mexico Transaction
Joint Venture With Cadila
On March 31, 2009, the Company entered into a Joint Venture Agreement (the JVA) with Cadila Pharmaceuticals Ltd., a private company incorporated under the laws of India (Cadila) pursuant to which the Company and Cadila formed CPL Biologicals Private Limited, a joint venture (the JV), of which 80% is owned by Cadila and 20% is owned by Novavax. The JV will develop and commercialize the Companys seasonal influenza and H1N1 pandemic vaccine candidates and Cadilas biogeneric products and other diagnostic products for the territory of India. The JV has the right to negotiate a definitive agreement for rights
to certain future Novavax products (other than RSV) and certain future Cadila products in India, prior to Novavax or Cadila licensing such rights to a third party. Novavax has the right to negotiate the licensing of vaccines developed by the JV using Novavaxs technology for commercialization in every country except for India and vaccines developed by the JV using Cadilas technology for commercialization in certain other countries, including the United States. Cadila has committed to contribute approximately $8 million over three years to support the JVs operations. In connection with the JVA, on March 31, 2009, the Company also entered into a license agreement, an option to enter into a license agreement, a technical services agreement and a supply agreement with the JV and a master services agreement with Cadila. Because the Company does not control the JV, the Company accounts for its investment using the equity method. Since the carrying value of the Companys
contribution was $0 and there is no guarantee or commitment to provide future funding, the Company does not expect to record losses related to this investment in the future.
Also on March 31, 2009, the Company entered into a Stock Purchase Agreement with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila, pursuant to which SOHL purchased 12.5 million shares of the Companys common stock at the market price of $0.88 per share, resulting in net proceeds of approximately $10.6 million.
H1N1 Mexico Transaction
On October 19, 2009, the Company entered into a Materials Transfer Agreement with Laboratorio Avi-Mex S.A. de C.V. (Avimex), pursuant to which it supplied Avimex with certain amounts of its 2009 H1N1 vaccine candidate and made payments to Avimex related to the Companys clinical trial. Avimex used the H1N1 vaccine to conduct clinical trials and is currently seeking regulatory approval in Mexico. Avimex made a milestone payment to the Company and is obligated to pay the Company a transfer fee for the H1N1
F-14
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 4 Joint Venture and H1N1 Mexico Transaction (continued)
vaccine based on the Companys production cost. The agreement and the option to enter into a non-exclusive distribution agreement to distribute the 2009 H1N1 vaccine in Mexico both expired by its terms on December 31, 2009. The second phase of the clinical trial is ongoing and the parties are continuing to cooperate in seeking regulatory approval in Mexico.
On October 20, 2009, the Company entered into a binding term sheet (as amended, the Xcellerex Agreement) with Xcellerex, Inc. A director of the Company was also a director of Xcellerex at the time the term sheet was negotiated. This director did not participate in any Board of Directors meetings regarding this transaction. Pursuant to the Xcellerex Agreement, Xcellerex performed scale-up and manufacturing activities related to the Companys 2009 H1N1 vaccine candidate for potential sale in Mexico. Although the H1N1 manufacturing campaign with Xcellerex did not result in the manufacture of acceptable vaccine to the Company, the
Company achieved proof of concept by scaling up to a commercial grade bioreactor. The success in scaling up its VLPs in stir tank bioreactors potentially provides an additional path to large scale, commercially viable vaccine production. As consideration, the Company paid Xcellerex a fixed payment and supplied materials. The Xcellerex Agreement expired by its terms on February 15, 2010.
Note 5 Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following at December 31 (in thousands):
|
|
|
|
|
|
|
2009
|
|
2008
|
Employee benefits and compensation
|
|
$
|
1,726
|
|
|
$
|
412
|
|
Research and development accruals
|
|
|
2,638
|
|
|
|
1,297
|
|
Other accrued expenses
|
|
|
1,038
|
|
|
|
782
|
|
Interest expense
|
|
|
15
|
|
|
|
478
|
|
Accrued expenses and other current liabilities
|
|
$
|
5,417
|
|
|
$
|
2,969
|
|
Note 6 Long-Term Debt
Notes Payable
Notes payable consist of the following at December 31 (in thousands):
|
|
|
|
|
|
|
2009
|
|
2008
|
Note payable; insurance financing; bears interest at 4.9% per annum; principal and interest due in monthly installments of $51,677 through September 2009
|
|
$
|
|
|
|
$
|
570
|
|
Opportunity Grant Fund notes payable; non-interest bearing; principal only payments due in monthly installments of $6,667 through April 2012
|
|
|
186
|
|
|
|
260
|
|
Loan agreements; bear interest at 3% per annum; repayment is conditional
|
|
|
300
|
|
|
|
300
|
|
Total
|
|
|
486
|
|
|
|
1,130
|
|
Less current portion
|
|
|
(80
|
)
|
|
|
(650
|
)
|
Long-term portion
|
|
$
|
406
|
|
|
$
|
480
|
|
F-15
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 6 Long-Term Debt (continued)
Opportunity Grant Fund Note Payable
In April 2007, the Company entered into a Settlement and Release Agreement with the Commonwealth of Pennsylvania, whereby the Company agreed to repay the original grant of $400,000 associated with its former corporate headquarters and product development activities in Malvern, Pennsylvania in 60 monthly installments of $6,667 each starting May 2007. Interest does not accrue on the outstanding balance.
Loan Agreements
In May 2008, the Company entered into loan agreements with the State of Maryland and Montgomery County whereby the repayment of the loan amounts and accrued interest is conditioned upon the Company meeting the capital investment and employment requirements during the term of the loans through 2013.
Convertible Notes
At December 31, 2008, the Company had convertible notes outstanding, net of a discount, totaling $21.8 million. These notes had a face value of $22 million, with interest at 4.75%, due July 15, 2009 and were convertible by the holders into 4,029,304 shares of the Companys common stock at $4.00 per share.
On April 29, 2009, the Company entered into amendment agreements (the 2009 Amendments) with holders of the outstanding Notes representing $17.0 million of the $22 million outstanding principal amount of the Notes to amend the terms of the Notes to allow for early retirement; 70% of this principal amount plus accrued and unpaid interest was paid in cash, totaling $12.1 million, and 30% was paid through issuance of 2,040,000 shares of common stock at $2.50 per share.
On July 15, 2009, the Company paid the $5.0 million balance of the Notes. Under the terms of the Notes, the Company paid approximately $2.6 million of principal and accrued and unpaid interest in cash and issued 1,016,939 shares of common stock to pay the remaining $2.6 million of principal and accrued and unpaid interest, based on a price of $2.5163 per share. As of July 15, 2009, the Notes were fully paid and extinguished.
Aggregate future minimum principal payments on long-term debt at December 31, 2009 are as follows (in thousands):
|
|
|
Year
|
|
Amount
|
2010
|
|
$
|
80
|
|
2011
|
|
|
80
|
|
2012
|
|
|
26
|
|
2013
|
|
|
300
|
|
|
|
$
|
486
|
|
Note 7 Sales of Common Stock
On November 25, 2009, the Company issued 6,800,000 shares of common stock at $3.30 per share in an underwritten public offering. The Company received net proceeds of approximately $21 million.
On June 30, 2009, the Company entered into a stock purchase agreement with ROVI Pharmaceuticals of Spain for the purchase of $3 million of common stock at $2.74 per share and issued approximately 1,094,891 shares of its common stock in this transaction.
On March 31, 2009, the Company entered into a stock purchase agreement with SOHL, pursuant to which SOHL purchased 12.5 million shares of common stock at the market price of $0.88 per share. The Company received net proceeds of approximately $10.6 million.
F-16
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 7 Sales of Common Stock (continued)
On January 12, 2009, the Company entered into an At the Market Sales Agreement (the January Sales Agreement) with Wm Smith & Co. (Wm Smith), under which the Company may sell an aggregate of up to $25 million in gross proceeds of its common stock from time to time through Wm Smith, as the agent for the offer and sale of the common stock. During 2009, the Company sold 7,489,207 shares at a range of $1.75-$5.03 and received net proceeds of approximately $22 million under the January Sales Agreement. On September 15, 2009, the Company entered into a second At Market Issuance Sales Agreement (the September Sales
Agreement), with Wm Smith, under which the Company may sell an aggregate of up to $10 million in gross proceeds of the Companys common stock from time to time through Wm Smith. The Company has not sold any common stock under the September Sales Agreement.
On March 15, 2010, the Company terminated the January Sales Agreement and the September Sales Agreement and entered into a sales agreement with McNicoll, Lewis & Vlak LLC, as sales agent, under which the Company may sell an aggregate of $50 million of gross proceeds of the Companys common stock. The Companys Board of Directors has authorized the sale of up to 25 million shares of common stock pursuant to this agreement.
On July 31, 2008, the Company completed a registered direct offering of 6,686,650 units (the Units), with each unit consisting of one share of common stock and a warrant to purchase 0.5 shares of common stock at a price of $2.68 per unit (or $2.8425 per unit for units sold to affiliates of the Company). The warrants represent the right to acquire an aggregate of 3,343,325 shares of common stock at an exercise price of $3.62 per share and are exercisable between January 31, 2009 and July 31, 2013. The Company received net proceeds of approximately $17.5 million.
In connection with the sale of Units, the Company estimated the fair value attributable to the warrants of approximately $4.1 million as of the date of grant by applying the Black-Scholes pricing valuation model. The Black-Scholes pricing valuation model utilized the following assumptions: warrant issue date stock price of $2.52, expected volatility of 80.32%, expected term of 5.0 years, risk-free interest rate of 3.30%, and dividend yield of 0%. The fair value of the warrants was included in additional paid-in-capital on the Companys consolidated balance sheet.
Note 8 Stockholders Equity
On August 7, 2002, the Company adopted a Shareholder Rights Plan which provides for the issuance of rights to purchase shares of Series D Junior Participating Preferred Stock, par value $0.01 per share (the Preferred Shares), of the Company. Under the Shareholder Rights Plan, the Company distributed one preferred share purchase right (a Right) for each outstanding share of common stock of the Company. The Rights were distributed to stockholders of record on August 16, 2002.
Each Right entitles the holder to purchase from the Company one-thousandth of a Preferred Share at a price of $40, subject to adjustment. The Rights become exercisable, with certain exceptions, 10 business days after any party, without prior approval of the Board of Directors, acquires or announces an offer to acquire beneficial ownership of 15% or more of the Companys outstanding common stock. In the event that any party acquires 15% or more of the Companys outstanding common stock, the Company enters into a merger or other business combination, or if a substantial amount of the Companys assets are sold after the time that the
Rights become exercisable, the Rights provide that the holder will receive, upon exercise, shares of the common stock of the surviving or acquiring company, as applicable, having a market value of twice the exercise price of the Right.
The Rights expire August 7, 2012, and are redeemable by the Company at a price of $0.00025 per Right at any time prior to the time that any party acquires 15% or more of the Companys outstanding common stock. Until the earlier of the time that the Rights become exercisable, are redeemed or expire, the Company will issue one Right with each new share of common stock issued.
F-17
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 9 Stock-Based Compensation
The Company has granted equity awards under several plans. Under the 2005 Stock Incentive Plan (the 2005 Plan), approved in May 2005 and amended in June 2007 by the Companys stockholders, equity awards may be granted to officers, directors, employees, consultants and advisors to the Company and any present or future subsidiary to purchase a maximum of 5,565,724 shares of the Companys common stock. In addition, at the time of approval of the 2005 Plan, a maximum 5,746,468 shares of common stock subject to stock options outstanding under the Companys 1995 Stock Option Plan (the 1995 Plan) may revert to and
become issuable under the 2005 Plan, if such options should expire or otherwise terminate unexercised. Although the term of the 1995 Plan has expired, stock options previously granted under the 1995 Plan remain in existence in accordance with their terms. No new awards will be made under the 1995 Plan.
Under the 2005 Plan, the 1995 Plan and the 1995 Director Stock Option Plan (the 1995 Director Plan) incentive stock options, having a maximum term of 10 years, can be or were granted at no less than 100% of the fair market value of the Companys stock at the time of grant and are generally exercisable over periods ranging from six months to four years. There is no minimum exercise price for non-statutory stock options. The 1995 Director Plan has expired. Stock options previously granted under the 1995 Director Plan remain in existence in accordance with their terms. No new awards will be made under the 1995 Directors Plan.
The Company recorded stock-based compensation expense in the consolidated statement of operation as follows (in thousands):
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
2009
|
|
2008
|
|
2007
|
Research and development
|
|
$
|
539
|
|
|
$
|
750
|
|
|
$
|
608
|
|
General and administrative
|
|
|
994
|
|
|
|
1,064
|
|
|
|
737
|
|
Total stock-based compensation expenses
|
|
$
|
1,533
|
|
|
$
|
1,814
|
|
|
$
|
1,345
|
|
F-18
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 9 Stock-Based Compensation (continued)
Stock Options Awards
The following is a summary of option activity under the 2005 Plan, the 1995 Plan and the 1995 Director Plan for the year ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 Stock Incentive Plan
|
|
1995 Stock Option Plan
|
|
1995 Director Stock Option Plan
|
|
|
Stock
Options
|
|
Weighted-
Average
Exercise
Price
|
|
Stock
Options
|
|
Weighted-
Average
Exercise
Price
|
|
Stock
Options
|
|
Weighted-
Average
Exercise
Price
|
Outstanding at January 1, 2009
|
|
|
4,604,509
|
|
|
$
|
2.46
|
|
|
|
1,433,969
|
|
|
$
|
5.43
|
|
|
|
40,000
|
|
|
$
|
5.63
|
|
Granted
|
|
|
1,339,525
|
|
|
$
|
1.99
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
Exercised
|
|
|
(541,832
|
)
|
|
$
|
1.72
|
|
|
|
(5,000
|
)
|
|
$
|
4.28
|
|
|
|
|
|
|
$
|
|
|
Canceled
|
|
|
(523,527
|
)
|
|
$
|
2.70
|
|
|
|
(342,650
|
)
|
|
$
|
4.45
|
|
|
|
(10,000
|
)
|
|
$
|
5.63
|
|
Outstanding at December 31, 2009
|
|
|
4,878,675
|
|
|
$
|
2.38
|
|
|
|
1,086,319
|
|
|
$
|
5.72
|
|
|
|
30,000
|
|
|
$
|
5.63
|
|
Vested and expected to vest at December 31, 2009
|
|
|
4,471,134
|
|
|
$
|
2.38
|
|
|
|
1,086,319
|
|
|
$
|
5.72
|
|
|
|
30,000
|
|
|
$
|
5.63
|
|
Shares exercisable at December 31, 2009
|
|
|
2,594,887
|
|
|
$
|
2.38
|
|
|
|
1,086,319
|
|
|
$
|
5.72
|
|
|
|
30,000
|
|
|
$
|
5.63
|
|
Shares available for grant at December 31, 2009
|
|
|
2,712,580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of the stock options granted for the years ended December 31, 2009, 2008 and 2007, was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
Weighted average fair value of options granted
|
|
|
$1.29
|
|
|
|
$1.59
|
|
|
|
$1.76
|
|
Risk-free interest rate
|
|
|
1.56% 3.19%
|
|
|
|
1.97% 3.29%
|
|
|
|
3.93% 4.62%
|
|
Dividend yield
|
|
|
0%
|
|
|
|
0%
|
|
|
|
0%
|
|
Volatility
|
|
|
85.68 119.53%
|
|
|
|
81.14% 87.78%
|
|
|
|
86.11% 93.80%
|
|
Expected life (in years)
|
|
|
3.89 7.05
|
|
|
|
3.62 6.37
|
|
|
|
4.03 5.94
|
|
Expected forfeiture rate
|
|
|
21.07%
|
|
|
|
21.96%
|
|
|
|
20.34%
|
|
The aggregate intrinsic value and weighted-average remaining contractual term of stock options exercisable as of December 31, 2009 was approximately $1.8 million and 5.1 years, respectively. The aggregate intrinsic value and weighted-average remaining contractual term of options vested and expected to vest as of December 31, 2009 was $3.0 million and 6.5 years, respectively. The aggregate intrinsic value represents the total intrinsic value (the difference between the Companys closing stock price on the last trading day of 2009 and the exercise price, multiplied by the number of in-the-money options) that would have been received by
F-19
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 9 Stock-Based Compensation (continued)
the option holders had all option holders exercised their options on December 31, 2009. This amount is subject to change based on changes to the fair market value of the Companys common stock. The aggregate intrinsic value of options exercised for 2009, 2008 and 2007 was $0.9 million, $0.1 million and $40,000, respectively.
Restricted Stock Awards
Under the 2005 Plan, the Company granted restricted stock awards subject to certain performance- or time-based vesting conditions which, if not met, would result in forfeiture of the shares and reversal of any previously recognized related stock-based compensation expense.
The following is a summary of restricted stock awards activity for the year ended December 31, 2009:
|
|
|
|
|
|
|
Number of
Shares
|
|
Per Share
Weighted-
Average
Grant-Date
Fair Value
|
Outstanding at January 1, 2009
|
|
|
148,332
|
|
|
$
|
3.07
|
|
Restricted stock granted
|
|
|
10,000
|
|
|
$
|
5.21
|
|
Restricted stock vested
|
|
|
(68,332
|
)
|
|
$
|
3.46
|
|
Restricted stock forfeited
|
|
|
|
|
|
$
|
0.00
|
|
Outstanding at December 31, 2009
|
|
|
90,000
|
|
|
$
|
3.04
|
|
As of December 31, 2009, there was approximately $2.0 million of total unrecognized compensation expense (net of estimated forfeitures) related to unvested options and restricted stock awards. This unrecognized compensation expense is expected to be recognized over a weighted average period of 1.4 years.
Note 10 Employee Benefits
The Company maintains a defined contribution 401(k) retirement plan, pursuant to which employees who have completed 90 days of service may elect to contribute up to 15% of their compensation on a tax deferred basis up to the maximum amount permitted by the Internal Revenue Code of 1986, as amended.
The Company currently matches 25% of the first 6% of the participants deferral. Contributions to the 401(k) plan vest equally over a three-year period. The Company has expensed, net of forfeitures, approximately $37,000, $77,000 and $59,000 in 2009, 2008 and 2007, respectively.
Note 11 Discontinued Operations
In February 2008, the Company sold certain assets used in the production of Estrasorb, an estrogen product currently licensed by Graceway Pharmaceuticals, LLC (Graceway), to Graceway. In connection with the sale, the Company agreed to manufacture and supply additional units of Estrasorb for Graceway, which the Company completed and exited the facility in August 2008. The Company received an upfront payment from Graceway upon the execution of the transaction agreements. As part of the transaction, once the Company satisfied its supply obligations, the Company transferred to Graceway manufacturing equipment related to the production of
Estrasorb, valued at $1.1 million on the closing date, which had been included as assets held for sale in the Companys consolidated balance sheet.
F-20
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 11 Discontinued Operations (continued)
Due to the operations and cash flows of the Estrasorb business being eliminated from continuing operations of the Company, and the fact that the Company does not have any significant continuing involvement in the business, the operations of the Estrasorb business have been classified as discontinued operations for the years ended December 31, 2008 and 2007. Summarized operating results from the discontinued operations included in the Companys consolidated statements of operations are as follows (in thousands):
|
|
|
|
|
|
|
2008
|
|
2007
|
Revenue
|
|
$
|
3,776
|
|
|
$
|
1,913
|
|
Income (loss) from discontinue operations
|
|
$
|
273
|
|
|
$
|
(6,175
|
)
|
The assets and liabilities of the discontinued operations in the Companys consolidated balance sheet are as follows as of December 31 (in thousands):
|
|
|
|
|
2008
|
Prepaid expenses and other current assets
|
|
$
|
132
|
|
Current assets of discontinued operations
|
|
$
|
132
|
|
Accounts payable
|
|
$
|
209
|
|
Accrued expenses and other current liabilities
|
|
|
33
|
|
Current liabilities of discontinued operations
|
|
$
|
242
|
|
Note 12 Income Taxes
The Company incurred a current tax liability for foreign and state income taxes of approximately $92,000 and $0 for the years ended December 31, 2009 and 2008, respectively. There is no deferred provision as the deferred tax asset has been entirely offset by a valuation allowance.
The components of the income tax provision (benefit) are as follows (in thousands):
|
|
|
|
|
|
|
2009
|
|
2008
|
Current
|
|
$
|
92
|
|
|
$
|
|
|
Deferred
|
|
|
|
|
|
|
|
|
Net provision
|
|
$
|
92
|
|
|
$
|
|
|
Deferred tax assets (liabilities) consist of the following at December 31 (in thousands):
|
|
|
|
|
|
|
2009
|
|
2008
|
Net operating losses
|
|
$
|
87,698
|
|
|
$
|
73,585
|
|
Research tax credits
|
|
|
3,880
|
|
|
|
3,278
|
|
Other
|
|
|
3,539
|
|
|
|
4,648
|
|
Total deferred tax assets
|
|
|
95,117
|
|
|
|
81,511
|
|
Other
|
|
|
(264
|
)
|
|
|
(712
|
)
|
Total deferred tax liabilities
|
|
|
(264
|
)
|
|
|
(712
|
)
|
Net deferred tax assets
|
|
|
94,853
|
|
|
|
80,799
|
|
Less valuation allowance
|
|
|
(94,853
|
)
|
|
|
(80,799
|
)
|
Deferred tax assets, net
|
|
$
|
|
|
|
$
|
|
|
F-21
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 12 Income Taxes (continued)
The differences between the United States federal statutory tax rate and the Companys effective tax rate are as follows:
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
Statutory federal tax rate
|
|
|
(34
|
)%
|
|
|
(34
|
)%
|
|
|
(34
|
)%
|
State income taxes, net of federal benefit
|
|
|
|
%
|
|
|
(6
|
)%
|
|
|
(7
|
)%
|
Research and development credit
|
|
|
(1
|
)%
|
|
|
(1
|
)%
|
|
|
|
%
|
Other
|
|
|
(4
|
)%
|
|
|
|
%
|
|
|
1
|
%
|
Change in valuation allowance
|
|
|
39
|
%
|
|
|
41
|
%
|
|
|
40
|
%
|
|
|
|
|
%
|
|
|
|
%
|
|
|
|
%
|
Realization of net deferred tax assets is dependent on the Companys ability to generate future taxable income, which is uncertain. Accordingly, a full valuation allowance was recorded against these assets as of December 31, 2009 and 2008 as management believes it is more likely than not that the assets will not be realizable.
As of December 31, 2009, the Company had tax return reported federal net operating losses and tax credits available as follows (in thousands):
|
|
|
|
|
Amount
|
Federal net operating losses expiring through the year 2029
|
|
$
|
237,569
|
|
Research tax credits expiring through the year 2029
|
|
|
4,576
|
|
Alternative-minimum tax credit (no expiration)
|
|
|
94
|
|
Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended, and similar state provisions. The Company has not performed a detailed analysis to determine whether an ownership change under Section 382 of the Internal Revenue Code occurred. The effect of an ownership change would be the imposition of an annual limitation on the use of net operating loss carryforwards and credits attributable to periods before the change and could result in a reduction in the total net operating losses and credits
available.
Beginning in 2006, the windfall equity-based compensation deductions are tracked off balance sheet in conformity with ASC 360. During 2009, 2008 and 2007, the Company recorded $0.5 million, $0.2 million and $0.4 million, respectively, of windfall stock compensation deductions that are being tracked off balance sheet. If and when realized, the tax benefit associated with these deductions will be credited to additional paid-in capital. These excess benefit deductions are included in the total Federal net operating losses disclosed above.
F-22
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 12 Income Taxes (continued)
Tabular Reconciliation of Unrecognized Tax Benefits (in thousands):
|
|
|
|
|
Amount
|
Balance as of January 1, 2008
|
|
$
|
6,113
|
|
Gross increases tax positions in prior period
|
|
|
|
|
Gross decreases tax position in prior period
|
|
|
(193
|
)
|
Gross increases current-period tax positions
|
|
|
619
|
|
Increases (decreases) from settlements
|
|
|
|
|
Unrecognized tax benefits as of December 31, 2008
|
|
$
|
6,539
|
|
Gross increases tax positions in prior period
|
|
|
|
|
Gross decreases tax position in prior period
|
|
|
(2,105
|
)
|
Gross increases current-period tax positions
|
|
|
425
|
|
Increases (decreases) from settlements
|
|
|
|
|
Unrecognized tax benefits as of December 31, 2009
|
|
$
|
4,859
|
|
To the extent these unrecognized tax benefits are ultimately recognized, it would affect the annual effective income tax rate.
The Company and its subsidiary file income tax returns in the United States federal jurisdiction and in various states. The Company had tax net operating losses and credits carryforwards that are subject to examination for a number of years beyond the year in which they are generated for tax purposes. Since a portion of these carryforwards may be utilized in the future, many of these attribute carryforwards remain subject to examination.
The Companys policy is to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2009 and December 31, 2008, the Company had no accruals for interest or penalties related to income tax matters.
Note 13 Commitments and Contingencies
Operating Leases
The Company conducts its operations from a leased facility, under an operating lease with a term expiring in 2017, in Rockville, Maryland. The lease obligates the Company to pay building operating costs. The Company also leased space in Malvern, Pennsylvania, its former corporate headquarters, under an operating lease with a term expiring in 2014. The Company has subleased this facility, under a sublease agreement expiring in 2011 and has granted the subtenant an option to renew the sublease for an additional three year term.
F-23
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 13 Commitments and Contingencies (continued)
Future minimum rental commitments under non-cancelable leases as of December 31, 2009 are as follows (in thousands):
|
|
|
|
|
|
|
Year
|
|
Operating
Leases
|
|
Sublease
|
|
Net Operating
Leases
|
2010
|
|
$
|
2,043
|
|
|
$
|
(339
|
)
|
|
$
|
1,704
|
|
2011
|
|
|
2,087
|
|
|
|
(259
|
)
|
|
|
1,828
|
|
2012
|
|
|
2,132
|
|
|
|
|
|
|
|
2,132
|
|
2013
|
|
|
2,179
|
|
|
|
|
|
|
|
2,179
|
|
2014
|
|
|
2,151
|
|
|
|
|
|
|
|
2,151
|
|
Thereafter
|
|
|
4,248
|
|
|
|
|
|
|
|
4,248
|
|
Total minimum lease payments
|
|
$
|
14,840
|
|
|
$
|
(598
|
)
|
|
$
|
14,242
|
|
Total rent expenses approximated $1.5 million, $2.7 million and $2.4 million for the years ended December 31, 2009, 2008 and 2007, respectively. Rent expense for the year ended December 31, 2008 includes an accrual of $0.4 million related to the exit of the Taft Court facility.
Purchase Obligations
On March 31, 2009, the Company and Cadila entered into a master services agreement (the Master Services Agreement) pursuant to which the Company may request services from Cadila in the areas of biologics research, pre-clinical development, clinical development, process development, manufacturing scale up and general manufacturing related services in India. If, at the third anniversary of the Master Services Agreement, the amount of services provided by Cadila is less than $7.5 million, the Company will pay Cadila the portion of the shortfall amount that is less than or equal to $2.0 million and 50% of the portion of the shortfall amount
that exceeds $2.0 million. When calculating the shortfall, the amount of services provided by Cadila includes amounts that have been paid under all project plans, the amounts that will be paid under ongoing executed project plans and amounts for services that had been offered to Cadila, that Cadila was capable of performing, but exercised its right not to accept such project. The term of the Master Services Agreement is five years, but may be terminated by either party if there is a material breach that is not cured within 30 days of notice or, at any time after three years, provided that 90 days prior notice is given to the other party. As of December 31, 2009, the Companys remaining obligation to Cadila under the Master Services Agreement is $7.4 million.
Contingencies
License Agreement With Wyeth Holdings Corporation
The Company entered into a license agreement in 2007 with Wyeth Holdings Corporation, a subsidiary of Wyeth (Wyeth). The license is a non-exclusive, worldwide license to a family of patent applications covering VLP technology for use in human vaccines in certain fields of use. The agreement provides for an upfront payment, annual license fees, milestone payments and royalties on any product sales. If each milestone is achieved for any particular product candidate, the Company would be obligated to pay an aggregate of $14.0 million to Wyeth for each product candidate developed and commercialized under the agreement. Annual license
maintenance fees under the agreement total $0.3 million per annum. The royalty to be paid by the Company under the agreement, if a product is approved by the FDA for commercialization, will be based on single digit percentage of net sales. Payments under the agreement to Wyeth as of December 31, 2009 aggregated $5.1 million. The agreement will remain effective as long as at least one claim of the licensed patent rights cover the manufacture, sale or use of any product unless terminated sooner at the Companys option or by Wyeth for an uncured breach by the Company.
F-24
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 13 Commitments and Contingencies (continued)
License Agreement With University of Massachusetts Medical School
The Company entered into an exclusive license agreement in 2007 with the University of Massachusetts (UMMS). The license is an exclusive, worldwide license of VLP technology to develop VLP vaccines for the prevention of any viral diseases in humans. The agreement provides for an upfront payment, annual license fees, milestone payments and royalties on any product sales. Payments under the agreement as of December 31, 2009 were not material. The agreement will remain effective as long as at least one claim of the licensed patent rights cover the manufacture, sale or use of any product unless terminated sooner at the Companys option
or by either party for an uncured breach by the other party.
Supplies Provided by GE Healthcare Bio-Sciences Corp.
GE Healthcare Bio-Sciences Corp. (GE) has supplied the Company consumables free-of-charge that were to be used by Xcellerex in the manufacturing activities related to its 2009 H1N1 vaccine candidate. The Company has arranged to reimburse GE for such consumables if it receives funding for the development or manufacture or receives payment for the commercial sale or supply of the vaccine. At December 31, 2009, the Company has not recorded this contingent liability since neither event has occurred and the likelihood of occurrence is currently not determinable.
Note 14 Related Party Transactions
Dr. Rajiv Modi, a director of Novavax, is also a managing director of Cadila Pharmaceuticals Ltd. The Company and Cadila have formed a joint venture called CPL Biologicals Private Limited, of which the Company owns 20%. The Company and Cadila have also entered into a Master Services Agreement, pursuant to which Cadila may perform certain research, development and manufacturing services for the Company up to $7.5 million. A subsidiary of Cadila owns 12.5 million shares of the Companys outstanding common stock. During the year ended December 31, 2009, the Company incurred $0.1 million related to the Master Services Agreement.
Mr. John Lambert, the Companys former Executive Chairman of the Board of Directors, had a consulting agreement with the Company, pursuant to which he assisted the Company with issues regarding the development and commercialization of its vaccine product candidates. His annual compensation for these services was $220,000. The Company also pays Mr. Lambert $30,000 annually for his service as a board member and also has granted him equity awards. For the years ended December 31, 2009, 2008 and 2007, the Company recorded consulting expenses of $220,000, $220,000 and $180,000, respectively, in accordance with the consulting agreement. On March 8,
2010, Mr. Lamberts consulting agreement expired by its terms.
On February 15, 2010, the Board of Directors elected Mr. Stanley Erck as its new Executive Chairman. Mr. Erck will be paid a salary of $300,000 per annum and has been granted equity awards.
Two of the Companys former directors have outstanding notes due to the Company in the aggregate principal amount of $1,572,000, as reflected on the Companys balance sheet as of December 31, 2009. The notes, in the initial principal amount of $1,479,268, were initially delivered by the former directors to the Company in March 2002 as payment of the exercise price of options. In May 2008, one of the Notes was amended and restated to, among other things, include accrued interest in the principal amount, bringing the aggregate principal amount outstanding to $1,610,516. As of December 31, 2009, the Company received payments of $65,000. As
security, the former directors pledged shares of the Companys common stock as collateral. The Company has the right to sell the pledged shares. As of December 31, 2009, the outstanding principal and interest for these two notes was $2.0 million. The Company has not accrued interest due to collection concerns. Both notes are currently in default and the Company is pursuing the collection of these promissory notes.
F-25
TABLE OF CONTENTS
NOVAVAX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2009, 2008 and 2007
Note 15 Quarterly Financial Information (Unaudited)
The Companys unaudited quarterly information for the years ended December 31, 2009 and 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
|
|
(In Thousands, Except per Share Data)
|
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
21
|
|
|
$
|
29
|
|
|
$
|
201
|
|
|
$
|
75
|
|
Net loss
|
|
$
|
(8,349
|
)
|
|
$
|
(8,540
|
)
|
|
$
|
(7,530
|
)
|
|
$
|
(13,955
|
)
|
Net loss per share
|
|
$
|
(0.12
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.15
|
)
|
2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
458
|
|
|
$
|
342
|
|
|
$
|
194
|
|
|
$
|
70
|
|
Loss from continuing operations
|
|
|
(7,103
|
)
|
|
|
(8,314
|
)
|
|
|
(10,330
|
)
|
|
|
(10,575
|
)
|
(Loss) income from discontinued operations
|
|
|
(652
|
)
|
|
|
(1,058
|
)
|
|
|
2,488
|
|
|
|
(505
|
)
|
Net loss
|
|
$
|
(7,755
|
)
|
|
$
|
(9,372
|
)
|
|
$
|
(7,842
|
)
|
|
$
|
(11,080
|
)
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(0.12
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.11
|
)
|
(Loss) income from discontinued operations
|
|
|
(0.01
|
)
|
|
|
(0.01
|
)
|
|
|
0.04
|
|
|
|
(0.04
|
)
|
Net loss per share
|
|
$
|
(0.13
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.15
|
)
|
The net income (loss) per share was calculated for each three-month period on a stand-alone basis. As a result, the sum of the net income (loss) per share for the four quarters does not equal the net income (loss) per share for the respective twelve-month period.
F-26
AMENDED
AND RESTATED GENERAL RELEASE OF CLAIMS AND RESTRICTIVE COVENANTS
AGREEMENT
THIS AMENDED AND RESTATED GENERAL
RELEASE OF CLAIMS AND RESTRICTIVE COVENANTS AGREEMENT (Agreement)
is made
and entered into by James M. Robinson (Employee), in consideration of the
promises and mutual covenants contained herein, and in the severance offer from
Novavax, Inc. (Employer) to Employee by memorandum dated January 25,
2010.
WHEREAS
, Employer employs
Employee as its Vice President, Technical Quality and Operations;
and
WHEREAS
, Employer and Employee
will terminate their employment relationship as of January 11,
2010.
NOW THEREFORE
, in
consideration of the mutual promises set forth herein and in the January 25,
2010 memorandum, Employee agrees as follows:
1.
Consideration
.
I am entering
into this Agreement in consideration of the offer of Employer to me severance of
$95,000 (minus all appropriate withholdings and deductions) and $10,155.64,
which represents all accrued but unused vacation time through January 11, 2010,
as well as other good and valuable consideration. The severance offer
and this General Release of Claims and Restrictive Covenants constitute the
“Agreement.” I hereby accept the severance offer and agree to be
bound by this Agreement.
2.
General
Release of Claims
.
I, for myself and
my heirs, executors, administrators, assigns, agents and beneficiaries, if any,
do hereby agree to execute and be bound by this General Release of
Claims. I waive, release, and forever discharge
Employer
(as defined
below) of and from any and all
Claims
(as defined
below) arising from the beginning of time up to and including the date of this
Agreement. I agree not to file a lawsuit or arbitration to assert any
such Claim. Further, I agree that should any other person,
organization or entity file a lawsuit or arbitration to assert any such Claim, I
will not seek or accept any personal relief in such action.
Exclusions
:
Notwithstanding
any other provision of this release, the following are
not
barred by the release: (a) Claims relating to the validity of this
Agreement; (b) Claims by either party to enforce this Agreement; (c) Claims
which legally may not be waived. In addition, this General Release of
Claims will not operate to limit or bar my right to file an administrative
charge of discrimination with the Equal Employment Opportunity Commission (EEOC)
and to participate in an investigation by the EEOC, although the General Release
of Claims does bar my right to recover any personal relief if I or anyone on my
behalf seeks to file a subsequent lawsuit or arbitration on the same basis as
the charge of discrimination.
The
following provisions further explain this General Release of Claims and promise
not to sue:
(a)
Definition
of “Claims
.”
Except as stated above, “Claims” includes without limitation all actions
or demands of any kind that I now have, or may have or claim to have in the
future. More specifically, Claims include rights, causes of action,
damages, penalties, losses, attorneys’ fees, costs, expenses, obligations,
agreements, judgments and all other liabilities of any kind or description
whatsoever, either in law or in equity, whether known or unknown, suspected or
unsuspected.
The
nature of Claims covered by this General Release of Claims and promise not to
sue includes without limitation all actions or demands in any way based on my
employment with Employer, the terms and conditions of such employment or my
separation from employment. More specifically, all of the following
are among the types of Claims which are waived and barred by this General
Release of Claims to the extent allowable under applicable law:
|
·
|
Contract
Claims, whether express or implied;
|
|
·
|
Tort
Claims, such as for defamation or emotional
distress;
|
|
·
|
Claims
under federal, state and municipal laws, regulations, ordinance or court
decisions of any kind including, but not limited to any action, under the
Maryland Wage Payment and Collection law as codified at Ann. Code. Md.
Labor and Employment, 3-501
et
seq
.;
|
|
·
|
Claims
of discrimination, harassment or retaliation, whether based on race,
color, religion, gender, sex, age, sexual orientation, handicap and/or
disability, national origin, whistleblowing or any other legally protected
class;
|
|
·
|
Claims
under the Age Discrimination in Employment Act, Title VII of the Civil
Rights Act of 1964, as amended, the Americans with Disabilities Act, the
Family and Medical Leave Act, and similar state and local statutes, laws
and ordinances;
|
|
·
|
Claims
under the Employee Retirement Income Security Act, the Occupational Safety
and Health Act, the False Claims Act, and similar state and local
statutes, laws and ordinances;
|
|
·
|
Claims
for wrongful discharge; and
|
|
·
|
Claims
for attorneys’ fees, including litigation expenses and/or
costs.
|
The
foregoing description of claims is intended to be illustrative and is not
exhaustive.
(b)
Definition
of “Employer
.”
“Employer” includes without limitation Novavax, Inc. and its respective
past, present and future parents, owners, affiliates, subsidiaries, divisions,
predecessors, successors, assigns, employee benefit plans and trusts, if
any. It also includes all past, present and future managers, members,
principals, directors, officers, partners, agents, employees (except James M.
Robinson), attorneys, representatives, consultants, associates, fiduciaries,
plan sponsors, administrators and trustees of each of the
foregoing.
3.
Restrictive
Covenants
(a)
All
Business to be Property of the Employer; Assignment of Intellectual
Property.
(i)
Employee
agrees that any and all presently existing business of the Employer and all
business developed by him or any other employee of the Employer including
without limitation all contracts, fees, commissions, compensation, records,
customer or client lists, agreements and any other incident of any business
developed, earned or carried on by Employee for the Employer is and shall be the
exclusive property of the Employer, and (where applicable) shall be payable
directly to the Employer.
(ii)
Employee
hereby acknowledges that any plan, method, data, know-how, research,
information, procedure, development, invention, improvement, modification,
discovery, design, process, software and work of authorship, documentation,
formula, technique, trade secret or intellectual property right whatsoever or
any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor (herein sometimes collectively referred to as
“Intellectual Property”) made, conceived, created, invested, developed, reduced
to practice and/or acquired by Employee solely or jointly with others is the
sole and exclusive property of the Employer, as work for hire, and that he has
no personal right in any such Intellectual Property. Employee hereby
grants to the Employer his entire right, title and interest throughout the world
in and to, all Intellectual Property, which was made, conceived, created,
invested, developed, reduced to practice and/or acquired by him solely or
jointly with others during his employment.
(iii)
Employee
shall cooperate fully with the Employer with respect to the procurement,
maintenance and enforcement of copyrights, patents and other intellectual
property rights (both in the United States and foreign countries) relating to
Intellectual Property. Without limiting the foregoing, Employee
agrees that to the extent copyrightable, any such original works of authorship
shall be deemed to be "works for hire" and that the Employer shall be deemed the
author thereof under the U.S. Copyright Act, provided that in the event and to
the extent such works are determined not to constitute "works for hire" as a
matter of law, Employee hereby irrevocably assigns and transfers to the Employer
all right, title and interest in such works, including but not limited to
copyrights thereof. Employee shall sign all papers, including,
without limitation, copyright applications, patent applications, declarations,
oaths, formal assignments, assignments of priority rights and powers of
attorney, which the Employer may deem necessary or desirable in order to protect
its rights and interests in any Intellectual Property (at the Employer’s
expense) and agrees that these obligations are binding upon his assigns,
executors, administrators and other legal representatives. To that
end, Employee shall provide current contact information to the Employer
including, but not limited to, home address, telephone number and email address,
and shall update his contact information whenever necessary.
(b)
Confidentiality
. Employee
acknowledges his obligation of confidentiality with respect to all proprietary,
confidential and non-public information of the Employer, including all
Intellectual Property. By way of illustration, but not limitation,
confidential and proprietary information shall be deemed to include any plan,
method, data, know-how, research, information, procedure, development,
invention, improvement, modification, discovery, process, work of authorship,
documentation, formula, technique, product, idea, concept, design, drawing,
specification, technique, trade secret or intellectual property right whatsoever
or any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor, personnel data, records, marketing techniques and
materials, marketing and development plans, customer names and other information
related to customers, including prospective customers and contacts at customers,
price lists, pricing policies and supplier lists of the Employer, in each case
coming into Employee’s possession during his employment, to which Employee had
access, or which Employee discovered or developed (whether or not related to the
business of the Employer at the time this Agreement is signed or any information
Employee originatee, discovered or developed, in whole or in part) as a result
of Employee’s employment by the Employer. Employee shall not for a
period of ten (10) years, use for any purpose disclose to any person whether
Employee has such information in his memory or such information is embodied in
writing, electronic or other tangible form.
All
originals and copies of any of the foregoing, however and whenever produced,
shall be the sole property of the Employer. All files, letters,
memoranda, reports, records, data, sketches, drawings, program listings, or
other written, photographic, or other tangible or electronic material containing
confidential or proprietary information or Intellectual Property, whether
created by Employee or others, which has come into Employee’s custody or
possession, shall be and are the exclusive property of the
Employer. All electronic material containing confidential or
proprietary information or Intellectual Property supplied to Employee by the
Employer will be promptly delivered to the Employer and/or a person or entity
identified by the Employer all such materials or copies of such materials and
all tangible property of the Employer in Employee’s custody or
possession. After such delivery, Employee will not retain any such
materials or copies or any such tangible property or any summaries or memoranda
regarding same.
(c)
Non-Competition
Covenant
.
Employee
agrees and warrants that, he will not, directly or indirectly, during the
Non-Competition Period, as defined below, own, operate, join, control,
participate in, or be connected as an officer, director, employee, partner,
stockholder, consultant or otherwise, with any business or entity which competes
with the business of the Employer (or its successors or assigns) as such
business is now constituted or as it may be constituted at any time during the
Non-Competition Period. The “Non-Competition Period” shall be a
period of
six
months
following termination of employment.
Employee
and the Employer are of the belief that the period of time and the area herein
specified are reasonable in view of the nature of the business in which the
Employer is engaged and proposes to engage, the state of its business
development and Employee’s knowledge of this business.
(d)
Non-Solicitation
Agreement
. Employee agrees and covenants that he will not,
directly or indirectly, during the Non-Competition Period (as defined in Section
c above) solicit, entice or attempt to entice away or interfere in any manner
with the Employer’s relationships or proposed relationships with any customer,
officer, employee, consultant, proposed customer, vendor, supplier, proposed
vendor or supplier or person or entity or person providing or proposed to
provide research and/or development services to, on behalf of or with the
Employer.
4.
Consideration
Period
.
I acknowledge
that I have carefully read and I understand the provisions of this
Agreement. I have been provided with a consideration period
consisting of at least twenty-one (21) calendar
days to consider the
terms of this Agreement from the date this Agreement first was presented to me
on January 25, 2010. I agree to notify Employer of my acceptance of
this Agreement by delivering a signed and notarized copy to Employer, addressed
to the attention of Jill Hoyt, Novavax, Inc., 9920 Belward Campus Drive,
Rockville, Maryland 20850 on or before February 1, 2010. I agree that
any change to this offer, whether material or immaterial, will not restart the
running of the consideration period.
I
understand that I may take the entire consideration period to consider this
Agreement. I acknowledge that if I sign and return this Agreement
before the end of the consideration period that I will have knowingly and
voluntarily waived my right to consider the Agreement for the full consideration
period and that I have executed this Agreement voluntarily and with full
knowledge of its significance, meaning and binding effect. I may
return this Agreement in less than the full consideration period only if my
decision to shorten it was knowing and voluntary and was not induced in any way
by Employer.
5.
Revocation
Period
.
I have seven (7)
calendar days from the date I sign this Agreement to revoke it if I choose to do
so. If I elect to revoke, I must give written notice of such
revocation to Employer by delivering it to Jill Hoyt, Novavax, Inc., 9920
Belward Campus Drive, Rockville, Maryland 20850 in such a manner that it is
actually received within the seven (7) calendar day period. I
understand that if I revoke this Agreement, I will not be entitled to the
benefits offered as consideration for this Agreement.
6.
Advice to
Consult Legal Representative
.
Employer
recommends that I consult with an attorney of my own choosing, at my own
expense, with regard to entering into this Agreement.
7.
Severability
.
I agree that if
any provision of this Agreement is or shall be declared invalid or unenforceable
by a court of competent jurisdiction, then such provision will be modified only
to the extent necessary to cure such invalidity, with a view to enforcing the
parties’ intention as set forth in this Agreement to the extent
permissible. All remaining provisions of this Agreement shall not be
affected thereby and shall remain in full force and effect.
8.
Choice of
Law
.
This Agreement
shall be governed by the laws of the State of Maryland, without giving effect to
choice of law principles of any state, except to the extent superseded by
federal law (e.g., ERISA).
9.
Employee
Certification - Validity of Agreement
.
I certify that I
have carefully read this Agreement and have executed it voluntarily and with
full knowledge and understanding of its significance, meaning and binding
effect. I further declare that I am competent to understand the
content and effect of this Agreement and that my decision to enter into this
Agreement has not been influenced in any way by fraud, duress, coercion, mistake
or misleading information. I have not relied on any information
except what is set forth in this Agreement.
10.
Effective
Date
.
I understand that
this Agreement shall not become effective or enforceable until the expiration of
the revocation period set forth above, provided that I do not elect to revoke
it.
11.
Effect
of Amendment.
For the convenience of the
parties this Amendment and Restatement uses the same language as the General
Release of Claims and Restrictive Covenants Agreement originally executed on
February 1, 2010. I understand and agree that the execution of this
Amended and Restated General Release of Claims and Restrictive Covenants
Agreement does not restart the running of the consideration period or the
revocation period as defined above in sections 4 and 5. I further
understand that there is no consideration or revocation period at the execution
of Amended and Restated General Release of Claims and Restrictive Covenants
Agreement
.
IN
WITNESS WHEREOF, and with the intention of being legally bound hereby, I have
executed this Agreement on the 11th day of March, 2010.
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/s/ James
M. Robinson
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James
M. Robinson
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Sworn to
and Subscribed Before Me
this 11th
day of March, 2010.
Exhibit
10.13
EMPLOYMENT
AGREEMENT
This
Employment Agreement (this “Agreement”) is dated as of
September 23, 2008
, between
Novavax, Inc., a Delaware corporation having its principal office at 9920
Belward Campus Drive, Rockville, MD 20850, and
Thomas S. Johnston,
an
individual with a mailing address of
18505 Cornflower Road, Boyds,
MD 20841
(“Executive”).
WHEREAS,
Executive commenced employment with the Company on March 5, 2007 pursuant to an
offer letter dated February 16, 2007; and
WHEREAS,
Executive and the Company wish to enter into a more formal contractual
relationship at this time.
The
Company and Executive hereby agree as follows:
1.
Employment
. The
Company hereby employs Executive and Executive hereby accepts employment as
Vice President, Strategy
upon the terms and conditions hereinafter set forth. As used
throughout this Agreement, “Company” shall mean and include any and all of its
present and future subsidiaries and any and all subsidiaries of a
subsidiary. Executive warrants and represents that he is free to
enter into and perform this Agreement and is not subject to any employment,
confidentiality, non-competition or other agreement which prohibits, restricts,
or would be breached by either his acceptance or his performance of this
Agreement.
2.
Duties
. During the
Term (as hereinafter defined), Executive shall devote his full business time to
the performance of services as
Vice President, Strategy
of
Novavax, Inc., performing such services, assuming such responsibilities and
exercising such authority as are set forth in the Bylaws of the Company for such
offices and assuming such other duties and responsibilities as prescribed by the
President and CEO and Board of Directors. During the Term,
Executive’s services shall be completely exclusive to the Company and he shall
devote his entire business time, attention and energies to the business of the
Company and the duties which the Company shall assign to him from time to
time. Executive agrees to perform his services faithfully and to the
best of his ability and to carry out the policies and directives of the
Company. Notwithstanding the foregoing, it shall not be a violation
of this Agreement for the Executive to serve as a director of any company whose
products do not compete with those of the Company and to serve as a director,
trustee, officer, or consultant to a charitable or non-profit entity; provided
that such service does not adversely affect Executive’s ability to perform his
obligations hereunder. Executive agrees to take no action which is in
bad faith and prejudicial to the interests of the Company during his employment
hereunder. Notwithstanding the location where Executive shall be
based, as set forth in this Agreement, he also may be required from time to time
to perform duties hereunder for reasonably short periods of time outside of said
area.
3.
Term
. The term of
this Agreement shall be for the period beginning on
October 2, 2008
and continuing
until
October 2, 2009
,
unless earlier terminated pursuant to Section 7 hereof (the “Term”) and shall be
renewable on the terms set forth herein upon agreement of the Company and
Executive of the term of such renewal and the initial base compensation
applicable to the renewal term. The parties acknowledge that the
employment hereunder is employment at will.
(a)
Base
Compensation
. For all Executive’s services and covenants under
this Agreement, the Company shall pay Executive an annual salary, which is
$
210,000
as of this
amendment and restatement, established by the Board of Directors or an
authorized committee thereof (in accordance with the management processes) and
payable in accordance with the Company’s payroll policy as constituted from time
to time. The Company may withhold from any amounts payable under this
Agreement all required federal, state, city or other taxes and all other
deductions as may be required pursuant to any law or government regulation or
ruling.
(b)
Bonus Program
. The
Company agrees to pay the Executive a performance and incentive bonus in respect
of Executive’s employment with the Company each year in an amount determined by
the President and CEO and Board of Directors (or any committee of the Board of
Directors authorized to make that determination) to be appropriate based upon
Executive’s, and the Company’s, achievement of certain specified goals, with a
target bonus of
40%
, or
any other percentage determined by the Board of Directors, of Executive’s base
salary during the year to which the bonus relates. Such bonus shall
be payable no later than two and one-half months following the year for which
the bonus applies. The bonus shall be paid out partly in cash and
partly in shares of restricted stock, in the discretion of the Board of
Directors.
(c)
Stock
Awards
. Executive will be eligible for additional stock awards
based upon performance subject to the approval of the President and Chief
Executive Officer and the Board of Directors.
5.
Reimbursable
Expenses
. Executive shall be entitled to reimbursement for
reasonable expenses incurred by him in connection with the performance of his
duties hereunder in accordance with such procedures and policies for executive
officers as the Company has heretofore or may hereafter
establish. The amount of expenses eligible for reimbursement during
any calendar year shall not affect the expenses eligible for reimbursement in
any other calendar year, and the reimbursement of an eligible expense shall be
made as soon as practicable after Executive submits the request for
reimbursement, but not later than December 31 following the calendar year in
which the expense was incurred.
6.
Benefits
. (a) Executive
shall be entitled to four weeks of paid vacation time per year starting from
April 1, 2008
,
calculated and administered in accordance with Company policies for executive
officers in effect from time to time. The Executive shall be entitled
to all other benefits associated with normal full time employment in accordance
with Company policies.
(b) Executive
shall be entitled to participate in the Company’s Change of Control Severance
Benefit Plan.
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7.
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Termination of
Employment
.
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(a) Notwithstanding
any other provision of this Agreement, Executive’s employment may be terminated,
without such action constituting a breach of this Agreement:
(i) By
the Company, for “Cause,” as defined in Section 7(b) below;
(ii) By
the Company, upon 30 days’ notice to Executive, if he should be prevented by
illness, accident or other disability (mental or physical) from discharging his
duties hereunder for one or more periods totaling three consecutive months
during any twelve-month period;
(iii) By
the Executive with “Good Reason”, as defined in Section 7(c) below, within 30
days of the occurrence or commencement of such Good Reason;
(iv) By
the event of Executive’s death during the Term.
(b) “Cause”
shall mean (i) Executive’s willful failure or refusal to perform in all material
respects the services required of him hereby, (ii) Executive’s willful failure
or refusal to carry out any proper and material direction by the President and
CEO or Board of Directors with respect to the services to be rendered by him
hereunder or the manner of rendering such services, (iii) Executive’s willful
misconduct in the performance of his duties hereunder, (iv) Executive’s
commission of an act of fraud, embezzlement or theft or a felony involving moral
turpitude, (v) Executive’s use or disclosure of Confidential Information (as
defined in Section 10 of this Agreement), other than for the benefit of the
Company in the course of rendering services to the Company or (vi) Executive’s
engagement in any activity prohibited by Section 11 of this
Agreement. For purposes of this Section 7, the Company shall be
required to provide Executive a specific written warning with regard to any
occurrence of subsections (b)(i), (ii) and (iii) above, which warning shall
include a statement of corrective actions and a 30 day period for the Executive
to respond to and implement such actions, prior to any termination of employment
by the Company pursuant to Section 7(a)(i) above.
(c) “Good
Reason” shall mean the Company’s material reduction or diminution of Executive’s
responsibilities and authority, other than for Cause, without his
consent.
8.
Separation
Pay
. (a) Subject to Executive’s execution and
delivery to the company of the Company’s standard form of Separation and Release
Agreement, the Company shall pay Executive an amount equal to the Separation Pay
upon the occurrence of the applicable Separation Event but in no case later than
two and one-half months following the year in which the Separation Event
occurs. Separation Pay shall each be payable in accordance with the
Company’s payroll policy as constituted from time to time, and shall be subject
to withholding of all applicable federal, state and local taxes and any other
deductions required by applicable law. In the event of Executive’s
death, the Company’s obligation to pay further compensation hereunder shall
cease forthwith, except that Executive’s legal representative shall be entitled
to receive his fixed compensation for the period up to the last day of the month
in which such death shall have occurred.
(b) Section
8(a) above shall not apply should Executive receive severance benefits under the
Company’s Change in Control Severance Benefit Plan.
9.
“Separation Pay” shall mean a lump sum amount equal to
six
months of Executive’s then
effective salary.
(a) “Separation
Event” shall mean:
(i) the
Company’s termination of Executive’s employment by the Company without Cause,
during the Term; or (ii) the termination of Executive’s employment by the
Executive for Good Reason.
10.
All Business to be Property of the
Company; Assignment of Intellectual Property
.
(a) Executive
agrees that any and all presently existing business of the Company and all
business developed by him or any other employee of the Company including without
limitation all contracts, fees, commissions, compensation, records, customer or
client lists, agreements and any other incident of any business developed,
earned or carried on by Executive for the Company is and shall be the exclusive
property of the Company, and (where applicable) shall be payable directly to the
Company.
(b) Executive
hereby acknowledges that any plan, method, data, know-how, research,
information, procedure, development, invention, improvement, modification,
discovery, design, process, software and work of authorship, documentation,
formula, technique, trade secret or intellectual property right whatsoever or
any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor (herein sometimes collectively referred to as
“Intellectual Property”) made, conceived, created, invested, developed, reduced
to practice and/or acquired by Executive solely or jointly with others during
the Term is the sole and exclusive property of the Company, as work for hire,
and that he has no personal right in any such Intellectual
Property. Executive hereby grants to the Company (without any
separate remuneration or compensation other than that received by him from time
to time in the course of his employment) his entire right, title and interest
throughout the world in and to, all Intellectual Property, which is made,
conceived, created, invested, developed, reduced to practice and/or acquired by
him solely or jointly with others during the Term.
(c) Executive
shall cooperate fully with the Company, both during and after his employment
with or engagement by the Company, with respect to the procurement, maintenance
and enforcement of copyrights, patents and other intellectual property rights
(both in the United States and foreign countries) relating to Intellectual
Property. Without limiting the foregoing, Executive agrees that to
the extent copyrightable, any such original works of authorship shall be deemed
to be "works for hire" and that the Company shall be deemed the author thereof
under the U.S. Copyright Act, provided that in the event and to the extent such
works are determined not to constitute "works for hire" as a matter of law,
Executive hereby irrevocably assigns and transfers to the Company all right,
title and interest in such works, including but not limited to copyrights
thereof. Executive shall sign all papers, including, without
limitation, copyright applications, patent applications, declarations, oaths,
formal assignments, assignments of priority rights and powers of attorney, which
the Company may deem necessary or desirable in order to protect its rights and
interests in any Intellectual Property (at the Company’s expense) and agrees
that these obligations are binding upon his assigns, executors, administrators
and other legal representatives. To that end, Executive shall provide
current contact information to the Company including, but not limited to, home
address, telephone number and email address, and shall update his contact
information whenever necessary.
11.
Confidentiality
. Executive
acknowledges his obligation of confidentiality with respect to all proprietary,
confidential and non-public information of the Company, including all
Intellectual Property. By way of illustration, but not limitation,
confidential and proprietary information shall be deemed to include any plan,
method, data, know-how, research, information, procedure, development,
invention, improvement, modification, discovery, process, work of authorship,
documentation, formula, technique, product, idea, concept, design, drawing,
specification, technique, trade secret or intellectual property right whatsoever
or any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor, personnel data, records, marketing techniques and
materials, marketing and development plans, customer names and other information
related to customers, including prospective customers and contacts at customers,
price lists, pricing policies and supplier lists of the Company, in each case
coming into Executive’s possession, or which Executive learns, or to which
Executive has access, or which Executive may discover or develop (whether or not
related to the business of the Company at the time this Agreement is signed or
any information Executive originates, discovers or develops, in whole or in
part) as a result of Executive’s employment by (either full-time or part-time),
or retention as a consultant of, the Company. Executive shall not,
either during the Term or for a period of ten (10) years thereafter, use for any
purpose other than the furtherance of the Company’s business, or disclose to any
person other than a person with a need to know such confidential, proprietary or
non-public information for the furtherance of the Company’s business who is
obligated to maintain the confidentiality of such information, any information
concerning any Intellectual Property, or other confidential, proprietary or
non-public information of the Company, whether Executive has such information in
his memory or such information is embodied in writing, electronic or other
tangible form.
All
originals and copies of any of the foregoing, however and whenever produced,
shall be the sole property of the Company. All files, letters,
memoranda, reports, records, data, sketches, drawings, program listings, or
other written, photographic, or other tangible or electronic material containing
confidential or proprietary information or Intellectual Property, whether
created by me or others, which shall come into Executive’s custody or
possession, shall be and are the exclusive property of the Company to be used by
Executive only in the performance of his duties for the Company. All
electronic material containing confidential or proprietary information or
Intellectual Property will be stored on a computer supplied to Executive by the
Company and, under no circumstances, will it be transferred to a personal
computer. Executive will promptly deliver to the Company and/or a
person or entity identified by the Company all such materials or copies of such
materials and all tangible property of the Company in Executive’s custody or
possession, upon the earlier of (i) a request by the Company or (ii) termination
of employment or engagement by the Company. After such delivery,
Executive will not retain any such materials or copies or any such tangible
property or any summaries or memoranda regarding same.
12.
Non-Competition
Covenant
. As the Executive has been granted options to
purchase stock in the Company and as such has a financial interest in the
success of the Company’s business and as Executive recognizes that the Company
would be substantially injured by Executive competing with the Company,
Executive agrees and warrants that within the United States, he will not, unless
acting with the Company’s express prior written consent, directly or indirectly,
while an employee of the Company and during the Non-Competition Period, as
defined below, own, operate, join, control, participate in, or be connected as
an officer, director, employee, partner, stockholder, consultant or otherwise,
with any business or entity which competes with the business of the Company (or
its successors or assigns) as such business is now constituted or as it may be
constituted at any time during the Term of this Agreement; provided, however,
that Executive may own, and exercise rights with respect to, less than one
percent of the equity of a publicly traded company. The
“Non-Competition Period” shall be a period of
six
months following
termination of employment.
Executive
and the Company are of the belief that the period of time and the area herein
specified are reasonable in view of the nature of the business in which the
Company is engaged and proposes to engage, the state of its business development
and Executive’s knowledge of this business; however, if such period or such area
should be adjudged unreasonable in any judicial proceeding, then the period of
time shall be reduced by such number of months or such area shall be reduced by
elimination of such portion of such area, or both, as are deemed unreasonable,
so that this covenant may be enforced in such area and during such period of
time as is adjudged to be reasonable.
13.
Non-Solicitation
Agreement
. Executive agrees and covenants that he will not,
unless acting with the Company’s express written consent, directly or
indirectly, during the Term of this Agreement or during the Non-Competition
Period (as defined in Section 12 above) solicit, entice or attempt to entice
away or interfere in any manner with the Company’s relationships or proposed
relationships with any customer, officer, employee, consultant, proposed
customer, vendor, supplier, proposed vendor or supplier or person or entity or
person providing or proposed to provide research and/or development services to,
on behalf of or with the Company.
14.
Notices
. All
notices and other communications hereunder shall be in writing and shall be
deemed to have been given on actual receipt after having been delivered by hand,
mailed by first class mail, postage prepaid, or sent by Federal Express or
similar overnight delivery services, as follows: (a) if to Executive, at the
address shown at the head of this Agreement, or to such other person(s) or
address(es) as Executive shall have furnished to the Company in writing and, if
to the Company, to it at the address set forth in the preamble hereto with a
copy to Jennifer L. Miller, Esq., Ballard Spahr Andrews & Ingersoll, LLP,
1735 Market Street, 51
st
Floor,
Philadelphia, Pennsylvania 19103, or to such other person(s) or address(es) as
the Company shall have furnished to Executive in writing.
15.
Assignability
. In
the event of a change of control (as defined in the Company’s Change of Control
Severance Benefit Plan), the terms of this Agreement shall inure to the benefit
of, and be assumed by, the acquiring person (as defined in the Company’s Change
of Control Severance Benefit Plan). This Agreement shall not be
assignable by Executive, but it shall be binding upon, and to the extent
provided in Section 8 shall inure to the benefit of, his heirs, executors,
administrators and legal representatives.
16.
Entire
Agreement
. This Agreement contains the entire agreement
between the Company and Executive with respect to the subject matter hereof and
there have been no oral or other prior agreements of any kind whatsoever as a
condition precedent or inducement to the signing of this Agreement or otherwise
concerning this Agreement or the subject matter
hereof. Notwithstanding the foregoing, Executive acknowledges that he
is required as a condition to continued employment, to comply at all times, with
the Company’s policies affecting employees, including the Company’s published
Code of Ethics, as in effect from time to time. Executive further
acknowledges that the Non-Disclosure, Proprietary Information and Invention
Assignment Agreement he signed upon becoming an employee or thereafter remains
in full force and effect despite the execution of this Agreement and any changes
in his employment status with the Company.
17.
Equitable
Relief
. Executive recognizes and agrees that the Company’s
remedy at law for any breach of the provisions of Sections 10, 11, 12 or 13
hereof would be inadequate, and he agrees that for breach of such provisions,
the Company shall, in addition to such other remedies as may be available to it
at law or in equity or as provided in this Agreement, be entitled to injunctive
relief and to enforce its rights by an action for specific
performance. Should Executive engage in any activities prohibited by
this Agreement, he agrees to pay over to the Company all compensation,
remuneration or monies or property of any sort received in connection with such
activities; such payment shall not impair any rights or remedies of the Company
or obligations or liabilities of Executive which such parties may have under
this Agreement or applicable law.
18.
Amendments
. This
Agreement may not be amended, nor shall any change, waiver, modification,
consent or discharge be effected except by written instrument executed by the
Company and Executive.
19.
Severability
. If
any part of any term or provision of this Agreement shall be held or deemed to
be invalid, inoperative or unenforceable to any extent by a court of competent
jurisdiction, such circumstances shall in no way affect any other term or
provision of this Agreement, the application of such term or provision in any
other circumstances, or the validity or enforceability of this
Agreement. Executive agrees that the restrictions set forth in
Sections 11 and 12 above (including, but not limited to, the geographical scope
and time period of restrictions) are fair and reasonable and are reasonably
required for the protection of the interests of the Company and its
affiliates. In the event that any provision of Section 12 or 13
relating to time period and/or areas of restriction shall be declared by a court
of competent jurisdiction to exceed the maximum time period or areas such court
deems reasonable and enforceable, said time period and/or areas of restriction
shall be deemed to become and thereafter be the maximum time period and/or areas
which such court deems reasonable and enforceable.
20.
Paragraph
Headings
. The paragraph headings used in this Agreement are
included solely for convenience and shall not affect, or be used in connection
with, the interpretation hereof.
21.
Governing Law
. This
Agreement shall be governed by and construed and enforced in accordance with the
law of the State of Maryland, without regard to the principles of conflict of
laws thereof.
22.
Resolution of
Disputes
. With the exception of proceedings for equitable
relief brought pursuant to Section 17 of this Agreement, any disputes arising
under or in connection with this Agreement including, without limitation, any
assertion by any party hereto that the other party has breached any provision of
this Agreement, shall be resolved by arbitration, to be conducted in Baltimore,
Maryland, in accordance with the rules and procedures of the American
Arbitration Association. The parties shall bear equally the cost of
such arbitration, excluding attorneys’ fees and disbursements which shall be
borne solely by the party incurring the same; provided, however, that if the
arbitrator rules in favor of Executive, Company shall be solely responsible for
the payment of all costs, fees and expenses (including without limitation
Executive’s reasonable attorneys’ fees and disbursements) of such
arbitration. Any reimbursement made by Company pursuant to this
Section 22 shall be payable as follows: (i) the amount of such expenses eligible
for reimbursement in any calendar year shall not affect the expenses eligible
for reimbursement in any other calendar year and (ii) all such reimbursements
must be made on or before the last day of the calendar year following the
calendar year in which the expense was incurred. The provisions of
this Section 22 shall survive the termination for any reason of the Term
(whether such termination is by the Company, by Executive or upon the expiration
of the Term).
23.
Indemnification;
Insurance
. The Executive shall be entitled to liability and
expense indemnification and reimbursement to the fullest extent permitted by the
Company’s current By-laws and Certificate of Incorporation, whether or not the
same are subsequently amended. During the Term, the Company will use
commercially reasonable efforts to maintain in effect directors’ and officers’
liability insurance no less favorable to Executive than that in effect as of the
date of this Agreement.
24.
Survival
. Sections
8 through 23 shall survive the expiration or earlier termination of this
Agreement, for the period and to the extent specified therein.
IN
WITNESS WHEREOF, the parties have executed or caused to be executed under seal
this Agreement as of the date first above written.
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NOVAVAX,
INC.
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[SEAL]
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By:
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/s/ Rahul Singhvi
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Name:
Rahul
Singhvi
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Title:
President
& Chief Executive
Officer
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Executive:
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/s/ Thomas S. Johnston
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Thomas
S. Johnston
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Exhibit
10.14
FIRST
AMENDMENT TO THE
EMPLOYMENT
AGREEMENT
Background
Executive
is employed as Vice President, Strategy of Company, and is responsible for the
functions and duties assigned to this position, and Company wishes to assure
itself of the services of Executive. Executive and the Company are
therefore amending the Agreement to extend the Term. All capitalized
terms not defined herein shall have the meaning set forth in the
Agreement.
Terms
NOW,
THEREFORE
, in consideration of the premises and mutual covenants and
obligations hereinafter set forth, intending to be legally bound hereby, the
parties hereto agree as follows:
1.
Term
. Section
3 of the Agreement is hereby deleted in its entirety and replaced with the
following:
Term
. The term of
this Agreement shall be for the period beginning on July 20, 2009 and continuing
until September 1, 2010, unless earlier terminated pursuant to Section 7 hereof
(the “Term”) and shall be renewed automatically for additional twelve-month
periods on the terms set forth herein, as they may be modified from time to time
by mutual agreement, unless one of the Company or the Executive provides notice
of termination at least 30 days before the expiration of the then current
term. The parties acknowledge that the employment hereunder is
employment at will.
2.
Resolution of
Disputes
. Section 22 of the Agreement is hereby deleted in its
entirety and replaced with the following:
“With the
exception of proceedings for equitable relief brought pursuant to Section 17 of
this Agreement, any disputes arising under or in connection with this Agreement
including, without limitation, any assertion by any party hereto that the other
party has breached any provision of this Agreement, shall be resolved by
arbitration, to be conducted in Baltimore, Maryland, in accordance with the
rules and procedures of the American Arbitration Association. The
parties shall bear equally the cost of such arbitration, excluding attorneys’
fees and disbursements which shall be borne solely by the party incurring the
same; provided, however, that if the arbitrator rules in favor of Executive on
at least one material component of the dispute, Company shall be solely
responsible for the payment of all costs, fees and expenses (including without
limitation Executive’s reasonable attorney’s fees and disbursements) of such
arbitration. The Company shall reimburse Executive for any such fees
and expenses incurred by Executive in any calendar year within a reasonable time
following Executive’s submission of a request for such reimbursement, which in
no case shall be later than the end of the calendar year following the calendar
year in which such expenses were incurred. Executive shall submit any
such reimbursement request no later than the June 30
th
next
following the calendar year in which the fees and expenses are
incurred. In the event the arbitrator rules against Executive,
Executive shall repay the Company the amount of such reimbursed expenses no
later than 180 days following the date as of which such arbitrator’s decision
becomes final. The provisions of this Section 22 shall survive the
termination for any reason of the Term (whether such termination is by the
Company, by Executive or upon the expiration of the Term).”
3.
Other
Provisions
. All of the other terms and conditions of the
Agreement, not inconsistent with the terms of this Amendment, shall remain in
full force and effect.
IN
WITNESS WHEREOF, the undersigned have executed this Agreement the date and year
first written above.
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NOVAVAX,
INC.
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[SEAL]
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By:
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/s/
Rahul Singhvi
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Name:
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Rahul
Singhvi
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Title:
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President
and Chief Executive Officer
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Thomas
S. Johnston
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Thomas
S.
Johnston
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Exhibit
10.15
EMPLOYMENT
AGREEMENT
This
Employment Agreement (this “Agreement”) is dated as of
July 16, 2009
, between
Novavax, Inc., a Delaware corporation having its principal office at 9920
Belward Campus Drive, Rockville, MD 20850, and
John J. Trizzino,
an
individual with a mailing address of
14228 Cervantes Avenue, Darnestown,
MD 20874
(“Executive”).
WHEREAS,
Executive will commence employment with the Company on or about July 16, 2009
pursuant to an offer letter dated July 16, 2009; and
The
Company and Executive hereby agree as follows:
1.
Employment
. The
Company hereby employs Executive and Executive hereby accepts employment as
Senior
Vice President, International and
Government Alliances
upon the terms and conditions hereinafter set
forth. Executive will report directly to the President and Chief
Executive Officer and participate as a full member of the Executive Committee as
a corporate officer. As used throughout this Agreement, “Company”
shall mean and include any and all of its present and future subsidiaries and
any and all subsidiaries of a subsidiary. Executive warrants and
represents that he is free to enter into and perform this Agreement and is not
subject to any employment, confidentiality, non-competition or other agreement
which prohibits, restricts, or would be breached by either his acceptance or his
performance of this Agreement.
2.
Duties
. During the
Term (as hereinafter defined), Executive shall devote his full business time to
the performance of services as
Senior Vice President, International
and Government Alliances
of Novavax, Inc., performing such services
related to managing the government RFP processes, managing the execution of
agreements and contracts with regional partners and assuming such
responsibilities and exercising such authority as are set forth in the Bylaws of
the Company for such offices and assuming such other duties and responsibilities
as prescribed by the President and CEO and Board of Directors. During
the Term, Executive’s services shall be completely exclusive to the Company and
he shall devote his entire business time, attention and energies to the business
of the Company and the duties which the Company shall assign to him from time to
time. Executive agrees to perform his services faithfully and to the
best of his ability and to carry out the policies and directives of the
Company. Notwithstanding the foregoing, it shall not be a violation
of this Agreement for the Executive to serve as a director of any company whose
products do not compete with those of the Company and to serve as a director,
trustee, officer, or consultant to a charitable or non-profit entity; provided
that such service does not adversely affect Executive’s ability to perform his
obligations hereunder. Executive agrees to take no action which is in
bad faith and prejudicial to the interests of the Company during his employment
hereunder. Notwithstanding the location where Executive shall be
based, as set forth in this Agreement, he also may be required from time to time
to perform duties hereunder for reasonably short periods of time outside of said
area.
3.
Term
. The term of
this Agreement shall be for the period beginning on
July 16, 2009
and continuing
until
September 1, 2010
,
unless earlier terminated pursuant to Section 7 hereof (the “Term”) and shall be
renewed automatically for additional twelve-month periods on the terms set forth
herein, as they may be modified from time to time by mutual agreement, unless
one of the Company or the Executive provides notice of termination at least 30
days before the expiration of the then current term. The parties
acknowledge that the employment hereunder is employment at
will.
4.
Compensation
.
(a)
Base
Compensation
. For all Executive’s services and covenants under
this Agreement, the Company shall pay Executive an annual salary, which is
$
285,000
as of this
amendment and restatement, established by the Board of Directors or an
authorized committee thereof (in accordance with the management processes) and
payable in accordance with the Company’s payroll policy as constituted from time
to time. The Company may withhold from any amounts payable under this
Agreement all required federal, state, city or other taxes and all other
deductions as may be required pursuant to any law or government regulation or
ruling.
(b)
Bonus Program
. The
Company agrees to pay the Executive a performance and incentive bonus in respect
of Executive’s employment with the Company each year in an amount determined by
the President and CEO and Board of Directors (or any committee of the Board of
Directors authorized to make that determination) to be appropriate based upon
Executive’s, and the Company’s, achievement of certain specified goals (to be
established at the beginning of the bonus period), with a target bonus of
40%
, or any other percentage
determined by the Board of Directors, of Executive’s base salary during the year
to which the bonus relates based on performance. Such bonus shall be
payable no later than two and one-half months following the year for which the
bonus applies. The bonus shall be paid out partly in cash and partly
in shares of restricted stock, in the discretion of the Board of
Directors.
(c)
Stock
Awards
. Subject to approval by the Board of Directors (or any
committee of the Board of Directors authorized to make that determination), the
Company will grant Executive (a) stock options to purchase 220,000 shares of the
Company’s Common Stock ($.01 par value) at an exercise price equal to the
closing price of the Company’s Common Stock on the later date of Executive’s
date of hire or the date of such Board of Directors’ approval. Each
of these awards will vest as to one-third of the award on each of the first
three (3) anniversaries of Executive’s date of employment. Executive
will be eligible to be considered for additional stock awards based upon
performance, the amount and terms of any such award subject to the approval of
the President and Chief Executive Officer and the Board of
Directors.
5.
Reimbursable
Expenses
. Executive shall be entitled to reimbursement for
reasonable expenses incurred by him in connection with the performance of his
duties hereunder in accordance with such procedures and policies for executive
officers as the Company has heretofore or may hereafter
establish. The amount of expenses eligible for reimbursement during
any calendar year shall not affect the expenses eligible for reimbursement in
any other calendar year, and the reimbursement of an eligible expense shall be
made as soon as practicable after Executive submits the request for
reimbursement, but not later than December 31 following the calendar year in
which the expense was incurred.
6.
Benefits
. (a)
Executive shall be entitled to four weeks of paid vacation time per year
starting from
July 16,
2009
, calculated and administered in accordance with Company policies for
executive officers in effect from time to time. The Executive shall
be entitled to all other benefits associated with normal full time employment in
accordance with Company policies.
(b) Executive
shall be entitled to participate in the Company’s Change of Control Severance
Benefit Plan.
7.
Termination of
Employment
.
(a) Notwithstanding
any other provision of this Agreement, Executive’s employment may be terminated,
without such action constituting a breach of this Agreement:
(i) By
the Company, for “Cause,” as defined in Section 7(b) below;
(ii) By
the Company, upon 30 days’ notice to Executive, if he should be prevented by
illness, accident or other disability (mental or physical) from discharging his
duties hereunder for one or more periods totaling three consecutive months
during any twelve-month period;
(iii) By
the Executive with “Good Reason”, as defined in Section 7(c) below, within 30
days of the occurrence or commencement of such Good Reason;
(iv) By
the event of Executive’s death during the Term.
(b) “Cause”
shall mean (i) Executive’s willful failure or refusal to perform in all material
respects the services required of him hereby, (ii) Executive’s willful failure
or refusal to carry out any proper and material direction by the President and
CEO or Board of Directors with respect to the services to be rendered by him
hereunder or the manner of rendering such services, (iii) Executive’s willful
misconduct in the performance of his duties hereunder, (iv) Executive’s
commission of an act of fraud, embezzlement or theft or a felony involving moral
turpitude, (v) Executive’s use or disclosure of Confidential Information (as
defined in Section 10 of this Agreement), other than for the benefit of the
Company in the course of rendering services to the Company or (vi) Executive’s
engagement in any activity prohibited by Section 11 of this
Agreement. For purposes of this Section 7, the Company shall be
required to provide Executive a specific written warning with regard to any
occurrence of subsections (b)(i), (ii) and (iii) above, which warning shall
include a statement of corrective actions and a 30 day period for the Executive
to respond to and implement such actions, prior to any termination of employment
by the Company pursuant to Section 7(a)(i) above.
(c) “Good
Reason” shall mean the Company’s material reduction or diminution of Executive’s
responsibilities and authority, other than for Cause, without his
consent.
8.
Separation
Pay
. (a) Subject to Executive’s execution and delivery
to the company of the Company’s standard form of Separation and Release
Agreement, the Company shall pay Executive an amount equal to the Separation Pay
upon the occurrence of the applicable Separation Event but in no case later than
two and one-half months following the year in which the Separation Event
occurs. Separation Pay shall each be payable in accordance with the
Company’s payroll policy as constituted from time to time, and shall be subject
to withholding of all applicable federal, state and local taxes and any other
deductions required by applicable law. In the event of Executive’s
death, the Company’s obligation to pay further compensation hereunder shall
cease forthwith, except that Executive’s legal representative shall be entitled
to receive his fixed compensation for the period up to the last day of the month
in which such death shall have occurred.
(b) Section
8(a) above shall not apply should Executive receive severance benefits under the
Company’s Change in Control Severance Benefit Plan.
9. “Separation
Pay” shall mean a lump sum amount equal to
twelve
months of Executive’s
then effective salary.
(a) “Separation
Event” shall mean:
(i) the
Company’s termination of Executive’s employment by the Company without Cause,
during the Term;
(ii) the
termination of Executive’s employment by the Executive for Good Reason:
or
(iii)
if the Company terminates this agreement under Section 3
above.
10.
All Business to be Property of the
Company; Assignment of Intellectual Property
.
(a) Executive
agrees that any and all presently existing business of the Company and all
business developed by him or any other employee of the Company including without
limitation all contracts, fees, commissions, compensation, records, customer or
client lists, agreements and any other incident of any business developed,
earned or carried on by Executive for the Company is and shall be the exclusive
property of the Company, and (where applicable) shall be payable directly to the
Company.
(b) Executive
hereby acknowledges that any plan, method, data, know-how, research,
information, procedure, development, invention, improvement, modification,
discovery, design, process, software and work of authorship, documentation,
formula, technique, trade secret or intellectual property right whatsoever or
any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor (herein sometimes collectively referred to as
“Intellectual Property”) made, conceived, created, invested, developed, reduced
to practice and/or acquired by Executive solely or jointly with others during
the Term is the sole and exclusive property of the Company, as work for hire,
and that he has no personal right in any such Intellectual
Property. Executive hereby grants to the Company (without any
separate remuneration or compensation other than that received by him from time
to time in the course of his employment) his entire right, title and interest
throughout the world in and to, all Intellectual Property, which is made,
conceived, created, invested, developed, reduced to practice and/or acquired by
him solely or jointly with others during the Term.
(c) Executive
shall cooperate fully with the Company, both during and after his employment
with or engagement by the Company, with respect to the procurement, maintenance
and enforcement of copyrights, patents and other intellectual property rights
(both in the United States and foreign countries) relating to Intellectual
Property. Without limiting the foregoing, Executive agrees that to
the extent copyrightable, any such original works of authorship shall be deemed
to be "works for hire" and that the Company shall be deemed the author thereof
under the U.S. Copyright Act, provided that in the event and to the extent such
works are determined not to constitute "works for hire" as a matter of law,
Executive hereby irrevocably assigns and transfers to the Company all right,
title and interest in such works, including but not limited to copyrights
thereof. Executive shall sign all papers, including, without
limitation, copyright applications, patent applications, declarations, oaths,
formal assignments, assignments of priority rights and powers of attorney, which
the Company may deem necessary or desirable in order to protect its rights and
interests in any Intellectual Property (at the Company’s expense) and agrees
that these obligations are binding upon his assigns, executors, administrators
and other legal representatives. To that end, Executive shall provide
current contact information to the Company including, but not limited to, home
address, telephone number and email address, and shall update his contact
information whenever necessary.
11.
Confidentiality
. Executive
acknowledges his obligation of confidentiality with respect to all proprietary,
confidential and non-public information of the Company, including all
Intellectual Property. By way of illustration, but not limitation,
confidential and proprietary information shall be deemed to include any plan,
method, data, know-how, research, information, procedure, development,
invention, improvement, modification, discovery, process, work of authorship,
documentation, formula, technique, product, idea, concept, design, drawing,
specification, technique, trade secret or intellectual property right whatsoever
or any interest therein whether patentable or non-patentable, patents and
applications therefor, trademarks and applications therefor or copyrights and
applications therefor, personnel data, records, marketing techniques and
materials, marketing and development plans, customer names and other information
related to customers, including prospective customers and contacts at customers,
price lists, pricing policies and supplier lists of the Company, in each case
coming into Executive’s possession, or which Executive learns, or to which
Executive has access, or which Executive may discover or develop (whether or not
related to the business of the Company at the time this Agreement is signed or
any information Executive originates, discovers or develops, in whole or in
part) as a result of Executive’s employment by (either full-time or part-time),
or retention as a consultant of, the Company. Executive shall not,
either during the Term or for a period of ten (10) years thereafter, use for any
purpose other than the furtherance of the Company’s business, or disclose to any
person other than a person with a need to know such confidential, proprietary or
non-public information for the furtherance of the Company’s business who is
obligated to maintain the confidentiality of such information, any information
concerning any Intellectual Property, or other confidential, proprietary or
non-public information of the Company, whether Executive has such information in
his memory or such information is embodied in writing, electronic or other
tangible form.
All
originals and copies of any of the foregoing, however and whenever produced,
shall be the sole property of the Company. All files, letters,
memoranda, reports, records, data, sketches, drawings, program listings, or
other written, photographic, or other tangible or electronic material containing
confidential or proprietary information or Intellectual Property, whether
created by me or others, which shall come into Executive’s custody or
possession, shall be and are the exclusive property of the Company to be used by
Executive only in the performance of his duties for the Company. All
electronic material containing confidential or proprietary information or
Intellectual Property will be stored on a computer supplied to Executive by the
Company and, under no circumstances, will it be transferred to a personal
computer. Executive will promptly deliver to the Company and/or a
person or entity identified by the Company all such materials or copies of such
materials and all tangible property of the Company in Executive’s custody or
possession, upon the earlier of (i) a request by the Company or (ii) termination
of employment or engagement by the Company. After such delivery,
Executive will not retain any such materials or copies or any such tangible
property or any summaries or memoranda regarding same.
12.
Non-Competition
Covenant
. As the Executive has been granted options to
purchase stock in the Company and as such has a financial interest in the
success of the Company’s business and as Executive recognizes that the Company
would be substantially injured by Executive competing with the Company,
Executive agrees and warrants that within the United States, he will not, unless
acting with the Company’s express prior written consent, directly or indirectly,
while an employee of the Company and during the Non-Competition Period, as
defined below, own, operate, join, control, participate in, or be connected as
an officer, director, employee, partner, stockholder, consultant or otherwise,
with any business or entity which competes with the business of the Company (or
its successors or assigns) as such business is now constituted or as it may be
constituted at any time during the Term of this Agreement; provided, however,
that Executive may own, and exercise rights with respect to, less than one
percent of the equity of a publicly traded company. The
“Non-Competition Period” shall be a period of
twelve
months following
termination of employment.
Executive
and the Company are of the belief that the period of time and the area herein
specified are reasonable in view of the nature of the business in which the
Company is engaged and proposes to engage, the state of its business development
and Executive’s knowledge of this business; however, if such period or such area
should be adjudged unreasonable in any judicial proceeding, then the period of
time shall be reduced by such number of months or such area shall be reduced by
elimination of such portion of such area, or both, as are deemed unreasonable,
so that this covenant may be enforced in such area and during such period of
time as is adjudged to be reasonable.
13.
Non-Solicitation
Agreement
. Executive agrees and covenants that he will not,
unless acting with the Company’s express written consent, directly or
indirectly, during the Term of this Agreement or during the Non-Competition
Period (as defined in Section 12 above) solicit, entice or attempt to entice
away or interfere in any manner with the Company’s relationships or proposed
relationships with any customer, officer, employee, consultant, proposed
customer, vendor, supplier, proposed vendor or supplier or person or entity or
person providing or proposed to provide research and/or development services to,
on behalf of or with the Company.
14.
Notices
. All
notices and other communications hereunder shall be in writing and shall be
deemed to have been given on actual receipt after having been delivered by hand,
mailed by first class mail, postage prepaid, or sent by Federal Express or
similar overnight delivery services, as follows: (a) if to Executive, at the
address shown at the head of this Agreement, or to such other person(s) or
address(es) as Executive shall have furnished to the Company in writing and, if
to the Company, to it at the address set forth in the preamble hereto with a
copy to Jennifer L. Miller, Esq., Ballard Spahr Andrews & Ingersoll, LLP,
1735 Market Street, 51
st
Floor,
Philadelphia, Pennsylvania 19103, or to such other person(s) or address(es) as
the Company shall have furnished to Executive in writing.
15.
Assignability
. In
the event of a change of control (as defined in the Company’s Change of Control
Severance Benefit Plan), the terms of this Agreement shall inure to the benefit
of, and be assumed by, the successor to the Company or the acquiring person in
such change in control transaction. This Agreement shall not be
assignable by Executive, but it shall be binding upon, and to the extent
provided in Section 8 shall inure to the benefit of, his heirs, executors,
administrators and legal representatives.
16.
Entire
Agreement
. This Agreement contains the entire agreement
between the Company and Executive with respect to the subject matter hereof and
there have been no oral or other prior agreements of any kind whatsoever as a
condition precedent or inducement to the signing of this Agreement or otherwise
concerning this Agreement or the subject matter
hereof. Notwithstanding the foregoing, Executive acknowledges that he
is required as a condition to continued employment, to comply at all times, with
the Company’s policies affecting employees, including the Company’s published
Code of Ethics, as in effect from time to time. Executive further
acknowledges that the Non-Disclosure, Proprietary Information and Invention
Assignment Agreement he signed upon becoming an employee or thereafter remains
in full force and effect despite the execution of this Agreement and any changes
in his employment status with the Company.
17.
Equitable
Relief
. Executive recognizes and agrees that the Company’s
remedy at law for any breach of the provisions of Sections 10, 11, 12 or 13
hereof would be inadequate, and he agrees that for breach of such provisions,
the Company shall, in addition to such other remedies as may be available to it
at law or in equity or as provided in this Agreement, be entitled to injunctive
relief and to enforce its rights by an action for specific
performance. Should Executive engage in any activities prohibited by
this Agreement, he agrees to pay over to the Company all compensation,
remuneration or monies or property of any sort received in connection with such
activities; such payment shall not impair any rights or remedies of the Company
or obligations or liabilities of Executive which such parties may have under
this Agreement or applicable law.
18.
Amendments
. This
Agreement may not be amended, nor shall any change, waiver, modification,
consent or discharge be effected except by written instrument executed by the
Company and Executive.
19.
Severability
. If
any part of any term or provision of this Agreement shall be held or deemed to
be invalid, inoperative or unenforceable to any extent by a court of competent
jurisdiction, such circumstances shall in no way affect any other term or
provision of this Agreement, the application of such term or provision in any
other circumstances, or the validity or enforceability of this
Agreement. Executive agrees that the restrictions set forth in
Sections 11 and 12 above (including, but not limited to, the geographical scope
and time period of restrictions) are fair and reasonable and are reasonably
required for the protection of the interests of the Company and its
affiliates. In the event that any provision of Section 12 or 13
relating to time period and/or areas of restriction shall be declared by a court
of competent jurisdiction to exceed the maximum time period or areas such court
deems reasonable and enforceable, said time period and/or areas of restriction
shall be deemed to become and thereafter be the maximum time period and/or areas
which such court deems reasonable and enforceable.
20.
Paragraph
Headings
. The paragraph headings used in this Agreement are
included solely for convenience and shall not affect, or be used in connection
with, the interpretation hereof.
21.
Governing Law
. This
Agreement shall be governed by and construed and enforced in accordance with the
law of the State of Maryland, without regard to the principles of conflict of
laws thereof.
22.
Resolution of
Disputes
. With the exception of proceedings for equitable
relief brought pursuant to Section 17 of this Agreement, any disputes arising
under or in connection with this Agreement including, without limitation, any
assertion by any party hereto that the other party has breached any provision of
this Agreement, shall be resolved by arbitration, to be conducted in Baltimore,
Maryland, in accordance with the rules and procedures of the American
Arbitration Association. The parties shall bear equally the cost of
such arbitration, excluding attorneys’ fees and disbursements which shall be
borne solely by the party incurring the same; provided, however, that if the
arbitrator rules in favor of the Executive on at least one material component of
the dispute, Company shall be solely responsible for the payment of all costs,
fees and expenses (including without limitation Executive’s reasonable
attorney’s fees and disbursements) of such arbitration. The Company
shall reimburse Executive for any such fees and expenses) incurred by Executive
in any calendar year within a reasonable time following Executive’s submission
of a request for such reimbursement, which in no case shall be later than the
end of the calendar year following the calendar year in which such expenses were
incurred. Executive shall submit any such reimbursement request no
later than the June 30
th
next
following the calendar year in which the fees and expenses are
incurred. In the event the arbitrator rules against Executive,
Executive shall repay the Company the amount of such reimbursed expenses no
later than 180 days following the date as of which such arbitrator’s decision
becomes final. The provisions of this Section 22 shall survive the
termination for any reason of the Term (whether such termination is by the
Company, by Executive or upon the expiration of the Term).
23.
Indemnification;
Insurance
. The Executive shall be entitled to liability and
expense indemnification, advancement of expenses and reimbursement to the
fullest extent permitted by the Company’s current By-laws and Certificate of
Incorporation, whether or not the same are subsequently
amended. During the Term, the Company will use commercially
reasonable efforts to maintain in effect directors’ and officers’ liability
insurance no less favorable to Executive than that in effect as of the date of
this Agreement.
24.
Survival
. Sections
8 through 23 shall survive the expiration or earlier termination of this
Agreement, for the period and to the extent specified therein.
IN
WITNESS WHEREOF, the parties have executed or caused to be executed under seal
this Agreement as of the date first above written.
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NOVAVAX,
INC.
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[SEAL]
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By:
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/s/ Rahul Singhvi
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Name: Rahul
Singhvi
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Title: President
& Chief Executive Officer
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Executive:
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/s/ John J. Trizzino
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John
J.
Trizzino
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Exhibit
10.19
DIRECTOR
INDEMNITY AGREEMENT
This
Agreement is made and entered into as of this 1
st
day of
January, 2010, by and between Novavax, Inc., a Delaware corporation (the
“Company”), and
_______________________
(“Indemnitee”), who is currently serving the Company in the capacity of a
director and/or officer thereof.
WITNESSETH:
WHEREAS,
the Company and Indemnitee recognize that the interpretation of ambiguous
statutes, regulations and court opinions and of the Amended and Restated
Certificate of Incorporation, as amended (the “Certificate of Incorporation”)
and Amended and Restated By-laws, as amended (the “By-laws”) of the Company, and
the vagaries of public policy, are too uncertain to provide directors and
officers of the Company with adequate or reliable advance knowledge or guidance
with respect to the legal risks and potential liabilities to which they become
personally exposed as a result of performing their duties in good faith for the
Company; and
WHEREAS,
the Company and the Indemnitee are aware that highly experienced and capable
persons are often reluctant to serve as directors and officers of a corporation
unless they are protected to the fullest extent permitted by law by
comprehensive insurance or indemnification; and
WHEREAS,
the General Corporation Law of the State of Delaware, which sets forth certain
provisions relating to the mandatory and permissive indemnification of, and
advancement of expenses to, officers and directors of a Delaware corporation by
such corporation, is specifically not exclusive of other rights to which those
indemnified thereunder may be entitled under any bylaw, agreement, vote of
stockholders or disinterested directors or otherwise, and, thus, does not by
itself limit the extent to which the Company may indemnify persons serving as
its officers and directors, provided such persons have met the applicable
standard of conduct; and
WHEREAS,
the Company desires to have Indemnitee continue to serve as a director and/or
officer of the Company, and, if applicable, to serve in any other capacity as
agreed by the Company and the Indemnitee, free from undue concern for
unpredictable, inappropriate or unreasonable legal risks and personal
liabilities by reason of his or her acting in good faith in the performance of
his or her duty to the Company; and Indemnitee desires to continue to serve
(provided that he or she is furnished the indemnity provided for hereinafter) as
a director and/or officer of the Company and, if applicable, to serve in any
other capacity as agreed by the Indemnitee and the Company; and
WHEREAS,
after due consideration and investigation of the terms and provisions of this
Agreement and the various other options available to the Company and the
Indemnitee in lieu thereof, the Board of Directors of the Company has determined
that the following Agreement is reasonable and prudent, and necessary to obtain
or retain Indemnitee’s service to and on behalf of the Company.
NOW,
THEREFORE, in consideration of the premises and the mutual agreements herein set
forth and for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Company and Indemnitee, intending to be
legally bound, do hereby agree as follows:
1.
Agreement to Serve.
Indemnitee
agrees to continue to serve as a director and/or officer of the Company and, as
Indemnitee and the Company may agree, in any other capacity for the Company
and/or as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust, or other enterprise, for so long as he or she
is duly elected or appointed and qualified in accordance with the provisions of
the General Corporation Law of the State of Delaware and the Certificate of
Incorporation and By-laws of the Company, or until such time as he or she
tenders a resignation. The Company acknowledges that the Indemnitee is relying
on this Agreement in so serving.
2.
Definitions.
As used in this
Agreement:
(a) The
term “Proceeding” shall mean any threatened, pending or completed action, suit,
or proceeding, whether civil, criminal, administrative, arbitrative or
investigative (including an action by or in the right of the Company), any
appeal in such an action, suit, or proceeding, and any inquiry or investigation
that could lead to such an action, suit or proceeding. The final disposition of
a Proceeding shall be as determined by a settlement or the judgment of a court
or other investigative or administrative body. The Board of Directors shall not
make a determination as to the final disposition of a Proceeding.
(b) “Change
in Control” means a change in control of the Company of a nature that would be
required to be reported in response to Item 6(e) of Schedule 14A of
Regulation 14A (or in response to any similar item on any similar schedule
or form) promulgated under the Securities Exchange Act of 1934, as amended (the
“Act”), whether or not the Company is then subject to such reporting
requirement;
provided
,
however
, that,
without limitation, such a Change in Control shall be deemed to have occurred if
(i) any “person” (as such term is used in Sections 13(d) and 14(d) of the
Act), other than a trustee or other fiduciary holding securities under an
employee benefit plan of the Company or a corporation owned directly or
indirectly by the stockholders of the Company in substantially the same
proportions as their ownership of stock of the Company, is or becomes the
“beneficial owner” (as defined in Rule 13d-3 under the Act), directly or
indirectly, of securities of the Company representing 15% or more of the
combined voting power of the Company’s then outstanding securities without the
prior approval of at least a majority of the members of the Board of Directors
of the Company in office immediately prior to such person attaining such
percentage interest; (ii) there occurs a proxy contest, or the Company is a
party to a merger, consolidation, sale of assets, plan of liquidation or other
reorganization not approved by at least a majority of the members of the Board
of Directors of the Company then in office, as a consequence of which members of
the Board of Directors in office immediately prior to such transaction or event
constitute less than a majority of the Board of Directors thereafter; or
(iii) during any period of two consecutive years, other than as a result of
an event described in clause (ii) of this subsection (b), individuals who
at the beginning of such period constituted the Board of Directors of the
Company (including for this purpose any new director whose election or
nomination for election by the Company’s stockholders was approved by a vote of
at least a majority of the directors then still in office who were directors at
the beginning of such period) cease for any reason to constitute at least a
majority of the Board of Directors.
(c) “Disinterested
Director” means a director of the Company who is not and was not a party to the
Proceeding in respect of which indemnification is sought by
Indemnitee.
(d) The
term “Expenses” includes, without limitation, all reasonable attorneys’ fees,
retainers, court costs, transcript costs, fees of experts, witness fees, travel
expenses, duplicating costs, printing and binding costs, telephone charges,
postage, delivery service fees and all other disbursements or expenses of the
types customarily incurred in connection with prosecuting, defending, preparing
to prosecute or defend, investigating, or being or preparing to be a witness in
a Proceeding. Expenses also shall include Expenses incurred in connection with
any appeal resulting from any Proceeding, including, without limitation, the
premium, security for, and other costs relating to any cost bond, supersedeas
bond, or other appeal bond or its equivalent.
(e) “Independent
Counsel” means a law firm, or a member of a law firm, that is experienced in
matters of corporation law and neither presently is, nor in the past five years
has been, retained to represent: (i) the Company or Indemnitee in any
matter material to either such party (other than with respect to matters
concerning the Indemnitee under this Agreement, or of other indemnitees under
similar indemnification agreements), or (ii) any other party to the Proceeding
giving rise to a claim for indemnification hereunder. Notwithstanding the
foregoing, the term “Independent Counsel” shall not include any person who,
under the applicable standards of professional conduct then prevailing, would
have a conflict of interest in representing either the Company or Indemnitee in
an action to determine Indemnitee’s rights under this Agreement. The Company
agrees to pay the reasonable fees and expenses of the Independent Counsel
referred to above and to fully indemnify such counsel against any and all
Expenses, claims, liabilities and damages arising out of or relating to this
Agreement or its engagement pursuant hereto.
(f) References
to “other enterprise” shall include employee benefit plans; references to
“fines” shall include any (i) excise taxes assessed with respect to any
employee benefit plan and (ii) penalties; references to “serving at the
request of the Company” shall include any service as a director, officer,
employee or agent of the Company which imposes duties on, or involves services
by, such director, officer, employee or agent with respect to an employee
benefit plan, its participants or beneficiaries; and a person who acts in good
faith and in a manner he or she reasonably believed to be in the interest of the
participants and beneficiaries of an employee benefit plan shall be deemed to
have acted in a manner “not opposed to the best interests of the Company” as
referred to in this Agreement.
3.
Indemnity in Third Party Proceedings.
Subject to Sections 8 and 9, the Company shall indemnify, defend and
hold harmless Indemnitee to the fullest extent permitted or required by the laws
of the State of Delaware in effect as of the date hereof or as such laws may
from time to time hereafter be amended to increase the scope of such permitted
indemnification, if Indemnitee was or is a party or is threatened to be made a
party to any Proceeding (other than a Proceeding by or in the right of the
Company) by reason of the fact that Indemnitee is or was a director and/or
officer of the Company, or is or was serving at the request of the Company as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust, or other enterprise, against all Expenses, judgments, fines and
amounts paid in settlement actually and reasonably incurred by Indemnitee (or on
his or her behalf) in connection with such Proceeding or any claim, issue or
matter therein,
provided
the
Indemnitee acted in good faith and in a manner which he or she reasonably
believed to be in or not opposed to the best interests of the Company and, in
the case of a criminal Proceeding, had no reasonable cause to believe that
Indemnitee’s conduct was unlawful. Indemnitee shall have the right to employ
Indemnitee’s own legal counsel in any Proceeding for which indemnification is
available under this Section 3, subject to Section 8
below.
4.
Indemnity in Proceedings By or In the
Right of the Company.
Subject to Sections 8 and 9, the Company shall
indemnify, defend and hold harmless Indemnitee to the fullest extent permitted
or required by the laws of the State of Delaware in effect as of the date hereof
or as such laws may from time to time hereafter be amended to increase the scope
of such permitted indemnification, if Indemnitee was or is a party or is
threatened to be made a party to any Proceeding by or in the right of the
Company to procure a judgment in its favor by reason of the fact that Indemnitee
is or was a director and/or officer of the Company, or is or was serving at the
request of the Company as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust, or other enterprise, against all
Expenses actually and reasonably incurred by Indemnitee (or on his or her
behalf) in connection with the defense or settlement of such Proceeding or any
claim, issue or matter therein,
provided
the
Indemnitee acted in good faith and in a manner which he or she reasonably
believed to be in or not opposed to the best interests of the Company and, in
the case of a criminal Proceeding, had no reasonable cause to believe that
Indemnitee’s conduct was unlawful, and except that no indemnification shall be
made under this Section 4 in respect of any claim, issue or matter as to
which Indemnitee shall have been adjudged to be liable to the Company unless and
only to the extent that the Delaware Court of Chancery or other court in which
such Proceeding was brought or is pending, shall determine upon application
that, despite the adjudication of liability but in view of all the circumstances
of the case, Indemnitee is fairly and reasonably entitled to indemnity for such
Expenses as the Delaware Court of Chancery or other court in such Proceeding
shall deem proper. Indemnitee shall have the right to employ Indemnitee’s own
legal counsel in any Proceeding for which indemnification is available under
this Section 4, subject to Section 8 below.
5.
Reimbursement for Expenses of a
Witness.
Notwithstanding any other provision of this Agreement, to the
extent that Indemnitee is, by reason of the fact that Indemnitee is or was a
director and/or officer of the Company, or is or was serving at the request of
the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust, or other enterprise, a witness at the
Company’s request in any Proceeding to which Indemnitee is not a party, he or
she shall be reimbursed against all Expenses actually and reasonably incurred by
Indemnitee (or on his or her behalf) in connection therewith upon Indemnitee’s
written request therefor.
6.
Indemnification for Expenses of
Successful Party.
Notwithstanding any other provision of this Agreement
to the contrary, to the extent that Indemnitee has been successful on the merits
or otherwise (whether partially or in full) in defense of any Proceeding
referred to in Sections 3 and/or 4 of this Agreement, or in defense of any
claim, issue or matter therein, Indemnitee shall be indemnified against all
Expenses actually and reasonably incurred by Indemnitee (or on his or her
behalf) in connection therewith. For purposes of this Section 6, and
without limitation, the termination of any claim, issue or matter in any
Proceeding referred to in Sections 3 and/or 4 of this Agreement by
dismissal shall be deemed to be a successful result as to such claim, issue or
matter.
7.
Advances of Expenses.
Indemnitee shall have the right to advancement by the Company prior to
the final disposition of any Proceeding or any claim, issue or other matter
therein of any and all Expenses incurred by Indemnitee in defense of such
Proceeding or any claim, issue or other matter therein. Without limiting the
generality or effect of the foregoing, within 10 business days after any request
by Indemnitee, the Company shall, in accordance with such request, (a) pay
such Expenses on behalf of Indemnitee, (b) advance to Indemnitee funds in
an amount sufficient to pay such Expenses or (c) reimburse Indemnitee for
such Expenses;
provided
that
Indemnitee shall repay any amounts actually advanced to Indemnitee that, at the
final disposition of the Proceeding to which the advance related, were in excess
of amounts paid or payable by Indemnitee in respect of Expenses relating to,
arising out of or resulting from such Proceeding; and
provided
further
the Company
receives an undertaking by or on behalf of Indemnitee (“Indemnitee Undertaking”)
to repay such amount paid, advanced or reimbursed to the extent that it is
ultimately determined that Indemnitee is not entitled to be indemnified by the
Company. The Indemnitee Undertaking shall be substantially on the form of
Exhibit A to this Agreement and shall be accepted without reference to the
financial ability of the Indemnitee to make such repayment.
8.
Notice and Defense of a Proceeding.
As a condition precedent to the right to be indemnified or receive
advancement of Expenses, the Indemnitee must notify the Company in writing as
soon as practicable of any Proceeding for which indemnity will or could be
sought. With respect to any such Proceeding of which the Company is so notified,
the Company will be entitled to participate therein at its own expense and/or to
assume the defense thereof at its own expense, with legal counsel reasonably
acceptable to the Indemnitee. After notice from the Company to the Indemnitee of
its election so to assume such defense, the Company shall not be liable to the
Indemnitee for any legal or other Expenses subsequently incurred by the
Indemnitee in connection with such Proceeding, other than as provided in this
Section 8. The Indemnitee shall have the right to employ his or her own
counsel in connection with such Proceeding, but the fees and expenses of such
counsel incurred after notice from the Company of its assumption of the defense
thereof shall be at the expense of the Indemnitee unless (i) the employment
of counsel by the Indemnitee has been authorized by the Company, (ii) counsel to
the Indemnitee shall have reasonably concluded that there may be a conflict of
interest or position on any significant issue between the Company and the
Indemnitee in the conduct of the defense of such Proceeding, or (iii) the
Company shall not in fact have employed counsel to assume the defense of such
action, in each of which cases the fees and other Expenses of counsel for the
Indemnitee shall be at the expense of and borne by the Company, except as
otherwise expressly provided by this Agreement, and in no event shall the
Company be required to bear the expense of more than one counsel for all
Indemnitees with respect to a Proceeding. The Company shall not be entitled,
without the consent of the Indemnitee, to assume the defense of any Proceeding
brought by or in the right of the Company or as to which counsel for the
Indemnitee shall have reasonably made the conclusion provided for in clause
(ii) above.
9. Procedure
for Determination of Entitlement to Indemnification.
(a) To
obtain indemnification or advancement of Expenses under this Agreement,
Indemnitee shall submit to the Company a written request therefor, including in
such request such documentation and information as is reasonably available to
the Indemnitee and is reasonably necessary to determine whether and to what
extent the Indemnitee is entitled to indemnification or advancement of
Expenses.
(b) It
is the express intention of the parties that the Indemnitee be entitled to
indemnification hereunder to the fullest extent permitted by Delaware law.
Without limiting the generality or effect of the immediately preceding sentence,
and without excluding any other basis upon which Indemnitee may be found to be
entitled to indemnification hereunder, the Indemnitee shall be entitled to
indemnification hereunder if (i) Indemnitee acted in good faith and in a
manner which he or she reasonably believed to be in or not opposed to the best
interests of the Company and, in the case of a criminal Proceeding, had no
reasonable cause to believe that Indemnitee’s conduct was unlawful, or
(ii) Indemnitee has been successful on the merits or otherwise in defense
of any Proceeding or any claim, issue or matter therein.
(c) Upon
written request by Indemnitee for indemnification pursuant to Section 9(a)
hereof, a determination, if required by applicable law, with respect to
Indemnitee’s entitlement thereto shall be made in the specific case: (i) if
a Change in Control shall have occurred, by Independent Counsel in a written
opinion to the Board of Directors of the Company, a copy of which shall be
delivered to Indemnitee; or (ii) if a Change in Control shall not have
occurred, (A) by a majority vote of the Disinterested Directors, even
though less than a quorum of the Board of Directors of the Company, or
(B) if there are no Disinterested Directors or, if the Disinterested
Directors so direct, by Independent Counsel in a written opinion to the Board of
Directors of the Company, a copy of which shall be delivered to Indemnitee, or
(C) a majority vote of a quorum of the outstanding shares of stock of all
classes entitled to vote for directors, voting as a single class, which quorum
shall consist of stockholders who are not at that time parties to the Proceeding
in question, or (D) a court of competent jurisdiction. If it is so
determined that Indemnitee is entitled to indemnification hereunder, payment to
Indemnitee shall be made within 60 days after receipt by the Company of the
request for indemnification required pursuant to Section 9(a) hereof. Any costs
or expenses (including reasonable attorneys’ fees and disbursements) incurred by
Indemnitee in cooperating with the person, persons or entity making the
determination discussed in this Section 9(c) with respect to Indemnitee’s
entitlement to indemnification, shall be borne by the Company (irrespective of
the determination as to Indemnitee’s entitlement to indemnification) and the
Company hereby indemnifies and agrees to hold Indemnitee harmless
therefrom.
(d) In
the event the determination of entitlement to indemnification is to be made by
Independent Counsel pursuant to Section 9(c) hereof, the Independent Counsel
shall be selected as provided in this Section 9(d). If a Change in Control
shall not have occurred, the Independent Counsel shall be selected by the Board
of Directors of the Company, and the Company shall give written notice to
Indemnitee advising him or her of the identity of the Independent Counsel so
selected. If a Change in Control shall have occurred, the Independent Counsel
shall be selected by Indemnitee (unless Indemnitee shall request that such
selection be made by the Board of Directors of the Company, in which event the
preceding sentence shall apply), and Indemnitee shall give written notice to the
Company advising it of the identity of the Independent Counsel so selected. In
either event, Indemnitee or the Company, as the case may be, may, within
10 days after such written notice of selection shall have been given,
deliver to the Company or to Indemnitee, as the case may be, a written objection
to such selection;
provided
,
however
, that such
objection may be asserted only on the ground that the Independent Counsel so
selected does not meet the requirements of “Independent Counsel” as defined in
this Agreement, and the objection shall set forth with particularity the factual
basis of such assertion. Absent a proper and timely objection, the person so
selected shall act as Independent Counsel. If such written objection is so made
and substantiated, the Independent Counsel so selected may not serve as
Independent Counsel unless and until such objection is withdrawn or a court has
determined that such objection is without merit. If, within 20 days after
submission by Indemnitee of a written request for indemnification pursuant to
Section 9(c) hereof, no Independent Counsel shall have been selected and not
objected to, either the Company or Indemnitee may petition a court of competent
jurisdiction for resolution of any objection which shall have been made by the
Company or Indemnitee to the other’s selection of Independent Counsel and/or for
the appointment as Independent Counsel of a person selected by the Court or by
such other person as the Court shall designate, and the person with respect to
whom all objections are so resolved or the person so appointed shall act as
Independent Counsel under this Section 9.
(e) Indemnitee
will be deemed a party to a Proceeding for all purposes hereof if Indemnitee is
named as a defendant or respondent in a complaint or petition for relief in that
Proceeding, regardless of whether Indemnitee is ever served with process or
makes an appearance in that Proceeding.
10. Presumptions
and Effect of Certain Provisions.
(a) Neither
the failure of the Company (including its Board of Directors or Independent
Counsel) to have made a determination prior to the commencement of any action
pursuant to Section 11 of this Agreement that indemnification is proper in
the circumstances because Indemnitee has met the applicable standard of conduct,
nor an actual determination by the Company (including its Board of Directors or
Independent Counsel) that Indemnitee has not met such applicable standard of
conduct, shall be a defense to the action or create a presumption that
Indemnitee has not met the applicable standard of conduct.
(b) If
the person, persons or entity empowered or selected under Section 9 of this
Agreement to determine whether Indemnitee is entitled to indemnification shall
not have made a determination within 60 days after receipt by the Company
of a request for indemnification, the requisite determination of entitlement to
indemnification shall be deemed to have been made and Indemnitee shall be
entitled to such indemnification, absent (i) a misstatement by Indemnitee
of a material fact, or an omission of a material fact necessary to make
Indemnitee’s statement not misleading, in connection with the request for
indemnification, which if such fact were previously known, the Indemnitee would
not have been entitled to indemnification, or (ii) a prohibition of such
indemnification under applicable law;
provided
,
however
, that such
60-day period may be extended for a reasonable time, not to exceed an additional
60 days, if the person, persons or entity making the determination with
respect to entitlement to indemnification in good faith requires such additional
time for the obtaining or evaluating of documentation and/or information
relating thereto.
(c) The
termination of any Proceeding or of any claim, issue or matter therein, by
judgment, order, settlement or conviction, or upon a plea of nolo contendere or
its equivalent, shall not, of itself, create a presumption that Indemnitee did
not act in good faith and in a manner that he or she reasonably believed to be
in or not opposed to the best interests of the Company, or, with respect to any
criminal Proceeding, had reasonable cause to believe that his or her conduct was
unlawful.
(d) For
purposes of any determination of whether Indemnitee acted in good faith and in a
manner reasonably believed to be in or not opposed to the best interests of the
Company, and, with respect to any criminal Proceeding, Indemnitee had no
reasonable cause to believe his or her conduct was unlawful (collectively, “Good
Faith”), Indemnitee shall be deemed to have acted in Good Faith if, with respect
to Indemnitee’s action, Indemnitee relied in good faith on the records or books
of account of the Company and any other corporation, partnership, joint venture,
trust, or other enterprise of which Indemnitee is or was serving at the request
of the Company as a director, officer, employee or agent (“Enterprise”), or on
information, opinions, reports or statements, including financial statements and
other financial information, concerning the Enterprise or any other Person which
were prepared or supplied to Indemnitee by: (i) one or more officers or
employees of the Enterprise; (ii) appraisers, engineers, investment bankers,
legal counsel or other Persons as to matters Indemnitee reasonably believed were
within the professional or expert competence of those Persons and who have been
selected with reasonable care by or on behalf of the Company or Enterprise; and
(iii) any committee of the Board of Directors or equivalent managing body
of the Enterprise of which Indemnitee is or was, at the relevant time, not a
member. The provisions of this Section 10(d) shall not be deemed to be exclusive
or to limit in any way the other circumstances in which the Indemnitee may be
deemed to have met the applicable standard of conduct set forth in this
Agreement.
(e) The
knowledge and/or actions, or failure to act, of any director, officer, agent or
employee of the Enterprise shall not be imputed to Indemnitee for purposes of
determining the right to indemnification under this Agreement.
11. Remedies
of Indemnitee.
(a) In
the event that (i) a determination is made pursuant to Section 9 of
this Agreement that Indemnitee is not entitled to indemnification under this
Agreement, (ii) advancement of Expenses is not timely made pursuant to
Section 7 of this Agreement, (iii) no determination of entitlement to
indemnification shall have been made within the time period provided in Section
9(c) after receipt by the Company of the written request for indemnification,
(iv) reimbursement or payment of indemnification is not made pursuant to
Section 5, Section 6 and/or Section 9(b)(ii), within 60 days
after receipt by the Company of a written request therefor, or (v) payment
of indemnification pursuant to Section 3 or Section 4 of this
Agreement is not timely made after a determination has been made, or deemed to
have been made, that Indemnitee is entitled to indemnification, Indemnitee shall
be entitled to an adjudication by the Delaware Court of Chancery or a court of
competent jurisdiction of his or her entitlement to such indemnification or
advancement of Expenses and appeals therefrom, concluding in a final and
unappealable judgment by the highest court in Delaware. The Board of Directors
shall not make a determination as to the final disposition of such
adjudication.
(b) In
the event that a determination shall have been made pursuant to Section 9
of this Agreement that Indemnitee is not entitled to indemnification, any
judicial proceeding commenced pursuant to this Section 11 shall be
conducted in all respects as a de novo trial on the merits and Indemnitee shall
not be prejudiced by reason of that adverse determination.
(c) If
a determination shall have been made pursuant to Section 9 of this
Agreement that Indemnitee is entitled to indemnification, the Company shall be
bound by such determination in any judicial proceeding commenced pursuant to
this Section 11, absent (i) a misstatement by Indemnitee of a material
fact, or an omission of a material fact necessary to make Indemnitee’s statement
not misleading, in connection with the request for indemnification, which if
such fact were previously known, the Indemnitee would not have been entitled to
indemnification or (ii) a prohibition of such indemnification under
applicable law.
(d) In
the event that Indemnitee, pursuant to this Section 11, seeks a judicial
adjudication of his or her rights under, or to recover damages for breach of,
this Agreement, Indemnitee shall be entitled to recover from the Company, and
shall be indemnified by the Company against, any and all expenses (of the types
described in the definition of Expenses in Section 2(d) of this Agreement)
actually and reasonably incurred by Indemnitee in such judicial
adjudication.
(e) The
Company shall be precluded from asserting in any judicial proceeding commenced
pursuant to this Section 11 that the procedures and presumptions of this
Agreement are not valid, binding and enforceable and shall stipulate in any such
court that the Company is bound by all the provisions of this
Agreement.
12.
Indemnification and Advancement of
Expenses Under this Agreement Not Exclusive; Survival of Rights.
The
rights of indemnification and to receive advancement of Expenses as provided by
this Agreement shall not be deemed exclusive of any other rights to which
Indemnitee may be entitled under the Certificate of Incorporation or By-laws of
the Company, any other agreement, any vote of stockholders or disinterested
directors, the General Corporation Law of the State of Delaware, or otherwise.
No amendment or alteration of this Agreement or of any provision hereof shall
limit or restrict any right of Indemnitee under this Agreement in respect of any
action taken or omitted by such Indemnitee prior to such amendment or
alteration. To the extent that a change in the General Corporation Law of the
State of Delaware, whether by statute or judicial decision, permits greater
indemnification or advancement of Expenses than would be afforded currently
under the Certificate of Incorporation of the Company and this Agreement, it is
the intent of the parties hereto that Indemnitee shall enjoy by this Agreement
the greater benefits so afforded by such change. No right or remedy herein
conferred is intended to be exclusive of any other right or remedy, and every
other right and remedy shall be cumulative and in addition to every other right
and remedy given hereunder or now or hereafter existing at law or in equity or
otherwise. The assertion or employment of any right or remedy hereunder, or
otherwise, shall not prevent the concurrent assertion or employment of any other
right or remedy.
13.
Partial Indemnification.
If
Indemnitee is entitled under any provision of this Agreement to indemnification
or to receive advancement by the Company for a portion of the Expenses,
judgments, fines, penalties or amounts paid in settlement actually and
reasonably incurred by Indemnitee (or on his or her behalf) in connection with
such Proceeding, or any claim, issue or matter therein, but not, however, for
the total amount thereof, the Company shall nevertheless indemnify Indemnitee
for the portion thereof to which Indemnitee is entitled.
14.
Rights Continued.
The rights
of indemnification and to receive advancement of Expenses as provided by this
Agreement shall continue as to Indemnitee even though Indemnitee may have ceased
to be a director or officer of the Company, and shall inure to the benefit of
Indemnitee’s personal or legal representatives, executors, administrators,
successors, heirs, distributees, devisees and legatees.
15.
No Construction as an Employment
Agreement or Any Other Commitment.
Nothing contained in this Agreement
shall be construed as giving Indemnitee any right to be retained in the employ
or as an officer of the Company or any of its subsidiaries, if Indemnitee
currently serves as an officer of the Company, or to be renominated or reelected
as a director of the Company, if Indemnitee currently serves as a director of
the Company.
16.
Liability Insurance.
For the
duration of Indemnitee’s service as a director and/or officer of the Company,
and thereafter for so long as Indemnitee shall be subject to any pending or
possible Proceeding or of any claim, issue or matter therein, the Company shall
use commercially reasonable efforts (taking into account the scope and amount of
coverage available relative to the cost thereof) to cause to be maintained in
effect policies of directors’ and officers’ liability insurance providing
coverage for directors and/or officers of the Company that is at least
substantially comparable in scope and amount to that provided by the Company’s
current policies of directors’ and officers’ liability insurance. Indemnitee
shall be covered by such policy or policies in accordance with its or their
terms.
17.
No Duplication of Payments.
The Company shall not be liable under this Agreement to make any payment
of amounts otherwise indemnifiable under this Agreement if, and to the extent
that, Indemnitee is entitled to or has otherwise actually received such payment
under any contract, agreement or insurance policy, the Certificate of
Incorporation or By-laws of the Company, or otherwise. Indemnitee hereby
releases the Company and its respective authorized representatives from any
claims for indemnification hereunder if and to the extent that Indemnitee
receives proceeds from any liability insurance policy or other third-party
source in payment or reimbursement for such Proceeding or claims. Indemnitee
hereby agrees to assign all proceeds Indemnitee receives under any such
insurance policy or third-party agreement to the extent of the amount of
indemnification made to Indemnitee under the terms of this
Agreement.
18.
Subrogation.
In the event of
payment under this Agreement, the Company shall be subrogated to the extent of
such payment to all the rights of recovery of Indemnitee, who shall execute all
papers required and shall do everything that may be necessary to secure such
rights, including without limitation the execution of such documents as may be
necessary to enable the Company effectively to bring suit to enforce such
rights.
19.
Exceptions.
Notwithstanding
any other provision in this Agreement, but except as provided in
Section 11(d), the Company shall not be obligated pursuant to the terms of
this Agreement, to indemnify or advance Expenses to Indemnitee with respect to
any Proceeding, or any claim, issue or matter therein, (i) brought or made
by Indemnitee, unless the bringing of such Proceeding or the making of such
claim, issue or matter shall have been approved by the Board of Directors of the
Company, (ii) in which a final judgment is rendered against Indemnitee for
an accounting of profits made from the purchase and sale or the sale and
purchase by Indemnitee of securities of the Company pursuant to the provisions
of Section 16(b) of the Securities Exchange Act of 1934, as amended, or similar
provisions of any federal, state or local statute, (iii) if a final
adjudication establishes that the Indemnitee’s acts or omissions involved a
breach of Indemnitee’s fiduciaries duties or intentional misconduct, fraud or a
knowing violation of the law, or (iv) charging an improper personal benefit
to Indemnitee and Indemnitee is adjudged liable on that basis, unless, in each
case, the Delaware Court of Chancery or other court in which such Proceeding was
brought or other court of competent jurisdiction determines upon application
that in view of all the circumstances of the case, the Indemnitee is fairly and
reasonably entitled to indemnity for such Expenses.
20.
Notices.
Any notice or other
communication required or permitted to be given or made to the Company or
Indemnitee pursuant to this Agreement shall be given or made in writing
(a) three business days after being deposited in the United States mail,
with return receipt requested and postage thereon prepaid, (b) upon
delivery, when delivered personally or by overnight national courier or express
delivery, or (c) upon delivery, when sent by facsimile and provided
confirmation of receipt is obtained, addressed to the person to whom such notice
or communication is directed at the address of such person on the records of the
Company. Any such notice or communication to the Company shall be addressed to
the Secretary of the Company at the address of the Company’s principal executive
office set forth in the Company’s most recent periodic or current filing under
the Act.
21.
Contractual Rights.
The right
to be indemnified or to receive advancement of Expenses under this Agreement
(i) is a contract right based upon good and valuable consideration,
pursuant to which Indemnitee may sue, (ii) is and is intended to be
retroactive and shall be available as to events occurring prior to the date of
this Agreement, and (iii) shall continue after any rescission or
restrictive modification of this Agreement as to events occurring prior
thereto.
22.
Severability.
If any provision
or provisions of this Agreement shall be held to be invalid, illegal or
unenforceable for any reason whatsoever, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected or
impaired thereby. To the fullest extent possible, the provisions of this
Agreement shall be construed so as to give effect to the intent manifested by
the provisions held invalid, illegal or unenforceable, and any provision or
provisions held to be invalid, illegal or unenforceable for any reason
whatsoever shall be deemed reformed to the extent necessary to conform to
applicable law and to give the maximum effect to the intent of the parties
hereto.
23.
Successors; Binding Agreement.
The Company shall use its commercially reasonable efforts to cause any
successor (whether direct or indirect by purchase, merger, consolidation or
otherwise to all or substantially all of the business or assets of the Company),
by written agreement in form and substance reasonably satisfactory to
Indemnitee, to expressly assume and agree to perform this Agreement in the same
manner and to the same extent that the Company would be required to perform if
no such succession had taken place. As used in this Agreement, “Company” shall
mean the Company as hereinbefore defined and any successor to its business
and/or assets as aforesaid that executes and delivers the agreement provided for
in this Section 23 or that otherwise becomes bound by the terms and
provisions of this Agreement by operation of law. This Agreement shall be
binding upon the Company and its successors and assigns (including, without
limitation, any direct or indirect successor by purchase, merger, consolidation
or otherwise to all or substantially all of the business or assets of the
Company).
24. Counterparts,
Modification, Headings, Gender.
(a) This
Agreement may be executed in counterparts, each of which shall be deemed an
original and all of which when taken together shall constitute one and the same
instrument, and either party hereto may execute this Agreement by signing any
such counterpart.
(b) No
provisions of this Agreement may be modified, waived or discharged unless such
waiver, modification or discharge is agreed to in writing and signed by
Indemnitee and an appropriate authorized officer of the Company. No waiver by
any party at any time of any breach by any other party of, or compliance with,
any condition or provision of this Agreement to be performed by any other party
shall be deemed a waiver of similar or dissimilar provisions or conditions at
the same time or at any prior or subsequent time.
(c) Section
headings are not to be considered part of this Agreement, are solely for
convenience of reference, and shall not affect the meaning or interpretation of
this Agreement or any provision set forth herein.
(d) Pronouns
in masculine, feminine and neuter genders shall be construed to include any
other gender, and words in the singular form shall be construed to include the
plural and vice versa, unless the context otherwise requires.
25.
Exclusive Jurisdiction; Governing
Law.
The Company and Indemnitee agree that all disputes in any way
relating to or arising under this Agreement, including, without limitation, any
action for advancement of Expenses or indemnification, shall be litigated, if at
all, exclusively in the Delaware courts, and if necessary, the corresponding
appellate courts. This Agreement shall be governed by and construed and enforced
in accordance with the laws of the State of Delaware applicable to contracts
made and to be performed in such state without giving effect to its principles
of conflicts of laws. The Company and Indemnitee (i) expressly submit
themselves to the personal jurisdiction of the Delaware courts for purposes of
any action or proceeding arising out of or in connection with this Agreement,
(ii) irrevocably appoint, to the extent such party is not a resident of the
State of Delaware, CT Corporation Systems, 1209 Orange Street, Wilmington,
Delaware 19801, as its agent in the State of Delaware as such party’s agent for
acceptance of legal process in connection with any such action or proceeding
against such party with the same legal force and validity as if served upon such
party personally within the State of Delaware, (iii) waive any objection to the
laying of venue of any such action or proceeding in the Delaware courts, and
(iv) waive, and agree not to plead or to make, any claim that any such
action or proceeding brought in the Delaware courts has been brought in an
improper or otherwise inconvenient forum.
26.
Duration of Agreement.
This
Agreement shall continue until and terminate upon the later of: (a) six
years after the date that Indemnitee shall have ceased to serve as a director
and/or officer of the Company or director, officer, employee or agent of any
other corporation, partnership, joint venture, trust, or other enterprise which
Indemnitee served at the request of the Company; or (b) one year after the
final, nonappealable termination of any Proceeding then pending in respect of
which Indemnitee is granted rights of indemnification or advancement of Expenses
hereunder and of any proceeding commenced by Indemnitee pursuant to
Section 11 of this Agreement relating thereto.
27.
Contribution.
If it is
established, under Section 9 or otherwise, that Indemnitee has the right to
be indemnified under this Agreement in respect of any claim, but that right is
unenforceable by reason of applicable law or public policy, then, to the fullest
extent applicable law permits, the Company, in lieu of indemnifying or causing
the indemnification of Indemnitee under this Agreement, will contribute to the
amount Indemnitee has incurred, whether for judgments, fines, penalties, excise
taxes, amounts paid or to be paid in settlement or for Expenses reasonably
incurred, in connection with that Proceeding, in such proportion as is deemed
fair and reasonable in light of all the circumstances of that Proceeding in
order to reflect:
(a) the
relative benefits Indemnitee and the Company have received as a result of the
event(s) or transactions(s) giving rise to that Proceeding; or
(b) the
relative fault of Indemnitee and of the Company and its other functionaries in
connection with those event(s) or transaction(s).
28.
Effect of Federal Law.
Both
the Company and Indemnitee acknowledge that in certain instances, federal law
will override Delaware law and prohibit the Company from indemnifying its
officers and directors. The Company and Indemnitee specifically acknowledge that
the Securities and Exchange Commission has taken the position that
indemnification is not permissible for liabilities arising under certain federal
securities laws, and federal law prohibits indemnification for certain
violations of the Employee Retirement Income Security Act.
29.
Savings Clause.
Nothing in
this Agreement is intended to require or shall be construed as requiring the
Company to do or fail to do any act in violation of applicable law. The
provisions of this Agreement (including any provision within a single section,
paragraph or sentence) shall be severable in accordance with this
Section 29. If this Agreement or any portion thereof shall be invalidated
on any ground by any court of competent jurisdiction, the Company shall
nevertheless indemnify Indemnitee as to Expenses, judgments, fines and penalties
with respect to any Proceeding to the fullest extent permitted by any applicable
portion of this Agreement that shall not have been invalidated or by any other
applicable law, and this Agreement shall remain enforceable to the fullest
extent permitted by law.
IN
WITNESS WHEREOF, the Company and Indemnitee have executed this Agreement as of
the date and year first above written.
|
NOVAVAX,
INC.
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By:
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Rahul
Singhvi
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President
and Chief
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Executive
Officer
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INDEMNITEE
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Print
Name:
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EXHIBIT
A
INDEMNITEE’S
UNDERTAKING
___________
, 20__
Novavax,
Inc.
9920
Belward Campus Drive
Rockville,
MD 20850
Re: Indemnity
Agreement
Ladies
and Gentlemen:
Reference
is made to the Indemnity Agreement dated as of January 1, 2010 by and between
Novavax, Inc. and the undersigned Indemnitee (the “Agreement”), and particularly
to Section 7 thereof relating to the advancement by the Company of certain
Expenses incurred by the undersigned Indemnitee. Capitalized terms used and not
otherwise defined in this Indemnitee’s Undertaking shall have the respective
meanings given to such terms in the Agreement.
The types
and amounts of Expenses incurred by or on behalf of the undersigned Indemnitee
are itemized on Attachment I to this Indemnitee’s Undertaking. The undersigned
Indemnitee hereby requests that the total amount of these Expenses (the
“Advanced Amount”) be paid by the Company in advance of the final disposition of
such Proceeding in accordance with the Agreement.
The
undersigned Indemnitee hereby agrees to repay the Advanced Amount to the Company
to the extent that it is determined, following the final disposition of such
Proceeding and in accordance with Section 9, that the undersigned
Indemnitee is not entitled to be indemnified therefor by the
Company.
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Very
truly yours,
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Signature
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Name
of Indemnitee (Type or Print)
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ATTACHMENT
I TO
INDEMNITEE’S
UNDERTAKING
ITEMIZATION
OF
TYPES AND AMOUNTS OF
EXPENSES
Attached
hereto are receipts, statements or invoices for the following qualifying
Expenses which Indemnitee represents have been incurred by Indemnitee in
connection with a Proceeding:
Type
Amount
1.
Total
Advanced Amount
Exhibit
10.37
At
Market Issuance Sales Agreement
March 15,
2010
McNicoll,
Lewis & Vlak LLC
420
Lexington Ave., Suite 628
New York,
NY 10170
Ladies
and Gentlemen:
Novavax,
Inc., a Delaware corporation (the “
Company
”), confirms
its agreement (this “
Agreement
”) with
McNicoll, Lewis & Vlak LLC, a Delaware limited liability company (“
MLV
”), as
follows:
1.
Issuance and Sale of
Shares
. The Company agrees that, from time to time during the
term of this Agreement, on the terms and subject to the conditions set forth
herein, it may issue and sell through MLV, acting as agent and/or principal, up
to $50,000,000 of shares (the “
Shares
”) of the
Company’s common stock, par value $0.01 per share (the “
Common
Stock
”). Notwithstanding anything to the contrary contained
herein, the parties hereto agree that compliance with the limitations set forth
in this Section 1 on the number of Shares issued and sold under this Agreement
shall be the sole responsibility of the Company and that MLV shall have no
obligation in connection with such compliance. The issuance and sale
of Shares through MLV will be effected pursuant to the Registration Statement
(as defined below) filed by the Company and declared effective by the Securities
and Exchange Commission (the “
Commission
”),
although nothing in this Agreement shall be construed as requiring the Company
to use the Registration Statement to issue Common Stock or Preferred
Stock.
The
Company intends to file, in accordance with the provisions of the Securities Act
of 1933, as amended, and the rules and regulations thereunder (collectively, the
“
Securities
Act
”), with the Commission a registration statement on Form S-3,
including one or more base prospectuses, with respect to equity and other
offerings, including the Shares, and which incorporates by reference documents
that the Company has filed or will file in accordance with the provisions of the
Securities Exchange Act of 1934, as amended, and the rules and regulations
thereunder (collectively, the “
Exchange
Act
”). The Company will, if necessary, prepare a prospectus
supplement (the “
Prospectus
Supplement
”) to the base prospectus included as part of such registration
statement. The Company will furnish to MLV, for use by MLV, copies of
the prospectus included as part of such registration statement, as supplemented,
if at all, by the Prospectus Supplement, relating to the
Shares. Except where the context otherwise requires, such
registration statement, as amended when it becomes effective, including all
documents filed as part thereof or incorporated by reference therein, and
including any information contained in a Prospectus (as defined below)
subsequently filed with the Commission pursuant to Rule 424(b) under the
Securities Act and also including any other registration statement filed
pursuant to Rule 462(b) under the Securities Act, collectively, are herein
called the “
Registration
Statement
,” and the base prospectus, including all documents incorporated
therein by reference, included in the Registration Statement, as it may be
supplemented by the Prospectus Supplement, in the form in which such prospectus
and/or Prospectus Supplement have most recently been filed by the Company with
the Commission pursuant to Rule 424(b) under the Securities Act is herein called
the “
Prospectus
.” Any
reference herein to the Registration Statement, the Prospectus or any amendment
or supplement thereto shall be deemed to refer to and include the documents
incorporated by reference therein, and any reference herein to the terms
“amend,” “amendment” or “supplement” with respect to the Registration Statement
or the Prospectus shall be deemed to refer to and include the filing after the
execution hereof of any document with the Commission deemed to be incorporated
by reference therein. For purposes of this Agreement, all references
to the Registration Statement, the Prospectus or to any amendment or supplement
thereto shall be deemed to include any copy filed with the Commission pursuant
to its Electronic Data Gathering Analysis and Retrieval System, or if
applicable, the Interactive Data Electronic Application system when used by the
Commission (collectively, “
EDGAR
”).
2.
Placements
. Each
time that the Company wishes to issue and sell Shares hereunder (each, a “
Placement
”), it will
notify MLV by email notice (or other method mutually agreed to in writing by the
Parties) of the number of Shares (the “
Placement Shares
”) to
be issued, the type of Shares, the time period during which sales are requested
to be made, any limitation on the number of Shares that may be sold in any one
day and any minimum price below which sales may not be made (a “
Placement Notice
”),
the form of which is attached hereto as Schedule 1. The Placement
Notice shall originate from any of the individuals from the Company set forth on
Schedule 3 (with a copy to each of the other individuals from the Company listed
on such schedule), and shall be addressed to each of the individuals from MLV
set forth on Schedule 3, as such Schedule 3 may be amended from time to
time. The Placement Notice shall be effective unless and until
(i) MLV declines to accept the terms contained therein as a result of any
suspension or limitation of trading in the Placement Shares or in securities
generally on the Exchange or any occurrence or event that causes a material
adverse change in the operation or prospects of the Company, (ii) the
entire amount of the Placement Shares have been sold, (iii) the Company
suspends or terminates the Placement Notice or (iv) the Agreement has been
terminated under the provisions of Section 12. The amount of any
discount, commission or other compensation to be paid by the Company to MLV in
connection with the sale of the Placement Shares shall be calculated in
accordance with the terms set forth in Schedule 2. It is expressly
acknowledged and agreed that neither the Company nor MLV will have any
obligation whatsoever with respect to a Placement or any Placement Shares unless
and until the Company delivers a Placement Notice to MLV and MLV does not
decline such Placement Notice pursuant to the terms set forth above, and then
only upon the terms specified therein and herein. In the event of a
conflict between the terms of this Agreement and the terms of a Placement
Notice, the terms of the Placement Notice will control.
3.
Sale of Placement Shares by
MLV
. Subject to the terms and conditions herein set forth,
upon the Company’s issuance of a Placement Notice, and unless the sale of the
Placement Shares described therein has been declined, suspended, or otherwise
terminated in accordance with the terms of this Agreement, MLV will use its
commercially reasonable efforts consistent with its normal trading and sales
practices to sell such Placement Shares up to the amount specified, and
otherwise in accordance with the terms of such Placement Notice. MLV
will provide written confirmation to the Company no later than the opening of
the Trading Day (as defined below) immediately following the Trading Day on
which it has made sales of Placement Shares hereunder setting forth the number
of Placement Shares sold on such day, the compensation payable by the Company to
MLV pursuant to Section 2 with respect to such sales, and the Net Proceeds (as
defined below) payable to the Company. MLV may sell Placement Shares
by any method permitted by law deemed to be an “at the market” offering as
defined in Rule 415 of the Securities Act, including without limitation sales
made directly on NASDAQ Capital Market (the “
Exchange
”), on any
other existing trading market for the Common Stock or to or through a market
maker. MLV may also sell Placement Shares in privately negotiated
transactions, subject to approval by the Company. The Company
acknowledges and agrees that (i) there can be no assurance that MLV will be
successful in selling Placement Shares, and (ii) MLV will incur no
liability or obligation to the Company or any other person or entity if it does
not sell Placement Shares for any reason other than a failure by MLV to use its
commercially reasonable efforts consistent with its normal trading and sales
practices to sell such Placement Shares as required under this Section
3. For the purposes hereof, “
Trading Day
” means
any day on which Common Stock is purchased and sold on the principal market on
which the Common Stock is listed or quoted.
4.
Suspension of
Sales
. The Company or MLV may, upon notice to the other party
in writing (including by email correspondence to each of the individuals of the
other Party set forth on Schedule 3, if receipt of such correspondence is
actually acknowledged by any of the individuals to whom the notice is sent,
other than via auto-reply) or by telephone (confirmed immediately by verifiable
facsimile transmission or email correspondence to each of the individuals of the
other Party set forth on Schedule 3), suspend any sale of Placement Shares;
provided, however, that such suspension shall not affect or impair either
party’s obligations with respect to any Placement Shares sold hereunder prior to
the receipt of such notice. Each of the Parties agrees that no such
notice under this Section 4 shall be effective against the other unless it is
made to one of the individuals named on Schedule 3 hereto, as such Schedule may
be amended from time to time.
5.
Settlement
.
(a)
Settlement of Placement
Shares
. Unless otherwise specified in the applicable Placement
Notice, settlement for sales of Placement Shares will occur on the third (3rd)
Trading Day (or such earlier day as is industry practice for regular-way
trading) (each, a “
Settlement Date
”)
following the respective Point of Sale (as defined below). The amount
of proceeds to be delivered to the Company on a Settlement Date against receipt
of the Placement Shares sold (the “
Net Proceeds
”) will
be equal to the aggregate sales price received by MLV at which such Placement
Shares were sold, after deduction for (i) MLV’s commission, discount or
other compensation for such sales payable by the Company pursuant to Section 2
hereof, (ii) any other amounts due and payable by the Company to MLV
hereunder pursuant to Section 7(g) (Expenses) hereof, and (iii) any
transaction fees imposed by any governmental or self-regulatory organization in
respect of such sales.
(b)
Delivery of Placement
Shares
. On or before each Settlement Date, the Company will,
or will cause its transfer agent to, electronically transfer the Placement
Shares being sold by crediting MLV’s or its designee’s account at The Depository
Trust Company through its Deposit and Withdrawal at Custodian System ("
DWAC
") or by such
other means of delivery as may be mutually agreed upon by the parties hereto
which in all cases shall be freely tradeable, transferable, registered shares in
good deliverable form. On each Settlement Date, MLV will deliver the
related Net Proceeds in same day funds to an account designated by the Company
on, or prior to, the Settlement Date. MLV will be responsible
for obtaining DWAC instructions or instructions for delivery by other means with
regard to the transfer of Placement Shares being sold. The Company
agrees that if the Company, or its transfer agent (if applicable), defaults in
its obligation to deliver Placement Shares on a Settlement Date, the Company
agrees that in addition to and in no way limiting the rights and obligations set
forth in Section 10(a) (Indemnification and Contribution) hereto, it will
(i) hold MLV harmless against any loss, claim, damage, or expense
(including reasonable legal fees and expenses), as incurred, arising out of or
in connection with such default by the Company and (ii) pay to MLV any
commission, discount, or other compensation to which it would otherwise have
been entitled absent such default.
6.
Representations and
Warranties of the Company
. The Company represents and warrants
to, and agrees with, MLV that as of the date of this Agreement and as of each
Representation Date (as defined in Section 7(m) below) on which a certificate is
required to be delivered pursuant to Section 7(m) of this Agreement, as the case
may be, except as may be disclosed in the Registration Statement or a Disclosure
Schedule delivered in connection herewith:
(a)
Registration Statement and
Prospectus
. The Company and, assuming no act or omission on
the part of MLV that would make such statement untrue, the transactions
contemplated by this Agreement meet the requirements for and comply with the
conditions for the use of Form S-3 under the Securities Act. The
Registration Statement has been filed with the Commission and has been declared
effective under the Securities Act. The Prospectus Supplement will
name MLV as an underwriter, acting as principal and/or agent, that the Company
might engage in the section entitled “Plan of Distribution.” The Company has not
received, and has no notice of, any order of the Commission preventing or
suspending the use of the Registration Statement, or threatening or instituting
proceedings for that purpose. The Registration Statement and the
offer and sale of Shares as contemplated hereby meet the requirements of
Rule 415 under the Act and comply in all material respects with said
Rule. Any statutes, regulations, contracts or other documents that
are required to be described in the Registration Statement or the Prospectus or
to be filed as exhibits to the Registration Statement have been so described or
filed. Copies of the Registration Statement, the Prospectus, and any
such amendments or supplements and all documents incorporated by reference
therein that were filed with the Commission on or prior to the date of this
Agreement have been delivered, or are available through EDGAR, to MLV and their
counsel. The Company has not distributed and, prior to the later to
occur of each Settlement Date and completion of the distribution of the
Placement Shares, will not distribute any offering material in connection with
the offering or sale of the Placement Shares other than the Registration
Statement and the Prospectus and any Issuer Free Writing Prospectus (as defined
below) to which MLV has consented. The Common Stock is currently
listed on the NASDAQ Global Market under the trading symbol
“NVAX”. Except as disclosed in the Registration Statement, the
Company has not, in the 12 months preceding the date hereof, received notice
from the Exchange to the effect that the Company is not in compliance with the
listing or maintenance requirements. The Company has no reason to
believe that it will not in the foreseeable future continue to be in compliance
with all such listing and maintenance requirements.
(b)
No Misstatement or
Omission
. The Registration Statement, when it became or
becomes effective, and the Prospectus, and any amendment or supplement thereto,
on the date of such Prospectus or amendment or supplement, conformed or will
conform in all material respects with the requirements of the Securities
Act. At each Settlement Date, the Registration Statement and the
Prospectus, as of such date, will conform in all material respects with the
requirements of the Securities Act. The Registration Statement, when
it became or becomes effective, did not, or will not, contain an untrue
statement of a material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein not
misleading. The Prospectus and any amendment or supplement thereto,
on the date thereof and at each Point of Sale, did not or will not include an
untrue statement of a material fact or omit to state a material fact necessary
to make the statements therein, in light of the circumstances under which they
were made, not misleading. The documents incorporated by reference in
the Prospectus or any Prospectus Supplement did not, and any further documents
filed and incorporated by reference therein will not, when filed with the
Commission, contain an untrue statement of a material fact or omit to state a
material fact required to be stated in such document or necessary to make the
statements in such document, in light of the circumstances under which they were
made, not misleading. The foregoing shall not apply to statements in,
or omissions from, any such document made in reliance upon, and in conformity
with, information furnished to the Company by MLV specifically for use in the
preparation thereof. “
Point of Sale
” means,
for a Placement, the time at which an acquiror of Placement Shares entered into
a contract, binding upon such acquiror, to acquire such Shares.
(c)
Conformity with Securities
Act and Exchange Act
. The documents incorporated by reference
in the Registration Statement, the Prospectus or any amendment or supplement
thereto, when such documents were or are filed with the Commission under the
Securities Act or the Exchange Act or became or become effective under the
Securities Act, as the case may be, conformed or will conform in all material
respects with the requirements of the Securities Act and the Exchange Act, as
applicable.
(d)
Financial
Information
. The consolidated financial statements and the
related notes thereto included or incorporated by reference in the Registration
Statement and the Prospectus comply with the applicable requirements of the Act
and the Exchange Act, as applicable, and present fairly, the financial position
of the Company as of the dates indicated and the results of its operations and
the changes in its consolidated cash flows for the periods specified; such
financial statements have been prepared in conformity with generally accepted
accounting principles applied on a consistent basis throughout the periods
covered thereby (except (i) as may be otherwise indicated in such financial
statements or the notes thereto or (ii) in the case of unaudited interim
financial statements, to the extent that they may not include footnotes or may
be condensed or summary statements), and the other financial information
included or incorporated by reference in the Registration Statement and the
Prospectus has been derived from the accounting records of the Company and
presents fairly the information shown thereby. Any pro forma
financial statements or data included or incorporated by reference in the
Registration Statement and the Prospectus comply with the requirements of
Regulation S-X of the Securities Act, including, without limitation,
Article 11 thereof, and the assumptions used in the preparation of such pro
forma financial statements and data are reasonable, the pro forma adjustments
used therein are appropriate to give effect to the circumstances referred to
therein and the pro forma adjustments have been properly applied to the
historical amounts in the compilation of those statements and
data. No other financial statements or schedules of the Company or
any other entity are required by the Act to be included in the Registration
Statement or the Prospectus. All disclosures contained in the
Registration Statement, the Pricing Disclosure Materials and the Prospectus
regarding “non-GAAP financial measures” (as such term is defined by Item 10 of
Regulation S-K under the Act) comply with Regulation G of the Exchange Act and
Item 10 of Regulation S-K under the Act, to the extent
applicable. The Company does not have any material liabilities or
obligations, direct or contingent (including any off-balance sheet obligations
and any “variable interest entities” within the meaning of Financial Accounting
Standards Board Interpretation No. 46(R) or Statement of Financial Accounting
Standards No. 167), not disclosed in the Registration Statement, the Pricing
Disclosure Materials and the Prospectus.
(e)
Conformity with EDGAR
Filing
. The Prospectus delivered to MLV for use in connection
with the sale of the Placement Shares pursuant to this Agreement will be
identical to the versions of the Prospectus created to be transmitted to the
Commission for filing via EDGAR, except to the extent permitted by Regulation
S-T.
(f)
Organization
. The
Company is, and will be, duly organized, validly existing as a corporation and
in good standing under the laws of its jurisdiction of
organization. The Company is, and will be, duly licensed or qualified
as a foreign corporation for transaction of business and in good standing under
the laws of each other jurisdiction in which its ownership or lease of property
or the conduct of its businesses requires such license or qualification, and has
all corporate power and authority necessary to own or hold its properties and to
conduct its business as described in the Registration Statement and the
Prospectus, except where the failure to be so qualified or in good standing or
have such power or authority would not, individually or in the aggregate, have a
material adverse effect or would reasonably be expected to have a material
adverse effect on or affecting the business, properties, management,
consolidated financial position, stockholders’ equity or results of operations
of the Company (a “
Material Adverse
Effect
”).
(g)
Subsidiaries
. The
Company has no active subsidiaries.
(h)
No Violation or
Default
. The Company is not (i) in violation of its
charter or by-laws or similar organizational documents; (ii) in default,
and no event has occurred that, with notice or lapse of time or both, would
constitute such a default, in the due performance or observance of any term,
covenant or condition contained in any indenture, mortgage, deed of trust, loan
agreement or other agreement or instrument to which the Company is a party or by
which the Company is bound or to which any of the property or assets of the
Company is subject; or (iii) in violation of any law or statute or any
judgment, order, rule or regulation of any court or arbitrator or governmental
or regulatory authority, except, in the case of each of clauses (ii) and (iii)
above, for any such violation or default that would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect. To the Company’s knowledge, no other party under any material
contract or other agreement to which it is a party is in default in any respect
thereunder where such default would have a Material Adverse
Effect.
(i)
No Material Adverse
Change
. Except as set forth in or otherwise contemplated by
the Registration Statement (exclusive of any amendment thereof) or the
Prospectus (exclusive of any supplement thereto), since the date of the most
recent financial statements of the Company included or incorporated by reference
in the Registration Statement and the Prospectus and prior to each Settlement
Date, (i) there has not been and will not have been any change in the
capital stock of the Company (except for changes in the number of outstanding
shares of Common Stock of the Company due to the issuance of shares upon the
exercise or conversion of securities exercisable for, or convertible into,
shares of Common Stock outstanding on the date hereof) or long-term debt of the
Company or any dividend or distribution of any kind declared, set aside for
payment, paid or made by the Company on any class of capital stock, that has
resulted in or that would reasonably be expected to result in a Material Adverse
Effect to the Company taken as a whole; (ii) other than this Agreement, the
Company has not entered and will not enter into any transaction or agreement,
not in the ordinary course of business, that is material to the Company taken as
a whole or incurred and will not incur any liability or obligation, direct or
contingent, not in the ordinary course of business, that is material to the
Company taken as a whole; (iii) there has not been any material adverse change
in the business, properties, management, financial position, stockholders’
equity, or results of operations of the Company, taken as a whole; and
(iv) the Company has not sustained any material loss or interference with
its business from fire, explosion, flood or other calamity, whether or not
covered by insurance, or from any labor disturbance or dispute or any action,
order or decree of any court or arbitrator or governmental or regulatory
authority.
(j)
Capitalization
. The
issued and outstanding shares of capital stock of the Company have been validly
issued, are fully paid and nonassessable and, other than as disclosed in or
contemplated by the Registration Statement or the Prospectus, are not subject to
any preemptive rights, rights of first refusal or similar rights. The
Company has an authorized, issued and outstanding capitalization as set forth in
the Registration Statement and the Prospectus as of the dates referred to
therein (other than the grant of additional options under the Company’s existing
stock option plans, or changes in the number of outstanding shares of Common
Stock of the Company due to the issuance of shares upon the exercise or
conversion of securities exercisable for, or convertible into, shares of Common
Stock outstanding on the date hereof) and such authorized capital stock conforms
to the description thereof set forth in the Registration Statement and the
Prospectus. The description of the securities of the Company in the
Registration Statement and the Prospectus is complete and accurate in all
material respects. Except as disclosed in or contemplated by the
Registration Statement or the Prospectus, as of the date referred to therein,
the Company does not have outstanding any options to purchase, or any rights or
warrants to subscribe for, or any securities or obligations convertible into, or
exchangeable for, or any contracts or commitments to issue or sell, any shares
of capital stock or other securities.
(k)
Authorization;
Enforceability
. The Company has full legal right, power and
authority to enter into this Agreement and perform the transactions contemplated
hereby. This Agreement has been duly authorized, executed and
delivered by the Company and is a legal, valid and binding agreement of the
Company enforceable in accordance with its terms, except to the extent that
(i) enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting creditors’ rights generally
and by general equitable principles and (ii) the indemnification and
contribution provisions of Section 10 hereof may be limited by federal or state
securities laws and public policy considerations in respect
thereof.
(l)
Authorization of Placement
Shares
. The Placement Shares, when issued and delivered
pursuant to the terms approved by the Board of Directors or a duly designated
committee thereof, against payment therefor as provided herein, will be duly and
validly authorized and issued and fully paid and nonassessable, free and clear
of any pledge, lien, encumbrance, security interest or other claim, including
any statutory or contractual preemptive rights, resale rights, rights of first
refusal or other similar rights, and will be registered pursuant to Section 12
of the Exchange Act. The Placement Shares, when issued, will conform
in all material respects to the description thereof set forth in or incorporated
into the Prospectus.
(m)
No Consents
Required
. No consent, approval, authorization, order,
registration or qualification of or with any court or arbitrator or governmental
or regulatory authority is required for the execution, delivery and performance
by the Company this Agreement, the issuance and sale by the Company of the
Placement Shares, except for the registration of the Placement Shares under the
Act and such consents, approvals, authorizations, orders and registrations or
qualifications as may be required under applicable state securities laws or by
the by-laws and rules of the Financial Industry Regulatory Authority (“
FINRA
”) or the
Exchange in connection with the sale of the Placement Shares by
MLV.
(n)
No Preferential
Rights
. Except as set forth in the Registration Statement and
the Prospectus, (i) no person, as such term is defined in Rule 1-02 of
Regulation S-X promulgated under the Securities Act (each, a “
Person
”), has the
right, contractual or otherwise, to cause the Company to issue or sell to such
Person any shares of Common Stock or shares of any other capital stock or other
securities of the Company, (ii) no Person has any preemptive rights, resale
rights, rights of first refusal, or any other rights (whether pursuant to a
“poison pill” provision or otherwise) to purchase any shares of Common Stock or
shares of any other capital stock or other securities of the Company, (iii) no
Person has the right to act as an underwriter or as a financial advisor to the
Company in connection with the offer and sale of the Shares, and (iv) no
Person has the right, contractual or otherwise, to require the Company to
register under the Securities Act any shares of Common Stock or shares of any
other capital stock or other securities of the Company, or to include any such
shares or other securities in the Registration Statement or the offering
contemplated thereby, whether as a result of the filing or effectiveness of the
Registration Statement or the sale of the Placement Shares as contemplated
thereby or otherwise.
(o)
Independent Public
Accountant
. Grant Thornton LLP (the "
Accountant
"), whose
report on the consolidated financial statements of the Company is filed with the
Commission as part of the Prospectus for the periods ended December 31, 2006,
December 31, 2007 and December 31, 2008, is and, during the periods covered by
their respective reports, was an independent public accountant within the
meaning of the Securities Act and the Public Company Accounting Oversight Board
(United States). To the Company’s knowledge, after due and careful
inquiry, the Accountant is not in violation of the auditor independence
requirements of the Sarbanes-Oxley Act of 2002 (the “
Sarbanes-Oxley Act
”)
with respect to the Company.
(p)
Enforceability of
Agreements
. To the knowledge of the Company, all agreements
between the Company and third parties expressly referenced in the Prospectus are
legal, valid and binding obligations of the Company enforceable in accordance
with their respective terms, except to the extent that (i) enforceability
may be limited by bankruptcy, insolvency, reorganization, moratorium or similar
laws affecting creditors’ rights generally and by general equitable principles
and (ii) the indemnification provisions of certain agreements may be
limited be federal or state securities laws or public policy considerations in
respect thereof and except for any unenforceability that, individually or in the
aggregate, would not unreasonably be expected to have a Material Adverse
Effect.
(q)
No
Litigation
. Except as set forth in the Registration Statement
or the Prospectus, there are no legal, governmental or regulatory actions, suits
or proceedings pending, nor, to the Company’s knowledge, any legal, governmental
or regulatory investigations, to which the Company is a party or to which any
property of the Company is the subject that, individually or in the aggregate,
if determined adversely to the Company, would reasonably be expected to have a
Material Adverse Effect or materially and adversely affect the ability of the
Company to perform its obligations under this Agreement; to the Company’s
knowledge, no such actions, suits or proceedings are threatened or contemplated
by any governmental or regulatory authority or threatened by others; and
(i) there are no current or pending legal, governmental or regulatory
investigations, actions, suits or proceedings that are required under the Act to
be described in the Prospectus that are not so described; and (ii) there
are no contracts or other documents that are required under the Act to be filed
as exhibits to the Registration Statement that are not so filed.
(r)
Licenses and
Permits
. Except as set forth in the Registration Statement or
the Prospectus, the Company possesses or has obtained, and at each Settlement
Date will possess and will have obtained, all licenses, certificates, consents,
orders, approvals, permits and other authorizations issued by, and have made all
declarations and filings with, the appropriate federal, state, local or foreign
governmental or regulatory authorities that are necessary for the ownership or
lease of its properties or the conduct of its business as described in the
Registration Statement and the Prospectus (the “
Permits
”), except
where the failure to possess, obtain or make the same would not, individually or
in the aggregate, reasonably be expected to have a Material Adverse
Effect. Except as disclosed in the Registration Statement or the
Prospectus, the Company has not received written notice of any proceeding
relating to revocation or modification of any such Permit and does not have any
reason to believe that such Permit will not be renewed in the ordinary course,
except where the failure to obtain any such renewal would not, individually or
in the aggregate, reasonably be expected to have a Material Adverse
Effect.
(s)
Market
Capitalization
. As of the close of trading on the
Exchange on the Trading Day immediately prior to the date of this Agreement
and the Trading Day immediately prior to the date of each Placement Notice (i)
the aggregate market value of the outstanding voting and non-voting common
equity (as defined in Securities Act Rule 405) of the Company held by persons
other than affiliates of the Company (pursuant to Securities Act Rule 144, those
that directly, or indirectly through one or more intermediaries, control, or are
controlled by, or are under common control with, the Company) (the “
Non-Affiliate
Shares
”), was equal to or greater than $75 million (calculated by
multiplying (x) the price at which the common equity of the Company was last
sold on the Exchange on the Trading Day immediately prior to the date of this
Agreement times (y) the number of Non-Affiliate Shares); or (ii) the aggregate
market value of securities sold by or on behalf of the Company as set forth on
Schedule 4 during the previous 12 calendar months, including the Placement
Shares, is no more than one-third the aggregate market value of the
Non-Affiliate Shares.
(t)
No Material
Defaults
. The Company has not defaulted on any installment on
indebtedness for borrowed money or on any rental on one or more long-term
leases, which defaults, individually or in the aggregate, could reasonably be
expected to have a Material Adverse Effect. The Company has not filed
a report pursuant to Section 13(a) or 15(d) of the Exchange Act since the filing
of its last Annual Report on Form 10-K, indicating that it (i) has failed
to pay any dividend or sinking fund installment on preferred stock or
(ii) has defaulted on any installment on indebtedness for borrowed money or
on any rental on one or more long-term leases, which defaults, individually or
in the aggregate, could reasonably be expected to have a Material Adverse
Effect.
(u)
Certain Market
Activities
. Neither the Company, nor any of its respective
directors, officers or controlling persons has taken, directly or indirectly,
any action designed, or that has constituted or might reasonably be expected to
cause or result in, under the Exchange Act or otherwise, the stabilization or
manipulation of the price of any security of the Company to facilitate the sale
or resale of the Placement Shares.
(v)
Broker/Dealer
Relationships
. Neither the Company nor any of its related
entities (i) is required to register as a “broker” or “dealer” in
accordance with the provisions of the Exchange Act or (ii) directly or
indirectly through one or more intermediaries, controls or is a “person
associated with a member” or “associated person of a member” (within the meaning
of Article I of the NASD Manual administered by FINRA).
(w)
No
Reliance
. The Company has not relied upon MLV or legal counsel
for MLV for any legal, tax or accounting advice in connection with the offering
and sale of the Placement Shares.
(x)
Taxes
. The
Company has filed all federal, state, local and foreign tax returns which have
been required to be filed and paid all taxes shown thereon through the date
hereof, to the extent that such taxes have become due and are not being
contested in good faith. Except as otherwise disclosed in or
contemplated by the Registration Statement or the Prospectus, no tax deficiency
has been determined adversely to the Company which has had, or would reasonably
be expected to have, individually or in the aggregate, a Material Adverse
Effect. The Company has no knowledge of any federal, state or other
governmental tax deficiency, penalty or assessment which has been or might be
asserted or threatened against it which could have a Material Adverse
Effect.
(y)
Title to Real and Personal
Property
. Except as set forth in the Registration Statement or
the Prospectus, the Company has good and valid title in fee simple to all items
of real property and good and valid title to all personal property described in
the Registration Statement or Prospectus as being owned by it that are material
to the business of the Company, in each case free and clear of all liens,
encumbrances and claims, except those that (i) do not materially interfere
with the use made and proposed to be made of such property by the Company or
(ii) would not reasonably be expected, individually or in the aggregate, to
have a Material Adverse Effect. Any real property described in the
Registration Statement or Prospectus as being leased by the Company is held by
it under valid, existing and enforceable leases, except those that (A) do
not materially interfere with the use made or proposed to be made of such
property by the Company or (B) would not be reasonably expected,
individually or in the aggregate, to have a Material Adverse
Effect.
(z)
Intellectual
Property
. Except as set forth in the Registration Statement or
the Prospectus, the Company owns or possesses adequate enforceable rights to use
all patents, patent applications, trademarks (both registered and unregistered),
service marks, trade names, trademark registrations, service mark registrations,
copyrights, licenses and know-how (including trade secrets and other unpatented
and/or unpatentable proprietary or confidential information, systems or
procedures) (collectively, the “
Intellectual
Property
”), necessary for the conduct of its business as conducted as of
the date hereof, except to the extent that the failure to own or possess
adequate rights to use such Intellectual Property would not, individually or in
the aggregate, reasonably be expected to have a Material Adverse Effect; the
Company has not received any written notice of any claim of infringement or
conflict which asserted Intellectual Property rights of others, which
infringement or conflict, if the subject of an unfavorable decision, would
result in a Material Adverse Effect; the Company has conducted reasonable
searches of the United States patents of record and to the Company's knowledge
none of the Company’s patents or patent applications interfere with any other
United States patents; the Company has conducted an infringement search and
determined that, to the Company's knowledge, no valid and enforceable patent
held by any third party is infringed by the activities of the Company; there are
no pending, or to the Company’s knowledge, threatened judicial proceedings or
interference proceedings challenging the Company’s rights in or to or the
validity of the scope of any of the Company’s patents, patent applications or
proprietary information; to the Company's knowledge no other entity or
individual has any right or claim in any of the Company’s patents, patent
applications or any patent to be issued therefrom by virtue of any contract,
license or other agreement entered into between such entity or individual and
the Company or by any non-contractual obligation, other than by written licenses
granted by the Company; the Company has not received any written notice of any
claim challenging the rights of the Company in or to any Intellectual Property
owned, licensed or optioned by the Company which claim, if the subject of an
unfavorable decision would result in an Material Adverse Effect.
(aa)
Compliance
Program
. The Company has established and administers a
compliance program applicable to the Company, to assist the Company and the
directors, officers and employees of the Company in complying with applicable
regulatory guidelines.
(bb)
Environmental
Laws
. Except as set forth in the Registration Statement or the
Prospectus, the Company (i) is in compliance with any and all applicable
federal, state, local and foreign laws, rules, regulations, decisions and orders
relating to the protection of human health and safety, the environment or
hazardous or toxic substances or wastes, pollutants or contaminants
(collectively, “
Environmental Laws
”);
(ii) has received and is in compliance with all permits, licenses or other
approvals required of them under applicable Environmental Laws to conduct their
respective businesses as described in the Registration Statement and the
Prospectus; and (iii) has not received notice of any actual or potential
liability for the investigation or remediation of any disposal or release of
hazardous or toxic substances or wastes, pollutants or contaminants, except, in
the case of any of clauses (i), (ii) or (iii) above, for any such failure to
comply or failure to receive required permits, licenses, other approvals or
liability as would not, individually or in the aggregate, reasonably be expected
to have a Material Adverse Effect.
(cc)
Disclosure
Controls
. The Company maintains systems of internal accounting
controls sufficient to provide reasonable assurance that (i) transactions
are executed in accordance with management’s general or specific authorizations;
(ii) transactions are recorded as necessary to permit preparation of
financial statements in conformity with generally accepted accounting principles
and to maintain asset accountability; (iii) access to assets is permitted
only in accordance with management’s general or specific authorization; and
(iv) the recorded accountability for assets is compared with the existing
assets at reasonable intervals and appropriate action is taken with respect to
any differences. The Company has established disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15 and 15d-15) for the Company
and designed such disclosure controls and procedures to ensure that material
information relating to the Company is made known to the certifying officers by
others within those entities, particularly during the period in which the
Company’s Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as the
case may be, is being prepared. The Company’s certifying officers
have evaluated the effectiveness of the Company’s controls and procedures as of
a date within 90 days prior to the filing date of the Form 10-K for the fiscal
year ended December 31, 2008 (such date, the “
Evaluation
Date
”). The Company presented in its Form 10-K for the fiscal
year ended December 31, 2008 the conclusions of the certifying officers about
the effectiveness of the disclosure controls and procedures based on their
evaluations as of the Evaluation Date. Since the Evaluation Date,
there have been no significant changes in the Company’s internal controls (as
such term is defined in Item 307(b) of Regulation S-K under the Act) or, to the
Company’s knowledge, in other factors that could significantly affect the
Company’s internal controls.
(dd)
Sarbanes-Oxley
. To
the knowledge of the Company, there is and has been no failure on the part of
the Company and any of the Company’s directors or officers, in their capacities
as such, to comply with any applicable provisions of the Sarbanes-Oxley Act and
the rules and regulations promulgated thereunder. Each of the
principal executive officer and the principal financial officer of the Company
(or each former principal executive officer of the Company and each former
principal financial officer of the Company as applicable) has made all
certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act with
respect to all reports, schedules, forms, statements and other documents
required to be filed by it or furnished by it to the Commission. For
purposes of the preceding sentence, “principal executive officer” and “principal
financial officer” shall have the meanings given to such terms in the
Sarbanes-Oxley Act.
(ee)
Finder’s
Fees
. The Company has not incurred any liability for any
finder’s fees, brokerage commissions or similar payments in connection with the
transactions herein contemplated, except as may otherwise exist with respect to
MLV pursuant to this Agreement.
(ff)
Labor
Disputes
. No labor disturbance by or dispute with employees of
the Company exists or, to the knowledge of the Company, is threatened which
would reasonably be expected to result in a Material Adverse
Effect
(gg)
Investment Company
Act
. The Company, after giving effect to the offering and sale of the
Placement Shares, will not be an “investment company” or an entity “controlled”
by an “investment company,” as such terms are defined in the Investment Company
Act of 1940, as amended (the “
Investment Company
Act
”).
(hh)
Operations
. The
operations of the Company are and have been conducted at all times in compliance
with applicable financial record keeping and reporting requirements of the
Currency and Foreign Transactions Reporting Act of 1970, as amended, the money
laundering statutes of all jurisdictions to which the Company is subject, the
rules and regulations thereunder and any related or similar rules, regulations
or guidelines, issued, administered or enforced by any governmental agency
(collectively, the “
Money Laundering
Laws
”), except as would not reasonably be expected to result in a
Material Adverse Effect; and no action, suit or proceeding by or before any
court or governmental agency, authority or body or any arbitrator involving the
Company with respect to the Money Laundering Laws is pending or, to the
knowledge of the Company, threatened.
(ii)
Off-Balance Sheet
Arrangements
. There are no transactions, arrangements and
other relationships between and/or among the Company, and/or, to the knowledge
of the Company, any of its affiliates and any unconsolidated entity, including,
but not limited to, any structural finance, special purpose or limited purpose
entity (each, an “
Off
Balance Sheet Transaction
”) that could reasonably be expected to affect
materially the Company’s liquidity or the availability of or requirements for
its capital resources, including those Off Balance Sheet Transactions described
in the Commission’s Statement about Management’s Discussion and Analysis of
Financial Conditions and Results of Operations (Release Nos. 33-8056;
34-45321; FR-61), required to be described in the Prospectus which have not been
described as required.
(jj)
Underwriter
Agreements
. The Company is not a party to any agreement with
an agent or underwriter for any other “at-the-market” or continuous equity
transaction.
(kk)
ERISA
. To
the knowledge of the Company, each material employee benefit plan, within the
meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974,
as amended (“
ERISA
”), that is
maintained, administered or contributed to by the Company or any of its
affiliates for employees or former employees of the Company has been maintained
in material compliance with its terms and the requirements of any applicable
statutes, orders, rules and regulations, including but not limited to ERISA and
the Internal Revenue Code of 1986, as amended (the “
Code
”); no prohibited
transaction, within the meaning of Section 406 of ERISA or Section 4975 of the
Code, has occurred which would result in a material liability to the Company
with respect to any such plan excluding transactions effected pursuant to a
statutory or administrative exemption; and for each such plan that is subject to
the funding rules of Section 412 of the Code or Section 302 of ERISA, no
“accumulated funding deficiency” as defined in Section 412 of the Code has been
incurred, whether or not waived, and the fair market value of the assets of each
such plan (excluding for these purposes accrued but unpaid contributions)
exceeds the present value of all benefits accrued under such plan determined
using reasonable actuarial assumptions.
(ll)
Forward Looking
Statements
. No forward-looking statement (within the meaning
of Section 27A of the Securities Act and Section 21E of the Exchange Act) (a
“
Forward Looking
Statement
”) contained in the Registration Statement and the Prospectus
has been made or reaffirmed without a reasonable basis or has been disclosed
other than in good faith. The Forward Looking Statements incorporated
by reference in the Registration Statement and the Prospectus from the Company’s
Annual Report on Form 10-K for the fiscal year most recently ended (i) are
within the coverage of the safe harbor for forward looking statements set forth
in Section 27A of the Act, Rule 175(b) under the Act or Rule 3b-6 under the
Exchange Act, as applicable, (ii) were made by the Company with a
reasonable basis and in good faith and reflect the Company’s good faith
commercially reasonable best estimate of the matters described therein, and
(iii) have been prepared in accordance with Item 10 of Regulation S-K under
the Act.
(mm)
MLV
Purchases
. The Company acknowledges and agrees that MLV has
informed the Company that MLV may, to the extent permitted under the Securities
Act and the Exchange Act, purchase and sell shares of Common Stock for its own
account while this Agreement is in effect, provided, that (i) no such
purchase or sales shall take place while a Placement Notice is in effect (except
to the extent MLV may engage in sales of Placement Shares purchased or deemed
purchased from the Company as a “riskless principal” or in a similar capacity)
and (ii) the Company shall not be deemed to have authorized or consented to
any such purchases or sales by MLV.
(nn)
Margin
Rules
. Neither the issuance, sale and delivery of the Shares
nor the application of the proceeds thereof by the Company as described in the
Registration Statement and the Prospectus will violate Regulation T, U or X of
the Board of Governors of the Federal Reserve System or any other regulation of
such Board of Governors.
(oo)
Insurance
. The
Company carries, or is covered by, insurance in such amounts and covering such
risks as the Company reasonably believe are adequate for the conduct of its
properties and as is customary for companies engaged in similar businesses in
similar industries.
(pp)
No Improper
Practices
. (i) Neither the Company, nor to the Company’s
knowledge, any of its respective executive officers has, in the past five years,
made any unlawful contributions to any candidate for any political office (or
failed fully to disclose any contribution in violation of law) or made any
contribution or other payment to any official of, or candidate for, any federal,
state, municipal, or foreign office or other person charged with similar public
or quasi-public duty in violation of any law or of the character required to be
disclosed in the Prospectus; (ii) no relationship, direct or indirect,
exists between or among the Company or, to the Company’s knowledge any
affiliate, on the one hand, and the directors, officers and stockholders of the
Company, on the other hand, that is required by the Securities Act to be
described in the Registration Statement and the Prospectus that is not so
described; (iii) no relationship, direct or indirect, exists between or
among the Company or any affiliate, on the one hand, and the directors,
officers, stockholders or directors of the Company, on the other hand, that is
required by the rules of FINRA to be described in the Registration Statement and
the Prospectus that is not so described; and (iv) except as described in
the Prospectus, there are no material outstanding loans or advances or material
guarantees of indebtedness by the Company to or for the benefit of any of its
officers or directors or any of the members of the families of any of
them.
(qq)
Status Under the Securities
Act
. The Company was not and is not an ineligible issuer as
defined in Rule 405 under the Securities Act at the times specified in Rules 164
and 433 under the Act in connection with the offering of the
Shares.
(rr)
No Misstatement or Omission
in an Issuer Free Writing Prospectus
. Each issuer free writing
prospectus, as defined in Rule 405 under the Act (an “
Issuer Free Writing
Prospectus
,” and together with the Preliminary Prospectus the “
Pricing Disclosure
Materials
”), when considered together with the Pricing Disclosure
Materials as of the applicable Point of Sale, did not or will not contain an
untrue statement of a material fact or omit to state a material fact required to
be stated therein or necessary to make the statements therein, in light of the
circumstances under which they were made, not misleading; provided, however,
that the Company makes no representation or warranty with respect to any
statement contained in any Issuer Free Writing Prospectus in reliance upon and
in conformity with information concerning MLV and furnished by MLV to the
Company expressly for use in the Issuer Free Writing Prospectus.
(ss)
Conformity of Issuer Free
Writing Prospectus
. Each Issuer Free Writing Prospectus
conformed or will conform in all material respects to the requirements of the
Act on the date of first use, and the Company has complied or will comply with
any filing requirements applicable to such Issuer Free Writing Prospectus
pursuant to the Act. Each Issuer Free Writing Prospectus, as of its
issue date and at all subsequent times through the completion of the public
offer and sale of the Shares, did not, does not and will not include any
information that conflicted, conflicts or will conflict with the information
contained in the Registration Statement or the Prospectus, including any
document incorporated by reference therein that has not been superseded or
modified. The Company has not made any offer relating to the Shares
that would constitute an Issuer Free Writing Prospectus without the prior
written consent of MLV. The Company has retained in accordance with
the Act all Issuer Free Writing Prospectuses that were not required to be filed
pursuant to the Act.
(tt)
Pricing Disclosure
Materials
. The Pricing Disclosure Materials did not, as of the
applicable Point of Sale contain an untrue statement of a material fact or omit
to state a material fact required to be stated therein or necessary to make the
statements therein, in light of the circumstances under which they were made,
not misleading; provided, however, that the Company makes no representation or
warranty with respect to any statement contained in the Pricing Disclosure
Materials in reliance upon and in conformity with information concerning MLV and
furnished in writing by MLV to the Company expressly for use in the Pricing
Disclosure Materials.
(uu)
No
Conflicts
. Neither the execution of this Agreement, nor the
issuance, offering or sale of the Shares, nor the consummation of any of the
transactions contemplated herein and therein, nor the compliance by the Company
with the terms and provisions hereof and thereof will conflict with, or will
result in a breach of, any of the terms and provisions of, or has constituted or
will constitute a default under, or has resulted in or will result in the
creation or imposition of any lien, charge or encumbrance upon any property or
assets of the Company pursuant to the terms of any contract or other agreement
to which the Company may be bound or to which any of the property or assets of
the Company is subject, except (i) such conflicts, breaches or defaults as may
have been waived and (ii) such conflicts, breaches and defaults that would not
have a Material Adverse Effect; nor will such action result (x) in any violation
of the provisions of the organizational or governing documents of the Company,
or (y) in any material violation of the provisions of any statute or any order,
rule or regulation applicable to the Company or of any court or of any federal,
state or other regulatory authority or other government body having jurisdiction
over the Company.
(vv)
Stock Transfer
Taxes
. On each Settlement Date, all stock transfer or other
taxes (other than income taxes) which are required to be paid in connection with
the sale and transfer of the Shares to be sold hereunder will be, or will have
been, fully paid or provided for by the Company and all laws imposing such taxes
will be or will have been fully complied with.
7.
Covenants of the
Company
. The Company covenants and agrees with MLV
that:
(a)
Registration Statement
Amendments
. After the date of this Agreement and during any
period in which a Prospectus relating to any Placement Shares is required to be
delivered by MLV under the Securities Act (including in circumstances where such
requirement may be satisfied pursuant to Rule 172 under the Securities Act),
(i) the Company will notify MLV promptly of the time when any subsequent
amendment to the Registration Statement, other than documents incorporated by
reference, has been filed with the Commission and/or has become effective or any
subsequent supplement to the Prospectus has been filed and of any request by the
Commission for any amendment or supplement to the Registration Statement or
Prospectus or for additional information, (ii) the Company will prepare and
file with the Commission, promptly upon MLV’s request, any amendments or
supplements to the Registration Statement or Prospectus that, in MLV’s
reasonable opinion, may be necessary or advisable in connection with the
distribution of the Placement Shares by MLV (provided, however, that the failure
of MLV to make such request shall not relieve the Company of any obligation or
liability hereunder, or affect MLV’s right to rely on the representations and
warranties made by the Company in this Agreement and provided, further, that the
only remedy MLV shall have with respect to the failure to make such filing shall
be to cease making sales under this Agreement until such amendment or supplement
is filed); (iii) the Company will not file any amendment or supplement to
the Registration Statement or Prospectus relating to the Placement Shares or a
security convertible into the Placement Shares unless a copy thereof has been
submitted to MLV within a reasonable period of time before the filing and MLV
has not reasonably objected thereto (provided, however, that the failure of MLV
to make such objection shall not relieve the Company of any obligation or
liability hereunder, or affect MLV’s right to rely on the representations and
warranties made by the Company in this Agreement and provided, further, that the
only remedy MLV shall have with respect to the failure by the Company to obtain
such consent shall be to cease making sales under this Agreement) and the
Company will furnish to MLV at the time of filing thereof a copy of any document
that upon filing is deemed to be incorporated by reference into the Registration
Statement or Prospectus, except for those documents available via EDGAR; and
(iv) the Company will cause each amendment or supplement to the Prospectus
to be filed with the Commission as required pursuant to the applicable paragraph
of Rule 424(b) of the Securities Act or, in the case of any document to be
incorporated therein by reference, to be filed with the Commission as required
pursuant to the Exchange Act, within the time period prescribed (the
determination to file or not file any amendment or supplement with the
Commission under this Section 7(a), based on the Company’s reasonable opinion or
reasonable objections, shall be made exclusively by the
Company).
(b)
Notice of Commission Stop
Orders
. The Company will advise MLV, promptly after it
receives notice or obtains knowledge thereof, of the issuance or threatened
issuance by the Commission of any stop order suspending the effectiveness of the
Registration Statement, of the suspension of the qualification of the Placement
Shares for offering or sale in any jurisdiction, or of the initiation or
threatening of any proceeding for any such purpose; and it will promptly use its
commercially reasonable efforts to prevent the issuance of any stop order or to
obtain its withdrawal if such a stop order should be issued. The
Company will advise MLV promptly after it receives any request by the Commission
for any amendments to the Registration Statement or any amendment or supplements
to the Prospectus or any Issuer Free Writing Prospectus or for additional
information related to the offering of the Shares or for additional information
related to the Registration Statement, the Prospectus or any Issuer Free Writing
Prospectus.
(c)
Delivery of Prospectus;
Subsequent Changes
. During any period in which a Prospectus
relating to the Placement Shares is required to be delivered by MLV under the
Securities Act with respect to the offer and sale of the Placement Shares,
(including in circumstances where such requirement may be satisfied pursuant to
Rule 172 under the Securities Act), the Company will comply with all
requirements imposed upon it by the Securities Act, as from time to time in
force, and to file on or before their respective due dates all reports and any
definitive proxy or information statements required to be filed by the Company
with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other
provision of or under the Exchange Act. If the Company has omitted
any information from the Registration Statement pursuant to Rule 430A under the
Act, it will use its best efforts to comply with the provisions of and make all
requisite filings with the Commission pursuant to said Rule 430A and to notify
MLV promptly of all such filings. If during such period any event
occurs as a result of which the Prospectus as then amended or supplemented would
include an untrue statement of a material fact or omit to state a material fact
necessary to make the statements therein, in the light of the circumstances then
existing, not misleading, or if during such period it is necessary to amend or
supplement the Registration Statement or Prospectus to comply with the
Securities Act, the Company will promptly notify MLV to suspend the offering of
Placement Shares during such period and the Company will promptly amend or
supplement the Registration Statement or Prospectus (at the expense of the
Company) so as to correct such statement or omission or effect such compliance;
provided, however, that the Company may delay any such amendment or supplement,
if in the judgment of the Company, it is in the best interests of the Company to
do so.
(d)
Listing of Placement
Shares
. During any period in which the Prospectus relating to
the Placement Shares is required to be delivered by MLV under the Securities Act
with respect to the offer and sale of the Placement Shares, the Company will use
its reasonable best efforts to cause the Placement Shares to be listed on the
Exchange and to qualify the Placement Shares for sale under the securities laws
of such jurisdictions as MLV reasonably designates and to continue such
qualifications in effect so long as required for the distribution of the
Placement Shares; provided, however, that the Company shall not be required in
connection therewith to qualify as a foreign corporation or dealer in securities
or file a general consent to service of process in any
jurisdiction.
(e)
Delivery of Registration
Statement and Prospectus
. The Company will furnish to MLV and
its counsel (at the expense of the Company) copies of the Registration
Statement, the Prospectus (including all documents incorporated by reference
therein) and all amendments and supplements to the Registration Statement or
Prospectus that are filed with the Commission during any period in which a
Prospectus relating to the Placement Shares is required to be delivered under
the Securities Act (including all documents filed with the Commission during
such period that are deemed to be incorporated by reference therein), in each
case as soon as reasonably practicable and in such quantities as MLV may from
time to time reasonably request and, at MLV’s request, will also furnish copies
of the Prospectus to each exchange or market on which sales of the Placement
Shares may be made; provided, however, that the Company shall not be required to
furnish any document (other than the Prospectus) to MLV to the extent such
document is available on EDGAR.
(f)
Earnings
Statement
. The Company will make generally available to its
security holders as soon as practicable, but in any event not later than 15
months after the end of the Company’s current fiscal quarter, an earnings
statement covering a 12-month period that satisfies the provisions of Section
11(a) and Rule 158 of the Securities Act.
(g)
Expenses
. The
Company, whether or not the transactions contemplated hereunder are consummated
or this Agreement is terminated, in accordance with the provisions of Section 12
hereunder, will pay all expenses incident to the performance of its obligations
hereunder, including, but not limited to, expenses relating to (i) the
preparation, printing and filing of the Registration Statement and each
amendment and supplement thereto, of each Prospectus and of each amendment and
supplement thereto, (ii) the preparation, issuance and delivery of the
Placement Shares, (iii) the qualification of the Placement Shares under
securities laws in accordance with the provisions of Section 7(d) of this
Agreement, including filing fees, (iv) the printing and delivery to MLV of
copies of the Prospectus and any amendments or supplements thereto, and of this
Agreement, (v) the fees and expenses incurred in connection with the
listing or qualification of the Placement Shares for trading on the Exchange,
(vi) filing fees and expenses, if any, of the Commission and the FINRA
Corporate Financing Department. MLV will pay all expenses incident to
the performance of its obligations hereunder.
(h)
Use of
Proceeds
. The Company will use the Net Proceeds as described
in the Prospectus in the section entitled “Use of Proceeds.”
(i)
Notice of Other
Sales
. Without the prior written consent of MLV, the Company
will not, directly or indirectly, offer to sell, sell, contract to sell, grant
any option to sell or otherwise dispose of any shares of Common Stock (other
than the Shares offered pursuant to the provisions of this Agreement) or
securities convertible into or exchangeable for Common Stock, warrants or any
rights to purchase or acquire, Common Stock during the period beginning on the
fifth (5th) Trading Day immediately prior to the date on which any Placement
Notice is delivered to MLV hereunder and ending on the fifth (5th) Trading Day
immediately following the final Settlement Date with respect to Placement Shares
sold pursuant to such Placement Notice (or, if the Placement Notice has been
terminated or suspended prior to the sale of all Shares covered by a Placement
Notice, the date of such suspension or termination); and will not directly or
indirectly in any other “at-the-market” or continuous equity transaction offer
to sell, sell, contract to sell, grant any option to sell or otherwise dispose
of any shares of Common Stock (other than the Shares offered pursuant to the
provisions of this Agreement) or securities convertible into or exchangeable for
Common Stock, warrants or any rights to purchase or acquire, Common Stock prior
to the later of the termination of this Agreement and the thirtieth (30th) day
immediately following the final Settlement Date with respect to Placement Shares
sold pursuant to such Placement Notice; provided, however, that such
restrictions will not be required in connection with the Company’s issuance or
sale of (i) Common Stock, options to purchase shares of Common Stock or
Common Stock issuable upon the exercise of options, pursuant to any employee or
director stock option or benefits plan, stock ownership plan or dividend
reinvestment plan (but not shares subject to a waiver to exceed plan limits in
its dividend reinvestment plan) of the Company whether now in effect or
hereafter implemented, and (ii) Common Stock issuable upon conversion of
securities or the exercise of warrants, options or other rights in effect or
outstanding, and disclosed in filings by the Company available on EDGAR or
otherwise in writing to MLV.
(j)
Change of
Circumstances
. The Company will, at any time during the
pendency of a Placement Notice advise MLV promptly after it shall have received
notice or obtained knowledge thereof, of any information or fact that would
alter or affect in any material respect any opinion, certificate, letter or
other document required to be provided to MLV pursuant to this
Agreement.
(k)
Due Diligence
Cooperation
. The Company will cooperate with any reasonable
due diligence review conducted by MLV or its agents in connection with the
transactions contemplated hereby, including, without limitation, providing
information and making available documents and senior corporate officers, during
regular business hours and at the Company’s principal offices, as MLV may
reasonably request.
(l)
Required Filings Relating to
Placement of Placement Shares
. The Company agrees that on such
dates as the Securities Act shall require, the Company will (i) file a
prospectus supplement with the Commission under the applicable paragraph of Rule
424(b) under the Securities Act (each and every filing under Rule 424(b), a
“
Filing Date
”),
which prospectus supplement will set forth, within the relevant period, the
maximum amount of Placement Shares to be sold through MLV and the compensation
payable by the Company to MLV with respect to such Placement Shares, and
(ii) deliver such number of copies of each such prospectus supplement to
each exchange or market on which such sales were effected as may be required by
the rules or regulations of such exchange or market.
(m)
Representation Dates;
Certificate
. During the term of this Agreement, on the date of
the first Placement Notice given hereunder and each time the Company
(i) files the Prospectus relating to the Placement Shares or amends or
supplements the Registration Statement or the Prospectus relating to the
Placement Shares (other than a prospectus supplement filed in accordance with
Section 7(l) of this Agreement) by means of a post-effective amendment, sticker,
or supplement but not by means of incorporation of document(s) by reference to
the Registration Statement or the Prospectus relating to the Placement Shares;
(ii) files an annual report on Form 10-K under the Exchange Act;
(iii) files its quarterly reports on Form 10-Q under the Exchange Act;
(iv) files a report on Form 8-K containing amended financial information
(other than an earnings release, to “furnish” information pursuant to Items 2.02
or 7.01 of Form 8-K or to provide disclosure pursuant to Item 8.01 of Form 8-K
relating to the reclassifications of certain properties as discontinued
operations in accordance with Statement of Financial Accounting Standards No.
144) under the Exchange Act or (v) files a Form 8-K under the Exchange Act
for any other purpose (other than to “furnish” information pursuant to Items
2.02 or 7.01 of revised Form 8-K) (each date of filing of one or more of the
documents referred to in clauses (i) through (v) shall be a “
Representation
Date
”); the Company shall furnish MLV (but in the case of clause (v)
above only if MLV reasonably determines that the information contained in such
Form 8-K is material) with a certificate, in the form attached hereto as Exhibit
7(m). The requirement to provide a certificate under this Section
7(m) shall be waived for any Representation Date occurring at a time at which no
Placement Notice is pending, which waiver shall continue until the earlier to
occur of the date the Company next delivers a Placement Notice hereunder (which
for such calendar quarter shall be considered a Representation Date) and the
next occurring Representation Date; provided, however, that such waiver shall
not apply for any Representation Date on which the Company files its annual
report on Form 10-K. Notwithstanding the foregoing, if the Company
subsequently decides to sell Placement Shares following a Representation Date
when the Company relied on such waiver and did not provide MLV with a
certificate under this Section 7(m), then before the Company delivers the
Placement Notice or MLV sells any Placement Shares, the Company shall provide
MLV with a certificate, in the form attached hereto as Exhibit 7(m), dated the
date of the Placement Notice.
(n)
Legal
Opinion
. Within ten days following the date of this Agreement
(but, in no event, later than the date of the initial Placement Notice given
hereunder) and, thereafter, within ten days following each date that the Company
files an annual report on Form 10-K under the Exchange Act or a quarterly report
on Form 10-Q under the Exchange Act during the term of this Agreement, the
Company shall cause to be furnished to MLV a written opinion of Ballard Spahr
LLP (“
Company
Counsel
”), or other counsel satisfactory to MLV, in form and substance
satisfactory to MLV and its counsel, substantially similar to the form attached
hereto as Exhibit 7(n), modified, as necessary, to relate to the Registration
Statement and the Prospectus as then amended or supplemented; provided, however,
the Company shall be required to furnish to MLV no more than one opinion
hereunder per calendar quarter; provided, further, that in lieu of such opinions
for subsequent periodic filings under the Exchange Act, counsel may furnish MLV
with a letter (a “
Reliance Letter
”) to
the effect that MLV may rely on a prior opinion delivered under this Section
7(n) to the same extent as if it were dated the date of such letter (except that
statements in such prior opinion shall be deemed to relate to the Registration
Statement and the Prospectus as amended or supplemented as of the date of the
Reliance Letter).
(o)
Comfort
Letter
. No later than ten Trading Days following the date the
Company files its annual report on Form 10-K for the year ended December 31,
2009 and thereafter within ten Trading Days following each subsequent date the
Company files an annual report on Form 10-K under the Exchange Act, during any
period in which the Prospectus relating to the Placement Shares is required to
be delivered by MLV (including in circumstances where such requirement may be
satisfied pursuant to Rule 172 under the Act) and with respect to which the
Company is obligated to deliver a certificate in the form attached hereto as
Exhibit 7(m) for which no waiver is applicable, the Company shall cause its
independent accountants to furnish MLV letters (the “
Comfort Letters
”),
dated the date the Comfort Letter is delivered; provided, that if requested by
MLV, the Company shall cause a Comfort Letter to be furnished to MLV within ten
Trading Days of the date of occurrence of any material transaction or event,
including the restatement of the Company's financial statements. The
Comfort Letter from the Company's independent public accounting firm shall be in
a form and substance satisfactory to MLV, (i) confirming that they are an
independent public accounting firm within the meaning of the Securities Act and
the PCAOB, (ii) stating, as of such date, the conclusions and findings of
such firm with respect to the financial information and other matters ordinarily
covered by accountants’ “comfort letters” to underwriters in connection with
registered public offerings (the first such letter, the “
Initial Comfort
Letter
”) and (iii) updating the Initial Comfort Letter with any
information that would have been included in the Initial Comfort Letter had it
been given on such date and modified as necessary to relate to the Registration
Statement and the Prospectus, as amended and supplemented to the date of such
letter.
(p)
Market
Activities
. The Company will not, directly or indirectly,
(i) take any action designed to cause or result in, or that constitutes or
might reasonably be expected to constitute, the stabilization or manipulation of
the price of any security of the Company to facilitate the sale or resale of the
Shares or (ii) sell, bid for, or purchase the Shares, or pay anyone any
compensation for soliciting purchases of the Shares other than MLV.
(q)
Investment Company
Act
. The Company will conduct its affairs in such a manner so
as to reasonably ensure that it will not be or become, at any time prior to the
termination of this Agreement, an “investment company,” as such term is defined
in the Investment Company Act, assuming no change in the Commission’s current
interpretation as to entities that are not considered an investment
company.
(r)
No Offer to
Sell
. Other than an Issuer Free Writing Prospectus approved in
advance by the Company and MLV in its capacity as principal or agent hereunder,
neither MLV nor the Company (including its agents and representatives, other
than MLV in its capacity as such) will make, use, prepare, authorize, approve or
refer to any written communication (as defined in Rule 405 under the Act),
required to be filed with the Commission, that constitutes an offer to sell or
solicitation of an offer to buy Shares hereunder.
(s)
Sarbanes-Oxley
Act
. The Company will maintain and keep accurate books and
records reflecting its assets and maintain internal accounting controls in a
manner designed 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
including those policies and procedures that (i) pertain to the maintenance
of records that in reasonable detail accurately and fairly reflect the
transactions and dispositions of the assets of the Company, (ii) provide
reasonable assurance that transactions are recorded as necessary to permit the
preparation of the Company’s consolidated financial statements in accordance
with generally accepted accounting principals, (iii) that receipts and
expenditures of the Company are being made only in accordance with management’s
and the Company’s directors’ authorization, and (iv) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition,
use or disposition of the Company’s assets that could have a material effect on
its financial statements. The Company will maintain such controls and
other procedures, including, without limitation, those required by Sections 302
and 906 of the Sarbanes-Oxley Act, and the applicable regulations thereunder
that are designed to ensure that information required to be disclosed by the
Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported, within the time periods specified
in the Commission’s rules and forms, including, without limitation, controls and
procedures designed to ensure that information required to be disclosed by the
Company in the reports that it files or submits under the Exchange Act is
accumulated and communicated to the Company’s management, including its Chief
Executive Officer and principal financial officer, or persons performing similar
functions, as appropriate to allow timely decisions regarding required
disclosure and to ensure that material information relating to the Company is
made known to them, particularly during the period in which such periodic
reports are being prepared.
8.
Covenants of
MLV
. MLV covenants and agrees that it is duly registered as a
broker-dealer under FINRA, the Exchange Act and the applicable statutes and
regulations of each state in which the Shares will be offered and sold, except
such states in which MLV is exempt from registration or such registration is not
otherwise required. MLV shall continue, for the term of this
Agreement, to be duly registered as a broker-dealer under FINRA, the Exchange
Act and the applicable statutes and regulations of each state in which the
Shares will be offered and sold, except such states in which MLV is exempt from
registration or such registration is not otherwise required, during the term of
this Agreement.
9.
Conditions to MLV’s
Obligations
. The obligations of MLV hereunder with respect to
a Placement will be subject to the continuing accuracy and completeness of the
representations and warranties made by the Company herein, to the due
performance by the Company of its obligations hereunder, to the completion by
MLV of a due diligence review satisfactory to MLV in its reasonable judgment,
and to the continuing satisfaction (or waiver by MLV in its sole discretion) of
the following additional conditions:
(a)
Registration Statement
Effective
. The Registration Statement shall have become
effective and shall be available for the (i) resale of all Placement Shares
issued to MLV and not yet sold by MLV and (ii) the sale of all Placement
Shares contemplated to be issued by any Placement Notice.
(b)
No Material
Notices
. None of the following events shall have occurred and
be continuing: (i) receipt by the Company of any request for additional
information from the Commission or any other federal or state governmental
authority during the period of effectiveness of the Registration Statement, the
response to which would require any post-effective amendments or supplements to
the Registration Statement or the Prospectus; (ii) the issuance by the
Commission or any other federal or state governmental authority of any stop
order suspending the effectiveness of the Registration Statement or the
initiation of any proceedings for that purpose; (iii) receipt by the
Company of any notification with respect to the suspension of the qualification
or exemption from qualification of any of the Placement Shares for sale in any
jurisdiction or the initiation or threatening of any proceeding for such
purpose; or (iv) the occurrence of any event that makes any material
statement made in the Registration Statement or the Prospectus or any material
document incorporated or deemed to be incorporated therein by reference untrue
in any material respect or that requires the making of any changes in the
Registration Statement, related Prospectus or documents so that, in the case of
the Registration Statement, it will not contain any materially untrue statement
of a material fact or omit to state any material fact required to be stated
therein or necessary to make the statements therein not misleading and, that in
the case of the Prospectus, it will not contain any materially untrue statement
of a material fact or omit to state any material fact required to be stated
therein or necessary to make the statements therein, in the light of the
circumstances under which they were made, not misleading.
(c)
No Misstatement or Material
Omission
. MLV shall not have advised the Company that the
Registration Statement or Prospectus, or any amendment or supplement thereto,
contains an untrue statement of fact that in MLV’s reasonable opinion is
material, or omits to state a fact that in MLV’s opinion is material and is
required to be stated therein or is necessary to make the statements therein not
misleading.
(d)
Material
Changes
. Except as contemplated in the Prospectus, or
disclosed in the Company’s reports filed with the Commission, there shall not
have been any material adverse change, on a consolidated basis, in the
authorized capital stock of the Company or any Material Adverse Effect, or any
development that could reasonably be expected to cause a Material Adverse
Effect, or a downgrading in or withdrawal of the rating assigned to any of the
Company’s securities (other than asset backed securities) by any rating
organization or a public announcement by any rating organization that it has
under surveillance or review its rating of any of the Company’s securities
(other than asset backed securities), the effect of which, in the case of any
such action by a rating organization described above, in the reasonable judgment
of MLV (without relieving the Company of any obligation or liability it may
otherwise have), is so material as to make it impracticable or inadvisable to
proceed with the offering of the Placement Shares on the terms and in the manner
contemplated in the Prospectus.
(e)
Legal
Opinion
. MLV shall have received the opinions of Company
Counsel required to be delivered pursuant Section 7(n) on or before the date on
which such delivery of such opinion is required pursuant to Section
7(n).
(f)
Comfort
Letter
. MLV shall have received the Comfort Letter required to
be delivered pursuant Section 7(o) on or before the date on which such delivery
of such opinion is required pursuant to Section 7(o).
(g)
Representation
Certificate
. MLV shall have received the certificate required
to be delivered pursuant to Section 7(m) on or before the date on which delivery
of such certificate is required pursuant to Section 7(m).
(h)
No
Suspension
. Trading in the Shares shall not have been
suspended on the Exchange.
(i)
Other
Materials
. On each date on which the Company is required to
deliver a certificate pursuant to Section 7(m), the Company shall have furnished
to MLV such appropriate further information, certificates and documents as MLV
may reasonably request and as are usually and customarily furnished pursuant to
a securities offering. All such opinions, certificates, letters and
other documents will be in compliance with the provisions hereof. The
Company will furnish MLV with such conformed copies of such opinions,
certificates, letters and other documents as MLV shall reasonably
request.
(j)
Securities Act Filings
Made
. All filings with the Commission required by Rule 424
under the Securities Act to have been filed prior to the issuance of any
Placement Notice hereunder shall have been made within the applicable time
period prescribed for such filing by Rule 424.
(k)
Approval for
Listing
. The Placement Shares shall either have been approved
for listing on the Exchange, subject only to notice of issuance, or the
Company shall have filed an application for listing of the Placement Shares on
the Exchange at, or prior to, the issuance of any Placement Notice.
(l)
No Termination
Event
. There shall not have occurred any event that would
permit MLV to terminate this Agreement pursuant to Section 12(a).
10.
Indemnification and
Contribution
.
(a)
Company
Indemnification
. The Company agrees to indemnify and hold
harmless MLV, the directors, officers, partners, employees and agents of MLV and
each person, if any, who (i) controls MLV within the meaning of Section 15
of the Securities Act or Section 20 of the Exchange Act, or (ii) is
controlled by or is under common control with MLV (a “
MLV Affiliate
”) from
and against any and all losses, claims, liabilities, expenses and damages
(including, but not limited to, any and all reasonable investigative, legal and
other expenses incurred in connection with, and any and all amounts paid in
settlement (in accordance with Section 10(c)) of, any action, suit or proceeding
between any of the indemnified parties and any indemnifying parties or between
any indemnified party and any third party, or otherwise, or any claim asserted),
as and when incurred, to which MLV, or any such person, may become subject under
the Securities Act, the Exchange Act or other federal or state statutory law or
regulation, at common law or otherwise, insofar as such losses, claims,
liabilities, expenses or damages arise out of or are based, directly or
indirectly, on (i) any untrue statement or alleged untrue statement of a
material fact contained in the Registration Statement or the Prospectus or any
amendment or supplement to the Registration Statement or the Prospectus or in
any Issuer Free Writing Prospectus or in any application or other document
executed by or on behalf of the Company or based on written information
furnished by or on behalf of the Company filed in any jurisdiction in order to
qualify the Shares under the securities laws thereof or filed with the
Commission, (ii) the omission or alleged omission to state in any such
document a material fact required to be stated in it or necessary to make the
statements in it not misleading or (iii) any breach by any of the
indemnifying parties of any of their respective representations, warranties and
agreements contained in this Agreement; provided, however, that this indemnity
agreement shall not apply to the extent that such loss, claim, liability,
expense or damage arises from the sale of the Placement Shares pursuant to this
Agreement and is caused directly or indirectly by an untrue statement or
omission made in reliance on and in conformity with information relating to
MLV. This indemnity agreement will be in addition to any liability
that the Company might otherwise have.
(b)
MLV
Indemnification
. MLV agrees to indemnify and hold harmless the
Company and its directors and each officer of the Company who signed the
Registration Statement, and each person, if any, who (i) controls the
Company within the meaning of Section 15 of the Securities Act or Section 20 of
the Exchange Act or (ii) is controlled by or is under common control with
the Company (a “Company Affiliate”) against any and all loss, liability, claim,
damage and expense described in the indemnity contained in Section 10(c), as
incurred, but only with respect to untrue statements or omissions, or alleged
untrue statements or omissions, made in the Registration Statement (or any
amendments thereto) or the Prospectus (or any amendment or supplement thereto)
in reliance upon and in conformity with information relating to MLV and
furnished to the Company by MLV.
(c)
Procedure
. Any
party that proposes to assert the right to be indemnified under this Section 10
will, promptly after receipt of notice of commencement of any action against
such party in respect of which a claim is to be made against an indemnifying
party or parties under this Section 10, notify each such indemnifying party of
the commencement of such action, enclosing a copy of all papers served, but the
omission so to notify such indemnifying party will not relieve the indemnifying
party from (i) any liability that it might have to any indemnified party
otherwise than under this Section 10 and (ii) any liability that it may
have to any indemnified party under the foregoing provision of this Section 10
unless, and only to the extent that, such omission results in the forfeiture of
substantive rights or defenses by the indemnifying party. If any such
action is brought against any indemnified party and it notifies the indemnifying
party of its commencement, the indemnifying party will be entitled to
participate in and, to the extent that it elects by delivering written notice to
the indemnified party promptly after receiving notice of the commencement of the
action from the indemnified party, jointly with any other indemnifying party
similarly notified, to assume the defense of the action, with counsel reasonably
satisfactory to the indemnified party, and after notice from the indemnifying
party to the indemnified party of its election to assume the defense, the
indemnifying party will not be liable to the indemnified party for any legal or
other expenses except as provided below and except for the reasonable costs of
investigation subsequently incurred by the indemnified party in connection with
the defense. The indemnified party will have the right to employ its
own counsel in any such action, but the fees, expenses and other charges of such
counsel will be at the expense of such indemnified party unless (1) the
employment of counsel by the indemnified party has been authorized in writing by
the indemnifying party, (2) the indemnified party has reasonably concluded
(based on advice of counsel) that there may be legal defenses available to it or
other indemnified parties that are different from or in addition to those
available to the indemnifying party, (3) a conflict or potential conflict
exists (based on advice of counsel to the indemnified party) between the
indemnified party and the indemnifying party (in which case the indemnifying
party will not have the right to direct the defense of such action on behalf of
the indemnified party) or (4) the indemnifying party has not in fact
employed counsel to assume the defense of such action within a reasonable time
after receiving notice of the commencement of the action, in each of which cases
the reasonable fees, disbursements and other charges of counsel will be at the
expense of the indemnifying party or parties. It is understood that
the indemnifying party or parties shall not, in connection with any proceeding
or related proceedings in the same jurisdiction, be liable for the reasonable
fees, disbursements and other charges of more than one separate firm admitted to
practice in such jurisdiction at any one time for all such indemnified party or
parties. All such fees, disbursements and other charges will be
reimbursed by the indemnifying party promptly as they are
incurred. An indemnifying party will not, in any event, be liable for
any settlement of any action or claim effected without its written
consent. No indemnifying party shall, without the prior written
consent of each indemnified party, settle or compromise or consent to the entry
of any judgment in any pending or threatened claim, action or proceeding
relating to the matters contemplated by this Section 10 (whether or not any
indemnified party is a party thereto), unless such settlement, compromise or
consent includes an unconditional release of each indemnified party from all
liability arising or that may arise out of such claim, action or
proceeding.
(d)
Contribution
. In
order to provide for just and equitable contribution in circumstances in which
the indemnification provided for in the foregoing paragraphs of this Section 10
is applicable in accordance with its terms but for any reason is held to be
unavailable from the Company or MLV, the Company and MLV will contribute to the
total losses, claims, liabilities, expenses and damages (including any
investigative, legal and other expenses reasonably incurred in connection with,
and any amount paid in settlement of, any action, suit or proceeding or any
claim asserted, but after deducting any contribution received by the Company
from persons other than MLV, such as persons who control the Company within the
meaning of the Securities Act, officers of the Company who signed the
Registration Statement and directors of the Company, who also may be liable for
contribution) to which the Company and MLV may be subject in such proportion as
shall be appropriate to reflect the relative benefits received by the Company on
the one hand and MLV on the other. The relative benefits received by
the Company on the one hand and MLV on the other hand shall be deemed to be in
the same proportion as the total net proceeds from the sale of the Placement
Shares (before deducting expenses) received by the Company bear to the total
compensation received by MLV (before deducting expenses) from the sale of
Placement Shares on behalf of the Company. If, but only if, the
allocation provided by the foregoing sentence is not permitted by applicable
law, the allocation of contribution shall be made in such proportion as is
appropriate to reflect not only the relative benefits referred to in the
foregoing sentence but also the relative fault of the Company, on the one hand,
and MLV, on the other, with respect to the statements or omission that resulted
in such loss, claim, liability, expense or damage, or action in respect thereof,
as well as any other relevant equitable considerations with respect to such
offering. Such relative fault shall be determined by reference to,
among other things, whether the untrue or alleged untrue statement of a material
fact or omission or alleged omission to state a material fact relates to
information supplied by the Company or MLV, the intent of the parties and their
relative knowledge, access to information and opportunity to correct or prevent
such statement or omission. The Company and MLV agree that it would
not be just and equitable if contributions pursuant to this Section 10(d) were
to be determined by pro rata allocation or by any other method of allocation
that does not take into account the equitable considerations referred to
herein. The amount paid or payable by an indemnified party as a
result of the loss, claim, liability, expense, or damage, or action in respect
thereof, referred to above in this Section 10(d) shall be deemed to include, for
the purpose of this Section 10(d), any legal or other expenses reasonably
incurred by such indemnified party in connection with investigating or defending
any such action or claim to the extent consistent with Section 10(c)
hereof. Notwithstanding the foregoing provisions of this Section
10(d), MLV shall not be required to contribute any amount in excess of the
commissions received by it under this Agreement and no person found guilty of
fraudulent misrepresentation (within the meaning of Section 11(f) of the
Securities Act) will be entitled to contribution from any person who was not
guilty of such fraudulent misrepresentation. For purposes of this
Section 10(d), any person who controls a party to this Agreement within the
meaning of the Securities Act, and any officers, directors, partners, employees
or agents of MLV, will have the same rights to contribution as that party, and
each officer of the Company who signed the Registration Statement will have the
same rights to contribution as the Company, subject in each case to the
provisions hereof. Any party entitled to contribution, promptly after
receipt of notice of commencement of any action against such party in respect of
which a claim for contribution may be made under this Section 10(d), will notify
any such party or parties from whom contribution may be sought, but the omission
to so notify will not relieve that party or parties from whom contribution may
be sought from any other obligation it or they may have under this Section 10(d)
except to the extent that the failure to so notify such other party materially
prejudiced the substantive rights or defenses of the party from whom
contribution is sought. Except for a settlement entered into pursuant
to the last sentence of Section 10(c) hereof, no party will be liable for
contribution with respect to any action or claim settled without its written
consent if such consent is required pursuant to Section 10(c)
hereof.
11.
Representations and
Agreements to Survive Delivery
. The indemnity and contribution
agreements contained in Section 10 of this Agreement and all representations and
warranties of the Company herein or in certificates delivered pursuant hereto
shall survive, as of their respective dates, regardless of (i) any
investigation made by or on behalf of MLV, any controlling persons, or the
Company (or any of their respective officers, directors or controlling persons),
(ii) delivery and acceptance of the Placement Shares and payment therefor
or (iii) any termination of this Agreement.
12.
Termination
.
(a) MLV
shall have the right by giving notice as hereinafter specified at any time to
terminate this Agreement if (i) any Material Adverse Effect, or any
development that has actually occurred and that is reasonably expected to cause
a Material Adverse Effect has occurred that, in the reasonable judgment of MLV,
may materially impair the ability of MLV to sell the Placement Shares hereunder,
(ii) the Company shall have failed, refused or been unable to perform any
agreement on its part to be performed hereunder; provided, however, in the case
of any failure of the Company to deliver (or cause another person to deliver)
any certification, opinion, or letter required under Sections 7(m), 7(n), or
7(o), MLV’s right to terminate shall not arise unless such failure to deliver
(or cause to be delivered) continues for more than thirty days from the date
such delivery was required; or (iii) any other condition of MLV’s
obligations hereunder is not fulfilled, or (iv), any suspension or limitation of
trading in the Placement Shares or in securities generally on the Exchange shall
have occurred. Any such termination shall be without liability of any
party to any other party except that the provisions of Section 7(g) (Expenses),
Section 9 (Indemnification), Section 11 (Survival of Representations), Section
17 (Applicable Law; Consent to Jurisdiction) and Section 18 (Waiver of Jury
Trial) hereof shall remain in full force and effect notwithstanding such
termination. If MLV elects to terminate this Agreement as provided in
this Section 12(a), MLV shall provide the required notice as specified in
Section 13 (Notices).
(b) The
Company shall have the right, by giving 30 days notice as hereinafter specified
to terminate this Agreement in its sole discretion at any time after the date of
this Agreement. Any such termination shall be without liability of
any party to any other party except that the provisions of Section 7(g), Section
10, Section 11, Section 17 and Section 18 hereof shall remain in full force and
effect notwithstanding such termination.
(c) MLV
shall have the right, by giving 60 days notice as hereinafter specified to
terminate this Agreement in its sole discretion at any time after the date of
this Agreement. Any such termination shall be without liability of
any party to any other party except that the provisions of Section 7(g), Section
10, Section 11, Section 17 and Section 18 hereof shall remain in full force and
effect notwithstanding such termination.
(d) Unless
earlier terminated pursuant to this Section 12, this Agreement shall
automatically terminate upon the issuance and sale of all of the Placement
Shares through MLV on the terms and subject to the conditions set forth herein;
provided that the provisions of Section 7(g), Section 10, Section 11, Section 17
and Section 18 hereof shall remain in full force and effect notwithstanding such
termination.
(e) This
Agreement shall remain in full force and effect unless terminated pursuant to
Sections 12(a), (b), (c), or (d) above or otherwise by mutual agreement of the
parties; provided, however, that any such termination by mutual agreement shall
in all cases be deemed to provide that Section 7(g), Section 10, Section 11,
Section 17 and Section 18 shall remain in full force and effect.
(f) Any
termination of this Agreement shall be effective on the date specified in such
notice of termination; provided, however, that such termination shall not be
effective until the close of business on the date of receipt of such notice by
MLV or the Company, as the case may be. If such termination shall
occur prior to the Settlement Date for any sale of Placement Shares, such
Placement Shares shall settle in accordance with the provisions of this
Agreement.
13.
Notices
. All
notices or other communications required or permitted to be given by any party
to any other party pursuant to the terms of this Agreement shall be in writing,
unless otherwise specified, and if sent to MLV, shall be delivered
to:
McNicoll, Lewis & Vlak
LLC
420 Lexington Ave., Suite
628
New York, NY 10170
|
Attention:
|
Patrice
McNicoll
|
|
Facsimile:
|
(646)
417-7205
|
with a copy to:
Holme Roberts & Owen
LLP
1700 Lincoln Street, Suite
4100
Denver,
CO 80203
|
Attention:
|
Garth
B. Jensen
|
and if to the Company, shall be
delivered to:
Novavax,
Inc.
9920 Belward Campus Drive
Rockville, MD 20850
|
Attention:
|
Frederick
Driscoll
|
with a copy to:
Ballard
Spahr LLP
1735
Market Street, 51st Floor
Philadelphia,
PA 19103
|
Attention:
|
Jennifer
Miller
|
Each
party to this Agreement may change such address for notices by sending to the
parties to this Agreement written notice of a new address for such
purpose. Each such notice or other communication shall be deemed
given (i) when delivered personally or by verifiable facsimile transmission
(with an original to follow) on or before 4:30 p.m., New York City time, on
a Business Day or, if such day is not a Business Day, on the next succeeding
Business Day, (ii) on the next Business Day after timely delivery to a
nationally-recognized overnight courier and (iii) on the Business Day
actually received if deposited in the U.S. mail (certified or registered mail,
return receipt requested, postage prepaid). For purposes of this
Agreement, “
Business
Day
” shall mean any day on which the Exchange and commercial banks in the
City of New York are open for business.
An
electronic communication (“
Electronic Notice
”)
shall be deemed written notice for purposes of this Section 13 if sent to the
electronic mail address specified by the receiving party under separate
cover. Electronic Notice shall be deemed received at the time the
party sending Electronic Notice receives verification of receipt by the
receiving party. Any party receiving Electronic Notice may request
and shall be entitled to receive the notice on paper, in a nonelectronic form
(“
Nonelectronic
Notic
e”) which shall be sent to the requesting party within ten (10) days
of receipt of the written request for Nonelectronic Notice.
14.
Successors and
Assigns
. This Agreement shall inure to the benefit of and be
binding upon the Company and MLV and their respective successors and the
affiliates, controlling persons, officers and directors referred to in Section
10 hereof. References to any of the parties contained in this
Agreement shall be deemed to include the successors and permitted assigns of
such party. Nothing in this Agreement, express or implied, is
intended to confer upon any party other than the parties hereto or their
respective successors and permitted assigns any rights, remedies, obligations or
liabilities under or by reason of this Agreement, except as expressly provided
in this Agreement. Neither party may assign its rights or obligations
under this Agreement without the prior written consent of the other party;
provided, however, that MLV may assign its rights and obligations hereunder to
an affiliate of MLV without obtaining the Company’s consent.
15.
Adjustments for Stock
Splits
. The parties acknowledge and agree that all
share-related numbers contained in this Agreement shall be adjusted to take into
account any stock split, stock dividend or similar event effected with respect
to the Shares.
16.
Entire Agreement; Amendment;
Severability
. This Agreement (including all schedules and
exhibits attached hereto and Placement Notices issued pursuant hereto)
constitutes the entire agreement and supersedes all other prior and
contemporaneous agreements and undertakings, both written and oral, among the
parties hereto with regard to the subject matter hereof. Neither this
Agreement nor any term hereof may be amended except pursuant to a written
instrument executed by the Company and MLV. In the event that any one
or more of the provisions contained herein, or the application thereof in any
circumstance, is held invalid, illegal or unenforceable as written by a court of
competent jurisdiction, then such provision shall be given full force and effect
to the fullest possible extent that it is valid, legal and enforceable, and the
remainder of the terms and provisions herein shall be construed as if such
invalid, illegal or unenforceable term or provision was not contained herein,
but only to the extent that giving effect to such provision and the remainder of
the terms and provisions hereof shall be in accordance with the intent of the
parties as reflected in this Agreement.
17.
Applicable Law; Consent to
Jurisdiction
. This Agreement shall be governed by, and
construed in accordance with, the internal laws of the State of Colorado without
regard to the principles of conflicts of laws. Each party hereby
irrevocably submits to the non-exclusive jurisdiction of the state and federal
courts sitting in the City of Denver, for the adjudication of any dispute
hereunder or in connection with any transaction contemplated hereby, and hereby
irrevocably waives, and agrees not to assert in any suit, action or proceeding,
any claim that it is not personally subject to the jurisdiction of any such
court, that such suit, action or proceeding is brought in an inconvenient forum
or that the venue of such suit, action or proceeding is
improper. Each party hereby irrevocably waives personal service of
process and consents to process being served in any such suit, action or
proceeding by mailing a copy thereof (certified or registered mail, return
receipt requested) to such party at the address in effect for notices to it
under this Agreement and agrees that such service shall constitute good and
sufficient service of process and notice thereof. Nothing contained
herein shall be deemed to limit in any way any right to serve process in any
manner permitted by law.
18.
Waiver of Jury
Trial
. The Company and MLV each hereby irrevocably waives any
right it may have to a trial by jury in respect of any claim based upon or
arising out of this agreement or any transaction contemplated
hereby.
19.
Counterparts
. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument. Delivery of an executed Agreement by one party to the
other may be made by facsimile transmission.
[Remainder
of Page Intentionally Blank]
If the
foregoing correctly sets forth the understanding between the Company and MLV,
please so indicate in the space provided below for that purpose, whereupon this
letter shall constitute a binding agreement between the Company and
MLV.
Very
truly yours,
|
|
NOVAVAX,
INC.
|
By:
|
/s/
Frederick W. Driscoll
|
|
Name:
Frederick W. Driscoll
|
|
Title: Vice
President, Chief Financial
Officer
and
Treasurer
|
ACCEPTED
as of the date
first-above
written:
|
|
McNICOLL,
LEWIS & VLAK LLC
|
|
By:
|
/s/
Patrice McNicoll
|
|
Name:
Patrice McNicoll
|
|
Title: President
|
SCHEDULE
1
FORM
OF PLACEMENT NOTICE
To:
|
McNicoll,
Lewis & Vlak LLC
|
Attention: Patrice
McNicoll
Subject:
|
At
Market Issuance—Placement Notice
|
Gentlemen:
Pursuant
to the terms and subject to the conditions contained in the At Market Issuance
Sales Agreement between Novavax, Inc. (the “
Company
”), and
McNicoll, Lewis & Vlak LLC (“
MLV
”) dated March 15,
2010, the Company hereby requests that MLV sell up to ____________ shares of the
Company’s common stock, par value $.01 per share, at a minimum market price of
$_______ per share, during the time period beginning [
month, day, time
] and
ending [
month, day,
time
].
SCHEDULE
2
Compensation
The
Company shall pay to MLV in cash, upon each sale of Shares pursuant to this
Agreement, an amount equal to 2.0% of the gross proceeds from each sale of
Shares pursuant to this Agreement.
EXHIBIT
7(m)
Form
of Representation Date Certificate
This
Officers Certificate (this “
Certificate
”) is
executed and delivered in connection with Section 7(m) of the At Market Issuance
Sales Agreement (the “
Agreement
”), dated
March 15, 2010, and entered into between Novavax, Inc. (the “
Company
”) and
McNicoll, Lewis & Vlak LLC (“
MLV
”). All
capitalized terms used but not defined herein shall have the meanings given to
such terms in the Agreement
The
undersigned, a duly appointed and authorized officer of the Company, having made
all necessary inquiries to establish the accuracy of the statements below and
having been authorized by the Company to execute this certificate, hereby
certifies as follows:
1. As
of the date of this Certificate, (i) the Registration Statement does not contain
any untrue statement of a material fact or omit to state a material fact
required to be stated therein or necessary in order to make the statements
therein not misleading and (ii) neither the Prospectus nor the Pricing
Disclosure Materials contain any untrue statement of a material fact or omit to
state a material fact required to be stated therein or necessary in order to
make the statements therein, in light of the circumstances under which they were
made, not misleading and (iii) no event has occurred as a result of which it is
necessary to amend or supplement the Prospectus in order to make the statements
therein not untrue or misleading.
2. Each
of the representations and warranties of the Company contained in the Agreement
were, when originally made, and are, as of the date of this Certificate, true
and correct in all material respects.
3. Each
of the covenants required to be performed by the Company in the Agreement on or
prior to the date of the Agreement, this Representation Date, and each such
other date as set forth in the Agreement, has been duly, timely and fully
performed in all material respects and each condition required to be complied
with by the Company on or prior to the date of the Agreement, this
Representation Date, and each such other date as set forth in the Agreement or
in the Waivers has been duly, timely and fully complied with in all material
respects.
4. Subsequent
to the date of the most recent financial statements in the Prospectus, there has
been no material adverse change.
5. No
stop order suspending the effectiveness of the Registration Statement or of any
part thereof has been issued, and no proceedings for that purpose have been
instituted or are pending or threatened by any securities or other governmental
authority (including, without limitation, the Commission).
6. No
order suspending the effectiveness of the Registration Statement or the
qualification or registration of the Shares under the securities or Blue Sky
laws of any jurisdiction are in effect and no proceeding for such purpose is
pending before, or threatened, to the Company's knowledge or in writing by, any
securities or other governmental authority (including, without limitation, the
Commission).
The undersigned has executed this
Officer's Certificate as of the date first written above.
EXHIBIT
7(n)
Form
Of Legal Opinion
Capitalized terms used and not defined
herein shall have the meanings ascribed to them in the At Market Issuance Sales
Agreement
(i) The
authorized capital stock of the Company conforms in all material respects as to
legal matters to the descriptions thereof set forth in the Registration
Statement, Prospectus and the Prospectus Supplement. The Shares have been duly
authorized and, when issued and delivered pursuant to the terms of the
Agreement, will be validly issued, fully paid and non-assessable; and will not
have been issued in violation of any preemptive rights granted under the
Company’s Certificate of Incorporation or under the corporate laws of the State
of Delaware.
(ii) The
Company is a validly existing corporation in good standing under the laws of the
State of Delaware, the jurisdiction of its organization. The Company
has the corporate power to execute and deliver the Agreement and to issue, sell
and deliver the Shares.
(iii) The
execution and delivery of the Agreement by the Company and the performance by
the Company of its obligations under the Agreement have been duly authorized by
all requisite corporate action on behalf of the Company. The
Agreement has been duly executed and delivered by the Company and constitutes
the legal, valid and binding obligation of the Company, enforceable against the
Company in accordance with its terms.
(iv) The
sale and issuance by the Company of the Shares has been duly authorized by all
requisite corporate action on behalf of the Company.
(v) The
Registration Statement, Prospectus and the Prospectus Supplement (other than the
financial statements and schedules and other financial data included or
incorporated by reference therein, as to which we express no opinion), as of
their respective effective and issue dates, complied as to form in all material
respects with the requirements of the Securities Act and the rules and
regulations thereunder.
The opinion of counsel will be
accompanied by a standard Rule 10b-5 negative assurance letter.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT
10.45
H1N1
LICENSE AGREEMENT
This
License Agreement
(the “
Agreement
”) is executed as of
this October 6, 2009 (the “
Effective
Date
”), by and between
Novavax,
Inc.
, a Delaware
corporation having an
address at 9920 Belward Campus Drive, Rockville, Maryland 20850, United States
of America (“
Novavax
”)
and
CPL Biologicals Private Limited
, a limited company incorporated under the
laws of India having an address at “Cadila Corporate Campus”, Sarkhej-Dholka
Road, Bhat, Ahmedabad – 382210, Gujarat, India
(“
C
ompany
”). Novavax
and Company are sometimes referred to herein each individually as a “Party” and
collectively as the “Parties.”
RECITALS
Whereas,
Novavax is a specialty biopharmaceutical company engaged in the research,
development and commercialization of its virus like particle technology into
vaccine products for the prevention of infectious diseases such as seasonal
influenza and other infectious diseases;
Whereas,
Novavax Controls the Licensed Rights, as defined below;
Whereas,
Company wishes to obtain a license under the Licensed Rights, to practice the
processes included or claimed in the Licensed Rights and to Develop and
Commercialize Licensed Product; and
Whereas,
Novavax is willing to grant such license on the terms and conditions of this
Agreement.
Now,
Therefore,
in consideration of the foregoing premises and the mutual
covenants set forth below, and for other good and valuable consideration, the
receipt of which is hereby acknowledged, Novavax and Company hereby agree as
follows:
ARTICLE
1
DEFINITIONS
References
in the body of this Agreement to “Sections” will refer to the sections of this
Agreement. In addition, as used herein, the following initially
capitalized terms will have the following meanings:
1.1
“Affiliate”
means any
corporation or other business entity controlled by, controlling, or under common
control with a Party, with
“control”
(for purposes of
this Section 1.1 only) meaning (a) direct or indirect beneficial ownership of
fifty percent (50%) or more of the voting stock (or, in the case of a
non-corporate entity, of the equity interests with the power to direct the
management and policies) of such corporation or other business entity, or (b)
possession, directly or indirectly, of the power to direct, or cause the
direction of, the management and policies of such corporation or other business
entity, whether through the ownership of voting securities, by contract, or
otherwise; provided that for purposes of this Agreement, Novavax and Cadila
Pharmaceuticals Limited shall not be deemed to be an Affiliate of
Company.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.2
“
Business Day”
means any day other than
a Saturday, Sunday or other day on which the principal commercial banks located
in Mumbai, India and Washington, DC, United States are not open for business
during normal business hours.
1.3
“
Com
mercialize”
or “
Commercialization”
means
all activities that are undertaken to prepare for launch before Regulatory
Approval (including pricing and reimbursement approvals) undertaken after
Regulatory Approval for Licensed Product and that relate to the commercial
marketing and sale of Licensed Product including advertising, sales, marketing,
promotion, distribution, and phase IV clinical trials.
1.4
“
Control”
means, with respect to
any intellectual property right, that a Party owns or has a license to such item
or right, and has the ability to grant a license or sublicense in or to such
right without violating the terms of any agreement or other arrangement with any
Third Party existing at the time that this Agreement first requires such Party
to grant the other Party such license or sublicense, provided that, for the
avoidance of doubt, if the ability to grant such license or sublicense without
violating the terms of any such agreement or other arrangement arises after such
time, the license or sublicense shall be deemed granted hereunder at such later
date.
1.5
“
Develop”
or “
Development”
means the performance of
all non-clinical, pre-clinical and clinical development, manufacturing and
regulatory activities for a Licensed Product that are required to obtain
Regulatory Approval of a Licensed Product in the Territory.
1.6
“
Developed Know-How”
has the
meaning in Section 5.1.
1.7
“
Effective Date
” means the date
set forth in the preamble.
1.8
“
Governmental Authority”
means any applicable
court, agency, department or other instrumentality of any foreign, federal,
state, county, city or other political subdivision.
1.9
“
IND”
means a U.S. Food and
Drug Administration investigational new drug application, or its foreign
equivalent.
1.10
“Joint Venture Agreement”
means the Amended and Restated Joint Venture Agreement by and between Novavax
and Cadila Pharmaceuticals Limited, dated June 29, 2009, as amended from time to
time.
1.11
“
Know-How”
means all tangible
and intangible (a) techniques, technology, practices, trade secrets,
inventions (whether patentable or not), methods, protocols, processes, formulas,
knowledge, know-how, skill, experience, records, documents, data and results
(including pharmacological, toxicological, non-clinical and clinical test data
and results), analytical and quality control data, results or descriptions,
software and algorithms and (b) compositions of matter, cells, cell lines,
assays, animal models and physical, biological or chemical
material.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.12
“
Laws”
means all applicable
laws, statutes, rules, regulations, ordinances and other pronouncements having
the effect of law of any federal, national, multinational, state, provincial, or
other political subdivision, domestic or foreign.
1.13
“
Licensed Product”
means
Novavax’s current monovalent intra-muscular H1N1 influenza vaccine containing a
virus like particle (VLP) consisting of [* * *] designated as pandemic by the
World Health Organization (WHO) Collaborating Centers for Reference and Research
on Influenza located at the Centers for Disease Control and Prevention (CDC) in
Atlanta, Georgia, together with any minor modifications thereto including, by
way of example but not limitation, changes to any excipient, changes arising
from a change in manufacturing process, or change in dosage. [* *
*].
1.14
“
Licensed Rights”
means the
Novavax Patents and any and all Know-How, including any Developed Know-How,
owned or Controlled by Novavax at any time during the term of this Agreement
which is used or embodied in, or useful for developing or manufacturing, any
Licensed Product, including, without limitation, Know-How regarding Novavax’s
proprietary baculovirus insect cell expression and manufacturing system and
improvements thereto.
1.15
“
Novavax Patents”
means any and
all Patents in the Territory owned or Controlled by Novavax at any time during
the term of this Agreement covering or claiming a Licensed Product and/or the
manufacture or use thereof including, without limitation, the Patents listed on
Schedule
1
.
1.16
“
Patent”
means any and all (a)
issued patents and inventors’ certificates and re-examinations, reissues,
renewals, extensions, registrations, substitutions, supplementary protection
certificates and term restorations with respect to any of the foregoing, and (b)
pending applications for patents and inventors’ certificates and patents that
issue therefrom, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications
with respect to any of the foregoing.
1.17
“
Program Data
” means (a)
research, preclinical, clinical, manufacturing and similar data, information,
material and results, (b) regulatory filings and approvals, and (c) sales and
marketing information.
1.18
“
Regulatory Approval”
means any
and all approvals (including supplements, amendments, pre- and post-approvals,
pricing and reimbursement approvals), licenses, registrations or authorizations
of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are
necessary for the manufacture, distribution, use or widespread sale of a
Licensed Product in a regulatory jurisdiction in the Territory.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.19
“
Regulatory Authority”
means
any Governmental Authority with responsibility for granting any licenses or
approvals necessary for the marketing and sale of pharmaceutical products in the
Territory.
1.20
“
Regulatory Documentation”
means, with respect to a Licensed Product, all Regulatory Filings and supporting
documents created, submitted to a Regulatory Authority, and all data contained
therein, including, without limitation, any Investigational New Drug
Application, New Drug Application, Marketing Authorization Application, foreign
counterparts thereof, Investigator’s Brochures, drug master files,
correspondence to and from a Regulatory Authority, minutes from teleconferences
with Regulatory Authorities, registrations and licenses, regulatory drug lists,
advertising and promotion documents shared with Regulatory Authorities, adverse
event files, complaint files and manufacturing records.
1.21
“
Regulatory Filing”
means the foreign
counterparts of an Investigation New Drug Application, New Drug Application,
Marketing Authorization Application and any other filings required by Regulatory
Authorities relating to the study, Development, manufacture or Commercialization
of any Licensed Product in the Territory.
1.22
“
Technical Services Agreement”
means that certain Amended and Restated Technical Services Agreement between
Novavax and Company dated as of the date hereof, as amended from time to
time.
1.23
“
Territory”
means
India.
1.24
“
Third
Party”
means a person or
entity other than (a) Novavax, (b) Company, (c) an Affiliate of Novavax or (d)
an Affiliate of Company.
1.25
“
U.S.”
means the United States
of America.
ARTICLE
2
LICENSES
2.1
License Grant to
Company.
Novavax hereby grants to Company an exclusive, fully
paid-up, royalty-free (except as expressly set forth in Section 2.7),
non-transferable, right and license under the Licensed Rights during the term of
this Agreement to (a) research, develop, use, sell, have sold, offer to sell and
import Licensed Product in the Territory, and (b) make (and have made solely by
Cadila Pharmaceuticals Ltd., a company incorporated under the laws of India
(
“
Cadila
”
)
or an Affiliate of Cadila,
subject to Novavax’s approval described below) Licensed Product in the Territory
solely to develop, use, sell, have sold, offer to sell and import Licensed
Product in the Territory. The foregoing license shall be exclusive
for Licensed Product in the Territory, even as to Novavax, provided that Novavax
retains the right to perform its obligations under this Agreement, the Technical
Services Agreement and any other agreement between Company and
Novavax.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Novavax
shall be reasonable in granting or withholding its approval to permit Cadila or
an Affiliate of Cadila to make Licensed Product in the
Territory. Novavax’s approval shall be subject to its consideration
of, among other things, any documentation or agreement surrounding such
manufacturing of the Licensed Product (which, in any case, shall be solely for
the benefit of the Company), the safeguards in place with regard to any such
manufacturing, the protection of the Licensed Rights, and Novavax’s ability to
conduct reasonable due diligence on any Affiliate of Cadila. In no
event does the license grant to the Company under this Section 2.1 permit the
Company to have Licensed Product made by a Third Party other than Cadila or an
Affiliate of Cadila, subject to the approval described above.
2.2
License Grant to Novavax.
The Company hereby grants to Novavax a fully paid-up, royalty-free
exclusive right and license under Developed Know-How owned or Controlled by the
Company, including any Patents that issue therefrom, to (a) research, develop,
use, sell, have sold, offer to sell and import (i) Licensed Product and (ii)
other influenza vaccines outside the Territory, and (b) make and have made (i)
Licensed Product and (ii) other influenza vaccines outside the Territory solely
to develop, use, sell, have sold, offer to sell and import Products outside the
Territory.
2.3
Sublicenses.
Company
shall not sublicense the Licensed Rights to any Third Party without the prior
written consent of Novavax, which consent may be withheld in its sole
discretion. Upon execution of a sublicense, after receipt of Novavax
consent, Company will notify Novavax of the execution of the sublicense and
provide a copy to Novavax promptly following execution thereof.
2.4
No Implied Rights or Licenses.
No right or license, other than those expressly set forth in this
Agreement are granted to either party hereunder, and no additional rights will
be deemed granted to either party by implication, estoppel or
otherwise. All rights not expressly granted by either party to the
other hereunder are reserved.
2.5 Research
Data; Right of Reference.
(a) Company
shall keep complete and accurate notes, accounts and records of all Program Data
with respect to Licensed Product, including the manufacture
thereof. Novavax shall have the right to access, use and reference
for its Development and Commercialization of its products outside the Territory
Program Data related to Licensed Product in the possession or control of the
Company. The Company shall provide such cooperation and assistance as
reasonably requested by Novavax from time to time to effectuate the foregoing,
including, without limitation by providing access to and disclosure of Program
Data to Novavax and by providing such authorization and consents required for
reference to regulatory filings and approvals.
(b) Company
shall have the right to access, use and reference for its Development and
Commercialization of Licensed Product in the Territory Program Data related to
Licensed Product in the possession or control of Novavax. Novavax
shall provide such cooperation and assistance as reasonably requested by Company
from time to time to effectuate the foregoing, including, without limitation by
providing access to and disclosure of Program Data to Company and by providing
such authorization and consents required for reference to regulatory filings and
approvals.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2.6
Grey Market.
The
Parties reasonably cooperate to formulate and implement reasonable precautions
designed to prevent Licensed Product made or sold by or for such Party or its
respective Affiliates and permitted sublicensees from being sold outside of its
respective territory (i.e., outside the Territory for the Company and inside the
Territory for Novavax). Further, each Party will take reasonable
measures so that its distributors, Affiliates and wholesalers to whom the
Company or Novavax provides its respective Licensed Product are aware of the
respective territorial limitations.
2.7
Third Party License
Agreements.
The license granted under Section 2.1 may be
subject to applicable terms and conditions of a license agreement with a Third
Party, under which any Licensed Rights are sublicensed to the Company hereunder
by Novavax (each a “
Third Party License
Agreement
”). Novavax shall be responsible for maintaining the
Third Party License Agreements and for any payments owed by Novavax thereunder;
provided, however, that if a royalty is owed on sales of Licensed Product by or
for the Company in the Territory under such Third Party License Agreement, such
payments will be paid by Company.
2.8
Combination Products
Reservation.
Novavax shall not, directly or indirectly, (i)
engage in, promote, or finance the research, development, or commercialization
of, or (ii) grant any license, or any similar rights with respect to, to a Third
Party, in each case of (i) and (ii), a Licensed Product in combination with
another active ingredient, antigen or adjuvant in the Territory.
ARTICLE
3
LICENSED
PRODUCT DEVELOPMENT AND COMMERCIALIZATION
3.1 Development
and Commercialization of Licensed Product.
(a)
General.
Company
will have sole responsibility, at Company’s sole expense, for all Development
and Commercialization of Licensed Product in the Territory in accordance with
the terms of this Agreement.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b)
Development and Commercialization of
Licensed
Product
.
Prior to [* * *],
Company shall present to Novavax for its written approval Development plans for
the Licensed Product which shall specify preclinical studies (including a
toxicology program and other preclinical testing), human clinical trials,
manufacturing scale up, Regulatory Approval strategy and any other significant
Development activities, that Company plans to perform to obtain Regulatory
Approval of such Licensed Product in the Territory (the “
H1N1 Development
Plans
”). Novavax may reasonably request adjustments to
activities described in such Development plans as a condition to granting its
approval. In no event shall Company materially alter a H1N1
Development Plan without Novavax’s prior written consent. Company
shall conduct Development of such Licensed Product in a manner that is
materially consistent with the H1N1 Development Plans. All clinical
trial protocols for Licensed Product conducted by Company shall require the
prior written approval of Novavax. Prior to [* * *], Company shall
present to Novavax for its written approval a plan to Commercialize the Licensed
Product which shall specify a multi-year marketing and public relations
strategy, operational plans to implement such strategies and any other
significant Commercialization activities (the “
H1N1 Commercialization
Plan
”). Novavax may reasonably request adjustments to the
Commercialization plan as a condition to granting its approval. In no
event shall Company materially alter the H1N1 Commercialization Plan without
Novavax’s prior written consent. Company shall conduct
Commercialization of such Licensed Product in a manner that is materially
consistent with the H1N1 Commercialization Plan. Novavax acknowledges
that the Licensed Product are being contributed by Novavax to the Company in
accordance with the Joint Venture Agreement and that if the Company cannot
Develop and Commercialize such Licensed Product it will not obtain the value of
such contribution. Company acknowledges that Novavax (or its
affiliates or licensees) are Developing and Commercializing Licensed Product
outside the Territory and Company’s activities could raise safety concerns and
have an impact on Novavax’s activities including the Regulatory Approval and
regulatory profile of an approved Licensed Product outside the
Territory. Accordingly, taking into account Novavax’s and Company’s
respective interests including, without limitation, as provided in the two
preceding sentences, Novavax shall not unreasonably withhold, delay or condition
any of its consents or approvals hereunder.
3.2
Regulatory Affairs.
Company
will be responsible for
developing Regulatory Documentation and preparing and submitting Regulatory
Filings, seeking Regulatory Approvals, and maintaining Regulatory Approvals for
Licensed Product in the Territory. Novavax will cooperate with
Company in preparing and filing all such reports in accordance with the
Technical Services Agreement. To effectuate such cooperation, the
Parties hereby agree to amend and amend Section 1.1(t) of the Technical Services
Agreement to revise the definition of “Novavax Products” to read in its entirety
as follows:
3.3
“Novavax
Product” shall mean (i) the Novavax Products (as defined in the Joint Venture
Agreement), and (ii) the Licensed Product (as that term is defined in the
License Agreement by and between Novavax and Company, dated October 6, 2009).
3.4
Manufacture and
Supply.
Company will be responsible for the manufacture of
Licensed Product in the Territory and for all costs associated
therewith. Certain amount of supply of preclinical and clinical
supply of Licensed Product will be made under the Amended and Restated Supply
Agreement, dated as of June 29, 2009, between Company and Novavax, as amended
from time to time (the “
Supply
Agreement
”). To effectuate such amount of supply under the
Supply Agreement, the Parties hereby agree to amend and amend Section 1.19 of
the Supply Agreement to revise the definition of “Products” to read in its
entirety as follows:
“
Products
” means
Novavax’s pre-clinical and clinical supplies of the Novavax Seasonal Product and
the Licensed Product (as that term is defined in the License Agreement by and
between Novavax and Company, dated October 6, 2009), in each case which conform
to the Specifications.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.5
Adverse Event
Reporting.
Company will maintain a record of all non-medical
and medical Licensed Product-related complaints and reports of Adverse Events in
the Territory with respect to any Licensed Product Developed or Commercialized
by the Company. At the request of either party, Novavax and the
Company shall enter into reasonable and customary pharmacovigilance agreement
with respect to sharing of adverse event data and information for Licensed
Product as required to comply with applicable laws and regulations.
3.6
Development and Commercial
Reporting.
During the Term of this Agreement, Company will provide
a half-yearly written progress report to Novavax summarizing the Development and
Commercialization of Licensed Product(s) during the prior
six months
. Each such progress report
will be provided to Novavax by Company no later than March 1
st
or
September 1
st
(as the
case may be) of each year following the Effective Date.
3.7
Minor
Modifications.
During the Term of this Agreement, Novavax will
promptly provide Company with details of any minor modifications it makes to the
Licensed Product as Novavax develops it for Regulatory Approval.
ARTICLE
4
RESERVED
ARTICLE
5
INTELLECTUAL
PROPERTY
5.1
Disclosure.
During
the Term, the Parties will promptly disclose to one another all Know-How
(whether patentable or not) developed, conceived or reduced to practice during
the Development, manufacture or Commercialization of a Licensed Product which is
regarding or directed to a Licensed Product (“
Developed
Know-How
”). Novavax shall also disclose to the Company any
Know-How within the Licensed Rights obtained, licensed or generated after the
Effective Date which is not included within the Developed Know-How.
5.2
Ownership.
Novavax
shall own all Developed Know-How and any other intellectual property that is
conceived and reduced to practice solely by Novavax. The Company
shall own all Developed Know-How and any other intellectual property that is
conceived and reduced to practice solely by Company. Novavax and the
Company shall jointly own in accordance with U.S. Laws regarding joint ownership
of the applicable type of intellectual property, all Developed Know-How and any
other intellectual property that is conceived or reduced to practice by Novavax
and Company jointly.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.3
Prosecution and Maintenance of
Patents.
Novavax shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance, and renewal of all
Novavax Patents and any Patents that result from Developed Know-How which is
owned by Novavax or jointly owned as provided in Section 5.2, at its own
expense. Company shall have the sole and exclusive right and
authority to control the filing, prosecution, maintenance and renewal of any
Patents that result from Developed Know-How owned by Company as provided in
Section 5.2. With respect to any such Patents in the Territory and
with respect to any such Patents that are subject to the license granted to
Novavax in Section 2.2 anywhere in the world (the “
ROW Patents
”), the prosecuting
party shall (i) provide the other party with copies of all material filings,
documentation and correspondence from, sent to or filed with patent offices in
the Territory or anywhere in the world for the ROW Patents, and (ii) provide the
other party with a reasonable opportunity to comment upon all filings and
actions with such patent offices in advance of submissions to such patent
offices. For purposes of this Section
5.3, “filing,
prosecution and maintenance” of patents shall be deemed to include, without
limitation, appeals to administrative or judicial entities having jurisdiction
over patentability, the conduct of interferences or oppositions, and/or requests
for re-examinations, reissues or extensions of patent terms.
5.4
Abandoned
Patents.
In the event the prosecuting party determines not to
initiate patent prosecution for any particular patentable Developed Know-How
invention or to cease prosecution or maintenance of, or otherwise abandon, any
Patents that are the subject of Section 5.3 in the Territory, or with respect to
ROW Patents anywhere in the world (which the prosecuting party may do in its
sole discretion), the prosecuting party shall provide reasonable prior written
notice to the other party sufficient for the other party to timely initiate or
take over the prosecution and maintenance of such Patent and timely file any
required documents and responses with the relevant government patent office in
the Territory, or with respect to ROW Patents anywhere in the world, with
respect thereto, and the other party may elect (in its sole discretion) to
prosecute and maintain such Patent, at the other party’s sole
expense. In such event, upon the request of and, at the expense of
the other party, the prosecuting party shall assign to the other party all of
its right, title and interest in, to and under such Patent which the prosecuting
party has decided to abandon and provide reasonable cooperation to the other
party with respect thereto (including, without limitation, providing necessary
information and executing relevant documents).
5.5 Enforcement
of Patents.
(a)
Infringement by Third
Parties.
In the event that Novavax or the Company becomes
aware of or has reasonable suspicions of third party activities in the Territory
that could constitute infringement of the Novavax Patents or Patents that issue
from Developed Know-How in the Territory, or with respect to ROW Patents
anywhere in the world, or misappropriation of the Novavax Know-How or Developed
Know-How in the Territory, or with respect to Developed Know-How any that is
subject to the license granted to Novavax in Section 2.2 anywhere in the world
(“
ROW Know-How
”), then
such party shall promptly notify the other parties of such third party
activities, including identification of the third party and delineation of the
facts relating to such third party activities. The Company shall have
the right (but shall not be obligated) to enforce the Novavax Patents, Novavax
Know-How and Developed Know-How against any actual or alleged infringement or
misappropriation thereof in the Territory by a third party (by bringing a suit,
action or proceeding against such third party), at the Company’s sole
expense. Novavax shall have the right (but shall not be obligated) to
enforce the ROW Patents and ROW Know-How within the scope of the licenses
granted to Novavax in Section 2.2 against any actual or alleged infringement or
misappropriation thereof outside the Territory by a third party (by bringing a
suit, action or proceeding against such third party), at Novavax’s sole
expense. If the Company does not enforce the Novavax Patents or
Know-How by (i) one hundred (100) days following the notice of alleged
infringement or (ii) thirty (30) days before the time limit, if any, set forth
in the appropriate laws and regulations for the filing of such an action,
whichever comes first, then Novavax shall have the right (but not the
obligation) to enforce the Novavax Patents and Novavax Know-How against any
actual or alleged infringement or misappropriation thereof in the Territory by a
third party (by bringing a suit, action or proceeding against such party), at
Novavax’s sole expense. The non-prosecuting party shall reasonably
cooperate with the prosecuting party in such enforcement activities, at the
prosecuting party’s expense, including by agreeing to be named as a party to (or
bringing in its own name) such suit, action or proceeding for the benefit of the
non-prosecuting party if required for such enforcement action to
proceed. The prosecuting party shall keep the non-prosecuting party
reasonably informed regarding any such enforcement action and shall consider in
good faith the reasonable comments and suggestions of the non-prosecuting party
related to such suit, action or proceeding. All recoveries received
by the prosecuting party from any such enforcement action shall be retained by
the prosecuting party.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b)
Challenge by Third
Parties.
Novavax and Company will each notify the other Party
in writing within ten (10) Business Days of learning of any alleged or
threatened opposition, reexamination request, action for declaratory judgment,
nullity action, interference or other attack upon the validity, title or
enforceability of the Licensed Rights or the ROW Patents or ROW Know-How by a
Third Party. Owner of the subject Patent will have the right (but not
the obligation) to defend any such challenge in the Territory. If the
owner of the subject Patent commences a defense against the alleged or
threatened challenge (i) within sixty (60) days following the detection of the
alleged challenge, or (ii) ten (10) Business Days before the time limit, if any,
set forth in appropriate Laws and regulations for making a filing in defense of
such a challenge, whichever comes first, then the owner of the subject Patent
will so notify the other party promptly. Notwithstanding the
foregoing, if any such action for declaratory judgment, nullity action, or other
attack upon the validity, title or enforceability of the Licensed Right includes
or will include counterclaims of infringement of the Licensed Rights, ROW
Patents or ROW Know-How by the Third Party, control of such action or other
attack shall be governed by Section 5.5(a).
ARTICLE
6
CONFIDENTIALITY;
PUBLICATION
6.1
Confidentiality
. The
Parties anticipate that under this Agreement each Party will provide
confidential and/or proprietary information to the other Party and that the use
and disclosure of such information shall be governed by Article 18 of the Joint
Venture Agreement which is hereby incorporated by reference.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
6.2
Publication.
(a) Each
Party shall have the right to publish the data and results related to Licensed
Product, subject to the rest of this Section 6.2. Prior to public
disclosure or submission for publication of a proposed publication describing
the results of any scientific or clinical activity relating to a Licensed
Product, the Party proposing such publication shall send the other Party by
expedited delivery a copy of the proposed publication to be submitted and shall
allow the other Party a reasonable time period (but not more than sixty (60)
days from the date of confirmed receipt) in which to determine whether the
proposed publication contains subject matter for which patent protection should
be sought (prior to publication of such proposed publication) for the purpose of
protecting an invention, or whether the proposed publication contains the
Confidential Information of such other Party, or whether the proposed
publication contains information that is reasonably likely to have a material
adverse impact on the development or commercialization of Licensed
Product. Following the expiration of applicable time period for
review, the Party proposing such publication shall be free to submit such
proposed publication for publication and publish or otherwise disclose to the
public such scientific or clinical results, subject to the procedures set forth
in Section 6.2(b).
(b) If
the Party reviewing such publication believes that the subject matter of the
proposed publication by the other Party contains Confidential Information of the
Party or a patentable invention owned by the Party or in which it otherwise has
exclusive rights hereunder, then prior to the expiration of the applicable time
period for review, such Party shall notify the Party proposing such publication
in writing of such belief. On receipt of written notice from the
other Party that such proposed publication contains its Confidential
Information, the Party proposing publication shall remove such Confidential
Information from such proposed publication prior to any publication thereof,
unless the other Party agrees otherwise in writing. On receipt of
written notice from the other Party that such proposed publication contains a
patentable invention owned by it or in which it otherwise has exclusive rights
hereunder, the Party proposing publication shall delay public disclosure of such
information or submission of the proposed publication for an additional period
of thirty (30) days to permit preparation and filing of a patent application on
such invention. The Party proposing publication shall thereafter be
free to publish or disclose such information.
ARTICLE
7
REPRESENTATIONS AND
WARRANTIES
7.1
Mutual
Warranties.
Each of Novavax and Company hereby represents,
warrants and covenants to the other as of the Effective Date that:
(a) it
has full corporate power and authority to enter into this Agreement and to carry
out the provisions hereof, and this Agreement is legally binding upon it and
enforceable in accordance with its terms.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) the
execution, delivery and performance of this Agreement by it does not conflict
with any agreement, instrument or understanding, oral or written, to which it is
a party or by which it may be bound, nor violate any Law of any governmental
authority having jurisdiction over it;
(c) it
has not granted, and during the Term it will not grant, any right to any Third
Party that would conflict with the rights granted to the other Party
hereunder. It has (or will have at the time performance is due)
maintained and will maintain and keep in full force and effect all agreements
necessary to perform its obligations hereunder; and
(d) all
necessary consents, approvals and authorizations of all governmental authorities
and other persons required to be obtained by such Party to enter into, or
perform its obligations under, this Agreement have been obtained.
7.2
Representations by
Novavax.
In addition to the representations and warranties
made in Section 7.1, Novavax hereby represents, warrants and covenants to
Company as of the Effective Date that:
(a)
the
Licensed Rights are subsisting and are not the subject of any interference,
re-issue, re-exam, opposition or appeal proceedings;
(b) no
Third Party has filed, pursued or maintained or, to the best of its knowledge,
threatened in writing to file, pursue or maintain any claim, lawsuit, charge or
other action involving any Licensed Right including any claim, lawsuit, charge,
or action alleging that any Licensed Right is invalid or
unenforceable;
(c) and
to the best of its knowledge, all employees and agents of Novavax who have
performed any activities on its behalf in connection with research regarding the
Licensed Rights have properly assigned to Novavax the whole of their rights in
any intellectual property made, discovered or developed by them as a result of
such research, and no Third Party has any rights to any such intellectual
property;
(d) the
Licensed Rights are free and clear of any liens, charges, encumbrances or rights
of others, to possession or use that may interfere with Novavax’s possession or
use under this Agreement;
(e)
it has sufficient rights to
grant the licenses granted to the Company hereunder; and
(f)
all third party agreements
licensing any Licensed Rights to Novavax, which are sublicensed to the Company
hereunder, are currently in full force and effect, and it has not received
notice of material breach or termination thereof.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.3
DISCLAIMER OF
WARRANTIES
. Except as expressly set forth herein, EACH PARTY
EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE
PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the
generality of the foregoing, each Party expressly does not warrant, and
disclaims any warranties with regards to: (a) the success of any
study or test commenced under this Agreement, (b) the safety or usefulness
for any purpose of the technology or Materials it provides or discovers under
this Agreement; and/or (c) the validity, enforceability, or non-infringement of
any intellectual property rights or technology it provides or licenses to the
other Party under this Agreement.
ARTICLE
8
INDEMNIFICATION
8.1
Indemnification by
Company.
Company will indemnify, defend and hold harmless
Novavax, its affiliates, directors, officers and employees (each a “
Novavax Indemnitee
”) from and
against any and all liability, loss, damage or expense (including without
limitation reasonable attorneys fees) it may suffer as the result of Third Party
claims, demands, actions and proceedings brought against it (collectively,
“
Losses
”) to the extent
such Losses result from the (a) negligence or willful misconduct by Company, its
Affiliates, employees, agents, or Third Party contractors, or (b) manufacture,
use, sale, or offer for sale of a Licensed Product in the Territory due to a
design defect or a manufacturing defect, including but not limited to, a Loss
related to the death of or injury to a Third Party. Company’s
obligation to indemnify Novavax pursuant to this Section 8.1 will not apply to
the extent of any Loss that arises from the (i) material breach by Novavax of
its representations, warranties or covenants contained within this Agreement,
(ii) negligence or willful misconduct of any Novavax Indemnitee, or (iii) a
manufacturing defect of Licensed Product supplied by Novavax under the Supply
Agreement.
8.2
Indemnification by
Novavax.
Novavax will indemnify, defend and hold harmless
Company, its affiliates, directors, officers and employees (each a “
Company Indemnitee
”) from and
against any and all Losses to the extent such Losses result from the (a)
negligence or willful misconduct by Novavax, its Affiliates, employees, agents
or Third Party contractors, or (b) manufacture, use, sale, or offer for sale of
a Licensed Product outside the Territory due to a design defect or a
manufacturing defect, including but not limited to, a Loss related to the death
of or injury to a Third Party. Novavax’s obligation to indemnify the
Company Indemnitee pursuant to this Section 8.2 will not apply to the extent of
any Loss that arises from the (i) material breach by Company of its
representations, warranties or covenants contained within this Agreement or (ii)
negligence or willful misconduct of any Company Indemnitee.
8.3
Procedures.
Indemnitor’s
agreement to indemnify, defend and hold harmless an Indemnitee is conditioned on
Indemnitee (a) providing prompt written notice of any claim giving rise to an
indemnification obligation hereunder but only if a failure to so notify causes
prejudicial harm to the Indemnitor’s ability to defend, (b) permitting
Indemnitor to assume full responsibility to investigate, prepare for and defend
against any such claim, (c) providing reasonable assistance in the defense of
such claim at Indemnitor’s reasonable expense, and (d) not compromising or
settling such claim without Indemnitor’s advance written
consent.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
8.4
Insu
rance.
Each Party
will maintain comprehensive general liability insurance coverage, including
products liability, in amounts it reasonably determines are appropriate with
respect to the Development and Commercialization of Licensed Product in its
respective territory.
8.5
Limitation of
Liability.
EXCEPT TO THE EXTENT (A) SUCH PARTY MAY BE REQUIRED TO
INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 8, OR (B) AS REGARDS A BREACH OF A
PARTY’S RESPONSIBILITIES PURSUANT TO ARTICLE 6, NEITHER PARTY NOR ITS RESPECTIVE
AFFILIATES WILL BE LIABLE TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS OF
BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR ANY OTHER INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES UNDER THIS AGREEMENT,
WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.
ARTICLE
9
TERM; BREACH
9.1
Term and
Termination.
The term of this Agreement will commence on the
Effective Date and will continue until (a) the Company provides sixty (60) days
prior written notice of termination to Novavax, (b) the Parties mutually agree
in writing to terminate the Agreement, or (c) Novavax terminates the Joint
Venture Agreement by providing a Notice of Termination under and pursuant to
Section 11.2 of the Joint Venture Agreement. In no event shall either
Party have the right to terminate this Agreement based upon any breach by the
other Party, and to the extent that any right to terminate is provided under any
Laws, the Parties hereby waive such right.
9.2
Breach and
Remedies.
In addition to any remedies available under any
laws, the following remedies shall be available to a party in the event of the
following breaches
(a) In
the event that Section 2.6 is materially breached by either party, the
non-breaching party shall be entitled to damages equal to its lost profit from
lost sales of Licensed Product in or out of the Territory (as applicable) due to
the “grey market” breach.
(b) In
the event that Company (i) materially alters an H1N1 Development Plan or H1N1
Commercialization Plan for Licensed Product without Novavax’s prior written
consent, or (ii) initiates a clinical trial of Licensed Product without
Novavax’s approval or materially deviates from an approved clinical trial
protocol for Licensed Product without the prior written consent of Novavax, then
Novavax shall have right to obtain injunctive relief with respect to such breach
before any court of competent jurisdiction in accordance with Section
10.3.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
9.3
Survival.
The
following provisions of this Agreement shall survive expiration or termination
of this Agreement for any reason: Article 8 and Sections 6.1 and
7.3. In the event that this Agreement is terminated under 9.1(c), the
license grant under Section 2.2 shall survive as a fully paid, exclusive license
solely under Developed Know-how owned or Controlled by Company, including any
Patents that issue therefrom, as of the effective date of termination (i.e.,
excluding any intellectual property developed or acquired after such date of
termination).
ARTICLE
10
DISPUTE
RESOLUTION
10.1
Disputes.
The
Parties recognize that disputes as to certain matters may from time to time
arise during the Term which relate to either Party’s rights and/or obligations
hereunder. It is the objective of the Parties to establish procedures
to facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow
the procedures set forth in this Article 10 if and when a dispute arises under
this Agreement.
10.2
Arbitration.
Any
dispute arising between the Parties out of or in connection with the
implementation or interpretation of this Agreement shall, if not settled
amicably within ninety (90) days from the date that the dispute arose, be
finally settled by three (3) arbitrators. Each Party shall be entitled to
appoint one (1) arbitrator and the two (2) so appointed shall appoint the third
arbitrator in accordance with the Indian Arbitration and Conciliation Act,
1996. It is hereby agreed that Part I of the Indian Arbitration and
Conciliation Act, 1996 (except for the provisions of Section 9 thereof) shall
not apply to the arbitration under this Agreement. The language of the
arbitration proceedings shall be English and its place shall be
Singapore. The arbitral award or determination shall be final and
subject to no appeal and shall deal with the question of costs of arbitration
and all matters related thereto.
The
Parties agree that it would be impossible or inadequate to measure and calculate
their damages from any breach of the Agreement though great and
irreparable. Accordingly, each Party agrees that if the other Party
breaches this Agreement, the non-breaching party will have available, in
addition to any other right or remedy available, the right to obtain an
injunction from a court of competent jurisdiction restraining such breach or
threatened breach and specific performance of any provision of this
Agreement.
10.3
Equitable
Claims.
Notwithstanding anything to the contrary in this
Article 10, either Party has the right to seek temporary injunctive relief
or any other interim equitable remedy in any court of competent jurisdiction as
may be available to such Party under the laws applicable to such jurisdiction
that may be necessary to protect the rights or property of that Party until such
time as any dispute underlying such temporary injunctive relief or any other
interim equitable remedy has been resolved in accordance with Section
10.2.
10.4
Governing Law.
The
substantive laws of India will govern the resolution of all disputes,
controversies and claims under, arising out of or relating to the validity,
construction, enforceability or performance of this Agreement and any related
remedies, without giving effect to any choice of law rules.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
10.5
Award.
Each Party
will abide by any arbitral award rendered pursuant to this Article
10. If a Party resists enforcement of an arbitral award, any costs,
fees or taxes incident to enforcement will be charged against that Party to the
extent permitted by Law. Each Party will bear its own legal fees for
arbitration, and the arbitrator(s) will assess their costs, fees and expenses
against the Party losing the arbitration.
10.6
Injunctive
Relief.
If a Party makes a sufficient showing under the rules
and standards set forth in the rules of civil procedure and applicable Law, the
arbitrator may, and the Parties will abide by, injunctive measures after either
Party submits in writing for arbitration claims requiring immediate
relief. Notwithstanding the foregoing, and in accordance with Section
10.3, a Party will also be free at any time to bring an Equitable Claim to any
court of competent jurisdiction without submitting such request to an
arbitrator.
10.7
Confident
iality.
Any
arbitration proceeding, including without limitation the existence of any
dispute submitted to arbitration and any arbitral award or decision, will be
Confidential Information of both Parties, and the arbitrator(s) will issue
appropriate protective orders to safeguard each Party’s Confidential
Information, provided that such Confidential Information may be disclosed solely
as necessary in connection with the enforcement of an arbitral award or as
otherwise required by Law (subject to Article 6).
ARTICLE
11
MISCELLANEOUS
11.1
Entire
Agreement.
This Agreement (including its Exhibits) sets forth
all the covenants, promises, agreements, warranties, representations, conditions
and understandings between the Parties with respect to the subject matter hereof
and supersedes and terminates all prior agreements and understanding between the
Parties with respect to such subject matter. No subsequent
alteration, amendment, change or addition to this Agreement will be binding upon
the Parties unless reduced to writing and signed by the respective authorized
officers of the Parties.
11.2
Third Party
Contractors.
The Parties will perform their obligations under
this Agreement as Third Party contractors and nothing contained in this
Agreement will be construed to be inconsistent with such relationship or
status. This Agreement will not constitute, create or in any way be
interpreted as a joint venture or partnership of any kind.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
11.3
Notices.
Any notice,
request, demand, waiver, consent, approval or other communication permitted or
required under this Agreement (
“
Notice”
) will be in writing,
will refer specifically to this Agreement and will be deemed given only if sent
by electronic mail (with receipt confirmed), facsimile transmission (with
transmission confirmed) or by an internationally recognized delivery service
that maintains records of delivery, addressed to the Parties at their respective
addresses specified in this Section 11.3 or to such other address as the Party
to whom notice is to be given may have provided to the other Party in accordance
with this Section 11.3. Any notice delivered by electronic mail or
facsimile will be confirmed by a hard copy delivered as soon as practicable
thereafter by an internationally recognized overnight delivery
service. Such Notice will be deemed to have been given on the second
Business Day (at the place of delivery) after deposit with an internationally
recognized delivery service. This Section 11.3 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
If
to Novavax:
|
Novavax,
Inc.
|
|
9920
Belaward Campus Drive
|
|
Rockville
Maryland 20850
|
|
Attn: Ray
Hage, Senior Vice President
|
|
Email:
Rhage@Novavax.com
|
|
Facsimile
No.: 240-268-2122
|
|
|
If
to Company:
|
CPL
Biologicals Private Limited
|
|
Cadila
Corporate Campus
|
|
Sarkhej-Dholka
Road
|
|
Bhat,
Ahmedabad – 382210
|
|
Gujarat,
India
|
|
Attn:
Dr. Rajiv I. Modi, Managing Director
|
|
Email:
rimodi@cadilapharma.co.in
|
|
Facsimile
No.: +91 (02718) 225031
|
11.4
Assignment.
(a) Novavax
may not assign this Agreement, in whole or in part, without the advance written
consent of the Company; provided, however, that this Agreement shall be
automatically assigned to Novavax’s successor in connection with the
acquisition, merger or sale of Novavax or the sale, transfer, lease, assignment
or disposal of all or substantially all of the property or assets of Novavax,
whether by way of a single transaction or a series of related transactions, and
such successor shall be fully bound by the terms and conditions
hereof.
(b) The
Company may not assign this Agreement, in whole or in part, without the advance
written consent of Novavax; provided, however, that this Agreement shall be
automatically assigned to the Company’s successor in connection with the sale,
transfer, lease, assignment or disposal of all or substantially all of the
property or assets of the Company , whether by way of a single transaction or a
series of related transactions, including a Change in Control of the Company (as
that term is defined in Schedule II of the Joint Venture Agreement), and such
successor shall be fully bound by the terms and conditions hereof; provided that
any such automatic assignment by Company within the scope of Schedule II of the
Joint Venture Agreement shall only be effective if such transaction was approved
by Novavax under and pursuant to the Joint Venture Agreement for so long as such
approval rights of Novavax under the Joint Venture Agreement have not been
terminated.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) Any
assignment or purported assignment by either Party in violation of this Section
11.4 will be null and void.
11.5
Force Majeure.
Both
Parties will be excused from the performance of their obligations under this
Agreement (except for the obligation to pay money) to the extent that such
performance is prevented by force majeure and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse
will be continued so long as the condition constituting force majeure continues
and the nonperforming Party takes reasonable efforts to remove the
condition. For purposes of this Agreement, force majeure will include
conditions beyond the control of the Parties, including without limitation, an
act of God, voluntary or involuntary compliance with any regulation, Law or
order of any government, war, civil commotion, labor strike or lock-out, acts of
terrorism, epidemic, failure or default of public utilities or common carriers,
destruction of production facilities or materials by fire, earthquake, storm or
like catastrophe.
11.6
Headings.
The
headings for each article and section in this Agreement have been inserted for
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or
section.
11.7
No Stri
ct
Construction.
This Agreement has been prepared jointly and
will not be strictly construed against either Party.
11.8
Ambiguities.
Ambiguities
and uncertainties in this Agreement, if any, will not be interpreted against
either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
11.9
English
Language.
All notices required or permitted to be given
hereunder, and all written, electronic, oral or other communications between the
Parties regarding this Agreement will be in the English
language. This Agreement is in the English language only, which
language will be controlling in all respects, and all versions hereof in any
other language will be for accommodation only and will not be binding upon the
Parties.
11.10
No Wa
iver.
Any delay in
enforcing a Party’s rights under this Agreement or any waiver as to a particular
default or other matter will not constitute a waiver of such Party’s rights to
the future enforcement of its rights under this Agreement, excepting only as to
an express written and signed waiver as to a particular matter for a particular
period of time.
11.11
Severability.
If
one or more of the provisions in this Agreement are deemed unenforceable by Law,
then such provision will be deemed stricken from this Agreement and the
remaining provisions will continue in full force and effect and shall be
interpreted to give full effect to the commercial agreement between the
Parties.
11.12
Counterparts.
This
Agreement may be executed in one or more identical counterparts, each of which
will be deemed to be an original, and which collectively will be deemed to be
one and the same instrument.
[Signature
Page to Follow]
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
In Witness
Whereof,
the Parties have by duly authorized persons executed this
Agreement as of the Effective Date.
Novavax,
Inc.
|
|
CPL
Biologicals Private Limited
|
|
|
|
|
|
By:
|
/s/ Rahul Singhvi
|
|
By:
|
/s/ Rajiv I. Modi
|
|
|
|
|
|
|
Rahul
Singhvi
|
|
|
Rajiv
I. Modi
|
|
President
and CEO
|
|
|
Director
|
[Signature
Page to H1N1 License Agreement]
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Schedule
1
[* *
*]
Exhibit
14
Code
of Business
Conduct
and Ethics
March
2004
Revised
June 2009
A Message
from Rahul Singhvi:
I am
pleased to share with you Novavax’s Code of Business Conduct and Ethics (the
“Code”).
Our Code
is more than a set of rules – it is intended to provide a practical guide to
help each of us with the difficult decisions we face everyday. It sets out
universal principles which should govern the way we conduct business at Novavax,
it provides clarity about the expectations at Novavax, and it identifies the
other Novavax resources and policies that you can use to support your decision
making. There is nothing “new” in this Code – it is simply a
codification of our existing business policies and practices governing, and the
goals and expectations for, the conduct of all Novavax officers, directors and
employees, all of which are founded in our Core Values of Respect, Integrity,
and Excellence.
This Code
is being communicated to you at this time as a result of two converging
factors. First, it is difficult to communicate our policies,
practices and expectations to each employee personally – this Code is meant to
help Novavax employees understand who we are and what we do. Second,
as many of you are aware, the business environment in which Novavax operates is
extremely sensitive to business practice issues, with discussions about
integrity, honesty and business ethics more prevalent, and the reputations of
institutions becoming increasingly fragile. This Code is meant to assist all of
us in vigilantly protecting the company’s reputation and, just as importantly,
ensure our compliance with the rules and regulations of the U.S. Securities and
Exchange Commission and The Nasdaq Stock Market.
As
Novavax employees, we are all trustees of the investments made in Novavax by our
shareholders. We owe it to them to ensure that the company is
successful and that its reputation remains strong. This Code is
crucial to the company’s success, its reputation – and its future. At the end of
the Code is a Novavax Personal Pledge form, which must be signed by each and
every one of our employees. I have signed this document, as have
every member of the Senior Management team. We require all employees
to sign and return the Personal Pledge as a demonstration of your commitment to
our Code of Business Conduct and Ethics. So, please read your copy of the Code
carefully, keep it handy for easy reference, and feel free to ask any questions
that you may have.
Finally,
please remember that Novavax’s reputation is in our hands,
everyday.
Rahul
Singhvi
Rahul
Singhvi,
President
and CEO
CODE
OF BUSINESS CONDUCT AND ETHICS
TABLE
OF CONTENTS
1.
OBJECT
AND SCOPE OF THIS CODE
|
1
|
|
|
2. OUR
CORE VALUES
|
3
|
|
|
3. OUR
BUSINESS PRACTICES
|
4
|
|
|
What
You Can Do If You Have A Concern About Business Practices
|
4
|
Our
Reporting and Non-Retaliation Policy
|
7
|
Our
Principles
|
9
|
|
|
4. CONFLICTS
OF INTEREST
|
11
|
|
|
In General
|
11
|
Corporate
Opportunities
|
13
|
|
|
5. CONFIDENTIAL
INFORMATION
|
15
|
|
|
In
General
|
15
|
Third-Party Confidential Information
|
16
|
|
|
6. USE
OF COMPANY ASSETS
|
17
|
|
|
7. INVENTIONS
AND INTELLECTUAL PROPERTY
|
19
|
|
|
8. AVOIDANCE
OF INSIDER TRADING
|
20
|
|
|
What
Are the Limitations on Trading?
|
21
|
What
is “Material Non-Public Information”?
|
21
|
Additional
Requirements for “Insiders”
|
22
|
|
|
9. POLITICAL
AND GOVERNMENT ACTIVITIES
|
23
|
|
|
Political
Activities
|
23
|
Government
Relations and Lobbying
|
23
|
|
|
10. PERSONAL
CONDUCT
|
24
|
|
|
Equal
Employment Opportunity
|
24
|
No
Discrimination
|
24
|
No
Harassment
|
24
|
Disability
Accommodations
|
25
|
Safe
Workplace
|
25
|
|
|
11. FAIR
COMPETITION
|
27
|
|
|
Sales
and Marketing Practices
|
28
|
Competitive
Information
|
29
|
|
|
12. ENVIRONMENT,
HEALTH AND SAFETY
|
30
|
|
|
13. COMPLIANCE
WITH LAWS
|
31
|
|
|
14. ACCURACY
OF BOOKS, RECORDS AND ACCOUNTS
|
32
|
|
|
15. DISCLOSURE
POLICIESAND COMMUNICATION WITH OUTSIDE PARTIES
|
35
|
|
|
The
Media and Investment Community
|
35
|
Our
Investors
|
35
|
|
|
16. ADMINISTRATION
OF THIS CODE
|
36
|
|
|
Distribution,
Availability and Revisions
|
36
|
Approvals
and Waivers
|
36
|
Signature
and Acknowledgement
|
36
|
Ongoing
Review of Compliance
|
37
|
Investigations
and Disciplinary Actions
|
37
|
Important
Disclaimers
|
40
|
|
|
17. NOVAVAX
PERSONAL PLEDGE
|
41
|
1. Object
and Scope of this Code
Novavax
has a strong commitment to business ethics, and we believe that the company and
every employee must conduct their affairs with honesty, integrity and respect,
and in compliance with all applicable laws. Our reputation for
integrity and excellence, particularly in today’s business environment, requires
careful observance of the spirit and letter of all applicable laws, as well as
scrupulous regard for the highest standards of conduct and personal
integrity.
The
purpose of this Code is to ensure that Novavax has in place a system to focus
attention throughout the company on the obligation of ethical
conduct. The policies and practices set forth herein are designed to
deter wrongdoing and promote:
|
·
|
honest
and ethical conduct, including the ethical handling of actual or apparent
conflicts of interest between personal and professional
relationships;
|
|
·
|
full,
fair, accurate, timely and understandable disclosure in reports and
documents that the company files with, or submits to, regulatory agencies
and in other public communications made by the
company;
|
|
·
|
compliance
with applicable governmental laws, rules and
regulations;
|
|
·
|
the
prompt internal reporting of violations of the Code or applicable law to
the appropriate person;
|
|
·
|
open
communication and dealings with third parties,
and
|
|
·
|
accountability
for adherence to the Code.
|
The Code
applies to all directors, officers and employees of Novavax and any of our
subsidiaries. Ignorance of the Code will not excuse any
employee from its requirements.
All
employees will have access to this Code and must use the Code as a general
guideline for behavior. You are responsible for reading, reviewing
and understanding the policies and procedures set forth in this Code, and can
obtain advice from or ask questions of your direct supervisor, or a member of
our Human Resources Department.
In
addition, Novavax will make the Code publicly available by posting it on the
company’s Internet and intranet sites.
The Code
provides a broad statement of certain key policies and procedures regarding
business conduct and ethics and conducting business in a legally and ethically
appropriate manner. The Code cannot, and is not intended to,
anticipate or address every possible situation, cover every topic in detail, or
answer every question. You must rely on your good sense and judgment
of what is right, including a sense of when it is appropriate to seek guidance
from others.
As noted above, if a
situation develops for which an employee seeks guidance, the employee should
speak with his or her direct supervisor or a member of our Human Resources
department. Employees should also refer to Novavax’s policy on
A
voidance of
Insider Trading
and Novavax’s
Employee
Handbook
, which includes more detailed information regarding the
company’s proprietary information, use of company property, Internet usage and
similar policies, copies of which can be obtained from the Human Resources
department or on the company intranet.
Note,
too, that the Code does not necessarily take into account all local laws or
requirements. Where more restrictive local laws or requirements
exist, those take precedence. Employees worldwide are expected to
comply with all laws and Novavax business policies in the country and area in
which they are conducting company business.
The Code
is not an express or implied contract of employment and does not create
contractual rights of any kind between Novavax and any employee. In
addition, you should understand that this Code does not modify your employment
relationship, whether at will or governed by contract, with
Novavax.
Finally,
it is essential that you keep an eye out for possible violations of this Code –
whether they occur in dealings with the government or the private sector, are
intentional or due to someone’s inadvertent conduct. Noncompliance
with the policies and practices set forth in this Code and applicable laws can
result in serious consequences, both to Novavax and our employees, including
civil and criminal penalties and adverse employment actions.
Employees
who have questions regarding possible violations or who wish to report suspect
activities should contact their direct supervisor or a member of our Human
Resources department. See also “What You Can Do If You Have A Concern
About Business Practices” on page 5.
2. Our
Core Values
These
are the fundamental values on which we guide our business:
3. Our
Business Practices
These
are the practices and procedures we use everyday to apply our Core
Values. Where we look to exhibit these Core Values in everything we
do, how we perform certain business practices is a greater demonstration of the
highlighted Core Value:
What
You Can Do If You Have A Concern About Business Practices
Novavax
is committed to creating a workplace conducive to the open discussion of its
business practices. If you have a general question about business
practices, there are a number of different resources you can go to for
advice. The diagram below outlines your options. Please
feel free to go to the resource that you are most comfortable with, but keep in
mind that your best resource is often your immediate supervisor or
manager.
Our
experience has shown that when employees deal openly and directly with
supervisors, the work environment is improved, communications can be clear, and
attitudes can be positive. We believe that Novavax amply demonstrates its
commitment to employees by responding effectively to employee
concerns.
Novavax
is also committed to openness in all forms of reporting and providing a
workplace free from fear of retribution and retaliation. If any
employee knows, reasonably believes or has genuine suspicions regarding any
legal violation in work-related issues, or breaches of the principles and
standards set forth in this Code, the employee must report them immediately to
his or her direct supervisor, Human Resources, or the appropriate Novavax
Compliance Official (discussed below), so that we can take any necessary
action. If you believe that the supervisor to whom you report is
implicated in the violation or potential violation, or you believe that the
supervisor to whom you reported the violation or potential violation has not
taken appropriate action, you should report such matter directly to one of our
Compliance Officials.
Concerns
about improprieties and wrongdoing involving our Avoidance of Insider Trading
Policy (#115) and matters involving the Securities Exchange Commission (SEC)
should be reported directly to our Chief Financial Officer
(CFO). Areas of concern regarding Human Resources related policies,
procedures or regulations or matters regarding personal conduct should be
brought to the immediate attention of the Chief Executive Officer
(CEO).
Suspected
Code violations that relate to financial statement disclosures or accounting,
internal control or auditing matters, should be reported directly to the
Chairperson of the Audit Committee of our Board of Directors. If an
employee feels uncomfortable speaking with any of the above resources for any
reason, Novavax’s Audit Committee has established a “Whistleblower” procedure by
which confidential complaints may be raised anonymously. Complaints
submitted through this confidential process will be presented to the Chairperson
of the Audit Committee if they involve the company’s accounting, auditing and
internal controls and disclosure practices, or our Board of Directors for other
non-financial related matters. Anyone may utilize this confidential
and anonymous process either to raise new concerns or complaints or if they feel
that a concern or complaint previously raised has not been appropriately
handled.
Our
Compliance Officials are:
Michael
McManus, Chairperson of the Audit Committee, who can be reached
at:
mmcmanus@misonix.com
,
631-694-9555;
Rahul
Singhvi, President and Chief Executive Officer, who can be reached at
rsinghvi@novavax.com
,
240-268-2020; and
Jill
Hoyt, Executive Director, HR and Administration, who can be reached at:
Jhoyt@novavax.com
,
240-268-2026
In order
to make a confidential, anonymous report or complaint, an employee may use our
toll-free telephone hotline – at
1-800-591-1044
– which may be
dialed into without revealing any caller identification
information. The telephone hotline is operational 24 hours a day,
seven days a week, and is staffed by employees of a third-party provider who
will take reports directly from the employee. Complaints and reports
submitted through this procedure will be collected on a daily basis and
presented to the Chairperson of our Audit Committee. Complaints
regarding the company’s financial statement disclosures or accounting, internal
control or auditing matters may be reported to the Audit Committee as deemed
necessary by its Chairperson.
Our
Reporting and Non-Retaliation Policy
Novavax
wants every employee to feel comfortable raising business practice, ethical and
legal issues internally. The company will listen to all issues raised
and respond to all questions asked.
As a result, Novavax strictly
prohibits reprisals or retaliation against anyone who raises a business
practice, ethical or legal issue or cooperates in the investigation of such an
issue.
Novavax
will make appropriate efforts to protect the confidentiality of those who raise
good faith concerns. As noted above, the company will not criticize
or retaliate, and will not permit criticism or retaliation by any party, against
any individual who speaks up. It is our policy to comply with all
applicable laws that protect employees from unlawful discrimination or
retaliation as a result of their lawfully reporting information regarding, or
their participating in investigations involving, potential or actual corporate
fraud or other violations by Novavax or its employees of federal, state, local
or foreign laws.
Specifically,
Novavax’s policy prevents any employee from being subject to disciplinary or
retaliatory action as a result of the employee’s:
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reporting
violations or potential violations of this Code, other company policies
and procedures, or applicable law that the employee reasonably believes to
have occurred;
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making
complaints regarding accounting, internal accounting controls or auditing
matters or voicing concerns regarding questionable accounting or auditing
matters that the employee reasonably believes to have
occurred;
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disclosing
information to a government or law enforcement agency, where the employee
has reasonable cause to believe that the information discloses a violation
or possible violation of foreign, federal, state or local law or
regulation; or
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providing
or causing information to be provided, filing or causing to be filed,
testifying, participating in a proceeding filed or about to be filed, or
otherwise assisting in an investigation or proceeding regarding any
conduct that the employee reasonably believes involves a violation of this
Code or applicable law, including criminal laws regarding securities law
violations or fraud, any rule or regulation of the Securities and Exchange
Commission (“SEC”) or any provision of law relating to fraud against
shareholders.
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Novavax
will treat any attempt by one employee to prevent another employee from raising
concerns or retaliating against the reporting employee for doing so as a serious
disciplinary offense.
If any
employee believes that he or she has been subject to any action that violates
this policy, the employee may file a complaint with his or her supervisor, the
Executive Director of Human Resources, or one of the Compliance
Officials. If it is determined that an employee has experienced any
improper employment action in violation of this policy, such employee will be
entitled to prompt appropriate corrective action.
Please
note that Novavax employees who file reports or provide evidence which they know
to be false or without a reasonable belief in the truth and accuracy of such
information will not be protected by this policy, and may be subject to
disciplinary action, including termination of employment.
Novavax
has designated three (3) Compliance Officials for administering the company’s
reporting and non-retaliation policy. Each Compliance Official is
responsible for collecting, reviewing, processing and resolving concerns and
reports by employees and others. Employees are encouraged to discuss
issues and concerns of the type covered by this policy with their supervisor or
manager, who in turn is responsible for informing the appropriate Compliance
Official. Again, if the employee prefers not to discuss these
sensitive matters with his or her own supervisor or manager, the employee may go
directly to Human Resources or appropriate Compliance Official, who will refer
complaints submitted, as he or she determines appropriate or required, to the
Board of Directors or an appropriate committee of the Board, including the Audit
Committee.
Do not be
afraid that your question, concern or issue may not be valid. When it
comes to business practices, ethical issues or legal issues, there is no such
thing as a dumb question. Use the individuals identified in this Code
to ask a question, get clarification, report a suspected violation, or voice a
concern. It is important that any potential problem or concern be
reviewed as soon as possible to prevent serious issues from
developing.
Question:
If
I do raise a business conduct or ethics issue, will I get in
trouble?
Answer:
No -
as long as you honestly have a concern or issue, you will not be
reprimanded or disciplined for raising an issue. Quite the
contrary, as a Novavax employee you have an obligation to question
situations with which you are uncomfortable and seek
assistance.
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Our
Principles
The
key principles found in Novavax’s Code of Business Conduct and Ethics
are:
We will
avoid any possible conflict of interest, or the appearance of a conflict of
interest, between our personal interests and our responsibility to
Novavax.
We will
maintain the confidentiality, privacy and security of information entrusted to
us in accordance with legal and ethical obligations.
We will
use company assets for the legitimate purposes of Novavax’s
business.
We will
constantly seek to create innovations in our business and notify Novavax when we
may have developed something new.
We will
not trade Novavax shares nor advise or inform others to trade in Novavax shares
when in possession of material non-public information.
We will
not seek to influence any political or governmental process in an inappropriate
manner.
We will
show genuine concern and respect for other people and treat one another with
understanding and appreciation. It is quite acceptable to disagree
with a fellow employee, however, it must be done respectfully and
constructively.
We will
value the diversity of our talented workforce and encourage diversity of
thoughts, ideas and opinions.
We will
uphold the ideals of free and competitive enterprise in order to conserve and
enhance shareholder value.
We will
conduct sales and marketing activities in accordance with Novavax’s Core Values,
policies and the law.
We will
not collect information on our competitors through inappropriate
means.
We will
operate our business in a safe and healthy manner, we will respect the
environment, and we will use our natural resources responsibly.
We will
comply with all applicable laws and regulations in the jurisdictions in which we
operate.
We will
reflect our business accurately in our records.
We will
protect the company’s reputation by allowing only the company’s designated
individuals to deal with inquiries from the media and investors.
4. Conflicts
of Interest
Standard: We
will avoid any possible conflict of interest, or the appearance of a conflict of
interest, between our personal interests and our responsibility to
Novavax.
In
General
While
Novavax does not wish to infringe on the personal lives of its employees,
employees must not have personal activities or relationships, including
commercial interests, that conflict or appear to conflict with the interests of
the company. A conflict of interest develops any time an employee
faces a choice between what is in his or her personal interest (financial or
otherwise) and the interest of the company. Novavax expects that the
interests of the company will take precedence over an employee’s personal
interests and that our employees will act only for the benefit of the
company.
Examples
of likely conflicts of interest include:
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unduly
using your influence or position to cause Novavax to employ, engage in a
business transaction or enter into a contract with your relatives
(including your spouse, parents, grandparents, children, siblings, in-laws
or life partner), friends, or a company in which you or your relatives or
friends has, directly or indirectly, an
interest;
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using
material, non-public Novavax, vendor, customer, partner or competitor
information for personal gain (including securities transactions based on
such information);
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serving
as a director or advisory board member of any current or likely competitor
of Novavax, or accepting such positions with any organization or
governmental agency with which we do or may do
business;
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receiving
or paying undisclosed fees, commissions or other payments from or to
vendors, customers, partners, competitors or others seeking to do business
with Novavax;
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making
or accepting gifts, loans, meals, entertainment or services from or to
vendors, customers, partners, competitors or others seeking to do business
with Novavax that are not reasonable and of modest value (generally, not
exceeding $100), or that do not support the legitimate business interests
of the company;
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having
outside employment that interferes with the employee’s performance,
ability to act in Novavax’s best interests, or comply with company
policies, or requires the employee to use confidential information or
company assets, or otherwise creates a conflict or the appearance of
impropriety;
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having
more than a modest financial interest in Novavax’s vendors, customers,
partners or competitors, whether such entities are public or private;
and
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competing,
or preparing to compete, with the company while still employed by the
company.
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It is not
possible to list all conflicts of interests and, therefore, employees should use
the above list and accompanying discussion merely as a
guide. Ultimately, it is the responsibility of each individual to
avoid any situation that is or could appear to present a conflict of
interest.
In
particular, members of our Board of Directors have a special responsibility
because of their duties to Novavax and our shareholders. Directors
are expected to avoid any action, position or interest (including any personal
activity, investment or association) that conflicts with an interest of the
company, or gives the appearance of a conflict, and to avoid using their
position, power, access to information or other advantage for their own personal
benefit, whether to the detriment of Novavax or our constituents.
Novavax
will annually solicit information from our directors in order to monitor
potential conflicts of interest, and directors are expected to be mindful of
their fiduciary duties, including the duty of loyalty, to the
company. Directors must be especially aware of “interested insider
transactions” – transactions in which the individual appears on both sides or
with respect to which an individual expects to derive a personal benefit,
distinct from any benefit that would be derived by Novavax or our
shareholders. In addition, an insider may be deemed interested where
he or she is controlled by, or obligated or related to, persons or entities that
have a material personal financial interest in a particular
transaction. If a director has a personal interest in a matter before
the Board of Directors, the director must disclose the interest to the Board,
excuse himself or herself from participation in the discussion, and abstain from
voting on the matter.
Directors
and executive officers must also be mindful of certain “related party”
transactions and relationships – our Audit Committee (or other independent body
of our Board) will be responsible for approving all transactions or business
relationships involving Novavax and any director or executive officer, including
any indebtedness of such individuals to the company and transactions between
Novavax and either the director or officer personally, members of their
immediate families, or entities in which they have an interest.
When
faced with a situation involving an actual or potential conflict of interest,
including interested insider transactions, directors, like all employees, are
encouraged to seek advice from the company’s Chief Executive Officer or Chief
Financial Officer and refer to the company’s policies on conflicts of interest
and Avoidance of Insider Trading.
The
proper implementation of this policy implies a continuing requirement that all
employees make prompt disclosure to their direct supervisor, or Human Resources,
of any fact or circumstance that may involve a conflict of
interest. All potential conflicts of interest between Novavax and any
employee, or an entity affiliated with an employee, must be disclosed and
approved in advance by the company’s Board of Directors or Audit Committee and,
when approved by the Audit Committee, should be promptly disclosed to the entire
Board of Directors. Waivers of conflicts of interests involving
directors or officers require the approval of the Audit Committee. In
the event that a waiver is granted, it will be disclosed by the company in
accordance with law.
Question:
My
spouse’s company is bidding on a contract with a subsidiary of
Novavax. Although I select vendors for projects in my own
business unit, I have no decision-making authority in the subsidiary where
my spouse’s company is competing on the bid. Do I need to
report this?
Answer:
Yes. Even
though you may not have direct control over the outcome of the bid, the
fact that your spouse has connections to the company might give the
appearance of a conflict of interest.
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Corporate
Opportunities
Employees
may not divert corporate opportunities to themselves. Generally, an
opportunity will be deemed a corporate opportunity if it is in Novavax’s line of
business, is one that the company is financially able to take, is of present or
potential advantage or unique value to Novavax, and is one in which the company
has an interest or expectancy. More broadly, opportunities may be
deemed corporate opportunities if issues of fairness dictate that Novavax,
rather than an employee, should be given the opportunity.
You must
disclose all potential corporate opportunities of which you are aware to the
company first for evaluation, and may not take away from Novavax any opportunity
for financial gain that you find out about because of your position at Novavax
or through the use of company property or information. You are also prohibited
from using company property, information or position for personal gain or
competing with Novavax, as discussed elsewhere in this Code.
* * * *
*
In
general, if you have any questions or doubts as to whether any situation gives
rise to a conflict of interest, you should consult with any of the resources
provided on Page 5.
5. Confidential
Information
Standard: We
will maintain the confidentiality, privacy and security of information entrusted
to us in accordance with legal and ethical obligations.
In
General
Novavax
expects all employees to respect and safeguard all confidential and proprietary
information of the company. Confidential information is both
sensitive and a valuable asset: you are expected to protect against its
unauthorized use and disclosure. Examples of confidential information
include but are not limited to:
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Financial information
and projections
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Quality
data
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Human
resource information, including employee files and salary
information
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Manufacturing
processes, techniques and layouts
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Formulations
and prototypes
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Competitive
information held by the company
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License
and partnering agreements
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Market
data
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Regulatory
plans
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R&D
information, data, proposals & plans
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Production
processes and schedules
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Product
ideas
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Customer
lists and information
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Inventions
& discoveries, whether patentable or not
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Business
methods
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Pre-Clinical
R&D information and data
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Strategic
plans and budgets
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Clinical
R&D protocols, information and data
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Planned
business acquisitions or divestitures
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Advertising
and marketing strategies
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All
employees must exercise caution not to disclose, either intentionally or
inadvertently, confidential information to third parties (including customers,
competitors, contractors and suppliers) under any circumstances, unless it is a
necessary part of your work responsibilities and the receiving party has a
business need to know. If you have a need to share information with
others outside of Novavax, you must secure the prior approval of your department
head, as well as have a confidentiality agreement signed.
In
particular, you should not discuss confidential information in public places
such as elevators, hallways, restaurants, airplanes, taxis or any other place
where they can be overheard. Be particularly careful when discussing
confidential information on wireless technologies (e.g., cell phones, cordless
phones or personal digital assistants) and when sending confidential information
over the Internet, because it may be intercepted. Employees,
especially R&D scientists, should guard against unintended disclosures of
confidential information when talking to employees of other companies (i.e., in
hallway conversations during scientific conferences). Employees
should also endeavor not to read confidential documents in public places,
discard such documents where others can retrieve them, or be careless with
documents such as by leaving them unattended in conference rooms or at photocopy
machines and printers. Keep your computer in a safe place and use a
password to limit access to the information stored on it.
Only
officials of Novavax with written authorization are permitted to respond to
inquiries for company information from the media, the financial community,
investors and others. Written authorization must be signed by the
President & CEO. All employees are to promptly refer all such
inquiries to the appropriate officials. For guidance, refer to the
Disclosures
section of this Code.
Every
employee may only use such confidential information in furtherance of the
company’s business purposes. Employees will be asked to sign an
employee proprietary information agreement as a condition of employment,
although the non-disclosure and use obligations apply whether or not the
agreement is executed.
If you
have a question regarding whether certain information is confidential, material
and/or has been adequately disclosed, you should contact the company’s Chief
Financial Officer and abstain from acting, including trading in
Novavax’s common stock or disclosing such information, until you have been
informed that the information is not confidential or material, or has been
appropriately disclosed.
Further,
unintended disclosure of company confidential information by an employee should
be immediately reviewed with your supervisor and the Chief Financial Officer to
determine if further action is appropriate.
Employees
should also remember that their obligation to protect the company’s confidential
information continues even after their employment with Novavax
ends. Employees and former employees who improperly use or disclose
confidential information will be subject to disciplinary action and legal
action, even if they do not actually benefit from the disclosed
information.
Third-Party
Confidential Information
We are
also often in receipt or possession of the confidential information of other
parties, including our vendors, customers, business partners and
competitors. Often this information is protected, and its use
governed, by confidentiality agreements with those parties.
You must treat this information in
the same way you treat Novavax’s confidential information.
Remember,
however, that the above confidentiality provisions apply to all company vendor,
customer, partner and competitor information,
whether or not
provided
pursuant to the terms of a confidentiality agreement. In particular,
the receipt of sensitive business or technical information from competitors
carries significant risks, as the company’s own internal development activities
in such areas may be foreclosed. Inappropriate handling of sensitive
information from competitors and other third parties can also lead to loss of
trust and liability for damages. You therefore should refuse
unsolicited third-party confidential information or, if inadvertently received,
should return such information unopened to the third party or transfer it to the
Chief Financial Officer for appropriate disposition.
6. Use
of Company Assets
Standard:
We will use company assets for the legitimate purposes of Novavax’s
business.
Novavax
provides you with a place to work and with the tools to do your
jobs. In return, you are expected to use these assets in a
responsible and ethical manner, maintain them with the utmost care and respect,
and guard them against waste and abuse. Company property
includes:
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Office
supplies, including telephones and cell phones
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Confidential
information
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Computers,
including software and computer files
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Communications
systems (including voicemail, e-mail, the Internet and the Novavax
intranet)
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Office
and laboratory equipment
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An
employee’s time at work and work-product
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Facilities
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Building
access cards
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Every
employee must use Novavax’s property and assets for company business. Of course,
occasional or incidental personal use is inevitable and acceptable – you are
permitted to use Novavax assets for occasional personal use as long as your
use:
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does
not affect your job performance or disrupt
others;
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is
truly occasional in nature;
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does
not result in any additional expense to
Novavax;
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does
not knowingly access or transmit material containing derogatory, racial,
gender or religious comments, sexual content, offensive language, material
which would negatively reflect upon Novavax or be likely to offend
co-workers, or contents prohibited by law or regulation;
and
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is
not used to carry on any form of business activity outside of the course
of your duties with Novavax - without Novavax
approval.
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Overall,
employees need to demonstrate a sense of responsibility and not abuse the
privilege.
Novavax
also believes that every employee is responsible for appropriately securing all
company property within his or her control to prevent its unauthorized
use. You must not allow company property to be used to help carry out
illegal or improper activities such as outside employment. Novavax
requires a workplace free of harassment and strives to be sensitive to the
diversity of its employees. Therefore, the company also prohibits the
use of all computers and communication systems in ways that are disruptive,
offensive to others, or harmful to morale. Email is intended as a
business tool to provide rapid, efficient and economical communication and
sharing of information and/or data, related to business
situations. Email is not intended, for example, to conduct
“arguments,” attempt to disparage or degrade others, supply or pass along
confidential information to those who do not have a business need to know, or
display or transmit sexually explicit images, messages or
cartoons. Other such misuse includes transmitting ethnic slurs,
racial comments, off-color jokes, or anything that may be construed as
harassment or showing disrespect for others, or attempting to access files for
which an employee has not been authorized. Any suspected incident of
improper use or operation, fraud or theft of Novavax property or assets should
be reported immediately. Any employee found to be abusing the
privilege of company-facilitated access to electronic media or services
including, but not limited to, those outlined in this Code and the Employee
Handbook, will be subject to disciplinary action, up to and including
termination of employment.
Remember,
your personal privacy on the company’s communications systems is not protected
and you should not expect it to be. Novavax reserves the right to
access or monitor all of its communication systems (including
computers). Remember, too, that all Internet data that is composed,
transmitted, or received via our computer communications systems is considered
to be part of the official records of Novavax and, as such, is subject to
disclosure to law enforcement or other third parties.
When your
employment with Novavax ends, it is your responsibility to return all company
property to Novavax.
If you
have specific questions regarding the use of company property, refer to the
Company’s Employee Handbook, which includes specific policies regarding Internet
usage (Policy # 510), chat rooms (Policy # 509), software licensing (Policy #
509), and company vehicles and equipment (Policy #505), among
others.
Question:
My
co-worker uses company e-mail to arrange her social life. I
think this is an inappropriate use of company assets but she
disagrees. Who is right?
Answer:
It
depends. If your friend occasionally uses e-mail to contact
friends or schedule social events, this is not a violation of policy or an
abuse of Novavax resources. However, if her use of e-mail for
personal reasons is prolonged and affecting her productivity, it is
inappropriate and she should stop.
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7. Inventions
and Intellectual Property
Standard: We
will constantly seek to create innovations in our business and notify Novavax
when we may have developed something new.
One of
Novavax’s most valuable assets is its intellectual property – patents, trade
secrets, trademarks, copyrights and other proprietary information. It
is Novavax’s policy to establish, protect, maintain and defend its rights in all
commercially significant intellectual property and to use those rights in
responsible ways. All employees must take steps to safeguard these
assets.
Intellectual
property rights consist of the following:
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Patents
– protect inventions by permitting inventors to exclude or prevent others
from making, using or selling their inventions. Employees
should report the unauthorized use of the company’s patents and notify the
company if they have an invention that needs patent
protection.
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Copyrights
– protect works of original authorship such as articles, drawings,
photographs, video, music, audiotapes and software. Generally,
copyrights prohibit others from copying or downloading the works without
consent. Employees should ensure that other parties’ use of
Novavax’s copyrights is only pursuant to the proper
authorization.
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Trademarks
and service marks – protect words, names and symbols that help consumers
recognize a product or service and distinguish it from those of
competitors. The use of Novavax’s trademarks and service marks
must be properly authorized or
licensed.
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Trade
secrets – include valuable information that creates a competitive
advantage for Novavax by being kept confidential. Examples
include information about customers, research and development data, and
financial, planning, marketing or strategic
information. Employees should treat trade secrets as
confidential information and safeguard them from unauthorized disclosure
or use.
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Novavax
respects the intellectual property rights of others. Unauthorized use
of the intellectual property rights of others may expose Novavax to civil
lawsuits and damages. Therefore, do not use the patents, copyrights,
trademarks, trade secrets or other intellectual property of third parties
without first ensuring that Novavax has obtained permission to do so, whether
pursuant to a license or otherwise.
Ideas,
inventions, discoveries and improvements conceived, created, developed or
reduced to practice in the course of your employment or association with Novavax
are the property of Novavax. If you believe that you have created
something new, you have an obligation to notify the company.
8. Avoidance
of Insider Trading
Standard:
We will not trade Novavax shares when in possession of material non-public
information.
Novavax
is proud when our employees choose to invest in the company. Personal
investment is an effective way to align the interests of employees with the
interests of our shareholders.
When
buying or selling company shares, all employees, directors, officers and other
“insiders” should be mindful of the legal and policy limitations on
trading. Set forth below is a brief summary of the legal requirements
and company policies with respect to insider trading. For more
detailed information regarding our insider trading policies, see our policy on
A
voidance
of Insider Trading (Policy # 115).
What
Are the Limitations on Trading?
Applicable
law and company policy forbid employees from both trading in company securities
while aware of, and disclosing or “tipping”, material non-public information
about the company. These regulations apply not only to employees,
officers and directors but also agents of Novavax, internal and external
consultants to the company, family members, and any outsiders who are designated
as “insiders” because they have access to material non-public information
concerning Novavax, as well as any person who has satisfied the definition of
“insider” for the six months preceding any subject transaction.
These
insider trading restrictions also may apply to the shares of companies
negotiating, competing, doing business or seeking to do business with Novavax
about which you may have material non-public information. In
addition to raising ethical considerations, any such trading subjects the users
to legal risks, including civil and criminal penalties. It could also
prove embarrassing and harmful to Novavax.
This
policy applies to
all
transactions
(including, without limitation, any purchase, sale or other disposition) by
“insiders” – defined below – and those tipped by insiders and
others. Transactions that may be necessary or justifiable for
independent reasons, such as the need to raise money for an emergency
expenditure, are no exception. Even the appearance of an improper
transaction must be avoided to protect the company’s reputation for adhering to
the highest standards of conduct.
What
is “Material Non-Public Information”?
Information
is “material” if it would be expected to affect the investment or voting
decisions of the reasonable shareholder, or if disclosure of the information
would be expected to significantly alter the total mix of information in the
marketplace about Novavax. The “materiality” of the information must
be viewed in light of the impact the information could have on the company as a
whole. While it may be difficult under this definition to determine
whether any particular information is material, there are various categories of
information that are particularly sensitive and, as a general rule, should
always be considered material. Examples of such information include,
but are not limited to:
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financial
results for the quarter or year
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financial
forecasts and budgets
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possible
mergers, acquisitions, joint ventures or business development
transactions
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gain
or loss of a substantial customer, supplier or
contract
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major
financing developments
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major
personnel changes
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major
patent or product developments
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major
litigation developments
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information
and results regarding pre-clinical & clinical
trials
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inventions
& discoveries, whether patentable or
not
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Either
positive or negative information may be material. Information that is likely to
affect the price of securities is almost always material.
Information
is considered to be non-public unless it has been effectively disclosed to the
public by widespread dissemination through major newswire services, national
news services and financial news services, or public filings with the SEC and
Novavax press releases. A speech to a small audience, a television or radio
appearance, or publication of an article in a limited circulation magazine do
not constitute effective disclosure.
For
information to be considered public, it must not only be disclosed publicly, but
adequate time must have passed for the market as a whole to assess the
information. For the purposes of company policy, information is not
considered public until twenty-four (24) hours after Novavax discloses it.
If
material non-public information is inadvertently disclosed by any Novavax
insider, no matter what the circumstances, the person making or discovering such
disclosure should immediately report the facts of such disclosure to the
company’s Chief Financial Officer.
Additional
Requirements for “Insiders”
An
“insider” is a person who possesses, or has access to, material information
concerning Novavax that is non-public. The people who are most likely
to be in receipt of “material non-public information” and therefore constitute
insiders, include members of Novavax’s board of directors, our executive
officers and certain other corporate employees; all insiders are required to
comply with the Code and the company’s policy on
Avoidance
of Insider Trading
. In essence, the policy prohibits the
trading of Novavax shares during those periods of time where “material
non-public information” is most likely to be circulating.
Remember,
a person can be an insider for a limited time, even though he or she is not an
officer or director, because the person possesses or has access to material
non-public information. For example, an advisor to Novavax who knows
that a large contract has just been received or that an acquisition is about to
occur may be an insider with respect to such information until the news has been
fully disclosed to the public.
If
you have any questions at all about the trading of Novavax shares, please
contact the company’s Chief Financial Officer, who has been designated as
Novavax’s insider trading compliance official with respect to its policy on
Avoidance of Insider Trading and as a matter of corporate policy announces the
opening and closing of the trading window of Novavax shares.
Question:
What
if an insider has material non-public information about
Novavax?
Answer:
When
any Novavax insider knows material information about the company that has
not been made public, they are prohibited from three
activities:
·
trading in Novavax’s
securities for their own account or for the account of another (including
any trust of which they are a trustee);
·
having anyone else trade for
them in Novavax’s securities; and
·
disclosing the information to
anyone else who might then trade or in turn “tip” another person who
trades.
Neither
the insiders nor anyone acting on their behalf nor anyone who learns the
information from them can trade. This prohibition continues whenever and
for as long as the information continues to be material and non-public,
and applies to all securities, not just to securities of Novavax but also
to those of other companies with which we are involved.
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9. Political
and Government Activities
Standard: We
will not seek to influence any political or governmental process in an
inappropriate manner.
Political
Activities
Novavax
encourages employees to be involved personally in political affairs by voting,
volunteering time or contributing money to candidates of your own
choosing. These decisions and choices are personal and so any
donation of time, money or other resources must also be personal and in no way
affiliated with Novavax. Do not give the impression that you are
speaking on behalf or representing Novavax while personally involved in the
political process.
Volunteer
work for political campaigns must not be done on company time, and Novavax funds
or assets must not be contributed to any political party, candidate or campaign
except in compliance with law. Similarly, Novavax’s name may not be
used in conjunction with any political issue.
Government
Relations and Lobbying
Novavax
will deal with all government agencies in a direct, open and honest
manner.
Any
contact with government personnel for the purpose of influencing legislation or
rule-making, including such activity in connection with marketing or procurement
matters, is considered lobbying. Some laws also define lobbying even
more broadly to include our normal marketing activities. If your job
responsibility is to lobby in behalf of Novavax, you are responsible for knowing
and adhering to all the relevant lobbying laws and associated gift laws, if
applicable, and for compliance with all reporting requirements.
You must
obtain the prior written approval from the President & CEO to lobby or
authorize anyone else (for example, a consultant or agent) to lobby on Novavax’s
behalf, except when lobbying involves only normal marketing activities and not
influencing legislation or rule-making. A copy of this written
approval must be forwarded to the Chief Financial Officer and outside
Counsel.
10. Personal
Conduct
Standard: We
will show genuine concern and respect for other people and treat one another
with understanding and appreciation.
Novavax
believes that our business success is directly related to our philosophy of
ensuring that
everyone with whom we
interact is treated with respect. We have an ongoing goal to provide
a work environment that is free from discrimination and where all employees are
provided with the opportunity to realize their fullest potential.
Novavax
also believes that equality of opportunity and fairness of treatment for all
individuals are basic human values. In commitment to that belief,
Novavax stresses its fundamental value of “respect the individual,” which
entails treating people as individuals with the same understanding and
appreciation that we seek for ourselves. We value the diversity of
our employees and encourage their diversity of thoughts, ideas and
opinions.
As a
Novavax employee, you should each treat people the way that you want to be
treated.
To assist
us in creating a great work environment, we have adopted a number of human
resources policies, some of which are outlined below. To obtain a
copy of any of these policies, ask a question, or voice a concern about
discrimination in the workplace, please contact a member of our Human Resources
department.
Equal
Employment Opportunity
In order
to provide equal employment and advancement opportunities to all individuals,
employment decisions at Novavax will be based on merit, qualifications, and
abilities. We conduct business with respect for all people and
provide equal employment opportunities without regard to differences or
similarities.
No
Discrimination
Novavax
does not discriminate on the basis of race, color, national origin, political or
religious affiliation, sex, sexual orientation, age, marital status, family
relationship, disability, or any other characteristic protected by
law.
No
Harassment
Sexual
and other types of harassment are a form of discrimination prohibited by law and
Novavax’s policies. Any appearance or intent to commit sexual or
other harassment in the workplace, whether physical or verbal, committed by any
manager, co-worker or third-party over whom we have control, such as vendors,
clients or customers, is strictly prohibited.
Our policy also prohibits conduct
that, although perhaps not unwelcome to the participants, creates an
intimidating, hostile or offensive environment for others who observe the
conduct. In addition, Novavax strictly prohibits reprisals or
retaliation against anyone who raises a business practice, ethical or legal
issue, files a complaint of harassment or cooperates in the investigation of
such an issue.
Disability
Accommodations
Novavax
is committed to complying with the Americans with Disabilities Act and other
applicable laws, and ensuring equal opportunity in employment for qualified
persons with disabilities. All employment practices and activities
are conducted on a non-discriminatory basis. We will make reasonable
accommodations for qualified individuals with known disabilities unless doing so
would result in a hardship for Novavax.
Question:
A
member of my team often makes disparaging remarks about other team
members, in particular one who suffers from a physical
disability. She does not believe this it is a problem because
she never makes the remarks in the person’s presence, but I have to work
with her on a daily basis and I find it offensive. What should
I do?
Answer:
Every member of your team
deserves respect. The preferred course of action is to clearly
tell the co-worker that you find the remarks offensive and ask her to
stop. Novavax considers such remarks inappropriate for our
professional work environment. If she does not cease the
conduct, you can ask a member of management to take appropriate
action.
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Safe
Workplace
Every
employee is responsible for, and shares in the benefits of, a safe and healthy
workplace. You have an obligation to follow the rules of conduct and
practices regarding a safe and healthy work environment.
All
employees, including supervisors and temporary employees, should be treated with
courtesy and respect at all times. Employees are expected to refrain
from fighting, “horseplay,” or other conduct that may be dangerous to
others. Firearms, explosives, and other dangerous, hazardous or
illegal devices and substances are prohibited on the premises of
Novavax.
Conduct
by a Novavax employee that threatens, intimidates, or coerces another will not
be tolerated. This prohibition includes all acts of harassment,
including harassment that is based on an individual’s sex, race, age, or any
characteristic protected by law.
All
threats of (or actual) violence, both direct and indirect, should be reported as
soon as possible to your immediate supervisor or any other member of management.
This includes threats by employees, as well as threats by customers, vendors,
solicitors, or other members of the public. In addition, only
authorized visitors are allowed in the workplace and solicitation is prohibited
– all suspicious individuals or activities on or near the workplace should be
reported as soon as possible. Do not place yourself in
peril. If you see or hear a commotion or disturbance near your
workstation, do not try to intercede or see what is happening.
Novavax
will promptly and thoroughly investigate all reports of threats of (or actual)
violence and of suspicious individuals or activities. Anyone
determined to be responsible for actual or threatened violence or other conduct
that is in violation of these guidelines will be subject to prompt disciplinary
action, up to and including termination.
* * * *
*
For
further discussion with respect to employee conduct and work rules, including
our policies regarding drug and alcohol use, sexual and other unlawful
harassment and employee conduct, refer to Novavax’s
Employee
Handbook
.
11. Fair
Competition
Standard:
We will uphold the ideals of free and competitive enterprise.
Novavax
expects openness, honesty and courtesy from all employees in their business
dealings. Every employee must act ethically and with respect for
others, and endeavor to deal fairly and honestly with the company’s customers,
vendors, partners and competitors.
Each
employee is also responsible for creating and sustaining a pleasant, secure and
productive working environment. No employee should take unfair
advantage of anyone through manipulation, concealment, abuse or disclosure of
privileged information, misrepresentation or any other unfair dealing
practice.
Novavax
also abides by and adheres to fair competition standards that are a matter of
law in virtually every jurisdiction in which we conduct
business. Novavax expects employees to act in accordance with such
standards, which include compliance with:
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all
antitrust rules and regulations, including rules against agreements or
understandings between Novavax and its competitors that affect the
process, terms or conditions of
sale;
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prohibitions
against unfair methods of competition and unfair and deceptive acts or
practices in commerce;
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all
foreign corrupt practices laws, including those making illegal any offer,
payment, promise to pay or authorization to pay any money, gift or
anything of value to foreign officials, political parties or candidates
for improper purposes; and
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laws
governing trade, boycotts, customs, embargoes and export
controls.
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These
standards mean that, among other things, you may not:
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agree
with a competitor to fix prices or share pricing
information;
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illegally
favor one customer over another; or
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attend
trade association meetings held for improper purposes, such as to discuss
setting prices or allocating markets or territories among
competitors.
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Question:
If
I do not talk about specific price levels, can I agree with a competitor
not to engage in a price war?
Answer:
No.
Any agreement between competitors that directly relates to the prices they
charge is a violation of fair competition laws, regardless of whether
specific prices are a part of the agreement.
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Sales
and Marketing Practices
Standard: We
will conduct sales and marketing activities in accordance with Novavax’s Core
Values, policies and the law.
Every
employee must preserve Novavax’s reputation as a leading company whose products
and services are desired for their quality and value and whose people are
respected for their integrity and high performance. The long-term
success of Novavax and each of us depends on our ability to build long-term
trusting relationships with our customers.
When
communicating with customers or potential customers you should always honestly
and accurately describe the features of Novavax’s products and
services. All literature and public statements must be true and you
may not misstate facts or create misleading impressions. Also, you
must not unfairly criticize or denigrate a competitor’s products or
services. You must only use another party’s confidential information
for the purposes that the information was provided to us and even
then only with their consent. Importantly, all safety and adverse
events should be reported to the company in a timely manner so that the company
can remain in compliance with all FDA guidelines.
Stricter
and more specific rules generally apply when Novavax is doing business with
governmental agencies and officials. There are many laws and specific agency
regulations governing our relationships with local, state and federal
governments. Those of you who work with governmental officials at any
level must ensure that you understand and follow the laws, regulations and
policies that apply to those relationships.
Because
of the sensitive nature of these relationships, you should also always talk to
your supervisor or manager before offering gifts or incentives of any nature to
any government or other public sector employees. In particular, no
employee may offer, make or authorize any payment of money or anything of value,
directly or indirectly, to:
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illegally
influence the judgment or conduct, or ensure a desired outcome or action,
of any individual, customer, company or company
representative;
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win
or retain business, or influence any act or decision of any government
official, political party, candidate for political office or official of a
public or international organization;
or
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gain
an improper advantage.
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Competitive
Information
Standard: We
will not collect information on our competitors through inappropriate
means.
In any
competitive business, information is valuable and it is useful to us to learn
more about our competitors, vendors and customers. However, we must be ethical
about how we acquire that information and must not improperly seek information
about our competitors or their products and services.
When
collecting information, our actions must be honest and fair and within the
law. Do not request or use information that violates laws
regulating:
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proprietary
information and data, and
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confidential
relationships between employees and
employers.
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Examples
of appropriate sources of competitive information include:
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tradeshows
and medical conferences
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discussions
with customers
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competitive
brochures and other widely distributed
information
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12. Environment,
Health and Safety
Standard: We
will operate our business in a safe and healthy manner, we will respect the
environment, and we will use our natural resources responsibly.
As
embodied in our Core Values, Novavax believes that the continued protection of
our personnel and the implementation of sound environmental practices are
crucial to accomplishing our strategic goals.
In
support of these beliefs Novavax strives to:
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provide
and maintain facilities and operations where health and safety are
promoted and hazards are
controlled.
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manage
facilities and operations such that their potential impacts on the
environment are controlled and
minimized.
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comply
with applicable environmental, health and safety legal
requirements.
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provide
environmental, health and safety training and education for all Novavax
employees as appropriate.
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Sound
environmental, health and safety management and performance are the
responsibility of everyone at Novavax. Individually and collectively
we should work together to build programs and to achieve performance in
environmental, health and safety matters that serve as a positive example for
other organizations.
Remember,
promptly report any environmental issues or violations of environmental, health
and safety rules, regulations and practices, and report accidents, injuries and
unsafe equipment, practices or conditions, to your supervisor, facility safety
officer or the company’s Human Resources department.
13. Compliance
with Laws
Standard:
We will comply with all applicable laws and regulations in the jurisdictions in
which we operate.
Obeying
the law, both in letter and spirit, is one of the foundations on which the
company’s ethical standards are built. All employees must respect and
obey the laws, rules and regulations of the jurisdictions in which the company
operates. Although not all employees are expected to know the details
of these laws, it is important to know enough to determine when to seek advice
from supervisors, Human Resources, or a member of the executive management
team.
Failure
to comply with applicable laws, rules and regulations, as well as our legal and
ethical standards, can have severe consequences for both the individuals
involved and the company, including damaging Novavax’s name, trade and customer
relationships, market value and business opportunities. It is our
policy to prevent the occurrence of both illegal and unethical behavior, to halt
any such behavior that may occur as soon as reasonably practicable after its
discovery, and to discipline those who engage in such behavior, including those
individuals who fail to exercise appropriate supervision and oversight, thereby
permitting such behavior by their subordinates to go undetected.
Violations
can subject the perpetrators to prosecution, fines and/or
imprisonment. Novavax also may be subject to prosecution, fines and
other penalties, including criminal penalties. Employees also could
be subject to discipline at work, including termination of
employment.
For
information on how to report suspect activity or violations, see “What You Can
Do If You Have A Concern About Business Practices” on page 5.
14. Accuracy
of Books, Records and Accounts
Standard:
We will reflect our business accurately in our records.
As a
publicly traded company, all employees have a responsibility to ensure that the
Company provides the investing public with information that reflects the
Company’s business transactions. Therefore, all of our public disclosures that
are filed with government agencies or communicated to the public must be
complete, fair, accurate, timely and understandable. In addition, they must be
prepared, reported and maintained in accordance with all applicable laws and
accounting standards. This obligation applies to all employees, including all
executives, with any responsibility for preparing such reports, including
drafting, reviewing, and signing or certifying the information they contain. The
Company must communicate to the extent required by government agencies about its
operations, without compromising proprietary and confidential
information.
You may
be called upon to provide information to finance, members of management and/or
the company’s financial auditors or consultants to ensure that the company’s
financial reports are accurate, complete and reliable. Novavax expects that all
employees will take this responsibility seriously and provide prompt and
accurate answers to inquiries related to our public reports and disclosure
documents.
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act. Management is responsible for assessing the
effectiveness of our internal control over financial reporting. In making this
assessment, management uses the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO) in
Internal Control-Integrated
Framework
. Management is responsible for developing and maintaining
corporate financial policies and procedures to support its internal control
environment. All employees must comply with corporate financial
policies.
Additionally,
management bears responsibility for promoting integrity throughout the company,
with responsibilities to stakeholders both inside and outside
Novavax. Management has a responsibility to adhere to these policies
and procedures themselves and to ensure that a culture exists throughout Novavax
as a whole that ensures the fair and timely reporting of the company’s financial
results and condition and maintains adequate internal control over financial
reporting
The
Executive Committee, which includes the Chief Executive Officer and the Chief
Financial Officer, along with all members of the company’s finance department
are bound by the following financial code of ethics, and by accepting the Code,
each agrees that he or she will:
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provide
information in accordance with generally accepted accounting principles
(GAAP) that is accurate, complete, reliable, objective, relevant and
timely for data and disclosures in reports and documents that Novavax
files with, or submits to, government and regulatory authorities, internal
management review and in other public
communications;
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to
the best of your knowledge, conduct business in compliance with the laws,
rules and regulations of applicable governments, and other appropriate
private and public regulatory
agencies;
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act
in good faith, responsibly, with due care, competence and diligence, and
without allowing one’s independent judgment to be subordinated in the
execution of their financial
duties;
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respect
the confidentiality of information acquired in the course of one’s work
except when authorized or otherwise legally obligated to disclose, and do
not use confidential information for personal
advantage;
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To
the extent estimates and accruals are necessary in company reports and
records, they must be based on good faith judgment and supported by
appropriate documentation.
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never
falsify any document, distort the true nature of any transaction or
manipulate financial accounts, records or reports, whether that of
Novavax, a customer, a partner or other
third-party;
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include
supporting documentation for all
transactions;
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cooperate
with any investigations or inquiries into the accuracy and timeliness of
financial records;
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promptly
report to the Chief Financial Officer or Chairperson of the Audit
Committee any material information of which he or she may become aware
that affects the disclosures made by the company in our public filings, or
that concerns either deficiencies in the design or operation of internal
control which could adversely affect Novavax’s ability to record, process,
summarize and report financial data, material weaknesses in internal
controls, or fraud, whether or not material, that involves management or
other employees who have a significant role in the company’s financial
reporting, disclosures or internal controls;
and
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promptly
report to the Chairperson of the Audit Committee of the Board of Directors
(in the case of the Chief Executive Officer or the Chief Financial
Officer) or to your supervisor (in the case of other employees
with financial reporting responsibilities) any activity that the
individual believes to be a violation of law, business ethics or of any
provisions of this Code, including any transaction or relationship that
reasonably could be expected to give rise to a conflict of
interest.
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Violations
of laws associated with accounting and financial reporting will result in
disciplinary action including, but not limited to, reprimands, warnings,
probation or suspension without pay, demotions, reductions in salary, discharge
and restitution. Certain violations of this Code may require the Company
to refer the matter to the appropriate governmental or regulatory authorities
for investigation or prosecution. Moreover, any supervisor who directs or
approves of any conduct in violation of this Code, or who has knowledge of such
conduct and does not immediately report it, also will be subject to disciplinary
action, up to and including discharge.
If you become aware of any action
related to accounting or financial reporting that you believe may be improper,
you must immediately tell the company (see page 6).
This can
be done through any of the channels identified in this Code.
Question:
I
do not have the time to check all of the invoices and expense reports that
come across my desk. Surely, it is the responsibility of the
individual who prepared them or the employee who submitted them to me to
make sure that they are correct. Am I right in my
assumption?
Answer:
No.
Accurate records are everyone’s responsibility. If you are
approving an invoice or expense report, you are responsible for its
accuracy.
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15. Disclosure
Policies And Communication With Outside Parties
Standard: We
will protect the company’s reputation by allowing the company’s
designated
individuals
to deal with inquiries from analysts, the media and current or potential
investors.
The
Media and Investment Community
What is
said or written about the company obviously has an impact on Novavax’s
reputation. We place great importance on maintaining effective
relationships with the news media, analysts and investment
community. To be consistent with our beliefs, we try to maintain the
company’s credibility by providing information to our audiences in accordance
with disclosure policies and in a timely, accurate and non-discriminating
manner.
As such,
all communications with the news media and members of the investment community,
including analysts and investment bankers, should be handled or coordinated by
the company’s Investor Relations department, our President & CEO or Chief
Financial Officer (CFO).
Questions
about legal matters should be referred to the Chief Financial Officer; questions
about employees or former employees, including requests for references and
related personnel information, should be referred to a member of our Human
Resources department.
Question:
I
received a call from a reporter who is looking for information that is
within the scope of my job. What should I do?
Answer:
The
prudent course of action in this case is to redirect the reporter to the
company’s Investor Relations department, CEO or CFO.
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Our
Investors
We are
required under U.S. federal securities laws to provide our shareholders and the
public with periodic disclosure regarding our business and financial condition
(such as quarterly and annual reports and materials for our annual stockholders
meeting). We provide additional disclosures through our quarterly earnings calls
and press releases. All Novavax employees who participate in the
preparation or dissemination of these disclosures, or who provide information
that they know may be used in the preparation of these disclosures, have a legal
and ethical duty to ensure that the content of the disclosures is accurate,
complete and timely.
We have
developed disclosure controls and procedures that are designed to ensure that
all public disclosures are accurate, complete and timely. If you become aware
that our public disclosures are not accurate, complete and timely, or become
aware of a transaction or development you believe may require disclosure, you
should report the matter immediately to your supervisor or manager, our Chief
Financial Officer or the appropriate Compliance Official.
16. Administration
of this Code
Distribution,
Availability and Revisions
All
Novavax employees will receive a copy of this Code at the time they join the
company and will receive periodic updates.
A copy of
this Code will be made publicly available in compliance with law and is
available on the company’s Internet and intranet sites.
Approvals
and Waivers
As
described in this Code, certain persons at the company must review and approve
in writing any circumstance requiring special permission. Copies of
these approvals will be maintained by the company and made available to auditors
or investigators.
Waivers
of any provision of this Code for directors and executive officers must be
approved by our Audit Committee and will be disclosed promptly in accordance
with law.
Given the
important position of trust and authority that they occupy, our Chief Executive
Officer and Chief Financial Officer (collectively, the “Financial Executives”)
should act extremely cautiously in interpreting and applying this Code.
Financial Executives should consult with the Chairperson of the Audit Committee
with respect to any proposed actions or arrangements that are not clearly
consistent with the Code. In the event that a Financial Executive
wishes to engage in a proposed action or arrangement that is not consistent with
the Code, the Financial Executive must obtain a waiver of the relevant Code
provisions in advance from our Audit Committee.
The
Sarbanes-Oxley Act of 2002 imposes certain reporting requirements on Novavax
with respect to our Financial Executives’ compliance with the Code. In
accordance with these requirements, we will publicly report on a Current Report
on Form 8-K any waivers of any provision of the Code granted by our Audit
Committee to any Financial Executive. Violations of the Code by our Financial
Executives may also be immediately reported on Form 8-K.
Signature
and Acknowledgement
All
employees must sign the Novavax Personal Pledge set forth at the end of this
Code, confirming that they have read this Code and understand its
provisions. Failure to read the Code or to sign the pledge, however,
does not excuse an employee from the duty to comply with its
terms.
This Code
may be revised, changed or amended at any time by our Board of Directors.
Following any material revisions or updates, an updated version of this Code
will be distributed to you, and will supersede the prior version of the Code
effective upon distribution. We may ask you to sign an
acknowledgement confirming that you have read and understood the revised version
of the Code and that you agree to comply with its provisions.
Ongoing
Review of Compliance
We
require all Novavax employees, officers and directors to comply with this
Code. As noted above, upon your receipt of this Code, and also from
time to time as we deem to be necessary, we will require you to sign an
acknowledgement confirming that you have read and understood the Code and agree
to comply with its provisions. We reserve the right to monitor your continuing
compliance with the provisions of this Code and to investigate any suspected
violations. If substantiated, these violations could result in
disciplinary action, as described more fully in the following
sections.
Investigations
and Disciplinary Actions
Novavax
expects that its employees will bring to the attention of their supervisors or
one of our Compliance Officials (or any people that such officers designate)
information about suspected violations of this Code. If you have
information about suspected improper accounting or auditing matters, or have
information about suspected violations of this Code involving any of our
Compliance Officers, you may also bring such information to the attention of a
member of our Audit Committee. To contact our Audit Committee or to
submit a report to them, please contact our Chief Financial Officer or Michael
McManus, Chairperson of our Audit Committee, who will make sure that your
information is conveyed to the Audit Committee.
If you
are not comfortable revealing your identity when making a report, you can also
make an anonymous report as discussed in the “What You Can Do If You Have A
Concern About Business Practices” section of this Code (see page
5).
You
should feel safe in reporting this information, without regard to the identity
or position of the suspected offender. Complaints and requests for
information will be handled promptly, discreetly and
professionally. Discussions and inquiries will be kept in strict
confidence to the extent appropriate or permitted by policy or
law. If the employee desires, he or she can be informed of any
follow-up action implemented by the company.
Novavax
will not take, and will not permit others under our control to take, any acts of
retribution or retaliation against you for making a report.
Retaliation
in any form against anyone who reports a violation of this Code (even if the
report is mistaken but was submitted in the good faith belief it was correct) or
who assists in the investigation of a reported violation is itself a serious
violation of this Code. Acts of retaliation should be reported immediately and
may result in severe disciplinary action.
Because
failure to report criminal activity can itself be understood to condone the
crime, we emphasize the importance of reporting. For both criminal activity and
other violations of this Code, failure to report knowledge of wrongdoing may
result in disciplinary action against those who fail to report.
Investigations
will be conducted by and under the supervision of Novavax’s Chief Executive
Officer, Vice President, Human Resources or the Chairman of the Audit Committee
depending on the issue, as they deem appropriate. It is imperative
that employees who make reports and persons to whom such reports are made do not
conduct their own preliminary investigations unless authorized to do so by our
President & CEO. You are expected to cooperate in the
investigation of reported violations to the extent possible.
You
should be aware that our CEOand CFOare legally obligated to act in the best
interests of Novavax as a company. They do not act as lawyers or personal
representatives for any individual Novavax employee, including members of our
senior management team. Our Board of Directors has ultimate responsibility for
final interpretation of this Code and for determining whether any violations of
this Code have occurred.
Novavax
will investigate any matter reported and may take appropriate corrective and
disciplinary actions, if, in our good faith discretion, it is determined that a
violation has occurred. Disciplinary actions may include, alone
or in combination, a warning or letter of reprimand, demotion, loss of merit
increase or bonus, suspension without pay or termination of
employment. We may also seek civil remedies or refer criminal
misconduct to law enforcement agencies.
Among
other things, individuals may be disciplined for:
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committing,
authorizing or directing an illegal act or violation of this
Code.
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failing
to exercise proper compliance oversight or tolerating illegal conduct, if
acting as a supervisor.
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failing
to report illegal or improper conduct of which he or she directly knows or
observes.
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refusing
to cooperate with an investigation, including deliberately withholding
relevant information or knowingly providing false information concerning a
violation of this Code or applicable laws and
regulations.
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discouraging
another individual from reporting a violation of law or this
Code.
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retaliating
against or condoning retaliation against an individual who reports a
violation or assists in an investigation of a suspected
violation.
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Important
Disclaimers
This Code
reflects general principles to guide you in making ethical decisions and cannot,
and is not intended to, address every specific situation in which we may find it
appropriate to take disciplinary action. This Code is not intended to
create any contract (express or implied) with you, including without limitation
any employment contract, or to constitute any promise that your employment will
not be terminated except for cause.
17. NOVAVAX
PERSONAL PLEDGE
As an
employee of Novavax or one of its subsidiaries, we all share the responsibility
to maintain the company’s reputation. Therefore, it is critical that
all employees not only read and understand the company’s Code of Business
Conduct and Ethics but also formally acknowledge their commitment to abide by
the Code. Accordingly, as a Novavax person I
acknowledge:
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·
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I
have received a copy of Novavax’s Code of Business Conduct and Ethics (the
“Code”);
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·
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I
have read, understand and will act consistent with the Code and any of its
future revisions;
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·
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If
I have questions regarding the content or interpretation of the Code, I
will bring them to the attention of my supervisor;
and
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·
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If
I observe or suspect a violation of the Code or any business practice or
legal or ethical standard, I will report it in accordance with this
Code.
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Employee Signature:
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Date:
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Employee Name:
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Exhibit
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have
issued our report dated March 16, 2010, with respect to the consolidated
financial statements, schedule and internal control over financial reporting
included in the Annual Report of Novavax, Inc. and subsidiary on Form 10-K for
the year ended December 31, 2009. We hereby consent to the incorporation by
reference of said report in the Registration Statements of Novavax, Inc. and
subsidiary on Forms S-3 (No. 333-118210 effective August 13, 2004;
No. 333-118181 effective August 12, 2004; and No. 333-22685
effective March 4, 1997) and on Forms S-8 (No. 333-145298 effective
August 9, 2007; No. 33-80277 effective December 11, 1995;
No. 33-80279 effective December 11, 1995; No. 333-130990 effective
January 12, 2006; No. 333-110401 effective November 12, 2003;
No. 333-97931 effective August 9, 2002; No. 333-46000 effective
September 18, 2000 and No. 333-77611, effective May 3,
1999).
/s/ Grant
Thornton LLP
Baltimore,
Maryland
March
16,
2010
Exhibit
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
I, Rahul
Singhvi, certify that:
1. I
have reviewed this Annual Report on Form 10-K of Novavax, Inc.;
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 we have:
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a)
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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;
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b)
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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;
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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 evaluations;
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. 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 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.
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By:
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/s/ Rahul Singhvi
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President
and Chief Executive Officer
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Date:
March 16, 2010
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Exhibit
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER
I,
Frederick W. Driscoll, certify that:
1. I
have reviewed this Annual Report on Form 10-K of Novavax, Inc.;
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 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 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 evaluations; 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 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.
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By:
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/s/ Frederick W.
Driscoll
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Vice
President, Chief Financial Officer and
Treasurer
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Date:
March 16, 2010
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Exhibit
32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER PURSUANT
TO
18 UNITED STATES C. §1350
(SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002)
In
connection with the Annual Report of Novavax, Inc. (the “Company”) on Form 10-K
for the fiscal year ended December 31, 2009 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, Rahul Singhvi,
President and Chief Executive Officer of the Company, hereby certify, pursuant
to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1) The
Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, as amended; and
2) The
information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company for the dates
and periods covered by this Report.
By:
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/s/ Rahul Singhvi
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Title:
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President
and Chief Executive Officer
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Date:
March 16, 2010
Exhibit
32.2
CERTIFICATION
OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER PURSUANT TO 18 UNITED STATES C.
§1350
(SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002)
In
connection with the Annual Report of Novavax, Inc. (the “Company”) on Form 10-K
for the fiscal year ended December 31, 2009 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, Frederick W.
Driscoll, Vice President, Chief Financial Officer and Treasurer, hereby certify,
pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
1) The
Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, as amended; and
2) The
information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company for the dates
and periods covered by this Report.
By:
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/s/ Frederick W.
Driscoll
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Vice
President, Chief Financial Officer and
Treasurer
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Date:
March 16, 2010