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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 FORM 10-K
  þ
    
    ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the fiscal year ended December 31, 2010
 or
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the transition period from  to
 Commission file number: 001-15070
 RegeneRx Biopharmaceuticals, Inc.
  Delaware
    
    52-1253406State or other jurisdiction of
    
    (I.R.S. Employerincorporation or organization
    
    Identification No.)15245 Shady Grove Road, Rockville, MD
    
    20850(Address of principal executive offices)
    
    (Zip Code)
      o þ
 o þ
 þ o
 o o
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  Large accelerated filer o
    
    Accelerated filer o
    
    Non-accelerated filer o
    
    Smaller reporting company þ(Do not check if a smaller reporting company)
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TABLE OF CONTENTS
 PART I
    
    
    3Item 1. Business
    
    
    3Item 1A. Risk Factors
    
    
    11Item 1B. Unresolved Staff Comments
    
    
    23Item 2. Properties
    
    
    23Item 3. Legal Proceedings
    
    
    23Item 4. Reserved
    
    
    23PART II
    
    
    24Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Securities
    
    
    24Item 6. Selected Financial Data
    
    
    24Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operation
    
    
    24Item 7A. Quantitative and Qualitative Disclosures About Market Risk
    
    
    30Item 8. Financial Statements and Supplementary Data
    
    
    30Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
    
    
    30Item 9A. Controls and Procedures
    
    
    30Item 9B. Other Information
    
    
    31PART III
    
    
    32Item 10. Directors, Executive Officers and Corporate Governance
    
    
    32Item 11. Executive Compensation
    
    
    34Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
    
    
    39Item 13. Certain Relationships and Related Transactions, and Director Independence
    
    
    40Item 14. Principal Accounting Fees and Services
    
    
    41PART IV
    
    
    42Item 15. Exhibits, Financial Statement Schedules
    
    
    42SIGNATURES
    
    
    47INDEX TO FINANCIAL STATEMENTS
    
    
    49EXHIBIT INDEX
    
    
    65Exhibit 23.1Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2
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PART I
 This Annual Report on Form 10-K , including the section entitled Managements Discussion
and Analysis of Financial Condition and Results of Operations, contains forward-looking
statements regarding us and our business, financial condition, results of operations and
prospects within the meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the words project, believe, anticipate,
plan, expect, estimate, intend, should, would, could, will, may or other
similar expressions. In addition, any statements that refer to projections of our future
financial performance or capital resources, our clinical development programs and schedules, our
anticipated growth and trends in our business, and other characterizations of future events or
circumstances are forward-looking statements. We cannot guarantee that we will achieve the
plans, intentions or expectations expressed or implied in our forward-looking statements. There
are a number of important factors that could cause actual results, levels of activity,
performance or events to differ materially from those expressed or implied in the
forward-looking statements we make, including those described under Risk Factors set forth
below. In addition, any forward-looking statements we make in this report speak only as of the
date of this report, and we do not intend to update any such forward-looking statements to
reflect events or circumstances that occur after that date.
 
 Item 1.
    
    Business.
 General
  
    
    RGN-352, an injectable product candidate to treat
cardiovascular diseases, central nervous system
diseases, and other medical indications that may be
treated by systemic administration, for which we
began a Phase 2 clinical trial in the second half
of 2010;
    
    RGN-259, a topical eye drop for ophthalmic
indications for which we are supporting a
physician-sponsored clinical trial in patients with
dry eye; and
    
    RGN-137, a topically applied gel for chronic dermal
wounds and reduction of scar tissue that is currently
in a Phase 2 clinical trial for the treatment of the
skin defect epidermolysis bullosa, or EB.
   Overview of Tß4
   
    
    Progenitor (Stem) Cell Differentiation.Research published in the
journal Naturein November 2006 featured the discovery that Tß4 is the
key signaling molecule that triggers adult epicardial progenitor
cells, or EPCs, to differentiate into coronary blood vessels. EPCs are
partially differentiated stem cells that can further differentiate
into specific cell types when needed. Confirmatory research published
in 2009 in the Journal of Molecular and Cellular Cardiologyconcluded
that Tß4 is responsible for the initiation of the embryonic coronary
developmental program and EPC differentiation in adult mice. These
publications confirm that Tß4s interaction with EPCs is necessary for
the maintenance of a healthy adult animal heart, as well as normal
fetal animal heart development.
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Nature Circulation
 Neuroscience
 
    
    Actin Regulation.Tß4 regulates actin, which
comprises up to 10% of the protein of non-muscle
cells in the body and plays a central role in cell
structure and in the movement of cells. Research
studies have indicated that Tß4 stimulates the
migration of human keratinocytes, or skin cells,
human endothelial cells, and progenitor cells.
Endothelial cells are the major cell type
responsible for the formation of new blood
vessels, a process known as angiogenesis. Certain
of these studies conducted at the National Institutes of Health, or NIH were the
first to suggest the role of Tß4 in wound healing.
The data from these studies encouraged us to
license the rights to Tß4 from the NIH in 2001 and
to launch an initial clinical development program
that targeted the use Tß4 for chronic dermal
wounds.
    
    Reduction of Inflammation.Uncontrolled
inflammation is the underlying basis of many
pathologies and injuries. Research has shown that
Tß4 is a potent anti-inflammatory agent in skin
cells and in corneal epithelial cells in the eye.
Tß4 has also been shown to decrease the levels of
inflammatory mediators and to significantly reduce
the influx of inflammatory cells in the reperfused
heart of animals. More recent preclinical research
suggests that Tß4 blocks activation of the NFκB
pathway, which is involved in DNA activation of
inflammatory mediators, thereby modulating
inflammation in the body. This anti-inflammatory
activity may explain, in part, the mechanism by
which Tß4 appeared to improve functional outcome
in the mouse multiple sclerosis model described
above, as well as promoting repair in the heart
and skin. Identifying a factor such as Tß4 that
blocks activation of NFκB suggests that Tß4 could
have additional important therapeutic applications
for inflammation-related diseases, such as cancer,
osteoarthritis, rheumatic diseases, autoimmune
diseases, inflammatory pulmonary disease and
pancreatitis.
    
    Collagen and Laminin-5 Stimulation.Tß4 has a
number of additional biological activities shown
to reduce inflammation, stimulate the formation of
collagen, and up-regulate the expression of
laminin-5, a subepithelial basement membrane
protein. Both collagen and laminin-5 are central
to healthy tissue and the prevention of disease.
    
    Apoptosis.Tß4 has been shown to prevent
apoptosis, or programmed cell death, in two animal
models and in two tissue types. In the rodent
model, corneal apoptosis, or loss of corneal
epithelial cells leading to corneal epithelial
thinning, was prevented through topical
administration of Tß4, and in the heart muscle of
ischemic animal models, such as in mice and pigs,
cell death was prevented by the systemic
administration of Tß4.
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Our Product Candidates
 RGN-352
 Nature
 Clinical Development.
   Future Plans.
  Neuroscience Journal
of Neurosurgery
 RGN-259
  Clinical Development.
   5




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Future Plans.
 RGN-137
  Clinical Development  Epidermolysis Bullosa.
  Clinical Development  Pressure Ulcers. 2
  6




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Clinical Development  Venous Stasis Ulcers. 2
  Future Plans.
 RGN-457
  Peptide Fragments for Cosmeceutical Applications
 in
vitro
 Our Strategy
    7




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Manufacturing
   Competition
  
    
    RGN-352.Currently, there are no approved
pharmaceutical products for regenerating cardiac
tissue following a heart attack, nor are there
approved pharmaceutical products for the
remyelination of axons for patients with multiple
sclerosis. However, many pharmaceutical companies and
research organizations are developing products and
technologies that are intended to prevent cardiac
damage, improve cardiac function, and regenerate
cardiac muscle after a heart attack. There are also
companies developing products that remyelinate
neurons and provide functional improvement for
multiple sclerosis patients. If we were to
successfully develop RGN-352 for other cardiovascular
indications, such as acute or chronic heart failure,
such a product would have to compete with other drugs
or therapies currently marketed by large
pharmaceutical companies for similar indications, as
would products for the treatment of multiple
sclerosis.
    
    RGN-259.Most specialty ophthalmic companies have a
number of products on the market that could compete
with RGN-259. There are numerous antibiotics to treat
eye infections that cause corneal wounds and many eye
lubrication products to help eye healing and
function, many of which are sold without
prescriptions. Companies also market steroids to
treat certain severe conditions within our area of
interest. Allergan, Inc. has marketed
RestasisTM, a relatively new
approved eye drop to treat dry eye. Dry eye is a
condition related to a number of diseases and one
that we believe could benefit from the use of
RGN-259.
    
    RGN-137.Johnson & Johnson has marketed
RegranexTM for patients with
diabetic foot ulcers. Companies such as Novartis are
developing and marketing artificial skins, which
would compete with RGN-137 in the treatment of dermal
wound healing. There are other companies developing
new pharmaceutical products for wound healing.
Products and therapies such as antibiotics,
honey-based ointments and low frequency cavitational
ultrasound are also used to treat certain types of
dermal wounds. Moreover, dermal wound healing is a
large and highly fragmented marketplace that includes
numerous therapeutic products and medical devices for
treating acute and chronic dermal wounds.
    
    RGN-457.CF is a genetic defect for which there is
no cure. There are mucolytic agents and antibiotic
drugs on the market, such as Genentechs pulmozyme
and Novartis TOBI®, an inhaled
version of tobramycin, that relieve the symptoms
posed by CF and could potentially compete with
RGN-457.
 
    
    Cosmeceuticals.The cosmetics industry is highly
competitive and dependent on effective marketing and
distribution. There are multiple products currently
launched by major international cosmetic enterprises
that claim the same or similar benefits that may be
claimed with our product candidates.
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Government Regulation
       9




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Intellectual Property
     Material Agreements
 National Institutes of Health
  Defiante/Sigma-Tau
   10




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Development Agreements
  Employees
  Corporate Information
  Available Information
 www.regenerx.com
 
 Item 1A.
    
    Risk Factors
 Risks Related to Our Liquidity and Need for Financing
 Before giving effect to any potential sales of our securities, we estimate that our existing
capital resources will only be sufficient to fund our operations into the second half of 2011,
or into 2012 if our Phase 2 AMI trial is delayed.
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We may not be able to access the full amounts available under the LPC committed equity facility.
    In addition to our current development objectives, we will need substantial additional capital
for the continued development of product candidates through marketing approval and for our
longer-term future operations.
  
    
    the scope of our clinical trials, which is significantly
influenced by the quality of clinical data achieved as
trials are completed and the requirements established by
regulatory authorities;
    
    the speed with which we complete our clinical trials,
which depends on our ability to attract and enroll
qualifying patients and the quality of the work performed
by our clinical investigators;
    
    the time required to prosecute, enforce and defend our
intellectual property rights, which depends on evolving
legal regimes and infringement claims that may arise
between us and third parties;
    
    the ability to manufacture at scales sufficient to supply
commercial quantities of any of our product candidates
that receive regulatory approval, which may require levels
of effort not currently anticipated; and
 
    
    the successful commercialization of our product candidates, which will
depend on our ability to either create or partner with an effective
commercialization organization and which could be delayed or prevented
by the emergence of equal or more effective therapies.
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We have incurred losses since inception and expect to incur significant losses in the
foreseeable future and may never become profitable.
   Our common stock has been delisted from the NYSE Amex stock exchange, which subjects us to the
SECs penny stock rules and will further decrease the liquidity of our common stock.
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The report of our independent registered public accounting firm contains explanatory language
that substantial doubt exists about our ability to continue as a going concern.
  Risks Related to Our Business and Operations
 Our pending Phase 2 clinical trial of RGN-352 was recently placed on clinical hold by the FDA
and we are unsure when, if ever, we will be able to resume this trial.
  All of our drug candidates are based on a single compound that has yet to be proven effective in
human subjects.
  We may never be able to commercialize our product candidates.
 in vitro
 
    
    be found ineffective or cause harmful side effects during preclinical studies or clinical trials;
    
    fail to receive necessary regulatory approvals;
    
    be precluded from commercialization by proprietary rights of third parties;
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
    
    be difficult to manufacture on a large scale; or
    
    be uneconomical or otherwise fail to achieve market acceptance.
  We are subject to intense government regulation, and we may not receive regulatory approvals for
our drug candidates.
   
    
    the FDA or other health regulatory authorities, or institutional review boards, or IRBs, do not approve a
clinical trial protocol or place a clinical trial on hold;
    
    suitable patients do not enroll in a clinical trial in sufficient numbers or at the expected rate, for reasons
such as the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria
for the trial, the perceptions of investigators and patients regarding safety, and the availability of other
treatment options;
    
    clinical trial data is adversely affected by trial conduct or patient withdrawal prior to completion of the trial;
    
    there may be competition with ongoing clinical trials and scheduling conflicts with participating clinicians;
    
    patients experience serious adverse events, including adverse side effects of our drug candidates, for a variety
of reasons that may or may not be related to our product candidates, including the advanced stage of their
disease and other medical problems;
    
    patients in the placebo or untreated control group exhibit greater than expected improvements or fewer than
expected adverse events;
    
    third-party clinical investigators do not perform the clinical trials on the anticipated schedule or consistent
with the clinical trial protocol and good clinical practices, or other third-party organizations do not perform
data collection and analysis in a timely or accurate manner;
    
    service providers, collaborators or co-sponsors do not adequately perform their obligations in relation to the
clinical trial or cause the trial to be delayed or terminated;
    
    we are unable to obtain a sufficient supply of manufactured clinical trial materials;
    
    regulatory inspections of manufacturing facilities, which may, among other things, require us or a co-sponsor to
undertake corrective action or suspend the clinical trials, such as the recent clinical hold with respect to our
pending Phase 2 clinical trial of RGN-352;
    
    the interim results of the clinical trial are inconclusive or negative;
    
    the clinical trial, although approved and completed, generates data that is not considered by the FDA or others
to be sufficient to demonstrate safety and efficacy; and
    
    changes in governmental regulations or administrative actions affect the conduct of the clinical trial or the
interpretation of its results.
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We may not successfully establish and maintain development and testing relationships with
third-party service providers and collaborators, which could adversely affect our ability to
develop our product candidates.
   
    
    we do not achieve our objectives under our collaboration agreements;
    
    we or our collaborators are unable to obtain patent protection for the products or proprietary technologies we
develop in our collaborations;
    
    we are unable to manage multiple simultaneous product development collaborations;
    
    our collaborators become competitors of ours or enter into agreements with our competitors;
    
    we or our collaborators encounter regulatory hurdles that prevent commercialization of our product candidates; or
    
    we develop products and processes or enter into additional collaborations that conflict with the business
objectives of our other collaborators.
  We are subject to intense competition from companies with greater resources and more mature
products, which may result in our competitors developing or commercializing products before or
more successfully than we do.
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Even if approved for marketing, our technologies and product candidates are unproven and they
may fail to gain market acceptance.
  
    
    the timing and receipt of marketing approvals;
    
    the safety and efficacy of the products;
    
    the emergence of equivalent or superior products;
    
    the cost-effectiveness of the products; and
    
    ineffective marketing.
  We have no marketing experience, sales force or distribution capabilities. If our product
candidates are approved, and we are unable to recruit key personnel to perform these functions,
we may not be able to commercialize them successfully.
  If we enter markets outside the United States our business will be subject to political,
economic, legal and social risks in those markets, which could adversely affect our business.
  
    
    changes and limits in import and export controls;
    
    increases in custom duties and tariffs;
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
    
    changes in currency exchange rates;
    
    economic and political instability;
    
    changes in government regulations and laws;
    
    absence in some jurisdictions of effective laws to protect our intellectual property rights; and
    
    currency transfer and other restrictions and regulations that may limit our ability to sell
certain product candidates or repatriate profits to the United States.
  Governmental and third-party payors may subject any product candidates we develop to sales and
pharmaceutical pricing controls that could limit our product revenues and delay profitability.
  We have no manufacturing or formulation capabilities and are dependent upon third-party
suppliers to provide us with our product candidates. If these suppliers do not manufacture our
product candidates in sufficient quantities, at acceptable quality levels and at acceptable
cost, or if we are unable to identify suitable replacement suppliers if needed, our clinical
development efforts could be delayed, prevented or impaired.
   
    
    the possibility that they may not be able to ensure quality and compliance with regulations relating to the
manufacture of pharmaceuticals, as illustrated by the FDAs recent determination that our contract manufacturer for
RGN-352 was in non-compliance with current Good Manufacturing Practices;
    
    their manufacturing capacity may not be sufficient or available to produce the required quantities of our product
candidates based on our planned clinical development schedule, if at all;
    
    they may not have access to the capital necessary to expand their manufacturing facilities in response to our needs;
    
    commissioning replacement suppliers would be difficult and time-consuming;
    
    individual suppliers may have used substantial proprietary know-how relating to the manufacture of our product
candidates and, in the event we must find a replacement or supplemental supplier, our ability to transfer this
know-how to the new supplier could be an expensive and/or time-consuming process;
    
    an individual supplier may experience events, such as a fire or natural disaster, that force it to stop or curtail
production for an extended period;
    
    an individual supplier could encounter significant increases in labor, capital or other costs that would make it
difficult for them to produce our products cost-effectively; or
 
    
    an individual supplier may not be able to obtain the raw materials or validated drug containers in sufficient
quantities, at acceptable costs or in sufficient time to complete the manufacture, formulation and delivery of our
product candidates.
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Our suppliers may use hazardous and biological materials in their businesses. Any claims
relating to improper handling, storage or disposal of these materials could be time-consuming
and costly to us, and we are not insured against such claims.
  We face the risk of product liability claims, which could adversely affect our business and
financial condition.
   If any of our key employees discontinue their services with us, our efforts to develop our
business may be delayed.
  Mauro Bove, a member of our Board, is also a director and officer of entities affiliated with
Sigma-Tau, a relationship which could
give rise to a conflict of interest involving Mr. Bove.
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Risks Related To Our Intellectual Property
 We are heavily reliant on our license from the National Institutes of Health for the rights to
Tß4, and any loss of these rights would adversely affect our business.
  If we are not able to maintain adequate patent protection for our product candidates, we may be
unable to prevent our competitors from using our technology or technology that we license.
      20




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Changes to U.S. patent laws could materially reduce any value our patent portfolio may have.
  We may not have adequate protection for our unpatented proprietary information, which could
adversely affect our competitive position.
  We may be subject to claims that we or our employees have wrongfully used or disclosed alleged
trade secrets of former employers.
  Risks Related To Our Securities
 Our common stock price is volatile, our stock is highly illiquid, and any investment in our
securities could decline substantially in value.
  
    
    the recent delisting of our common stock from the NYSE Amex exchange;
    
    results of pre-clinical studies and clinical trials;
    
    commercial success of approved products;
    
    corporate partnerships;
    
    technological innovations by us or competitors;
    
    changes in laws and government regulations both in the U.S. and overseas;
    
    changes in key personnel at our company;
    
    developments concerning proprietary rights, including patents and litigation matters;
    
    public perception relating to the commercial value or safety of any of our product candidates;
    
    future sales of our common stock, including to LPC under our committed equity facility;
    
    other issuances of our common stock causing dilution;
    
    anticipated or unanticipated changes in our financial performance;
  21




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
    
    general trends related to the biopharmaceutical and biotechnological industries; and
    
    general conditions in the stock market.
  Our principal stockholders have significant voting power and may take actions that may not be in
the best interests of our other stockholders.
  If securities or industry analysts do not publish research or reports or publish unfavorable
research about our business, the price of our common stock and other securities and their
trading volume could decline.
  The exercise of options and warrants and other issuances of shares of common stock or securities
convertible into common stock will dilute your interest.
    The sale of shares of our common stock to LPC may cause substantial dilution to our existing
stockholders and could cause the price of our common stock to decline.
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Our certificate of incorporation, our stockholder rights plan and Delaware law contain
provisions that could discourage or prevent a takeover or other change in control, even if such
a transaction would be beneficial to our stockholders, which could affect our stock price
adversely and prevent attempts by our stockholders to replace or remove our current management.
  We may become involved in securities class action litigation that could divert managements
attention and harm our business and our insurance coverage may not be sufficient to cover all
costs and damages.
  
 Item 1B.
    
    Unresolved Staff Comments.
  
 Item 2.
    
    Properties.
  
 Item 3.
    
    Legal Proceedings.
  
 Item 4.
    
    Reserved.
  23




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PART II
 
 Item 5.
    
    Market for Registrants Common Equity,
Related Stockholder Matters and Issuer
Purchases of Securities.
   2010
    
    
    2009High
    
    
    Low
    
    
    High
    
    
    LowFirst Quarter
    
    $
    0.65
    
    
    $
    0.53
    
    
    $
    1.75
    
    
    $
    0.42Second Quarter
    
    $
    0.68
    
    
    $
    0.26
    
    
    $
    0.85
    
    
    $
    0.45Third Quarter
    
    $
    0.35
    
    
    $
    0.24
    
    
    $
    1.12
    
    
    $
    0.52Fourth Quarter
    
    $
    0.30
    
    
    $
    0.21
    
    
    $
    0.83
    
    
    $
    0.55
   
 Item 6.
    
    Selected Financial Data.
  
 Item 7.
    
    Managements Discussion and Analysis of Financial Condition and Results of Operation.
 You should read the following discussion and analysis together with our consolidated
financial statements and the related notes included elsewhere in this annual report.
 Overview
  
    
    RGN-352, an injectable product candidate to treat cardiovascular
diseases, central nervous system diseases, and other medical indications that may
be treated by systemic administration;
 
    
    RGN-259, a topical eye drop for regeneration of corneal tissues damaged by injury,
disease or other pathology; and
 
    
    RGN-137, a topically applied gel for dermal wounds and reduction of scar tissue.
     24




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Neuroscience Journal of Neurosurgery
     Financial Operations Overview
   25




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Critical Accounting Policies
  Share-based payment
    Costs of pre-clinical studies and clinical trials
   26




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Recent Accounting Pronouncements
   Results of Operations
 Comparison of years ended December 31, 2010 and 2009
 Revenues
 Expenses  Research and development
    Expenses  General and administrative
 Interest Income
 Liquidity and Capital Resources
   27




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Net Cash Used in Operating Activities.
 Net Cash Used in Investing Activities.
 Net Cash Provided by Financing Activities.
 Future Funding Requirements
    
    
    the progress of our clinical trials;
    
    the progress of our research activities;
    
    the number and scope of our research programs;
    
    the progress of our preclinical development activities;
    
    the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent
and other intellectual property claims;
    
    the costs related to development and manufacture of preclinical, clinical and validation lots for
regulatory purposes and commercialization of drug supply associated with our product candidates;
    
    our ability to enter into corporate collaborations and the terms and success of these collaborations;
    
    the costs and timing of regulatory approvals; and
    
    the costs of establishing manufacturing, sales and distribution capabilities.
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
    
    the number of patients that ultimately participate in the trial;
    
    the duration of patient follow-up that seems appropriate in view of the results;
    
    the number of clinical sites included in the trials; and
    
    the length of time required to enroll suitable patient subjects.
    Sources of Liquidity
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Off Balance Sheet Arrangements
  
 Item 7A.
    
    Quantitative and Qualitative Disclosures About Market Risk.
  
 Item 8.
    
    Financial Statements and Supplementary Data.
  
 Item 9.
    
    Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
  
 Item 9A.
    
    Controls and Procedures.
    30




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Managements Annual Report on Internal Control over Financial Reporting
    Internal ControlIntegrated Framework
 Changes in Internal Control over Financial Reporting
  
 Item 9B.
    
    Other Information.
   31




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PART III
 
 Item 10.
    
    Directors, Executive Officers and Corporate Governance.
 Executive Officers and Directors
   Name
    
    Age
    
    PositionExecutive Officers:Mr. J.J. Finkelstein
    
    59
    
    President, Chief Executive Officer and DirectorMr. C. Neil Lyons
    
    54
    
    Chief Financial OfficerMr. David R. Crockford
    
    65
    
    Vice President, Clinical and Regulatory AffairsDirectors:Dr. Allan L. Goldstein
    
    73
    
    Former Chairman, Department of Biochemistry and Molecular Biology, The George Washington University School of Medicine and Health Sciences; Founder, Chairman of the Board and Chief Scientific AdvisorMr. R. Don Elsey
    
    57
    
    Senior Vice President Finance & Administration and Chief Financial Officer of Emergent BioSolutions, Inc.Mr. Joseph C. McNay
    
    77
    
    Chairman, Chief Investment Officer and Managing Principal, Essex Investment Management CompanyMr. Mauro Bove
    
    56
    
    Head of Corporate and Business Development and Director, Sigma-Tau Finanziaria S.p.A and certain of its affiliatesDr. L. Thompson Bowles, M.D.
    
    79
    
    Retired, former thoracic surgeon and former Dean of Medicine and Professor of Surgery, The George Washington University School of Medicine and Health Sciences
 Mr. Finkelstein
 Mr. Lyons
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Mr. Crockford Development of Thymosin ß4 for Treatment of Patients with
Ischemic Heart Disease
 Dr. Goldstein  a b b
 Mr. Elsey
 Mr. McNay
 Mr. Bove
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Dr. Bowles
 Section 16(a) Beneficial Ownership Reporting Compliance
   Corporate Code of Conduct and Ethics
  Audit Committee and Audit Committee Financial Expert
    
 Item 11.
    
    Executive Compensation.
 Summary Compensation Table
    34




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##### Table of Contents



Option
    
    
    All OtherSalary(1)
    
    
    Bonus(2)
    
    
    Awards(3)
    
    
    Compensation(4)
    
    
    TotalName and Principal Position
    
    Year
    
    
    ($)
    
    
    ($)
    
    
    ($)
    
    
    ($)
    
    
    ($)J.J. Finkelstein, President and
    
    
    2010
    
    
    
    299,520
    
    
    
    
    
    
    
    19,396
    
    
    
    18,425
    
    
    
    337,341Chief Executive Officer
    
    
    2009
    
    
    
    244,608
    
    
    
    18,720
    
    
    
    116,198
    
    
    
    13,005
    
    
    
    392,531C. Neil Lyons,
    
    
    2010
    
    
    
    202,537
    
    
    
    2,000
    
    
    
    15,284
    
    
    
    6,886
    
    
    
    226,707Chief Financial Officer
    
    
    2009
    
    
    
    167,093
    
    
    
    11,140
    
    
    
    74,395
    
    
    
    4,999
    
    
    
    257,627David R. Crockford,
    
    
    2010
    
    
    
    210,223
    
    
    
    2,000
    
    
    
    15,284
    
    
    
    10,321
    
    
    
    237,828Vice President, Clinical and Regulatory Affairs
    
    
    2009
    
    
    
    210,223
    
    
    
    5,781
    
    
    
    
    
    
    
    6,818
    
    
    
    222,822
 
 (1)
    
    Reflects base salary before pretax contributions and therefore includes compensation deferred under our 401(k) plan.(2)
    
    Reflects the payment of discretionary bonus.(3)
    
    These amounts reflect the aggregate total grant date fair values (computed in accordance with FASB ASC Topic 718)
of options granted to executives during the respective fiscal years.(4)
    
    Primarily reflects our match of executive compensation deferrals into our 401(k) plan, along with supplemental life
and disability insurance premiums. None of the individual items exceeded $10,000. Employment Agreements; Potential Payments Upon Termination or Change in Control
  J.J. Finkelstein
    35




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##### Table of Contents



C. Neil Lyons
    David R. Crockford
    36




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##### Table of Contents



Outstanding Equity Awards at December 31, 2010
  Number ofShares
    
    
    Number of SharesUnderlying
    
    
    UnderlyingUnexercised
    
    
    Unexercised
    
    
    OptionOptions (#)
    
    
    Options (#)
    
    
    Exercise Price
    
    
    OptionName
    
    Exercisable
    
    
    Unexercisable
    
    
    ($)
    
    
    Expiration Date
    
    
    NoteMr. Finkelstein
    
    
    500,000
    
    
    
    
    
    
    
    0.33
    
    
    
    1/1/2012100,000
    
    
    
    
    
    
    
    3.21
    
    
    
    4/1/201593,750
    
    
    
    31,250
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1
    )62,500
    
    
    
    62,500
    
    
    
    1.15
    
    
    
    4/15/2015
    
    
    
    (1
    )114,748
    
    
    
    
    
    
    
    0.57
    
    
    
    4/10/201931,250
    
    
    
    93,750
    
    
    
    0.76
    
    
    
    10/11/2016
    
    
    
    (1
    )
    
    
    
    125,000
    
    
    
    0.27
    
    
    
    07/14/2017
    
    
    
    (1
    )Mr. Lyons
    
    
    166,667
    
    
    
    33,333
    
    
    
    3.10
    
    
    
    4/7/2015
    
    
    
    (2
    )56,250
    
    
    
    18,750
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1
    )37,500
    
    
    
    37,500
    
    
    
    1.50
    
    
    
    6/15/2015
    
    
    
    (1
    )77,728
    
    
    
    
    
    
    
    0.57
    
    
    
    4/10/201918,750
    
    
    
    56,250
    
    
    
    0.76
    
    
    
    10/11/2016
    
    
    
    (1
    )
    
    
    
    98,500
    
    
    
    0.27
    
    
    
    07/14/2017
    
    
    
    (1
    )Mr. Crockford
    
    
    15,000
    
    
    
    
    
    
    
    1.07
    
    
    
    7/1/2013125,000
    
    
    
    
    
    
    
    0.86
    
    
    
    1/1/2014100,000
    
    
    
    
    
    
    
    3.21
    
    
    
    4/1/201525,000
    
    
    
    
    
    
    
    3.82
    
    
    
    5/25/201537,500
    
    
    
    12,500
    
    
    
    2.15
    
    
    
    1/16/2014
    
    
    
    (1
    )56,250
    
    
    
    18,750
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1
    )37,500
    
    
    
    37,500
    
    
    
    1.15
    
    
    
    4/15/2015
    
    
    
    (1
    )
    
    
    
    98,500
    
    
    
    0.27
    
    
    
    07/14/2017
    
    
    
    (1
    )
 
 (1)
    
    This option vests in equal installments on the first four anniversaries of the grant date. In each case these
options were granted seven years prior to the listed expiration dates.(2)
    
    This option vests in equal installments on the first six anniversaries of the grant date which was April 7, 2005. Post-Employment Compensation
  Director Compensation
      37




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##### Table of Contents



Director Compensation for Fiscal 2010
 Fees Earnedor Paid
    
    
    Option
    
    
    All Otherin Cash
    
    
    Awards
    
    
    Compensation
    
    
    TotalName
    
    ($)
    
    
    ($)(1)
    
    
    ($)
    
    
    ($)Allan Goldstein, Ph.D.
    
    
    
    
    
    
    15,284
    
    
    
    187,460
    (2)
    
    
    202,744R. Don Elsey
    
    
    7,726
    
    
    
    6,403
    
    
    
    
    
    
    
    14,129L. Thompson Bowles M.D., Ph.D.
    
    
    28,017
    
    
    
    3,103
    
    
    
    
    
    
    
    31,120Joseph McNay
    
    
    25,028
    
    
    
    3,103
    
    
    
    
    
    
    
    28,131Mauro Bove
    
    
    17,303
    
    
    
    3,103
    
    
    
    
    
    
    
    20,406Richard Hindin (3)
    
    
    21,836
    
    
    
    
    
    
    
    
    
    
    
    21,836
 
 (1)
    
    These amounts reflect the aggregate total grant date fair
values (computed in accordance with FASB ASC Topic 718)
of options granted to directors during 2010. Options held
by each Board member as of December 31, 2010, are as
follows: Allan Goldstein, Ph.D.
    
    
    795,442R. Don Elsey
    
    
    40,000L. Thompson Bowles M.D., Ph.D.
    
    
    174,843Joseph McNay
    
    
    248,024Mauro Bove
    
    
    247,155
 (2)
    
    In addition to being Chairman of our Board of Directors,
Dr. Goldstein also serves as our Chief Scientific
Advisor. In this capacity, Dr. Goldstein received a base
salary of $187,460 for 2010. Under Dr. Goldsteins
employment agreement, in the event that his employment is
terminated by us without cause, as defined in his
employment agreement, or if he voluntarily terminates his
employment within 12 months following a change in
control, as defined in his employment agreement, then in
each case, subject to Dr. Goldsteins entering into and
not revoking a release of claims in a form acceptable to
us, Dr. Goldstein will be entitled to receive a lump sum
severance payment equal to his annual base salary then in
effect, plus any earned bonus as of the date of
termination, in each case less applicable taxes and
withholdings. Dr. Goldstein is not entitled to receive
any continuing health and welfare benefits as part of our
severance obligation to him. If Dr. Goldsteins
employment had been terminated for any of the reasons
described in this paragraph as of December 31, 2010, he
would have been entitled to receive a lump sum payment of
$187,460, less taxes and withholdings. Dr. Goldstein is
eligible to receive options to purchase common stock
under our equity incentive plans. The decision to grant
any such options and the terms of such options are within
the discretion of our board of directors or the
compensation committee. In addition, if Dr. Goldsteins
employment is terminated without cause, or if there is
a change in control event, in each case as defined in
either the applicable benefit plan or in Dr. Goldsteins
employment agreement, then the unvested portion of Dr.
Goldsteins options would accelerate in full. All vested
options are exercisable for a period of time following
any termination of Dr. Goldsteins employment as may be
set forth in the applicable benefit plan or in any option
agreement between Dr. Goldstein and us.(3)
    
    Mr. Hindins term as a director ended in July 2010.  38




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##### Table of Contents



Item 12.
    
    Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
  Beneficial Ownership(1)Beneficial Owner
    
    Number of Shares
    
    
    Percent of Total5% Stockholders:Entities affiliated with Sigma-Tau Finanziaria, S.p.A.
Via Sudafrica, 20, Rome, Italy 00144
    
    
    33,997,378
    (2)
    
    
    40.5
    %Named Executive Officers and Other Directors:J.J. Finkelstein
    
    
    2,393,386
    (3)
    
    
    3.0
    %Allan L. Goldstein
    
    
    1,958,788
    (4)
    
    
    2.4
    %R. Don Elsey
    
    
    
    
    
    
    *Joseph C. McNay
    
    
    1,548,385
    (5)
    
    
    1.9
    %Mauro Bove
    
    
    208,405
    (6)
    
    
    *L. Thompson Bowles
    
    
    136,093
    (7)
    
    
    *C. Neil Lyons
    
    
    438,978
    (8)
    
    
    *David R. Crockford
    
    
    446,250
    (7)
    
    
    *All directors and executive officers as a group (8 persons)
    
    
    7,130,285
    (9)
    
    
    8.6
    %
 
 *
    
    Less than one percent.(1)
    
    This table is based upon information supplied by officers, directors and principal stockholders. Unless otherwise indicated in
the footnotes to this table and subject to community property laws where applicable, we believes that each of the stockholders
named in this table has sole voting and investment power with respect to the shares indicated as beneficially owned. Applicable
percentages are based on 79,860,282 shares of common stock outstanding on March 15, 2010, adjusted as required by rules
promulgated by the Securities and Exchange Commission (the SEC).(2)
    
    Consists of 984,615 shares of common stock held of record held by Sigma-Tau Finanziaria, S.p.A. (Sigma-Tau); 12,937,111 shares
of common stock held of record and 589,481 shares of common stock issuable upon exercise of warrants held by Defiante
Farmaceutica S.A. (Defiante), a subsidiary of Sigma-Tau, that are exercisable within 60 days of March 15, 2011; 6,348,878
shares of common stock held of record and 1,228,486 shares of common stock issuable upon exercise of warrants held by Taufin
International S.A. (Taufin), an entity wholly owned by Taufin SPA, which is owned directly by Claudio Cavazza, who directly and
indirectly owns 57% of Sigma-Tau, that are exercisable within 60 days of March 15, 2011; and 9,711,407 shares of common stock
held of record and 2,197,400 shares of common stock issuable upon exercise of warrants held by Sinaf S.A. (Sinaf), an indirect
wholly-owned subsidiary of Aptafin S.p.A., which is owned by Paolo Cavazza and members of his family, that are exercisable within
60 days of March 15, 2011. Paolo Cavazza directly and indirectly owns 38% of Sigma-Tau.(3)
    
    Consists of 1,377,638 shares of common stock held of record by Mr. Finkelstein and 51,000 shares of common stock
held of record by Mr. Finkelsteins daughter over which Mr. Finkelstein shares voting and dispositive power. Also
includes 964,748 shares of common stock issuable upon exercise of options exercisable within 60 days of March
15, 2011.(4)
    
    Consists of 1,336,846 shares of common stock held of record by Dr. Goldstein and 621,942 shares of common stock
issuable upon exercise of options exercisable within 60 days of March 15, 2011.(5)
    
    Consists of 1,339,111 shares of common stock held of record by Mr. McNay and 209,274 shares of common stock
issuable upon exercise of options exercisable within 60 days of March 15, 2011.(6)
    
    Consists of shares of common stock issuable upon exercise of options exercisable within 60 days of March 15,
2011. Mr. Bove is an officer of Sigma-Tau, but he has no beneficial ownership over the reported securities as he
has no voting or dispositive power with respect to the securities held by Sigma-Tau and its affiliates described
in Note 2 above.(7)
    
    Consists of shares of common stock issuable upon exercise of options exercisable within 60 days of March 15, 2011.(8)
    
    Consists of 30,000 shares of common stock held of record by Mr. Lyons and 408,978 shares of common stock issuable
upon exercise of options exercisable within 60 days of March 15, 2011.(9)
    
    Consists of 4,134,595 shares of common stock held of record and 2,995,690 shares of common stock issuable upon
exercise of options exercisable within 60 days of March 15, 2011.  39




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##### Table of Contents



Equity Compensation Plan Information
  Number of securitiesremaining available forNumber of securities to
    
    
    
    
    
    
    future issuance underbe issued upon exercise
    
    
    Weighted-average exercise
    
    
    equity compensation plansof outstanding options,
    
    
    price of outstanding options,
    
    
    (excluding securitieswarrants and rights
    
    
    warrants and rights
    
    
    reflected in column (a))Plan Category
    
    (a)
    
    
    (b)
    
    
    (c)Equity
compensation plans
approved by
security holders
    
    
    5,348,863
    
    
    $
    1.37
    
    
    
    4,327,500Equity
compensation plans
not approved by
security holders
    
    
    
    
    
    
    
    
    
    
    Total
    
    
    5,348,863
    
    
    $
    1.37
    
    
    
    4,327,500
 
 Item 13.
    
    Certain Relationships and Related Transactions, and Director Independence.
 Related Party Transactions
      40




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##### Table of Contents



Director Independence
    
 Item 14.
    
    Principal Accounting Fees and Services.
  2010
    
    
    2009Audit fees
    
    $
    77,453
    
    
    $
    76,000Tax fees (1)
    
    
    22,053
    
    
    
    25,000Total Fees
    
    $
    99,506
    
    
    $
    101,000
 (1)
    
    Tax fees include the preparation of our corporate federal and state
income tax returns.    41




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##### Table of Contents



PART IV
 
 Item 15.
    
    Exhibits, Financial Statement Schedules.
 Exhibit No.
    
    Description of Exhibit
    
    Reference*3.1
    
    
    Restated Certificate of Incorporation
    
    Exhibit 3.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.2
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.3
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.4
    
    
    Certificate of Amendment of Restated
Certificate of Incorporation
    
    Exhibit 3.4 to
Registration
Statement on Form
S-8 (File No.
333-168252) (filed
July 21, 2010)3.5
    
    
    Certificate of Designation of Series
A Participating Cumulative Preferred
Stock
    
    Exhibit 3.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.6
    
    
    Amended and Restated Bylaws
    
    Exhibit 3.4 to
Quarterly Report on
Form 10-Q (File No.
001-15070) for the
quarter ended June
30, 2006 (filed
August 14, 2006)3.7
    
    
    Amendment to Amended and Restated
Bylaws
    
    Exhibit 3.6 to
Registration
Statement on Form
S-8 (File No.
333-152250) (filed
July 10, 2008)4.1
    
    
    Specimen Common Stock Certificate
    
    Exhibit 4.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.2
    
    
    Specimen Rights Certificate
    
    Exhibit 4.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.3
    
    
    Rights Agreement, dated April 29,
1994, between the Company and
American Stock Transfer & Trust
Company, as Rights Agent
    
    Exhibit 4.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.4
    
    
    Amendment No. 1 to Rights Agreement,
dated March 4, 2004, between the
Company and American Stock Transfer
& Trust Company, as Rights Agent
    
    Exhibit 4.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)
  42




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*4.5
    
    
    Warrant Agreement, dated May 21,
2010, between the Company and
American Stock Transfer & Trust
Company, as Warrant Agent
    
    Exhibit 4.1 to
Current Report on
Form 8-K (File No.
001-15070) (filed
May 21, 2010)4.6
    
    
    Form of Warrant Certificate
    
    Exhibit 4.6 to
Amendment No. 1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
May 17, 2010)10.1
    ^
    
    Amended and Restated 2000
Stock Option and Incentive
Plan, as amended
    
    Annex A to the
Companys Proxy
Statement on Schedule
14A (File No.
001-15070) (filed May
9, 2008)10.2
    ^
    
    2010 Equity Incentive Plan
    
    Exhibit 10.1 to Current
Report on Form 8-K
(File No. 001-15070)
(filed July 20, 2010)10.3
    
    
    Form of Stock Option Grant
Notice and Stock Option
Agreement under the 2010
Equity Incentive Plan
    
    Exhibit 10.2 to Current
Report on Form 8-K
(File No. 001-15070)
(filed July 20, 2010)10.4
    
    
    Patent License Agreement 
Exclusive, dated January 24,
2001, between the Company and
the U.S. Public Health
Service
    
    Exhibit 10.1 to Annual
Report on Form 10-KSB
for the year ended
December 31, 2000 (File
No. 001-15070) (filed
April 2, 2001)**10.5
    
    
    Thymosin Beta 4 License and
Supply Agreement, dated
January 21, 2004, between the
Company and Defiante
Farmaceutica S.A.
    
    Exhibit 10.10 to
Registration Statement
on Form SB-2 (File No.
333-113417) (filed
March 9, 2004)**10.6
    ^

    
    Second Amended and Restated
Employment Agreement, dated
March 11, 2009, between the
Company and Allan L.
Goldstein, as amended
    
    Exhibit 10.4 to
Amendment No. 1 to
Annual Report on Form
10-K for the year ended
December 31, 2008 (File
No. 001-15070) (filed
April 30, 2009)10.7
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 12, 2009, between the
Company and J.J. Finkelstein,
as amended
    
    Exhibit 10.5 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)10.8
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 31, 2009, between the
Company and C. Neil Lyons, as
amended
    
    Exhibit 10.6 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)10.9
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 31, 2009, between the
Company and David Crockford
    
    Exhibit 10.7 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)10.10
    
    
    Lease, by and between the
Company and The Realty
Associates Fund V, L.P.,
dated December 10, 2009
    
    Exhibit 10.25 to Annual
Report on Form 10-K for
the year ended December
31, 2009 (File No.
001-15070) (filed March
31, 2010)
  43




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.11
    
    
    Stock Purchase Agreement,
dated June 23, 2005
    
    Exhibit 99.2 to Current
Report on Form 8-K
(File No. 001-15070)
(filed June 23, 2005)10.12
    
    
    Form of Warrant to Purchase
Common Stock, dated March 17,
2006
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed March 7,
2006)10.13
    
    
    Registration Rights Agreement,
dated December 15, 2006
    
    Exhibit 10.2 to Current Report
on Form 8-K (File No.
001-15070) (filed December 18,
2006)10.14
    
    
    Form of Warrant to Purchase
Common Stock, dated December
18, 2006
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 18,
2006)10.15
    
    
    Form of Securities Purchase
Agreement, dated February 27,
2008
    
    Exhibit 99.1 to Current Report
on Form 8-K (File No.
001-15070) (filed February 27,
2008)10.16
    
    
    Form of Warrant to Purchase
Common Stock, dated February
29, 2008
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed February 27,
2008)10.17
    
    
    Form of Securities Purchase
Agreement, dated December 10,
2008
    
    Exhibit 99.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 12,
2008)10.18
    
    
    Form of Warrant to Purchase
Common Stock, dated December
10, 2008
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 12,
2008)10.19
    
    
    Form of Warrant to Purchase Common Stock
dated April 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
April 16, 2009)10.20
    
    
    Securities Purchase Agreement, dated
April 13, 2009
    
    Exhibit 10.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
April 16, 2009)10.21
    
    
    Form of Common Stock Purchase Warrant,
dated October 5, 2009
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
September 30, 2009)10.22
    
    
    Securities Purchase Agreement, dated
September 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
September 30, 2009)10.23
    
    
    Form of Warrant, dated October 15, 2009
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
October 5, 2009)
  44




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.24
    
    
    Securities Purchase Agreement, dated
September 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
October 5, 2009)10.25
    
    
    Representatives Warrant to Purchase
Common Stock, dated May 21, 2010
    
    Exhibit 4.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed May
21, 2010)10.26
    
    
    Purchase Agreement, dated January 4, 2011
    
    Exhibit 10.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.27
    
    
    Registration Rights Agreement, dated
January 4, 2011
    
    Exhibit 10.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.28
    
    
    Securities Purchase Agreement, dated
January 5, 2011
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.29
    
    
    Warrant to Purchase Common Stock, dated
January 7, 2011, issued to Lincoln Park
Capital
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.30
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Defiante Farmaceutica S.A.
    
    Exhibit 10.4 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.31
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Taufin International S.A.
    
    Exhibit 10.5 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.32
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Sinaf S.A.
    
    Exhibit 10.6 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.33
    
    
    Form of Warrant to Purchase Common
Stock, dated January 7, 2011, issued to
the Sigma-Tau Purchasers
    
    Exhibit 4.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.34
    
    
    Omnibus Warrant Amendment Agreement,
dated January 5, 2011
    
    Exhibit 4.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)
  45




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*23.1
    
    
    Consent of Reznick Group, P.C.
    
    Filed herewith24.1
    
    
    Powers of Attorney
    
    Included on signature page31.1
    
    
    Certification of Principal Executive
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities
Exchange Act of 1934
    
    Filed herewith31.2
    
    
    Certification of Principal Financial
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities
Exchange Act of 1934
    
    Filed herewith32.1
    
    
    Certification of Principal Executive
Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
    
    Filed herewith***32.2
    
    
    Certification of Principal Financial
Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
    
    Filed herewith***
 
 *
    
    Except where noted, the exhibits referred to in this
column have heretofore been filed with the Securities
and Exchange Commission as exhibits to the documents
indicated and are hereby incorporated by reference
thereto. The Registration Statements referred to are
Registration Statements of the Company.**
    
    The registrant has been granted confidential treatment
with respect to certain portions of this exhibit
(indicated by asterisks), which have been filed
separately with the Securities and Exchange Commission.***
    
    These certifications are being furnished solely to
accompany this annual report pursuant to 18 U.S.C.
Section 1350, and are not being filed for purposes of
Section 18 of the Securities Exchange Act of 1934 and
are not to be incorporated by reference into any filing
of the registrant, whether made before or after the
date hereof, regardless of any general incorporation
language in such filing.^
    
    Compensatory plan, contract or arrangement.  46




---



##### Table of Contents



SIGNATURES
  RegeneRx Biopharmaceuticals, Inc.
(Registrant)Date: March 31, 2011
    By:
    /s/ J.J. FinkelsteinJ.J. FinkelsteinPresident and Chief Executive OfficerBy:
    /s/ C. Neil LyonsC. Neil LyonsChief Financial Officer  47




---



##### Table of Contents



POWER OF ATTORNEY
   Name
    
    Title
    
    Date/s/ Allan L. Goldstein
    
    Chairman of the Board,
    
    March 31, 2011Allan L. Goldstein
    
    Chief Scientific
Advisor, and Director/s/ J.J. Finkelstein
    
    President, Chief Executive Officer, and
Director
    
    March 31, 2011J.J. Finkelstein
    
    (Principal
Executive Officer)/s/ C. Neil Lyons
    
    Chief Financial Officer and Treasurer
    
    March 31, 2011C. Neil Lyons
    
    (Principal Financial
Officer and 
Principal
Accounting Officer)/s/ R. Don Elsey
    
    Director
    
    March 31, 2011R. Don Elsey/s/ Joseph C. McNay
    
    Director
    
    March 31, 2011Joseph C. McNay/s/ Mauro Bove
    
    Director
    
    March 31, 2011Mauro Bove/s/ L. Thompson Bowles
    
    Director
    
    March 31, 2011L. Thompson Bowles
  48




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Index to Financial Statements
 PageReport of Independent Registered Public Accounting Firm
    
    
    50Balance Sheets
    
    
    51Statements of Operations
    
    
    52Statements of Changes in Stockholders Equity
    
    
    53Statements of Cash Flows
    
    
    54Notes to Financial Statements
    
    
    55
  49




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##### Table of Contents



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
      
  50




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Balance Sheets
 December 31,
    
    
    December 31,2010
    
    
    2009ASSETSCurrent assetsCash and cash equivalents
    
    $
    3,790,352
    
    
    $
    4,355,768Grant receivable
    
    
    10,703
    
    
    
    Prepaid expenses and other current assets
    
    
    384,806
    
    
    
    196,546Total current assets
    
    
    4,185,861
    
    
    
    4,552,314Property and equipment, net of accumulated
depreciation of $107,907 and $98,171
    
    
    24,940
    
    
    
    8,492Other assets
    
    
    17,255
    
    
    
    22,948Total assets
    
    $
    4,228,056
    
    
    $
    4,583,754LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilitiesAccounts payable
    
    $
    185,643
    
    
    $
    140,206Accrued expenses
    
    
    430,996
    
    
    
    740,198Total current liabilities
    
    
    616,639
    
    
    
    880,404Commitments
    
    
    
    
    
    
    Stockholders equityPreferred stock, $.001 par value per share,
1,000,000 shares authorized; no shares issued
    
    
    
    
    
    
    Common stock, par value $.001 per share,
200,000,000 shares authorized, 73,531,578
shares issued and outstanding as of December
31, 2010; 100,000,000 shares authorized,
60,406,828 shares issued and outstanding as of
December 31, 2009
    
    
    73,532
    
    
    
    60,407Additional paid-in capital
    
    
    93,063,201
    
    
    
    88,144,347Accumulated deficit
    
    
    (89,525,316
    )
    
    
    (84,501,404
    )Total stockholders equity
    
    
    3,611,417
    
    
    
    3,703,350Total liabilities and stockholders equity
    
    $
    4,228,056
    
    
    $
    4,583,754
   51




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Operations
 Years ended December 31,2010
    
    
    2009Sponsored research revenue
    
    $
    849,539
    
    
    $
    Operating expensesResearch and development
    
    
    2,707,909
    
    
    
    3,724,514General and administrative
    
    
    3,173,729
    
    
    
    2,781,790Total operating expenses
    
    
    5,881,638
    
    
    
    6,506,304Loss from operations
    
    
    (5,032,099
    )
    
    
    (6,506,304
    )Interest income
    
    
    8,187
    
    
    
    12,444Net loss
    
    $
    (5,023,912
    )
    
    $
    (6,493,860
    )Basic and diluted net loss per common share
    
    $
    (0.07
    )
    
    $
    (0.12
    )Weighted average number of common shares outstanding
    
    
    68,444,011
    
    
    
    55,680,525
   52




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Changes in Stockholders Equity  Years ended December 31, 2010 and 2009
 Accumulatedother
    
    
    TotalCommon stock
    
    
    Additional
    
    
    Accumulated
    
    
    comprehensive
    
    
    stockholdersShares
    
    
    Amount
    
    
    paid-in capital
    
    
    deficit
    
    
    income/(loss)
    
    
    equityBalance, December 31, 2008
    
    
    53,622,491
    
    
    $
    53,623
    
    
    $
    82,550,585
    
    
    $
    (78,007,544
    )
    
    $
    
    
    
    $
    4,596,664Issuance of common stock, net
of offering costs of $447,933
    
    
    6,784,337
    
    
    
    6,784
    
    
    
    4,845,282
    
    
    
    
    
    
    
    
    
    
    
    4,852,066Share-based compensation expense
    
    
    
    
    
    
    
    
    
    
    748,480
    
    
    
    
    
    
    
    
    
    
    
    748,480Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (6,493,860
    )
    
    
    
    
    
    
    (6,493,860
    )Balance, December 31, 2009
    
    
    60,406,828
    
    
    
    60,407
    
    
    
    88,144,347
    
    
    
    (84,501,404
    )
    
    $
    
    
    
    $
    3,703,350Issuance of common stock, net
of offering costs of $923,524
    
    
    13,124,750
    
    
    
    13,125
    
    
    
    4,444,499
    
    
    
    
    
    
    
    
    
    
    
    4,457,624Share-based compensation expense
    
    
    
    
    
    
    
    
    
    
    474,355
    
    
    
    
    
    
    
    
    
    
    
    474,355Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (5,023,912
    )
    
    
    
    
    
    
    (5,023,912
    )Balance, December 31, 2010
    
    
    73,531,578
    
    
    $
    73,532
    
    
    $
    93,063,201
    
    
    $
    (89,525,316
    )
    
    $
    
    
    
    $
    3,611,417
   53




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Cash Flows
 Years ended December 31,2010
    
    
    2009Operating activities:Net loss
    
    $
    (5,023,912
    )
    
    $
    (6,493,860
    )Adjustments to reconcile net loss to net cash used in
operating activities:Depreciation and amortization
    
    
    9,736
    
    
    
    16,547Non-cash share-based compensation
    
    
    474,355
    
    
    
    748,480Gain on settlement of accrued expenses
    
    
    (141,016
    )
    
    
    (100,000
    )Changes in operating assets and liabilities:Grant receivable
    
    
    (10,703
    )
    
    
    Prepaid expenses and other current assets
    
    
    (188,260
    )
    
    
    39,931Other assets
    
    
    5,693
    
    
    
    (17,255
    )Accounts payable
    
    
    45,437
    
    
    
    69,652Accrued expenses
    
    
    (168,186
    )
    
    
    (415,160
    )Net cash used in operating activities
    
    
    (4,996,856
    )
    
    
    (6,151,665
    )Investing activities:Purchase of property and equipment
    
    
    (26,184
    )
    
    
    Net cash used in investing activities
    
    
    (26,184
    )
    
    
    Financing activities:Net proceeds from issuance of common stock
    
    
    4,457,624
    
    
    
    4,852,066Net cash provided by financing activities
    
    
    4,457,624
    
    
    
    4,852,066Net decrease in cash and cash equivalents
    
    
    (565,416
    )
    
    
    (1,299,599
    )Cash and cash equivalents at beginning of year
    
    
    4,355,768
    
    
    
    5,655,367Cash and cash equivalents at end of year
    
    $
    3,790,352
    
    
    $
    4,355,768
   54




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##### Table of Contents



Organization and Nature of Operations. b
 Management Plans to Address Operating Conditions.
 b
   b
   55




---



##### Table of Contents



Use of Estimates.
 Cash and Cash Equivalents.
 Concentration of Credit Risk.
 Property and Equipment.
 Impairment of Long-lived Assets.
 Sponsored Research Revenues.
 Research and Development b b b
 Cost of Preclinical Studies and Clinical Trials.
 Patent Costs.
 Income Taxes.
  56




---



##### Table of Contents



Net Loss Per Common Share.
 Share-Based Compensation.
 Fair Value of Financial Instruments.
 Recent Accounting Pronouncements.
     
    
    Level 1  Quoted prices in active markets for identical assets and liabilities.
    
    Level 2  Observable inputs other than quoted prices in active markets for identical assets and liabilities.
    
    Level 3  Unobservable inputs.
   57




---



##### Table of Contents



b b
   b b
    December 31,2010
    
    
    2009Prepaid research and development
    
    $
    245,498
    
    
    $
    Legal retainer
    
    
    100,000
    
    
    
    100,000Prepaid compensation
    
    
    24,960
    
    
    
    24,960Prepaid insurance
    
    
    8,596
    
    
    
    55,063Other
    
    
    5,753
    
    
    
    16,523$
    384,806
    
    
    $
    196,546
  December 31,2010
    
    
    2009Accrued clinical research
    
    $
    208,515
    
    
    $
    496,997Accrued professional fees
    
    
    128,847
    
    
    
    122,590Accrued vacation
    
    
    48,096
    
    
    
    35,300Other
    
    
    43,538
    
    
    
    26,316Accrued compensation
    
    
    2,000
    
    
    
    28,995Accrued license fees
    
    
    
    
    
    
    30,000$
    430,996
    
    
    $
    740,198
  58




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##### Table of Contents



Shareholders Rights Plan.
 Registration Rights Agreements.
  Common Stock.
       Share-Based Compensation.
  59




---



##### Table of Contents



Stock Option and Incentive Plans.
   December 31,2010
    
    
    2009Research and development
    
    $
    206,427
    
    
    $
    369,814General and administrative
    
    
    267,928
    
    
    
    378,666$
    474,355
    
    
    $
    748,480
  Options outstandingWeightedShares
    
    
    
    
    
    
    
    
    
    
    averageavailable for
    
    
    Number of
    
    
    Exercise price
    
    
    exercisegrant
    
    
    shares
    
    
    range
    
    
    priceDecember 31, 2008
    
    
    2,347,500
    
    
    
    4,117,500
    
    
    $
    0.27  3.82
    
    
    $
    1.72Grants
    
    
    (1,192,939
    )
    
    
    1,192,939
    
    
    
    0.57  0.76
    
    
    
    0.64Exercises
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    396,327
    
    
    
    (396,327
    )
    
    
    0.57  2.59
    
    
    
    0.82December 31, 2009
    
    
    1,550,888
    
    
    
    4,914,112
    
    
    
    0.28  3.82
    
    
    
    1.53Grants
    
    
    (672,500
    )
    
    
    672,500
    
    
    
    0.27  0.28
    
    
    
    0.27Exercises
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Newly authorized
    
    
    5,000,000
    
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    (1,550,888
    )
    
    
    (237,749
    )
    
    
    0.46  3.21
    
    
    
    1.52December 31, 2010
    
    
    4,327,500
    
    
    
    5,348,863
    
    
    $
    0.27  $3.82
    
    
    $
    1.37Vested and expected to
vest at December 31, 2010
    
    
    
    
    
    
    5,075,220Exercisable at
December 31, 2010
    
    
    
    
    
    
    3,716,153
  60




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##### Table of Contents



Outstanding options
    
    
    Exercisable optionsWeighted-
    
    
    
    
    
    
    
    
    
    
    Weighted-average
    
    
    Weighted-
    
    
    
    
    
    
    average
    
    
    Weighted-Number of
    
    
    remaining
    
    
    average
    
    
    Number of
    
    
    remaining
    
    
    averageshares
    
    
    contractual
    
    
    exercise
    
    
    shares
    
    
    contractual
    
    
    exerciseRange of exercise prices
    
    outstanding
    
    
    life (in years)
    
    
    price
    
    
    exercisable
    
    
    life (in years)
    
    
    price$0.27  $0.86
    
    
    2,691,363
    
    
    
    4.3
    
    
    $
    0.44
    
    
    
    1,709,488
    
    
    
    3.2
    
    
    $
    0.45$1.07  $1.93
    
    
    812,500
    
    
    
    4.0
    
    
    $
    1.32
    
    
    
    558,750
    
    
    
    3.8
    
    
    $
    1.36$2.02  $2.68
    
    
    845,000
    
    
    
    3.3
    
    
    $
    2.26
    
    
    
    481,250
    
    
    
    3.4
    
    
    $
    2.30$3.00  $3.82
    
    
    1,000,000
    
    
    
    4.4
    
    
    $
    3.19
    
    
    
    966,665
    
    
    
    4.4
    
    
    $
    3.195,348,863
    
    
    
    4.1
    
    
    $
    1.37
    
    
    
    3,716,153
    
    
    
    3.6
    
    
    $
    1.54Intrinsic value
of in-the-money
options, using the
December 31, 2010
closing price of $0.22
    
    $
    
    
    
    
    
    
    
    
    
    
    
    $
    
 Determining the Fair Value of Options.
 2010
    
    2009Dividend yield
    
    0.0%
    
    0.0%Risk free rate of return
    
    1.47  1.76%
    
    1.9  2.3%Expected life in years
    
    4.75
    
    4.75  5.38Volatility
    
    70%
    
    71  72%Forfeitures
    
    2.61%
    
    2.61%
   Warrants to Purchase Common Stock
  Warrants outstandingWeightedaverageNumber of
    
    
    Exercise price
    
    
    exerciseshares
    
    
    range
    
    
    priceDecember 31, 2008
    
    
    5,249,091
    
    
    $
    1.60  $4.06
    
    
    $
    2.80Grants
    
    
    3,129,011
    
    
    
    0.91  1.12
    
    
    
    1.10Exercises
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    (444,250
    )
    
    
    4.06
    
    
    
    4.06December 31, 2009
    
    
    7,933,852
    
    
    
    0.91  4.06
    
    
    
    2.01Grants
    
    
    6,054,900
    
    
    
    0.45  0.56
    
    
    
    0.55Exercises
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    
    
    
    
    
    
    
    
    December 31, 2010
    
    
    13,988,752
    
    
    $
    0.45  $4.06
    
    
    $
    1.38
  61




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##### Table of Contents



December 31,2010
    
    
    2009Deferred tax assets:Net operating loss carryforwards
    
    $
    15,890,000
    
    
    $
    16,988,000Research and development tax credit carryforward
    
    
    1,836,000
    
    
    
    1,710,000Charitable contribution carryforward
    
    
    37.000
    
    
    
    37,000Accrued vacation
    
    
    17,000
    
    
    
    8,000Accrued expenses
    
    
    83.000
    
    
    
    163,000Amortization
    
    
    4,000
    
    
    
    5,000Depreciation
    
    
    
    
    
    
    1,000Non-cash share based compensation
    
    
    980,000
    
    
    
    975,00018,847,000
    
    
    
    19,887,000Less  valuation allowance
    
    
    (18,847,000
    )
    
    
    (19,887,000
    )Net deferred tax asset
    
    $
    
    
    
    $
    
     December 31,2010
    
    
    2009Tax benefit at statutory rate
    
    $
    (1,700,000
    )
    
    $
    (2,213,000
    )State taxes
    
    
    (274,000
    )
    
    
    (354,000
    )Permanent M-1s
    
    
    259,000
    
    
    
    339,000Limited/expired net operating loss carryforwards
    
    
    2,881,000
    
    
    
    3,546,000Limited/expired research and development tax credit carryforward
    
    
    59,000
    
    
    
    120,000Research and development tax credit carryforward
    
    
    (185,000
    )
    
    
    (202,000
    )Change in valuation allowance
    
    
    (1,040,000
    )
    
    
    (1,236,000
    )$
    
    
    
    $
    
    62




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##### Table of Contents



Lease
 Employment Continuity Agreements.
   Purchase Agreements with Lincoln Park Capital Fund, LLC
       63




---



##### Table of Contents




 
  Purchase Agreements with Affiliates of Sigma-Tau Group
   Warrant Amendment Agreement with Affiliates of Sigma-Tau Group
   64




---



##### Table of Contents



EXHIBIT INDEX
 Exhibit No.
    
    Description of Exhibit
    
    Reference*3.1
    
    
    Restated Certificate of Incorporation
    
    Exhibit 3.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.2
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.3
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.4
    
    
    Certificate of Amendment of Restated
Certificate of Incorporation
    
    Exhibit 3.4 to
Registration
Statement on Form
S-8 (File No.
333-168252) (filed
July 21, 2010)3.5
    
    
    Certificate of Designation of Series
A Participating Cumulative Preferred
Stock
    
    Exhibit 3.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.6
    
    
    Amended and Restated Bylaws
    
    Exhibit 3.4 to
Quarterly Report on
Form 10-Q (File No.
001-15070) for the
quarter ended June
30, 2006 (filed
August 14, 2006)3.7
    
    
    Amendment to Amended and Restated
Bylaws
    
    Exhibit 3.6 to
Registration
Statement on Form
S-8 (File No.
333-152250) (filed
July 10, 2008)4.1
    
    
    Specimen Common Stock Certificate
    
    Exhibit 4.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.2
    
    
    Specimen Rights Certificate
    
    Exhibit 4.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.3
    
    
    Rights Agreement, dated April 29,
1994, between the Company and
American Stock Transfer & Trust
Company, as Rights Agent
    
    Exhibit 4.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)
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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*4.4
    
    
    Amendment No. 1 to Rights Agreement,
dated March 4, 2004, between the
Company and American Stock Transfer
& Trust Company, as Rights Agent
    
    Exhibit 4.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.5
    
    
    Warrant Agreement, dated May 21,
2010, between the Company and
American Stock Transfer & Trust
Company, as Warrant Agent
    
    Exhibit 4.1 to
Current Report on
Form 8-K (File No.
001-15070) (filed
May 21, 2010)4.6
    
    
    Form of Warrant Certificate
    
    Exhibit 4.6 to
Amendment No. 1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
May 17, 2010)10.1
    ^
    
    Amended and Restated 2000
Stock Option and Incentive
Plan, as amended
    
    Annex A to the
Companys Proxy
Statement on Schedule
14A (File No.
001-15070) (filed May
9, 2008)10.2
    ^
    
    2010 Equity Incentive Plan
    
    Exhibit 10.1 to Current
Report on Form 8-K
(File No. 001-15070)
(filed July 20, 2010)10.3
    
    
    Form of Stock Option Grant
Notice and Stock Option
Agreement under the 2010
Equity Incentive Plan
    
    Exhibit 10.2 to Current
Report on Form 8-K
(File No. 001-15070)
(filed July 20, 2010)10.4
    
    
    Patent License Agreement 
Exclusive, dated January 24,
2001, between the Company and
the U.S. Public Health
Service
    
    Exhibit 10.1 to Annual
Report on Form 10-KSB
for the year ended
December 31, 2000 (File
No. 001-15070) (filed
April 2, 2001)**10.5
    
    
    Thymosin Beta 4 License and
Supply Agreement, dated
January 21, 2004, between the
Company and Defiante
Farmaceutica S.A.
    
    Exhibit 10.10 to
Registration Statement
on Form SB-2 (File No.
333-113417) (filed
March 9, 2004)**10.6
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 11, 2009, between the
Company and Allan L.
Goldstein, as amended
    
    Exhibit 10.4 to
Amendment No. 1 to
Annual Report on Form
10-K for the year ended
December 31, 2008 (File
No. 001-15070) (filed
April 30, 2009)10.7
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 12, 2009, between the
Company and J.J. Finkelstein,
as amended
    
    Exhibit 10.5 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)10.8
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 31, 2009, between the
Company and C. Neil Lyons, as
amended
    
    Exhibit 10.6 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)10.9
    ^
    
    Second Amended and Restated
Employment Agreement, dated
March 31, 2009, between the
Company and David Crockford
    
    Exhibit 10.7 to Annual
Report on Form 10-K for
the year ended December
31, 2008 (File No.
001-15070) (filed April
15, 2009)
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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    

    Reference*10.10
    
    
    Lease, by and between the
Company and The Realty
Associates Fund V, L.P.,
dated December 10, 2009
    
    Exhibit 10.25 to Annual
Report on Form 10-K for
the year ended December
31, 2009 (File No.
001-15070) (filed March
31, 2010)10.11
    
    
    Stock Purchase Agreement,
dated June 23, 2005
    
    Exhibit 99.2 to Current
Report on Form 8-K
(File No. 001-15070)
(filed June 23, 2005)10.12
    
    
    Form of Warrant to Purchase
Common Stock, dated March 17,
2006
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed March 7,
2006)10.13
    
    
    Registration Rights Agreement,
dated December 15, 2006
    
    Exhibit 10.2 to Current Report
on Form 8-K (File No.
001-15070) (filed December 18,
2006)10.14
    
    
    Form of Warrant to Purchase
Common Stock, dated December
18, 2006
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 18,
2006)10.15
    
    
    Form of Securities Purchase
Agreement, dated February 27,
2008
    
    Exhibit 99.1 to Current Report
on Form 8-K (File No.
001-15070) (filed February 27,
2008)10.16
    
    
    Form of Warrant to Purchase
Common Stock, dated February
29, 2008
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed February 27,
2008)10.17
    
    
    Form of Securities Purchase
Agreement, dated December 10,
2008
    
    Exhibit 99.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 12,
2008)10.18
    
    
    Form of Warrant to Purchase
Common Stock, dated December
10, 2008
    
    Exhibit 4.1 to Current Report
on Form 8-K (File No.
001-15070) (filed December 12,
2008)10.19
    
    
    Form of Warrant to Purchase Common Stock
dated April 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
April 16, 2009)10.20
    
    
    Securities Purchase Agreement, dated
April 13, 2009
    
    Exhibit 10.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
April 16, 2009)10.21
    
    
    Form of Common Stock Purchase Warrant,
dated October 5, 2009
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
September 30, 2009)10.22
    
    
    Securities Purchase Agreement, dated
September 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
September 30, 2009)
  67




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.23
    
    
    Form of Warrant, dated October 15, 2009
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
October 5, 2009)10.24
    
    
    Securities Purchase Agreement, dated
September 30, 2009
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
October 5, 2009)10.25
    
    
    Representatives Warrant to Purchase
Common Stock, dated May 21, 2010
    
    Exhibit 4.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed May
21, 2010)10.26
    
    
    Purchase Agreement, dated January 4, 2011
    
    Exhibit 10.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.27
    
    
    Registration Rights Agreement, dated
January 4, 2011
    
    Exhibit 10.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.28
    
    
    Securities Purchase Agreement, dated
January 5, 2011
    
    Exhibit 10.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.29
    
    
    Warrant to Purchase Common Stock, dated
January 7, 2011, issued to Lincoln Park
Capital
    
    Exhibit 4.1 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.30
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Defiante Farmaceutica S.A.
    
    Exhibit 10.4 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.31
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Taufin International S.A.
    
    Exhibit 10.5 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.32
    
    
    Securities Purchase Agreement, dated
January 5, 2011, by and between the
Company and Sinaf S.A.
    
    Exhibit 10.6 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.33
    
    
    Form of Warrant to Purchase Common
Stock, dated January 7, 2011, issued to
the Sigma-Tau Purchasers
    
    Exhibit 4.2 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)10.34
    
    
    Omnibus Warrant Amendment Agreement,
dated January 5, 2011
    
    Exhibit 4.3 to Current
Report on Form 8-K (File
No. 001-15070) (filed
January 7, 2011)
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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*23.1
    
    
    Consent of Reznick Group, P.C.
    
    Filed herewith24.1
    
    
    Powers of Attorney
    
    Included on signature page31.1
    
    
    Certification of Principal Executive
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities
Exchange Act of 1934
    
    Filed herewith31.2
    
    
    Certification of Principal Financial
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the Securities
Exchange Act of 1934
    
    Filed herewith32.1
    
    
    Certification of Principal Executive
Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
    
    Filed herewith***32.2
    
    
    Certification of Principal Financial
Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
    
    Filed herewith***
 
 *
    
    Except where noted, the exhibits referred to in this
column have heretofore been filed with the Securities
and Exchange Commission as exhibits to the documents
indicated and are hereby incorporated by reference
thereto. The Registration Statements referred to are
Registration Statements of the Company.**
    
    The registrant has been granted confidential treatment
with respect to certain portions of this exhibit
(indicated by asterisks), which have been filed
separately with the Securities and Exchange Commission.***
    
    These certifications are being furnished solely to
accompany this annual report pursuant to 18 U.S.C.
Section 1350, and are not being filed for purposes of
Section 18 of the Securities Exchange Act of 1934 and
are not to be incorporated by reference into any filing
of the registrant, whether made before or after the
date hereof, regardless of any general incorporation
language in such filing.^
    
    Compensatory plan, contract or arrangement.  69