As filed with the Securities and Exchange Commission on February 11, 2013
Registration No. 333-                 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________________
 
Form S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
____________________
 
ADMA BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
____________________

Delaware
8731
56-2590442
(State or other jurisdiction of
incorporation or organization)
(Primary standard industrial
classification code number)
(I.R.S. employer
identification number)

65 Commerce Way
Hackensack, New Jersey 07601
(201) 478-5552
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
____________________
 
Adam S. Grossman
Chief Executive Officer
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, New Jersey 07601
(201) 478-5552
(Name, address, including zip code, and telephone number,
 including area code, of agent for service)
____________________
 
Copies to:
Jeffrey A. Baumel, Esq.
SNR Denton US LLP
1221 Avenue of the Americas
New York, New York 10020-1089
Tel. No.: 212-768-6700
Fax No.: 212-768-6800
Michael D. Maline, Esq.
Thomas S. Levato, Esq.
Goodwin Procter LLP
The New York Times Building
620 Eighth Avenue
New York, New York 10018-1405
Tel. No.: 212-813-8800
Fax No.: 212-355-3333
____________________
 
Approximate date of commencement of proposed sale to the public :  As soon as practicable after the effective date of this registration statement. o
 
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box. o
 
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
 
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
 
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
 
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):
____________________
 
Large Accelerated Filer
¨
 
Accelerated filer
¨
         
Non-accelerated filer
¨
(Do not check if a smaller reporting company)
Smaller reporting company
x

CALCULATION OF REGISTRATION FEE

Title of Each Class of
Securities Being Registered
 
Proposed Maximum
Aggregate Offering Price (1)
 
Amount of
Registration Fee (2)
Common Stock, $0.0001 par value
  
$
 34,500,000
  
$
  4,705.80
             

(1)
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act.
 
(2)
Calculated pursuant to Rule 457(o) under the Securities Act based on an estimate of the proposed maximum offering price.
 
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
 
 
 

 
 
The information in this prospectus is not complete and may be changed.  These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective.  This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.
 
Subject to Completion, Dated  February 11, 2013
 
Shares
 
Common Stock
$           per share

ADMA Biologics, Inc. is offering             shares of common stock.
 
There is not currently, and there has never been, any public market for our common stock.  Our common stock is not currently eligible for trading on any national securities exchange or any over-the-counter markets, including the OTC Bulletin Board.  In connection with this offering, we have applied to have our common stock quoted on the OTC Bulletin Board under the symbol "                ".  We cannot assure you that our common stock will continue to be quoted on the OTC Bulletin Board after this offering.
 
We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company.”
 
Investing in our common stock involves risks.  See “Risk Factors” beginning on page 8.
 
   
Per Share
   
Total
 
Public offering price
  $       $    
                 
Underwriting discount and commission (1)
  $       $    
                 
Proceeds to us, before expenses
  $       $    

(1)
In addition, we have agreed to reimburse the underwriters for certain out-of-pocket expenses.  See the section captioned “Underwriting” in this prospectus for additional information.
 
We have granted an over-allotment option to the underwriters.  Under this option, the underwriters may elect to purchase a maximum of          additional shares from us within 30 days following the date of this prospectus to cover over-allotments.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete.  Any representation to the contrary is a criminal offense.
 
The shares will be ready for delivery on or about                     , 2013.
 
 
Joint Book-Running Managers
 
 
Oppenheimer & Co.
 
BMO Capital Markets
     
  Co-Manager  
     
    Ladenburg Thalmann & Co. Inc.  

The date of this prospectus is                          , 2013
 
 
 

 
 
Table of Contents
 
1
   
8
   
26
   
27
   
28
   
29
   
30
   
31
   
33
   
44
   
57
   
69
   
72
   
79
   
82
   
86
   
87
   
88
   
F-1
 
You should rely only on the information contained in this prospectus. We have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus we have prepared. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.
 
Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction.
 
We obtained statistical data and certain other industry forecasts used throughout this prospectus from market research, publicly available information and industry publications. Industry publications generally state that they obtain their information from sources that they believe to be reliable. While we believe that the statistical and industry data and forecasts and market research used herein are reliable, we have not independently verified such data. We have not sought the consent of the sources to refer to their reports in this prospectus.
 
 
Prospectus Summary
 
This summary highlights information contained in other parts of this prospectus.  Because it is a summary, it does not contain all of the information that you should consider before investing in our securities.  You should read the entire prospectus carefully.
 
As used in this prospectus, unless the context otherwise requires, “ADMA,” “ADMA Biologics,” the “Company,” “we,” “us” and “our” refer to ADMA Biologics, Inc., a Delaware corporation, as well as its subsidiary, ADMA Plasma Biologics, Inc., a Delaware corporation, taken as a whole, and also refer to the operations of ADMA Plasma Biologics, Inc. prior to the merger on February 13, 2012, as discussed in this prospectus, which resulted in ADMA Plasma Biologics, Inc. becoming our wholly-owned subsidiary.  In each case, references to ADMA Plasma Biologics, Inc. also include its subsidiary ADMA BioCenters Georgia Inc., or ADMA BioCenters, a Delaware corporation.
 
The Company
 
Overview
 
ADMA Biologics is a specialty immune globulin company that develops, manufactures and intends to market plasma-based biologics for the treatment and prevention of certain infectious diseases.  Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-suppressed for medical reasons.  Our lead product candidate, RI-002, for which we have commenced a pivotal Phase III clinical trial, is intended for the treatment of primary immune deficiency disease, or PIDD.  RI-002 is an injectable immune globulin derived from human plasma enriched with high levels of naturally occurring polyclonal antibodies including those targeted to respiratory syncytial virus, or RSV.  RSV is a common virus that ordinarily leads to mild, cold-like symptoms in healthy adults and children.  In high-risk groups, such as the immune-compromised, RSV can lead to a more serious infection and may even cause death.  Our proprietary microneutralization assay allows us to effectively identify and isolate donor plasma with high-titer RSV antibodies, to standardize RI-002’s potency and thereby potentially garner a premium price.
 
PIDD, a genetic disorder that causes a deficient or absent immune system, is caused by hereditary or genetic defects and can affect anyone regardless of age or gender.  PIDD patients are more vulnerable to infections and more likely to suffer complications from these infections.  Intravenous immune globulin, or IGIV, is a plasma derived product that is used to prevent serious infections in patients with PIDD.  It is comprised of polyclonal antibodies, which are proteins produced by B-cells that are used by the body’s immune system to neutralize foreign objects such as bacteria and viruses.  RI-002, a specialty IGIV with standardized levels of high-titer RSV antibodies, is intended to prevent infections in PIDD patients.  The polyclonal antibodies which are present in RI-002 are expected to prevent infections in immune-compromised patients. It is estimated that there are about 250,000 diagnosed PIDD patients in the United States approximately half of whom are treated with IGIV regularly.  In the United States, sales of immune globulin products for all its uses were reported to be approximately $3.5 billion in 2011.  Since the introduction of IGIV therapy, the incidence of infections in IGIV-treated patients has dropped significantly.  
 
We commenced our pivotal Phase III clinical trial of RI-002 for the treatment of patients with PIDD in 2013.  The trial is a single arm, open label study in which patients will be treated approximately once per month for a period of 12 months of treatment plus 90 days for follow up. We intend to treat an aggregate of between 60 and 70 patients in approximately 12 treatment centers in the United States.  The pivotal Phase III primary endpoint follows the published FDA industry guidance, which provides for a reduction in the incidence of serious infections to less than one per year in those receiving IGIV.  The secondary endpoint is safety and includes other data collection points including antibody titers for certain agents, including RSV antibody levels at various time points after infusion.  Following the FDA’s guidance for our protocol should provide that a successful single Phase III trial and Biological License Application, or BLA, submission should lead to FDA approval.  RI-001 was the subject of a Phase II randomized, double-blind, placebo-controlled human clinical trial in RSV-infected, immune-compromised patients. In that trial, RI-001 treated patients demonstrated a statistically significant rise in anti-RSV titers compared to patients receiving placebo.  RI-002 is an improved formulation of our prior product candidate RI-001, which successfully completed a Phase II trial.  RI-002 is manufactured using the same FDA-approved contract manufacturing facility as its predecessor.  RI-002 has demonstrated improved production yields, an improved stability profile and comparable anti-RSV antibody titer potency relative to the prior formulation.
 
 
We have established, qualified and validated a proprietary microneutralization assay for plasma collection and donor screening as well as for determining the appropriate anti-RSV antibody potency for the manufacture of RI-002.  Our assay provides for measurement of RSV antibody titer levels of RI-002 that are consistent and reproducible, which we believe is a competitive advantage and a barrier to the entry of competitive products.  Our microneutralization assay could serve as a platform for identifying next generation virus-specific plasma-based therapeutics.
 
We have an FDA-licensed source plasma collection facility, ADMA BioCenters, which provides us with a portion of our blood plasma for the manufacture of RI-002.  A typical plasma collection center, such as ADMA BioCenters, can collect 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale.  Plasma collected from ADMA BioCenters that is not used for making RI-002 is sold to customers under an existing supply agreement or in the open “spot” market.  We have entered into long term manufacturing and licensing agreements with Biotest AG and their United States subsidiary, Biotest Pharmaceuticals, Inc., together referred to as Biotest, that provide for the exclusive manufacture of RI-002.  At the same time, we granted Biotest an exclusive royalty-bearing license to market and sell RSV antibody-enriched IGIV in Europe and in other selected territories in North Africa and the Middle East.
 
The founders of ADMA have a combined 60 years of experience marketing and distributing blood plasma products and devices.  With the appointment of the executive team and the board of directors, we added over 150 years of deep medical, technical and development experience in the biologics and pharmaceutical industry.
 
Our mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche immune-compromised patient populations.  We intend to accomplish our mission by achieving the following:
 
·  
Complete our pivotal Phase III trial and obtain FDA approval to manufacture and market RI-002 for the treatment of patients with PIDD.
 
·  
Establish a specialty sales force to commercialize RI-002.
 
·  
Explore other possible indications for RI-002.
 
·  
Develop additional plasma-derived products for the treatment of infectious diseases in immune-compromised patient populations.
 
·  
Expand our network of ADMA BioCenters facilities, both to maintain control of a portion of our raw material supply and to generate additional revenue through the collection and sale of source plasma to third party customers.
 
Risks Associated with Our Business
 
We are a clinical-stage company with no approved products and limited historical revenues, which makes it difficult to assess our future viability. As of September 30, 2012, we had an accumulated deficit of approximately $34.9 million. In addition to our history of operating losses, our business, financial condition, results of operations and prospects are subject to a number of risks and uncertainties. These risks and uncertainties are discussed more fully in the “Risk Factors” and “Special Note Regarding Forward-Looking Statements” sections of this prospectus. You should carefully consider all of the information set forth in this prospectus and, in particular, should evaluate the specific factors set forth under “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in deciding whether to invest in our common stock. Among these important risks and uncertainties that could adversely affect our business, financial condition, results of operations and prospects are the following:
 
·  
To date, we have generated limited product revenues.  We are not currently profitable and may never become profitable.  We have a limited operating history upon which to base an investment decision.
 
 
·  
Our current product candidate, RI-002, requires extensive additional clinical testing. Clinical trials are very expensive, time-consuming and difficult to design and implement. If we are unsuccessful in obtaining regulatory approval for RI-002 or if our trials do not provide positive results, we will be required to delay or abandon development of such product, which would have a material adverse impact on our business.
 
·  
We depend on a third-party manufacturer for the production of RI-002, and such party is outside of our control.
 
·  
We do not own any issued patents and we do not have any patent applications in process relating to RI-002.  If we are unable to protect our trade secrets or other proprietary rights, our competitiveness and business prospects may be materially damaged.
 
·  
We expect our securities will be quoted on the OTC Bulletin Board quotation system, which will limit the liquidity and price of our securities more than if we were quoted on a national securities exchange.
 
Corporate History
 
ADMA Biologics, Inc. was incorporated in New Jersey on June 24, 2004 and re-incorporated in Delaware on July 16, 2007. On February 13, 2012, ADMA Biologics, Inc., merged into a subsidiary of R&R Acquisition VI, Inc., a Delaware "blank check" company, which had been incorporated in 2006 and which then changed its name to ADMA Biologics, Inc.
 
Corporate Information
 
Our primary executive offices are located at 65 Commerce Way, Hackensack, New Jersey, and our telephone number is (201) 478-5552. Our website address is http://www.admabiologics.com. The information contained in, or that can be accessed through, our website is not part of this prospectus.
 
Common Stock Market Data
 
We have been a public reporting company since February 13, 2012.  However, there is not currently, and there has never been, any public market for our common stock.  Our common stock is not currently eligible for trading on any national securities exchange or any over-the-counter markets, including the OTC Bulletin Board.  In connection with this offering, we have applied to have our common stock quoted on the OTC Bulletin Board under the symbol "               ".  We cannot assure you that our common stock will continue to be quoted on the OTC Bulletin Board after this offering.
 
Implications of Being an Emerging Growth Company
 
As a company with less than $1 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012.  The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for qualifying public companies.  As an “emerging growth company,” we may, under Section 7(a)(2)(B) of the Securities Act of 1933, as amended, or the Securities Act, delay adoption of new or revised accounting standards applicable to public companies until such standards would otherwise apply to private companies. We may take advantage of this extended transition period until the first to occur of the date that we (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of this extended transition period.
 
We have elected to take advantage of the benefits of this extended transition period.  Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.  Until the date that we are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(B), upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-emerging growth companies and the date on which we will adopt the recently issued accounting standard.
 
We could be an emerging growth company for up to five years after the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act, which such fifth anniversary will occur in 2018. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1 billion or we issue more than $1 billion of non-convertible debt in any three-year period, we would cease to be an emerging growth company prior to the end of such five-year period.
 
 
We are also a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available to smaller reporting companies.
 
 
- 4 -

 
The Offering
 
Common stock offered by us
                            shares
   
Common stock to be outstanding after the offering
                            shares
   
Option to purchase additional shares
The underwriters have a 30-day option to purchase up to an additional                            shares of our common stock at the public offering price less the underwriting discount and commission.
   
Use of proceeds
We estimate that the net proceeds from this offering, after deducting the underwriting discount and commission and estimated offering expenses payable by us, will be approximately $           .  We intend to use the proceeds of this offering to continue clinical development and testing of RI-002 and for working capital and other general corporate purposes.
   
   
Risk factors
See “Risk Factors” beginning on page 8 for a discussion of risks you should consider before purchasing shares of our common stock.
   
   
Proposed OTC Bulletin Board symbol
 

Unless otherwise noted, the number of shares of our common stock to be outstanding after this offering is based on 4,622,831 shares outstanding as of December 31, 2012, and excludes:
 
·  
589,937 shares of common stock issuable upon the exercise of options outstanding as of December 31, 2012 at a weighted average exercise price of $8.71 per share;
 
·  
112,865 shares of common stock issuable upon the exercise of warrants outstanding as of December 31, 2012 at a weighted average exercise price of $9.60 per share; and
 
·  
121,263 shares of common stock reserved for future issuance under our stock option plans.
 
Unless we specifically state otherwise, all information in this prospectus assumes no exercise of the underwriters’ option to purchase additional shares of common stock.
 
 
Summary Consolidated Financial Information
 
This section presents our summary historical consolidated financial data.  You should read carefully the consolidated financial statements included in this prospectus, including the notes to the consolidated financial statements.  The summary consolidated data in this section are not intended to replace the consolidated financial statements.
 
We derived the statement of operations data for the years ended December 31, 2010 and 2011 and the balance sheet data as of December 31, 2010 and 2011 from the audited consolidated financial statements included in this prospectus.  We derived the statement of operations data and balance sheet data as of September 30, 2012 and for the nine months ended September 30, 2011 and 2012 from the unaudited consolidated financial statements included in this prospectus.  Our management believes that the unaudited historical consolidated financial statements contain all adjustments needed to state fairly the information contained in those statements, and that the adjustments made consist only of normal recurring adjustments.
 
   
For the year ended
December 31,
   
For the nine months ended
September 30,
 
   
2010
   
2011
   
2011
   
2012
 
                         
                         
Statement of Operations data:
             
(Unaudited)
   
(Unaudited)
 
                         
Revenues
  $ -     $ 761,042     $ -     $ 594,834  
Cost of sales
    -       207,570       -       288,761  
Gross profit
    -       553,472       -       306,073  
Operating expenses:
                               
Research and development
    2,193,838       646,756       443,188       2,201,131  
Loss on sale of inventory
    -       1,934,630       1,934,630       -  
                                 
Plasma center operating expenses
    1,876,644       1,163,148       1,191,243       1,327,761  
                                 
General and administrative
    1,425,951       1,431,894       932,248       2,446,043  
                                 
Total operating expenses
    5,496,433       5,176,428       4,501,309       5,974,935  
Loss from operations
    (5,496,433 )     (4,622,956 )     (4,501,309 )     (5,668,862 )
Other income (expense), net
    (451,279 )     (1,601,269 )     (768,130 )     1,471  
                                 
Loss before income taxes
    (5,947,712 )     (6,224,225 )     (5,269,439 )     (5,667,391 )
State income tax benefit
    -       320,765       320,765       617,615  
                                 
Net loss
  $ (5,947,712 )   $ (5,903,460 )   $ (4,948,674 )   $ (5,049,776 )
                                 
Basic and diluted net loss per common share
  $ (16.92 )   $ (16.72 )   $ (14.08 )   $ (1.27 )
                                 
Weighted average common shares outstanding—basic and diluted
    351,535       353,098       351,535       3,988,005  
 
 
   
As of December 31,
   
As of
September 30,
 
   
2010
   
2011
   
2012
 
                   
Balance Sheet Data:
             
(Unaudited)
 
                   
Current assets
  $ 3,684,207     $ 1,294,360     $ 11,981,577  
Total assets
  $ 5,204,906     $ 2,925,909     $ 13,224,826  
Total liabilities
  $ 9,131,598     $ 2,540,093     $ 1,617,786  
Total stockholders’ equity (deficiency)
  $ (3,926,692 )   $ 385,816     $ 11,607,040  
Total liabilities and stockholders’ equity (deficiency)
  $ 5,204,906     $ 2,925,909     $ 13,224,826  
 
 
 
There are numerous and varied risks that may prevent us from achieving our goals.  We believe that the following are the material risks that we face.  If any of the following risks actually occurs, our business, financial condition or results of operation may be materially adversely affected.  In such case, the trading price of our common stock could decline and investors in our common stock could lose all or part of their investment.
 
Risks Relating to our Business
 
To date, we have generated limited product revenues and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.
 
To date, we have generated limited revenues.  All of our revenues to date have been derived from the sale of plasma collected by ADMA BioCenters, as well as our other plasma inventory sales.  Unless and until we receive approval from the FDA and other regulatory authorities for our RI-002 product candidate, we will be unable to sell and generate revenues from that product.  Therefore, for the foreseeable future, we will have to fund all of our operations and capital expenditures from the revenues that may be generated by the sale of plasma collected by ADMA Biocenters, as well as cash on hand and potential future capital raises.  While ADMA BioCenters is committed to maintain compliance with all applicable regulations, we cannot assure you that we will be able to retain the FDA license for our plasma collection center, which we need in order to sell plasma collected by ADMA BioCenters.  We also cannot assure you that the net proceeds from this offering will be sufficient to enable us to complete the FDA approval process for our RI-002 product candidate.
 
Our ability to continue as a going concern depends on our ability to raise additional capital, to fund our research and development and commercial programs and meet our obligations on a timely basis.  If we are unable to successfully raise sufficient additional capital, we will likely not have sufficient cash flow and liquidity to fund our business operations, forcing us to curtail our activities and, ultimately, potentially cease operations.  Even if we are able to raise additional capital, such financings may only be available on unattractive terms, resulting in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of our common stock may decline.
 
Based upon our projected revenue and expenditures for the next two years, we estimate that our cash currently on hand combined with the proceeds from this offering will be sufficient to enable us to fund our operating expenses, research and development expenses and capital expenditures through 2015.  If our assumptions underlying our estimated expenses prove to be wrong, we may have to raise additional capital sooner than anticipated, and we currently do not have arrangements to obtain additional financing.  Any such financing could be difficult to obtain or only available on unattractive terms and could result in significant dilution of stockholders’ interests.  Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our business plan and financial performance and could delay, discontinue or prevent product development and clinical trial activities or the approval of any of our potential products.  In addition, we could be forced to reduce or forego sales and marketing efforts and forego attractive business opportunities.
 
Our shares have never traded and even after the completion of this Offering, we will be quoted on the OTC Bulletin Board and trading volume in our shares could be limited .
 
We have been a public reporting company since February 13, 2012.  However, we have fewer than ten stockholders and there is not currently, nor has there ever been, any public market for our common stock.  We have applied to have our common stock quoted on the OTC Bulletin Board after this Offering.  However, to the extent that we will not be eligible for listing on the NASDAQ or any other national securities exchange for 12 months, our trading volume and the liquidity of our shares could be limited.  In addition, even after the completion of this Offering, we may not have a widespread retail distribution of our shares and our trading volume and liquidity could be limited.  Accordingly, we cannot assure you that after the completion of the Offering there will be significant trading in our shares, that there will be support for the trading thereof, that trading prices will not be volatile or that you will be able to dispose of your shares, if you so choose, at prices that are reflective of the value of the shares.
 
We are not currently profitable and may never become profitable.
 
We have a history of losses and expect to incur substantial losses and negative operating cash flow for the foreseeable future, and we may never achieve or maintain profitability.  For the year ended December 31, 2011 and nine months ended September 30, 2012, we had a net loss of $5.9 million and $5.0 million, respectively, and from our inception in 2004 through September 30, 2012, we have incurred a net loss of $34.9 million.  Even if we succeed in developing and commercializing one or more product candidates, we expect to incur substantial losses for the foreseeable future and may never become profitable.  We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:
 
·  
continue to undertake development and clinical trials for RI-002;
 
·  
seek regulatory approval(s);
 
 
·  
implement additional internal systems, controls and infrastructure; and
 
·  
hire additional personnel.
 
We also expect to experience negative cash flow for the foreseeable future as we fund our operating losses and capital expenditures.  As a result, we will need to generate significant revenues in order to achieve and maintain profitability.  We may not be able to generate these revenues or achieve profitability in the future.  Our failure to achieve or maintain profitability could negatively impact the value of our securities.
 
We have a limited operating history upon which to base an investment decision.
 
We have not demonstrated an ability to perform the functions necessary for the successful commercialization of RI-002.  The successful development and commercialization of any product candidate will require us or our collaborators to perform a variety of functions, including:
 
·  
undertaking product development and clinical trials;
 
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participating in regulatory approval processes;
 
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formulating and manufacturing products; and
 
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conducting sales and marketing activities once authorized.
 
Our operations thus far provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our securities.
 
Our current product candidate, RI-002, requires extensive additional clinical testing. Clinical trials are very expensive, time-consuming and difficult to design and implement. If we are unsuccessful in obtaining regulatory approval for RI-002 or any of our product candidates don’t provide positive results, we may be required to delay or abandon development of such product, which would have a material adverse impact on our business.
 
Continuing product development requires additional and extensive clinical testing.  Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.  The clinical trial process is also time consuming.  We cannot provide any assurance or certainty regarding when we might complete the clinical trial process or submit a Biological License Application, or BLA, for regulatory approval for RI-002 or whether any such BLA will be accepted or approved.  We estimate that clinical trials of our product candidate will take at least 18 months to several years to complete.  Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.  The commencement and completion of clinical trials may be delayed by several factors, including:
 
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unforeseen safety issues;
 
·  
determination of dosing issues;
 
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lack of effectiveness during clinical trials;
 
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slower than expected rates of patient recruitment;
 
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inability to monitor patients adequately during or after treatment; and
 
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inability or unwillingness of medical investigators to follow our clinical protocols.
 
In addition, we or the FDA or an Institutional Review Board, or IRB, may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our Investigational New Drug Application, or IND, submissions or the conduct of these trials.  Therefore, we cannot provide any assurance or predict with certainty the schedule for future clinical trials.  We completed clinical trials in 2008 and 2009, during which we enrolled 21 patients.  The focus of our planned Phase III clinical trial has been designed in accordance with the FDA Guidance for Industry and we believe that the revised design will increase the probability of successful trial enrollment.  No assurance can be given that we will be able to enroll sufficient patients to complete a successful Phase III clinical trial.
 
 
In the event we do not ultimately receive regulatory approval for RI-002, we may be required to terminate development of our only product candidate.  Unless we acquire or develop other product candidates that are saleable, our business will be limited to plasma collection and sales.
 
If the results of our clinical trials do not support our product candidate claims, completing the development of such product candidate may be significantly delayed or we may be forced to abandon development of such product candidate altogether.
 
Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims.  Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and preclinical testing.  The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses.  This failure would cause us to abandon a product candidate and may delay development of other product candidates.  Any delay in, or termination of, our clinical trials will delay the filing of a BLA with the FDA and, ultimately, our ability to commercialize our product candidates and generate product revenues.  In addition, our clinical trials involve a relatively small patient population.  Because of the small sample size, the results of these clinical trials may not be indicative of future results.  In addition, certain portions of the clinical trial for RI-002 were performed outside the United States, and therefore, may not have been performed in accordance with standards normally required by the FDA and other regulatory agencies.
 
Currently, our only viable product candidate is RI-002.  If we do not obtain the necessary U.S. or worldwide regulatory approvals to commercialize RI-002, or any other product candidate, we will not be able to sell RI-002.
 
At the present time, our entire focus is obtaining regulatory approval for RI-002, our only product candidate.  If we cannot obtain regulatory approval for RI-002, our only source of revenue will be plasma collection and sales.  We cannot assure you that we will receive the approvals necessary to commercialize RI-002 or any other product candidate we may acquire or develop in the future.  In order to obtain FDA approval of RI-002 or any other product candidate requiring FDA approval, our clinical development must demonstrate that the product candidate is safe for humans and effective for its intended use, and we must submit a BLA.  To attain required FDA approval of any other product candidate generally requires significant research and testing, referred to as preclinical studies, as well as human tests, referred to as clinical trials.  Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing.  We cannot predict whether our research and clinical approaches will result in products that the FDA considers safe for humans and effective for indicated uses.  The FDA has substantial discretion in the product approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies.  The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review.  Delays in obtaining regulatory approvals may:
 
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delay commercialization of, and our ability to derive product revenues from, our product candidate;
 
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impose costly procedures on us; and
 
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diminish any competitive advantages that we may otherwise enjoy.
 
Even if we comply with all FDA requests, the FDA may ultimately reject our BLA.  We may never obtain regulatory approval for RI-002 or any other potential product candidate.  Failure to obtain FDA approval of any of our product candidates will severely undermine our business by leaving us without a saleable product beyond the plasma collected by ADMA BioCenters, and therefore without any source of additional revenues if and until another product candidate can be developed and commercialized.  There is no guarantee that we will ever be able to develop or acquire another product candidate.
 
 
In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize any products.  Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above.  We cannot assure you that we will receive the approvals necessary to commercialize any product candidate for sale outside the United States.
 
We depend on third-party researchers and developers to develop RI-002, and such parties are, to some extent, outside of our control.
 
We depend on independent investigators and collaborators, such as universities and medical institutions, to conduct our preclinical and clinical trials under agreements with us.  These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs.  These investigators may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves.  If outside collaborators fail to devote sufficient time and resources to our product-development programs, or if their performance is substandard, the approval of our FDA application(s), if any, and our introduction of new products, if any, will be delayed.  These collaborators may also have relationships with other commercial entities, some of whom may compete with us.  If our collaborators assist our competitors at our expense, our competitive position would be harmed.
 
Relying exclusively on third parties to manufacture our product candidates exposes us to risks that may delay testing, development, regulatory approval and commercialization of our product candidates.
 
We have limited experience in manufacturing and do not intend to establish our own manufacturing facilities.  We lack the resources to manufacture RI-002.  Although we have agreements pertaining to the manufacture, supply, storage and distribution of product supplies of RI-002 for clinical development purposes, we do not have any agreements for the commercial scale manufacture of RI-002, and upon commercialization, it is possible that our manufacturing requirements may exceed the available supply allotments under our existing agreements.  We will rely on one or more third-party contractors to manufacture our products.  Our anticipated future reliance on a limited number of third-party manufacturers exposes us to the following risks:
 
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We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any replacement contractor.  This approval would require new testing and compliance inspections.  In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products after receipt of FDA approval, if any.
 
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Third-party manufacturers might be unable to manufacture our products in the volume and of the quality required to meet our clinical and commercial needs, if any.
 
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Contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.
 
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Product manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, and corresponding state agencies to ensure strict compliance with good manufacturing practice and other government regulations and corresponding foreign standards.  We do not have control over third-party manufacturers’ compliance with these regulations and standards.
 
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If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation.  We may be required to pay fees or other costs for access to such improvements.
 
 
Each of these risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenues.
 
If physicians and patients do not accept and use our product, our ability to generate revenue from sales will be materially impaired.
 
Even if the FDA approves RI-002, physicians and patients may not accept and use it.  Acceptance and use of our product will depend on a number of factors including:
 
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perceptions by members of the health care community, including physicians, about the safety and effectiveness of our product;
 
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cost-effectiveness of our product relative to competing products;
 
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availability of reimbursement for our product from government or other healthcare payers; and
 
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effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
 
Because we expect sales of RI-002, if approved, to generate substantially all of our product revenues other than the revenue attainable from the sale of plasma collected by ADMA BioCenters, the failure of this product to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.
 
Our long-term success may depend on our ability to supplement our existing RI-002 product candidate through new product development or the in-license or acquisition of other new products, and if our business development efforts are not successful, our ability to achieve profitability may be negatively impacted.
 
Our current product development portfolio consists primarily of RI-002.  We intend to seek to expand our current portfolio through new product development efforts or to in-license or acquire additional products.  If we are not successful in developing or acquiring additional products, we will depend on our ability to raise capital for, and the successful development and commercialization of, RI-002 and the revenue we may generate from the sale of plasma attributable to the operations of ADMA BioCenters.
 
Our loan and security agreement with Hercules is subject to acceleration in specified circumstances, which may result in Hercules taking possession and disposing of any collateral.
 
On December 21, 2012, we entered into a Loan and Security Agreement, or the Loan Agreement, with Hercules Technology Growth Capital, Inc., or Hercules.  Under the Loan Agreement, we may borrow up to a maximum of $6 million.  We borrowed $4 million on the closing date and have the option to borrow an additional $2 million in two equal tranches of $1 million upon the satisfaction of certain milestones. Our obligations under the Loan Agreement are secured by a security interest in all of our assets, except for our intellectual property (which is subject to a negative pledge). The Loan Agreement contains customary representations, warranties and covenants, including limitations on acquisitions, dispositions, incurrence of indebtedness and the granting of security interests. Upon the occurrence and during the continuance of any event of default, including upon the occurrence of any event deemed to result in a material adverse event, Hercules may, and at the written request of the requisite lenders shall, terminate the commitments under the facilities and declare any or all of the obligations to be immediately due and payable, without demand or notice to us. However, any event of default relating to timely payment of debts, insolvency, liquidation, bankruptcy or similar events will result in automatic acceleration. Among the remedies available to Hercules in case of an event of default are the taking possession and disposition of any collateral under the Loan Agreement.
 
 
Developments by competitors may render our products or technologies obsolete or non-competitive.
 
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change.  Should we obtain regulatory approval for RI-002 or any future product we may develop, we will have to compete with existing therapies.  In addition, other companies may pursue the development of pharmaceuticals that target the same diseases and conditions that we are targeting.  We face competition from pharmaceutical and biotechnology companies in the United States and abroad.  In addition, companies pursuing different but related fields represent substantial competition.  Many of these organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do.  These organizations also compete with us to attract qualified personnel and parties for acquisitions, joint ventures or other collaborations.
 
We do not own any issued patents and we do not have any patent applications currently pending relating to our primary product candidate.  If we are unable to protect our trade secrets or other proprietary rights, our competitiveness and business prospects may be materially damaged.
 
We do not own any issued patents and we do not have any patent applications currently pending relating to our primary product candidate.  Rather, we rely exclusively on a combination of trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so.  While we intend to defend against any threats to our intellectual property, there can be no assurance that our trade secret policies and practices or other agreements will adequately protect our intellectual property.  We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.  These processes, systems, and/or security measures may be breached, and we may not have adequate remedies as a result of any such breaches.  In addition, our trade secrets may otherwise become known or be independently discovered by competitors.  We also seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees, consultants, scientific advisors and contractors.  Although we rely, in part, on confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, there can be no assurance that these agreements or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.  To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
 
Third parties could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable terms or at all.
 
We may not be able to operate our business without infringing third-party patents.  Numerous U.S. and foreign patents and pending patent applications owned by third parties exist in fields that relate to the development and commercialization of immune globulins.  In addition, many companies have employed intellectual property litigation as a way to gain a competitive advantage.  It is possible that infringement claims may occur as the number of products and competitors in our market increases.  In addition, to the extent that we gain greater visibility and market exposure as a public company, we face a greater risk of being the subject of intellectual property infringement claims.  We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the United States and in foreign jurisdictions.  If our products, methods, processes and other technologies are found to infringe third party patent rights, we could be prohibited from manufacturing and commercializing the infringing technology, process or product unless we obtain a license under the applicable third party patent and pay royalties or are able to design around such patent.  We may be unable to obtain a license on terms acceptable to us, or at all, and we may not be able to redesign our products or processes to avoid infringement.  Even if we are able to redesign our products or processes to avoid an infringement claim, our efforts to design around the patent could require significant time, effort and expense and ultimately may lead to an inferior or more costly product and/or process.  Any claim of infringement by a third party, even those without merit, could cause us to incur substantial costs defending against the claim and could distract our management from our business.  Furthermore, if any such claim is successful, a court could order us to pay substantial damages, including compensatory damages for any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees.  These damages could be substantial and could harm our reputation, business, financial condition and operating results.  A court also could enter orders that temporarily, preliminarily or permanently prohibit us, our licensees, if any, and our customers from making, using, selling, offering to sell or importing one or more of our products or practicing our proprietary technologies or processes, or could enter an order mandating that we undertake certain remedial activities.  Any of these events could seriously harm our business, operating results and financial condition.
 
 
Continued instability in the credit and financial markets may negatively impact our business, results of operations, and financial condition.
 
Financial markets in the United States, Canada, Europe and Asia continue to experience disruption, including, among other things, significant volatility in security prices, declining valuations of certain investments, as well as severely diminished liquidity and credit availability.  Business activity across a wide range of industries and regions continues to be greatly reduced and local governments and many businesses are still suffering from the lack of consumer spending and the lack of liquidity in the credit markets.  As a clinical-stage biotechnology company, we rely on third parties for several important aspects of our business, including contract manufacturing of drug product, plasma collection supplies, transportation and storage of plasma, and conduct of our clinical trials.  These third parties may be unable to satisfy their commitments to us due to tightening of global credit from time to time, which would adversely affect our business.  The continued instability in the credit and financial market conditions may also negatively impact our ability to access capital and credit markets and our ability to manage our cash balance.  While we are unable to predict the continued duration and severity of the adverse conditions in the United States and other countries, any of the circumstances mentioned above could adversely affect our business, financial condition, operating results and cash flow or cash position.
 
If we are unable to successfully manage our growth, our business may be harmed.
 
Our success will depend on the expansion of our operations and the effective management of our growth, which will place a significant strain on our management and on our administrative, operational and financial resources.  To manage this growth, we must expand our facilities, augment our operational, financial and management systems and hire and train additional qualified personnel.  If we are unable to manage our growth effectively, our business would be harmed.
 
The loss of one or more key members of our management team could adversely affect our business.
 
Our performance is substantially dependent on the continued service and performance of our management team, who have extensive experience and specialized expertise in our business.  In particular, the loss of Adam S. Grossman, our president and chief executive officer, could adversely affect our business and operating results. We do not have “key person” life insurance policies for any members of our management team. We have employment agreements with each of our executive officers, however, the existence of an employment agreement does not guarantee retention of members of our management team and we may not be able to retain those individuals for the duration of or beyond the end of their respective terms.
 
If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.
 
We will need to hire additional qualified personnel with expertise in finance and accounting, clinical research and testing, government regulation, formulation and manufacturing and sales and marketing.  In particular, over the next 12 months, we expect to hire up to 10 new employees devoted to medical and scientific affairs, regulatory affairs, quality control, financial services, and general and operational management.  We expect that the hiring of such additional personnel will increase our annual expenditures by approximately $1.5 million or more.  We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions.  Competition for such individuals is intense, and we cannot assure you that our search for such personnel will be successful.  Attracting and retaining qualified personnel will be critical to our success, and any failure to do so successfully may have a material adverse effect on us.
 
 
We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.
 
The testing and marketing of medical products entail an inherent risk of product liability.  If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products.  Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with collaborators.
 
Many of our business practices are subject to scrutiny by regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws.  Failure to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us.
 
The laws governing our conduct in the United States are enforceable by criminal, civil and administrative penalties.  Violations of laws such as the Federal Food, Drug, and Cosmetic Act, the False Claims Act and the Anti-Kickback Law and the Public Health Service Act, and any regulations promulgated under their authority, may result in jail sentences, fines or exclusion from federal and state programs, as may be determined by Medicare, Medicaid and the Department of Health and Human Services and other regulatory authorities as well as by the courts.  There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.
 
For example, under the Anti-Kickback Law, and similar state laws and regulations, even common business arrangements, such as discounted terms and volume incentives for customers in a position to recommend or choose products for patients, such as physicians and hospitals, can result in substantial legal penalties, including, among others, exclusion from the Medicare and Medicaid programs, and arrangements with referral sources must be structured with care to comply with applicable requirements.  Also, certain business practices, such as consulting fees to healthcare providers, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers that prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare providers to prescribe or purchase particular products or as a reward for past prescribing.  Under the Patient Protection and Affordable Care Act and the Companion Healthcare and Education Reconciliation Act, which together are referred to as the healthcare reform law, such payments by pharmaceutical manufacturers to United States healthcare practitioners and academic medical centers must be publicly disclosed.  A number of states have similar laws in place.  Additional and stricter prohibitions could be implemented by federal and state authorities.  Where such practices have been found to be improper incentives to use such products, government investigations and assessments of penalties against manufacturers have resulted in substantial damages and fines.  Many manufacturers have been required to enter into consent decrees or orders that prescribe allowable corporate conduct.
 
Failure to satisfy requirements under the Federal Food, Drug, and Cosmetic Act can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe allowable corporate conduct.
 
In addition, while regulatory authorities generally do not regulate physicians’ discretion in their choice of treatments for their patients, they do restrict communications by manufacturers on unapproved uses of approved products or on the potential safety and efficacy of unapproved products in development.  Companies in the United States, Canada and the European Union cannot promote approved products for other indications that are not specifically approved by the competent regulatory authorities (e.g., FDA in the United States), nor can companies promote unapproved products.  In limited circumstances, companies may disseminate to physicians information regarding unapproved uses of approved products or results of studies involving investigational products.  If such activities fail to comply with applicable regulations and guidelines of the various regulatory authorities, we may be subject to warnings from, or enforcement action by, these authorities.  Furthermore, if such activities are prohibited, it may harm demand for our products.
 
 
Promotion of unapproved drugs or devices or unapproved indications for a drug or device is a violation of the Federal Food, Drug, and Cosmetic Act and subjects us to civil and criminal sanctions.  Furthermore, sanctions under the Federal False Claims Act have recently been brought against companies accused of promoting off-label uses of drugs, because such promotion induces the use and subsequent claims for reimbursement under Medicare and other federal programs.  Similar actions for off-label promotion have been initiated by several states for Medicaid fraud.  The healthcare reform law significantly strengthened provisions of the Federal False Claims Act, Medicare and Medicaid Anti-Kickback provisions, and other health care fraud provisions, leading to the possibility of greatly increased qui tam suits by relators for perceived violations.  Violations or allegations of violations of the foregoing restrictions could materially and adversely affect our business.
 
We may be required to report detailed pricing information, net of included discounts, rebates and other concessions, to the Centers for Medicare & Medicaid Services, or CMS, for the purpose of calculating national reimbursement levels, certain federal prices and certain federal and state rebate obligations.  We will need to establish systems for collecting and reporting this data accurately to CMS and institute a compliance program to assure that the information collected is complete in all respects.  If we report pricing information that is not accurate to the federal government, we could be subject to fines and other sanctions that could adversely affect our business.
 
If we choose to pursue clinical development and commercialization in the European Union or otherwise market and sell our products outside of the United States, we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions.  The approval procedures vary among countries in complexity and timing.  We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all, which would preclude us from commercializing products in those markets.  In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals.  In these countries, pricing discussions with governmental authorities can take considerable time after the receipt of marketing approval for a product.  To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of their product candidate to other available therapies.  Such trials may be time-consuming and expensive, and may not show an advantage in efficacy for our products.  If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, in either the United States or the European Union, we could be adversely affected.  Also, under the United States Foreign Corrupt Practices Act, or FCPA, the United States has increasingly focused on regulating the conduct by United States businesses occurring outside of the United States, generally prohibiting remuneration to foreign officials for the purpose of obtaining or retaining business.
 
To enhance compliance with applicable health care laws, and mitigate potential liability in the event of noncompliance, regulatory authorities, such as the United States Health and Human Services Department Office of Inspector General, or OIG, have recommended the adoption and implementation of a comprehensive health care compliance program that generally contains the elements of an effective compliance and ethics program described in Section 882.1 of the United States Sentencing Commission Guidelines Manual.  Increasing numbers of United States-based pharmaceutical companies have such programs.  In the future, we may need to adopt healthcare compliance and ethics programs that would incorporate the OIG’s recommendations, and train our applicable employees in such compliance.  Such a program may be expensive and may not assure that we will avoid compliance issues.
 
Our manufacturing processes are complex and involve biological intermediates that are susceptible to contamination.
 
Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable as raw material for further manufacturing.  For instance, improper storage of plasma, by us or third-party suppliers, may require us to destroy some of our raw material.  If unsuitable plasma is not identified and discarded prior to the release of the plasma to the manufacturing process, it may be necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of goods sold.
 
The manufacture of our plasma products is an extremely complex process of fractionation, purification, filling and finishing.  Although we and our contract manufacturers attempt to maintain high standards for product testing, manufacturing, process controls and quality assurance, our products can become non-releasable or otherwise fail to meet our stringent specifications through a failure of one or more of these processes.  Extensive testing is performed throughout the process to ensure the safety and effectiveness of our products.  We may, however, detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with our current Good Manufacturing Practices, or cGMP, or other regulations.  Such an event of noncompliance would likely result in our determination that the implicated products should not be released and therefore should be destroyed.
 
 
Once manufactured, our plasma-derived products must be handled carefully and kept at appropriate temperatures.  Our failure, or the failure of third parties that supply, ship or distribute our products, to properly care for our products may require that those products be destroyed.
 
While we expect to write off small amounts of work-in-progress in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations and the reserves we have established for these purposes.  Such write-offs and other costs could cause material fluctuations in our profitability.  Furthermore, contamination of our products could cause investors, consumers, or other third parties with whom we conduct business to lose confidence in the reliability of our manufacturing procedures, which could adversely affect our sales and profits.  In addition, faulty or contaminated products that are unknowingly distributed could result in patient harm, threaten the reputation of our products and expose us to product liability damages and claims from companies for whom we do contract manufacturing.
 
Our ability to continue to produce safe and effective products depends on the safety of our plasma supply against transmittable diseases.
 
Despite overlapping safeguards, including the screening of donors and other steps to remove or inactivate viruses and other infectious disease causing agents, the risk of transmissible disease through blood plasma products cannot be entirely eliminated.  For example, since plasma-derived therapeutics involve the use and purification of human plasma, there has been concern raised about the risk of transmitting human immunodeficiency virus, or HIV, prions, West Nile virus, H1N1 virus or “swine flu” and other blood-borne pathogens through plasma-derived products.  There are also concerns about the future transmission of H5N1 virus, or “bird flu.”  In the 1980s, thousands of hemophiliacs worldwide were infected with HIV through the use of contaminated Factor VIII.  Bayer and other producers of Factor VIII, though not us, were defendants in numerous lawsuits resulting from these infections.
 
New infectious diseases emerge in the human population from time to time.  If a new infectious disease has a period during which time the causative agent is present in the bloodstream but symptoms are not present, it is possible that plasma donations could be contaminated by that infectious agent.  Typically, early in an outbreak of a new disease, tests for the causative agent do not exist.  During this early phase, we must rely on screening of donors (e.g., for behavioral risk factors or physical symptoms) to reduce the risk of plasma contamination.  Screening methods are generally less sensitive and specific than a direct test as a means of identifying potentially contaminated plasma units.
 
During the early phase of an outbreak of a new infectious disease, our ability to manufacture safe products would depend on the manufacturing process’ capacity to inactivate or remove the infectious agent.  To the extent that a product’s manufacturing process is inadequate to inactivate or remove an infectious agent, our ability to manufacture and distribute that product would be impaired.
 
If a new infectious disease were to emerge in the human population, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our ability to procure plasma, manufacture our products or both.  Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for plasma-derived products.
 
In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma.  There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.
 
 
We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source plasma.
 
In order for plasma to be used in the manufacturing of our products, the individual centers at which the plasma is collected must be licensed by the FDA, and approved by the regulatory authorities of any country in which we may wish to commercialize our products.  When we open a new plasma center, and on an ongoing basis after licensure, it must be inspected by the FDA for compliance with cGMP and other regulatory requirements.  An unsatisfactory inspection could prevent a new center from being licensed or risk the suspension or revocation of an existing license.  We do not and will not have adequate source plasma to manufacture RI-002.  Therefore, we are reliant on purchasing normal source plasma to manufacture RI-002.  We can give no assurances that normal source plasma will be available to us on commercially reasonable terms or at all.
 
In order to maintain a plasma center’s license, its operations must continue to conform to cGMP and other regulatory requirements.  In the event that we determine that plasma was not collected in compliance with cGMP, we may be unable to use and may ultimately destroy plasma collected from that center, which would be recorded as a charge to cost of goods.  Additionally, if non-compliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted.  Consequently, we could experience significant inventory impairment provisions and write-offs which could adversely affect our business and financial results.
 
We plan to increase our supplies of plasma for use in the manufacturing processes through increased collections at our existing and possible future plasma collection centers.  This strategy is dependent upon our ability to successfully integrate develop new centers, to obtain FDA approval for any unlicensed plasma centers, to maintain a cGMP compliant environment in all plasma centers and to expand production and attract donors to our centers.
 
There is no assurance that the FDA will inspect and license our unlicensed plasma collection centers in a timely manner consistent with our production plans.  If we misjudge the readiness of a center for an FDA inspection, we may lose credibility with the FDA and cause the FDA to more closely examine all of our operations.  Such additional scrutiny could materially hamper our operations and our ability to increase plasma collections.
 
Our ability to expand production and increase our plasma collection centers to more efficient production levels may be affected by changes in the economic environment and population in selected regions where ADMA BioCenters operates its current or future plasma centers, by the entry of competitive plasma centers into regions where ADMA BioCenters operates such centers, by misjudging the demographic potential of individual regions where ADMA BioCenters expects to expand production and attract new donors, by unexpected facility related challenges, or by unexpected management challenges at selected plasma centers.
 
Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.
 
Our ability to commercialize our products, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from government and health administration authorities, private health maintenance organizations and health insurers and other healthcare payers.
 
Significant uncertainty exists as to the reimbursement status of newly approved healthcare products.  Healthcare payers, including Medicare, are challenging the prices charged for medical products and services.  Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for products.  Even if one of our product candidates is approved by the FDA, insurance coverage may not be available, and reimbursement levels may be inadequate, to cover such product.  If government and other healthcare payers do not provide adequate coverage and reimbursement levels for one of our products, once approved, market acceptance of such product could be reduced.
 
 
Prices in many countries, including many in Europe, are subject to local regulation and certain pharmaceutical products, such as plasma-derived products, are subject to price controls in several of the world’s principal markets, including many countries within the European Union.  In the United States, where pricing levels for our products are substantially established by third-party payors, if payors reduce the amount of reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions.  These actions could have a negative effect on financial results, particularly in cases where our products command a premium price in the marketplace, or where changes in reimbursement induce a shift in the site of treatment.  The existence of direct and indirect price controls and pressures over our products could materially adversely affect our financial prospects and performance.
 
The implementation of the healthcare reform law in the United States may adversely affect our business.
 
Through the March 2010 adoption of the healthcare reform law in the United States, substantial changes are being made to the current system for paying for healthcare in the United States, including programs to extend medical benefits to millions of individuals who currently lack insurance coverage.  The changes contemplated by the healthcare reform law are subject to rule-making and implementation timelines that extend for several years, and this uncertainty limits our ability to forecast changes that may occur in the future.  However, implementation has already begun with respect to certain significant cost-saving measures under the healthcare reform law, for example with respect to several government healthcare programs that may cover the cost of our future products, including Medicaid, Medicare Parts B and D, and these efforts could have a materially adverse impact on our future financial prospects and performance.
 
For example, with respect to Medicaid, in order for a manufacturer’s products to be reimbursed by federal funding under Medicaid, the manufacturer must enter into a Medicaid rebate agreement with the Secretary of the United States Department of Health and Human Services, and pay certain rebates to the states based on utilization data provided by each state to the manufacturer and to CMS, and pricing data provided by the manufacturer to the federal government.  The states share this savings with the federal government, and sometimes implement their own additional supplemental rebate programs.  Under the Medicaid drug rebate program, the rebate amount for most branded drug products was previously equal to a minimum of 15.1% of the Average Manufacturer Price, or AMP, or the AMP less Best Price, whichever is greater.  Effective January 1, 2010, the healthcare reform law generally increases the size of the Medicaid rebates paid by manufacturers for single source and innovator multiple source (brand name) drug product from a minimum of 15.1% to a minimum of 23.1% of the AMP, subject to certain exceptions, for example, for certain clotting factors, the increase is limited to a minimum of 17.1% of the AMP.  For non-innovator multiple source (generic) products, the rebate percentage is increased from a minimum of 11.0% to a minimum of 13.0% of AMP.  In 2010, the healthcare reform law also newly extended this rebate obligation to prescription drugs covered by Medicaid managed care organizations.  These increases in required rebates may adversely affect our future financial prospects and performance.
 
The healthcare reform law also creates new rebate obligations for our products under Medicare Part D, a partial, voluntary prescription drug benefit created by the United States federal government primarily for persons 65 years old and over.  The Part D drug program is administered through private insurers that contract with CMS.  Beginning in 2011, the healthcare reform law generally requires that in order for a drug manufacturer’s products to be reimbursed under Medicare Part D, the manufacturer must enter into a Medicare Coverage Gap Discount Program agreement with the Secretary of the United States Department of Health and Human Services, and reimburse each Medicare Part D plan sponsor an amount equal to 50% savings for the manufacturer’s brand name drugs and biologics which the Part D plan sponsor has provided to its Medicare Part D beneficiaries who are in the “donut hole” (or a gap in Medicare Part D coverage for beneficiaries who have expended certain amounts for drugs). The Part D plan sponsor is responsible for calculating and providing the discount directly to its beneficiaries and for reporting these amounts paid to CMS’s contractor, which notifies drug manufacturers of the rebate amounts it must pay to each Part D plan sponsor.  The rebate requirement could adversely affect our future financial performance, particularly if contracts with Part D plans cannot be favorably renegotiated or the Part D plan sponsors fail to accurately calculate payments due in a manner that overstates our rebate obligation.
 
 
The healthcare reform law also introduced a biosimilar pathway that will permit companies to obtain FDA approval of generic versions of existing biologics based upon reduced documentation and data requirements deemed sufficient to demonstrate safety and efficacy than are required for the pioneer biologics.  The new law provides that a biosimilar application may be submitted as soon as 4 years after the reference product is first licensed, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed.  With the likely introduction of biosimilars in the United States, we expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges.  The FDA has reported meeting with sponsors who are interested in developing biosimilar products, and is developing regulations to implement the abbreviated regulatory review pathway.
 
Regarding access to our products, the healthcare reform law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research, or CER.  While the stated intent of CER is to develop information to guide providers to the most efficacious therapies, outcomes of CER could influence the reimbursement or coverage for therapies that are determined to be less cost-effective than others.  Should any of our products be determined to be less cost-effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our future financial prospects and results.
 
Developments in the economy may adversely impact our business.
 
The difficult economic environment may adversely affect demand for our products.  RI-002, our current product candidate, is expected to be sold to hospitals, specialty pharmacies and clinicians in the U.S.  As a result of loss of jobs, patients may lose medical insurance and be unable to purchase supply or may be unable to pay their share of deductibles or co-payments.  Hospitals adversely affected by the economy may steer patients to less costly therapies, resulting in a reduction in demand, or demand may shift to public health hospitals, which may purchase at a lower government price.  While to date we cannot directly trace any material reduction in demand to the recession, if economic conditions do not improve, the impact may become material.
 
Risks Relating to our Finances, Capital Requirements and Other Financial Matters
 
We are a clinical stage company with a history of operating losses that are expected to continue and we are unable to predict the extent of future losses, whether we will generate significant revenues or whether we will achieve or sustain profitability.
 
We are a clinical stage company and our prospects must be considered in light of the uncertainties, risks, expenses and difficulties frequently encountered by similarly situated companies.  We have generated net losses in all periods since our inception in June 2004 including losses of approximately $5.9 million and $5.9 million for the years ended December 31, 2010 and 2011, respectively, and $5.0 million for the nine months ended September 30, 2012.  At September 30, 2012, we had an accumulated deficit of approximately $34.9 million.  We expect to make substantial expenditures and incur increasing operating costs in the future and our accumulated deficit will increase significantly as we expand development and clinical trial activities for our product candidates.  Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets and stockholders’ equity.  Because of the risks and uncertainties associated with product development, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability.
 
During the 2010 and 2011 audits, our independent registered public accounting firm identified material weaknesses in our internal control over financial reporting.  Specifically, the independent registered public accounting firm identified material weaknesses regarding inadequate segregation of duties by management in the financial reporting area caused by the limited number of employees that we employ.
 
As we expand our operations, we intend to hire additional personnel to enable us to strengthen the segregation of duties by management in the financial reporting area.
 
There can be no assurance that we will be able to successfully implement our plans to remediate any material weakness in our financial reporting process.  Our failure to successfully implement our plans to remediate material weaknesses could cause us to fail to meet our reporting obligations, to produce timely and reliable financial information, and to effectively prevent fraud.  Additionally, such failure could cause investors to lose confidence in our reported financial information, which could have a negative impact on our financial condition and stock price.
 
 
We will need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, curtail or eliminate one or more of our research and development programs or commercialization efforts.
 
Our operations have consumed substantial amounts of cash since inception.  During the years ended December 31, 2010 and 2011, we incurred research and development expenses of approximately $2.2 million and $0.6 million, respectively, and $2.2 million for the nine months ended September 30, 2012.  We expect to continue to spend substantial amounts on product development, including conducting clinical trials for our product candidates and purchasing clinical trial materials from our suppliers.  We believe that our cash on hand and the net proceeds from this offering will sustain our operations through 2015 in order to support our continued research and development activities, as well as the anticipated costs of preclinical studies and clinical trials, regulatory approvals and potential commercialization.  We have based this estimate, however, on assumptions that may prove to be wrong, and we could spend our available financial resources much faster than we currently expect.  Our current financial condition raises substantial doubt about our ability to continue as a going concern.
 
Until such time, if ever, as we can generate a sufficient amount of product revenue and achieve profitability, we expect to seek to finance future cash needs through equity or debt financings or corporate collaboration and licensing arrangements.  Other than this offering, we currently have no agreements or arrangements relating to any of these types of transactions and we cannot be certain that additional funding will be available on acceptable terms, or at all.  If we are unable to raise additional capital, we will have to delay, curtail or eliminate one or more of our research and development programs.
 
Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
 
To the extent that we raise additional capital by issuing equity securities, the share ownership of existing stockholders will be diluted.  Any future debt financing may involve covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, redeem our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions, among other restrictions.  In addition, if we raise additional funds through licensing arrangements, it may be necessary to relinquish potentially valuable rights to our product candidates, or grant licenses on terms that are not favorable to us.
 
If we fail to maintain proper and effective internal controls over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.
 
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 and related rules, or SOX, for the year ending December 31, 2012, our management will be required to report on the effectiveness of our internal control over financial reporting.  The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.  To comply with the requirements of being a reporting company under the Securities Exchange Act of 1934, or the Exchange Act, we may need to further upgrade our systems, including information technology, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff.
 
Historically we did not have sufficient accounting and supervisory personnel with the appropriate level of technical accounting experience and training necessary for, or adequate documented accounting policies and procedures to support effective, internal controls.  This material weakness contributed to material audit adjustments for the years ended December 31, 2010 and 2011.  While we have commenced the process of documenting, reviewing and improving our internal controls over financial reporting for compliance with Section 404 of SOX and have made efforts to improve our internal controls and accounting policies and procedures, including hiring new accounting personnel and engaging external temporary resources, we may in the future identify deficiencies and weaknesses in our internal controls.  If material weaknesses or deficiencies in our internal controls exist and go undetected, our financial statements could contain material misstatements that, when discovered in the future could cause us to fail to meet our future reporting obligations and cause the price of our common stock to decline.
 
 
Risks Associated with our Capital Stock
 
The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
 
Our stock price may experience substantial volatility as a result of a number of factors, including:
 
·  
sales or potential sales of substantial amounts of our common stock;
 
·  
delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;
 
·  
announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;
 
·  
developments concerning our licensors or product manufacturers;
 
·  
litigation and other developments relating to our patents or other proprietary rights or those of our competitors;
 
·  
conditions in the pharmaceutical or biotechnology industries;
 
·  
governmental regulation and legislation;
 
·  
variations in our anticipated or actual operating results; and
 
·  
change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.
 
Many of these factors are beyond our control.  The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically experienced extreme price and volume fluctuations.  These fluctuations often have been unrelated or disproportionate to the operating performance of these companies.  These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.
 
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
 
Almost all of our 4.7 million outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, are available for sale in the public market, either pursuant to Rule 144 under the Securities Act or an effective registration statement.  Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
 
We have never paid and do not intend to pay cash dividends.  As a result, capital appreciation, if any, will be your sole source of gain.
 
We have never paid cash dividends on any of our capital stock and we currently intend to retain future earnings, if any, to fund the development and growth of our business.  In addition, the terms of existing and future debt agreements may preclude us from paying dividends.  As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.
 
 
Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
 
Provisions of our certificate of incorporation, our by-laws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices.  In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests.  These provisions include:
 
·  
the inability of stockholders to call special meetings; and
 
·  
the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our Board of Directors.
 
In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
 
The existence of the forgoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock.  They could also deter potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.
 
Risks Associated with the Offering
 
We have broad discretion in the use of the net proceeds of this offering and may not use them effectively.
 
We intend to use the net proceeds from this offering  to continue clinical testing and commercialization of RI-002 and for working capital and other general corporate purposes.  However, our management will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock.  The failure by management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of our product candidates.  Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
 
You will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase.
 
Because the public offering price per share of our common stock is substantially higher than the net tangible book value per share of our common stock, you will suffer substantial dilution in the net tangible book value of the common stock you purchase in this offering.  Based on an assumed public offering price of $           per share, if you purchase shares of common stock in this offering, you will suffer immediate and substantial dilution of approximately $          per share in the net tangible book value of the common stock.  See the section entitled “Dilution” in this prospectus for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering.
 
We expect our common stock will be quoted on the OTC Bulletin Board quotation system, which will limit the liquidity and price of our common stock more than if we were quoted on The NASDAQ Stock Market or another national securities exchange and result in our stockholders not receiving the benefit of our being subject to the listing standards of a national securities exchange.
 
 
We expect that our common stock will be traded over-the-counter on the OTC Bulletin Board quotation system, which is a FINRA-sponsored entity and operated inter-dealer automated quotation system for equity securities not included in a national exchange. Quotation of our common stock on the OTC Bulletin Board will limit the liquidity and price of our common stock more than if our common stock were quoted or listed on The NASDAQ Stock Market, which is a national securities exchange.  In light of the size of the offering, moreover, there may only be a relatively small number of purchasers in the offering, and this would limit the liquidity of the common stock.  Lack of liquidity will limit the price at which you may be able to sell our common stock or your ability to sell our common stock at all.
 
Since our common stock will be quoted on the OTC Bulletin Board, our common stockholders may face significant restrictions on the resale of our common stock due to state “blue sky" laws.
 
Each state has its own securities laws, often called "blue sky" laws, which (i) limit sales of securities to a state's residents unless the securities are registered in that state or qualify for an exemption from registration, and (ii) govern the reporting requirements for broker-dealers doing business directly or indirectly in the state. Before a security is sold in a state, there must be a registration in place to cover the transaction, or the transaction must be exempt from registration. The applicable broker must be registered in that state. We do not know whether our common stock will be registered or exempt from registration under the laws of any state. Since our common stock will be quoted on the OTC Bulletin Board, a determination regarding registration will be made by those broker-dealers, if any, who agree to serve as the market-makers for our common stock. There may be significant state blue sky law restrictions on the ability of investors to sell, and on purchasers to buy, our common stock. You should therefore consider the resale market for our common stock to be limited, as you may be unable to resell your common stock without the significant expense of state registration or qualification.
 
If our common stock becomes subject to the penny stock rules, this may make it more difficult to sell our shares.
 
The Securities and Exchange Commission has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00 (other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system). The OTC Bulletin Board does not meet such requirements and if the price of our common stock is less than $5.00, our securities will be deemed penny stocks. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that prior to effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore security holders may have difficulty selling their shares.
 
We are an “emerging growth company,” and may elect to comply with reduced public company reporting requirements applicable to emerging growth companies, which could make our common stock less attractive to investors.
 
We are an “emerging growth company,” as defined by the JOBS Act. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for qualifying public companies.  As an “emerging growth company,” we may, under Section 7(a)(2)(B) of the Securities Act, delay adoption of new or revised accounting standards applicable to public companies until such standards would otherwise apply to private companies.   We may take advantage of this extended transition period until the first to occur of the date that we (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of this extended transition period.
 
We could be an emerging growth company for up to five years after the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act, which such fifth anniversary will occur in 2018. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1 billion or we issue more than $1 billion of non-convertible debt in any three-year period, we would cease to be an emerging growth company prior to the end of such five-year period.
 
 
We have elected to take advantage of the benefits of this extended transition period.  Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.  Until the date that we are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(B), upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-emerging growth companies and the date on which we will adopt the recently issued accounting standard.
 
We cannot predict if investors will find our common stock less attractive as a result of our reliance on these exemptions. If some investors find our common stock less attractive as a result of any choice we make to reduce disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile.
 
 
 
Some of the information in this prospectus contains forward-looking statements within the meaning of the federal securities laws.  These statements include, among others, statements about:
 
·  
our plans to develop RI-002, including ongoing and planned clinical trials of RI-002, particularly the timing for initiation, enrollment and outcome;
 
·  
the expected timing of and our ability to obtain and maintain regulatory approvals for our product candidates;
 
·  
the potential indications for our product candidates;
 
·  
our intellectual property position;
 
·  
our manufacturing capabilities and strategy;
 
·  
our plans relating to manufacturing, supply and other collaborative agreements; and
 
·  
our estimates regarding expenses, capital requirements and needs for additional financing.
 
These statements may be found under “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.”  Forward-looking statements typically are identified by the use of terms such as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms, although some forward-looking statements are expressed differently.  You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to the factors referenced above.
 
You should also consider carefully the statements under “Risk Factors” and other sections of this prospectus, which address additional factors that could cause our actual results to differ from those set forth in the forward-looking statements.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward- looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
 
 
 
We have been a public reporting company since February 13, 2012.  However, there is not currently, and there has never been, any public market for our common stock.  Our common stock is not currently eligible for trading on any national securities exchange or any over-the-counter markets, including the OTC Bulletin Board.  In connection with this offering, we have applied to have our common stock quoted on the OTC Bulletin Board under the symbol "            ".  We cannot assure you that our common stock will continue to be quoted on the OTC Bulletin Board after this offering.
 
 
 
We estimate that the net proceeds from the sale of the shares of common stock we are offering will be approximately $         .  If the underwriters fully exercise the over-allotment option, the net proceeds of the shares we sell will be approximately $         .  “Net proceeds” is what we expect to receive after deducting the underwriting discount and commission and estimated offering expenses payable by us.
 
Each $1.00 increase (decrease) in the assumed offering price of $       would increase (decrease) the net proceeds to us from this offering by approximately $      million, after deducting estimated underwriting discount and commission and estimated offering expenses payable by us, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same.  Each increase of 1 million shares in the number of shares offered by us at the assumed public offering price would increase the net proceeds to us in this offering by approximately $      million. Similarly, each decrease of 1 million shares in the number of shares offered by us at the assumed public offering price would decrease the net proceeds to us from this offering by approximately $     million.  We do not expect that a change in the offering price or the number of shares by these amounts would have a material effect on our uses of the proceeds from this offering, although it may impact the amount of time prior to which we will need to seek additional capital.
 
We intend to use the net proceeds of this offering primarily to continue clinical testing and commercialization of RI-002 and for working capital and other general corporate purposes.  We estimate that the costs associated with (i) completion of clinical trials for RI-002 will be approximately $15 million, (ii) preliminary development expenses for a commercial organization in anticipation of FDA approval of RI-002 will be approximately $1 million; (iii) expansion of approved uses of RI-002 and development of additional plasma-derived products will be approximately $5 million; and (iv) expansion of plasma collection programs including the development of additional plasma facilities will be less than $5 million.  The remaining amount will be allocated for working capital and other general corporate purposes.
 
While we expect to use the net proceeds for the purposes described above, the amounts and timing of our actual expenditures will depend upon numerous factors, including the ongoing status and results of the RI-002 clinical trials. We believe that the net proceeds from this offering and our existing cash and equivalents, together with interest thereon, will be sufficient to fund our operations through 2015.  In the event that our plans change, our assumptions change or prove to be inaccurate, or the net proceeds of this offering prove to be insufficient, it may be necessary or advisable to reallocate proceeds or to use proceeds for other purposes, or we may be required to seek additional financing or we may be required to curtail our operations. As a result of the foregoing, our success will be affected by our discretion and judgment with respect to the application and allocation of the net proceeds of this offering.
 
Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States government.
 
 
 
We have never paid any cash dividends on our capital stock.  We anticipate that we will retain earnings, if any, to support operations and to finance the growth and development of our business.  In addition, the terms of existing and future debt agreements may preclude us from paying dividends.  Therefore, we do not expect to pay cash dividends in the foreseeable future.
 
Any future determination relating to dividend policy will be made at the discretion of our board of directors and will depend on our future earnings, capital requirements, financial condition, prospects, applicable Delaware law, which provides that dividends are only payable out of surplus or current net profits, and other factors that our board of directors deems relevant.
 
 
 
The following table shows:
 
·  
Our cash and cash equivalents and capitalization on  September 30, 2012; and
 
·  
Our cash and cash equivalents and capitalization on September 30, 2012, assuming the completion of the offering at an assumed public offering price of $            per share and the use of the net proceeds as described under “Use of Proceeds.”
 
   
September 30, 2012
 
       
   
Actual
(Unaudited)
   
As Adjusted (1) (Unaudited)
 
             
Cash and cash equivalents
  $ 10,720,397     $    
                 
Stockholders’ equity:
               
                 
Common Stock, $.0001 par value, 75,000,000 shares authorized, 4,654,303 shares issued and outstanding, actual;           shares issued and outstanding, as adjusted
    465          
                 
Additional paid-in capital
    46,464,366          
                 
Deficit accumulated during the development stage
    (34,857,791 )        
                 
Total stockholders’ equity and capitalization
  $ 11,607,040     $    

(1)
Each $1.00 increase (decrease) in the assumed offering price would increase (decrease) cash and cash equivalents, additional paid-in capital, and total stockholders’ equity and capitalization by approximately $       million, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. Each increase of 1,000,000 shares in the number of shares offered by us at the assumed public offering price would increase cash and cash equivalents, additional paid-in capital, and total stockholders’ equity and capitalization by approximately $      million. Similarly, each decrease of 1,000,000 shares in the number of shares offered by us at the assumed public offering price would decrease cash and cash equivalents, additional paid-in capital, and total stockholders’ equity and capitalization by approximately $      million. The as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.
 
The information in the above table does not give effect to the receipt of proceeds under a credit facility, entered into in December 2012, under which we received $4 million on the closing date with an option to borrow up to an additional $2 million upon the satisfaction of certain milestones.
 
 
 
Our net tangible book value on September 30, 2012 was $11,607,040, or $2.49 per share.  “Net tangible book value” is total assets minus the sum of liabilities and intangible assets.  “Net tangible book value per share” is net tangible book value divided by the total number of shares outstanding on September 30, 2012.
 
After giving effect to adjustments relating to the offering, our pro forma net tangible book value on September 30, 2012, would have been $           ; or $            per share.  The adjustments made to determine pro forma net tangible book value per share are the following:
 
·  
An increase in total assets to reflect the net proceeds of the offering as described under “Use of Proceeds”  (assuming that the public offering price will be $            per share).
 
·  
The addition of the number of shares offered by this prospectus to the number of shares outstanding.
 
The following table illustrates the pro forma increase in net tangible book value of $            per share and the dilution (the difference between the offering price per share and net tangible book value per share) to new investors:
 
Assumed public offering price per share
  $    
Net tangible book value per share as of September 30, 2012
  $ 2.49  
Increase in net tangible book value per share attributable to the offering
       
Pro forma net tangible book value per share as of September 30, 2012 after giving effect to the offering
       
Dilution per share to new investors in the offering
  $    
 
Each $1.00 increase (decrease) in the assumed public offering price of $      per share would increase (decrease) our as adjusted net tangible book value after this offering by approximately $       , or approximately $      per share, and the dilution per share to new investors by approximately $      per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering from the assumed number of shares set forth on the cover page of this prospectus. An increase of 1,000,000 shares in the number of shares offered by us from the assumed number of shares set forth on the cover page of this prospectus would increase our as adjusted net tangible book value after this offering by approximately $        , or approximately $      per share, and the dilution per share to new investors would be approximately $       per share, assuming that the assumed public offering price remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, a decrease of 1,000,000 shares in the number of shares offered by us from the assumed number of shares set forth on the cover page of this prospectus would decrease our as adjusted net tangible book value after this offering by approximately $      , or approximately $       per share, and the dilution per share to new investors would be approximately $      per share, assuming that the assumed public offering price remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of shares that we offer in this offering, and other terms of this offering determined at pricing.
 
If the underwriters exercise their over-allotment option to purchase up to             additional shares of common stock from us in full in this offering at the assumed public offering price of $            per share, the adjusted net tangible book value as of September 30, 2012 after giving effect to this offering would increase to $            per share, and dilution per share to new investors in this offering would be $            per share.
 
 
The number of shares of our common stock to be outstanding immediately after this offering is based on 4,654,303 shares of our common stock outstanding as of September 30, 2012.  The number of shares outstanding as of September 30, 2012 excludes:
 
·  
589,937 shares issuable upon exercise of outstanding options with a weighted average exercise price of $8.71; and
 
·  
87,865 shares issuable upon exercise of outstanding warrants with a weighted average exercise price of $9.60.
 
The foregoing table does not give effect to the exercise of any outstanding options or warrants.  To the extent options and warrants are exercised, there may be further dilution to new investors.
 
 
Financial Condition and Results of Operations
 
This discussion, which refers to the historical results of ADMA and its predecessor business, should be read in conjunction with the other sections of this prospectus, including “Risk Factors,” “Business” and the consolidated financial statements and other consolidated financial information included in this prospectus.  The various sections of this discussion contain a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risk factors described throughout this prospectus.  See “Special Note Regarding Forward-Looking Statements.”  Our actual results may differ materially.
 
Overview
 
Revenue
 
As of September 30, 2012, we have generated $1,360,276 of revenue since inception from the sale of normal source human plasma collected at our plasma collection center and plasma-derived medicinal products.  Revenue is recognized at the time of transfer of title and risk of loss to the customer, which usually occurs at the time of shipment; however, revenue is recognized at the time of delivery if we retain the risk of loss during shipment.
 
Research and Development Expenses
 
Research and development expenses consists of clinical research organization and clinical trial costs related to our clinical trial; consulting expenses relating to regulatory affairs; quality control and manufacturing; assay development and ongoing testing costs, drug product manufacturing including the cost of plasma, plasma storage and transportation costs; as well as wages and benefits for employees directly related to the research and development of RI-002.  All research and development is expensed as incurred.
 
The process of conducting preclinical studies and clinical trials necessary to obtain FDA approval is costly and time consuming.  The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability.  As a result of the uncertainties discussed above, the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates.  Development timelines, probability of success and development costs vary widely.  We expect that our research and development expenses will increase during 2013 as a result of our pivotal Phase III clinical program, the hiring of a Chief Scientific and Medical Officer and additional clinical operations staff, consultants and vendor requirements attributed to the development of RI-002.
 
General and Administrative Expenses
 
General and administrative expenses consists of rent, maintenance and utilities, insurance, wages, stock-based compensation and benefits for senior management and staff unrelated to research and development, legal fees, accounting and auditing fees, information technology, travel and other expenses related to the general operations of the business.  We expect that our general administrative expenses will increase during 2013, as a result of our hiring a Chief Financial Officer and additional staff after becoming a public reporting company in February 2012.
 
Interest Income and Interest Expense
 
Interest income consists of interest earned on our cash and cash equivalents.  Interest expense consists of interest incurred on our convertible notes up to their automatic conversion into our common stock upon the completion of our private placement in February 2012, as well as the amortization and write-off of deferred financing costs and debt discounts and a charge for the beneficial conversion feature relating to our convertible notes.
 
 
Results of Operations
 
Nine Months Ended September 30, 2011 Compared to Nine Months Ended September 30, 2012
 
Summary Table
 
The following table presents a summary of our results of operations for the nine months ended September 30, 2011 compared to the nine months ended September 30, 2012:
 
   
Nine Months Ended September 30, 2011
(Unaudited)
   
Nine Months Ended September 30, 2012
(Unaudited)
 
Revenues
  $ -     $ 594,834  
Cost of sales
  $ -     $ 288,761  
Gross profit
  $ -     $ 306,073  
Research and development expenses
  $ 443,188     $ 2,201,131  
Loss on sale of inventory
  $ 1,934,630     $ -  
Plasma center operating expenses
  $ 1,191,243     $ 1,327,761  
General and administrative expenses
  $ 932,248     $ 2,446,043  
Total operating expenses
  $ 4,501,309     $ 5,974,935  
Interest income
  $ 1,212     $ 15,712  
Interest expense
  $ 769,342     $ 14,241  
Loss before income taxes
  $ (5,269,439)     $ (5,667,391)  
Income tax benefit
  $ 320,765     $ 617,615  
Net loss
  $ (4,948,674)     $ (5,049,776)  
Loss before income taxes in plasma collection segment
  $ (1,198,398)     $ (1,028,153)  
Loss before income taxes in research and development segment
  $ (443,188)     $ (2,201,131)  

Revenue
 
We received FDA approval for ADMA BioCenters in August 2011.  As a result, we recorded revenue of $594,834 during the nine months ended September 30, 2012 from the sale of normal source human plasma collected by ADMA BioCenters, compared to no revenues for the nine months ended September 30, 2011.  The revenue for the nine months ended September 30, 2012 was primarily attributed to sales made pursuant to a plasma supply agreement entered into with Biotest during June 2012, under which Biotest purchases normal source plasma from ADMA BioCenters to be used in their manufacturing.  We have not generated any revenue from our therapeutics/research and development business.
 
 
Cost of Sales
 
Cost of sales was $288,761 for the nine months ended September 30, 2012, with no cost of sales for the comparable prior year period of 2011.  The cost of sales for the nine months ended September 30, 2012 related to the costs associated with the sales of normal source plasma.
 
Research and Development Expenses
 
Research and development expenses was $2,201,131 for the nine months ended September 30, 2012, an increase of $1,757,943 from $443,188 for the nine months ended September 30, 2011.  Research and development expenses increased compared to the quarter ended September 30, 2011, primarily as a result of higher manufacturing, testing and regulatory costs in preparation for our upcoming pivotal Phase III clinical study along with the recent appointment of our Chief Scientific and Medical Officer and related wages and stock-based compensation expense during the nine months ended September 30, 2012.
 
During the nine months ended September 30, 2012, there was no loss on the sale of research and development inventory as compared to a loss of $1,934,630 during the nine months ended September 30, 2011, as a result of disposal of certain of our inventory that we previously acquired to conduct research and development for a different product.  The total amount of inventory sold at book value was $2,439,487, of which we received $504,857 in total net proceeds from the inventory sales, thus resulting in a loss on the sale of research and development inventory of $1,934,630 for the nine months ended September 30, 2011.  This plasma, which was sold on a non-recurring basis, had not been collected at our plasma collection facility, but had been purchased from third parties.
 
Plasma Center Operating Expenses
 
Plasma center operating expenses was $1,327,761 for the nine months ended September 30, 2012, an increase of $136,518 from $1,191,243 for the nine months ended September 30, 2011.  Plasma center operating expenses consists of general and administrative overhead, including rent, maintenance and utilities, wages and benefits for center staff, plasma collection supplies, plasma transportation and storage (off-site) and computer software fees directly related to donor collections.  The increase in plasma center expenses was a result of increased donor collections during the nine months ended September 30, 2012, which was attributed to the FDA licensing of ADMA BioCenters in August 2011.  We expect that as plasma collection increases, our plasma center operating expenses will also increase accordingly.
 
General and Administrative Expenses
 
General administrative expenses was $2,446,043 for the nine months ended September 30, 2012, an increase of $1,513,795 from $932,248 for the nine months ended September 30, 2011.  General administrative expenses increased as a result of higher compensation and stock-based compensation costs resulting from option grants to our President and Chief Executive Officer, board members, our Chief Financial Officer who was appointed in May 2012, and other employees during 2012 in addition to increased professional services fees and SEC filing fees attributable to being a public reporting company since February 2012.
 
Total Operating Expenses
 
Total operating expenses were $5,974,935 for the nine months ended September 30, 2012, an increase of $1,473,626 from $4,501,309 for the nine months ended September 30, 2011, for the reasons stated above.  The increase in total operating expense was offset by a loss on the sale of inventory of $1,934,630 during the nine months ended September 30, 2011, as a result of disposal of our inventory of high priced, high-titer plasma that we previously acquired to conduct research and development for a different product.  The total amount of inventory sold at book value was $2,439,487, of which we received $504,857 in total net proceeds from the inventory sales, thus resulting in a loss on the sale of inventory of $1,934,630 for the nine months ended September 30, 2011 compared to no loss on the sale of inventory during the nine months ended September 30, 2012.  We subsequently abandoned a research program and sold the high-titer plasma to generate additional funds for operations.  This plasma, which was sold on a non-recurring basis, had not been collected at ADMA BioCenters, but had been purchased from third parties.
 
 
Other Income (Expense); Interest Income/Expense
 
Interest income, net, was $1,471 for the nine months ended September 30, 2012, compared to interest expense, net, of $(768,130) for the nine months ended September 30, 2011.  The increase in interest income was attributed to having higher cash reserves during the nine months ended September 30, 2012 compared to the comparable period in 2011 as a result of the private placement of 1,800,000 shares of our common stock with gross proceeds in cash of $17,287,288 in February 2012.  The decrease in interest expense was a result of the conversion of our notes in December 2011 and February 2012.
 
Loss Before Income Taxes
 
Loss before income taxes was $5,667,391 for the nine months ended September 30, 2012, an increase of $397,952 from $5,269,439 for the nine months ended September 30, 2011, for the reasons stated above.
 
State Income Tax Benefit
 
In January 2012 and 2011, we received $617,615 and $320,765, respectively, from the sale of our State of New Jersey net operating losses.  These losses were sold through the New Jersey Economic Development Authority Technology Business Tax Certificate Transfer Program.  Under the terms of this program, if we do not use the proceeds from these sales for costs incurred with operating our biotechnology business in New Jersey, we have to refund the face value of the proceeds.  If we do not maintain our headquarters or a base of operations in New Jersey during the five years following receipt of these proceeds (other than due to liquidation), we have to refund the face value of the proceeds less 20% for each year completed of the five year period.  We cannot make assurances that we will qualify under this program in future years or even that the program will exist in future years.
 
Net Loss
 
Net loss was $5,049,776 for the nine months ended September 30, 2012 and $4,948,674 for the nine months ended September 30, 2011, for the reasons stated above.
 
Cash Flows
 
Net Cash Used in Operating Activities
 
Net cash used in operating activities was $5,096,745 for the nine months ended September 30, 2012.  The net loss for this period is lower than net cash used in operating activities by $46,969, which was primarily attributable to decreases in accounts payable of $412,652 related to cash disbursements to vendors, a decrease in inventories of $137,658 and prepaid expenses of $130,352, primarily related to the costs of manufacturing of our product candidate RI-002 in preparation for its use in the pivotal Phase III clinical study and our director’s and officer’s insurance policy premiums for 2012, respectively, and an increase in accounts receivable of $61,897 related to sales of our normal source plasma during the three months ended September 30, 2012, offset by depreciation and amortization of $140,743 and stock-based compensation of $408,544.
 
Net cash used in operating activities was $1,417,549 for the nine months ended September 30, 2011.  The net loss for the nine months ended September 30, 2011 was higher than net cash used in operating activities by $3,531,125, which was primarily attributable to a loss on the sale of inventory of $1,934,630, depreciation and amortization of $166,161, the amortization of debt discount and beneficial conversion charges of $184,185, a decrease in inventories of $481,389, a decrease in other assets of $90,000, and increases in accounts payable of $92,404 and accrued interest of $575,173.
 
 
Net Cash Used in Investing Activities
 
Net cash used in investing activities of $83,521 for the nine months ended September 30, 2012, was attributable to computer hardware and software purchases, which were related to the expansion and upgrade of our information technology systems.
 
Net Cash Provided by Financing Activities
 
Net cash provided by financing activities of $15,812,892 for the nine months ended September 30, 2012, was attributable to the proceeds of $17,287,288 received from the private placement of our common stock on February 13, 2012, net of equity issuance costs of $1,266,495 and the repayment of our notes payable of $200,000.  Net cash provided by financing activities for the nine months ended September 30, 2011 was $1,192,776, which was primarily related to the proceeds from notes payable.
 
Year Ended December 31, 2010 Compared to Year Ended December 31, 2011
 
Summary Table
 
The following table presents a summary of our results of operations for the year ended December 31, 2010 compared to the year ended December 31, 2011.
 
   
Year ended December 31, 2010
   
Year ended December 31, 2011
 
Revenues
  $ -     $ 761,042  
Cost of sales
  $ -     $ 207,570  
Gross profit
  $ -     $ 553,472  
Research and development expenses
  $ 2,193,838     $ 646,756  
Loss on sale of inventory
  $ -     $ 1,934,630  
Plasma center operating expenses
  $ 1,876,644     $ 1,163,148  
General and administrative expenses
  $ 1,425,951     $ 1,431,894  
Total operating expenses
  $ 5,496,433     $ 5,176,428  
Other income
  $ 244,479     $ -  
Interest income
  $ 10,235     $ 1,689  
Interest expense
  $ 705,993     $ 1,602,958  
Loss before income taxes
  $ (5,947,712)     $ (6,224,225)  
Income tax benefit
  $ -     $ 320,765  
Net loss
  $ (5,947,712)     $ (5,903,460)  
Loss before income taxes in plasma collection segment
  $ (1,876,644)     $ (609,676)  
Loss before income taxes in research and development
  $ (2,193,838)     $ (2,581,386)  
 
 
Revenue
 
We recorded revenue of $761,042 during the year ended December 31, 2011 compared to no revenues for the year ended December 31, 2010 from the sale of blood plasma collected by ADMA BioCenters.  We have not generated any revenue from our therapeutics/research and development business.
 
Research and Development Expenses
 
Research and development expenses declined from $2,193,838 for the year ended December 31, 2010 to $646,756 for the year ended December 31, 2011.  Research and development expenses consist of consulting expenses relating to regulatory affairs, quality control and manufacturing, assay development and ongoing testing costs, clinical trial costs and fees, drug product manufacturing including the cost of plasma, plasma storage and transportation costs, as well as wages and benefits for staff directly related to the research and development of RI-001.
 
Research and development expenses declined in the comparable twelve-month period from 2010 to 2011, primarily because we had an ongoing Phase II trial that was completed in 2010 but did not have an ongoing clinical trial in 2011.
 
Plasma Center Operating Expenses
 
Plasma center operating expenses declined from $1,876,644 for the year ended December 31, 2010 to $1,370,718 for the year ended December 31, 2011.  Plasma center operating expenses consist of general and administrative overhead including rent, maintenance and utilities, wages and benefits for center staff, plasma collection supplies, plasma transportation and storage (off-site) and computer software fees directly related to donor collections.  Plasma center expenses declined because we slowed the rate of donor collections in the year ended December 31, 2011 which was lower than in 2010; however, donor collections increased after FDA approval of our plasma center in August 2011.  We expect that as plasma collection increases, ADMA BioCenters operating expenses will also increase accordingly.
 
General and Administrative Expenses
 
General and administrative expenses increased slightly from $1,425,951 for the year ended December 31, 2010 to $1,431,894 for the year ended December 31, 2011.  General and administrative expenses consist of rent, maintenance and utilities, insurance, wages and benefits for senior management and staff unrelated to research and development, professional fees for our attorneys, accountants and auditors, information technology, travel and other expenses related to the general operations of the business.
 
Total Operating Expenses
 
Total operating expenses decreased from $5,496,433 during the year ended December 31, 2010 to $5,176,428 for the year ended December 31, 2011, primarily as a result of the reduction of research and development expenses, general and administrative expenses, and plasma center operating expenses, partially offset by the loss on sale of inventory.
 
Other Income (Expense); Interest Income/Expense
 
We had interest income of $1,689 and $10,235 during the years ended December 31, 2011 and 2010, respectively, and interest expense of $1,602,958 and $705,993 on loans from related parties during the years ended December 31, 2011 and 2010, respectively.  All but $450,000 in principal amount of those loans was converted or repaid prior to December 31, 2011, with the remaining $250,000 (plus $12,740 in accrued interest) invested in the private placement of securities completed in 2012 and $200,000 repaid in 2012.
 
 
Loss Before Income Taxes
 
Loss before income taxes increased from $5,947,712 during the year ended December 31, 2010 to $6,224,225 during the year ended December 31, 2011.  Loss before income taxes in the plasma collection segment was $609,676 for the year ended December 31, 2011 compared to $1,876,644 for the year ended December 31, 2010 while the loss before income taxes attributable to the research and development segment increased from $2,193,838 during the year ended December 31, 2010 to $2,581,386 during the year ended December 31, 2011.  The decrease in losses in the plasma collection business is attributable primarily to the sale of blood plasma during 2011 following FDA approval of the operations of our plasma collection operations.
 
Income Taxes
 
In January 2011, we received approximately $321,000 from the sale of our 2010 State of New Jersey net operating losses.  These losses were sold through the New Jersey Economic Development Authority Technology Business Tax Certificate Transfer Program.
 
Net Loss
 
Net loss decreased from $5,947,712 to $5,903,460 from the year ended December 31, 2010 to the year ended December 31, 2011.
 
Net Cash Used in Operating Activities
 
Net cash used in operating activities was $4,812,998 for the year ended December 31, 2010.  The net loss for the year ended December 31, 2010 is higher than cash used in operating activities by $1,134,714 due to an increase in accounts payable and non-cash interest expense attributable to the convertible notes offset in part by increases in inventory and decreases in accrued expenses.
 
Net cash used in operating activities was $1,431,188 for the year ended December 31, 2011.  The net loss for this period is higher than net cash used in operating activities by $4,472,272, which was primarily due to the loss on sale of inventory, an increase in non-cash interest expense and a decrease in inventories.
 
Net Cash Used in Investing Activities
 
Net cash used in investing activities for the year ended December 31, 2010 was $3,183 related to equipment purchases.
 
Minimal cash was used in investing activities for the year ended December 31, 2011.
 
Net Cash Provided by Financing Activities
 
Net cash provided by financing activities for the year ended December 31, 2010 was $2,291,094, which primarily related to cash proceeds from the issue of convertible notes.
 
Net cash provided by financing activities for the year ended December 31, 2011 was $1,290,258, principally attributable to proceeds from the issue of convertible notes of $1,500,000, net of repayment of notes payable of $200,000.
 
 
Liquidity and Capital Resources
 
Overview
 
We have had limited revenue from operations and we have incurred cumulative losses of $34,857,791 since inception.  We have funded our operations to date primarily from equity investments and loans from our primary stockholders.  We received net cash proceeds of approximately $15.6 million in our February 2012 private placement, after the payment of all related expenses, including legal, printing, and travel expenses, the placement agent’s commissions and expense reimbursements, which amount does not include the secured promissory notes that were satisfied in exchange for common stock in the private placement.  We anticipate that the proceeds raised in this offering, along with existing resources, will be sufficient to fund our operations at least through 2015.
 
Based upon our projected revenue and expenditures for 2012 and 2013, management currently believes that the net proceeds of the February 2012 private placement, together with our previously-existing cash, will be sufficient to enable us to fund our operating expenses, research and development expenses and capital expenditures into the third quarter of 2013.  As we do not anticipate receiving FDA approval for RI-002, until at the earliest, the second half of 2015, if at all, and would therefore not be able to generate revenues from the commercialization of RI-002 until after that date, we will have to raise additional capital prior to the third quarter of 2013 to continue product development and operations.  We are unable to predict with reasonable certainty when, if ever, we will generate revenues from the commercialization of RI-002 and, therefore, how much additional capital we will need to raise prior to the third quarter of 2013.  Furthermore, if our assumptions underlying our estimated revenues and expenses prove to be wrong, we may have to raise additional capital sooner than anticipated.  There can be no assurance that such funds, if available at all, can be obtained on terms acceptable to us.  As there are numerous risks and uncertainties associated with the research, development and future commercialization of our product candidate, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with our anticipated clinical trials and development activities.  Our current estimates may be subject to change as circumstances regarding requirements further develop.  We may decide to raise capital through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements.  We do not have any existing commitments for future external funding.  We may seek to sell additional equity or debt securities or obtain a bank credit facility.  The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders.  The incurrence of indebtedness would result in increased fixed obligations and could also result in covenants that would restrict our operations or other financing alternatives.
 
Additional equity or debt financing, grants, or corporate collaboration and potential licensing arrangements may not be available on acceptable terms, if at all.  If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our research and development programs, reduce our planned clinical trials and delay or abandon potential commercialization efforts of our lead product candidate.  See also “Future Financing Needs” below.
 
As of September 30, 2012, we had working capital of $10,578,044, consisting primarily of $10,720,397 of cash and cash equivalents and $1,009,687 of inventories, offset by $1,393,356 in accounts payable and accrued expenses.
 
During January 2012, we received $617,615 from the sale of our State of New Jersey net operating losses through the New Jersey Economic Development Authority program.  We cannot make assurances that funding will be available for us in the future under this program.
 
Future Financing Needs
 
The net proceeds from our February 2012 private placement have been used to test plasma donors for RSV titers, collect and procure plasma, manufacture drug product, conduct clinical trials, and the remainder for payment of existing accounts payable, general and administrative expenses as well as other business activities and general corporate purposes, including for the payment of accrued expenses, premiums for directors’ and officers’ insurance.  We anticipate that the proceeds raised in this offering, along with existing resources, will be sufficient to fund our operations at least through 2015.
 
 
Our ability to continue as a going concern will be dependent on our ability to raise additional capital, to fund our research and development and commercial programs and meet our obligations on a timely basis.  If we are unable to successfully raise sufficient additional capital we will likely not have sufficient cash flow and liquidity to fund our business operations, forcing us to delay, discontinue or prevent product development and clinical trial activities or the approval of any of our potential products or curtail our activities and, ultimately, potentially cease operations.  Even if we are able to raise additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of our common stock may decline.  In addition, the incurrence of indebtedness would result in increased fixed obligations and could result in covenants that would restrict our operations or other financing alternatives.
 
Financial markets in the United States, Canada, Europe and Asia continue to experience disruption, including, among other things, significant volatility in security prices, declining valuations of certain investments, as well as severely diminished liquidity and credit availability.  Business activity across a wide range of industries and regions continues to be greatly reduced and local governments and many businesses are still suffering from the lack of consumer spending and the lack of liquidity in the credit markets.  The continued instability in the credit and financial market conditions may negatively impact our ability to access capital and credit markets and our ability to manage our cash balance.  While we are unable to predict the continued duration and severity of the adverse conditions in the United States and other countries, any of the circumstances mentioned above could adversely affect our business, financial condition, operating results and cash flow or cash position.
 
Recent Accounting Pronouncements
 
The Financial Accounting Standards Board has issued certain accounting pronouncements as of September 30, 2012 that will become effective in subsequent periods; however, we do not believe that any of those pronouncements would have significantly affected our financial accounting measurements or disclosures had they been in effect during the nine months ended September 30, 2012 or that they will have a significant impact at the time they become effective.
 
Critical Accounting Policies and Estimates
 
On April 5, 2012, the JOBS Act was signed into law.  The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for qualifying public companies.  As an “emerging growth company,” we may, under Section 7(a)(2)(B) of the Securities Act, delay adoption of new or revised accounting standards applicable to public companies until such standards would otherwise apply to private companies.  We may take advantage of this extended transition period until the first to occur of the date that we (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of this extended transition period.  We have elected to take advantage of the benefits of this extended transition period.  Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.  Until the date that we are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(B), upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-emerging growth companies and the date on which we will adopt the recently issued accounting standard.
 
This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP.  The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses.  On an ongoing basis, we evaluate these estimates and assumptions, including those described below.  We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances.  These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  Actual results and experiences may differ materially from these estimates.
 
Some of the estimates and assumptions we have to make under GAAP require difficult, subjective and/or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from those estimates.  Due to the estimation processes involved, the following summarized accounting policies and their application are considered to be critical to understanding our business operations, financial condition and results of operations.
 
 
Stock-Based Compensation
 
Stock-based compensation cost is measured at grant date, based on the estimated fair value of the award, and is recognized as expense over the employee’s requisite service period on a straight-line basis.
 
We account for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model.  The non-cash charge to operations for non-employee options with vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to consulting expense over the related contract service period.
 
For the purpose of valuing options and warrants granted to our employees, non-employees and directors and officers during the nine months ended September 30, 2012, we used the Black-Scholes option pricing model.  We granted options to purchase an aggregate of 506,559 shares of common stock during the nine months ended September 30, 2012.  Of the 506,559 options granted, 212,134 options were granted to our President and Chief Executive Officer, 106,067 options were granted to our Chief Scientific and Medical Officer, 66,292 options were granted to our Chief Financial Officer, 106,066 options in the aggregate were granted to our Board of Directors and 16,000 options in the aggregate were granted to non-executive employees.  To determine the risk-free interest rate, we utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of our awards.  The expected term of the options granted is in accordance with Staff Accounting Bulletin 107 which is based the average between vesting term and contractual term.  The expected dividend yield reflects our current and expected future policy for dividends on our common stock.  The expected stock price volatility for our stock options was calculated by examining historical volatilities for similar publicly traded industry peers, since we do not have any trading history for our common stock.  We will continue to analyze the expected stock price volatility and expected term assumptions as historical data for our common stock becomes available.  We have not experienced forfeitures of stock options and as such, have not established a forfeiture rate.  Since the stock options currently outstanding are primarily held by our senior management and directors, we will continue to evaluate the effects of such future potential forfeitures, as they may arise, to evaluate our estimated forfeiture rate.
 
Research and Development Costs
 
Our expenses include all research and development costs as incurred including on the disposition plasma and equipment for which there is no alternative future use.  Such expenses include costs associated with planning and conducting clinical trials.
 
Our agreement with Biotest includes the in-license of certain rights to incomplete, in-process technology, which we expect to finalize during the first quarter of 2013.  As such, we expect to account for the value of this license as a charge to operations once the terms of the in-license agreement are finalized.
 
Revenue Recognition
 
Revenue from the sale of human plasma collected by ADMA BioCenters and plasma-derived medicinal products is recognized at the time of transfer of title and risk of loss to the customer, which usually occurs at the time of shipment.  Revenue is recognized at the time of delivery if we retain the risk of loss during shipment.
 
The plasma inventory sold in 2011 had been purchased from third parties specifically for use in research and development activities.  It had not been collected by ADMA BioCenters and sold in the ordinary course of business.  Therefore, the sale was not recorded as revenue with related cost of sales, but was instead recorded as a loss on sale.
 
 
Off-Balance Sheet Arrangements
 
We do not have any off-balance sheet arrangements except that we are currently obligated under a ten-year lease agreement for our ADMA BioCenters plasma collection facility.  There is a total minimum rent due under the lease of $1,142,138 through the end of the lease term in September 2018.
 
Hercules Loan and Security Agreement

On December 21, 2012, we and our subsidiaries entered into a Loan and Security Agreement, or the Loan Agreement, with Hercules Technology Growth Capital, Inc., or Hercules.  Under the Loan Agreement, we may borrow up to a maximum of $6 million.  We borrowed $4 million on the closing date and we have the option to borrow an additional $2 million in two equal tranches of $1 million upon the satisfaction of certain milestones. The loan bears interest at a rate per annum equal to the greater of (i) 8.5% and (ii) the sum of (a) 8.5% plus (b) the Prime Rate (as reported in The Wall Street Journal ) minus 5.75%. The loan is secured by our assets, except for our intellectual property (which is subject to a negative pledge). The principal will be repaid over 27 months beginning no later than May 1, 2014, unless accelerated as a result of certain events of default. Interest is due and payable on the first of every month and at the termination date, unless accelerated as a result of an event of default. In addition, a backend fee equal to 2.65% of the amount funded under the facility is due on the maturity or prepayment date or the date that the secured obligations become due and payable and a 1% facility fee in the amount of $60,000 and a commitment fee in the amount of $25,000 were both due at closing.  The loan matures no later than August 2016.
 
In the event we elect to prepay the loan, we are obligated to pay a prepayment charge corresponding to a percentage of the principal amount of the loan, with such percentage being: 3.0% if prepayment occurs in the first year, 2% if prepayment occurs in the second year and 0.5% if prepayment occurs after the second year but prior to the last day of the term.
 
The Loan Agreement contains customary representations, warranties and covenants, including limitations on incurring indebtedness, engaging in mergers or acquisitions and making investments, distributions or transfers.  The representations, warranties and covenants contained in the Loan Agreement were made only for purposes of such agreement and as of a specific date or specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Loan Agreement.
 
Events of default under the agreement include, but are not limited to: (i) insolvency, liquidation, bankruptcy or similar events; (ii) failure to pay any debts due under the Loan Agreement or other loan documents on a timely basis; (iii) failure to observe any covenant or secured obligation under the Loan Agreement or other loan documents, which failure, in most cases, is not cured within 10 days of written notice by lender; (iv) occurrence of any default under any other agreement between us and the lender, which is not cured within 10 days; (v) occurrence of an event that could reasonably be expected to have a material adverse effect;  (vi) material misrepresentations; (vii) occurrence of any default under any other agreement involving indebtedness in excess of $50,000 or the occurrence of a default under any agreement that could reasonably be expected to have a material adverse effect; and (viii) certain money judgments are entered against us or a certain portion of our assets are attached or seized.   Remedies for events of default include acceleration of amounts owing under the Loan Agreement and taking immediate possession of, and selling, any collateral securing the loan.
 
In connection with the Loan Agreement, we issued to Hercules a warrant to purchase 25,000 shares of common stock with an exercise price set at the lower of (i) $9.60 or (ii) the price per share of the next round of financing, subject to customary anti-dilution adjustments  The warrant expires after 10 years and has piggyback registration rights with respect to the shares of common stock underlying the warrant.  In addition, we have also granted Hercules the option to invest (until the loan maturity date) up to $1 million in future equity financings at the same terms as the other investors.

The Loan Agreement contains certain provisions that require the warrants issued to Hercules to be accounted for as a liability and “marked-to-market” each reporting period.  Changes in the valuation of this liability at the end of each reporting period will be included in our reported operating results, and may create volatility in our reported operating results.
 
 
 
Unless the context otherwise requires, references in this section to “ADMA,”  the “Company,” “ADMA Biologics,” “we,” “us” and “our” refer to ADMA Biologics, Inc., a Delaware corporation, as well as its subsidiary, ADMA Plasma Biologics, Inc., a Delaware corporation, taken as a whole, and also refer to the operations of ADMA Plasma Biologics, Inc. prior to the merger on February 13, 2012, as discussed below, which resulted in ADMA Plasma Biologics, Inc. becoming our wholly-owned subsidiary.  In each case, references to ADMA Plasma Biologics, Inc. also include its subsidiary ADMA BioCenters Georgia Inc., or ADMA BioCenters, a Delaware corporation.
 
Business of ADMA
 
Overview
 
ADMA Biologics is a specialty immune globulin company that develops, manufactures and intends to market plasma-based biologics for the treatment and prevention of certain infectious diseases.  Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-suppressed for medical reasons.  Our lead product candidate, RI-002, for which we have commenced a pivotal Phase III clinical trial, is intended for the treatment of primary immune deficiency disease, or PIDD.  RI-002 is an injectable immune globulin derived from human plasma enriched with high levels of naturally occurring polyclonal antibodies including those targeted to respiratory syncytial virus, or RSV.  RSV is a common virus that ordinarily leads to mild, cold-like symptoms in healthy adults and children.  In high-risk groups, such as the immune-compromised, RSV can lead to a more serious infection and may even cause death.  Our proprietary microneutralization assay allows us to effectively identify and isolate donor plasma with high titer RSV antibodies, to standardize RI-002’s potency and thereby potentially garner a premium price.
 
PIDD, a genetic disorder that causes a deficient or absent immune system, is caused by hereditary or genetic defects and can affect anyone regardless of age or gender.  PIDD patients are more vulnerable to infections and more likely to suffer complications from these infections.  Intravenous immune globulin, or IGIV, is a plasma derived product that is used to prevent serious infections in patients with PIDD.  It is comprised of polyclonal antibodies, which are proteins produced by B-cells that are used by the body’s immune system to neutralize foreign objects such as bacteria and viruses.  RI-002, a specialty IGIV with standardized levels of high-titer RSV antibodies, is intended to prevent infections in PIDD patients.  The polyclonal antibodies which are present in RI-002 are expected to prevent infections in immune-compromised patients. It is estimated that there are about 250,000 diagnosed PIDD patients in the United States approximately half of whom are treated with IGIV regularly. Since the introduction of IGIV therapy, the incidence of infections in IGIV-treated patients has dropped significantly.  In the United States, sales of immune globulin products for all its uses were reported to be approximately $3.5 billion in 2011. 
 
We commenced our pivotal Phase III clinical trial of RI-002 for the treatment of patients with PIDD in 2013.  The trial is a single arm, open label study in which patients will be treated approximately once per month for a period of 12 months of treatment plus 90 days for follow up. We intend to treat an aggregate of between 60 and 70 patients in approximately 12 treatment centers in the United States.  The pivotal Phase III primary endpoint follows the published FDA industry guidance, which provides for a reduction in the incidence of serious infections to less than one per year in those receiving IGIV.  The secondary endpoint is safety and includes other data collection points including antibody titers for certain agents, including RSV antibody levels at various time points after infusion.  Following the FDA’s guidance for our protocol should provide that a successful single Phase III trial and Biological License Application, or BLA, submission should lead to FDA approval.  RI-001 was the subject of a Phase II randomized, double-blind, placebo-controlled human clinical trial in RSV-infected, immune-compromised patients. In that trial, RI-001 treated patients demonstrated a statistically significant rise in anti-RSV titers compared to patients receiving placebo.  RI-002 is an improved formulation of our prior product candidate RI-001, which successfully completed a Phase II trial.  RI-002 is manufactured using the same FDA-approved contract manufacturing facility as its predecessor.  RI-002 has demonstrated improved production yields, an improved stability profile and comparable anti-RSV antibody titer potency relative to the prior formulation.
 
We have established, qualified and validated a proprietary microneutralization assay for plasma collection and donor screening as well as for determining the appropriate anti-RSV antibody potency for the manufacture of RI-002.  Our assay provides for measurement of RSV antibody titer levels of RI-002 that are consistent and reproducible, which we believe is a competitive advantage and a barrier to the entry of competitive products.  Our microneutralization assay could serve as a platform for identifying next generation virus-specific plasma-based therapeutics.
 
 
We have an FDA-licensed source plasma collection facility, ADMA BioCenters, which provides us with a portion of our blood plasma for the manufacture of RI-002.  A typical plasma collection center, such as ADMA BioCenters, can collect 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale.  Plasma collected from ADMA BioCenters that is not used for making RI-002 is sold to customers under an existing supply agreement or in the open “spot” market.  We have entered into long term manufacturing and licensing agreements with Biotest AG and their United States subsidiary, Biotest Pharmaceuticals, Inc., together referred to as Biotest, that provide for the exclusive manufacture of RI-002.  At the same time, we granted Biotest an exclusive royalty-bearing license to market and sell RSV antibody-enriched IGIV in Europe and in other selected territories in North Africa and the Middle East.
 
The founders of ADMA have a combined 60 years of experience marketing and distributing blood plasma products and devices.  With the appointment of the executive team and the board of directors, we added over 150 years of deep medical, technical and development experience in the biologics and pharmaceutical industry.
 
Our mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche immune-compromised patient populations.  We intend to accomplish our mission by achieving the following:
 
·  
Complete our pivotal Phase III trial and obtain FDA approval to manufacture and market RI-002 for the treatment of patients with PIDD.
 
·  
Establish a specialty sales force to commercialize RI-002.
 
·  
Explore other possible indications for RI-002.
 
·  
Develop additional plasma-derived products for the treatment of infectious diseases in immune-compromised patient populations.
 
·  
Grow our network of ADMA BioCenters facilities both to maintain control of a portion of our raw material supply and to generate additional revenue through the collection and sale of source plasma to third party customers.
 
Our Strategy
 
Our goal is to be a leader in developing and commercializing specialized, targeted, plasma-derived therapeutics to extend and enhance the lives of individuals who are naturally or medically immune-compromised.
 
The key elements of our strategy for achieving this goal are as follows:
 
·  
Obtain FDA approval of RI-002 as a treatment for PIDD .  We will be conducting a pivotal Phase III clinical trial for RI-002 for the treatment of PIDD in accordance with the FDA Guidance for Industry.  If the pivotal Phase III trial produces the anticipated safety and efficacy results, we would expect to file a BLA in the second half of 2014 and anticipate potential FDA approval within approximately a year of filing.
 
·  
Commercialize RI-002 as a treatment for PIDD .  We plan to hire a small, specialty sales force to market RI-002 to hospitals, physician offices/clinics, and other specialty treatment organizations.  We anticipate staffing our company with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs, reimbursement, inventory and logistics, human resources, and financial and operational management.  We may also use a network of national distributors to fulfill orders for RI-002.
 
 
·  
Expand RI-002’s FDA-approved uses .  If RI-002 is approved by the FDA as a treatment for PIDD, we plan to evaluate the clinical and regulatory paths to grow the RI-002 franchise through expanded FDA-approved uses.  We believe that there may be patient populations beyond PIDD that would derive clinical benefit from RI-002.  Previously marketed RSV IGIV product and RI-001 have historically been used in immune-compromised patient populations, including patients with cystic fibrosis, prematurely born infants, stem cell and solid organ transplant patients, oncology patients and other patients at risk for or requiring treatment for RSV.  Currently, there are no approved treatments specifically for RSV infections in PIDD.
 
·  
Develop additional plasma-derived products .  Our core competency is in the development and commercialization of plasma-derived therapeutics.  We believe there are a number of under addressed medical conditions for which plasma-derived therapeutics may be beneficial.  Utilizing our proprietary assays and other technologies, we have identified potential new product candidates that we may advance into preclinical activities.
 
·  
Develop and expand ADMA BioCenters .  In order to generate revenues in advance of RI-002’s commercialization and to control a portion of our raw material plasma supply for RI-002, we formed ADMA BioCenters, a subsidiary, that operates a plasma collection facility in Norcross, Georgia.  The facility received its FDA license in August 2011.  Under FDA license, ADMA BioCenters can collect normal source plasma and high-titer RSV plasma.  We sell a portion of our normal source plasma to buyers in the open “spot” market.  We also plan to use the high-titer RSV plasma collected by ADMA BioCenters in the manufacturing of RI-002.  We may initiate other hyperimmune plasma collection programs at the Norcross facility.  These programs will be initiated during the normal course of business and are expected to cost less than $1 million to implement.  We may also consider growth through the creation and licensing of additional ADMA BioCenters facilities in various regions of the United States.  Additional ADMA BioCenters may allow us to cost-effectively secure additional high-titer RSV plasma for RI-002, and potentially increase revenues through the collection and sale of normal source plasma and other hyperimmune plasma to third parties. 
 
The Plasma Industry
 
Primary Immunodeficiency Disease
 
PIDD is a class of hereditary disorder characterized by defects in the immune system, due to either a lack of necessary antibodies or a failure of these antibodies to function properly.  According to the World Health Organization, there are over 150 different presentations of PIDD.  As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IGIV therapy.  Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases.  PIDD has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people.  Of these 250,000 people diagnosed with PIDD in the United States, approximately 125,000 receive monthly infusions of IGIV and it is estimated that over 300,000 patients worldwide receive monthly IGIV infusions for PIDD.
 
As most patients with PIDD present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation.  In subjects with PIDD, individual infections are not necessarily more severe than those that occur in a normal host.  Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common pathogens that may result in end organ damage, such as bronchiectasis.  In addition, subjects with PIDD will often respond poorly to standard antimicrobial therapy or they may have repeated infections with the same pathogen.  The virulence of the infecting organism should also be considered, and a subject’s immunocompetence should be questioned when invasive infections are caused by low virulence or opportunistic pathogens.  For example, infection with the opportunistic pathogens Pneumocystis jiroveci (previously Pneumocystis carinii) or atypical mycobacteria should prompt an investigation for underlying immunodeficiency.
 
Typical clinical presentations for subjects with PIDD are:
 
·  
Antibody deficiency and recurrent bacterial infections;
 
 
·  
T-lymphocyte deficiency and opportunistic infections;
 
·  
Other lymphocyte defects causing opportunistic infections;
 
·  
Neutrophil defects causing immunodeficiency; and
 
·  
Complement deficiencies.
 
PIDD can present at any age from birth to adulthood, posing a considerable challenge for the practicing physician to know when and how to evaluate a subject for a possible immune defect.  Subjects with marked antibody deficiencies are generally dependent on IGIV therapy for survival.  Benefits of adequate IGIV therapy in subjects not able to produce antibodies normally include: a reduction of the severity and frequency of infections, prevention of chronic lung disease and prevention of enteroviral meningoencephalitis.  Several immune globulin products have already been approved by the FDA.
 
RI-002, our IGIV product contains polyclonal antibodies against various infectious agents, including antibodies agaist RSV. RSV is a common respiratory virus that often presents during the winter months.  Nearly all children will have been infected with RSV by three years of age, however, the immune systems of most healthy children prevent significant morbidity and mortality.  Conversely, in patients that are immune-compromised, such as those with PIDD or who have undergone a hematopoietic stem cell or solid organ transplant and may be on immunosuppressive drugs or chemotherapy, RSV infection can be associated with significant morbidity and mortality.  Immune-compromised patients historically have a 5% to 15% rate of RSV infection, and, if left untreated, lower respiratory tract RSV infections in immune-compromised patients can result in a mortality rate of up to 40% of infected patients.  In hematopoietic stem cell transplant, or HSCT, patients, a subset of the immune-compromised patient population with approximately 25,000 transplants being performed annually in the United States, it is estimated that about 25% of patients treated with the current standard of care (aerosolized Ribavirin) will progress to lower respiratory tract infection, or LRTI, while 41% of patients untreated with the current standard of care will progress to LRTI.
 
The Plasma Industry
 
Human blood contains a number of components including:
 
·  
Red blood cells – Used to carry oxygen from the lungs to the body;
 
·  
White blood cells – Used by the immune system to fight infection;
 
·  
Platelets – Used for blood clotting; and
 
·  
Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.
 
Plasma is the most abundant blood component, representing approximately 55% of total blood volume.  Plasma, which is 90% water, is rich in proteins used by the human body for blood clotting and fighting infection.  These proteins account for approximately 7% of plasma’s volume.  As plasma contains these valuable proteins, plasma collection and the manufacturing of human plasma-derived therapeutics provide therapeutic benefits for ill patients.
 
In order to produce plasma-derived therapeutics that can be administered to ill patients, raw material plasma must be collected from human donors and then manufactured into specialized products.  Plasma is collected from healthy donors at FDA-licensed plasma donation centers.  To ensure safety of the collected plasma, all plasma donations are tested using FDA-approved methods of Nucleic Acid Testing, or NAT, for various infectious diseases, such as human immunodeficiency virus, or HIV, and hepatitis C virus, or HCV.
 
 
Plasma is collected using a process called “plasmapheresis.” During plasmapheresis, a donor’s blood is drawn into a specialized medical device that separates the plasma component through centrifugation, and then returns the other blood components back into the donor’s bloodstream.  Plasmapheresis is performed utilizing an FDA-approved, automated device with a sterile, self-contained collection kit.  The plasma that is collected is known as “normal source plasma.” There are over 400 plasma donation centers in the United States.  In 2011, approximately 20 million plasma donations were made in the United States in which over 19 million liters of source plasma were collected.  In the United States, a donor may donate plasma a maximum of two times in every seven-day period, with at least two days in between donations.  Plasma donation centers in the United States typically pay donors $25 to $50 per donation and some donors with rare or high antibody levels can be paid more.
 
In order to isolate the desired therapeutic elements in normal source plasma, it must initially undergo a manufacturing process called “fractionation.”  The process of fractionation was invented in the 1940’s by E.J. Cohn and is referred to as the Cohn method or cold ethanol fractionation.  First, the source plasma undergoes a process called pooling, in which the individual plasma donations are combined into a pooling tank.  Second, the Cohn fractionation method, which is a combination of time, temperature, pH, alcohol concentration, and centrifugation, is used to separate the desired plasma protein components, or “fractions.” After fractionation, the separated proteins are then re-suspended and are treated with a solvent detergent treatment process for viral inactivation.  Next, other forms of filtration (e.g., nanofiltration) are performed as an additional viral removal and viral reduction step.  Finally, with the various components separated and purified, the bulk product is formulated and filled into final, finished vials.  During these various steps of manufacturing, each lot is reviewed and tested for potency and purity prior to being approved for release.
 
The proteins in human plasma fall into four categories: albumin (60% of protein volume), immune globulins (15% of protein volume), coagulation factors (1% of protein volume), and other proteins (24% of protein volume) such as alpha-1 proteinase inhibitor, C1 esterase inhibitor, fibrin sealants and fibrinogen.  Many of the other proteins in plasma have yet to be developed into commercial therapies.  In the United States, not only are the plasma collection centers subject to FDA licensure, but each plasma protein product that is derived and fractionated from plasma must undergo an approval process with FDA’s Center for Biologics Evaluation and Research, or CBER.  In June 2008, the FDA published “Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency,” which we refer to as the FDA Guidance for Industry outlining the regulatory pathway for the approval of intravenous immune globulins, or IGIV, for the treatment of PIDD.
 
Immune globulins can be administered in three ways: intramuscularly, intravenously or subcutaneously.  IGIV principally contains antibodies and, as such, provides passive immunization for individuals who are immune-deficient or who have been exposed to various infectious agents.  IGIV is used therapeutically in a variety of immunological diseases/deficiencies, such as PIDD, idiopathic thrombocytopenic purpura, Guillain-Barré syndrome, Kawasaki disease, bone marrow transplant, and chronic inflammatory demyelinating polyneuropathy.  We are aware that other companies are also evaluating IGIV in a clinical study for the treatment of Alzheimer’s disease. Additionally, IGIV is also used as therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis, skin disease, and asthma.  These latter uses are referred to as “off-label” or evidence-based uses because the FDA has not approved their use in these indications and promotion of such uses is not permitted by FDA unless a BLA or BLA supplement with additional data is approved.  Among the various IGIV products, there are only 14 labeled indications approved by the FDA.  However, medical literature identifies at least 150 evidence based uses for IGIV, of which approximately 60 are currently included on lists of reimbursable uses by Medicare and other healthcare plans.  This provides opportunities for new product development and submissions.
 
There are two types of immune globulins, standard and hyperimmune.  The difference between standard immune globulins and hyperimmune globulins is that the latter are manufactured using plasma obtained from donors who have elevated amounts (high titers) of specific antibodies.  These high-titer products can be used to treat and prevent diseases that present those specific antigens that are reactive with the high-titer antibodies.  Hyperimmune products currently available include hepatitis B, tetanus, rabies cytomegalovirus and RhoD immune globulins.
 
In 2011, the worldwide market for plasma-derived therapeutic drug products was approximately $15 billion and the United States market for all plasma-derived products was approximately $5 billion.  IGIV products accounted for approximately $3.5 billion of sales in the United States in 2011.  IGIV products are used to treat primary immune deficiencies, certain autoimmune diseases, other illnesses for immune-compromised patients and certain neuropathy indications.  New research and data, additional labeled indications, an aging population and emerging countries with new markets are all adding to the worldwide growth of IGIV utilization.
 
 
RI-002, Our Lead Product Candidate
 
General
 
RI-002 is a plasma-derived, polyclonal IGIV, with standardized high levels of antibodies against RSV.  RI-002 is initially being developed as a treatment for patients with PIDD.  By using our proprietary assay, we are able to identify plasma donors with elevated amounts of RSV antibodies, measure these donors’ plasma RSV levels and formulate RI-002 with standardized high levels of RSV antibodies.  In addition, by using our assay within manufacturing, we are able to demonstrate consistent lot-to-lot RSV antibody titer potency.  To our knowledge, there is no other IGIV product on the market that contains standardized high levels of RSV antibodies and that is produced with reported consistent lot-to-lot potency.  We believe these characteristics will differentiate RI-002 from currently marketed IGIV products.
 
Results of Phase II Clinical and Compassionate Use Experience
 
We conducted a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate RI-001, RI-002’s predecessor product candidate, in immune-compromised, RSV-infected patients. This trial was conducted with 21 patients in the United States, Canada, Australia, and New Zealand.  The Phase II dose ranging trial demonstrated a statistically significant improvement in the change from baseline RSV titers to Day 18 in the high dose and low dose treatment groups when compared with placebo (p=0.0043 and p=0.0268, respectively).  The mean fold increase for high dose was 9.24 (95% CI 4.07, 21.02) and the observed mean fold increase for low dose was 4.85 (95% CI 2.22, 10.59).  The mean fold change for placebo treated patients was 1.42 (95% CI 0.64, 3.17).  In addition, more patients in the high dose (85.7%) and lose dose (42.9%) groups experienced greater than a 4-fold increase from baseline to Day 18 in RSV titer levels compared to placebo (0%).  There were no serious drug-related adverse events reported during the trial.
 
From April 2009 through February 2011, RI-001 was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients with documented lower respiratory tract RSV infections.  Serum samples were obtained from 13 patients. Samples showed that patients had a four-fold or greater rise in RSV antibody titers from baseline. Serum samples were not obtained from two patients that received Palivizumab.   The drug was well-tolerated in these 15 patients and there were no reports of serious adverse events attributable to RI-001.
 
Phase III Clinical Trial
 
We commenced our pivotal Phase III clinical trial of RI-002 as a treatment for PIDD in accordance with FDA Guidance for Industry. Our pivotal Phase III clinical study is a single arm, open label study in which patients will be treated approximately once per month for 12 months of treatment plus 90 days for follow up. We intend to treat an aggregate of between 60 and 70 patients in approximately 12 treatment centers in the United States. Dosage will vary by patient and may range from 300mg/kg to 800mg/kg, based on the patient’s current IGIV dose, every 21 to 28 days. The pivotal Phase III study’s primary endpoint is the occurrence of less than a single serious infection per person over 12 months and the secondary endpoint will be safety. We will also include other data collection points, including anti-RSV antibody levels and antibody levels for other agents as well.
 
Manufacturing and Supply
 
In order to produce plasma-derived therapeutics that can be administered to patients, raw material plasma is collected from healthy donors at plasma collection facilities licensed by the FDA.  ADMA BioCenters, an FDA-licensed source plasma collection facility, is our wholly-owned subsidiary and provides us with a portion of our plasma requirements.  By using our proprietary assay, we can identify plasma donors with elevated amounts of RSV antibodies and formulate RI-002 with an appropriate RSV titer level to ensure the final product is standardized to contain high levels of RSV antibodies.  Once source plasma has been collected, it is then fractionated and purified into specialized therapies, which are used by patients who require them.  We have agreements with independent third parties for the sourcing of blood plasma and for the fractionation and purification stages of manufacturing.  The contracts are with well-regarded facilities that are fully licensed to manufacture biologics.  We are dependent upon our third party suppliers for the manufacture of RI-002.  Our principal supplier of source plasma is Biotest AG and their United States subsidiary, Biotest Pharmaceuticals, Inc., together referred to as Biotest.
 
 
On December 31, 2012, we entered into a new Manufacturing, Supply and License Agreement with Biotest, which replaces a prior agreement that expired on December 31, 2012.  Under the agreement, we agreed to purchase exclusively from Biotest our worldwide requirements of RSV immune globulin manufactured from human plasma containing RSV antibodies.  The term of the agreement is for a period of ten years from January 1, 2013, renewable for two additional five year periods at the agreement of both parties. We are obligated under this agreement to purchase a minimum of at least one lot of product during each calendar year after the finished product is approved by the FDA.  This number is subject to increase at our option.  As consideration for Biotest’s obligations under the agreement, we are obligated to pay a dollar amount per lot of RSV immune globulin manufactured from human plasma containing RSV antibodies, as well as a percentage royalty on the sales thereof and of RI-002, up to a specified cumulative maximum.  The agreement may be terminated by either party (a) by reason of a material breach if the breaching party fails to remedy the breach within 120 days after receiving notice of the breach from the other party, (b) upon bankruptcy, insolvency, dissolution, or winding up of the other party, or (c) if the other party is unable to fulfill its obligations under the agreement for 120 consecutive days or more as a result of (a) or (b) above.
 
Pursuant to the terms of a Plasma Purchase Agreement with Biotest, we have agreed to purchase from Biotest an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of RI-002.  This volume will increase at the earlier of our receipt of a BLA from the FDA, or March 31, 2016.  We must purchase a to-be-determined and agreed upon annual minimum volume from Biotest but may also collect high-titer RSV plasma from up to five wholly-owned ADMA BioCenters.  Unless terminated earlier, the agreement expires in November 2021, after which it may be renewed for two additional five-year periods if agreed to by the parties.  Either party may terminate the agreement if the other party fails to remedy any material default in the performance of any material condition or obligation under the agreement following notice.  Either party may also terminate the agreement, after providing written notice, if a proceeding under any bankruptcy, reorganization, arrangement of debts, insolvency or receivership law is filed by or against the other party, and is not dismissed or stayed, or a receiver or trustee is appointed for all or a substantial portion of the assets of the other party, or the other party makes an assignment for the benefit of its creditors or becomes insolvent.  We may also terminate the agreement upon written notice if the clinical development of our product candidate is halted or terminated, whether by the FDA, a Data Safety Monitoring Board, or any other regulatory authority.  Upon termination of the agreement, we must pay for any source plasma already delivered to us and for any source plasma collected under the terms of the agreement.
 
On June 22, 2012, we entered into a Plasma Supply Agreement with Biotest for the purchase of normal source plasma from our ADMA BioCenters facility to be used in Biotest's manufacturing.  The agreement expires on December 31, 2014, unless terminated earlier as provided in the agreement.  After the initial term, the agreement may be renewed on an annual basis upon the mutual consent of the parties.  In addition to any other remedy it may have, either party has the right to terminate the agreement if the other party fails to remedy any material default in the performance of a material condition or obligation under the agreement following written notice.  In addition, upon giving the appropriate written notice, either party may terminate the agreement upon the occurrence of any of the following events: a proceeding under bankruptcy, reorganization, agreement of debts, insolvency or receivership law is filed by or against the other party, and is not dismissed or stayed, or a receiver or trustee is appointed for all or a substantial portion of the assets of the other party, or the other party makes an assignment for the benefit of its creditors or becomes insolvent.  Neither party can assign the agreement or any of its right or obligations there under without the express written consent of the other party.  However, with notice to the other party, either party without the other party’s consent may assign the agreement to (i) its affiliate, or (ii) a successor to all or substantially all of the assets relating to the business of that party which is involved in the fulfillment of its obligations under the agreement.  Under the agreement, once Biotest applies to the German Health Authority, we must use our best effort to take necessary steps as soon as possible to become compliant with such authority’s regulations and receive its certification.
 
 
On June 7, 2012, we entered into a Testing Services Agreement with Quest Diagnostics Clinical Laboratories, Inc., or Quest, in which Quest agreed to provide biomarker testing and related support services for protocol screening and recertification which are exclusive to us.  If either party believes the other party is in material breach of any of their obligations under the agreement, the non-breaching party has the right to terminate the agreement by providing the breaching party with written notice specifying the material breach(es) and indicating clearly its intention to terminate the agreement.  If the breaching party cures such breach, the non-breaching party’s notice is void.  In addition, either party can terminate the agreement without cause upon written notice.  All data, test results, studies and other information generated by Quest in performing services under the agreement will be our sole property.  Neither party can assign the agreement or any of its right or obligations under the agreement without the express written consent of the other party, except under specified circumstances.  Quest agrees and acknowledges that the Company paid for the development and validation of the testing assay and as such, the assay is the sole property of ADMA and shall only be utilized for our benefit.
 
Marketing and Sales
 
We intend to market and sell our product through a small specialty sales force, distribution relationships and other customary industry methods.  We will focus our efforts specifically on the easily identifiable treatment centers which specialize in the care and management of immune compromised individuals.  We estimate that there are approximately 500 leading specialty programs in the United States which have significant patient populations for PIDD, suitable for treatment with RI-002.  We plan to hire our own specialty sales force which will consist of account managers, medical science liaisons and other normal and customary scientific, medical and detail representatives.  Our management and board of directors has substantial prior direct marketing, sales and distribution experience with plasma derived drugs, specialty immune globulins and other biological products.  We anticipate staffing the company with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs, reimbursement, supply chain and logistics, human resources and financial and other operational management positions.  As is normal and customary in the plasma products industry, we may also use a network of national distribution organizations that have specialty divisions that focus on plasma products to fulfill orders for RI-002.
 
In a license agreement effective December 31, 2012, we granted Biotest an exclusive license to market and sell RSV antibody-enriched IGIV in Europe and in selected countries in North Africa and the Middle East, collectively referred to as the Territory, to have access to our testing services for testing of Biotest’s plasma samples using our proprietary RSV assay, and to reference (but not access) our proprietary information for the purpose of Biotest seeking regulatory approval for the RSV antibody-enriched IGIV in the Territory.  As consideration for the license, Biotest agreed to provide us with certain services at no charge and also compensate us with cash payments upon the completion of certain milestones.  Biotest is also obligated to pay us an adjustable royalty based on a percentage of revenues from the sale of RSV antibody-enriched IGIV in the Territory for 20 years from the date of first commercial sale. Additionally, Biotest has agreed to grant us an exclusive license for marketing and sales in the United States and Canada for Biotest’s Varicella Zoster Immune Globulin, or VZIG.
 
Competition
 
Although blood plasma and its derivative proteins are not subject to patent protection, the FDA recognizes each immunoglobulin product as unique and generally requires a separate IND, clinical trial and BLA for each as a condition to approval.  Regardless of whether competitors are able to develop an assay that can achieve our level of consistency and reproducibility in providing RSV antibody titer data, we believe they would still be required to validate and qualify such an assay as well as conduct clinical trials and undergo an FDA review prior to marketing an immune globulin product.  The plasma products industry is highly competitive.  We face, and will continue to face, intense competition from both United States-based and foreign producers of plasma products, some of which have lower cost structures, greater access to capital, direct ownership of manufacturing facilities, greater resources for research and development, and sophisticated marketing capabilities.
 
These competitors may include Baxter HealthCare Corporation, CSL Behring, Grifols Biologicals, Octapharma and Biotest.  In addition to competition from other large worldwide plasma products providers, we face competition in local areas from smaller entities.  In Europe, where the industry is highly regulated and health care systems vary from country to country, local companies may have greater knowledge of local health care systems, more established infrastructures and have existing regulatory approvals or a better understanding of the local regulatory process, allowing them to market their products more quickly.  Moreover, plasma therapy generally faces competition from non-plasma products and other courses of treatments.  For example, recombinant Factor VIII products compete with plasma-derived products in the treatment of Hemophilia A.
 
 
Intellectual Property
 
We rely on a combination of trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property and will continue to do so.  We do not own any issued patents.  We also seek to enhance and ensure our competitive position through a variety of means including our unique and proprietary plasma donor selection criteria, our proprietary formulation methodology for plasma pooling, and the proprietary reagents, controls, testing standards, standard operating procedures and methods we use in our anti-RSV microneutralization assay.  While we intend to defend against any threats to our intellectual property, there can be no assurance that our trade secret policies and practices or other agreements will adequately protect our intellectual property.  We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.  These processes, systems, and/or security measures may be breached, and we may not have adequate remedies as a result of any such breaches.  Third parties may also own or could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable terms or at all.
 
In addition, our trade secrets may otherwise become known or be independently discovered by competitors.  We also seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees, consultants, scientific advisors and contractors.  Although we rely, in part, on confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, there can be no assurance that these agreements or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.  To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.  We have two pending provisional patent applications filed with the United States relating to expanded hyperimmune globulin products.
 
Government Regulation and Product Approval
 
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of products and product candidates.  If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted.  We and our manufacturers may also be subject to regulations under other federal, state, and local laws.
 
United States Government Regulation
 
In the United States, the FDA regulates products under the Federal Food, Drug, and Cosmetic Act, or FDCA, and related regulations.  The process required by the FDA before our product candidates may be marketed in the United States generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):
 
 
1.
completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies performed in accordance with the FDA’s good laboratory practice regulations and other regulations;
 
 
2.
submission to the FDA of an Investigational New Drug, or IND, application which must become effective before clinical trials may begin;
 
 
 
3.
performance of adequate and well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication;
 
 
4.
manufacturing (through an FDA-licensed contract manufacturing organization) of product in accordance with current Good Manufacturing Practices, or cGMP, to be used in the clinical trials and providing manufacturing information need in regulatory filings;
 
 
5.
submission of a BLA to the FDA;
 
 
6.
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with cGMP regulations and other applicable regulations; and
 
 
7.
the FDA review and approval of the BLA prior to any commercial marketing, sale or shipment of the product.
 
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.  See “Risk Factors.”
 
We submit manufacturing and analytical data, among other information, to the FDA as part of an IND application.  Subject to certain exceptions, an IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, issues a clinical hold to delay a proposed clinical investigation due to concerns or questions about the product or the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks.  In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.  Our submission of an IND, or those of our collaboration partners, may not result in the FDA allowance to commence a clinical trial.  A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development.  The FDA must also approve certain changes to an existing IND, such as certain manufacturing changes.  Further, an independent institutional review board, or IRB, duly constituted to meet FDA requirements, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the safety of the study and study subjects until completed.  The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.  Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, requirements and regulations for informed consent.
 
Clinical Trials
 
For purposes of BLA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different trials may be required by the FDA as well):
 
 
1.
Phase I clinical trials are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients.
 
 
2.
Phase II clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product candidate for specific targeted indications and to determine tolerance and optimal dosage.  Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials.  
 
 
3.
Certain Phase III clinical trials are referred to as pivotal trials.  When Phase II clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to provide substantial evidence of reproducibility of clinical efficacy results and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.
 
 
A BLA must contain data to assess the safety and effectiveness of the product candidate for the claimed indications in all relevant pediatric subpopulations. The FDA may grant deferrals for submission of data or full or partial waivers. In some cases, the FDA may condition continued approval of a BLA on the sponsor’s agreement to conduct additional clinical trials, or other commitments.  Such post-approval studies are typically referred to as Phase IV studies.
 
Biological License Application
 
The results of product candidate development, preclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA.  The FDA reviews all BLAs submitted before it accepts them for filing and may reject the filing as inadequate to merit review or may request additional information to be submitted in a very short time frame before accepting a BLA for filing.  Once a BLA is accepted for filing, the FDA begins an in-depth review of the application.
 
During its review of a BLA, the FDA may refer the application to an advisory committee of experts for their review, evaluation and recommendation as to whether the application should be approved, which information is taken into consideration along with FDA’s own review findings.  The FDA may refuse to approve a BLA and issue a Complete Response Letter, or CRL if the applicable regulatory criteria are not satisfied.  In a CRL, it may also require additional clinical or other data, including one or more additional pivotal Phase III clinical trials.  Even if such requested data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval and issue a denial of the BLA.  Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do.  If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue an approval letter or a CRL, which contains the conditions that must be met in order to secure final approval of the BLA.  If a CRL is issued, if and when those items have been resolved to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the product for certain indications.  The FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market.  In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.  Products may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label.  Further, if there are any modifications to the product, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials, and/or require additional manufacturing data.
 
Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.  Typically, if a product candidate is intended to treat a chronic disease, as is the case with RI-002, safety and efficacy data must be gathered over an extended period of time.  Government regulation may delay or prevent marketing of product candidates for a considerable period of time and impose costly procedures upon our activities.  The FDA or any other regulatory agency may not grant approvals for changes in dose form or new indications for a product candidate on a timely basis, or at all.  Even if a product candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages.  Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.  Delays in obtaining, or failures to obtain, regulatory approvals for any of our product candidates would harm our business.  In addition, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action.
 
 
Other Regulatory Requirements
 
Any products manufactured or distributed by us pursuant to future FDA approvals are subject to continuing regulation by the FDA, including certain kinds of monitoring in the manufacturing of our products, recordkeeping requirements and reporting of adverse experiences associated with the product.  Product manufacturers and their subcontractors are required to register with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.  Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive action or possible fines and other penalties.  We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements.  If we or our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a product from distribution, or withdraw approval of the BLA for that product.
 
The FDA closely regulates the post-approval marketing and promotion of products, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet.  A company can make only those claims relating to safety and efficacy that are approved by the FDA.  Failure to comply with these requirements can result in adverse publicity, warning and/or other regulatory letters, corrective advertising and potential major fines and other penalties.
 
Regulation of ADMA BioCenters
 
All blood and blood product collection and manufacturing centers which engage in interstate commerce must be licensed by the FDA.  In order to achieve licensure, the organization must submit a BLA and undergo pre-licensure inspection.  ADMA BioCenters has completed these requirements and received its FDA license in August 2011.  In order to maintain the license, the facilities operated by ADMA BioCenters will be inspected at least every two years.  ADMA BioCenters is also required to submit annual reports to the FDA.
 
Blood plasma collection and manufacturing centers are also subject to the Clinical Laboratory Improvement Amendments, or CLIA, state licensure, and compliance with industry standards such as the International Quality Plasma Program, or IQPP. Compliance with state and industry standards is verified by means of routine inspection. We believe that ADMA BioCenters is currently in compliance with state and industry standards.  Delays in obtaining, or failures to obtain, regulatory approvals for any facility operated by ADMA BioCenters would harm our business.  In addition, we cannot predict what adverse federal and state regulations and industry standards may arise in the future.
 
Foreign Regulation
 
In addition to regulations in the United States, if we choose to pursue clinical development and commercialization in the European Union, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of any future product.  Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries.  The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval.  The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.
 
Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure.  The centralized procedure provides for the grant of a single marking authorization that is valid for all European Union member states.  The mutual recognition procedure provides for mutual recognition of national approval decisions.  Under this procedure, the holder of a national marking authorization may submit an application to the remaining member states.  Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval, refuse it or request additional information.
 
 
Employees
 
ADMA Plasma Biologics has nine full-time employees, as well as additional full- and part-time consultants and temporary staff.  ADMA BioCenters, which has its own dedicated staff trained and certified to operate the plasma collection center, has 18 full-time employees, as well as specialized consultants and select temporary staff.  Over the course of the next year, we anticipate hiring additional full-time employees devoted to research and development and general and administrative activities as well as hiring additional staff to the plasma collection center as appropriate.  We intend to use clinical research organizations, or CROs, third parties and consultants to perform our clinical studies and manufacturing and other regulatory affairs and quality control services.
 
Properties
 
Our executive offices are located in approximately 5,000 square feet of space at 65 Commerce Way, Hackensack, New Jersey.  Our telephone number is (201) 478-5552.  Currently we operate under a shared services agreement with Areth, LLC for the office, warehouse space and related services and have the ability to cancel this agreement upon 30 days’ notice.  Areth, LLC is a company controlled by Dr. Jerrold B. Grossman, our Vice Chairman, and we pay monthly fees for the use of such office space and for other information technology, general warehousing and administrative services.  Rent under the shared services agreement is $8,037 per month.  Although we may relocate our offices in the future, we anticipate that we will continue to maintain a services relationship with Areth LLC.  We do not anticipate the amount of space and cost of rent to materially change from current levels.
 
ADMA BioCenters’ facility is located at 6290 Jimmy Carter Boulevard, Suite 208, Norcross, Georgia.  In June 2008, we entered into a lease of the property for approximately 15,000 square feet of space which has been designed to meet the needs of a plasma collection center.  The current rent is $15,475 per month.  Annual rent increases of no more than 2.5% per year are provided for in the lease agreement.  The lease agreement expires on September 30, 2018.
 
Legal Proceedings
 
We are not involved in any pending legal proceedings and are not aware of any threatened legal proceedings against us.
 
 
 
Our directors and executive officers are as follows:
 
Name
 
Age
 
Positions
Steven A. Elms
 
49
 
Chairman of the Board of Directors
         
Dr. Jerrold B. Grossman
 
65
 
Vice Chairman of the Board of Directors
         
Adam S. Grossman
 
36
 
Director, President and Chief Executive Officer
         
Bryant E. Fong
 
40
 
Director
         
Dov A. Goldstein, M.D.
 
45
 
Director
         
Lawrence P. Guiheen
 
62
 
Director
         
Eric I. Richman
 
51
 
Director
         
Brian Lenz
 
40
 
Chief Financial Officer
         
James Mond, M.D., Ph.D.
 
66
 
Chief Scientific and Medical Officer
         

Our directors hold office until the earlier of their death, resignation, removal or until their successors have been duly elected and qualified.  Our executive officers are appointed by the board of directors and serve at the discretion of the board.  Other than as disclosed below, there are no family relationships among our directors and executive officers.
 
Steven A. Elms – Chairman .  Mr. Elms has been a director of ADMA since 2007.  Mr. Elms serves as a Managing Partner at Aisling Capital, which he joined in 2000.  Previously, he was a Principal in the Life Sciences Investment Banking Group of Hambrecht & Quist.  During his five years at Hambrecht & Quist, Mr. Elms was involved in over 60 financing and merger and acquisition transactions, helping clients raise in excess of $3.3 billion in capital.  Prior to joining Hambrecht & Quist, Mr. Elms traded mortgage-backed securities at Donaldson, Lufkin & Jenrette.  His previous healthcare sector experience includes over two years as a pharmaceutical sales representative for Marion Laboratories and two years as a consultant for The Wilkerson Group.  Mr. Elms received a B.A. in Human Biology from Stanford University and an M.B.A. from Kellogg Graduate School of Management at Northwestern University.  Mr. Elms serves on the boards of Pernix Therapeutics Holdings, Inc. and a number of other private companies.  Mr. Elms was chosen to serve on the Board of Directors because of his valuable experience in the investment and investment banking industry, particularly with respect to strategic and financing transactions.
 
Jerrold B. Grossman D.P.S. – Founder and Vice Chairman .  Dr. Grossman has been a director of ADMA since 2007.  He served as the Chief Executive Officer of ADMA, on a part-time basis, between 2007 and October 2011.  He is the founder and Chief Executive Officer of National Hospital Specialties, a specialty plasma derivatives distribution business, and has served as CEO of that company since 1980.  Additionally, Dr. Grossman is the founder and President of GenesisBPS, a medical device firm specializing in blood collection and processing equipment, and has served as President of that company since 1990.  Previously, he has held positions at the New York Blood Center and Immuno-U.S., Inc. Currently, he serves as the Chairman of the Board of Bergen Community Blood Services, is a member of the New Jersey Blood Bank Task Force and a founder and director of the New Jersey Association of Blood Bank Professionals.  He is a founder and director of Pascack Bancorp, Inc. and chairman of its Investment and Funds Management Committee.  Dr. Grossman has also provided consulting services to various government agencies and international organizations.  He received a B.A. in Economics and Finance from Fairleigh Dickinson University, an M.B.A. from Fairleigh Dickinson University, and his D.P.S. in Business Management from Pace University.  Dr. Grossman is the father of Adam S. Grossman, our President and Chief Executive Officer.  He was chosen to serve on the Board of Directors because of his role as founder and past CEO of the Company, as well as his more than 35 years of experience serving a variety of companies and associations in the blood and plasma industry.
 
 
Adam S. Grossman – Founder, Director, President and Chief Executive Officer .  Mr. Grossman has been a director of ADMA since 2007, has served as ADMA’s President and Chief Executive Officer since October 2011 and as ADMA’s President and Chief Operating Officer between 2007 and October 2011.  Mr. Grossman has over 15 years experience in the blood and plasma industry.  Prior to founding ADMA, Mr. Grossman was the Executive Vice President of National Hospital Specialties and GenesisBPS, a position he held between 1994 and 2011.  He has experience in launching new products, building and managing national and international sales forces, managing clinical trials, and completing numerous business development transactions.  Previously, he worked at MedImmune, Inc., where he worked on marketing teams for RSV and CMV immunoglobulins, and at the American Red Cross, where he launched new products with the Biomedical Services division.  Mr. Grossman received a B.S. in Business Administration, with a specialization in International Business and Marketing, from American University.  Mr. Grossman is the son of Dr. Jerrold B. Grossman, our Vice Chairman.  Mr. Grossman was chosen to serve on the Board of Directors because, as ADMA’s Chief Executive Officer, he is able to provide the Board with critical insight into the day-to-day operations of the Company.
 
Bryant E. Fong – Director .  Mr. Fong, who became a director of ADMA in 2012, joined Burrill & Company, an affiliate of Burrill, in 1998 and has more than 16 years of experience in the biotechnology industry.  His current position at Burrill & Company is Managing Director and Co-Head of Venture Capital, a position he has held since 2009.  Burrill & Company invests in life science companies whose technologies and products are applicable across a wide range of life science sub-sectors.  Prior to joining Burrill & Company, Mr. Fong held positions as a biochemist and molecular biologist with two early stage biotechnology companies located in the San Francisco Bay Area.  Mr. Fong’s aggregate research experiences include recombinant protein expression in yeast, development of linear artificial chromosomes for pathway engineering/heterologous gene transfer in yeast, and catalytic RNA technology.  Mr. Fong currently serves on the boards of directors of a number of private life science companies.  Mr. Fong earned his bachelors degree with honors in Molecular and Cell Biology-Biochemistry from the University of California, Berkeley.  Mr. Fong was chosen by Burrill to serve on the Board of Directors because of his extensive experience in the biotechnology industry.
 
Dov A. Goldstein, M.D. – Director .  Dr. Goldstein has been a director of ADMA since 2007.  Dr. Goldstein has been a Principal (2006 - 2008) and a Partner (since 2008) at Aisling Capital.  Between July 2000 and August 2003, Dr. Goldstein served as Vice President and Chief Financial Officer, and between August 2003 and September 2005 as Executive Vice President and Chief Financial Officer, of Vicuron Pharmaceuticals, Inc. up until its acquisition by Pfizer, Inc.  Prior to joining Vicuron, Dr. Goldstein was Director of Venture Analysis at HealthCare Ventures.  He also completed an internship in the Department of Medicine at Columbia-Presbyterian Hospital.  Dr. Goldstein serves as a member of the board of directors of Cempra, Inc. and Durata Therapeutics, Inc.  Dr. Goldstein received a B.S. from Stanford University, an M.B.A. from Columbia Business School and received his M.D. from Yale School of Medicine.  Dr. Goldstein was chosen to serve on the Board of Directors because of his experience as a senior executive officer of Vicuron Pharmaceuticals and his technical knowledge as a medical doctor.
 
Lawrence P. Guiheen – Director .  Mr. Guiheen, who became a director of ADMA in July 2012, has over 25 years of experience in the blood and plasma industry.  Since July 2011, Mr. Guiheen has been principal of Guiheen and Associates, a consulting group that specializes in biopharmaceutical, pharmaceutical and medical device commercialization.  Prior to July 2011, Mr. Guiheen was employed by Baxter Healthcare Corporation for over 30 years.  Most recently he held the positions of General Manager Global Hemophilia Franchise (from December 2010), President of Global BioPharmaceuticals for Baxter Healthcare’s BioScience Division (March 2010 - December 2010) and President of BioPharmaceuticals US (January 2004 - March 2010).  Mr. Guiheen had been a member of the BioScience Division’s Senior Management Team for over 14 years and has extensive experience leading global and domestic commercial organizations in the plasma and recombinant therapies.  Mr. Guiheen is past Chairman of the Global Board of Directors for the Plasma Proteins Therapeutics Association (PPTA) and a past member of the Board of Directors of California Healthcare Institute (CHI).  Mr. Guiheen holds a Bachelor of Arts degree in business administration from Rutgers University.  Mr. Guiheen was chosen to serve on the Board of Directors because of his extensive experience in the plasma and pharmaceutical industries.
 
 
Eric I. Richman – Director .  Mr. Richman has been a director of ADMA since 2007.  Mr. Richman is the President and Chief Executive Officer of biodefense company PharmAthene, Inc.  He has served in that position since October 2010.  He served as the President and interim Chief Executive Officer of PharmAthene between May and October 2010, as President and Chief Operating Officer between March and May 2010 and as Senior Vice President, Business Development and Strategic Planning between August 2003 and March 2010.  He has also served on PharmAthene’s board of directors since May 2010.  Prior to joining PharmAthene, Mr. Richman held various commercial and strategic positions of increasing responsibility over a 12 year period at MedImmune, Inc. from its inception and was Director, International Commercialization at that company.  Mr. Richman served as director of Lev Pharmaceuticals and Chairman of its Commercialization Committee and currently serves as director of American Bank.  Mr. Richman received a Bachelor of Science in Biomedical Science from the Sophie Davis School of Biomedical Education (CUNY Medical School) and a Master of Business Administration from the American Graduate School of International Management.  Mr. Richman was chosen to serve on the Board of Directors because of his experience in the development and commercialization of plasma-derived products and experience as an executive officer of PharmAthene.
 
Brian Lenz – Chief Financial Officer .  Mr. Lenz joined us as Chief Financial Officer on May 1, 2012.  Mr. Lenz was previously at CorMedix Inc., a developmental-stage pharmaceutical and medical device company, where he held the position of Chief Financial Officer from February 2010 and Chief Operating Officer and Chief Financial Officer from January 2012.  Prior to joining CorMedix, Mr. Lenz was CFO of Arno Therapeutics from July 2008 to February 2010, CFO of VioQuest Pharmaceuticals from April 2004 to June 2008, Controller of Chiral Quest, Inc., a subsidiary of VioQuest Pharmaceuticals, from October 2003 to March 2004, Controller of Smiths Detection from July 2000 to October 2003, and senior auditor at KPMG, LLP from October 1998 to July 2000.  Mr. Lenz received a B.S. from Rider University, an M.B.A. from Saint Joseph’s University and is a licensed Certified Public Accountant.
 
James Mond, M.D., Ph.D. – Chief Scientific and Medical Officer .  Dr. Mond joined us as Chief Scientific and Medical Officer on July 18, 2012.  Dr. Mond was most recently Chief Scientific Officer and Executive Vice President at Biosynexus, where he was responsible for the preclinical and clinical development of three drug candidates from December 1999 through June 2011.  Biosynexus engaged in immunological and non-immunologic approaches to treat or prevent staphylococcus infections.  Dr. Mond also functioned as its Chief Medical Officer and had extensive involvement with the Food and Drug Administration in designing clinical studies.  While at Biosynexus Dr. Mond served as Chief Medical Officer for a Phase III clinical trial that was run in 93 neonatal intensive care units in Europe and North America.  Prior to that time, he was professor of Medicine, Rheumatology and Immunology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, actively practicing internal medicine, rheumatology and teaching medical students.  Dr. Mond’s lab invented a vaccine technology that was licensed to GlaxoSmithKline and is currently the basis of a number of pediatric vaccines that are commercialized around the world.  Dr. Mond also led the laboratory of Immunology at the University and authored 168 papers published in peer reviewed scientific journals and 20 invited articles and book chapters.  He has over 20 issued patents in the area of vaccines.  Dr. Mond received his M.D and Ph.D. from the New York University Medical School.
 
Director Independence
 
We are not currently a “listed company” under SEC rules and are therefore not required to have a board comprising a majority of independent directors or separate committees comprised of independent directors.  We use the definition of “independence” under the NASDAQ Rules, as applicable and as may be modified or supplemented from time to time and the interpretations thereunder, to determine if the members of our Board are independent.  In making this determination, our Board considers, among other things, transactions and relationships between each director and his immediate family and the Company, including those reported in this prospectus under the caption “Certain Relationships and Related Transactions.”  The purpose of this review is to determine whether any such relationships or transactions are material and, therefore, inconsistent with a determination that the directors are independent.  On the basis of such review and its understanding of such relationships and transactions, our Board is expected to determine that four of our Board members, Mr. Richman, Dr. Goldstein, Mr. Fong and Mr. Guiheen, are independent directors.
 
Board Committees
 
Audit Committee
 
The primary functions of the Audit Committee are to: (a) review the financial reports and other financial information prepared by the Company for submission to any governmental or regulatory body or the public and monitor the integrity of such financial reports; (b) review the Company’s systems of internal controls established for finance, accounting, legal compliance and ethics; (c) review the Company’s accounting and financial reporting processes generally and the audits of the financial statements of the Company; (d) monitor compliance with legal regulatory requirements; (e) monitor the independence and performance of the Company’s registered independent public accounting firm; and (f) provide effective communication between the Board, senior and financial management and the Company’s registered independent public accounting firm.
 
 
The members of our Audit Committee are Eric Richman (Chair), Lawrence P. Guiheen and Bryant Fong.  Our Board is expected to determine that each committee member meets the independence criteria for directors set forth under the NASDAQ Rules and the additional independence criteria for members of audit committees specified in the NASDAQ Rules and Rule 10A-3 under the Exchange Act of 1934.
 
Our Board is expected to determine that Mr. Richman, the chairman of the Audit Committee, qualifies as an “audit committee financial expert,” as such term is defined by SEC rules.
 
Compensation Committee
 
The members of our Board’s Compensation Committee are Dr. Goldstein (Chairman), Mr. Richman and Mr. Fong.  The current members of our Compensation Committee are “independent” as required by the NASDAQ Rules and in accordance with the requirements of Section 952 of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
 
The Company’s executive compensation program is administered by the Compensation Committee.  Each member of the Committee qualifies as an outside director within the meaning of Section 162(m) of the Internal Revenue Code of 1986, as amended.  The primary functions of the Compensation Committee are to: review and recommend to the Board of Directors, or the Board, appropriate executive compensation policies, compensation of the directors and officers, and executive and employee benefit plans and programs, and oversee such policies, compensation, plans and programs approved by the Board and, where appropriate, by the shareholders.
 
Compensation of our President and Chief Executive Officer is determined, or recommended to the Board for determination, by the Compensation Committee comprised solely of independent directors.  The President and Chief Executive Officer is not present during voting or deliberations.  Compensation for all other officers is determined, or recommended to the Board for determination, by the Compensation Committee comprised solely of independent directors.
 
Under the Compensation Committee Charter, our President and Chief Executive Officer and our Chairman of the Board may recommend to the Compensation Committee individual compensation awards for our officers.  The Compensation Committee would then have to review the recommendation and make its own recommendation to the Board.
 
Governance and Nominations Committee
 
The members of our Board’s Governance and Nominations Committee are Mr. Guiheen (Chairman), Mr. Fong and Mr. Richman, all of whom are “independent” as required by the NASDAQ Rules.
 
The primary functions of the Governance and Nominations Committee are to: review and make recommendations on the range of skills and expertise which should be represented on the Board, and the eligibility criteria for individual Board and Committee membership; review and recommend to the Board the appropriate structure of the Board; identify individuals qualified to become Board members and recommend to the Board the nominees for election to the Board at the next Annual Meeting of Stockholders; implement a policy and procedures with regard to consideration of any director candidate recommended by stockholders; retain and terminate any search firm to be used to identify director candidates, and to approve the search firm, fees and other retention terms; and review and recommend to the Board the appropriate structure of Board Committees, Committee assignments and the Board Committee chairman.
 
Among the factors the Governance and Nominations Committee considers when determining persons to be nominated include whether such individuals are actively engaged in business endeavors, have an understanding of financial statements, corporate budgeting and capital structure, are familiar with the requirements of a publicly traded company, are familiar with industries relevant to our business endeavors, are willing to devote significant time to the oversight duties of the Board of Directors of a public company, and are able to promote a diversity of views based on the person’s education, experience and professional employment. The Governance and Nominations Committee evaluates each individual in the context of the board as a whole, with the objective of recommending a group of persons that can best implement our business plan, perpetuate our business and represent stockholder interests.  The Governance and Nominations Committee may require certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time.
 
 
The Company is of the view that the continuing service of qualified incumbents promotes stability and continuity in the board room, contributing to the ability of the Board of Directors to work as a collective body, while giving the Company the benefit of the familiarity and insight into the Company’s affairs that its directors have accumulated during their tenure.  Accordingly, the process of the Governance and Nominations Committee for identifying nominees reflects the Company’s practice of re-nominating incumbent directors who continue to satisfy the Governance and Nominations Committee’s criteria for membership on the Board of Directors, whom the Governance and Nominations Committee believes continue to make important contributions to the Board of Directors and who consent to continue their service on the Board of Directors.  The Governance and Nominations Committee will identify and/or solicit recommendations for new candidates when there is no qualified and available incumbent.
 
The Governance and Nominations Committee will consider nominees recommended by stockholders.  There are no differences in the manner in which the committee evaluates nominees for director based on whether the nominee is recommended by a stockholder.  Stockholders who would like to have our Governance and Nominations Committee consider their recommendations for nominees for the position of director, should submit their recommendations, in accordance with the procedures set forth below, in writing to: Corporate Secretary, ADMA Biologics, Inc., 65 Commerce Way, Hackensack, New Jersey.
 
For nominations, a stockholder’s notice must include: (i) as to each person whom the stockholder proposes to nominate for election as a director, (A) the name, age, business address and residential address of such person, (B) the principal occupation or employment of such person, (C) the class and number of shares of stock of ADMA that are beneficially owned by such person, (D) any other information relating to such person that is required to be disclosed in solicitations of proxies for election of directors or is otherwise required by the rules and regulations of the SEC promulgated under the Exchange Act, and (E) the written consent of the nominee to be named in the proxy statement as a nominee and to serve as a director if elected and (ii) as to the stockholder giving the notice, (A) the name, business address, and residential address, as they appear on our stock transfer books, of the nominating stockholder, (B) a representation that the nominating stockholder is a stockholder of record and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice, (C) the class and number of shares of stock of ADMA beneficially owned by the nominating stockholder and (D) a description of all arrangements or understandings between the nominating stockholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the nominating stockholder.
 
Code of Ethics
 
Our Code of Ethics and Business Conduct, or the Code, applies to all directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller or persons performing similar functions, and contains the general guidelines for conducting the business of the Company.  The overall purpose of the Code is to ensure compliance of general guidelines for conducting the business of the Company consistent with the understanding of Company personnel of the Company’s standards of ethical business practices.  The Code includes provisions relating to compliance with all laws and regulations governing its operations, compliance with Regulation FD, professional and personal use of the Company’s information systems, the Company’s commitment to providing a safe, orderly, diverse and tolerant work environment that is free of any discrimination or harassment, and the Company’s employment practices regarding alcohol, drugs and violence prevention.  All of our directors, officers and employees are expected to be familiar with the Code and to adhere to those principles and procedures set forth in the Code that apply to them.  The Company will post the Code, any amendments to the Code, as well as any waivers that are required to be disclosed by the rules of the SEC, on the Company’s web site.  A copy of our Code will be provided to any person requesting same without charge.  To request a copy of our Code, please make written request to our President and Chief Executive Officer c/o ADMA Biologics, Inc., 65 Commerce Way, Hackensack, New Jersey.
 
 
Stockholder Communications
 
As of the date of this prospectus, we do not yet have a defined process for security holders to send communications to the Board.  Security holders that wish to communicate with the Board are encouraged to contact the Company at its principal executive offices by letter or telephone.
 
Director Compensation
 
The following table sets forth the compensation paid to non-executive directors for the year ended December 31, 2012.
 
For the Fiscal Year Ended December 31, 2012
 
Name
 
Fees Earned or Paid in
Cash ($) (1)
 
Option Awards ($) (2)
 
Total ($)
                   
Dr. Jerrold B. Grossman (3)
    75,000       180,700       255,700  
Steven A. Elms (4)
    20,000       90,400       110,400  
Dov A. Goldstein, M.D. (4)
    30,000       90,400       120,400  
Eric I. Richman
    35,000       180,700       215,700  
Bryant E. Fong  (5)
    20,000       90,400       110,400  
Lawrence P. Guiheen (6)
    15,000       91,500       106,500  
 
(1)           The amounts reflected in this column represent the cash fees earned by non-executive directors for services during 2012.  Fees earned are based on membership on the Board, committee membership and committee leadership positions. Of the amounts shown, 50% were paid in 2012 and 50% in 2013, except for Mr. Guiheen, who received the full amount in 2013, and  Dr. Grossman, who received $25,000 in 2012, $25,000 in 2013 and an additional $25,000 cash payment in 2013.  Please refer to our general policy on compensation of the members of our Board below in the section entitled “General Policy Regarding Compensation of Directors.”
 
 
(2)           The amounts in this column represent the aggregate grant date fair value for stock option awards issued during 2012 computed in accordance with FAS ASC Topic 718.  Please see footnote (5) to the Summary Compensation Table below for relevant assumptions made.  As of December 31, 2012, the aggregate number of option awards outstanding (vested and unvested) for Dr. Grossman was 51,199, for Mr. Elms was 13,258, for Dr. Goldstein was 13,258, for Mr. Richman was 32,399, for Mr. Fong was 13,258 and for Mr. Guiheen was 13,258.
 
(3)           Amount also reflects an additional $25,000 cash payment made in 2013 for services rendered in 2012.
 
(4)           Board fees and option grants paid to Mr. Elms and Dr. Goldstein are assigned to Aisling.
 
(5)           Mr. Fong joined our Board in February 2012.  Board fees and option grants paid to Mr. Fong are assigned to Burrill.
 
(6)           Mr. Guiheen joined our Board in July 2012.
 
Prior to the merger, it had been ADMA’s policy to pay Mr. Richman $2,000 per Board meeting attended.  On February 8, 2008, ADMA granted Mr. Richman options to purchase 2,205 shares at an exercise price of $3.40, which vested over four years.  On January 22, 2009, ADMA granted Mr. Richman options to purchase 3,677 shares at an exercise price of $1.71, which were fully vested on the date of grant.  Exercise price and number of shares underlying the options have been adjusted to reflect the 1-for-6.8 share reverse split in 2012.  On April 4, 2012, ADMA granted Mr. Richman options to purchase 26,517 shares of common stock at an exercise price of $9.60, which vest over four years with 25% vesting on April 4, 2013, the first anniversary of the date of grant, and the remaining 75% vesting pro rata over the next 36 months.
 
Prior to April 4, 2012, Dr. Grossman, Mr. Grossman, Mr. Elms and Dr. Goldstein had not been paid any compensation for their services on the Board of ADMA.  On April 4, 2012, ADMA granted Dr. Grossman options to purchase 26,517 shares of common stock and each of Mr. Elms, Dr. Goldstein and Mr. Fong options to purchase 13,258 shares of common stock, each at an exercise price of $9.60 and vesting over four years with 25% vesting on April 4, 2013, the first anniversary of the date of grant, and the remaining 75% vesting pro rata over the next 36 months.  On July 17, 2012, in connection with his appointment to the Board, Lawrence Guiheen was also granted options to purchase 13,258 shares of common stock pursuant to the same terms (with initial vesting occurring on July 17, 2013, the first anniversary of the date of grant).  Our directors have been, and will continue to be, reimbursed for the reasonable out-of-pocket costs incurred by them in connection with travel to and from Board and committee meetings.  Such reimbursements did not amount to $10,000 or more for any one of them in 2012.
 
General Policy Regarding Compensation of Directors
 
ADMA expects to pay its non-executive Vice Chairman, Dr. Jerrold B. Grossman, annual director fees of $50,000, subject to an additional payment of $25,000 per year at the discretion of the Board.   The Board exercised such discretion in favor of Dr. Grossman in January 2012 with respect to 2012 services.  On June 19, 2012, the Board approved a Board compensation program pursuant to which each director of the Company will be paid a cash retainer equal to $20,000 payable on an annual basis immediately following the date of the Company’s annual meeting; the Chairman of the Board’s Audit Committee will be paid $15,000 (in addition to any amounts payable for service on the Board), payable on an annual basis immediately following the date of the Company’s annual meeting; the Chairman of the Board’s Compensation Committee and the Chairman of the Board’s Governance and Nominations Committee each will be paid $10,000 (in addition to any amounts payable for service on the Board), payable on an annual basis immediately following the date of the Company’s annual meeting; and the grant of stock purchase options to the Board members on an annual basis following the date of the Company’s annual meeting, in an amount determined in good faith by the Board and granted pursuant to the Company’s 2007 Employee Stock Option Plan.  On August 7, 2012, the Board amended its compensation program to provide for the disbursement of 50% of annual Board and Committee fees on January 1 and 50% on July 1 of each year.
 
Our sole director prior to the February 2012 merger, Mr. Arnold P. Kling, did not receive any compensation from us during the fiscal years ended June 30, 2010 and 2011.  Information regarding compensation for those of our directors who are also employees is set forth in the Executive Compensation – Summary Compensation Table below.
 
 
Executive Compensation
 
The following table sets forth, for the periods indicated, all of the compensation awarded to, earned by or paid to (i) each individual serving as ADMA’s principal executive officer during our last completed fiscal year; and (ii) each other individual that served as ADMA’s executive officer at the conclusion of the fiscal year ended December 31, 2012 and who received in excess of $100,000 in compensation during such fiscal year collectively referred to as the named executive officers.
 
Summary Compensation Table
 
Name and  
Principal Position
 
Year
 
Salary
   
Bonus (1)
   
Stock
Options (2)
   
Total
 
                             
Adam S. Grossman
 
2012
  $ 332,692     $ 100,000     $ 1,441,500     $ 1,874,192  
                                     
Director, President and
Chief Executive Officer (3)
 
2011
  $ 218,269     $ 50,000     $ -     $ 268,269  
                                     
Dr. James Mond
 
2012
  $ 115,000     $ 52,000     $ 729,900     $ 896,900  
                                     
Chief Scientific and Medical Officer (4)
 
2011
  $ -     $ -     $ -     $ -  
                                     
Brian Lenz
 
2012
  $ 168,365     $ 77,250     $ 450,200     $ 695,815  
                                     
Chief Financial Officer (5)
 
2011
  $ -     $ -     $ -     $ -  

 
(1)       Bonuses for 2012 were paid in January 2013.  The 2011 bonus for Mr. Grossman was paid in February 2012 in connection with Mr. Grossman’s new employment agreement with respect to service provided in 2011.
 
(2)      The amount reflected in the table represents the aggregate grant-date fair value of options computed in accordance with FASB ASC Topic 718 (formerly FAS 123R). We estimate the fair value of each option on the grant date using the Black-Scholes model with the following assumptions: To determine the risk-free interest rate, we utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of our awards.  The expected term of the options granted is in accordance with Staff Accounting Bulletin 107 which is based the average between vesting term and contractual term.  The expected dividend yield reflects our current and expected future policy for dividends on our common stock.  The expected stock price volatility for our stock options was calculated by examining historical volatilities for similar publicly traded industry peers, since we do not have any trading history for our common stock.  We will continue to analyze the expected stock price volatility and expected term assumptions as historical data for our common stock becomes available.  We have not experienced forfeitures of stock options and as such, has not established a forfeiture rate.  Since the stock options currently outstanding are primarily held by our senior management and directors, we will continue to evaluate the effects of such future potential forfeitures, as they may arise, to evaluate our estimated forfeiture rate.  The material terms of the options held are described in the footnotes to the Outstanding Equity Awards at Fiscal-Year End table.
 
(3)      Mr. Grossman served as President and Chief Operating Officer of our predecessor company beginning in 2010 and through October 2011.  He has served as our President and Chief Executive Officer since October 2011.
 
(4)      Dr. Mond joined us as Chief Scientific and Medical Officer in July 2012.
 
(5)      Mr. Lenz joined us as Chief Financial Officer in April 2012.
 
 
Outstanding Equity Awards at Fiscal Year-End
 
The following table sets forth information regarding each unexercised option held by each of the named executive officers as of December 31, 2012.
 
         
Option Awards (1)
Name
       
Number of Securities Underlying Unexercised Options Exercisable
   
Number of Securities Underlying Unexercised Options Unexercisable
   
Stock Option Exercise Price
 
Stock Option Expiration Date
                           
Adam S. Grossman
                         
                           
Director, President and
Chief Executive Officer (2)
           
33,088
47,436
     
-
164,698
   
$
$
3.40
9.60
 
7/16/2017
2/13/2022
                                   
Dr. James Mond
                                 
                                   
Chief Scientific and Medical Officer (3)
            12,227       93,840     $ 9.60  
7/18/2022
                                   
Brian Lenz
                                 
                                   
Chief Financial Officer (4)
            11,233       55,059     $ 9.60  
4/30/2022

(1)           Gives effect to the 1-for-6.8 share reverse split in 2012 and a 1:1 share exchange in the February 2012 merger.
 
(2)           Mr. Grossman served as President and Chief Operating Officer of our predecessor company beginning in 2010 and through October 2011.  He has served as our President and Chief Executive Officer since October 2011.  Amounts reflect a February 11, 2008 option grant with respect to 33,088 shares, vesting over four years, subject to accelerated vesting as a result of change of control and termination of employment.  Exercise price and number of shares underlying the options have been adjusted to reflect the 1-for-6.8 share reverse split in 2012.  Amounts also reflect a February 13, 2012 option grant with respect to 212,134 shares, vesting over four years, with 25% vesting immediately and the remaining 75% vesting in equal monthly installments over the following 48 months of continued employment, subject to accelerated vesting upon a change of control and termination of employment.
 
(3)           Dr. Mond joined us as Chief Scientific and Medical Officer in July 2012.  Amounts also reflect a July 18, 2012 option grant with respect to 106,067 shares, vesting over four years, with 25% vesting on the first anniversary of the grant date and the remaining 75% vesting in equal monthly installments over the following 36 months, subject to accelerated vesting upon a change of control and termination of employment.
 
 
(4)           Mr. Lenz joined us as Chief Financial Officer in April 2012.  Amount reflects a May 1, 2012 option grant with respect to 66,292 shares, vesting over four years, with 25% vesting on the first anniversary of the grant date and the remaining 75% vesting in equal monthly installments over the following 36 months, subject to accelerated vesting upon a change of control and termination of employment.
 
Agreements with Executive Officers
 
President and Chief Executive Officer
 
In February 2012, we entered into a new employment agreement with our President and Chief Executive Officer, Adam S. Grossman, which has an initial term of three years, with automatic three year renewal periods unless notice is provided 90 days in advance.  The employment agreement provides that Mr. Grossman (i) will initially be paid $350,000 annually beginning on the date on which the February 2012 merger closed, referred to as the Effective Date; (ii) is eligible for an annual cash bonus, the target of which is $100,000, based upon the attainment of certain performance objectives mutually agreed to by the Board of Directors and Mr. Grossman; and (iii) is eligible to participate in our standard benefits package.  In addition, pursuant to the employment agreement, options to purchase 212,134 shares of common stock at an exercise price of $9.60 were granted to Mr. Grossmann.  All options granted to Mr. Grossman were issued under our stock option plan and vest over a four year period, with 25% of the options vesting on the Effective Date, and the remaining 75% vesting in equal monthly installments over the following 48 months of continued employment (full vesting on the fourth anniversary of the Effective Date), subject to accelerated vesting (i) upon a “change of control” (as defined in the agreement) of the Company of all options if Mr. Grossman is terminated by the Company or its successor for any reason other than cause or by Mr. Grossman for “good reason” (as defined in the agreement) immediately preceding or within two years thereafter and (ii) of that portion of the options that would have vested over the one year period following the date of termination upon a termination of employment by the Company without cause or by Mr. Grossman for good reason or as a result of death or disability.  Mr. Grossman also received a bonus in connection with his 2011 performance, including in connection with the February 2012 private placement and merger, of $50,000 on the date on which the merger closed.  We were obligated to reimburse Mr. Grossman for up to $10,000 in legal expenses incurred in connection with the employment agreement.
 
The employment agreement also provides that Mr. Grossman cannot, directly or indirectly, in any capacity, provide services to any person or entity which competes with the Company, unless he obtains our prior written consent for a period of 12 months following his termination.
 
The employment agreement furthermore provides that, in the event (i) that Mr. Grossman is terminated by the Company “without cause” (as such term is defined under the employment agreement), (ii) that Mr. Grossman resigns for “good reason” (as such term is defined under the employment agreement), or (iii) of any termination resulting from a “change of control” (as defined in the agreement) in which the existing employment agreement is not assumed by the successor to the Company, he would be entitled to (A) a severance payment equal to one year base salary payable in 12 monthly, equal installments after termination (lump sum if immediately preceding or within 24 months of a change of control), (B) prior year bonus (if unpaid)  and a pro rata bonus for year of termination (calculated as if 50% of the target had been met for the year of termination) and (C) one year of additional vestings on equity incentives then granted to Mr. Grossman or all remaining vestings if such termination is immediately preceding or within 2 years following a change of control.
 
Chief Financial Officer
 
On April 30, 2012, our Board appointed Brian Lenz as our Vice President and Chief Financial Officer, effective May 1, 2012.
 
 
On April 30, 2012, in connection with Mr. Lenz’s appointment as our Vice President and Chief Financial Officer, we entered into an employment agreement with Mr. Lenz.  Pursuant to the employment agreement, Mr. Lenz will serve as our Vice President and Chief Financial Officer for an initial term of three years, which term will extend automatically for additional three year periods unless appropriate notice is given by one of the parties.  Mr. Lenz will receive an annual base salary of $257,500, and will be eligible for annual bonus payments of up to 30% of his base salary, based upon the achievement of certain milestones as established annually by our Chief Executive Officer and Mr. Lenz and approved by the Compensation Committee.
 
Pursuant to his employment agreement, if a Change in Control (as defined under the employment agreement) occurs and the successor to the Company does not assume the employment agreement or within 12 months following such Change in Control Mr. Lenz is terminated Without Cause (as defined under the employment agreement) or Mr. Lenz resigns for Good Reason (as defined under the employment agreement), Mr. Lenz or his estate, as applicable, will receive his base salary, health insurance benefits and any accrued but unpaid benefits for a period of twelve months and all of his unvested stock options shall immediately become fully vested and exercisable from the date of Mr. Lenz’s termination. If we terminate Mr. Lenz as a result of his death, Mr. Lenz or his estate, as applicable, will receive his base salary for 60 days.  If we terminate Mr. Lenz for Cause (as defined under the employment agreement), if Mr. Lenz terminates his employment other than for Good Reason, or if Mr. Lenz’s employment terminates by expiration of the term of the employment agreement, Mr. Lenz will receive any salary and benefits earned and unpaid to the date of termination.  If we terminate Mr. Lenz for reasons other than those stated above or Mr. Lenz terminates his employment for Good Reason, Mr. Lenz will receive his salary and benefits for a period of time ending on the date that is six months from the date of termination, except that such health benefits shall cease upon the earlier to occur of the expiration of such six month period or the date upon which Mr. Lenz begins regular, full-time employment with a third party and is eligible to commence health insurance coverage.  The employment agreement also contains certain noncompete and non-solicitation provisions effective during the period Mr. Lenz receives termination benefits under the employment agreement, if any, as well as standard confidentiality provisions.
 
Additionally, on May 1, 2012, pursuant to the terms of his employment agreement, Mr. Lenz was issued an option to purchase 66,292 shares of our common stock at an exercise price of $9.60 per share, which is equal to the fair market value of one share of our common stock on the date of grant.  Such option will vest in over a four year period as follows: an initial 25% of the stock options will become exercisable on May 1, 2013; and the remaining stock options will become exercisable in equal monthly installment of the total remaining number of shares covered by the stock options over the following 36 months.
 
Chief Scientific and Medical Officer
 
On July 17, 2012, we appointed James Mond, M.D., Ph.D. as our Chief Scientific and Medical Officer, effective July 18, 2012.
 
On July 18, 2012, we entered into an employment agreement with Dr. Mond.  Pursuant to the employment agreement, Dr. Mond will serve as our Executive Vice President, Chief Scientific and Medical Officer for an initial term of three years, which term will extend automatically for additional three year periods unless appropriate notice is given by one of the parties.  Dr. Mond will receive an annual base salary of $260,000, and will be eligible for annual bonus payments of up to 20% of his base salary, based upon the achievement of certain milestones as established annually by our Chief Executive Officer and Dr. Mond and approved by the Compensation Committee.
 
Pursuant to the employment agreement, if a Change in Control (as defined under the employment agreement) occurs and the successor to the Company does not assume the employment agreement or within 12 months following such Change in Control, Dr. Mond is terminated Without Cause (as defined under the employment agreement) or Dr. Mond resigns for Good Reason (as defined under the employment agreement), Dr. Mond or his estate, as applicable, will receive his base salary, health insurance benefits and any accrued but unpaid benefits for a period of twelve months and all of his unvested stock options shall immediately become fully vested and exercisable from the date of Dr. Mond’s termination.  If we terminate Dr. Mond as a result of his death, his estate will receive his base salary for 60 days.  If we terminate Dr. Mond for Cause (as defined under the employment agreement), if Dr. Mond terminates his employment other than for Good Reason, or if Dr. Mond’s employment terminates by expiration of the term of the employment agreement, Dr. Mond will receive any salary and benefits earned and unpaid to the date of termination.  If we terminate Dr. Mond for reasons other than those stated above or Dr. Mond terminates his employment for Good Reason, Dr. Mond will receive his salary and benefits for a period of time ending on the date that is six months from the date of termination, except that such health benefits shall cease upon the earlier to occur of the expiration of such six month period or the date upon which Dr. Mond begins regular, full-time employment with a third party and is eligible to commence health insurance coverage.  The employment agreement also contains certain non-compete and non-solicitation provisions effective during the period Dr. Mond receives termination benefits under the employment agreement, if any, as well as standard confidentiality provisions.
 
 
In connection with his appointment, the Board approved the grant to Dr. Mond of options to purchase 106,067 shares of our common stock at an exercise price of $9.60 per share, which is equal to the value of our common stock on the date of grant.  The options will vest over a four year period as follows: 25% of the options will become exercisable on July 18, 2013, with the remaining options becoming exercisable in equal monthly installments over the following 36 months.  The options are subject to approval by our stockholders of an amendment to the Company’s 2007 Employee Stock Option Plan, which would increase the number of shares of common stock reserved for issuance under such plan.
 
Equity Incentive Plan
 
2007 Employee Stock Option Plan
 
In July 2007, the stockholders of our predecessor company approved the 2007 Employee Stock Option Plan (as amended), or the 2007 Plan, which provides for the granting of incentive and non-qualified stock options to our officers and employees.  Additionally, the 2007 Plan authorizes the granting of non-qualified stock options to our directors and to any independent consultants.  The Board of Directors in conjunction with management determines who receives awards, the vesting conditions of which are generally four years, and the exercise price of which may be no less than the fair market value of the common stock.  Options may have a maximum term of no more than 10 years.  Net issue exercise of options is permitted with the consent of the Board.  We assumed the 2007 Plan in the February 2012 merger.
 
After an increase in authorized shares under the 2007 Plan in connection with the February 2012 merger and again in November 2012, and grants of options to purchase an aggregate of 108,808 shares made on April 4, 2012 (the director grants of which are described under “Director Compensation” above), 66,292 shares made on May 1, 2012, 13,258 shares made on July 17, 2012 to Lawrence Guiheen, and 106,067 shares made on July 18, 2012 to James Mond, we currently have options to purchase 589,937 shares of common stock issued and outstanding under the 2007 Plan and have reserved for future issuance under the 2007 Plan an additional 97,615 shares of common stock.
 
As indicated above, on November 19, 2012, our stockholders approved an amendment to the 2007 Plan which provided for an increase in the maximum aggregate number of shares of common stock that may be granted under the plan to 711,200.
 
 
 
The following table sets forth information regarding the beneficial ownership (as such term is defined in Rule 13d-3 under the Exchange Act) of our common stock as of January 28, 2012, except as noted below, by:
 
·  
each of our directors;
 
·  
each of our Named Executive Officers (as defined in Item 402(m) of Regulation S-K);
 
·  
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our common stock; and
 
·  
all of our directors and executive officers as a group.
 
Shares of our common stock subject to options, warrants, or other rights currently exercisable or exercisable within 60 days of January 28, 2012 are deemed to be beneficially owned and outstanding for purposes of computing the share ownership and percentage of the person holding such options, warrants or other rights, but are not deemed outstanding for computing the percentage of any other person.  Except as indicated in the footnotes below, each holder listed below possesses sole voting and investment power with respect to their shares and such holder’s address is c/o ADMA Biologics, Inc, 65 Commerce Way, Hackensack, New Jersey.  An asterisk (*) denotes less than 1%.  The information is not necessarily indicative of beneficial ownership for any other purpose. Percentage ownership calculations for beneficial ownership prior to this offering are based on 4,622,831 shares of common stock outstanding as of January 28, 2012. 
 
   
Shares Beneficially
Owned
Prior to Offering
   
Shares Beneficially
Owned
After Offering
 
Name of Beneficial Owner
 
Number
   
Percent (1)
   
Number
   
Percent (1)
 
                         
Dr. Jerrold B. Grossman (2)
    428,227       9.26 %     428,227    
%
 
Adam S. Grossman (3)
    684,141       14.79 %     684,141    
%
 
Steven A. Elms (4)
    2,516,855       54.44 %     2,516,855    
%
 
Dov A. Goldstein, M.D. (5)
    -       -       -       -  
Eric I. Richman (6)
    5,882       *       5,882       *  
Bryant E. Fong (7)
    885,417       19.15 %     885,417       -  
Lawrence P. Guiheen (8)
    -       -       -       -  
Brian Lenz (9)
    -       -       -       -  
James Mond, M.D., Ph.D. (10)
    -       -       -       -  
All directors and executive officers as a group (9 persons)
    4,520,522       91.45 %     4,520,522    
%
 
                                 
Owners of 5% of our common stock
                               
Aisling Capital II LP (11)
    2,516,855       54.08 %     2,516,855    
%
 
Maggro, LLC (12)
    390,286       8.39 %     290,286    
%
 
Hariden, LLC (13)
    438,919       9.43 %     438,919    
%
 
Burrill Capital Fund IV, LP (14)
    885,417       19.02 %     -       -  
Ayer Capital (15)
    364,585       7.83 %     -       -  

* Less than 1%.
 
 
(1)           Based on 4,622,831 shares of common stock outstanding.
 
(2)           390,286 shares are owned by Maggro, LLC (“Maggro”).  Dr. Grossman is the managing member of Maggro and the Vice Chairman of ADMA.  See footnote 12. Also includes options to purchase 37,941 shares of common stock but does not include options to purchase 13,258 shares of common stock, which do not begin to vest until April 2013.
 
(3)           438,919 shares are owned by Hariden, LLC (“Hariden”).  Mr. Grossman is the managing member of Hariden as well as a director and the President and Chief Executive Officer of ADMA.  See footnote 13.  Also includes options to purchase 245,222 shares of common stock.
 
(4)           Amount does not include options to purchase 13,258 shares of common stock, which do not begin to vest until April 2013. Mr. Elms is the Chairman of the ADMA Board of Directors.  As a Managing Member of Aisling Partners, a control person of Aisling (see footnote 11), and as a member of the six member investment committee of Aisling’s General Partner, Mr. Elms may be deemed to be the beneficial owner of shares of common stock owned of record by Aisling.  Mr. Elms disclaims beneficial ownership over the shares owned of record by Aisling except to the extent of his pecuniary interest therein and as it relates to his role on the investment committee.  The address for Mr. Elms is 888 Seventh Avenue, 30th Floor, New York, New York.
 
(5)           Amount does not include options to purchase 13,258 shares of common stock, which do not begin to vest until April 2013.  Dr. Goldstein is a partner at Aisling (see footnote 11).  The address for Dr. Goldstein is 888 Seventh Avenue, 30th Floor, New York, New York.
 
(6)           Amounts include options to purchase 5,882 shares of common stock but does not include options to purchase 26,517 shares of common stock, which do not begin to vest until April 2013. Mr. Richman is a director of ADMA.
 
(7)           Amount does not include options to purchase 13,258 shares of common stock, which do not begin to vest until April 2013. Mr. Fong is Burrill’s designee on the board of directors of ADMA.  He is deemed to beneficially own the common stock held by Burrill as described in footnote 14.  The address for Mr. Fong is One Embarcadero Center, Suite 2700, San Francisco, California.
 
(8)           Amount does not include options to purchase 13,258 shares of common stock, which do not begin to vest until July 2013.  Mr. Guiheen is a director of ADMA.
 
 
- 70 -

 
(9)           Amount does not include options to purchase 66,292 shares of common stock, which do not begin to vest until May 2013. Mr. Lenz is Vice President and Chief Financial Officer of ADMA.
 
(10)           Amount does not include options to purchase 106,067 shares of common stock, the grant of which is subject to approval by the stockholders of an increase in the shares issuable under the 2007 Plan.  Dr. Mond is Executive Vice President and Chief Scientific and Medical Officer of ADMA.
 
(11)           The shares directly held by Aisling Capital II, LP (“Aisling”) are deemed to be beneficially owned by Aisling Capital Partners, LP (“Aisling GP”), as general partner of Aisling, Aisling Capital Partners, LLC (“Aisling Partners”), as general partner of Aisling GP, and each of the individual managing members of Aisling Partners.  The individual managing members (collectively, the “Managers”) of Aisling Partners are Dennis Purcell, Dr. Andrew Schiff and Steve Elms. Aisling GP, Aisling Partners, and the Managers may share voting and dispositive power over the shares owned of record by Aisling.  The address for Aisling GP, Aisling Partners, and the Managers is 888 Seventh Avenue, 30th Floor, New York, New York.  The information in this footnote is based on Aisling’s Schedule 13D filed with the SEC on February 22, 2012.  Amount does not include options to purchase an aggregate of 26,516 shares of common stock held by Mr. Elms and Dr. Goldstein for the benefit of Aisling, which do not begin to vest until April 2013. See footnotes 4 and 5.
 
(12)           The managing member of Maggro is Dr Jerrold B. Grossman, who is therefore deemed to be the beneficial owner of the securities held by Maggro.  See also footnote 2.
 
(13)           The managing member of Hariden is Adam S. Grossman, who is therefore deemed to be the beneficial owner of the securities held by Hariden.  See also footnote 3.
 
(14)           The shares directly held by Burrill Capital Fund IV, L.P. (“Burrill”) are deemed to be beneficially owned by Burrill & Company (BCF IV GP), LLC (“Burrill GP”), and each of the individual managing directors of Burrill GP.  The individual managing directors (collectively, the “Managers”) of Burrill GP, who are members of the investment committee of Burrill GP, are G. Steven Burrill, Bryant E. Fong, Victor Hebert, Douglas Lind, David Wetherell and Joshua Zelig. Burrill GP and the Managers may share voting and dispositive power over the shares owned of record by Burrill.  The address for Burrill GP and the Managers is One Embarcadero Center, Suite 2700, San Francisco, California.  The information in this footnote is based on Burrill’s Schedule 13D filed with the SEC on February 23, 2012.  See also footnote 7.
 
(15)           The shares are directly held by Ayer Capital Partners Master Fund, L.P. (“Master Fund”)(336,475 shares), Ayer Capital Partners Kestrel Fund, LP (“Kestrel Fund”)(7,463 shares) and Epworth - Ayer Capital (“Epworth”)(20,647 shares).  Master Fund, Kestrel Fund and Epworth are collectively referred to as the “Funds.” The investment advisor for each of the Funds is Ayer Capital Management, LP, of which Jay Venkatesan serves as managing member.  Mr. Venkatesan may therefore be deemed to beneficially own the shares of common stock held by the Funds, as he holds or shares voting and dispositive power over such shares.  The address for Ayer Capital Management, LP, Mr. Venkatesan and the Funds is 230 California Street, Suite 600, San Francisco, California.  The information in this footnote is based on Ayer’s Schedule 13G filed with the SEC on February 22, 2012.
 
 
 
Other than the compensation agreements and other arrangements described under "Management" in this prospectus and the transactions set forth below, since January 1, 2009, there has not been any transaction or series of transactions to which we were or are a party in which the amount involved exceeded or exceeds $120,000 and in which any director, executive officer, holder of more than 5% of any class of our voting securities or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest. We believe the transactions set forth below were executed on terms no less favorable to us than we could have obtained from unaffiliated third parties.
 
Our board is responsible for reviewing and approving all material transactions with any related party on a continuing basis. Related parties can include any of our directors or officers, holders of 5% or more of our voting securities and their immediate family members. We may not enter into a related person transaction unless our board has reviewed and approved such transaction.
 
General
 
We owed deferred rent to Areth, LLC in the amount of $72,336 as of December 31, 2011 and an additional $8,037 as of February 13, 2012 for a total of $80,373.  These amounts were for office space rent and services previously rendered and were paid out of the proceeds from the February 2012 private placement.  Technomed Inc. provides certain services pursuant to the shared services agreement between the Company and Areth, LLC.  Technomed Inc. is owned by Adam S. Grossman and Dr. Jerrold B. Grossman as well as their family members.  In addition, the Company owed Eric Richman deferred director fees of $8,000, which were paid out of the proceeds from the February 2012 private placement.
 
We maintain deposits and other accounts at Pascack Bankcorp, a bank of which Dr. Grossman serves as a director and which is approximately 5%-owned by members of the Grossman family.
 
See “Business—Properties” for a discussion of a related party transaction relating to our facility in Hackensack, New Jersey.  Rent expense for such facility amounted to $96,448 and $96,539 for the years ended December 31, 2011 and 2010, respectively.
 
The Merger
 
On February 13, 2012, we entered into an Agreement and Plan of Merger, or the Merger Agreement, with ADMA Biologics, Inc., a privately-held Delaware corporation, or Former ADMA, and ADMA Acquisition Sub, Inc., a Delaware corporation and our wholly-owned subsidiary, or Acquisition Sub.  Upon the closing of the merger transaction contemplated under the Merger Agreement, or the Merger, Acquisition Sub was merged with and into Former ADMA, and Former ADMA, as the surviving corporation in the Merger, became our wholly-owned subsidiary.  Our corporate name was changed from R&R Acquisition VI, Inc. to ADMA Biologics, Inc. and the name of Former ADMA was changed to ADMA Plasma Biologics, Inc.
 
Prior to the transactions contemplated by the Merger Agreement with Former ADMA, there were no material relationships between us and Former ADMA, or any of our and their respective affiliates, directors or officers, or any associates of our and their respective directors or officers.
 
In connection with the Merger and pursuant to the terms of the Merger Agreement:
 
·  
all of the then issued and outstanding shares of Former ADMA’s common stock, including the common stock issued in the 2012 Financing (as defined below under “2012 Financing”) and including the shares of Former ADMA’s Series A preferred stock, which were converted into Former ADMA’s common stock immediately prior to and as part of the Merger, were automatically exchanged into 4,601,270 shares of our common stock at a 1:1 exchange ratio;
 
 
·  
all warrants, options and other rights to purchase or acquire shares of Former ADMA’s common stock outstanding immediately prior to the Merger, including the Placement Agent Warrants (as defined below) and including the additional options granted to Adam S. Grossman under his new employment agreement, were converted into warrants, options or other rights, as the case may be, to purchase an aggregate of 383,380 shares of our common stock at the same exercise prices; and
 
·  
2,446,967 of the 2,500,000 shares of our common stock held by our stockholders immediately prior to the Merger were canceled such that these stockholders were left owning 53,033 shares of our common stock, not including the 87,865 shares issuable upon exercise of the Placement Agent Warrants held by an affliate of one of such stockholders and certain of its employees.
 
Immediately prior to the Merger and the transactions described above, (i) 3,386,454 shares of Series A Preferred Stock of Former ADMA were converted into 11,243,748 shares of Former ADMA’s common stock after giving effect to cumulative anti-dilution adjustments and accrued dividends, and 4,835,224 shares of Former ADMA’s Series A Preferred Stock issued in December 2011 upon the conversion of convertible notes were converted into an equal number of shares of Former ADMA’s common stock and (ii) the shares of common stock of Former ADMA were reverse split at a ratio of 1-for-6.8 (the “Reverse Split”).
 
As part of the Merger, we assumed certain of Former ADMA’s obligations under an investors’ rights agreement, dated July 17, 2007, by and among Former ADMA and its shareholders (the “Investors’ Rights Agreement”), assumed Former ADMA’s obligations under the Securities Purchase Agreement (as defined under “- Recent Financings - 2012 Financing” below), and assumed Former ADMA’s 2007 Employee Stock Option Plan.
 
Change in Management
 
In connection with the Merger, our board of directors was reconstituted by the resignation of Mr. Arnold P. Kling from his role as our sole director and the appointment of Steven A. Elms, Dov A. Goldstein, Jerrold B. Grossman, Adam S. Grossman, Eric I. Richman and Bryant E. Fong as directors (all of whom except for Mr. Fong were directors of Former ADMA immediately prior to the Merger).  Bryant Fong is the designee of Burrill Capital Fund IV, LP (“Burrill”), Steven Elms is the designee of Aisling Capital II, LP (“Aisling”) and Dr. Jerrold B. Grossman is the designee of Jerrold and Adam Grossman and their related entities (the “Grossman Group”).  Burrill, Aisling and the Grossman Group were the lead investors (the “Lead Investors”) in the 2012 Financing (defined below).  Each of the Lead Investors is entitled to designate one nominee to our board of directors for as long as it owns 50% of the shares of common stock that it received in the Merger in exchange for the shares of Former ADMA’s common stock that it owned immediately following the closing of the 2012 Financing.  Our executive management team was also reconstituted following the resignation of Mr. Kling as our President and Mr. Kirk M. Warshaw as our Chief Financial Officer and Secretary, and Adam S. Grossman was appointed our President and Chief Executive Officer.  On April 30, 2012, the Board ADMA appointed Brian Lenz as the Company’s Vice President and Chief Financial Officer, effective May 1, 2012.  On July 17, 2012, Lawrence P. Guiheen was appointed to our Board.  On July 18, 2012, James Mond, M.D., Ph.D., joined us as our Chief Scientific and Medical Officer.  See “Directors and Executive Officers.”
 
Change of Control
 
Immediately after the closing of, and giving effect to, the Merger, the holders of Former ADMA’s common stock, including the investors in the 2012 Financing, held approximately 97% of the issued and outstanding shares of our common stock, on a fully-diluted basis, while our stockholders immediately prior to the Merger, including the placement agent in the 2012 Financing (who is an affiliate of one of such stockholders) held approximately 3%.  Accordingly, the Merger represents a change of control.
 
 
Recent Financings
 
Convertible Notes
 
In 2009, 2010 and 2011, we issued senior secured convertible promissory notes to significant stockholders, as further detailed in the table below.  The notes provided that the outstanding principal and interest under the notes would be due and payable upon the earliest to occur of:  (i) December 31, 2011 (as extended by amendment); (ii) the date on which the Company would consummate a preferred stock financing in which the gross proceeds to the Company totaled at least $10,000,000 (“Qualified Financing”); and (iii) the occurrence of an Event of Default (as defined in the notes), the first of these three events to occur referred to as the “Maturity Date.”  Interest accrued on the outstanding principal at the rate stated in the table below and was payable on the Maturity Date.  The notes provided that in the Qualified Financing, the unpaid principal and accrued interest on the notes would automatically convert into the preferred stock issued in such Qualified Financing at a price per share equal to the lesser of (A) the price per share paid by the investors in the Qualified Financing or (B) the conversion price listed in the table below.
 
In December 2011, all then-outstanding senior secured convertible promissory notes were converted into 4,835,224 shares of Series A Preferred Stock in accordance with their terms.  No such notes remain outstanding.
 
Non-Convertible Notes
 
In 2011, we issued senior secured promissory notes to significant stockholders, as further detailed in the table below.  The notes stated that the outstanding principal and interest under them would be due and payable upon the earliest of (such date is referred to as the “Maturity Date”) (i) December 31, 2011 (extended by amendment to March 31, 2012 with respect to $250,000 in aggregate principal amount of such notes); or (ii) the occurrence of an Event of Default (as defined in the notes).  Interest accrued on the outstanding principal at the rate stated below and was payable on the Maturity Date.  In an Event of a Default, the interest rate stated on the notes would have been increased by three percent (3%) per annum.  The notes were collateralized by all of our assets.
 
The notes also stated that they would be repaid prior to the Maturity Date upon (i) the receipt by Former ADMA of funds from the sale of plasma inventory of Former ADMA or its subsidiary; (ii) Former ADMA’s sale of any of its securities in a public offering or (ii) a Change of Control (as defined in the notes).
 
Senior secured promissory notes in the aggregate principal amount of $400,000 were repaid prior to the Merger.  Senior secured promissory notes in the aggregate principal amount of $250,000 (plus $12,740 in accrued interest) were invested in the 2012 Financing by the holders of the notes in exchange for shares of Former ADMA’s common stock.  No such notes remain outstanding.
 
Warrants
 
In connection with the issuance of certain of the above notes, we issued common stock purchase warrants expiring ten years from the date of issue to existing common and preferred stockholders at an exercise price of $0.07 per share.  Such warrants vested immediately and could be exercised at any time up to the expiration date.  The warrants were exercised for shares of Former ADMA common stock prior to the Merger.
 
Summary Table
 
The amounts listed for the investors below were the largest amounts of principal outstanding for those investors since the issuance of the notes.  None of the notes remain outstanding.  In the table below, “Aisling” refers to Aisling Capital II, L.P., “Maggro” refers to Maggro, LLC and “Hariden” refers to Hariden, LLC.  The managing members of the control person of Aisling include our Chairman Steven Elms.  Our Vice Chairman Dr. Jerrold B. Grossman is the managing member of Maggro.  Our President and Chief Executive Officer Adam S. Grossman is the managing member of Hariden.
 
 
Issue
Date
Security
 
Principal Amount and Investors
   
Interest
Rate
 
Interest
paid in
2010
 
Conversion
Price
   
Convertible
Into
   
Warrants Issued
 
                                         
August 2009
Senior Secured Convertible Promissory Notes
 
$ 2,500,000
 
(Aisling: $2,075,000
      9 %       $ 15.24941    
Preferred
Series A-1
       
     
Maggro: $212,500
                                 
     
Hariden: $212,500)
                                 
December 2009
    $ 2,500,000       9 %       $ 15.24941    
Preferred
Series A-1
       
     
(Aisling: $2,075,000
                                 
     
Maggro: $212,500
                                 
     
Hariden: $212,500)
                                 
June 2010
    $ 1,800,000       12 %       $ 13.55240    
Preferred
Series A-2
      52,730  
     
(Aisling: $1,695,000
                                   
     
Maggro: $52,500
                                   
     
Hariden: $52,500)
                                   
December 2010
    $ 500,000       10 %       $ 13.55240    
Preferred
Series A-2
         
     
(Aisling: $500,000)
                                   
February 2011
    $ 300,000       10 %       $ 13.55240    
Preferred
Series A-2
         
     
(Maggro: $150,000
                                   
     
Hariden: $150,000)
                                   
May 2011
    $ 250,000       10 %       $ 13.55240    
Preferred
Series A-2
         
     
(Aisling: $212,500
                                   
     
Maggro: $18,750
                                   
     
Hariden: $18,750)
                                   
                                             
June 2011
    $ 300,000       10 %       $ 13.55240    
Preferred
Series A-2
         
     
(Aisling: $249,000
                                   
     
Maggro: $25,500
                                   
     
Hariden: $25,500)
                                   
August 2011
Senior Secured Promissory Notes
  $ 250,000       10 %         N/A       N/A       4,612  
     
(Aisling: $200,000
                                     
     
Maggro: $25,000
                                     
     
Hariden: $25,000)
                                     
September 2011
    $ 100,000       18 %         N/A       N/A          
     
(Maggro: $50,000
                                     
     
Hariden: $50,000)
                                     
October 2011
    $ 100,000       18 %         N/A       N/A          
     
(Maggro: $50,000
                                     
     
Hariden: $50,000)
                                     
December 2011
    $ 200,000       18 %         N/A       N/A          
     
(Aisling: $100,000
                                     
     
Maggro: $50,000
                                     
     
Hariden: $50,000)
                                     
 
 
2012 Financing
 
In connection with, and immediately prior to the closing of the Merger, Former ADMA completed a private placement (the “2012 Financing”) of 1,828,128 shares of Former ADMA’s common stock at a price per share of $9.60 to accredited investors, for gross proceeds to ADMA of $17,550,029 pursuant to a securities purchase agreement, dated as of February 13, 2012 (the “Securities Purchase Agreement”).  The 2012 Financing closed on February 13, 2012.  In lieu of repayment of senior secured promissory notes in the aggregate principal amount of $250,000 (plus $12,740 in accrued interest), the aggregate amount of unpaid principal and interest on the notes was invested by the holders of such notes in the 2012 Financing in exchange for shares of Former ADMA’s common stock.  The net cash proceeds from the 2012 Financing, after the payment of all expenses related to the 2012 Financing and the Merger, including legal, printing, travel, the Placement Agent’s cash fee and expense reimbursement and miscellaneous, were approximately $15.7 million, not including in such proceeds the senior secured promissory notes that were satisfied in exchange for shares of Former ADMA’s common stock in the 2012 Financing.
 
Pursuant to the terms of the Securities Purchase Agreement, for a period ending on the earlier to occur of (a) 18 months following the closing of the 2012 Financing or (b) such date that we have sold in one or more transactions (other than exempt issuances as defined in the agreement) securities having an aggregate purchase price of at least $5 million, if we sell any common stock or common stock equivalents for a price less than $9.60 (a “Dilutive Issuance”), each investor in the 2012 Financing will be given the right to subscribe, for $0.01 per share, for such number of additional shares of common stock equal to (x) the total subscription amount paid by the investor in the 2012 Financing divided by the price per share of common stock paid (or payable per share of common stock in the case of common stock equivalents) by investors in connection with the Dilutive Issuance, less (y) the total number of shares of common stock purchased by such investor at the closing of the 2012 Financing and any such additional shares of common stock acquired under this right.  We must use commercially reasonable efforts to complete a financing transaction pursuant to which we would sell common stock or common stock equivalents resulting in gross proceeds of at least $5 million within 18 months of the closing of the 2012 Financing (the “First Follow-On Financing”).
 
Burrill, Aisling, and Jerrold and Adam Grossman and their related entities (the “Grossman Group”), which we collectively refer to as the “Lead Investors,” purchased 885,417, 458,334 and 114,584 shares of Former ADMA’s common stock, respectively, for approximately $8,500,000, $4,400,000 and $1,100,000, respectively.  $262,740 in consideration paid by Aisling and the Grossman Group was in the form of secured promissory notes in lieu of cash.  ADMA reimbursed the Lead Investors for their reasonable costs (including legal fees and expenses) of $38,184 in connection with the 2012 Financing.  The Lead Investors, and Former ADMA’s officers and directors, agreed not to sell, transfer or otherwise dispose of any of their common stock or securities convertible, exercisable or exchangeable for common stock for a period of 180 days following the closing of the 2012 Financing.  In addition, with respect to any Lead Investor, until such time that such Lead Investor owns less than 50% of the shares of common stock that it received in the Merger in exchange for the shares of common stock that it owned immediately following the closing of the 2012 Financing, if we propose to offer any shares of its equity securities, or securities or debentures exchangeable for or convertible into additional shares of its equity securities for the purpose of financing its business (other than shares issued to employees, directors and consultants in the form of stock or options, shares issued upon exercise, exchange or conversion of any securities issued in the 2012 Financing or outstanding as of the date of the Securities Purchase Agreement, shares issued pursuant to strategic agreements, shares offered to the public pursuant to an underwritten public offering, or other customary exclusions), the Company will offer such Lead Investor the right to participate in any such offering on the same terms and conditions otherwise available to investors therein, to the extent of an amount at least equal to their beneficial ownership percentage at the time of such offer.
 
 
In the event we are unable to raise at least $5 million in the First Follow-On Financing, then Burrill, Aisling and the Grossman Group will subscribe to purchase $1.5 million, $2.0 million and $0.5 million, respectively, which amounts will decline proportionately if we raise more than $1 million in addition to the amounts contributed by such Lead Investors.
 
In connection with the 2012 Financing and the Merger, we agreed, pursuant to a registration rights agreement, dated as of February 13, 2012 (the “Registration Rights Agreement”), to register on a registration statement (the “Investor Registration Statement”) the resale of the shares of common stock issued in the Merger in exchange for the shares of common stock issued in the 2012 Financing and the shares of common stock owned by our pre-Merger stockholders, as well as the resale of the shares of common stock issuable upon exercise of the warrants issued to the placement agent and its designees in the Merger in exchange for the Placement Agent Warrants (as defined below).  Such registration statement was declared effective on August 13, 2012.
 
We refer to the securities the resale of which is required to be registered on the Investor Registration Statement as the “Registrable Securities.”  If, among other events, the Investor Registration ceases to remain effective for more than 10 consecutive trading days or any 15 trading days during any 12-month period, we are required to pay in cash to the investors in the 2012 Financing an amount per month equal to one percent of the investors’ subscription amount for Registrable Securities still held by the investors, until the Investor Registration Statement is filed, declared effective or continues to be effective (as the case may be).  This payment is subject to a maximum of (i) one percent of the investors’ subscription amount for Registrable Securities still held by the investors if we are diligently using our best efforts to have the Investor Registration Statement declared effective and the delays associated with the effectiveness of the Investor Registration Statement are the result of either continuing comments from or delays in reviewing by the SEC and (ii) ten percent of the investors’ subscription amount for Registrable Securities still held by the investors in all other cases.
 
We agreed to make such filings as are necessary to keep the Investor Registration Statement effective until the date on which all of the Registrable Securities have been sold or are saleable pursuant to Rule 144 (“Rule 144”) or its other subsections (or any successor thereto) under the Securities Act.  We are obligated to bear registration expenses (exclusive of transfer taxes, underwriters’ discounts and commission) of all such registrations required.
 
The stockholders of Former ADMA also have registration rights with respect to the shares of common stock issued in the Merger in exchange for shares of Former ADMA’s common stock and shares of common stock issuable upon exercise of options they hold, pursuant to the Investors’ Rights Agreement.  They have agreed to waive their piggy back registration rights with respect to the Investor Registration Statement; however, they will be entitled to require the filing of a resale registration statement pursuant to the Investors’ Rights Agreement.
 
Under the terms of the Securities Purchase Agreement, we are obligated to cause securities to be delivered to non-affiliates without any restrictive legends if the resale of such securities has been registered, such securities have been sold pursuant to Rule 144 or, in certain circumstances, if such securities are eligible for sale under Rule 144.  If we fail to do so, we are obligated to pay to the investor, for each $1,000 of shares, $1 per trading day, increasing to $2 per trading day five trading days after such damages have begun to accrue, until unrestricted certificates are delivered.  In addition, if the Company fails to satisfy the current public information requirement under Rule 144(c), then the Company is obligated to pay to an investor, for any delay in or reduction of its ability to sell the securities, an amount equal to 1% of the aggregate subscription amount of such investor’s securities on the date of such current public information failure and on every 30th day thereafter (prorated for shorter periods) until the failure is cured or public information is no longer required for a Rule 144 sale.
 
 
Rodman & Renshaw, LLC (the “Placement Agent”) acted as the exclusive placement agent in connection with the 2012 Financing, in connection with which it entered into a Placement Agency Agreement with Former ADMA on February 12, 2012.
 
In connection with the 2012 Financing, the Lead Investors each entered into a lock-up agreement with the Placement Agent in reference to a Placement Agency Agreement, dated February 12, 2012 by and between the Company and the Placement Agent, and agreed that until August 11, 2012, it would not offer, pledge, sell, contract to sell, grant any option or contract to purchase, purchase any option or contract to sell, or otherwise dispose of, directly or indirectly, any shares of common stock or securities convertible into or exchangeable or exercisable for any shares of common stock, or enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of common stock, whether any such transaction is to be settled by delivery of common stock or such other securities, in cash or otherwise.  Such restrictions do not apply, subject to certain conditions, to transactions relating to (i) bona fide gifts, (ii) shares of common stock acquired in the open market on or after the completion of the Merger, (iii) the transfer of shares of common stock to a family member or a trust for the benefit of the restricted party or a family member (including by will or intestacy) or (iv) a distribution to the partners, members or shareholders of the restricted party, provided that the recipient agrees in writing prior to such transfer to be bound by the foregoing restrictions.
 
 
 
General
 
ADMA is authorized by its certificate of incorporation to issue an aggregate of 85,000,000 shares of capital stock, of which 75,000,000 are shares of common stock and 10,000,000 are shares of preferred stock, each with a par value of $.0001 per share.
 
ADMA currently has 4,622,831 shares of common stock issued and outstanding and an additional 726,450 shares issuable upon exercise of outstanding options and warrants.  Of the 726,450 shares of common stock issuable upon exercise of outstanding options and warrants,  567,469 shares are issuable to officers and directors of ADMA, 46,116 shares are issuable to other employees of ADMA, 87,865 shares of common stock are issuable to the representatives and designees of, and transferees from, the placement agent in the 2012 Financing. Options to purchase an additional 97,615 shares are available for grant under the 2007 plan.
 
Common Stock
 
All outstanding shares of common stock are of the same class and have equal rights and attributes.  The holders of common stock are entitled to one vote per share on all matters submitted to a vote of stockholders of the Company.  The holders of a majority of the outstanding shares of common stock constitute a quorum at a meeting of stockholders for the transaction of any business.  Directors are elected by a plurality of the votes of the shares present in person or represented by proxy at the meeting and entitled to vote on the election of directors.  Any other action is authorized by a majority of the votes cast, except where the Delaware General Corporation Law, or DGCL, prescribes a different percentage of votes and/or a different exercise of voting power.
 
All stockholders are entitled to share equally in dividends, if any, as may be declared from time to time by the board of directors out of funds legally available.  In the event of liquidation, the holders of common stock are entitled to share ratably in all assets remaining after payment of all liabilities.  The holders of common stock do not have cumulative or preemptive rights.
 
Preferred Stock
 
No shares of preferred stock are currently outstanding, and we have no current plans to issue preferred stock.  The issuance of shares of preferred stock, or the issuance of rights to purchase preferred stock, could be used to discourage an unsolicited acquisition proposal.  For example, a business combination could be impeded by the issuance of a series of preferred stock containing class voting rights that would enable the holder or holders of such series to block any such transaction.  Alternatively, a business combination could be facilitated by the issuance of a series of preferred stock having sufficient voting rights to provide a required percentage vote of our shareholders.  In addition, under some circumstances, the issuance of preferred stock could adversely affect the voting power and other rights of the holders of our common stock.  Although prior to issuing any series of preferred stock our board is required to make a determination as to whether the issuance is in the best interests of our stockholders, our board could act in a manner that would discourage an acquisition attempt or other transaction that some, or a majority, of our stockholders might believe to be in their best interests or in which our stockholders might receive a premium for their stock over prevailing market prices of such stock.  Our board of directors does not presently intend to seek stockholder approval prior to any issuance of currently authorized preferred stock, unless otherwise required by law or applicable stock exchange requirements.
 
 
Warrants
 
Warrants to purchase 112,865 shares of common stock are currently outstanding. Warrants to purchase 87,865 shares, exercisable at $9.60 per share, were issued to the representatives and designees of the placement agent in the Merger in exchange for the Placement Agent Warrants and expire after five years. The warrants permit cashless exercise if at the time of the exercise an effective registration statement is not available for the resale of the underlying shares.  Cashless exercise means that in lieu of paying the aggregate purchase price for the shares being purchased upon exercise of the warrants in cash, the holder will forfeit a number of shares underlying the warrants with a “fair market value” equal to the aggregate exercise price.  We will not receive additional proceeds to the extent that warrants are exercised on a cashless basis.  The exercise price and number of shares of our common stock issuable upon exercise of the warrants may be adjusted in certain circumstances, including in the event of a stock dividend or stock split, certain rights offerings, or our recapitalization, reorganization, merger or consolidation.  The warrants are subject to a beneficial ownership blocker, meaning that they may not be exercised, to the extent that after giving effect to the issuance of the underlying shares, the holder of the warrants (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates), would beneficially own in excess of the 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon exercise of the warrants.
 
Registration Rights
 
In connection with the 2012 Financing and the Merger, we agreed, pursuant to a registration rights agreement, to register on a registration statement the resale of the shares of common stock issued in the Merger in exchange for the shares of common stock issued in the 2012 Financing and the shares of common stock owned by our pre-Merger stockholders, as well as the resale of the shares of common stock issuable upon exercise of the warrants issued to the representatives and designees of the placement agent in the Merger in exchange for the Placement Agent Warrants.  The description of the terms of the registration rights agreement is incorporated herein by reference to “Certain Relationships and Related Transactions - 2012 Financing.” In addition, the warrants issued to Hercules contain piggy-back registration rights. Warrants to purchase 25,000 shares were issued to Hercules in connection with the loan agreement of December 21, 2012. They have an exercise price set at the lower of (i) $9.60 or (ii) the price per share of the next institutional round of financing, subject to customary anti-dilution adjustments. The warrants expire after 10 years and have piggyback registration rights. These warrants also permit cashless exercise.
 
Liability and Indemnification of Directors and Officers
 
Our certificate of incorporation provides that no director is personally liable to the Company or its stockholders for monetary damages for any breach of fiduciary duty by such director as a director.  Nonetheless, a director is liable to the extent provided by applicable law, (i) for breach of the director’s duty of loyalty to the Company or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) pursuant to Section 174 of the DGCL (relating to unlawful payment of dividend or unlawful stock purchase or redemption) or (iv) for any transaction from which the director derived an improper personal benefit.  If the DGCL is amended to authorize the further elimination or limitation of the liability of directors, then the liability of a director of the Company, in addition to the limitation on personal liability provided in our certificate of incorporation, will be limited to the fullest extent permitted by the amended DGCL.  No amendment to or repeal of the relevant article of our certificate of incorporation will apply to or have any effect on the liability or alleged liability of any director of the Company for or with respect to any acts or omissions of such director occurring prior to such amendment.
 
Our certificate of incorporation furthermore states that we shall indemnify, to the fullest extent permitted by Section 145 of the DGCL, as amended from time to time, each person that such section grants the Company the power to indemnify.
 
Insofar as indemnification for liability under the Securities Act may be permitted for our directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
 
Delaware Anti-Takeover Law
 
We are subject to the provisions of section 203 of the DGCL. Section 203 prohibits publicly held Delaware corporations from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.  A “business combination” includes mergers, asset sales and other transactions resulting in a financial benefit to the interested stockholder.  Subject to certain exceptions, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years did own, 15% or more of the corporation’s voting stock.  These provisions could have the effect of delaying, deferring or preventing a change of control of us or reducing the price that certain investors might be willing to pay in the future for shares of our common stock.
 
 
Future Stock Issuances
 
Except as expressly set forth herein or pursuant to our equity incentive plan and any successor plans, we have no current plans to issue any additional shares of our capital stock.
 
Trading Information
 
Our common stock is not currently eligible for trading on any national securities exchange or any over-the-counter markets, including the OTC Bulletin Board.  In connection with this offering, we have applied to have our common stock quoted on the OTC Bulletin Board under the symbol "               ".
 
Transfer Agent
 
Continental Stock Transfer & Trust Company, 17 Battery Place, New York, New York, serves as the transfer agent and registrar for the common stock.  We serve as warrant agent for the outstanding warrants.
 
 
 
We have entered into an underwriting agreement with the underwriters named below.  Oppenheimer & Co. Inc. and BMO Capital Markets Corp. are acting as representatives of the underwriters.
 
The underwriting agreement provides for the purchase of a specific number of shares of common stock by each of the underwriters.  The underwriters’ obligations are several, which means that each underwriter is required to purchase a specified number of shares, but is not responsible for the commitment of any other underwriter to purchase shares.  Subject to the terms and conditions of the underwriting agreement, each underwriter has severally agreed to purchase the number of shares of common stock set forth opposite its name below:
 
Underwriter
Number of Shares
   
Oppenheimer & Co. Inc.
 
   
BMO Capital Markets Corp.
 
   
Landenburg Thalmann & Co. Inc.  
   
Total
 
   

The underwriters have agreed to purchase all of the shares offered by this prospectus (other than those covered by the over-allotment option described below) if any are purchased.  Under the underwriting agreement, if an underwriter defaults in its commitment to purchase shares, the commitments of non-defaulting underwriters may be increased or the underwriting agreement may be terminated, depending on the circumstances.
 
The shares should be ready for delivery on or about              , 2013 against payment in immediately available funds.  The underwriters are offering the shares subject to various conditions and may reject all or part of any order.  The representatives have advised us that the underwriters propose to offer the shares directly to the public at the public offering price that appears on the cover page of this prospectus.  In addition, the representatives may offer some of the shares to other securities dealers at such price less a concession of $            per share.  The underwriters may also allow, and such dealers may reallow, a concession not in excess of $             per share to other dealers.  After the shares are released for sale to the public, the representatives may change the offering price and other selling terms at various times.
 
We have granted the underwriters an over-allotment option.  This option, which is exercisable for up to 30 days after the date of this prospectus, permits the underwriters to purchase a maximum of              additional shares from us to cover overallotments.  If the underwriters exercise all or part of this option, they will purchase shares covered by the option at the initial public offering price that appears on the cover page of this prospectus, less the underwriting discount.  If this option is exercised in full, the total price to public will be $             and the total proceeds to us will be $            .  The underwriters have severally agreed that, to the extent the over-allotment option is exercised, they will each purchase a number of additional shares proportionate to the underwriter’s initial amount reflected in the foregoing table.
 
The following table provides information regarding the amount of the discount to be paid to the underwriters by us:
 
Per Share
 
Total Without Exercise of
Over-Allotment Option
   
Total With Full Exercise of
Over-Allotment Option
 
             
$
  $       $    
                 
In addition, we have agreed to reimburse the underwriters for certain out-of-pocket expenses incurred by them in connection with this offering up to $125,000 in the aggregate.
 
 
We estimate that our total expenses of the offering, excluding the underwriting discount, will be approximately $            .
 
We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act of 1933.
 
We and our officers and directors have agreed to a 180-day “lock up” with respect to shares of common stock that they beneficially own, including securities that are convertible into shares of common stock and securities that are exchangeable or exercisable for shares of common stock.  This means that, subject to certain exceptions, for a period of 180 days following the date of this prospectus, we and such persons may not offer, sell, pledge or otherwise dispose of these securities without the prior written consent of the representatives.
 
Rules of the Securities and Exchange Commission may limit the ability of the underwriters to bid for or purchase shares before the distribution of the shares is completed.  However, the underwriters may engage in the following activities in accordance with the rules:
 
·  
Stabilizing transactions—The representatives may make bids or purchases for the purpose of pegging, fixing or maintaining the price of the shares, so long as stabilizing bids do not exceed a specified maximum.
 
·  
Over-allotments and syndicate covering transactions—The underwriters may sell more shares of our common stock in connection with this offering than the number of shares than they have committed to purchase.  This overallotment creates a short position for the underwriters.  This short sales position may involve either “covered” short sales or “naked” short sales.  Covered short sales are short sales made in an amount not greater than the underwriters’ over-allotment option to purchase additional shares in this offering described above.  The underwriters may close out any covered short position either by exercising their over-allotment option or by purchasing shares in the open market.  To determine how they will close the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market, as compared to the price at which they may purchase shares through the over-allotment option.  Naked short sales are short sales in excess of the over-allotment option.  The underwriters must close out any naked short position by purchasing shares in the open market.  A naked short position is more likely to be created if the underwriters are concerned that, in the open market after pricing, there may be downward pressure on the price of the shares that could adversely affect investors who purchase shares in this offering.
 
·  
Penalty bids—If the representatives purchase shares in the open market in a stabilizing transaction or syndicate covering transaction, they may reclaim a selling concession from the underwriters and selling group members who sold those shares as part of this offering.
 
Similar to other purchase transactions, the underwriters’ purchases to cover the syndicate short sales or to stabilize the market price of our common stock may have the effect of raising or maintaining the market price of our common stock or preventing or mitigating a decline in the market price of our common stock.  As a result, the price of the shares of our common stock may be higher than the price that might otherwise exist in the open market.  The imposition of a penalty bid might also have an effect on the price of the shares if it discourages resales of the shares.
 
Neither we nor the underwriters makes any representation or prediction as to the effect that the transactions described above may have on the price of the shares.  If such transactions are commenced, they may be discontinued without notice at any time.
 
Our common stock is not currently eligible for trading on any national securities exchange or any over-the-counter markets, including the OTC Bulletin Board.  In connection with this offering, we have applied to have our common stock quoted on the OTC Bulletin Board under the symbol "            ".
 
Electronic Delivery of Prospectus: A prospectus in electronic format may be delivered to potential investors by one or more of the underwriters participating in this offering.  The prospectus in electronic format will be identical to the paper version of such prospectus.  Other than the prospectus in electronic format, the information on any underwriter’s web site and any information contained in any other web site maintained by an underwriter is not part of this prospectus or the registration statement of which this prospectus forms a part.
 
 
Notice to Non-United States Investors
 
In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, or a Relevant Member State, an offer to the public of any securities which are the subject of the offering contemplated by this prospectus may not be made in that Relevant Member State except that an offer to the public in that Relevant Member State of any securities may be made at any time under the following exemptions under the Prospectus Directive, if they have been implemented in that Relevant Member State:
 
(a)           to legal entities which are authorised or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
 
(b)           to any legal entity which has two or more of (i) an average of at least 250 employees during the last financial year; (ii) a total balance sheet of more than €43,000,000 and (iii) an annual net turnover of more than €50,000,000, as shown in its last annual or consolidated accounts;
 
(c)           by the representatives to fewer than 100 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or
 
(d)           in any other circumstances falling within Article 3(2) of the Prospectus Directive,
 
provided, that no such offer of securities shall result in a requirement for the publication by us or any representative of a prospectus pursuant to Article 3 of the Prospectus Directive.
 
For the purposes of this provision, the expression an “offer to the public” in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression “Prospectus Directive” means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.
 
Each underwriter has represented, warranted and agreed that:
 
(a)           it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, or the FSMA, received by it in connection with the issue or sale of any securities in circumstances in which section 21(1) of the FSMA does not apply to us; and
 
(b)           it has complied with and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the securities in, from or otherwise involving the United Kingdom.
 
In the State of Israel, the common stock offered hereby may not be offered to any person or entity other than the following:
 
(a)           a fund for joint investments in trust (i.e., mutual fund), as such term is defined in the Law for Joint Investments in Trust, 5754-1994, or a management company of such a fund;
 
(b)           a provident fund as defined in Section 47(a)(2) of the Income Tax Ordinance of the State of Israel, or a management company of such a fund;
 
 
(c)           an insurer, as defined in the Law for Oversight of Insurance Transactions, 5741-1981, (d) a banking entity or satellite entity, as such terms are defined in the Banking Law (Licensing), 5741-1981, other than a joint services company, acting for their own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;
 
(d)           a company that is licensed as a portfolio manager, as such term is defined in Section 8(b) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;
 
(e)           a company that is licensed as an investment advisor, as such term is defined in Section 7(c) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account;
 
(f)           a company that is a member of the Tel Aviv Stock Exchange, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;
 
(g)           an underwriter fulfilling the conditions of Section 56(c) of the Securities Law, 5728-1968;
 
(h)           a venture capital fund (defined as an entity primarily involved in investments in companies which, at the time of investment, (i) are primarily engaged in research and development or manufacture of new technological products or processes and (ii) involve above-average risk);
 
(i)           an entity primarily engaged in capital markets activities in which all of the equity owners meet one or more of the above criteria; and
 
(j)           an entity, other than an entity formed for the purpose of purchasing common stock in this offering, in which the shareholders equity (including pursuant to foreign accounting rules, international accounting regulations and U.S. generally accepted accounting rules, as defined in the Securities Law Regulations (Preparation of Annual Financial Statements), 1993) is in excess of NIS 250 million.
 
Any offeree of the common stock offered hereby in the State of Israel shall be required to submit written confirmation that it falls within the scope of one of the above criteria. This prospectus will not be distributed or directed to investors in the State of Israel who do not fall within one of the above criteria.
 
 
 
The validity of the shares of our common stock offered hereby has been passed upon for us by SNR Denton, New York, New York.  Goodwin Procter LLP, New York, New York, is acting as counsel for the underwriters in this offering.
 
 
 
The consolidated financial statements as of December 31, 2010 and 2011 and for the years then ended have been included in this prospectus in reliance on the report of CohnReznick LLP, an independent registered public accounting firm, given on the authority of said firm as experts in accounting and auditing.
 
 
 
We have filed a registration statement on Form S-1 with the Securities and Exchange Commission in connection with this offering.  In addition, we file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission.  You may read and copy the registration statement and any other documents we have filed at the Securities and Exchange Commission’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549.  Please call the SEC at 1-800-SEC-0330 for more information on its Public Reference Room.  Our Securities and Exchange Commission filings are also available to the public at the Securities and Exchange Commission’s Internet site at http://www.sec.gov.  Our Internet website address is http://www.admabiologics.com.  Information contained on our website does not constitute part of this prospectus or the registration statement.
 
This prospectus is part of the registration statement and does not contain all of the information included in the registration statement.  Whenever a reference is made in this prospectus to any of our contracts or other documents, the reference may not be complete and, for a copy of the contract or document, you should refer to the exhibits that are a part of the registration statement.
 
You may request a copy of these filings at no cost by contacting us at:
 
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, New Jersey  07601
(201) 478-5552
Chief Financial Officer: Brian Lenz
 
 
 
 
CONSOLIDATED FINANCIAL STATEMENTS
 
TABLE OF CONTENTS
 
 
Page
   
Report of Independent Registered Public Accounting Firm
F-2
   
Consolidated Balance Sheets as of December 31, 2010 and 2011 and September 30, 2012 (Unaudited)
F-3
   
Consolidated Statements of Operations for the years ended December 31, 2010 and 2011 and nine months ended September 30, 2011 (Unaudited) and 2012 (Unaudited)
F-4
   
Consolidated Statements of Changes in Stockholders’ Equity (Deficiency) for the years ended December 31, 2010 and 2011 and nine months ended September 30, 2012 (Unaudited)
F-5
   
Consolidated Statements of Cash Flows for the years ended December 31, 2010 and 2011 and nine months ended September 30, 2011 (Unaudited) and 2012 (Unaudited)
F-6
   
Notes to Consolidated Financial Statements
F-7
 
 
Report of Independent Registered Public Accounting Firm
 
The Board of Directors and Stockholders
 
ADMA Biologics, Inc.
 
We have audited the accompanying consolidated balance sheets of ADMA Biologics, Inc. and Subsidiaries as of December 31, 2010 and 2011, and the related consolidated statements of operations, changes in stockholders’ equity (deficiency) and cash flows for the years then ended.  These consolidated financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these consolidated financial statements 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 audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of ADMA Biologics, Inc. and Subsidiaries as of December 31, 2010 and 2011, and their results of operations and cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
 
/s/ CohnReznick LLP
Roseland, New Jersey
March 29, 2012
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, 2010 and 2011 and September 30, 2012 (Unaudited)
 
ASSETS
                 
Current Assets:
 
2010
   
2011
   
September 30, 2012
(Unaudited)
 
Cash and Cash Equivalents
  $ 228,971     $ 87,771     $ 10,720,397  
Accounts Receivable
    -       -       61,897  
Inventories
    3,390,455       1,147,345       1,009,687  
Prepaid Expenses
    64,781       59,244       189,596  
Total Current Assets
    3,684,207       1,294,360       11,981,577  
Property and Equipment at Cost, Net
    1,081,159       860,932       803,709  
Other Assets
                       
Equity Issuance Costs
    -       421,077       -  
Restricted Cash
    426,963       336,963       426,963  
Deposits
    12,577       12,577       12,577  
Total Other Assets
    439,540       770,617       439,540  
TOTAL ASSETS
  $ 5,204,906     $ 2,925,909     $ 13,224,826  
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
                       
Current Liabilities:
                       
Accounts Payable
  $ 842,178     $ 1,303,414     $ 890,762  
Accrued Expenses
    242,398       526,924       502,594  
Accrued Interest
    650,301       10,781       -  
Current Portion of Leasehold Improvement Loan
    9,669       10,576       10,177  
Notes Payable - Related Parties (Net of debt discount of $0 and $184,185 in 2011 and 2010, respectively)
    7,115,815       450,000       -  
Total Current Liabilities
    8,860,361       2,301,695       1,403,533  
Deferred Rent Liability
    171,975       149,785       133,142  
Leasehold Improvement Loan
    99,262       88,613       81,111  
TOTAL LIABILITIES
    9,131,598       2,540,093       1,617,786  
COMMITMENTS AND CONTINGENCIES
                       
STOCKHOLDERS’ EQUITY (DEFICIENCY)
                       
Preferred Stock - $0.001 par value, 8,221,678 and 3,400,000 shares authorized, 3,386,454 and 8,221,678 shares issued and outstanding with a liquidation preference of $21,114,465 and  $31,959,545 at December 31, 2010 and 2011, respectively
    3,386       8,222       -  
Common Stock - $0.001 par value at December 31, 2010 and 2011 and $0.0001 at September 30, 2012; 16,800,000, 6,500,000 and 75,000,000 shares authorized, 351,535, 408,589 and 4,654,303 shares issued and outstanding at December 31, 2010 and 2011 and September 30, 2012 (Unaudited), respectively
    352       409       465  
Additional Paid-In Capital
    19,974,125       30,185,200       46,464,366  
Accumulated Deficit
    (23,904,555 )     (29,808,015 )     (34,857,791 )
TOTAL STOCKHOLDERS’ EQUITY (DEFICIENCY)
    (3,926,692 )     385,816       11,607,040  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
  $ 5,204,906     $ 2,925,909     $ 13,224,826  

See notes to consolidated financial statements
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, 2010 and 2011 and
Nine Months Ended September 30, 2011 and 2012
 
   
Year Ended December 31,
   
Nine Months Ended
September 30,
 
   
2010
   
2011
   
2011
(Unaudited)
   
2012
(Unaudited)
 
REVENUES
  $ -     $ 761,042       -     $ 594,834  
Cost of sales
    -       207,570       -       288,761  
Gross profit
    -       553,472       -       306,073  
                                 
OPERATING EXPENSES
                               
Research and development expenses
    2,193,838       646,756       443,188       2,201,131  
                                 
Loss on sale of inventory
    -       1,934,630       1,934,630       -  
                                 
Plasma center operating expenses
    1,876,644       1,163,148       1,191,243       1,327,761  
                                 
General and administrative expenses
    1,425,951       1,431,894       932,248       2,446,043  
                                 
Total operating expenses
    5,496,433       5,176,428       4,501,309       5,974,935  
                                 
Loss from operations
    (5,496,433 )     (4,622,956 )     (4,501,309 )     (5,668,862 )
                                 
Total other income (expense)
    (451,279 )     (1,601,269 )     (768,130 )     1,471  
                                 
Loss before income taxes
    (5,947,712 )     (6,224,225 )     (5,269,439 )     (5,667,391 )
                                 
Income tax benefit
    -       320,765       320,765       617,615  
                                 
Net loss
  $ (5,947,712 )   $ (5,903,460 )   $ (4,948,674 )   $ (5,049,776 )
                                 
Net loss per share - basic and diluted
  $ (16.92 )   $ (16.72 )   $ (14.08 )   $ (1.27 )
                                 
Weighted average number of shares outstanding - basic and diluted
    351,535       353,098       351,535       3,988,005  

See notes to consolidated financial statements
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
Years Ended December 31, 2010 and 2011 and
Nine Months Ended September 30, 2012 (Unaudited)
 
   
Preferred Stock
   
Common Stock
   
Additional
             
   
Shares
   
Amount
   
Shares
   
Amount
   
Paid-in Capital
   
Accumulated
Deficit
   
Total
 
Balance - January 1, 2010
    3,386,454     $ 3,386       351,535     $ 352     $ 19,622,469     $ (17,956,843 )   $ 1,669,364  
                                                         
Stock based compensation
    -       -       -       -       34,809       -       34,809  
                                                         
Beneficial conversion charge
    -       -       -       -       316,847       -       316,847  
                                                         
Net loss
    -       -       -       -       -       (5,947,712 )     (5,947,712 )
Balance - December 31, 2010
    3,386,454       3,386       351,535       352       19,974,125       (23,904,555 )     (3,926,692 )
                                                         
Stock based compensation
    -       -       -       -       22,947       -       22,947  
                                                         
Beneficial conversion charge
    -       -       -       -       556,418       -       556,418  
                                                         
Cashless exercise of warrants
    -       -       57,054       57       (57 )     -       -  
                                                         
Conversion of notes payable and accrued interest - December 22, 2011
    4,835,224       4,836       -       -       9,631,767       -       9,636,603  
                                                         
Net loss
    -       -       -       -       -       (5,903,460 )     (5,903,460 )
Balance – December 31, 2011
    8,221,678       8,222       408,589       409       30,185,200       (29,808,015 )     385,816  
                                                         
Conversion of preferred shares and accumulated dividends
    (8,221,678 )     (8,222 )     2,364,553       2,364       5,858       -       -  
                                                         
Conversion of notes payable and accrued interest into common stock in private placement
    -       -       27,369       27       262,713       -       262,740  
Common stock sold in private placement, net of expenses
    -       -       1,800,759       1,801       15,597,915       -       15,599,716  
                                                         
Common stock retained by stockholders of shell company as part of reverse merger
    -       -       53,033       53       (53 )     -       -  
Effects of change in par value from $0.001 to $0.0001 as a result  of the reverse merger
    -       -       -       (4,189 )     4,189       -       -  
                                                         
Stock-based compensation
    -       -       -       -       408,544       -       408,544  
                                                         
Net loss
    -       -       -       -       -       (5,049,776 )     (5,049,776 )
Balance – September 30, 2012 (Unaudited)
    -     $ -       4,654,303     $ 465     $ 46,464,366     $ (34,857,791 )   $ 11,607,040  

See notes to consolidated financial statements
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended December 31, 2010 and 2011 and
Nine Months Ended September 30, 2011 (Unaudited) and 2012 (Unaudited)
 
   
Years Ended
December 31,
   
Nine Months Ended
September 30,
 
   
2010
   
2011
   
2011
(Unaudited)
   
2012
(Unaudited)
 
Cash Flows from Operating Activities:
                       
Net Loss
  $ (5,947,712 )   $ (5,903,460 )   $ (4,948,674 )   $ (5,049,776 )
Adjustments to reconcile net loss to net cash used in operating activities:
                               
Depreciation and Amortization
    220,201       219,552       166,161       140,743  
Stock Based Compensation
    34,809       22,947       19,623       408,544  
Amortization of Debt Discount and Beneficial Conversion Charge
    132,662       740,603       184,185       -  
Non-Cash Interest Expense Related to Notes Payable
    562,767       847,082       -       -  
Loss on Sale of Inventory
    -       1,934,630       1,934,630       -  
Loss on Disposal of Equipment
    -       945       -       -  
Changes in Operating Assets and Liabilities:
                               
Accounts Receivable
    -       -       -       (61,897 )
        Inventories
    (232,821 )     308,480       481,389       137,658  
Prepaid Expenses
    15,660       5,537       (35,504 )     (130,352 )
Restricted Cash
    -       90,000       90,000       (90,000 )
        Accounts Payable
    553,418       40,160       92,404       (412,652 )
Accrued Expenses
    (129,791 )     284,526       39,706       (24,330 )
        Accrued Interest
    -       -       575,173       1,959  
        Deferred Rent Liability
    (22,191 )     (22,190 )     (16,642 )     (16,642 )
       Net Cash Used in Operating Activities
    (4,812,998 )     (1,431,188 )     (1,417,549 )     (5,096,745 )
Cash Flows from Investing Activities:                                
     Purchase of Equipment
    (3,183 )     (270 )     -       (83,521 )
       Net Cash Used in Investing Activities
    (3,183 )     (270 )     -       (83,521 )
Cash Flows from Financing Activities:
                               
    Proceeds from the issuance of common stock, net of note payable conversion
    -       -       -       17,287,288  
    Proceeds from Convertible Notes Payable
    2,300,000       1,500,000       1,200,000       -  
Payment of Equity Issuance Costs
    -       -       -       (1,266,495 )
    Repayments on Notes Payable
    -       (200,000 )     -       (200,000 )
    Payments of Leasehold Improvement Loan
    (8,906 )     (9,742 )     (7,224 )     (7,901 )
Net Cash Provided by Financing Activities
    2,291,094       1,290,258       1,192,776       15,812,892  
                                 
Net (Increase) Decrease in Cash and Cash Equivalents
    (2,525,087 )     (141,200 )     (224,773 )     10,632,626  
                                 
Cash and Cash Equivalents, Beginning of Period
    2,754,058       228,971       228,971       87,771  
                                 
Cash and Cash Equivalents, End of Period
  $ 228,971     $ 87,771     $ 4,198     $ 10,720,397  
                                 
SUPPLEMENTAL INFORMATION:
                               
Interest paid
  $ 10,564     $ 15,273     $ 3,820     $ -  
SUPPLEMENTAL DISCLOSURES:
                               
NON-CASH FINANCING ACTIVITIES:
                               
Preferred stock issued upon note payable and interest conversion
  $ -     $ 9,636,603     $ -     $ -  
Reclassification of equity issuance costs accrued not paid
  $ -     $ 421,077     $ -     $ -  
Conversion of notes payable and interest in private placement
  $ -     $ -     $ -     $ 262,740  
Issuance of common stock through the cashless exercise of warrants
  $ -     $ 57     $ -     $ -  
Stock retained by stockholders of shell company
  $ -     $ -     $ -       53  
 
See notes to consolidated financial statements
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
1.       ORGANIZATION AND BUSINESS
 
ADMA Biologics, Inc. (“ADMA” or the “Company”) develops and commercializes human plasma and plasma-derived therapeutics. ADMA focuses on developing and commercializing plasma-derived human immune globulins through its wholly-owned subsidiary, ADMA Plasma Biologics, Inc. founded in 2004.  ADMA is based in Hackensack, New Jersey.  In addition, ADMA operates ADMA Bio Centers of Georgia. This wholly-owned subsidiary is a Delaware corporation that was formed on April 3, 2008.  ADMA Bio Centers of Georgia is an FDA-licensed source plasma collection facility located in Norcross, Georgia. 

The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.  The Company has needed to raise capital from the sales of its securities to sustain operations.  As of December 31, 2011, the Company had minimal cash balances.  In February 2012, the Company completed a private placement to raise gross proceeds of $17.5 million (see Note 12).
 
Based upon the Company’s projected revenue and expenditures for 2012 and 2013, management currently believes that the net proceeds of the private placement, together with the Company’s existing cash, will be sufficient to enable it to fund its operating expenses, research and development expenses and capital expenditures into the third quarter of 2013.  Because the Company does not anticipate receiving FDA approval for RI-002 until, at the earliest, the second half of 2015, if at all, and would therefore not be able to generate revenues from the commercialization of RI-002 until after that date, it will have to raise additional capital prior to the third quarter of 2013 to continue product development and operations.  The Company is unable to predict with reasonable certainty when, if ever, it will generate revenues from the commercialization of RI-002 and, therefore, how much additional capital it will need to raise prior to the third quarter of 2013.  Furthermore, if the Company’s assumptions underlying its estimated revenues and expenses prove to be wrong, it may have to raise additional capital sooner than anticipated.  There can be no assurance that such funds, if available at all, can be obtained on terms acceptable to the Company.  Because of numerous risks and uncertainties associated with the research, development and future commercialization of the Company’s product candidate, it is unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with its anticipated clinical trials and development activities.  Its current estimates may be subject to change as circumstances regarding requirements further develop.
 
There can be no assurance that the Company’s research and development will be successfully completed or that any product will be approved or commercially viable.  The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.
 
Prior to the last quarter of 2011, ADMA was a development stage company.  ADMA’s primary focus since 2004 has been conducting research and development of human plasma-derived products for the treatment of specific disease states.  The plasma collection center in Georgia was established in 2008 as a complementary business operation.  ADMA transitioned to an operating company from the development stage during the fourth quarter of 2011 when they began to generate revenues from this business segment.
 
2.       SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
The following comprises the Company’s significant accounting policies:
 
Basis of presentation
 
The accompanying consolidated financial statements include the accounts of ADMA Biologics, Inc. and its wholly-owned subsidiaries.  All significant intercompany transactions and balances have been eliminated in consolidation.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Cash and cash equivalents
 
The Company considers all highly-liquid instruments purchased with a maturity of three months or less to be cash equivalents.
 
Inventories
 
Plasma inventories (both plasma intended for resale and plasma intended for internal use in our research and development activities) are carried at the lower of cost or market value determined on the first-in, first-out method.  Physical inventories are conducted at the end of each year and perpetual records are adjusted accordingly.  Once the research and development plasma is processed to a finished good for ongoing trials it is then expensed to research and development.  Inventory at December 31, 2010 and 2011 consists of raw materials.  Inventory also includes plasma collected at the Company’s FDA licensed plasma collection center.  Approximately 9,000 liters of plasma inventory was sold in 2011, and the Company recorded a loss of $1,934,630.  The total amount of inventory sold at book value was $2,439,487 and the Company received $504,857 in proceeds from the sales.
 
Revenue recognition
 
Revenue from the sale of human plasma collected at the Company’s plasma collection center and plasma-derived medicinal products is recognized at the time of transfer of title and risk of loss to the customer, which usually occurs at the time of shipment.  Revenue is recognized at the time of delivery if the Company retains the risk of loss during shipment.
 
The plasma inventory sold in 2011 had been purchased from third parties specifically for use in research and development activities.  It had not been collected at the Company’s plasma collection center and sold in the ordinary course of business.  Therefore, the sale was not recorded as revenue with related cost of sales, but was instead recorded as a loss on sale.
 
Research and development costs
 
The Company expenses all research and development costs as incurred including plasma and equipment for which there is no alternative future use.  Such expenses include licensing fees and costs associated with planning and conducting clinical trials.
 
Use of estimates
 
The preparation of financial statements 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 revenues and expenses during the reporting period.  Actual results could differ from those estimates.  Significant estimates include valuation of inventory, assumptions used in the fair value of stock-based compensation, and the allowance for the valuation of future tax benefits.
 
Concentration of credit risk
 
Financial instruments which potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents.
 
Property and equipment
 
Fixed assets are stated at cost less accumulated depreciation.  Depreciation is calculated using the straight-line method over the asset’s estimated useful life, which is five to ten years.  Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives.
 

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Income taxes
 
From June 24, 2004 to July 16, 2007, the Company elected to be taxed as an S corporation for both Federal and state income tax reporting purposes.  Accordingly, the taxable income or loss related to that period was includable in the personal income tax returns of the stockholders.
 
Effective July 16, 2007, the Company was merged into a C corporation and adopted guidance issued by the Financial Accounting Standards Board, “Accounting for Income Taxes” which requires that the Company recognize deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns.  Under this method, deferred tax liabilities and assets are determined on the basis of the difference between the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at enacted tax rates in effect for the years in which the temporary differences are expected to reverse.  The Company records a valuation allowance on its deferred income tax assets if it is more likely than not that these deferred income tax assets will not be realized.
 
The Company has no unrecognized tax benefits at December 31, 2010 and 2011.  The Company’s U.S. Federal and state income tax returns prior to fiscal year 2008 are closed and management continually evaluates expiring statutes of limitations, audits, proposed settlements, changes in tax law and new authoritative rulings.
 
The Company will recognize interest and penalties associated with tax matters as income tax expense.
 
Earnings (Loss) Per Share
 
Net loss per share is determined in accordance with the two-class method.  This method is used for computing basic net loss per share when companies have issued securities other than common stock that contractually entitle the holder to participate in dividends and earnings of the Company.  Under the two-class method, net loss is allocated between common shares and other participating securities based on their participation rights in both distributed and undistributed earnings.  The Company’s Series A convertible preferred stock are participating securities, since the stockholders are entitled to share in dividends declared by the board of directors with the common stock based on their equivalent common shares.
 
Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period.  Because the holders of the Series A convertible Preferred Stock are not contractually required to share in the Company’s losses in applying the two-class method to compute basic net loss per common share, no allocation to preferred stock was made for the years ended December 31, 2010 and 2011.
 
Diluted net loss per share is calculated by dividing net loss applicable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of common stock and dilutive common stock outstanding during the period.  Potential common shares include the shares of common stock issuable upon the exercise of outstanding stock options and a warrant (using the treasury stock method) and the conversion of the shares of Series A convertible preferred stock (using the more dilutive of the (a) as converted method or (b) the two –class method).  Potential common shares in the diluted net loss per share computation are excluded to the extent that they would be anti-dilutive.  No potentially dilutive securities are included in the computation of any diluted per share amounts as the Company reported a net loss for all periods presented.  Potentially dilutive securities that would be issued upon conversion of convertible notes, conversion of Series A convertible preferred stock, and the exercise of outstanding warrants and stock options were 1.7 million as of both December 31, 2010 and 2011 and 1.9 million and 0.7 million as of September 30, 2011 (unaudited) and 2012 (unaudited), respectively.
 
Stock-based compensation
 
The Company follows recognized accounting guidance which requires all stock-based payments, including grants of stock options, to be recognized in the Statement of Operations as compensation expense, based on their fair values on the grant date.  The estimated fair value of options granted under the Company’s 2007 Employee Stock Option Plan (the “Plan”) are recognized as compensation expense over the option-vesting period.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
During the years ended December 31, 2010 and 2011, the Company recorded stock-based compensation expense to employees and a consultant of $34,809 and $22,947, respectively.  During the nine months ended September 30, 2011 (unaudited) and 2012 (unaudited), the Company recorded stock-based compensation expense to employees and a consultant of $19,623 and $408,544, respectively.
 
The fair value of employee options granted was determined on the date of grant using the Black-Scholes model.  The Black-Scholes option valuation model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.  In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility.  The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate.  Because there is no public market for the Company’s stock and very little historical experience with the Company’s stock options, a small similar publicly traded company was used for comparison and expectations as to assumptions required for fair value computation using the Black-Scholes methodology.  Accordingly, the Company’s stock price volatility is expected to be 72% and the expected term of options outstanding is 6.25 years.  The Company’s dividend yield has been assumed at 0% as the Company has not paid any dividends on common stock since its inception and does not anticipate paying dividends on its common stock in the foreseeable future.
 
Guidance for stock-based compensation requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.  The Company currently estimates there will be no forfeitures of options.
 
Fair value of financial instruments
 
The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents and accounts payable, are shown at cost which approximates fair value due to the short-term nature of these instruments.
 
3.       PROPERTY AND EQUIPMENT
 
Property and equipment consist of the following at December 31:
 
   
2010
   
2011
 
Lab and office equipment
  $ 467,492     $ 465,778  
Computer software
    141,277       141,277  
Leasehold improvements
    940,103       940,103  
      1,548,872       1,547,158  
Less: accumulated depreciation and amortization
    (467,713 )     (686,226 )
    $ 1,081,159     $ 860,932  

The Company recorded depreciation and amortization expense of $220,201 and $219,552 for the years ended December 31, 2010 and 2011, respectively.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
4.       LEASEHOLD IMPROVEMENT LOAN
 
In connection with the lease of commercial real estate by the Company’s wholly-owned subsidiary for the operation of the plasma collection center, the Company borrowed $125,980 from the lessor to pay for leasehold improvement costs in excess of the allowance provided for in the lease agreement.  The loan bears interest at 9% and is payable in 120 monthly installments of $1,596 maturing December 31, 2018.  Principal maturities under the loan are as follows:
 
2012
  $ 10,576  
2013
    11,569  
2014
    12,654  
2015
    13,841  
2016
    15,139  
Thereafter
    35,410  
Total
  $ 99,189  

5.       NOTES PAYABLE TO SIGNIFICANT STOCKHOLDERS
 
As of February 13, 2012, all Notes and accrued interest and Preferred Stock have been converted into common stock or repaid in full.
 
Prior to February 13, 2012, the Company has issued senior secured convertible promissory notes (the “Notes”) to significant stockholders pursuant to the terms of Note Purchase Agreements.  The outstanding principal and interest under the notes are due and payable upon the earliest to occur of:  (i) March 31, 2012 (as amended); (ii) the date on which the Company consummates a preferred stock financing in which the gross proceeds to the Company total at least $10,000,000 (“Qualified Financing” as defined in the Notes); and (iii) the occurrence of an Event of Default (as defined in the Notes), the first of these three events to occur referred to as the “Maturity Date”.  Interest accrues on the outstanding principal at the stated rate and is payable on the Maturity Date.
 
If all or any of the principal and accrued interest thereon remains outstanding prior to the date of a Qualified Financing, those amounts shall automatically convert into shares of the Company’s preferred stock at the lower of (a) the price per share paid by investors in the Qualified Financing or (b) the stated Conversion Price.
 
Any principal and accrued interest thereon that remains outstanding will convert into preferred shares at the stated conversion price if immediately prior to the Maturity Date, a Qualified Financing has not occurred and the Company does not have sufficient cash on hand to repay the outstanding balance in full.  The Series A-1 and A-2 Preferred Stock shall have the same rights and privileges as the Company’s Series A Preferred Stock and shall be senior to the Series A Preferred Stock in liquidation preference.
 
If the principal amounts due under these notes are repaid on the Maturity Date, the payees have the option to convert all of the accrued interest into shares of Series A Preferred Stock determined by dividing the interest by the Conversion Price.
 
In the Event of a Default, the interest rate stated on the notes shall be increased by three percent (3%) per annum.  The Notes are collateralized by all of the assets of the Company.
 
The Company issued promissory notes which are not convertible to significant stockholders pursuant to the terms of Note Purchase Agreements.  The outstanding principal and interest under the notes are due and payable upon the earliest to occur of: (i) March 31, 2012 (as amended); (ii) the occurrence of a prepayment event (as defined in the Notes) or (iii) the occurrence of an Event of Default (as defined in the Notes), the first of these three events to occur referred to as the “Maturity Date”.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
In December 2011, $8,150,000 of the convertible notes payable and $1,486,603 of accrued interest thereon were converted into 4,835,224 shares of the Company’s Series A-1 preferred stock at a conversion price of $1.9930 per share.
 
Notes payable consist of the following at December 31, 2010 and 2011:
 
Issue Date
 
Principal
12/31/10
   
Principal Issued in 2011
   
Principal Converted in 2011
   
Principal
Repaid in
2011
   
Principal
12/31/11
   
Interest Rate
   
Conversion Price
 
                                           
Aug-09
  $ 2,500,000     $ -     $ (2,500,000 ) *   $ -     $ -       9 %   $ 1.9930  
Dec-09
    2,500,000       -       (2,500,000 ) *     -       -       9 %   $ 1.9930  
Jun-10
    1,800,000       -       (1,800,000 )     -       -       12 %   $ 1.9930  
Dec-10
    500,000       -       (500,000 )     -       -       10 %   $ 1.9930  
Feb-11
    -       300,000       (300,000 )     -       -       10 %   $ 1.9930  
May-11
    -       250,000       (250,000 )     -       -       10 %   $ 1.9930  
Jun-11
    -       300,000       (300,000 )     -       -       10 %   $ 1.9930  
Aug-11
    -       250,000       -       -       250,000       10 %   $ 1.9930  
Sep-11
    -       100,000 **     -       (100,000 )     -       18 %     -  
Oct-11
    -       100,000 **     -       (100,000 )     -       18 %     -  
Dec-11
    -       200,000       -       -       200,000       18 %     -  
    $ 7,300,000     $ 1,500,000     $ (8,150,000 )   $ (200,000 )   $ 450,000                  

*Notes payable convertible into Series A-1 Preferred Stock.  The conversion price was amended to $1.9930 on December 22, 2011, resulting in a charge to interest expense of $556,418.  Additional charges to interest of $132,662 and $184,185 were recorded in 2010 and 2011, respectively, for the beneficial conversion feature on the notes issued in June and December 2010.
 
**Notes paid in full during the year ended December 31, 2011 including interest of $1,972.
 
Total interest expense incurred on the notes payable for the years ended December 31, 2010 and 2011 was $693,401 and $1,587,685, respectively.
 
Stock purchase warrants
 
In connection with the issuance of the June 2010, August 2011 and September 2011 Notes, the Company issued stock purchase warrants expiring ten years from date of issue to existing common and preferred stockholders at an exercise price of $0.07 per share.  Such warrants vested immediately and can be exercised at any time up to the expiration date.  Warrants outstanding as of December 31, 2010 and 2011 are as follows:
 
   
Number Of
Warrants
   
Weighted
Average
Exercise
Price
   
Weighted
Average Remaining Contractual Term
Balance Outstanding – December 31, 2009
    -            
Issued January 1 – December 31, 2010
    52,730     $ 0.07    
9.5 years
Balance Outstanding and Exercisable – December 31, 2010
    52,730     $ 0.07    
9.5 years
Warrants vested and expected to vest – December 31, 2010
    52,730     $ 0.07    
9.5 years
Balance Outstanding – December 31, 2010
    52,730     $ 0.07    
9.5 years
Issued January 1 – December 31, 2011
    5,198     $ 0.07    
9.9 years
Cancelled January 1 – December 31, 2011
    (586 )   $ 0.07      
Exercised January 1 – December 31, 2011
    (57,342 )   $ 0.07      
Balance Outstanding – December 31, 2011
    -            
 
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
6.       STOCKHOLDERS’ EQUITY
 
The Company was originally organized as an S corporation and issued 100 shares of stock at a par value of $0.01 each.  On July 16, 2007, the Company merged into a C corporation and, concurrent with this election, each of the shares of stock of the terminating S corporation converted into 23,904.38 shares of common stock of the C corporation, resulting in a total of 351,535 shares outstanding.  Since the shareholders of the S corporation became the majority shareholders of the C corporation, this was accounted for as a reverse merger.  Accordingly, the pre-merger financial statements of the S corporation have become the historical financial statements of the C corporation.
 
Upon conversion of the Company from an S corporation to a C corporation, the Company increased its authorized common stock to 6,500,000 shares with a par value of $.001 per share and authorized 3,400,000 shares of Series A preferred (Series A shares), with a par value of $.001 per share.  On July 17, 2007, the Company completed a private placement and raised gross proceeds of $17,000,000 from the sale of 3,386,454 Series A convertible preferred shares at a sale price of $5.02 per share.
 
In December 2011, 57,054 shares of Common Stock were issued in connection with the cashless exercise of 57,342 Stock Purchase Warrants and 4,835,224 shares of Series A-1 Preferred Stock were issued in connection with the conversion of notes payable and accrued interest thereon.
 
In December 2011, the corporate charter was amended to increase the authorized capital from 6,500,000 to 16,800,000 common shares and from 3,400,000 to 8,221,678 preferred shares.
 
On December 22, 2011, $8,150,000 of notes payable to significant shareholders plus accrued interest were converted to Series A Preferred Stock at a conversion rate of $1.993 per share resulting in the issuance of 4,835,224 additional shares of Series A Preferred Stock.  The note holders also exercised 57,342 warrants in a cashless transaction for 57,054 shares of common stock and cancelled warrants for an additional 586 shares of common stock.  The due date on all remaining notes payable to significant shareholders was extended from December 31, 2011 to March 31, 2012.
 
The Series A Preferred Shares have the following rights and preferences:
 
Dividends
 
From and after the date of their issuance, dividends at the rate per annum of $0.3514 per share shall accrue on Series A Preferred shares.  The Company is under no obligation to pay such accruing dividends.  However, dividends on the Preferred Shares shall be cumulative from the date of issuance and shall be paid before any dividends on shares of any other class of stock of the Company.  No such dividends were declared prior to December 31, 2010.  As of December 31, 2010 and 2011, $4,117,726 and $5,326,207, respectively, in dividends had accumulated on the Series A shares.
 
Conversion
 
The holders of the Series A Preferred Shares have the right to convert their shares to common stock at any time at an initial conversion price of $5.02 per share.  In certain situations, the Preferred Shares are protected from dilution by future issuances of common stock at less than the Series A Preferred Share conversion price.  At December 31, 2011, the conversion price was $13.5524 per share under these anti-dilution provisions.
 
The Company is required, at all times, to reserve a sufficient number of shares of common stock to effect the conversion of all outstanding shares of preferred stock.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)

 
Liquidation preference
 
Upon liquidation or dissolution of the Company, the holders of the Series A shares are entitled to be paid an amount per share equal to the Series A Original Issue Price ($5.02 per share) plus the cumulative unpaid dividends and any other dividends declared but unpaid.
 
Voting
 
The stockholders of the Series A Preferred Shares vote together with all other classes of stock as a single class on matters presented to the stockholders of the Company.  Each holder of Series A Preferred Shares is entitled to a number of votes (one vote) equal to the number of whole shares of common stock into which the Series A Preferred Shares of such holder are convertible as of the record date for determining stockholders to vote on such matters, except with respect to certain corporate actions, which require a fifty percent (50%) approval of the then outstanding Series A Preferred Shares.  The holders of record of the Series A shares, as a separate class, are entitled to elect two directors of the five-member Board of the Company.  One of the two “Series A Directors” shall serve as Chairman of the Board.  The holders of record of the common stock are also entitled to elect two directors.
 
As of February 13, 2012, there were no Preferred Shares outstanding.
 
7.       RELATED PARTY TRANSACTIONS
 
The Company leases an office building and equipment from an entity owned by related parties on a month-to-month basis.  Rent expense amounted to $96,539 and $96,448 for the years ended December 31, 2010 and 2011, respectively.  As of December 31, 2011, the Company owed such entity $72,336.
 
The Company maintains deposits and other accounts at a bank which is less than 5%-owned by related parties and where a stockholder is a member of the Board of Directors of the bank.
 
The Company owed $7,300,000 and $450,000 to existing common and preferred stockholders under senior secured convertible promissory notes and nonconvertible promissory notes at December 31, 2010 and 2011, respectively.  Interest in the amount of $650,301 and $10,781 has been accrued on these notes as of December 31, 2010 and 2011, respectively.  During 2011, there were additional borrowings of $1,500,000 from the Company’s existing common and preferred stockholders and repayments of $200,000 plus interest of $1,972.
 
8.       COMMITMENTS AND CONTINGENCIES
 
Lease commitments
 
Effective June 1, 2008, the Company entered into a 10-year lease for commercial space in a Georgia office building, commencing October 1, 2008.  The lease provides for annual rent increases and renewal options at market rent.  Rent expense under this lease was approximately $140,000 in both 2010 and 2011.
 
Future minimum lease payments for each of the five years ending December 31 and thereafter are as follows:
 
2012
  $ 152,247  
2013
    156,058  
2014
    159,995  
2015
    164,026  
2016
    168,089  
Thereafter
    303,894  
    $ 1,104,309  
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Irrevocable letter of credit
 
On May 27, 2008, the Company established a $426,963 Standby Letter of Credit in favor of a landlord to guarantee payment under the Georgia office building lease.  The landlord granted a temporary reduction of $90,000 in the amount of the required letter of credit to $336,963.  This reduction is valid until the Company receives FDA license for its plasma collection center in Georgia and begins to receive proceeds from the sale of plasma collected from the center.  This license was granted by the FDA in August 2011 and the Company is in the process of restoring the letter of credit.  The entire amount under this letter of credit is maintained in a restricted cash account as of December 31, 2010 and 2011.  The letter of credit expires on September 30, 2018.
 
Purchase commitments
 
In 2008, the Company entered into an agreement with Biotest Pharmaceuticals (“BPC”) for the purchase of plasma pursuant to which the Company will purchase plasma to be utilized in its clinical trials.  In 2010 and 2011, the Company purchased $244,937 and $23,467, respectively, of plasma under this agreement.  In October 2011, the Company entered into a new agreement with BPC for the purchase and sale or RSV plasma with an initial term of 10 years and two five year renewal terms.  Under these agreements, the Company is committed to purchase minimum quantities at specified prices, subject to change upon mutual agreement.
 
9.       STOCK OPTIONS
 
On July 16, 2007 (the “Effective Date”), the Company’s Board and stockholders adopted the Plan.  The Plan has been adopted as a means of attracting, motivating, and retaining the best available personnel for positions of substantial responsibility within the Company.  Under the Plan, the initial maximum number of options to acquire shares of the Company’s common stock that were available for issuance to Optionees was 94,853.
 
The Plan provides for the Board or a Committee of the Board (the “Committee”) to grant Awards to Optionees and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the Awards, including acceleration of the vesting of an Award at any time.  All options granted under the Plan are intended to be non-qualified options (“NQOs”) unless specified by the Committee to be incentive stock options (“ISOs”), as defined by the Internal Revenue Code.  NQOs may be granted to employees, consultants or Board members at an option price not less than the fair market value of the common stock subject to the Stock Option Agreement.  The following table summarizes information about stock options outstanding as of December 31, 2010 and 2011:
 
   
Number Of
Options
   
Weighted Average Exercise Price
   
Weighted Average Remaining Contractual Term
Balance Outstanding – December 31, 2009
    80,441     $ 3.33    
6.8 years
Options issued
    3,676     $ 1.70      
Options forfeited
    (739 )   $ 3.44      
Balance Outstanding – December 31, 2010
    83,378     $ 3.33    
6.8 years
                     
Options issued
    -              
Options forfeited
    -              
Balance Outstanding – December 31, 2011
    83,378     $ 3.33    
5.8 years
Options issued
    506,559     $ 9.60      
Balance Outstanding – September 30, 2012
    589,937     $ 8.71    
8.9 years
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
As of December 31, 2010 and 2011, the Company had 11,471 options available for future grant under the Plan and exercisable options of 68,268 and 80,736, respectively.  As of September 30, 2012, the total compensation expense related to unvested options not yet recognized totaled $3,050,944. The weighted-average vesting period over which the total compensation expense will be recorded related to unvested options not yet recognized at September 30, 2012 was approximately 3.5 years.
 
10.       INCOME TAXES
 
A reconciliation of income taxes at the U.S. Federal statutory rate to the benefit for income taxes is as follows:
 
   
Year ended December 31,
 
   
2010
   
2011
 
Benefit at US federal statutory rate
  $ (2,022,222 )   $ (2,116,237 )
State taxes - deferred
    (272,271 )     (373,454 )
Beneficial conversion feature
    45,108       189,182  
Increase in valuation allowance
    2,582,235       2,076,757  
Research and development credits
    (332,850 )     (97,013 )
Benefit for income taxes
  $ -     $ (320,765 )
Deferred tax assets:
               
Federal and state net operating loss carryforwards
  $ 7,612,221     $ 10,267,000  
Federal and state research credits
    1,793,953       1,890,966  
       Total gross deferred tax assets
    9,406,174       12,157,966  
Less: valuation allowance for deferred tax assets
    (9,406,174 )     (12,157,966 )
Net deferred tax assets
  $ -     $ -  

As of December 31, 2011, the Company had federal and state net operating loss carryforwards of approximately $25.0 million and $21.3 million, respectively, The Company also had federal and state research and development tax credit carryforwards of approximately $1.2 million and $0.7 million, respectively.  The net operating loss carryforwards and tax credits will expire at various dates beginning in 2027 if not utilized.  During the year ended December 31, 2010, the Company received a Federal Research and Development Grant in the amount of $244,479 under Section 48D of the Internal Revenue Code for a Qualified Therapeutic Discovery Project.
 
The Company received $320,765 and $617,615 in January 2011 and January 2012, respectively, from the sale of net operating loss and research and development credit carryforwards under the New Jersey Economic Development Authority Technology Business Tax Certificate Transfer Program.  These amounts are recorded on the financial statements as income tax benefits in the year they are received.
 
11.       SEGMENTS
 
The Company is engaged in the development and commercialization of human plasma and plasma-derived therapeutics.  The Company also operates an FDA-licensed source plasma collection facility located in Norcross, Georgia.  The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze performance and allocate resources.
 
The plasma collection center segment includes the Company’s operation in Georgia.  The research and development segment includes the Company’s plasma development operations in New Jersey.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Summarized financial information concerning reportable segments is shown in the following table:
 
Year ended December 31, 2010
 
Plasma Collection Center
   
Research
and
Development
   
Corporate
   
Consolidated
   
Revenues
  $ -     $ -     $ -     $ -  
Loss from operations
    (1,876,644 )     (2,193,838 )     (1,425,951 )     (5,496,433 )
Other expense
    -       -       (451,279 )     (451,279 )
Loss before income taxes
    (1,876,644 )     (2,193,838 )     (1,877,230 )     (5,947,712 )
Property plant and equipment, net
    1,020,214       47,067       13,878       1,081,159  
Depreciation and amortization expense
    198,130       18,144       3,927       220,201  
 
Year ended December 31, 2011
 
Plasma Collection Center
   
Research
and
Development
   
Corporate
   
Consolidated
 
Revenues
  $ 761,042     $ -     $ -     $ 761,042  
Loss from operations
    (609,676 )     (2,581,386 )     (1,431,894 )     (4,622,956 )
Other expense
    -       -       (1,601,269 )     (1,601,269 )
Loss before income taxes
    (609,676 )     (2,581,386 )     (3,033,163 )     (6,224,225 )
Property plant and equipment, net
    822,265       28,924       9,743       860,932  
Depreciation and amortization expense
    197,274       18,144       4,134       219,552  
 
Nine Months Ended September 30, 2011 (Unaudited)
 
Plasma Collection Center
   
Research
and
Development
   
Corporate
   
Consolidated
 
Revenues
  $ -     $ -     $ -     $ -  
Cost of sales
    -       -       -       -  
Gross profit
    -       -       -       -  
Loss from operations
        (1,191,243 )         (2,377,818 )         (932,248 )         (4,501,309 )
Other expense
    (7,155 )     -       (760,975 )     (768,130 )
Loss before income taxes
    (1,198,398 )     (2,377,818 )     (1,693,223 )     (5,269,439 )
Property and equipment, net
    869,829       33,460       11,709       914,998  
Depreciation and amortization expense
    148,500       14,861       2,800       166,161  
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Nine Months Ended September 30, 2012 (Unaudited)
 
Plasma Collection Center
   
Research
and
Development
   
Corporate
   
Consolidated
 
Revenues
  $ 594,834     $ -     $ -     $ 594,834  
Cost of sales
    288,761       -       -       288,761  
Gross profit
    306,073       -       -       306,073  
Loss from operations
        (1,021,688 )         (2,201,131 )         (2,446,043 )         (5,668,862 )
Other income (expense)
    (6,465 )     -       7,936       1,471  
Loss before income taxes
    (1,028,153 )     (2,201,131 )     (2,438,107 )     (5,667,391 )
Property and equipment, net
    701,637       16,306       85,766       803,709  
Depreciation and amortization expense
    121,553       12,618       6,572       140,743  
 
The “Corporate” column includes general and administrative overhead expenses.  The column for Research and Development expense includes the loss on sale of research and development inventory incurred during the nine months ended September 30, 2011.
 
Property and equipment, net, included in the “Corporate” column above includes assets related to corporate and support functions.
 
12.       SUBSEQUENT EVENTS
 
On February 13, 2012, in connection with, and immediately prior to the closing of the Merger (as defined below), the Company completed a private placement (the “2012 Financing”) of 1,828,128 shares of the Company’s common stock at a price per share of $9.60 to accredited investors, for gross proceeds to the Company of $17,550,029 pursuant to a securities purchase agreement (the “Securities Purchase Agreement”). In lieu of repayment of senior secured promissory notes in the aggregate principal amount of $250,000 (plus $12,740 in accrued interest), the aggregate amount of unpaid principal and interest on the notes was invested by the holders of such notes in the 2012 Financing in exchange for shares of the Company’s common stock.  The net cash proceeds from the 2012 Financing, after the payment of all expenses related to the 2012 Financing and the Merger, approximated $15.7 million.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
Rodman & Renshaw, LLC (the “Placement Agent”) acted as the exclusive placement agent in connection with the 2012 Financing.  The Company paid the Placement Agent a cash fee for its services equal to 7% of the aggregate offering price paid by each investor in the 2012 Financing, other than with respect to certain investors.  As additional compensation, the Company issued the Placement Agent warrants (the “Placement Agent Warrants”) to purchase 87,865 shares of common stock of the Company.  The Placement Agent Warrants, which were exchanged for warrants of ParentCo (as defined below) in the Merger, are exercisable at $9.60 per share of Common Stock at any time beginning on August 11, 2012 and ending on February 12, 2017.  The Company also agreed to reimburse the Placement Agent for up to $100,000 of expenses it incurs in connection with the 2012 Financing and to indemnify it against certain liabilities in connection with the 2012 Financing.
 
On February 13, 2012, R & R Acquisition VI, Inc. (“ParentCo”) entered into a merger agreement (the “Merger Agreement”) with the Company and ADMA Acquisition Sub, Inc., a Delaware corporation (“Acquisition Sub”) (“Merger”). Upon closing of the Merger, Acquisition Sub was merged with and into the Company, and the Company, as the surviving corporation in the Merger, became a wholly-owned subsidiary of ParentCo.  ParentCo’s corporate name was changed to ADMA Biologics, Inc.
 
In connection with the Merger and pursuant to the terms of the Merger Agreement, all of the then issued and outstanding shares of the Company’s common stock, including the common stock issued in the 2012 Financing and including the shares of the Company’s Series A preferred stock, which were converted into common stock immediately prior to and as part of the Merger, were automatically exchanged into 4,601,270 shares of common stock of ParentCo, par value $0.0001 per share (the “Common Stock”) at a 1:1 exchange ratio; all warrants, options and other rights to purchase or acquire shares of the Company’s common stock outstanding immediately prior to the Merger, including the Placement Agent Warrants and including the additional options granted to Adam S. Grossman, CEO, under his new employment agreement, were converted into warrants, options or other rights, as the case may be, to purchase an aggregate of 383,380 shares of Common Stock at the same exercise prices; and 2,446,967 of the 2,500,000 shares of Common Stock held by the stockholders of ParentCo immediately prior to the Merger were canceled such that these stockholders now hold 53,033 shares of Common Stock, not including the 87,865 shares issuable upon exercise of the Placement Agent Warrants, held by an affiliate of one of such stockholders.
 
Immediately prior to the Merger and the transactions described above, (i) 3,386,454 shares of Series A Preferred Stock of the Company were converted into 11,243,748 shares of the Company’s common stock after giving effect to cumulative anti-dilution adjustments and accrued dividends, and 4,835,224 shares of the Company’s Series A Preferred Stock issued in December 2011 upon the conversion of convertible notes were converted into an equal number of shares of the Company’s common stock and (ii) the shares of common stock of the Company were reverse split at a ratio of 1-for-6.8 (the “Reverse Split”). The consolidated financial statements were adjusted to give retroactive effect to the Reverse Split.
 
As part of the Merger, ParentCo assumed certain of the Company’s obligations under an investors’ rights agreement, dated July 17, 2007, by and among the Company and its stockholders (the “Investors’ Rights Agreement”), assumed the Company’s obligations under the Securities Purchase Agreement, and assumed the Company’s Plan.  After an increase in authorized shares under the Plan in connection with the Merger, the Company currently has options to purchase 295,515 shares of Common Stock issued and outstanding under the Plan and has reserved for future issuance under the Plan an additional 265,685 shares of Common Stock.
 
 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010 AND 2011 AND SEPTEMBER 30, 2011 (UNAUDITED) AND 2012 (UNAUDITED)
 
For accounting purposes, the Merger will be accounted for as a reverse acquisition, with the Company as the accounting acquiror (legal acquiree) and ParentCo as the accounting acquiree (legal acquiror), effectively a recapitalization of the Company.  On February 13, 2012, the Company entered into a new employment agreement with its President and Chief Executive Officer, Adam S. Grossman, which has an initial term of three (3) years, with automatic three (3) year renewal periods unless notice is provided 90 days in advance.  The employment agreement provides that Mr. Grossman (i) will initially be paid $350,000 annually beginning on the date on which the Merger closed (the “Effective Date”); (ii) is eligible for an annual cash bonus, the target of which is $100,000, based upon the attainment of certain performance objectives mutually agreed to by the Board of Directors and Mr. Grossman; (iii) was to be granted on the Effective Date options to purchase shares of Common Stock representing 4% of the Company’s equity on a fully diluted basis (options to purchase 212,134 shares of Common Stock at an exercise price of $9.60 were granted pursuant to this provision) and (iv) is eligible to participate in the Company’s standard benefits package.  All options granted to Mr. Grossman were issued under the Company’s stock option plan and vest over a four year period, with 25% of the options vesting on the Effective Date, and the remaining 75% vesting in equal monthly installments over the following 48 months of continued employment (full vesting on the fourth anniversary of the Effective Date), subject to accelerated vesting under certain circumstances.  Mr. Grossman also received a bonus in connection with his 2011 performance, including in connection with the 2012 Financing and Merger, of $50,000 on the date on which the Merger closed.

Unaudited

On October 1, 2012, the Company and Rodman & Renshaw, LLC, entered into a Securities Purchase Agreement (“SPA”) whereby the Company purchased 31,472 shares of common stock, par value $0.0001 per share, for $150,000 from Rodman & Renshaw, LLC.  The shares of common stock purchased by the Company had originally been issued to R&R Investments IV, Inc., an affiliate of Rodman & Renshaw, LLC. See Note 1 - Organization and Business for additional information regarding the Merger and the 2012 Financing.  These shares of common stock were retired, thus reducing the total shares of common stock outstanding from 4,654,303 to 4,622,831.
 
 
 
                          Shares

Common Stock

PROSPECTUS

                                          , 2013
 
 
Joint Book-Running Managers
 
Oppenheimer & Co.
 
BMO Capital Markets
     
  Co-Manager  
     
    Ladenburg Thalmann & Co. Inc.  
 


You should rely only on the information contained in this prospectus.  No dealer, salesperson or other person is authorized to give information that is not contained in this prospectus.  This prospectus is not an offer to sell nor is it seeking an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.  The information contained in this prospectus is correct only as of the date of this prospectus, regardless of the time of the delivery of this prospectus or any sale of these securities.
 
 
PART II
 
INFORMATION NOT REQUIRED IN PROSPECTUS
 
Item 13.  Other Expenses of Issuance and Distribution.
 
Set forth below is an estimate (except for registration fees and FINRA Filing Fees, which are actual) of the approximate amount of the fees and expenses payable by us in connection with the issuance and distribution of the shares of our common stock.
 
EXPENSE
 
AMOUNT
 
       
Registration Fees
  $ 4,705.80  
         
FINRA filing fees
       
         
Legal Fees and Expenses
       
         
Accounting Fees and Expenses
       
         
Miscellaneous Fees and Expenses
       
         
Total
  $    

Item 14.  Indemnification of Directors and Officers.
 
Our certificate of incorporation provides that no director is personally liable to the Company or its stockholders for monetary damages for any breach of fiduciary duty by such director as a director.  Nonetheless, a director is liable to the extent provided by applicable law, (i) for breach of the director’s duty of loyalty to the Company or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) pursuant to Section 174 of the DGCL (relating to unlawful payment of dividend or unlawful stock purchase or redemption) or (iv) for any transaction from which the director derived an improper personal benefit.  If the DGCL is amended to authorize the further elimination or limitation of the liability of directors, then the liability of a director of the Company, in addition to the limitation on personal liability provided in our certificate of incorporation, will be limited to the fullest extent permitted by the amended DGCL.  No amendment to or repeal of the relevant article of our certificate of incorporation will apply to or have any effect on the liability or alleged liability of any director of the Company for or with respect to any acts or omissions of such director occurring prior to such amendment.
 
Our certificate of incorporation and bylaws furthermore state that the Company shall indemnify, to the fullest extent permitted by Section 145 of the DGCL, as amended from time to time, each person that such section grants the Company the power to indemnify.
 
Section 145 of the DGCL provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee of or agent to the Registrant.  The statute provides that it is not exclusive of other rights to which those seeking indemnification may be entitled under any by-law, agreement, or vote of stockholders or disinterested directors or otherwise.
 
 
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of ours under Delaware law or otherwise, we have been advised the opinion of the SEC is that such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.  In the event a claim for indemnification against such liabilities (other than payment by us for expenses incurred or paid by a director, officer or controlling person of ours in successful defense of any action, suit, or proceeding) is asserted by a director, officer or controlling person in connection with the securities being registered, we will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction, the question of whether such indemnification by it is against public policy in the Securities Act and will be governed by the final adjudication of such issue.
 
Item 15.  Recent Sales of Unregistered Securities.
 
Sales of unregistered securities by Former ADMA since January 1, 2008 are described in the section “Certain Relationships and Related Transactions - Recent Financings” in the prospectus to which this registration statement relates.
 
Item 16.  Exhibits and Financial Statement Schedules.
 
Exhibit No.
 
Description
2.1 (1)
 
Agreement and Plan of Merger, dated February 13, 2012, among R&R Acquisition VI, Inc., ADMA Biologics, Inc. and ADMA Acquisition Sub, Inc.
2.2 (1)
 
Certificate of Merger, dated February 13, 2012, merging ADMA Acquisition Sub, Inc. with and into ADMA Biologics, Inc.
3.1 (1)
 
Certificate of Incorporation of R&R Acquisition VI, Inc., as amended
3.2 (8)
 
Bylaws of R&R Acquisition VI, Inc.
4.1 (2)
 
Specimen Common Stock Certificate
4.2 (1)
 
Form of Placement Agent Warrant
4.3
 
Form of Warrant Agreement with Hercules Technology Growth Capital, Inc. ("Hercules")
4.4  
Form of Secured Term Loan Promissory Note issued to Hercules
5.1*
 
Opinion of SNR Denton US LLP
10.1** (6)
 
2007 Employee Stock Option Plan (as amended)
10.2 (1)
 
Form of Securities Purchase Agreement, dated as of February 13, 2012, between ADMA Biologics, Inc. and each purchaser identified on the signature pages thereto
10.3 (1)
 
Form of Registration Rights Agreement, dated as of February 13, 2012, between R&R Acquisition VI, Inc. and each of the several purchasers signatory thereto
10.4 (1)
 
Amended and Restated Placement Agency Agreement, dated February 12, 2012, between ADMA Biologics, Inc. and Rodman & Renshaw, LLC
10.5 (2)
 
Form of Lockup Agreement (February 13, 2012)
10.6** (1)
 
Employment Agreement, dated February 13, 2012, by and between ADMA Biologics, Inc. and Adam Grossman
10.7 (1)
 
Investors’ Rights Agreement, dated July 17, 2007, by and among the Company and each of the investors listed on Schedule A thereto
 
 
10.8+ (5)
 
Manufacturing Agreement, dated as of October 23, 2006, by and between Biotest Pharmaceuticals Corporation ("Biotest") and ADMA Biologics, Inc., as amended as of October 23, 2011 and as of December 2, 2011
10.9+ (5)
 
Plasma Purchase Agreement, dated as of November 17, 2011, between Biotest and ADMA Biologics, Inc., as amended as of December 1, 2011
10.10 (2)
 
Agreement for Services between the Company and Areth Inc., dated July 23, 2007
10.11 (1)
 
Agreement of Lease between the Company and C1VF I-GA1W15-W23, LLC (DCT Holdings), effective June 1, 2008 and confirmed on November 13, 2008, for the premises located at 6290 Jimmy Carter Boulevard, Suite 206-208, Norcross, Georgia, as amended
10.12 (1)
 
Form of Indemnification Agreement
10.13 ** (3)
 
Employment Agreement, dated as of April 30, 2012, by and between ADMA Biologics, Inc. and Brian Lenz
10.14 (4)
 
Modification and Release Agreement dated June 15, 2012, between ADMA Biologics, Inc and Rodman & Renshaw, LLC
10.15+ (7)
 
Testing Services Agreement, dated June 7, 2012, between ADMA and Quest Diagnostics Clinical Laboratories, Inc.
10.16+ (7)
 
Plasma Supply Agreement, dated June 22, 2012, between ADMA and Biotest
10.17** (7)
 
Employment Agreement, dated July 18, 2012, by and among the Company and James Mond
10.18
 
Loan and Security Agreement, dated as of December 21, 2012 by and among ADMA, ADMA Plasma Biologics, Inc., ADMA Bio Centers Georgia Inc. and Hercules
10.19
 
Equity Rights Letter, dated December 21, 2012, from ADMA to Hercules
10.20+
 
Manufacturing, Supply and License Agreement, dated as of December 31, 2012, by and between Biotest and ADMA
10.21+
 
License Agreement, dated December 31, 2012, by and between ADMA and Biotest Aktiengesellschaft
16.1 (1)
 
Letter from Sherb & Co, LLP regarding change in certifying accountants
21.1 (2)
 
Subsidiaries of Registrant
23.1
 
Consent of CohnReznick LLP
23.2*
 
Consent of SNR Denton US LLP (contained in their opinion included under Exhibit 5.1)
24.1
 
Power of Attorney (included on signature page)
101
 
Interactive data files formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Cash Flows, and (iv) the Notes to the Consolidated Financial Statements
 
 
101.INS
 
XBRL Instance Document***
101.SCH
 
XBRL Taxonomy Extension Schema Document***
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase Document***
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase Document***
101.LAB
 
XBRL Taxonomy Extension Label Linkbase Document***
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase Document***

+  Confidential treatment requested as to certain portions of this exhibit.  Such portions have been redacted and submitted separately to the SEC.
 
*  To be filed by amendment.
 
**  Management compensatory plan, contract or arrangement.
 
*** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
 
(1)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on February 13, 2012.
 
(2)
Incorporated herein by reference to the Company’s Current Report on Form 8-K/A filed with the Commission on March 29, 2012.
 
(3)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on May 3, 2012.
 
(4)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on June 21, 2012.
 
(5)
Incorporated herein by reference to Amendment No. 3 to the Company’s current report on Form 8-K filed with the Commission on June 22, 2012.
 
(6)
Incorporated herein by reference to Exhibit A to the Information Statement on Schedule 14C filed with the Commission on October 29, 2012.
 
(7)
Incorporated by reference to Amendment No. 4 to the Company’s registration statement on  Form S-1 (333-180449) filed with the Commission on August 10, 2012.
 
(8)
Incorporated by reference to Exhibit 3.2 to R&R Acquisition VI, Inc.’s registration statement on Form 10-SB, as filed with the Securities and Exchange Commission on July 10, 2006
 
Item 17.  Undertakings.
 
The undersigned registrant hereby undertakes that:
 
(1)
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
 
 
(2)
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
 
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue.
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, in the City of Hackensack, State of New Jersey on  February 11 , 2013.
 
 
ADMA Biologics, Inc.
 
       
 
By:
  /s/Adam S. Grossman  
       
 
Name: Adam S. Grossman
 
     
 
Title     President and Chief Executive
Officer
 
       
 
POWER OF ATTORNEY: KNOW ALL PERSONS BY THESE PRESENTS that each individual whose signature appears below constitutes and appoints Adam S. Grossman and Dr. Jerrold B. Grossman, and each of them, his or her true and lawful attorneys-in-fact and agents with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement, and to sign any registration statement for the same offering covered by the Registration Statement that is to be effective upon filing pursuant to Rule 462(b) promulgated under the Securities Act, and all post-effective amendments thereto, and to file the same, with all exhibits thereto and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or his, her or their substitute or substitutes, may lawfully do or cause to be done or by virtue hereof.
 
In accordance with the requirements of the Securities Act of 1933, as amended, this registration statement was signed by the following persons in the capacities and on the dates stated:
 
Signature
 
Title
 
Date
         
         
/s/ Adam S. Grossman   President and Chief Executive    
Adam S. Grossman
 
Officer (Principal Executive Officer)
 
February 11 , 2013
         
         
/s/  Brian Lenz        
Brian Lenz
 
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
 
February 11 , 2013
         
         
/s/ Steven A. Elms           
Steven A. Elms
 
Chairman of the Board of Directors
 
February 11 , 2013
         
         
 
 
 
/s/  Dr. Jerrold B. Grossman        
Dr. Jerrold B. Grossman
 
Vice Chairman of the Board of Directors and Director
 
February 11 , 2013
 
/s/  Bryant E. Fong        
Bryant E. Fong
 
Director
 
February 11 , 2013
         
         
/s/  Dov A. Goldstein, M.D.        
Dov A. Goldstein, M.D.
 
Director
 
February 11 , 2013
         
 
/s/ Lawrence P. Guiheen        
Lawrence P. Guiheen
 
Director
 
February 11 , 2013
         
         
/s/  Eric I. Richman        
Eric I. Richman
 
Director
 
February 11 , 2013
 
 
II-7

 
EXHIBIT INDEX
 
Exhibit No.
 
Description
2.1 (1)
 
Agreement and Plan of Merger, dated February 13, 2012, among R&R Acquisition VI, Inc., ADMA Biologics, Inc. and ADMA Acquisition Sub, Inc.
2.2 (1)
 
Certificate of Merger, dated February 13, 2012, merging ADMA Acquisition Sub, Inc. with and into ADMA Biologics, Inc.
3.1 (1)
 
Certificate of Incorporation of R&R Acquisition VI, Inc., as amended
3.2 (8)
 
Bylaws of R&R Acquisition VI, Inc.
4.1 (2)
 
Specimen Common Stock Certificate
4.2 (1)
 
Form of Placement Agent Warrant
4.3
 
Form of Warrant Agreement with Hercules Technology Growth Capital, Inc. ("Hercules")
4.4  
Form of Secured Term Loan Promissory Note issued to Hercules
5.1*
 
Opinion of SNR Denton US LLP
10.1** (6)
 
2007 Employee Stock Option Plan (as amended)
10.2 (1)
 
Form of Securities Purchase Agreement, dated as of February 13, 2012, between ADMA Biologics, Inc. and each purchaser identified on the signature pages thereto
10.3 (1)
 
Form of Registration Rights Agreement, dated as of February 13, 2012, between R&R Acquisition VI, Inc. and each of the several purchasers signatory thereto
10.4 (1)
 
Amended and Restated Placement Agency Agreement, dated February 12, 2012, between ADMA Biologics, Inc. and Rodman & Renshaw, LLC
10.5 (2)
 
Form of Lockup Agreement (February 13, 2012)
10.6** (1)
 
Employment Agreement, dated February 13, 2012, by and between ADMA Biologics, Inc. and Adam Grossman
10.7 (1)
 
Investors’ Rights Agreement, dated July 17, 2007, by and among the Company and each of the investors listed on Schedule A thereto
 
 
10.8+ (5)
 
Manufacturing Agreement, dated as of October 23, 2006, by and between Biotest Pharmaceuticals Corporation ("Biotest") and ADMA Biologics, Inc., as amended as of October 23, 2011 and as of December 2, 2011
10.9+ (5)
 
Plasma Purchase Agreement, dated as of November 17, 2011, between Biotest and ADMA Biologics, Inc., as amended as of December 1, 2011
10.10 (2)
 
Agreement for Services between the Company and Areth Inc., dated July 23, 2007
10.11 (1)
 
Agreement of Lease between the Company and C1VF I-GA1W15-W23, LLC (DCT Holdings), effective June 1, 2008 and confirmed on November 13, 2008, for the premises located at 6290 Jimmy Carter Boulevard, Suite 206-208, Norcross, Georgia, as amended
10.12 (1)
 
Form of Indemnification Agreement
10.13 ** (3)
 
Employment Agreement, dated as of April 30, 2012, by and between ADMA Biologics, Inc. and Brian Lenz
10.14 (4)
 
Modification and Release Agreement dated June 15, 2012, between ADMA Biologics, Inc and Rodman & Renshaw, LLC
10.15+ (7)
 
Testing Services Agreement, dated June 7, 2012, between ADMA and Quest Diagnostics Clinical Laboratories, Inc.
10.16+ (7)
 
Plasma Supply Agreement, dated June 22, 2012, between ADMA and Biotest
10.17** (7)
 
Employment Agreement, dated July 18, 2012, by and among the Company and James Mond.
10.18
 
Loan and Security Agreement, dated as of December 21, 2012 by and among ADMA, ADMA Plasma Biologics, Inc., ADMA Bio Centers Georgia Inc. and Hercules
10.19
 
Equity Rights Letter, dated December 21, 2012, from ADMA to Hercules
10.20+
 
Manufacturing, Supply and License Agreement, dated as of December 31, 2012, by and between Biotest and ADMA
10.21+
 
License Agreement, dated December 31, 2012, by and between ADMA and Biotest Aktiengesellschaft
16.1 (1)
 
Letter from Sherb & Co, LLP regarding change in certifying accountants
21.1 (2)
 
Subsidiaries of Registrant
23.1
 
Consent of CohnReznick LLP
23.2*
 
Consent of SNR Denton US LLP (contained in their opinion included under Exhibit 5.1)
24.1
 
Power of Attorney (included on signature page)
101
 
Interactive data files formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Cash Flows, and (iv) the Notes to the Consolidated Financial Statements
 
 
101.INS
 
XBRL Instance Document***
101.SCH
 
XBRL Taxonomy Extension Schema Document***
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase Document***
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase Document***
101.LAB
 
XBRL Taxonomy Extension Label Linkbase Document***
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase Document***

+  Confidential treatment requested as to certain portions of this exhibit.  Such portions have been redacted and submitted separately to the SEC.
 
*  To be filed by amendment.
 
**  Management compensatory plan, contract or arrangement.
 
*** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
 
(1)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on February 13, 2012.
 
(2)
Incorporated herein by reference to the Company’s Current Report on Form 8-K/A filed with the Commission on March 29, 2012.
 
(3)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on May 3, 2012.
 
(4)
Incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the Commission on June 21, 2012.
 
(5)
Incorporated herein by reference to Amendment No. 3 to the Company’s current report on Form 8-K filed with the Commission on June 22, 2012.
 
(6)
Incorporated herein by reference to Exhibit A to the Information Statement on Schedule 14C filed with the Commission on October 29, 2012.
 
(7)
Incorporated by reference to Amendment No. 4 to the Company’s registration statement on  Form S-1 (333-180449) filed with the Commission on August 10, 2012.
 
(8)
Incorporated by reference to Exhibit 3.2 to R&R Acquisition VI, Inc.’s registration statement on Form 10-SB, as filed with the Securities and Exchange Commission on July 10, 2006
 
THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS.  THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL (WHICH MAY BE COMPANY COUNSEL) REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAWS.
 
WARRANT AGREEMENT

To Purchase Shares of the Common Stock of

ADMA Biologics, Inc.

Dated as of December 21, 2012 (the " Effective Date ")

WHEREAS, ADMA Biologics, Inc., a Delaware corporation (the " Company "), has entered into a Loan and Security Agreement of even date herewith (as amended and in effect from time to time, the " Loan Agreement ") with Hercules Technology Growth Capital, Inc., a Maryland corporation (the " Warrantholder ");

WHEREAS, the Company desires to grant to Warrantholder, in consideration for, among other things, the financial accommodations provided for in the Loan Agreement, the right to purchase shares of its Common Stock pursuant to this Warrant Agreement (this “ Warrant ” or this “ Agreement ”);
 
NOW, THEREFORE, in consideration of the Warrantholder executing and delivering the Loan Agreement and providing the financial accommodations contemplated therein, and in consideration of the mutual covenants and agreements contained herein, the Company and Warrantholder agree as follows:
 
SECTION 1.  
GRANT OF THE RIGHT TO PURCHASE COMMON STOCK.
 
(a)           For value received, the Company hereby grants to the Warrantholder, and the Warrantholder is entitled, upon the terms and subject to the conditions hereinafter set forth, to subscribe for and purchase, from the Company, up to 25,000 shares of Common Stock (as defined below), at a purchase per share equal to the Exercise Price (as defined below).  The number and Exercise Price of such shares are subject to adjustment as provided in Section 8.  As used herein, the following terms shall have the following meanings:
 
Act ” means the Securities Act of 1933, as amended.
 
Charter ” means the Company’s Certificate of Incorporation or other constitutional document, as may be amended and in effect from time to time.
 
Common Stock ” means the Company’s common stock, $0.0001 par value per share, as presently constituted under the Charter, and any class and/or series of Company capital stock for or into which such common stock may be converted or exchanged in a reorganization, recapitalization or similar transaction.
 
 
 

 
 
Exercise Price ” means $9.60 , subject to adjustment from time to time in accordance with the provisions of this Warrant; provided , that if, on and as of the closing of the Next Equity Round, the Next Equity Round Price is lower than the then-effective Exercise Price, then the “Exercise Price” shall be the Next Equity Round Price from and after such closing, subject to adjustment thereafter from time to time in accordance with the provisions of this Warrant.
 
Merger Event ” means any sale, lease or other transfer of all or substantially all assets of the Company, or any merger or consolidation involving the Company in which the Company is not the surviving entity or in which the outstanding shares of the Company’s capital stock are otherwise converted into or exchanged for shares of preferred stock, other securities or property of another entity, or any sale by holders of the outstanding voting equity securities of the Company in a single transaction or series of related transactions of shares constituting a majority of the outstanding combined voting power of the Company.
 
Next Equity Round ” means the first sale and issuance of Common Stock or other equity securities by the Company after the Effective Date, in a single transaction or series of related transactions (and including, without limitation, a sale of Common Stock pursuant to an effective registration statement under the Act), principally for equity financing purposes in which cash is received by the Company and/or debt of the Company is cancelled or converted in exchange for equity securities of the Company.
 
Next Equity Round Price ” means the lowest price per share received by the Company (net of underwriter, broker and placement agent fees, commissions and discounts) for shares of the Next Equity Round Series sold and issued by the Company for cash in the Next Equity Round.
 
Next Equity Round Series ” means the class and/or series of Company capital stock or other equity security sold and issued by the Company in the Next Equity Round.
 
" Purchase Price " means, with respect to any exercise of this Warrant, an amount equal to the then-effective Exercise Price multiplied by the number of shares of Common Stock as to which this Warrant is then exercised.

SECTION 2.  
TERM OF THE AGREEMENT.
 
Except as otherwise provided for herein, the term of this Agreement and the right to purchase Common Stock as granted herein shall commence on the Effective Date and shall be exercisable for a period ending upon the tenth (10 th ) anniversary of the Effective Date.
 
SECTION 3.  
EXERCISE OF THE PURCHASE RIGHTS.
 
(a)            Exercise .  The purchase rights set forth in this Agreement are exercisable by the Warrantholder, in whole or in part, at any time, or from time to time, prior to the expiration of the term set forth in Section 2, by tendering to the Company at its principal office a notice of exercise in the form attached hereto as Exhibit I (the " Notice of Exercise "), duly completed and executed.  Promptly upon receipt of the Notice of Exercise and the payment of the Purchase Price in accordance with the terms set forth below, and in no event later than five (5) days thereafter, the Company shall issue to the Warrantholder a certificate for the number of shares of Common Stock purchased and shall execute the acknowledgment of exercise in the form attached hereto as Exhibit II (the " Acknowledgment of Exercise ") indicating the number of shares which remain subject to future purchases, if any.
 
 
2

 

 
The Purchase Price may be paid at the Warrantholder's election either (i) by cash or check, or (ii) by surrender of all or a portion of the Warrant  for shares of Common Stock to be exercised under this Agreement and, if applicable, an amended Agreement representing the remaining number of shares purchasable hereunder, as determined below (" Net Issuance ").  If the Warrantholder elects the Net Issuance method, the Company will issue shares of Common Stock in accordance with the following formula:
 
X = Y(A-B)
A
 
 
Where:
X =
the number of shares of Common Stock to be issued to the Warrantholder .
 
 
Y =
the number of shares of Common Stock requested to be exercised under this Agreement.
 
 
A =
the then-current fair market value of one (1) share of Common Stock at the time of exercise.
 
 
B=
the Exercise Price.
 
For purposes of the above calculation, current fair market value of shares of Common Stock shall mean with respect to each share of Common Stock:

(i)           at all times when the Common Stock shall be traded on a national securities exchange, inter-dealer quotation system or over-the-counter bulletin board service, the average of the closing prices over a five (5) day period ending three days before the day the current fair market value of the securities is being determined;

(ii)           if the exercise is in connection with a Merger Event, the fair market value of a share of Common Stock shall be deemed to be the per share value received by the holders of the outstanding shares of Common Stock pursuant to such Merger Event as determined in accordance with the definitive transaction documents executed among the parties in connection therewith; or

(iii)           in cases other than as described in the foregoing clauses (i) and (ii), the current fair market value of a share of Common Stock shall be determined in good faith by the Company’s Board of Directors.

Upon partial exercise by either cash or Net Issuance, prior to the expiration or earlier termination hereof, the Company shall promptly issue an amended Agreement representing the remaining number of shares purchasable hereunder. All other terms and conditions of such amended Agreement shall be identical to those contained herein, including, but not limited to the Effective Date hereof.

(b)            Exercise Prior to Expiration .  To the extent this Warrant is not previously exercised as to all shares subject hereto, and if the fair market value of one share of Common Stock is greater than the Exercise Price then in effect, this Agreement shall be deemed automatically exercised on a Net Issuance basis pursuant to Section 3(a) (even if not surrendered) as of immediately before its expiration.  For purposes of such automatic exercise, the fair market value of one share of Common Stock upon such expiration shall be determined pursuant to Section 3(a).  To the extent this Warrant or any portion hereof is deemed automatically exercised pursuant to this Section 3(b), the Company agrees to promptly notify the Warrantholder of the number of shares of Common Stock if any, the Warrantholder is to receive by reason of such automatic exercise, and to issue a certificate to Warrantholder evidencing such shares.
 
 
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SECTION 4.  
RESERVATION OF SHARES.
 
During the term of this Agreement, the Company will at all times have authorized and reserved a sufficient number of shares of its Common Stock to provide for the exercise of the rights to purchase Common Stock as provided for herein.
 
SECTION 5.  
NO FRACTIONAL SHARES OR SCRIP.
 
No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Agreement, but in lieu of such fractional shares the Company shall make a cash payment therefor upon the basis of the Exercise Price then in effect.
 
SECTION 6.  
NO RIGHTS AS SHAREHOLDER/STOCKHOLDER.
 
Without limitation of any provision hereof, Warrantholder agrees that this Agreement does not entitle the Warrantholder to any voting rights or other rights as a shareholder/stockholder of the Company prior to the exercise of any of the purchase rights set forth in this Agreement.
 
SECTION 7.  
WARRANTHOLDER REGISTRY.
 
The Company shall maintain a registry showing the name and address of the registered holder of this Agreement.  Warrantholder's initial address, for purposes of such registry, is set forth in Section 12(g) below.  Warrantholder may change such address by giving written notice of such changed address to the Company.
 
SECTION 8.  
ADJUSTMENT RIGHTS.
 
The Exercise Price and the number of shares of Common Stock purchasable hereunder are subject to adjustment from time to time, as follows:
 
(a)   Merger Event .  If at any time there shall be Merger Event, then, as a part of such Merger Event, lawful provision shall be made so that the Warrantholder shall thereafter be entitled to receive, upon exercise of this Agreement, the number of shares of preferred stock or other securities, cash or other property (collectively, “R eference Property ”) that the Warrantholder would have received in connection with such Merger Event if Warrantholder had exercised this Agreement immediately prior to the Merger Event.  In any such case, appropriate adjustment (as determined in good faith by the Company’s Board of Directors) shall be made in the application of the provisions of this Agreement with respect to the rights and interests of the Warrantholder after the Merger Event to the end that the provisions of this Agreement (including adjustments of the Exercise Price and  adjustments to ensure that the provisions of this Section 8 shall thereafter be applicable, as nearly as possible, to the purchase rights under this Agreement in relation to any Reference Property thereafter acquirable upon exercise of such purchase rights) shall continue to be applicable in their entirety, and to the greatest extent possible.  Without limiting the foregoing, in connection with any Merger Event in which the consideration received or to be received by the Company’s stockholders consists of other than cash and/or readily tradable securities, upon the closing thereof, the successor or surviving entity shall assume the obligations of this Agreement; provided that if the Reference Property includes shares of stock or other securities and assets of an entity other than the successor or purchasing company, as the case may be, in such Merger Event, then such other entity shall assume the obligations under this Agreement and any such assumption shall contain such additional provisions to protect the interests of the Warrantholder as reasonably necessary by reason of the foregoing (as determined in good faith by the Company’s Board of Directors) .  In connection with a Merger Event and upon Warrantholder’s written election to the Company, the Company shall cause this Warrant Agreement to be exchanged for the consideration that Warrantholder would have received if Warrantholder had chosen to exercise its right to have shares issued pursuant to the Net Issuance provisions of this Warrant Agreement without actually exercising such right, acquiring such shares and exchanging such shares for such consideration. The provisions of this Section 8(a) shall similarly apply to successive Merger Events.
 
 
4

 
 
(b)   Reclassification of Shares .  Except for Merger Events subject to Section 8(a), if the Company at any time shall, by combination, reclassification, exchange or subdivision of securities or otherwise, change any of the securities as to which purchase rights under this Agreement exist into the same or a different number of securities of any other class or classes, this Agreement shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities which were subject to the purchase rights under this Agreement immediately prior to such combination, reclassification, exchange, subdivision or other change. The provisions of this Section 8(b) shall similarly apply to successive combination, reclassification, exchange, subdivision or other change.
 
(c)   Subdivision or Combination of Shares .  If the Company at any time shall combine or subdivide its Common Stock, (i) in the case of a subdivision, the Exercise Price shall be proportionately decreased and the number of shares for which this Warrant is exercisable shall be proportionately increased, or (ii) in the case of a combination, the Exercise Price shall be proportionately increased and the number of shares for which this Warrant is exercisable shall be proportionately decreased.
 
(d)   Stock Dividends .  If the Company at any time while this Agreement is outstanding and unexpired shall:
 
(i)   pay a dividend with respect to the outstanding shares of Common Stock payable in additional shares of Common Stock, then the Exercise Price shall be adjusted, to that price determined by multiplying the Exercise Price in effect immediately prior to such date of determination by a fraction (A) the numerator of which shall be the total number of shares of Common Stock outstanding immediately prior to such dividend or distribution, and (B) the denominator of which shall be the total number of shares of Common Stock outstanding immediately after such dividend or distribution, and the number of shares of Common Stock for which this Warrant is exercisable shall be proportionately increased; or
 
(ii)   make any other distribution with respect to Common Stock (or stock into which the Common Stock is convertible), except any distribution specifically provided for in any other clause of this Section 8, then, in each such case, provision shall be made by the Company such that the Warrantholder shall receive upon exercise or conversion of this Warrant a proportionate share of any such distribution as though it were the holder of the Common Stock (or other stock for which the Common Stock is convertible) as of the record date fixed for the determination of the shareholders of the Company entitled to receive such distribution.
 
(e)   Notice of Adjustments .  If: (i) the Company shall declare any dividend or distribution upon its outstanding Common Stock, payable in stock, cash, property or other securities (assuming Warrantholder in its capacity as lender under the Loan Agreement consents to such dividend); (ii) the Company shall offer for subscription pro rata to the holders of its Common Stock any additional shares of stock of any class or other rights; (iii) there shall be any Merger Event; or (iv) there shall be any voluntary dissolution, liquidation or winding up of the Company; then, in connection with each such event, the Company shall give the Warrantholder notice thereof at the same time and in the same manner as it gives notice thereof to the holders of Common Stock.
 
 
5

 
 
SECTION 9.  
REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.
 
(a)   Reservation of Common Stock .  The Company covenants and agrees that all shares of Common Stock that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be validly issued and outstanding, fully paid and nonassessable. The Company further covenants and agrees that the Company will, at all times during the term hereof, have authorized and reserved, free from preemptive rights, a sufficient number of shares of Common Stock to provide for the exercise of the rights represented by this Warrant.  If at any time during the term hereof the number of authorized but unissued shares of Common Stock shall not be sufficient to permit exercise of this Warrant in full, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes.
 
(b)   Due Authority .  The execution and delivery by the Company of this Agreement and the performance of all obligations of the Company hereunder, including the issuance to Warrantholder of the right to acquire the shares of Common Stock, have been duly authorized by all necessary corporate action on the part of the Company.  This Agreement: (1) does not violate the Company's Charter or current bylaws; (2) does not contravene any law or governmental rule, regulation or order applicable to it; and (3) does not and will not contravene any provision of, or constitute a default under, any indenture, mortgage, contract or other instrument to which it is a party or by which it is bound.  This Agreement constitutes a legal, valid and binding agreement of the Company, enforceable in accordance with its terms.
 
(c)   Consents and Approvals .  No consent or approval of, giving of notice to, registration with, or taking of any other action in respect of any state, federal or other governmental authority or agency is required with respect to the execution, delivery and performance by the Company of its obligations under this Agreement, except for the filing of notices pursuant to Regulation D under the Act and any filing required by applicable state securities law, which filings will be effective by the time required thereby.
 
(d)   Issued Securities .  All issued and outstanding shares of Common Stock and other securities of the Company have been duly authorized and validly issued and are fully paid and nonassessable.  All outstanding shares of Common Stock and other securities were issued in full compliance with all federal and state securities laws.
 
(e)   Insurance .  The Company has in full force and effect insurance policies, with extended coverage, insuring the Company and its property and business against such losses and risks, and in such amounts, as are customary for corporations engaged in a similar business and similarly situated and as otherwise may be required pursuant to the terms of any other contract or agreement.
 
(f)   Exempt Transaction .  Subject to the accuracy of the Warrantholder's representations in Section 10, the issuance of the Common Stock upon exercise of this Agreement will constitute a transaction exempt from (i) the registration requirements of Section 5 of the Act, in reliance upon Section 4(2) thereof, and (ii) the qualification requirements of the applicable state securities laws.
 
 
6

 
 
(g)   Registration Rights .  The Company covenants and agrees with Warrantholder that if the Company, at any time and from time to time on or after the Effective Date and on or before the expiration or earlier termination of this Warrant, proposes to register under the Act any shares of Common Stock held by one or more stockholders of the Company for resale by such stockholders, whether on a Form S-3 registration statement or otherwise, the Company shall give written notice thereof to Warrantholder and permit Warrantholder to include any or all of the shares of Common Stock issuable upon exercise of this Warrant (and any or all shares previously issued to Warrantholder upon any prior exercise(s) hereof) in such registration on a pari passu basis with such other stockholder(s) and on the same terms and conditions applicable to such other stockholder(s).
 
(h)   Information Rights .  At all times (if any) during the term of this Warrant (for so long as Warrantholder holds this Warrant) when (i) the Company shall not be required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended (the “ 1934 Act”), and/or (ii) the Common Stock is not traded on a national securities exchange, inter-dealer quotation system or over-the-counter bulletin board service, Warrantholder shall be entitled to the information rights contained in Section 7.1 of the Loan Agreement, and in any such event Section 7.1 of the Loan Agreement is hereby incorporated into this Agreement by this reference as though fully set forth herein, provided, however, that the Company shall not be required to deliver a Compliance Certificate once all Indebtedness (as defined in the Loan Agreement) owed by the Company to Warrantholder has been repaid.
 
(i)   Rule 144 Compliance .   The Company shall at all times prior to later to occur of (i) expiration hereof, and (ii) the sale or other disposition by Warrantholder in full of this Warrant or all shares of Common Stock issued on exercise in full of this Warrant timely file all reports required under the 1934 Act and otherwise timely take all actions necessary to permit the Warrantholder to sell or otherwise dispose of this Warrant and the shares of Common Stock issued on exercise hereof pursuant to Rule 144 promulgated under the Act as amended and in effect from time to time.  If the Warrantholder proposes to sell Common Stock issuable upon the exercise of this Agreement  in compliance with Rule 144, then, upon Warrantholder’s written request to the Company, the Company shall furnish to the Warrantholder, within five (5) days after receipt of such request, a written statement confirming the Company’s compliance with the filing and other requirements of such Rule.
 
SECTION 10.  
REPRESENTATIONS AND COVENANTS OF THE WARRANTHOLDER.
 
This Agreement has been entered into by the Company in reliance upon the following representations and covenants of the Warrantholder:
 
(a)   Investment Purpose .  This Warrant and the shares issued on exercise hereof will be acquired for investment and not with a view to the sale or distribution of any part thereof in violation of applicable federal and state securities laws, and the Warrantholder has no present intention of selling or engaging in any public distribution of the same except pursuant to a registration or exemption.
 
(b)   Private Issue .  The Warrantholder understands (i) that the Common Stock issuable upon exercise of this Agreement is not, as of the Effective Date, registered under the Act or qualified under applicable state securities laws, and (ii) that the Company's reliance on exemption from such registration is predicated on the representations set forth in this Section 10.  Warrantholder understands that this Warrant and the shares of Common Stock issued upon any exercise or conversion hereof must be held indefinitely unless subsequently registered under the Act and qualified under applicable state securities laws, or unless exemption from such registration and qualification are otherwise available.
 
 
7

 
 
(c)   Financial Risk .  The Warrantholder has such knowledge and experi­ence in financial and business matters as to be capable of evaluating the merits and risks of its investment, and has the ability to bear the economic risks of its investment.
 
(d)   Accredited Investor .  Warrantholder is an "accredited investor" within the meaning of the Securities and Exchange Rule 501 of Regulation D, as presently in effect.
 
(e)   No Short Sales .  Warrantholder has not at any time on or prior to the Effective Date engaged in any short sales or equivalent transactions in the Common Stock. Warrantholder agrees that at all times from and after the Effective Date and on or before the expiration or earlier termination of this Warrant, it shall not engage in any short sales or equivalent transactions in the Common Stock.
 
SECTION 11.  
TRANSFERS.
 
Subject to compliance with applicable federal and state securities laws, this Agreement and all rights hereunder are transferable, in whole or in part, without charge to the holder hereof (except for transfer taxes) upon surrender of this Agreement properly endorsed.  Each taker and holder of this Agreement, by taking or holding the same, consents and agrees that this Agreement, when endorsed in blank, shall be deemed negotiable, and that the holder hereof, when this Agreement shall have been so endorsed and its transfer recorded on the Company’s books, shall be treated by the Company and all other persons dealing with this Agreement as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented by this Agreement.  The transfer of this Agreement shall be recorded on the books of the Company upon receipt by the Company of a notice of transfer in the form attached hereto as Exhibit III (the " Transfer Notice "), at its principal offices and the payment to the Company of all transfer taxes and other governmental charges imposed on such transfer.  Until the Company receives such Transfer Notice, the Company may treat the registered owner hereof as the owner for all purposes.
SECTION 12.  
MISCELLANEOUS.
 
(a)   Effective Date .  The provisions of this Agreement shall be construed and shall be given effect in all respects as if it had been executed and delivered by the Company on the date hereof.  This Agreement shall be binding upon any successors or assigns of the Company.
 
(b)   Remedies .  In the event of any default hereunder, the non-defaulting party may proceed to protect and enforce its rights either by suit in equity and/or by action at law, including but not limited to an action for damages as a result of any such default, and/or an action for specific performance for any default where Warrantholder will not have an adequate remedy at law and where damages will not be readily ascertainable.
 
(c)   No Impairment of Rights .  The Company will not, by amendment of its Charter or through any other means, avoid or seek to avoid the observance or performance of any of the terms of this Agreement, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate in order to protect the rights of the Warrantholder against impairment.
 
(d)   [ Intentionally Omitted ]
 
(e)   Attorney's Fees .  In any litigation, arbitration or court proceeding between the Company and the Warrantholder relating hereto, the prevailing party shall be entitled to reasonable attorneys' fees and expenses and all costs of proceedings incurred in enforcing this Agreement.  For the purposes of this Section 12(e), attorneys' fees shall include without limitation fees incurred in connection with the following: (i) contempt proceedings; (ii) discovery; (iii) any motion, proceeding or other activity of any kind in connection with an insolvency proceeding; (iv) garnishment, levy, and debtor and third party examinations; and (v) post-judgment motions and proceedings of any kind, including without limitation any activity taken to collect or enforce any judgment.
 
 
8

 
 
(f)   Severability .  In the event any one or more of the provisions of this Agreement shall for any reason be held invalid, illegal or unenforceable, the remaining provisions of this Agreement shall be unimpaired, and the invalid, illegal or unenforceable provision shall be replaced by a mutually acceptable valid, legal and enforceable provision, which comes closest to the intention of the parties underlying the invalid, illegal or unenforceable provision.
 
(g)   Notices .  Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication that is required, contemplated, or permitted under this Agreement or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (a) personal delivery to the party to be notified, (b) when sent by confirmed telex, electronic transmission or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt, and shall be addressed to the party to be notified as follows:
 
If to Warrantholder:
 
HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
Legal Department
Attention:  Chief Legal Officer and Manuel Henriquez
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301
Facsimile:  650-473-9194
Telephone:  650-289-3060
 
If to the Company:
 
ADMA Biologics, Inc.
Attention: Legal Department
65 Commerce Way
Hackensack, NJ 07601
Facsimile: 201-478-5553
Telephone: 201-478-5552

 
or to such other address as each party may designate for itself by like notice.
 
(h)   Entire Agreement; Amendments .  This Agreement constitutes the entire agreement and understanding of the parties hereto in respect of the subject matter hereof, and supersedes and replaces in their entirety any prior proposals, term sheets, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof.  None of the terms of this Agreement may be amended except by an instrument executed by each of the parties hereto.
 
 
9

 
 
(i)   Headings .  The various headings in this Agreement are inserted for convenience only and shall not affect the meaning or interpretation of this Agreement or any provisions hereof.
 
(j)   Advice of Counsel .  Each of the parties represents to each other party hereto that it has discussed (or had an opportunity to discuss) with its counsel this Agreement and, specifically, the provisions of Sections 12(n), 12(o), 12(p), 12(q) and 12(r).
 
(k)   No Strict Construction .  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
 
(l)   No Waiver .  No omission or delay by Warrantholder at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by the Company at any time designated, shall be a waiver of any such right or remedy to which Warrantholder is entitled, nor shall it in any way affect the right of Warrantholder to enforce such provisions thereafter.
 
(m)   Survival .  All agreements, representations and warranties contained in this Agreement or in any document delivered pursuant hereto shall be for the benefit of Warrantholder and shall survive the execution and delivery of this Agreement and the expiration or other termination of this Agreement.
 
(n)   Governing Law .  This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.
 
(o)   Consent to Jurisdiction and Venue .  All judicial proceedings arising in or under or related to this Agreement may be brought in any state or federal court of competent jurisdiction located in the State of Delaware.  By execution and delivery of this Agreement, each party hereto generally and unconditionally: (a) consents to personal jurisdiction in the State of Delaware; (b) waives any objection as to jurisdiction or venue in the State of Delaware; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement.  Service of process on any party hereto in any action arising out of or relating to this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 12(g), and shall be deemed effective and received as set forth in Section 12(g).  Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.
 
(p)   Mutual Waiver of Jury Trial .  Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes be resolved by a judge applying such applicable laws.  EACH OF THE COMPANY AND WARRANTHOLDER SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, "CLAIMS") ASSERTED BY THE COMPANY AGAINST WARRANTHOLDER OR ITS ASSIGNEE OR BY WARRANTHOLDER OR ITS ASSIGNEE AGAINST THE COMPANY.  This waiver extends to all such Claims, including Claims that involve persons or entities other the Company and Warrantholder; Claims that arise out of or are in any way connected to the relationship between the Company and Warrantholder; and any Claims for damages, breach of contract, specific performance, or any equitable or legal relief of any kind, arising out of this Agreement.
 
 
10

 
 
(q)   Arbitration .  If the Mutual Waiver of Jury Trial set forth in Section 12(p) is ineffective or unenforceable, the parties agree that all Claims shall be submitted to binding arbitration in accordance with the commercial arbitration rules of JAMS (the “Rules”), such arbitration to occur before one arbitrator, which arbitrator shall be a retired Delaware state judge or a retired Federal court judge.  Such proceeding shall be conducted in the State of Delaware, with Delaware rules of evidence and discovery applicable to such arbitration.  The decision of the arbitrator shall be binding on the parties, and shall be final and nonappealable to the maximum extent permitted by law.  Any judgment rendered by the arbitrator may be entered in a court of competent jurisdiction and enforced by the prevailing party as a final judgment of such court.
 
(r)   Pre-arbitration Relief .  In the event Claims are to be resolved by arbitration, either party may seek from a court of competent jurisdiction identified in Section 12(o), any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by binding arbitration.
 
(s)   Counterparts .  This Agreement and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.
 
(t)   Specific Performance .  The parties hereto hereby declare that it is impossible to measure in money the damages which will accrue to Warrantholder by reason of the Company’s failure to perform any of the obligations under this Agreement and agree that the terms of this Agreement shall be specifically enforceable by Warrantholder.  If Warrantholder institutes any action or proceeding to specifically enforce the provisions hereof, any person against whom such action or proceeding is brought hereby waives the claim or defense therein that Warrantholder has an adequate remedy at law, and such person shall not offer in any such action or proceeding the claim or defense that such remedy at law exists.
 
(u)   Lost, Stolen, Mutilated or Destroyed Warrant .  If this Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as this Warrant so lost, stolen, mutilated or destroyed.  Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated or destroyed Warrant shall be at any time enforceable by anyone.
 
[Remainder of Page Intentionally Left Blank]
 
 
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IN WITNESS WHEREOF, the parties hereto have caused this Warrant Agreement to be executed by its officers thereunto duly authorized as of the Effective Date.
 
COMPANY:                            ADMA BIOLOGICS, INC.

Signature:     /s/ Adam Grossman _______
Print Name:  Adam Grossman
Title:              Pres & CEO
 

WARRANTHOLDER:           HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
 
By:        /s/ K. Nicholas Martitsch __________
Name:   K. Nicholas Martitsch
Title:     Associate General Counsel
 
 
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EXHIBIT  I

NOTICE  OF  EXERCISE


To:           [____________________________]

(1)
The undersigned Warrantholder hereby elects to purchase [_______] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement dated the [___] day of [______, _____] (the "Agreement") between [_________________] and the Warrantholder, and tenders herewith payment of the Purchase Price in full, together with all applicable transfer taxes, if any.

(2)
Please issue a certificate or certificates representing said shares of Common Stock in the name of the undersigned or in such other name as is specified below.
 

 
 
_________________________________
(Name)

_________________________________
(Address)
 
WARRANTHOLDER:  HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
 
By:       ____________________________
Name:  ____________________________
Title:    ____________________________
 
 
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EXHIBIT II

1.  
ACKNOWLEDGMENT OF EXERCISE
 
The undersigned [____________________________________], hereby acknowledge receipt of the "Notice of Exercise" from Hercules Technology Growth Capital, Inc., to purchase [____] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement, and further acknowledges that [______] shares remain subject to purchase under the terms of the Agreement.
 
COMPANY:  [_________________]


By:     ________________________________

Title:  ________________________________

Date:  ________________________________
 
 
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EXHIBIT III

TRANSFER NOTICE

(To transfer or assign the foregoing Agreement execute this form and supply required information.  Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the foregoing Agreement and all rights evidenced thereby are hereby transferred and assigned to

________________________________________________________________________________
(Please Print)

whose address is___________________________________________________________________

________________________________________________________________________________


Dated:   ______________________________________________


Holder's Signature:   _____________________________________


Holder's Address:    _____________________________________


_______________________________________________________


Signature Guaranteed:        ________________________________________________________


NOTE:     The signature to this Transfer Notice must correspond with the name as it appears on the face of the Agreement, without alteration or enlargement or any change whatever. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Agreement.
 
15

SECURED TERM LOAN PROMISSORY NOTE
 
$4,000,000.00
Advance Date:  December 21, 2012
   
 
Maturity Date:  February 1, 2016 1
 
FOR VALUE RECEIVED, ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”) hereby promises to pay to the order of HERCULES TECHNOLOGY GROWTH CAPITAL, INC., a Maryland corporation, or the current holder of this Note (the “Lender”) at 400 Hamilton Avenue, Suite 310, Palo Alto, CA 94301 or such other place of payment as the holder of this Secured Term Loan Promissory Note (this “Promissory Note”) may specify from time to time in writing, in lawful money of the United States of America, the principal amount of FOUR MILLION DOLLARS ($4,000,000.00) or such other principal amount as Lender has advanced to Borrower, together with interest at a floating rate per annum equal to the greater of (i) eight and one-half of one percent (8.50%), or (ii) the sum of (A) eight and one-half of one percent (8.50%), plus (B) the Prime Rate as reported in the “Money Rates” section of The Wall Street Journal , minus five and three-quarters of one percent (5.75%), based upon a year consisting of 360 days, with interest computed daily based upon the actual number of days in each month.
 
This Promissory Note is the Note referred to in, and is executed and delivered in connection with, that certain Loan and Security Agreement dated December 21, 2012, by and between Borrower and Lender (as the same may from time to time be amended, modified or supplemented in accordance with its terms, the “Loan Agreement”), and is entitled to the benefit and security of the Loan Agreement and the other Loan Documents (as defined in the Loan Agreement), to which reference is made for a statement of all of the terms and conditions thereof.  All payments shall be made in accordance with the Loan Agreement.  All terms defined in the Loan Agreement shall have the same definitions when used herein, unless otherwise defined herein.  An Event of Default under the Loan Agreement shall constitute a default under this Promissory Note.
 
Borrower waives presentment and demand for payment, notice of dishonor, protest and notice of protest under the UCC or any applicable law.   Borrower agrees to make all payments under this Promissory Note without setoff, recoupment or deduction and regardless of any counterclaim or defense.  This Promissory Note has been negotiated and delivered to Lender and is payable in the State of California.  This Promissory Note shall be governed by and construed and enforced in accordance with, the laws of the State of California, excluding any conflicts of law rules or principles that would cause the application of the laws of any other jurisdiction.
_________________________ 
1 May, 1, 2016 if the Amortization Date is extended to February 1, 2014 in accordance with the Loan and Security Agreement or  August, 1, 2016 if the Amortization Date is extended to May 1, 2014 in accordance with the Loan and Security Agreement or
 
 
 

 
 
BORROWER:
 
 
ADMA BIOLOGICS, INC.
 
By: ______________________________
Name:
Title:

ADMA PLASMA BIOLOGICS, INC.
 
By: ______________________________
Name:
Title:

ADMA BIO CENTERS GEORGIA INC.
 
By: ______________________________
Name:
Title:
 

 
 
 
EXECUTION VERSION
 
LOAN AND SECURITY AGREEMENT
 
THIS LOAN AND SECURITY AGREEMENT is made and dated as of December 21, 2012 and is entered into by and among ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”), and HERCULES TECHNOLOGY GROWTH CAPITAL, INC., a Maryland corporation (“Lender”).
 
RECITALS
 
A.           Borrower has requested Lender to make available to Borrower term loans in an aggregate principal amount of up to Six Million Dollars ($6,000,000.00) in up to three (3) tranches (each a “Term Loan” and, collectively, the “Term Loans”); and
 
B.           Lender is willing to make the Term Loans on the terms and conditions set forth in this Agreement.
 
AGREEMENT
 
NOW, THEREFORE, Borrower and Lender agree as follows:
 
SECTION 1.   DEFINITIONS AND RULES OF CONSTRUCTION
 
1.1           Unless otherwise defined herein, the following capitalized terms shall have the following meanings:
 
“Account Control Agreement(s)” means any agreement entered into by and among Lender, Borrower and a third party bank or other institution (including a Securities Intermediary) in which Borrower maintains a Deposit Account (other than (i) deposit accounts used exclusively for payroll provided that the amount on deposit therein shall at no time exceed the amount necessary to fund the payroll for the next succeeding payroll cycle, (ii) “zero balance” accounts and (iii) Borrower’s Deposit Accounts at Sun Trust Bank provided that amount on deposit therein do not exceed $20,000 in the aggregate at any time) or an account holding Investment Property and which grants Lender a perfected first priority security interest in the subject account or accounts.
 
“ACH Authorization” means the ACH Debit Authorization Agreement in substantially the form of Exhibit H .
 
“ACH Failure” means (ii) the failure of the Automated Clearing House (ACH) system to effect a transfer of funds requested by Lender to be used to satisfy all or part of Borrower’s obligations to pay principal and interest due hereunder or (ii) a failure by Lender to initiate debit entries for the periodic payments of such principal or interest.
 
“Advance(s)” means a Term Loan Advance.
 
“Advance Date” means the funding date of any Advance.
 
 
 

 
 
“Advance Request” means a request for an Advance submitted by Borrower to Lender in substantially the form of Exhibit A .
 
“Agreement” means this Loan and Security Agreement, as amended from time to time.
 
“Amortization Date” means November 1, 2013; provided that the Amortization Date shall be extended to February 1, 2014 upon the commencement of the Second Tranche Draw Period; and provided further that the Amortization Date shall be further extended to May 1, 2014 upon the commencement of the Third Tranche Draw Period.
 
“Assignee” has the meaning given to it in Section 11.13.
 
“Borrower Products” means all products, software, service offerings, technical data or technology currently being designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its incorporation.
 
“Cash” means all cash and liquid funds.
 
“Change in Control” means (i) any reorganization, recapitalization, consolidation or merger (or similar transaction or series of related transactions) of Borrower or any Subsidiary (except a merger of Borrower with and into Subsidiary or a merger of any Subsidiary with and into Borrower, provided that Borrower is the surviving entity), sale or exchange of outstanding shares (or similar transaction or series of related transactions) of Borrower or any Subsidiary in which the holders of Borrower or Subsidiary’s outstanding shares immediately before consummation of such transaction or series of related transactions do not, immediately after consummation of such transaction or series of related transactions, retain shares representing more than fifty percent (50%) of the voting power of the surviving entity of such transaction or series of related transactions (or the parent of such surviving entity if such surviving entity is wholly owned by such parent), in each case without regard to whether Borrower or Subsidiary is the surviving entity, or (ii) the sale or issuance by Borrower of equity securities to one or more purchasers, in a single transaction or series of related transactions not registered under the Securities Act of 1933, which securities represent, as of immediately following the closing (or, if there be more than one, any closing) thereof, fifty percent (50%) or more of the then-outstanding total combined voting power of Borrower.
 
“Claims” has the meaning given to it in Section 11.10.
 
“Closing Date” means the date of this Agreement.
 
“Collateral” means the property described in Section 3.
 
“Commitment Fee” means Twenty Five Thousand Dollars ($25,000.00), which fee is due to Lender on or prior to the Closing Date, and shall be deemed fully earned on such date regardless of the early termination of this Agreement.
 
 
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“Confidential Information” has the meaning given to it in Section 11.12.
 
“Contingent Obligation” means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any indebtedness, lease, dividend, letter of credit or other obligation of another, including any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate credit cards or merchant services issued for the account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term “Contingent Obligation” shall not include endorsements for collection or deposit in the ordinary course of business.  The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.
 
“Copyright License” means any written agreement granting any right to use any Copyright or Copyright registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
 
“Copyrights” means all copyrights, whether registered or unregistered, held pursuant to the laws of the United States, any State thereof, or of any other country.
 
“Deposit Accounts” means any “deposit accounts,” as such term is defined in the UCC, and includes any checking account, savings account, or certificate of deposit.
 
“Equity Documents” means the Warrant and the Right to Invest Letter, as the same may from time to time be amended, modified, supplemented or restated.
 
“ERISA” is the Employee Retirement Income Security Act of 1974, and its regulations.
 
“Event of Default” has the meaning given to it in Section 9.
 
“Excluded Collateral” has the meaning given to it in Section 3.1.
 
“Facility Charge” means $60,000 (i.e., one percent (1.00%) of the Maximum Term Loan Amount).
 
“Financial Statements” has the meaning given to it in Section 7.1.
 
“GAAP” means generally accepted accounting principles in the United States of America, as in effect from time to time.
 
 
3

 
 
“Indebtedness” means indebtedness of any kind, including (a) all indebtedness for borrowed money or the deferred purchase price of property or services (excluding trade credit entered into in the ordinary course of business due within sixty (60) days), including reimbursement and other obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (c) all capital lease obligations, and (d) all Contingent Obligations.
 
“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
 
“Intellectual Property” means all of Borrower’s Copyrights; Trademarks; Patents; Licenses; trade secrets and inventions; mask works; Borrower’s applications therefor and reissues, extensions, or renewals thereof; and Borrower’s goodwill associated with any of the foregoing, together with Borrower’s rights to sue for past, present and future infringement of Intellectual Property and the goodwill associated therewith.
 
“Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of all, or substantially all, of the assets of another Person.
 
“Joinder Agreements” means for each Subsidiary, a completed and executed Joinder Agreement in substantially the form attached hereto as Exhibit G .
 
“Lender” has the meaning given to it in the preamble to this Agreement.
 
“License” means any Copyright License, Patent License, Trademark License or other license of rights or interests.
 
“Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest, encumbrance, levy, lien or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest.
 
“Loan” means the Term Loan Advances made under this Agreement.
 
“Loan Documents” means this Agreement, the Note, the ACH Authorization, the Account Control Agreements, the Joinder Agreements, all UCC Financing Statements, and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby (other than the Equity Documents), as the same may from time to time be amended, modified, supplemented or restated.
 
“Material Adverse Effect” means a material adverse effect upon: (i) the business, operations, properties, assets, prospects or condition (financial or otherwise) of Borrower; or (ii) the ability of Borrower to perform the Secured Obligations in accordance with the terms of the Loan Documents, or the ability of Lender to enforce any of its rights or remedies with respect to the Secured Obligations; or (iii) the Collateral or Lender’s Liens on the Collateral or the priority of such Liens.
 
 
4

 
 
“Maximum Term Loan Amount” means Six Million Dollars ($6,000,000.00).
 
“Maximum Rate” shall have the meaning assigned to such term in Section 2.2.
 
“Note(s)” means the Term Note(s).
 
“Patent License” means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.
 
“Patents” means all letters patent of, or rights corresponding thereto, in the United States or in any other country, all registrations and recordings thereof, and all applications for letters patent of, or rights corresponding thereto, in the United States or any other country.
 
“Permitted Indebtedness” means: (i) Indebtedness of Borrower in favor of Lender arising under this Agreement or any other Loan Document or any Equity Document; (ii) Indebtedness existing on the Closing Date which is disclosed in Schedule 1A; (iii) Indebtedness of up to $2,000,000 outstanding at any time secured by a Lien described in clause (vii) of the defined term “Permitted Liens,” provided such Indebtedness does not exceed the lesser of the cost or fair market value of the Equipment financed with such Indebtedness; (iv) Indebtedness to trade creditors incurred in the ordinary course of business, including Indebtedness incurred in the ordinary course of business with corporate credit cards; (v) Indebtedness that also constitutes a Permitted Investment; (vi) Subordinated Indebtedness; (vii) reimbursement obligations in connection with letters of credit that are secured by cash or cash equivalents and issued on behalf of the Borrower or a Subsidiary thereof in an amount not to exceed $500,000 at any time outstanding; (viii) other Indebtedness in an amount not to exceed $250,000 at any time outstanding; and (ix) extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that the principal amount is not increased or the terms modified to impose materially more burdensome terms upon Borrower or its Subsidiary, as the case may be.
 
“Permitted Investment” means: (i) Investments existing on the Closing Date which are disclosed in Schedule 1B; (ii) (a) marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one year from the date of acquisition thereof, (b) commercial paper maturing no more than one year from the date of creation thereof and currently having a rating of at least A-2 or P-2 from either Standard & Poor’s Corporation or Moody’s Investors Service, (c) certificates of deposit issued by any bank with assets of at least $500,000,000 maturing no more than one year from the date of investment therein, and (d) money market accounts; (iii) repurchases of stock from former employees, directors, or consultants of Borrower under the terms of applicable repurchase agreements at the original issuance price of such securities in an aggregate amount not to exceed $500,000 in any fiscal year, provided that no Event of Default has occurred, is continuing or would exist after giving effect to the repurchases; (iv) Investments accepted in connection with Permitted Transfers; (v) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of Borrower’s business; (vi) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not affiliates, in the ordinary course of business, provided that this subparagraph (vi) shall not apply to Investments of Borrower in any Subsidiary; (vii) Investments consisting of loans not involving the net transfer on a substantially contemporaneous basis of cash proceeds to employees, officers or directors relating to the purchase of capital stock of Borrower pursuant to employee stock purchase plans or other similar agreements approved by Borrower’s Board of Directors; (viii) Investments consisting of travel advances in the ordinary course of business; (ix) Investments in newly-formed Subsidiaries organized in the United States, provided that such Subsidiaries enter into a Joinder Agreement promptly after their formation by  Borrower and execute such other documents as shall be reasonably requested by Lender; (x) Investments in subsidiaries organized outside of the United States approved in advance in writing by Lender; (xi) joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of the nonexclusive licensing of technology, the development of technology or the providing of technical support, provided that any cash Investments by Borrower do not exceed $500,000 in the aggregate in any fiscal year;(xii) additional Investments that do not exceed $500,000 in the aggregate and (xiii) the build out and construction of a blood plasma collection center in Metropolitan Atlanta, Georgia area (provided the costs of such build out and construction and licensing do not exceed the lesser of (A)$2,000,000 and (B) 125% of the costs incurred by Borrower in the build out of its existing FDA approved blood plasma collection center).
 
 
5

 
 
“Permitted Liens” means any and all of the following: (i) Liens in favor of Lender; (ii) Liens existing on the Closing Date which are disclosed in Schedule 1C; (iii) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; provided, that Borrower maintains adequate reserves therefor in accordance with GAAP; (iv) Liens securing claims or demands of materialmen, artisans, mechanics, carriers, warehousemen, landlords and other like Persons arising in the ordinary course of Borrower’s business and imposed without action of such parties; provided, that the payment thereof is not yet required; (v) Liens arising from judgments, decrees or attachments in circumstances which do not constitute an Event of Default hereunder; (vi) the following deposits, to the extent made in the ordinary course of business:  deposits under worker’s compensation, unemployment insurance, social security and other similar laws, or to secure the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure indemnity, performance or other similar bonds for the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure statutory obligations (other than liens arising under ERISA or environmental liens) or surety or appeal bonds, or to secure indemnity, performance or other similar bonds; (vii) Liens on Equipment or software or other intellectual property constituting purchase money liens and liens in connection with capital leases securing Indebtedness permitted in clause (iii) of “Permitted Indebtedness”;  (viii) Liens incurred in connection with Subordinated Indebtedness; (ix) leasehold interests in leases or subleases and licenses granted in the ordinary course of business and not interfering in any material respect with the business of the licensor; (x) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of custom duties that are promptly paid on or before the date they become due; (xi) Liens on insurance proceeds securing the payment of financed insurance premiums that are promptly paid on or before the date they become due (provided that such Liens extend only to such insurance proceeds and not to any other property or assets); (xii) statutory and common law rights of set-off and other similar rights as to deposits of cash and securities in favor of banks, other depository institutions and brokerage firms; (xiii) easements, zoning restrictions, rights-of-way and similar encumbrances on real property imposed by law or arising in the ordinary course of business so long as they do not materially impair the value or marketability of the related property; (xiv) Liens on cash or cash equivalents securing obligations permitted under clause (vii) of the definition of Permitted Indebtedness; and (xv) Liens incurred in connection with the extension, renewal or refinancing of the indebtedness secured by Liens of the type described in clauses (i) through (xi) above; provided, that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced (as may have been reduced by any payment thereon) does not increase.
 
 
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“Permitted Transfers” means (i) sales of Inventory (including, without limitation, blood plasma or any blood plasma product) in the normal course of business, (ii) non-exclusive licenses and similar arrangements for the use of Intellectual Property in the ordinary course of business and licenses that could not result in a legal transfer of title of the licensed property but that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discreet geographical areas outside of the United States in the ordinary course of business, (iii) an exclusive license that may be granted to Biotest Pharmaceuticals Corporation in respect of marketing and sales of product in Europe, (iv) dispositions of worn-out, obsolete or surplus Equipment at fair market value in the ordinary course of business, (v) the sale of tax loss carry-forwards to the State of New Jersey for cash consideration in a manner consistent with past practice and (vi) other Transfers of assets having a fair market value of not more than $500,000 in the aggregate in any fiscal year.
 
“Person” means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, limited liability company, institution, other entity or government.
 
“Prepayment Charge” shall have the meaning assigned to such term in Section 2.4.
 
“Prime Rate” means the “prime rate” as reported in The Wall Street Journal , and if not reported, then the prime rate most recently reported in The Wall Street Journal .
 
“Receivables” means (i) all of Borrower’s Accounts, Instruments, Documents, Chattel Paper, Supporting Obligations, letters of credit, proceeds of any letter of credit, and Letter of Credit Rights, and (ii) all customer lists, software, and business records related thereto.
 
“Right to Invest Letter” means that certain letter agreement dated as of December 21, 2012 by and between Lender and Borrower in the form attached hereto as Exhibit I.
 
“Second Tranche Draw Conditions” means Borrower’s initiation of (and enrollment of at least one (1) patient in) a pivotal clinical study (phase III) of Borrower’s lead product (RI-002) for the treatment of patients with Primary Immune Deficiency Disease (PIDD).
 
 
7

 
 
“Second Tranche Draw Period” means the period commencing on the occurrence of the Second Tranche Draw Conditions and ending on the earlier to occur of (i) an Event of Default and (ii) June 30, 2013.
 
“Secured Obligations” means Borrower’s obligations under this Agreement and any Loan Document, including any obligation to pay any amount now owing or later arising.
 
“Subordinated Indebtedness” means Indebtedness subordinated to the Secured Obligations in amounts and on terms and conditions satisfactory to Lender in its sole discretion.
 
“Subsequent  Equity Event” means receipt by Borrower during the period commencing on the Closing Date and ending on June 30, 2013 of unrestricted net cash proceeds from the closing of an equity financing or subordinated unsecured convertible debt financing in an aggregate amount of at least Ten Million Dollars ($10,000,000) 1 .
 
“Subsequent Financing” has the meaning given to such term in the Right to Invest Letter.
 
“Subsidiary” means an entity, whether corporate, partnership, limited liability company, joint venture or otherwise, in which Borrower owns or controls 50% or more of the outstanding voting securities, including each entity listed on Schedule 1 hereto.
 
“Term Loan Advance” means any Term Loan funds advanced under this Agreement.
 
“Term Loan Interest Rate” means for any day, a floating rate per annum equal to the greater of (i) eight and one-half of one percent (8.50%), or (ii) the sum of (A) eight and one-half of one percent (8.50%), plus (B) the Prime Rate minus five and three-quarters of one percent (5.75%).  The Term Loan Interest Rate will change from time to time on the day the Prime Rate changes.
 
“Term Loan Maturity Date” means the date that is twenty seven (27) months after the Amortization Date.
 
“Term Note” means a Promissory Note in substantially the form of Exhibit B .
 
“Third Tranche Draw Conditions” means (i) the advance by Lender of Term Loans in the aggregate principal amount of $1,000,000 during the Third Tranche Draw Period, (ii) the Borrower’s meeting of the Second Tranche Draw Conditions, and (iii) the occurrence of the Subsequent Equity Event.
 
“Third Tranche Draw Period” means the period commencing on the occurrence of the Third Tranche Draw Conditions and ending on the earlier to occur of (i) an Event of Default and (ii) June 30, 2013.
 
____________________
 
1 Investments made pursuant to the Right to Invest Letter shall count towards the minimum equity raise amount.
 
 
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“Trademark License” means any written agreement granting any right to use any Trademark or Trademark registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
 
“Trademarks” means all trademarks (registered, common law or otherwise) and any applications in connection therewith, including registrations, recordings and applications in the United States Patent and Trademark Office or in any similar office or agency of the United States, any State thereof or any other country or any political subdivision thereof.
 
“UCC” means the Uniform Commercial Code as the same is, from time to time, in effect in the State of Delaware; provided, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of, or remedies with respect to, Lender’s Lien on any Collateral is governed by the Uniform Commercial Code as the same is, from time to time, in effect in a jurisdiction other than the State of Delaware, then the term “UCC” shall mean the Uniform Commercial Code as in effect, from time to time, in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority or remedies and for purposes of definitions related to such provisions.
 
“Warrant” means the warrant entered into in connection with the Loan.
 
Unless otherwise specified, all references in this Agreement or any Annex or Schedule hereto to a “Section,” “subsection,” “Exhibit,” “Annex,” or “Schedule” shall refer to the corresponding Section, subsection, Exhibit, Annex, or Schedule in or to this Agreement.  Unless otherwise specifically provided herein, any accounting term used in this Agreement or the other Loan Documents shall have the meaning customarily given such term in accordance with GAAP, and all financial computations hereunder shall be computed in accordance with GAAP, consistently applied. Unless otherwise defined herein or in the other Loan Documents, terms that are used herein or in the other Loan Documents and defined in the UCC shall have the meanings given to them in the UCC.
 
SECTION 2.   THE TERM LOANS
 
2.1            Term Loans .
 
(a)            Advances .  Subject to the terms and conditions of this Agreement, Lender will make, and Borrower agrees to draw, an initial Term Loan Advance of Four Million Dollars ($4,000,000) on the Closing Date.  During the Second Tranche Draw Period, Borrower may request one an additional Term Loan Advance in an amount of up to One Million Dollars ($1,000,000).  In addition, during the Third Tranche Draw Period, Borrower may request one additional Term Loan Advance in an amount up to One Million Dollars ($1,000,000) in one Advance. The aggregate outstanding Term Loan Advances shall not exceed the Maximum Term Loan Amount. Proceeds of any Advance shall be deposited in an account that is subject to a perfected security interest in favor of Lender.
 
(b)            Advance Request .  To obtain a Term Loan Advance, Borrower shall complete, sign and deliver to Lender an Advance Request (at least five (5) business days before the Advance Date) and a Term Note for the amount of such Term Loan Advance.  Lender shall fund the Term Loan Advance in the manner requested by the Advance Request provided that each of the conditions precedent to such Term Loan Advance is satisfied as of the requested Advance Date.
 
 
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(c)            Interest .  The principal balance of each Term Loan Advance shall bear interest thereon from such Advance Date at the Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed.  The Term Loan Interest Rate will float and change on the day the Prime Rate changes from time to time.
 
(d)            Payment .  Borrower will pay interest on each Term Loan Advance on the first day of each month, beginning the month after the Advance Date.  Borrower shall repay the aggregate Term Loan principal balance that is outstanding on the Amortization Date in twenty-seven (27) equal monthly installments of principal and interest beginning on the Amortization Date and continuing on the first business day of each month thereafter.  The entire Term Loan principal balance and all accrued but unpaid interest hereunder, shall be due and payable on Term Loan Maturity Date.  Borrower shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Borrower’s account as authorized on the ACH Authorization on each payment date of all periodic obligations payable to Lender under each Term Note or Term Advance. Once repaid, a Term Loan or any portion thereof may not be reborrowed.
 
2.2            Maximum Interest .  Notwithstanding any provision in this Agreement, the Notes, or any other Loan Document, it is the parties’ intent not to contract for, charge or receive interest at a rate that is greater than the maximum rate permissible by law that a court of competent jurisdiction shall deem applicable hereto (which under the laws of the State of California shall be deemed to be the laws relating to permissible rates of interest on commercial loans) (the “Maximum Rate”).  If a court of competent jurisdiction shall finally determine that Borrower has actually paid to Lender an amount of interest in excess of the amount that would have been payable if all of the Secured Obligations had at all times borne interest at the Maximum Rate, then such excess interest actually paid by Borrower shall be applied as follows:  first, to the payment of principal outstanding on the Notes; second, after all principal is repaid, to the payment of Lender’s accrued interest, costs, expenses, professional fees and any other Secured Obligations; and third, after all Secured Obligations are repaid, the excess (if any) shall be refunded to Borrower.
 
2.3            Default Interest .  In the event any payment is not paid on the scheduled payment date other than due to an ACH Failure, an amount equal to five percent (5%) of the past due amount shall be payable on demand. In addition, upon the occurrence and during the continuation of an Event of Default hereunder, all Secured Obligations, including principal, interest, compounded interest, and professional fees, shall bear interest at a rate per annum equal to the rate set forth in Section 2.1(c), plus five percent (5%) per annum.  In the event any interest is not paid when due hereunder, delinquent interest shall be added to principal and shall bear interest on interest, compounded at the rate set forth in Section 2.1(c).
 
 
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2.4            Prepayment .  At its option, upon at least seven (7) business days prior notice to Lender, Borrower may prepay all, but not less than all, of the outstanding Advances by paying the entire principal balance, all accrued and unpaid interest thereon, all unpaid Lender’s  fees and expenses accrued to the date of the prepayment, together with a prepayment charge equal to the following percentage of the principal amount of the Advances: if the principal amount of the Advances are prepaid in any of the first twelve (12) months following the Closing Date, three percent (3%); if prepaid after twelve (12) months but prior to twenty four (24) months, two percent (2%); and if prepaid thereafter, but prior to the Term Loan Maturity Date, one-half of one percent (0.5%) (each, a “Prepayment Charge”).  Borrower agrees that the Prepayment Charge is a reasonable calculation of Lender’s lost profits in view of the difficulties and impracticality of determining actual damages resulting from an early repayment of the Advances.  Borrower shall prepay the entire principal balance of the Advances, all accrued and unpaid interest thereon, all unpaid Lender’s fees and expenses accrued to the date of the prepayment and the Prepayment Charge upon the occurrence of a Change in Control.
 
2.5            End of Term Charge .  On the earliest to occur of (i) the Term Loan Maturity Date, (ii) the date that Borrower prepays the outstanding Secured Obligations, or (iii) the date that the Secured Obligations become due and payable, Borrower shall pay Lender a fee of two and sixty-five one-hundredths percent (2.65%) of the aggregate principal amount funded under the Term Loans.  Notwithstanding the required payment date of such charge, it shall be deemed earned by Lender as of the Closing Date.
 
SECTION 3.   SECURITY INTEREST
 
3.1           As security for the prompt, complete and indefeasible payment when due (whether on the payment dates or otherwise) of all the Secured Obligations, Borrower grants to Lender a security interest in all of Borrower’s right, title, and interest in and to the following personal property whether now owned or hereafter acquired (collectively, the “Collateral”):  (a) Receivables; (b) Equipment; (c) Fixtures; (d) General Intangibles (other than Intellectual Property constituting Excluded Collateral); (e) Inventory; (f) Investment Property (but excluding thirty-five percent (35%) of the capital stock of any foreign Subsidiary that constitutes a Permitted Investment); (g) Deposit Accounts; (h) Cash; (i) Goods; and all other tangible and intangible personal property of Borrower whether now or hereafter owned or existing, leased, consigned by or to, or acquired by, Borrower and wherever located, and any of Borrower’s property in the possession or under the control of Lender; and, to the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for, and rents, profits and products of each of the foregoing ; provided , however ,   the security interest grant hereunder shall not extend to and the term “Collateral” shall not include (such property so excluded from Collateral is referred to herein as the “Excluded Collateral”); the Intellectual Property; provided , further , that notwithstanding the foregoing, (x) the   Collateral   shall include all Accounts and General Intangibles that consist of rights to payment and proceeds from   the sale, licensing or   disposition of all or any part, or rights in, the Intellectual Property (the “Rights to Payment”), and (y) if a court of competent jurisdiction (including a U.S. Bankruptcy Court) holds that it is necessary to have a security interest in the Intellectual Property out of which such Rights to Payment arise in order to have a security interest in such Rights to Payment, then the Collateral shall automatically, and effective as of the date of this Agreement, include that portion of the Intellectual Property to the extent necessary to permit perfection of Lender’s security interest in such Rights to Payment.  In the event Lender obtains a security interest in any Intellectual Property under the immediately preceding clause (y), then Lender shall not exercise any rights or remedies (under the UCC or otherwise) with respect to such Intellectual Property except to the extent necessary to exercise rights and remedies in respect of Rights to Payment.
 
 
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SECTION 4.   CONDITIONS PRECEDENT TO TERM LOANS
 
The obligation of Lender to make the Term Loan Advances hereunder is subject to the satisfaction by Borrower of the following conditions:
 
4.1            Initial Advance .  On or prior to the Closing Date, Borrower shall have delivered to Lender the following:
 
(a)           executed originals of the Loan Documents, Account Control Agreements and all other documents and instruments reasonably required by Lender to effectuate the transactions contemplated hereby or to create and perfect the Liens of Lender with respect to all Collateral, in all cases in form and substance reasonably acceptable to Lender;
 
(b)           certified copy of resolutions of Borrower’s board of directors evidencing approval of (i) the Loan and other transactions evidenced by the Loan Documents; and (ii) the Equity Documents and transactions evidenced thereby;
 
(c)           certified copies of the Certificate of Incorporation and the Bylaws, as amended through the Closing Date, of Borrower;
 
(d)           a certificate of good standing for Borrower from its state of incorporation and similar certificates from all other jurisdictions in which it does business and where the failure to be qualified would have a Material Adverse Effect;
 
(e)           originals of the Equity Documents executed by the parties thereto;
 
(f)           payment of the Facility Charge and reimbursement of Lender’s current expenses reimbursable pursuant to this Agreement, which amounts, if not previously paid, may be deducted from the initial Advance; and
 
(g)           such other documents as Lender may reasonably request.
 
4.2            All Advances .  On each Advance Date:
 
(a)           Lender shall have received (i) an Advance Request and a Note for the relevant Advance as required by Section 2.1(b), each duly executed by Borrower’s Chief Executive Officer or Chief Financial Officer, and (ii) any other documents Lender may reasonably request.
 
 
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(b)           The representations and warranties set forth in this Agreement and in Section 5 and in the Warrant shall be true and correct in all material respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date.
 
(c)           Borrower shall be in compliance with all the terms and provisions set forth herein and in each other Loan Document on its part to be observed or performed, and at the time of and immediately after such Advance no Event of Default shall have occurred and be continuing.
 
4.3           Each Advance Request shall be deemed to constitute a representation and warranty by Borrower on the relevant Advance Date as to the matters specified in paragraphs (b) and (c) of this Section 4.2 and as to the matters set forth in the Advance Request.
 
4.4            Second and Third Tranche Draw Periods .  In addition to the conditions set forth in the foregoing Sections 4.1 and 4.2, (i) on the Advance Date, if any, during the Second Tranche Draw Period, Borrower shall have satisfied the Second Tranche Draw Conditions, and (ii) on the Advance Date, if any, during the Third Tranche Draw Period, Borrower shall have satisfied the Third Tranche Draw Conditions.
 
4.5            No Default .  As of the Closing Date and each Advance Date, (i) no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default and (ii) no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.
 
SECTION 5.   REPRESENTATIONS AND WARRANTIES OF BORROWER
 
Borrower represents and warrants that:
 
5.1            Corporate Status .  Borrower is a corporation duly organized, legally existing and in good standing under the laws of the State of Delaware, and is duly qualified as a foreign corporation in all jurisdictions in which the nature of its business or location of its properties require such qualifications, except where the failure to be qualified could reasonably be expected to have a Material Adverse Effect.  Borrower’s present name, former names (if any), locations, state of incorporation, tax identification number, organizational identification number and other information are correctly set forth in Exhibit C , as may be updated by Borrower in a written notice (including any Compliance Certificate) provided to Lender after the Closing Date.
 
5.2            Collateral .  Borrower owns the Collateral and the Intellectual Property, free of all Liens, except for Permitted Liens.  Borrower has the power and authority to grant to Lender a Lien in the Collateral as security for the Secured Obligations .
 
5.3            Consents .  Borrower’s execution, delivery and performance of the Notes, this Agreement and all other Loan Documents, and Borrower’s execution of the Equity Documents, (i) have been duly authorized by all necessary corporate action of Borrower, (ii) will not result in the creation or imposition of any Lien upon the Collateral, other than Permitted Liens and the Liens created by this Agreement and the other Loan Documents, (iii) do not violate any provisions of Borrower’s Certificate or Articles of Incorporation (as applicable), bylaws, or any, law, regulation, order, injunction, judgment, decree or writ to which Borrower is subject and (iv) except as described on Schedule 5.3, do not violate any contract or agreement to which Borrower is a party or require the consent or approval of any other Person, other than those consents or approvals which have been obtained.  The individual or individuals executing the Loan Documents and the Equity Documents are duly authorized to do so.
 
 
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5.4            Material Adverse Effect .  No event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing. Borrower is not aware of any event likely to occur that is reasonably expected to result in a Material Adverse Effect.
 
5.5            Actions Before Governmental Authorities .  Except as described on Schedule 5.5, there are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of Borrower, threatened against or affecting Borrower or its property, which if adversely determined would reasonably be expected to result in a Material Adverse Effect.
 
5.6           Laws.  Borrower is not in violation of any law, rule or regulation, or in default with respect to any judgment, writ, injunction or decree of any governmental authority, where such violation or default is reasonably expected to result in a Material Adverse Effect.  Borrower is not in default in any manner under any provision of any agreement or instrument evidencing indebtedness in a principal amount in excess of $100,000, or any other material agreement to which it is a party or by which it is bound.
 
5.7            Information Correct and Current .  No information, report, Advance Request, financial statement, exhibit or schedule furnished, by or on behalf of Borrower to Lender in connection with any Loan Document or included therein or delivered pursuant thereto contained, contains or will contain any material misstatement of fact or omitted, omits or will omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were, are or will be made, not misleading at the time such statement was made or deemed made. Additionally, any and all financial or business projections provided by Borrower to Lender shall be (i) provided in good faith and based on the most current data and information available to Borrower, and (ii) the most current of such projections provided to Borrower’s Board of Directors.
 
5.8            Tax Matters .  Except as described on Schedule 5.8, (a) Borrower has filed all federal, state and local tax returns that it is required to file, (b) Borrower has duly paid or fully reserved for all taxes or installments thereof (including any interest or penalties) as and when due, which have or may become due pursuant to such returns, and (c) Borrower has paid or fully reserved for any tax assessment received by Borrower for the three (3) years preceding the Closing Date, if any (including any taxes being contested in good faith and by appropriate proceedings).
 
 
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5.9            Intellectual Property Claims .  Borrower is the sole owner of, or otherwise has the right to use, the Intellectual Property.  Except as described on Schedule 5.9,(i) each of the material Copyrights, Trademarks and Patents is valid and enforceable, (ii) no material part of the Intellectual Property has been judged invalid or unenforceable, in whole or in part, and (iii) no claim has been made to Borrower that any material part of the Intellectual Property violates the rights of any third party. Exhibit D is a true, correct and complete list of each of Borrower’s Patents, registered Trademarks, registered Copyrights, and material agreements under which Borrower licenses Intellectual Property from third parties (other than shrink-wrap software licenses), together with application or registration numbers, as applicable, owned by Borrower or any Subsidiary, in each case as of the Closing Date. Borrower is not in material breach of, nor has Borrower failed to perform any material obligations under, any of the foregoing contracts, licenses or agreements and, to Borrower’s knowledge, no third party to any such contract, license or agreement is in material breach thereof or has failed to perform any material obligations thereunder.
 
5.10            Intellectual Property .  Except as described on Schedule 5.10, Borrower has, or in the case of any proposed business, will have, all material rights with respect to Intellectual Property necessary in the operation or conduct of Borrower’s business as currently conducted and proposed to be conducted by Borrower.  Without limiting the generality of the foregoing, and in the case of Licenses, except for restrictions that are unenforceable under Division 9 of the UCC, Borrower has the right, to the extent required to operate Borrower’s business, to freely transfer, license or assign Intellectual Property without condition, restriction or payment of any kind (other than license payments in the ordinary course of business) to any third party, and Borrower owns or has the right to use, pursuant to valid licenses, all software development tools, library functions, compilers and all other third-party software and other items that are used in the design, development, promotion, sale, license, manufacture, import, export, use or distribution of Borrower Products.
 
5.11            Borrower Products .  Except as described on Schedule 5.11, no Intellectual Property owned by Borrower or Borrower Product has been or is subject to any actual or, to the knowledge of Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of Borrower or Borrower Products.  Borrower has not received any written notice or claim, or, to the knowledge of Borrower, oral notice or claim, challenging or questioning Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s knowledge, is there a reasonable basis for any such claim.  Neither Borrower’s use of its Intellectual Property nor the production and sale of Borrower Products infringes the Intellectual Property of others.
 
 
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5.12            Financial Accounts .   Exhibit E , as may be updated by the Borrower in a written notice provided to Lender after the Closing Date, is a true, correct and complete list of (a) all banks and other financial institutions at which Borrower or any Subsidiary maintains Deposit Accounts and (b) all institutions at which Borrower or any Subsidiary maintains an account holding Investment Property, and such exhibit correctly identifies the name, address and telephone number of each bank or other institution, the name in which the account is held, a description of the purpose of the account, and the complete account number therefor.
 
5.13            Employee Loans .  Except to the extent otherwise permitted under Section 7.8(c), Borrower has no outstanding loans to any employee, officer or director of the Borrower nor has Borrower guaranteed the payment of any loan made to an employee, officer or director of the Borrower by a third party.
 
5.14            Capitalization and Subsidiaries .  Borrower’s capitalization as of the Closing Date is set forth on Schedule 5.14 annexed hereto.  Borrower does not own any stock, partnership interest or other securities of any Person, except for Permitted Investments.  Attached as Schedule 5.14, as may be updated by Borrower in a written notice provided after the Closing Date, is a true, correct and complete list of each Subsidiary.
 
SECTION 6.   INSURANCE; INDEMNIFICATION
 
6.1            Coverage .  Borrower shall cause to be carried and maintained commercial general liability insurance, on an occurrence form, against risks customarily insured against in Borrower’s line of business.  Such risks shall include the risks of bodily injury, including death, property damage, personal injury, advertising injury, and contractual liability per the terms of the indemnification agreement found in Section 6.3.  Borrower must maintain a minimum of $2,000,000 of commercial general liability insurance for each occurrence.  Borrower has and agrees to maintain a minimum of $2,000,000 of directors and officers’ insurance for each occurrence and $5,000,000 in the aggregate.  So long as there are any Secured Obligations outstanding, Borrower shall also cause to be carried and maintained insurance upon the Collateral, insuring against all risks of physical loss or damage howsoever caused, in an amount not less than the full replacement cost of the Collateral, provided that such insurance may be subject to standard exceptions and deductibles.
 
6.2            Certificates .  Borrower shall deliver to Lender certificates of insurance that evidence Borrower’s compliance with its insurance obligations in Section 6.1 and the obligations contained in this Section 6.2.  Borrower’s insurance certificate shall state Lender is an additional insured for commercial general liability, a loss payee for all risk property damage insurance, subject to the insurer’s approval, and a loss payee for property insurance and additional insured for liability insurance for any future insurance that Borrower may acquire from such insurer.  Attached to the certificates of insurance will be additional insured endorsements for liability and lender’s loss payable endorsements for all risk property damage insurance and fidelity.  Borrower shall endeavor to cause all certificates of insurance to provide for a minimum of thirty (30) days advance written notice to Lender of cancellation or any other change adverse to Lender’s interests.  Any failure of Lender to scrutinize such insurance certificates for compliance is not a waiver of any of Lender’s rights, all of which are reserved.
 
 
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6.3            Indemnity .  Borrower agrees to indemnify and hold Lender and its officers, directors, employees, agents, in-house attorneys, representatives and shareholders harmless from and against any and all claims, costs, expenses, damages and liabilities (including such claims, costs, expenses, damages and liabilities based on liability in tort, including strict liability in tort), including reasonable attorneys’ fees and disbursements and other costs of investigation or defense (including those incurred upon any appeal), that may be instituted or asserted against or incurred by Lender or any such Person as the result of credit having been extended, suspended or terminated under this Agreement and the other Loan Documents or the administration of such credit, or in connection with or arising out of the transactions contemplated hereunder and thereunder, or any actions or failures to act in connection therewith, or arising out of the disposition or utilization of the Collateral, excluding in all cases claims resulting solely from Lender’s gross negligence or willful misconduct. Borrower agrees to pay, and to save Lender harmless from, any and all liabilities with respect to, or resulting from any delay in paying, any and all excise, sales or other similar taxes (excluding taxes imposed on or measured by the net income of Lender) that may be payable or determined to be payable with respect to any of the Collateral or this Agreement.
 
SECTION 7.   COVENANTS OF BORROWER
 
Borrower agrees as follows:
 
7.1            Financial Reports .  Borrower shall furnish to Lender the financial statements and reports listed hereinafter (the “Financial Statements”):
 
(a)           as soon as practicable (and in any event within 30 days) after the end of each month, unaudited interim and year-to-date financial statements as of the end of such month (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows accompanied by a report detailing any material contingencies (including the commencement of any material litigation by or against Borrower) or any other occurrence that would reasonably be expected to have a Material Adverse Effect, all certified by Borrower’s Chief Executive Officer or Chief Financial Officer to the effect that they have been prepared in accordance with GAAP, except (i) for the absence of footnotes, (ii) that they are subject to normal year end adjustments, and (iii) they do not contain certain non-cash items that are customarily included in quarterly and annual financial statements;
 
(b)           as soon as practicable (and in any event within 45 days) after the end of each calendar  quarter, unaudited interim and year-to-date financial statements as of the end of such calendar quarter (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows accompanied by a report detailing any material contingencies (including the commencement of any material litigation by or against Borrower) or any other occurrence that would reasonably be expected to have a Material Adverse Effect,  certified by Borrower’s Chief Executive Officer or Chief Financial Officer to the effect that they have been prepared in accordance with GAAP, except (i) for the absence of footnotes, and (ii) that they are subject to normal year end adjustments; as well as the most recent capitalization table for Borrower, including the weighted average exercise price of employee stock options;
 
 
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(c)           as soon as practicable (and in any event within one hundred twenty (120) days) after the end of each fiscal year, unqualified audited financial statements as of the end of such year (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows, and setting forth in comparative form the corresponding figures for the preceding fiscal year, certified by a firm of independent certified public accountants selected by Borrower and reasonably acceptable to Lender, accompanied by any management report and unqualified opinion (other than a “going concern” qualification in respect of the fiscal years ending December 31, 2010 and December 31, 2011 due to a lack of liquidity) from such Auditor.  Lender acknowledges and agrees that the Borrower’s current Auditor, CohnReznick LLP, is acceptable for purposes of this Section 7.1(c);
 
(d)            as soon as practicable (and in any event within 30 days) after the end of each month, a Compliance Certificate in the form of Exhibit F;
 
(e)           promptly after the sending or filing thereof, as the case may be, copies of any regular, periodic and special reports or registration statements that Borrower files with the Securities and Exchange Commission or any governmental authority that may be substituted therefor, or any national securities exchange.
 
Documents required to be delivered pursuant to the terms of this clause (e) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower provides Lender a link thereto; and
 
(f)           financial and business projections within fifteen (15) business days following their approval by Borrower’s Board of Directors, as well as budgets, operating plans and other financial information reasonably requested by Lender.
 
 
Borrower shall not make any change in its (a) accounting policies or reporting practices, except as required by GAAP, or (b) fiscal years or fiscal quarters. The fiscal year of Borrower ends on December 31.
 
 
The executed Compliance Certificate may be sent via facsimile to Lender at (650) 473-9194 or via e-mail to bjadot@herculestech.com.  All Financial Statements required to be delivered pursuant to clauses (a), (b) and (c) shall be sent via e-mail to financialstatements@herculestech.com with a copy to bjadot@herculestech.com provided, that if e-mail is not available or sending such Financial Statements via e-mail is not possible, they shall be sent via facsimile to Lender at: (866) 468-8916, attention Chief Credit Officer.
 
 
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7.2            Management Rights .  Borrower shall permit any representative that Lender authorizes, including its attorneys and accountants, to inspect the Collateral and examine and make copies and abstracts of the books of account and records of Borrower at reasonable times and upon reasonable notice during normal business hours.  In addition, any such representative shall have the right to meet with management and officers of Borrower to discuss such books of account and records.  In addition, Lender shall be entitled at reasonable times and intervals to consult with and advise the management and officers of Borrower concerning significant business issues affecting Borrower.  Such consultations shall not unreasonably interfere with Borrower’s business operations.  The parties intend that the rights granted Lender shall constitute “management rights” within the meaning of 29 C.F.R Section 2510.3-101(d)(3)(ii), but that any advice, recommendations or participation by Lender with respect to any business issues shall not be deemed to give Lender, nor be deemed an exercise by Lender of, control over Borrower’s management or policies.
 
7.3            Further Assurances .  Borrower shall from time to time execute, deliver and file, alone or with Lender, any financing statements, security agreements, collateral assignments, notices, control agreements, or other documents to perfect or give the highest priority to Lender’s Lien on the Collateral.  Borrower shall from time to time procure any instruments or documents as may be requested by Lender, and take all further action that may be necessary or desirable, or that Lender may reasonably request, to perfect and protect the Liens granted hereby and thereby.  In addition, and for such purposes only, Borrower hereby authorizes Lender to execute and deliver on behalf of Borrower and to file such financing statements, collateral assignments, notices, control agreements, security agreements and other documents without the signature of Borrower either in Lender’s name or in the name of Lender as agent and attorney-in-fact for Borrower.  Borrower shall protect and defend Borrower’s title to the Collateral and Lender’s Lien thereon against all Persons claiming any interest adverse to Borrower or Lender other than Permitted Liens.
 
7.4            Intentionally Omitted .
 
7.5            Indebtedness .  Borrower shall not create, incur, assume, guarantee or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness, or prepay any Indebtedness or take any actions which impose on Borrower an obligation to prepay any Indebtedness, except for the conversion of Indebtedness into equity securities and the payment of cash in lieu of fractional shares in connection with such conversion.
 
7.6            Collateral .  Borrower shall at all times keep the Collateral, the Intellectual Property and all other property and assets used in Borrower’s business or in which Borrower now or hereafter holds any interest free and clear from any legal process or Liens whatsoever (except for Permitted Liens), and shall give Lender prompt written notice of any legal process affecting the Collateral, the Intellectual Property, such other property and assets, or any Liens thereon, provided that any abandonment of any Intellectual Property based on Borrower’s reasonable business judgment shall not be deemed a breach hereof.  Borrower shall cause its Subsidiaries to protect and defend such Subsidiary’s title to its assets from and against all Persons claiming any interest adverse to such Subsidiary, and Borrower shall cause its Subsidiaries at all times to keep such Subsidiary’s property and assets free and clear from any legal process or Liens whatsoever (except for Permitted Liens), and shall give Lender prompt written notice of any legal process affecting such Subsidiary’s assets. Borrower shall not agree with any Person other than Lender not to encumber its property.
 
 
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7.7            Investments .  Borrower shall not directly or indirectly acquire or own, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments.
 
7.8            Distributions .  Borrower shall not, and shall not allow any Subsidiary to, (a) repurchase or redeem any class of stock or other equity interest other than pursuant to employee, director or consultant repurchase plans or other similar agreements, provided, however, in each case the repurchase or redemption price does not exceed the original consideration paid for such stock or equity interest, or (b) declare or pay any cash dividend or make a cash distribution on any class of stock or other equity interest, except that a Subsidiary may pay dividends or make distributions to Borrower, or (c) lend money to any employees, officers or directors or guarantee the payment of any such loans granted by a third party in excess of $100,000 in the aggregate or (d) waive, release or forgive any indebtedness owed by any employees, officers or directors in excess of $100,000 in the aggregate.
 
7.9            Transfers .  Except for Permitted Transfers, Borrower shall not voluntarily or involuntarily transfer, sell, lease, license, lend or in any other manner convey any equitable, beneficial or legal interest in any material portion of their assets.
 
7.10            Mergers or Acquisitions .  Except in connection with a Permitted Investment, Borrower shall not merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or consolidations of a Subsidiary into another Subsidiary or into Borrower), or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person.
 
7.11            Taxes .  Borrower and its Subsidiaries shall pay when due all taxes, fees or other charges of any nature whatsoever (together with any related interest or penalties) now or hereafter imposed or assessed against Borrower, Lender or the Collateral or upon Borrower’s ownership, possession, use, operation or disposition thereof or upon Borrower’s rents, receipts or earnings arising therefrom.  Borrower shall file on or before the due date therefor all personal property tax returns in respect of the Collateral.  Notwithstanding the foregoing, Borrower may contest, in good faith and by appropriate proceedings, taxes for which Borrower maintains adequate reserves therefor in accordance with GAAP.
 
7.12            Corporate Changes .  Neither Borrower nor any Subsidiary shall change its corporate name, legal form or jurisdiction of formation without at least twenty (20) days’ prior written notice to Lender.  Neither Borrower nor any Subsidiary shall relocate its chief executive office or its principal place of business unless: (i) it has provided prior written notice to Lender; and (ii) such relocation shall be within the continental United States.  Neither Borrower nor any Subsidiary shall relocate any item of Collateral (other than (w) sales of Inventory in the ordinary course of business, (x) relocations of Equipment from the blood plasma collection center in metropolitan Atlanta, Georgia area having an aggregate value of up to $2,000,000 in any fiscal year, (y) relocations of other Equipment having an aggregate value of up to $250,000 in any fiscal year, and (z) relocations of Collateral from a location described on Exhibit C to another location described on Exhibit C ) unless (i) it has provided prompt written notice to Lender, (ii) such relocation is within the continental United States and, (iii) if such relocation is to a third party bailee, it has delivered a bailee agreement in form and substance reasonably acceptable to Lender.
 
 
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7.13            Deposit Accounts .  Neither Borrower nor any Subsidiary shall maintain any Deposit Accounts, or accounts holding Investment Property, except with respect to which Lender has an Account Control Agreement.
 
7.14            Subsidiaries .  Borrower shall notify Lender of each Subsidiary formed subsequent to the Closing Date and, within 15 days of formation, shall cause any such Subsidiary organized under the laws of any State within the United States to execute and deliver to Lender a Joinder Agreement.
 
SECTION 8.   RIGHT TO INVEST
 
8.1           Lender or its assignee or nominee shall have the right, in its discretion, to participate in any Subsequent Financing pursuant to the terms of the Right to Invest Letter.
 
SECTION 9.   EVENTS OF DEFAULT
 
The occurrence of any one or more of the following events shall be an Event of Default:
 
9.1            Payments .  Borrower fails to pay any amount due under this Agreement, the Notes or any of the other Loan Documents on the due date; or
 
9.2            Covenants .  Borrower breaches or defaults in the performance of any covenant or Secured Obligation under this Agreement, the Notes, or any of the other Loan Documents, and (a) with respect to a default under any covenant under this Agreement (other than under Sections 6, 7.5, 7.6, 7.7, 7.8, 7.9 or 7.14) such default continues for more than ten (10) days after the earlier of the date on which (i) Lender has given notice of such default to Borrower, or (ii) Borrower has actual knowledge of such default, or (b) with respect to a default under any of Sections 6, 7.5, 7.6, 7.7, 7.8, 7.9 or 7.14, the occurrence of such default; or
 
9.3            Material Adverse Effect .  A circumstance has occurred that has had or would reasonably be expected to have a Material Adverse Effect; or
 
9.4            Other Loan Documents .  The occurrence of any default under any Loan Document or any other agreement between Borrower and Lender and such default continues for more than ten (10) days after the earlier of (a) Lender has given notice of such default to Borrower, or (b) Borrower has actual knowledge of such default; or
 
 
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9.5            Representations .  Any representation or warranty made by Borrower in any Loan Document or in the Warrant shall have been false or misleading in any material respect when made; or
 
9.6            Insolvency .  Borrower (A) (i) shall make an assignment for the benefit of creditors; or (ii) shall be unable to pay its debts as they become due, or be unable to pay or perform under the Loan Documents, or shall become insolvent; or (iii) shall file a voluntary petition in bankruptcy; or (iv) shall file any petition, answer, or document seeking for itself any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation pertinent to such circumstances; or (v) shall seek or consent to or acquiesce in the appointment of any trustee, receiver, or liquidator of Borrower or of all or any substantial part (i.e., 33-1/3% or more) of the assets or property of Borrower; or (vi) shall cease operations of its business as its business has normally been conducted, or terminate substantially all of its employees; or (vii) Borrower or its directors or majority shareholders shall take any action initiating any of the foregoing actions described in clauses (i) through (vi); or (B) either (i) forty-five (45) days shall have expired after the commencement of an involuntary action against Borrower seeking reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, without such action being dismissed or all orders or proceedings thereunder affecting the operations or the business of Borrower being stayed; or (ii) a stay of any such order or proceedings shall thereafter be set aside and the action setting it aside shall not be timely appealed; or (iii) Borrower shall file any answer admitting or not contesting the material allegations of a petition filed against Borrower in any such proceedings; or (iv) the court in which such proceedings are pending shall enter a decree or order granting the relief sought in any such proceedings; or (v) forty-five (45) days shall have expired after the appointment, without the consent or acquiescence of Borrower, of any trustee, receiver or liquidator of Borrower or of all or any substantial part of the properties of Borrower without such appointment being vacated; or
 
9.7            Attachments; Judgments .  Any portion of Borrower’s assets is attached or seized, or a levy is filed against any such assets, or a judgment or judgments is/are entered for the payment of money, individually or in the aggregate, of at least $250,000 and shall remain unsatisfied, unvacated or unstayed for a period of twenty (20) days after the entry thereof, or Borrower is enjoined or in any way prevented by court order from conducting any part of its business; or
 
9.8            Other Obligations .  The occurrence of any default under any agreement or obligation of Borrower involving any Indebtedness in excess of $50,000, or the occurrence of any default under any agreement  or obligation of Borrower that could reasonably be expected to have a Material Adverse Effect.
 
 
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SECTION 10.   REMEDIES
 
10.1            General .  Upon and during the continuance of any one or more Events of Default, (i) Lender may, at its option, accelerate and demand payment of all or any part of the Secured Obligations together with a Prepayment Charge and declare them to be immediately due and payable (provided, that upon the occurrence of an Event of Default of the type described in Section 9.6, the Notes and all of the Secured Obligations shall automatically be accelerated and made due and payable, in each case without any further notice or act), (ii) Lender may terminate any commitment of Lender to make any further Advances hereunder, and (iii) Lender may notify any of Borrower’s account debtors to make payment directly to Lender, compromise the amount of any such account on Borrower’s behalf and endorse Lender’s name without recourse on any such payment for deposit directly to Lender’s account.  Lender may exercise all rights and remedies with respect to the Collateral under the Loan Documents or otherwise available to it under the UCC and other applicable law, including the right to release, hold, sell, lease, liquidate, collect, realize upon, or otherwise dispose of all or any part of the Collateral and the right to occupy, utilize, process and commingle the Collateral.  All Lender’s rights and remedies shall be cumulative and not exclusive.
 
10.2            Collection; Foreclosure .  Upon the occurrence and during the continuance of any Event of Default, Lender may, at any time or from time to time, apply, collect, liquidate, sell in one or more sales, lease or otherwise dispose of, any or all of the Collateral, in its then condition or following any commercially reasonable preparation or processing, in such order as Lender may elect.  Any such sale may be made either at public or private sale at its place of business or elsewhere.  Borrower agrees that any such public or private sale may occur upon ten (10) calendar days’ prior written notice to Borrower.  Lender may require Borrower to assemble the Collateral and make it available to Lender at a place designated by Lender that is reasonably convenient to Lender and Borrower.  The proceeds of any sale, disposition or other realization upon all or any part of the Collateral shall be applied by Lender in the following order of priorities:
 
 
First, to Lender in an amount sufficient to pay in full Lender’s costs and professionals’ and advisors’ fees and expenses as described in Section 11.11;
 
 
Second, to Lender in an amount equal to the then unpaid amount of the Secured Obligations (including principal, interest, and the Default Rate interest), in such order and priority as Lender may choose in its sole discretion; and
 
 
Finally, after the full, final, and indefeasible payment in Cash of all of the Secured Obligations, to any creditor holding a junior Lien on the Collateral, or to Borrower or its representatives or as a court of competent jurisdiction may direct.
 
Lender shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it complies with the obligations of a secured party under the UCC and applicable law.
 
10.3            No Waiver .  Lender shall be under no obligation to marshal any of the Collateral for the benefit of Borrower or any other Person, and Borrower expressly waives all rights, if any, to require Lender to marshal any Collateral.
 
10.4            Cumulative Remedies .  The rights, powers and remedies of Lender hereunder shall be in addition to all rights, powers and remedies given by statute or rule of law and are cumulative.  The exercise of any one or more of the rights, powers and remedies provided herein shall not be construed as a waiver of or election of remedies with respect to any other rights, powers and remedies of Lender.
 
 
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SECTION 11.   MISCELLANEOUS
 
11.1            Severability .  Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be prohibited by or invalid under such law, such provision shall be ineffective only to the extent and duration of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.
 
11.2            Notice .  Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication (including the delivery of Financial Statements) that is required, contemplated, or permitted under the Loan Documents or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (i) the day of transmission by facsimile or hand delivery or delivery by an overnight express service or overnight mail delivery service; or (ii) the third calendar day after deposit in the United States mails, with proper first class postage prepaid, in each case addressed to the party to be notified as follows:
 
(a)           If to Lender:
 
HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
Legal Department
Attention:  Chief Legal Officer and Mr. Bryan Jadot
400 Hamilton Avenue, Suite 310
Palo Alto, California  94301
Facsimile:  650-473-9194
Telephone:  650-289-3060
 
(b)           If to Borrower:
 
c/o ADMA BIOLOGICS, INC.
Attention:  ADMA Biologics, Legal Department
65 Commerce Way
Hackensack, New Jersey 07601
Facsimile:  201-478-5553
Telephone:  201-478-5552
 
or to such other address as each party may designate for itself by like notice.
 
11.3            Entire Agreement; Amendments .  This Agreement, the Notes, and the other Loan Documents constitute the entire agreement and understanding of the parties hereto in respect of the subject matter hereof and thereof, and supersede and replace in their entirety any prior proposals, term sheets, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof or thereof (including Lender’s proposal letter dated September 27, 2012).  None of the terms of this Agreement, the Notes or any of the other Loan Documents may be amended except by an instrument executed by each of the parties hereto.
 
 
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11.4            No Strict Construction .  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
 
11.5            No Waiver .  The powers conferred upon Lender by this Agreement are solely to protect its rights hereunder and under the other Loan Documents and its interest in the Collateral and shall not impose any duty upon Lender to exercise any such powers.  No omission or delay by Lender at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by Borrower at any time designated, shall be a waiver of any such right or remedy to which Lender is entitled, nor shall it in any way affect the right of Lender to enforce such provisions thereafter.
 
11.6            Survival .  All agreements, representations and warranties of Borrower contained in this Agreement, the Notes and the other Loan Documents or in any document delivered pursuant hereto or thereto shall be for the benefit of Lender and shall survive the execution and delivery of this Agreement and the expiration or other termination of this Agreement.
 
11.7            Successors and Assigns .  The provisions of this Agreement and the other Loan Documents shall inure to the benefit of and be binding on Borrower and its permitted assigns (if any).  Borrower shall not assign its obligations under this Agreement, the Notes or any of the other Loan Documents without Lender’s express prior written consent, and any such attempted assignment shall be void and of no effect.  Lender may assign, transfer, or endorse its rights hereunder and under the other Loan Documents (except to a competitor of Borrower operating in the same field (i.e., plasma and blood products) unless an Event of Default has occurred and is continuing) without prior notice to Borrower, and all of such rights shall inure to the benefit of Lender’s successors and assigns.
 
11.8            Governing Law .  This Agreement, the Notes and the other Loan Documents have been negotiated and delivered to Lender in the State of Delaware, and shall have been accepted by Lender in the State of Delaware.  Payment to Lender by Borrower of the Secured Obligations is due in the State of Delaware.  This Agreement, the Notes and the other Loan Documents shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.
 
11.9            Consent to Jurisdiction and Venue .  All judicial proceedings (to the extent that the reference requirement of Section 11.10 is not applicable) arising in or under or related to this Agreement, the Notes or any of the other Loan Documents may be brought in any state or federal court located in the State of California.  By execution and delivery of this Agreement, each party hereto generally and unconditionally: (a) consents to nonexclusive personal jurisdiction in Santa Clara County, State of California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement, the Notes or the other Loan Documents.  Service of process on any party hereto in any action arising out of or relating to this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 11.2, and shall be deemed effective and received as set forth in Section 11.2.  Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.
 
 
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11.10            Mutual Waiver of Jury Trial / Judicial Reference .
 
(a)           Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes be resolved by a judge applying such applicable laws.  EACH OF BORROWER AND LENDER SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, “CLAIMS”) ASSERTED BY BORROWER AGAINST LENDER OR ITS ASSIGNEE OR BY LENDER OR ITS ASSIGNEE AGAINST BORROWER.  This waiver extends to all such Claims, including Claims that involve Persons other than Borrower and Lender; Claims that arise out of or are in any way connected to the relationship between Borrower and Lender; and any Claims for damages, breach of contract, tort, specific performance, or any equitable or legal relief of any kind, arising out of this Agreement, any other Loan Document.
 
(b)           If the waiver of jury trial set forth in Section 11.10(a) is ineffective or unenforceable, the parties agree that all Claims shall be resolved by reference to a private judge sitting without a jury, pursuant to Code of Civil Procedure Section 638, before a mutually acceptable referee or, if the parties cannot agree, a referee selected by the Presiding Judge of the Santa Clara County, California.  Such proceeding shall be conducted in Santa Clara County, California, with California rules of evidence and discovery applicable to such proceeding.
 
(c)           In the event Claims are to be resolved by judicial reference, either party may seek from a court identified in Section 11.9, any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by judicial reference.
 
 
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11.11            Professional Fees .  Borrower promises to pay Lender’s fees and expenses necessary to finalize the loan documentation, including but not limited to reasonable attorneys fees, UCC searches, filing costs, and other miscellaneous expenses. In addition, Borrower promises to pay any and all reasonable attorneys’ and other professionals’ fees and expenses (including fees and expenses of in-house counsel) incurred by Lender after the Closing Date in connection with or related to:  (a) the Loan; (b) the administration, collection, or enforcement of the Loan; (c) the amendment or modification of the Loan Documents; (d) any waiver, consent, release, or termination under the Loan Documents; (e) the protection, preservation, sale, lease, liquidation, or disposition of Collateral or the exercise of remedies with respect to the Collateral; (f) any legal, litigation, administrative, arbitration, or out of court proceeding in connection with or related to Borrower or the Collateral, and any appeal or review thereof; and (g) any bankruptcy, restructuring, reorganization, assignment for the benefit of creditors, workout, foreclosure, or other action related to Borrower, the Collateral, the Loan Documents, including representing Lender in any adversary proceeding or contested matter commenced or continued by or on behalf of Borrower’s estate, and any appeal or review thereof.
 
11.12            Confidentiality .  Lender acknowledges that certain items of Collateral and information provided to Lender by Borrower are confidential and proprietary information of Borrower, if and to the extent such information either (x) is marked as confidential by Borrower at the time of disclosure, or (y) should reasonably be understood to be confidential (the “Confidential Information”).  Accordingly, Lender agrees that any Confidential Information it may obtain in the course of acquiring, administering, or perfecting  Lender’s security interest in the Collateral shall not be disclosed to any other person or entity in any manner whatsoever, in whole or in part, without the prior written consent of Borrower, except that Lender may disclose any such information:  (a) to its own directors, officers, employees, accountants, counsel and other professional advisors and to its affiliates if Lender in its sole discretion determines that any such party should have access to such information in connection with such party’s responsibilities in connection with the Loan or this Agreement and, provided that such recipient of such Confidential Information either (i) agrees to be bound by the confidentiality provisions of this paragraph or (ii) is otherwise subject to confidentiality restrictions that reasonably protect against the disclosure of Confidential Information; (b) if such information is generally available to the public by no fault of Lender; (c) if required or appropriate in any report, statement or testimony submitted to any governmental authority having or claiming to have jurisdiction over Lender; (d) if required or appropriate in response to any summons or subpoena or in connection with any litigation, to the extent permitted or deemed advisable by Lender’s counsel; (e) to comply with any legal requirement or law applicable to Lender; (f) to the extent reasonably necessary in connection with the exercise of any right or remedy under any Loan Document, including Lender’s sale, lease, or other disposition of Collateral after default; (g) to any participant or assignee of Lender or any prospective participant or assignee; provided, that such participant or assignee or prospective participant or assignee agrees in writing to be bound by this Section prior to disclosure; or (h) otherwise with the prior written consent of Borrower; provided, that any disclosure made in violation of this Agreement shall not affect the obligations of Borrower or any of its affiliates or any guarantor under this Agreement or the other Loan Documents.
 
 
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11.13            Assignment of Rights .  Borrower acknowledges and understands that Lender may sell and assign all or part of its interest hereunder and under the Note(s) and Loan Documents to any person or entity (an “Assignee”).  After such assignment the term “Lender” as used in the Loan Documents shall mean and include such Assignee, and such Assignee shall be vested with all rights, powers and remedies of Lender hereunder with respect to the interest so assigned; but with respect to any such interest not so transferred, Lender shall retain all rights, powers and remedies hereby given.  No such assignment by Lender shall relieve Borrower of any of its obligations hereunder.  Lender agrees that in the event of any transfer by it of the Note(s), it will endorse thereon a notation as to the portion of the principal of the Note(s), which shall have been paid at the time of such transfer and as to the date to which interest shall have been last paid thereon.
 
11.14            Revival of Secured Obligations .  This Agreement and the Loan Documents shall remain in full force and effect and continue to be effective if any petition is filed by or against Borrower for liquidation or reorganization, if Borrower becomes insolvent or makes an assignment for the benefit of creditors, if a receiver or trustee is appointed for all or any significant part of Borrower’s assets, or if any payment or transfer of Collateral is recovered from Lender.  The Loan Documents and the Secured Obligations and Collateral security shall continue to be effective, or shall be revived or reinstated, as the case may be, if at any time payment and performance of the Secured Obligations or any transfer of Collateral to Lender, or any part thereof is rescinded, avoided or avoidable, reduced in amount, or must otherwise be restored or returned by, or is recovered from, Lender or by any obligee of the Secured Obligations, whether as a “voidable preference,” “fraudulent conveyance,” or otherwise, all as though such payment, performance, or transfer of Collateral had not been made.  In the event that any payment, or any part thereof, is rescinded, reduced, avoided, avoidable, restored, returned, or recovered, the Loan Documents and the Secured Obligations shall be deemed, without any further action or documentation, to have been revived and reinstated except to the extent of the full, final, and indefeasible payment to Lender in Cash.
 
11.15            Counterparts .  This Agreement and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.
 
11.16            No Third Party Beneficiaries .  No provisions of the Loan Documents are intended, nor will be interpreted, to provide or create any third-party beneficiary rights or any other rights of any kind in any person other than Lender and Borrower unless specifically provided otherwise herein, and, except as otherwise so provided, all provisions of the Loan Documents will be personal and solely between Lender and the Borrower.
 
11.17            Publicity .  Lender may use Borrower’s name and logo, and include a brief description of the relationship between Borrower and Lender, in Lender’s marketing materials.
 
 
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11.18               Borrower Liability .  Each Borrower hereunder shall be jointly and severally obligated to repay all Advances made hereunder, regardless of which Borrower actually receives said Advance, as if each Borrower hereunder directly received all Advances.  Each Borrower waives (a) any suretyship defenses available to it under the Code or any other applicable law, and (b) any right to require Lender to: (i) proceed against any Borrower or any other person; (ii) proceed against or exhaust any security; or (iii) pursue any other remedy.  Lender may exercise or not exercise any right or remedy it has against any Borrower or any security it holds (including the right to foreclose by judicial or non-judicial sale) without affecting any Borrower’s liability.  Notwithstanding any other provision of this Agreement or other related document, each Borrower irrevocably waives all rights that it may have at law or in equity (including, without limitation, any law subrogating Borrower to the rights of Lender under this Agreement) to seek contribution, indemnification or any other form of reimbursement from any other Borrower, or any other Person now or hereafter primarily or secondarily liable for any of the Secured Obligations, for any payment made by Borrower with respect to the Secured Obligations in connection with this Agreement or otherwise and all rights that it might have to benefit from, or to participate in, any security for the Secured Obligations as a result of any payment made by Borrower with respect to the Secured Obligations in connection with this Agreement or otherwise.  Any agreement providing for indemnification, reimbursement or any other arrangement prohibited under this Section shall be null and void.  If any payment is made to a Borrower in contravention of this Section, such Borrower shall hold such payment in trust for Lender and such payment shall be promptly delivered to Lender for application to the Secured Obligations, whether matured or unmatured.
 
(SIGNATURE PAGE FOLLOWS)
 
 
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IN WITNESS WHEREOF, Borrower and Lender have duly executed and delivered this Loan and Security Agreement as of the day and year first above written.
 
 
 
BORROWER:
 
ADMA BIOLOGICS, INC.
 
Signature:   /s/ Adam Grossman
Print Name:  Adam Grossman
Title:  President and CEO
 
ADMA PLASMA BIOLOGICS, INC.
 
Signature:   /s/ Adam Grossman
Print Name:  Adam Grossman
Title:  CEO
 
ADMA BIO CENTERS GEORGIA INC.
 
Signature:   /s/ Adam Grossman
Print Name:  Adam Grossman
Title:  CEO
   
Accepted in Palo Alto, California:   
   
 
LENDER:
 
HERCULES TECHNOLOGY GROWTH CAPITAL, INC.,
a Maryland corporation
 
By: /s/ K. Nicholas Martitsch
Name: K. Nicholas Martitsch
 
[Signature page to Loan Agreement – ADMA Biologics]
 
 
 

 
 
Its: Associate General Counsel
 
Table of Addenda, Exhibits and Schedules
 
Exhibit A:
Advance Request
 
Attachment to Advance Request
   
Exhibit B:
Term Note
   
Exhibit C:
Name, Locations, and Other Information for Borrower
   
Exhibit D:
Borrower’s Patents, Trademarks, Copyrights and Licenses
   
Exhibit E:
Borrower’s Deposit Accounts and Investment Accounts
   
Exhibit F:
Compliance Certificate
   
Exhibit G:
Joinder Agreement
   
Exhibit H:
ACH Debit Authorization Agreement
   
Exhibit I:
Right to Invest Letter
   
Schedule 1
Subsidiaries
Schedule 1A
Existing Permitted Indebtedness
Schedule 1B
Existing Permitted Investments
Schedule 1C
Existing Permitted Liens
Schedule 5.3
Consents, Etc.
Schedule 5.5
Actions Before Governmental Authorities
Schedule 5.8
Tax Matters
Schedule 5.9
Intellectual Property Claims
Schedule 5.10
Intellectual Property
Schedule 5.11
Borrower Products
Schedule 5.14   
Capitalization
 
[Table of Addenda, Exhibits and Schedules]
 
 
 

 
 
EXHIBIT A
 
ADVANCE REQUEST
 
To:           
Lender:        
                                                                    
Hercules Technology Growth Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301
Facsimile:  650-473-9194
Attn:
  Date:                      __________, 20___
 
ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”) hereby requests from Hercules Technology Growth Capital, Inc. (“Lender”) an Advance in the amount of _____________________ Dollars ($________________) on ______________, 20___ (the “Advance Date”) pursuant to the Loan and Security Agreement between Borrower and Lender (the “Agreement”). Capitalized words and other terms used but not otherwise defined herein are used with the same meanings as defined in the Agreement.
Please:
 
(a)           Issue a check payable to Borrower                                                                ________
 
or
 
(b)           Wire Funds to Borrower’s account                                                                ________
 
Bank:                        _____________________________
Address:                  _____________________________
                                  _____________________________
 
ABA Number:        _____________________________
Account Number:  _____________________________
Account Name:      _____________________________
 
Borrower represents that the conditions precedent to the Advance set forth in the Agreement are satisfied and shall be satisfied upon the making of such Advance, including but not limited to:  (i) that no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing; (ii) that the representations and warranties set forth in the Agreement and in the Warrant are and shall be true and correct in all material respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date; (iii) that Borrower is in compliance with all the terms and provisions set forth in each Loan Document on its part to be observed or performed; and (iv) that as of the Advance Date, no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default under the Loan Documents.  Borrower understands and acknowledges that Lender has the right to review the conditions precedent to the Advance requested and, based upon such review in its sole discretion, Lender may decline to fund the requested Advance if such conditions have not been satisfied to the satisfaction of Lender.
 
 
A-1

 
 
Borrower hereby represents that Borrower’s corporate status and locations have not changed since the date of the Agreement or, if the Attachment to this Advance Request is completed, are as set forth in the Attachment to this Advance Request.
 
Borrower agrees to notify Lender promptly before the funding of the Loan if any of the matters which have been represented above shall not be true and correct on the Advance Date and if Lender has received no such notice before the Advance Date then the statements set forth above shall be deemed to have been made and shall be deemed to be true and correct as of the Advance Date.
 
Executed as of ________________, 20____.
 
 
 
BORROWER:
 
ADMA BIOLOGICS, INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
ADMA PLASMA BIOLOGICS, INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
ADMA BIO CENTERS GEORGIA INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
 
A-2

 
 
ATTACHMENT TO ADVANCE REQUEST
 
Dated: _______________________
 
Borrower hereby represents and warrants to Lender that Borrower’s current name and organizational status is as follows:
 
 
Name:
ADMA BIOLOGICS, INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4168997
 
 
Name:
ADMA PLASMA BIOLOGICS, INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4385118
 
 
Name:
ADMA BIO CENTERS GEORGIA INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4528628
 
Borrower hereby represents and warrants to Lender that the street addresses, cities, states and postal codes of its current locations are as follows:
 
 
A-3

 
 
EXHIBIT B
 
SECURED TERM LOAN PROMISSORY NOTE
 
$________________
Advance Date:  ________, 201__
 
 
Maturity Date:  [            ], 20[ ]
 
FOR VALUE RECEIVED, ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”) hereby promises to pay to the order of Hercules Technology Growth Capital, Inc., a Maryland corporation, or the current holder of this Note (the “Lender”) at 400 Hamilton Avenue, Suite 310, Palo Alto, CA 94301 or such other place of payment as the holder of this Secured Term Loan Promissory Note (this “Promissory Note”) may specify from time to time in writing, in lawful money of the United States of America, the principal amount of [_____________] DOLLARS ($__________) or such other principal amount as Lender has advanced to Borrower, together with interest at a floating rate per annum equal to the greater of (i) eight and one-half of one percent (8.50%), or (ii) the sum of (A) eight and one-half of one percent (8.50%), plus (B) the Prime Rate as reported in the “Money Rates” section of The Wall Street Journal , minus five and three-quarters of one percent (5.75%), based upon a year consisting of 360 days, with interest computed daily based upon the actual number of days in each month.

This Promissory Note is the Note referred to in, and is executed and delivered in connection with, that certain Loan and Security Agreement dated December 21, 2012, by and between Borrower and Lender (as the same may from time to time be amended, modified or supplemented in accordance with its terms, the “Loan Agreement”), and is entitled to the benefit and security of the Loan Agreement and the other Loan Documents (as defined in the Loan Agreement), to which reference is made for a statement of all of the terms and conditions thereof.  All payments shall be made in accordance with the Loan Agreement.  All terms defined in the Loan Agreement shall have the same definitions when used herein, unless otherwise defined herein.  An Event of Default under the Loan Agreement shall constitute a default under this Promissory Note.
 
Borrower waives presentment and demand for payment, notice of dishonor, protest and notice of protest under the UCC or any applicable law.   Borrower agrees to make all payments under this Promissory Note without setoff, recoupment or deduction and regardless of any counterclaim or defense.  This Promissory Note has been negotiated and delivered to Lender and is payable in the State of California.  This Promissory Note shall be governed by and construed and enforced in accordance with, the laws of the State of California, excluding any conflicts of law rules or principles that would cause the application of the laws of any other jurisdiction.
 
 
B-1

 
 
 
 
BORROWER:
 
ADMA BIOLOGICS, INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
ADMA PLASMA BIOLOGICS, INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
ADMA BIO CENTERS GEORGIA INC.
 
 
Signature:  ________________________
 
Print Name:  _______________________
 
Title:  ____________________________
 
 
B-2

 
 
 
EXHIBIT C
 
NAME, LOCATIONS, AND OTHER INFORMATION FOR BORROWER
 
1.  Borrower represents and warrants to Lender that Borrower’s current name and organizational status as of the Closing Date is as follows:
 
 
Name:
ADMA BIOLOGICS, INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4168997
 
 
Name:
ADMA PLASMA BIOLOGICS, INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4385118
 
 
Name:
ADMA BIO CENTERS GEORGIA INC.
 
 
Type of organization:
Corporation
 
 
State of organization:
Delaware
 
 
Organization file number:
4528628
 
2.  Borrower represents and warrants to Lender that for five (5) years prior to the Closing Date, Borrower did not do business under any other name or organization or form except the following:
 
 
Name: R&R Acquisition VI, Inc.
 
Used during dates of:  2006 to 2012
 
Type of Organization: Corporation
 
State of organization: Delaware
 
Borrower’s fiscal year ends on 12/31
 
Borrower’s federal employer tax identification number are: 56-2590442
 
ADMA Plasma Biologics, Inc. was formerly named ADMA Biologics, Inc.
 
       3.  Borrower represents and warrants to Lender that its chief executive office is located at 65 Commerce Way, Hackensack, New Jersey 07601.
 
 
C-1

 
 
EXHIBIT D
 
BORROWER’S PATENTS, TRADEMARKS, COPYRIGHTS AND LICENSES
 
Patents :
 
1.           U.S. Provisional Patent Application Serial No. 61/661,908
 
2.           U.S. Provisional Patent Application Serial No. 61/709,848
 
 
D-1

 
 
EXHIBIT E
 
BORROWER’S DEPOSIT ACCOUNTS AND INVESTMENT ACCOUNTS
 
Pascack Community Bank
 
Morgan Stanley
 
Sun Trust
 
 
E-1

 
 
EXHIBIT F
 
COMPLIANCE CERTIFICATE
 
Hercules Technology Growth Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301

Reference is made to that certain Loan and Security Agreement dated December 21, 2012 and all ancillary documents entered into in connection with such Loan and Security Agreement all as may be amended from time to time, (hereinafter referred to collectively as the “Loan Agreement”) between Hercules Technology Growth Capital, Inc., a Maryland corporation  (“Hercules”) as Lender and ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”). All capitalized terms not defined herein shall have the same meaning as defined in the Loan Agreement.
 
The undersigned is an Officer of Borrower, knowledgeable of all Borrower financial matters, and is authorized to provide certification of information regarding Borrower; hereby certifies that in accordance with the terms and conditions of the Loan Agreement, Borrower is in compliance for the period ending ___________ of all covenants, conditions and terms and hereby reaffirms that all representations and warranties contained therein are true and correct in all material respects on and as of the date of this Compliance Certificate with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such representations and warranties.  Attached are the required documents supporting the above certification.  The undersigned further certifies that these are prepared in accordance with GAAP (except for the absence of footnotes with respect to unaudited financial statement and subject to normal year end adjustments) and are consistent from one period to the next except as explained below.
 
REPORTING REQUIREMENT
REQUIRED
CHECK IF ATTACHED
Interim Financial Statements
Monthly within 30 days
 
Interim Financial Statements
Quarterly within 45 days
 
Audited Financial Statements
FYE within 120 days
 
 
 
F-1

 
 
 
 
Very Truly Yours,
 
ADMA BIOLOGICS, INC.
 
By: _______________________________
 
Name:   _____________________________
 
Its: ________________________________
 
 
 
F-2

 
 
EXHIBIT G
 
FORM OF JOINDER AGREEMENT
 
This Joinder Agreement (the “Joinder Agreement”) is made and dated as of [          ], 20[  ], and is entered into by and between__________________., a ___________ corporation (“Subsidiary”), and HERCULES TECHNOLOGY GROWTH CAPITAL, INC., a Maryland corporation, as a Lender.
 
RECITALS
 
A.  Subsidiary’s Affiliate, ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”) has entered into that certain Loan and Security Agreement dated December 21, 2012, with Lender, as such agreement may be amended (the “Loan Agreement”), together with the other agreements executed  and delivered in connection therewith;
 
B.  Subsidiary acknowledges and agrees that it will benefit both directly and indirectly from Borrower’s execution of the Loan Agreement and the other agreements executed and delivered in connection therewith;
 
AGREEMENT
 
NOW THEREFORE, Subsidiary and Lender agree as follows:
 
1.
The recitals set forth above are incorporated into and made part of this Joinder Agreement.  Capitalized terms not defined herein shall have the meaning provided in the Loan Agreement.
 
2.
By signing this Joinder Agreement, Subsidiary shall be bound by the terms and conditions of the Loan Agreement the same as if it were the Borrower (as defined in the Loan Agreement) under the Loan Agreement, mutatis mutandis, provided however, that Lender shall have no duties, responsibilities or obligations to Subsidiary arising under or related to the Loan Agreement or the other agreements executed and delivered in connection therewith.  Rather, to the extent that Lender has any duties, responsibilities or obligations arising under or related to the Loan Agreement or the other agreements executed and delivered in connection therewith, those duties, responsibilities or obligations shall flow only to Borrower and not to Subsidiary or any other person or entity.  By way of example (and not an exclusive list): (a) Lender’s providing notice to Borrower in accordance with the Loan Agreement or as otherwise agreed between Borrower and Lender shall be deemed provided to Subsidiary; (b) a Lender’s providing an Advance to Borrower shall be deemed an Advance to Subsidiary; and (c) Subsidiary shall have no right to request an Advance or make any other demand on Lender.
 
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
 
 
G-1

 
 
[SIGNATURE PAGE TO JOINDER AGREEMENT]
 
SUBSIDIARY:
 
_________________________________.
 
By:
Name:
Title:
 
Address:
 
Telephone: ___________
Facsimile: ____________
 
LENDER:
 
HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
 
a Maryland corporation
 
 
By: __________________________________
Name:
Its:      
 
Address:
400 Hamilton Ave., Suite 310
Palo Alto, CA 94301
Facsimile:  650-473-9194
Telephone:  650-289-3060
 
 
G-2

 
 
EXHIBIT H
 
ACH DEBIT AUTHORIZATION AGREEMENT
 
Hercules Technology Growth Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA  94301

Re:  Loan and Security Agreement dated December 21, 2012 among ADMA Biologics, Inc., a Delaware corporation (“Biologics”), ADMA Plasma Biologics, Inc., a Delaware corporation (“Plasma”),  ADMA Bio Centers Georgia Inc., a Delaware corporation (“Georgia”; Biologics, Plasma and Georgia are hereinafter referred to individually and collectively, jointly and severally, as “Borrower”) and Hercules Technology Growth Capital, Inc., a Maryland corporation (“Lender”) (the “Agreement”)
 
In connection with the above referenced Agreement, the Borrower hereby authorizes Lender to initiate debit entries for the periodic payments due under the Agreement to the Borrower’s account indicated below.  The Borrower authorizes the depository institution named below to debit to such account.
 
DEPOSITORY NAME
 
BRANCH
CITY
 
STATE AND ZIP CODE
TRANSIT/ABA NUMBER
 
ACCOUNT NUMBER
 
This authority will remain in full force and effect so long as any amounts are due under the Agreement.
 
 
BORROWER:
 
ADMA BIOLOGICS, INC.
 
 
Signature:  _______________________
 
Print Name:  _______________________
 
Title:  _______________________
 
 
H-1

 
 
 
ADMA PLASMA BIOLOGICS, INC.
 
 
Signature:  _______________________
 
Print Name:  _______________________
 
Title:  _______________________
 
ADMA BIO CENTERS GEORGIA INC.
 
 
Signature:  _______________________
 
Print Name:  _______________________
 
Title:  _______________________
 
 
H-2

 

 

 
 
EQUITY RIGHTS LETTER
 
  December 21, 2012
 
Hercules Technology Growth Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301
Attention:  Mr. Manuel A. Henriquez

Ladies and Gentlemen:
 
For good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by ADMA Biologics, Inc., a Delaware corporation (the “ Company ”), the Company hereby grants to Hercules Technology Growth Capital, Inc., a Maryland corporation (“ Hercules ”), the right to participate in and/or designate one or more of its affiliates (collectively, “ Hercules Purchasers ”) to participate in any one or more Subsequent Financings (as defined below) of the Company selected by Hercules in its sole discretion by permitting all Hercules Purchasers who participate in such Subsequent Financings to  purchase up to a maximum aggregate of $1,000,000 of Subsequent Financing Securities (as defined below).   Hercules Purchasers shall have no obligation to purchase Subsequent Financing Securities in any Subsequent Financing.  Any Hercules Purchaser purchasing Subsequent Financing Securities shall be an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended (the “ Act ”).
 
As used herein:
 
Subsequent Financing ” means each sale and issuance by the Company on or after the date hereof, in a single transactions or series of related transactions, of shares of its convertible preferred stock or other equity securities (or instruments exercisable for or convertible into shares of convertible preferred stock or other equity securities) to one or more investors for cash for financing purposes, other than a sale effected pursuant to an effective registration statement under the Act.
 
Subsequent Financing Securities ” means, with respect to any Subsequent Financing, the class and series of convertible preferred stock or other equity security of the Company (or instruments exercisable for or convertible into shares of convertible preferred stock or other equity securities) sold and issued by the Company to the investor purchasers in such Subsequent Financing.
 
The purchase by each Hercules Purchaser of Subsequent Financing Securities in any Subsequent Financing shall be made, subject to the provisions of this letter (and subject to Hercules’ rights set forth in that certain Loan and Security Agreement of even date herewith among Hercules, the Company and the other parties named therein (as amended and in effect from time to time, the “ Loan Agreement ”)), upon the same terms and conditions (including, without limitation, price) as purchases by the other investor purchasers of Subsequent Financing Securities therein, and each such Hercules Purchaser shall execute the definitive stock or securities purchase agreement, investor rights agreement, stockholders agreement, voting agreement and other agreements and documents (collectively, the “ Operative Documents ”) executed by such other investor purchasers in connection with such Subsequent Financing.
 
 
 

 
 
The Company shall give Hercules not less than three (3) business days’ written notice prior to the anticipated closing of each Subsequent Financing, which notice shall summarize the principal terms and conditions of such Subsequent Financing (including, without limitation, price, and the principal investor purchasers), and shall provide such drafts and definitive copies of the Operative Documents and other documents and information in connection with such Subsequent Financing as are provided to the other investor purchasers or potential investor purchasers of Subsequent Financing Securities therein.  Any Hercules Purchaser may exercise its purchase rights hereunder by delivering written notice thereof to the Company no later than one (1) business day prior to such closing.  The Operative Documents and other materials and information provided by the Company to Hercules Purchasers in connection with any Subsequent Financing shall be held and treated by each such Hercules Purchaser in confidence in accordance with the provisions of Section 11.12 of the Loan Agreement.
 
This Agreement, and all rights and obligations hereunder, shall terminate on the Term Loan Maturity Date (as defined in the Loan Agreement).
 
[Remainder of page left blank intentionally]
 
 
2

 
 
This Agreement shall be governed by, and interpreted and enforced in accordance with, the laws of the State of Delaware, excluding its conflict of laws provisions that would cause the application of the laws of any other jurisdiction.
 
 
Very truly yours,
 
ADMA BIOLOGICS, INC.

By:                 /s/ Adam Grossman __
Print Name:  Adam Grossman
Title:             Pres & CEO
 
Acknowledged and agreed to :
 
HERCULES TECHNOLOGY GROWTH
CAPITAL, INC.
 
By: /s/ K. Nicholas Martitsch _______
Name: K. Nicholas Martitsch
Its:  Associate General Counsel
 
3

 
 
Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]
 
MANUFACTURING, SUPPLY AND LICENSE AGREEMENT
 
THIS MANUFACTURING, SUPPLY AND LICENSE AGREEMENT (the “ Agreement ”) is made and entered into as of  December 31, 2012 by and between Biotest Pharmaceuticals Corporation , a Delaware corporation, having a place of business at 5800 Park of Commerce Boulevard NW, Boca Raton, Florida 33487 (“ BPC ”) and ADMA Biologics, Inc. , a Delaware corporation, having a place of business at 65 Commerce Way, Hackensack, New Jersey 07601 (“ ADMA ”).  BPC and ADMA are each sometimes referred to herein individually as a “ Party ” or collectively as the “ Parties.
 
RECITALS
 
WHEREAS , BPC (by virtue of assignment from Nabi Biopharmaceuticals) and ADMA previously entered into a certain Manufacturing Agreement, effective October 23, 2006 and Letter Agreement, dated January 26, 2007, as amended (the “ Prior Agreement ”) whereby BPC would manufacture and supply Respiratory syncytial virus (“ RSV ”)  Immune Globulin manufactured from human plasma containing RSV antibodies, including any conformance Lots;

WHEREAS , the Prior Agreement expires December 31, 2012 and the Parties wish to enter into a new agreement effective January 1, 2013 (the “ Effective Date ”); and
 
WHEREAS , BPC has developed a certain purification and fractionation manufacturing processes for Intravenous Immune Globulin (“ IVIG ”);
 
WHEREAS , the Parties also wish to enter into a license agreement whereby BPC would license certain of its rights to ADMA for the use in the manufacture of the Product (as defined below) in return for royalty payments; and
 
WHEREAS , all manufacturing services to be performed by BPC for ADMA on or after the Effective Date will be subject to the terms and conditions of this Agreement.
 
PROVISIONS
 
NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and with the intent to be legally bound hereby, ADMA and BPC agree as follows:
 
ARTICLE 1.   DEFINITIONS
 
1.1            “ Act ” means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. § 321 et seq.), and the regulations promulgated thereunder.
 
1.2           “ Additional Quantities ” shall have the meaning set forth in Section 2.2.
 
1.3           “ Affiliate ” means any Person that controls, is controlled by, or is under common control with another Person.
 
1.4           “ Agreement ” shall have the meaning set forth in the preamble.
 
 
Page 1 of 30

 
 
1.5             “BPC Technology” shall mean all rights, know-how, ideas, concepts, techniques, inventions, discoveries, improvements, systems, procedures, methods, designs, programs, software, drawings, specifications, trade secrets  and other intellectual property rights developed by BPC, outside the scope of this Agreement, without reference to, use or knowledge of ADMA’s Confidential Information, regarding BPC’s proprietary purification and fractionation manufacturing processes for IVIG, including but not limited to, validation studies, qualification studies, viral reduction studies, standard operating procedures, the processes used to procure FDA approval for IVIG manufacturing and any additional data in BPC’s possession that is required by any U.S. regulatory authority, which does not include ADMA’s Confidential Information, to the extent required for FDA approval and continued licensure of ADMA’s Finished Product.
 
1.6           “ Business Day ” means any day other than (a) a Saturday or Sunday or (b) a day on which banking institutions located in New York, New York are permitted or required by law, executive order, or governmental decree to remain closed.
 
1.7           “ By-Products " means [***], such as, but not limited to, [***] produced as part of, or recovered from, the manufacturing process for the Product.
 
1.8            “ cGMP ” means current Good Manufacturing Practice regulations promulgated by the FDA, as amended (21 C.F.R. Parts 210-211).
 
1.9           “ Confidential Information ” shall have the meaning set forth in Section 6.1.
 
1.10           [ *** ] shall mean the increase or decrease (if any) in the [***] published [***] for the prior [***] period.
 
1.11           “ Critical Deviation ” shall mean a deviation that is likely to result in a hazardous or unsafe condition for individuals using the Product.  A Critical Deviation affects the quality, strength, purity, identity, and/or integrity of the Lot.
 
1.12           “ Defective Product ” shall have the meaning set forth in Section 2.6.
 
1.13           “ Deficiency ” shall have the meaning set forth in Section 2.3.
 
1.14           “ Deviation ” shall mean departure from an established procedure or specification, which may directly affect a product, material, process, or system requirement.  This includes but is not limited to SOPs, PQs, Analytical Method Protocols, IPARs, Specifications, Master Batch Production Records (BPRs), etc.  These Deviations are not anticipated and/or may be related to an error, failure or malfunction, and are documented at the time of occurrence or after the occurrence.
 
1.15           “ Effective Date ” shall have the meaning set forth in the preamble.
 
1.16           “ Executed Batch Record ” means an executed batch record for a batch of Product, including a certificate of analysis and any associated deviations or investigation reports.
 
1.17           “ Facility ” means BPC’s Boca Raton facility.
 
1.18           “ FDA ” means the United States Food and Drug Administration or any successor entity thereto.
 
1.19           “ Final Forecast ” shall have the meaning set forth in Section 2.3.
 
 
Page 2 of 30

 
 
1.20           “ Finished Product ” shall mean the filled, packaged and labeled RSV (Respiratory syncytial virus) Immune Globulin manufactured from human plasma containing RSV antibodies.
 
1.21           “ Firm Purchase Commitment ” shall have the meaning set forth in Section 2.3.
 
1.22           “ Indemnitee ” shall have the meaning set forth in Section 7.
 
1.23           “ Indemnitor ” shall have the meaning set forth in Section 7.
 
1.24           ” Latent Defect ” shall have the meaning set forth in Section 2.5.
 
1.25            “Long Term Forecast ” shall have the meaning set forth in Section 2.2.
 
1.26           “ Lot ” shall mean Product resulting from processing an approximately [***] liter batch of Plasma, as specified in the purchase order and as accepted by BPC.
 
1.27           “ Person ” means an individual, corporation, limited liability company, partnership, association, trust or other entity or organization.
 
1.28            “Plasma” means human plasma containing RSV antibodies.
 
1.29           “ Product Price ” shall mean the price of one Lot of Product.
 
1.30           “ Product ” means RSV (Respiratory syncytial virus) Immune Globulin bulk drug substance manufactured from human plasma containing RSV antibodies. For avoidance of doubt, Product does not include any other fractions or by-products.
 
1.31           “ Quality Agreement ” means that certain Quality Agreement between BPC and ADMA as set forth in Exhibit A , to be attached hereto.
 
1.32           “ Regulatory Approval ” means any and all approvals (including drug approvals), licenses, registrations, or authorizations by the FDA.
 
1.33           “ Regulatory Authority ” means the FDA.
 
1.34            "Revenues" means (a) the sum of all revenues and payments received by, due to or billed by ADMA, including its subsidiaries, affiliates, employees, representatives, licensees, successors and assigns or any other company or person at the request of ADMA, for the sale of Product or Finished Product, less (b) any amounts paid, credited or deducted by ADMA for (i) discounts, customary in the trade, for quantity purchases, but excluding promotional advertising, (ii) free goods, (iii)  refunds for damaged Finished Product, (iv) sales, value added, excise and use taxes imposed by a governmental authority on Finished Product sales,   (v) any government rebates, (vi) any Medicare payments, (vii) any Medicaid payments, (viii) any payments associated with the U.S. Department of Health and Human Services - Health Resources and Services Administration 340B Drug Pricing Program, (x) any other reductions to payments received by ADMA for any of its drug products that relate to the Healthcare Affordability Act, (xi) any other similar and customary deduction, all determined in accordance with ADMA’s revenue recognition policy and generally accepted accounting principles consistently applied and (xii) less the pro-rated Product Price. For the purposes of this paragraph, payments include the fair market value of the Finished Product or any other thing or service of value which is received in lieu of cash.  Further, where transfers have been made between ADMA and an affiliated party, such Finished Product is not deemed to have been sold until the Finished Product is sold to an independent purchaser, in an arm’s length transaction between unrelated parties. In no event shall the Revenues associated with a particular transaction or series of transactions be less than the fair market value of ADMA’s contribution to the transaction or series of transactions.  Nothing in this paragraph shall be construed as expanding, or limiting the limitations on, the scope of this Agreement.
 
 
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1.35           “ Royalty Payments   means the amounts corresponding to a percentage of Revenues, as set forth in Section 4.1.
 
1.36           “ Specifications ” means the specifications for the Product set forth in Exhibit B attached hereto.   Exhibit B may be amended from time to time upon the written agreement of BPC and ADMA.
 
ARTICLE 2.   SUPPLY OF PRODUCT
 
2.1            Supply of Product .
 
(a)            Subject to the terms and conditions of this Agreement, ADMA shall purchase exclusively from BPC, ADMA’s worldwide requirements of the Product.
 
(b)            All Product supplied to ADMA shall be in bulk form as set forth in the Specifications in Exhibit B and any additional specifications that may be mutually agreed upon in writing by the Parties, and shall include, without limitation, all Product yield.
 
(c)            Except to the extent the Parties may otherwise agree with respect to a particular shipment, the Product shall be ordered pursuant to section 2.3.
 
(d)            BPC shall supply the Product resulting from processing of [***] liters, or if requested by ADMA, [***] liters, as specified in the Purchase Order, of Plasma supplied by ADMA and shall deliver such Product to ADMA within [***] of the delivery dates specified in such purchase order.  There shall be a purchase order for each Lot.
 
(e)            All Product will be packaged, in bulk, in accordance with ADMA’s requirements, as set forth in Exhibit “C”.
 
(f)            All Product shall be delivered to ADMA’s designated carrier at the Facility.
 
(g)           In the event the Purchase Order, as defined below, conflicts with or adds to the Specifications in Exhibit B , the Specifications shall prevail, unless otherwise agreed to in writing by the Parties.  In the event that any terms of a Purchase Order conflict with or add to the Agreement, the Agreement shall prevail unless otherwise agreed to in writing by the Parties.  ADMA shall purchase and BPC shall supply a minimum of [***] during each calendar year after the Finished Product is approved by the FDA, provided, however , that if ADMA requests any additional Lots during any calendar year, during the Term of this Agreement, after the Finished Product is approved by the FDA, BPC agrees to manufacture and supply to ADMA a minimum of [***] of the Product in each calendar year after receipt of Regulatory Approval for the Finished Product.
 
 
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(h)           Notwithstanding anything to the contrary in this Agreement, to the extent that BPC is unable to supply Product in the quantities as ordered by ADMA pursuant to a Firm Purchase Order, during any annual period, BPC shall provide prompt notification to ADMA of such and ADMA shall have the right to seek regulatory approval for an alternative facility to manufacture the Product.  Upon obtaining regulatory approval for the alternative facility, thereafter ADMA shall have the right to manufacture and/or purchase [***] of its annual Product requirements, as set forth in the Final Forecast, from the alternative facility during each annual period.  All Products produced at the alternative facility shall be subject to the Royalty obligations pursuant to Article 4 and as set forth hereunder.
 
2.2            Annual Forecast .
 
(a)            No later than [***] of each calendar year, ADMA shall provide BPC with a preliminary estimate for its desired Product requirements and manufacturing schedule for the following year.  No later than [***] of each calendar year, ADMA shall provide updated and final annual Product requirements and the manufacturing schedule for the following year (“Final Forecast”).
 
(b)            BPC shall provide in writing, within [***] from receipt of ADMA’s Final Forecast, confirmation of its ability to accommodate ADMA’s Product requirements and manufacturing schedule or otherwise propose an alternate schedule.  Notwithstanding anything to the contrary, BPC agrees to use commercially reasonable efforts to accommodate ADMA’s Final Forecast.
 
(c)            Notwithstanding anything to the contrary in Section 2.3 below or any other provision in this Agreement, BPC agrees to use commercially reasonable efforts to manufacture up to [***] of the prior calendar year’s volume of Product purchased by ADMA.  Further, BPC agrees to use commercially reasonable efforts to manufacture in excess of [***] of the prior calendar year’s volume of Product purchased by ADMA, provided that:
 
 
i.
ADMA delivers to BPC, its preliminary estimate for its desired Product requirements and manufacturing schedule for the following year no later than [***] of the prior calendar year; and
 
 
ii.
ADMA delivers to BPC, a Firm Purchase Order for one-half of the preliminary estimate referenced in Section 2.2 (i) for its desired Product requirements and manufacturing schedule for the following year, no later than [***] of the prior calendar year; and
 
 
iii.
ADMA delivers to BPC, a Firm Purchase Order for remainder of the preliminary estimate referenced in Section 2.2 (i) for its desired Product requirements and manufacturing schedule for the following year, no later than [***] of the prior calendar year; and
 
(d)            If BPC is unable to manufacture its own IgG product in its Facility and is relocating the manufacture of its IgG products to another facility, then BPC will use commercially reasonable efforts to assist ADMA in relocating the manufacturing of the Product to such new facility.  However, if BPC resumes manufacturing its IgG products at the Facility then the manufacturing of the ADMA Products shall also resume at the Facility.
 
 
 2.3      Firm Purchase Commitment .
 
(a)           ADMA shall, on or before [***] of each calendar year during the term of this Agreement, provide BPC with a binding purchase order (the “ First Purchase Order ”) for Product to be manufactured and delivered in the first two calendar quarters of the following calendar year, with an estimated quarterly volume breakdown and Product delivery dates.   ADMA shall, on or before [***] of each calendar year during the term of this Agreement, provide BPC with a binding purchase order (the “ Second Purchase Order ”) for Product to be manufactured and delivered in the last two calendar quarters of such calendar year, with an estimated quarterly volume breakdown and Product delivery dates. Each of the First Purchase Order and the Second Purchase Order is also referred to herein as a “ Purchase Order .”  All Purchase Orders shall be in Lot increments
 
 
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(b)           BPC shall confirm its acceptance of each Purchase Order in writing (the “ Confirmation ”) within [***] from the receipt of such Purchase Order. Such Purchase Order shall thereupon be binding on the parties (a “ Firm Purchase Commitment ”).
 
(c)           In the event that ADMA fails to purchase the aggregate quantity stated in the two Firm Purchase Commitments during any calendar year, then, at the end of the calendar year to which such Firm Purchase Commitments relate, BPC shall invoice ADMA and ADMA shall be obligated to pay BPC the difference between ordered Product and Product committed in such Firm Purchase Commitments to be purchased (“Deficiency”), provided, however, that if the total of the two Firm Purchase Commitments during any calendar year is more than [***] ADMA will not be obligated to pay for [***] of such Deficiency. The foregoing will not apply to the extent the parties agree differently in writing.
 
[***]
 
[***]
 
(d)            Notwithstanding anything to the contrary,  either ADMA or BPC may elect to delay [***] under a Firm Purchase Commitment until the next calendar year without penalty.
 
2.4            Materials/Lead Times .  The Plasma and equipment necessary to transport the Product will be provided by ADMA, at least [***] prior to the date of manufacture of the Product by BPC unless otherwise agreed to by the parties in writing.
 
2.5            Acceptance; Right to Reject the Product
 
(a)            Before shipment of any Product, BPC shall deliver to ADMA the Executed Batch Record as well as a short form Certificate of Analysis (“Short Form CoA”).  The Short Form CoA shall be completed in accordance with [***] or any revisions thereof. A sample Short Form CoA is attached hereto as Exhibit “D”.  Within [***] after receipt of such Executed Batch Record, ADMA shall have the right to reject the delivery of any Product if the Executed Batch Record shows any Critical Deviation from the Specifications
 
(b)            In the event BPC has a reasonable basis to dispute any Product rejection by ADMA, BPC shall give ADMA prompt written notice of such dispute. Samples of the Product in question shall be submitted promptly to an independent testing laboratory, mutually agreed to by both Parties or selected by an independent third party agreed to by both Parties, for a retest of the results.  Such retest shall be binding on the Parties and the Party found to be in error shall pay all retesting costs.
 
(c)            Any Product not so rejected within said [***] period shall be deemed accepted, except with respect to Latent Defects (as defined below).
 
 
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(d)            Notwithstanding anything to the contrary, if a portion or all of any shipment of Product has a Latent Defect that renders such Product a Defective Product prior to the expiry date of such Product and that (a) was not reasonably discoverable within the inspection period specified in this Section 2.5 and (b) was attributable to BPC’s manufacture and/or supply and (iii) did not occur after receipt of such Product by ADMA as described in Section 2.5 (each such defect, a “ Latent Defect ”), ADMA shall promptly, and in no event more than [***] after the discovery or notification of such Latent Defect, notify BPC of such Latent Defect. If BPC accepts ADMA’s determination that the Product is a Defective Product or that the Product contains a Latent Defect, then ADMA shall be entitled to the remedies set forth in Section 2.6 hereof. If BPC does not accept ADMA’s determination that the Product is a Defective Product or that the Product contains a Latent Defect and ADMA does not accept BPC’s conclusion, then BPC and ADMA shall jointly select an independent third party (“ Third Party ”) to determine whether it conforms to the Specifications or contains a Latent Defect, as applicable. The parties agree that such Third Party’s determination shall be final. If the Third Party rules that the Product conformed to the Specifications as of the time the Product was delivered to ADMA or that the Product does not contain a Latent Defect, as applicable, then ADMA shall be deemed to have accepted the Product at the agreed upon price and ADMA shall bear the cost of such independent Third Party determination. If the Third Party rules that the Product did not conform to the Specifications at the time the Product was delivered to ADMA or that the Product contains a Latent Defect, then ADMA shall be entitled to the remedies set forth in Section 2.6 hereof and BPC shall bear the cost of such independent Third Party determination.
 
2.6            Remedies for Non-Conforming Product .  In the event that BPC agrees that any Product rejected by ADMA is non-conforming solely as a result of the default, error, gross negligence or willful misconduct of BPC or the independent testing laboratory, referred to in Section 2.5, determines that the Product is non-conforming because of non-compliance with the Specifications solely as a result of the default, error,  gross negligence or willful misconduct of BPC (“ Defective Product ), [***] pursuant to the  Plasma Purchase Agreement between the Parties, with an effective date of November 17, 2011, as amended, provided however, that [***] shall provide the [***] for the [***].  If a Lot of Product fails to meet Specifications due [***].
 
2.7            Modifications; Improvements; Intellectual Property .
 
(a)            Any improvement or modification to the manufacturing process for the Product developed or implemented by BPC during the term of this Agreement shall be the sole property of BPC and shall constitute Confidential Information of BPC.  BPC agrees to provide access to such improvements or modifications to the manufacturing process for the Product to ADMA under the applicable terms and conditions of this Agreement during the term of this Agreement for no additional cost to ADMA unless mutually agreed to in writing by the parties, provided that the improvement or modification is required for FDA approval and continued licensure of ADMA’s Finished Product.
 
(b)            BPC agrees to that it will not make any material change or modification to the manufacturing process for the Product that would significantly reduce Product yield from currently obtained volumes, or negatively affect potency, purity or safety, unless the change or modification is required by the FDA or any other governmental agency.
 
(c)            BPC agrees that during the Term hereof, it will not manufacture Product for any other entity (including BPC, Biotest and any Affiliates, as defined below) for sale or distribution in North America, other than Product produced on behalf of ADMA hereunder. BPC states that neither it nor any other person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, BPC (collectively “ Affiliates ”) as of the date hereof manufacture Product (i) for any other unrelated third party entity or (ii) for its or their own use, other than as set forth in an agreement between the Parties.  Notwithstanding the foregoing,   throughout the Term hereof, BPC shall have the right to produce Product on behalf of its parent entity, Biotest AG (" Biotest ") and its Affiliates to the extent that Biotest and its Affiliates are permitted to commercialize, distribute and sell Product under the terms of that certain License Agreement of even date herewith by and between ADMA and Biotest, but under no circumstances, with respect to the production of Product for distribution and sale in North America until such time that this Agreement expires or terminates.
 
 
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(d)            BPC hereby grants a limited license to ADMA to use BPC Technology in the manufacturing of the Product.  BPC shall furthermore provide to ADMA ongoing support with respect to regulatory matters, Product quality, Product recalls, Product complaints, and other Product support, all as further provided in the Quality Agreement, upon ADMA’s request as Additional Services set forth in Section 3.6 at the rate of [***] per hour.
 
2.8            Regulatory Compliance .  ADMA shall be responsible for compliance with legal and regulatory requirements applicable to the manufacture, packaging, marketing, sale, and distribution of the Product.  BPC shall be responsible for compliance with legal and regulatory requirements applicable to the Facility and for manufacture of the Product.  Each Party shall notify the other within a reasonable amount of time (such time not to exceed [***] after any regulatory contact or correspondence with respect to the Product and shall cooperate fully with one another in the handling of such matter.  Each Party shall keep the other regularly informed as to regulatory developments relating to this Agreement or to the Product of which it becomes aware.
 
2.9            Product Complaints .  BPC shall cooperate with ADMA in responding to all Product complaints, medical complaints, and adverse drug experience reports involving the Finished Product as set forth in more detail in the Quality Agreement.
 
2.10            Product Recalls .  BPC shall cooperate with ADMA in the event of any Finished Product recall.  In addition, each Party shall maintain appropriate records to administer a Finished Product recall and shall provide any information which the other Party shall reasonably request in order to administer a recall.
 
2.11            Title and Risk of Loss .  Title to and risk of loss for each shipment of Product shall pass to ADMA upon delivery of Product to ADMA’s designated carrier at Facility.
 
2.12            Storage and Delivery .  BPC shall not be required to store any Product for more than [***] after ADMA has approved or has been deemed to have approved the Executed Batch Record. BPC may assess reasonable storage charges for any Product stored for longer than [***].  After a [***] period, the parties agree that all risk of loss of or damage to the Product shall pass on to ADMA.
 
2.13            Right to Audit . ADMA shall have access to BPC's facilities as outlined in the audit section of the Quality Agreement.

2.14            Quality Agreement . The respective quality representatives of the Parties shall meet and negotiate in good faith a quality agreement, to be signed by authorized representatives of each Party within sixty (60) days after the execution of this Agreement (“Quality Agreement”).

2.15            Adverse Events .  Each Party agrees to comply with the procedures set forth herein regarding the reporting of adverse events as outlined in the Quality Agreement.

2.16            R egulatory Documentation .                                                      During the term of this Agreement, (i) ADMA will be permitted to cross-reference information and/or data contained in BPC’s Investigational New Drug (“IND”) application and their Biologics License Application (“BLA”) as it relates to the Chemistry, Manufacturing and Control section of BPC’s BLA (“CMC information”) and (ii) BPC will provide a cross-reference letter to FDA regarding the CMC information, upon ADMA’s request. Additionally,  BPC shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such agreements, documents, and instruments, as may be necessary under, or as ADMA may reasonably request in connection with the CMC information.  Upon reasonable written request by ADMA, BPC shall not unreasonably refuse to provide such additional information or cross-reference letter to the FDA relating to information required by the FDA with respect to the Product or Finished Product or approval thereof.
 
 
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ARTICLE 3.   PAYMENTS FOR PRODUCT
 
3.1            Product Price .  BPC shall sell the Product to ADMA and ADMA shall purchase the Product from BPC at an initial price of [***] per [***] liter Lot.  Should ADMA elect at its option to request Product resulting from processing an approximately [***] liter batch of Plasma, the price for the first [***] liters shall be [***] and the price for the second [***] liters shall be [***].  All pricing is in US dollars. All delivery terms for the Product shall be F.O.B. the Facility.  For avoidance of doubt, the Product Price does not include stability and other testing services, which will be covered under a separate agreement between the parties.
 
3.2            Annual Increase .  After January 1, 2014, and on each January 1 st thereafter, the pricing for the Product will be the price in effect as of December 31 of the previous year, [***].  Notwithstanding the foregoing, in the event that at any time under the Agreement, BPC can demonstrate to ADMA’s reasonable satisfaction, that during any calendar year it has sustained significant (i.e. more than [***] per annum) increases in its costs and fees in connection with the manufacturing of the Product, pricing for the Product may be adjusted by BPC accordingly, subject to not less than [***] prior written notice to ADMA.  In such case, ADMA shall have the right to make reasonable requests for additional documentation from BPC relevant to such increases and BPC shall promptly supply such documentation.
 
3.3            Required Change . In the event one or more new government regulation, required test, quality procedure or change in the Specifications requested by ADMA  (any of the foregoing being a “ Required Change ”) is required but is not contemplated in this Agreement and results in an increase to BPC’s  actual costs to manufacture and supply the Product, both Parties shall re-negotiate the change in the purchase price in good faith within [***] of the Required Change, which shall be retroactive to the effective date of the Required Change.
 
3.4            Taxes.   The Product Price does not include sales, use, consumption, or excise taxes of any taxing authority.  The amount of such taxes, if any, shall be added to the Product Price in effect at the time of shipment and shall be separately itemized in the invoices submitted to ADMA by BPC pursuant to this Agreement.
 
3.5            Invoicing.   At the time of each shipment of Product hereunder, BPC shall invoice ADMA, and ADMA shall pay such invoice within [***] from the date of such invoice.  All undisputed amounts not paid when due shall be subject to interest at the rate of [***] per month (or such other amount, as shall not exceed the maximum rate permitted by law).  All payments due hereunder to BPC shall be sent to BPC at the times set forth herein by check or wire transfer to such accounts as BPC may designate to ADMA.
 
Invoices to ADMA, shall be directed to:
 
Attn: Accounts Payable
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, NJ  07601
 
 
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Inquiries and correspondence regarding payment should be directed to:

Accounts Payable
ADMA Biologics
65 Commerce Way
Hackensack, NJ  07601
Fax:  201-478-5553

3.6            Additional Services .  At ADMA’s written request, BPC may provide preparation of batch records and specifications, validation work, and regulatory support at the rate of [***] per hour, plus any necessary travel and out of pocket expenses. Any Additional Services must be agreed to by the parties before the commencement of any Additional Services.  Notwithstanding the foregoing, BPC agrees to provide preparation of the batch records and specifications for the first Lot manufactured under this Agreement at no cost to ADMA.

ARTICLE 4.   ROYALTIES/CLINICAL DATA ON FINISHED PRODUCT
 
4.1            Royalty Payments .  ADMA agrees to pay a royalty to BPC in an amount equal to [ ***] of Revenues (“ Actual Royalties ”) from the sale of Product and Finished Product by ADMA.  The parties agree that the total Royalty Payments to be paid by ADMA to BPC relating to sales of the Product and Finished Product will not exceed a cumulative total of [***]  (the “ Maximum Royalty Payment ”).  Once the cumulative amount of Royalty Payments reach the Maximum Royalty Payment, ADMA will be deemed to and will have met all of its royalty obligations under this   Agreement and forever, and ADMA will have no further royalty obligations to BPC relating to the Products, Finished Products or technology covered by this Agreement.
 
4.2                Quarterly Royalty Payments and Reports
 
(a)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, ADMA shall provide BPC with a preliminary report certified by a duly authorized officer of ADMA (the "Preliminary Royalty Report ") which shall identify this Agreement and include the information set forth in Schedule A as well as any other information BPC may reasonably require from time to time.
 
(b)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, ADMA shall provide BPC with a final report certified by a duly authorized officer of ADMA (the " Final Royalty Report ") which shall identify this Agreement and include the information set forth in Schedule A as well as any other information BPC may reasonably require from time to time.
 
(c)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, ADMA shall pay BPC the total Actual Royalties accrued during such calendar quarter.
 
(d)  BPC shall have the right to audit with reasonable notice ADMA’s books and records as it relates to Revenue and Actual Royalties, which right BPC may not exercise more than once annually.  Access to ADMA’s records shall be provided to BPC within [***] from BPC’s request to perform an audit. Should such an audit indicate that, in any of ADMA’s statements, the Revenues and Actual Royalties have been understated, and ADMA agrees to the understatement, then ADMA agrees to pay the difference between the understated amount and the actual amount owed to BPC within [***] from receipt of written notice from BPC of the under payment.  If the audit indicates that Revenues and Actual Royalties have been understated by more than a [***] variance and ADMA agrees to the understatement, then ADMA shall pay to BPC the reasonable cost of such an audit, the amount of the understatement, and interest on the understated Royalty Payment in an amount at the rate of interest of [***] per annum within [***] from ADMA’s agreement as to the understatement.
 
 
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4.3            Accrual .  Actual Royalties shall accrue from the date of ADMA’s recognition of Revenues.
 
4.4            Method of Payment and Reporting .  As per Article 3.4, all royalty payments shall be made to BPC by wire transfer to such accounts as BPC may designate to ADMA.  Quarterly Royalty Reports shall be addressed to BPC Corporate Controller.
 
4.5              Survival .  ADMA agrees that Royalty payments shall be made in connection with sales of all Finished Product, including sales of the   Finished Product that may occur after the expiration of the Term of this Agreement up to the maximum, cumulative Royalty Payment of [***].  Under no circumstances do the Actual Royalties or Royalty Payments give BPC any right, title or interest to any of ADMA’s confidential or proprietary information, trade secrets, know-how or equity ownership in the Product, Finished Product or in ADMA or any of its affiliates.

4.6           During the term of this Agreement, (i) BPC will be permitted to cross-reference information and/or data contained in ADMA’s Investigational New Drug (“IND”) application and Biologics License Application (“BLA”) as it relates to the Finished Product’s infusion rate; (ii) ADMA will provide a cross-reference letter to FDA regarding the infusion rate information and/or data, upon BPC’s request; (iii) ADMA shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such agreements, documents, and instruments, as may be necessary in this regard; and (iv) ADMA will provide BPC with information and/or data related to the infusion rate on any completed or ongoing studies.
Upon reasonable written request by BPC, ADMA shall not unreasonably refuse to provide such additional information or cross-reference letter to the FDA relating to information required by the FDA with respect to the infusion rate.
 
ARTICLE 5.   REPRESENTATIONS AND WARRANTIES
 
5.1            Organization and Authority of BPC .  BPC represents and warrants to ADMA that BPC is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware and has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby.
 
5.2            Warranties by BPC .  BPC further represents and warrants to ADMA that all Product delivered to ADMA by BPC shall, upon delivery to ADMA’s carrier, (a)  conform to the Specifications, as then in effect, including but not limited to the manufacturing procedures, in-process controls, testing, and storage and other conditions set forth in the Specifications, and (b) be manufactured in accordance with cGMP, applicable FDA CFR regulations, BPC’s standard operating procedures and any other applicable laws or regulations.
 
5.3            Non-Infringement .  BPC represents and warrants to ADMA that the manufacturing process or BPC technology provided by BPC hereunder shall not infringe or violate any third party intellectual property rights and that BPC’s actions hereunder are not based on a misappropriation of any third party intellectual property or other rights.
 
 
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5.4            Compliance with Regulations/Etc .  BPC further represents and warrants to ADMA that (a) the manufacture of the Product shall comply with regulatory requirements and applicable law, rules, and regulations, and that BPC will maintain all obligations with respect thereto; and (b) BPC will comply with applicable law and that it will keep ADMA fully informed of any development which would affect the Product.
 
5.5           During the term of this Agreement, BPC, in its sole discretion, may sponsor ADMA’s plasma centers for purposes of obtaining German Health Authority (“GHA”) Certifications (“Sponsor Period”).   In the event BPC elects to sponsor ADMA’s plasma centers, for purposes of obtaining German Health Authority (“GHA”) Certifications, then ADMA shall be obligated to maintain such certifications during the Sponsor Period.
 
5.6            DISCLAIMER BY BPC .  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, BPC EXPRESSLY DISCLAIMS (A) ANY WARRANTY THAT THE PRODUCT (I) WILL BE MERCHANTABLE OR (II) WILL BE FIT FOR ANY PARTICULAR PURPOSE AND (B) ANY OTHER WARRANTIES WITH RESPECT TO THE SALE, DISTRIBUTION, OR USE OF PRODUCT, EXPRESS OR IMPLIED.
 
5.7             Organization and Authority of ADMA .  ADMA represents and warrants to BPC that ADMA is a corporation duly organized, validly existing, and in good standing under the laws of the State of New Jersey and has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby.
 
5.8            Compliance with Regulations/Etc .  ADMA further represents and warrants to BPC that:
 
(a)           the filling, labeling, packaging, distribution, marketing, and sale of the Finished Product shall comply with regulatory requirements and applicable law, and that ADMA will maintain all obligations with respect thereto;
 
(b)           ADMA will comply with applicable law and that it will keep BPC fully informed of any development which would affect BPC’s production of the Product hereunder;
 
(c)           in the event ADMA ships Product outside of the United States, ADMA will comply fully with all export administration and control laws and regulations of the United States government as may be applicable to the export, resale or other disposition of any Product purchased from BPC; and
 
(d)           ADMA represents, warrants and agrees that any and all Plasma and any production processes provided or specified by ADMA shall be collected, produced and delivered in accordance with all specifications, applicable local, state and national laws, regulations,  regulatory approvals and permits, including but not limited to FDA, iQPP, CLIA, required state licensing.
 
 
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ARTICLE 6.   COVENANTS
 
6.1            Confidential Information .
 
(a)            It is recognized by the Parties that during the term of this Agreement and the Quality Agreement the Parties may exchange Confidential Information (as hereinafter defined).  BPC shall not disclose Confidential Information received from ADMA and shall not use Confidential Information disclosed to it by ADMA for BPC’s benefit (other than in the performance of its obligations hereunder) or for the benefit of any third person; provided, however, that BPC may disclose Confidential Information to a third party in the performance of its obligations hereunder if such third party agrees in writing to be bound by the confidentiality obligations set forth in this Agreement.  ADMA shall not disclose Confidential Information received from BPC and shall not use Confidential Information disclosed to it by BPC for ADMA’s benefit (other than in the performance of its obligations hereunder) or for the benefit of any third person; provided, however, that ADMA may disclose Confidential Information to a third party in the performance of its obligations hereunder if such third party agrees in writing to be bound by the confidentiality obligations set forth in this Agreement.  Each Party agrees that Confidential Information provided to the other Party shall only be shown to persons who have a need to see it in order for the Party to carry out its obligations hereunder.  Upon termination or expiration of this Agreement, each Party agrees to (i) return all copies of Confidential Information to the Party who provided it, and (ii) destroy all copies of any and all materials created by such Party based on the Confidential Information.  Each Party shall provide written certification of its compliance with its obligations relating to the return and/or destruction of Confidential Information, unless required to be retained by a government agency.
 
(b)            For purposes of this Agreement, “ Confidential Information ” means any information of a sensitive or proprietary nature, including, without limitation, know-how, trade secrets, information, technology, inventions (whether patentable or unpatentable), materials, methods, formulas and formulations, processes, drawings, specifications, designs, test data, concepts, ideas, knowledge, data, marketing plans, business strategies, sales figures, sales forecasts, financial information, prices, costs, and business practices, and all writing of a Party or its representatives derived from or based on the foregoing.  The Parties also agree to keep in confidence all ADMA testing lab locations and key ADMA personnel involved with the development of and manufacturing of the Product.  Confidential Information shall include all information in connection with this Agreement disclosed in writing and identified as being confidential or disclosed orally and reduced to writing within thirty (30) days of oral disclosure and identified as being confidential, or any other information that by its nature or context is clearly confidential or proprietary, whether or not so identified, except any portion thereof which:  (i) is known to the recipient before receipt thereof under this Agreement as documented by written records; (ii) is disclosed in good faith to the recipient after acceptance of this Agreement by a third person lawfully in possession of such information and not under an obligation of non-disclosure; (iii) is or becomes part of the public domain through no fault of the recipient; or (iv) is disclosed by law or regulation or in response to a valid order of a court or other governmental body, but only to the extent of and for the purpose of such law, regulation or order, and only if the recipient first notifies the other Party of the required disclosure and permits the other Party, at its expense, to seek an appropriate legal remedy to maintain the Confidential Information in secret.  BPC’s officers’ acknowledge that it may become aware of material, non-public information concerning ADMA in the course of the discussions and negotiations contemplated herein.  Accordingly, BPC’s officers agree not to: (i) effect or seek, offer or propose (whether publicly or otherwise) to effect, or cause or participate in or in any way assist any other person to effect or seek, offer or propose (whether publicly or otherwise) to effect or participate in any trading of any securities (or beneficial ownership thereof) of ADMA; (ii) disclose or “tip” material non-public information concerning ADMA to any person or entity; (iii) give trading advice of any kind to any person or entity concerning ADMA; or (iv) subject to Section 9.10 of this Agreement, except with the prior written consent of ADMA, take any action that might force ADMA to make a public announcement under applicable securities laws.
 
6.2            Trademarks .
 
(a)            Each Party hereby acknowledges that it does not have, and shall not acquire, any interest in any of the other Party’s trademarks or trade names unless otherwise expressly agreed in writing by the Parties.
 
 
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(b)            Each Party agrees not to use any trade names or trademarks of the other Party, except as specifically authorized by the other Party in writing both as to the names or marks which may be used and as to the manner and prominence of use.
 
6.3            Injunctive Relief .  The Parties hereto understand and agree that remedies at law may be inadequate to protect against any breach of any provisions of this Article 6 by either Party or its employees, agents, officers or directors or any other person acting in concert with it or on its behalf.  Accordingly, each Party shall be entitled to the granting of injunctive relief by a court of competent jurisdiction against any action that constitutes any such breach of this Article 6, without any requirement to post a bond.
 
6.4            Survival .  The provisions of this Article 6 shall survive for a period of ten (10) years following expiration or termination of this Agreement for any reason.
 
ARTICLE 7.   INDEMNIFICATION
 
7.1            Indemnification by BPC.   BPC agrees to defend, indemnify and hold ADMA, and its and their respective directors, officers, employees, and agents harmless against any and all claims, demands, suits, losses, judgments, liabilities, damages, costs, fees (including but not limited to reasonable attorneys’ fees), and expenses resulting solely from or arising out of (a) any breach by BPC of this Agreement; (b) violations of any applicable law or regulation by BPC; (c) claims for personal injury, illness, death, or property damage attributable to the manufacture of the Product by BPC; or (d) any alleged or actual infringement, misappropriation or violation of any third party intellectual property rights relating to the manufacturing process or BPC technology provided by BPC under the Agreement; provided, however, that BPC shall have no indemnification obligations with regard to any matter arising out of the breach of this Agreement by ADMA or ADMA’s negligence or willful misconduct.  Additionally, BPC agrees to defend, indemnify and hold ADMA, and its and their respective directors, officers, employees, and agents harmless against any and all claims, suits, losses, judgments, liabilities, damages, costs, fees (including but not limited to reasonable attorneys’ fees), and expenses resulting solely from or arising out of the sale of the By-Products.
 
7.2            Indemnification by ADMA .  ADMA agrees to defend, indemnify and hold BPC and its and their respective directors, officers, employees, and agents harmless against any and all claims, suits, losses, judgments, liabilities, damages, costs, fees (including but not limited to reasonable attorneys’ fees), and expenses resulting from or arising out of (a) any breach by ADMA of this Agreement; (b) violations of any applicable law or regulation by ADMA; (c) claims for personal injury, illness, death, or property damage attributable to the marketing, sale, or distribution of the Finished Product by ADMA; or (d) a Finished Product recall for which ADMA is responsible pursuant to Section 2.9; provided, however, that ADMA shall have no indemnification obligations with regard to any matter arising out of the breach of this Agreement by BPC or BPC’s negligence or willful misconduct.
 
7.3            Procedures .  Any Party (the “ Indemnitee ”) that intends to claim indemnification under this Article 7 shall promptly notify the other Party (the “ Indemnitor ”) of any loss, claim, damage, liability, or action in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall assume the defense thereof with counsel mutually satisfactory to the Parties.  The indemnity agreement in this Article 7 shall not apply to amounts paid in settlement of any loss, claim, damage, liability, or action if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably.  The failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action shall not relieve the Indemnitor of any liability to the Indemnitee under this Article 6, except to the extent that the Indemnitor is prejudiced by such delay.  The Indemnitee and its employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any loss, claim, damage, liability, or action covered by this Article 6.  In the event that the Indemnitee claims indemnity from the Indemnitor and the Indemnitor is finally held liable to indemnify the Indemnitee, the Indemnitor shall additionally be liable to pay the reasonable legal costs and attorneys’ fees incurred by the Indemnitee in establishing its claim for indemnity.
 
 
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7.4            Insurance .  ADMA and BPC shall each be required to maintain general and product liability insurance in an amount of at least [***] prior to FDA approval of the Finished Product, and in an amount of at least [***] after FDA approval of the Finished Product; and each shall provide to the other, upon request, written certification of such coverage.  Before commencing any work hereunder, the Parties shall furnish certificates evidencing the insurance required by this Section.  All such insurance policies obtained by a Party shall name the other Party and its parents, affiliates and subsidiaries and its and their employees and agents as additional insured parties.  It is understood that such insurance will not be construed to limit a Party’s liability with respect to its indemnification obligations under Article 7.  Each Party will provide to the other Party upon request a certificate evidencing the insurance the Party is required to obtain and keep in force under this Article 7.  Such certificate will provide that such insurance will not expire without renewal or be cancelled or modified without at least thirty (30) days’ prior notice to the other Party.
 
7.5            Limitation of Liability .  EXCEPT FOR THE INDEMNIFICATION OBLIGATIONS AND CONFIDENTIALITY OBLIGATIONS HEREUNDER, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE OR EXEMPLARY DAMAGES HOWEVER CAUSED, REGARDLESS OF THE FORM OF ACTION, WHETHER FOR BREACH OF CONTRACT, BREACH OF WARRANTY, TORT, NEGLIGENCE, STRICT PRODUCT LIABILITY, INFRINGEMENT OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, DAMAGES BASED ON WILLFULNESS, LOSS OF PROFITS, LOST REVENUES, OR LOSS OF BUSINESS OPPORTUNITY), AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OR KNEW OF THE POSSIBILITY OF SUCH DAMAGES.  THIS LIMITATION SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
 
7.6           AGGREGATE DAMAGES FOR WHICH EITHER PARTY SHALL BE LIABLE TO THE OTHER, SHALL NOT EXCEED [***], UNLESS DEEMED TO BE CAUSED DUE TO THE , GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF SUCH PARTY.
 
ARTICLE 8.   TERM AND TERMINATION
 
8.1            Term .  Subject to Section 8.2, the term of this Agreement shall be for a period of ten (10) years from January 1, 2013, renewable for two (2) additional five (5) year periods if both parties agree, provided that each Party agrees that it will endeavor, in good faith, to conclude any negotiations relating to such renewals no less than [***] before the expiration of this Agreement.  The parties agree to begin such negotiations no less than [***] prior to the expiration of this Agreement.  The parties agree that in the event of a Change of Control (as defined below) of BPC, Parent or ADMA this Agreement shall survive and continue in full force and effect and be binding upon any successor to the business of the surviving entity.
 
8.2            Termination .  This Agreement may be terminated by either Party (a) by reason of a material breach if the breaching Party fails to remedy such breach within one hundred twenty (120) days after the non-breaching Party has given the breaching Party written notice of such breach, (b) upon bankruptcy, insolvency, dissolution, or winding up of the other Party, or (c) if the other Party is unable to fulfill its obligations hereunder for a period of one hundred twenty (120) consecutive days or more by reason of an event described in Section 8.2(a) or (b).  For purposes of this Agreement, a material breach under this Agreement includes observations identified during ADMA's initial audit of BPC's facility that would cause the Facility to be deemed unsuitable for manufacture of the Product.   For the purpose of clarity, nothing in this Section 8.2 will remove ADMA’s obligation to make  accrued and unpaid   Royalty   Payments  up to the Maximum Royalty to BPC under this Agreement.
 
 
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8.3            Survival .  Expiration or termination of this Agreement shall not affect any accrued rights or obligations (including any payment obligations set forth herein). The provisions of Articles 6 and 7 (solely to the extent relating to (i) matters occurring prior to the date of termination, and/or (ii) those matters that expressly survive termination under this Section 8.3) and Section 2.5(d), 2.6, 2.7(d) (solely with respect to the first sentence of Section 2.7(d)), 2.10 (solely with respect to Product produced by BPC for ADMA), 4.5, 9.6, 9.7, 9.8, 9.9, 9.11, 9.13, and 9.15 shall survive the expiration or termination of this Agreement for any reason..
 
8.4            Effect of Termination, Cancellation or Expiration .  Termination, cancellation or expiration of this Agreement through any means and for any reason shall not relieve the Parties of any obligation accruing prior thereto and shall be without prejudice to the rights and remedies of either Party with respect to any antecedent breach of any of the provisions of this Agreement.  Upon cancellation, expiration or termination of this Agreement, BPC shall supply and ADMA shall purchase the quantity of Lots of Product previously ordered by ADMA pursuant to written purchase orders, initial term in accordance with the terms of this Agreement, but thereafter neither Party shall be obligated to the other Party to supply or purchase any additional quantities of Product hereunder.
 
8.5            Change of Control .  For purposes of this Agreement, the term “ Change of Control ” shall mean the effective date or date of consummation of any transaction or series of transactions (other than a transaction to which only ADMA, BPC or Parent, as applicable, and one or more of their respective subsidiaries are parties) pursuant to which ADMA, BPC or Parent, as applicable, (a) becomes a subsidiary of another entity; (b) is merged or consolidated with or into another entity; (c) engages in an exchange of shares with another entity; or (d) transfers, sells or otherwise disposes of all or substantially all of its assets to a single purchaser or a group of purchasers.  A Change of Control shall not include a transaction or series of transactions if the stockholders of ADMA, BPC or Parent, as applicable, immediately prior to such transaction or series of transactions own, immediately after giving effect to such transaction or transactions, a majority of the voting capital stock of the successor or surviving entity.
 
ARTICLE 9.   GENERAL PROVISIONS
 
9.1            Facility Modifications .  In the event of any Facility modifications resulting from mandatory changes in industry standards, FDA regulatory requirements and/or cGMP, if such Facility modifications do not relate solely to ADMA’s Product, ADMA shall bear no cost for such modifications, subject to Section 3.2.  BPC agrees to maintain the Facility in accordance with industry standards and FDA, cGMP and other applicable regulations during the term of this Agreement.
 
ADMA may, from time to time, request BPC to make other changes in the BPC processes or to the Product Specifications, etc., including additional testing, which are not the result of changes in industry or regulatory standards.  ADMA must submit requests for such changes in writing to BPC.  BPC shall not unreasonably withhold its consent to any such changes.  Any such ADMA requested change(s) which result in increased costs to BPC shall be reflected in adjusted pricing, to be mutually agreed upon by the Parties in good faith.
 
 
Page 16 of 30

 
 
9.2            By-Products .  [***] for By-Products manufactured and obtained [***].  Under no circumstances will [***].
 
9.3            Yield [***] . [***] acknowledges that [***]. The parties agree that [***] will be provided [***], provided that [***].
 
9.4            Force Majeure .  Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or be in breach of this Agreement for any delay or failure to perform any obligation under this Agreement (other than a failure to pay money) when such delay or failure to perform is caused by or results from causes beyond the reasonable control of the affected Party, including, without limitation, fire, flood, embargo, war, act of war (whether war is declared or not), insurrection, riot, civil commotion, strike, lockout or other labor disturbance, act of God, omission or delay in acting by any governmental authority or the other Party; provided, however, that the affected Party shall provide the other Party with prompt written notice of any such delay or failure to perform and shall use commercially reasonable efforts to cure any such delay or failure to perform at the earliest practicable date.
 
9.5            Notices .  All notices, requests, consents and other communications hereunder shall be in writing, addressed to the receiving Party’s address set forth below or to such other address as a Party may designate by notice hereunder, and either (a) delivered by hand, (b) made by facsimile transmission, (c) sent by recognized overnight courier, or (d) sent by registered or certified mail, return receipt requested, postage prepaid.
 
If to BPC:
Supply Chain
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Boulevard, N.W.
Boca Raton, FL 33487
Fax: 561-989-5800

with a copy to:
Legal Department
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Boulevard, N.W.
Boca Raton, FL 33487
Fax: 561-989-5517

If to ADMA:          Manufacturing Department
ADMA Biologics Inc.
65 Commerce Way
Hackensack, NJ 07061
Fax: 201-478-5553

with a copy to:
General Counsel
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, NJ 07061

All notices, requests, consents and other communications hereunder shall be deemed to have been properly given (a) if by hand, at the time of the delivery thereof to the receiving Party at the address of such Party set forth above, (b) if made by facsimile transmission, at the time that receipt thereof has been acknowledged by electronic confirmation or otherwise, (c) if sent by overnight courier, on the next business day following the day such notice is delivered to the courier service, or (d) if sent by registered or certified mail, on the fifth business day following the day such mailing is made.
 
 
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9.6            Entire Agreement .  This Agreement constitutes the entire agreement between BPC and ADMA with respect to the subject matter hereof.  This Agreement supersedes any prior agreements or understandings between BPC and ADMA, whether written or oral, with respect to the subject matter hereof, except for one (1) Lot which will be manufactured pursuant to the terms and conditions of the 2006 Amendment.
 
9.7            Waiver Amendment .  No waiver of any breach of any provision of this Agreement shall constitute a waiver of any other breach of that or any other provision hereof.  No supplement or modification of or amendment to this Agreement shall be binding unless agreed to and executed in writing by BPC and ADMA.
 
9.8            Governing Law .  This Agreement and the rights and obligations of the Parties hereunder shall be construed in accordance with and governed by the internal laws of the State of Delaware, without giving effect to the conflict of law principles thereof.
 
9.9            Severability .  In the event that any court of competent jurisdiction shall finally determine that any provision, or any portion thereof, contained in this Agreement shall be void or enforceable in any respect, then such provision shall be deemed limited to the extent that such court determines it enforceable, and as so limited shall remain in full force and effect.  In the event that such court shall determine any such provision, or portion thereof, wholly unenforceable, the remaining provisions of this Agreement nevertheless shall remain in full force and effect.
 
9.10            No Public Announcement .  Neither ADMA shall, on the one hand, nor BPC, on the other hand, shall, without the approval of the other, make any press release or other public announcement concerning the transactions contemplated by this Agreement, except as and to the extent that any such Party shall be so obligated by law, in which case the other Party shall be advised and the Parties shall use their commercially reasonable efforts to cause a mutually agreeable release or announcement to be issued; provided, however, that the foregoing shall not preclude communications or disclosures necessary to implement the provisions of this Agreement or to comply with the accounting and disclosure obligations of the Securities and Exchange Commission (“ SEC ”) or the rules of any stock exchange or NASDAQ.   Notwithstanding any contrary term contained in the confidentiality provisions of this Agreement, to the extent that either Party determines that it or the other Party is required to file or register this Agreement, a summary thereof, or a notification thereof, and/or descriptions related thereto, to comply with the requirements of an applicable stock exchange, SEC regulation, or any Governmental Authority, including the SEC, or to enable either Party to obtain debt or equity financing, such Party shall use its best efforts to provide the maximum amount of advance written notice of any such required disclosure to the other Party, to the extent practicable, with a minimum advance notice period of three (3) business days.  Prior to making any such filing, registration or notification, the Parties shall consult with respect thereto regarding confidentiality.  The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including such confidential treatment request, and shall execute all documents reasonably required in connection therewith.
 
9.11            Expenses; Taxes .  Except as otherwise provided herein, each Party hereto will pay all costs and expenses incident to its negotiation and preparation of this Agreement and to the performance and compliance with all agreements and conditions contained herein on its part to be performed or complied with, including the fees, expenses and disbursements of its counsel and accounting firm.
 
 
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9.12            Descriptive Headings .  The descriptive headings herein are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement.
 
9.13            Counterparts .  This Agreement may be executed in one or more counterparts, and by different Parties hereto on separate counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
9.14            Parties in Interest; Assignment .  This Agreement shall be binding upon and inure solely to the benefit of each Party hereto and their respective successors and permitted assigns, and nothing in this Agreement, expressed or implied, is intended to confer upon any other person any rights or remedies of any nature whatsoever under or by reason of this Agreement.  Other than pursuant to a sale of all or substantially all of a Party’s assets or any operation of law or change of control of a Party, neither Party may assign this Agreement or any of its rights and obligations hereunder without the other Party’s prior written consent, which may not be unreasonably withheld or delayed, except as hereinafter provided.  With notice to the other Party, either Party may, without the other Party's consent, assign this Agreement to its Affiliate.  No such assignment to an Affiliate shall relieve the assignor of its obligations and liabilities under this Agreement, all of which shall remain direct and primary in any event.
 
9.15            Relationship of the Parties .  The relationship of the Parties under this Agreement is that of independent contractors.  Except as expressly provided in this Agreement, neither Party shall hold itself out as an agent, legal representative, joint venture, or partner of the other Party for any purpose whatsoever.  Neither Party is authorized to make any contract, warranty, or representation by or on behalf of the other Party.
 
[SIGNATURE PAGES TO FOLLOW]
 
 
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first above written.
 
 
BIOTEST PHARMACEUTICALS CORPORATION
 
       
 
By:
/s/ Jordan Siegel  
  Name: Jordan Siegel  
  Title:     Chief Executive Officer  
       
       
 
ADMA BIOLOGICS INC.
 
       
 
By:
/s/ Adam Grossman  
  Name:   Adam Grossman  
  Title: Chief Executive Officer  
       
 
 
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     EXHIBIT A:  QUALITY AGREEMENT
 
 
Page 21 of 30

 
 
[To be negotiated]
 
 
Page 22 of 30

 
 
 
EXHIBIT B:  SPECIFICATIONS
 
 
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Biotest
Pharmaceuticals
Corporation
Product Spec No.: [***]
Rev.: 1
Page: 1 of 1
Title :  RI-002 Immune Globulin Intravenous (IGIV) Formulated Bulk
 
Product Specifications (Required Testing)
 
Expiration Date: [***] from formulated bulk fill date
 
TEST
SOP #
SPECIFICATION
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
     
 
[***]
 
Reference Certificate of Analysis of [***]
 
 
Page 24 of 30

 
 
EXHIBIT C: BULK PRODUCT SHIPPING CONTAINER SPECIFICATIONS
 
 
Page 25 of 30

 
 
[To be determined]
 
 
Page 26 of 30

 
 
 
EXHIBIT D: SAMPLE SHORT FORM CERTIFICATE OF ANALYSIS
 
 
Page 27 of 30

 
 
Short Form for [***] - RI-002 Immune Globulin Intravenous (IGIV) Formulated Bulk
 
Part Name: RI-002 Immune Globulin Intravenous (IGIV) Formulated Bulk
 
Lot Number: Part Number: [***]
 
Certificate of Analysis
 
Assay
SOB #
Specification
Results
[***]
[***]
[***]
 
[***]
[***]
[***]
 
[***]
[***]
[***]
 
[***]
[***]
[***]
 
       
This is to certify that this RI-002 Immune Globulin Intravenous (IGIV) Formulated Bulk was tested and found to meet all release specifications.
 
QA Prepared by: __________________________
 
QA Approved by: _________________________ 
 Date:  __________________________ 
 
Date:  __________________________
                     
[***]  Rev.: 0  Page 1 of 1 
 
 
Page 28 of 30

 
 
SCHEDULE A
 
 
 
Page 29 of 30

 
 
[To be determined]
 
 
Page 30 of 30

 






 
Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]
 
LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this " Agreement "), effective as of December 31, 2012 (the " Effective Date "), is entered into by and between ADMA Biologics, Inc. a Delaware corporation (" ADMA "), and BiotestAktiengesellschaft , a corporation organized under the laws of Germany (" Biotest ").  ADMA and Biotest are also referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

WITNESSETH:

WHEREAS , ADMA is engaged in the business of developing and commercializing human plasma and plasma-derived therapeutics, including an Human Immunoglobulin with standardized elevated levels of Respiratory Syncytial Virus antibodies; and

WHEREAS , As part of the RSV Product development process, ADMA has established, qualified and validated a proprietary microneutralization assay process and procedures, through which ADMA is able to identify plasma donors with naturally occurring elevated amounts of anti-RSV antibodies (the “ RSV Assay ”); and

WHEREAS , Biotest manufactures preparations derived from human blood plasma using state-of-the-art biotechnological processes, which preparations are used as immunotherapeutic agents in the treatment of various deficiencies, diseases, infections,  and other disorders; and

WHEREAS , Biotest desires to obtain, and ADMA is willing to grant to Biotest, an exclusive license in the Territory (as defined herein) to have access to test Biotest’s own plasma samples using ADMA’s RSV Assay for the identification of plasma donors with elevated amounts of RSV antibodies and to use the ADMA Know-How (as defined herein) in accordance with the terms and conditions of the Agreement; and

WHEREAS , Biotest desires to obtain, and ADMA is willing to grant to Biotest, an exclusive license in the Territory to Commercialize the Product and Finished Product upon achieving Regulatory Approval in accordance with the terms and conditions, and subject to the limitations, of this Agreement.

NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:
 
ARTICLE 1
DEFINITIONS
 
ADMA Know-How ” means ADMA’s testing services to be performed by ADMA using ADMA’s RSV Assay which will include the expertise of ADMA, including any FDA Product Dossier and any copyright, trade secret, other registered or unregistered industrial or intellectual property rights, including, without limitation, ideas, concepts, inventions, discoveries, data, samples, designs, formulas, specifications, procedures, protocols, and testing and any Improvements by ADMA to the foregoing relating to, referencing, covering or otherwise necessary or useful in the Development, manufacturing, use and/or Commercialization of the Licensed Product, whether developed before or during the term of this Agreement.
 
 
1

 
 
ADMA Patents ” means all of the patents, patent applications, divisional applications, continuation applications and continuation-in-part applications, and all patents issuing from any said applications, and foreign counterparts thereof that relate to, arise from or have claims covering the RSV Assay or the Licensed Product.

ADMA Proprietary Information ” means the ADMA Know-How and ADMA Patents owned or Controlled by ADMA on the date hereof and as each such arises or is developed throughout the Term.

Agreement ” shall have the meaning set forth in the Preamble.

Applicable Law ” means all applicable federal, state, local, national and supra-national laws, statutes, rules and regulations, including any rules, regulations, guidelines or requirements of Regulatory Authorities, national securities exchanges or securities listing organizations that may be in effect from time to time during the Term.

Clinical Data ” means all Information with respect to the Licensed Product that is made, collected, or otherwise generated under or in connection with Clinical Studies, including any data, reports, and results with respect thereto, that ADMA has elected to conduct at its own discretion.

Clinical Studies ” means [Phase I, Phase II, Phase IIb, Phase III, Phase IIIb, Post-Marketing Studies] and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approval for a Licensed Product for an indication.

Clinical Trial Application ” means an Investigational New Drug Application for any Product filed with the FDA pursuant to Title 21 of the Code of Federal Regulations, Part 312 (“ IND ”) or the submission to a competent Regulatory Authority within the EU of a request for an authorization concerning a clinical trial, as envisaged in Article 9, paragraph 2, of Directive 2001/20/EC, or any comparable filing made with a Regulatory Authority in another country or territory other than the U.S. or the EU.

Commercialization ” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of the Product and Finished Product, including activities related to marketing, promoting, distributing, importing and exporting such Product and Finished Product. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.
 
 
2

 
 
Confidential Information ” means any technical, business, or other Information provided by or on behalf of one Party to the other Party in connection with this Agreement, whether prior to, on, or after the Effective Date, including Information relating to the terms of this Agreement, the Licensed Product (including the Regulatory Documentation and Regulatory Data), any Development or Commercialization of the Licensed Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates, or the scientific, regulatory or business affairs or other activities of either Party. The Parties agree that the material financial terms of the Agreement will be considered Confidential Information of both Parties. Notwithstanding the foregoing, all Regulatory Documentation owned by either Party shall be deemed to be the Confidential Information of such Party, and such Party shall be deemed to be the disclosing Party and the other Party shall be deemed to be the receiving Party with respect thereto. As used herein, “Confidential Information” shall not include any information that:

(a)           is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party;
 
(b)           can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
 
(c)           is subsequently received by the receiving Party from a third party who is not bound by any obligation of confidentiality with respect to such information;
 
(d)           has been published by a third party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or
 
(e)           can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to, use of or knowledge of the disclosing Party’s Confidential Information; provided, that the foregoing exception shall not apply with respect to Regulatory Documentation.
 
Development ” means, with respect to the Licensed Product, all activities undertaken for the purpose of obtaining a final,  Regulatory Approval for such Licensed Product, including activities related to research, preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, development stage manufacturing activities (including process development and process improvement and preparation of manufacturing documentation required for Clinical Trial Applications and other applications for Regulatory Approvals), qualification and validation, quality assurance/quality control, Clinical Studies, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” means to engage in Development.

Drug Approval ” means an approval of a BLA, NDA, or of a MAA, or any corresponding Regulatory Approval for the Commercialization of a pharmaceutical product for a particular indication in any other country or region of the world, including other than the U.S. and the EU /European Economic Area.
 
 
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Drug Approval Application ” means a New Drug Application (“ NDA ”) or Biologics License Application (“BLA”) as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the EU, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in the EU with respect to the mutual recognition or any other approval procedure (“ MAA ”), including all supplements, amendments, variations, extensions and renewals thereof.

Effective Date ” shall have the meaning given to it in the Preamble.

Finished Product ” shall mean the filled, packaged and labeled Product.

First Commercial Sale ” means, with respect to the Product or  Finished Product and a country, the first sale for monetary value to an unrelated third party of such Product or Finished Product in such country after Drug Approval for such Product or Finished Product has been obtained in such country.  Sales prior to receipt of Drug Approval for such Product or Finished Product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall be considered as a First Commercial Sale.

Improvements ” shall mean and include any and all inventions, and any and all changes, modifications, derivatives and amendments to either Party's know-how or other intellectual property rights (including in the case of ADMA, to the ADMA Know-How and any patents covering the RSV Assay or the Licensed Product).

Information ” means all technical and scientific information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, sequences, structures, models, instructions, skills, techniques, procedures, compilations, experiences, ideas, technical assistance, designs, drawings, assembly procedures, protocols, computer programs, apparatuses, specifications, data and results, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols; assays; and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable) in
written, electronic or any other form now known or hereafter developed.

Licensed Product ” means generally, the Product and/or Finished Product.
 
Lot ” shall mean Product resulting from processing an approximately [***] or approximately [***] liter batch of Plasma, as specified in the purchase order and as accepted by Biotest.

Manufacturing Agreement ” means the Manufacturing, Supply and License Agreement between the Parties, dated December 24, 2012 (including as amended by the parties).

Person ” means an individual, corporation, limited liability company, partnership, association, trust or other entity or organization.

“Plasma” means human plasma containing RSV antibodies.
 
 
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Product ” means RSV (Respiratory syncytial virus) antibody enriched Human Immune Globulin bulk drug substance manufactured from human plasma containing elevated anti-RSV antibody levels that were tested using the RSV Assay. For avoidance of doubt, Product does not include any other fractions or by-products.

“Product Dossier” means the collection of the various documents and data (including Regulatory Data and Regulatory Documentation) concerning the research, development safety and efficacy of the Licensed Product.

“Report” shall have the meaning given to it in Section 4.06 of this Agreement.

Regulatory Approval ” means, with respect to a country in the Territory, any and all approvals (including drug approvals), licenses, registrations, or authorizations of any Regulatory Authority required to commercially distribute, sell, or market the Product or Finished Product in such country, including, where applicable, (i) pricing or reimbursement approvals in such country, (ii) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto), and (iii) approval of product labeling.

Regulatory Authority ” means any applicable supra-national, federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils, or other government entities regulating or otherwise exercising authority with respect to the Commercialization, use and/or manufacturing of the Licensed Product in the United States or the Territory.

Regulatory Data ” means all non-clinical data, pre-clinical and Clinical Data, and other Information, results, and analyses, with respect to any Development or Commercialization of the RSV Assay or the Licensed Product.

Regulatory Documentation ” means all (i) applications, registrations, licenses, authorizations, and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, safety information including adverse event files, and complaint files; and (iii) Regulatory Data and data contained or relied upon in any of the foregoing, in each case (i), (ii), and (iii) relating to the RSV Assay and the Licensed Product.

"Revenues" means (a) the sum of all revenues and payments received by, due to or billed by Biotest, including its subsidiaries, affiliates, employees, representatives, licensees, successors and assigns or any other company or person at the request of Biotest, for the sale of Product or Finished Product, less (b) any amounts paid by Biotest for (i) discounts, customary in the trade, for quantity purchases, but excluding promotional advertising, (ii) refunds for damaged Product or Finished Product, (iii) sales, value added, excise and use taxes imposed by a governmental authority on Product or Finished Product sales,  (iv) any government rebates, (v) any payments to governmental agencies located in the Territory, and (vi) any other similar and customary deduction, all determined in accordance with Biotest’s revenue recognition policy and generally accepted accounting principles consistently applied. For the purposes of this paragraph, payments include the fair market value of the Product and Finished Product or any other thing or service of value which is received in lieu of cash.  Further, where transfers have been made between Biotest and an affiliated party, such Product and Finished Product is not deemed to have been sold until the Product or Finished Product is sold to an independent purchaser, in an arm’s length transaction between unrelated parties. In no event shall the Revenues associated with a particular transaction or series of transactions be less than the fair market value of Biotest’s contribution to the transaction or series of transactions.  Nothing in this paragraph shall be construed as expanding, or limiting the limitations on, the scope of this Agreement.
 
 
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" Territory " shall mean the countries listed on Exhibit A attached hereto.

Testing ” shall have the meaning as set forth in Section 6.01.

“Valid Claim” means a claim of any issued and unexpired patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, dedication to the public; or (b) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal.
 
ARTICLE 2
LICENSE AND OPTION
 
Section 2.01.   Grant of License . ADMA hereby grants to Biotest:
 
(a)           an exclusive license in the Territory, with the right to grant sublicenses in accordance with Section 2.02, under the ADMA Proprietary Information to have access to testing services performed by ADMA using the RSV Assay for the purpose of identifying Plasma donors with elevated amounts of RSV antibodies, which Plasma Biotest may use in the production of the Product and Finished Product and related purposes for sale in the Territory;
 
(b)           an exclusive license in the Territory to reference the ADMA Proprietary Information (but not obtain access to such Proprietary Information) for the purpose of seeking Regulatory Approval of the Product and Finished Product in the Territory; and
 
(c)           an exclusive license, with the right to grant sublicenses in the Territory in accordance with Section 2.02, under the ADMA Proprietary Information to (i) manufacture and have manufactured Product and Finished Product to be distributed in the Territory and (ii) to Commercialize the Product and Finished Product in the Territory;
 
in each case in accordance with the terms and conditions, and subject to the limitations of, this Agreement.
 
 
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Section 2.02.   Sublicense .  The license granted by ADMA to Biotest may be sublicensed by Biotest to any Affiliate or third party consistent with the terms of this Agreement and shall include confidentiality and nonuse obligations no less stringent than those set forth in Article 8; provided that prior to Biotest entering into any sublicense with a non-Affiliate third party it must obtain written approval from ADMA, which approval will not be unreasonably withheld or delayed.  Each sublicensee approved by ADMA is referred to herein as a “Sublicensee”.
 
Section 2.03.   No Other Licenses .  Other than the license rights expressly granted under this Agreement, no other rights, licenses, or covenants in or to any intellectual property, whether by implication, estoppel, or otherwise, are granted herein.
 
ARTICLE 3
REGULATORY APPROVAL AND MANUFACTURING
 
Section 3.01.   Clinical Trials .  As between the Parties, ADMA shall be responsible for conducting at its expense and option all pre-clinical activities and Clinical Studies associated with the Licensed Product and for preparing, filing, obtaining and maintaining all Clinical Trial Applications with respect to the Licensed Product in any and all territories it so chooses so long as ADMA does not distribute or sell Products or Finished Products in the Territory.  ADMA shall promptly provide to Biotest copies of or access to all Regulatory Data, when and as such Regulatory Data becomes available, as is reasonably requested for a regulatory filing by Biotest for the Finished Product in the Territory.
 
Section 3.02.    Regulatory Approval .
 
(a)           Biotest shall have the right in concert with ADMA to prepare, obtain, and maintain Regulatory Approvals and filings for Regulatory Approvals in the Territory, including presenting, setting and proposing strategy with respect to the overall regulatory approval strategy relating to the foregoing, and to conduct communications with the Regulatory Authorities, with respect to obtaining Regulatory Approval for the Licensed Product in the Territory.  ADMA will have the right to review all regulatory correspondence and filings which reference the Product and ADMA Know-How and participate in any meetings with the Regulatory Agencies as expert representatives for the ADMA RSV Assay and Know-How and any other data presented or submitted as part of such regulatory approval application.
 
(b)           ADMA shall use commercially reasonable efforts to support Biotest, as may be reasonably necessary, and in a timely manner in Biotest’s efforts to obtain Regulatory Approval for the Licensed Product in the Territory, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, as well as permitting Biotest to conduct and assisting Biotest with audits (at Biotest’s expense) of any studies being conducted, or already conducted, by or on behalf of ADMA (which audits shall be conducted upon reasonable notice to ADMA and during normal business hours, and [***] unless Biotest reasonably determines that additional audits are necessary for regulatory-submission and/or response related matters).  ADMA shall pay its own costs associated with the preparation and submission of Drug Approval Applications and in connection with obtaining Regulatory Approval of the Licensed Product in the United States.  Biotest shall pay its own costs associated with the preparation and submission of Drug Approval Applications (or comparable filings in the Territory) and in connection with obtaining Regulatory Approval of the Licensed Product in the Territory.
 
 
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(c)           All Regulatory Documentation is subject to the exclusive license granted to Biotest hereunder and ADMA hereby grants Biotest the right of reference to Regulatory Approvals and other Regulatory Documentation controlled by ADMA in accordance with the terms hereof.  ADMA shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such agreements, documents, and instruments, as may be necessary under, or as Biotest may reasonably request in connection with, the exclusive license granted to Biotest to use the Regulatory Documentation as provided herein.
 
(d)           Biotest may use Regulatory Documentation and Regulatory Data or disclose such Regulatory Documentation or Regulatory Data to third parties as is reasonably necessary (i) for preparing, filing, obtaining and maintaining Regulatory Approvals (or applications for Regulatory Approvals) in the Territory, (ii) for the preparation and attendance of meetings with the applicable Regulatory Authorities in the Territory, (iii) for the manufacture of Licensed Product by Biotest and/or its Affiliates or Sublicensees and (iv) for the Commercialization of Licensed Product in the Territory.
 
(e)           In all agreements concluded by ADMA after the Effective Date with its Affiliates or third parties involving the generation of Regulatory Data, ADMA shall (i) require that such Affiliates, and (ii) use commercially reasonable efforts to require third parties to, provide Biotest access to, and the right to use, all such Regulatory Data for the purpose of (A) the preparation, filing, or maintenance of all regulatory filings and Regulatory Approvals in the Territory or (B) the Commercialization of Licensed Product by Biotest (or its respective Affiliates, Sublicensees and distributors) in the Territory, or (C) the manufacture of Licensed Product by Biotest (or its Affiliates or Sublicensees) as contemplated in this Agreement.
 
ARTICLE 4
PAYMENTS AND ROYALTIES.
 
Section 4.01.    Payment . In consideration of the licenses granted to Biotest under this Agreement, Biotest agrees to pay ADMA the following:
 
(a)           upon execution of this Agreement, Biotest will in accordance with ADMA’s requested manufacturing schedule commence production of [***] Lots of Product (approx. [***] liters of plasma) and shall deliver such Lots of Product to ADMA [***];
 
(b)           [***] in immediately available funds within [***] of ADMA’s submission of its BLA Product Dossier to the FDA for Regulatory Approval of the Licensed Product in the United States;
 
 
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(c)           [***] in immediately available funds within [***] of Biotest’s submission of its Product Dossier for  Regulatory Approval  of the Licensed Product in the Territory; provided that should Biotest fail to submit the Product Dossier within [***] from the date of receipt of BLA Approval for the Product in the United States, Biotest shall [***] in immediately available funds and Biotest shall have an additional [***] in which to file the Product Dossier for  Regulatory Approval.  If following such [***] Biotest still has failed to file the Product Dossier for Regulatory Approval of the Licensed Product in the Territory (i) [***], (ii) ADMA shall have the right to submit its Product Dossier for  Regulatory Approval of the Licensed Product in the Territory, and (iii) either Party may terminate the Agreement in accordance with the appropriate provision of Article 10.  For the avoidance of doubt, any delay caused in obtaining Regulatory Approval due to actions, inactions or requirements of the Regulatory Authorities in the United States or in the Territory or due to any changes in Applicable Law shall extend the [***] and [***] time periods referenced above until such time that a submission of the Product Dossier or a decision concerning Regulatory Approval of the Licensed Product can be rendered by the Regulatory Authorities.
 
(d)           Within [***] from receipt of Regulatory Approval for the Licensed Product in the Territory, Biotest and ADMA shall mutually agree on [***] for sales of the Licensed Product in the Territory which shall become effective after receipt of Regulatory Approval for the Licensed Product in the Territory.  Such [***] shall be negotiated by the parties in good faith.
 
(e)           Biotest shall grant to ADMA exclusive rights to market, sell and distribute Biotest’s Varicella Zoster Immune Globulin in the United States and Canada.  The terms of such agreement will be addressed in a subsequent agreement which the parties agree to execute within sixty (60) days from the Effective Date of this Agreement.  Such rights shall not be extinguished as a result of termination of this Agreement, and such rights shall continue in force in accordance with the terms of such agreement after termination of this Agreement.
 
Section 4.02.   Royalty .   Commencing on the date of the First Commercial Sale of Product or Finished Product and for the duration of the Royalty Term, Biotest shall pay to ADMA a royalty (the “ Royalty ”) with respect to the sale of Product and Finished Product in the Territory as follows:
 
(a)           for Revenues between U.S. [***] to U.S. [***], a Royalty of [***] of the Revenues within such range;
 
(b)           for Revenues between U.S. [***] to U.S. [***], a Royalty of [***] of the Revenues within such range;
 
(c)           for Revenues between U.S. [***] to U.S. [***], a Royalty of [***] of the Revenues within such range;
 
(d)           for Revenues between U.S. [***] to U.S. [***], a Royalty of [***] of the Revenues within such range; and
 
(e)           for Revenues over U.S. [***], a Royalty of [***] of the Revenues over such amount.
 
 
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Section 4.03.    Quarterly Royalty Payments and Reports
 
(a)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, Biotest shall provide ADMA with a preliminary report certified by a duly authorized officer of Biotest (the "Preliminary Royalty Report ") which shall identify this Agreement and include the information set forth in Schedule A as well as any other information ADMA may reasonably require from time to time.
 
(b)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, Biotest shall provide ADMA with a final report certified by a duly authorized officer of Biotest (the " Final Royalty Report ") which shall identify this Agreement and include the information set forth in Schedule A as well as any other information ADMA may reasonably require from time to time.
 
(c)           Within [***] after the end of each calendar quarter (i.e., within [***] after March 31, June 30, September 30 and December 31) during the term of this Agreement, Biotest shall pay ADMA the total Royalties accrued during such calendar quarter.
 
(d)           ADMA shall have the right to audit with reasonable notice Biotest’s books and records solely as it relates to Revenues and Royalties, which right ADMA may not exercise more than once annually.  Access to Biotest’s records shall be provided to ADMA or ADMA’s representatives within [***] from ADMA’s request to perform an audit. Should such an audit indicate that, in any of Biotest’s statements, the Revenues and Royalties have been understated, and Biotest agrees to the understatement, then Biotest agrees to pay the difference between the understated amount and the actual amount owed to ADMA within [***] from receipt of written notice from ADMA of the under payment.  If the audit indicates that Revenues and Royalties have been understated by more than a [***] variance and Biotest agrees to the understatement, then Biotest shall pay to ADMA the reasonable cost of such an audit, the amount of the understatement, and interest on the understated Royalty payment in an amount at the rate of interest of [***] per annum within [***] from notice of the understatement.
 
Section 4.04.    Accrual .   Royalties shall accrue from Biotest’s recognition of Revenues.
 
Section 4.05.    Method of Payment and Reporting All Royalties shall be paid to ADMA by wire transfer to such accounts as ADMA may designate in writing to Biotest.  Quarterly Royalty Reports shall be addressed to ADMA Biologics Inc, Attn CFO, 65 Commerce Way, Hackensack, NJ 07601  FAX: 201-478-5553. 
 
Section 4.06.     Royalty Term .  Royalties shall be payable with respect to each country in the Territory during the period commencing with First Commercial Sale of the Product and Finished Product in such country, and ending on the twentieth (20th) anniversary of the First Commercial Sale of the Product or Finished Product in such country (“ Royalty Term ”). Upon expiration of the Royalty Term in any country, the license grants in Article 2 shall be deemed to be irrevocable, unrestricted, perpetual and fully paid-up with respect to the Product and Finished Product in such country with rights to sublicense.
 
 
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Section 4.07.      Royalty Reduction .
 
(a)           After the [***] anniversary of the Royalty Term, in the event that the Product or Finished Product is subject to generic competition from another RSV (Respiratory syncytial virus) antibody enriched Human Immune Globulin drug substance manufactured from human plasma containing elevated anti-RSV antibody levels (“ RSV Product ”) in any country in the Territory, then the Royalty rates set forth in Section 4.02 shall be reduced by [***] in such country; provided that the Royalty rates in each country shall never fall below [***] the rates set forth in Section 4.02.  Such royalty reduction shall become effective on the first day of the month after the month in which such generic competition first occurs and shall expire on the last day of the month in which such generic competition ceases to exist, subject to the expiration of the Royalty Term.
 
(b)           From and after the [***] anniversary of the Royalty Term, the Royalty rates set forth in Section 4.02 shall be reduced by [***] provided that the Royalty rates in each country shall never fall below [***] the rates set forth in Section 4.02.
 
Section 4.08.    Exchange Rate . Revenues recorded in currencies other than U.S. Dollars shall be converted to U.S. Dollars for purposes of calculating royalties at the rate of exchange for each such currency published in the Wall Street Journal (New York Edition) for the last business day of the calendar quarter to which such Net Sales relate.
 
Section 4.09.     Taxes; Withholding . Any tax or charges required to be withheld by Biotest under the laws of the Territory for the accounts of ADMA shall be promptly paid by Biotest for and on behalf of ADMA to the appropriate governmental authority; provided that should ADMA be subject to any exemption or reduction, subject to the requirements of applicable law, Biotest shall only pay the amounts not subject to the exemption or deduction. Any such tax or other charges actually paid on ADMA's behalf shall be deducted from royalty payments due ADMA.
 
Section 4.10.     Overpayment of Royalties .  Any overpayment of royalties due to an allowable deduction under the definition of Revenues that is not taken by Biotest for a particular accounting period for which royalties already have been paid shall be credited against future royalty obligations when such deduction is applied against Revenues (or, if no such future royalty obligations exist, refunded).
 
ARTICLE 5
INTELLECTUAL PROPERTY RIGHTS.
 
Section 5.01.     Ownership .  Each Party shall own and retain all right, title, and interest in and to any and all Intellectual Property Rights that are owned or controlled by such Party on and as of the date hereof and all Intellectual Property Rights conceived, discovered, developed, or otherwise made by or on behalf of such Party (or its Affiliates or Sublicensees) independently of this Agreement and the activities hereunder.  Any Intellectual Property Rights developed by ADMA and/or Biotest under or in connection with this Agreement that relate to or are derived from the ADMA Know-How or ADMA Proprietary Information and any Intellectual Property Rights developed by ADMA and/or Biotest under or in connection with this Agreement that relate to or are derived from the Product shall belong to and be owned exclusively by ADMA (“ New ADMA IP Rights ”).  Any Intellectual Property Rights (i) relating to the products or technology covered by this Agreement that are not derived from the ADMA Know-How, ADMA Proprietary Information, or the Product and developed independently by Biotest, and (ii) that relate to or are otherwise derived from Biotest’s Intellectual Property Rights in existence on the date hereof and otherwise independently developed by Biotest, shall belong to and be owned exclusively by Biotest (“ New Biotest IP Rights ”).  Biotest agrees to assign and hereby assigns to ADMA all of its rights, title and interest in and to any and all New ADMA IP Rights conceived, reduced to practice or developed by Biotest, and ADMA agrees to assign and hereby assigns to Biotest all of its rights, title and interest in and to any and all New Biotest IP Rights conceived, reduced to practice or developed by ADMA.  In furtherance of such assignment of rights, each Party agrees to and shall execute all assignments and other documents, as reasonably requested by the other Party, to effectuate such transfer of rights and for purposes of recording such transfer of rights. To the extent that ADMA desires to obtain a license to any of the New Biotest IP Rights, Biotest agrees to consider in good faith whether to grant such license and to negotiate in good faith the terms of such license, but Biotest is not obligated to grant a license to ADMA.
 
 
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Section 5.02.     Prosecution and Maintenance . ADMA shall have the right but not the obligation, at its sole expense, to prepare, file, prosecute and maintain any patents and patent applications relating to the ADMA Proprietary Information.  Subject to the express written approval of ADMA, Biotest shall have the right to file and/or assume the prosecution and maintenance of any such patent, patent application, in ADMA’ name(s), in the Territory, subject to Biotest paying for all of the costs and expenses associated therewith, and Biotest may set-off [***] of such costs or expenses against the Royalty Payments due hereunder.
 
Section 5.03.     Enforcement .
 
(a)           Each Party shall promptly inform the other if it becomes aware of any actions by any third party which might reasonably be expected to constitute misappropriation, infringement or threatened infringement of ADMA Proprietary Information.  ADMA has the obligation to defend against any declaratory judgment, noninfringement or invalidity actions in the Territory.  ADMA shall prosecute, defend or settle all infringement, misappropriation, declaratory judgment and similar actions in the Territory at its expense and through counsel of its selection.  In the event that ADMA fails to or refuses to comply with its obligations under this Section 5.03(a), or fails to act in a timely manner, Biotest shall have the option to take such action as Biotest deems necessary or appropriate to protect the ADMA Proprietary Information in the Territory.  The Parties shall reasonably co-operate to prevent such infringement, misappropriation or unauthorized use of ADMA Proprietary Information by a third party in the Territory and shall reasonably cooperate in connection with any actions to protect such ADMA Proprietary Information.   Each Party shall bear its own litigation costs incurred hereunder.
 
(b)           With respect any action to protect ADMA Proprietary Information in the Territory, all monies recovered upon the final judgment or settlement of any such action shall be used (a) first, to reimburse the costs and expenses (including reasonable attorneys' fees and costs) of ADMA and Biotest; (b) then to the extent that damages are awarded for lost sales or lost profits from the sale of Licensed Product in the Territory, to ADMA in an amount equal to the applicable royalty on lost sales of Licensed Product , and (ii) the balance of any award for lost sales or lost profits from the sale of Licensed Product in the Territory shall be paid to Biotest; and (c) the remainder to the account of the Party that initiated and asserted the action to protect the ADMA Proprietary Information.
 
 
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ARTICLE 6
GENERAL OBLIGATIONS AND TESTING
 
Section 6.01.    Testing .  Upon the formal request of Biotest, and upon the issuance of a Purchase Order for testing Services, ADMA will, using its RSV Assay perform testing on Plasma samples provided by Biotest (“Testing”).  The specific scope of the testing, the schedule of delivery of the results thereof and such other related details shall be discussed and mutually agreed by Biotest and ADMA, and, as necessary, shall be described in a statement of work to be executed by the parties and attached hereto when fully executed.  All testing of Plasma provided by ADMA under this Agreement shall be at Biotest’s expense, and will be billed by ADMA at [***].  Biotest shall be responsible for the transportation and shipping of all samples to ADMA’s testing location.  All samples shall remain the property of Biotest and Biotest shall remain responsible for insuring all such samples.  Should ADMA incur any additional shipping or storage cost relating to the Testing, such costs shall be billed to Biotest at [***].  Biotest understands that it must, and Biotest agrees to, inform ADMA of the complete composition of all samples provided to ADMA for testing prior to ADMA initiating any such testing.
 
Section 6.02.    Modifications .    Any and all modifications to the RSV Assay or any testing protocols or procedures as used for any Product approved in the United States required by Biotest (and not unilaterally imposed by ADMA) for purposes of Testing the Biotest samples shall be at the sole cost and expense of Biotest.
 
Section 6.03.    Information and Materials . Each Party will provide to the other party such information and materials and reasonable technical assistance as the Parties mutually agree to be reasonably necessary or useful to carry out the activities contemplated by this Agreement.  All additional activities provided by ADMA or Biotest hereunder shall be billed to the other Party at the rate of [***] plus any necessary travel and out of pocket expenses relating thereto.  Should Biotest require the assistance of any ADMA vendor, Biotest shall be obligated to pay ADMA [***].
 
Section 6.04.     Payment Terms .  ADMA shall bill Biotest for all costs and expenses identified in Article 6 on a monthly basis.  All such invoices shall be paid within [***] from receipt of such invoice by Biotest.  Any late payments shall be subject to interest at the rate of [***] per annum.
 
Section 6.05.     Compliance with Law .  Each Party represents that it is, and covenants that it agrees to be and will remain in compliance at all times during the term of this Agreement with all Applicable Laws relating to the operation of its business and its performance of its rights and obligations hereunder.
 
Section 6.06.      Non-Competition .
 
(a)           During the Term, Biotest agrees not to market or sell another RSV Product in North America or in the Territory.  If this Agreement is terminated after [***] from the date hereof, Biotest agrees not to market or sell another RSV Product in North America or in the Territory for a period of [***] from the date of termination.  Notwithstanding the foregoing, if Biotest terminates this Agreement due to a material breach by ADMA, the noncompetition provisions set forth herein shall be of no force or effect.
 
 
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(b)           During the Term, Biotest agrees not to sell or distribute another RSV Product outside the Territory unless [***].
 
ARTICLE 7
REPRESENTATIONS, WARRANTIES AND COVENANTS
 
Section 7.01.      Mutual Representations and Warranties
 
.  Each Party hereby represents and warrants to the other Party that:
 
(a)           it is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets.
 
(b)           it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms;
 
(c)           it has not entered (and covenants that it shall not enter) into any agreement with any third party that is in conflict with the rights granted or contemplated to be granted to the other Party under this Agreement, and has not taken (and covenants that it shall not take) any action that would in any way prevent it from granting the rights granted or contemplated to be granted to the other Party under this Agreement, or that would otherwise materially conflict with or adversely affect the rights granted or contemplated to be granted to the other Party under this Agreement.
 
Section 7.02.     Representations and Warranties of ADMA .  ADMA represents and warrants to Biotest that, as of the Effective Date and throughout the Term hereof that:
 
(a)           ADMA has the sole, exclusive and unencumbered right to grant the licenses and rights herein granted to Biotest;
 
(b)           to ADMA’s best knowledge and belief, the RSV Assay and the  Licensed Product do not and will not infringe any valid or enforceable claims of any third party issued patent or other intellectual property right, or, if published, any claims of any third party pending patent applications;
 
(c)           ADMA has not and shall not misappropriate the trade secrets or intellectual property rights of any other entities in its activities to develop the RSV Assay or the Licensed Product;
 
 
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(d)           ADMA is unaware of any activities by third parties that would constitute infringement of ADMA Proprietary Information;
 
(e)           ADMA shall conduct all testing of the Plasma sample provided by Biotest in accordance with the requirements, protocols and specifications of the RSV Assay and the test results concerning the levels of RSV titre in the Plasma tested by ADMA using the RSV Assay shall be accurate; and
 
(f)           ADMA is not aware of any claims, judgments or settlements against or owed by ADMA and has not received notice of any pending or threatened claims or litigation relating to the ADMA Proprietary Information or the practice thereof.
 
(g)           EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ADMA EXPRESSLY DISCLAIMS (A) ANY WARRANTY THAT THE PRODUCT OR FINISHED PRODUCT (I) WILL BE MERCHANTABLE OR (II) WILL BE FIT FOR ANY PARTICULAR PURPOSE AND (B) ANY OTHER WARRANTIES WITH RESPECT TO THE INFRINGEMENT BY, SALE, DISTRIBUTION, OR USE OF PRODUCT AND FINISHED PRODUCT, EXPRESS OR IMPLIED.
 
ARTICLE 8
CONFIDENTIALITY AND PUBLICATION.
 
Section 8.01.      Confidential Information .  Each Party shall maintain all Confidential Information of the other Party in confidence and shall not disclose any such confidential Information to any third party (except as expressly provided below) or use any such confidential Information for any purposes other than those necessary or permitted for performance under this Agreement.  No Party shall disclose Confidential Information of the other Party to any employee, agent, consultant, Affiliate, or sublicensee who does not have a reasonable need for such Information and who is not subject to binding obligations of confidentiality and limited use at least as restrictive in scope as those of this Article 8 (but may disclose to those that have such a reasonable need and are so bound).  Neither Party shall disclose Confidential Information received from other Party and neither Party shall use Confidential Information disclosed to it by the other Party (other than in the performance of its obligations hereunder) or for the benefit of any third person.  The duration of such obligations of confidentiality under this Section shall survive the expiration or termination of this Agreement and shall remain in effect for as long as such information is maintained in confidence by the disclosing Party).   Each Party shall use at least the same standard of care as it uses to protect its own confidential Information of a similar nature to prevent unauthorized disclosures or uses of Confidential Information of the other Party.  Each Party shall promptly notify the other Party upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.
 
Section 8.02.     Authorized Disclosure .  Notwithstanding any other provision of this Agreement, each Party may disclose Confidential Information of the other Party only to the extent that any such disclosure is necessary:
 
 
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(a)           to the extent and to the persons and entities required by an applicable governmental law, rule, regulation or order; provided, however, that the responding Party shall first have given prompt notice to the other Party hereto to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party;
 
(b)           to the extent and to the persons and entities required by rules of other securities regulators, or exchanges on which such Party’s stock is listed; or
 
(c)           as necessary to prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement, or
 
(d)            to bona fide potential (and actual) corporate partners or licensees, potential (and actual) investors or merger or acquisition partners, and to financial underwriters and legal and financial advisors, provided that all such disclosures shall be made only to such parties under binding written obligations of confidentiality and non-use consistent with the provisions of this Article 8.
 
Such disclosed Information shall remain Confidential Information.

Section 8.03.     Return of Confidential Information .  Upon expiration of the Agreement or if this Agreement is terminated for breach according to the provisions of Section ­­­10.02, the Party receiving Confidential Information will, at the other Party's option, either promptly return, or destroy and certify that it has destroyed, all copies, in its or any of its representatives’ possession or control, of any and all documents, computer files and other materials that contain or are derived from any Confidential Information.  Each Party will be allowed to keep one archival copy of the other Party’s Confidential Information for record-keeping purposes only, but shall destroy such Confidential Information prior to expiration of the confidentiality obligations hereunder.
 
Section 8.04.     Survival .  The provisions of Section 8.01 and 8.02 shall survive for a period of [***] following expiration or termination of this Agreement for any reason.
 
Section 8.05.      Press Release .  Neither ADMA shall, on the one hand, nor Biotest, on the other hand, shall, without the approval of the other, make any press release or other public announcement concerning the transactions contemplated by this Agreement, except as and to the extent that any such Party shall be so obligated by law, in which case the other Party shall be advised and the Parties shall use their commercially reasonable efforts to cause a mutually agreeable release or announcement to be issued; provided, however, that the foregoing shall not preclude communications or disclosures necessary to implement the provisions of this Agreement or to comply with the accounting and disclosure obligations of the Securities and Exchange Commission (“SEC”) or the rules of any U.S. or foreign stock exchange or NASDAQ.   Notwithstanding any contrary term contained in the confidentiality provisions of this Agreement, to the extent that either Party determines that it or the other Party is required to file or register this Agreement, a summary thereof, or a notification thereof, and/or descriptions related thereto, to comply with the requirements of an applicable stock exchange, SEC or foreign regulation, or any Governmental Authority, including the SEC, or to enable either Party to obtain debt or equity financing, such Party shall use its best efforts to provide the maximum amount of advance written notice of any such required disclosure to the other Party, to the extent practicable, with a minimum advance notice period of three (3) business days.  Prior to making any such filing, registration or notification, the Parties shall consult with respect thereto regarding confidentiality.  The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including such confidential treatment request, and shall execute all documents reasonably required in connection therewith.  The Parties agree to issue a mutually acceptable press release in connection with the signing of this Agreement.
 
 
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Section 8.06.      Use of Names, Logos or Symbols .  Other than legally required disclosures and disclosures required by the rules of any securities exchange on which a disclosing Party’s stock is (at the time) traded (of which advance notice and discussion to the full extent reasonably practicable shall be provided, but for which a Party shall not be required to obtain consent from the other Party), neither Party shall use the name, trademarks, logos, physical likeness, employee names or owner symbol of the other Party for any publicity, promotion or similar public use without the prior written consent of the affected Party.  Unless expressly stated herein, nothing in this Agreement shall be construed as granting either Party any rights or license to use any of the other Party’s trademarks or trade names without separate, express prior written permission of the owner of such trademark or trade name.
 
ARTICLE 9
INDEMNIFICATION
 
Section 9.01.      Indemnification by ADMA .  ADMA shall indemnify, hold harmless and defend (collectively, “Indemnify”) Biotest, its Affiliates, the sublicensees and their respective officers, directors, employees and agents (the “Biotest Indemnitees”) from and against any and all losses, damages, liabilities, judgments, fines, amounts paid in settlement, expenses and costs of defense (including reasonable attorneys’ fees and witness fees) (collectively “Losses” and each a “Loss”) resulting from any demand, claim, action or proceeding brought or initiated by a third party (each a “Third Party Claim”) against any Biotest Indemnitees(s) to the extent that such Third Party Claim arises out of (i) the breach or alleged breach of any representation, warranty or covenant by ADMA, (ii) the infringement or alleged infringement or misappropriation of third party intellectual property rights by the ADMA Proprietary Information; (iii) the failure of ADMA to perform testing using the RSV Assay in accordance with the specifications and protocols related thereto or to provide accurate reports in connection therewith (iv) violations of any applicable law or regulation by ADMA; (v) a Finished Product recall for which ADMA is responsible or (vi) the gross negligence or willful misconduct of any ADMA Indemnitee (defined in Section 9.02); provided that such indemnity shall not apply to the extent Biotest has an indemnification obligation pursuant to Section 9.02 for such Loss.
 
Section 9.02.      Indemnification by Biotest .  Biotest shall indemnify ADMA, its Affiliates, and their respective officers, directors, employees and agents (the “ADMA Indemnitees”) from and against any and all Losses resulting from any Third Party Claim against any ADMA Indemnitees to the extent that such Third Party Claim arises out of:  (i) any breach of any representation, warranty or covenant by Biotest; (ii) violations of any applicable law or regulation by Biotest; (iii) a Finished Product recall for which Biotest is responsible; (iv) the infringement or alleged infringement or misappropriation of third party intellectual property rights caused by Biotest’s owned intellectual property; or (v) the gross negligence or willful misconduct of any Biotest Indemnitee; provided that such indemnity shall not apply to the extent ADMA has an indemnification obligation pursuant to Section 9.01 for such Loss.
 
 
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Section 9.03.      Procedures .  A Party who is entitled to be indemnified pursuant to this Article 9 (the “Indemnified Party”) shall give prompt notice of the Third Party Claim to the other Party (the “Indemnifying Party”) and the Indemnifying Party shall defend against such Third Party Claim with the reasonable cooperation of the Indemnified Party; provided that the Indemnifying Party shall not settle any such Third Party Claim for anything other than money damages without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Indemnified Party shall have the right to be present in person or through counsel at substantive legal proceedings relating to the Third Party Claim giving rise to the Indemnified Party’s right to indemnification hereunder.  If the Parties cannot agree as to the application of Sections 9.01 and 9.02 to any Loss or Third Party Claim, the Parties may conduct separate defenses of such Third Party Claim.  In such case, each Party further reserves the right to claim indemnity from the other in accordance with Sections 9.01 and 9.02 upon resolution of such underlying Third Party Claim.
 
Section 9.04.      Insurance .  ADMA and Biotest shall each be required to maintain general and product liability insurance in an amount of at least [***] prior to European Union approval of the Finished Product, and in an amount of at least [***] after European Union approval of the Finished Product; and each shall provide to the other, upon request, written certification of such coverage.  Such certificate will provide that such insurance will not expire without renewal or be cancelled or modified without at least [***] prior notice to the other Party.  Before commencing any work hereunder, the Parties shall furnish certificates evidencing the insurance required by this Section.  All such insurance policies obtained by a Party shall name the other Party and its parents, affiliates and subsidiaries and its and their employees and agents as additional insured parties.  It is understood that such insurance will not be construed to limit a Party’s liability with respect to its indemnification obligations under Article 9.
 
Section 9.05.      No Consequential Damages .  EXCEPT WITH RESPECT TO CLAIMS FOR INDEMNIFICATION UNDER ARTICLE 9 AND BREACHES OF THE OBLIGATIONS SET FORTH IN ARTICLE 8 (REGARDING CONFIDENTIALITY), IN NO EVENT SHALL ANY PARTY OR ITS RESPECTIVE AFFILIATES AND SUBLICENSEES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED (INCLUDING ARISING OUT OF OR RELATED TO THIS AGREEMENT, THE ADMA PROPRIETARY INFORMATION, PRODUCTS, FINISHED PRODUCTS, LICENSED PRODUCTS, PERFORMANCE OF THE SERVICES OR ANY PERSONS’ USE OF THE PRODUCTS, FINISHED PRODUCTS OR LICENSED PRODUCTS), REGARDLESS OF THE FORM OF ACTION, WHETHER FOR BREACH OF CONTRACT, BREACH OF WARRANTY, TORT, NEGLIGENCE, STRICT PRODUCT LIABILITY, INFRINGEMENT OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, DAMAGES BASED ON WILLFULNESS, LOSS OF PROFITS, LOST REVENUES, OR LOSS OF BUSINESS OPPORTUNITY), AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OR KNEW OF THE POSSIBILITY OF SUCH DAMAGES.  THIS LIMITATION SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
 
 
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Section 9.06.       Limitation of Liability . EXCEPT FOR THE OBLIGATIONS OF INDEMNITY, AS SET FORTH IN SECTIONS 9.01 AND 9.02, WITH RESPECT TO CLAIMS RESULTING FROM A FINISHED PRODUCT RECALL, AND BREACH OF CONFIDENTIALITY, AGGREGATE DAMAGES FOR WHICH EITHER PARTY SHALL BE LIABLE TO THE OTHER, SHALL NOT EXCEED (I) [***] PRIOR TO EUROPEAN UNION APPROVAL OF THE FINISHED PRODUCT OR (II) [***] AFTER EUROPEAN UNION APPROVAL OF THE FINISHED PRODUCT, UNLESS DEEMED TO BE CAUSED DUE TO THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF THE PARTY.
 
ARTICLE 10
TERM AND TERMINATION
 
Section 10.01.    Term .   The term of this Agreement shall commence upon the Effective Date and, unless sooner terminated as provided in this Article 10, expire on the expiration of the last to expire of the Royalty Term.
 
Section 10.02.    Termination for Breach .  Either Party may terminate this Agreement if the another Party materially breaches this Agreement, by [***] written notice to the breaching Party, provided that (a) the written notice explicitly states that it is a notice of breach under this Section 10.02 and describes the alleged material breach, and (b) the breaching Party fails to cure the breach within such [***] notice period, or in the case of a material breach that is incapable of cure within [***] fails (i) to provide within such [***] notice period a commercially reasonable written plan to cure the breach as soon as practicable and (ii) to initiate measures to cure such breach; provided that the cure period for any breach of a payment obligation hereunder shall be [***].
 
Section 10.03.    Termination by Biotest .  Biotest may terminate this Agreement at any time upon [***] written notice to ADMA; provided however, that ADMA’s right to receive [***] of Product in accordance with Section 4.01(a) shall remain in effect notwithstanding such termination.  Upon any termination by Biotest under this Section 10.03, Biotest shall remain obligated to continue paying Royalties to ADMA with respect to all Product and Finished Product produced prior to the date of termination pursuant to and as set forth in Article 4 hereof.
 
Section 10.04.    Termination for Insolvency .  Either Party (herein the “ Non-Debtor Party ”) may terminate this Agreement at any time upon providing written notice to the other Party (i) upon the declaration by a court of competent jurisdiction that the other Party (herein the “Debtor Party”) is bankrupt and, pursuant to the U.S. Bankruptcy Code, the Debtor Party’s assets are to be liquidated, (ii) upon the filing or institution of bankruptcy, liquidation or receivership proceedings (other than reorganization proceedings under Chapter 11 of the U.S. Bankruptcy Code or other similar law of any jurisdiction) with respect to the Debtor Party, (iii) upon an assignment of a substantial portion of the assets for the benefit of creditors by the Debtor Party, (iv) in the event a receiver or custodian is appointed for the Debtor Party’s business, or (v) if a substantial portion of the Debtor Party’s business is subject to attachment or similar process; provided, however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall become effective only if the proceeding is not dismissed within [***] after the filing thereof.
 
 
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Section 10.05.     Effects of Termination .  Upon expiration or termination of this Agreement,
 
(a)           subject to Section 10.05(c) below, all rights granted to Biotest hereunder shall terminate and all sublicenses that may have been granted by Biotest to third parties also shall terminate;
 
(b)           each Party shall return or destroy all copies of the other Party’s Confidential Information, retaining only one copy in its outside legal counsel’s office for the sole purpose of compliance with surviving terms of this Agreement or defense against any legal actions related to this Agreement; and
 
(c)           Biotest shall have the right for a period of [***] following expiration or termination to sell off any remaining inventory of Product or Finished Product.
 
Section 10.06.     Accrued Rights and Obligations; Survival .  Expiration or termination of this Agreement shall not affect any accrued rights or obligations (including any payment obligations set forth in Article 4).  The provisions of Articles 9 (solely to the extent relating to (i) matters occurring prior to the date of termination, and/or (ii) those matters that expressly survive termination under this Section 10.06), and 11, and Sections 5.01, 6.04, 6.06, 8.01, 8.02, 8.03, 10.03, 10.05(b), 10.05(c), 10.06, 12.05, 12.06, 12.07, 12.08, 12.09, 12.12, 12.13, and 12.14 of this Agreement shall survive expiration or termination of this Agreement for any reason (in accordance with any subsequent dates of termination referred to in such Sections).
 
ARTICLE 11
DISPUTE RESOLUTION
 
Section 11.01.      Dispute Resolution .
 
(a)           The Parties recognize that disputes may from time to time arise between the Parties during the term of this Agreement.  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 prior to resort to litigation.  To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 11.01 to resolve any dispute arising under this Agreement.
 
(b)           Upon the request of either Party, the Parties agree to meet and discuss in good faith a possible resolution of any disputes, controversies or differences which may arise between the Parties out of or in relation to or in connection with this Agreement, which good faith efforts shall include at least one in-person meeting between the senior management of each Party, including the Chief Executive Officer.  If the matter is not resolved within thirty (30) days following the request for discussions, the Parties agree to submit the matter to non-binding mediation in accordance with the rules of JAMS in an effort to resolve the dispute.  If the dispute remains unresolved, each Party shall have the right to seek a resolution of the dispute by final and binding arbitration administered by the American Arbitration Association under the United Nations Commission on International Trade Law (UNCITRAL) Arbitration Rules.  The location of arbitration will be New York, NY, and the language of the arbitration proceeding will be in English. The arbitration will be conducted by a panel of three (3) arbitrators, with one arbitrator being selected by each Party and the third being selected by the two arbitrators selected by the Parties.  The arbitrators shall issue a written decision which shall be a reasoned determination and shall set forth the legal basis for any such decision.  The Federal Rules of Evidence shall apply to any such arbitration proceeding.  Any award granted in the arbitration may be entered in any court of competent jurisdiction.   The arbitrators shall have the right to award attorneys fees and expenses to the prevailing Party or based on their determination of an equitable allocation of such fees and expenses as related to each Party’s role and relative fault in the dispute.
 
 
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Section 11.02.     Injunctive Relief .  Notwithstanding the provisions of Section 11.01, each Party shall have the right to seek preliminary or permanent injunctive or other equitable relief in any court of competent jurisdiction as such Party deems necessary to preserve its rights, to protect its interests or to preserve the status quo with respect to any breach or threatened breach of the confidentiality or non-compete provisions hereunder.
 
ARTICLE 12
MISCELLANEOUS PROVISIONS
 
Section 12.01.      Entire Agreement .  This Agreement contains the entire understanding between the Parties with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements, negotiations, representations, and promises between them with respect to such subject matter.
 
Section 12.02.
 
Section 12.03.       Amendment .  No change, modification, alteration, or addition to any provision of this Agreement will be valid or binding unless in writing and signed by authorized representatives of both Parties.
 
Section 12.04.       Force Majeure .  Any delay in or failure of performance by any Party under this Agreement shall not be considered a breach of this Agreement if and to the extent caused by occurrences beyond the reasonable control of the Party affected, including but not limited to acts of God, if any, embargoes, governmental restrictions, strikes or other concerted acts of workers, fire, flood, earthquake, explosion, riots, wars, terrorism, civil disorder, rebellion or sabotage.  The Party suffering such occurrence shall notify the other Party and any time for performance hereunder shall be extended by the actual time of delay caused by the occurrence, provided that the Party suffering such occurrence use reasonable efforts to overcome such, and notifies the other party when such occurrence ceases.
 
Section 12.05.       Notices .  Any notice or other communication required or permitted to be given to either Party hereto shall be in writing unless otherwise specified and shall be deemed to have been properly given and to be effective (a) on the date of delivery if delivered in person; or (b) two (2) Business Days after sending for next Business Day delivery by internationally recognized expedited courier service; or (c) five (5) Business Days after sending by first class certified mail return receipt requested:
 
 
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In the case of ADMA:
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, NJ 07601
Attn:  Legal Department

with a required copy to:

SNR Denton US LLP
101 JFK Parkway
Short Hills, NY 07078
Attn:  Jeff Baumel

In the case of Biotest:
 
BiotestAktiengesellschaft
Landsteinerstraße 5
63303 Dreieich, Germany
Attention:______________
Facsimile:______________
 
with a copy (which shall not constitute notice) to:
 
Greenberg Traurig LLP
3333 Piedmont Road, NE
Terminus 200, Suite 2500
Atlanta, GA 30305
Attn: Wayne H. Elowe
Facsimile:  678-553-2453
 
Section 12.06.     Waiver .  No failure on the part of either Party to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of either Party in exercising any power, right, privilege or remedy under this Agreement, will operate as a waiver thereof.  No single or partial exercise of any such power, right, privilege or remedy will preclude any other or further exercise thereof or of any other power, right, privilege or remedy.  Waivers of powers, rights, privileges and remedies under this Agreement may only be waived in a written document executed by a duly authorized officer of the waiving Party.
 
Section 12.07.     Headings .  The headings contained in this Agreement are intended for convenience or reference only and shall not in any way control or affect the meaning or construction of any provisions of this Agreement.
 
Section 12.08.     Governing Law .  This Agreement, and all disputes directly or indirectly arising from, relating to or in connection with this Agreement, will be governed by and interpreted in accordance with the laws of the state of New York, without regard to its conflict of laws rules. The United Nations Convention on the International Sale of Goods is hereby expressly excluded from application to the terms of this Agreement.
 
 
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Section 12.09.      Binding Effect .  This Agreement will be binding upon the Parties and their respective successors and assigns.
 
Section 12.10.      Assignment .  This Agreement may not be assigned or transferred without the prior written consent of both Parties, which consent shall not be unreasonably withheld.  Upon receipt of consent, such assignment shall only be allowed upon written agreement by the assignee to be bound by all of the terms of the Agreement.  Any assignment in contravention to this provision shall be null and void.
 
Section 12.11.      Bankruptcy; Intellectual Property .  All rights and licenses granted under or pursuant to this Agreement by a bankrupt Party to the other Party are, and shall be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code and any similar law or regulation in any other country, licenses of rights to "intellectual property" as defined under Section 101(35A) of the Bankruptcy Code.  The Parties agree that all intellectual property rights licensed hereunder are part of the “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code subject to the protections afforded the non-terminating Party under Section 365(n) of the Bankruptcy Code.  To the extent that ADMA enters into bankruptcy during the term of this Agreement, it shall continue to honor its obligations under Section 3.02(c).
 
Section 12.12.      Severability .  Should one or more provisions of this Agreement be or become invalid, then the Parties shall substitute such invalid provisions by valid ones, which in their economic effect come so close to the invalid provisions that it can be reasonably assumed that the Parties would have contracted this Agreement also with those new provisions. In case such provisions cannot be found, the invalidity of one or several provisions of this Agreement shall not affect the validity of the Agreement as a whole, unless the invalid provisions are of such essential importance for this Agreement that it is to be reasonably assumed that the Parties would not have contracted this Agreement without the invalid provisions.
 
Section 12.13.      Cumulative Rights .  The rights, powers and remedies hereunder shall be in addition to, and not in limitation of, all rights, powers and remedies provided at law or in equity.  All of such rights, powers and remedies shall be cumulative, and may be exercised successively or cumulatively.
 
Section 12.14.      Counterparts . This Agreement may be executed by its authorized representatives in one or more counterparts, each of which shall be deemed to be an original document, but all such separate counterparts shall constitute one and the same agreement.

(Signature page follows)
 
 
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IN WITNESS WHEREOF , the Parties hereto have each caused this Agreement to be executed by their duly-authorized representatives as of the Effective Date.
 
ADMA:
ADMA Biologics, Inc.
 
By:   /s/ Adam Grossman            
Name: Adam Grossman              
Title:   Chief Executive Officer                                                          
 
BIOTEST:
Biotest Aktiengesellschaft
 
By:   /s/ Dr. Martin Reinecke        
Name:   Martin Reinecke               
Title:   [Illegible]                                                         
 
Biotest Aktiengesellschaft
 
By:   Dr. Joachim Uevborg                      
Name:   Joachim Uevborg                       
Title:   Exec. VP Commercial Operations
 
 
 

 
 
EXHIBIT A
 
TERRITORY
 
Europe:
 
Albania
Andorra
Armenia
Austria
Azerbaijan
Hungary
Iceland
Ireland
Italy
Kosovo
Russia
San Marino
Serbia
Slovakia
Slovenia
Belarus
Belgium
Bosnia & Herzegovina
Bulgaria
Latvia
Liechtenstein
Lithuania
Luxembourg
Spain
Sweden
Switzerland
Turkey
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Macedonia
Malta
Moldova
Monaco
Montenegro
Ukraine
United Kingdom
 
Finland
France
Georgia
Germany
Greece
The Netherlands
Norway
Poland
Portugal
Romania
 
 
North Africa and Middle East :
 
Bahrain
Iran
Iraq
Qatar
Oman
Jordan
Kuwait
Saudi Arabia
Tunisia
United Arab Emirates
 

 

 

Exhibit 23.1
 
Consent of Independent Registered
Public Accounting Firm
 
We consent to the inclusion in this registration statement on Form S-1 of our report dated March 29, 2012, on our audits of the consolidated financial statements of Adma Biologics, Inc. as of December 31, 2011 and 2010 and for the years then ended. We also consent to the reference to our firm under the caption "Experts".
 
/s/CohnReznick LLP
February 7, 2013