FORM 10-Q
Table of Contents

 
 
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
 
(Mark One)
     
þ   Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended September 30, 2008
or
     
o   Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from                      to                     
Commission file Number 000-23661
ROCKWELL MEDICAL TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
     
MICHIGAN   38-3317208
     
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)
     
30142 Wixom Road, Wixom, Michigan   48393
     
(Address of principal executive offices)   (Zip Code)
(248) 960-9009
(Registrant’s telephone number, including area code)
 
(Former name, former address and former fiscal year,
if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
þ Yes     o No
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 o   Accelerated filer o   Non-accelerated filer o   Smaller reporting company þ
        (Do not check if a smaller reporting company)    
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
o Yes      þ No
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
     
Class   Outstanding as of October 31, 2008
     
Common Stock, no par value   13,834,953 shares
 
 

 


 

Rockwell Medical Technologies, Inc.
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 EX-31.1
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 EX-32.1

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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of September 30, 2008 and December 31, 2007
                 
    September 30,     December 31,  
    2008     2007  
    (Unaudited)          
ASSETS
               
Cash and Cash Equivalents
  $ 7,481,792     $ 11,097,092  
Accounts Receivable, net of a reserve of $96,000 in 2008 and $69,000 in 2007
    5,356,536       4,687,229  
Inventory
    3,166,566       2,559,051  
Other Current Assets
    535,437       302,573  
 
           
Total Current Assets
    16,540,331       18,645,945  
 
               
Property and Equipment, net
    3,332,569       2,840,331  
Intangible Assets
    248,338       270,446  
Goodwill
    920,745       920,745  
Other Non-current Assets
    116,850       125,667  
 
           
Total Assets
  $ 21,158,833     $ 22,803,134  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
 
               
Notes Payable & Capitalized Lease Obligations
  $ 187,682     $ 194,239  
Accounts Payable
    3,977,321       2,982,899  
Accrued Liabilities
    2,252,257       1,122,737  
Customer Deposits
    331,043       337,396  
 
           
Total Current Liabilities
    6,748,303       4,637,271  
 
               
Long Term Notes Payable & Capitalized Lease Obligations
    58,190       204,837  
 
               
Shareholders’ Equity:
               
Common Shares, no par value, 13,834,953 and 13,815,186 shares issued and outstanding
    34,262,611       33,415,106  
Common Share Purchase Warrants, 1,414,169 and 1,204,169 warrants issued and outstanding
    3,413,443       3,038,411  
Accumulated Deficit
    (23,323,714 )     (18,492,491 )
 
           
Total Shareholders’ Equity
    14,352,340       17,961,026  
 
           
 
               
Total Liabilities And Shareholders’ Equity
  $ 21,158,833     $ 22,803,134  
 
           
The accompanying notes are an integral part of the consolidated financial statements.

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ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and nine months ended September 30, 2008 and September 30, 2007
(Unaudited)
                                 
    Three Months     Three Months     Nine Months     Nine Months  
    Ended     Ended     Ended     Ended  
    Sept. 30, 2008     Sept. 30, 2007     Sept. 30, 2008     Sept. 30, 2007  
Sales
  $ 13,533,986     $ 11,073,774     $ 38,128,359     $ 31,096,399  
Cost of Sales
    12,755,377       9,953,863       35,400,671       28,942,171  
 
                       
Gross Profit
    778,609       1,119,911       2,727,688       2,154,228  
Selling, General and Administrative
    2,314,188       765,457       5,183,675       2,288,903  
Research and Product Development
    993,262       735,393       2,557,718       2,319,452  
 
                       
Operating (Loss)
    (2,528,841 )     (380,939 )     (5,013,705 )     (2,454,127 )
Interest Expense (Income), net
    (17,795 )     51,973       (182,482 )     101,924  
 
                       
Net (Loss)
  $ (2,511,046 )   $ (432,912 )   $ (4,831,223 )   $ (2,556,051 )
 
                       
 
                               
Basic Earnings (Loss) per Share
  $ (.18 )   $ (.04 )   $ (.35 )   $ (.22 )
 
                               
Diluted Earnings (Loss) per Share
  $ (.18 )   $ (.04 )   $ (.35 )   $ (.22 )
The accompanying notes are an integral part of the consolidated financial statements.

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ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended September 30, 2008 and September 30, 2007
(Unaudited)
                 
    2008     2007  
Cash Flows From Operating Activities:
               
Net (Loss)
  $ (4,831,223 )   $ (2,556,051 )
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
               
Depreciation and Amortization
    651,710       601,362  
(Gain) on Disposal of Assets
    (7,534 )      
Warrants issued for Services
    375,032        
Stock Option Compensation
    740,783        
 
               
Changes in Assets and Liabilities:
               
Decrease (Increase) in Accounts Receivable
    (669,307 )     (1,444,062 )
(Increase) in Inventory
    (607,515 )     (133,895 )
(Increase) in Other Assets
    (224,047 )     (54,285 )
Increase in Accounts Payable
    994,422       51,394  
Increase (Decrease) in Other Liabilities
    1,123,167       (265,281 )
 
           
Changes in Assets and Liabilities
    616,720       (1,846,129 )
 
           
Cash (Used) In Operating Activities
    (2,454,512 )     (3,800,818 )
 
               
Cash Flows From Investing Activities:
               
Purchase of Equipment
    (1,122,958 )     (766,314 )
Proceeds on Sale of Assets
    9,555        
Purchase of Intangible Assets
    (903 )     (6,286 )
 
           
Cash (Used ) In Investing Activities
    (1,114,306 )     (772,600 )
 
               
Cash Flows From Financing Activities:
               
Proceeds From Borrowings on Line of Credit
          1,800,000  
Issuance of Common Shares and Purchase Warrants
    106,722       386,099  
Payments on Notes Payable
    (153,204 )     (275,554 )
 
           
Cash Provided (Used) By Financing Activities
    (46,482 )     1,910,545  
 
               
(Decrease) In Cash
    (3,615,300 )     (2,662,873 )
Cash At Beginning Of Period
    11,097,092       2,662,873  
 
           
Cash At End Of Period
  $ 7,481,792     $ -0-  
 
           
Supplemental Cash Flow disclosure
                 
    2008   2007
Interest Paid
  $ 41,523     $ 108,159  
Non-Cash Investing and Financing Activity — Equipment Acquired Under Capital Lease Obligations
    -0-     $ 53,676  
The accompanying notes are an integral part of the consolidated financial statements

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Rockwell Medical Technologies, Inc. and Subsidiary
Notes to Consolidated Financial Statements
1. Description of Business
     We manufacture, sell and distribute hemodialysis concentrates and other ancillary medical products and supplies used in the treatment of patients with End Stage Renal Disease, or “ESRD”. We supply our products to medical service providers who treat patients with kidney disease. Our products are used to cleanse patients’ blood and replace nutrients lost during the kidney dialysis process. We primarily sell our products in the United States. References in these Notes to “the Company,” “we,” “our” and “us” are references to Rockwell Medical Technologies, Inc. and its subsidiaries.
     We are regulated by the Federal Food and Drug Administration, or “FDA,” under the Federal Drug and Cosmetics Act, as well as by other federal, state and local agencies. We have received 510(k) approval from the FDA to market hemodialysis solutions and powders and to sell our Dri-Sate Dry Acid Concentrate product line and our Dri-Sate Mixer. We have also obtained global licenses for certain dialysis related drugs which we are developing and for which we are seeking FDA approval to market.
2. Summary of Significant Accounting Policies
Basis of Presentation
     Our consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiary, Rockwell Transportation, Inc. All intercompany balances and transactions have been eliminated. The accompanying consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America, or “GAAP,” and with the instructions to Form 10-Q and Securities and Exchange Commission Regulation S-X as they apply to interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The balance sheet at December 31, 2007 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements.
     In the opinion of our management, all adjustments have been included which are necessary to make the financial statements not misleading. All of these adjustments that are material are of a normal and recurring nature. Our operating results for the three month and nine month periods ended September 30, 2008 are not necessarily indicative of the results to be expected for the year ending December 31, 2008. You should read our unaudited interim financial statements together with the financial statements and related footnotes for the year ended December 31, 2007 included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2007. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2007 includes a description of our significant accounting policies.
Revenue Recognition
     We recognize revenue at the time we transfer title to our products to our customers consistent with GAAP. Generally, we recognize revenue when our products are delivered to our customer’s location consistent with our terms of sale. We recognize revenue for international shipments when title has transferred consistent with standard terms of sale.
     We require certain customers, mostly international customers, to pay for product prior to the transfer of title to the customer. Deposits received from customers and payments in advance for orders are recorded as liabilities under Customer Deposits until such time as orders are filled and title transfers to the customer consistent with our terms of sale. At September 30, 2008 and December 31, 2007, we had customer deposits of $331,043 and $337,396, respectively.

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Research and Product Development
     We recognize research and product development costs as expenses are incurred. We incurred product development and research costs related to the commercial development, patent approval and regulatory approval of new products, including iron supplemented dialysate (SFP), aggregating approximately $2.5 million and $2.3 million in the first nine months of 2008 and 2007, respectively. We are conducting human clinical trials on SFP and we recognize the costs of these clinical trials as the costs are incurred and services are performed over the duration of the trials.
Net Earnings Per Share
     We computed our basic earnings (loss) per share using weighted average shares outstanding for each respective period. Diluted earnings per share also reflect the weighted average impact from the date of issuance of all potentially dilutive securities, consisting of stock options and common share purchase warrants, unless inclusion would have had an anti-dilutive effect. Actual weighted average shares outstanding used in calculating basic and diluted earnings per share were:
                                 
    Three months ended Sept. 30,   Nine months ended Sept. 30,
    2008   2007   2008   2007
Basic Weighted Average Shares Outstanding
    13,834,953       11,619,117       13,826,208       11,545,725  
Effect of Dilutive Securities
                       
 
                               
Diluted Weighted Average Shares Outstanding
    13,834,953       11,619,117       13,826,208       11,545,725  
 
                               
3. Inventory
     Components of inventory as of September 30, 2008 and December 31, 2007 are as follows:
                 
    September 30,     December 31,  
    2008     2007  
Raw Materials
  $ 1,205,527     $ 1,096,191  
Finished Goods
    1,961,039       1,462,860  
 
           
Total Inventory
  $ 3,166,566     $ 2,559,051  
 
           
4. Fair Value Measurements
     On January 1, 2008, the Company adopted the methods of fair value as described in Statement of Financial Accounting Standards, or “SFAS”, No. 157, “Fair Value Measurements” (“SFAS 157”) to value its financial assets and liabilities. The adoption of the provisions of this pronouncement related to financial assets and liabilities did not have a material impact on our financial condition or consolidated results of operation. As defined in SFAS 157, fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, SFAS 157 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
     Level 1:   Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
     Level 2:   Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.

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     Level 3:   Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
     In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value. The Company’s cash and cash equivalents are valued using Level 1 inputs in the fair value hierarchy as these short term investments are immediately available at the Company’s direction and without market risk to principal. The Company does not have other financial assets that would be characterized as Level 2 or Level 3 assets.
     SFAS 157 is effective for non-financial assets and liabilities for the year beginning January 1, 2009. We are currently assessing the impact of this pronouncement as it relates to non-financial assets and liabilities.
     The Company chose not to elect the fair value option as prescribed by SFAS No. 159, “The Fair Value Option for Financial Assets and Liabilities Including an Amendment of Financial Accounting Standards Board, or “FASB”, Statement No. 115” (“SFAS 159”) for its financial assets and liabilities that had not been previously carried at fair value. Therefore, material financial assets and liabilities not carried at fair value, such as the Company’s trade accounts receivable and payable are still reported at their face values.
     Although the Company has not elected the fair value option for financial assets and liabilities existing at January 1, 2008 or transacted in the nine months ended September 30, 2008, any future transacted financial asset or liability will be evaluated for the fair value election as prescribed by SFAS 159 and valued under the provisions of SFAS 157.
5. Litigation Settlement
          In the third quarter of 2008, the Company reached a settlement with respect to certain litigation related to property and equipment the Company had leased from the plaintiffs. The Company recorded an expense of $750,000 in the third quarter of 2008 pursuant to this settlement agreement.
6. Common Share Purchase Warrants
     The Company has entered into several consulting agreements for which consideration for some or all of the services rendered include Common Share Purchase Warrants. During 2008, three such agreements were entered into, including one entered into subsequent to the end of the third quarter of 2008 on November 5, 2008, which provide for the right to purchase in the aggregate up to 460,000 Common Shares at prices ranging from $1.99 to $9.00. The warrants were valued using the Black-Scholes method with an aggregate estimated fair market value of $445,000 to be amortized over the period that services are rendered under the agreements ranging from 12 to 18 months. The warrants have terms of three to four years and expire between November 5, 2011 and September 30, 2012. However, warrants issued under two of the agreements may be canceled if the agreement is terminated under conditions specified in the agreements.
7. Recent Accounting Pronouncements
     In December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business Combinations” (“SFAS 141R”). SFAS 141R establishes principles and requirements for how an acquirer recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, any non-controlling interest in the acquiree and the goodwill acquired. SFAS 141R also establishes disclosure requirements to enable the evaluation of the nature and financial effects of the business combination. SFAS 141R is effective for fiscal years beginning after December 15, 2008, and will be adopted by the Company in the first quarter of 2009. We do not expect the adoption of SFAS 141R to have a material effect on our consolidated results of operations and financial condition.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
     The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements and the Notes thereto included elsewhere in this report. References in this report to “we,” “our” and “us” are references to Rockwell Medical Technologies, Inc. and its subsidiaries.
Forward-Looking Statements
     The discussion that follows contains certain forward-looking statements, including without limitation statements relating to our anticipated future financial condition, operating results, cash flows and our business plans, as well as the timing and cost of obtaining FDA approval of our new SFP product. Also, when we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,”

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“projected,” “intend” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements.
     These forward-looking statements represent our outlook only as of the date of this report. We claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 for all of our forward-looking statements. While we believe that our forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this report. Because these forward-looking statements are based on estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors that might cause such a difference include, without limitation, the risks and uncertainties discussed in this report and from time to time in our other reports filed with the Securities and Exchange Commission, including, without limitation, in “Item 1A — Risk Factors” in our Form 10-K for the year ended December 31, 2007 and the following:
  The dialysis provider market is highly concentrated in national and regional dialysis chains that account for the majority of our domestic revenue. Our business is substantially dependent on several customers that account for the majority of our sales. The loss of any of these customers would have a material adverse effect on our results of operations and cash flows.
 
  We operate in a very competitive market against substantially larger competitors with greater resources.
 
  Our new drug product requires FDA approval and expensive clinical trials before it can be marketed.
 
  Even if our new drug product is approved by the FDA it may not be successfully marketed.
 
  We depend on government funding of healthcare.
 
  We may not be successful in improving our gross profit margins and our business may remain unprofitable.
 
  Orders from our international distributors may not result in recurring revenue.
 
  We depend on key personnel.
 
  Our business is highly regulated.
 
  Foreign approvals to market our new drug products may be difficult to obtain.
 
  Health care reform could adversely affect our business.
 
  We may not have sufficient cash to fund clinical trials and drug approval efforts in future years.
 
  We may not have sufficient product liability insurance.
 
  Our Board of Directors is subject to potential deadlock.
 
  Shares eligible for future sale may affect the market price of our common shares.
 
  The market price of our securities may be volatile.
 
  Voting control and anti-takeover provisions reduce the likelihood that you will receive a takeover premium.
 
  We do not anticipate paying dividends in the foreseeable future.

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     Other factors not currently anticipated may also materially and adversely affect our results of operations, cash flows and financial position. There can be no assurance that future results will meet expectations. We do not undertake, and expressly disclaim, any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as may be required by applicable law.
Overview and Recent Developments
     We operate in a single business segment, the manufacture and distribution of hemodialysis concentrates, dialysis kits and ancillary products used in the kidney dialysis process. We have gained domestic market share each year since our inception in 1996. Our strategy is to continue to develop and expand our dialysis products business while at the same time developing new products, including pharmaceutical products for this market.
     Our strategy is also to expand the geographic footprint of our business in North America. We realized a unique business opportunity to do so in the last quarter of 2006 and the first quarter of 2007 due to the exit of one of our competitors, Gambro Healthcare, Inc., or “Gambro”, from the market. Concurrent with Gambro’s withdrawal from the concentrate business, we began to service many of the chain and independent clinics serviced by Gambro, including many clinics owned by DaVita, Inc., the second largest dialysis provider in the United States. As a result, the number of clinics we service increased by over 50% during 2007 and to a lesser extent in 2008. Largely as a result of the increase in serviced clinics, our sales increased by over 50% in 2007 compared to 2006 and by 22.6% in the first nine months of 2008 compared to the first nine months of 2007.
     We intend to continue to increase the size of our customer portfolio in order to expand our production and distribution operations into regions where we previously had business but no production facility. We believe this strategic initiative will ultimately lead to efficiencies and economies of scale, and will position us for an adequate and sustainable return on investment. We anticipate that we will continue to gain domestic market share, though not as dramatically as in 2007.
     As a result of the increase in sales volume and the increased geographic diversity of the clinics we serve, we took actions during the first quarter of 2007 to ensure adequacy of product supply and uninterrupted order fulfillment for the new business we added. We expanded and relocated one of our production facilities in a region where the additional business we acquired had outstripped our ability to properly supply, distribute and service the business. As a result of this relocation, we incurred costs aggregating approximately $500,000 for physical relocation, extra labor, plant start-up expenses, distribution start-up expenses, inventory write-offs and dual facility operating costs during the start-up period. Although these costs are not expected to recur at this location, we expect to incur similar types of costs in other regions as we continue to adjust our production and distribution facilities to meet new or changing demand.
     We continue to raise our average selling prices in 2008 to offset the higher costs of diesel fuel and raw materials. While we raised prices on maturing contracts in 2007 and in the first nine months of 2008, we have not fully recovered the significant ongoing increases in fuel and key raw materials, which have reduced our gross profit margins. If we are successful in implementing price increases in the remainder of 2008 and beyond, our gross profit margins may improve and increase the profitability of our core business operations. However, commodity markets, particularly diesel fuel and feedstock materials that are key raw materials and packaging components, continued to increase during the first nine months of 2008 at higher than anticipated rates and may require higher than anticipated price increases. Increased operating costs that are subject to inflation, such as fuel and material costs, may not be recoverable through price increases to our customers if our competitors do not also raise prices. If we are not able to recover cost increases, it could materially adversely affect our gross profit, business, financial condition and results of operations. We generally enter into short and medium term contracts of one to two years for our major raw materials as feasible and we generally enter into customer contracts of similar or lesser duration to mitigate our exposure to raw material and other cost increases. In October 2008, we began to realize a decline in diesel fuel costs compared to the third quarter of 2008 following a global softening in oil prices.

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     We could also experience changes in our customer and product mix in future quarters that could impact gross profit, since we sell a wide range of products with varying profit margins and to customers with varying order patterns. These changes in mix may cause our gross profit and our gross profit margins to vary period to period. As we add business in certain markets and regions in order to increase the scale of our business operations, we may incur additional costs that are greater than the additional revenue generated from these initiatives until we have achieved a scale of operations that is profitable.
     The dialysis supply market is very competitive and is characterized by having a few dialysis providers treating the majority of patients in the United States. We compete against companies which have substantially greater resources than we have. Our revenue is highly concentrated in a few customers and the loss of any of those customers would adversely affect our results. However, we expect to continue to grow our business while executing our strategic plan to expand our product lines, to expand our geographic reach and to develop our proprietary technology, which may include adding facilities and personnel to support our growth.
     While the majority of our business is with domestic clinics that order routinely, certain major distributors of our products internationally have not ordered consistently, resulting in variation in our sales from period to period. We anticipate that we will realize substantial orders from time to time from our largest international distributors but we expect the size and frequency of these orders to fluctuate from period to period. These orders may increase in future quarters or may not recur at all. We realized substantial growth from new international customers in the third quarter of 2008 and anticipate that we may realize an increased portion of our business from international markets in the future due to higher demand and penetration into new markets.
     We are seeking to gain FDA approval for SFP, our iron supplemented dialysate product. We believe our SFP product, which has a unique method of action and other substantive benefits compared to current IV iron treatment options, has the potential to compete in the iron maintenance therapy market. The cost to obtain regulatory approval for a drug in the United States is expensive and the approval process can take several years. Due to the significant expenditures expected over the next several years, we expect to incur losses during the approval process.
Results of Operations for the Three and Nine Months Ended September 30, 2008 and September 30, 2007
Sales
     Sales in the third quarter of 2008 were $13.5 million, an increase of $2.5 million or 22.2% over the third quarter of 2007. We increased our domestic market share and realized a significant increase in international orders in the third quarter of 2008. In 2007, we substantially increased our domestic market share following the exit of Gambro from our market. In both 2007 and 2008, we increased prices on maturing contractual arrangements due to rising fuel and material cost increases. Sales of our dialysis concentrate product lines, which represented over 95% of our sales in the third quarter of 2008, increased approximately 24% in the third quarter of 2008 compared to the third quarter of 2007. Our international sales increased by $1.1 million in the third quarter of 2008 to $1.6 million from $0.5 million in the third quarter of 2007 due to our penetration into new markets and increased orders from our international distributors.
     Sales in the first nine months of 2008 were $38.1 million, which represented a $7 million or 22.6% increase over the first nine months of 2007. We increased our domestic market share with domestic sales 16.7% higher than the first nine months of 2007. Overall, approximately 75% of our sales increase in the first nine months of 2008 compared to 2007 was due to unit volume growth with the remainder attributable to higher prices. International sales increased by 147% to $3.5 million during the first nine months of 2008 over the comparable period of 2007.
Gross Profit
     Gross profit in the third quarter of 2008 was $0.78 million compared to $1.1 million in the third quarter of 2007. Gross profit margins decreased to 5.8% in the third quarter of 2008 compared to 10.1% in the third quarter of 2007.

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The decrease in gross profit was primarily the result of significantly higher costs for fuel, transportation operations, key raw material ingredients in our products and other operating costs that more than offset the effect of our price increases. Record diesel fuel prices in the third quarter of 2008 caused the fuel cost per mile driven to increase by over 51% compared to the third quarter of 2007 with the aggregate increase in fuel costs accounting for the overall decrease in gross profit. If fuel and other operating costs remain at October 2008 levels, we anticipate that fourth quarter fuel, transportation and other operating expenses may be $0.2-$0.3 million lower than the in third quarter of 2008.
     Gross profit for the first nine months of 2008 was $2.7 million, an increase of $0.6 million compared to the first nine months of 2007. Gross profit margins increased to 7.2% in the first nine months of 2008 compared to 6.9% in the first nine months of 2007. Improvement in gross profit was due to a combination of higher prices, increased volume of products sold in 2008 and the effect of $500,000 in facility relocation costs incurred in the first quarter of 2007. Our price increases have only partially offset the cost increases in our key cost drivers — material and fuel. In order to improve our gross profit margins, we expect to continue to raise prices and to encourage the migration of our product mix to more cost effective powder products from liquid products, which are more expensive to deliver.
Selling, General and Administrative Expense
     Selling, general and administrative expense, or “SG&A,” during the third quarter of 2008 increased by $1.5 million compared to the third quarter of 2007. Half of the increase was attributable to the settlement of certain litigation in the third quarter of 2008 for $0.75 million. See Part II Item 1 Litigation of this report. Other operating costs increased by $0.75 million compared to the third quarter of 2007, including non-cash expenses for employee and director stock options and common share purchase warrants paid to consultants, which aggregated $0.3 million in the third quarter of 2008. Other increases in operating expenses included increased personnel costs of approximately $0.3 million, higher information technology costs and higher legal services costs primarily pertaining to litigation and intellectual property matters.
     SG&A costs increased by $2.9 million in the first nine months of 2008 compared to the first nine months of 2007, including non-cash expenses for employee and director stock options and common share purchase warrants paid to consultants which aggregated $1.1 million. The aforementioned legal settlement represented $0.75 million of the increase while increased personnel costs were $0.8 million. We incurred higher costs to support information technology improvements of $0.1 million and incurred higher costs for legal services for litigation and intellectual property matters aggregating $0.2 million.
Research and Development
     Research and development costs were $1.0 million in the third quarter of 2008 compared to $0.7 million in the third quarter of 2007. In the first nine months of 2008, total research and development spending was $2.6 million compared to $2.3 million in the first nine months of 2007. Spending in all periods was primarily devoted to development and approval of SFP, our proprietary anemia drug used to treat iron deficiency in dialysis patients. Spending in 2007 was primarily related to completion of our pre-clinical testing plan and preparation for clinical trials while spending in 2008 was primarily for human clinical testing and other development expenses. We anticipate total SFP related development and regulatory approval spending to be approximately $4-5 million in the next twelve months.
Interest Income, Net
     Net interest income increased by $0.1 million and $0.3 million in the third quarter and nine months ended September 30, 2008, respectively, compared to the comparable periods of 2007 primarily due to investment income from our cash investments following our equity offering in late 2007 and, to a lesser extent, to a decrease in interest expense because of lower overall borrowings.

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Liquidity and Capital Resources
     We have two major areas of strategic focus in our business. First, we plan to develop our dialysis products business and to expand our product offering to include drugs and vitamins administered to dialysis patients. Second, we expect to expend substantial amounts in support of our clinical development plan and regulatory approval of SFP and its extensions. All of these initiatives require investments of substantial amounts of capital.
     In 2007, we raised approximately $12.75 million in equity capital (net of related expenses) primarily for the purpose of funding the clinical development and FDA approval of SFP. We expect to spend approximately $4-5 million on SFP development and testing in the next twelve months. We believe our cash resources are sufficient to fund our foreseeable requirements for SFP and ordinary course operating requirements in the year ahead. Should our testing and clinical trial expenses exceed our capital resources in the future, we may need to seek additional sources of financing or an international development partner to facilitate the domestic and global approval of SFP.
     Our cash resources include cash generated from our business operations and the remaining proceeds from our November 2007 equity offering. As of September 30, 2008, we had $7.5 million in cash. Through the first nine months of 2008, we used $3.6 million in cash which included $1.1 million in capital expenditures. During the first nine months of 2008, we used $2.5 million in cash in our operations, compared to $3.8 million in the first nine months of 2007. The use of cash in 2008 was primarily due to our net loss of $4.8 million, partially offset by non-cash charges for stock option expense and warrant expense totaling $1.1 million and depreciation and amortization of $0.6 million. Other liabilities increased by $1.1 million from December 31, 2007 due to accrued expenses associated with the aforementioned legal settlement that will be funded over the next two quarters.
     We expect to add additional manufacturing equipment and one or more facilities to continue expanding our production and distribution network which will require additional capital. We anticipate that we will enter into equipment leasing arrangements and other lending arrangements to fund the majority of capital expenditures associated with facility expansions or additions. As we had no foreseeable borrowing requirements under our line of credit, we allowed our prior working capital line of credit to expire on April 1, 2008. We expect to negotiate a new working capital and equipment financing arrangement in the future as needed.
     We believe our current and expected sources of liquidity and capital resources discussed above will be adequate to fund our cash requirements through 2009. However, we may need to raise additional capital or enter into development arrangements with an international partner in order to fully execute our strategic plan. In our efforts to obtain additional capital resources, we will evaluate both debt and equity financing as potential sources of funds. We will also evaluate alternative sources of business development funding, licensing agreements with international marketing partners, sub-licensing of certain products for certain markets as well as other potential funding sources. Should we not be able to obtain additional financing, we may be forced to alter our strategy, delay spending on development initiatives or take other actions to conserve cash resources.
Interest Rate Risk
     Our current exposure to interest rate risk is limited to changes in interest rates on short term investments of cash. As of September 30, 2008, we had invested $7.25 million in commercial paper with a financial institution.
     A hypothetical 100 basis point increase or decrease in market interest rates for commercial paper would increase or reduce, respectively, our annualized interest income by approximately $0.1 million, assuming our cash level remained constant for the year.
Foreign Currency Exchange Rate Risk
     Our international business is conducted in U.S. dollars. It has not been our practice to hedge the risk of appreciation of the U.S. dollar against the predominant currencies of our trading partners. We have no significant foreign currency exposure to foreign supplied materials, and an immediate 10% strengthening or weakening of the U.S. dollar would not have a material impact on our shareholders’ equity or net income.

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Item 3. Quantitative and Qualitative Disclosures about Market Risk
     Not applicable.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
     Management is responsible for establishing and maintaining effective disclosure controls and procedures, as defined under Rule 13a-15 of the Securities Exchange Act of 1934, as amended, that are designed to ensure that material information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required financial disclosure. In designing and evaluating the disclosure controls and procedures, we recognized that a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
     As of the end of the period covered by this report, we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective, at the reasonable assurance level, as of the end of the period covered by this report.
Changes in Internal Control over Financial Reporting
     No changes were made to our internal control over financial reporting (as defined in Rule 13a-15 under the Exchange Act) during the last fiscal quarter that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
     On September 24, 2008, the Company executed a Mutual Release and Settlement Agreement with FWLL, LLC and ST Holdings, Inc. (“Plaintiffs”), which had previously leased to the Company a facility and related equipment, to settle the outstanding litigation it had brought against the Company in South Carolina on June 6, 2007. Pursuant to the Mutual Release and Settlement Agreement, the Company will make two payments to Plaintiffs: an initial payment of $375,000 to be made by October 24, 2008 and a second payment of $375,000 to be made on or before January 1, 2009. The parties also agreed to dismiss with prejudice all claims in the above litigation, to a mutual non-disparagement covenant and to a mutual release and waiver of all claims each may have against the other.
Item 1A. Risk Factors
     For information regarding risk factors affecting us, see “Risk Factors” in Item 1A of Part I of our 2007 Annual Report on Form 10-K. There have been no material changes to the risk factors described in such Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

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     On September 30, 2008, we entered into an advisory agreement with RJ Aubrey IR Services LLC, or RJ Aubrey, pursuant to which we issued warrants to acquire 60,000 shares of our common stock in a private placement exempt from registration under Section 4(2) of the Securities Act. The warrants were issued as compensation for the investor relations consulting services to be rendered under the agreement. RJ Aubrey is a financially sophisticated accredited investor who had access to information relating to the investment, the warrants were sold in a manner not involving general solicitation or advertising and the warrants and underlying shares are subject to customary restrictions on transfer.
     The warrants are earned in 20,000 share increments on September 30, 2008, January 1, 2009 and July 1, 2009. The warrants will expire on September 30, 2012. Upon a termination of the agreement (A) by us due to a material breach of the agreement by RJ Aubrey or (B) by RJ Aubrey, any unearned warrants at the time of such termination will expire. The warrants have an exercise price of $6.50 per share. Warrants may be exercised in whole or in part at any time until their expiration by the submission of an exercise notice accompanied by payment of the exercise price in cash or certified check or by cashless exercise. To the extent the shares issuable upon exercise of the warrants are not registered prior to issuance, they will bear a legend restricting transfer. The agreement with RJ Aubrey will terminate on December 31, 2009 and may be terminated by either party upon 30 days prior written notice.
     The terms and conditions of the warrants will be set forth in a separate agreement containing terms and conditions set forth above and such other terms and conditions as are mutually acceptable to us and RJ Aubrey.
     Additionally, on November 5, 2008, we entered into an advisory agreement with Emerald Asset Advisors, LLC, or Emerald, pursuant to which we issued warrants to acquire 300,000 shares of our common stock in a private placement exempt from registration under Section 4(2) of the Securities Act. The warrants were issued as compensation for services to be rendered over a 12 month period under the agreement, including introducing the Company to potential licensing partners and acquisition candidates and acting as a liaison to the equity investment community. Emerald is a financially sophisticated accredited investor who had access to information relating to the investment, the warrants were sold in a manner not involving general solicitation or advertising and the warrants and underlying shares are subject to customary restrictions on transfer.
     The warrants were immediately earned and will become exercisable on November 5, 2009. The warrants will expire on the earlier of (i) November 5, 2011, or (ii) the termination of the agreement prior to November 5, 2009 (A) by us due to a material breach of the agreement by Emerald or (B) by Emerald. The warrants have an exercise price of $1.99 per share. Warrants may be exercised in whole or in part at any time until their expiration by the submission of an exercise notice accompanied by payment of the exercise price in cash or certified check. We have agreed to use reasonable commercial efforts to register, under the Securities Act of 1933, the shares to be issued upon exercise of the warrants. To the extent the shares issuable upon exercise of the warrants are not registered prior to issuance, they will bear a legend restricting transfer.
     The terms and conditions of the warrants will be set forth in a separate agreement containing terms and conditions set forth above and such other terms and conditions as are mutually acceptable to us and Emerald.
Item 6. Exhibits
     See Exhibit Index following signature page, which is incorporated herein by reference.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
  ROCKWELL MEDICAL TECHNOLOGIES, INC.
               (Registrant)
 
 
            Date: November 13, 2008  /s/ ROBERT L. CHIOINI    
  Robert L. Chioini   
  President and Chief Executive Officer
(principal executive officer) (duly authorized officer) 
 
 
     
            Date: November 13, 2008  /s/ THOMAS E. KLEMA    
  Thomas E. Klema   
  Vice President and Chief Financial Officer
(principal financial officer and principal accounting officer) 
 
 

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10-Q EXHIBIT INDEX
     
Exhibit No.   Description
 
   
     10.25
  Mutual Release and Settlement Agreement dated September 24, 2008 by and among the Company, FWLL, LLC and ST Holdings, Inc.
 
   
     10.26
  Advisory Agreement dated September 30, 2008 between the Company and RJ Aubrey IR Services LLC
 
   
     10.27
  Advisory Agreement dated November 5, 2008 between the Company and Emerald Asset Advisors, LLC
 
   
     31.1
  Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
 
   
     31.2
  Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
 
   
     32.1
  Certification pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(b) of the Securities Exchange Act of 1934

17

EX-10.25
Exhibit 10.25
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF SOUTH CAROLINA
ANDERSON/GREENWOOD DIVISION
             
ST Holdings, Inc. and FWLL, LLC,
    )     Civil Action No. 8:07-cv-01585-GRA
 
    )      
Plaintiffs,
    )      
 
    )      
vs.
    )      
 
    )      
Rockwell Medical Technologies, Inc.,
    )      
 
    )      
Defendant.
    )      
 
    )      
             
MUTUAL RELEASE AND SETTLEMENT AGREEMENT
PLEASE READ CAREFULLY
          THIS MUTUAL RELEASE AND SETTLEMENT AGREEMENT (“Agreement”) memorializes the agreement entered into on the 26th day of August, 2008, by and among Plaintiffs, FWLL, LLC and ST Holdings, Inc. (collectively, the “Plaintiffs”) and Defendant, Rockwell Medical Technologies, Inc. (“Defendant”) (collectively, the “parties’), and is intended to set forth the terms and conditions of the agreement reached by the parties in connection with all disputes between them. This Agreement is not and shall not be construed as an admission of liability or wrongdoing on the part of any party hereto.
          WHEREAS, Plaintiffs initiated the above-captioned action (the “Litigation”), alleging claims against Defendant for breach of contract, tenancy at will, conversion, trespass, trespass to chattels, and gross negligence, all of which allegations are denied by Defendant;

 


 

          WHEREAS, Defendant answered Plaintiffs’ Complaint, denying liability to Plaintiffs;
          WHEREAS, the parties have agreed to amicably resolve the Litigation and to settle all matters before them;
          NOW, THEREFORE, based on the mutual obligations set forth below and for such other good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties hereby agree to the following settlement agreement:
          1. Unless the context plainly requires otherwise, the terms “Plaintiffs” includes Plaintiffs FWLL, LLC and ST Holdings, Inc., in each and every capacity, together with their respective agents, employees, subsidiaries, affiliates, investigators, insurers, attorneys, relatives, heirs, executors, administrators, successors, and assigns. The term “Defendant” includes Rockwell Medical Technologies, Inc., in each and every capacity, together with its respective agents, employees, subsidiaries, affiliates, investigators, insurers, attorneys, relatives, heirs, executors, administrators, successors, and assigns.
          2. Plaintiffs agree to irrevocably and unconditionally release and forever discharge Defendant of and from any and all claims, damages, demands, actions, causes of action or suits at law, whether in tort or in contract, in law or in equity, of any kind or nature whatsoever that may exist or could be alleged to exist as of the date of this Agreement, including but not limited to those claims asserted by Plaintiffs in the Litigation, for or because of any matter or thing done or omitted to be done by Defendant, and the effects and results thereof, whether known or unknown by Plaintiffs, from the beginning of time through the date of this Agreement. The parties specifically acknowledge and agree, however, that this provision in no

2


 

way prohibits any party from responding to a subpoena or any other lawful process issued by a court or government agency.
          3. Defendant agrees to irrevocably and unconditionally release and forever discharge Plaintiffs of and from any and all claims, damages, demands, actions, causes of action or suits at law, whether in tort or in contract, in law or in equity, of any kind or nature whatsoever that may exist or could be alleged to exist as of the date of this Agreement, for or because of any matter or thing done or omitted to be done by Plaintiffs, and the effects and results thereof, whether known or unknown by Plaintiffs, from the beginning of time through the date of this Agreement. The parties specifically acknowledge and agree, however, that this provision in no way prohibits any party from responding to a subpoena or any other lawful process issued by a court or government agency.
          4. The parties represent and warrant that they have not assigned or transferred and that they will not assign or transfer, any of the claims, or any portion thereof, which have or could have been alleged or asserted in the Litigation and/or those which are being released or that are contemplated by this Agreement, including, but not limited to, all claims, liens, obligations, liabilities, charges, demands, actions, rights, debts, and causes of action, and from all liability for legal or equitable relief of whatsoever nature, known or unknown, that they ever had, now have, or may hereafter claim to have against any other party to the Litigation arising directly or indirectly out of, in any way connected with, or related to, any facts, acts, conduct, representations, omissions, contracts, claims, events, causes, matters, or things of any conceivable kind or character, which were, or could have been, included in the Litigation.
          5. Within thirty (30) days of the execution of this agreement by all parties, Defendant will make payment to Plaintiffs in the amount of THREE HUNDRED SEVENTY-

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FIVE THOUSAND AND 0/100 ($375,000.00) DOLLARS by delivery of settlement draft to the offices of Nicholson & Anderson, 109 West Court Avenue, Greenwood, South Carolina 29646. This settlement draft will be made payable to “FWLL, LLC, ST Holdings, Inc., and their attorneys, Nicholson & Anderson.”
          6. On or before January 1, 2009, Defendant will make a second payment to Plaintiffs in the amount of THREE HUNDRED SEVENTY-FIVE THOUSAND AND 0/100 ($375,000.00) DOLLARS by delivery of settlement draft to the offices of Nicholson & Anderson, 109 West Court Avenue, Greenwood, South Carolina 29646. This settlement draft will be made payable to “FWLL, LLC, ST Holdings, Inc., and their attorneys, Nicholson & Anderson.”
          7. Within five (5) days of the execution of this agreement by both parties, a Consent Stipulation of Dismissal with prejudice for the above-referenced civil action will be executed by counsel for Plaintiffs and Defendant and filed with the Court.
          8. Plaintiffs and Defendant agree not to disparage one another in any manner, including with respect to the allegations made in the Litigation.
          9. Plaintiffs and Defendant agree that the terms of the settlement set forth herein shall be confidential except where disclosure is required by law.
          10. The parties mutually agree to cooperate and take all steps necessary and reasonable to effectuate this Agreement.
          11. Nothing in this Agreement shall be construed as an admission by any party or its officers or representatives of the validity of any claims by any other party or of any wrongdoing on their part or on the part of any of its management representatives, and any such alleged wrongdoing and/or liability is expressly denied.

4


 

          12. The parties acknowledge they have received good and sufficient consideration for their execution of this Agreement, and that the consideration stated herein is sufficient to support and does, in fact, support the full and final release and waiver of all claims each may have against the other.
          13. The parties expressly acknowledge and declare that no other or further contract, promise or inducement whatsoever has been made to them by each other, that they have carefully read and fully understand all of the provisions of this Agreement, that they have reviewed and discussed the terms of this Agreement with their legal counsel and that the they have signed the Agreement of their own free will and accord.
          14. The parties agree that they shall each bear their own attorneys’ fees, costs and expenses associated with this action.
          15. The parties agree that this Agreement may be used in a subsequent proceeding in which either of the parties alleges a breach of this agreement.
          16. The parties mutually agree that if any provision of this Agreement is found to be unenforceable, said provision shall be severed from the Agreement and shall have no effect on the enforceability of any other provision in the Agreement.
          17. This Agreement constitutes the complete understanding between the parties in this matter and supersedes any and all prior or contemporaneous representations, promises, inducements, understandings, and agreements. It may not be amended except by a written instrument signed by Plaintiffs and Defendant.
          18. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original Agreement, and all of which shall constitute one agreement to be

5


 

effected. Photocopies or facsimile copies of this Agreement may be treated as an original. A duly authorized attorney may sign on behalf of a corporate entity.
          19. This Agreement shall be governed by the laws of the State of South Carolina and federal law where applicable. The parties mutually agree that a breach of the terms of this Agreement shall be deemed a violation of an Order of the Court.
          IN TESTIMONY WHEREOF, the parties have hereunto set their hands and seals the day and year first written above.
[SIGNATURES ON FOLLOWING PAGE]

6


 

         
 
  Rockwell Medical Technologies, Inc.    
 
       
 
  /s/ Robert L. Chioini    
 
       
 
  By: Robert L. Chioini    
 
  Its: Chief Executive Officer    
 
       
 
  APPROVED:    
 
       
 
  /s/ Giles M. Schanen, Jr., Esq.    
 
       
Dated: September 24, 2008.
  Giles M. Schanen, Jr., Esq.    
 
  Counsel for Defendant    
 
       
 
  FWLL, LLC    
 
       
 
  /s/ Dwight Funderburk    
 
       
 
  By: Dwight Funderburk    
 
  Its: Managing Partner    
 
       
 
  APPROVED:    
 
       
 
  /s/ William H. Nicholson, Jr., Esq.    
 
       
Dated: September 24, 2008.
  William H. Nicholson, Jr., Esq.    
 
  Counsel for Plaintiff FWLL, LLC    
 
       
 
  ST HOLDINGS, INC.    
 
       
 
  /s/ J. Benjamin Lawrence    
 
       
 
  By: J. Benjamin Lawrence    
 
  Its: President    
 
       
 
  APPROVED:    
 
       
 
  /s/ William H. Nicholson, Jr., Esq.    
 
       
Dated: September 24, 2008.
  William H. Nicholson, Jr., Esq.    
 
  Counsel for Plaintiff, ST Holdings, Inc.    

7

EX-10.26
Exhibit 10.26
     
DATE:
  September 30, 2008
 
   
PARTIES:
  Rockwell Medical Technologies, Inc. (the “Company”)
 
  30142 Wixom Road
 
  Wixom, MI 48393 USA
 
   
 
  RJ Aubrey IR Services LLC (the “Advisor”)
 
  PO Box 2801
 
  Glen Ellyn, IL 60138-2801
RECITALS:
WHEREAS, the Company wishes to engage the Advisor to perform certain investor relations services.
WHEREAS, the Advisor declares that Advisor is engaged in an independent business or employed by a party other than the Company and that the Company is not the Advisor’s sole and only client, customer or employer.
WHEREAS, the parties hereto wish to enter into this Agreement for their mutual benefit, and further wish to set forth the terms of such association herein.
AGREEMENTS:
NOW, THEREFORE, in consideration of the foregoing representations and the mutual covenants set forth herein, and other good and valuable consideration, the receipt and sufficiency of which is acknowledged, the Company and the Advisor agree as follows:
1.   Services to be Performed. The Company hereby engages the Advisor to advise and perform services for the Company consisting of investor relationship development for the Company, liaison to the equity investment community and investor relations support services as requested by the Company from time to time, including without limitation, message development, PR coordination and website development and oversight, provision of investment statistical information, investor monitoring and communications with the investment community, including but not limited to retail investors, stock brokers, analysts, money managers, institutional investors, mutual funds, broker-dealers, wire-houses, newspapers, television, and trade publications. The Company and Advisor acknowledge that: (a) Advisor (through its employee, Ronald J. Aubrey) is anticipated to devote substantive amounts of time and effort to investor relations and related support services; (b) The scope of work hereunder does not include tax, legal, regulatory, accounting or other technical advice; and (c) the Advisor is being retained solely for the Company’s benefit and not for any third party, including the Company’s shareholders.
 
2.   Fees, Terms of Payment and Warrant. The Company agrees as compensation to (a) pay Advisor a monthly fee of $4,500 in cash or Company check, and (b) issue to the Advisor 60,000 cashless Common Stock Purchase Warrants (“Warrants”), for services rendered over an 18 month period commencing July 1, 2008. The terms and conditions of the Warrants will be set forth in a separate agreement containing the terms and conditions set forth in this paragraph and such other terms and conditions as are mutually acceptable to the Company and the Advisor. The Warrants will become earned as follows: (x) 20,000 Warrants upon execution of this Agreement, (y) 20,000 additional Warrants on January 1, 2009 and (z) the remaining 20,000 Warrants on July 1, 2009. The Warrants, once earned, will become exercisable on January 1, 2010 and will have an exercise price of $6.50 per share. The Warrants, once earned, will expire at the close of business on the fourth anniversary of the execution date of this Agreement. If this Agreement is terminated (A) by the Company due to a material breach of this Agreement by Advisor or (B) by Advisor, any unearned Warrants at the time of such termination will expire and not become exercisable. A “material breach” would be either (1) a

1


 

    failure to perform, in a commercially reasonable manner, the services required under paragraph 1 of this Agreement; or (2) a breach of any of the representations in paragraph 5 of this Agreement. Once exercisable, Warrants may be exercised in whole or in part at any time until their expiration by the submission of an exercise notice in the form to be attached as an exhibit to the Warrant agreement and payment as provided therein. Determination of compliance with Federal and State securities laws will be at the sole discretion of the Company. To the extent the shares issuable upon exercise are not registered prior to issuance, they will bear a legend restricting transfer. The Warrants will not be transferable, other than to an affiliate (as defined in Rule 405 under the Securities Act of 1933, as amended) of the Advisor (so long as such affiliate is an “accredited investor” as defined below and agrees to be bound by the terms and provisions of this Agreement and the Warrant agreement as if, and to the fullest extent as, the Advisor, and will bear a legend to that effect). The Company reasonably believes that all information it provides to Advisor is accurate and complete in all material respects. Company acknowledges that Advisor shall be entitled to rely on all such information and materials.
3.   Instrumentalities. The Advisor shall supply all equipment, tools, materials and supplies to accomplish the designated jobs or services set forth in Paragraph 1, except if approved by the Company.
 
4.   Expenses. The Company shall not be responsible or liable for any expenses incurred by the Advisor in performing any jobs or services under this Agreement, except accountable out-of-pocket expenses of Advisor related to the engagement and approved by the Company.
 
5.   The Advisor’s Status. This Agreement is not intended to, does not constitute and shall not be construed as a hiring by either party. The parties hereto are and shall remain independent contractors. The Advisor retains the sole and exclusive right to control or direct the manner or means by which the jobs or services described herein are to be performed. The Company retains only the right to control the results to insure their conformity with that specified herein.
 
    The Advisor shall comply with all federal, state and local laws, and rules and regulations that are now or may in the future become applicable to the Advisor, its business, equipment and personnel engaged in accomplishing the jobs or services provided under this Agreement or arising out of the performance of this Agreement.
 
    Advisor represents that Advisor is an “accredited investor” as defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933 and was not organized for the purpose of acquiring the Warrants or the underlying shares. Advisor’s financial condition is such that Advisor is able to bear the risk of holding the Warrants and the shares underlying the Warrants for an indefinite period of time. Advisor has sufficient knowledge and experience in investing in companies similar to the Company so as to be able to evaluate the risks and merits of Advisor’s investment in the Company and has so evaluated the risks and merits of such investment. Advisor understands that an investment in the Warrants and the shares underlying the Warrants involves a significant degree of risk, including a risk of total loss of Advisor’s investment, and understands the risk factors included, or that may be included in the future, in the Company’s periodic reports filed from time to time with the Securities and Exchange Commission. Advisor is acquiring the Warrants and the shares underlying the Warrants for Advisor’s own account for investment and not for resale or with a view to distribution thereof in violation of the Securities Act of 1933.
 
6.   Payroll or Employment Taxes. The Advisor will not be treated as an employee for federal, state or local tax purposes or for any other purpose. No payroll or employment taxes of any kind shall be withheld or paid with respect to payments to the Advisor, including but not limited to FICA, FUTA, federal personal income tax, state personal income tax, state disability insurance tax, and state unemployment insurance tax. The Advisor agrees that Advisor is responsible for making all filings with and payments to the Internal Revenue Service and state and local taxing authorities as are appropriate.
 
7.   Workers’ Compensation, Unemployment Compensation, Benefits. No workers’ compensation insurance has been or will be obtained by the Company for the Advisor. The Advisor understands that

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    Advisor is not entitled to unemployment compensation benefits or any other benefits normally afforded to any employee of the Company.
8.   Termination. This Agreement will terminate on December 31, 2009 and may be terminated prior to that date by either party upon 30 days written notice in advance of termination. Following termination, neither party shall have any continuing liability or obligations hereunder.
 
9.   Law Governing Contract. This Agreement and all questions arising in connection with it shall be governed by the laws of the State of Michigan.
 
10.   Entire Agreement. This Agreement states the entire Agreement of the parties, and merges all prior negotiations, agreements and understandings, if any, except for any confidentiality agreements between the parties. No modification, release, discharge or waiver of any provision hereof shall be of any force or effect unless made in writing and signed by the parties hereto. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their representative laws, personal representatives, successors and assigns, provided that neither party may assign the Agreement without the other party’s prior written consent.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date stated on the first page of this Agreement.
             
    “COMPANY”    
 
           
    Rockwell Medical Technologies, Inc.    
 
           
 
  By:   /s/ Robert L. Chioini    
 
      Robert L. Chioini    
 
           
 
       Its: Chairman/CEO/President    
 
           
    ADVISOR    
 
           
    RJ AUBREY IR SERVICES LLC    
 
           
 
  By:   /s/ Ronald J. Aubrey    
 
      Ronald J. Aubrey    
 
           
 
       Its: President    

3

EX-10.27
Exhibit 10.27
     
DATE:
  November 5, 2008
 
   
PARTIES:
  Rockwell Medical Technologies, Inc. (the “Company”)
 
  30142 Wixom Road
 
  Wixom, MI 48393 USA
 
   
 
  Emerald Asset Advisors, LLC (the “Advisor”)
 
  425 Broad Hollow Road
 
  Suite 115
 
  Melville, New York 11747
RECITALS:
     WHEREAS, the Company wishes to engage the Advisor to perform certain business development, investor relations and other consulting services.
     WHEREAS, the Advisor declares that it is engaged in an independent business or employed by a party other than the Company and that the Company is not the Advisor’s sole and only client, customer or employer.
     WHEREAS, the parties hereto wish to enter into a Client-Independent Advisory / Contractor relationship for their mutual benefit, and further wish to set forth the terms of such association herein..
AGREEMENTS:
     NOW, THEREFORE, in consideration of the foregoing representations and the mutual covenants set forth herein, and other good and valuable consideration, the receipt and sufficiency of which is acknowledged, the Company and the Advisor agree as follows:
  1.   Services to be Performed . The Company hereby engages the Advisor to advise and perform work for the Company consisting of introducing the Company to potential licensing partners, to acquisition candidates and to the equity investment community, which includes but is not limited to: analysts, money managers, institutional investors, stock-brokers, mutual funds, broker-dealers, wire-houses, newspapers, television, and trade publications. If Company desires Advisor to perform any services in addition to those described above, the terms and conditions relating to such services will be mutually agreed upon by the parties. The Company acknowledges that: (a) Advisor is not obligated to devote any specific amount of time to providing advice and consultation to the Company except as agreed from time to time by the parties hereto; (b) The scope of work hereunder does not include tax, legal, regulatory, accounting or other technical advice, and (c) the Advisor is being retained solely for the Company’s benefit and not for any third party, including the Company’s shareholders.
 
  2.   Fees, Terms of Payment and Warrant .
The Company agrees as compensation to issue to the Advisor 300,000 Common Stock Purchase Warrants (“Warrants”) for services rendered over a 12 month period commencing with the date of this Agreement. The terms and conditions of the Warrants will be set forth in a separate agreement containing the terms and conditions set forth in this paragraph and such other terms and conditions as are mutually acceptable to the Company and the Advisor. The Warrants will become earned upon execution of this Agreement and will have an exercise price of $1.99 per share. The Warrants will expire at the earlier of (i) the close of business on the third anniversary of the execution date of this Agreement, or (ii) the termination of this Agreement prior to the one year anniversary of the date of this Agreement (A) by the Company due to a material breach of this Agreement by Advisor or (B) by Advisor. A “material breach” would be either (1) a failure to perform, in a commercially reasonable manner, the services required or to be required under paragraph 1 of this agreement; or (2) a breach of any of the representations in paragraph 5 of this agreement. Warrants will become exercisable on the first anniversary of the date of this Agreement and may be exercised in whole or in part at any time until their expiration by the submission of an exercise notice in the form to be attached as an exhibit to the Warrant agreement. The Company will use reasonable commercial efforts to

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register, under the Securities Act of 1933, the shares to be issued upon exercise of the Warrants, at its discretion, in one or more of the following ways: (i) for resale by Advisor, following issuance of the shares to be registered, either on a separate registration statement filed for that purpose or as part of another registration statement that the Company may file, provided that the Company shall not be required at any time to file a registration statement for less than 50,000 shares issued upon exercise of Warrants; or (ii) prior to exercise of the Warrants by Advisor if the Company determines, in its sole discretion, that it is then eligible to use a Form S-3 registration statement for such registration. Determination of compliance with registration requirements under Federal and State securities laws will be at the sole discretion of the Company. To the extent the shares issuable upon exercise are not registered prior to issuance, they will bear a legend restricting transfer. The Warrants will not be transferable, other than to an affiliate (as defined in Rule 405 under the Securities Act of 1933, as amended) of the Advisor (so long as such affiliate is an “accredited investor” as defined below and agrees to be bound by the terms and provisions of this Agreement and the Warrant agreement as if, and to the fullest extent as, the Advisor, and will bear a legend to that effect. The Company reasonably believes that all information it provides to Advisor is accurate and complete in all material respects. Company acknowledges that Advisor shall be entitled to rely on all such information and materials.
  3.   Instrumentalities . The Advisor shall supply all equipment, tools, materials and supplies to accomplish the designated jobs or services set forth in Paragraph 1, except if approved by the Company.
 
  4.   Expenses . The Company shall not be responsible or liable for any expenses incurred by the Advisor in performing any jobs or services under this Agreement, except accountable out-of-pocket expenses of Advisor related to the engagement and approved by the Company.
 
  5.   The Advisor’s Status . This Agreement is not intended to, does not constitute and shall not be construed as a hiring by either party. The parties hereto are and shall remain independent contractors. The Advisor retains the sole and exclusive right to control or direct the manner or means by which the jobs or services described herein are to be performed. The Company retains only the right to control the results to insure their conformity with that specified herein. The Advisor shall comply with all federal, state and local laws, and rules and regulations that are now or may in the future become applicable to the Advisor, its business, equipment and personnel engaged in accomplishing the jobs or services provided under this Agreement or arising out of the performance of this Agreement.

Advisor represents that it is an “accredited investor” as defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933 and was not organized for the purpose of acquiring the Warrants or the underlying shares. Advisor’s financial condition is such that it is able to bear the risk of holding the Warrants and the shares underlying the Warrants for an indefinite period of time. Advisor has sufficient knowledge and experience in investing in companies similar to the Company so as to be able to evaluate the risks and merits of its investment in the Company and has so evaluated the risks and merits of such investment. Advisor understands that an investment in the Warrants and the shares underlying the Warrants involves a significant degree of risk, including a risk of total loss of Advisor’s investment, and understands the risk factors included, or that may be included in the future, in the Company’s periodic reports filed from time to time with the Securities and Exchange Commission. Advisor is acquiring the Warrants and the shares underlying the Warrants for its own account for investment and not for resale or with a view to distribution thereof in violation of the Securities Act of 1933.
 
  6.   Payroll or Employment Taxes . The Advisor will not be treated as an employee for federal, state or local tax purposes or for any other purpose. No payroll or employment taxes of any kind shall be withheld or paid with respect to payments to the Advisor, including but not limited to FICA, FUTA, federal personal income tax, state personal income tax, state disability insurance tax, and state unemployment insurance tax. The Advisor agrees that it is responsible for making all filings with and payments to the Internal Revenue Service and state and local taxing authorities as are appropriate to its status as an Advisor.
 
  7.   Workers’ Compensation, Unemployment Compensation, Benefits . No workers’ compensation insurance has been or will be obtained by the Company for the Advisor. The Advisor understands that he is not entitled to unemployment compensation benefits or any other benefits normally afforded to any employee of the Company, due to his status as an Advisor.

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  8.   Indemnification. Except as otherwise provided in paragraph 4 above, the Company agrees to indemnify, defend and hold the Advisor, its affiliates, control persons, officers, directors, employees and agents (collectively, the “Indemnified Persons”) harmless from and against all losses, claims, damages, liabilities, costs or expenses (including reasonable attorneys’ fees and disbursements) arising out of the services rendered pursuant to this Agreement, whether or not the Advisor is a party to such dispute. This indemnity shall not apply, however, where a court of competent jurisdiction has made a final non-appealable determination that the Advisor was grossly negligent or engaged in willful misconduct in the performance of its services hereunder, which directly gave rise to the loss, claim, damage, liability, cost or expense sought to be recovered hereunder. Promptly after receipt by an Indemnified Party of notice of the occurrence of the commencement of any action or proceeding in respect of which indemnity may be sought against the Company, such Indemnified Party will notify the Company in writing of the commencement thereof, and the Company shall be entitled to immediately assume the defense thereof. If the defense is assumed by the Company, it shall have no further obligation to indemnify the Indemnified Persons for attorneys’ fees and disbursements). The reimbursement, indemnity and contribution obligations of the Company under this paragraph shall be in addition to any liability which the Company may otherwise have and shall be binding upon and inure to the benefit of any successors, assigns, heirs and personal representatives of the Company, the Advisor and any other Indemnified Person.
 
  9.   Termination . The consulting arrangement provided herein may be terminated by either party upon 30 days notice. Following termination, neither party shall have any continuing liability or obligations hereunder; provided, the terms of section 8 shall survive any termination hereof.
 
  10.   Law Governing Contract . This Agreement and all questions arising in connection with it shall be governed by the laws of the State of Michigan.
 
  11.   Entire Agreement. This Agreement states the entire Agreement of the parties, and merges all prior negotiations, agreements and understandings, if any, except for any confidentiality agreements between the parties. No modification, release, discharge or waiver of any provision hereof shall be of any force or effect unless made in writing and signed by the parties hereto. This Agreement shall inure to the benefit of and be binding upon the parties hereto and their representative laws, personal representatives, successors and assigns, provided that neither party may assign the Agreement without the other party’s prior written consent.
IN WITNESS WHEREOF, the parties have executed this Agreement and caused it to be dated as of the day and year first written above.
             
    “COMPANY”    
 
           
    Rockwell Medical Technologies, Inc.    
 
           
 
  By   /s/ Robert L. Chioini    
 
           
 
      Its: Chairman/CEO/President    
 
           
    “ADVISOR”    
 
           
    Emerald Asset Advisors, LLC    
 
           
 
  By   /s/Michael Xirinachs    
 
           
 
      Its: General Partner    

3

EX-31.1
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a)
          I, Robert L. Chioini, certify that:
          1. I have reviewed this quarterly report on Form 10-Q of Rockwell Medical Technologies, Inc.;
          2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
          3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
          4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
          a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
          b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
          c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
          d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
          5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
          a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
          b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
         
Date:
  November 13, 2008    
 
       
 
  /s/ Robert L. Chioini    
 
       
 
  Robert L. Chioini    
 
       
 
  President and Chief Executive Officer    

 

EX-31.2
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a)
          I, Thomas E. Klema, certify that:
          1. I have reviewed this quarterly report on Form 10-Q of Rockwell Medical Technologies, Inc.;
          2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
          3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
          4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
          a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
          b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
          c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
          d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
          5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
          a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
          b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
         
Date:
  November 13, 2008    
 
       
 
  /s/ Thomas E. Klema    
 
       
 
  Thomas E. Klema    
 
       
 
  Vice President and Chief Financial Officer    

 

EX-32.1
EXHIBIT 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
AND CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
          In connection with the Quarterly Report of Rockwell Medical Technologies, Inc. (the “Company”) on Form 10-Q for the quarter ending September 30, 2008 as filed with the Securities and Exchange Commission on the date hereof (the “Periodic Report”), I, Robert L. Chioini, Chief Executive Officer of the Company and I, Thomas E. Klema, Chief Financial Officer of the Company, each certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
  1.   the Periodic Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
  2.   the information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
         
     
Dated: November 13, 2008  /s/ Robert L. Chioini    
  Robert L. Chioini   
  President and Chief Executive Officer   
 
     
Dated: November 13, 2008  /s/ Thomas E. Klema    
  Thomas E. Klema   
  Vice President and Chief Financial Officer