COMMON STOCK PURCHASE AGREEMENT

Exhibit 10.20

ROCKWELL MEDICAL TECHNOLOGIES, INC.

COMMON STOCK PURCHASE AGREEMENT

     This COMMON STOCK PURCHASE AGREEMENT (this “ Agreement ”) is dated as of November 28, 2007, and is by and among (i) Rockwell Medical Technologies, Inc., a Michigan corporation, with its principal office at 30142 Wixom Road, Wixom, Michigan 48393 (the “ Company ”) and (ii) each person listed on Schedule 1 hereto (each of the persons or entities described in clause (ii), individually, a “ Purchaser ” and, collectively, the “ Purchasers ”).

     WHEREAS, the Company desires to issue and sell to the Purchasers, and the Purchasers desire to purchase from the Company, (i) an aggregate of 2,158,337 shares (the “ Shares ”) of the authorized but unissued shares of common stock, no par value per share, of the Company (the “ Common Stock ”), and (ii) warrants to purchase an aggregate of 1,079,169 shares of Common Stock, for an aggregate purchase price of $12,950,022, in each case all upon the terms and subject to the conditions set forth in this Agreement;

     WHEREAS, the Company and the Purchasers are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(2) of the Securities Act of 1933, as amended and the provisions of Regulation D (“ Regulation   D ”), as promulgated by the U.S. Securities and Exchange Commission thereunder; and

     WHEREAS, simultaneously with entering in this Agreement, the Company and the Purchasers are entering into that certain Registration Rights Agreement, dated as of the date hereof (as amended, the “ Registration Rights Agreement ”), pursuant to which the Company shall register for resale the Shares and the Warrant Shares (as defined below) on the terms set forth therein.

     NOW THEREFORE, in consideration of the mutual agreements, representations, warranties and covenants herein contained, the parties hereto agree as follows:

     1.  Definitions . As used in this Agreement, the following terms shall have the following respective meanings:

          (a) “ Affiliate ” means any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, a Person, as such terms are used and construed under Rule 144 (as defined below). With respect to a Purchaser, any investment fund or managed account that is managed on a discretionary basis by the same investment manager as such Purchaser will be deemed to be an Affiliate of such Purchaser.

          (b) “ Board ” means the board of directors of the Company.

          (c) “ Effective Date ” means the date on which the registration statement(s) covering the resale of all of the Shares and the Warrant Shares is initially declared effective by the SEC.

          (d) “ Exchange Act ” means the Securities Exchange Act of 1934, as amended, and all of the rules and regulations promulgated thereunder.

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          (e) “ FDA ” means the U.S. Food and Drug Administration or other successor administration or agency.

          (f) “ knowledge ” when used in reference to a business entity means the actual or constructive knowledge of the directors and executive officers of such business entity, and when used in reference to an individual means the actual or constructive knowledge of such individual. For this purpose, “constructive” knowledge means the knowledge that a person should have had after reasonable inquiry or investigation, whether or not such inquiry or investigation has actually occurred.

          (g) “ Majority Purchasers ” has the meaning set forth in Section 8.12.

          (h) “ Material Adverse Effect ” has the meaning set forth in Section 3.1 of this Agreement.

          (i) “ Person ” (whether or not capitalized) means an individual, entity, partnership, limited liability company, corporation, association, trust, joint venture, unincorporated organization or any other form of entity not specifically listed herein, and any government, governmental department or agency or political subdivision thereof.

          (j) “ Product ” has the meaning set forth in Section 3.18 of this Agreement.

          (k) “ Regulatory Authority(ies) ” means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.

          (l) “Rule 144” means Rule 144 promulgated under the Securities Act and any successor or substitute rule, law or provision.

          (m) “ SEC ” means the Securities and Exchange Commission.

          (n) “ Securities Act ” means the Securities Act of 1933, as amended, and all of the rules and regulations promulgated thereunder.

          (o) “ Transfer Agent Instructions ” means irrevocable instructions given in writing by the Company to the Company’s transfer agent to issue an original stock certificate to each Purchaser for the number of Shares purchased by such Purchaser as set forth on Schedule   1 hereto and registered in the name of such Purchaser.

          (p) “ Transaction Documents ” means, collectively, this Agreement, the Registration Rights Agreement, the Warrants and any other documents or agreements executed in connection with the transactions contemplated by this Agreement.

          (q) “ Warrants ” means the warrants to purchase shares of Common Stock, dated as of the Closing Date, issued by the Company to the Purchasers, in the form attached hereto as Exhibit   A .

          (r) “ Warrant Shares ” means the shares of Common Stock issued or issuable upon the exercise of the Warrants.

     2. Purchase and Sale; Closing .

          2.1 Purchase and Sale . Subject to and upon the terms and conditions set forth in this Agreement, the Company agrees to issue and sell to each Purchaser, and each Purchaser hereby agrees, severally and not jointly, to purchase from the Company, at the Closing, units consisting of one (1) Share and a Warrant to purchase one-half (1/2) share of Common Stock, with the aggregate number of Shares and Warrants being purchased under this Agreement by each Purchaser as set forth opposite such Purchaser’s name on Schedule   1 hereto. The Shares and the corresponding Warrants shall be purchased as a unit at a purchase price per unit equal to $6.00.

          2.2 Closing . The closing of the transactions contemplated under this Agreement (the “ Closing ”) shall take place as soon as possible after the satisfaction or waiver of the conditions set forth in Section 5 below, and in any event on or prior to 11:30 a.m. (Eastern Time) on Wednesday, November 28, 2007, remotely via exchange of documents and signatures. At the Closing, (a) the Company shall deliver to each Purchaser (i) an original stock certificate, registered in the name of such Purchaser, representing the number of Shares purchased by such Purchaser, and (ii) an original warrant, registered in the name of such Purchaser, representing the number of Warrants purchased by such Purchaser, and (b) each Purchaser shall deliver to the Company payment of the purchase price for such Shares and Warrants by wire transfer of immediately available funds to such account as the Company shall designate in writing. The date on which the Closing actually occurs is the “Closing Date”.

     3. Representations and Warranties of the Company . Except as otherwise specifically described in the Company’s SEC Documents (as defined herein) and the exhibits thereto, which qualifies the following representations, warranties and covenants in their entirety, or as set forth on the specific schedule furnished by the Company to each Purchaser (collectively, the “ Disclosure Schedule ”) attached hereto as Exhibit   B , the Company hereby represents and warrants to each Purchaser, as of the date of this Agreement and as of the Closing Date (if different)as follows:

          3.1 Incorporation . The Company and each of the Subsidiaries (as defined in Section 3.17 below), if any, is a corporation or other entity duly organized, validly existing and in good standing under the laws of the State of Michigan (or such other applicable jurisdiction of incorporation or formation), and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or the character of the property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, would not result in a material adverse effect on the assets, liabilities (contingent or otherwise), business, operations, prospects or condition (financial or otherwise) of the Company and its subsidiaries taken as a whole (“ Material Adverse Effect ”). The Company and each of the Subsidiaries, if any, have all requisite corporate power and authority to carry on its business as now conducted and to carry out the transactions contemplated hereby and in the Transaction Documents. Neither the Company nor any of the Subsidiaries is in violation of any of the provisions of its articles of incorporation (or other similar corporate formation or organization document) or by-laws (or other similar corporate governance document).

          3.2 Capitalization . The authorized capital stock of the Company consists of (i) 20,000,000 shares of Common Stock, of which 11,656,849 shares are outstanding as of the date of this Agreement, and (ii) 3,416,664 shares of preferred stock, of which there are zero (0) shares outstanding as of the date of this Agreement; and (iii) 4,237,135 shares of Common Stock are issuable and reserved for issuance pursuant to option (or other equity incentive) plans or securities exercisable for, or convertible into or exchangeable for any shares of capital stock of the Company comprised of (a) outstanding stock options to purchase 3,132,135 shares of the Company’s Common Stock under existing approved stock

option or other equity incentive plans, (b) 925,000 shares of Common Stock reserved for future issuance under existing approved stock plans, and (c) 180,000 shares of the Company’s Common Stock are reserved for issuance under outstanding warrant agreements. All shares of the Company’s issued and outstanding capital stock have been duly authorized, are validly issued and outstanding, and are fully paid and non-assessable and were issued in full compliance with applicable state and federal securities laws and rights of third parties. Except as set forth on Schedule 3.2 to the Disclosure Schedule, there are no existing options, warrants, calls, preemptive (or similar) rights, subscriptions or other rights, agreements, arrangements or commitments of any character obligating the Company to issue, transfer or sell, or cause to be issued, transferred or sold, any shares of the capital stock of the Company or other equity interests in the Company or any securities convertible into or exchangeable for such shares of capital stock or other equity interests, excluding the Shares, the Warrants and the Warrant Shares to be issued to the Purchasers as contemplated by this Agreement, and there are no outstanding contractual obligations of the Company to repurchase, redeem or otherwise acquire any shares of its capital stock or other securities or equity interests. The issue and sale of the Shares, the Warrants and the Warrant Shares will not obligate the Company to issue or sell, pursuant to any pre-emptive right or otherwise, shares of Common Stock or other securities to any Person (other than the Purchasers) and will not result in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price under any outstanding shares of capital stock or other securities. The issuance and sale of the Shares, the Warrants (and the Warrant Shares pursuant to the Warrants) will not result in the adjustment of the exercise, conversion, exchange or reset price of any outstanding security.

          3.3 Registration Rights . Except as set forth on Schedule 3.3 to the Disclosure Schedule, the Company has not granted or agreed to grant to any Person any right (including “piggy-back” and demand registration rights) to have any shares of capital stock or other securities of the Company registered with the SEC or any other governmental authority. The Company is eligible to utilize the registration statement on Form S-3 in connection with fulfilling its obligations to the Purchasers under the Registration Rights Agreement and, to the Company’s knowledge, no facts or circumstances currently exist or are pending or threatened which could reasonably be expected to prevent the Company from remaining eligible to use Form S-3 to register the Shares and Warrant Shares pursuant to said Registration Rights Agreement.

          3.4 Authorization . All corporate action on the part of the Company, its officers, directors and shareholders, necessary for the authorization, execution, delivery and performance of this Agreement and the Transaction Documents and the consummation of the transactions contemplated herein and therein has been taken. When executed and delivered by the Company, each of this Agreement and the Transaction Documents shall constitute a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such may be limited by bankruptcy, insolvency, reorganization or other laws affecting creditors’ rights generally and by general equitable principles. The Company has all requisite corporate power and authority to enter into this Agreement and the Transaction Documents and to carry out and perform its obligations under their respective terms.

          3.5 Valid Issuance of the Shares . The Shares, the Warrants and the Warrant Shares have been duly authorized, and the Shares and the Warrant Shares, upon issuance pursuant to the terms hereof and the terms of the Warrants, respectively, will be validly issued, fully paid and nonassessable and not subject to any encumbrances and restrictions except for restrictions on transfer set forth in the Transaction Documents or imposed by applicable securities laws, preemptive rights or any other similar contractual rights of the stockholders of the Company or any other Person. The Company has reserved from its duly authorized capital stock the number of shares of Common Stock issuable under the terms of this Agreement and upon the exercise in full of all of the Warrants.

          3.6 Financial Statements . The Company has prepared and made available to the Purchasers copies of (i) the audited consolidated balance sheet of the Company and the Subsidiaries as of the fiscal year ended December 31, 2006 and the related audited consolidated income statement, audited consolidated statement of cash flows and audited consolidated statement of stockholders’ equity of the Company and the Subsidiaries for the year then ended (the “ Audited Financial Statements ”), and (ii) the unaudited consolidated balance sheet of the Company and the Subsidiaries as of September 30, 2007 (the “ Most Recent Balance Sheet ”), and the related unaudited consolidated income statement and unaudited consolidated statement of cash flows of the Company and the Subsidiaries for the same periods then ended (the financial statements in this clause (ii) are hereinafter referred to, collectively, as the “ Unaudited Financial Statements ”). All of the financial statements described in clauses (i)-(ii) above are hereinafter referred to, collectively, as the “ Financial Statements ”. The Financial Statements have been prepared in accordance with United States generally accepted accounting principles applied on a consistent basis during the periods covered thereby, subject, in the case of the Unaudited Financial Statements, to normal year-end adjustments (which individually and in the aggregate are not material) and to the absence of footnotes thereto, and present fairly, in all material respects, the financial position of the Company and the Subsidiaries and the results of operations as of the date and for the periods indicated therein.

          3.7 SEC Documents . The Company has prepared and made available to the Purchasers copies of the following reports of the Company (collectively, the “ SEC Documents ”): (i) the annual report on Form 10-K for the year ended December 31, 2006 (the “ Annual Report ”) and (ii) quarterly reports on Form 10-Q for the periods ended September 30, 2007, June 30, 2007 and March 31, 2007. As of their respective filing dates, the SEC Documents complied in all material respects with the requirements of the Exchange Act, and the rules and regulations promulgated thereunder, and none of the SEC Documents contain any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading. The financial statements of the Company included in the SEC Documents comply in all material respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto in effect at the time of filing. All contracts, agreements, instruments and other documents to which the Company is a party or to which the property or assets of the Company are subject are included as part of, or specifically identified in, the SEC Documents to the extent required by the rules and regulations of the SEC as in effect at the time of filing, and each such contract, agreement, instrument and other document is legal, valid, binding and enforceable against the Company in accordance with their respective terms, except as such may be limited by bankruptcy, insolvency, reorganization or other laws affecting creditors’ rights generally and by general equitable principles. For the three (3) full fiscal years prior to this year, the Company has prepared and filed with the SEC all filings and reports required by the Securities Act and the Exchange Act to make the Company’s filings and reports current in all respects. Except as set forth in the SEC Documents, and except for liabilities and obligations incurred since the date of the Most Recent Balance Sheet in the ordinary course of business, consistent with past practice: (i) the Company and its Subsidiaries do not have any material liabilities or obligations (whether absolute, accrued, contingent or otherwise) and (ii) there has not been any aspect of the prior or current conduct of the business of the Company or its Subsidiaries which may form the basis for any material claim by any third party which if asserted could result in a Material Adverse Effect.

          3.8 Consents . Except for (a) the filing and effectiveness of any registration statement required to be filed by the Company under the Securities Act pursuant to the terms of the Registration Rights Agreement; (b) any required state “blue sky” law filings in connection with the transactions contemplated hereunder or under the Transaction Documents; and (c) the possible filing of Form D with

the SEC; the execution and delivery by the Company of this Agreement and the Transaction Documents, the consummation of the transactions contemplated herein and therein, and the issuance of the Shares, the Warrants and the Warrant Shares, do not require the consent or approval of any third party or the stockholders of, or any lender to, the Company or the Trading Market (as defined below). All material consents, approvals, orders and authorizations required on the part of the Company in connection with the execution or delivery of, or the performance of the obligations under, this Agreement and the Transaction Documents, and the consummation of the transactions contemplated herein and therein, including the issuance of the Shares the Warrants and the Warrant Shares, have been obtained or will be obtained and will be effective as of the Closing Date.

          3.9 No Conflict; Compliance With Laws .

          (a) The execution, delivery and performance by the Company of this Agreement and the Transaction Documents, and the consummation of the transactions contemplated hereby and thereby, including the issuance of the Shares, the Warrants and the Warrant Shares, do not and will not (i) conflict with or violate any provision of the articles of incorporation (or other charter documents) or by-laws (or other similar documents) of the Company or any of the Subsidiaries, (ii) breach, conflict with or result in any violation of or default (or an event that with notice or lapse of time or both would become a default) under, or give rise to a right of termination, amendment, acceleration or cancellation (with or without notice or lapse of time, or both) of any obligation, contract, commitment, lease, agreement, mortgage, note, bond, indenture or other instrument or obligation to which the Company or any of the Subsidiaries is a party or by which they or any of their properties or assets are bound, except in each case to the extent such breach, conflict, violation, default, termination, amendment, acceleration or cancellation does not, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, or (iii) result in a violation of any statute, law, rule, regulation, order, ordinance or restriction applicable to the Company, the Subsidiaries or any of their properties or assets, or any judgment, writ, injunction or decree of any court, judicial or quasi-judicial tribunal applicable to the Company, the Subsidiaries or any of their properties or assets.

          (b) Neither the Company nor any of the Subsidiaries, (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any of the Subsidiaries), nor has the Company or any of the Subsidiaries received written notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties or assets is bound (whether or not such default or violation has been waived), except in each case to the extent such default or violation does not, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (ii) is in violation of any statute, rule or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, food and drugs, product quality and safety, employment and labor matters, and securities regulation (including the Securities Act, the Exchange Act and the Federal Food, Drug and Cosmetic Act, and all rules and regulations promulgated under each such Act).

          3.10 Brokers or Finders . Except as set forth in Schedule 3.10 , neither the Company nor any of the Subsidiaries has dealt with any broker or finder in connection with the transactions contemplated by this Agreement or the Transaction Documents, and neither the Company nor any of the Subsidiaries has incurred, or shall incur, directly or indirectly, any liability for any brokerage or finders’ fees or agents’ commissions or any similar charges in connection with this Agreement or the Transaction Documents, or any transaction contemplated hereby or thereby.

          3.11 Trading Market Listing and Maintenance . The Company’s Common Stock is currently traded, and thus quoted, on The Nasdaq Global Market (“ Trading Market ”). Since January 1, 2004, the Company has complied in all material respects with all of the marketplace rules and regulations of the Trading Market. The Company has not, in the twelve (12) months preceding the date hereof, received notice from any Trading Market on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements of such Trading Market. The Company is currently in material compliance with all such listing and maintenance requirements and, to the Company’s knowledge, there is currently no basis for the delisting of the Common Stock from the Trading Market. The Company and its directors, officers, employees and agents has not at any time prior to the Closing Date provided any Purchaser with any material, non-public information regarding the Company or any of the Subsidiaries.

          3.12 Absence of Litigation . There is no action, suit, inquiry, notice of violation, proceeding or, to the knowledge of the Company, investigation pending nor, to the knowledge of the Company, is any of the above threatened against the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (each an “ Action ”) which (i) adversely affects or challenges the legality, validity or enforceability of this Agreement or any of the Transaction Documents or any of the transactions contemplated hereby or thereby, including the issuance of the Shares, the Warrants and the Warrant Shares, or (ii) could reasonably be expected to, if there were an unfavorable decision, have or result in a Material Adverse Effect. Neither the Company nor any Subsidiary, nor, to the knowledge of the Company, any director or officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty associated with such director or officer’s service to or association with the Company. To the knowledge of the Company, there has not been and there is not pending or threatened, any investigation by the SEC involving the Company or any current or former director or officer of the Company associated with such director or officer’s service to or other association with the Company. The SEC has not issued any stop order or other order suspending the effectiveness of any registration statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act.

          3.13 No Undisclosed Liabilities; Indebtedness . Since the date of the Most Recent Balance Sheet, the Company and the Subsidiaries have incurred no liabilities or obligations, whether known or unknown, asserted or unasserted, fixed or contingent, accrued or unaccrued, mature or unmatured, liquidated or unliquidated, or otherwise, except for liabilities or obligations, that, individually or in the aggregate, do not or would not have a Material Adverse Effect and other than liabilities and obligations arising in the ordinary course of business. Except for indebtedness reflected in the Most Recent Balance Sheet, the Company has no indebtedness outstanding as of the date hereof. The Company is not in default with respect to any outstanding indebtedness or any instrument relating thereto.

          3.14 Title to Assets . Each of the Company and the Subsidiaries has good and marketable title to all real and personal property owned by it that is material to the business of the Company or such Subsidiaries, in each case free and clear of all liens and encumbrances, except those, if any, reflected in the Financial Statements or incurred in the ordinary course of business consistent with past practice. Any real property and facilities held under lease by the Company or the Subsidiaries are held by it or them under valid, subsisting and enforceable leases (subject to laws of general application relating to bankruptcy, insolvency, reorganization, or other similar laws affecting creditors’ rights generally and other equitable remedies) with which the Company and the Subsidiaries are in compliance in all material respects.

          3.15 Labor Relations . No labor or employment dispute exists or, to the knowledge of the Company, is imminent or threatened, with respect to any of the employees of the Company or any of the consultants who serve on any scientific advisory board or other similar committee of the Company, that has, or could reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

          3.16 Intellectual Property . The Company and the Subsidiaries own or have the right to use all (i) valid and enforceable patents, patent applications, trademarks, trademark registrations, service marks, service mark registrations, Internet domain name registrations, copyrights, copyright registrations, licenses, trade secret rights and (ii) inventions, software, works of authorship, trade names, databases, formulae, know how, Internet domain names and other intellectual property (including trade secrets and other unpatented and/or unpatentable proprietary confidential information, systems, or procedures) (collectively, the “ Intellectual Property ”) used in, or necessary to conduct, their respective businesses as currently conducted and as proposed to be conducted, and as described in the SEC Documents. To the knowledge of the Company, the Company and the Subsidiaries’ ownership or use of the Intellectual Property in their respective businesses as currently conducted and proposed to be conducted do not give rise to any infringement, misappropriation, or other violation of any valid and enforceable intellectual property rights of any other person. Except as set forth on Schedule   3.16 to the Disclosure Schedule, there have been no written claims or notice made against the Company or any of the Subsidiaries (a) asserting the invalidity, abuse, misuse, or unenforceability of any of the Intellectual Property, and, to the Company’s knowledge, there are no reasonable grounds for any such claims, or (b) that they are in conflict with or infringing upon the asserted rights of others in connection with the Intellectual Property. Neither the Company nor its Subsidiaries have made any claim of any violation or infringement by others of the Company’s or the Subsidiaries’ rights in or to the Intellectual Property, and to the Company’s knowledge, no reasonable grounds for such claims exist. Other than as set forth on Schedule   3.16 to the Disclosure Schedule, no material royalties or fees (license or otherwise) are payable by the Company or any of the Subsidiaries to any Person by reason of the ownership or use of any of the Intellectual Property.

          3.17 Subsidiaries; Joint Ventures . Except for the subsidiaries listed on Schedule 3.17 to the Disclosure Schedule (the “ Subsidiaries ”), the Company has no subsidiaries and does not otherwise own or control, directly or indirectly, any other Person. The Company is not a participant in any joint venture, partnership, or similar arrangement material to its business.

          3.18 Compliance with FDA and Other Regulatory Requirements .

          (a) With respect to any existing products and, to the extent applicable, any other products currently under development by the Company (collectively, the “ Products ”), (i) (A) the Company and each of its Subsidiaries has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of its Products in jurisdictions where it currently conducts such activities or contemplates conducting such activities (the “ Activities to Date ”) with respect to each Product as are required for each Product at its current stage of development (collectively, the “ Company Licenses ”); (B) the Company and each of its Subsidiaries, as the case may be, is in compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries, as the case may be, is in compliance with all applicable laws regarding registration, license, certification for each site at which a Product is manufactured, labeled, sold, or distributed; and (D) to the extent that any Product has been exported from the United States, the Company

or, as applicable, a Subsidiary of the Company exporting such Product, has exported such Product in compliance in all material respects with applicable law; (ii) all manufacturing operations performed by or on behalf of the Company or its Subsidiaries have been and are being conducted in all respects in compliance with the Quality Systems Regulations of the FDA and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Products under development, sponsored by the Company or any of its Subsidiaries and intended to be used to support regulatory clearance or approval, have been and are being conducted in material compliance with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable law.

          (b) The Company and each of its Subsidiaries is in material compliance with all FDA and non-United States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Products. Schedule 3.18(b) sets forth a list of all adverse event reports related to the Products, including any Medical Device Reports (as defined in 21 CFR 803). The public complaint review and analysis reports of the Company and each of its Subsidiaries through the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, are accurate in all material respects, and except as set forth on Schedule 3.18(b) , to the best of the Company’s knowledge, there are no material, undisclosed complaints against the Company or the Products that relate to the medical aspects of the Products or which require public disclosure by the Company (and have not been disclosed).

          (c) Neither the Company nor any of its Subsidiaries has received any written notice or other written communication from the FDA or any other Regulatory Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Products, or (ii) otherwise alleging any violation of any laws by the Company or any of its Subsidiaries. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or, to the knowledge of the Company, threatened) by the FDA or any other Regulatory Authority with respect to any of the Products, including any facilities where any such Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three (3) years, either voluntarily or at the request of any Regulatory Authority, initiated or participated in a recall of any Product or provided post-sale warnings regarding any Product. The Company and each of its Subsidiaries have conducted all of their clinical trials with reasonable care and in compliance with all applicable laws and the stated protocols for such clinical trials.

          (d) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made by the Company or any of its Subsidiaries with regard to the Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

          3.19 Taxes . The Company and each of the Subsidiaries has filed (or has had filed on its behalf), will timely file or will cause to be timely filed, or has timely filed for an extension of the time to file, all material Tax Returns (as defined below) required by applicable law to be filed by it or them prior to or as of the date hereof, and such Tax Returns are, or will be at the time of filing, true, correct and complete in all material respects. Each of the Company and the Subsidiaries has paid (or has had paid on its behalf) or, where payment is not yet due, has established (or has had established on its behalf and for

its sole benefit and recourse) or will establish or cause to be established in accordance with United States generally accepted accounting principles on or before the date of hereof an adequate accrual for the payment of, all material Taxes (as defined below) due with respect to any period ending prior to or as of the date hereof. “ Taxes ” shall mean any and all taxes, charges, fees, levies or other assessments, including income, gross receipts, excise, real or personal property, sales, withholding, social security, retirement, unemployment, occupation, use, goods and services, license, value added, capital, net worth, payroll, profits, franchise, transfer and recording taxes, fees and charges, and any other taxes, assessment or similar charges imposed by the Internal Revenue Service or any taxing authority (whether state, county, local or foreign) (each, a “ Taxing Authority ”), including any interest, fines, penalties or additional amounts attributable to or imposed upon any such taxes or other assessments. “ Tax Return ” shall mean any report, return, document, declaration or other information or filing required to be supplied to any Taxing Authority, including information returns, any documents with respect to accompanying payments of estimated Taxes, or with respect to or accompanying requests for extensions of time in which to file any such return, report, document, declaration or other information. There are no claims or assessments pending against the Company or any of the Subsidiaries for any material alleged deficie