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UNDERWRITING AGREEMENT

Underwriting Agreement

UNDERWRITING AGREEMENT | Document Parties: BANC OF AMERICA SECURITIES LLC | GOLDMAN, SACHS  CO | Introductory Inverness Medical Innovations, Inc | Issuers and US Bank National Association | UBS SECURITIES LLC You are currently viewing:
This Underwriting Agreement involves

BANC OF AMERICA SECURITIES LLC | GOLDMAN, SACHS CO | Introductory Inverness Medical Innovations, Inc | Issuers and US Bank National Association | UBS SECURITIES LLC

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Title: UNDERWRITING AGREEMENT
Governing Law: New York     Date: 5/12/2009
Industry: Biotechnology and Drugs     Law Firm: Foley Hoag;Cahill Gordon     Sector: Healthcare

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Exhibit 1.1

Inverness Medical Innovations, Inc.

$400,000,000 9.00% Senior Subordinated Notes due 2016

UNDERWRITING AGREEMENT

May 7, 2009

UBS SECURITIES LLC
GOLDMAN, SACHS & CO.
BANC OF AMERICA SECURITIES LLC
As Representatives of the several Underwriters
c/o UBS SECURITIES LLC
299 Park Avenue
New York, New York 10171

Ladies and Gentlemen:

           Introductory . Inverness Medical Innovations, Inc., a Delaware corporation (the “ Company ”), proposes to issue and sell to the several underwriters named in Schedule A (the “ Underwriters ”) $400,000,000 aggregate principal amount of its 9.00% senior subordinated unsecured notes due 2016 (the “ Notes ”). The Company’s obligations under the Notes and the Indenture (as defined below) will be, jointly and severally, unconditionally guaranteed (the “ Guarantees ”), on a senior subordinated unsecured basis, by each of the Subsidiaries (as defined below) listed on the signature pages hereto (collectively, the “ Guarantors ,” and, together with the Company, the “ Issuers ”). The Notes and the Guarantees are referred to herein as the “ Securities .” The respective principal amounts of the Notes to be so purchased by the several Underwriters are set forth opposite their names in Schedule A hereto. The Notes are to be issued under an indenture as supplemented by a first supplemental indenture (collectively, the “ Indenture ”) each to be dated the Closing Date (as defined below), by and between the Issuers and U.S. Bank National Association, as Trustee (the “ Trustee ”).

          UBS Securities LLC (“ UBS ”), Goldman, Sachs & Co. (“ GS ”) and Banc of America Securities LLC (“ BAS ”) have agreed to act as representatives of the several Underwriters (in such capacity, the “ Representatives ”) in connection with the offering and sale of the Securities.

          The Issuers have prepared and filed with the Securities and Exchange Commission (the “ Commission ”) a shelf registration statement on Form S-3 (File No. 333 158542), and have prepared a base prospectus to be used in connection with the public offering and sale of the Securities. Such base prospectus, as modified and attached to the Preliminary Prospectus (as defined below) is referred to herein as the “ Base Prospectus ”. Such registration statement, as amended, including the financial statements, exhibits and schedules thereto, in the form in which it became automatically effective under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (collectively, the “ Securities Act ”), including all documents incorporated or deemed to be incorporated by reference therein and any information deemed to be a part thereof at the time of effectiveness pursuant to Rule 430B under

 


 

the Securities Act or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “ Exchange Act ”), is called the “ Registration Statement .” The Issuers’ preliminary prospectus supplement dated May 1, 2009 describing the Securities and the offering thereof, together with the Base Prospectus, is called the “ Preliminary Prospectus ,” and the Preliminary Prospectus and any other preliminary prospectus supplement to the Base Prospectus that describes the Securities and the offering thereof and is made available by the Issuers and used prior to the filing of the Prospectus (as defined below), together with the Base Prospectus, is called a “ preliminary prospectus .” As used herein, the term “ Prospectus ” shall mean the final prospectus supplement to the Base Prospectus that describes the Securities and the offering thereof (the “ Final Prospectus Supplement ”), together with the Base Prospectus, in the form made available by the Issuers and first used by the Underwriters to confirm sales of the Securities or in the form first made available to the Underwriters by the Issuers to meet requests of purchasers pursuant to Rule 173 under the Securities Act. As used herein, “ Applicable Time ” is 3:00 p.m. (New York time) on May 7, 2009. As used herein, “ free writing prospectus ” means any “free writing prospectus” within the meaning set forth in Rule 405 under the Securities Act related to the offering of the Securities contemplated hereby, and “ Time of Sale Prospectus ” means the preliminary prospectus, as amended or supplemented immediately prior to the Applicable Time, together with the information and free writing prospectuses, if any, identified in Schedule B hereto. As used herein, the terms “Registration Statement,” “preliminary prospectus,” “Time of Sale Prospectus” and “Prospectus” shall include the documents incorporated and deemed to be incorporated by reference therein. All references in this Agreement to the Registration Statement, any preliminary prospectus, or the Prospectus, or any amendments or supplements to any of the foregoing, shall include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“ EDGAR ”).

          All references in this Agreement to financial statements and schedules and other information which are “ contained ,” “ included ” or “ stated ” in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which are or are deemed to be incorporated by reference in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus or the Prospectus, as the case may be; and all references in this Agreement to amendments or supplements to the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus or the Prospectus, as the case may be, shall be deemed to mean and include the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in the Registration Statement, any preliminary prospectus, the Time of Sale Prospectus or the Prospectus, as the case may be.

          This Agreement, the Notes, the Guarantees, and the Indenture are hereinafter sometimes referred to collectively as the “ Note Documents .”

          The Issuers hereby confirm their respective agreements with the Underwriters as follows:

      Section 1. Representations and Warranties of the Issuers . The Issuers hereby represent and warrant to each Underwriter, as of the date of this Agreement, as of the Closing

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Date (as hereinafter defined) and jointly and severally covenant with each Underwriter, as follows:

          (a) Compliance with Registration Requirements . (i) At the time of filing the Registration Statement, (ii) at the time of the most recent amendment to the Registration Statement for the purposes of complying with Section 10(a)(3) of the Securities Act (whether such amendment was by post-effective amendment, incorporated report filed pursuant to Section 13 or 15(d) of the Exchange Act or form of prospectus), if any, and (iii) at the time the Company or any person acting on its behalf (within the meaning, for this clause only, of Rule 163(c) under the Securities Act) made any offer relating to the Securities in reliance on the exemption of Rule 163 under the Securities Act, the Company was a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act.

          The Registration Statement is an “automatic shelf registration statement,” as defined in Rule 405, which became effective on April 10, 2009. The Company has not received from the Commission any notice pursuant to Rule 401(g)(2) under the Securities Act objecting to the Company’s use of the automatic shelf registration form. No stop order suspending the effectiveness of the Registration Statement is in effect and no proceedings for such purpose have been instituted or are pending or, to the knowledge of the Company, are contemplated or threatened by the Commission.

          Each preliminary prospectus and the Prospectus when filed complied in all material respects with the Securities Act and, if filed by electronic transmission pursuant to EDGAR (except as may be permitted by Regulation S-T under the Securities Act), was identical in all material respects to the copy thereof delivered by the Company to the Underwriters for use in connection with the offer and sale of the Securities. Each of the Registration Statement, and any post-effective amendment thereto, at the time it became effective and at all subsequent times through the Closing Date, complied and will comply in all material respects with the Securities Act and, at the time it became effective and as of the Closing Date (as defined in Section 2), did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. As of the Applicable Time, the Time of Sale Prospectus did not, and at the Closing Date, the Time of Sale Prospectus, will not, contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Prospectus, as amended or supplemented by the Company, if applicable, as of its date and at all subsequent times through the Closing Date, did not and will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The representations and warranties set forth in the three immediately preceding sentences do not apply to statements in or omissions from the Registration Statement, or any post-effective amendment thereto, or the Prospectus or the Time of Sale Prospectus, or any amendments or supplements thereto, made in reliance upon and in conformity with information relating to any Underwriter furnished to the Company in writing by the Representatives expressly for use therein, it being understood and agreed that the only such information furnished by the Representatives to the Company consists of the information described in Section 8(b) below. There are no contracts or other documents required to be

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described in the Time of Sale Prospectus or the Prospectus or to be filed as exhibits to the Registration Statement which have not been described or filed as required.

          The Company is not an “ineligible issuer” in connection with the offering of the Securities pursuant to Rules 164, 405 and 433 under the Securities Act. Any free writing prospectus that the Company is required to file pursuant to Rule 433(d) under the Securities Act has been, or will be, filed with the Commission in accordance with the requirements of the Securities Act. Each free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under the Securities Act or that was prepared by or on behalf of (within the meaning, for this clause only, of Rule 163(c) under the Securities Act) or used or referred to by the Company complies or will comply in all material respects with the requirements of Rule 433 under the Securities Act including timely filing with the Commission or retention where required and legending, and each such free writing prospectus, as of its issue date and at all subsequent times through the Closing Date did not, does not and will not (i) include any information that conflicted, conflicts with or will conflict with the information contained in the Registration Statement, the Prospectus or any preliminary prospectus, including any document incorporated by reference therein, in each case not superseded or modified, or (ii) when taken together with the Time of Sale Prospectus contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. Except for the free writing prospectuses, if any, identified in Schedule B hereto, and Road Shows, if any, furnished by the Company to you before first use and identified in Schedule C hereto, the Company has not prepared, used or referred to, and will not, without your prior consent, prepare, use or refer to, any free writing prospectus. “ Road Show ” means each “ road show ” (as defined in Rule 433 under the Securities Act), if any, related to the offering of the Securities contemplated hereby that is a “ written communication ” (as defined in Rule 405 under the Securities Act). Each Road Show that was prepared by or behalf of (within the meaning, for this clause only, of Rule 163(c) under the Securities Act) or used or referred to by the Company as of its issue date and at all subsequent times through the Closing Date did not, does not and will not (i) include any information that conflicted, conflicts with or will conflict with the information contained in the Registration Statement, the Prospectus or any preliminary prospectus, including any document incorporated by reference therein, in each case not superseded or modified, or (ii) when taken together with the Time of Sale Prospectus contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

          (b) Offering Materials Furnished to Underwriters . The Company has delivered to the Representatives three complete manually signed copies of the Registration Statement, each amendment thereto, if any, and of each consent and certificate of experts filed as a part thereof, if any, and conformed copies of the Registration Statement, each amendment thereto (without exhibits), if any, and preliminary prospectuses, the Time of Sale Prospectus, the Prospectus, as amended or supplemented, and any free writing prospectus of the Company, in such quantities and at such places as the Representatives have reasonably requested for each of the Underwriters.

          (c) Distribution of Offering Material by the Issuers . The Issuers have not distributed and will not distribute, prior to the completion of the Underwriters’ distribution of the

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Securities, any offering material in connection with the offering and sale of the Securities other than a preliminary prospectus, the Time of Sale Prospectus, the Prospectus, any free writing prospectus reviewed and consented to by the Representatives, or the Registration Statement.

          (d) The Underwriting Agreement . This Agreement has been duly and validly authorized, executed and delivered by, and is a valid and binding agreement of, each Issuer, enforceable against it in accordance with its terms, except as rights to indemnification hereunder may be limited by applicable law and except as the enforcement hereof may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting the enforcement of creditors’ rights generally and by general principles of equity and the discretion of the court before which any proceeding therefor may be brought (all such exceptions collectively, the “ Enforceability Exceptions ”). This Agreement conforms in all material respects to the description thereof in the Time of Sale Prospectus.

          (e) Authorization of the Indenture. The Indenture has been duly and validly authorized by each Issuer and, when duly executed and delivered by the Issuers (assuming the due authorization, execution and delivery thereof by the Trustee), will be a legally binding and valid obligation of each such Issuer, enforceable against it in accordance with its terms, except as the enforcement thereof may be limited by Enforceability Exceptions. The Indenture, when executed and delivered, will conform in all material respects to the description thereof in the Time of Sale Prospectus. The Indenture has been duly qualified under the Trust Indenture Act of 1939, as amended (the “ Trust Indenture Act ”).

          (f) Authorization of the Notes. The Notes have been duly and validly authorized for issuance and sale to the Underwriters by the Company, and when issued and delivered by or on behalf of the Company and authenticated by the Trustee against payment therefor by the Underwriters in accordance with the terms of this Agreement and the Indenture, the Notes will be legally binding and valid obligations of the Company, entitled to the benefits of the Indenture and enforceable against the Company in accordance with their terms, except as the enforcement thereof may be limited by the Enforceability Exceptions. The Notes, when issued, authenticated and delivered, will conform in all material respects to the description thereof in the Time of Sale Prospectus.

          (g) Authorization of the Guarantees. Each Guarantee has been duly and validly authorized by the applicable Guarantor and, when the Notes are issued and delivered by or on behalf of the Company and authenticated by the Trustee against payment therefor by the Underwriters in accordance with the terms of this Agreement and the Indenture, will be legally binding and valid obligations of such Guarantor, enforceable against such Guarantor in accordance with its terms, except that enforceability thereof may be limited by the Enforceability Exceptions. The Guarantees, when issued, authenticated and delivered, will conform in all material respects to the description thereof in the Time of Sale Prospectus.

          (h) No Applicable Registration or Other Similar Rights . There are no persons with registration or other similar rights to have any equity or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement, except for such rights as have been duly waived.

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          (i) No Material Adverse Change . Except as otherwise disclosed in the Time of Sale Prospectus, subsequent to the respective dates as of which information is given in Time of Sale Prospectus: (i) there has been no material adverse change, or any development that could reasonably be expected to result in a material adverse change, in the condition, financial or otherwise, or in the earnings, business, operations or prospects, whether or not arising from transactions in the ordinary course of business, of the Company and its subsidiaries, considered as one entity (any such change is called a “ Material Adverse Change ”); (ii) the Company and its subsidiaries, considered as one entity, have not incurred any material liability or obligation, indirect, direct or contingent, not in the ordinary course of business nor entered into any material transaction or agreement not in the ordinary course of business; and (iii) there has been no dividend or distribution of any kind (other than regular quarterly dividends on the Company’s Series B Convertible Perpetual Preferred Stock) declared, paid or made by the Company or, except for dividends paid to the Company or other subsidiaries, any of its subsidiaries on any class of capital stock or repurchase or redemption by the Company or any of its subsidiaries of any class of capital stock.

          (j) Independent Accountants . To the Company’s knowledge, BDO Seidman, LLP, who have expressed their opinion with respect to the financial statements (which term as used in this Agreement includes the related notes thereto) and supporting schedules filed with the Commission as a part of the Registration Statement and included in the Prospectus and Time of Sale Prospectus (each, an “ Applicable Prospectus ” and collectively, the “ Applicable Prospectuses ”), are (i) independent public or certified public accountants as required by the Securities Act and the Exchange Act, (ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X and (iii) a registered public accounting firm as defined by the Public Company Accounting Oversight Board (the “ PCAOB ”) whose registration has not been suspended or revoked and who has not requested such registration to be withdrawn.

          (k) Preparation of the Financial Statements . The financial statements filed with the Commission as a part of the Registration Statement and included in the Time of Sale Prospectus and the Prospectus present fairly the consolidated financial position of the Company and its subsidiaries (or its applicable subsidiaries) as of and at the dates indicated and the results of their operations and cash flows for the periods specified. The supporting schedules included in the Registration Statement present fairly the information required to be stated therein. Such financial statements and supporting schedules have been prepared in conformity with generally accepted accounting principles as applied in the United States applied on a consistent basis throughout the periods involved, except as may be expressly stated in the related notes thereto. No other financial statements or supporting schedules are required to be included in the Registration Statement or any Applicable Prospectus. The financial data set forth in each Applicable Prospectus under the caption “Summary—Summary Consolidated Financial Information” fairly present the information set forth therein on a basis consistent with that of the audited financial statements contained in the Registration Statement and each Applicable Prospectus. The pro forma condensed financial statements of the Company and its subsidiaries and the related notes thereto included in the Time of Sale Prospectus and the Prospectus present fairly the information contained therein, have been prepared in accordance with the Commission’s rules and guidelines with respect to pro forma financial statements and have been properly presented on the bases described therein, and the assumptions used in the preparation

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thereof are reasonable and the adjustments used therein are appropriate to give effect to the transactions and circumstances referred to therein. To the Company’s knowledge, no person who has been suspended or barred from being associated with a registered public accounting firm, or who has failed to comply with any sanction pursuant to Rule 5300 promulgated by the PCAOB, has participated in or otherwise aided the preparation of, or audited, the financial statements, supporting schedules or other financial data filed with the Commission as a part of the Registration Statement and included in any Applicable Prospectus.

          (l) Company’s Accounting System . The Company makes and keeps accurate books and records and maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles as applied in the United States and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

          (m) Incorporation and Good Standing of the Company and its Subsidiaries . Each of the Company and its subsidiaries has been duly incorporated or organized, as the case may be, and is validly existing as a corporation, partnership or limited liability company, as applicable, in good standing under the laws of the jurisdiction of its incorporation or organization and has the power and authority (corporate or other) to own, lease and operate its properties and to conduct its business as described in each Applicable Prospectus and, in the case of each Issuer, to enter into and perform its obligations under this Agreement. Each of the Company and the subsidiaries of the Company set forth on Schedule D attached hereto (each a “ Subsidiary ” and, collectively, the “ Subsidiaries ”) is duly qualified as a foreign corporation, partnership or limited liability company, as applicable, to transact business and is in good standing in each other jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, result in a Material Adverse Change. Each “significant subsidiary” (as such term is defined in Rule 1-02 of Regulation S-X) of the Company is set forth on Schedule D attached hereto. All of the issued and outstanding capital stock or other equity or ownership interests of each Subsidiary wholly owned by the Company or any other Subsidiary have been duly authorized and validly issued, are (in the case of capital stock) fully paid and nonassessable and are owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse claim other than (A) the security interests created by (1) that certain First Lien Credit Agreement dated as of June 26, 2007 among, inter alia, the Company, the lenders party thereto and General Electric Capital Corporation as administrative agent and (2) that certain Second Lien Credit Agreement dated as of June 26, 2007 among, inter alia, the Company, the lenders party thereto and General Electric Capital Corporation as administrative agent, in each case, including any notes, guarantees, collateral and security documents, instruments and agreements executed in connection therewith (the “ Senior Credit Documents ”) and (B) any other liens or security interests permitted by the Senior Credit Documents. The Company does not own or control, directly or indirectly, any corporation, association or other entity other than (i) the subsidiaries listed in Exhibit 21 to the Company’s Annual Report on Form 10-K for the fiscal

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year ended December 31, 2008 and the subsidiaries listed in Schedule D attached hereto and (ii) such other entities omitted from Exhibit 21 or Schedule D attached hereto which, when such omitted entities are considered in the aggregate as a single subsidiary, would not constitute a “significant subsidiary” within the meaning of Rule 1-02(w) of Regulation S-X. All subsidiaries of the Company that are guarantors of the Senior Credit Documents and organized under the laws of a state of the United States are Guarantors, other than Diamics, Inc. and SPDH, Inc.

          (n) Capitalization and Other Capital Stock Matters . The authorized, issued and outstanding capital stock of the Company is as set forth in each Applicable Prospectus in the Company’s balance sheet as of December 31, 2008 (other than for subsequent issuances, if any, pursuant to employee benefit plans described in the Time of Sale Prospectus or upon the exercise of outstanding options or warrants described in each Applicable Prospectus). All of the issued and outstanding shares of capital stock of the Company have been duly authorized and validly issued, are fully paid and nonassessable and have been issued in compliance with federal and state securities laws. None of the outstanding equity interests of the Company was issued in violation of any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. All outstanding options, warrants, preemptive rights, rights of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for, any capital stock of the Company are as set forth and accurately and fairly described, in all material respects, in each Applicable Prospectus. The description of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, set forth in each Applicable Prospectus accurately and fairly presents, in all material respects, the information required to be shown with respect to such plans, arrangements, options and rights.

          (o) Listing Approval . The Securities have been approved for listing on the New York Stock Exchange, subject to notice of issuance.

          (p) Non-Contravention of Existing Instruments; No Further Authorizations or Approvals Required . Neither the Company nor any of its subsidiaries is in violation of its charter or by-laws, partnership agreement or operating agreement or similar organizational document, as applicable, or is in default (or, with the giving of notice or lapse of time, would be in default) (“ Default ”) under any indenture, mortgage, loan or credit agreement, note, contract, franchise, lease or other instrument to which the Company or any of its subsidiaries is a party or by which it or any of them may be bound (including, without limitation, any credit agreement, indenture, pledge agreement, security agreement or other instrument or agreement evidencing, guaranteeing, securing or relating to indebtedness of the Company or any of its subsidiaries), or to which any of the property or assets of the Company or any of its subsidiaries is subject (each, an “ Existing Instrument ”), except for such Defaults as would not, individually or in the aggregate, result in a Material Adverse Change. The Issuers’ execution, delivery and performance of this Agreement and the Indenture, the consummation by the Issuers of the transactions contemplated hereby and by each Applicable Prospectus and the issuance and sale of the Securities to be sold by the Issuers (i) have been duly authorized by all necessary corporate or other organizational action and will not result in any violation of the provisions of the charter or by-laws, partnership agreement or operating agreement or similar organizational document of the Company or any subsidiary, as applicable, (ii) will not conflict with or constitute a breach of, or Default or a Debt Repayment Triggering Event (as defined below) under, or result in the creation or imposition of any lien, charge or encumbrance upon any

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property or assets of the Company or any of its subsidiaries pursuant to, or require the consent of any other party to, any Existing Instrument (other than (A) requiring the consent of General Electric Capital Corporation as administrative agent under the respective Senior Credit Documents and (B) accelerating certain payments pursuant to the terms of the Acquisition Agreement dated as of March 16, 2009 among the Company and ACON Laboratories, Inc. and certain related entities as described in the Time of Sale Prospectus) and (iii) will not result in any violation of any law, administrative regulation or administrative or court decree applicable to the Company or any subsidiary, except, with respect to clauses (ii) and (iii), for such conflicts, breaches, Defaults, Debt Repayment Triggering Events, liens, charges, encumbrances or violations as would not, individually or in the aggregate, result in a Material Adverse Change. No consent, approval, authorization or other order of, or registration or filing with, any court or other governmental or regulatory authority or agency, is required for the Issuers’ execution, delivery and performance of this Agreement and the consummation by the Issuers of the transactions contemplated hereby and by each Applicable Prospectus, except (1) such as have been obtained or made by the Company or the Trustee and are in full force and effect under the Securities Act or the Trust Indenture Act, (2) such as may be required under applicable state securities or blue sky laws and (3) such as may be required from the FINRA. As used herein, a “ Debt Repayment Triggering Event ” means any event or condition which gives, or with the giving of notice or lapse of time would give, the holder of any note, debenture or other evidence of indebtedness (or any person acting on such holder’s behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company or any of its subsidiaries.

          (q) No Material Actions or Proceedings . Except as otherwise disclosed in each Applicable Prospectus, there are no legal or governmental actions, suits or proceedings pending or, to the Company’s knowledge, threatened (i) against or affecting the Company or any of its subsidiaries, (ii) which have as the subject thereof any officer or director of, or property owned or leased by, the Company or any of its subsidiaries or (iii) relating to environmental or discrimination matters, where in any such case (A) any such action, suit or proceeding, if determined adversely to the Company, such subsidiary or such officer or director, would reasonably be expected to result in a Material Adverse Change or, individually or in the aggregate, adversely affect the consummation of the transactions contemplated by this Agreement or (B) any such action, suit or proceeding is or would be material in the context of the sale of Securities. No material labor dispute with the employees of the Company or any of its Subsidiaries exists or, to the Company’s knowledge, is threatened or imminent.

          (r) Intellectual Property Rights . To the Company’s knowledge, the Company owns, possesses or can acquire on reasonable terms sufficient trademarks, servicemarks, trade names, patents, copyrights, and any registrations and applications for any of the foregoing, domain names, licenses, approvals, trade secrets, know-how, inventions, technology and other similar rights (collectively, “ Intellectual Property Rights ”) reasonably necessary to conduct its business as now conducted and as proposed to be conducted as set forth in each Applicable Prospectus (the “ Business ”). The operation of the Business by the Company, together with the Company’s use of the Intellectual Property Rights purported to be owned by, or exclusively licensed to, the Company and used by the Company in the Business (collectively, “ Company Intellectual Property Rights ”), does not infringe, misappropriate or otherwise violate the Intellectual Property Rights of any third party, other than the rights of any third party under any

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patent, and to the Company’s knowledge, the operation of the Business, together with the Company’s use of any Company Intellectual Property Rights, does not infringe or otherwise violate the rights of any third party under any patent. Except as disclosed in each Applicable Prospectus, no actions, suits, claims or proceedings have been asserted or, to the knowledge of the Company, threatened against the Company alleging any of the forgoing or seeking to challenge, deny or restrict the operation of the Business by the Company, except for such actions, suits, claims or proceedings as would not, individually or in the aggregate, result in a Material Adverse Change. The Company has not received any written notice of a claim of infringement, misappropriation or conflict with Intellectual Property Rights of others, except for such claims, individually or in the aggregate, as would not result in a Material Adverse Change. Except as disclosed in each Applicable Prospectus or except as would not, individually or in the aggregate, be reasonably expected to result in a Material Adverse Change, no court, administrative body or arbitral body has issued any order, judgment, decree or injunction restricting the operation of the Business by the Company.

          Except as disclosed in each Applicable Prospectus or except as would not, individually or in the aggregate, be reasonably expected to result in a Material Adverse Change, the Company Intellectual Property Rights owned by the Company and, to the knowledge of the Company, any Intellectual Property Rights exclusively licensed to the Company have not been adjudged invalid or unenforceable, in whole or in part, and, except as aforesaid, there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property Rights. Except as disclosed in each Applicable Prospectus or except as would not, individually or in the aggregate, be reasonably expected to result in a Material Adverse Change, there is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim by others challenging the Company’s right in or to any Company Intellectual Property Rights. Except as otherwise disclosed in each Applicable Prospectus, the Company is not a party to or bound by any agreements with respect to the Intellectual Property Rights of any other person or entity that are required to be set forth in each such Applicable Prospectus. None of the technology or intellectual property included in, or that is the subject matter of, the Company Intellectual Property Rights has been obtained or is being used by the Company in violation of any contractual obligation binding on the Company or, to the Company’s knowledge, any of its officers, directors or employees.

          Other than the patent applications acquired by the Company from a third party (the “ Acquired Patent Applications ”), the Company has duly filed or caused to be filed with the U.S. Patent and Trademark Office (the “ PTO ”) or foreign and international patent authorities all patent applications disclosed in each Applicable Prospectus as owned by the Company (the “ Company Patent Applications ”). The Company has complied with the PTO’s duty of candor and disclosure for the Company Patent Applications and has made no material misrepresentation during prosecution of the Company Patent Applications and the Acquired Patent Applications. To the Company’s knowledge, the Company Patent Applications disclose patentable subject matters and correctly name the inventors of the claimed subject matter. With respect to the Company Patent Applications, the Company has not been notified of any inventorship challenges nor has any interference been declared.

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          The Company has used reasonable security measures, but in no event less than those efforts that would accord with normal industry practice, to maintain the confidentiality of the trade secrets and other confidential information included in the Company Intellectual Property Rights. To the knowledge of the Company, all material trade secrets included in the Company Intellectual Property Rights are valid and protectible. Furthermore, to the knowledge of the Company, (i) there has been no misappropriation of any material trade secrets included in the Company Intellectual Property Rights by any other person, (ii) no employee, independent contractor or agent of the Company has misappropriated any trade secrets of any other person in the course of performance as an employee, independent contractor or agent of the Company, and (iii) no employee, independent contractor or agent of the Company is in material default or breach of any term of any employment agreement, nondisclosure agreement, assignment of invention agreement or similar agreement or contract relating in any way to the protection, ownership, development, use or transfer of Company Intellectual Property Rights owned by the Company.

          (s) All Necessary Permits, etc . The Company and each subsidiary possess such valid and current certificates, authorizations or permits issued by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their respective businesses, and neither the Company nor any subsidiary has received, or has any reason to believe that it will receive, any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate, authorization or permit which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could result in a Material Adverse Change.

          (t) Title to Properties . Except as otherwise disclosed in each Applicable Prospectus, each of the Company and its subsidiaries has good and marketable title to all of the real and personal property and other assets reflected as owned in the financial statements referred to in Section 1(k) above (or elsewhere in any Applicable Prospectus), in each case free and clear of any security interests, mortgages, liens, encumbrances, equities, adverse claims and other defects, except such as do not materially and adversely affect the value of such property and do not materially interfere with the use made or proposed to be made of such property by the Company or such subsidiary and except for (A) the security interests created by the Senior Credit Documents and (B) any other liens or security interests permitted by the Senior Credit Documents. The real property, improvements, equipment and personal property held under lease by the Company or any subsidiary are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere with the use made or proposed to be made of such real property, improvements, equipment or personal property by the Company or such subsidiary.

          (u) Tax Law Compliance . The Company and its subsidiaries have filed all necessary federal, state and foreign income and franchise tax returns and have paid all taxes required to be paid by any of them and, if due and payable, any related or similar assessment, fine or penalty levied against any of them, except for such failure to file or pay as would not, individually or in the aggregate, result in a Material Adverse Change. The Company has made adequate charges, accruals and reserves in the applicable financial statements referred to in Section 1(k) above in respect of all federal, state and foreign income and franchise taxes for all

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periods as to which the tax liability of the Company or any of its consolidated subsidiaries has not been finally determined.

          (v) Each Issuer Not an “Investment Company” . Each Issuer has been advised of the rules and requirements under the Investment Company Act of 1940, as amended (the “ Investment Company Act ”). Each Issuer is not, and will not be, either after receipt of payment for the Securities or after the application of the proceeds therefrom as described under “Use of Proceeds” in each Applicable Prospectus, an “ investment company ” within the meaning of the Investment Company Act.

          (w) Insurance . The Company and its subsidiaries are insured by recognized institutions with policies in such amounts and with such deductibles and covering such risks as are generally deemed adequate and customary for their businesses including, but not limited to, policies covering real and personal property owned or leased by the Company and its subsidiaries against theft, damage, destruction, acts of vandalism and earthquakes and policies covering the Company and its subsidiaries for product liability claims and clinical trial liability claims. The Company has no reason to believe that it or any subsidiary will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that would not, individually or in the aggregate, result in a Material Adverse Change. Neither the Company nor any subsidiary has been denied any insurance coverage which it has sought or for which it has applied.

          (x) No Price Stabilization or Manipulation; Compliance with Regulation M . No Issuer has taken, directly or indirectly, any action designed to or that might be reasonably expected to cause or result in stabilization or manipulation of the price of the Securities or any other “reference security” (as defined in Rule 100 of Regulation M under the 1934 Act (“ Regulation M ”)) whether to facilitate the sale or resale of the Securities or otherwise, or has taken any action which would directly or indirectly violate Regulation M.

          (y) Related-Party Transactions . There are no business relationships or related-party transactions involving the Company or any of its subsidiaries or any other person required to be described in each Applicable Prospectus which have not been described as required.

          (z) S-3 Eligibility . At the time the Registration Statement originally became effective and at the time the Company’s Annual Report on Form 10-K for the year ended December 31, 2008 was filed with the Commission, the Company met the applicable requirements for use of Form S-3 under the Securities Act. The Company meets the requirements for use of Form S-3 under the Securities Act specified in Rule 5110(b)(7)(C)(i) of the Financial Industry Regulatory Authority (the “ FINRA ”).

          (aa) Exchange Act Compliance . The documents incorporated or deemed to be incorporated by reference in each Applicable Prospectus, at the time they were or hereafter are filed with the Commission, complied and will comply in all material respects with the requirements of the Exchange Act, and, when read together with the other information in each Applicable Prospectus, at the time the Registration Statement and any amendments thereto

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become effective and at the Closing Date will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

          (bb) Statistical and Market-Related Data . The statistical, demographic and market-related data included in the Registration Statement and each Applicable Prospectus are based on or derived from sources that the Company believes to be reliable and accurate or represent the Company’s good faith estimates that are made on the basis of data derived from such sources.

          (cc) No Unlawful Contributions or Other Payments . Neither the Company nor any of its subsidiaries nor, to the Company’s knowledge, any employee or agent of the Company or any subsidiary, has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign office in violation of any law or of the character required to be disclosed in the Registration Statement and each Applicable Prospectus.

          (dd) Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting . The Company has established and maintains disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), which (i) are designed to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to the Company’s principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of a date within 90 days prior to the earlier of the date that the Company filed its most recent annual or quarterly report with the Commission and the date of the Time of Sale Prospectus; and (iii) are effective in all material respects to perform the functions for which they were established. There has not been and is no material weakness in the Company’s internal control over financial reporting since January 1, 2008, and since December 31, 2008, there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. The principal executive officers (or their equivalents) and principal financial officers (or their equivalents) of the Company have made all certifications required by the Sarbanes-Oxley Act of 2002 (the “ Sarbanes-Oxley Act ”) and any related rules and regulations promulgated by the Commission.

          (ee) Compliance with Environmental Laws . Except as described in each Applicable Prospectus and except as would not, individually or in the aggregate, result in a Material Adverse Change, (i) neither the Company nor any of its subsidiaries is in violation of any federal, state, local or foreign statute, law, rule, regulation, ordinance, code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum or petroleum products (collectively, “ Hazardous

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Materials ”) or to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “ Environmental Laws ”), (ii) the Company and its subsidiaries have all permits, authorizations and approvals required under any applicable Environmental Laws and are each in compliance with their requirements, (iii) there are no pending or, to the Company’s knowledge, threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating to any Environmental Law against the Company or any of its subsidiaries and (iv) there are no events or circumstances that might reasonably be expected to form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or governmental body or agency, against or affecting the Company or any of its subsidiaries relating to Hazardous Materials or any Environmental Laws.

          (ff) ERISA Compliance . The Company and its subsidiaries and any “ employee benefit plan ” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ ERISA ”)) established or maintained by the Company, its subsidiaries or their “ERISA Affiliates” (as defined below) are in compliance in all material respects with ERISA. “ ERISA Affiliate ” means, with respect to the Company or a subsidiary, any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations thereunder (the “ Code ”) of which the Company or such subsidiary is a member. No “ reportable event ” (as defined under ERISA) has occurred or is reasonably expected to occur with respect to any “employee benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates. No “employee benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates, if such “employee benefit plan” were terminated, would have any “ amount of unfunded benefit liabilities ” (as defined under ERISA). Neither the Company, its subsidiaries nor any of their ERISA Affiliates has incurred or reasonably expects to incur any liability under (i) Title IV of ERISA with respect to termination of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each “employee benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification.

          (gg) Brokers . Except for the underwriting discounts and commissions payable to the Underwriters as described in each Applicable Prospectus, there is no broker, finder or other party that is entitled to receive from the Company any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.

          (hh) No Outstanding Loans or Other Extensions of Credit . Since the adoption of Section 13(k) of the Exchange Act, neither the Company nor any of its subsidiaries has extended or maintained credit, arranged for the extension of credit, or renewed any extension of credit, in the form of a personal loan, to or for any director or executive officer (or equivalent thereof) of the Company and/or such subsidiary except for such extensions of credit as are expressly permitted by Section 13(k) of the Exchange Act.

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          (ii) Compliance with Laws . The Company and each of its subsidiaries are conducting business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting business, except where failure to be so in compliance would not, individually or in the aggregate, result in a Material Adverse Change. The Company, its subsidiaries and, to the Company’s knowledge, the Company’s directors and officers are each in compliance in all material respects with all applicable effective provisions of the Sarbanes-Oxley Act and the rules and regulations of the Commission and the New York Stock Exchange promulgated thereunder.

          (jj) Dividend Restrictions . Except as otherwise described in each Applicable Prospectus and except as set forth in the Senior Credit Documents, no subsidiary of the Company is prohibited or restricted, directly or indirectly, from paying dividends to the Company, or from making any other distribution with respect to such subsidiary’s equity securities or from repaying to the Company or any other subsidiary of the Company any amounts that may from time to time become due under any loans or advances to such subsidiary from the Company or from transferring any property or assets to the Company or to any other subsidiary.

          (kk) Foreign Corrupt Practices Act . Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other person acting on behalf of the Company or any of its subsidiaries is aware of or has taken any action, directly or indirectly, that has resulted or would result in a violation of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “ FCPA ”), including, without limitation, making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “ foreign official ” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the FCPA; and the Company and its subsidiaries and, to the knowledge of the Company, the Company’s affiliates have conducted their respective businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably intended to continue to ensure, continued compliance therewith.

          (ll) Money Laundering Laws . The operations of the Company and its subsidiaries are, and have been conducted at all times, in compliance in all material respects with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “ Money Laundering Laws ”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.

          (mm) OFAC . Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or person acting on behalf of the Company or any of its subsidiaries is currently subject to any U.S. sanctions

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administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“ OFAC ”); and the Company will not directly or indirectly use the proceeds of this offering, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

          (nn) Summaries of Certain Sections. The statements in the Time of Sale Prospectus and the Prospectus under the headings “Description of common stock we may offer,” “Material United States Federal Income Tax Consequences” and “Description of Notes” and under the subheadings “Business—Government Regulation&r


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