1 EXHIBIT 8 DRAFT May __, 1996 PolyMedica Industries, Inc. 11 State Street Woburn, MA 01801 Re: Distribution of Stock of CardioTech International, Inc. ------------------------------------------------------- Ladies and Gentlemen: We have represented PolyMedica Industries, Inc. ("PMI") in connection with the distribution by PMI of all of the common stock of CardioTech International, Inc. ("CardioTech") to the shareholders of PMI and the registration of the CardioTech Common Stock under Section 12(b) or 12(g) of the Securities Exchange Act of 1934 pursuant to Form 10 as originally filed with the Securities and Exchange Commission on March 19, 1996 and amended by the filing dated May __, 1996 (the "Information Statement"). In conjunction with such representation, you have requested our opinion regarding certain of the federal income tax consequences of the proposed Distribution of the CardioTech Common Stock. For purposes of this opinion letter, capitalized terms not otherwise defined shall have the meaning given such terms in the Information Statement. In rendering this opinion, we have examined and relied upon the Information Statement, including all exhibits thereto, the Intercompany Agreements, the License Agreement, the Common Stock Subscription Agreement, the Distribution Agreement, the Credit Agreement, the letter from you and CardioTech of even date herewith containing certain factual representations (the "Representation Letter"), the opinion of Cruttenden Roth, Inc. of even date herewith, and such other documents as we considered relevant to our analysis. We have assumed that all parties to documents relating to the Distribution have acted, and will act, in accordance with the terms of such documents. Moreover, we have assumed that all documents reviewed by us will continue in effect without material change and that the parties to such documents will act in accordance with their terms. In our examination, we have assumed the authenticity of original documents, the accuracy of copies and the genuineness of 2 PolyMedica Industries, Inc. May __, 1996 Page 2 signatures. We have relied upon certificates of public officials and the representations and statements of authorized representatives of PMI and CardioTech in the Representation Letter. We have not attempted to verify independently such representations and statements, but in the course of our representation, nothing has come to our attention which would cause us to question the accuracy thereof. The conclusions expressed herein represent our judgment of the proper treatment of certain aspects of the Distribution under the income tax laws of the United States, based on the Internal Revenue Code of 1986, as amended (the "Code"), Treasury Regulations issued thereunder, case law, and rulings and other pronouncements of the Internal Revenue Service (the "IRS") as in existence on the date of this letter. No assurances can be given that such law will not be amended or otherwise changed in the future. In addition, we express no opinions (and none should be inferred) regarding the tax consequences of the Distribution under the laws of any jurisdiction other than the United States. Our opinion represents our best judgment of how a court would conclude if presented with the issues addressed herein and is not binding upon either the IRS or any court. Thus, no assurances can be given that a position taken in reliance on our opinions will not be challenged by the IRS or rejected by a court. ASSUMPTIONS - ----------- Our opinions set forth are based upon the following factual assumptions: 1. The Distribution was effected in the manner and for the reasons described in the Information Statement (including all exhibits thereto). 2. There is no plan or intention by the shareholders of PMI who receive CardioTech Common Stock in the Distribution to sell, exchange, or otherwise dispose of a material number of such shares other than in the ordinary course of their investment activities. 3. There is no plan or intention by the shareholders of PMI who owned PMI Common Stock at the time of the Distribution to sell, exchange, or otherwise dispose of a material number of such shares other than in the ordinary course of their investment activities. 4. None of the CardioTech Common Stock received by the PMI shareholders in the Distribution will be received by a shareholder 3 PolyMedica Industries, Inc. May __, 1996 Page 3 in his, her or its capacity as a creditor, employee, or in any capacity other than as a shareholder of PMI. 5. Any cash payments received by the PMI shareholders in lieu of fractional shares of CardioTech Common Stock otherwise distributable in the Distribution represent the mere mechanical rounding off of fractions resulting from the Distribution and will not constitute separately bargained-for consideration. 6. All factual representations made on behalf of PMI and/or CardioTech in the Representation Letter are correct and complete in all material respects. OPINION - ------- On the basis of and subject to the representations and assumptions described above, we are of the opinion that the Distribution will qualify under Code Section 355 of the Code such that it will give rise to the tax consequences described in the Information Statement under "Tax Considerations of the Distribution." You should be aware, however, that certain of the requirements of Code Section 355 (discussed in more detail below) are subjective in nature or have a relative absence of authority addressing their application on facts similar to those presented by the Distribution. Accordingly, the IRS and/or a court could reach a different conclusion. BUSINESS PURPOSE - ---------------- In order for a distribution of the stock of a subsidiary to qualify under Code Section 355, it must be motivated by a valid business purpose. Under applicable regulations, the requisite business purpose will only exist with regard to the Distribution if the Distribution was carried out for a "real and substantial nonfederal tax" corporate (rather than stockholder) purpose that was "germane to the business" of PMI or CardioTech; there was no practical tax-free alternative to the Distribution for achieving such purpose; and the Distribution was "required by business exigencies." PMI has represented that the Distribution was undertaken primarily to provide both PMI and CardioTech with greater access to the capital markets to enable them to obtain financing necessary for their respective businesses at the lowest cost. PMI and CardioTech believe that such objective can only be achieved if CardioTech and PMI are completely separated so that investors will analyze them independently and the retention of a significant interest in CardioTech by PMI would increase the cost of capital to each of CardioTech and PMI. 4 PolyMedica Industries, Inc. May __, 1996 Page 4 In addition, PMI has represented that its Board of Directors believes that additional benefits of the Distribution include: (i) it will enable management of each company to adopt strategies and pursue objectives directly focused on its business and products; (ii) it will enhance the ability of each company to attract and motivate existing and potential key employees by providing them with equity compensation tied directly to the results of their efforts; (iii) it will eliminate PMI's expenses associated with the development of CardioTech's business; (iv) it will enable the Board of Directors of PMI to avoid conflicts in the use of limited capital resources by the two companies; and (v) it will enhance the ability of the two companies to enter into strategic alliances and joint ventures. Cruttenden Roth, Inc. has also advised PMI that the Distribution is, from a financial point of view, the best of the alternative methods considered by PMI for achieving its financial goal of providing PMI and CardioTech (in the aggregate) with greater and cheaper access to the capital necessary to finance their ongoing operations. Although similar rationales have been accepted by the IRS as sufficient to meet the business purpose requirement of Code Section 355, there can be no assurances that the IRS or the courts would accept the foregoing purposes as the primary purpose for the Distribution. In addition, the IRS or the courts could conceivably find that the business purposes for the Distribution could have been equally well achieved by some other transaction not requiring the complete distribution of all of the CardioTech stock by PMI. Because of the inherently subjective nature of the business purpose requirement of Code Section 355, there can be no certainty that such requirement will be met. ACTIVE TRADE OR BUSINESS REQUIREMENT - ------------------------------------ In order for the distribution of the stock of a subsidiary to qualify under Code Section 355, immediately following the distribution, each of the distributing corporation and the "spun-off" subsidiary must be engaged in an active trade or business that was actively conducted for the five-year period preceding the distribution. Applicable Treasury Regulations define an active trade or business as a specific group of activities which (i) are carried on for the purpose of earning income or profit and (ii) include "every operation that forms a part of, or step in, the process of earning income or profit," including, ordinarily, the collection of income. However, because applicable authority does not clearly define what constitutes an active trade or business, it is possible that the IRS could take the position that the activities of CardioTech following the 5 PolyMedica Industries, Inc. May __, 1996 Page 5 Distribution do not meet the active trade or business requirement of Code Section 355. Nevertheless, it is our opinion that CardioTech should be considered to be engaged in an active trade or business that has been carried on for at least five years prior to the Distribution. Prior to the Distribution, PMI and its subsidiaries should generally be considered to be engaged in the trade or business of the development and commercial exploitation of its proprietary polyurethanes. Although each of (i) the wound care operations, (ii) the R&D service arrangements pursuant to which PMI (or its subsidiaries) attempts to customize one or more of its polyurethanes to meet the particular needs of a customer, (iii) the bulk sale of polyurethanes to customers or (iv) the manufacture and sale of vascular grafts involve somewhat different activities, they all are premised on the common goal of generating sales of PMI's polyurethanes. As such, the Distribution should be considered a vertical division of one historic trade or business into two component parts. Such a vertical division of one trade or business is allowable under Treasury Regulation Section 1.355-3, provided that each of the distributing company and the "spun-off" subsidiary continues to be actively involved in the portion of the original business. Alternatively, even if the IRS chose to consider each of the wound care operations, contract R&D arrangements, bulk sales of products, and wound graft manufacture and sale as separate businesses, CardioTech will continue the contract R&D activities with respect to its biodurable polyurethanes following the Distribution. Since the contract R&D operations were conducted throughout the preceding five-year period, the active trade or business test of Code Section 355 should be met with respect to CardioTech even if its overall activities are divided into component parts for purposes of applying such test. DEVICE TEST - ----------- Code Section 355 requires that any distribution of the stock of a subsidiary not be "a transaction used principally as a device for the distribution of the earnings and profits" of the distributing corporation. Application of this test is uncertain because of its subjective nature. However, based upon (i) representations by PMI that the Distribution was not undertaken principally as a device for the distribution of earnings and profits, (ii) the assumption set forth above that there was no plan or intention on the part of PMI's shareholders to dispose of their stock in PMI or CardioTech following the Distribution and (iii) the fact that distributions of stock of subsidiaries by publicly traded companies are generally not 6 PolyMedica Industries, Inc. May __, 1996 Page 6 considered to be "devices" for the distribution of earnings and profits, it is our opinion that the Distribution should not be treated as such a device. However, because of the exceedingly subjective nature of the device test and the fact that the IRS may challenge the representations and assumptions upon which we rely in issuing our opinion, there can be no assurances that the IRS will not successfully assert that the Distribution was such a device. Except as expressly stated above, no opinion is given as to any other income tax consequences of the Distribution to PMI, CardioTech or the PMI shareholders. In addition, no opinion is given nor should any be implied as to the income tax consequences of any transactions undertaken in contemplation of the Distribution or otherwise. Very truly yours, HALE AND DORR