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SECURITIES AND EXCHANGE COMMISSION
Michigan | 94-3096597 | |
(State or other jurisdiction of | (I.R.S. Employer Identification | |
incorporation or organization) | Number) |
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive
offices)
President and Chief Executive Officer
Aastrom Biosciences, Inc.
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Danielle M. Lauzon
Goodwin Procter LLP
Exchange Place
Boston, Massachusetts 02109
Telephone: (617) 570-1000
Facsimile: (617) 523-1231
box:þ
Large accelerated filero | Accelerated filerþ | Non-accelerated filero | Smaller reporting companyþ | |||
(Do not check if a smaller reporting company) |
Proposed | Proposed | |||||||||||||
Amount | Maximum | Maximum | ||||||||||||
Title of Each Class of | to be | Offering Price | Aggregate | Amount of | ||||||||||
Securities to be Registered | Registered (1) | Per Unit (2) | Offering Price (3) | Registration Fee (4) | ||||||||||
Debt Securities (5) | ||||||||||||||
Preferred Stock (6) | ||||||||||||||
Common Stock (7) | ||||||||||||||
Warrants (8) | ||||||||||||||
Units (9) | ||||||||||||||
Total | $75,000,000 | N.A. | $75,000,000 | $5,348 | ||||||||||
(1) | The amount to be registered consists of up to $75,000,000 of an indeterminate amount of debt securities, preferred stock, common stock, warrants and/or units. There is also being registered hereunder such currently indeterminate number of (i) shares of common stock or other securities of the registrant as may be issued upon conversion of, or in exchange for, convertible or exchangeable debt securities and/or preferred stock registered hereby, or (ii) shares of preferred stock or common stock or debt securities or units as may be issued upon exercise of warrants registered hereby, as the case may be. Any securities registered hereunder may be sold separately or as units with the other securities registered hereunder. | |
(2) | The proposed maximum aggregate offering price per unit will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of security pursuant to General Instruction II.D. of Form S-3 under the Securities Act. | |
(3) | Estimated solely for purposes of computing the registration fee. No separate consideration will be received for (i) common stock or other securities of the registrant that may be issued upon conversion of, or in exchange for, convertible or exchangeable debt securities and/or preferred stock registered hereby, or (ii) preferred stock, common stock, debt securities or units that may be issued upon exercise of warrants registered hereby, as the case may be. | |
(4) | The registration fee has been calculated in accordance with Rule 457(o) under the Securities Act. | |
(5) | Including such indeterminate principal amount of debt securities as may be issued from time to time at indeterminate prices or upon exercise of warrants registered hereby, as the case may be. | |
(6) | Including such indeterminate amount of preferred stock as may be issued from time to time at indeterminate prices or upon conversion of debt securities and/or preferred stock registered hereby, or upon exercise of warrants registered hereby, as the case may be. | |
(7) | Including such indeterminate amount of common stock as may be issued from time to time at indeterminate prices or upon conversion of debt securities and/or preferred stock registered hereby, or upon exercise of warrants registered hereby, as the case may be. | |
(8) | Including such indeterminate number of warrants or other rights, including without limitation share purchase or subscription rights, as may be issued from time to time at indeterminate prices. | |
(9) | Each unit will be issued under a unit agreement and will represent an interest in two or more securities, which may be or may not be separable from one another. |
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The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any state where the offer or sale is not permitted.
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• | designation or classification; | ||
• | aggregate principal amount or aggregate offering price; | ||
• | maturity; | ||
• | original issue discount, if any; | ||
• | rates and times of payment of interest, dividends or other payments, if any; | ||
• | redemption, conversion, exchange, settlement or sinking fund terms, if any; | ||
• | conversion, exchange or settlement prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion, exchange or settlement prices or rates and in the securities or other property receivable upon conversion, exchange or settlement; | ||
• | ranking; | ||
• | restrictive covenants, if any; | ||
• | voting or other rights, if any; and | ||
• | important federal income tax considerations. |
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• | the names of those underwriters, dealers or agents; | ||
• | applicable fees, discounts and commissions to be paid to them; | ||
• | details regarding over-allotment options, if any; and | ||
• | the net proceeds to us. |
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• | continued scientific progress in our research, clinical and development programs; | ||
• | costs and timing of conducting clinical trials and seeking regulatory approvals; | ||
• | competing technological and market developments; | ||
• | our ability to establish additional collaborative relationships; | ||
• | the effect of commercialization activities and facility expansions, if and as required; and | ||
• | complementary business acquisition or development opportunities. |
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• | the rate and degree of progress for our product development; | ||
• | the rate of regulatory approval to proceed with clinical trial programs; | ||
• | the level of success achieved in clinical trials; | ||
• | the requirements for marketing authorization from regulatory bodies in the United States and other countries; | ||
• | the liquidity and market volatility of our equity securities; and | ||
• | regulatory and manufacturing requirements and uncertainties, technological developments by competitors. |
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• | clinical trial results; | ||
• | the amount of our cash resources and our ability to obtain additional funding; | ||
• | announcements of research activities, business developments, technological innovations or new products by us or our competitors; | ||
• | entering into or terminating strategic relationships; | ||
• | changes in government regulation; | ||
• | disputes concerning patents or proprietary rights; | ||
• | changes in our revenues or expense levels; | ||
• | public concern regarding the safety, efficacy or other aspects of the products or methodologies we are developing; | ||
• | news or reports from other stem cell, cell therapy or regenerative medicine companies; | ||
• | reports by securities analysts; | ||
• | status of the investment markets; | ||
• | concerns related to management transitions; and | ||
• | delisting from the NASDAQ Capital Market. |
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• | potential strategic collaborations with others; | ||
• | future capital needs; | ||
• | adequacy of existing capital to support operations for a specified time; | ||
• | product development and marketing plan; | ||
• | clinical trial plans and anticipated results; | ||
• | anticipation of future losses; | ||
• | commercialization plans; or | ||
• | revenue expectations and operating results. |
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• | through underwriters for resale to the public or investors; | ||
• | transactions on the Nasdaq Stock Market or on any national securities exchange or U.S. inter-dealer system of a registered national securities association on which our common stock may be listed or quoted at the time of sale; | ||
• | in the over-the-counter market; | ||
• | in private transactions and transactions otherwise than on these exchanges or systems or in the over-the-counter market; | ||
• | in “at the market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act of 1933, as amended, or the Securities Act, to or through a market maker or into an existing trading market, on an exchange or otherwise; | ||
• | in connection with short sales of the shares; | ||
• | by pledge to secure debt and other obligations; | ||
• | through the writing of options, whether the options are listed on an options exchange or otherwise; | ||
• | in connection with the writing of non-traded and exchange-traded call options, in hedge transactions and in settlement of other transactions in standardized or over-the-counter options; | ||
• | through a combination of any of the above transactions; or | ||
• | any other method permitted by law. |
• | the name or names of any agents, dealers, underwriters or investors who purchase the securities; | ||
• | the purchase price of the securities being offered and the proceeds we will receive from the sale; | ||
• | the amount of any compensation, discounts commissions or fees to be received by the underwriters, dealer or agents; | ||
• | any over-allotment options under which underwriters may purchase additional securities from us; | ||
• | any discounts or concessions allowed or reallowed or paid to dealers; | ||
• | any securities exchanges on which such securities may be listed; | ||
• | the terms of any indemnification provisions, including indemnification from liabilities under the federal securities laws; and | ||
• | the nature of any transaction by an underwriter, dealer or agent during the offering that is intended to stabilize or maintain the market price of the securities. |
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• | dividend rights, | ||
• | dividend rates, | ||
• | conversion rights, | ||
• | voting rights, | ||
• | terms of redemption, and | ||
• | liquidation preferences. |
• | the title and stated value; | ||
• | the number of shares authorized; | ||
• | the liquidation preference per share; | ||
• | the purchase price; | ||
• | the dividend rate, period and payment date, and method of calculation for dividends; | ||
• | whether dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate; | ||
• | the procedures for any auction and remarketing, if any; |
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• | the provisions for a sinking fund, if any; | ||
• | the provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights; | ||
• | any listing of the preferred stock on any securities exchange or market; | ||
• | whether the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be calculated, and the conversion period; | ||
• | whether the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated, and the exchange period; | ||
• | voting rights, if any, of the preferred stock; | ||
• | preemptive rights, if any; | ||
• | restrictions on transfer, sale or other assignment, if any; | ||
• | whether interests in the preferred stock will be represented by depositary shares; | ||
• | a discussion of any material United States federal income tax considerations applicable to the preferred stock; | ||
• | the relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; | ||
• | any limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and | ||
• | any other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock. |
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• | do not limit the amount of debt securities that we may issue; | ||
• | allow us to issue debt securities in one or more series; | ||
• | do not require us to issue all of the debt securities of a series at the same time; | ||
• | allow us to reopen a series to issue additional debt securities without the consent of the holders of the debt securities of such series; and | ||
• | provide that the debt securities will be unsecured, except as may be set forth in the applicable prospectus supplement. |
• | the title of the debt securities and whether they are senior or subordinated; | ||
• | the aggregate principal amount of the debt securities being offered, the aggregate principal amount of the debt securities outstanding as of the most recent practicable date and any limit on their aggregate principal amount, including the aggregate principal amount of debt securities authorized; | ||
• | the price at which the debt securities will be issued, expressed as a percentage of the principal and, if other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof or, if applicable, the portion of the principal amount of such debt securities that is convertible into common stock or other securities of Aastrom or the method by which any such portion shall be determined; | ||
• | if convertible, the terms on which such debt securities are convertible, including the initial conversion price or rate and the conversion period and any applicable limitations on the ownership or transferability of common stock or other securities of Aastrom received on conversion; | ||
• | the date or dates, or the method for determining the date or dates, on which the principal of the debt securities will be payable; |
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• | the fixed or variable interest rate or rates of the debt securities, or the method by which the interest rate or rates is determined; | ||
• | the date or dates, or the method for determining the date or dates, from which interest will accrue; | ||
• | the dates on which interest will be payable; | ||
• | the record dates for interest payment dates, or the method by which such dates will be determine; | ||
• | the persons to whom interest will be payable; | ||
• | the basis upon which interest will be calculated if other than that of a 360-day year of twelve 30-day months; | ||
• | any make-whole amount, which is the amount in addition to principal and interest that is required to be paid to the holder of a debt security as a result of any optional redemption or accelerated payment of such debt security, or the method for determining the make-whole amount; | ||
• | the place or places where the principal of, and any premium or make-whole amount, and interest on, the debt securities will be payable; | ||
• | where the debt securities may be surrendered for registration of transfer or conversion or exchange; | ||
• | where notices or demands to or upon us in respect of the debt securities and the applicable indenture may be served; | ||
• | the times, prices and other terms and conditions upon which we may redeem the debt securities; | ||
• | any obligation we have to redeem, repay or purchase the debt securities pursuant to any sinking fund or analogous provision or at the option of holders of the debt securities, and the times and prices at which we must redeem, repay or purchase the debt securities as a result of such obligation; | ||
• | the currency or currencies in which the debt securities are denominated and payable if other than United States dollars, which may be a foreign currency or units of two or more foreign currencies or a composite currency or currencies and the terms and conditions relating thereto, and the manner of determining the equivalent of such foreign currency in United States dollars; | ||
• | whether the principal of, and any premium or make-whole amount, or interest on, the debt securities of the series are to be payable, at our election or at the election of a holder, in a currency or currencies other than that in which the debt securities are denominated or stated to be payable, and other related terms and conditions; | ||
• | whether the amount of payments of principal of, and any premium or make-whole amount, or interest on, the debt securities may be determined according to an index, formula or other method and how such amounts will be determined; |
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• | whether the debt securities will be in registered form, bearer form or both and (i) if in registered form, the person to whom any interest shall be payable, if other than the person in whose name the security is registered at the close of business on the regular record date for such interest, or (ii) if in bearer form, the manner in which, or the person to whom, any interest on the security shall be payable if otherwise than upon presentation and surrender upon maturity; | ||
• | any restrictions applicable to the offer, sale or delivery of securities in bearer form and the terms upon which securities in bearer form of the series may be exchanged for securities in registered form of the series and vice versa, if permitted by applicable laws and regulations; | ||
• | whether any debt securities of the series are to be issuable initially in temporary global form and whether any debt securities of the series are to be issuable in permanent global form with or without coupons and, if so, whether beneficial owners of interests in any such permanent global security may, or shall be required to, exchange their interests for other debt securities of the series, and the manner in which interest shall be paid; | ||
• | the identity of the depositary for securities in registered form, if such series are to be issuable as a global security; | ||
• | the date as of which any debt securities in bearer form or in temporary global form shall be dated if other than the original issuance date of the first security of the series to be issued; | ||
• | the applicability, if any, of the defeasance and covenant defeasance provisions described in this prospectus or in the applicable indenture; | ||
• | whether and under what circumstances we will pay any additional amounts on the debt securities in respect of any tax, assessment or governmental charge and, if so, whether we will have the option to redeem the debt securities in lieu of making such a payment; | ||
• | whether and under what circumstances the debt securities being offered are convertible into common stock or other securities of Aastrom, as the case may be, including the conversion price or rate and the manner or calculation thereof; | ||
• | the circumstances, if any, specified in the applicable prospectus supplement, under which beneficial owners of interests in the global security may obtain definitive debt securities and the manner in which payments on a permanent global debt security will be made if any debt securities are issuable in temporary or permanent global form; | ||
• | any provisions granting special rights to holders of securities upon the occurrence of such events as specified in the applicable prospectus supplement; | ||
• | if the debt securities of such series are to be issuable in definitive form only upon receipt of certain certificates or other documents or satisfaction of other conditions, then the form and/or terms of such certificates, documents or conditions; | ||
• | the name of the applicable trustee and the nature of any material relationship with us or any of our affiliates, and the percentage of debt securities of the class necessary to require the trustee to take action; | ||
• | any deletions from, modifications of or additions to our events of default or covenants with regard to such debt securities and any change in the right of any trustee or any of the holders to declare the principal amount of any of such debt securities due and payable; | ||
• | applicable CUSIP numbers; and | ||
• | any other terms of such debt securities not inconsistent with the provisions of the applicable indenture. |
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• | exchange them for any authorized denomination of other debt securities of the same series and of a like aggregate principal amount and kind upon surrender of such debt securities at the corporate trust office of the applicable trustee or at the office of any transfer agent that we designate for such purpose; and | ||
• | surrender them for registration of transfer or exchange at the corporate trust office of the applicable trustee or at the office of any transfer agent that we designate for such purpose. |
• | issue, register the transfer of or exchange debt securities of any series during a period beginning at the opening of business 15 days before the day that the notice of redemption of any debt securities selected for redemption is mailed and ending at the close of business on the day of such mailing; | ||
• | register the transfer of or exchange any debt security, or portion thereof, so selected for redemption, in whole or in part, except the unredeemed portion of any debt security being redeemed in part; and | ||
• | issue, register the transfer of or exchange any debt security that has been surrendered for repayment at the option of the holder, except the portion, if any, of such debt security not to be so repaid. |
• | either we are the continuing entity, or the successor entity, if other than us, assumes the obligations (a) to pay the principal of, and any premium or make-whole amount, and interest on, all of the debt securities and (b) to duly perform and observe all of the covenants and conditions contained in each indenture; | ||
• | after giving effect to the transaction, there is no event of default under the indentures and no event which, after notice or the lapse of time, or both, would become such an event of default, occurs and continues; and | ||
• | an officers’ certificate and legal opinion covering such conditions are delivered to each applicable trustee. |
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• | default in the payment of any installment of interest on any debt security of such series continuing for 30 days; | ||
• | default in the payment of principal of, or any premium or make-whole amount on, any debt security of such series for five business days at its stated maturity; | ||
• | default in making any sinking fund payment as required for any debt security of such series for five business days; | ||
• | default in the performance or breach of any covenant or warranty in the debt securities or in the indenture by Aastrom continuing for 60 days after written notice as provided in the applicable indenture, but not of a covenant added to the indenture solely for the benefit of a series of debt securities issued thereunder other than such series; |
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• | a default under any bond, debenture, note, mortgage, indenture or instrument: |
(i) | having an aggregate principal amount of at least $75,000,000; or | ||
(ii) | under which there may be issued, secured or evidenced any existing or later created indebtedness for money borrowed by us or our subsidiaries, if we are directly responsible or liable as obligor or guarantor, |
• | bankruptcy, insolvency or reorganization, or court appointment of a receiver, liquidator or trustee of Aastrom or any significant subsidiary of Aastrom; and | ||
• | any other event of default provided with respect to a particular series of debt securities. |
• | we have deposited with the applicable trustee all required payments of the principal, any premium or make-whole amount, interest and, to the extent permitted by law, interest on overdue installment of interest, plus applicable fees, expenses, disbursements and advances of the applicable trustee; and | ||
• | all events of default, other than the non-payment of accelerated principal, or a specified portion thereof, and any premium or make-whole amount, have been cured or waived. |
• | in the payment of the principal, any premium or make-whole amount, or interest; | ||
• | in respect of a covenant or provision contained in the applicable indenture that cannot be modified or amended without the consent of the holders of the outstanding debt security that is affected by the default; or | ||
• | in respect of a covenant or provision for the benefit or protection of the trustee, without its express written consent. |
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• | is in conflict with any law or the applicable indenture; | ||
• | may involve the trustee in personal liability; or | ||
• | may be unduly prejudicial to the holders of debt securities of the series not joining the proceeding. |
• | change the stated maturity of the principal of, or any premium or make-whole amount on, or any installment of principal of or interest on, any such debt security; | ||
• | reduce the principal amount of, the rate or amount of interest on, or any premium or make-whole amount payable on redemption of, any such debt security; | ||
• | reduce the amount of principal of an original issue discount security that would be due and payable upon declaration of acceleration of the maturity thereof or would be provable in bankruptcy, or adversely affect any right of repayment of the holder of any such debt security; |
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• | change the place of payment or the coin or currency for payment of principal of, or any premium or make-whole amount, or interest on, any such debt security; | ||
• | impair the right to institute suit for the enforcement of any payment on or with respect to any such debt security; | ||
• | reduce the percentage in principal amount of any outstanding debt securities necessary to modify or amend the applicable indenture with respect to such debt securities, to waive compliance with particular provisions thereof or defaults and consequences thereunder or to reduce the quorum or voting requirements set forth in the applicable indenture; and | ||
• | modify any of the foregoing provisions or any of the provisions relating to the waiver of particular past defaults or covenants, except to increase the required percentage to effect such action or to provide that some of the other provisions may not be modified or waived without the consent of the holder of such debt security. |
• | to evidence the succession of another person to us as obligor under such indenture; | ||
• | to add to our covenants for the benefit of the holders of all or any series of debt securities or to surrender any right or power conferred upon us in such indenture; | ||
• | to add events of default for the benefit of the holders of all or any series of debt securities; | ||
• | to add or change any provisions of an indenture (i) to change or eliminate restrictions on the payment of principal of, or premium or make-whole amount, or interest on, debt securities in bearer form, or (ii) to permit or facilitate the issuance of debt securities in uncertificated form, provided that such action shall not adversely affect the interests of the holders of the debt securities of any series in any material respect; | ||
• | to change or eliminate any provisions of an indenture, provided that any such change or elimination shall become effective only when there are no debt securities outstanding of any series created prior thereto which are entitled to the benefit of such provision; | ||
• | to secure the debt securities; | ||
• | to establish the form or terms of debt securities of any series; | ||
• | to provide for the acceptance of appointment by a successor trustee or facilitate the administration of the trusts under an indenture by more than one trustee; | ||
• | to cure any ambiguity, defect or inconsistency in an indenture, provided that such action shall not adversely affect the interests of holders of debt securities of any series issued under such indenture; and | ||
• | to supplement any of the provisions of an indenture to the extent necessary to permit or facilitate defeasance and discharge of any series of such debt securities, provided that such action shall not adversely affect the interests of the holders of the outstanding debt securities of any series. |
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• | the principal amount of an original issue discount security that shall be deemed to be outstanding shall be the amount of the principal thereof that would be due and payable as of the date of such determination upon declaration of acceleration of the maturity thereof; | ||
• | the principal amount of any debt security denominated in a foreign currency that shall be deemed outstanding shall be the United States dollar equivalent, determined on the issue date for such debt security, of the principal amount or, in the case of an original issue discount security, the United States dollar equivalent on the issue date of such debt security of the amount determined as provided in the preceding bullet point; | ||
• | the principal amount of an indexed security that shall be deemed outstanding shall be the principal face amount of such indexed security at original issuance, unless otherwise provided for such indexed security under such indenture; and | ||
• | debt securities owned by us or any other obligor upon the debt securities or by any affiliate of ours or of such other obligor shall be disregarded. |
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• | there shall be no minimum quorum requirement for such meeting; and | ||
• | the principal amount of the outstanding debt securities of such series that vote in favor of such request, demand, authorization, direction, notice, consent, waiver or other action shall be taken account in determining whether such request, demand, authorization, direction, notice, consent, waiver or other action has been made, given or taken under such indenture. |
• | either (i) all securities of such series have already been delivered to the applicable trustee for cancellation; or (ii) all securities of such series have not already been delivered to the applicable trustee for cancellation but (a) have become due and payable, (b) will become due and payable within one year, or (c) if redeemable at our option, are to be redeemed within one year, and we have irrevocably deposited with the applicable trustee, in trust, funds in such currency or currencies, currency unit or units or composite currency or currencies in which such debt securities are payable, an amount sufficient to pay the entire indebtedness on such debt securities in respect of principal and any premium or make-whole amount, and interest to the date of such deposit if such debt securities have become due and payable or, if they have not, to the stated maturity or redemption date; |
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• | we have paid or caused to be paid all other sums payable; and | ||
• | an officers’ certificate and an opinion of counsel stating the conditions to discharging the debt securities have been satisfied has been delivered to the trustee. |
• | to defease and be discharged from any and all obligations with respect to such debt securities; or | ||
• | to be released from its obligations with respect to such debt securities under the applicable indenture or, if provided in the applicable prospectus supplement, its obligations with respect to any other covenant, and any omission to comply with such obligations shall not constitute an event of default with respect to such debt securities. |
• | direct obligations of the United States or the government that issued the foreign currency in which the debt securities of a particular series are payable, for the payment of which its full faith and credit is pledged; or | ||
• | obligations of a person controlled or supervised by and acting as an agency or instrumentality of the United States or other government that issued the foreign currency in which the debt securities of such series are payable, the payment of which is unconditionally guaranteed as a full faith and credit obligation by the United States or such other government, which are not callable or redeemable at the option of the issuer thereof and shall also include a depository receipt issued by a bank or trust company as custodian with respect to any such government obligation or a specific payment of interest on or principal of any such government obligation held by such custodian for the account of the holder of a depository receipt. However, except as required by law, such custodian is not authorized to make any deduction from the amount payable to the holder of such depository receipt from any amount received by the custodian in respect of the government obligation or the specific payment of interest on or principal of the government obligation evidenced by such depository receipt. |
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• | a currency, currency unit or composite currency both by the government of the country that issued such currency and for the settlement of transactions by a central bank or other public institutions of or within the international banking community; | ||
• | the European Currency Unit both within the European Monetary System and for the settlement of transactions by public institutions of or within the European Communities; or | ||
• | any currency unit or composite currency other than the European Currency Unit for the purposes for which it was established. |
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• | the offering price and aggregate number of warrants offered; | ||
• | the currency for which the warrants may be purchased; | ||
• | if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security; | ||
• | if applicable, the date on and after which the warrants and the related securities will be separately transferable; | ||
• | in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise; | ||
• | in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise; | ||
• | the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants; | ||
• | the terms of any rights to redeem or call the warrants; | ||
• | any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; | ||
• | the dates on which the right to exercise the warrants will commence and expire; | ||
• | the manner in which the warrant agreement and warrants may be modified; | ||
• | federal income tax consequences of holding or exercising the warrants; | ||
• | the terms of the securities issuable upon exercise of the warrants; and | ||
• | any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
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• | in the case of warrants to purchase debt securities, the right to receive payments of principal of, or any premium or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or | ||
• | in the case of warrants to purchase common stock or preferred stock, the right to receive any dividends or payments upon our liquidation, dissolution or winding up or to exercise any voting rights. |
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• | the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately; | ||
• | any provisions of the governing unit agreement; | ||
• | the price or prices at which such units will be issued; | ||
• | the applicable United States federal income tax considerations relating to the units; | ||
• | any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and | ||
• | any other terms of the units and of the securities comprising the units. |
• | to cure any ambiguity; any provisions of the governing unit agreement that differ from those described below; | ||
• | to correct or supplement any defective or inconsistent provision; or | ||
• | to make any other change that we believe is necessary or desirable and will not adversely affect the interests of the affected holders in any material respect. |
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• | impair any right of the holder to exercise or enforce any right under a security included in the unit if the terms of that security require the consent of the holder to any changes that would impair the exercise or enforcement of that right; or | ||
• | reduce the percentage of outstanding units or any series or class the consent of whose holders is required to amend that series or class, or the applicable unit agreement with respect to that series or class, as described below. |
• | If the change affects only the units of a particular series issued under that agreement, the change must be approved by the holders of a majority of the outstanding units of that series; or | ||
• | If the change affects the units of more than one series issued under that agreement, it must be approved by the holders of a majority of all outstanding units of all series affected by the change, with the units of all the affected series voting together as one class for this purpose. |
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• | Holders may exchange or transfer their units at the office of the unit agent. Holders may also replace lost, stolen, destroyed or mutilated units at that office. We may appoint another entity to perform these functions or perform them ourselves. | ||
• | Holders will not be required to pay a service charge to transfer or exchange their units, but they may be required to pay for any tax or other governmental charge associated with the transfer or exchange. The transfer or exchange, and any replacement, will be made only if our transfer agent is satisfied with the holder’s proof of legal ownership. The transfer agent may also require an indemnity before replacing any units. | ||
• | If we have the right to redeem, accelerate or settle any units before their maturity, and we exercise our right as to less than all those units or other securities, we may block the exchange or transfer of those units during the period beginning 15 days before the day we mail the notice of exercise and ending on the day of that mailing, in order to freeze the list of holders to prepare the mailing. We may also refuse to register transfers of or exchange any unit selected for early settlement, except that we will continue to permit transfers and exchanges of the unsettled portion of any unit being partially settled. We may also block the transfer or exchange of any unit in this manner if the unit includes securities that are or may be selected for early settlement. |
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• | our annual report on Form 10-K for the fiscal year ended June 30, 2010, filed with the SEC on September 7, 2010; | ||
• | portions of our definitive Proxy Statement for the Annual Meeting of Shareholders held on October 21, 2010 that have been incorporated by reference into the Form 10-K; | ||
• | our quarterly report on Form 10-Q, filed with the SEC on November 8, 2010; | ||
• | our current reports on Form 8-K filed with the SEC on July 6, 2010, July 14, 2010, August 2, 2010, August 31, 2010, October 25, 2010 and November 12, 2010; and | ||
• | the description of our common stock contained in our registration statement on Form S-1, which was filed with the SEC on November 1, 1996, including any amendment or report filed for the purpose of updating such description. |
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FOR SECURITIES ACT LIABILITIES
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TERM | DEFINITION | |
Adverse Event | Any adverse change in health or “side-effect” that occurs in a person participating in a clinical trial, from the time they consent to joining the trial until a pre-specified period of time after their treatment has been completed. | |
Autologous | Originating from the patient receiving treatment. (Aastrom uses only autologous cells) | |
BLA — Biologics License Application | An application containing product safety, efficacy and manufacturing information required by the FDA to market biologics products in the U.S. | |
Catheter-DCM | Aastrom’s U.S. Phase 2 clinical trial investigating catheter-based delivery of our product in the treatment of dilated cardiomyopathy. | |
CLI — Critical Limb Ischemia | A vascular disease characterized by insufficient blood flow in the lower extremities that causes severe pain, tissue loss or both. | |
Controlled Clinical Trial | A clinical study that compares patients receiving a specific treatment to patients receiving an alternate treatment for the condition of interest. The alternate treatment may be another active treatment, standard of care for the condition and/or a placebo (inactive) treatment. | |
DCM — Dilated Cardiomyopathy | A chronic cardiac disease where expansion of the patient’s heart reduces the pumping function to a point that the normal circulation of blood cannot be maintained. | |
Double-Blind Clinical Trial | Clinical trials in which neither the patient nor the physician know if the patient received the experimental treatment or a control/placebo. | |
FDA — Food & Drug Administration | The U.S. FDA ensures that medicines, medical devices, and radiation-emitting consumer products are safe and effective. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually. | |
GMP — Good Manufacturing Practice | GMP regulations require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. | |
IMPACT-DCM | Aastrom’s U.S. Phase 2 clinical trial investigating surgical delivery of our product in the treatment of dilated cardiomyopathy. | |
IND — Investigational New Drug | An application submitted to the FDA for a new drug or biologic that, if allowed, will be used in a clinical trial. |
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TERM | DEFINITION | |
Ischemia | A shortage or inadequate flow of blood to a body part (commonly an organ or tissue) caused by a constriction or obstruction of the blood vessels supplying it. | |
LVEF — Left Ventricular Ejection Fraction | The fraction of blood pumped out of the left ventricle with each heart beat. | |
Open-label Clinical Trial | A trial in which both the treating physician and the patient know whether they are receiving the experimental treatment or control/placebo treatment. | |
Orphan Drug Designation | “Orphan drug” refers to a drug or biologic that is intended for use in the treatment of a rare disease or condition. Orphan drug designation from the U.S. Food and Drug Association (FDA) qualifies the sponsor to receive certain benefits from the Government in exchange for developing the drug for a rare disease or condition. The drug must then go through the FDA marketing approval process like any other drug or biologic which evaluates for safety and efficacy. Usually a sponsor receives a quicker review time and lower application fees for an orphan product. | |
Phase 1 Clinical Trial | A Phase 1 trial represents an initial study in a small group of patients to test for safety and other relevant factors. | |
Phase 2 Clinical Trial | A Phase 2 trial represents a study in a moderate number of patients to assess the safety and efficacy of a product. | |
Phase 2b Clinical Trial | A Phase 2b trial is a moderately-sized Phase 2 trial that is more specifically designed assess the efficacy of a product than a Phase 2a trial. | |
Phase 3 Clinical Trial | Phase 3 studies are initiated to establish safety and efficacy in an expanded patient population at multiple clinical trial sites and are generally larger than trials in earlier phases of development. | |
Progenitor Cells | A “parent” cell that gives rise to a distinct cell lineage by a series of cell divisions. | |
Prospective Clinical Trial | A clinical trial in which participants are identified and then followed throughout the study going forward in time. | |
Randomized Clinical Trial | A clinical trial in which the participants are assigned randomly to different treatment groups. | |
SPP — Single-Pass Perfusion | SPP is Aastrom’s proprietary technology that controls gas and cell culture media exchange to enable the replication of early-stage stem and progenitor cells while preventing their differentiation into mature cells. | |
Stem Cell | Unspecialized (undifferentiated) cells that retain the ability to divide throughout a lifetime and give rise to more specialized (differentiated) cells which take the place of cells that die or are lost. | |
In culture, these undifferentiated cells possess the ability to divide for indefinite periods in culture and may give rise to highly specialized cells. |
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Preferred Stock
Debt Securities
Warrants
Units
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Securities and Exchange Commission registration fee | $ | 5,348 | ||
Legal fees and expenses | * | |||
Accounting fees and expenses | * | |||
Printing fees and expenses | * | |||
Transfer agent and trustee fees | * | |||
Miscellaneous | * | |||
Total | $ | 5,348 | ||
* | Estimated expenses not presently known |
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AASTROM BIOSCIENCES, INC. | ||||
By: | /s/ Timothy M. Mayleben | |||
Timothy M. Mayleben | ||||
President and Chief Executive Officer | ||||
Signature | Title | Date | ||
/s/ Timothy M. Mayleben | President, Chairman of the Board and Chief Executive Officer (Principal Executive Officer) | November 12, 2010 | ||
/s/ Scott C. Durbin | Chief Financial Officer (Principal Financial and Accounting Officer) | November 12, 2010 | ||
/s/ Nelson M. Sims | Director | November 12, 2010 | ||
/s/ Ronald Cresswell, Ph.D. | Director | November 12, 2010 | ||
/s/ Alan L. Rubino | Director | November 12, 2010 | ||
/s/ Harold C. Urschel, Jr., M.D. | Director | November 12, 2010 | ||
/s/ Robert L. Zerbe, M.D. | Director | November 12, 2010 |
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Exhibit | ||
No. | Description | |
3.1 | Restated Articles of Incorporation of Aastrom, filed as Exhibit 4.1 to Aastrom’s Current Report on Form 8-K filed on December 17, 2009 and incorporated herein by reference. | |
3.2 | Certificate of Amendment to Restated Articles of Incorporation of Aastrom dated February 9, 2010, filed as Exhibit 3.2 to Aastrom’s Post Effective Amendment No. 1 to Form S-1 filed on March 31, 2010 and incorporated herein by reference. | |
3.3 | Amended and Restated Bylaws, filed as Exhibit 3.1 to Aastrom’s Current Report on Form 8-K filed on November 12, 2010 and incorporated herein by reference. | |
4.1 | Form of Senior Indenture for Senior Debt Securities. | |
4.2 | Form of Senior Debt Security (included in Exhibit 4.1 hereto). | |
4.3 | Form of Indenture for Subordinated Debt Securities. | |
4.4 | Form of Subordinated Debt Security (included in Exhibit 4.3 hereto) | |
4.5 | Specimen Common Stock Certificate, filed as Exhibit 4.1 to Amendment No. 2 to Aastrom’s Registration Statement on Form S-1/A filed on December 20, 1996 and incorporated herein by reference. | |
4.6* | Form of Certificate of Designations | |
4.7* | Form of Preferred Stock Certificate | |
4.8* | Form of Warrant Agreement | |
4.9* | Form of Warrant Certificate | |
4.10* | Form of Unit Agreement | |
4.11* | Form of Unit Certificate | |
5.1 | Opinion of Dykema Gossett PLLC. | |
12.1* | Computation of Ratio of Earnings to Fixed Charges | |
23.1 | Consent of PricewaterhouseCoopers LLP | |
23.2 | Consent of Dykema Gossett PLLC (included in Exhibit 5.1 hereto) | |
24.1 | Power of Attorney (included in Part II of this registration statement) | |
25.1** | Form T-1 Statement of Eligibility of Trustee for Senior Indenture under the Trust Indenture Act of 1939 | |
25.2** | Form T-1 Statement of Eligibility of Trustee for Subordinated Indenture under the Trust Indenture Act of 1939 |
* | To be filed, if necessary, by amendment or as an exhibit to a document to be incorporated or deemed to be incorporated by reference in this registration statement, including a Current Report on Form 8-K. | |
** | To be filed, if necessary, separately under the electronic form type 305B2. |