Document:

Exhibit
      10.10

     

    OMNIBUS
      STOCKHOLDERS’ AGREEMENT

     

    This
      OMNIBUS STOCKHOLDERS’ AGREEMENT (this “Agreement”)
      is
      made and entered into as of October 24, 2003, by and among Arbios Technologies,
      Inc., a Delaware corporation (“Arbios”),
      Historical Autographs U.S.A., Inc., a Nevada corporation (“HAUSA”),
      Spectrum Laboratories, Inc., a Delaware corporation (“Spectrum”),
      Cedars-Sinai Medical Center, a California nonprofit public benefit corporation
      (the “Junior
      Preferred Investor”),
      Achilles A. Demetriou, M.D., Ph.D. and Kristin P. Demetriou, as Trustees of
      the
      A & K Demetriou Family Trust created on November 13, 2000 (collectively,
“Demetriou”)
      and
      Jacek Rozga, M.D., Ph.D. and Joanna Rozga (collectively, “Rozga,”
and,
      collectively with Demetriou, the "Founders").
      Spectrum, the Junior Preferred Investor, and the Founders are sometimes
      collectively hereinafter referred to as the "Holders".

     

    RECITALS

     

    A. Arbios
      has entered into that certain Agreement and Plan of Reorganization (the
“Plan
      of Reorganization”),
      dated
      October 20, 2003, among Arbios, HAUSA, HAUSA Acquisition, Inc., a Nevada
      corporation, Raymond J. Kuh and Cindy K. Swank, pursuant to which Arbios will
      merge with HAUSA Acquisition, Inc. (the “Merger”).
      As a
      result of the Merger, each share of common stock of Arbios outstanding
      immediately before the Merger will be converted into one share of common stock
      of HAUSA (the common stock of HAUSA to be issued in the Merger is herein
      referred to as the “Common
      Stock”).

     

    B. 
      Arbios
      and the Holders are parties to that certain First Amended and Restated
      Stockholders’ Agreement, dated as of December 21, 2001 (the “Existing
      Stockholders’ Agreement”).

     

    C. Arbios,
      the Founders and the Junior Preferred Investor are parties to that certain
      Investors’ Rights Agreement, dated as of June 29, 2001 (the “Investors’
      Rights Agreement”).

     

    D. As
      a
      result of the reorganization of Arbios’ ownership that will occur in the Merger,
      (i) Arbios and the Holders agree that the Existing Stockholders’ Agreement
      should be terminated, effective as of the Merger, and (ii) Arbios, the Junior
      Preferred Investor and the Founders agree that the Investors’ Rights Agreement
      should be terminated, effective as of the Merger.

     

    E. Pursuant
      to the Plan of Reorganization, all outstanding shares of preferred stock of
      Arbios are required to be converted into additional shares of Arbios common
      stock, which shares of Arbios common stock will be converted into shares of
      Common Stock in the Merger.

     

    F. The
      Junior Preferred Investor, the owner of all of the issued and outstanding shares
      of Arbios’ preferred stock, is willing to convert its 681,818 shares of Junior
      Preferred Stock for 681,818 shares of Arbios common stock immediately prior
      to
      the Merger on the terms and conditions of this Agreement. 

     

    
      
        
        

      

      
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    G. The
      parties to this Agreement agree that the restrictions imposed by the two
      Founder’s Restricted Stock Purchase Agreements, each entered into as of
      September 1, 2002 by one of the Founders and Arbios (the “Founder’s
      Agreements”),
      on
      the Arbios shares owned by the Founders will no longer be necessary or
      appropriate following the Merger.

     

    H. The
      Merger and the other transactions contemplated by the Plan of Reorganization
      are
      scheduled to occur by no later than October 30, 2003.

     

    AGREEMENT

     

    NOW,
      THEREFORE, for and in consideration of the premises, covenants and obligations
      contained herein, and for other good and valuable consideration, the receipt
      and
      sufficiency of which are hereby acknowledged, the parties hereto hereby agree
      as
      follows:

     

    1. TERMINATION
      OF PRIOR AGREEMENTS

     

    1.1 Termination
      of Prior Agreements. Subject
      to the consummation of the Merger, the parties to the Existing Stockholders’
Agreement and to the Investors’ Rights Agreement hereby agree that each such
      agreement shall automatically terminate and be cancelled effective as of the
      effectiveness of the Merger.

     

    1.2 Waiver
      of Rights Under Prior Agreements. Each
      party to this Agreement who is also a party to either of the Existing
      Stockholders’ Agreement or the Investors’ Rights Agreement hereby waives any and
      all rights such party may have under such agreements relating to this Agreement,
      the Plan or Reorganization, or any of the transactions contemplated by any
      of
      the foregoing agreements, including the right to approve such transactions
      or
      the right of first refusal to purchase any shares issuable in any such
      transactions. 

     

    2. CONVERSION/EXCHANGE
      OF PREFERRED STOCK

     

    2.1 The
      Junior Preferred Investor hereby agrees to exchange/convert all of the 681,818
      shares of Junior Preferred Stock owned by the Junior Preferred Investor for
      681,818 shares of Arbios common stock (the “Exchange”).
      In
      order to effect the Exchange, the Junior Preferred Investor is hereby delivering
      to Arbios the stock certificate representing all of the shares of Junior
      Preferred Stock owned by the Junior Preferred Investor, which certificate has
      been duly endorsed for cancellation. Subject to Section 2.2 below, the Junior
      Preferred Investor hereby irrevocably instructs Arbios to cancel the foregoing
      certificate and the shares of Junior Preferred Stock immediately prior to the
      Merger, and Arbios hereby agrees to cancel the Junior Preferred Stock and to
      issue the 681,818 shares of Arbios common stock in the Exchange immediately
      before the Merger becomes effective. However, Arbios agrees that it will not
      cancel the shares of Junior Preferred Stock until immediately prior to the
      closing of the Merger. Arbios and the Junior Preferred Investor hereby agree
      that the Exchange shall for all purposes be deemed to be effective immediately
      prior to the closing of the Merger if the Merger occurs, and that the shares
      of
      Junior Preferred Stock shall be deemed to have been exchanged for shares of
      Arbios common stock at the time that the Merger occurs. Since the 681,818 shares
      of Arbios common stock to be issued to the Junior Preferred Investor in the
      Exchange shall, in connection with the Merger, automatically be converted into
      681,818 shares of Common Stock of HAUSA, the parties hereto agree that the
      stock
      certificate to be received by the Junior Preferred Investor as a result of
      the
      Exchange may be issued as a stock certificate for 681,818 shares of Common
      Stock
      of HAUSA immediately after the Merger.

     

    
      
        
        

      

      
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    2.2 In
      the
      event that the Merger has not been consummated by October 31, 2003, Arbios
      shall
      thereafter not cancel the shares of Junior Preferred Stock and shall promptly
      thereafter return to the Junior Preferred Investor the stock certificate
      representing the Junior Preferred Stock.

     

    3. REGISTRATION
      RIGHTS

     

    3.1 Definitions.
      For
      purposes of this Section 3:

     

    (a) Registration
      Rights Holders.
      The
      term “Registration
      Rights Holder”
means
      the Junior Preferred Investor and the Founders, and any assignee of record
      of
      the Registrable Securities to whom rights set forth herein have been duly
      assigned in accordance with this Agreement.

     

    (b) Registration.
      The
      terms “register,”
      “registered,”
and
      “registration”
refer
      to a registration effected by preparing and filing a registration statement
      in
      compliance with the Securities Act, and the declaration or ordering of
      effectiveness of such registration statement.

     

    (c) Registrable
      Securities.
      The
      term “Registrable
      Securities"
      means:
      (i) all shares of Common Stock of HAUSA listed on Schedule A, which shares
      are
      expected to be issued to the Registration Rights Holders in the Merger, together
      with any other shares of HAUSA that may be acquired by the Registration Rights
      Holders or any of the Registration Rights Holders' permitted successors and
      assigns after the Merger; and (ii) any shares of Common Stock of HAUSA issued
      as
      (or issuable upon the conversion or exercise of any warrant, right or other
      security which is issued as) a dividend or other distribution with respect
      to,
      or in exchange for or in replacement of, all such shares of Common Stock
      described in clause (i) of this Section 3.1 (c); excluding
      in all
      cases, however, any Registrable Securities sold by a person in a transaction
      in
      which rights under this Section 3 are not assigned in accordance with this
      Agreement or any Registrable Securities sold to the public or sold pursuant
      to
      Rule 144 promulgated under the Securities Act. 

     

    (d) SEC.
      The
      term “SEC”
or
      “Commission”
means
      the U.S. Securities and Exchange Commission.

     

    (e) Securities
      Act.
      The
      term “Securities
      Act”
means
      the Securities Act of 1933, as amended.

     

    3.2 Piggyback
      Registrations.

     

    (a) Registration
      Rights.
      Subject
      to the completion of the Merger, HAUSA agrees to the following registration
      provisions. HAUSA shall notify the Registration Rights Holders in writing at
      least thirty (30) days prior to filing any registration statement under the
      Securities Act for purposes of effecting a public offering of securities of
      HAUSA (including, but not limited to, registration statements relating to
      secondary offerings of securities of HAUSA), and will afford the Registration
      Rights Holders an opportunity to include in such registration statement all
      or
      any part of the Registrable Securities then held by the Registration Rights
      Holders. Notwithstanding the foregoing, the registration rights provided by
      this
      Section 3.2 shall not apply to any registration statement (i) relating to any
      employee benefit plan or an SEC Rule 145 transaction, (ii) filed by HAUSA
      pursuant to those certain Subscription Agreements--Bridge Offering entered
      into
      in September 2003 between Arbios and the purchasers of $400,000 of Arbios’
convertible promissory notes, or (iii) filed by HAUSA pursuant to those certain
      Subscription Agreements entered into between Arbios and the investors who
      purchased up to $4,010,000 of Arbios’ Units (consisting of shares of Arbios
      common stock and warrants) in September and October 2003. If a Registration
      Rights Holder desires to include in any such registration statement all or
      any
      part of the Registrable Securities held by such Registration Rights Holder,
      it
      shall, within twenty (20) days after receipt of the above-described notice
      from
      HAUSA, so notify HAUSA in writing, and in such notice shall inform HAUSA of
      the
      number of Registrable Securities such Registration Rights Holder wishes to
      include in such registration statement. If a Registration Rights Holder decides
      not to include all of its Registrable Securities in any registration statement
      thereafter filed by HAUSA, such Registration Rights Holder shall nevertheless
      continue to have the right to include any Registrable Securities in any
      subsequent registration statement or registration statements as may be filed
      by
      HAUSA with respect to offerings of its securities, all upon the terms and
      conditions set forth herein.

     

    
      
        
        

      

      
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    (b) Underwriting.
      If a
      registration statement under which HAUSA gives notice under this
      Section 3.2 is for an underwritten offering, then HAUSA shall so advise the
      Registration Rights Holders in writing. In such event, the right of each
      Registration Rights Holder to have its Registrable Securities included in a
      registration pursuant to this Section 3.2 shall be conditioned upon such
      Registration Rights Holder's participation in such underwriting and the
      inclusion of such Registration Rights Holder's Registrable Securities in the
      underwriting to the extent provided herein. In connection with such underwritten
      offering, each participating Registration Rights Holder shall enter into an
      underwriting agreement in customary form with the managing underwriter or
      underwriters selected for such underwriting. Notwithstanding any other provision
      of this Agreement, if the managing underwriter or underwriters determine(s)
      in
      good faith that marketing factors require a limitation of the number of shares
      to be underwritten, then the managing underwriter(s) may exclude shares
      (including Registrable Securities) from the registration and the underwriting,
      and the number of shares that may be included in the registration and the
      underwriting shall be allocated, first,
      to
      HAUSA in full for shares of HAUSA stock it proposes to offer in a primary
      offering, and second,
      to the
      participating Registration Rights Holders ratably in accordance with the number
      of shares each requesting Registration Rights Holder requested to be
      underwritten; provided,
      however,
      that
      the right of the underwriters to exclude shares (including Registrable
      Securities) from the registration and underwriting as described above shall
      be
      restricted so that the aggregate number of Registrable Securities of all
      Registration Rights Holders included in any such registration is not reduced
      below ten percent (10%) of the shares included in the registration. If a
      Registration Rights Holder disapproves of the terms of any such underwriting,
      such Registration Rights Holder may elect to withdraw therefrom by written
      notice to HAUSA and the underwriter, delivered at least twenty (20) business
      days prior to the effective date of the registration statement. Any Registrable
      Securities excluded or withdrawn from such underwriting shall be excluded and
      withdrawn from the registration. Any such exclusion or withdrawal in such
      underwriting shall not limit the rights of the Registration Rights Holder to
      include its Registrable Securities in any subsequent underwritten offering
      under
      this Section 3.2(b).

     

    
      
        
        

      

      
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    (c) Expenses.
      All
      expenses incurred in connection with a registration pursuant to this
      Section 3.2 (excluding underwriters' and brokers' discounts and
      commissions), including, without limitation all federal and “blue sky”
registration and qualification fees, printers' and accounting fees, fees and
      disbursements of counsel for HAUSA, shall be borne by HAUSA. The participating
      Registration Rights Holders shall bear their proportionate share (based on
      the
      total number of their shares sold in such registration) of any counsel
      representing all of the participating Registration Rights Holders and all
      discounts, commissions or other amounts payable to underwriters or brokers
      in
      connection with such registration.

     

    3.3 Obligations
      of HAUSA.
      Whenever required to effect the registration of any Registrable Securities
      under
      this Agreement, HAUSA shall, as expeditiously as reasonably
      possible:

     

    (a) Prepare
      and file with the SEC a registration statement with respect to such Registrable
      Securities and use its best efforts to cause such registration statement to
      become effective, and, upon the request of any participating Registration Rights
      Holder, keep such registration statement effective for ninety (90) days (or
      until all Registrable Securities included therein have been sold if the
      registration is filed on Form S-3 or any similar successor form).

     

    (b) Prepare
      and file with the SEC such amendments and supplements to such registration
      statement and the prospectus used in connection with such registration statement
      as may be necessary to comply with the provisions of the Securities Act with
      respect to the disposition of all securities covered by such registration
      statement.

     

    (c) Furnish
      to each participating Registration Rights Holder such number of copies of a
      prospectus, including a preliminary prospectus, in conformity with the
      requirements of the Securities Act, and such other documents as such
      Registration Rights Holder may reasonably request in order to facilitate the
      disposition of the Registrable Securities owned by the Registration Rights
      Holder that are included in such registration.

     

    (d) Use
      its
      reasonable efforts to register and qualify the securities covered by such
      registration statement under such other securities or “blue sky” laws of such
      jurisdictions as shall be reasonably requested by any participating Registration
      Rights Holder, provided that HAUSA shall not be required in connection therewith
      or as a condition thereto to qualify to do business or to file a general consent
      to service of process in any such states or jurisdictions.

     

    (e) In
      the
      event of any underwritten public offering, enter into and perform its
      obligations under an underwriting agreement, in usual and customary form, with
      the managing underwriter(s) of such offering. Each Registration Rights Holder
      participating in such underwriting hereby agrees to also enter into and perform
      its obligations under such an agreement.

     

    (f) Notify
      the participating Registration Rights Holders (at any time when a prospectus
      relating to such registration statement is required to be delivered under the
      Securities Act) of the happening of any event as a result of which the
      prospectus included in such registration statement, as then in effect, includes
      an untrue statement of a material fact or omits to state a material fact
      required to be stated therein or necessary to make the statements therein not
      misleading in the light of the circumstances then existing. HAUSA will use
      reasonable efforts to amend or supplement such prospectus in order to cause
      such
      prospectus not to include 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 in light of the circumstances then
      existing.

     

    
      
        
        

      

      
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    (g) Cause
      all
      Registrable Securities registered pursuant hereunder to be listed on each
      securities exchange or trading system on which similar securities issued by
      HAUSA are then listed.

     

    3.4 Furnish
      Information.
      It
      shall be a condition precedent to the obligations of HAUSA to take any action
      pursuant to Section 3.3 that the Registration Rights Holders shall furnish
      to
      HAUSA such information regarding Registration Rights Holders, the Registrable
      Securities held by them, and the intended method of disposition of such
      securities as shall be required to timely effect the registration of their
      Registrable Securities.

     

    3.5 Delay
      in Registration.
      No
      Registration Rights Holder shall have any right to obtain or seek an injunction
      restraining or otherwise delaying any such registration as the result of any
      controversy that might arise with respect to the interpretation or
      implementation of this Section 3.

     

    3.6 Indemnification.
      In the
      event any Registrable Securities are included in a registration statement under
      Section 3.2:

     

    (a) By
      HAUSA.
      To the
      extent permitted by law, HAUSA shall indemnify and hold harmless each of the
      participating Registration Rights Holders and each of its partners, members,
      directors, officers and shareholders, any underwriter (as defined in the
      Securities Act) for any such Registration Rights Holder and each person, if
      any,
      who controls any such Registration Rights Holder or underwriter within the
      meaning of the Securities Act or the Securities Exchange Act of 1934, as
      amended, (the “1934
      Act”)
      (collectively, “Registration
      Rights Holder Indemnitees”),
      against any losses, claims, damages, or liabilities (joint or
      several) to
      which
      they (or any of them) may become subject under the Securities Act, the 1934
      Act
      or other federal or state law, insofar as such losses, claims, damages, or
      liabilities (or actions in respect thereof) arise out of or are based upon
      any
      of the following statements, omissions or violations (collectively a
“Violation”):

     

    (i) any
      untrue statement or alleged untrue statement of a material fact contained in
      such registration statement, including any preliminary prospectus or final
      prospectus contained therein or any amendments or supplements
      thereto;

     

    (ii) the
      omission or alleged omission to state therein a material fact required to be
      stated therein, or necessary to make the statements therein not misleading;
      or

     

    (iii) any
      violation or alleged violation by HAUSA of the Securities Act, the 1934 Act,
      any
      federal or state securities law or any rule or regulation promulgated under
      the
      Securities Act, the 1934 Act or any federal or state securities law in
      connection with the offering covered by such registration
      statement;

     

    
      
        
        

      

      
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    and
      HAUSA
      will reimburse each of the Registration Rights Holder Indemnitees for any legal
      or other expenses reasonably incurred by them, as incurred, in connection with
      investigating or defending any such loss, claim, damage, liability or action;
      provided,
      however,
      that
      the indemnity agreement contained in this Section 3.6(a) shall not apply to
      amounts paid in settlement of any such loss, claim, damage, liability or action
      if such settlement is effected without the consent of HAUSA (which consent
      shall
      not be unreasonably withheld, delayed or conditioned), nor shall HAUSA be liable
      in any such case for any such loss, claim, damage, liability or action to the
      extent that it arises out of or is based upon a Violation which occurs in
      reliance upon and in conformity with written information furnished expressly
      for
      use in connection with such registration by any Registration Rights Holder
      Indemnitees, including without limitation, any information furnished by the
      participating Registration Rights Holders to HAUSA pursuant to Section 3.4
      hereof.

    

    (b) By
      the
      Participating Registration Rights Holders.
      To the
      extent permitted by law, each participating Registration Rights Holder will
      indemnify and hold harmless HAUSA, each of its directors, each of its officers
      who have signed the registration statement, and each person, if any, who
      controls HAUSA within the meaning of the Securities Act or the 1934 Act
      (collectively, “Company
      Indemnitees”),
      against any losses, claims, damages or liabilities (joint or several) to which
      HAUSA or any such Company Indemnitee may become subject under the Securities
      Act, the 1934 Act or other federal or state law, but only insofar as such
      losses, claims, damages or liabilities (or actions in respect thereto) arise
      out
      of or are based upon any Violation, in each case to the extent (and only to
      the
      extent) that such Violation occurs in reliance upon and in conformity with
      written information furnished by such participating Registration Rights Holder
      expressly for use in connection with such registration, including without
      limitation, any information furnished by such participating Registration Rights
      Holder to HAUSA pursuant to Section 3.4 hereof; and such participating
      Registration Rights Holder will reimburse any legal or other expenses reasonably
      incurred by HAUSA or any such Company Indemnitee as incurred in connection
      with
      investigating or defending any such loss, claim, damage, liability or action;
      provided,
      however,
      that
      the indemnity agreement contained in this Section 3.6(b) shall not apply to
      amounts paid in settlement of any such loss, claim, damage, liability or action
      if such settlement is effected without the consent of such participating
      Registration Rights Holder which consent shall not be unreasonably withheld,
      delayed or conditioned; and provided
      further,
      that
      the total amounts payable in indemnity by any participating Registration Rights
      Holder under this Section 3.6(b) in respect of any Violation shall not
      exceed the net proceeds received by such participating Registration Rights
      Holder in the registered offering out of which such Violation
      arises.

     

    (c) Notice.
      Promptly after receipt by an indemnified party under this Section 3.6 of
      notice of the commencement of any action (including any governmental action),
      such indemnified party will, if a claim in respect thereof is to be made against
      any indemnifying party under this Section 3.6, deliver to the indemnifying
      party a written notice of the commencement thereof and the indemnifying party
      shall have the right to participate in, and, to the extent the indemnifying
      party so desires, jointly with any other indemnifying party similarly noticed,
      to assume the defense thereof with counsel mutually satisfactory to the parties;
      provided,
      however,
      that an
      indemnified party shall have the right to retain its own counsel, with the
      fees
      and expenses to be paid by the indemnifying party, if representation of such
      indemnified party by the counsel retained by the indemnifying party would be
      inappropriate due to actual or potential conflict of interests between such
      indemnified party and any other party represented by such counsel in such
      proceeding. The failure to deliver written notice to the indemnifying party
      within a reasonable time of the commencement of any such action, if prejudicial
      to its ability to defend such action, shall relieve such indemnifying party
      of
      any liability to the indemnified party under this Section 3.6, but the
      omission so to deliver written notice to the indemnifying party will not relieve
      it of any liability that it may have to any indemnified party otherwise than
      under this Section 3.6.

     

    
      
        
        

      

      
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    (d) Defect
      Eliminated in Final Prospectus.
      The
      foregoing indemnity agreements of HAUSA and the participating Registration
      Rights Holders are subject to the condition that, insofar as they relate to
      any
      Violation made in a preliminary prospectus but eliminated or remedied in the
      amended prospectus on file with the SEC at the time the registration statement
      in question becomes effective or the amended prospectus filed with the SEC
      pursuant to SEC Rule 424(b) (the “Final
      Prospectus”),
      such
      indemnity agreement shall not inure to the benefit of any person if a copy
      of
      the Final Prospectus was furnished to the indemnified party and was not
      furnished to the person asserting the loss, liability, claim or damage at or
      prior to the time such action is required by the Securities Act.

     

    (e) Contribution.
      If the
      indemnification provided for in this Section 3.6 is held by a court of competent
      jurisdiction to be unavailable to an indemnified party with respect to any
      loss
      or expense referred to herein, then the indemnifying party, in lieu of
      indemnifying the indemnified party, shall contribute to the amount paid or
      payable by such indemnified party with respect to such loss or expense in the
      proportion that is appropriate to reflect the relative fault of the indemnifying
      party and the indemnified party in connection with the statements or omissions
      that resulted in such loss or expense, as well as any other relevant equitable
      considerations. The relative fault of the indemnifying party and the indemnified
      party shall be determined by reference to, among other things, whether the
      untrue or alleged untrue statement of material fact or the omission to state
      a
      material fact relates to information supplied by the indemnifying party or
      by
      the indemnified party, and the parties’ relative intent, knowledge, access to
      information and opportunity to correct or prevent such statement or omission.
      In
      any such case, (A) no such Registration Rights Holder will be required to
      contribute any amount in excess of the net proceeds received from all such
      Registrable Securities offered and sold by such Registration Rights Holder
      pursuant to such registration statement; and (B) no person or entity guilty
      of
      fraudulent misrepresentation (within the meaning of Section 11(f) of the
      Securities Act) will be entitled to contribution from any person or entity
      who
      was not guilty of such fraudulent misrepresentation.

     

    (f) Conflict
      with Underwriting Agreement.
      Notwithstanding the foregoing, to the extent that the provisions on
      indemnification and contribution contained in any underwriting agreement entered
      into in connection with an underwritten public offering are in conflict with
      the
      foregoing provisions, the provisions in the underwriting agreement will
      control.

     

    
      
        
        

      

      
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    (g) Survival.
      The
      obligations of HAUSA and the participating Registration Rights Holders under
      this Section 3.6 shall survive the completion or termination of any
      offering of Registrable Securities in a registration statement.

     

    3.7 Rule
      144 Reporting.
      With a
      view to making available the benefits of certain rules and regulations of the
      Commission which may at any time permit the sale of the Registrable Securities
      to the public without registration, HAUSA agrees to:

     

    (a) Make
      and
      keep public information concerning HAUSA available, as those terms are
      understood and defined in Rule 144 under the Securities Act;

     

    (b) Use
      reasonable, diligent efforts to file with the Commission in a timely manner
      all
      reports and other documents required of HAUSA under the Securities Act and
      the
      1934 Act (at any time after it has become subject to such reporting
      requirements); and

     

    (c) So
      long
      as a Registration Rights Holder owns Registrable Securities, to furnish to
      such
      Registration Rights Holder upon request such information as the holder may
      reasonably request in availing itself of any rule or regulation of the
      Commission allowing a Registration Rights Holder to sell any such securities
      without registration.

     

    3.8 Assignment.
      Notwithstanding anything herein to the contrary, the registration rights of
      the
      Registration Rights Holders under Section 3 hereof may be assigned only to
      a party who acquires at least 200,000 shares of Registrable Securities,
provided,
      however
      that no
      party may be assigned any of the foregoing rights unless HAUSA is given written
      notice by the assigning party at the time of such assignment stating the name
      and address of the assignee and identifying the securities of HAUSA as to which
      the rights in question are being assigned; and provided further
      that any
      such assignee shall receive such assigned rights subject to all the terms and
      conditions of this Agreement.

     

    4. “MARKET
      STAND-OFF” AGREEMENT. Each
      Holder has previously entered into a “market stand-off agreement” with Arbios,
      either in the Investors’ Rights Agreement or in a stock purchase agreement.
      Arbios and the Holders hereby agree that all such existing market stand-off
      agreements shall terminate and become ineffective if and when the Merger is
      closed. 

     

    The
      parties hereto agree to the following market stand-off provisions, which
      provisions shall become effective if and when the Merger is closed. Each Holder
      hereby agrees that it shall not, to the extent requested by HAUSA or an
      underwriter of securities of HAUSA, sell, make any short sale of, loan, grant
      any option for the purchase of, or otherwise transfer or dispose of any Common
      Stock or other shares of stock of HAUSA then owned by such Holder (other than
      to
      transferees or partners of the Holder who agree to be similarly bound) for
      such
      period of time beginning on the date such Holder is notified in writing by
      HAUSA
      or the representative of the underwriters of HAUSA’s Common Stock that HAUSA
      proposes to file a registration statement under the Securities Act and ending
      on
      the date specified by HAUSA or the representatives of such underwriters, such
      period not to exceed ninety (90) days following the effective date of the
      registration statement of HAUSA filed under the Securities Act; provided,
      however,
      that
      (i) all executive officers and directors of HAUSA then holding Common Stock
      and
      (ii) each stockholder of HAUSA holding in the aggregate at least one percent
      (1%) of the total equity of HAUSA, enter into similar agreements.

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    In
      order
      to enforce the foregoing covenant, HAUSA shall have the right to place
      restrictive legends on the certificates representing the shares subject to
      this
      Section and to impose stop transfer instructions with respect to the Common
      Stock and such other shares of stock of each Holder (and the shares or
      securities of every other person subject to the foregoing restriction) until
      the
      end of such period. Each Holder further agrees to enter into any agreement
      reasonably required by the underwriters to implement the foregoing within any
      reasonable timeframe so requested.

     

    5. AMENDMENT
      OF FOUNDER’S AGREEMENTS; VESTING OF STOCK
      Arbios
      and the Holders hereby agree that the Repurchase Option and the Right of First
      Refusal (as such terms are defined in the Founder’s Agreements) shall be
      terminated effective immediately prior to the effectiveness of the Merger.
      Accordingly, the parties to this Agreement hereby agree that, effective
      immediately prior to the Merger, (i) the vesting periods of all of the shares
      of
      Arbios common stock owned by each of the Founders (or their assignees) shall
      be
      accelerated and all such shares shall become fully Vested Shares (as defined
      in
      the Founder’s Agreements), (ii) the Repurchase Option and the Right of First
      Refusal, and all of the other provisions of Sections 5 and 6 of the Founder’s
      Agreements, shall become null and void and shall be deemed to be deleted from
      those agreements, and (iii) Arbios, as the Escrow Holder, shall release any
      of
      the Founders’ shares then held in escrow pursuant to the Founder’s Agreements.
      The parties to this Agreement further agree that the certificates representing
      the Common Stock issuable to the Founders following the Merger shall not bear
      any legend referring to the Repurchase Option and the Right of First
      Refusal.

     

    6. TERMINATION
      This
      Agreement shall automatically terminate in the event that the Merger has not
      been consummated on or before October 31, 2003.

     

    7. MISCELLANEOUS

     

    7.1 Entire
      Agreement Superseding Prior Agreements.
      This
      Agreement constitutes and contains the entire agreement and understanding of
      the
      parties with respect to the subject matter hereof and supersedes any and all
      prior negotiations, correspondence, agreements, understandings, duties or
      obligations, both written or oral, between the parties with respect to the
      subject matter hereof. Specifically, this Agreement amends, restates and
      supersedes in whole the Existing Stockholders’ Agreement and the Investors’
Rights Agreement.

     

    7.2 Amendments
      of Rights and Waivers.
      Any
      provision of this Agreement may be amended, and the observance thereof may
      be
      waived (either generally or in a particular instance and either retroactively
      or
      prospectively), only with the written consent of Arbios, HAUSA and Registration
      Rights Holders holding at least 50% of the then Registrable Securities then
      outstanding. Notwithstanding the foregoing, however, in the event that any
      proposed amendment or waiver of any provision of this Agreement adversely
      affects the rights or remedies of the Junior Preferred Investor, then such
      amendment or waiver shall also require the written consent of the Junior
      Preferred Investor. 

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    7.3 Successors
      And Assigns.
      Subject
      to the provisions of Section 4 hereof, the terms and conditions of this
      Agreement shall inure to the benefit of, and shall be binding upon, the
      respective successors and permitted assigns of the parties hereto.

     

    7.4 Governing
      Law.
      This
      Agreement shall be governed by and construed exclusively in accordance with
      the
      internal laws of the State of Delaware as applied to agreements among Delaware
      residents entered into and to be performed entirely within Delaware excluding
      that body of law relating to conflict of laws and choice of law.

     

    7.5 Severability.
      If one
      or more provisions of this Agreement are held to be unenforceable under
      applicable law, such provision(s) shall be excluded from this Agreement and
      the
      balance of the Agreement shall be interpreted as if such provision(s) were
      so
      excluded and shall be enforceable in accordance with its terms.

     

    7.6 Notices.
      Unless
      otherwise provided, any notice required or permitted under this Agreement shall
      be given in writing and shall be deemed effectively given upon personal delivery
      to the party to be notified or five (5) days after deposit with the United
      States Post Office by registered or certified mail, postage prepaid and
      addressed as follows: (i) If to the Holders, at their addresses indicated on
      signature page of this Agreement; and (ii) if to HAUSA (after the Merger),
      at
      its principal executive offices, or (iii) in each case at such other address
      as
      any party may designate by giving ten (10) days advance written notice to all
      other parties.

     

    7.7 Headings.
      The
      headings or captions to sections used in this Agreement are used for convenience
      only and are not to be considered in construing or interpreting this
      Agreement.

     

    7.8 Costs
      and Attorneys’ Fees.
      If any
      action at law or in equity is instituted concerning or arising out of this
      Agreement or any transaction contemplated hereunder, the prevailing party shall
      recover all of such party's costs and reasonable attorneys' fees and
      disbursements incurred in each such action, including any and all appeals or
      petitions therefrom, in addition to any other relief to which such party may
      be
      entitled.

     

    7.9 Third
      Parties.
      Nothing
      in this Agreement, express or implied, is intended to confer upon any person,
      other than the parties hereto and their successors and assigns, any rights
      or
      remedies under or by reason of this Agreement.

     

    7.10 Adjustments
      for Stock Splits, Etc.
      Wherever in this Agreement there is a reference to a specific number of shares
      of Common Stock of HAUSA of any class or series, then, upon the occurrence
      of
      any subdivision, combination or stock dividend of such class or series of stock,
      the specific number of shares so referenced in this Agreement shall
      automatically be proportionally adjusted to reflect the effect on the
      outstanding shares of such class or series of stock by such subdivision,
      combination or stock dividend.

     

    7.11 Aggregation
      of Stock.
      All
      shares held or acquired by affiliated entities or persons shall be aggregated
      together for the purpose of determining the availability of any rights under
      this Agreement.

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

    7.12 Counterparts.
      This
      Agreement may be executed in two or more counterparts, and signature pages
      may
      be delivered by facsimile, each of which shall be deemed an original, but all
      of
      which together shall constitute one and the same instrument.

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

    

    IN
      WITNESS WHEREOF, the Holders, Arbios and HAUSA have caused this OMNIBUS
      STOCKHOLDERS’ AGREEMENT to be duly executed as of the date first written
      above.

     

     

    
      	Achilles
              A. Demetriou	 	Kristin
              P. Demetriou
	Achilles A. Demetriou, M.D., Ph.D.,
              as	 	Kristin P. Demetriou, as Trustee of
              Trustee
              of
	the A & K Demetriou Family
              Trust	 	the
              A & K Demetriou Family Trust
	created on November 13, 2000	 	created on November 13, 2000
	2331 Buckingham Lane	 	2331
              Buckingham Lane
	Los Angeles, California 90077	 	Los Angeles, California
              90077

    

     

     

    
      
        	
                Jacek
                  Rozga

              	 	
                Joanna
                  Rozga

              
	
                Jacek
                  Rozga, M.D., Ph.D.

              	 	
                Joanna
                  Rozga

              
	
                2385
                  Roscomare Road, Unit F-16

              	 	
                2385
                  Roscomare Road, Unit F-16

              
	
                Los
                  Angles, California 90077

              	 	
                Los
                  Angeles, California 90077

              

      

    

     

     

    
      
        	
                Arbios
                  Technologies, Inc.

              	 	
                Historical
                  Autographs U.S.A., Inc.

              
	 	 	 
	
                By:
Jacek
                  Rozga 

              	 	
                By:
                  Cindy
                  K. Swank 

              
	
                Name:
                  Jacek
                  Rozga 

              	 	
                Name:
                  Cindy
                  K. Swank 

              
	
                
                  Title:
                    President 

                

              	 	
                
                  Title:
                    President
                    & Director 

                

              

      

    

     

     

    
      	
              
                Cedars-Sinai
                  Medical Center

              

            	 	
              
                Spectrum
                  Laboratories, Inc.

              

            
	 	 	 
	
              By:
Shlomo
                Melmed

            	 	
              By:
Roy
                Eddleman

            
	
              Name: Shlomo
                Melmed, M.D.

            	 	
              Name:
                Roy Eddleman

            
	
              
                
                  Title: Senior
                    Vice President

                   
                    for Academic Affairs

                

              

            	 	
              
                Title:
                  Chief Executive Officer

              

            
	 	 	 
	 	 	 
	By:
Edward
              Prunchunas	 	c/o
              Roy T. Eddleman
	Name: Edward
              M. Prunchunas	 	18617 Broadwick
              Street
	Title: Senior
              Vice President	 	
              Rancho
                Dominguez, California 90220 

            
	
               
for
                Finance and CFO

            	 	 
	Address: 8700
              Beverly Boulevard	 	 
	
               Room
                2211

            	 	 
	
               Los
                Angeles, CA 90048-1865

            	 	 
	 	 	 

    

     

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

     

    SCHEDULE
      A

     

    
      	
              NAME
                OF REGISTRATION

              RIGHTS
                HOLDERS

            	 	
              NUMBER
                OF SHARES

              OF
                COMMON STOCK

              OWNED
                IMMEDIATELY AFTER THE MERGER

            
	
              Achilles
                A. Demetriou, M.D., Ph.D, and Kristin P. Demetriou, as Trustees of
                the A
                & K Demetriou Family Trust

            	 	
              2,500,000

            
	 	 	 
	
              Jacek
                Rozga, M.D., Ph.D. and Joanna Rozga

            	 	
              2,500,000

            
	 	 	 
	
              Cedars-Sinai
                Medical Center

            	 	
              681,818

            
	
               

            	 	 

    

     

    
      
         

      

      
        14Portions
        of this Exhibit were omitted and have been filed separately with the Secretary
        of the Commission 

      pursuant
        to the Company’s application requesting confidential treatment under
        Rule 24b-2 of the Exchange Act

    

    
 

    Exhibit
      10.26

    
 

    MANUFACTURING
      & SUPPLY AGREEMENT

    

    BETWEEN

    

    ARBIOS
      SYSTEMS, INC.

    AND

    

    NXSTAGE
      MEDICAL, INC.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    THIS
      AGREEMENT is
      made
      this 19th day of October, 2007 (the “Effective Date”) between

    

    
      	
              (1)

            	
              NxStage
                Medical, Inc.,
                a
                corporation organized under the laws of the State of Delaware and
                having a principal place of business at 439 South Union Street,
                5th
                Floor, Lawrence, MA 01843, USA (together with its Affiliates, “NxStage”)
                and

            

    

    

    
      	
              (2)

            	
              Arbios
                Systems, Inc.,
                a
                corporation organized under the laws of the State of Delaware and
                having a
                principal place of business at 1050 Winter Street, Suite 1000, Waltham,
                MA
                02451, USA (together with its Affiliates, “Arbios”),
                

            

    

    

    each
      a
“Party” and collectively the “Parties”

    

    WHEREAS
      Arbios wishes to appoint NxStage as the manufacturer of certain of its products
      and NxStage wishes to be appointed as manufacturer of certain of Arbios’
products; and

    

    WHEREAS
      Arbios and NxStage intend to implement this Agreement to effect such appointment
      subject to the terms and conditions set forth herein.

    

    IT
      IS HEREBY AGREED AS FOLLOWS:

    

    1. DEFINITIONS
      

    

    In
      this
      Agreement the following expressions shall unless the context otherwise requires
      have the following meanings, that is to say:

    

    “Affiliate”
      means any company, partnership or other entity which directly or indirectly
      controls, is controlled by or is under common control with the Party in question
      and for the purposes of this definition the term control shall mean the
      ownership of not less than fifty percent (50%) of the equity of such company,
      partnership or other entity, or the power to direct the policies and management
      of such company, partnership or other entity.

    

    “Agreement”
      means this Manufacturing Agreement as amended, restated or otherwise modified
      from time to time.

    

    “Applicable
      Law” means all material applicable ordinances, rules, regulations, laws,
      guidelines, guidances, requirements and court orders.

    

    “Arbios
      Know-How” means any and all Know-How owned or used by Arbios or its Affiliates
      in relation to the Product(s) or the Manufacture thereof prior to or after
      the
      Effective Date.

    

    “Arbios
      Intellectual Property” means all Intellectual Property Rights owned or used by
      Arbios or its Affiliates in relation to the Product(s) prior to or after the
      Effective Date, and shall include Arbios Know-How.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    “Certificate
      of Conformance” means a document signed by an authorized representative of
      NxStage, which certifies that Product was Manufactured in accordance with the
      Specifications. 

     

    “Change
      of Control” means each and all of the following occurrences (with “the Company”
used for purposes of this definition to refer to either Arbios or NxStage,
      as
      the case may be): 

     

    
      	 	 	
              (i)
                The stockholders of the Company approve a merger or consolidation
                of the
                Company with any other corporation, other than a merger or consolidation
                which would result in the voting securities of the Company outstanding
                immediately prior thereto continuing to represent (either by remaining
                outstanding or by being converted into voting securities of the surviving
                entity or its parent company) more than fifty percent (50%) of the
                total
                voting power represented by the voting securities of the Company
                or such
                surviving entity, or its parent company, outstanding immediately
                after
                such merger or consolidation, or the stockholders of the Company
                approve a
                plan of complete liquidation of the Company or an agreement for the
                sale
                or disposition by the Company of all or substantially all the Company's
                assets. 

            

    

     

    
      	 	 	
              (ii)
                The acquisition by any Person as Beneficial Owner, directly or indirectly,
                of securities of the Company representing fifty percent (50%) or
                more of
                the total voting power represented by the Company's then outstanding
                voting securities. 

            

    

     

    
      	 	 	
              Any
                other provision of this Section notwithstanding, the term Change
                in
                Control shall not include either of the following events undertaken
                at the
                election of the Company: 

            

    

     

    
      	 	 	
              (x)
                Any transaction, the sole purpose of which is to change the state
                of the
                Company's incorporation; 

            

    

     

    
      	 	 	
              (y)
                A transaction, the result of which is to sell all or substantially
                all of
                the assets of the Company to another corporation (the "surviving
                corporation"); provided that the surviving corporation is owned directly
                or indirectly by the stockholders of the Company immediately following
                such transaction in substantially the same proportions as their ownership
                of the Company's Common Stock immediately preceding such transaction;
                and
                provided, further, that the surviving corporation expressly assumes
                this
                Agreement. 

            

    

     

    “Commercial
      Launch” means the first commercial sale of Product by Arbios following Product
      Approval.

     

    “Competing
      Product” means any filter-based medical device which
      is
      not a Product and which is promoted,
      indicated and/or FDA (or similarly outside the US) approved
      for use
      in the Exclusive Field. The parties expressly agree that Competing Product
      shall
      not include any product FDA (or similarly outside the US) approved for the
      treatment of end stage renal disease, acute kidney failure or fluid overload,
      even if such product is also used in the Exclusive Field in the absence of
      promotion, indication or regulatory approval. 

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    “Confidential
      Information” means, without limitation, any and all current and future
      proprietary product information, technical, financial, employment related,
      regulatory or legally sensitive information, customer names, addresses and
      related data, contracts, practices, procedures, software, hardware, files and
      other business information including but not limited to specifications,
      compounds, ingredients, formulae, recipes, samples, reports, methods,
      strategies, plans, documents, drawings, machines, tools, models inventions,
      patent disclosures and materials that may be disclosed between the Parties
      heretofore or hereafter whether received, obtained or developed as a result
      of
      entering into or performing this Agreement and whether in written, oral,
      electronic, website-based or other form including information obtained during
      facility tours but shall not include information which:

    

    
      	 	
              (a)

            	
              is
                in the public domain at the date of this Agreement or subsequently
                comes
                into the public domain otherwise than through breach of the terms
                of this
                Agreement by the recipient;

            

      	 	 	 

    

    
      	 	
              (b)

            	
              the
                receiving Party can prove was in its possession at the date of disclosure
                or which subsequently comes into its possession without in either
                case
                being subject to any obligation of confidentiality to the disclosing
                Party; or

            

      	 	 	 

    

    
      	 	
              (c)

            	
              can
                be demonstrated to have been developed independently by the recipient
                without the aid of or reference to information disclosed to the recipient
                hereunder.

            

    

    

    “Cost” means
      the
      actual cost incurred by NxStage calculated in accordance with GAAP (generally
      accepted accounting principles) and using the normal standard cost accounting
      and allocation methods and procedures of NxStage consistently applied.
 

    

    “Delivery
      Date” means the date for the delivery of Product to the shipping destination as
      stated in the applicable purchase order for such shipment.

    

    “Effective
      Date” means the date first above written.

    

    “Exclusive
      Field” means the treatment of liver disease, multi-organ failure and/or
      sepsis.

    

    “Exclusive
      Period” means the period from the Effective Date until the fifth anniversary of
      the date of first Product Approval authorizing Commercial Launch of the
      Product.

    

    “FDA”
      means the United States Food and Drug Administration or any successor
      thereto.

    

    “FD&C
      Act” means the United States Federal Food, Drug and Cosmetic Act, as
      amended.

    

    “Fiber
      Bundles” shall mean polyethersulfone fiber bundles to be provided to NxStage by
      or on behalf of Arbios for use in Manufacturing Product for Arbios
      hereunder.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    “Force
      Majeure” means any circumstances beyond the
      reasonable control of a Party including, without limitation, flood, war,
      terrorism, insurrection, acts of God, governmental action or inaction, accident,
      strike, fire or explosion which are not the result of the other Party’s
      negligence.

    “Intellectual
      Property Rights” 
      means
      all rights in and to Confidential Information and Know-How, patents (including
      applications therefor and supplementary protection certificates) copyrights,
      trademarks, service marks or similar rights. 

    

    “Know-How”
      means data, knowledge, techniques, inventions, designs, drawings, health and
      safety information including without limitation material safety data sheets,
      tests, reports, procedures, processes, models, manuals, formulae, systems,
      experiments, samples, specimens, results, statistics, research, tables of
      operating conditions and the like and all other know-how and information and
      including without limitation:

    

    
      	 	
              (a)

            	
              analytical
                standards for analysis of Products and Raw Materials and/or the
                manufacture thereof;

            

      	 	 	 

    

    
      	 	
              (b)

            	
              in-process
                quality assurance standards and methods of
                production;

            

      	 	 	 

      	 	(c) 	hazard data, storage requirements and manufacturing
              records;

      	 	 	 

      	 	(d) 	validation protocols and reports;
              and

    

     

    
      	 	
              (e)

            	
              safety
                procedures, manuals and systems, process parameters; and Batch
                records.

            

    

    

    “Manufacture”
      has the meaning set forth in Section 3.1 below.

    

    “NxStage
      Know-How” means any and all Know-How owned or used by NxStage or its Affiliates
      prior to or after the Effective Date.

    

    “NxStage
      Intellectual Property” means all Intellectual Property Rights owned or used by
      NxStage or its Affiliates prior to or after the Effective Date, and shall
      include all NxStage Know-How. 

    

    “Packaging
      Specifications” means the packaging and labeling specifications for the Product
      attached hereto as Attachment
      A,
      as such
      specifications may be amended from time to time by mutual agreement of the
      Parties.

    

    “Plant” 
      means
      the premises of NxStage’s Affiliate, NxStage GmbH, situated in Rosdorf, Germany,
      NxStage Medical in Lawrence, or such other facility of NxStage as is approved
      by
      Arbios in writing for the purpose of Manufacture hereunder, which approval
      shall
      not be unreasonably held.

    

    “Product”
      means Arbios’ SEPET medical device in finished, packaged form meeting the
      relevant Specifications, or any successor medical
      device
      developed, marketed, licensed or sold by Arbios or its Affiliates or Third
      Parties on behalf of Arbios
      having
      substantially similar specifications,
      for use
      in the Exclusive Field.

    

    “Product
      Approval” means written FDA approval authorizing the sale of Arbios’ Product,
      together with any supplements thereto or equivalent thereof outside the
      U.S.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    “Product
      Specifications” means the specifications for the Product attached hereto as
Attachment
      B
      including a bill of materials and references to any manufacturing SOPS and
      process specifications, as such specifications may be amended from time to
      time
      by mutual written agreement of the Parties, including without limitation such
      amendments as may be required to obtain Product Approval.

    

    “Quality
      Control Specifications” (“QCS”) means the Quality Control Specifications
      relating to the Product and incorporated herein, as may be amended, restated
      or
      otherwise modified from time to time attached hereto as Attachment
      C.

    

    “Raw
      Materials” means, in relation to each Product, the components and packaging
      materials used in the Manufacture thereof, but excluding the Fiber
      Bundles.

    

    “Raw
      Material Specifications” means the specifications relating to the procurement,
      handling, warehousing, and storage of Raw Materials attached hereto as
Attachment
      D,
      as such
      specifications may be amended from time to time by mutual agreement of the
      Parties.

    

    “Records”
      shall have the meaning provided in Section 3.5.5 hereof.

    

    “Regulatory
      Standards” means the principles detailed in FDA
      Quality System Regulation (21CFR, Part 820), ISO 13485:2003, Quality Systems
      for
      Medical Devices, and Medical Device Directive (MDD 93/42/EEC) , as amended
      or
      updated from time to time.

    

    “Requirements”
      means any of Arbios’, or its Affiliates’, successors’, assigns’, licensees’,
      agents’, distributors’ or contractees’, requirements for sales, use
      (other
      than research use),
      and
      inventory of Product.

    

    “SEPET”
      means Selective Exchange Plasma Therapy technology, which is proprietary to
      Arbios.

    

    “Specification”
      means each of the following as they relate to Raw Materials and/or Product
      as
      appropriate:

    

    (a) the
      Product Specifications,

     

    (b) the
      Raw
      Material Specifications

     

    (c) the
      Packaging Specifications,
      or

     

    (d) the
      Quality
      Control
      Specifications,

    

    each
      as
      set forth in the attachments hereto and as may be amended, restated or otherwise
      modified from time to time by mutual written agreement of the
      Parties.
      

    

    “Stock-out”
      means any point in time that Arbios has no inventory of Product on hand.

    

    “Third
      Party” means any person, or entity other than the Parties to this
      Agreement.

    

    “Unit”
      means one unit of Product in finished and packaged form.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    “Unit
      Price” means the Price of a Unit identified in Attachment
      E,
      as
      otherwise modified pursuant to the terms hereof. 

    

    “Year”
      means the period from the Effective Date to December 31, 2007 and each
      subsequent calendar year thereafter beginning January 1, 2008 during the term
      of
      this Agreement or any extension thereof.

    

    2. COOPERATION
      BETWEEN THE PARTIES

    

    Arbios
      and NxStage shall each cooperate with one another to establish general oversight
      and management of certain aspects of implementation of Manufacture and quality
      control during the course of this agreement through each Party’s designated
      representatives, whether employees, consultants or Affiliates. Without prejudice
      to the generality of the foregoing, the Parties shall work together
      to:

    

    
      	
              2.1

            	
              oversee
                the timing and implementation of relevant phases of Manufacture in
                relation to the Product; including as needed, obtaining expert consultants
                to assist in the process optimization;
                and

            

    

    

    
      	
              2.2

            	
              review
                the operation of this Agreement including with regard to volume forecasts,
                and technical and pricing issues in accordance with the terms
                hereof.

            

    

    

    3. MANUFACTURE
      AND SUPPLY OF PRODUCTS AND RAW MATERIALS 

    

    
      	
              3.1

            	
              General.
                During the Exclusive Period, NxStage shall Manufacture (as defined
                below)
                100% of all Requirements for Product. NxStage shall conduct for Arbios
                the
                production, manufacturing, testing and packaging (“Manufacture”) of
                Product according to the Specifications, and the other provisions
                of this
                Agreement and shall supply Product to Arbios in accordance with the
                terms
                hereof. Product shall be Manufactured and supplied in accordance
                with the
                following provisions:

            

    

    

    
      	 	
              3.1.1

            	
              Subject
                to the terms and conditions hereof, during the Exclusive Period,
                NxStage
                shall Manufacture all Requirements for Product, and Arbios shall
                purchase
                all of its Requirements of Product from NxStage.
                

            

    

    
      	 	
              3.1.2

            	
              During
                the term of this Agreement, NxStage shall not Manufacture, supply
                or sell
                Product for or to or any Third Party or sell Product itself. NxStage
                shall
                notify Arbios in writing at least [ * ] days prior to knowingly engaging
                in the Manufacture, supply or sale of a Competing Product for or
                to any
                Third Party, or selling any such Competing Product itself, and shall
                promptly notify Arbios upon becoming aware of any such event of which
                NxStage did not have [ * ] days prior
                notice.

            

    

    

    
      	 	
              3.1.3

            	
              During
                the term of this Agreement, unless otherwise provided in Section
                13.1,
                Arbios agrees that it will not itself enter into any arrangement,
                or
                directly or indirectly enter into any arrangement with a Third Party,
                or
                solicit or encourage any Third Party to enter into any arrangement,
                whereby access for NxStage’s customers in the U.S. to an open system
                configuration of the Product would be precluded.
                

            

    

     

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
 

    
      	 	
              3.1.4

            	
              All
                Product shall be Manufactured by NxStage at its Plants in accordance
                with
                the Product Specifications, using the Fiber Bundles to be provided
                by
                Arbios. 

            

    

    

    
      	 	
              3.1.5

            	
              Product
                will be supplied to Arbios in non-sterile form and the Parties agree
                that
                NxStage shall have no obligation to supply products hereunder which
                would
                require NxStage to register its Plant in Germany with the
                FDA.

            

    

    

    
      	 	
              3.1.6

            	
              NxStage
                shall assist Arbios in compiling a design history file for the Product
                at
                Arbios’ expense. Arbios shall be responsible for maintenance of the design
                history file.

            

    

    

    
      	 	
              3.1.7

            	
              NxStage
                shall conduct quality control testing, as set forth in the
                QCS.  

            

    

    

    
      	 	
              3.1.8

            	
              NxStage
                shall have sole responsibility for disposing of all waste Product
                and
                other wastes arising from Manufacture in accordance with all Applicable
                Laws. Arbios shall advise NxStage on waste disposal issues unique
                to the
                Fiber Bundles.

            

    

    

    
      	 	
              3.1.9

            	
              In
                the event Arbios fails to purchase all of its Requirements for Product
                from NxStage
                to
                the extent required pursuant to this Agreement,
                in addition to any other remedies NxStage may have hereunder, Arbios
                shall
                pay NxStage a fee equal to [ * ] percent ([ * ]%) of the then-current,
                or
                most recent, Product purchase price hereunder, whichever is higher,
                for
                each Product obtained from another source, including without limitation,
                Product manufactured by Arbios.
                Any payments made hereunder shall be creditable against any shortfall
                payment due to NxStage pursuant to Section
                4.4.

            

    

    

    
      	 	
              3.1.10

            	
              Each
                Party
                shall have the right, no more than [ * ] during any calendar year
                hereunder, to have an independent Third
                Party
                audit the
                other Party’s
                records to ensure its compliance with,
                for Arbios,
                its exclusive purchase obligations hereunder
                and, for NxStage, its obligations under Section
                3.1.2.

            

    

    

    
      	 	
              3.2

            	
              Pricing.
                The Unit Price and other charges to be paid by Arbios for the Product
                are
                set forth in Attachment
                E.
                

            

    

    

    
      	 	
              3.3

            	
              Starting
                Materials.
                

            

    

    

    
      	 	
              3.3.1

            	
              All
                Raw Materials required for the Manufacture of Product shall be acquired
                by
                NxStage from Third Parties. Arbios shall be promptly notified in
                writing
                of any changes in any Raw Materials or a change in suppliers which
                occurs
                after the Effective Date. 

            

    

     

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
 

    
      	 	
              3.3.2

            	
              All
                Fiber Bundles required for the Manufacture of Product shall be provided
                by
                Arbios to the Plant in such quantity and quality, at such times,
                and in
                accordance with the relevant Specifications, in order to enable NxStage
                to
                perform its obligations hereunder without delay. The Parties shall
                mutually agree on specific procedures for the supply and handling
                of Fiber
                Bundles prior to the first shipment thereof to NxStage.
                

            

    

    

    
      	 	
              3.3.3

            	
              Arbios
                will at all times retain title to and ownership of the Fiber Bundles.
                Arbios further represents and warrants that at all times during the
                term
                of this Agreement, the supplier of the Fiber Bundles shall distinguish
                the
                Fiber Bundles through some visual means that are readily apparent
                to the
                naked eye so that NxStage employees and representatives can easily
                observe
                the difference between the Fiber Bundles and other fiber bundles
                routinely
                used by NxStage in the manufacture of filters at its Plant. NxStage
                will
                provide within the Plant an area or areas where the Fiber Bundles
                are
                segregated in such a way as to be able at all times to clearly distinguish
                such materials from products and materials belonging to NxStage,
                or held
                by it for a Third Party's account. NxStage will at all times use
                commercially reasonable efforts to protect the Fiber Bundles from
                risk of
                loss or damage at all stages of Manufacture. NxStage will ensure
                that the
                Fiber Bundles are free and clear of any liens or encumbrances, except
                as
                may be imposed on Arbios or its assets by any Third Party. NxStage
                will
                within [ * ] business days notify Arbios if at any time it believes
                any
                Fiber Bundles have been damaged, lost or stolen. 

            

    

    

    
      	 	
              3.3.4

            	
              NxStage
                agrees (a) to account for all Fiber Bundles delivered to NxStage,
                (b) not
                to provide Fiber Bundles to any Third Party without the express prior
                written consent of Arbios, (c) not to use Fiber Bundles for any purpose
                other than conducting the Manufacture of Products for Arbios hereunder,
                including, without limitation, not to analyze, characterize, modify
                or
                reverse engineer any Fiber Bundles or take any action to determine
                the
                structure or composition of any Fiber Bundle unless required pursuant
                to
                this Agreement, and (d) to return to Arbios all unused quantities
                of Fiber
                Bundles upon request. 

            

    

    

    
      	 	
              3.3.5

            	
              NxStage
                agrees to conduct testing of the Fiber Bundles, as set forth in the
                Specifications. Arbios agrees that it shall be responsible for all
                Fiber
                Bundle scrap, including scrap caused by Fiber Bundle leaks, and that
                it
                shall pay NxStage [ * ] times the then-current price of the Product
                for
                each Fiber Bundle that is found to leak after incorporation in a
                Product
                for which Manufacture hereunder has been completed, and a mutually
                agreed
                upon [ * ] amount for all other Fiber Bundles scrapped due to other
                causes, depending upon the level of manufacturing conducted by NxStage
                prior to the point of scrapping. Notwithstanding the foregoing, NxStage
                agrees that Arbios shall not be responsible for scrapping caused
                by the
                negligence or willful misconduct of NxStage. The Parties expect that
                Fiber
                Bundle scrap hereunder shall not exceed [ * ]% of the total supplied
                Fiber
                Bundles, where scrap is determined based on fiber leakage (integrity);
                provided that NxStage shall not be liable for scrapping in excess
                of this
                rate, except where scrapping is caused by the negligence or willful
                misconduct of NxStage. NxStage shall cooperate with Arbios, as reasonably
                requested and at Arbios’ expense, in efforts to seek refunds or credits
                from Arbios’ Fiber Bundle supplier for scrap, including without limitation
                by retaining for a reasonable period and/or providing, at Arbios’ expense,
                scrap to any site as reasonably directed by
                Arbios.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	 	
              3.4

            	
              Specification
                Changes.
                Either Party may from time to time request changes to the Specifications;
                provided that no change may be made without the prior written agreement
                of
                the Parties. Arbios understands and agrees that if any such change
                to the
                Specifications would be, in the sole opinion of NxStage, unduly burdensome
                or inconsistent with its business interests, NxStage shall have no
                obligation to agree to, or implement, such Specification change;
                provided,
                however, that the
                Parties will work together in good faith to come to agreement on
                any such
                change in Specifications. In the event that, within [ * ]) days of
                any
                notice to NxStage by Arbios requesting a change to Specifications,
                which
                includes the reasons therefor, the Parties, despite good faith
                negotiations, cannot agree on terms for the supply of Product meeting
                such
                changed Specifications on terms and conditions reasonably similar
                to those
                specified herein (it being understood that changes in Specifications
                may
                require changes in price),
                Arbios shall have the right to terminate this Agreement
                on
                at least [ * ]days prior written notice to NxStage; provided that
                following any such termination, Arbios shall not be permitted to
                manufacture or purchase Product meeting any previously agreed
                Specifications from any Third Party;
                and provided further that no Third Party may supply Product meeting
                such
                changed Specifications on terms not materially more favorable to
                Arbios
                than those offered by NxStage prior to such Agreement termination.
                

            

    

    
      	 	
              3.5

            	
              Prior
                to implementing any agreed-to changes to the Specifications, the
                Parties
                agree to negotiate in good faith in an attempt to reach agreement
                on (a)
                the new Unit Price which embodies such change, giving due consideration
                solely to the effect thereof on NxStage’s direct Manufacturing Costs for
                the Product and (b) any other amendments to this Agreement which
                may be
                necessitated by such changes (i.e., an adjustment to the lead time
                for
                purchase orders). 

            

    

    

    
      	 	
              3.6

            	
              Regulatory
                Matters; Audits.

            

    

    

    
      	 	
              3.6.1

            	
              Arbios
                will be responsible for obtaining, at its expense, all regulatory
                and
                governmental approvals and permits necessary for Arbios’ use of any
                Product Manufactured under this Agreement. NxStage will be responsible
                for
                providing Arbios, at Arbios’ expense, with all supporting data and
                information relating to the Manufacture of Product reasonably necessary
                for obtaining such approvals, including, without limitation, all
                Records,
                raw data, reports, authorizations, certificates, methodologies, raw
                material specifications, SOPs, standard test methods, Certificates
                of
                Analysis and other documentation in the possession or under the control
                of
                NxStage relating to the Manufacture of Product (or any component
                thereof).
                All such information provided by NxStage shall be deemed Confidential
                Information of NxStage;
                provided, however, that information, such as Certificates of Analysis,
                which is reasonably required to be disclosed to regulatory agencies
                including the FDA in connection with the development, approval, use
                or
                sale of Products by or on behalf of Arbios, shall not be deemed NxStage
                Confidential Information.
                All Confidential Information of NxStage is
                subject to Section 7 hereof. Arbios will,
                to the extent reasonable,
                seek confidential treatment for any Confidential Information of
                NxStage.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	 	
              3.6.2

            	
              NxStage,
                at its sole expense,
                will be responsible for performing all validation of its Plants,
                equipment
                and cleaning and maintenance processes employed in the Manufacture
                of
                Product in accordance with Regulatory Standards, Manufacturer’s SOPs, the
                QCS, and Applicable Law.

            

    

    

    
      	 	
              3.6.3

            	
              NxStage,
                in accordance with Applicable Law, shall permit representatives of
                any
                regulatory agency having jurisdiction over the Manufacture or marketing
                of
                Product to inspect its facilities in conjunction with the Manufacture
                of
                Product. NxStage will give as much advance notice as possible to
                Arbios of
                any such visit or inspection which involves the facility, equipment
                or
                processes used to manufacture the Product. NxStage will provide to
                Arbios
                a copy of any report or other written communication received from
                such
                regulatory authority in connection with such visit or inspection,
                and any
                written communication received from any regulatory authority relating
                to
                any Product or the Plant (if it relates directly to or affects directly
                the Manufacture of Product), within [ * ] after receipt thereof,
                and will
                consult with, Arbios before responding to each such communication.
                NxStage
                will provide Arbios with a copy of its final responses within [ *
                ])
                business days after submission thereof, again, if it relates directly
                to
                or affects directly the Manufacture of Product.

            

    

    

    
      	 	
              3.6.4

            	
              Arbios
                shall have the right to hire an independent third party quality auditor,
                not affiliated with Arbios or NxStage, and reasonably acceptable
                to
                NxStage, who shall, at reasonable times and upon prior notice in
                writing
                with representatives of NxStage present, visit the Plant no more
                than [ *
                ] per year (but more often if Arbios has reasonable cause for concern
                of a
                material non-compliance by NxStage with
                its obligations hereunder),
                to review quality control procedures and NxStage’s compliance with this
                Agreement, including, without limitation, inspection of (i) the equipment
                and materials used in the Manufacture of Product, and (ii) all Records
                relating to such Manufacture. Any such independent third party quality
                auditor shall not disclose NxStage Know-How to Arbios in connection
                with
                these activities, including without limitation, NxStage Know-How
                relating
                to manufacturing processes.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
 

    
      	 	
              3.6.5

            	
              NxStage
                will keep complete and accurate records of all work done by it under
                this
                Agreement, in form and substance as specified in the QCS, as required
                by
                the Regulatory Standards, Applicable Law, and/or as required by this
                Agreement (collectively, the “Records”). Subject to Section 7.2, NxStage
                will not transfer, deliver or otherwise provide any such Records
                to any
                party other than Arbios, without the prior written approval of Arbios.
                Records will be available at reasonable times for inspection, examination
                and copying by or on behalf of Arbios. All original Records of the
                Manufacture of Product under this Agreement will be retained and
                archived
                by NxStage in accordance with Regulatory Standards and Applicable
                Law, but
                in no case for less than a period of [ * ] years following shipment
                of the
                relevant Product. Upon Arbios’ request and at Arbios’ expense, NxStage
                will promptly provide Arbios with copies of such Records.
                

            

    

     

    4. FORECASTS;
      ORDERS

    

    
      	
              4.1

            	
              Long
                Term Forecast.
                Within [ * ] days of the Effective Date and [ * ] days prior to the
                end of
                every calendar quarter thereafter, Arbios shall deliver to NxStage
                a
                rolling quarterly forecast of Arbios’ projected orders for Product
                covering the next [ * ] calendar quarters, the [ * ] of which shall
                be
                100% binding on Arbios (the
“Forecast”).

            

    

    

    
      	
              4.2

            	
              Product
                Availability.
                NxStage shall promptly notify Arbios if at any time it expects to
                have any
                difficulty in filling orders contemplated by the then-current forecast
                or
                covered by any pending purchase
                order.

            

    

    

    
      	
              4.3

            	
              Excess
                Product.
                Should any Purchase Order include volume of Product in amounts that
                exceed
                [ * ]% of amounts set forth in the most recent forecast provided
                by Arbios
                to NxStage pursuant to Section 4.1 hereof, or should Arbios desire
                to
                increase the amount of Products to be manufactured pursuant to any
                already
                submitted Purchase Order, then NxStage shall use reasonable efforts
                to
                comply with such requested changes. Notwithstanding the foregoing,
                NxStage
                shall not be liable to Arbios for any inability, despite its reasonable
                efforts, to Manufacture such excess
                Product.

            

    

    

    
      	
              4.4

            	
              Minimum
                Purchase Requirements.
                In the event Arbios purchases more than [ * ] units of Product from
                NxStage hereunder in any one calendar year, NxStage and Arbios shall
                meet
                within [ * ] days thereafter to determine an appropriate annual Product
                minimum purchase requirement (“Minimum Purchase Requirement”), which shall
                in no event be less than [ * ] percent ([ * ]%) of Arbios’ total Product
                purchase volume over the preceding twelve (12) calendar months. The
                Minimum Purchase Requirement shall be adjusted annually, within [
                * ] days
                of the end of each calendar year hereunder, if necessary, to reflect
                increased or decreased purchase volumes of Arbios over the preceding
                year.
                Without limiting the obligations set forth in Section 3.1.9 hereof,
                in the
                event Arbios fails in any calendar year to satisfy the applicable
                Minimum
                Purchase Requirement, Arbios shall pay to NxStage a shortfall payment
                equivalent to the difference between the [ * ] and the[ * ], for
                Product
                hereunder.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    5. PURCHASE
      OF PRODUCT; DELIVERIES

    

    
      	
              5.1

            	
              Purchase
                Orders.
                Except to the extent the Parties may otherwise agree with respect
                to a
                particular shipment, the Product shall be ordered by Arbios pursuant
                to
                written purchase orders, which shall be sent to NxStage with not
                less than
                [ * ] days’ lead time prior to the relevant Delivery Dates (and after the
                date on which the relevant Fiber Bundles are available at the Plant),
                and
                which shall not include requested Delivery Dates more than [ * ]
                months
                after the date of the relevant purchase order. NxStage
                shall accept any such purchase order and supply the Product in such
                quantities and on the Delivery Dates set forth in the relevant purchase
                order; provided such orders are consistent with the Forecast and
                the other
                terms and conditions of this Agreement.

            

    

    

    
      	 	
              5.1.1

            	
              NxStage
                shall furnish to Arbios with each shipment of Product ordered by
                Arbios
                hereunder, (i) a Certificate of Conformance reflecting that such
                Product
                conforms to the relevant Specifications and (ii) all documentation
                required by law, regulation or any regulatory authority having
                jurisdiction over such shipment. 

            

    

    

    
      	
              5.2

            	
              Delivery.
                The terms of delivery for the Product shall be FOB NxStage’s Plant.
                

            

    

    

    
      	5.3	
              Risk
                and Transfer of Title.
                Property in, title to and risk of loss of or damage to all Raw Materials
                and Product shall remain with NxStage and pass to Arbios only upon
                delivery of Product to the carrier. Products shall be properly prepared
                for safe and lawful shipment by NxStage and shall be shipped via
                the
                common carrier mutually agreed upon by the Parties. All shipments
                shall be
                accompanied by appropriate transportation documentation, as mutually
                agreed by the parties.[ * ]

            

    

     

    
      	
              5.4

            	
              Non-conforming
                Product.
                In the event that any Product shall fail to strictly conform with
                the
                Specifications, Arbios shall reject such Product by giving written
                notice
                to NxStage within [ * ] days from the date of receipt of such Products
                at
                Arbios, or [ * ] of the discovery of any defect that could not be
                reasonably discovered by Arbios during such [ * ] day period following
                a
                diligent Product inspection; provided that such notice must, in any
                event,
                be provided within the first [
                *
                ] months of the Product’s labelled shelf life when the average annual
                purchase volume is below [ * ] Units, and [
                *
                ] months of the Product’s labelled shelf life
                when the average annual purchase volume exceeds [ * ] Units.
                Any notice given hereunder shall specify the manner in which the
                Product
                fails to conform with the Specifications.

            

    

    

    
      	 	
              5.4.1

            	
              If
                it is determined by agreement of the Parties (or in the absence of
                agreement of the Parties by a mutually acceptable independent testing
                laboratory or consultant whose fees shall be paid by the non-prevailing
                Party) that the non-conformity is due to damage to the Product (i)
                caused
                by Arbios or its agents or (ii) which occurs subsequent to delivery
                of
                such Product to the carrier at the point of origin, NxStage shall
                have no
                liability to Arbios with respect thereto. If the non-conformity is
                caused
                by the negligence of NxStage or breach by NxStage of any term of
                this
                Agreement, NxStage shall, as Arbios’ sole and exclusive remedy,
                for Product rejected pursuant to this Section 5.4,
                credit Arbios’ account the price invoiced for such non-conforming Product
                (including without limitation reimbursement to Arbios for the cost
                of any
                Fiber Bundles included in such non-conforming Product). If payment
                for non
                conforming Product has previously been made by Arbios, at Arbios’ option,
                NxStage shall (i) pay Arbios the amount of such credit (including
                without
                limitation reimbursement to Arbios for the cost of any Fiber Bundles
                included in such non-conforming Product), (ii) offset the amount
                thereof
                (including without limitation reimbursement to Arbios for the cost
                of any
                Fiber Bundles included in such non-conforming Product) against other
                amounts then due NxStage hereunder or (iii) replace such non-conforming
                Product with conforming Product at no additional cost to Arbios (including
                without limitation reimbursement to Arbios for the cost of any Fiber
                Bundles needed to make such replacement Product).
                For clarity, this section shall not be deemed to limit NxStage’s
                indemnification obligations pursuant to Section
                11.3.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
 

    
      	 	
              5.4.2

            	
              Disposition
                of Non-conforming Product. In
                any case where Arbios rejects non-conforming Product, Arbios shall
                await
                written instructions from NxStage as to further disposition of the
                non-conforming Product. If NxStage does not provide such instructions
                within [ * ] days of receipt of Arbios’ rejection notice, Arbios shall
                dispose of the Product and invoice NxStage for the costs of destruction.
                In any event, Arbios may retain samples of non-conforming Product
                for the
                purpose of determining any dispute.

            

    

    

    
      	
              5.5

            	
              Late
                Delivery Charge.
                Arbios shall not be required to take receipt of Product shipped [
                * ] ([ *
                ]) or more after the Delivery Date indicated in the relevant accepted
                purchase order; provided, however, that in addition to any other
                remedy
                available to Arbios, in the event that Arbios elects at its sole
                discretion to accept Product that is shipped [ * ] ([ * ]) or more
                after
                the Delivery Date specified in the applicable purchase order, Arbios
                shall
                be due a late delivery credit of [ * ] percent ([ * ]%) of the invoice
                price of the relevant shipment.

            

    

    

    6. FINANCIAL
      PROVISIONS 

    

    6.1 Unit
      Price/Engineering Fees.

    

    
      	 	
              6.1.1

            	
              Arbios
                shall pay to NxStage the Unit Price for each Unit Manufactured and
                delivered by NxStage in accordance with the terms of this Agreement,
                and
                such additional Engineering Fees as are indicated in Attachment
                E.

            

    

    

    
      	 	
              6.1.2

            	
              Until
                Arbios becomes cash flow positive in its consolidated operations
                for [ * ]
                consecutive quarters, payments
                to
                NxStage will be due
                [
                *
                ]% on shipment and [ * ]% within
                [
                * ] days from the date of NxStage’s invoice, which invoice shall be sent
                out concurrently with shipment of Product. All payments due hereunder
                shall be made in Euro to an account or address of NxStage unless
                otherwise
                agreed by the Parties.  Payments
                made after the stated term shall be subject to late charges equivalent
                to
                the lesser of [ * ]%) of such overdue amount per month or the maximum
                rate
                allowed by law. In addition, if full payment for each invoice properly
                issued hereunder is not received within [ * ]) days of the invoice
                date,
                NxStage may restrict or completely stop subsequent shipments of Product
                until payment is received or terminate this
                Agreement.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	
            	6.1.3	
              If
                at
                any time during
                the term of this Agreement,
                Arbios is not required to provide public financial statements,
                NxStage
                may request, not more than [ * ] for each calendar quarter during
                any such
                period, Arbios’ balance sheet and income statement. Arbios shall
                then
                provide to NxStage, promptly following such
                request,
                but in any event within [ * ] days of the end of such
                calendar
                quarter, its balance sheet and income statement. 

            

    

    

    
      	
              6.2

            	
              Raw
                Material Costs.
                All Raw Materials acquired by NxStage for the Manufacture of Products
                shall be paid for by NxStage and the costs thereof are incorporated
                into
                the Unit Price and pricing associated with the tubing, Luer assembly
                and
                packaging, to be paid by Arbios for the
                Product.

            

    

    

    
      	6.3	
              Miscellaneous
                Costs.
                The following costs shall be borne or allocated as
                follows:

            

    

    

    
      	 	
              6.3.1

            	
              the
                Costs of routine testing by NxStage as included in the Specifications
                are
                included in the prices to be charged pursuant to Section 6.1. Should
                additional testing beyond such routine testing be required or requested
                by
                Arbios, Arbios shall bear all
                costs.

            

    

    

    
      	 	
              6.3.2

            	
              the
                Costs of all testing to release Raw Materials, in-process testing
                and
                finished Product testing shall be paid by NxStage and are incorporated
                into the Unit Price.

            

    

    

    
      	
              6.4

            	
              Price
                Variations.
                The Unit Price may be adjusted [ * ] in accordance with the following
                provisions:

            

    

    

    
      	 	
              6.4.1

            	
              the
                Unit Price may be increased [ * ] commencing upon the first anniversary
                of
                the Effective Date by an amount not to exceed [ *
                ].

            

      	 	 	 

    

    
      	 	
              6.4.2

            	
              Arbios
                shall have the right, upon reasonable notice and not more than [
                * ], to
                have a Third Party audit NxStage’s records with respect to the cost basis
                for any price increase under this Section 6.4. 

            

    

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    
      	
              6.5

            	
              Taxes.
                Duty, sales, use or excise taxes imposed by any governmental entity
                that
                apply to the Manufacture of Product hereunder will be borne by Arbios
                (other than taxes based upon the income of
                NxStage).

            

    

    

    7. CONFIDENTIAL
      INFORMATION AND PUBLICITY 

    

    
      	
              7.1

            	
              Subject
                to Sections 7.2 and 7.4 below, each Party agrees that it will not
                disclose
                to any Third Party any Confidential Information received in relation
                to
                this Agreement during the term of this Agreement and for a period
                of [ * ]
                years following the expiration or termination for any reason of this
                Agreement, or in the case of Know-How, in perpetuity until such Know-How
                ceases to be Confidential Information of NxStage or Arbios, as the
                case
                may be, and that it will not (i) use such information for any purpose
                other than in accordance with its rights hereunder and to carry out
                its
                obligations under this Agreement or (ii) disclose such information
                to or
                permit its use by any person other than such of the receiving Party’s
                permitted officers, employees and agents who reasonably require access
                to
                the Confidential Information for the purpose of carrying out such
                Party’s
                rights and obligations under this Agreement and who have an enforceable
                legal obligation to the receiving Party of confidentiality and non-use
                of
                the Confidential Information no less onerous than the terms hereof.
                The
                Parties agree that they shall use best efforts to avoid the disclosure
                of
                Know How to each other. In the event that Know How needs to be disclosed
                pursuant to the terms hereof, such Know How shall be identified in
                writing
                as “Know How” prior to its disclosure. If Know How is inadvertently
                disclosed, the disclosing Party shall promptly provide written notice
                to
                the receiving Party of such inadvertent disclosure promptly upon
                becoming
                aware of it, with such notice including an identification of the
                Know How
                disclosed.

            

    

    

    
      	
              7.2

            	
              The
                foregoing notwithstanding, the Confidential Information may be disclosed
                by the receiving Party in the event that it is required to do so
                by
                operation of law or by a governmental authority, but only to the
                extent
                that such disclosure has been so required or requested and provided
                that
                the disclosing Party has, where possible, been given notice a reasonable
                amount of time in advance to enable it to seek legal protection or
                confidential treatment of such Confidential Information. The receiving
                Party shall also consult with the disclosing Party, and include the
                disclosing Party’s reasonable
                suggestions,
                in connection with any Freedom of Information Act request relating
                to the
                Confidential Information of the disclosing
                Party.

            

    

    

    
      	
              7.3

            	
              For
                the purposes of this Agreement, Arbios Know-How and NxStage Know-How
                disclosed hereunder shall be deemed Confidential Information of Arbios
                and
                NxStage, respectively.

            

    

    

    
      	
              7.4

            	
              Absent
                written consent from the other Party, which consent shall not be
                unreasonably withheld or delayed, neither Arbios nor NxStage shall
                originate any publicity, news release or public announcement, written
                or
                oral, whether to the public or press (“Announcement”), relating to
                performance under this Agreement or any of its terms, except where,
                in the
                opinion of counsel for the Party making such Announcement, it is
                required
                by law to be made. In the event that such disclosure is required,
                as
                aforesaid, the disclosing Party shall make reasonable efforts to
                provide
                the other Party with notice beforehand and to coordinate with the
                other
                Party to the maximum extent possible with respect to the wording
                and
                timing of any such disclosure. The Parties shall mutually agree on
                a press
                release announcing the execution of this Agreement. Notwithstanding
                the
                foregoing, Arbios is in no way restricted from making Announcements
                relating to the Product and Arbios may, in its sole discretion, make
                such
                Announcements without written consent from NxStage so long as an
                Announcement does not reference NxStage’s name. Notwithstanding the
                foregoing, the Parties agree that either Party can make disclosures
                relating to this Agreement or the activities conducted hereunder,
                without
                the other Party’s prior written consent, as required by Applicable Laws,
                including securities laws. 

            

    

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    8. RECALLS

    

    
      	
              8.1

            	
              Arbios
                shall respond to all consumer complaints regarding Products supplied
                to
                Arbios hereunder and shall bear the cost of all recalls, market
                withdrawals or corrections of Product unless such recall, market
                withdrawal or correction shall have arisen as the sole result of
                NxStage’s
                failure to Manufacture Products that meet the Specifications and
                not as
                the result, in any way, of the negligence or other misconduct of
                Arbios,
                in which case NxStage shall bear the direct and reasonably incurred
                out-of-pocket costs and expenses of such recall, market withdrawal
                or
                correction (meaning the costs of notifying customers and the costs
                associated with shipping recalled Products from customers). Arbios
                shall
                have the sole right to initiate and manage any recall, and shall
                promptly
                inform NxStage of any such occurrence. Arbios shall consult with
                NxStage
                in good faith regarding any recommendations made by NxStage relating
                to
                whether Arbios should initiate a
                recall.

            

    

     

    9. INTELLECTUAL
      PROPERTY RIGHTS 

    

    
      	 	
              9.1

            	
              NxStage
                acknowledges and agrees that all Arbios Intellectual Property Rights
                are
                the exclusive property of and belong to Arbios or its Affiliates.
                Arbios
                acknowledges and agrees that all NxStage Intellectual Property Rights
                are
                the exclusive property of and belong to NxStage or its Affiliates.
                

            

    

    

    
      	 	
              9.2

            	
              The
                parties acknowledge and agree that no joint development is contemplated
                by
                the terms of this Agreement.

            

    

    

    
      	 	
              9.3

            	
              Nothing
                contained in this Agreement shall be construed as conferring any
                rights by
                implication, estoppel or otherwise, under any Intellectual Property
                Right,
                other than the rights expressly granted in this Agreement. Neither
                Party
                is required hereunder to furnish or disclose to the other Party
                any
                technical or other information, except as expressly provided
                herein.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    10. WARRANTIES
      

    

    
      	
              10.1

            	
              NxStage
                represents and warrants to Arbios that the Product supplied to Arbios
                hereunder will be Manufactured in compliance with the Specifications.
                

            

    

    

    
      	
              10.2

            	
              NxStage
                represents and warrants to Arbios that NxStage is in material compliance
                with all Applicable Laws with respect to the Plant and, to NxStage’s
                knowledge, there are no circumstances or conditions which would reasonably
                be expected to prevent compliance from continuing during the duration
                of
                this Agreement or interfere with NxStage’s ability to Manufacture Product,
                in each case, or create any financial liability on Arbios or its
                Affiliates.

            

    

    

    
      	
              10.3

            	
              NxStage
                and Arbios each represents and warrants to the other that all corporate
                action on the part of NxStage and
                Arbios, respectively, and
                its officers and directors necessary for the authorization, execution
                and
                delivery of this Agreement and the performance of all obligations
                of
                NxStage and Arbios, respectively, hereunder has been taken.
                

            

    

    

    
      	
              10.4

            	
              NxStage
                represents and warrants to Arbios that it has not been debarred,
                nor is it
                subject to a pending debarment, and that it will not use in any capacity
                in connection with the Manufacture of Products hereunder any person
                who
                has been debarred pursuant to section 306 of the FDCA, 21 U.S.C.
§ 335a,
                or any foreign equivalent thereof, or who is the subject of a conviction
                described in such section or any foreign equivalent thereof. NxStage
                agrees to notify Arbios in writing immediately if NxStage or any
                person
                who is performing Manufacture of Products hereunder is debarred or
                is the
                subject of a conviction described in section 306 or any foreign equivalent
                thereof, or if any action, suit, claim, investigation, or proceeding
                is
                pending, or to the best of NxStage’s knowledge, is threatened, relating to
                the debarment or conviction of NxStage or any person performing
                Manufacture of Product hereunder.

            

    

    

    
      	
              10.5

            	
              NxStage
                and Arbios each represent and warrant that, to the best of its knowledge,
                use of the NxStage Intellectual Property or the Arbios Intellectual
                Property, respectively, as contemplated herein will not infringe
                or
                violate any patent, trademark, trade name, copyright, trade secret
                or
                other proprietary right of any Third
                Party.

            

    

    

    
      	
              10.6

            	
              EXCEPT
                AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
                REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS
                OR
                IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY,
                FITNESS FOR A PARTICULAR PURPOSE, OR
                NON-INFRINGEMENT.

            

    

    

    11. LIABILITY
      AND INDEMNITIES 

    

    
      	
              11.1

            	
              Each
                Party shall promptly notify the other, in writing, if it learns of
                any
                litigation, claim, administrative or criminal proceedings (collectively
                “Actions”), asserted or threatened against such Party (the “Aggrieved
                Party”) for which such Party is entitled to indemnification hereunder from
                the other Party. With respect to any such Action, the other Party
                shall
                reasonably cooperate with and provide such reasonable assistance
                to such
                Aggrieved Party as such Aggrieved Party may reasonably request. Such
                reasonable assistance may include, without limitation, providing
                copies of
                all relevant correspondence and other materials that the Aggrieved
                Party
                may reasonably request; provided, however, that any Confidential
                Information shall be treated in accordance with the provisions of
                Section
                7 hereof.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	
              11.2

            	
              Arbios
                hereby agrees to defend, indemnify and hold harmless NxStage and
                each of
                its Affiliates and their respective officers, directors and employees
                from
                and against any Third Party liability, claims, loss, damage, costs
                and
                expenses (including reasonable legal fees) (each a “Liability”) to the
                extent arising from (i) Arbios’ negligence or wilful misconduct, or (ii)
                the use, application, storage, marketing, distribution or sale of
                Product,
                except, in any case, to the extent that such Liability arises as
                a result
                of NxStage’s wilful misconduct, negligence or material breach of this
                Agreement. 

            

    

    

    
      	
              11.3

            	
              NxStage
                hereby agrees to defend, indemnify and hold harmless Arbios and each
                of
                its Affiliates and their respective officers, directors, and employees
                from and against any Third Party Liability to the extent arising
                from (i)
                NxStage’s negligence or wilful misconduct, or (ii) NxStage’s failure to
                Manufacture Product meeting the Specifications, except, in any case,
                to
                the extent that such Liability arises as a result of Arbios’ wilful
                misconduct, negligence or material breach of this Agreement.
                

            

    

    

    
      	
              11.4
                

            	
              No
                indemnity may be claimed by or given to the Party seeking to rely
                on such
                indemnity:

            

    

    

    
      	 	
              11.4.1

            	
              unless
                the Party claiming indemnity shall have notified the other Party
                of the
                relevant potential Liability promptly upon becoming aware of such
                potential Liability except to the extent the failure to provide such
                notice does not prejudice the indemnifying Party’s ability to defend or
                contest any suit or claim relating to such potential Liability,
                

            

    

    

    
      	 	
              11.4.2

            	
              where
                the Party seeking indemnification has made any offer or any settlement
                without the prior written consent of the indemnifying Party, which
                consent
                shall not be unreasonably withheld or delayed,
                and

            

    

    

    
      	 	
              11.4.3

            	
              unless
                the Party seeking indemnification has allowed the indemnifying Party
                to
                assume full control of all proceedings in relation to any such potential
                Liability within [ * ] of having been given notice of such proceedings;
                provided, that (i) the Party seeking indemnification shall have the
                right
                to appoint independent counsel at its own cost to participate therein
                and
                (ii) no compromise or settlement may be effected by the indemnifying
                Party
                without the prior written consent of the other Party, which shall
                not be
                unreasonably withheld or delayed. 

            

    

    

    
      	
              11.5

            	
              The
                Party seeking indemnification shall cooperate fully with the indemnifying
                Party and its legal representatives in the investigation and defense
                of
                any action or claim with respect to which indemnification is sought
                hereunder.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	
              11.6

            	
              Insurance.
                

            

    

    

    
      	
              11.6.1

            	
              NxStage
                shall maintain, throughout the term of this Agreement, products liability,
                comprehensive general liability and broad form contractual liability
                insurance.  Products liability insurance must have minimum limits of
                at least $[ * ] per occurrence, and general liability and broad form
                contractual liability insurance must, in each case, have minimum
                limits of
                at least $[ * ] per occurrence.  Simultaneously with the execution of
                this Agreement, NxStage shall provide Arbios certificates of insurance,
                issued by a company or companies reasonably acceptable to Arbios,
                evidencing the existence of the insurance required to be maintained
                pursuant to this Section and providing that Arbios is an additional
                insured under such policies.  NxStage agrees to provide at least [ *
                ] notice of the expiration or cancellation of any insurance required
                by
                this Section.

            

    

    

    
      	
              11.6.2

            	
              Arbios
                shall maintain, throughout the term of this Agreement, products liability,
                comprehensive general liability and broad form contractual liability
                insurance.  Products liability insurance must have minimum limits of
                at least $[ * ] per occurrence (provided that such minimum limit
                shall be
                increased to $[ * ], which shall also cover liabilities associated
                with
                human clinical trials, prior to the initiation of the first human
                patient
                treatment using Product supplied by NxStage hereunder), and general
                liability and broad form contractual liability insurance must, in
                each
                case, have minimum limits of at least $[ * ] per occurrence. 
                Simultaneously with the execution of this Agreement, Arbios shall
                provide
                NxStage certificates of insurance, issued by a company or companies
                reasonably acceptable to NxStage, evidencing the existence of the
                insurance required to be maintained pursuant to this Section and
                providing
                that NxStage is an additional insured under such policies.  Arbios
                agrees to provide at least [ * ]) days notice of the expiration or
                cancellation of any insurance required by this Section.  Arbios
                agrees that to provide NxStage at least [ * ]) days prior notice
                before
                initiating the first human patient treatment using Product supplied
                by
                NxStage hereunder, and further agrees that NxStage shall have no
                obligation to supply Product to Arbios for human use until Arbios
                provides
                NxStage an updated certificate of insurance, issued by a company
                or
                companies reasonably acceptable to NxStage, evidencing the increase
                in
                products liability insurance coverage required by this
                Section.

            

    

     

    
      	
              11.7

            	
              NOTWITHSTANDING
                ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER
                PARTY
                BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT
                DAMAGES
                ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
                LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS
                BEEN
                ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT
                THIS
                LIMITATION WILL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A
                PARTY OF
                ITS DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 7 OR
                ITS
                INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION
                11.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

       

    

    
      	
              11.8

            	
              THE
                TOTAL LIABILITY OF NXSTAGE ARISING UNDER THIS AGREEMENT SHALL NOT
                EXCEED
                U.S. [ * ] [ * ])
                UNTIL THE ANNUAL PURCHASE VOLUME EXCEEDS [ * ] UNITS, IN WHICH EVENT
                IT
                WILL INCREASE TO U.S. [ * ]). 

            

    

    

    12. CAPACITY

    

    NxStage
      shall use commercially reasonable efforts to ensure that Arbios’ Product
      Requirements are met. In the event that NxStage in its reasonable judgement
      anticipates that it will not be able to satisfy Arbios’ Requirements for Product
      based on Arbios’ most recent Forecast, NxStage shall give written notice to
      Arbios. Within [ * ] days of receipt of such notice, Arbios and NxStage shall
      meet to determine courses of action to address such capacity issues. NxStage
      shall consider in good faith obtaining additional manufacturing capacity for
      the
      Product; provided that (i) Arbios must agree to mutually acceptable Product
      minimum purchase requirements as a condition to NxStage obtaining such
      additional capacity, and (ii) NxStage shall have no obligation to obtain
      additional manufacturing capacity and shall have no liability to Arbios
      hereunder if it fails to meet Arbios’ demand for Product beyond its available
      capacity constraints, other than, subject to Section 15, liability arising
      from
      a failure to fill any purchase order previously accepted by NxStage. Arbios
      understands
      and
      agrees that in the event of any capacity constraints at the Plant, available
      capacity will be allocated based on the previous [
      *
      ]
      months
      of production, and that NxStage shall have no liability to Arbios based on
      such
      allocation.

    

    13. TERM
      AND TERMINATION 

    

    
      	
              13.1

            	
              Unless
                terminated as otherwise provided herein, this Agreement shall commence
                on
                the Effective Date and shall expire seven (7) years from the date
                of first
                Product Approval authorizing Commercial Launch of the Product (“Expiration
                Date”). Notwithstanding the foregoing, in the event that Commercial Launch
                has not occurred prior to the seventh (7th)
                anniversary of the Effective Date, this Agreement and the Exclusive
                Period
                shall expire as of such date. 

            

    

    

    
      	
              13.2

            	
              Either
                Party is entitled to terminate this Agreement by notice given in
                writing
                to the other if:

            

    

    

    
      	 	
              13.2.1

            	
              the
                other Party commits any continuing or material breach of any of the
                provisions of this Agreement and fails to remedy the same within
                [ * ]
                days after receipt of a written notice giving full particulars of
                the
                breach and requiring it to be so remedied; provided that such period
                may
                be extended for a period not to exceed an additional [ * ] days if
                such
                breach cannot reasonably be cured within such [ * ] day period and
                the
                breaching party has undertaken reasonable steps to cure such breach
                within
                such [ * ] days and appears likely to cure such breach within such
                additional period.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	 	
              13.2.2

            	
              the
                other Party becomes or is adjudged insolvent, makes an assignment
                for the
                benefit of its creditors, has a petition filed in bankruptcy for
                or
                against it or goes into liquidation (except for the purposes of a
                bona
                fide amalgamation or other reorganization) or a receiver is appointed
                over
                all or a major part of the property or assets of that other
                Party.

            

    

     

    
      	
              13.3

            	
              Notwithstanding
                Section 15.1, and in addition to any other remedies available under
                this
                Agreement, Arbios is entitled in its sole discretion to terminate
                this
                Agreement or to convert it to a non-exclusive arrangement upon [
                * ]) [ *
                ] notice given in writing to NxStage if:

            

      	 	 

    

    
      	 	
              13.3.1

            	
              At
                anytime during the term of this Agreement, NxStage knowingly Manufactures,
                supplies, or sells any Competing Product for or to any Third Party,
                or
                sells any such Competing Product itself and NxStage fails to cease
                this
                activity following [ * ] notice thereof from
                Arbios,

            

    

    

    
      	 	
              13.3.2

            	
              NxStage
                fails to ship at least [ * ] percent ([ * ]%) of the quantity of
                Product
                meeting the Specifications which was otherwise to be delivered within
                any
                [ * ] period as provided in outstanding purchase orders, except due
                to an
                event of Force Majeure or otherwise the fault of Arbios, including
                without
                limitation any failure to timely supply Fiber Bundles, or any failure
                in
                the quality of Fiber Bundles supplied; provided such orders are consistent
                with the terms hereof, including without limitation those set forth
                in
                Section 4.3, 

            

    

    

    
      	 	
              13.3.3

            	
              The
                regulatory status of the Plant is such that for at least [ * ] consecutive
                [ * ] Manufacture in accordance with the Regulatory Standards in
                accordance with agreed delivery time is not possible, as reasonably
                agreed by NxStage,

            

    

    

    
      	 	
              13.3.4

            	
              Arbios,
                in its sole reasonable discretion determines that it is commercially
                unfeasible to continue commercializing the Product, provided that
                if
                Arbios, within [ * ] subsequent thereto, elects to commercialize
                the
                Product, the Agreement may be reinstated, at NxStage’s option,
                or

            

    

     

    
      	 	
              13.3.3

            	
              NxStage
                seeks to excuse performance hereunder due to a Force Majeure for
                a period
                of more than [ * ].

            

    

    

    
      	
              13.4

            	
              In
                addition, either party is entitled to terminate this Agreement by
                giving a
                [ * ] notice in writing. In
                such event, and pursuant to Arbios purchase orders, NxStage will
                continue
                to supply Arbios with Product per the terms of this Agreement,
                for
                up
                to [ * ]% of the volume
                of Product ordered by Arbios during the [ * ] prior to such notice
                of
                termination, during
                the [
                *
                ]
                period after any
                such termination
                notice
                is
                given.
                Arbios agrees that in the event Arbios seeks to terminate this Agreement
                pursuant to this Section 13.4, Arbios may not, prior to the termination
                notice, directly or indirectly initiate steps to, make arrangements
                for,
                or commence for itself or at a Third Party, activities relating to
                the
                manufacture of Products. Further, as soon as Product is supplied
                by a
                Third Party or manufactured by Arbios, NxStage’s obligations and
                agreements hereunder to supply Product shall immediately terminate;
                it
                being understood and agreed that all of Arbios’ obligations and agreements
                hereunder, including without limitation those with respect to Product
                purchase Requirements under Section 3.1.9 and Minimum Purchase
                Requirements under Section 4.4 (prorated as relevant), shall remain
                in
                effect until the termination of the Agreement at the conclusion of
                the [ *
                ] notice period.

            

    

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    14. CONSEQUENCES
      OF TERMINATION 

    

    
      	14.1	
              Upon
                the expiration or termination for any reason of this
                Agreement:

            

    

    

    
      	 	
              14.1.1

            	
              the
                terms of Sections 3.3.3, 3.3.4, 6.1, 7, 9, 10, 11, 14, 17 and 18
                shall
                continue in full force and effect in accordance with their respective
                terms;

            

    

    

    
      	 	
              14.1.2

            	
              NxStage
                and Arbios shall, upon request of the other, return to the other
                all
                Confidential Information received from it in relation to the Products,
                along with all records or copies thereof, except for one copy which
                may be
                retained in the recipient’s inactive files for the purpose of determining
                its obligations hereunder; 

            

    

    

    
      	 	
              14.1.3

            	
              Unless
                this Agreement is terminated by NxStage under Section 13.2 or 13.4,
                or by
                Arbios under Section 13.4 or 13.3.4, if this Agreement is terminated
                prior
                to the Expiration Date, NxStage shall continue the Manufacture of
                Product
                in accordance with the terms of this Agreement for delivery to Arbios
                on
                terms specified herein for such period as may be reasonably necessary
                for
                Arbios to transfer production to an alternative manufacturer including
                without limitation time to negotiate terms and qualify and validate
                any
                such alternative manufacturer, and otherwise Manufacture all outstanding
                orders; provided, however, that in no event shall NxStage be required
                to
                do any of the foregoing for any period beyond the earlier of (i)
                [ * ]
                after termination and (ii) the Expiration Date then in
                effect.

            

    

    

    
      	
            	14.1.4	
              NxStage
                shall ship and invoice to Arbios, and Arbios shall pay an amount
                equal to
                the Cost of, all Raw Materials, whether or not in the form of finished
                Product, in NxStage’s possession or in transit to NxStage as of such date
                of expiration or termination, provided that NxStage demonstrates
                that such
                Raw Materials (i) were purchased in reliance on Arbios’ most recently
                submitted forecast pursuant to Section 4.1 and (ii) are in compliance
                with
                all relevant Specifications and otherwise fit for commercial use.
                

            

    

     

    15. FORCE
      MAJEURE 

    

    
      	
              15.1

            	
              If
                either Party is unable to perform its obligations hereunder due to
                an
                event or occurrence constituting Force Majeure, it shall promptly
                notify
                the other Party of the nature and extent of the circumstances in
                question.
                In the event of any delay in the performance of its obligations under
                this
                Agreement or the non-performance thereof by either Party due to Force
                Majeure, the Party so affected shall be under no liability for loss
                or
                injury suffered by the other Party thereby and the time for performance
                of
                the relevant obligations shall be extended accordingly provided it
                uses
                its reasonable endeavors to minimize the effect of and overcome or
                remove
                the cause of such Force Majeure.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	
              15.2

            	
              In
                the event that either Party is prevented or delayed in performing
                any of
                its obligations under this Agreement due to Force Majeure for an
                aggregate
                period in excess of [ * ]) days in any [ * ] period then the Parties
                shall
                meet as soon as practicable to discuss in good faith how best to
                alleviate
                the circumstances in question.

            

    

    

    
      	
              16.

            	
              LEGAL
                COMPLIANCE; REGULATORY
                COMPLIANCE

            

    

    

    
      	
              16.1

            	
              Legal
                Compliance.
                Each Party shall comply with all material applicable federal, state
                and
                international laws, and all other material regulations applicable
                to the
                conduct of its business pursuant to this Agreement, including, but
                not
                limited to, the FD&C Act.

            

    

    

    
      	
              16.2

            	
              Licenses
                and Permits.
                NxStage will at all times during the term of this Agreement ensure
                that it
                has, complies with and maintains in force all licenses, consents,
                permits
                and authorizations which may be required with respect to its performance
                of its obligations hereunder, including without limitation those
                required
                in relation to NxStage’s generation, storage, treatment, transport,
                possession, handling and disposal of any waste in the performance
                of its
                obligations under this Agreement. For clarity, NxStage is not responsible
                for any license, consent, permission or authorization relating to
                any
                clinical trial conducted by or on behalf of
                Arbios.

            

    

    

    
      	
              17.

            	
              DISPUTE
                RESOLUTION 

            

    

     

    
      	17.1	
              The
                Parties recognize that a bona fide dispute as to certain matters
                may from
                time to time arise during the term of this Agreement which relates
                to
                either Party’s rights and/or obligations hereunder. In the event of the
                occurrence of such a dispute, either Party may, by notice to the
                other
                Party, have such dispute referred to their senior officers as may
                be
                designated by each Party for attempted resolution by good faith
                negotiations within [ * ] days after such notice is received. In
                the event
                the designated officers are not able to resolve such dispute within
                such [
                * ] day period, or such other period of time as the Parties may mutually
                agree in writing, each Party shall have the right to pursue available
                remedies through the dispute procedure set forth in Section
                17.2.

            

    

     

    
      	17.2	
              Any
                disputes relating to this Agreement of whatever nature that cannot
                be
                resolved by negotiation between the Parties shall be referred for
                final
                resolution to arbitration in Boston, Massachusetts by an arbitration
                panel
                comprising one arbitrator appointed by NxStage and one arbitrator
                appointed by Arbios, and a Chairman of the Arbitration Panel who
                shall be
                appointed by the first two (2) arbitrators. Any such arbitration
                proceeding shall be conducted in accordance with the arbitration
                rules of
                the American Arbitration Association, and the arbitration award shall
                be
                final and nonappealable and such award may be entered in any court
                having
                jurisdiction.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    18. OTHER
      PROVISIONS

    

    
      	
              18.1

            	
              Agreement
                Controls.
                In the event of a conflict between the terms set forth in this Agreement
                and the terms contained in any purchase order or other documentation
                related to the supply of Product or the subject matter hereof, the
                terms
                of this Agreement shall control.

            

    

    

    
      	
              18.2

            	
              Notices.
                Any notices, requests, estimates or other communications hereunder
                shall
                be deemed to have been properly given upon receipt thereof when sent
                via
                nationally recognized next business day courier addressed to the
                address
                of the applicable Party as set forth in the preamble of this Agreement.
                

            

    

    

    
      	
              18.3

            	
              Entire
                Agreement.
                This Agreement constitutes the entire agreement between the Parties
                with
                respect to the subject matter hereof and shall supersede all previous
                arrangements and agreements between the two
                Parties.

            

    

    

    
      	
              18.4

            	
              Governing
                Law.
                This Agreement shall be governed by and construed in all respects
                in
                accordance with the laws of the Commonwealth of Massachusetts, regardless
                of the laws that might otherwise govern this Agreement under applicable
                conflicts of law principles. 

            

    

    

    
      	
              18.5

            	
              Severability.
                Each provision in this Agreement is independent and severable from
                the
                others, and no provision will be rendered unenforceable as a result
                of any
                other provision(s) being held to be invalid or unenforceable in whole
                or
                in part. If any provision of this Agreement is invalid, unenforceable
                or
                too broad, that provision will be appropriately limited and reformed
                to
                the maximum extent permitted by applicable
                law.

            

    

    

    
      	
              18.6

            	
              No
                Waiver.
                Failure by either Party on one or more occasions to avail itself
                of a
                right conferred by this Agreement shall not be construed as a waiver
                of
                such Party’s right to enforce such right or any other
                right.

            

    

    

    
      	
              18.7

            	
              Relationship
                of the Parties.
                Nothing in this Agreement shall create or be deemed to create any
                relationship of agency, partnership or joint venture between the
                Parties.

            

    

    

    
      	
              18.8

            	
              Assignment.
                This Agreement shall be binding upon and inure to the benefit of
                the
                Parties, their successors and permitted assigns and, subject to Section
                13.4, shall survive and be assigned to any successor corporation
                of
                a
                Party upon a Change of Control of such Party. Subject to the foregoing,
                this Agreement shall not be assigned by either Party without the
                prior
                written consent of the other Party; provided, however, that either
                Party
                may assign this Agreement to any entity controlled by or under common
                control with such
                Party
                without the prior written consent of the
                other Party
                and in such event such Party shall
                provide the
                other Party
                with written notice of such assignment. Without limiting the generality
                of
                the foregoing, and subject to Section 13.4, this Agreement shall
                be the
                obligation and responsibility of any Third
                Party
                that acquires, through sale, license or other transfer, Arbios
                Intellectual Property sufficient to make, use or sell the Product
                (an
                “Arbios IP Change of Control”), and Arbios agrees that as a condition of
                any such Arbios IP Change of Control, such Third
                Party
                shall execute a
                written
                instrument
                confirming such obligation and responsibility.

            

    

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      	18.9	
              Expenses.
                Except as otherwise provided herein, each Party shall be solely
                responsible for its respective costs and expenses incurred in connection
                with preparation of this Agreement and the performance of its obligations
                hereunder, including, without limitation, any and all attorneys’ or
                accountants’ fees.

            

    

     

    
      	18.10	
              Use
                of Name.
                Neither Party shall have any right, express or implied, to use in
                any
                manner the name or other designation of the other Party, or any other
                trade name or trademark of the other Party for any purpose, except
                as may
                be required by applicable law or
                regulation.

            

    

     

    
      	18.11	
              Further
                Assurances.
                Each Party agrees to execute, acknowledge and deliver such further
                instruments, and do such other acts, as may be necessary and appropriate
                in order to carry out the purposes and intent of this
                Agreement.

            

    

     

    
      	18.12	
              Counterparts.
                This Agreement may be executed in any number of counterparts, each
                of
                which shall be considered an original and all of which taken together
                shall constitute one instrument.

            

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    WHEREAS
      THE DULY AUTHORIZED REPRESENTATIVES OF THE PARTIES HAVE EXECUTED THIS AGREEMENT
      THE DAY AND YEAR FIRST ABOVE WRITTEN

    

    ARBIOS
      SYSTEMS, INC.

    
      	 	 	 	 
	By:
Shawn
              P. Cain	 	 	
            
	
              
                

              
Title: Interim
              President and Chief Executive Officer	 	 	
            

    

     

    Signature:
      Shawn
      P.
      Cain

     

    NXSTAGE
      MEDICAL, INC.

    
      	 	 	 	 
	By:
              Jeffrey H.
              Burbank	 	 	
            
	
              
                

              
Title: President
              and Chief Executive Officer	 	 	
            

    

     

    Signature:
      Jeffrey
      H. Burbank

     

     

    Attachments:

     

    A—
      Packaging Specifications 

    B
—
      Product Specifications

    C
      —
      Quality
      Control Specifications

    D
      —
      Raw
      Material Specifications

    E
      —
      Pricing

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    Attachment
      A

    

    [
      *
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      *
      ]

    

    

    Attachment
      B

    

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              [
                *
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      * ]

    
      	
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                * ]

            

    

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      * ]

     

    Attachment
      C

    

    [
      *
      ]

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      *
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                * ]

            	 	
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      *
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    Attachment
      D

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      * ]

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      *
      ]

     

    
      	
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    Attachment
      E

    Pricing

    

    
      	 	
              
                ·

              

            	
              For
                the first purchase order there will be a Non-recurring Engineering
                Fee of
                [ * ]

            

    

    

    
      	 	
              
                
                  ·

                

              

            	
              For
                every purchase order there will be a Recurring Engineering Fee plus
                unit
                pricing:

            

    

    

    
      	 	
              
                ·

              

            	
              The
                fixed Recurring Engineering Fee will be [ * ] per purchase
                order

            

    

    

    
      	 	
              
                ·

              

            	
              The
                Unit pricing, based on number of Units ordered, is specified in the
                table
                below:

            

    

     

    
      	
              Order
                Quantity

            	 	
              Filter
                Unit Price (€)

            	 	
              Tubing,
                Luers & Unit Polybag

              $
                

            
	
              0-100

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              101
                - 999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              1,000
                --
                4,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              5,000
                --
                9,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              10,000
                --
                24,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              25,000
                --
                49,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              50,000
                --
                99,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              100,000
                --
                249,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              250,000
                --
                499,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              500,000
                --
                749,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              750,000
                - 999,999

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            
	
              1,000,000
                - 1,250,000

            	 	
              [
                *
                ]

            	 	
              [
                *
                ]

            

    

    

    
      	 	
              
                ·

              

            	
              Further
                reduced pricing for purchase orders above [ * ] Units will be negotiated
                in good faith by the Parties.

            

    

    

    
      	 	
              
                ·

              

            	
              Pricing
                may be adjusted as provided in Section
                6.4.

            

    

    

    
      	 	
              
                ·

              

            	
              Tubing,
                luers, and unit polybag pricing is incremental to the Filter Unit
                Price,
                with both prices together constituting the “Unit
                Price”.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00139-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00139-of-00352.parquet"}]]