Document:

EXHIBIT
        10.1

      

      1989
        EMPLOYEE STOCK PURCHASE PROGRAM

      OF

      PAR
        PHARMACEUTICAL COMPANIES, INC.

      AS
        AMENDED AND RESTATED EFFECTIVE JANUARY 1, 2008

      

      

      1.  Purpose
        and effect of the Program.

      

      The
        purpose of the Par Pharmaceutical Companies, Inc. Employee Stock Purchase
        Program (“Stock
        Purchase Program”
or
        “Program”)
        is to
        secure for Par Pharmaceutical Companies, Inc., a Delaware corporation (the
        “Company”),
        and
        its stockholders the benefits of the incentives inherent in the ownership
        of the
        Company’s capital stock by present and future employees of the Company and its
        subsidiaries. The Stock Purchase Program is intended to comply with the
        provisions of Sections 421, 423 and 425 of the Internal Revenue Code of 1986,
        as
        amended (the “Code”),
        and
        the Program shall be administered, interpreted and construed in accordance
        with
        such provisions. The Program was originally approved by the stockholders
        September 28, 1990 (“Effective
        Date”).
        The
        Program, as amended and restated herein, has been approved by the Board of
        Directors to be effective as of January 1, 2008 (“Restated
        Effective Date”).

      

      2.  Shares
        reserved for the Program.

      

      There
        shall be reserved for issuance and purchase by employees under the Stock
        Purchase Program an aggregate of 1,000,000 shares of Common Stock, par value
        $.01 per share, of the Company (“Common
        Stock”),
        subject to adjustment as provided in Section 12. Shares subject to the Program
        may be shares now or hereafter authorized but unissued, or shares that were
        once
        issued and subsequently reacquired by the Company. If and to the extent that
        any
        right to purchase reserved shares shall not be exercised by any employee
        for any
        reason or if such right to purchase shall terminate as provided herein, such
        shares which have not been so purchased hereunder shall again become available
        for the purposes of the Program (subject to adjustment as provided in Section
        12).

      

      3.  Administration
        of the Program.

      

      Subject
        to the general control of, and superseding action by the Company’s Board of
        Directors (the “Board
        of Directors”)
        the
        Company’s Benefits Committee (“Committee”)
        shall
        have the full power to administer and interpret the Program. Except as otherwise
        expressly provided in this Program, the Committee shall prescribe, amend
        and
        rescind rules and regulations relating to it, and to make all other
        determinations necessary or advisable in administering the Program, all of
        which
        determinations shall be final and binding upon all Participating Employees
        unless otherwise determined by the Board of Directors. A quorum of the Board
        of
        Directors or Committee for purposes of the Program shall consist of a majority
        of its members. Any action may be taken by the Board of Directors or Committee
        at a meeting duly called, at which a quorum shall be present, or without
        a
        meeting by a written consent to their action taken signed by all members
        of the
        Board of Directors or Committee, as the case may be. 

       

      _____________

      Approved
        by stockholders September 28, 1990

      As
        amended by the Board, effective January 1,
        2008

       

      
        
          
          

        

        
          1

          
            

          

        

        
          
          

        

      

       

      4.  Eligible
        Employees.

       

      Each
        current and future employee of the Company and those of its subsidiaries
        (which
        subsidiaries are designated by the Board of Directors or Committee) shall
        be
        eligible to participate in the Program, provided, each of such
        employees,

      

      	(a)  	
              is
                actively employed by the Company and/or any of its subsidiaries (or
                any
                predecessor thereof) on the Enrollment Date (as hereinafter defined),
                and

            

       

      	(b)  	
              does
                not own, immediately after the Investment Date (as defined in Section
                8
                below), stock possessing five (5%) percent or more of the total combined
                voting power or value of all classes of stock of the Company and/or
                of a
                subsidiary thereof.

            

       

      In
        determining whether a company is a subsidiary, the rules of Section 425(f)
        of
        the Code shall be followed, and in determining stock ownership under this
        paragraph, the rules of Section 425(d) of the Code shall apply and stock
        which
        the employee may purchase under outstanding options shall be treated as stock
        owned by the employee. Employees whose employment terminated or are retired,
        at
        the date the Program becomes effective or on the first day of each calendar
        quarter (“Enrollment
        Date”),
        are
        not eligible to participate on such date. Employees eligible to participate
        in
        the Program pursuant to the provisions of this Section 4 are hereinafter
        referred to as “Eligible
        Employees.”

      

      5.  Election
        to participate and payroll deductions.

      

      Each
        Eligible Employee, at the effective date of the Program and each Enrollment
        Date
        thereafter, may participate in the Program by enrolling during the ten-day
        period prior to such effective date or Enrollment Date, as the case may be,
        (an
“Enrollment
        Period”)
        authorizing specified regular payroll deductions (“Payroll
        Deductions”)
        during
        each calendar year expressed in whole percentages in multiples of one (1%)
        percent not to exceed ten (10%) percent of his/her Eligible Compensation
        (as
        hereinafter defined). Such Payroll Deductions shall be made regularly and
        in
        equal amounts commencing on the effective date or the Enrollment Date, as
        the
        case may be, by the Company and shall be credited, as promptly as practicable,
        to an account in the name of each Participating Employee (as hereinafter
        defined). The Board of Directors or Committee, in lieu of Payroll Deductions,
        may approve equivalent direct payments by an Eligible Employee, which shall
        be
        deemed to be Payroll Deductions. Pending the purchase of shares, all Payroll
        Deductions may be used by the Company for any corporate purpose. Eligible
        Employees who so elect to participate in the Program are referred to herein
        as
“Participating
        Employees.”
A
        Participating Employee may increase or decrease his/her Payroll Deduction
        only
        during an Enrollment Period. If a Participating Employee withdraws from the
        Program, he or she will not be eligible to participate again until an Enrollment
        Date not earlier than six months after the date of his/her withdrawal from
        the
        Program.

       

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

       

      For
        the
        purpose of the Program, “Eligible
        Compensation”
shall
        mean base salary plus overtime and shift differential actually paid in each
        pay
        period. Eligible Compensation shall not include any payments for or
        reimbursement of expenses, finders’ fees, suggestion awards, bonuses, deferred
        profit-sharing distributions or similar non-regular payments unless otherwise
        determined by the Board of Directors or the Committee.

      

      6.  Limitation
        on employee share purchases.

      

      No
        right
        to purchase shares under this Program shall permit an employee to purchase
        stock
        under all employee stock purchase plans of the Company and its subsidiaries
        (as
        defined in Section 423 of the Code) at a rate which in the aggregate exceeds
        $25,000 of the Fair Market Value (as defined in Section 7 below) of such
        stock
        as determined on the Investment Date for each calendar year in which the
        right
        is outstanding at any time.

      

      7.  Purchase
        price.

      

      The
        purchase price for each whole and fractional share of Common Stock shall
        be
        determined by the Board of Directors for each Investment Date but in no event
        shall the purchase price be less than eighty-five percent (85%) of the Fair
        Market Value of such whole or fractional share on the Investment Date.
“Fair
        Market Value”
shall
        be the mean of the high and low sales prices of a share of Common Stock on
        the
        New York Stock Exchange on the Investment Date, or if the Common Stock shall
        have not been traded on such date, for the first day prior thereto on which
        the
        Common Stock was so traded, or such other amount as the Board of Directors
        may
        determine by any other fair and reasonable means.

      

      8.  Methods
        of purchase and Investment Accounts.

      

      As
        of the
        last Friday in each calendar quarter (each of such dates being known as an
        “Investment
        Date”),
        each
        Participating Employee shall purchase the number of whole and fractional
        shares
        of Common Stock determined by dividing the amount of his/her Payroll Deductions
        not theretofore invested by the purchase price as determined in Section 7.
        All
        whole and fractional shares purchased shall be maintained by the broker
        designated by the Board of Directors or Committee (“Designated
        Broker”)
        in
        separate investment accounts (“Investment
        Account”)
        for
        each Participating Employee, which account shall represent the sum of shares,
        fractional shares and any Payroll Deductions not theretofore invested as
        allocated to each individual Participating Employee. All dividends paid with
        respect to the whole and fractional shares in the Investment Account shall
        be
        credited to each Participating Employee’s respective interest in the Investment
        Account, and dividends credited to his or her Investment Account will be
        automatically applied by the Designated Broker to the purchase of whole and
        fractional shares of Common Stock as of the next Investment Date. 

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

       

      9.  Title
        of Investment Accounts.

      

      Each
        Investment Account may be in the name of the Participating Employee or, if
        he/she so indicates, in his/her name jointly with a member of his/her family,
        with right of survivorship. A Participating Employee who is a resident of
        a
        jurisdiction that does not recognize such a joint tenancy may have an Investment
        Account in his/her name as tenant in common with a member of his/her family,
        without right of survivorship.

      

      10.  Rights
        as a stockholder.

      

      When
        a
        Participating Employee’s Investment Account shall be charged with the amount of
        the purchase price of the Common Stock, he or she shall have all the rights
        or
        privileges of a stockholder of the Company with respect to shares purchased
        under the Program whether or not certificates representing full shares have
        been
        issued.

      

      11.  Rights
        not transferable.

      

      Rights
        under the Program are not transferable by a Participating Employee other
        than by
        will or the laws of descent and distribution and are exercisable during his
        or
        her lifetime only by him or her.

      

      12.  Adjustments
        in case of changes affecting the Company’s Common Stock.

      

      In
        the
        event of a subdivision of outstanding shares of Common Sock, or the payment
        of a
        stock dividend thereon, the number of shares reserved or authorized to be
        reserved under this Program shall be increased proportionately, and such
        other
        adjustments shall be made as may be deemed necessary or equitable by the
        Board
        of Directors. In the event of any other change affecting the Common Stock,
        such
        adjustment shall be made as may be deemed equitable by the Board of Directors
        to
        give proper effect to such event subject to the limitations of Section 425
        of
        the Code.

      

      13.  Withdrawal,
        retirement, termination and death.

      

      A
        Participating Employee may withdraw from the Program only during an Enrollment
        Period, and such withdrawal shall become effective on the ensuing Enrollment
        Date, except as the Committee may otherwise determine. If a Participating
        Employee withdraws from the Program, he/she will not be eligible to participate
        again until an Enrollment Date not earlier than six months after the date
        of
        his/her withdrawal from the Program.

       

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

       

      In
        the
        event of a Participating Employee’s withdrawal from the Program, retirement or
        termination of employment or death during a calendar year in which the Program
        is in effect, the amount of his/her Payroll Deductions not theretofore invested
        shall be used to purchase whole or fractional shares of Common Stock on the
        next
        occurring Investment Date. 

      

      14.  Amendment
        of the Program.

      

      The
        Board
        of Directors may at any time, or from time to time, amend the Program in
        any
        respect, provided, however, that the Program may not be amended in any way
        that
        will cause rights issued under it to fail to meet the requirements for employee
        stock purchase plans as defined in Section 423 of the Code, including
        stockholder approval if required.

      

      15.  Termination
        of the Program.

      

      The
        Program and all rights of employees hereunder shall terminate:

      

      	(a)  	
              on
                the Investment Date that Participating Employees become entitled
                to
                purchase a number of shares greater than the number of reserved shares
                remaining available for purchase; or

            

       

      	(b)  	
              at
                any time, at the discretion of the Board of
                Directors.

            

       

      In
        the
        event that the Program terminates under circumstances described in (a) above,
        reserved shares remaining as of the termination date shall be issued to
        Participating Employees on a pro rata basis.

      

      16.  Effective
        Date of the Program.

      

      The
        Program originally became effective on September 28, 1990. The Program, as
        amended and restated herein, shall be effective January 1, 2008. For purposes
        of
        the operation and administration of the Program, the original Stock Purchase
        Program shall govern for any time period prior to the Restated Effective
        Date.

      

      17.  Governmental
        and other regulations.

      

      The
        Program, and the grant and exercise of the rights to purchase shares hereunder,
        and the Company’s obligation to sell and deliver shares upon the exercise of
        rights to purchase shares, shall be subject to all applicable Federal, State
        and
        foreign laws, rules and regulations, and to such approvals by any regulatory
        or
        governmental agency as may, in the opinion of counsel for the Company, be
        required.

      

      18.  Indemnification
        of Committee.
        

      

      Each
        person who is or shall have been a member of the Board of Directors or the
        Committee shall be indemnified and held harmless by the Company against and
        from
        any loss, cost, liability, or expense that may be imposed upon or reasonably
        incurred by him or her in connection with or resulting from any claim, action,
        suit, or proceeding to which he or she may be a party or in which he or she
        may
        be involved by reason of any action taken or failure to act under the Program
        and against and from any and all amounts paid by him or her in settlement
        thereof, with the Company’s approval, or paid by him or her in satisfaction of
        any judgment in any such action, suit, or proceeding against him or her,
        provided he or she shall give the Company an opportunity, at its own expense,
        to
        handle and defend the same before he or she undertakes to handle and defend
        it
        on his or her own behalf, unless such loss, cost, liability, or expense is
        a
        result of his or her own willful misconduct or except as expressly provided
        by
        statute. The foregoing right of indemnification shall not be exclusive of
        any
        other rights of indemnification to which such persons may be entitled under
        the
        Company’s Certificate of Incorporation or Bylaws, as a matter of law, or
        otherwise, or any power that the Company may have to indemnify them or hold
        them
        harmless.

       

      
        
          
          

        

        
          5EXHIBIT
      10.31

     

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      INFORMATION OMITTED AND FILED SEPARATELY

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    LICENSE
      AGREEMENT

     

    This
      License Agreement (the
      “Agreement”)
      is
      made and entered into as of January 14, 2008 (the “Effective
      Date”),
      between Alfacell
      Corporation,
      a
      Delaware corporation with its principal place of business at 300 Atrium Drive,
      Somerset, New Jersey 08873 (“Alfacell”),
      and
Par
      Pharmaceutical, Inc.,
      a
      Delaware corporation with its principal place of business at 300 Tice
      Boulevard, Woodcliff Lake, New Jersey 07677 (“Par”).
      Alfacell and Par may be referred to herein individually as a “Party”,
      or
      together as the “Parties”.

     

    Recitals

     

    Whereas,
      Alfacell
      has expertise developing pharmaceutical products and has developed and owns
      certain proprietary technology and know-how relating to the design and
      manufacture of the Product (as defined in Section 1.1) in the Field;
      and

     

    Whereas,
      Par has
      expertise in developing, manufacturing and marketing certain pharmaceutical
      products and wishes to develop and market the Product in the Field in the
      Territory as further described herein, and Alfacell agrees to grant Par the
      rights to do so pursuant to the terms of this Agreement.

     

    Now,
      Therefore,
      in
      consideration of the foregoing and the covenants and promises contained herein,
      the Parties hereby agree as follows:

     

    ARTICLE
      I

     

    DEFINITIONS

     

    1.1 Definitions.
      For the
      purposes of this Agreement, the following defined terms have the respective
      meanings set forth below:

     

    “Accelerated
      Approval”
means
      approval of a Product NDA pursuant to 21 C.F.R. Part 314 Subpart H (a) in which
      the FDA evaluation of the NDA is performed on the basis of a surrogate marker
      (a
      measurement intended to be a substitute for the clinical measurement of
      interest) that is considered likely to predict patient benefit and (b) that
      may
      be a provisional approval, with a required written commitment to complete
      clinical studies that formally demonstrate patient benefit.

     

    “Affiliate”
means,
      with respect to a Party and for so long as the relationship exists, any other
      entity that directly or indirectly controls, is controlled by, or is under
      common control with, such Party. An entity shall be regarded as in control
      of
      another entity if it owns, or directly or indirectly controls, greater than
      fifty percent (50%) of the voting stock or other ownership interest of such
      entity, or if it directly or indirectly possesses the power to direct or cause
      the direction of the management and policies of the other entity by any means
      whatsoever.

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

     

    CONFIDENTIAL
      INFORMATION OMITTED AND FILED SEPARATELY

    WITH
      SECURITIES AND EXCHANGE COMMISSION

    ASTERISKS
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    “AG
      Product”
means
      a
      generically-labeled version of the Product (i.e.,
      such
      Product does not bear the Trade Name) supplied by Alfacell and sold by Par
      and/or its Sub-distributors or permitted sublicensees.

     

    “Agreement”
has
      the
      meaning set forth in the introductory paragraph.

     

    “Alfacell”
has
      the
      meaning set forth in the introductory paragraph.

     

    “Alfacell
      Indemnitee”
has
      the
      meaning set forth in Section 12.2.

     

    “Alfacell
      Information”
means
      any Product-related information Owned or Controlled by Alfacell as of the
      Effective Date or Owned or Controlled by Alfacell after the Effective Date
      that,
      with respect to a Product in the Field in the Territory, (a) is directly related
      to use or sale of the Commercialized Product, (b) is included in an Alfacell
      NDA
      filing for the Product within the scope of this Agreement, (c) is otherwise
      reasonably requested by Par and provided by Alfacell in its sole discretion,
      or
      (d) is lawfully obtained by Alfacell from a Third Party without restriction
      on
      disclosure to Par, but only to the extent that such Product-related information
      is necessary or useful for, and is specific to use, utilization, or sale of
      the
      Product, and is disclosed to Par by Alfacell pursuant to this Agreement. Program
      Developments Owned or Controlled by Alfacell that are not Alfacell Patents,
      shall be Alfacell Information. For the avoidance of doubt, Alfacell shall have
      no obligation to disclose to Par any Ranpirnase or Product manufacturing
      Know-How Owned or Controlled by Alfacell, except in connection with Section
      4.2
      of this Agreement.

     

    “Alfacell
      Patents”
means
      any United States patents and patent applications Owned or Controlled by
      Alfacell as of the Effective Date or Owned or Controlled by Alfacell after
      the
      Effective Date that cover Ranpirnase or Product, the importation, use or making
      of Ranpirnase or Product, or any part of the foregoing or that in Par’s opinion
      may cover Competing Products, the importation, use or making of Competing
      Product, or any part thereof. Such Alfacell patents and patent applications
      as
      of the Effective Date are set forth on Schedule
      1.1,
      which
      is attached hereto and made part of this Agreement. Schedule
      1.1
      shall be
      amended from time to time during the Term to reflect any such patents Owned
      or
      Controlled by Alfacell after the Effective Date. The term “Alfacell Patents”
shall include continuations, divisions, provisionals or any substitute
      applications of the patents and patent applications set forth on Schedule
      1.1,
      any
      patent issued with respect to any such patent applications, and any reissue,
      reexamination, renewal or extension (whether by patent law or regulation, or
      any
      other law or regulation, for example FDA related extensions) of any such
      patent.

     

    “Alfacell
      Technology”
means
      Alfacell Patents and Alfacell Information.

     

    “Amphinase(s)”
      means
      all pharmaceutical agents disclosed or claimed in one or more of the
      following:

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

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      INFORMATION OMITTED AND FILED SEPARATELY

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    Patent
      No. US 7,229,824 B1

    

    U.S.
      Patent Application No. 11/759,247 filed 7 JUN 2007

    

    U.S.
      Patent Application No. 11/759,249 filed 7 JUN 2007

    

    U.S.
      Patent Application No. 11/759,250 filed 7 JUN 2007

    

    U.S.
      Patent Application No. 11/759,251 filed 7 JUN 2007

    

    U.S.
      Patent Application No. 11/759,952 filed 8 JUN 2007

    

    U.S.
      Patent Application No. 11/759,953 filed 8 JUN 2007

    

    U.S.
      Patent Application No. 11/759,954 filed 8 JUN 2007

    

    U.S.
      Patent Application No. 11/759,955 filed 8 JUN 2007

    

    The
      term
“Amphinase” also means and includes all pharmaceutical agents disclosed or
      claimed in any patents issuing on any of the above-referenced patent
      applications, and all pharmaceutical agents disclosed or claimed in any
      continuation, division, reexamination, or reissue thereof.

     

    “cGMP”
means
      the regulatory requirements for current good manufacturing practices promulgated
      by the FDA under authority of the U.S. Food, Drug and Cosmetic Act, particularly
      21 C.F.R. Section 210 et seq., as the same may be amended from
      time to time.

     

    “Change
      of Control” means,
      in
      respect of either Party, an event in which: (a) any other person or group of
      persons (as the term “person” is used for purposes of Section 13(d) or 14(d) of
      the Exchange Act) not then beneficially owning more than fifty percent (50%)
      of
      the voting power of the outstanding securities of such Party acquires or
      otherwise becomes the beneficial owner (within the meaning of Rule 13d-3
      promulgated under the Exchange Act) of securities of such Party representing
      more than fifty percent (50%) of the voting power of the then outstanding
      securities of such Party with respect to the election of directors of such
      Party; or (b) such Party (i) consummates a merger, consolidation or similar
      transaction with another person where the voting securities of such Party
      outstanding immediately preceding such transaction (or the voting securities
      issued with respect to the voting securities of such Party outstanding
      immediately preceding such transaction) represent less than fifty percent (50%)
      of the voting power of such Party or surviving entity, as the case may be,
      immediately following such transaction, or (ii) disposes by sale, assignment,
      exclusive license or otherwise of all or substantially all of its intellectual
      property rights, except for licenses under such intellectual property rights
      in
      the ordinary course of business and any isolated sale or assignment of specific
      items of intellectual property.

     

    
      
        
        

      

      
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      INFORMATION OMITTED AND FILED SEPARATELY

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    “Clinical Supplies”
means
      supplies of the Product, manufactured, packaged and labeled in compliance with
      cGMP and applicable law, in such form and dosage as is determined by Alfacell
      pursuant to the Development Program, and suitable for use in the conduct of
      pre-clinical and/or human clinical trials of the Product in the United States
      pursuant to the Development Program.

     

    “CMC
      Section”
means
      the Chemistry, Manufacturing and Controls section of an NDA
      submission.

     

    “Code”
has
      the
      meaning set forth in Section 13.3.

     

    “Commercialization”
means
      the marketing, promotion, advertising, selling and/or distribution of the
      Product in the Field in the Territory after Regulatory Approval has been
      obtained; and the term “Commercialize”
has
      a
      corresponding meaning.

     

    “Commercialization
      Committee”
has
      the
      meaning set forth in Section 2.2.

     

    “Commercially
      Reasonable Efforts”
means,
      with respect to each Party, the continuous and diligent efforts and commitment
      of resources of a degree and kind in accordance with such Party’s reasonable
      business, legal, medical and scientific judgment that are consistent with the
      efforts and resources such Party uses for other products owned by it or to
      which
      it has similar rights, which are of similar market potential and at a similar
      stage in their life cycle, taking into account the competitiveness of the
      marketplace, the regulatory structure involved and other relevant factors;
      and
      the term “Commercially
      Reasonable”
has
      a
      corresponding meaning. For a Product other than an AG Product, Par’s efforts and
      commitments for purposes of this definition will be determined by comparison
      to
      Par’s branded products; for an AG Product, Par’s efforts and commitments for
      purposes of this definition will be determined by comparison to Par’s other
      authorized generic products.

     

    “Competing
      Product”
means
      any pharmaceutical product containing (a) Ranpirnase or (b) any compound or
      moiety that includes Ranpirnase or is derived from, or substantially similar
      to,
      Ranpirnase or its nucleic acid sequences as a starting material, intermediate
      or
      base material and, in either case (i) for parenteral administration or (ii)
      in
      the Field; provided,
      however,
      that
      (x) no Amphinase shall be considered a Competing Product, and (y) on and after
      the date that a Third Party sells or offers for sale a generically-labeled
      version of the Product, the definition of the term “Competing Product” will be
      limited to a pharmaceutical product containing Ranpirnase and any generic
      equivalent thereof (as determined by the FDA). 

     

    “Confidential
      Information”
means
      information of a Party that is disclosed to or obtained by the other Party
      (including information obtained by a Party as a result of access to the
      facilities of the other Party) either prior to or during the Term, which
      information is non-public, confidential or proprietary in nature, including
      trade secrets, financial data, product information, manufacturing methods,
      market research data, marketing plans, identity of customers, nature and source
      of raw materials, product formulation and methods of producing, testing and
      packaging; provided,
      however,
      that
      Confidential Information shall not include information that a Party can
      demonstrate by written evidence: (a) is in the public domain other than as
      a result of a breach by such Party (or any of its Sub-distributors) of its
      obligations of confidentiality contained herein; (b) was known by the
      receiving Party prior to receipt from the disclosing Party; (c) has been
      developed by the receiving Party independent of any Confidential Information
      of
      the disclosing Party; or (d) was subsequently, lawfully and in good faith,
      obtained by the receiving Party on a non-confidential basis from a Third Party
      that was not under an obligation to treat such information in a confidential
      manner and had a lawful right to make such disclosure. Without limiting the
      foregoing, the terms of this Agreement shall constitute “Confidential
      Information” of both Parties hereunder.

     

    
      
        
        

      

      
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    CONFIDENTIAL
      INFORMATION OMITTED AND FILED SEPARATELY

    WITH
      SECURITIES AND EXCHANGE COMMISSION

    ASTERISKS
      DENOTE SUCH OMISSION

    

    “Contract
      Year”
means
      (a) if the Initial Commercial Sale occurs during the first 45 days of a
      calendar quarter, a twelve (12) month period starting on the first day of
      the calendar quarter in which the Initial Commercial Sale (or an anniversary
      thereof, as the case may be) occurs or (b) if the Initial Commercial Sale
      occurs other than during the first 45 days of a calendar quarter, a
      twelve (12) month period starting on the first day of the calendar quarter
      immediately following the calendar quarter in which the Initial Commercial
      Sale
      (or an anniversary thereof, as the case may be) occurs;
      provided, however,
      that if
      a Contract Year is triggered pursuant to the foregoing clause (b), then, for
      purposes of computing Net Sales during the initial Contract Year, the Parties
      will include the Net Sales during the forty-five (45) days immediately prior
      to
      thereto.

     

    “CPR”
has
      the
      meaning set forth in Section 14.5.

     

    “Damages”
has
      the
      meaning set forth in Section 9.3(e).

     

    “Detail”
means,
      with respect to the Product, a face-to-face contact between a sales
      representative and a physician or other medical professional licensed in the
      Territory to prescribe drugs, during which a First Position Detail or Secondary
      Position Detail is made to such person, in each case as measured by each Party’s
      internal recording of such activity; provided,
      that
      such meeting is consistent with and in accordance with the requirements of
      applicable laws and this Agreement. 

     

    “Development
      Committee”
has
      the
      meaning set forth Section 2.1(a).

     

    “Development Costs”
means
      all direct and indirect costs and expenses incurred by Alfacell in connection
      with the Development Program, which may include (a) costs associated with
      designing, planning and conducting Phase III Clinical Trials and/or the Phase
      IIB studies for the Product and all subsequent clinical testing and trials,
      including all third-party costs and expenses of any and all Phase IIIB and
      Phase
      IV studies with respect to the Product that are required by the FDA, and
      including all costs associated with meeting with the ODAC and/or completion
      of
      any studies as a result of such meetings, (b) costs in connection with seeking,
      obtaining and maintaining Regulatory Approval, including all FDA filing fees,
      (c) payments made to Third Parties in connection with the Development
      Program, (d) materials and supplies, and (e) license or acquisition
      fees and other costs and expenses associated with Alfacell’s obtaining from a
      Third Party any trademarks, tradenames, logos, trade dress or similar
      intellectual property rights licensed or acquired by Alfacell after the
      Effective Date for use in connection with Commercialization of the Product
      in
      the Field in the Territory.

     

    
      
        
        

      

      
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    CONFIDENTIAL
      INFORMATION OMITTED AND FILED SEPARATELY

    WITH
      SECURITIES AND EXCHANGE COMMISSION

    ASTERISKS
      DENOTE SUCH OMISSION

    

    “Development
      Program”
means
      Alfacell’s activities associated with Alfacell’s development of the Product in
      the Field for sale in the Territory by Par pursuant to this Agreement, including
      (a) research and development of a recombinant version of Ranpirnase; (b)
      manufacture and formulation of the Product for preclinical and clinical studies;
      (c) planning, implementation, evaluation and administration of human clinical
      trials of the Product in the Field in the Territory; (d) manufacturing process
      development and scale-up for the manufacture of the Product; (e) preparation
      and
      submission of applications for Regulatory Approval in the Field in the
      Territory; and (f) post-market surveillance of approved Product
      Indications.

     

    “Direct
      Cost”
means
      the actual costs and expenses paid by Alfacell to Third Party manufacturers
      for
      Product in finished form, filled, labeled and packaged for commercial sale,
      such
      costs and expenses not to exceed $*** per
      1 mg
      vial except with the prior written consent of Par, which consent shall not
      be
      unreasonably withheld; provided,
      however,
      that if
      the Parties determine to launch a Product where Ranpirnase has been obtained
      from a recombinant source, then the Direct Cost shall be amended as the Parties
      mutually agree.

     

    “Effective
      Date”
means
      the date set forth in the introductory paragraph.

     

    “Ex-U.S.
      Shipping Costs”
means,
      if Alfacell’s manufacturing facility or that of its Third Party Manufacturer (as
      defined in the Supply Agreement) as designated by Alfacell pursuant to Section
      5.1 of the Supply Agreement is located outside of the continental United States,
      all charges and fees for freight, shipping, customs, duties, and insurance
      incurred by Par for shipment of Product from such facility.

     

    “Fair
      Market Value”
means,
      when determined on an annual basis, the total annual cost per sales
      representative including salary, commission, benefits, car allowance and
      legitimate reimbursable travel and/or home office expenses,
      divided by the number of annual Details delivered by the sales representative,
      multiplied by the percentage of Product presentation time per Detail (based
      on
      the Product presentation position in the Detail, e.g.,
      60% for
      First Position Details, 40% for Secondary Position Details). The Fair Market
      Value may also be determined on a calendar quarter basis, as
      applicable.

     

    “FDA”
means
      The Food and Drug Administration of the United States Department of Health
      and
      Human Services, or any successor agency(ies) thereof performing similar
      functions.

     

    “Field”
means
      all uses for cancer in humans.

     

    “First
      Position Detail”
means
      a
      Detail in which no more than three (3) products are presented, in which key
      attributes of the Product are verbally presented consistent with the terms
      of
      this Agreement and applicable laws, and where the Product receives *** percent
      (***%) or more of the total call time and is given primary emphasis
      (i.e.,
      an
      emphasis that is more important than the emphasis given to any other product
      presented).

     

    “Force
      Majeure Event”
has
      the
      meaning set forth in Section 14.7.

     

    
      
        
        

      

      
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    CONFIDENTIAL
      INFORMATION OMITTED AND FILED SEPARATELY

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    ASTERISKS
      DENOTE SUCH OMISSION

    

    “Future
      Indication”
means
      an Indication of the Product for the treatment of *** any other specific disease
      or condition in the Field to which the Parties mutually agree in
      writing.

     

    “Full
      Approval”
means,
      in respect of the Product for the Primary UMM Indication, Secondary UMM
      Indication or any Future Indication, Regulatory Approval upon which the FDA
      has
      granted full approval (i.e.,
      any FDA
      approval that is not Accelerated Approval) to market the Product for such
      Indication in the United States.

     

    “GAAP”
      means
      generally accepted accounting principles in the United States, as in effect
      from
      time to time.

     

    “Governmental
      Authority”
      means
      any court, tribunal, arbitrator, agency, legislative body, commission, official
      or other instrumentality of (a) any government of any country, (b) a federal,
      state, province, county, city or other political subdivision thereof or (c)
      any
      supranational body. The term “Governmental Authority” includes the
      FDA.

     

    “Indemnitor”
has
      the
      meaning set forth in Section 12.3.

     

    “Indication”
means
      any approved human therapeutic use(s) for the Product in the Field.

     

    “Initial
      Commercial Sale”
means
      the first sale of the Product by Par or a Sub-distributor to a Third Party
      in
      the Field in the Territory following Regulatory Approval for the Primary UMM
      Indication, the Secondary UMM Indication or a Future Indication (whichever
      Indication is approved for the first Product sale in the
      Territory).

     

    “Insolvent
      Party”
has
      the
      meaning set forth in Section 13.3.

     

    “Knowledge”
of
      Alfacell means the actual knowledge of Kuslima Shogen, Lawrence A. Kenyon,
      Andrew P. Aromando and/or Diane Scudiery, in each case after due and reasonable
      inquiry.

     

    “Losses”
has
      the
      meaning set forth in Section 12.1.

     

    “Material
      Commercialization Decision”
has
      the
      meaning set forth in Section 2.2(d).

     

    “Material
      Development Decision”
has
      the
      meaning set forth in Section 2.1(b)(iii).

     

    “Modified
      Targeted Ranpirnase”
means
      Targeted Ranpirnase other than for UMM or any Future Indication. 

     

    “Net
      Margin”
means
      Net Sales minus Ex-U.S. Shipping Costs (if applicable).

     

    “Net
      Sales”
means,
      ***.

     

    “NDA”
means
      the New Drug Application and all amendments and supplements thereto for the
      Product submitted by Alfacell to the FDA, including all documents, data and
      other information included in an accepted NDA submission for Regulatory Approval
      to market and sell the Product in the Field in the Territory.

     

    
      
        
        

      

      
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    ASTERISKS
      DENOTE SUCH OMISSION

    

    “ODAC”
has
      the
      meaning set forth in Section 3.1.

     

    “Owned
      or Controlled by”
means,
      with respect to any patent or other intellectual property right, the possession
      of the ability, whether directly or indirectly, and whether by ownership,
      license or otherwise, to grant a license, sublicense or other right to or under
      such Patent or right as provided for herein without violating the terms of
      any
      agreement or other arrangement with any Third Party (and in the case of United
      States Patent Nos. 6,649,392 and 6,649,393, subject to the interests of the
      U.S.
      Government therein).

     

    “Par”
has
      the
      meaning set forth in the introductory paragraph.

     

    “Par Indemnitee”
has
      the
      meaning set forth in Section 12.1.

     

    “Par
      Promoted Products”
means
      all FDA-approved branded products that Par is promoting or co-promoting in
      the
      Territory for their approved indications.

     

    “Party”
and
      “Parties”
have
      the meaning set forth in the introductory paragraph.

     

    “Phase
      III Clinical Trials”
means
      that portion of the Development Program that provides for human clinical studies
      in the Field that (a) are conducted in a number of patients that is intended
      to
      be sufficient to obtain a definitive evaluation of the therapeutic efficacy
      and
      safety of a Product in patients for a given Indication as required by
      21 C.F.R. §312.21(c), and (b) are needed to evaluate the overall
      risk-benefit relationship of the Product and to provide adequate basis for
      obtaining requisite Regulatory Approvals.

     

    “Primary
      UMM Indication”
means
      the Indication of the Product for the treatment of patients with UMM whose
      disease is either unresectable or who are otherwise not candidates for surgery,
      wherein (a) the labeling for such Indication recites “ONCONASE® (ranpirnase) in
      combination with doxorubicin is indicated for the treatment of patients with
      malignant pleural mesothelioma whose disease is unresectable or who are
      otherwise not candidates for curative surgery” or a substantially equivalent or
      broader label for such Indication, (b) neither the indication nor clinical
      pharmacology section of the label is limited to use only in patients who have
      first used and/or failed Altima, and (c) such Indication is supported by data
      from a pivotal study that demonstrates a statistically significant survival
      benefit of at least two months.

     

    “Product”
means
      any pharmaceutical product containing Ranpirnase for parenteral administration
      that has been developed by Alfacell or is developed by Alfacell pursuant to
      this
      Agreement, including as the Product may be modified to obtain Regulatory
      Approval thereof, including the AG Product.

     

    “Product Infringement”
has
      the
      meaning set forth in 9.3(c).

     

    
      
        
        

      

      
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      CONFIDENTIAL
        INFORMATION OMITTED AND FILED SEPARATELY

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      ASTERISKS
        DENOTE SUCH OMISSION

    

     

    “Product
      Studies”
means
      clinical studies, pre-clinical studies, safety studies, epidemiological studies,
      modeling and pharmacoeconomic studies, in each case including any ancillary
      or
      incidental development, investigation or research pertaining thereto, that
      are
      designed (a) to support Regulatory Approval for the Product in the Field in
      the
      Territory, or (b) to support publications, promotional and educational
      activities, future labeling changes or new Indications for Ranpirnase. Unless
      otherwise expressly provided herein or agreed to by the Parties, all “Product
      Studies” shall be owned by Alfacell.

     

    “Program
      Developments”
means
      all inventions, discoveries, patents, patent applications, know-how, copyrights
      and works of authorship and other intellectual property that are related to
      Ranpirnase in the Field and are made, developed, created, conceived or reduced
      to practice during the Term of this Agreement by Alfacell in connection with
      its
      work in the Development Program, regardless of whether the invention, discovery,
      patent application, know-how, or work is patentable.

     

    “Ranpirnase”
means
      the active pharmaceutical ingredient described in Exhibit
      A,
      which
      may be obtained from natural sources or a recombinant source. For the sake
      of
      clarity, sequence variants, and fusion proteins and conjugates that incorporate
      Ranpirnase, are expressly excluded, but various formulations of the active
      pharmaceutical ingredient described in Exhibit
      A
      are
      included.

     

    “Regulatory
      Approval”
means
      all approvals (including, where applicable, pricing and reimbursement approval
      and schedule classifications), product and/or establishment licenses,
      registrations or authorizations of any Governmental Authority, necessary for
      the
      commercialization, use, storage, import, export, transport, offer for sale,
      or
      sale of a pharmaceutical product for human use in a regulatory jurisdiction
      within the Territory, including, if and as applicable, the issuance by the
      FDA
      of an action letter indicating approval of the NDA; provided,
      however,
      that
      Regulatory Approval for the Product in any Future Indication can occur following
      issuance by the FDA of an action letter indicating Accelerated Approval of
      the
      NDA.

     

    “Representatives” has
      the
      meaning set forth in Section 8.1.

     

    “Royalty”
has
      the
      meaning set forth in Section 6.3(a).

     

    “SEC”
has
      the
      meaning set forth in Section 14.13.

     

    “Secondary
      Position Detail”
shall
      mean a Detail in which no more than three products are presented, in which
      key
      attributes of the Product are verbally presented consistent with the terms
      of
      this Agreement and applicable laws, and where the Product is given significant
      emphasis (i.e.,
      an
      emphasis that is more important than the emphasis given to any other product
      presented (other than the product that is presented as the First Position
      Detail)).

     

    “Secondary
      UMM Indication”
means
      an Indication of the Product for the treatment of UMM,
      other
      than the Primary UMM Indication.

     

    “Solvent Party”
has
      the
      meaning set forth in Section 13.3.

     

    
      
        
        

      

      
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    ASTERISKS
      DENOTE SUCH OMISSION

    

    “Sub-distributor”
has
      the
      meaning set forth in Section 4.3.

     

    “Supply Agreement”
has
      the
      meaning set forth in Section 2.4.

     

    “Targeted
      Ranpirnase”
means
      any Competing Product that is designed to act, and does act, or is reasonably
      understood to act, only in a specific manner on only a particular cell, tissue
      or organ system, for an indication in the Field.

     

    “Territory”
means
      the United States of America, including its territories, possessions,
      protectorates and the Commonwealth of Puerto Rico and any United States military
      base or installation located outside of the United States of
      America.

     

    “Term”
has
      the
      meaning set forth in Section 13.1.

     

    “Third
      Party”
means
      any person or entity other than Alfacell or Par or an Affiliate of Alfacell
      or
      Par.

     

    “Third Party Product Event”
has
      the
      meaning set forth in Section 7.4.

     

    “Trademark”
means
      the trademark under which the Product may be sold in the Field in the Territory,
      including as set forth in Exhibit
      B,
      as may
      be amended by the Parties from time to time.

     

    “Trade
      Name”
means
      each trade name (i.e., Trademark) established for the Product under this
      Agreement.

     

    “Transfer
      Price”
means
      ***.

     

    “UMM”
means
      unresectable malignant mesothelioma or mesothelioma presented in a patient
      who
      otherwise is not a candidate for surgery.

     

    “Valid
      Claim” means
      (a) an unexpired claim of an issued patent within the Alfacell Patents that
      has not been held to be unpatentable, invalid or unenforceable by a United
      States court, the United States Patent and Trademark Office, or other authority
      in the United States, from which decision no appeal is taken or can be taken;
      and (b) a claim of a pending application within the Alfacell
      Patents.

     

    1.2 Certain
      Rules of Construction.

     

    (a) As
      used
      in this Agreement, unless the context otherwise requires: Section, Schedule,
      Article and Exhibit references are intended to refer to this Agreement; words
      describing the singular number shall include the plural and vice versa; words
      denoting any gender shall include all genders; words denoting natural persons
      shall include corporations, partnerships and other entities, and vice versa;
      the
      words “hereof”, “herein” and “hereunder”, and words of similar import, shall
      refer to this Agreement as a whole, and not to any particular provision of
      this
      Agreement; the term “include” and derivations thereof are not intended to apply
      any limitation to the item(s) specified; and terms such as licensor, licensee
      and license will be interpreted broadly to refer also to sub-licensing
      arrangements and/or the Parties thereto. 

     

    
      
        
        

      

      
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    (b) This
      Agreement is between financially sophisticated and knowledgeable entities and
      is
      entered into by the Parties in reliance upon the economic and legal bargains
      contained herein, the language used in this Agreement has been negotiated by
      the
      Parties hereto and shall be interpreted and construed in a fair and impartial
      manner without regard to such factors as the Party who prepared, or caused
      the
      preparation of, this Agreement or the relative bargaining power of the
      Parties.

     

    ARTICLE
      II

    

      MANAGEMENT
        OF THE COLLABORATION

    

     

    2.1 Development
      Committee.

     

    (a) Establishment.
      The
      Parties hereby establish a committee consisting of such even number as shall
      be
      agreed by the Parties, fifty percent (50%) of whom shall be Par designees and
      fifty percent (50%) of whom shall be Alfacell designees (the “Development
      Committee”).
      Each
      of the Development Committee members shall have appropriate expertise to perform
      the functions assigned to the Development Committee pursuant to this Agreement.
      The initial Development Committee shall consist of a total of six (6) members
      who shall be designated by each Party within ten (10) business days after the
      Effective Date. Each Party shall have the right at any time and from time to
      time to designate a replacement, on a permanent or temporary basis, for any
      or
      all of its previously-designated members of the Development Committee. At the
      beginning of each calendar year during the Term, each Party shall appoint one
      of
      its designees to serve as a Co-Chair of the Development Committee. The initial
      Co-Chairs shall be designated by each Party within ten (10) business days after
      the Effective Date.

     

    (b) Meetings
      and Procedures.

     

    (i) The
      Development Committee shall meet at least once per calendar quarter, and more
      frequently at the reasonable request of either Party or as required to discuss
      and make efforts to resolve disputes, disagreements or deadlocks of the
      Development Committee, on such dates, and at such places and times, as the
      Parties shall agree; provided,
      however,
      that the
      Parties shall use their Commercially Reasonable Efforts to cause the first
      meeting of the Development Committee to occur within thirty (30) days after
      the Effective Date. The two Co-Chairs shall cooperate to send a notice and
      agenda for each meeting of the Development Committee to all members of the
      Development Committee reasonably in advance of the meeting. The location of
      regularly-scheduled Development Committee meetings shall alternate between
      the
      offices of the Parties, unless otherwise agreed. The members of the Development
      Committee also may convene or be polled or consulted from time to time by means
      of telephone conference, video conference, electronic mail or correspondence
      and
      the like, as deemed necessary or appropriate by the Co-Chairs. The Party hosting
      any Development Committee meeting shall appoint one person (who need not be
      a
      member of the Development Committee) to attend the meeting and record the
      minutes of the meeting in writing. Such minutes shall be circulated to the
      members of the Development Committee promptly following the meeting for review
      and comment.

     

    
      
        
        

      

      
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    (ii) Alfacell
      agrees to keep the Development Committee reasonably informed in respect of
      its
      conduct of the Development Program pursuant to its authority and responsibility
      set forth in Section 3.1, and in particular Alfacell shall provide the
      Development Committee with information related to the overall progress of the
      Development Program. Upon the request of Par’s members, Alfacell shall provide
      copies and updates of its development plans to the Development Committee. Par’s
      members shall provide advice, suggestions and constructive feedback on the
      Development Program. Additionally, Alfacell shall promptly notify the
      Development Committee if, during the Term, it discovers any new, reproducible
      uses for Ranpirnase in the Field which have been confirmed by Alfacell and/or
      are the subject of an invention disclosure or draft patent application, and
      relevant information related thereto (as such information provided by Alfacell
      shall be deemed Alfacell Information hereunder). 

     

    (iii) The
      Development Committee has no decision-making authority except as expressly
      set
      forth herein. Subject to Section 3.7, the final protocol design for any Phase
      III Clinical Trials for any Future Indication, including any material
      modification thereof (the “Material
      Development Decision”),
      shall
      be determined by a vote of the Development Committee. All decisions of the
      Development Committee shall be made by unanimous vote or unanimous written
      consent of both Parties, with each Party having, collectively among its
      respective designees, one vote in all decisions. The members of the Development
      Committee shall use Commercially Reasonable Efforts to decide all matters
      assigned to the Development Committee under this Agreement or otherwise referred
      to it by mutual agreement of the Parties; provided,
      however,
      that if
      the members of the Development Committee are unable to make a decision by
      unanimous vote or unanimous written consent within ten (10) days after
      commencing discussions regarding such decision, or if Development Program timing
      constraints make submission of any matter to the Development Committee
      impracticable, then Alfacell shall have the final decision-making authority
      with
      respect to such decision, except (A) in respect of the Material Development
      Decision, and/or (B) in respect of the Development Committee’s recommendation
      that Alfacell should not pursue a recombinant source of Ranpirnase, wherein
      any
      final decision not to pursue a recombinant source of Ranpirnase shall require
      the written approval of both Parties.

     

    (c) Purposes
      and Powers.
      The
      principal purpose of the Development Committee shall be to provide a forum
      for
      open communication between the Parties with respect to development and
      manufacturing of the Product in general, and for Par to act in an advisory
      and
      consultative capacity with respect to the Development Program. The Development
      Committee shall make recommendations regarding the overall strategy for the
      Development Program, and shall provide advice, guidance, direction and other
      recommendations with respect to the Development Program. Subject to the express
      rights of the Parties as set forth herein, the functions of the Development
      Committee shall include:

     

    (i) Acting
      as
      liaison between the Parties to ensure open and regular communication channels,
      and more particularly to ensure that the Parties are informed of, and have
      a
      forum to discuss, the ongoing progress of the Development Program;

     

    
      
        
        

      

      
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    (ii) Reviewing
      and recommending (or declining to recommend) proposed amendments to the
      Development Program;

     

    (iii) Reviewing,
      consulting on and providing input in respect of activities related to the
      manufacturing of the Product and the selection of manufacturer(s) of the Product
      (provided that Alfacell shall not be required to renegotiate any previously
      negotiated terms and conditions with any such Product manufacturer(s), and
      further provided that such consultation and input shall not unreasonably delay
      Alfacell’s negotiation and completion of its Product contract manufacturing
      arrangements, wherein the reasonableness of any delay shall be determined by
      Alfacell in good faith after consultation with Par); 

     

    (iv) Reviewing
      and recommending (or declining to recommend), in consultation with the
      Commercialization Committee, activities (A) related to the publication and/or
      dissemination of the clinical data and reports related to Product Studies,
      including publications, posters, abstracts and presentations, and (B) with
      respect to other matters that intersect or overlap with Commercialization
      activities; and

     

    (v) Performing
      such other activities and discharging such other responsibilities as may be
      assigned to the Development Committee by the Parties pursuant to this Agreement
      or as may be mutually agreed upon by the Parties from time to time.

     

    2.2 Commercialization
      Committee.

     

    (a) The
      Parties hereby establish a committee, separate from the Development Committee,
      which shall provide a forum for open communication between the Parties regarding
      Product Commercialization activities in the Field, and which shall be
      responsible for such matters related to Commercialization of the Products in
      the
      Field in the Territory as may be described below. The Commercialization
      Committee shall consist of such even number as shall be agreed by the Parties,
      fifty percent (50%) of whom shall be Par designees and fifty percent (50%)
      of
      whom shall be Alfacell designees (the “Commercialization
      Committee”).
      Each
      Party shall have the right at any time and from time to time to designate a
      replacement, on a permanent or temporary basis, for any or all of its
      previously-designated members of the Commercialization Committee. At the
      beginning of each calendar year during the Term, each Party shall appoint one
      of
      its designees to serve as a Co-Chair of the Commercialization Committee. The
      initial Commercialization Committee shall consist of six (6) members (including
      the Co-Chairs of such Committee), who shall be designated by each Party within
      ten (10) business days after the Effective Date. For the sake of clarity, an
      individual may serve on both the Development Committee and the Commercialization
      Committee. The Commercialization Committee shall meet at least once per calendar
      quarter, and more frequently as mutually agreed by the Parties, on such dates,
      and at such places and times, as the Parties shall agree.

     

    
      
        
        

      

      
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    (b) Par
      agrees to keep the Commercialization Committee reasonably informed in respect
      of
      its Commercialization of Products in the Field in the Territory pursuant to
      its
      authority and responsibility set forth in Section 5.1, and in particular Par
      shall (a) provide the Commercialization Committee at its regularly scheduled
      meetings with copies of Par’s annual Product marketing plans, information
      regarding Par’s Commercialization strategy, and updates regarding the foregoing
      and the progress of Par’s Commercialization activities, (b) promptly advise the
      Commercialization Committee of any unforeseen material problems or delays
      encountered since the date of its last report in connection with the
      Commercialization activities, and (c) provide Alfacell as soon as reasonably
      practicable with such other material information as Alfacell’s Commercialization
      Committee members may reasonably request in writing from time to time with
      respect to the status of the Commercialization activities and progress.
      Alfacell’s members shall provide advice, suggestions and constructive feedback
      on such Commercialization strategy, plans and activities (especially in view
      of
      Alfacell’s retained rights regarding Product commercialization outside of the
      Field and outside of the Territory, and Alfacell’s desire to achieve (to the
      extent appropriate) global harmonization of Product commercialization (including
      branding) worldwide). Par will reasonably and in good faith consider any
      comments and recommendations that the Commercialization Committee may have
      with
      respect to the Commercialization of the Product.

     

    (c) The
      Commercialization Committee shall (i) review and recommend (or decline to
      recommend), in consultation with the Development Committee, (A) activities
      related to the publication and/or dissemination of the clinical data and reports
      related to Product Studies, including publications, posters, abstracts and
      presentations and (B) matters that intersect or overlap with Product development
      and/or manufacturing activities, (ii) support Par’s strategy and plans regarding
      Commercialization (to the extent that such strategy and plans have been provided
      to the Commercialization Committee), and (iii) perform such other activities
      and
      discharge such other responsibilities as may be assigned to the
      Commercialization Committee by the Parties pursuant to this Agreement or as
      may
      be mutually agreed upon by the Parties from time to time. Par will reasonably
      and in good faith consider any comments and recommendations that the
      Commercialization Committee may have with respect to the Commercialization
      of
      the Product.

     

    (d) The
      Commercialization Committee has no decision-making authority except as expressly
      set forth herein. All Commercialization issues related to the initial medical
      claims for the core launch materials for the Product that will be submitted
      to
      the FDA for pre-clearance review (the “Material
      Commercialization Decision”)
      shall
      be determined by a vote of the Commercialization Committee. If the
      Commercialization Committee is unable to agree on the Material Commercialization
      Decision, such dispute or disagreement shall be referred to the CEO of Alfacell
      and the CEO of Par for resolution, and the CEOs shall resolve the matter
      (without resort to Section 14.5). All decisions of the Commercialization
      Committee shall be made by unanimous vote or unanimous written consent of both
      Parties, with each Party having, collectively among its respective designees,
      one vote in all decisions. The members of the Commercialization Committee shall
      use Commercially Reasonable Efforts to decide all matters assigned to the
      Commercialization Committee under this Agreement or otherwise referred to it
      by
      mutual agreement of the Parties; provided,
      however,
      that if
      the members of the Commercialization Committee are unable to make a decision
      by
      unanimous vote or unanimous written consent within ten (10) days after
      commencing discussions regarding such decision, then, except in respect of
      any
      Material Commercialization Decision, Par shall have the final decision-making
      authority with respect to such decision (subject to any limitations on such
      authority expressly set forth herein); provided,
      however,
      that if
      Commercialization timing constraints make submission of the matter to the
      Commercialization Committee impracticable, then Par shall have the discretion
      to
      make such determination. 

     

    
      
        
        

      

      
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    2.3 Expenses.
      Each
      Party shall be responsible for all travel and related costs and expenses for
      its
      members and approved invitees to attend meetings of, and otherwise participate
      on, the Development Committee and/or Commercialization Committee.

     

    2.4 Ancillary
      Agreements.
      All
      designees of each Party serving on the Development Committee and/or the
      Commercialization Committee shall as a condition to such service execute a
      nondisclosure agreement in form and substance reasonably satisfactory to the
      Parties. Additionally (i) as of the Effective Date, the Parties shall enter
      into
      a Supply Agreement which is attached hereto as Exhibit
      C
      (the
“Supply
      Agreement”),
      and
      (ii) within sixty (60) days of the date that the first NDA is submitted to
      the
      FDA by Alfacell, the Parties shall enter into a Quality Agreement on mutually
      agreeable and customary terms, and (iii) within sixty (60) days after Alfacell’s
      election to co-promote Product pursuant to Section 5.3 or 5.4, the Parties
      shall
      enter into a definitive, written Co-Promotion Agreement on mutually agreeable
      terms in accordance with Section 5.4.

     

    ARTICLE
      III

     

    DEVELOPMENT
      PROGRAM

     

    3.1 Alfacell
      Responsibility and Control.
      Subject
      to Sections 2.1(b)(iii) and 3.7, Alfacell shall have final decision-making
      authority and primary responsibility for the Development Program and all
      non-Commercialization strategies, plans and activities regarding the Product.
      Alfacell shall use its Commercially Reasonable Efforts to conduct the
      Development Program, to obtain Regulatory Approval for the Product, and to
      manufacture the Product, all in accordance with this Agreement. More
      specifically, Alfacell shall use its Commercially Reasonable Efforts to (a)
      develop the Product for the Primary UMM Indication and, subject to Section
      3.7,
      at least one Future Indication, (b) prepare and submit all required
      application(s) for Regulatory Approval in the Field in the Territory in respect
      of the Product for such Indications, including the applicable NDA(s), and (c)
      if
      necessary, and subject to Section 6.2(a)(ii), work in consultation with the
      Development Committee to prepare for any meeting before, and comply with any
      action plans negotiated by Alfacell and the FDA in response to requests of,
      the
Oncologic
      Drugs Advisory Committee to the FDA (the “ODAC”).
      Subject
      to Section 3.7, Alfacell has the sole right to develop the Product for Future
      Indications. Subject to the terms and conditions contained in this Agreement,
      Alfacell shall have sole responsibility and control over development and
      manufacture of the Product for use in the Field for the Territory and, subject
      to Section 3.3(b), all regulatory matters related thereto, including control
      over and responsibility for executing all aspects of the Development Program,
      including planning, strategy, administrative management, and fiscal control;
      provided,
      however,
      that,
      subject to Section 6.2(a)(ii), Alfacell shall include Par (through the
      Development Committee) in such efforts in an advisory and consultative capacity.
      As of the Effective Date, the Parties anticipate that the Development Program
      shall be conducted at and coordinated from the facilities of Alfacell. Alfacell
      shall comply, and shall require all of its Third Party agents and contractors,
      if any, to comply, with all applicable laws in the conduct of the Development
      Program.

     

    
      
        
        

      

      
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    3.2 Development
      Program.
      Subject
      to the provisions of this Agreement, Alfacell shall determine the development
      plan(s) and the Development Program, and the execution thereof shall be within
      Alfacell’s decision-making authority and control (subject to Section
      2.1(b)(iii)). Notwithstanding the foregoing or any other provision of this
      Agreement, Par acknowledges and agrees that (a) the Development Program is
      experimental in nature; and (b) Alfacell does not guarantee that the
      Development Program will be successful or that Regulatory Approval will be
      obtained for the Product in the Field in the Territory. During the Term, subject
      to the other provisions of this Agreement, Alfacell may revise the development
      plan(s) and/or the Development Program at any time and from time to time,
      provided that (y) Alfacell provides the Development Committee with a reasonable
      opportunity to review and comment on any proposed revision to the development
      plan(s) and/or the Development Program, and (z) Alfacell shall consider in
      good
      faith any such comments prior to the adoption and implementation of such
      revisions.

     

    3.3 Clinical
      and Regulatory Approval.

     

    (a) Conduct
      by Alfacell.
      The
      Parties acknowledge that Alfacell has initiated Phase III Clinical Trials in
      the
      Territory in respect of the Product for the Primary UMM Indication. Alfacell
      shall use Commercially Reasonable Efforts to (i) conduct required clinical
      trials of the Product for the Primary UMM Indication in the Territory and,
      subject to Section 3.7, for the Future Indications in the Territory agreed
      to be
      pursued by the Parties, and undertake steps to obtain Regulatory Approval in
      accordance with this Agreement and in a manner consistent with the Development
      Program; and (ii) through the Development Committee, include Par in such efforts
      in an advisory and consultative capacity. Alfacell acknowledges that certain
      Product-related activities undertaken by Alfacell outside of the Territory
      may
      trigger material reporting obligations to the FDA and may materially affect
      the
      Commercialization of the Product by Par in the Territory, and with respect
      to
      such activities that Alfacell determines in good faith are likely to trigger
      such materially reporting obligations and/or are likely to materially affect
      such Commercialization by Par, Alfacell shall disclose such Product-related
      activities outside of the Territory to Par and permit Par to promptly review
      them and provide comments and suggestions that would enable both Parties to
      achieve their objectives under this Agreement. If the Parties are unable to
      reach mutual agreement regarding a fair and reasonable approach that would
      avoid
      or minimize any material reporting obligations and material effects on
      Commercialization of the Product by Par, such dispute or disagreement regarding
      such fair and reasonable approach shall be referred to the CEO of Alfacell
      and
      the CEO of Par for resolution, and the CEOs shall resolve the matter (without
      resort to Section 14.5); provided,
      however,
      that
      this dispute resolution provision shall not empower Par’s CEO with any
      decision-making authority regarding Alfacell’s Product-related activities
      outside the Territory, including the right to veto any such
      activities.

     

    
      
        
        

      

      
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    (b) Regulatory
      Submissions.

     

    (i) The
      Parties acknowledge that no Product has been reviewed or approved for sale
      or
      use as a human therapeutic product by any Governmental Authority. Subject to
      Section 3.1, Alfacell shall prepare any required application(s) for Regulatory
      Approval in the Field in the Territory. Unless otherwise agreed by the Parties,
      Alfacell shall own, in its entirety, all clinical data and reports related
      to
      Product Studies including clinical trials for the Product; provided,
      however,
      that,
      during the Term, Par shall have the right to (i) obtain copies of, and to use,
      Alfacell Information that is included in Alfacell’s NDA for the Product for an
      Indication, as Par reasonably determines is necessary or desirable to further
      the Commercialization of the Product in the Field in the Territory, and (ii)
      request copies of, and to use, Alfacell Information that is not included in
      Alfacell’s NDA for the Product for an Indication, with Alfacell’s consent (such
      consent not to be unreasonably withheld) as Par reasonably determines is
      necessary or desirable to further the Commercialization of the Product in the
      Field in the Territory. At all times both prior to and following Regulatory
      Approval of the Product in the Field in the Territory, Alfacell shall
      (A) inform Par of all substantive communications from the FDA concerning
      the NDA and any other material communications from the FDA concerning the
      Product in the Field within forty-eight (48) hours of receipt thereof, such
      substantiality and materiality to be solely based on Alfacell’s reasonable
      evaluation, and (B) provide copies of proposed material FDA communications
      and submissions concerning the Product to the Development Committee and Par
      prior to their submission to the FDA, subject to the extent practicable, as
      described below. Except to the extent that Alfacell must respond to the FDA
      or
      make a submission to the FDA before receipt of the Development Committee’s
      and/or Par’s comments, Alfacell will not respond substantively in writing to any
      FDA communication or otherwise make any written submissions to the FDA
      concerning, in either case, the Product in the Field without first giving Par
      a
      reasonable opportunity to review and comment thereon. Such opportunity shall
      not
      exceed ten (10) days, unless otherwise required by the FDA, in which case
      Alfacell shall use Commercially Reasonable Efforts to provide Par with an
      opportunity to review and comment to the extent practicable, but Par agrees
      that
      Alfacell shall be entitled to respond in any manner as Alfacell determines
      in
      its reasonable discretion is appropriate given the timing of the FDA regulatory
      review process. Alfacell shall review and consider in good faith any comments
      received from Par related to such FDA communications or submissions related
      to
      the Product in the Field, and any comments or suggestions timely received from
      Par that are otherwise related to Regulatory Approvals for the Product in the
      Field in the Territory. For the sake of clarity, the Parties recognize that
      the
      FDA regulatory review process may involve both non-Commercialization
      (i.e.,
      development and/or manufacturing) and Commercialization aspects of the Product
      in the Field in the Territory (for example, proposed labeling of the Product
      for
      a given Indication). If any such intersection or overlap of Alfacell’s final
      decision-making authority regarding development and manufacturing and Par’s
      final decision-making authority regarding Commercialization results in a dispute
      or disagreement, such dispute or disagreement shall be referred to the CEO
      of
      Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the
      matter (without resort to Section 14.5).

     

    (ii) The
      Parties shall cooperate in good faith with respect to obtaining, and Alfacell
      shall use Commercially Reasonable Efforts to enable representatives of Par
      to
      attend, if and as requested by Par and as permitted by the FDA, formal meetings
      with the FDA relating to Regulatory Approval of the Product in the Field in
      the
      Territory. The Parties shall cooperate in good faith with respect to the conduct
      of any inspections by the FDA or equivalent foreign regulatory authority of
      a
      Party’s site and facilities related to the Product. To the extent either Party
      receives any material written or oral communication from the FDA or equivalent
      foreign regulatory authority relating to the Regulatory Approval process with
      respect to the Product in the Field in the Territory, the Party receiving such
      communication shall promptly notify the other Party and provide a copy of such
      written communication and/or a written summary of such oral communication as
      soon as reasonably practicable.

     

    
      
        
        

      

      
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    (iii) If
      “ONCONASE®”
is
      not
      approved by the FDA as the Product Trade Name, Alfacell shall not submit any
      other Trade Name(s) for the Product for approval by the FDA unless such other
      Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the
      license rights granted herein, Alfacell shall own all right, title, and interest
      to ONCONASE and all such Trade Names and intellectual property rights related
      thereto (including trademark and copyright), and Par shall (A) assign any
      right, title, and interest it has in any Trade Names (including intellectual
      property rights related thereto (including trademark and copyright)) to
      Alfacell, free and clear of all liens, claims, and encumbrances, and
      (B) take any and all actions reasonably requested by Alfacell in
      furtherance of the foregoing. *** related to the choosing of any new Trade
      Name
      for the Product in the Field in the Territory, including any market research
      studies conducted by Par pertaining to ONCONASE or any new proposed Trade
      Name(s) for the Product.

     

    3.4 Development
      Program Funding.
      Except
      as otherwise expressly provided herein or as otherwise expressly agreed by
      the
      Parties in writing, Alfacell shall be solely responsible for payment of all
      Development Costs.

     

    3.5 Development
      Program Reporting.
      Alfacell shall (a) provide Par at regularly scheduled meetings of the
      Development Committee with summary updates regarding the progress of the
      Development Program and Regulatory Approval process, (b) promptly advise Par
      of
      any unforeseen material problems or delays encountered since the date of its
      last report in connection with the Development Program, and (c) provide Par
      as
      soon as reasonably practicable with such other material information as Par
      may
      reasonably request in writing from time to time with respect to the status
      of
      the Development Program.

     

    3.6 Post-Regulatory
      Approval. Alfacell
      shall, at its sole cost and expense and under its control and responsibility,
      (a) maintain Regulatory Approval(s) of the Product in the Field in the
      Territory at all times during the Term following receipt of the same, subject
      to
      Par’s cooperation with such efforts as may be required to maintain such
      Regulatory Approval(s) and (b) conduct any post-Regulatory Approval
      development programs for the Product that are required by or negotiated with
      the
      FDA as a condition to obtaining or maintaining Regulatory Approval of the
      Product. If mutually determined by the Parties to be beneficial to the
      development and/or Commercialization of Product in the Field in the Territory,
      the Parties shall collaborate and cooperate in conducting any post-Regulatory
      Approval development programs for the Product in the Field in the Territory
      that
      are not required by or negotiated with the FDA, ***. Such post-Regulatory
      Approval development programs shall be conducted in accordance with a written
      agreement and budget which are accepted in writing by both Parties.

     

    
      
        
        

      

      
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    3.7 Future
      Indications Programs.
      Notwithstanding the scope of Alfacell’s decision-making authority set forth
      herein (including in Section 3.1), (a) without the prior consent of the
      Development Committee, Alfacell will not initiate a Phase III Clinical Trial
      on
      the Product for any Future Indication in the Territory unless the Development
      Committee has agreed to the design of such trial, and (b) even with such prior
      consent by the Development Committee, without the prior written consent of
      Par,
      (i) in any consecutive twenty-four (24) month period Alfacell shall not initiate
      first Phase III Clinical Trials on, and Par shall have no financial obligations
      in Section 6.2(b) (Future Indication Milestones) for, more than two (2) ongoing
      Future Indications in the Territory (where the initiation of a first Phase
      III
      Clinical Trial in a Future Indication in the Territory shall be deemed to occur
      on the date of administration of the first dose of the Product to the first
      patient in such first Phase III Clinical Trial), and (ii) Alfacell shall not
      initiate, in the aggregate, first Phase III Clinical Trials on more than three
      (3) Future Indications in the Territory. As of the Effective Date, the
      Indications recited in clauses (a)-(c) of the definition of “Future Indications”
have been mutually agreed by the Parties to be Indications eligible for study
      by
      Alfacell pursuant to this Section 3.7. Upon the determination of the design
      of
      the Phase III Clinical Trials for any Future Indication in the Territory by
      the
      Development Committee, Alfacell shall use Commercially Reasonable Efforts to
      develop the Product for such Future Indication in the Territory. In the event
      that the Development Committee is unable to agree as to the design of such
      trial
      described in clause (a) above, such dispute or disagreement shall be referred
      to
      the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall use
      their best efforts to resolve the matter in good faith within thirty (30) days
      after such referral, subject to Section 14.5. 

     

    3.8 Recombinant
      Source.
      Unless
      otherwise agreed by the Parties, during the Term, Alfacell shall use its
      Commercially Reasonable Efforts to pursue a recombinant source of Ranpirnase.
      As
      of the Effective Date, the Parties agree that obtaining such recombinant source
      would be advantageous and would further the objectives of both Parties under
      this Agreement. Notwithstanding the foregoing or any other provision of this
      Agreement, (i) Par acknowledges and agrees that Alfacell does not guarantee
      that
      such pursuit will be successful or that Regulatory Approval in the Field in
      the
      Territory will be obtained for any Product containing recombinant Ranpirnase
      and
      (ii) Alfacell shall not use in the manufacturer of the Product Ranpirnase that
      has been obtained from a recombinant source without Par’s prior written
      consent.

     

    ARTICLE
      IV

     

    LICENSE

     

    4.1 Grant
      to Par.

     

    (a) License
      Generally; Appointment as Exclusive Distributor.
      Alfacell
      hereby grants to Par the following rights and licenses:

     

    (i) an
      exclusive (even as to Alfacell, but subject to the co-exclusive rights provided
      for or referred to in Section 4.1(c)(iii) and 5.4), royalty-bearing license
      under the Alfacell Patents and under any and all applicable Regulatory Approvals
      in the Field to
      promote, market, have marketed, distribute, sell, offer for sale and otherwise
      Commercialize Product in the Field in the Territory and to do such other things
      necessary to comply with Par’s obligations under this Agreement. 

     

    
      
        
        

      

      
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    (ii) as
      further provided in, and subject to Article IX, in order to protect the Product
      in the Field, an exclusive (even as to Alfacell but subject to Alfacell’s rights
      in Article IX) license to enforce the Alfacell Patents against any potential
      Third Party infringement that could reasonably be expected to adversely affect
      the Commercialization or value of the Product in the Territory.

     

    (b) Restriction
      on Right to Sublicense.
      Notwithstanding the license grants provided in Section 4.1(a), Par (i) shall
      have the right to market, sell, offer for sale, and have sold AG Product only
      beginning (a) on the date on or, with Alfacell’s prior written consent,
      immediately prior to the anticipated date that a Third Party sells or offers
      for
      sale a generically-labeled version of the Product or (b) if applicable, upon
      (or
      as part of) settlement of a litigation under Section 9.3 that allows a Third
      Party to sell or offer for sale a generically-labeled version of the Product
      and
      (ii) shall not have a general right to sublicense, but shall have the limited
      right to grant sublicenses only under its rights to market, sell, offer for
      sale, and have sold AG Product and only in connection with settlement of a
      litigation under Section 9.3 that allows a Third Party to sell or offer for
      sale
      a generically-labeled version of the Product, provided, that Par has obtained
      the consent of Alfacell to such settlement to the extent required under Section
      9.3. Par will at all times remain responsible to Alfacell for all of its
      obligations under this Agreement and shall be responsible for the acts or
      omissions of its sublicensees in exercising rights granted hereunder. Each
      sublicense granted by Par shall be consistent with the terms of this Agreement,
      and Par shall furnish Alfacell a copy of any such sublicense it grants.

     

    (c) Reservation
      of Rights.
      

     

    (i)
      Alfacell hereby retains any and all rights which are not expressly granted
      to
      Par hereunder.

     

    (ii)
      Nothing in Section 4.1(a) limits Alfacell from exercising its co-promote rights
      under Section 5.4.

     

    (iii)
      Nothing in Section 4.1(a) limits Alfacell’s ability to perform its obligations
      under this Agreement, the Supply Agreement, the Quality Agreement and the
      Co-Promotion Agreement (if Alfacell exercises its co-promote right).

     

    (iv)
      For
      purposes of clarity and without limitation, Alfacell has exclusively retained
      (even as to Par) the right to perform (alone or with Third Parties) any and
      all
      activities related to the use, research, manufacture and development of Products
      within and outside the Field and the Territory, and to Commercialize the
      Products outside the Field in the Territory and in all fields outside the
      Territory. 

     

    
      
        
        

      

      
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    (v)
      Alfacell has retained the right to enforce the Alfacell Patents as it sees
      fit
      against any potential Third Party infringement that could not reasonably be
      expected to adversely affect the Commercialization or value of the Product
      under
      this Agreement, including any patent rights not related to Ranpirnase, Product
      or Competing Product. For purposes of clarity, Par shall not have any right
      to
      enforce, and Alfacell shall exclusively have the right to enforce, each patent
      claim covering one or more Amphinases. Similarly, with respect to each Modified
      Targeted Ranpirnase that becomes subject to an Option granted to Par under
      Section 4.5, if Par rejects its Option under Section 4.5, or if Par does not
      inform Alfacell of its exercise of the Option within the required time period,
      or if the Parties have not executed a New License Agreement within the
      prescribed period under Section 4.5(b) after Par’s exercise of the Option, then
      thereafter Par shall not have any right to enforce, and Alfacell shall
      exclusively have the right to enforce, patent claims covering the particular
      Modified Targeted Ranpirnase that was subject to the Option. In all events,
      prior to the enforcement of any Alfacell Patent against any Third Party in
      the
      Territory, Par and Alfacell shall confer in good faith regarding such
      enforcement.

     

    (d) Trademark
      and Trade Name License.
      

     

    (i) Alfacell
      hereby grants to Par an exclusive (even as to Alfacell, subject to the
      co-promote right provided to Alfacell in Section 5.4), royalty-bearing (but
      at no additional consideration except as expressly provided herein) license
      in
      the Field in the Territory, without the right to sublicense, under the Trademark
      and each Trade Name that has obtained or hereafter obtains Regulatory Approval
      for use in connection with the Product, to promote, market, offer for sale,
      sell
      and have sold Product in the Field in the Territory; provided,
      however,
      that
      Alfacell retains the right to exercise the foregoing rights only as and to
      the
      extent required to permit Alfacell to exercise its co-promote right under
      Section 5.4 and to perform its obligations under this Agreement. To the
      extent required by applicable law in the Territory, Alfacell shall make
      applications to the applicable Governmental Authority for the registration
      of
      Par as a registered user of the Trademark and each Trade Name that has obtained
      or hereafter obtains Regulatory Approval for use in connection with the Product,
      respectively, in respect of each respective registration of the Trademark or
      such Trade Name(s), and Par shall cooperate with Alfacell in making such
      applications. For the avoidance of doubt, Alfacell retains all rights to the
      Trademark and each Trade Name except to the extent explicitly granted to Par
      hereunder, and all goodwill associated with the use of the Trademark and each
      Trade Name will inure exclusively to the benefit of Alfacell.

     

    (ii) Par
      shall
      comply with the guidelines attached hereto (or to be attached hereto after
      the
      Effective Date by Alfacell, subject to Par's consent, not to be unreasonably
      withheld) as Schedule
      4.1(d)
      in
      respect of the size, form, and manner of the use of the Alfacell name and logo,
      and the Trademark and Trade Name(s) in the Commercialization of the Product
      in
      the Field in the Territory, subject to any reasonable future revisions thereto
      requested by Alfacell in writing, provided that any such material revisions
      thereto shall not be effective unless and until consented to by Par, such
      consent not to be unreasonably withheld (however, if Par does not so consent,
      such dispute shall be resolved by the CEO of Alfacell and the CEO of Par
      (without resort to Section 14.5)). All packaging, inserts, labels, promotional
      or other materials for the Product sold or to be sold by Par and its
      Sub-distributors in the Territory shall display the name and Trademark of
      Alfacell and each such Trade Name (except in respect of the AG Product), and
      shall identify Alfacell as licensor and manufacturer of the Product.
Any
      failure by Par or its Sub-distributors to comply with this Section 4.1(d) shall
      be a material breach of this Agreement.

     

    
      
        
        

      

      
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    (e) Challenge.
      If Par
      or any of its Affiliates or Sub-distributors directly challenges, or directly
      assists any Third Party in challenging, in any forum the validity,
      enforceability, scope or any other elements of the Alfacell Patents, then
      Alfacell may terminate this Agreement on thirty (30) days’ notice to Par if Par
      or any of its Affiliates or Sub-distributors shall not cease such challenge
      within such 30-day period. Without limiting the generality of the foregoing,
      Par
      specifically agrees that filing a request for reexamination, attempting to
      institute an interference, or filing an opposition with respect to any Alfacell
      Patent(s) or foreign counterparts thereof will be deemed a “challenge” under
      this Section 4.1(e). 

     

    4.2 Information
      Transfer.
       

     

    (a) Promptly
      after the Effective Date, Alfacell shall, at its own cost, disclose to Par
      in
      writing, or via mutually acceptable electronic media, copies or reproductions
      of
      all Alfacell Information, but only to the extent not previously disclosed to
      Par, that are reasonably necessary or useful for Par and its Sub-distributors
      to
      market, sell or have sold the Product in the Field in the Territory. In
      addition, during the Term of this Agreement, Alfacell shall promptly disclose
      to
      Par in writing, or via mutually acceptable electronic media, on an ongoing
      basis, copies or reproductions of all new Alfacell Information that is
      reasonably necessary for Par and its Sub-distributors to market, sell or have
      sold the Product in the Field in the Territory. Such disclosed Alfacell
      Information shall be automatically deemed to be within the scope of the licenses
      granted to Par under Section 4.1 without payment of any additional
      compensation.

     

    (b) During
      the Term of this Agreement, (i) when either Party becomes aware of a potential
      infringement of the Alfacell Patents by a Third Party in the Field in the
      Territory, (ii) during the course of a Third Party infringement action brought
      by or against the Parties as a result of the Party’s (Parties’) activities
      pursuant to this Agreement, or (iii) on Par’s reasonable request, Alfacell shall
      promptly disclose to Par in writing, or via mutually acceptable electronic
      media, copies or reproductions of all new Alfacell Information described in
      Section 4.2(a) which has not been previously disclosed to Par and which is
      reasonably necessary for Par to exploit its rights under Article IX. Such
      disclosed Alfacell Information shall be automatically deemed to be within the
      scope of the licenses granted to Par under Section 4.1 without payment of any
      additional compensation. 

     

    4.3 Appointment
      of Sub-distributors.
      Par may,
      with the prior written consent of Alfacell in its sole discretion (such consent
      not to be withheld for any potential sub-distributor that is an Affiliate of
      Par), appoint sub-distributors (which may be Par’s Affiliates or non-Affiliates;
      each a “Sub-distributor”)
      to
      distribute Product for use in the Field in the Territory, subject to the
      following clauses (a-e) and the other terms and conditions of this
      Agreement:

     

    (a) each
      agreement with a Sub-distributor shall be in writing and shall state that the
      Sub-distributor’s rights under such agreement are subject to all relevant terms
      and conditions of this Agreement, including (without limitation) provisions
      and
      restrictions relating to Field, Territory, price, payment, reporting, audit
      of
      books and records, promotional materials, trade name, and
      termination;

     

    
      
        
        

      

      
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    (b) if
      this
      Agreement terminates, in whole or in part, the rights of any Sub-distributors
      shall automatically be terminated in accordance therewith;

     

    (c) Par
      shall
      promptly notify Alfacell in writing of any breaches of this Agreement that
      are
      due to any act or omission by any Sub-distributor(s), and shall report to
      Alfacell the full details of such breach and the actions to be taken by Par
      to
      cure such breach;

     

    (d) Par
      shall
      ensure that each Sub-distributor complies with all applicable terms and
      conditions of this Agreement, and shall be liable to Alfacell for any failure
      of
      any Sub-distributor to do so; and

     

    (e) Par
      shall
      provide Alfacell with the names and primary business addresses of all
      Sub-distributors and, within fifteen (15) days of the effective date of each
      agreement with a Sub-distributor, Par shall provide a copy of each such
      agreement to Alfacell.

     

    For
      the
      avoidance of doubt, (i) any act or omission of a Sub-distributor that would
      be a
      breach of this Agreement if performed by Par will be deemed to be a breach
      by
      Par of this Agreement, and (ii) Par’s customers (e.g., wholesalers) shall not be
      considered Sub-distributors for purposes of this Agreement.

     

    4.4 Exclusivity.

     

    (a) Alfacell
      agrees that, during the Term, it will not, and it will not enable or contract
      with any Third Party to, (i) market, sell or distribute the Product in the
      Field
      in the Territory or develop or supply the Product for sale in the Field in
      the
      Territory, except in accordance with Section 5.4 and/or for the development
      and
      supply of the Product in the Field in the Territory pursuant to this Agreement,
      (ii) market, sell or distribute any Competing Product in the Territory or
      develop or supply any Competing Product for sale in the Territory; or (iii)
      use
      the Trademark in connection with any product in the Territory other than the
      Product pursuant to this Agreement; provided,
      however,
      that,
      subject to Section 4.5, the foregoing restrictions provided in this Section
      4.4(a) shall not restrict Alfacell, directly or through a Third Party, from
      developing, manufacturing, importing, marketing, selling or distributing
      Modified Targeted Ranpirnase.

     

    (b) Par
      agrees that, and shall cause its Sub-distributors to agree that, during the
      Term, Par and its Sub-distributors will not, and will not enable or contract
      with any Third Party to manufacture, import, market, sell or distribute any
      Competing Product in the Territory.
      To
      the
      fullest extent permitted by applicable law, Par is prohibited from selling
      (and
      Par shall not permit its Sub-distributors to sell), and Par and its
      Sub-distributors shall not sell, Product (i) outside the Territory, (ii) to
      customers in the Territory that Par or its Sub-distributors know, or have reason
      to know, plan to resell or in the past have resold the Product for use outside
      the Territory, and Par shall not during the Term actively approach, or accept
      or
      fill orders from, customers outside the Territory. This prohibition includes
      detailing, visiting, calling, mailing, or marketing Product to such customers.
      If Par or its Sub-distributors knowingly sell the Product outside of the
      Territory, Par shall provide full details of such Product sale to Alfacell
      and
      pay Alfacell, at Alfacell’s option, in addition to any other remedies available
      to Alfacell, for each Product thus sold, ***. In addition, Alfacell may
      terminate this Agreement on sixty (60) days’ notice to Par if Par does not cease
      such sales, and cause its Sub-distributors to cease such sales, outside the
      Territory within such 60-day period. Additionally, Par agrees that, and shall
      cause its Sub-distributors to agree that, during the Term, Par and its
      Sub-distributors will not, and will not enable or contract with any Third Party
      to, promote, market, have marketed, distribute, offer for sale, sell or have
      sold the Product outside of the Field.

     

    
      
        
        

      

      
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    4.5 Right
      of First Negotiation.
      

     

    (a) If,
      following the Effective Date, Alfacell determines that a particular Modified
      Targeted Ranpirnase compound demonstrates activity across one or more tumor
      cell
      types and has commercial viability (and such determination is reasonably
      supported by reasonable non-clinical or pre-clinical data in respect of such
      cell type(s)), Alfacell shall, prior to instituting any Phase III development
      program in respect thereof, provide Par with a one time written notice of
      information that Alfacell possesses or that Alfacell has a contractual right
      with any Third Party to obtain, subject to any corresponding contractual
      obligation, including copies of such data, and an estimate of the cost for
      developing and obtaining regulatory approval therefor, that is reasonably
      required by Par to determine whether or not to enter into negotiations for
      a
      license agreement with Alfacell with respect to such Modified Targeted
      Ranpirnase. The delivery of such notice shall automatically grant to Par an
      exclusive option (the “Option”)
      to
      enter into an agreement with Alfacell for an exclusive license to permit Par
      to
      market, sell and have sold such Modified Targeted Ranpirnase in respect of
      the
      applicable indications (the “New
      License Agreement”).
      Par
      shall determine and notify Alfacell of its determination in writing, as soon
      as
      practicable, and in any event no more than *** days after the grant of such
      Option by Alfacell, to (i) exercise the Option by delivery of written notice
      to
      Alfacell of its exercise of such Option, or (ii) reject the Option. The
      exercise, or determination not to exercise, by Par of its rights under this
      Section 4.5(a) in respect of any granted Option shall not affect its rights
      in
      respect of any other Modified Targeted Ranpirnase compound that was not subject
      to such Option. Any data or other information provided by Alfacell to Par
      pursuant to this Section 4.5(a) shall be deemed and treated as Confidential
      Information in accordance with and subject to Section 8.1. If Par fails to
      exercise its Option within such *** period, or if Par rejects its Option,
      or if the Parties do not execute a New License Agreement despite their good
      faith efforts during the *** described in subsection (b) below, then within
      ten
      (10) business days after such failure, rejection or absence of execution (as
      applicable), Par shall return to Alfacell all documentation containing
      Confidential Information of Alfacell that was received by Par pursuant to this
      Section 4.5(a).

     

    (b) If
      Par
      exercises its Option, the Parties shall, during the *** from the date of
      exercise of the Option, negotiate exclusively a New License Agreement with
      one
      another in good faith. If, following such ***, the Parties have not executed
      the
      New License Agreement despite their good faith efforts, Alfacell may, but shall
      not be obligated to, offer such license for Modified Targeted Ranpirnase for
      the
      applicable indication(s) to a Third Party. If Par rejects the Option, or does
      not inform Alfacell of its exercise of the Option within the *** after the
      grant
      of such Option by Alfacell, (i) Alfacell may, but shall not be obligated to,
      negotiate and enter into a license agreement with a Third Party, and (ii)
      thereafter the particular Modified Targeted Ranpirnase that had been subject
      to
      such Option shall be deemed to no longer be a “Competing Product” for purposes
      of this Agreement. 

     

    
      
        
        

      

      
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    ARTICLE
      V

     

    COMMERCIALIZATION

     

    5.1 Par
      Responsibility and Control.
      Except
      as otherwise expressly set forth herein, subject to the input of the
      Commercialization Committee, Par shall have responsibility for all
      Commercialization activities in the Field in the Territory, including developing
      strategies and tactics related to the advertising, promotion, pricing, marketing
      and selling the Product. Par shall have final decision-making authority and
      primary responsibility for all Commercialization strategies, plans and
      activities regarding the Product in the Field in the Territory. Par shall use
      its Commercially Reasonable Efforts to Commercialize the Product in the Primary
      UMM Indication, the Secondary UMM Indication and any Future Indications that
      have obtained Regulatory Approval in the Territory. Par shall include Alfacell
      in such efforts in an advisory and consultative capacity. Par shall comply,
      shall cause its Sub-distributors to comply, and shall require all of its Third
      Party agents and contractors, if any, to comply, with all applicable laws in
      Commercializing the Product in accordance with this Agreement.

     

    5.2 Certain
      Present Intentions and General Obligations of Par.
      As of
      the Effective Date, Par intends on or before the Initial Commercial Sale to
      assign a dedicated product manager for Commercialization of the Product. In
      addition, following the Initial Commercial Sale, Par shall (if it has not
      theretofore) employ or engage a sales training manager (such position may be
      filled by an employee or a consultant experienced in oncology) and a
      reimbursement specialist (who shall be knowledgeable about Part B).

     

    5.3 Specific
      Commercialization Rights and Obligations of Par.
      

     

    (a) Following
      Regulatory Approval for the Product for the Primary UMM Indication, Secondary
      UMM Indication and any Future Indication, Par shall use Commercially Reasonable
      Efforts to Commercialize the Product for each such applicable Indication in
      accordance with this Agreement and in a manner consistent with the then-current
      Commercialization plan(s), and shall include Alfacell in such efforts in an
      advisory and consultative capacity. Subject to any conditions or limitations
      set
      forth herein, it shall be Par’s sole right and responsibility to (a) determine
      the commercially reasonable launch dates for the Product, (b) develop
      advertising and promotional materials related to the Product, (c) book sales
      for
      the Product, (d) handle all returns of the Product, (e) handle all
      aspects of order processing, invoicing and collection of receivables for the
      Product, (f) collect data regarding sales to hospitals and other end users
      of the Product, (g) monitor inventory levels of the Product, (h) provide
      first line customer support and pharmacovigilance (and after such initial
      support, pharmacovigilance support shall be handled in accordance with Article
      X), (i) warehouse the Product, and (j) determine the prices for the Product
      and any discounts and rebates that may be offered thereto, including decisions
      relating to customer allowances and credits. Par shall determine the
      Commercialization plan(s) and Commercialization activities, and the execution
      thereof shall be within Par’s decision-making authority and control. Par shall
      use Commercially Reasonable Efforts to achieve an Initial Commercial Sale within
      *** after Alfacell obtains Regulatory Approval for the Primary UMM Indication,
      Secondary UMM Indication and/or any Future Indication (as applicable). Par
      shall
      utilize proactive and continuous Product Commercialization efforts (which may
      be
      subject to factors that are beyond the reasonable control of Par) by Par during
      the first ***
      after
      Initial Commercial Sale to advance the objectives and optimize the financial
      returns of both Parties under this Agreement (i.e., during such ***, Par shall
      not cease Commercializing, or engage in di minimis Commercialization of, the
      Product). 

     

    
      
        
        

      

      
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    (b) On
      no
      less than ninety (90) days’ written notice to Par given on or after the *** of
      the Initial Commercial Sale, Alfacell may elect to add up to *** sales
      representatives under Alfacell’s control, at Alfacell’s expense, to co-promote
      the Product for the approved Indication(s), subject to a mutually agreeable
      co-promote agreement. If Alfacell so elects, then such co-promotion by Alfacell
      of the Product for the approved Indication(s) (including UMM Indications) shall
      be deemed to be an accelerated exercise by Alfacell of its co-promote right
      pursuant to Section 5.4; provided,
      however,
      that
      Alfacell shall continue to pay for such additional sales representatives only
      until such time as its co-promote right could have otherwise been exercised
      pursuant to Section 5.4
      (subject
      to Section 5.4(a)(z)).

     

    5.4 Co-promote.
      

     

    (a) Subject
      to Section 5.4(b) and Alfacell’s right to elect an accelerated exercise of
      Alfacell’s co-promote right with respect to all approved Indications pursuant to
      Section 5.3(b), Alfacell shall have the right to co-promote the Product on
      the
      approval of any Future Indication in the Territory (i) by providing written
      notice to Par at least *** in advance of Alfacell’s planned commencement of
      such co-promote activities and (ii) by entering into a mutually agreeable,
      definitive, written co-promotion agreement with Par setting forth the
      particulars of the Parties’ rights and obligations concerning co-promotion of
      the Product. The Parties shall use good faith to enter into, prior to the
      Initial Commercial Sale, such co-promotion agreement, which shall, among other
      things, include (x) an obligation of Par to pay Alfacell only the Fair Market
      Value per Detail for Alfacell’s sales representatives for such co-promotion,
      which Details provided by Alfacell’s sales representatives shall not exceed ***
      percent (***%) of all of the Details for the Product for the applicable Future
      Indication, (y) if Alfacell intends use such Alfacell sales representatives
      to
      promote or co-promote a pharmaceutical product (other than the Product) that
      shares an FDA-approved, labeled indication with any Par Promoted Product,
      Alfacell shall be entitled to promote or co-promote such pharmaceutical product
      if, and only if, Alfacell provides written notice of such intention to Par,
      and
      (z) if Alfacell provides such written notice indicating its intent to promote
      or
      co-promote such pharmaceutical product, or if Alfacell in fact promotes or
      co-promotes such pharmaceutical product, then Par shall no longer be obligated
      to pay to Alfacell the Fair Market Value per Detail for co-promotion by Alfacell
      of the Product, and such co-promotion by Alfacell of the Product shall
      thereafter be at Alfacell’s sole cost and expense (until such time as Alfacell
      no longer promotes or co-promotes such pharmaceutical product, which shall
      not
      occur prior to 60 days following the delivery by Alfacell of written notice
      to
      Par in respect thereof). Alfacell shall not be entitled to initiate any
      co-promotion activities for the Product unless and until the Parties enter
      into
      such co-promotion agreement.

     

    
      
        
        

      

      
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    (b) If
      the
      Product obtains Regulatory Approval for a Future Indication prior to the
      Regulatory Approval of the Product for the Primary UMM Indication or Secondary
      UMM Indication, and if the Parties do not waive the pre-condition related
      thereto set forth in Section 6.2(b), then, subject to Section 5.3, Alfacell’s
      right to co-promote the Product may not be exercised by Alfacell until the
      later
      of (i) *** following the initial commercial sale of
      the
      Product for such Future Indication and (ii) the earlier to occur of (a)
      Regulatory Approval of the Product for the Primary UMM Indication or Secondary
      UMM Indication, or (b) the *** of Regulatory Approval related to the Product
      for
      such Future Indication.

     

    ARTICLE
      VI

     

    PAYMENTS

     

    6.1 Upfront
      Payment.
      In
      consideration for the execution and delivery of this Agreement by Alfacell,
      Par
      shall pay Alfacell a fully earned, non-refundable, non-creditable license fee
      in
      the amount of US$5,000,000 by wire transfer of immediately available funds
      upon
      execution and delivery of this Agreement.

     

    6.2 Milestone
      Payments.

     

    (a) UMM
      Indication Milestone Payments.

     

    (i) Subject
      to the terms and conditions of this Agreement, including Section
      6.2(a)(ii):

     

    (1) if
      Alfacell obtains Full Approval for the Product for the Primary UMM Indication
      on
      or before July 31, 2010, Par shall pay to Alfacell US$30,000,000; 

     

    (2) if Alfacell
      obtains Full Approval for the Product for the Primary UMM Indication after
      July
      31, 2010, then in lieu of the milestone payment provided in Section
      6.2(a)(i)(1), Par shall instead pay to Alfacell US$***; and

     

    (3) if
      Alfacell has not obtained Full Approval for the Product for the Primary UMM
      Indication at the time that it obtains Full Approval for the Product for a
      Secondary UMM Indication, then, in lieu of any milestone payment provided in
      Section 6.2(a)(i)(1) or 6.2(a)(i)(2), Par shall pay to Alfacell US$***;
provided,
      however,
      that if
      Alfacell subsequently obtains Full Approval for the Product for the Primary
      UMM
      Indication, then Par shall pay to Alfacell either US$*** (if such Full Approval
      for the Product for the Primary UMM Indication is obtained on or before July
      31,
      2010) or US$*** (if such Full Approval for the Product for the Primary UMM
      Indication is obtained after July 31, 2010), as applicable.

     

    
      
        
        

      

      
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    (ii) If
      a meeting with the ODAC is called for by the FDA or if Par reasonably believes
      that the FDA will have outstanding review issues and/or questions relevant
      to
      the CMC Section, then Par may, in its sole discretion, make a partial prepayment
      of the amounts provided in Section 6.2(a)(i) in an amount not to exceed US$***;
      provided, however, that (A) any such prepayment amount shall be used
      exclusively in the preparation of the CMC Section or, as applicable, preparation
      for the meeting with, or in compliance with any requests of, the ODAC, and
      (B)
      in consideration of such prepayment, Par and Alfacell shall be entitled to
      jointly control, subject to Section 14.5, the preparation for any meeting with
      the ODAC or preparation of the CMC Section, as applicable, the compliance with
      any requests of the ODAC and the allocation of funds related
      thereto.

     

    (b) Future
      Indication Milestones.
      Provided
      Alfacell shall have received Full Approval for either the Primary UMM Indication
      or the Secondary UMM Indication, or provided that each of the Parties agrees
      in
      writing, in its sole discretion, to waive the foregoing pre-condition due to
      unexpected and/or unavoidable delays in receipt of such Full Approval for a
      UMM
      Indication despite Alfacell’s Commercially Reasonable Efforts to obtain such
      receipt, then and in addition to the milestones payments set forth in Section
      6.2(a) and subject to Section 3.7, upon the achievement of certain milestones,
      Par shall make fully earned, non-refundable, non-creditable payments to Alfacell
      by wire transfer of immediately available funds as follows:

     

    (i) Upon
      the
      administration of the first dose of the Product to the first patient in a first
      Phase III Clinical Trial for each Future Indication, Par shall pay to Alfacell
      US$***;

     

    (ii) Upon
      the
      acceptance for filing by the FDA of Alfacell’s NDA subject to a Special Protocol
      Assessment (as described as of the Effective Date at
      http://www.fda.gov/cber/gdlns/protocol.htm#i) for each Future Indication, Par
      shall pay to Alfacell US$***; provided,
      however,
      that in
      the event a Special Protocol Assessment is not used, then, prior to filing
      of
      the applicable Alfacell NDA with the FDA, up to two (2) experts shall be
      retained by each Party (for a total of four (4) experts), and if such experts
      reasonably agree that the Phase III Clinical Trial data package is unlikely
      to
      support FDA approval for such Future Indication, then Par shall not be obligated
      to pay to Alfacell such amount; and

     

    (iii) Upon
      a
      Regulatory Approval of each Future Indication, Par shall pay to Alfacell
      US$***.

     

    (c) Sales
      Milestone Payments.
      In
      addition to the milestone payments set forth above, following the Initial
      Commercial Sale, on the terms and subject to the conditions contained herein,
      Par shall additionally be obligated as follows:

     

    (i) Subject
      to Section 6.2(c)(ii), Par will pay to Alfacell the following one-time only
      milestone payments: 

     

    ***

     

    
      
        
        

      

      
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    (ii) The
      milestone payments set forth in Section 6.2(c)(i) (“Sales
      Milestone Payments”)
      are
      subject to the following: (A) each such Sales Milestone Payment is
      available to Alfacell on a one-time basis, such that once achieved and paid,
      such Sales Milestone Payment shall not be payable again regardless of the amount
      of Net Sales in any future Contract Year; (B) if more than one milestone is
      achieved for the first time in any given Contract Year, then Par shall make
      each
      Sales Milestone Payment, and each such achieved milestone shall be forever
      satisfied hereunder; and (C) the aggregate of all Sales Milestone Payments
      under this Section 6.2(c) during the Term shall not exceed an amount equal
      to US$***.

     

    6.3 Royalty.

     

    (a) Royalty
      Payment.
      In
      addition to the milestone payments set forth above in Section 6.2, following
      the
      Initial Commercial Sale of the Product, in respect of any Contract Year, Par
      shall pay to Alfacell an amount equal to (i) *** (amounts owed to Alfacell
      pursuant to this Section 6.3(a), the “Royalty”).

     

    (b) Royalty
      Step Down.
      Upon
      expiration of the last to expire Valid Claim within the Patents licensed to
      Par
      during the Term pursuant to Section 4.1, each of the royalty rates set forth
      in
      Section 6.3(a) shall be reduced as follows ***;
      and
      further provided, in
      the
      event that, after such expiration of the last to expire Valid Claim, a
      subsequent Valid Claim should come into existence during the Term, then the
      royalty rates set forth in Section 6.3(a) shall again apply without reduction
      pursuant to this Section 6.3(b).

     

    (c) Termination
      of Royalty.
      Unless
      otherwise expressly provided herein, the obligation of Par to pay Royalties
      to
      Alfacell pursuant to Section 6.3(a) shall cease upon expiration or termination
      of this Agreement.

     

    6.4 Other
      Payment Obligations of Par.
      Par
      shall pay to Alfacell the amounts set forth in Section 5.4 (Co-promote) and
      Section 7.2 (Pricing), in each case subject to the terms set forth
      therein.

     

    6.5 Payment
      Procedures.

     

    (a) Manner
      of Payment.
      Remittance of payments to Alfacell hereunder will be made in immediately
      available funds by means of wire or electronic transfer to an Alfacell account
      in a bank in the United States to be designated by Alfacell.

     

    (b) Payments
      and Reports.
      All
      amounts payable to Alfacell under this Agreement shall be paid in U.S. Dollars.
      Milestone Payments under Section 6.2 shall be made no later than ten (10) days
      after the satisfaction of the milestone giving rise to the applicable payment.
      The Royalty shall accrue at the time of sale of the Product by Par or a
      Sub-distributor to a Third Party. Royalty obligations that accrue during a
      calendar quarter shall be paid within forty-five (45) days after the end of
      such calendar quarter, and other payments owing shall be made as specified
      herein. Each payment of Royalties due to Alfacell shall be accompanied by a
      report listing the number of units of Product sold, the gross invoiced sales
      amounts of the Product sold during such period, the calculation of Net Sales
      based on such sales, the applicable royalty rate, the Royalties payable, all
      other information necessary to determine the appropriate amount of such Royalty
      payments, and any additional information or reports required under this
      Agreement or reasonably requested by Alfacell.

     

    
      
        
        

      

      
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      (c) Records
        and Audit.

       

      (i) For
        a
        period of three (3) years after the calendar year to which the records
        relate, Par shall keep, and shall cause its Sub-distributors to keep, complete
        and accurate records pertaining to the sale or other disposition of the Product
        in sufficient detail to permit Alfacell to confirm the accuracy of all payments
        due hereunder. Alfacell shall have the right to cause an independent, certified
        public accountant to which Par has no reasonably, well-founded objection
        to
        audit such records to confirm the gross invoiced sales amounts, the Net Sales,
        Net Margin and Royalty payments; provided,
        however,
        that
        such auditor shall not disclose Par’s Confidential Information to Alfacell,
        except to the extent such disclosure is necessary to verify the amount of
        Royalties and other payments due under this Agreement, and such auditor shall
        enter into a non-disclosure agreement reasonably acceptable to Par. Such
        audits
        may be exercised once a year on reasonable advance notice to Par and during
        normal business hours, within three (3) years after the Royalty period to
        which such records relate. Any amounts shown to be owing by such audits shall
        be
        paid promptly. Alfacell shall bear the cost of such audit unless such audit
        discloses a variance in the amounts paid by Par of more than five
        percent (5%) from the amount of Royalties and/or other payments actually
        owed to Alfacell for the period audited. In such case, Par shall bear the
        reasonable cost of such audit.

       

      (ii) For
        a
        period of three (3) years after the calendar year to which the records
        relate or such longer period as may be required by applicable law, Alfacell
        shall keep records pertaining to calculation of Direct Cost in sufficient
        detail
        to permit Par to confirm the accuracy of Direct Cost (and thus accuracy of
        the
        Transfer Price), as well as records pertaining to any other amounts charged
        to
        or reimbursed by Par hereunder. Par shall have the right to cause an
        independent, certified public accountant to which Alfacell has no reasonably,
        well-founded objection to audit such records to confirm Direct Cost and any
        such
        other amounts charged to or reimbursed by Par pursuant to the terms hereof;
        provided,
        however,
        that
        such auditor shall not disclose Alfacell’s Confidential Information to Par,
        except to the extent such disclosure is necessary to verify the amount of
        any
        overpayments made by Par to Alfacell, and such auditor shall enter into a
        non-disclosure agreement reasonably acceptable to Alfacell. Such audits may
        be
        exercised once a year on reasonable advance notice and during normal business
        hours, within three (3) years after the date of payment to which such
        records relate, upon notice to Alfacell and during normal business hours.
        Any
        amounts shown to be owing by such audits shall be paid promptly. Par shall
        bear
        the cost of such audit unless such audit discloses an overpayment by Par
        of more
        than five percent (5%) as compared to the amount of payments and/or
        reimbursements actually owed to Alfacell for the period audited. In such
        case,
        Alfacell shall bear the reasonable cost of such audit.

       

      (iii) The
        terms
        of this Section 6.5(c) shall survive any termination or expiration of this
        Agreement for a period of three (3) years following the calendar year in
        which
        the relevant payment obligation hereunder expires or terminates.

       

      (d) Withholding
        of Taxes.
        Par may
        withhold from milestones, royalties or other amounts due to Alfacell under
        this
        Agreement such amounts for payment of any withholding tax that is required
        by
        law to be paid to any taxing authority with respect to such amounts payable
        to
        Alfacell; provided,
        however,
        that in
        regard to any such tax withholding, Par shall give Alfacell such documents
        and
        provide any other cooperation or assistance on a reasonable basis as may
        reasonably be requested by Alfacell by to enable Alfacell to claim exemption
        therefrom, to receive a full refund of such withholding tax or to claim a
        foreign tax credit and shall, upon Alfacell’s request, give proper evidence from
        time to time as to the payment of such tax.

       

      
        
          
          

        

        
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      (e) Late
        Payment and Interest.
        Any
        payments due under this Agreement by either Party that are not paid by the
        date
        such payments are due shall bear interest at one
        percent (1%) per month from the date such payments are due. The foregoing
        interest shall be due from the Party owing the payment amount without any
        special notice and shall be in addition to any other remedies that the Party
        entitled to such payment may have pursuant to this Agreement.

       

      ARTICLE
        VII

       

      MANUFACTURE
        AND SUPPLY

       

      7.1 Clinical
        and Commercial Supplies.
        Alfacell shall manufacture or cause to be manufactured all Clinical Supplies
        of
        the Product for the Development Program, including the completion of
        pre-clinical work and human clinical trials. Subject to the terms of the
        Supply
        Agreement, Alfacell will establish a commercial manufacturing process for
        manufacturing or causing to be manufactured Commercial supplies of the Product
        at the scale and in the amounts required to meet Par’s sales forecast, and
        Alfacell will exclusively supply Par with Par’s requirements of commercial
        supplies of the Product pursuant to the Supply Agreement.

       

      7.2 Pricing.
        Subject
        to the terms and conditions of this Agreement and the Supply Agreement, Par
        shall acquire the Product from Alfacell at the Transfer Price, as provided
        in
        the Supply Agreement. The Parties acknowledge and agree that both would benefit
        from any commercially reasonably, achievable reduction in the Direct Cost,
        but
        only if the corresponding cost reduction does not negatively impact Product
        yields, output, quality, purity and the like.

       

      7.3 Par
        Labeling and Packaging.
        The
        Parties agree that the label for the Product in the Field in the Territory
        shall
        be, and all packaging and presentations concerning such Product shall display,
        a
        Par label in accordance with Par’s customary practices, subject to Section
        4.1(b), and the Parties shall use Commercially Reasonable Efforts to cooperate
        in gaining Regulatory Approval to sell Products in the Field in the Territory
        under the Par label.

       

      7.4 Citizen’s
        Petitions.
        Each
        Party shall notify the other in writing if it becomes aware of a Third Party
        product under development, or a regulatory filing by a Third Party with respect
        to a product, that in either case incorporates Ranpirnase, including, with
        respect to any such regulatory filing, any 505(j) filing, 505(b)(2) filing
        or
        other form of application for approval (such development or filing, a
“Third
        Party Product Event”).
        Par
        shall, following Regulatory Approval of the Product, have the first right
        to
        institute a citizen’s petition addressing the safety and/or efficacy of such
        Third Party Product Event, and, to the extent Par exercises its right in
        respect
        thereof, shall reasonably control all aspects of such citizen’s petition in a
        commercially reasonable manner, including correspondence and/or negotiations
        with the FDA; provided,
        however,
        that Par
        shall include Alfacell in such efforts in a consultative capacity. In the
        event
        Par does not exercise its rights above with respect to such a Third Party
        Product Event within three (3) months of the notice referenced above, then
        Alfacell shall have the exclusive right to institute a citizen’s petition
        addressing the safety and/or efficacy of such Third Party Product Event,
        and, to
        the extent Alfacell exercises its right in respect thereof, shall control
        all
        aspects of such citizen’s petition in a Commercially Reasonable fashion,
        including correspondence and/or negotiations with the FDA, provided,
        however,
        that
        Alfacell shall include Par in such efforts in a consultative capacity.

       

      
        
          
          

        

        
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      ARTICLE
        VIII

       

      CONFIDENTIAL
        AND TECHNICAL INFORMATION

       

      8.1 Treatment
        of Confidential Information.
        Each
        Party agrees to retain in strict confidence and not to disclose, divulge
        or
        otherwise communicate to any Third Party any Confidential Information of
        the
        other Party, whether received prior to or after the Effective Date, and further
        agrees not to use any such Confidential Information for any purpose, except
        pursuant to, and in order to carry out, the terms and objectives of this
        Agreement, except that each Party may disclose Confidential Information of
        the
        other Party to the officers, directors, employees, agents, accountants,
        attorneys, consultants, subcontractors or other representatives of the receiving
        Party or its Affiliates (the “Representatives”),
        who,
        in each case, (a) need to know such Confidential Information for purposes
        of the implementation and performance by the receiving Party of this Agreement
        and (b) will use the Confidential Information only for such limited
        purposes. Each Party hereby agrees to use at least the same standard of care
        in
        complying with its confidentiality obligations hereunder as it uses to protect
        its own Confidential Information of comparable sensitivity and to exercise
        reasonable precautions to prevent and restrain the unauthorized disclosure
        of
        such Confidential Information by any of its Representatives. Each Party warrants
        that each of its Representatives to whom any Confidential Information is
        revealed shall previously have been informed of the confidential nature of
        the
        Confidential Information and shall have agreed to maintain its confidentiality
        under terms no less restrictive than those set forth in this Article VIII.
        Without limiting the generality of any of the foregoing, the Parties agree
        not
        to make any disclosure of Confidential Information that would be reasonably
        likely to impair the Parties’ ability to obtain U.S. or foreign patents on any
        patentable invention or discovery described or otherwise embodied in such
        Confidential Information. The Confidential Information of each Party includes
        information from Third Parties disclosed by one Party to this Agreement to
        the
        other Party to this Agreement.

       

      8.2 Release
        from Restrictions.

       

      (a) The
        provisions of Section 8.1 shall not apply to any Confidential Information
        disclosed hereunder to the extent that such Confidential Information is required
        to be disclosed by the receiving Party to defend or prosecute litigation
        or to
        comply with applicable laws or regulations, including filing an Information
        Disclosure Statement with the U.S. Patent and Trademark Office or any other
        patent office, or pursuant to an order of a court or regulatory agency;
provided,
        however,
        that the
        receiving Party shall provide prior written notice of such disclosure to
        the
        other Party and shall take actions as are reasonable and lawful to avoid
        and/or
        minimize the degree of such disclosure, including assisting the other Party
        in
        seeking a protective order or other means for preventing disclosure or use.
        To
        the extent, if any, that a Party concludes in good faith that it is required
        by
        applicable laws or regulations to file or register this Agreement or a
        notification thereof with any governmental authority, including the U.S.
        Securities and Exchange Commission, such Party may do so, and the other Party
        shall cooperate in such filing or notification and shall execute all documents
        reasonably required in connection therewith. In such situation, the filing
        Party
        shall request confidential treatment of sensitive provisions of the Agreement
        to
        the extent permitted by law. The Parties shall promptly inform each other
        as to
        the activities or inquiries of any such governmental authority relating to
        this
        Agreement, and shall cooperate to respond to any request for further information
        therefrom.

       

      
        
          
          

        

        
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      (b) A
        Party
        may disclose this Agreement to a Third Party in connection with or in
        conjunction with a proposed merger, consolidation, sale of assets that include
        those related to this Agreement, an assignment of this Agreement or loan
        financing, raising of capital, or sale of securities; provided,
        however,
        that the
        disclosing Party obtains an agreement for confidential treatment
        thereof.

       

      8.3 No
        Implied Rights. Except
        as
        otherwise set forth in this Agreement, nothing herein shall be construed
        as
        giving either Party any right, title, interest in or ownership of the
        Confidential Information of the other Party. For the purposes of this Agreement,
        specific information disclosed as part of Confidential Information shall
        not be
        deemed to be in the public domain or in the prior possession of the receiving
        Party merely because it is embraced by more general information in the public
        domain or by more general information in the prior possession of the receiving
        Party.

       

      8.4 Survival
        of Confidentiality Obligations.
        The
        confidentiality obligations of the Parties contained in this Article VIII
        shall remain binding on both Parties during the Term and for a period of
        five
        (5) years after the expiration or termination of this Agreement, regardless
        of
        the cause of such termination. The Parties acknowledge that breach of this
        Article VIII may constitute irreparable harm, and that the non-breaching
        Party shall be entitled to seek specific performance or injunctive relief
        to
        enforce this Article VIII in addition to whatever remedies such Party may
        otherwise be entitled to at law or in equity.

       

      8.5 Superseding
        Prior Confidentiality Agreement.
        The
        provisions of this Article VIII shall supersede the Confidentiality
        Agreement between the Parties dated September 17, 2007, with respect to the
        subject matter hereof, and shall establish the sole obligations of
        confidentiality and nonuse of Confidential Information received by a Party
        prior
        to or after the Effective Date.

       

      ARTICLE
        IX

       

      PATENT
        PROSECUTION AND ENFORCEMENT

       

      9.1 Program
        Developments.
        All
        Program Developments shall be the sole and exclusive property of Alfacell.
        All
        United States patent applications covering Program Developments and all United
        States patents issuing thereon will immediately, and without further action
        of
        the Parties, (a) be deemed to be Alfacell Patents and listed in Schedule
        1.1
        and (b)
        be exclusively licensed to Par in accordance with the terms of this
        Agreement. 

       

      
        
          
          

        

        
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      9.2 Patent
        Prosecution and Maintenance.

       

      (a) The
        Parties shall cooperate in good faith to determine whether to seek or continue
        to seek or to maintain patent protection in the Territory with respect to
        any
        Alfacell Patent, Alfacell Information and any Program Development or such
        other
        things that that could reasonably be expected to affect the Commercialization
        or
        value of the Product in the Territory. In connection therewith, Alfacell
        shall
        promptly provide Par with copies of all correspondence to and from the U.S.
        Patent and Trademark Office, as well as any related demand, notice and summons,
        that relates to such Alfacell Patent or Program Development. Each Party,
        and its
        employees and agents, shall provide the other Party and its legal
        representatives with reasonable assistance and cooperation with respect to
        such
        Patent prosecution, including entering into any joint defense and/or joint
        privilege agreement that may be reasonably requested by such Party and Alfacell
        shall consider in good faith all reasonable suggestions of Par and its patent
        counsel related thereto. Alfacell’s patent prosecution and maintenance expenses
        associated with Alfacell Patents including the filing of any patent term
        extensions, shall be borne by Alfacell; prosecution- and maintenance-related
        expenses incurred by Par in connection with its review and consultation
        concerning any Alfacell Patents, including Alfacell’s filing of any patent term
        extensions, shall be borne by Par. Alfacell will timely apply for any applicable
        patent term extensions.

       

      (b) Par
        agrees to cooperate fully in the preparation, filing, prosecution and
        maintenance of any Alfacell Patents in the Territory under this Agreement,
        and
        in the obtaining and maintenance of any patent extensions and the like with
        respect to any Alfacell Patent.

       

      (c) If
        Alfacell elects (i) to abandon the prosecution or maintenance of any Alfacell
        Patent under which Par has a license hereunder, or (ii) elects not to file
        a
        patent application in the Territory for any invention within Program
        Developments that could reasonably be expected to affect the Commercialization
        or value of the Product in the Territory under this Agreement, then Alfacell
        shall promptly notify Par in writing at least sixty (60) days before the
        abandonment or applicable filing deadline therefore, and Par shall have the
        right, upon providing written notice to Alfacell of Par’s election to do so, at
        Par’s expense, to file, prosecute, continue prosecution and/or maintenance, as
        applicable, of such Alfacell Patent or Patent within Program Developments.
        In
        such case, Par shall keep Alfacell reasonably informed on matters regarding
        such
        filing, prosecution and maintenance, including by providing Alfacell with
        a copy
        of any and all correspondence between Par and the U.S. Patent and Trademark
        Office, providing Alfacell with sufficient time to review and comment on
        such
        communications (excluding any non-substantive correspondence or communications),
        and Par shall consider in good faith the requests and suggestions of Alfacell
        with respect to such communications with the U.S. Patent and Trademark Office.
        With respect to the activities set forth in this Section 9.2 that are continued
        by Par, Alfacell shall provide a power of attorney and relevant files and
        other
        information Owned or Controlled by Alfacell pertaining to such Alfacell Patents
        or Program Developments, as soon as reasonably practical after receiving
        such
        written election by Par.

       

      
        
          
          

        

        
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      9.3 Infringement
        by a Third Party.

       

      (a) Par
        and
        Alfacell shall inform each other promptly in writing of any alleged or suspected
        infringement by a Third Party in the Territory of any of Alfacell Patent
        that
        could reasonably be expected to have an adverse effect on the Commercialization
        or value of the Product in the Territory,
        and of
        any available evidence thereof.

       

      (b) Subject
        to Sections 9.3(c), 9.3(d), and 9.3(e), Par shall have the first right, but
        not
        the obligation, at its sole option and expense, to prosecute the infringement
        by
        a Third Party in the Territory of any Alfacell Patent that could reasonably
        be
        expected to have an adverse effect on the Commercialization or value of the
        Product in the Territory.

       

      (c) If
        a
        Third Party so infringes (or constructively infringes by filing an application
        for regulatory approval with the FDA) an Alfacell Patent, or if a declaratory
        judgment action alleging invalidity, unenforceability or non-infringement
        of any
        Alfacell Patent, shall be brought by a Third Party in the Territory against
        Par
        or against Alfacell or both of them (applicable to Ranpirnase, Product or
        Competing Product), or a Citizen’s Petition in respect of the Product shall have
        been filed with the FDA (each of the foregoing, a “Product
        Infringement”),
        then
        the Parties shall discuss whether or not to institute an infringement action
        (and/or defend against applicable declaratory judgment actions) with respect
        to
        such Product Infringement (and any legally or commercially relevant belief
        by
        Alfacell that it is in the Parties’ interest to not institute such action shall
        be considered in good faith by Par). Subject to Sections 9.3(b) and 9.3(d),
        Par shall have the first right to institute such a suit and control the
        prosecution, settlement or compromise thereof (including defense of applicable
        declaratory judgment actions); provided,
        however,
        that no
        such settlement, compromise, consent judgment or other voluntary final
        disposition of any Product Infringement action which invalidates or restricts
        any Valid Claim(s) Owned or Controlled by Alfacell may be entered into by
        Par
        without the prior written consent of Alfacell, which consent shall not be
        unreasonably withheld. At Par’s option, Alfacell shall agree to be joined as a
        party, or otherwise initiate suit if necessary, in such Product Infringement
        action and Par and Alfacell shall execute all papers and perform such acts
        as
        may be reasonably required to accomplish the same, at the sole expense of
        Par;
provided,
        however,
        that
        Alfacell’s joining of or participation in such action shall not affect Par’s
        control thereof in accordance with this Section 9.3(c). Alfacell shall, at
        the
        reasonable request of Par, provide reasonable cooperation and use its
        Commercially Reasonable Efforts to have its employees testify when requested
        and
        make available relevant records, papers, information, samples, specimens
        and the
        like that Alfacell’s counsel agrees should be provided to Par, regardless of
        whether Alfacell has joined such suit. Alfacell shall have the right to join
        such action and/or select, at Alfacell’s expense, separate counsel to
        participate in such suit on Alfacell’s behalf.

       

      (d) Within
        ninety (90) days of being notified of alleged or suspected Product Infringement,
        Par shall either (i) institute a suit for Product Infringement pursuant to
        Section 9.3(c) or (ii) notify Alfacell that it has a good faith belief that
        it is in the Parties’ interest to not institute such suit within such time and
        Par shall provide to Alfacell a reasoned legal and/or commercial basis for
        not
        instituting such a suit at that time. If Alfacell disagrees with such reasoned
        legal and/or commercial basis, then such dispute or disagreement shall be
        referred to the CEO of Alfacell and the CEO of Par for resolution, and the
        CEOs
        shall resolve the matter (without resort to Section 14.5). If Par takes neither
        action provided in the foregoing clause (i) or (ii) above within such ninety
        (90)-day period, or if within such ninety (90)-day period Par notifies Alfacell
        that it does not intend to institute such a suit, then thereafter Alfacell
        shall
        have the exclusive right to institute an action and control the prosecution,
        settlement or compromise thereof. At Alfacell’s option Par shall agree to be
        joined as a party in such litigation; provided,
        however,
        that
        Par’s joining of such action shall not affect Alfacell’s control thereof in
        accordance with this Section 9.3(d). Par shall, at the reasonable request
        of
        Alfacell, provide reasonable cooperation and, to the extent practicable,
        Par
        shall use its Commercially Reasonable Efforts to have its employees testify
        when
        requested and make available relevant records, papers, information, samples,
        specimens and the like that Par’s counsel agrees should be provided to Alfacell,
        regardless of whether Par has joined such suit. Par shall have the right
        to join
        such action and/or select, at Par’s expense, separate counsel to participate in
        such suit on Par’s behalf. 

       

      
        
          
          

        

        
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      (e) Any
        payments that represent royalties for sales of infringing products, other
        payments, damages, expenses, fees or other awards (collectively “Damages”),
        received by Par and/or Alfacell as a result of a Product Infringement suit,
        whether through judgment or settlement, shall first be used to reimburse
        each
        Party for its expenses associated with such infringement suit. Thereafter,
        (i)
        if Par shall have instituted and controlled a suit in accordance with Section
        9.3(c), then any remainder *** and (ii) if Alfacell shall have instituted
        and
        controlled a suit in accordance with Section 9.3(d), then any remainder
        ***.

       

      9.4 Infringement
        of Third Party Rights.

       

      (a) If
        either
        Party becomes aware of a patent or patent application that, when issued,
        might
        provide a basis for a Third Party argument that its valid rights are being
        infringed by the use, offer for sale or sale of the Product in the Territory,
        then such Party shall promptly inform the other Party of such patent or patent
        application, and the Parties shall cooperate with each other so that each
        Party
        can determine whether valid rights of a Third Party are likely to be so
        infringed.

       

      (b) In
        the
        event that a Third Party institutes any suit against Par and/or Alfacell
        for
        patent infringement that could reasonably be expected to have an adverse
        effect
        on the Commercialization or value of the Product in the Territory, the Party
        sued shall promptly notify the other Party in writing. Par shall assume the
        defense of such suit at Par’s expense;
        provided, however,
        that if
        Alfacell is also a defendant in such action and Alfacell shall have reasonably
        concluded that there may be legal defenses available to it that are different
        from or additional to those available to Par, Alfacell shall have the right
        to
        select, at Alfacell’s expense, separate counsel to participate in such legal
        defenses on Alfacell’s behalf; provided, further that notwithstanding any such
        different or additional legal defenses of Alfacell, Par shall have the first
        right to control the defense of any such patent infringement suit pursuant
        to
        this Section 9.4 and Par may settle or compromise such suit with the prior
        written consent of Alfacell, which consent shall not be unreasonably withheld.
        To the extent that any Damages become payable to any Third Party whether
        as a
        result of judgment or through settlement of such suit, ***.

       

      
        
          
          

        

        
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      (c) If
        either
        Party becomes aware of a patent or patent application of a Third Party that
        could reasonably be expected to have an adverse effect on the Commercialization
        or value of the Product in the Territory and for which pursuit of a license
        would be reasonable in connection with Commercialization of the Product in
        the
        Territory, the Commercialization Committee shall: (A) determine whether or
        not Alfacell should seek such a license, (B) recommend whether or not to
        enter into such a license as negotiated by Alfacell, (C) determine how the
        expenses of such a license shall be borne by the Parties and (D) insure that
        Par
        is a beneficiary thereof consistent with the licenses granted herein. If
        the
        Commercialization Committee cannot agree with regard to any item set forth
        in
        the preceding sentence, such issue shall be determined by the CEOs of the
        Parties.

       

      9.5 Trademark
        Infringement.
        Alfacell
        and Par shall promptly notify the other in writing of any alleged or threatened
        infringement or any challenge to the validity of the Trademark or any challenge
        to Alfacell’s ownership of or Par’ s right to use the Trademark in the Territory
        of which they become aware. Both Parties shall use their reasonable efforts
        in
        cooperating with each other to terminate such infringement without litigation.
        Alfacell shall have the sole right to bring and control any action or proceeding
        with respect to infringement of any of the Trademark at its own expense and
        by
        counsel of its own choice, subject to the following provisions. With respect
        to
        infringement of any of the Trademark in the Territory, if Alfacell fails
        to
        bring an action or proceeding within (i) thirty (30) days following the
        notice of alleged infringement or (ii) ten (10) days before the time limit,
        if any, set forth in the appropriate laws and regulations for the filing
        of such
        actions, whichever comes first, Par shall have the right to bring and control
        any such action at its own expense and by counsel of its own choice, and
        Alfacell shall have the right, at its own expense, to be represented in any
        such
        action by counsel of its own choice. In the event a Party brings an infringement
        action, the other Party shall cooperate fully, including if required to bring
        such action, the furnishing of a power of attorney or being named as a party.
        Neither Party shall have the right to settle any infringement litigation
        under
        this Section 9.5 relating to the Trademark in
        a
        manner that diminishes the rights or interests of the other Party without
        the prior written consent of the other Party,
        which
        shall not be unreasonably withheld, delayed or conditioned.
        Except
        as otherwise agreed to by the Parties as part of a cost-sharing arrangement,
        any
        recovery realized as a result of such litigation, after reimbursement of
        any
        litigation expenses of Alfacell and Par, ***.

       

      ARTICLE
        X

       

      ADVERSE
        EXPERIENCES

       

      10.1 Notification.
        The
        Parties shall, during the Term, keep each other promptly and fully informed
        of
        all of their pharmacological, toxicological and clinical trials, investigations
        and findings relating to the Product in the Field in the Territory in accordance
        with a pharmacovigilance agreement. To the extent required, Alfacell will
        notify
        appropriate Governmental Authorities in accordance with applicable law with
        respect thereto and notify Par promptly after receipt of information with
        respect to any adverse reaction directly or indirectly attributable to the
        use
        or application of the Product in the Field in the Territory. In such a case,
        the
        Parties shall meet as soon as possible to define, according to applicable
        law,
        appropriate procedures and actions to address the difficulty. Each Party
        also
        shall forward to the other Party, on a regular basis, information on adverse
        reactions and any material difficulty associated with clinical use, studies,
        investigations, tests and prescriptions of the Product in the Field in the
        Territory. Par will forward all ADE reports related to the Product in the
        Field
        in the Territory received by Par or its Sub-distributors to Alfacell within
        five
        days of receipt of the applicable event. The information forwarded will be
        the
        initial event information obtained from Par’s call center. Par will not make any
        medical evaluation of the event. Alfacell will be responsible for any follow-up
        activities with the reporting party and all tracking, trending and signal
        detection for the Product. The Parties will use their Commercially Reasonable
        Efforts to inform each other without delay of any other governmental action
        which may adversely impact, in a direct manner, Commercialization of the
        Product
        in the Field in the Territory, and will furnish each other copies of any
        relevant documents relating thereto.

       

      
        
          
          

        

        
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      10.2 Reporting.
        Alfacell, as the NDA holder, is responsible for preparing, processing,
        assessment, and submitting aggregate and periodic reports and individual
        case
        safety reports within the Territory as required by regulatory authorities.
        Alfacell shall also hold and maintain reports of all adverse events and adverse
        drug reactions, both serious and non-serious, and reports of pregnancies
        in a
        database for the Product for preparing and submitting aggregate, periodic,
        and
        single case reports to the FDA for the Product in the Field in the
        Territory.
        Par
        shall reasonably cooperate at its own expense.

       

      10.3 Literature
        Reports.
        Alfacell shall be responsible for screening published scientific and medical
        literature for ADEs/ICSRs related to the Product in the Field. A copy of
        any
        such relevant literature reports and/or articles shall be promptly provided
        to
        the other Party.
        To the
        extent of additional obligations contained in Section 8.1.3 of the Supply
        Agreement, such obligations are hereby incorporated by reference
        herein.

       

      ARTICLE
        XI

       

      REPRESENTATIONS
        AND WARRANTIES 

       

      11.1 Representations
        and Warranties.

       

      (a) Mutual
        Representations and Warranties.
        Each
        Party hereby represents and warrants to the other Party that: (i) it has
        full
        corporate power and authority under the laws of the state of its incorporation
        to enter into this Agreement and to carry out the provisions hereunder; (ii)
        this Agreement is a legal and valid obligation binding upon it and is
        enforceable in accordance with its terms; (iii) the execution, delivery and
        performance of this Agreement by it does not materially conflict with any
        agreement, oral or written, to which it is a party or by which it may be
        bound,
        nor violate any law or regulation of any court, governmental body or
        administrative or other agency having authority over it; and (iv) to the
        knowledge of such Party as of the Effective Date (without undertaking any
        special investigation), there is no claim, action, suit, proceeding or
        investigation pending or threatened against or affecting the transaction
        contemplated hereby.

       

      (b) Alfacell
        Representations, Warranties and Covenants.
        Alfacell hereby represents, warrants and covenants to Par that: 

       

      
        
          
          

        

        
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      (i) neither
        Alfacell nor any of its Affiliates has granted or, during the Term, will
        grant
        to any Third Party any rights under the Alfacell Patents, or any rights,
        that
        are in conflict with or prevent the grant of the rights granted by Alfacell
        to
        Par in this Agreement;

       

      (ii) the
        Alfacell Patents constitute all of the patents and patent applications Owned
        or
        Controlled by Alfacell as of the Effective Date that are necessary or are
        useful
        to Commercialize the Product in the Field in the Territory (as the Product
        is
        known to Alfacell as of the Effective Date, and if such Product were to be
        Commercialized as of the Effective Date);

       

      (iii) Schedule
        1.1
        sets
        forth a true and complete list of all patents and patent applications Owned
        or
        Controlled by Alfacell that claim Ranpirnase, the Product or their uses in
        the
        Field in the Territory as of the Effective Date, which Schedule
        1.1
        will be
        updated periodically during the Term by Alfacell to reflect additions thereto;
        

       

      (iv) Alfacell
        Owns or Controls the Patents listed on Schedule
        1.1,
        and it
        has the right and authority to enter into this Agreement and to grant the
        license under Section 4.1(a) hereof;

       

      (v) Alfacell
        has received no notice alleging infringement of a Third Party patent in
        connection with its development and/or manufacture of the Product in the
        Field
        in the Territory;

       

      (vi) Alfacell
        has provided to Par copies of all material correspondence with the FDA related
        to the Product;

       

      (vii) as
        of the
        Effective Date, the molecule for the Primary UMM Indication has been granted
        orphan drug designation by the FDA under the Orphan Drug Act, as
        amended;

       

      (viii) as
        of the
        Effective Date, (A) there is no action or proceeding pending or, to
        Alfacell’s Knowledge, threatened in the Territory with respect to use,
        development, manufacture or importation of the Product in the Field in the
        Territory in accordance with this Agreement, including with respect to
        infringement of any Third Party patent in the Field in the Territory, the
        conduct of any clinical trials, manufacturing activities or development
        activities involving the Product, or that reasonably calls into question
        the
        validity of this Agreement or any action taken by Alfacell in connection
        with
        the execution of this Agreement, and (B) there are no unsatisfied judgments
        or outstanding orders, injunctions, decrees, stipulations or awards (whether
        rendered by a court, an administrative agency or by an arbitrator) against
        Alfacell with respect to the Product or the Alfacell Patents in the Field
        in the
        Territory;

       

      (ix) Alfacell
        has not as of the Effective Date, and will not during the Term, grant or
        place
        any liens, security interests, other encumbrances and/or licenses in or on,
        or
        otherwise divest, the Alfacell Patents that would conflict or interfere with
        the
        licenses granted to Par in the Field in the Territory, as set forth herein;
        

       

      
        
          
          

        

        
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      (x) Alfacell
        has not violated and will not, during the Term, violate the trade secrets
        and
        has not misappropriated, and will not, during the Term, misappropriate, the
        confidential information or intellectual property of any Third Party in
        connection with the development or manufacturing of the Product for use in
        the
        Field in the Territory;

       

      (xi) none
        of
        the Alfacell Patents is currently involved in any interference, reissue,
        or
        reexamination proceeding, and neither Alfacell nor any of its Affiliates
        has
        received any written notice from any person of such actual or threatened
        proceeding;

       

      (xii) based
        on
        its calculations as of the Effective Date, Alfacell has in its possession,
        or
        has access to, a sufficient egg inventory as of the Effective Date to
        manufacture enough Product to complete the current Phase III Clinical Trial
        for
        UMM and to supply *** vials of the Product after anticipated Initial Commercial
        Sale in the Field in the Territory and Alfacell shall not, without the prior
        consent of Par, utilize such egg inventory other than in respect of the Products
        under this Agreement; 

       

      (xiii) to
        Alfacell’s Knowledge, as of the Effective Date, there is no unauthorized use,
        infringement or misappropriation of any of the Alfacell Patents by any Third
        Party in the Field in the Territory, including any current or former employee
        or
        consultant of Alfacell and its Affiliates; and

       

      (xiv) as
        of the
        Effective Date, any Alfacell research or development programs for potential
        follow-on RNase products (including sequence variants of Ranpirnase) are
        pre-IND
        programs.

       

      ARTICLE
        XII

       

      INDEMNIFICATION
        AND LIMITATION ON LIABILITY; INSURANCE

       

      12.1 Indemnification
        by Alfacell.
        Subject
        to Section 12.3, Alfacell shall defend, indemnify and hold harmless each of
        Par and its directors, officers and employees and the successors and assigns
        of
        any of the foregoing (each a “Par
        Indemnitee”)
        from
        and against any and all liabilities, damages, settlements, penalties, fines,
        costs or expenses (including reasonable attorneys’ fees and other expenses of
        litigation) (collectively, “Losses”)
        arising, directly or indirectly, out of or in connection with Third Party
        claims, suits, actions, demands or judgments to the extent relating to or
        based
        on Alfacell’s gross negligence, willful misconduct, or breach of its
        representations, warranties or obligations under this Agreement, except,
        in each
        case, to the extent Par has an obligation to indemnify Alfacell under
        Section 12.2.

       

      12.2 Indemnification
        by Par.
        Subject
        to Section 12.3, Par shall defend, indemnify and hold harmless each of
        Alfacell and its directors, officers and employees and the successors and
        assigns of any of the foregoing (each an “Alfacell
        Indemnitee”)
        from
        and against any and all Losses arising, directly or indirectly, out of or
        in
        connection with Third Party claims, suits, actions, demands or judgments
        to the
        extent relating to or based on Par’s gross negligence, willful misconduct,
        or breach of its representations, warranties or obligations under this
        Agreement, except, in each case, to the extent Alfacell has an obligation
        to
        indemnify Par under Section 12.1.

       

      
        
          
          

        

        
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      12.3 Notice
        and Procedures.
        If an
        Alfacell Indemnitee or a Par Indemnitee (the “Indemnitee”)
        intends to claim indemnification under this Article XII, it shall promptly
        notify the other Party (the “Indemnitor”)
        in
        writing of any such alleged Losses promptly after it becomes aware of the
        basis
        for such indemnification. The Indemnitor shall have the right to control
        the
        defense thereof with counsel of its choice, provided,
        however,
        that
        such counsel is reasonably acceptable to Indemnitee; and, provided,
        further,
        that
        any Indemnitee shall have the right to retain its own counsel at its own
        expense, for any reason, including if representation of any Indemnitee by
        the
        counsel retained by the Indemnitor would be inappropriate due to actual or
        potential differing interests between such Indemnitee and any other Party
        reasonably represented by such counsel in such proceeding. The Indemnitee,
        its
        employees and agents, shall reasonably cooperate with the Indemnitor and
        its
        legal representatives in the investigation of any Losses covered by this
        Article XII. The obligations of this Section 12.3 shall not apply to
        amounts paid in settlement of any claim, demand, action or other proceeding
        if
        such settlement is effected without the consent of the Indemnitor, which
        consent
        shall not be withheld, conditioned or delayed unreasonably. The failure to
        deliver prompt written notice to the Indemnitor shall relieve the Indemnitor
        of
        any obligation to the Indemnitee of liability under this Section 12.3 to
        the extent it is prejudiced thereby. It is understood that only Alfacell
        or Par
        may claim indemnity under this Article XII (on its own behalf or on behalf
        of its Indemnitees), and other Indemnitees may not directly claim indemnity
        hereunder.

       

      12.4 Limitation
        of Damages.
        EXCEPT
        IN RESPECT OF (A) ANY CLAIM RELATED TO THE WILLFUL MISCONDUCT OF A PARTY
        OR
        INTENTIONAL BREACH OF A REPRESENTATION, WARRANTY OR OBLIGATION BY A PARTY
        UNDER
        THIS AGREEMENT OR (B) ANY THIRD PARTY CLAIMS UNDER ARTICLE XII, NEITHER
        PARTY NOR ANY OF ITS REPRESENTATIVES (AS DEFINED IN SECTION 8.1) OR AFFILIATES
        SHALL BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES
        OF
        ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS,
        REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON
        TO
        KNOW OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.

       

      12.5 Insurance.
         During
        the Term and a period of three (3) years thereafter, each Party shall have
        and
        maintain, at its own expense, with a reputable and financially secure insurance
        carrier or carriers, (a) general liability insurance coverage for the
        manufacture, supply, use and sale of the Product and such Party's activities
        related to this Agreement as is reasonable, normal and customary in the
        pharmaceutical industry generally for parties similarly situated and as is
        appropriate to such activities, and (b) product liability insurance coverage
        as
        is reasonable, normal and customary in the pharmaceutical industry generally
        for
        the manufacture, supply, use and sale of pharmaceutical products of similar
        risk
        profile to the Product.  Subject to the foregoing, each Party shall have in
        place prior to the Initial Commercial Sale product liability insurance coverage
        in an amount of not less than *** US dollars ($***) per occurrence, and Alfacell
        shall have a maximum self-insured retention or deductible of *** US dollars
        ($***) with respect thereto.  Upon the request of the other Party, each
        Party shall provide a certificate of insurance evidencing such coverage to
        the
        other Party.

       

      
        
          
          

        

        
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      ARTICLE
        XIII

       

      TERM
        AND TERMINATION

       

      13.1 Term.
        The
        term of this Agreement (the “Term”)
        shall
        commence on the Effective Date and shall expire, unless earlier terminated
        as
        provided under Sections 13.2, 13.3, 13.4 or 13.5, on the earlier to occur
        of

       

      (a) January
        1, 2015, if no Full Approval has been obtained for the Product for the Primary
        UMM Indication or Secondary UMM Indication in the Territory by such date;
        provided,
        however,
        that if
        Par agrees to waive the precondition in respect thereof pursuant to Section
        6.2
        and becomes obligated to make a payment to Alfacell of $*** upon the
        administration of the first dose of the Product to the first patient in a
        first
        Phase III Clinical Trial for any Future Indication, then the Term shall
        automatically be extended until the seventh (7th) anniversary of such payment;
        or 

       

      (b) the
        latest to occur of the following: (i) in respect of any Indication, the twelfth
        (12th) anniversary of the initial commercial sale for the Product with such
        Indication, (ii) the date of expiration of the last Valid Claim within the
        Alfacell Patents; and (iii) a date later than the foregoing (i) or (ii),
        which
        shall be mutually agreed by the Parties in writing, if the Parties agree
        that
        Product sales in the Field in the Territory should be continued; provided,
        however,
        that if
        Par becomes obligated to make a payment to Alfacell of $*** upon the
        administration of the first dose of the Product to the first patient in a
        first
        Phase III Clinical Trial for any Future Indication, then the Term shall
        automatically be extended until the seventh (7th) anniversary of such
        payment.

       

      13.2 Termination
        for Breach.
        If
        either Party commits a material breach or material default in the performance
        or
        observance of any of its obligations under this Agreement, and such breach
        or
        default continues for a period of sixty (60) days after delivery by the other
        Party of written notice reasonably detailing such breach or default and
        demanding its cure, then the non-breaching or non-defaulting Party shall
        have
        the right to terminate this Agreement, with immediate effect, by giving written
        notice to the breaching or defaulting Party. The Parties shall retain all
        rights
        and remedies (at law or in equity) in respect of any breach hereof. In the
        event
        that Par reasonably believes that Alfacell has materially breached or materially
        defaulted under this Agreement and failed to cure such breach or default
        as
        provided above, and Par does not wish to terminate its license hereunder,
        then
        Par may, in its discretion, retain its license and seek to have a court or
        an
        arbitrator (a) determine whether Alfacell has materially breached or defaulted
        under this Agreement and failed to timely cure such material breach or default,
        and (b) if such court or arbitrator determines that Alfacell has so materially
        breached or defaulted and has failed to timely cure such material breach
        or
        default, and that Par has suffered Losses arising, directly or indirectly,
        out
        of or in connection with or relating to or based on such uncured material
        breach
        or default, then such court or arbitrator may either (i) award monetary damages
        or (ii) prospectively reduce royalty rates and/or other payments hereunder
        (including reduction in milestone payments), where (i) or (ii) would be
        objectively determined by such court or arbitrator to be a fair and reasonable
        remedy for any actual damages determined to have been suffered by Par by
        such
        material breach or default by Alfacell. 

       

      
        
          
          

        

        
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      13.3 Termination
        for Bankruptcy. 
        Each
        Party (the “Insolvent
        Party”)
        shall
        promptly notify the other Party (the “Solvent
        Party”)
        in
        writing upon the initiation of any proceeding in bankruptcy, reorganization,
        dissolution, liquidation or arrangement for the appointment of a receiver
        or
        trustee to take possession of the assets of the Insolvent Party or similar
        proceeding under the law for release of creditors by or against the Insolvent
        Party or if the Insolvent Party shall make a general assignment for the benefit
        of its creditors. If the applicable circumstance described above shall have
        continued for sixty (60) days undismissed, unstayed, unbonded and
        undischarged, the Solvent Party may terminate this Agreement upon written
        notice
        to the Insolvent Party within ninety (90) days of the Insolvent Party
        providing the notice referenced above; provided,
        however,
        if the
        Insolvent Party provides for the cure of all of its defaults under this
        Agreement (if any) and provides adequate assurance of its future performance
        of
        its obligations to the Solvent Party’s reasonable satisfaction, then the Solvent
        Party shall not have the right to terminate this Agreement pursuant to this
        Section 13.3. All licenses and rights to licenses granted under or pursuant
        to
        this Agreement and the Supply Agreement are, and shall otherwise be deemed
        to
        be, for purposes of Section 365(n) of the United States Bankruptcy Code
        (the “Code”),
        licenses of rights to “intellectual property” as defined under
        Section 101(35A) of the Code. Par, as the licensee of such rights under
        this Agreement, shall retain and may fully exercise all of its rights and
        elections under the Code. The foregoing provisions of this Section 13.3 are
        without prejudice to any rights Par may have arising under the Code or other
        applicable law.

       

      13.4 Termination
        for Failure to Meet UMM Milestones.
        Par
        shall have the right to terminate this Agreement on ninety days’ written notice
        to Alfacell if (a) the Product for the Primary UMM Indication shall not obtain
        Full Approval on or before January 1, 2012, or (b) the Product for the Primary
        UMM Indication receives a Not Approvable communication from the
        FDA.

       

      13.5 Other
        Grounds for Termination.
        A Party
        may terminate this Agreement pursuant to the terms and conditions of Sections
        4.1(e) and/or 4.4(b). 

       

      13.6 Effects
        of Termination.

       

      (a) If
        Par
        elects to terminate this Agreement in accordance with Section 13.2, all
        rights and licenses granted to Par shall automatically and immediately terminate
        and shall revert to Alfacell (unless otherwise expressly set forth
        herein).

       

      (b) If
        Alfacell elects to terminate this Agreement in accordance with Section 13.2,
        (i)
        all rights and licenses granted to Par pursuant to this Agreement shall
        automatically and immediately terminate and Par immediately shall discontinue
        Commercialization of Product and all use of the Product Trademarks, Trade
        Names
        and the Alfacell Technology (without any right to sell inventory pursuant
        to
        subsection (d) below); and (ii) Par shall pay within thirty (30) days after
        such termination: (x) all accrued and unpaid amounts due to Alfacell in
        accordance with the terms of this Agreement (including, if such termination
        shall occur following the grant of Regulatory Approval, any payments under
        Section 6.2 that have been achieved but not yet paid by Par, any unpaid
        Royalties and the Transfer Price for Product manufactured or in process pursuant
        to Par’s binding sales forecast but not yet delivered to Par, as well as raw
        materials purchased therefor, but only to the extent that Alfacell is unable
        to
        sell such Product); and (y) any other amounts that will become due to Alfacell
        through or after the effective date of such termination in accordance with
        the
        terms hereof. The remedies set forth in this Section 13.6(b) are in addition
        to
        any rights and remedies otherwise available to Alfacell at law or in
        equity.

       

      
        
          
          

        

        
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      (c) Upon
        the
        termination or expiration of this Agreement each Party shall return to the
        other
        Party, or destroy, all Confidential Information of the other Party.

       

      (d) Except
        in
        the case of termination of this Agreement by Alfacell under Section 13.2,
        Par may continue to sell inventory of Product then on hand for an additional
        period not to exceed six (6) months, and the sale of such Product shall be
        subject to the terms and conditions of this Agreement.

       

      13.7 Surviving
        Rights.
        The
        expiration or termination of this Agreement shall not affect the obligations
        and
        rights of the Parties which from their context are intended to survive such
        expiration or termination. Without limiting the foregoing sentence, the
        provisions of Section 6.5; Section 10.1 (with respect to Par’s obligation to
        forward all ADE reports); Sections 12.1 through 12.4; Sections 13.3 (with
        respect to Par’s rights under the Code) and 13.6; this Section 13.7; and Section
        13.8; and Articles I, VIII and XIV, shall survive termination or expiration
        of this Agreement. 

       

      13.8 Accrued
        Rights and Surviving Obligations.
        The
        termination or expiration of this Agreement for any reason shall be without
        prejudice to any rights which shall have accrued to the benefit of either
        Party
        prior to such termination or expiration, including any damages arising from
        any
        breach hereunder. Such termination or expiration shall not relieve either
        Party
        from obligations which are expressly indicated to survive termination or
        expiration of this Agreement.

       

      ARTICLE
        XIV

       

      MISCELLANEOUS

       

      14.1 Entire
        Agreement; Modification.
        This
        Agreement, together with the Schedules attached hereto and incorporated herein,
        constitutes the entire understanding and agreement of the Parties with respect
        to the subject matter hereof and cancels and supersedes any and all prior
        negotiations, correspondence, understandings and agreements, whether verbal
        or
        written, between the Parties with respect to the subject matter hereof. No
        modification or amendment of any provision of this Agreement shall be valid
        or
        effective unless made in writing and signed by a duly authorized officer
        of each
        Party.

       

      14.2 Assignment.
        This
        Agreement shall be binding upon and inure to the benefit of the Parties hereto
        and their successors and permitted assigns; provided,
        however,
        that
        neither Party shall assign any of its rights and obligations hereunder without
        the prior written consent of the other Party except to an Affiliate or as
        incident to the merger, consolidation, reorganization or acquisition of stock
        or
        assets affecting substantially all of the assets or actual voting control
        of the
        assigning Party. Any assignment or attempted assignment by either Party in
        violation of the terms of this Section 14.2 shall be null and void. In the
        event of a Change of Control of Par or Alfacell, the surviving entity shall
        promptly confirm to Alfacell or Par, as applicable, in writing its obligation
        to
        abide by the terms and conditions of this Agreement, and shall meet with
        Alfacell or Par, as applicable, within thirty (30) days of such Change of
        Control to discuss and review continued performance under this
        Agreement.

       

      
        
          
          

        

        
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          CONFIDENTIAL
            INFORMATION OMITTED AND FILED SEPARATELY

          WITH
            SECURITIES AND EXCHANGE COMMISSION

          ASTERISKS
            DENOTE SUCH OMISSION

        

      

       

      14.3 Performance
        by Sub-distributors.
        The
        Parties recognize that, subject to Section 4.3, Par may perform some or all
        of
        its obligations under this Agreement through one (1) or more of its
        Sub-distributors, which may or may not be Affiliates of Par; provided,
        however,
        that Par
        shall remain responsible for and shall guarantee such performance by its
        Sub-distributors (whether or not Affiliates), and shall cause its
        Sub-distributors (whether or not Affiliates) to comply with the provisions
        of
        this Agreement in connection with such performance.

       

      14.4 Notices.
        Any
        notices given under this Agreement shall be in writing, addressed to the
        Parties
        at the following addresses, and delivered by person, by facsimile followed
        by
        U.S. Mail, return receipt requested, or by FedEx or other reputable national
        courier service. Any such notice shall be deemed to have been given as of
        the
        day of personal delivery, one (1) business day after the date sent by
        facsimile service or on the day of delivery to the other Party confirmed
        by the
        courier service.

       

      
        	
                In
                  the case of Alfacell:

                 

              	
                Alfacell
                  Corporation

                300
                  Atrium Drive

                Somerset,
                  NJ 08873

                Attention:
                  Chief Executive Officer

                Facsimile:
                  (732) 652-4575

              
	 	 
	
                with
                  a copy (which shall not 

                constitute
                  notice) to:

                 

              	
                Heller
                  Ehrman LLP

                Times
                  Square Tower

                7
                  Times Square

                New
                  York, New York 10036

                Attention:
                  Kevin T. Collins

                Facsimile:
                  (212) 763-7600

              
	 	 
	
                In
                  the case of Par:

                 

              	
                Par
                  Pharmaceutical, Inc.

                300
                  Tice Boulevard

                Woodcliff
                  Lake, NJ 07677

                Attn:
                  General Counsel’s Office

                Fax:
                  (201) 802-4223

              

      

       

      
        
          
          

        

        
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          CONFIDENTIAL
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            SECURITIES AND EXCHANGE COMMISSION

          ASTERISKS
            DENOTE SUCH OMISSION

        

      

       

      
        	
                with
                  a copy (which
                  shall not 

                constitute
                  notice) to:

              	
                Orrick,
                  Herrington & Sutcliffe LLP

                666
                  Fifth Avenue

                New
                  York, NY 10103-0001

                Attn:
                  R. King Milling, Jr., Esq.

                Fax:
                  (212) 506-5151

              

      

       

      Either
        Party may change its address for communications by a notice to the other
        Party
        in accordance with this Section 14.4.

       

      14.5 Dispute
        Resolution.
        The
        Parties recognize that a bona fide
        dispute
        as to certain matters may, from time to time, arise during the Term that
        relates
        to a Party’s rights and/or obligations hereunder. In the event of the occurrence
        of such a dispute, either Party may, by written notice to the other Party,
        have
        such dispute referred to the respective officers designated below, or their
        successors, for attempted resolution by good faith negotiation within thirty
        (30) days after such notice is received. Such designated officers are as
        follows:

       

      

        
          	
                  For
                    Alfacell:

                	
                  Kuslima
                    Shogen, CEO

                
	 	 
	
                  For
                    Par:

                	
                  John
                    MacPhee, President, Strativa Pharmaceuticals (a division of Par
                    Pharmaceutical, Inc.)

                

        

      

       

      In
        the
        event that the designated officers are not able to resolve the dispute within
        such thirty (30)-day period, or such other period of time as the Parties
        may mutually agree to in writing, the Parties shall attempt in good faith
        to
        resolve such dispute in a voluntary, amicable and expeditious manner
        through  non-binding mediation  in
        New
        York, New York under the International Institute for Conflict Prevention
        and
        Resolution (“CPR”)
        Mediation Procedure then currently in effect. Unless the Parties agree
        otherwise, the mediator will be selected from the JAMS panel of
        neutrals and
        each Party shall bear its own costs. 
        If the
        dispute is not resolved within sixty (60) days of a Party’s written request for
        mediation, there is no further obligation to mediate.  If the Parties
        are unable to resolve any dispute through mediation as  set
        forth in this Section 14.5, each Party shall have the right to pursue any
        and all remedies available at law or in equity.  

       

      14.6 Governing
        Law; Waiver of Jury Trial.
        This
        Agreement shall be governed by, and construed in accordance with, the laws
        of
        the State of New York without reference to any rules of conflicts of laws.
        The
        Parties hereby consent to the exclusive jurisdiction of the Federal and State
        courts of New York and hereby waive any objection to venue or forum laid
        therein. The Parties hereby agree that service of process by certified mail,
        return receipt requested, shall constitute personal service for all purposes
        hereof. The Parties expressly reject the application of the United Nations
        Convention on Contracts for the International Sale of Goods and all implementing
        legislation thereunder. EACH PARTY HEREBY WAIVES ITS RIGHT TO A TRIAL BY
        JURY OF
        ANY CLAIM OR CAUSE OF ACTION BASED UPON, ARISING OUT OF OR RELATED TO THIS
        AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, IN ANY ACTION, PROCEEDING
        OR
        OTHER LITIGATION OF ANY TYPE BROUGHT BY ANY PARTY AGAINST THE OTHER, WHETHER
        WITH RESPECT TO CONTRACT CLAIMS, TORT CLAIMS OR OTHERWISE. THIS WAIVER SHALL
        APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS
        TO
        THIS AGREEMENT.

       

      
        
          
          

        

        
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          CONFIDENTIAL
            INFORMATION OMITTED AND FILED SEPARATELY

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            SECURITIES AND EXCHANGE COMMISSION

          ASTERISKS
            DENOTE SUCH OMISSION

        

      

       

      14.7 Force
        Majeure.
        A Party
        hereto shall be excused and shall not be held liable or responsible for failure
        or delay in fulfilling or performing any of its obligations under this Agreement
        if such failure or delay is caused by acts of God, acts of the public enemy,
        fire, explosion, flood, drought, war, terrorists, riot, unavailability of
        raw
        material, sabotage, embargo, strikes or other labor disputes, intervention
        of
        governmental authority, or by any other event or circumstance of like or
        different character to the foregoing beyond the reasonable control and without
        the fault or negligence of the affected Party (each, a “Force
        Majeure Event”).
        Such
        excuse shall continue as long as the Force Majeure Event continues. Upon
        cessation of such Force Majeure Event, such Party shall promptly resume
        performance hereunder. Each Party agrees to give the other Party prompt written
        notice of the occurrence of any Force Majeure Event, the nature thereof and
        the
        extent to which the affected Party will be unable to perform its obligations
        hereunder. Each affected Party further agrees to use reasonable efforts to
        correct or otherwise address the Force Majeure Event as soon as practicable
        and
        to give the other Party prompt written notice when it is again fully able
        to
        perform such obligations.

       

      14.8 Independent
        Contractors.
        In
        making and performing this Agreement, Par and Alfacell act and shall act
        at all
        times as independent contractors and nothing contained in this Agreement
        shall
        be construed or implied to create an agency, partnership or employer and
        employee relationship between Alfacell and Par. At no time shall one Party
        make
        commitments or incur any charges or expenses for or in the name of the other
        Party.

       

      14.9 Severability;
        Waiver.
        If
        one (1) or more of the provisions of this Agreement are held by any court
        or authority having jurisdiction over this Agreement or either of the Parties
        to
        be invalid, illegal or unenforceable, such provision or provisions shall
        be
        validly reformed to as nearly as possible approximate the intent of the Parties
        and, if unreformable, shall be divisible and deleted in such jurisdiction;
        elsewhere, this Agreement shall not be affected so long as the Parties are
        still
        able to realize the principal benefits bargained for in this Agreement. The
        failure of a Party to insist upon strict performance of any provision of
        this
        Agreement or to exercise any right arising out of this Agreement shall neither
        impair that provision or right nor constitute a waiver of that provision
        or
        right, in whole or in part, in that instance or in any other instance. Any
        waiver by a Party of a particular provision or right shall be in writing,
        shall
        be as to a particular matter and, if applicable, for a particular period
        of time
        and shall be signed by such Party.

       

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

       

      14.11 Cumulative
        Rights.
        The
        rights, powers and remedies hereunder shall be in addition to, and not in
        limitation of, all rights, powers and remedies provided at law or in equity,
        or
        under any other agreement between the Parties. All of such rights, powers
        and
        remedies shall be cumulative, and may be exercised successively or
        cumulatively.

       

      
        
          
          

        

        
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          CONFIDENTIAL
            INFORMATION OMITTED AND FILED SEPARATELY

          WITH
            SECURITIES AND EXCHANGE COMMISSION

          ASTERISKS
            DENOTE SUCH OMISSION

           

        

      

      14.12 Counterparts.
        This
        Agreement may be executed in two (2) or more counterparts, each of which
        shall be an original and all of which shall constitute together the same
        document. Counterparts may be signed and delivered by facsimile, each of
        which
        shall be binding when sent.

       

      14.13 Publicity
        and Press Releases.
        Neither
        Party shall (a) originate any publicity, news release or other public
        announcement, written or oral, whether to the public press, stockholders
        or
        otherwise, relating to this Agreement, any amendment hereto or performance
        hereunder, or (b) use the name of the other Party in any publicity, news
        release
        or other public announcement, except (i) with the prior written consent of
        the
        other Party, which consent shall not be unreasonably withheld or delayed,
        or
        (ii) as required by applicable law or regulation, in which case the originating
        Party shall submit to the other Party
        (for
        review and any proposed modifications, as well as the Parties’ coordination,
        prior to such disclosure or use) each such required disclosure, and shall
        comply
        with the terms of Article VIII;
        provided, however,
        that if
        a Party determines in good faith that it is required to make a public disclosure
        with respect to the subject matter of this Agreement pursuant to any applicable
        securities laws or the rules of any securities exchange on which its securities
        are traded, it shall not be required to obtain the prior written approval
        of the
        contents of such public disclosure from the other Party, but it shall use
        its
        reasonable best efforts to provide the other Party with a reasonable opportunity
        to review such public disclosure before it is made public and will consider
        in
        good faith changes to such public disclosure suggested by the other Party.
        Public disclosures with respect to the subject matter of this Agreement that
        contain only information that is consistent with the information contained
        in
        prior public disclosures made by one of the Parties in accordance with the
        terms
        of this Section 14.13 shall not require prior review or approval by the
        non-disclosing Party. Par acknowledges that Alfacell will be obligated to
        file a
        copy of this Agreement with the United States Securities and Exchange Commission
        (“SEC”).
        Alfacell will seek confidential treatment of those portions of this Agreement
        which it deems appropriate under applicable regulations of the SEC.

       

      [Signature
        Page Follows]

       

      
        
          
          

        

        
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        CONFIDENTIAL
          INFORMATION OMITTED AND FILED SEPARATELY

        WITH
          SECURITIES AND EXCHANGE COMMISSION

        ASTERISKS
          DENOTE SUCH OMISSION

      

       

      IN
        WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
        by
        their duly authorized representatives as of the Effective Date.

       

      
        	 	
                ALFACELL
                  CORPORATION

              
	 	 
	 	 
	 	
                By:

              	/s/
                Kuslima Shogen
	 	Name: 	Kuslima Shogen
	 	
                Title:  

              	Chairman
                & CEO
	 	 	 
	 	 	 
	 	
                PAR
                  PHARMACEUTICAL, INC.

              
	 	 
	 	 
	 	
                By:

              	/s/
                Patrick G. LePore
	 	Name: 	Patrick G. LePore
	 	
                Title: 

              	CEO
                & President

      

       

      
        
          
          

        

        
          49

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