Document:

Portions
        of this exhibit have been omitted and filed separately with the Securities
        and Exchange Commission pursuant to a confidential treatment request.
        Asterisks denote such omissions.

  EXHIBIT
      10.41

     

    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

        

        

      

      
        
        

      

    

    “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:

    

    Patent
      No. US 7,229,824 B1

    

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

    
      
        
        

      

        2

        

        

      

      
        
        

      

    

    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.

     

    “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.

    
      
        
        

      

        3

        

        

      

      
        
        

      

    

    “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 

    
      
        
        

      

        4

        

        

      

      
        
        

      

    

    limiting
      the foregoing, the terms of this Agreement shall constitute “Confidential
      Information” of both Parties hereunder.

     

    “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.

    
      
        
        

      

        5

        

        

      

      
        
        

      

    

    Confidential
      information omitted and filed with the 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.

     

    “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.

    
      
        
        

      

        6

        

        

      

      
        
        

      

    

    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    “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.

     

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

    
      
        
        

      

        7

        

        

      

      
        
        

      

    

    “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).

     

    “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.

    
      
        
        

      

        8

        

        

      

      
        
        

      

    

    “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.

     

    “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.

    
      
        
        

      

        9

        

        

      

      
        
        

      

    

    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    “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. 

     

    (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.

    
      
        
        

      

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    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.

     

    (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 

    
      
        
        

      

        11

        

        

      

      
        
        

      

    

    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;

     

    (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); 

    
      
        
        

      

        12

        

        

      

      
        
        

      

    

    (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.

     

    (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 

    
      
        
        

      

        13

        

        

      

      
        
        

      

    

    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. 

     

    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 

    
      
        
        

      

        14

        

        

      

      
        
        

      

    

    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.

     

    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.

    
      
        
        

      

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    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.

     

    (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

    
      
        
        

      

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    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    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.

     

    (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.

    
      
        
        

      

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    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    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.

     

    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 

    
      
        
        

      

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    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. 

     

    (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 

    
      
        
        

      

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    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. 

     

    (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 

    
      
        
        

      

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    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.

     

    (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.

    
      
        
        

      

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    (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;

     

    (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

    
      
        
        

      

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    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    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.

     

    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 *** 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 

    
      
        
        

      

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      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    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 ***, 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. 

     

    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.
      

    
      
        
        

      

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      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    (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). 

     

    (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 

    
      
        
        

      

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      denote such omission.

    

    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.

     

    (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;

    
      
        
        

      

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    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    (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.

     

    (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

    
      
        
        

      

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    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    (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: 

     

    ***

     

    (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.

    
      
        
        

      

        28

        

        

      

      
        
        

      

    

    Confidential
      information omitted and filed with the Securities and Exchange Commission.
      Asterisks
      denote such omission.

    

    (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.

     

    (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 

    
      
        
        

      

        29

        

        

      

      
        
        

      

    

    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.

     

    (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), 

    
      
        
        

      

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    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.

     

    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 

    
      
        
        

      

        31

        

        

      

      
        
        

      

    

    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.

     

    (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 

    
      
        
        

      

        32

        

        

      

      
        
        

      

    

    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. 

     

    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

    
      
        
        

      

        33

        

        

      

      
        
        

      

    

    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.

     

    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

    
      
        
        

      

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      denote such omission.

    

    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. 

     

    (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, 

    
      
        
        

      

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    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, ***.

     

    (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 

    
      
        
        

      

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    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.

     

    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, 

    
      
        
        

      

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    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: 

     

    (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;

    
      
        
        

      

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      denote such omission.

    

    (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;
      

     

    (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.

     

    
      
        
        

      

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    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.

     

    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

    
      
        
        

      

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      Asterisks
      denote such omission.

    

    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 *** million 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.

     

    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.

    
      
        
        

      

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    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 a

     

    13.3 nd
      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.
      

     

    13.4 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.

     

    13.5 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 

    
      
        
        

      

        42

        

        

      

      
        
        

      

    

    Product
      for the Primary UMM Indication receives a Not Approvable communication from
      the
      FDA.

     

    13.6 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). 

     

    13.7 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.

     

    (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.

     

    13.8 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. 

     

    13.9 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
      

    
      
        
        

      

        43

        

        

      

      
        
        

      

    

    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.

     

    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.

    
      
        
        

      

        44

        

        

      

      
        
        

      

    

    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

               

            
	
              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.)

               

            

    

    
      
        
        

      

        45

        

        

      

      
        
        

      

    

    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.

     

    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

    
      
        
        

      

        46

        

        

      

      
        
        

      

    

    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.

     

    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

    
      
        
        

      

        47

        

        

      

      
        
        

      

    

    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]

    
      
        
        

      

        48

        

        

      

      
        
        

      

    
    

    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:

            	 
	 	
              Name:

            
	 	
              Title:

            
	 	 
	 	 
	 	
              PAR
                PHARMACEUTICAL, INC.

            
	 	 
	 	 
	 	
              By:

            	 
	 	
              Name:

            
	 	
              Title:

            

    

    
      
        
        

      

        49

        

        

      

      
        
        

      

    

    Schedule
      1.1

    

    Alfacell
      Patents

    

    US
      Patent
      No. 5,559,212

    US
      Patent
      No. 5,540,925

    US
      Patent
      No. 5,595,734 

    US
      Patent
      No. 5,529,775 

    US
      Patent
      No. 5,728,805 

    US
      Patent
      No. 6,290,951

    US
      Patent
      No. 6,175,003 

    US
      Patent
      No. 6,423,515 

    US
      Patent
      No. 6,649,392 

    US
      Patent
      No. 6,649,393

    
      
        
        

      

        50

        

        

      

      
        
        

      

    

    Schedule
      4.1(d)

    

    Trademark
      Guidelines

    

    [To
      be
      added pursuant to Section 4.1(d)]

    
      
        
        

      

        51

        

        

      

      
        
        

      

    

    Exhibit
      A

    

    Ranpirnase

    

    Ranpirnase
      has the following 104 amino acid sequence:

    

    GluAspTrpLeuThrPheGlnLysLysHisIleThrAsnThrArgAspValAspCysAsp
      [20]

    AsnIleMetSerThrAsnLeuPheHisCysLysAspLysAsnThrPheIleTyrSerArg
      [40]

    ProGluProValLysAlaIleCysLysGlyIleIleAlaSerLysAsnValLeuThrThr
      [60]

    SerGluPheTyrLeuSerAspCysAsnValThrSerArgProCysLysTyrLysLeuLys
      [80]

    LysSerThrAsnLysPheCysValThrCysGluAsnGlnAlaProValHisPheValGly
      [100]

    ValGlySerCys
      [104]

     

    It
      is
      understood that the N-terminal amino acid residue, denoted as "Glu" in the
      initial position of the above sequence, is, in the bioactive pharmaceutical,
      pyroglutamic acid, a cyclized derivative of glutamate 

    
      
        
        

      

        52

        

        

      

      
        
        

      

    

    Exhibit
      B

    

    United
      States Trademark Reg. No. 1,651,885, covering ONCONASE as applied to
“pharmaceuticals; namely, cancer-treating drugs”.

    
      
        
        

      

        53

        

        

      

      
        
        

      

    

    Exhibit
      C

    

    Supply
      Agreement

    

    [Attached]

    
      
        
        

      

        54EXHIBIT
      10.42

    

    SUPPLY
      AGREEMENT

     

    This
      Supply Agreement (the
      “Agreement”)
      is
      dated January 14, 2008 by and 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 Blvd,
      Woodcliff Lake, NJ 07677, USA (“Par”).
      Alfacell and Par may be referred to herein individually as a “Party”,
      or
      together as the “Parties”.
      Capitalized terms not defined herein shall have the meanings ascribed to them
      in
      the License Agreement (as defined below).

     

    Recitals

     

    Whereas,
      Par and
      Alfacell are entering into a License Agreement on even date herewith (the
“License
      Agreement”)
      under
      which Par is receiving a license to, among other things, promote, market, have
      marketed, distribute, offer for sale, sell and have sold the Product in the
      Field in the Territory; and 

     

    Whereas,
      Alfacell
      desires to supply Product to Par in connection with the License Agreement and
      on
      the terms and conditions set forth herein.

     

    Agreement

     

    Now,
      Therefore,
      in
      consideration of the foregoing premises and the mutual covenants contained
      herein and other good and valuable consideration, the receipt and sufficiency
      of
      which are hereby acknowledged, the Parties agree as follows:

     

    
      	
              1.

            	
              Definitions

            

    

     

    1.1 “Adverse
      Event”
      means an
“adverse drug experience” as such term is defined at 21 C.F.R. 310.305(b) (as
      such definition may be amended, supplemented or replaced from time to time)
      and
      includes any adverse event associated with the use of a drug in humans, whether
      or not considered drug related, including any failure of expected
      pharmacological action and any adverse event occurring (i) in the course of
      the
      use of a drug product in professional practice; (ii) from drug overdose, whether
      accidental or intentional; (iii) from drug abuse or (iv) from drug
      withdrawal.

     

    1.2 “Agreement”
      has the
      meaning provided in the Preamble.

     

    1.3 “Alfacell”
      has the
      meaning provided in the Preamble. 

     

    1.4 “Alfacell
      Indemnitee” has
      the
      meaning provided in Section 12.2.

     

    1.5 “Calendar
      Quarter” means
      each respective period of three consecutive months ending on March 31,
      June 30, September 30 or December 31.

     

    1.6 “Certificates”
      has the
      meaning provided in Section 6.1.

    
      
        
        

      

        
        

        

        

      

      
        
        

      

    

    1.7 “Confidential
      Information” has
      the
      meaning set forth in the License Agreement.

     

    1.8 “Field”
      means
      all
      uses for cancer in humans.

     

    1.9 “Label”
shall
      refer to such labels and other written, printed or graphic matter (i)
      used
      on
      vials of Product and boxes of vials
      or (ii)
      accompanying the Product, including package inserts.
      “Labeled”
or
      “Labeling”
shall
      have correlative meaning.

     

    1.10 “Launch
      Quantities”
      has the
      meaning provided in Section 3.1.

     

    1.11 “License
      Agreement” has
      the
      meaning provided in the Recitals.

     

    1.12 “Losses”
      has
      the
      meaning provided in Section 12.1.

     

    1.13 “Manufacture”
      means
      all activities related to the manufacturing of a pharmaceutical product, or
      any
      ingredient thereof, including to manufacturing Product or supplies for
      development, manufacturing of Product for commercial sale, Packaging, Labeling,
      in-process and finished product testing, release of product or any component
      or
      ingredient thereof, quality assurance activities related to the manufacturing
      and release of product, ongoing stability tests and regulatory activities
      related to any of the foregoing. “Manufactured”
      or
“Manufacturing”
      shall
      have correlative meaning.

     

    1.14 “Manufacturing
      Process” has
      the
      meaning provided in Section 7.3.

     

    1.15 “Objection
      Notice” has
      the
      meaning provided in Section 6.2.3.

     

    1.16 “Package”
      means
      all primary containers, cartons and shipping cases, used in packaging or
      accompanying the Product for delivery to Par hereunder. “Packaged”
or
      “Packaging”
shall
      have correlative meaning.

     

    1.17 “Par”
      has the
      meaning provided in the Preamble.

     

    1.18 “Par
      Indemnitee” has
      the
      meaning provided in Section 12.1.

     

    1.19 “Product
      Specifications” means
      the
      specifications for the Product contained in the applicable Regulatory Approval
      and any specifications mutually agreed upon by the Parties, such agreement
      not
      to be unreasonably withheld, conditioned or delayed, established in connection
      with the Product and any changes to such specifications made at the request
      of
      the FDA or by mutual agreement of the Parties from time to time, including
      the
      specifications set forth in Exhibit
      A.
      

     

    1.20 “Quality
      Agreement” has
      the
      meaning provided in Section 6.3.

     

    1.21 “Term”
      has the
      meaning provided in Section 11.1.

     

    1.22 “Third
      Party Manufacturer”
      means
      (i) either Scientific Protein Laboratories LLC or Ben Venue Laboratories, Inc.
      or any of their respective Affiliates or (ii) such other 

    
      
        
        

      

        2.

        

        

      

      
        
        

      

    

    Third
      Party as Alfacell shall contract to Manufacture Product under this Agreement,
      subject in respect of this clause (ii) to Par’s prior written consent, such
      consent not to be unreasonably withheld.

     

    
      	
              2.

            	
              Supply
                of Products.

            

    

     

    2.1 Supply
      by Alfacell. Subject
      to the terms and conditions of this Agreement, Alfacell shall Manufacture and
      supply, or cause its Third Party Manufacturer to Manufacture and supply to
      Par
      such quantities of Product, in finished form, as are ordered by Par in
      accordance with the requirements of this Agreement of its total commercial
      requirements for Product. Alfacell shall not supply any Third Party with Product
      for sale in the Territory. Alfacell shall not be required to provide samples
      of
      Product to Par. Par shall only purchase Product from Alfacell and from no other
      party. 

     

    
      	
              3.

            	
              Forecasts
                and Purchase Orders.

            

    

     

    3.1 Commercial
      Launch.
      Par
      shall notify Alfacell at least twelve (12) months in advance of the anticipated
      date of the Initial Commercial Sale, which notification shall include a
      preliminary estimate of the quantity of Product needed for the Initial
      Commercial Sale. Par may change the estimated date of the Initial Commercial
      Sale and the estimated quantity of Product needed for such Initial Commercial
      Sale at any time by notifying Alfacell in writing; provided,
      however,
      that
      Par shall notify Alfacell of the minimum amount of Product that Par will require
      for the Initial Commercial Sale at least six (6) months (or at least nine (9)
      months, if such amount is less than or greater than the initial estimate by
      more
      than twenty-five percent (25%)) prior to the anticipated date of the Initial
      Commercial Sale (the “Launch
      Quantities”).
      

     

    3.2 Forecasts.
      Each
      month, Par shall provide Alfacell with a written twelve (12)-month rolling
      forecast
      of its
      estimated orders and delivery dates for Product in the Territory (each a
“Forecast”).
      The
      volume forecasted for the first five (5) months of each Forecast shall be
      binding upon Par. The remainder of each Forecast shall not be
      binding.

     

    3.3 Purchase
      Orders.
      Par
      shall order Product as set forth in the binding portions of the Forecast by
      submitting to Alfacell written purchase orders, in such form as the Parties
      shall agree from time to time, specifying the quantities of Product ordered
      and
      the desired delivery dates for such Product. Par shall submit each purchase
      order to Alfacell at least three (3) months in advance of the delivery date
      specified in the Forecast.  Alfacell
      shall, or shall cause its Third Party Manufacturer to, make each delivery of
      Product in the quantity and on the delivery date specified on Par’s purchase
      order. Any purchase orders for Product submitted by Par to Alfacell shall
      reference this Agreement and shall be governed exclusively by the terms
      contained herein. The Parties hereby agree that the terms and conditions of
      this
      Agreement shall supersede any term or condition in any order, confirmation
      or
      other document furnished by Par or Alfacell that is in any way inconsistent
      with
      these terms and conditions. 

    
      
        
        

      

        3.

        

        

      

      
        
        

      

    

    3.4 Quantity
      of Orders. The
      Parties agree that Forecasts and orders of Product will be expressed by multiple
      boxes of Product in a unit size to be mutually agreed to by the Parties, subject
      to Section 13.1. 

     

    
      	
              4.

            	
              Price
                and Taxation.

            

    

     

    4.1 Transfer
      Price.
      For the
      Manufacture of the Product, Par shall pay Alfacell a price equal to the Transfer
      Price. The Parties shall cooperate in good faith and use Commercially Reasonable
      Efforts to reduce the Direct Cost of Product. Subject to Section 6, Par shall
      be
      responsible for shipping and related insurance costs.

     

    4.2 Invoices.
      Alfacell
      shall, or shall cause its Third Party Manufacturer to, invoice Par for the
      aggregate Transfer Price of each delivery of Product at the time of such
      delivery.

     

    4.3 Method
      of Payment.
      All
      payments due hereunder to Alfacell shall be paid to Alfacell in U.S. Dollars
      not
      later than thirty (30) days following applicable delivery.

     

    4.4 Launch
      Quantities.
      Notwithstanding anything else to the contrary herein, Par shall not be obligated
      to take ownership or to
      make
      payment to Alfacell for any Launch Quantities until Regulatory Approval for
      the
      Product is obtained.

     

    4.5 Financial
      Audit.
      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, and
      shall cause the Third Party Manufacturer to, keep records pertaining to any
      payments made
      by Alfacell
      that are components of Direct Costs in
      sufficient detail to permit Par to confirm the
      accuracy of the amounts
      paid.
      Par
      shall have the right to cause an independent, certified public accountant
      reasonably acceptable to Alfacell to audit such records solely to
      confirm the amounts
      of
such
      payments;
      provided,
      however,
      that
      such auditor shall not disclose Alfacell’s Confidential Information or
      any
      Third
      Party Manufacturer’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 per 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; provided,
      however,
      that
      Alfacell may cause an independent, certified public accountant reasonably
      acceptable to Par to participate with Par’s accountant in such audit of any
      Third Party Manufacturer. 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.

     

    4.6 Late
      Payments.
      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 

    
      
        
        

      

        4.

        

        

      

      
        
        

      

    

    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.

     

    
      	
              5.

            	
              Delivery.
                

            

    

     

    5.1 Delivery
      Terms.
      Subject
      to compliance with Section 3.1, the Launch Quantities shall be delivered to
      Par at least two (2) weeks before the anticipated Initial Commercial Sale.
      Deliveries shall be made EXW (Incoterms 2000) at Alfacell’s manufacturing
      facility or that of its Third Party Manufacturer as designated by Alfacell.
      Product
      delivered to Par shall be appropriately Labeled and Packaged by Alfacell at
      its
      expense in fully finished form for supply to the ultimate consumer in accordance
      with law and all applicable Regulatory Approvals. Products supplied by Alfacell
      shall have a shelf life of at least twenty (20) months from the date of
      delivery.

     

    
      	
              6.

            	
              Quality
                Assurance Control -
                Acceptance.

            

    

     

    6.1 Specifications;
      Testing.

     

    6.1.1 Certificates
      of Analysis and Compliance. Alfacell
      shall provide Par with a copy of the certificate of analysis and a certificate
      of compliance (together, the “Certificates”),
      with,
      or at the same time of, each delivery of Product supplied hereunder. In the
      event Par requires additional documentation due to a change in the law or a
      Regulatory Approval without which the release into commerce and selling of
      Product in the Field in the Territory under any Regulatory Approval would be
      impossible or impracticable, Alfacell will use Commercially Reasonable Efforts
      to supply (unless such documentation is required from all manufacturers of
      pharmaceutical products, in which case Alfacell shall supply or cause its Third
      Party Manufacturer to supply) such documentation with each delivery of Product.
      Subject to variations agreed to in the Quality Agreement, such Certificates
      shall certify, with respect to each shipment and batch (identified by batch
      number): (i) the quantity of the shipment, (ii) that the Product
      delivered conforms to, and was handled in compliance with, the Product
      Specifications and (iii) that the Product was Manufactured in accordance with
      cGMP and any applicable Regulatory Approval, as well as any further information
      required by the relevant regulatory authorities that Par may have previously
      notified Alfacell is necessary. Par shall be under no obligation to accept
      any
      shipment of Product without the accompanying Certificates.

     

    6.2 Acceptance
      and Rejection.

     

    6.2.1 Quality
      Control Problem. If
      Alfacell identifies a quality problem with respect to any batch of the Product,
      then it shall promptly notify Par. 

     

    6.2.2 Product
      Rejection. Par
      may
      reject any delivery of Product if the Product does not conform to the Product
      Specifications or if it fails to conform to any Product warranty set forth
      in
      this Agreement. In addition, Par will visually inspect each delivery of Product
      upon receipt and shall, within forty five (45) days from receipt of delivery,
      notify Alfacell in writing (i) of any defects discovered by such visual
      inspection and (ii) that it is rejecting the delivery and the reasons for such
      rejection. If Par fails to 

    
      
        
        

      

        5.

        

        

      

      
        
        

      

    

    deliver
      such notice to Alfacell within the forty five (45)-day period, Par shall be
      deemed to have accepted such delivery; provided,
      however,
      that,
      other than with respect to defects or other non-compliance plainly observable
      from a visual inspection, any such acceptance, or deemed acceptance, shall
      not
      operate to limit the warranties of Alfacell set forth in this Agreement relating
      to such Product shipment and shall not preclude a subsequent rejection by Par
      of
      such shipment due to the discovery of latent defects in such Product (including
      discovery of any substance that would cause Product to be adulterated within
      the
      meaning of the United States Food, Drug, and Cosmetic Act); and provided,
      further,
      that
      Par notifies Alfacell in writing within five (5) business days of its discovery
      of such latent defect. 

     

    6.2.3 Replacement
      of Product and Dispute Procedure. If
      Alfacell believes that Product was wrongly rejected, it shall notify Par in
      writing, within twenty (20) days of receipt by Alfacell of Par’s written notice
      of rejection, that Alfacell disagrees with such basis for rejection (an
“Objection
      Notice”).
      If
      Par and Alfacell cannot agree, within twenty (20) days after receipt by Par
      of
      the Objection Notice, whether Product rejected by Par is defective,
      representative samples of the batch of Product in question shall be submitted
      to
      a mutually-acceptable independent laboratory or consultant for analysis and/or
      review. The results of such evaluation shall be binding upon the Parties. The
      Party that is determined to have been incorrect in its determination of whether
      the Product should be rejected shall pay the costs of any such evaluation and
      reimburse the other Party for any amounts previously paid by the other Party
      to
      the independent laboratory or consultant in connection with such evaluation.
      If
      such evaluation is inconclusive as to whether the Product rejected is defective,
      or if it is conclusive as to the fact that the Product rejected is defective
      but
      it cannot be determined which Party is responsible for such defect, then the
      Parties shall each be responsible for one-half of the costs related to such
      evaluation and Par may, in its discretion, purchase replacement Product when
      available for delivery. The Parties may also mutually agree in their discretion
      to further testing.

     

    6.2.4 Cost
      of Replacement of Rejected Product. If
      any
      delivery or portion thereof is rejected by Par, unless already paid, Par’s
      obligation to pay all amounts payable to Alfacell in respect of the rejected
      delivery or portion thereof shall be suspended until there is agreement between
      the Parties or a determination by the independent laboratory or consultant
      regarding whether the respective delivery or portion thereof should be rejected.
      If such agreement or determination is in support of Alfacell’s Objection Notice,
      Par shall pay the amount due under the respective invoice for such improperly
      rejected delivery or portion thereof. If no agreement can be reached or the
      determination as to whether the delivery or portion thereof should be rejected
      is inconclusive, or if it is determined or agreed that the Product rejected
      is
      defective but it cannot be determined or agreed which Party is responsible
      for
      such defect, as the case may be, Par shall only be obligated to pay one-half
      of
      the outstanding amount applicable to the rejected delivery or portion thereof,
      as the case may be, less one-half of Ex-U.S. Shipping Costs or domestic shipping
      and insurance costs related to such Product, as applicable. If such agreement
      or
      determination is in favor of Par, Par shall not be obligated to pay any amount
      applicable to the rejected delivery or portion thereof, as the case may be,
      and
      Alfacell shall reimburse Par for the Ex-U.S. Shipping Costs or domestic shipping
      and 

    
      
        
        

      

        6.

        

        

      

      
        
        

      

    

    insurance
      costs related to such Product, as applicable, within thirty (30) days of Par's
      providing to Alfacell reasonable documentation of such costs.

     

    6.2.5 Delivery
      Rejections. If
      a
      delivery or portion thereof is rejected by Par pursuant to the provisions of
      this Section 6.2, after determination that the rejection is legitimate in
      accordance with this Agreement, Par shall return to Alfacell at Alfacell’s
      request and expense (or, at the election of Alfacell, destroy and provide
      evidence of such destruction to Alfacell) any such rejected Product. If the
      Product was rightly rejected, Alfacell shall (i) credit the original invoice
      in
      respect of the rejected Product and (ii) adjust such invoice so that it includes
      only Product not rejected. Payment in respect of such adjusted invoice shall
      be
      due thirty (30) days after receipt by Par of such adjusted invoice.

     

    6.2.6 Replacement
      Product. During
      the pendency of any rejection discussions, Alfacell shall, or shall use its
      Commercially Reasonable Efforts to cause its Third Party Manufacturer to, supply
      Par with the same amount of Product as is subject to rejection discussions
      and
      Par shall purchase such amount on the same terms as such rejected Product.
      Notwithstanding Section 7.5, Alfacell shall, or shall use its Commercially
      Reasonable Efforts to cause its Third Party Manufacturer to, make the supply
      of
      such replacement Product Alfacell's first supply priority and shall ship via
      air
      courier such replacement Product to Par at Alfacell’s expense. Shipping costs
      related to such replacement Product shall be borne by Alfacell, unless the
      evaluation as to whether the Product rejected is defective, or if conclusive
      as
      to the fact that the Product rejected is defective but it cannot be determined
      which Party is responsible for such defect, in which event Par and Alfacell
      shall each be responsible for one-half of such shipping costs. Any replacement
      Product that replaces rejected Product shall have a shelf life, at the time
      of
      delivery, equal to or greater than the remaining shelf life of the rejected
      Product at the time Par delivered notice of rejection in respect
      thereof.

     

    6.3 Quality
      Agreement.
      Within
      sixty (60) days following the date that the first NDA is submitted to the FDA
      by
      Alfacell, the Parties shall enter into an agreement that details the quality
      assurance obligations of each Party on mutually agreeable and customary terms
      (the “Quality
      Agreement”).

     

    
      	
              7.

            	
              Manufacture
                of Product.

            

    

     

    7.1 Changed
      Specifications.
      The
      Parties shall notify each other within seventy-two (72)
      hours of any new instructions or specifications required by the FDA or by other
      Governmental Authorities. The Parties shall confer with each other with respect
      to any response regarding such instruction or specification and the best means
      to comply with such requirements and Alfacell shall bear the costs for
      implementing such changes.

     

    7.2 Labeling.
      All
      Labels and Packaging of Product shall specify Par as the distributor and display
      the logo of Par and the artwork, text, and SKU numbers and other necessary
      items
      supplied by Par to Alfacell. The Labels and Packaging shall also include
      references to the Third Party Manufacturer in accordance with applicable law
      and
      all Regulatory Approvals. All Labels and Packaging or trade dress shall comply
      with applicable laws and Regulatory Approvals, and the presentation of the
      Trademark thereon shall comply 

    
      
        
        

      

        7.

        

        

      

      
        
        

      

    

    with
      the
      provisions regarding the Trademark under the License Agreement. Except for
      all
      information and services provided to Alfacell by Par, Alfacell shall be
      responsible for ensuring the accuracy of all information contained on all Labels
      and Packaging of the Product and for the compliance of all such Labels and
      Packaging with the law and all Regulatory Approvals. Should Par desire or be
      required pursuant to applicable law and any Regulatory Approvals to make any
      change in any such Labels or Packaging, Alfacell shall be responsible for
      procuring the updating of all artwork and text associated with such change
      and
      for providing such changes to Par. Upon approval by Par, Alfacell shall make
      all
      necessary arrangements for such changed Labels or Packaging to be printed and
      shall provide Par with agreed artwork documents for Par’s review. Par shall,
      within one (1) week of receipt of agreed artwork documents, either provide
      Alfacell with any necessary corrections thereto or notify Alfacell of its
      approval of such agreed artwork documents. Par shall supply Alfacell with all
      of
      Par’s necessary artwork, text, SKU numbers and other necessary items by the
      dates reasonably requested by Alfacell so that Alfacell can prepare the Labels
      and Packaging for the Launch Quantities. Alfacell’s obligations to supply Par
      and its Affiliates with Product, including the Launch Quantities by the
      specified delivery dates, shall be contingent upon Alfacell’s timely receipt of
      the foregoing artwork, text, and SKU numbers and other necessary items from
      Par.

     

    7.3 Changes
      to the Product Specifications or to the Manufacturing Process.
Alfacell
      shall obtain the prior written consent of Par, which consent shall not be
      unreasonably withheld, conditioned or delayed, with respect to any proposed
      revision to the Product Specifications, site of manufacture and any change
      in
      the Raw Materials, equipment, process or procedures used to Manufacture the
      Product (the “Manufacturing
      Process”)
      that
      would require approval of or notification to the FDA, or other applicable
      Governmental Authority, in the Territory. The corresponding costs of
      implementing any changes to the Product Specifications or to the Manufacturing
      Process shall be borne by Alfacell.

     

    7.4 Reprocessing
      and Reworking of Product.
      Any
      reprocessing or reworking of any batch or lot of Product shall be made in full
      compliance with the procedures described in the Regulatory Approvals for the
      Product, or, if not made in compliance with the procedures described in the
      Regulatory Approvals for the Product, Alfacell shall obtain the prior written
      consent of Par, not to be unreasonably withheld, delayed or
      conditioned.

     

    7.5 Product
      Shortfall.
      Alfacell
      shall, or shall cause its Third Party Manufacturer to, use Commercially
      Reasonable Efforts to avoid shortfalls in supply of Product based on the
      Forecasts provided by Par. In the event Alfacell is unable to supply to Par,
      in
      whole or in part, Product requested for any reason (except to the extent caused
      by Par), then, in addition to other rights or remedies available to Par,
      Alfacell shall promptly notify Par in writing of such shortage, or potential
      shortage, or inability to timely supply Product and, if possible, the date
      when
      Alfacell will again be able to supply Product. Alfacell shall make efforts
      to
      cause its Third Party Manufacturer to use commercially reasonable efforts to
      remedy any shortfall of the Product as soon as practicable and to promptly
      allocate its available production capacity for the production of Product.
      Notwithstanding anything contained herein to the contrary, during Product
      shortfalls, Product will be allocated on a pro rata basis among the worldwide
      Product distributors and partners of Alfacell based on estimated market,

    
      
        
        

      

        8.

        

        

      

      
        
        

      

    

    determined
      on the basis of quantities of Product ordered in the two fiscal quarters
      immediately preceding the Product shortfall. 

     

    
      	
              8.

            	
              Regulatory.
                

            

    

     

    8.1 Adverse
      Event Reporting; Product Complaints. 

     

    8.1.1 Notification.
      During
      the Term, the Parties shall keep each other promptly and fully informed of
      all
      of their pharmacological, toxicological and clinical trials, investigations
      and
      findings relating to the Product relevant to the Territory or the activities
      of
      the other Party. To
      such
      end, Alfacell and Par shall enter into a pharmacovigilance agreement to
      coordinate the flow of safety information. Par shall forward all Adverse Events
      reports or ISCRs received for the Product to Alfacell within five (5) calendar
      days after receipt by Par. Format for Adverse Events reporting from Par to
      Alfacell shall be a copy or facsimile of the source documentation. All event
      information will be transmitted via fax or secure electronic mail. The
      regulatory reporting time clock for submitting Adverse Events reports or ICSRs
      to Alfacell is deemed to start on the date when any individual within Par is
      first notified of a case report that fulfills the minimum criteria for a case
      report.

     

    8.1.2 Reporting.
      With
      regard to the Product, Alfacell is responsible for preparing and submitting
      aggregate and individual case regulatory safety reports within the Territory
      as
      required by any Governmental Authority. Alfacell shall also hold and maintain
      reports of all Adverse Events, both serious and non-serious, in a database
      for
      the Product for preparing and submitting aggregate and single case reports
      to
      the FDA for the Product.
      Par
      shall reasonably cooperate at its own expense.

     

    8.1.3 Literature
      Reports.
      Alfacell
      shall be responsible for screening published scientific and medical literature
      for Adverse Events or ICSRs. Par
      shall be
      responsible for notifying Alfacell of any relevant Adverse Events or ICSRs
      that
      may come to its attention in the Territory via local scientific or medical
      journals, or unpublished scientific or conference papers. A copy of any such
      documentation shall be provided at the same time as the report.

     

    8.1.4 Product
      Complaints.
      Par will
      notify Alfacell within five (5) calendar days of any customer complaints that
      relate to the Manufacture, Labeling or Packaging of the Product.

     

    8.2 cGMP
      Compliance and QA Audits.
      Upon
      written request to Alfacell by Par or otherwise upon the reasonable request
      of
      Par and subject to the consent of Alfacell, not to be unreasonably withheld,
      delayed or conditioned, Par may accompany Alfacell to a Third Party
      Manufacturer’s Manufacturing facilities during normal business hours to discuss
      any issues regarding Manufacturing and management personnel, and to review
      and
      inspect (i) the Manufacturing and storage facilities, (ii) the quality control
      procedures, and/or (iii) any records and reports pertinent to the Manufacture,
      disposition or transport of Product as may be necessary to evidence the Third
      Party Manufacturer’s compliance with all applicable Regulatory Approvals for the
      Manufacture of Product supplied to Par hereunder, including 

    
      
        
        

      

        9.

        

        

      

      
        
        

      

    

    compliance
      with cGMP. Par may make such visits with Alfacell to the Third Party
      Manufacturer’s Manufacturing facilities once per calendar year unless Par
      identifies, during any such visit or as a result of any Form 483 received by
      such Third Party Manufacturer, any defects or deficiencies provided in any
      of
      the foregoing clauses (i), (ii) or (iii) above, in which case Par may make
      as
      many subsequent visits to such facilities as are reasonably required to
      determine whether such defects or deficiencies have been cured. 

     

    8.3 Regulatory
      Support. To
      the
      extent practicable, Alfacell shall notify Par within two (2) business days
      prior
      to any inspection (of which Alfacell is aware) by the FDA or other regulatory
      agency relating to Product or any Product-related facility that is involved
      in
      the supply of Product to Par hereunder and, within twenty-four (24) hours after
      such inspection, shall furnish Par with a copy of all documentation, including
      any Form 483 and the Third Party Manufacturer’s response thereto, relating to
      such inspection. In addition, Alfacell shall notify Par within five (5) business
      days of its receipt of any other written regulatory actions or communications
      (other than ministerial, non-substantive communications) relating to the Product
      or any Product-related facility that is involved in the supply of Product to
      Par
      hereunder. The Parties shall confer with each other with respect to any response
      regarding such action or communication and the best means to comply with such
      action or communication, but the final response shall be within Alfacell’s final
      decision-making authority.

     

    8.4 Recall
      of Product. In
      the
      event either Party believes a recall, field alert, product withdrawal or field
      correction, may be necessary with respect to Product provided under this
      Agreement, such Party shall immediately notify the other Party in writing.
      Neither Party shall act to initiate a recall, field alert, Product withdrawal
      or
      field correction, without the express prior written approval of the other Party,
      unless required by applicable law. Both Parties shall cooperate with one another
      with respect to such recall, field alert, product withdrawal or field
      correction. Alfacell shall be responsible for conducting any recall, field
      alert, product withdrawal or field correction; provided,
      however,
      that
      the cost of any such recall, field alert, product withdrawal or field correction
      shall be borne equally by the Parties, except to the extent such recall, field
      alert, Product withdrawal or field correction is caused by a breach by either
      Alfacell or Par of its respective warranties, representations or obligations
      under this Agreement, the License Agreement or applicable law or its gross
      negligence or willful misconduct, in which case such cost shall be borne by
      the
      responsible Party. For purposes hereof, such cost shall be limited to
      reasonable, actual and documented costs incurred by the Parties for such recall,
      field alert, product withdrawal or field correction, and for the replacement
      of
      the Product to be recalled. In the event of a recall, Par shall provide to
      Alfacell copies of distribution records in its control and shall otherwise
      reasonably cooperate with Alfacell in respect of any such recall.

     

    8.5 Compliance
      with Laws.
      Alfacell
      shall, and
      shall
      require the Third Party Manufacturer to, comply
      with all applicable present and future orders, regulations, requirements and
      laws of any and all Governmental Authorities, including all laws and regulations
      of such territories applicable to the transportation, storage, use, handling
      and
      disposal, of hazardous materials. Alfacell represents and warrants to Par that
      it has and will maintain during the Term all governmental permits (including
      health, safety and environmental permits) necessary for the conduct of the
      actions and procedures that it 

    
      
        
        

      

        10.

        

        

      

      
        
        

      

    

    undertakes
      pursuant to this Agreement;
      provided, however,
      that if
      Alfacell or the Third Party Manufacturer ceases to hold such permits, licenses,
      registrations and other forms of governmental authorizations, Alfacell or the
      Third Party Manufacturer shall have a reasonable time to regain compliance
      with
      the foregoing requirements so long as during such time Alfacell is able to
      supply Product to Par in accordance with this Agreement. 

     

    8.6 Documentation.
      For
      three (3) years after the termination of this Agreement, Alfacell shall keep
      complete, accurate and authentic accounts, notes, data and records of the work
      performed under this Agreement (including batch records), including by the
      Third
      Party Manufacturer. Each Party shall maintain complete and adequate records
      pertaining to the methods and facilities used for the Manufacture, processing,
      testing, packing, Labeling, holding and distribution, of the Product in
      accordance with all applicable domestic and foreign laws and regulations so
      that
      such Product may be used in humans. 

     

    8.7 Samples.
      Alfacell
      shall retain samples of Product for the period and in quantities agreed by
      the
      Parties in the Quality Agreement.

     

    9.  Representations
      and Warranties.

     

    9.1 Product
      Warranty.
      Alfacell
      represents and warrants that Product delivered hereunder will: (i) be
      Manufactured in accordance with all applicable Regulatory Approvals (to the
      extent applicable at the time of Manufacturing), relevant cGMPs and other
      applicable U.S. laws, rules and regulations, as then in effect;
      (ii) conform to the Product Specifications at the time of delivery; (iii)
      be capable of maintaining conformity to said Product Specifications and
      requirements when handled and stored in accordance with the Labeling until
      the
      applicable expiry date of such Product (assuming such expiry date is based
      upon
      the accurate shelf life for Product); and (iv) not be misbranded or adulterated
      under the law. WITHOUT LIMITING ALFACELL’S INDEMNIFICATION OBLIGATIONS UNDER
      SECTION 12.1 WITH RESPECT TO THIRD-PARTY CLAIMS AND EXPENSES ARISING OUT
      OF, OR RESULTING FROM, ALFACELL’S BREACH OF THE PRODUCT WARRANTY IN THIS SECTION
      9.1, EXCEPT FOR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE BY ALFACELL, ITS
      AFFILIATES OR ITS THIRD PARTY MANUFACTURER OR ANY OF THEIR RESPECTIVE EMPLOYEES
      OR AGENTS, ALFACELL’S EXCLUSIVE LIABILITY FOR ALFACELL’S SUPPLY OF DEFECTIVE
      PRODUCT SHALL BE REPLACEMENT OF SUCH PRODUCT OR CREDIT THEREFOR.
      THE
      WARRANTY SET FORTH IN THIS SECTION 9.1 IS VOID TO THE EXTENT PRODUCT FAILURE
      OR
      DEFICIENCIES ARE ATTRIBUTABLE TO AN ACT OR OMISSION OF PAR, ITS AFFILIATES,
      EMPLOYEES, AGENTS OR PERMITTED SUB-DISTRIBUTORS, OR ANY OF THEIR RESPECTIVE
      EMPLOYEES OR AGENTS. 

     

    9.2 No
      Debarred or Disqualified Persons.
      Alfacell
      and Par shall
      not, and Alfacell shall require that the Third Party Manufacturer not,
      employ, contract with or retain, any person, directly or indirectly, to perform
      any services under this Agreement if such person: (a) is under investigation
      by
      the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C.
      § 335a or its successor provisions, or (b) has a disqualification hearing
      pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or
      its 

    
      
        
        

      

        11.

        

        

      

      
        
        

      

    

    successor
      provisions. In addition, Alfacell and Par each represents and warrants that
      it
      has not engaged in any conduct or activity which could lead to any of the
      above-mentioned disqualification or debarment actions. If, during the Term,
      Alfacell, Par or any person employed or retained by them, or employed or
      retained by the Third Party Manufacturer, to perform under this Agreement
      (i) comes under investigation by the FDA or other Governmental Authority
      for a debarment action or disqualification, (ii) is debarred or
      disqualified or (iii) engages in any conduct or activity that could lead to
      any of the above-mentioned disqualification or debarment actions, Alfacell
      or
      Par, as the case may be, shall immediately notify the other Party of
      same.

     

    9.3 Both
      Parties’ Representations and Warranties.  Each
      Party represents and warrants to the other that: (a) it is duly organized
      and validly existing under the laws of its jurisdiction of incorporation, and
      has full corporate or other power and authority to enter into this Agreement
      and
      to carry out the provisions hereof; (b) it is duly authorized to execute
      and deliver this Agreement and to perform its obligations hereunder, and the
      person or persons executing this Agreement on its behalf has been duly
      authorized to do so by all requisite corporate actions; (c) this Agreement
      is legally binding upon it, enforceable in accordance with its terms, and does
      not conflict with any agreement, instrument or understanding, oral or written,
      to which it is a party or by which it may be bound, nor violate any material
      law
      or regulation of any court, governmental body or administrative or other agency
      having jurisdiction over it; and (d) it will conduct all of its activities
      related to this Agreement in accordance with applicable laws, rules, regulations
      and guidelines, including in respect of the commercialization of
      Product.

     

    9.4 Limitation
      of Liability. EXCEPT
      IN
      RESPECT OF (A) ANY CLAIM RELATED TO THE WILLFUL MISCONDUCT OR GROSS NEGLIGENCE
      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 SECTION 12,
      NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL,
      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.

     

    9.5 Disclaimer.
      EXCEPT THE EXPRESS WARRANTIES SET FORTH IN SECTION 9, ALFACELL MAKES
      NO
      WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
      STATUTE OR OTHERWISE, AND ALFACELL SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY
      OF QUALITY, WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR
      PURPOSE OR WARRANTY OF NONINFRINGEMENT WITH RESPECT TO THE PRODUCT.

     

    
      	
              10.

            	
              Confidentiality

            

    

     

    10.1 Confidential
      Information. Each
      Party agrees to retain in strict confidence and not to disclose, divulge or
      otherwise communicate to any Third Party any Confidential 

    
      
        
        

      

        12.

        

        

      

      
        
        

      

    

    Information
      of the other Party, whether received prior to or after the date hereof 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 10.
      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.

     

    10.2 Authorized
      Disclosure. Each
      Party may disclose Confidential Information belonging to the other Party to
      the
      extent such disclosure is reasonably necessary in the following
      instances:

     

    10.2.1 regulatory
      filings for Product as contemplated by the License Agreement; 

     

    10.2.2 disclosure
      to the Third Party Manufacturer to enable it to perform under this Agreement;
      provided,
      that
      the Third Party Manufacturer agrees to be bound by terms of confidentiality
      and
      non-use comparable in scope to those set forth in this Article 10;

     

    10.2.3 prosecuting
      or defending litigation as permitted by the License Agreement;
      

     

    10.2.4 to
      the
      extent necessary to perform its obligations under this Agreement and/or the
      License Agreement; and

     

    10.2.5 complying
      with applicable court orders or governmental regulations or inquiries, including
      the listing standard of any national or international securities exchange.
      

     

    Notwithstanding
      the foregoing, in the event a Party is required to make a disclosure of the
      other Party’s Confidential Information pursuant to Section 10.2.2 or 10.2.3, it
      shall give, except 

    
      
        
        

      

        13.

        

        

      

      
        
        

      

    

    where
      impracticable, reasonable advance notice to the other Party of such disclosure
      and use efforts to secure confidential treatment of such information at least
      as
      diligent as such Party would use to protect its own confidential information,
      but in no event less than reasonable efforts. In any event, the Parties agree
      to
      take all reasonable actions to avoid disclosure of Confidential Information
      hereunder. The Parties shall consult with each other on the provisions of this
      Agreement to be redacted in any filings made by the Parties with any regulatory
      authority (such as the Securities and Exchange Commission) or as otherwise
      required by law.

     

    
      	
              11.

            	
              Term
                and Termination

            

    

     

    11.1 Term.
      The term
      of this Agreement (the “Term”)
      shall
      commence on the effective date of the License Agreement (the “Effective
      Date”)
      and
      shall end upon the expiration or
      termination of the License Agreement (or upon earlier termination of this
      Agreement, if such termination occurs before the expiration or termination
      of
      the License Agreement). 

     

    11.2 Termination
      for Uncured Material Breach. Each
      Party shall have the right to terminate this Agreement, upon written notice
      to
      the other as a result of a material breach of this Agreement by the other Party
      that is not cured by the breaching Party within sixty (60) days (twenty (20)
      business days in the event of an undisputed payment default) following written
      notice of such breach by the non-breaching Party.

     

    11.3 Effect
      of
      Expiration or Termination; Surviving Obligations. 

     

    11.3.1 Effect
      of Termination.
      Upon the
      expiration of the Term or the earlier termination of this Agreement pursuant
      to
      Section 11.1 or 11.2, all rights and obligations of the Parties under this
      Agreement shall terminate, except as provided in this Section 11.3.

     

    11.3.2 Surviving
      Obligations.
      Expiration or termination of this Agreement shall not relieve the Parties of
      any
      obligation accruing prior to such expiration or termination. For a twenty-four
      (24)-month period following the termination or expiration of this Agreement,
      Alfacell’s obligations under Sections 8.1, 8.3, 8.4 and 8.6 shall remain in full
      force and effect. Except as set forth below or elsewhere in this Agreement,
      the
      obligations and rights of the Parties under the following provisions of this
      Agreement shall survive expiration or termination of this
      Agreement:

     

    Section 1
      – Definitions

    Section 4.5
      – Financial Audit

    Section 10
      – Confidentiality

    Section 11.3
      – Effect of Expiration or Termination; Surviving Obligations

    Section 12
      – Indemnification

    Section
      13 – Dispute Resolution

    Section 14
      – General Provisions

    
      
        
        

      

        14.

        

        

      

      
        
        

      

    

    
      	
              12.

            	
              Indemnification

            

    

     

    12.1 Indemnification
      by Alfacell. Alfacell
      hereby
      agrees to defend, indemnify and hold harmless Par
      and its
      directors, officers and employees (each, a “Par
      Indemnitee”)
      from
      and against any and all claims, suits, actions, demands, liabilities, expenses
      and/or loss, including reasonable legal expense and attorneys’ fees
      (collectively, “Losses”),
      to
      which any Par Indemnitee may become subject as a result of any claim, demand,
      action or other proceeding by any Third Party to the extent such Losses arise
      directly or indirectly from (i) any material breach of this Agreement by
      Alfacell (including any material breach of any of its warranties hereunder),
      including any material breach of any warranty made by Alfacell on behalf of
      a
      Third Party Manufacturer; (ii) any mishandling of the Product by Alfacell or
      a
      Third Party Manufacturer before delivery of the Product to Par or (iii) the
      gross negligence or willful misconduct of Alfacell, Alfacell Indemnitee or
      any
      Third Party Manufacturer, except, in each case, to the extent such Losses are
      subject to indemnification pursuant to Section 12.2.

     

    12.2 Indemnification
      by Par.
      Par
      hereby agrees to defend, indemnify and hold harmless Alfacell and its directors,
      officers and employees (each, an “Alfacell
      Indemnitee”)
      from
      and against any and all Losses to which any Alfacell Indemnitee may become
      subject as a result of any claim, demand, action or other proceeding by any
      Third Party to the extent such Losses arise directly or indirectly from (i)
      any
      material breach of this Agreement by Par (including any material breach of
      any
      of its warranties hereunder), including any material breach by a permitted
      Sub–distributor of any obligation of Par hereunder, (ii) any mishandling of
      the Product by Par or any act or omission of Par that causes the Product not
      to
      meet the Product warranties set forth herein after delivery to Par or
      (iii) the gross negligence or willful misconduct of Par or a Par
      Indemnitee, except, in each case, to the extent such Losses are subject to
      indemnification pursuant to Section 12.1.

     

    12.3 Notice
      and Procedures.
      If an
      Alfacell Indemnitee or a Par Indemnitee (the “Indemnitee”)
      intends to claim indemnification under this Article 12, 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 12. 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 12 

    
      
        
        

      

        15.

        

        

      

      
        
        

      

    

    (on
      its
      own behalf or on behalf of its Indemnitees), and other Indemnitees may not
      directly claim indemnity hereunder.

     

    12.4 Insurance.
      Alfacell
      shall require that the Third Party Manufacturer maintain, at its own expense,
      general liability coverage appropriate to its activities with reputable and
      financially secure insurance carriers to cover its activities related to this
      Agreement. In addition, such insurance coverage shall include product liability
      coverage in an amount not less than that commensurate with industry standards
      for similar products, to be in place prior to the Initial Commercial Sale and
      for the remainder of the Term. The Third Party Manufacturer shall provide a
      certificate of insurance (or evidence of self-insurance) evidencing such
      coverage to the other Party upon request. In addition, Alfacell shall have
      and
      maintain, at its own expense, general liability insurance coverage for the
      manufacture, supply, use and sale of the Product as is reasonable, normal and
      customary in the pharmaceutical industry generally and otherwise consistent
      with
      Article XII of the License Agreement.

     

    
      	
              13.

            	
              Dispute
                Resolution

            

    

     

    13.1 Disputes.
      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 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 from 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 13.1, each Party shall have the right to pursue any
      and all remedies available at law or in equity.  

     

    
      	
              14.

            	
              General
                Provisions

            

    

     

    14.1 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 

    
      
        
        

      

        16.

        

        

      

      
        
        

      

    

    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.

     

    14.2 Entire
      Agreement; Modification.
      This
      Agreement, together with the Exhibits 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.

     

    14.3 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, joint venture or
      employer and employee relationship between Alfacell and Par. Neither Party
      is a
      legal representative of the other Party and at no time shall one Party make
      commitments, create any obligations or incur any charges or expenses for or
      in
      the name of the other Party.

     

    14.4 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.

     

    14.5 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 14.5 shall be null and void. In the
      event 

    
      
        
        

      

        17.

        

        

      

      
        
        

      

    

    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. 

     

    14.6 No
      Third Party Beneficiaries. This
      Agreement is neither expressly nor impliedly made for the benefit of any party
      other than those executing it other than as expressly provided in
      Section 12. 

     

    14.7 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. Unless specified otherwise herein, 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

              Attn:
                Chief Executive Officer

              Fax:
                (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

              Attn:
                Kevin T. Collins, Esq.

              Fax:
                (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

            
	 	 
	
              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 14.7.

    
      
        
        

      

        18.

        

        

      

      
        
        

      

    

    14.8 Interpretation.

     

    14.8.1 Captions
      & Headings. The
      captions and headings of clauses contained in this Agreement preceding the
      text
      of the articles, sections, subsections and paragraphs hereof are inserted solely
      for convenience and ease of reference only and shall not constitute any part
      of
      this Agreement, or have any effect on its interpretation or
      construction.

     

    14.8.2 Singular
      & Plural. All
      references in this Agreement to the singular shall include the plural where
      applicable, and all references to gender shall include both genders and the
      neuter.

     

    14.8.3 Articles,
      Sections & Subsections. Unless
      otherwise specified, references in this Agreement to any article shall include
      all sections, subsections, and paragraphs in such article; references in this
      Agreement to any section shall include all subsections and paragraphs in such
      sections; and references in this Agreement to any subsection shall include
      all
      paragraphs in such subsection.

     

    14.8.4 Days.
      All
      references to days in this Agreement shall mean calendar days, unless otherwise
      specified.

     

    14.8.5 Ambiguities.
      Ambiguities
      and uncertainties in this Agreement, if any, shall not be interpreted against
      either Party, irrespective of which Party may be deemed to have caused the
      ambiguity or uncertainty to exist. 

     

    14.8.6 English
      Language.
      This
      Agreement has been prepared in the English language and the English language
      shall control its interpretation. In addition, all notices required or permitted
      to be given hereunder, and all written, electronic, oral or other communications
      between the Parties regarding this Agreement, shall be in the English
      language.

     

    14.8.7 Miscellaneous.
      Unless
      the context of this Agreement otherwise requires, (a) the terms “hereof,”
“herein,” “hereby” and other similar words refer to this entire Agreement; (b)
      the terms “include,” “includes” or “including” shall be deemed to be followed by
      the words “without limitation”; (c) the terms “US,” “U.S.,” “USA” and “United
      States” refer to the United States of America and (d) references in this
      Agreement to “Dollars” or “$” shall mean the legal tender of the
      US.

     

    14.9 Currency.
      All
      monetary amounts referenced in this agreement shall be denominated in United
      States dollars or other legal currency of the United States.

     

    14.10 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.

     

    [Remainder
      of this page intentionally left blank]

    
      
        
        

      

        19.

        

        

      

      
        
        

      

    

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

     

    
      	
              ALFACELL
                CORPORATION

            
	 
	
              By:

            	 
	
              Name:

            	 
	
              Title:

            	 
	 
	
              PAR
                PHARMACEUTICAL, INC.

            
	 
	
              By:

            	 
	
              Name:

            	 
	
              Title:

            	 

    

    
      
        
        

      

        
        

        

        

      

      
        
        

      

    

    

    

    

    

    EXHIBIT
      A

    

    PRODUCT
      SPECIFICATIONS

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