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.

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“AG Product” means a generically-labeled version of the Product (i.e., such
Product does not bear the Trade Name) supplied by Alfacell and sold by Par
and/or its Sub-distributors or permitted sublicensees.
 
“Agreement” has the meaning set forth in the introductory paragraph.
 
“Alfacell” has the meaning set forth in the introductory paragraph.
 
“Alfacell Indemnitee” has the meaning set forth in Section 12.2.
 
“Alfacell Information” means any Product-related information Owned or Controlled
by Alfacell as of the Effective Date or Owned or Controlled by Alfacell after
the Effective Date that, with respect to a Product in the Field in the
Territory, (a) is directly related to use or sale of the Commercialized Product,
(b) is included in an Alfacell NDA filing for the Product within the scope of
this Agreement, (c) is otherwise reasonably requested by Par and provided by
Alfacell in its sole discretion, or (d) is lawfully obtained by Alfacell from a
Third Party without restriction on disclosure to Par, but only to the extent
that such Product-related information is necessary or useful for, and is
specific to use, utilization, or sale of the Product, and is disclosed to Par by
Alfacell pursuant to this Agreement. Program Developments Owned or Controlled by
Alfacell that are not Alfacell Patents, shall be Alfacell Information. For the
avoidance of doubt, Alfacell shall have no obligation to disclose to Par any
Ranpirnase or Product manufacturing Know-How Owned or Controlled by Alfacell,
except in connection with Section 4.2 of this Agreement.
 
“Alfacell Patents” means any United States patents and patent applications Owned
or Controlled by Alfacell as of the Effective Date or Owned or Controlled by
Alfacell after the Effective Date that cover Ranpirnase or Product, the
importation, use or making of Ranpirnase or Product, or any part of the
foregoing or that in Par’s opinion may cover Competing Products, the
importation, use or making of Competing Product, or any part thereof. Such
Alfacell patents and patent applications as of the Effective Date are set forth
on Schedule 1.1, which is attached hereto and made part of this Agreement.
Schedule 1.1 shall be amended from time to time during the Term to reflect any
such patents Owned or Controlled by Alfacell after the Effective Date. The term
“Alfacell Patents” shall include continuations, divisions, provisionals or any
substitute applications of the patents and patent applications set forth on
Schedule 1.1, any patent issued with respect to any such patent applications,
and any reissue, reexamination, renewal or extension (whether by patent law or
regulation, or any other law or regulation, for example FDA related extensions)
of any such patent.
 
“Alfacell Technology” means Alfacell Patents and Alfacell Information.
 
“Amphinase(s)” means all pharmaceutical agents disclosed or claimed in one or
more of the following:

Patent No. US 7,229,824 B1

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

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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.

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“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

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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.

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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.

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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.

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“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.

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“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.

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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

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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);

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(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

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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

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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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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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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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(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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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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(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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(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.

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(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

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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

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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

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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

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

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

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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

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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.

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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.)
 

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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

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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

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prior public disclosures made by one of the Parties in accordance with the terms
of this Section 14.13 shall not require prior review or approval by the
non-disclosing Party. Par acknowledges that Alfacell will be obligated to file a
copy of this Agreement with the United States Securities and Exchange Commission
(“SEC”). Alfacell will seek confidential treatment of those portions of this
Agreement which it deems appropriate under applicable regulations of the SEC.
 
[Signature Page Follows]

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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:

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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

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Schedule 4.1(d)

Trademark Guidelines

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

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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

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Exhibit B

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

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Exhibit C

Supply Agreement

[Attached]

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