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Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the
information subject to the confidentiality request. Omissions are designated as
[***]. A complete
version of this exhibit has been filed separately with the Securities and
Exchange Commission.

EXECUTION VERSION

 

 

DEVELOPMENT SERVICES AND COMMERCIALIZATION AGREEMENT
BY AND BETWEEN

PAR PHARMACEUTICAL, INC.

AND

INTELGENX CORP.

 

DATED AS OF JANUARY 8, 2014

 

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DEVELOPMENT SERVICES AND COMMERCIALIZATION AGREEMENT

THIS DEVELOPMENT SERVICES AND COMMERCIALIZATION AGREEMENT (this "Agreement") is
hereby entered into and effective as of January 8, 2014 (the "Effective Date")
by and between Par Pharmaceutical, Inc., a Delaware corporation with offices
located at One Ram Ridge Road, Spring Valley, New York 10977, U.S.A. ("Par"),
and IntelGenx Corp., a Canadian corporation with offices located at 6425 rue
Abrams, Saint Laurent, Quebec, Canada H4S-1X9 ("IntelGenx").

WHEREAS, IntelGenx has undertaken certain development activities relating to the
preparation of a generic pharmaceutical formulation of the Product(s) (as
defined below); and

WHEREAS, Par desires to have IntelGenx exclusively develop, and IntelGenx
desires to exclusively develop for Par generic versions of all strengths and
presentations of the applicable Brand Product (as defined below), as may be
approved pursuant to the NDA (as defined below) for such Brand Product, as
further addressed below.

NOW, THEREFORE, in consideration of the mutual covenants and agreements of the
Parties contained herein and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:

ARTICLE 1.      DEFINITIONS

Capitalized terms used in this Agreement shall have the following definitions:

"Acquisition Cost" means, with respect to a Product or AG Product, the fully
allocated cost of acquiring such Product or AG Product by Par and/or its
Affiliates, calculated in accordance with GAAP, including the following: (i) the
transfer price as calculated by the Manufacturer; (ii) all costs for inbound
shipping, handling, intake testing, process validation and stability testing,
and holding and storing such Product or AG Product; (iii) any amounts paid for
the acquisition or supply of such AG Product; and (iv) any amounts payable to
Third Parties on the sale or profits from such AG Product pursuant to an
associated supply and/or license agreement or the like, less (in each case, to
the extent applicable) any rebates or discounts accorded to and actually
received by, or credited to, Par.

"Affiliate(s)" means, with respect to IntelGenx, any Person which directly or
indirectly controls, is controlled by, or is under common control with such
Person; and with respect to Par, Sky Growth Holdings Corporation, a Delaware
corporation and indirect parent of Par, and any Person directly or indirectly
controlled by Sky Growth Holdings Corporation. For purposes of the foregoing
definition only, the term "control" (including with correlative meaning, the
terms "controlling", "controlled by", and "under common control with") as used
with respect to the applicable Person, means the possession, directly or
indirectly, of the power to direct or cause the direction of the management and
policies of such Person, whether through ownership of equity, securities, or
partnership interest or by contract, or otherwise. Ownership of more than fifty
percent (50%) of the securities or other ownership interests representing the
equity, the voting stock or general partnership interest in an entity, or
greater than fifty percent (50%) interest in the income of such entity shall,
without limitation, be deemed to be control for purposes of this definition.

"AG Agreement" has the meaning set forth in Section 6.7.

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"AG Product" means a generically labelled version of a Brand Product that is
approved for sale under the Regulatory Approval for such Brand Product.

"Agreement" has the meaning given to such term in the introductory paragraph of
this Agreement.

"ANDA" means an Abbreviated New Drug Application pursuant to 21 U.S.C. § 355(j)
et seq., and the regulations promulgated thereunder.

"API" means, with respect to a Product, the active pharmaceutical ingredient(s)
in such Product.

"Applicable Laws" means all laws, rules, regulations and guidelines of any
Governmental Authority with jurisdiction over the development, manufacturing,
exportation, importation, promotion, marketing, sale or distribution of the
Product and/or the performance of a Party's obligations under this Agreement, to
the extent applicable and relevant, and including specifically all cGMP or
similar standards or guidelines of the FDA and compendial guidelines (e.g.,
United States Pharmacopeia or European Pharmacopeia), where applicable, as well
as U.S. export control laws and the U.S. Foreign Corrupt Practices Act.

"Appointed Legal Counsel" has the meaning set forth in Section 6.9.4.

"Batch" means, with respect to a Product, the specific quantity of such Product,
as mutually agreed upon by Par and IntelGenx, that (a) is intended to have a
uniform character and quality within specified limits and (b) is produced
according to a single manufacturing order during the same cycle of manufacture.

"Bioequivalence Studies" means a study undertaken to satisfy the FDA's
requirements for bioequivalence in connection with establishing that a drug
product subject to an ANDA is a Therapeutic Equivalent of the Brand Product
referenced in such ANDA.

"Brand Product" means, with respect to a Product, the branded pharmaceutical
product of such Product as set forth on Exhibit A hereto, including any future
strengths thereof.

"Calendar Quarter" means a three (3) consecutive month period ending on March
31, June 30, September 30 or December 31.

"Clinical Expert" has the meaning set forth in Section 2.4.3.

"Commercial Launch" means, with respect to a Product, the first commercial sale
in the Territory of such Product by Par, its Affiliate or a permitted
sublicensee, as the case may be, to a Third Party.

"Commercially Reasonable Efforts" means, with respect to each Party, efforts and
commitment of resources in accordance with such Party's reasonable business,
legal, medical, and scientific judgment that are consistent with the efforts and
resources that such Party uses for other products owned by it or to which it has
exclusive rights, that 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, the profitability of the applicable products
and other relevant factors, including technical, legal, scientific, medical,
sales performance, and/or marketing factors, including the good faith
performance of any associated commitments under this Agreement.

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"Confidential Information" means, with respect to a Party disclosing such
Information (the "Disclosing Party"), all non-public information of any kind
whatsoever (including data, materials, compilations, formulae, models, patent
disclosures, procedures, processes, projections, protocols, results of
experimentation and testing, specifications, strategies, techniques and all
non-public Intellectual Property as defined herein), and all tangible and
intangible embodiments thereof of any kind whatsoever (including materials,
samples, compositions, documents, drawings, patent applications, records and
reports), that are disclosed by the Disclosing Party to the other Party (the
"Receiving Party"), including any and all copies, replication or embodiments
thereof.

Notwithstanding the foregoing, Confidential Information of a Disclosing Party
shall not include information that the Receiving Party can establish by
competent proof to have (a) been publicly known prior to disclosure of such
information by the Disclosing Party to the Receiving Party, (b) become publicly
known, without fault on the part of the Receiving Party, subsequent to
disclosure of such information by the Disclosing Party to the Receiving Party,
(c) been received by the Receiving Party from a source rightfully having
possession of, and the right to disclose, such information free of an obligation
of confidentiality, (d) been otherwise rightfully known by the Receiving Party
prior to disclosure of such information by the Disclosing Party to the Receiving
Party, or (e) been independently developed by employees or agents of the
Receiving Party without the use of Confidential Information of the Disclosing
Party.

"Control" means the legal or regulatory right (whether by ownership, license or
otherwise) to grant access, right, title, a license or a sublicense to
Intellectual Property without violating the terms of any Third Party agreement,
court order, or other arrangement or legal obligation.

"Disclosing Party" has the meaning set forth in the definition of “Confidential
Information”.

"Drug Product" means a drug product, as defined in 21 C.F.R. § 314.3, for
administration to human subjects.

"Engineering Batch" means a Batch produced from an Engineering Run.

"Engineering Run" means a Run used for process developing or demonstrating
and/or engineering of some or all of the Manufacturing Process steps.

"Effective Date" has the meaning given to such term in the introductory
paragraph of this Agreement.

"FDA" means the United States Food and Drug Administration, and any successor
agency thereto.

"First Applicant" means a first applicant, as defined in 21 U.S.C. §
355(j)(5)(B)(iv)(II)(bb), as amended.

"Force Majeure Event" has the meaning set forth in Section 13.10.

"GAAP" means generally accepted accounting principles in effect in the United
States from time to time, consistently applied.

"Governmental Authority" means any court, tribunal, arbitrator, agency,
legislative body, commission, official or other instrumentality of (i) any
government of any country, or (ii) a federal, state, province, county, city or
other political subdivision thereof.

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"Gross Amount" means the gross amount invoiced for a Product or AG Product, sold
by Par, its Affiliate or a permitted sublicensee, as the case may be, in the
Territory.

"Indemnitee" has the meaning set forth in Section 9.3.

"Indemnitor" has the meaning set forth in Section 9.3.

"IntelGenx" has the meaning given to such term in the introductory paragraph of
this Agreement.

"lntelGenx Indemnitee" has the meaning set forth in Section 9.2.

"Intellectual Property" means all of the following: (i) patent applications,
continuation applications, continuation-in-part applications, divisional
applications, and United States patents corresponding to any of the foregoing
that may grant or may have been granted on any of the foregoing, including
reissues, re-examinations and extensions and any supplemental protection
certificates, or the like; (ii) all Know-How, work product, trade secrets,
inventions (whether patentable or otherwise), data, processes, techniques,
procedures, compositions, devices, methods, formulas, protocols and information,
whether patentable or not; (iii) copyrightable works, copyrights and
applications, registrations and renewals; (iv) logos, trademarks, service marks,
and all applications and registrations relating thereto; (v) other proprietary
rights; (vii) any regulatory exclusivities or the like; and (viii) copies and
tangible embodiments of any one or more of the foregoing.

"Know-How" means all of the following: manufacturing protocols and methods,
product specifications, analytical methods and assays, processes, product
designs, plans, trade secrets, ideas, concepts, manufacturing information,
engineering and other manuals and drawings, standard operating procedures, flow
diagrams, chemical data, pharmacological data, pharmacokinetic data,
toxicological data, pharmaceutical data, physical and analytical data, safety
data, quality assurance data, quality control and clinical data, technical
information, other data, and research records.

"Liabilities" has the meaning set forth in Section 9.1.

"Manufacturer" has the meaning set forth in Section 2.5.1.

"Manufacturing Process" means, with respect to a Product, the production process
for the manufacture of such Product, as such process may be changed from time to
time in accordance with this Agreement.

"Marketing Cost Allowance" means, with respect to a Product or AG Product, an
expense allowance used as an approximation (and not subject to adjustment) for
any and all of Par's costs and expenses in the marketing, promotion,
distribution, sale, shipping and transport (from Par to its customers, including
related insurance and freight expense) for such Product or AG Product, which
shall be equal to [***] of Net Sales.

"NDA" means a New Drug Application, as defined in 21 U.S.C. § 355(b) et seq.,
and the regulations promulgated thereunder.

"Net Profits" means Net Sales, less Par's Total Cost.

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"Net Sales" means the Gross Amount, less all discounts and deductions that are
customary in size and nature in the generic pharmaceutical products industry,
including:

(a)      sales credits for customer returns, returned goods allowances, billing
and shipping errors, rejected goods; cash or term discounts; customer rebate
programs; chargebacks and administration fees or similar credits or payments
granted to customers pursuant to contract or other purchases; sales promotions,
trade show discounts and stock allowances; price adjustments, including those on
customer inventories following price changes; and Product or AG Product recalls;

(b)      payments or rebates incurred pursuant to federal, state and local
government assistance programs, whether now in existence or hereafter enacted;

(c)      redistribution center (RDC) fees, information service agreement (ISA)
fees, other fees that are customary in the industry and related to the sales of
Product or AG Product to customers, and ANDA filing fees;

(d)      customs duties, and sales, use or excise taxes;

(e)      write-offs for unsold inventory or batches;

(f)      freight, insurance and other transportation charges to the extent added
to the sale price and set forth separately as such in the total amount invoiced;
and

(g)      any “failure-to-supply” and/or reprocurement penalties that Par may
incur from any customer purchasing Product or AG Product pursuant to a written
agreement between Par and such customer.

Par shall not sell any Product or AG Product as a loss leader, for any non-cash
element or as part of a bundle, basket or group sale with any other product(s)
not covered by this Agreement; provided, however, that the provision of a
discount by Par to a customer based on the aggregate volume of such customer's
purchases of such Product or AG Product and other products shall not, for
purposes of this definition of “Net Sales”, be considered a sale of such Product
or AG Product as a loss leader or as part of a bundle, basket or group sale so
long as such discount is (i) allocated on a proportionate basis to such Product
or AG Product and such other products, and (ii) consistent with Par's ordinary
course of business for its products other than such Product or AG Product. For
example, if a Product or AG Product and another product are sold under a volume
discount arrangement and have a combined volume discount of $200,000 on a total
undiscounted sales price of $1,000,000 and the units of such Product or AG
Product included in such volume discount arrangement have an undiscounted sales
price of $600,000 and the units of such other product have an undiscounted sales
price of $400,000, such discount shall not be considered a sale of such Product
or AG Product as a loss leader or as part of a bundle, basket or group sale so
long as no more than sixty percent (60%), or $120,000, of such discount is
allocated to such Product or AG Product.

"Orange Book" means the FDA publication Approved Drug Products with Therapeutic
Equivalence Evaluations, as may be amended from time to time.

"Par" has the meaning given to such term in the introductory paragraph of this
Agreement.

"Par Indemnitee" has the meaning set forth in Section 9.1.

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"Par's Total Cost" means, with respect to a Product or AG Product, the
Acquisition Cost for such Product or AG Product, plus the Marketing Cost
Allowance for such Product or AG Product, plus the estimated annual branded
prescription drug product fee that will be payable by Par pursuant to Section
9008 of the Patient Protection and Affordable Care Act of 2010, to the extent
attributable to the sale of a Product or AG Product.

"Party" means Par or IntelGenx, as applicable, and "Parties" means both Par and
IntelGenx.

"Patent Litigation" has the meaning set forth in Section 6.9.

"Person" means an individual, corporation, partnership, limited liability
company, firm, association, joint venture, estate, trust, governmental or
administrative body or agency, or any other entity.

"Pivotal Bioequivalence Study" means, with respect to a Product, the
Bioequivalence Study that is submitted to the FDA for the purpose of seeking
Regulatory Approval for such Product in the Territory.

"[***]"

“[***]”

"Proceedings" means governmental, judicial, administrative or adversarial
proceedings (public or private), litigation, suits, patent oppositions,
arbitration, disputes, claims, causes of action or investigations.

"Product" means a Drug Product set forth on Exhibit A hereto that is formulated
to be an A-rated Therapeutic Equivalent to the applicable Brand Product,
including all dosage strengths, and all packaging configurations thereof.

"Product ANDA" means, with respect to a Product, an ANDA filed by Par for such
Product pursuant to this Agreement to seek marketing approval by the FDA wherein
the same may be supplemented and/or amended as required.

"Product Claim" has the meaning set forth in Section 9.4.

"Receiving Party" has the meaning set forth in the definition of “Confidential
Information”.

"Regulatory Approval" means the applicable approval(s) necessary to market a
Drug Product and/or active pharmaceutical ingredient, including all applicable
product and/or establishment licenses, registrations, permits or other
authorizations as may be necessary for the commercial manufacture,
commercialization, use, storage, importation, transport, promotion, pricing,
distribution or sale thereof.

"Regulatory Authority(ies)" means the Governmental Authority(ies) in the
Territory with authority over the manufacture or distribution of a
pharmaceutical product in the Territory (including the grant of Regulatory
Approval by the FDA).

"Regulatory Litigation" has the meaning set forth in Section 6.9.

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"Representatives" has the meaning set forth in Section 7.1.

"Run" means a single complete operation of all, or a discrete portion, of the
Manufacturing Process at the Manufacturer.

"Specifications" means, with respect to a Product, the specifications for the
manufacture of such Product a set forth in the Product ANDA for such Product
submitted for Regulatory Approval.

"Stable" means a Drug Product that meets FDA requirements for stability for
purposes of an ANDA.

"Submission Batch" means, with respect to a Product, the Batch that is
manufactured in order to generate data, results and/or other information to be
submitted or intended to be submitted to the FDA for the purpose of seeking the
Regulatory Approval for such Product in the Territory.

"[***]"

"Term" has the meaning set forth in Section 11.1.

"Territory" means the United States of America, and its territories, districts
and possessions, including the Commonwealth of Puerto Rico; any installation,
territory, location or jurisdiction under the purview of the FDA or control of
the United States government; and any United States military bases and
installations worldwide.

"Therapeutic Equivalent" has the meaning given to it by the FDA in the current
edition of the Orange Book.

"Third Party" or "Third Parties" means any Person other than a Party or its
Affiliates.

ARTICLE 2.      DEVELOPMENT

2.1      IntelGenx Development Responsibilities. lntelGenx shall develop a final
finished Stable dosage form of each Product corresponding to each strength and
presentation of the applicable Brand Product and conforming to the
Specifications for such Product, and otherwise develop such Product to be Stable
and an A-rated Therapeutic Equivalent to the corresponding Brand Product, as
further provided herein. IntelGenx's development responsibilities shall include
completing the tasks set forth on Exhibit B hereto and making any changes that
are necessary to support obtaining Regulatory Approval for each Product.

2.2     Cooperation. In carrying out its development responsibilities, lntelGenx
shall cooperate and coordinate with Par, and Par shall have decision-making
control with respect to all Specifications and development activities necessary
to support the filing of any Product ANDA with the FDA.

2.3      API Supply. At the request of IntelGenx, accompanied by appropriate
justification thereof, Par shall provide, at Par's expense, (i) all reasonable
quantities of API required to develop the formulation and Manufacturing
Processes in respect of a Product; (ii) samples of the applicable Brand Product
in reasonable quantities required to develop analytical methods and conduct
stability and other testing; and (iii) any reference standards reasonably
obtainable by Par from the supplier of the API for purposes of analysis,
including in-process impurities and degradants, required to develop stability
indicating methods.

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2.4      Bioequivalence Studies.

2.4.1    Par may require IntelGenx to conduct a [***] for any Product by
providing written notice thereof to IntelGenx. IntelGenx shall be responsible,
at its expense, for completion of all [***] required to be conducted pursuant to
this Section 2.4.1. IntelGenx shall own any and all data, results, or other
information developed and/or generated during any [***] that are required to be
conducted pursuant to this Section 2.4.1. For purposes of this Agreement, a
[***] for a Product shall be deemed to be successful if the criteria set forth
on Exhibit E hereto has been satisfied.

2.4.2    IntelGenx shall conduct [***] for each Product. IntelGenx shall be
responsible, at its expense, for completion of all [***]. IntelGenx shall own
any and all data, results, or other information developed and/or generated
during any [***].

2.4.3    In the event that [***] for a Product is unsuccessful, as mutually
agreed upon by the Parties, IntelGenx shall, at its expense, conduct at least
one additional [***] for such Product. In the event that a dispute relating to
the success criteria and/or successful completion of a [***] arises between the
Parties, the Parties shall have the dispute settled by a mutually agreed upon
independent Third Party consultant with relevant experience in the
pharmaceutical industry (the "Clinical Expert"), and if the Clinical Expert
determines that such [***] was unsuccessful, IntelGenx shall, at its expense,
conduct at least one additional [***] for such Product.

2.4.4    In the event of successful completion of the [***] for a Product
required by Sections 2.4.2 and 2.4.3, as applicable, Par shall be responsible,
at its expense, for carrying out (or causing to be carried out by a Third Party
selected by Par) the Pivotal Bioequivalence Study for such Product. Par may, at
Par's sole discretion, elect to conduct one or more additional Pivotal
Bioequivalence Study for such Product. IntelGenx shall cooperate fully with Par
in connection therewith, and shall promptly provide Par, as requested and at no
additional charge, such technical and other assistance, including all available
information and data in its control, reasonably necessary or useful for Par to
conduct the Pivotal Bioequivalence Studies for such Product.

2.5      Manufacturer.

2.5.1    Par shall select one or more competent manufacturer(s) to manufacture
and supply each Product (the "Manufacturer"); and Par shall use Commercially
Reasonable Efforts to negotiate a manufacture and supply agreement with any
Third Party Manufacturer. Notwithstanding the foregoing, except as otherwise
expressly provided in this Agreement, IntelGenx shall, at all times, retain all
Intellectual Property rights related to the manufacture of the Product and
invented or conceived by IntelGenx

2.5.2    IntelGenx shall have the right to cause Par to modify a Product ANDA in
order to qualify IntelGenx as a manufacturer under such Product ANDA, provided
that (i) IntelGenx has obtained the requisite regulatory approvals to
manufacture and export the related Product on a commercial scale for sale in the
United States (including, without limitation, any approvals required by the FDA
and the U.S. Drug Enforcement Administration); (ii) Par has obtained
pre-approval from the U.S. Drug Enforcement Administration to import commercial
quantities of the related Product into the United States; and (iii) in Par’s
sole determination, the modification to such Product ANDA will not delay its
final approval by the FDA. Any incremental cost associated with a manufacturing
site change to IntelGenx manufacturing site shall be at IntelGenx sole cost and
expense.

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2.5.3    IntelGenx shall be responsible, at its expense, for the manufacture and
supply of the Engineering Batch for a Product and all other Batches for such
Product prior to the Submission Batches for such Product required by Par for and
in the course of such Product’s development.

2.5.4    Par shall be responsible, at its expense, for causing the manufacture
and supply of all Submission Batches for a Product.

2.6      Technology Transfer of the IntelGenx Formulation. Upon successful
completion of the [***] for a Product, and on an ongoing basis thereafter,
IntelGenx shall, at its own cost and expense, supply to the Manufacturer the
materials and documentation reasonably necessary to enable the Manufacturer to
develop and manufacture, on a commercial scale, a Stable, commercially saleable,
final dosage form of such Product. Such materials and documentation shall
include any and all information set forth on Exhibit C hereto and all Know-How
relating to such Product owned or controlled by IntelGenx, such as manufacturing
formulae, information, methods and processes, analytical and processing
techniques, product and API samples, stability data, or processing techniques,
and any other knowledge, documentation and information that may be reasonably
necessary or useful for the Manufacturer to complete commercial development of
such Product.

2.7      Technology Transfer Assistance.

2.7.1    At Par's request, IntelGenx shall make at least one (1) representative
available at the Manufacturer's facility during production of the exhibit and
Submission Batches for a Product and during the validation of the analytical
methods for such Product.

2.7.2    For each Product, lntelGenx shall also provide all other reasonable
assistance with respect to any development work that may be reasonably required
in order for Par to submit the Product ANDA for such Product for Regulatory
Approval and the commercial process validation for such Product, and for the
Manufacturer to commercially manufacture such Product. IntelGenx shall
reasonably make available IntelGenx personnel (or contractors) who are
knowledgeable regarding the existing manufacturing processes in order to provide
assistance to Par and/or the Manufacturer. IntelGenx's obligation under this
Section 2.7 shall continue until the Manufacturer successfully manufactures a
Submission Batch for such Product. IntelGenx will bear all of its own costs and
expenses required to perform its obligations under this Section 2.7.2.

2.8      Updates. IntelGenx shall keep Par informed of the progress of the
development of each Product, as practical and reasonable, including responding
in a prompt manner to Par's inquiries, and participating in periodically
scheduled telephone conferences regarding the status of the development work.
IntelGenx shall use its diligent efforts to complete timely requests from Par
relating to the development and manufacture of each Product. IntelGenx shall
provide updates to Par at Par's request on the development of each Product, and
shall promptly advise Par of any delays or problems encountered during
development of such Product or the Manufacturing Process for such Product.

2.9      IntelGenx Facilities. All development work, other than the [***]
Pivotal Bioequivalence Studies for a Product, shall be conducted by IntelGenx at
IntelGenx's facilities; provided, however, that all work relating to process
scale-up and Submission Batches for a Product shall be conducted, at Par's
direction based on IntelGenx's formulation and manufacturing guidelines, at the
Manufacturer's facilities. Par shall, during the course of such development
work, be permitted to inspect and audit such IntelGenx facilities once during
each calendar year (and additionally in the event of a reasonable need or
request by Par) during normal business hours upon reasonable advance notice of
at least five (5) business days. Following the Effective Date, IntelGenx shall
not subcontract any of its responsibilities under this Agreement without the
prior written approval of Par, which shall not be unreasonably withheld, delayed
or conditioned; provided, however, that IntelGenx may utilize another facility,
subject to such facility passing an audit by Par, in Par's sole discretion.
IntelGenx shall notify Par in writing promptly, but in no event later than one
(1) business day, after learning that any inspection, relating to the Product,
by the FDA or other applicable Governmental Authority is being conducted or will
be conducted. IntelGenx shall provide Par with copies of any Form FDA 483 or
other correspondence from the FDA or other applicable Governmental Authority
regarding the compliance with Applicable Laws, including cGMP and ICH
Guidelines, within one (1) business day of receipt by IntelGenx of such
correspondence.

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ARTICLE 3.      REGULATORY MATTERS

3.1      Ownership. Par shall exclusively own and control all Regulatory
Approvals within the Territory (including all associated contents and
correspondence) and applications therefor related to any Product, including the
Product ANDA(s) and any other marketing authorizations within the Territory.

3.1.1    In the event that Par intends to divest or sell any Product ANDA (other
than in connection with a merger or acquisition or sale of all or substantially
all of the assets of Par), Par shall provide written notice thereof to
IntelGenx; and IntelGenx shall provide written notice to Par, within five (5)
business days after delivery of such notice by Par, indicating whether it
desires to have its rights under this Agreement included in such divestiture or
sale.

(a) In the event that IntelGenx provides affirmative notice to Par in accordance
with Section 3.1.1, Par shall use Commercially Reasonable Efforts to procure an
offer to purchase all of the rights, title and interest in, to and under such
Product ANDA; and if Par procures such an offer, Par shall provide written
notice thereof, including the material economic terms with respect thereto.
IntelGenx shall provide written notice to Par, within five (5) business days
after delivery of such notice by Par, indicating whether, based on such terms,
it desires to participate in such divestiture or sale.

(b) In the event that IntelGenx provides affirmative notice to Par in accordance
with Section 3.1.1(a), Par shall use Commercially Reasonable Efforts to
negotiate a definitive agreement based on such terms.

3.1.2    In the event that (i) lntelGenx does not provide affirmative notice
described in Section 3.1.1 or 3.1.1(a) to Par, or (ii) IntelGenx provides such
notice but, despite Par's use of such Commercially Reasonable Efforts, Par is
unable to negotiate a definitive agreement with respect to such terms, Par shall
be entitled to sell such Product ANDA, subject to the rights set forth herein,
including those set forth in Section 5.5.1.

3.2      Regulatory Approvals and Applications. Par shall author and assemble
all aspects of the Product ANDA(s). IntelGenx shall fully support Par's efforts
to assemble the Product ANDA(s) by providing such assistance as Par requests,
including providing any necessary documents to Par in common technical document
(CTD) format, as recognized by the FDA.

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3.2.1    Par shall have the sole right and responsibility to communicate with
the FDA and all other applicable Regulatory Authorities relating to the approval
of any Product or submission for Regulatory Approval, and lntelGenx shall not
submit material to the FDA or any Regulatory Authority related to such Product
without Par's prior written approval.

3.2.2    Notwithstanding anything else in this Agreement to the contrary, Par
shall have sole control of and responsibility (including expenses) for preparing
any patent certifications and related notice letters in connection with any
Product ANDA and the prosecution and/or defense of any citizen's petition
associated with such Product ANDA, in each case as may be applicable in any
jurisdiction in the Territory.

3.2.3    IntelGenx shall fully cooperate with Par in pursuing Regulatory
Approval for each Product in the Territory, and shall promptly provide Par, as
requested and at no additional charge, such technical and other assistance,
including all available information and data in its control, reasonably
necessary or useful for Par to apply for, obtain, and maintain Regulatory
Approvals to manufacture, import, export, sell or otherwise commercialize such
Product throughout the Territory.

3.2.4    IntelGenx shall, at Par's direction, assist Par in (i) communications
with or to applicable Regulatory Authorities, (ii) all activities relating to
Regulatory Approvals for each Product, and (iii) responding to any Regulatory
Authority request relating to such Product, API for such Product, or facilities
used in, or proposed for use in, the development or manufacture of such Product
or API for such Product.

3.2.5    IntelGenx shall provide Par with written notice in the event IntelGenx
intends to commercialize any product comprising the same active pharmaceutical
ingredients, dosage form and strength(s) as any Product outside of the
Territory. Upon receipt of such notice, Par shall, subject to the negotiation
and execution of a written agreement by Par and lntelGenx in respect thereof,
grant IntelGenx an exclusive, royalty-bearing license to use and have access to
any information or Intellectual Property disclosed within the Product ANDA for
such Product, including the results of the Pivotal Bioequivalence Studies for
such Product, for the sole purpose of commercializing such Product outside the
Territory.

ARTICLE 4.      COMMERCIALIZATION AND MANUFACTURE

4.1      Product Commercialization. Par shall, in its sole discretion, determine
the timing of the Commercial Launch of each Product taking into consideration
the expected timing of the Regulatory Approval of such Product, availability of
supply of such Product, and intellectual property and regulatory risks
associated with such launch. Upon the Commercial Launch of a Product, Par will
promote, market and sell such Product, from Par's Spring Valley facility or such
other Par or Third Party facility as Par may elect in its sole discretion, under
Par's label in a manner consistent with Par's normal practices with respect to
its other generic products.

4.2      Manufacture. The Manufacturer shall be responsible for the manufacture,
labeling and packaging of all commercial supplies of a Product. Par shall test
and release, or cause to be tested and released by a Third Party testing
facility selected by Par, each Product manufactured pursuant to this Agreement
for determining compliance in accordance with cGMP and all Applicable Laws.

4.3      API. Par shall be solely responsible, at its sole cost and expense, for
procuring a commercially acceptable source of API supply for development and
commercialization performed under this Agreement (and IntelGenx shall confirm
that such source is technically acceptable). IntelGenx shall cooperate with
Par's procurement of API under this Agreement.

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ARTICLE 5.      FINANCIAL PROVISIONS

5.1      Development Fee. Par shall pay to IntelGenx the following
non-refundable development fees, if and as applicable:

5.1.1    [***] upon the execution of this Agreement by IntelGenx and Par;

5.1.2    [***] in respect of a Product upon the first successful (as determined
under Section 2.4.1) completion of a [***] for such Product required by Par
pursuant to Section 2.4.1;

5.1.3    [***] in respect of a Product upon the first successful completion of a
[***] for such Product;

5.1.4    [***] in respect of a Product upon successful completion of the Pivotal
Bioequivalence Study for such Product; and

5.1.5    [***] in respect of a Product upon acceptance for filing of the Product
ANDA for such Product for all strengths and presentations of the applicable
Brand Product listed in the Orange Book as of the date on which such Product
ANDA was filed.

5.2      Conditional Incentive Fee. If, and only if, Par is (a) the sole First
Applicant with respect to a Product and (b) eligible at the time of final FDA
approval of the Product ANDA for such Product for the 180-day marketing
exclusivity under 21 U.S.C. § 355(J)(5)(B)(iv)(II)(aa), then Par shall pay to
IntelGenx a one-time, conditional and non-refundable incentive fee of [***] in
respect of such Product upon obtaining final FDA approval of such Product ANDA
or the first commercial sale in the Territory of an AG Product related to such
Product by Par, its Affiliate or a permitted sublicensee, as the case may be, to
a Third Party.

5.3      Payment. Upon the occurrence of the applicable events under Sections
5.1 and 5.2, Par shall (i) promptly provide written notice thereof to IntelGenx
and, (ii) within fourteen (14) days following the receipt of an invoice therefor
provided by IntelGenx, remit the fee payments payable to IntelGenx under
Sections 5.1 and/or 5.2 (as applicable) by wire transfer of immediately
available funds to a bank account designated in writing by IntelGenx.

5.4      Expenses. Each party shall bear all costs and expenses associated with
its responsibilities under this Agreement, except as expressly set forth in this
Agreement.

5.5      Royalties.

5.5.1    Royalty Rates. Par shall pay to IntelGenx a royalty equal to [***] of
the Net Profits of each Product and AG Product during the Term.

5.5.2    Payment of Royalties. Following Commercial Launch of a Product or
commercial launch of an AG Product, within thirty (30) days of the end of each
Calendar Quarter during the Term, Par shall, for such Product or AG Product sold
by Par during such Calendar Quarter, (i) compute in accordance with GAAP, the
Net Sales and Net Profit and (ii) pay IntelGenx's share of the Net Profit
payable pursuant to Section 5.5.1. Each payment shall be accompanied by a
written report (in the format attached as Exhibit D hereto) outlining the
details surrounding the calculation of Net Profits.

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5.5.3    Records and Audits. Par and its Affiliates shall keep and maintain or
cause to be maintained books and records pertaining to the calculation of Net
Profits during the Term and for three (3) years thereafter. Such books and
records shall be maintained in accordance with GAAP and with all records and
details necessary to enable IntelGenx to verify the foregoing. All factors
included in the determination of the Net Profits shall be specific to each
Product and/or AG Product, reasonably documented, and available for independent
audit purposes. IntelGenx shall have the right once per calendar year, at its
own expense, during the Term and for three (3) years thereafter, to have an
independent public accountant, reasonably acceptable to Par, audit the relevant
financial books and records of account of Par for up to the preceding three (3)
years during normal business hours, upon reasonable advance notice, to determine
or verify the applicable Net Profits. If errors are found, any deficiency shall
be paid promptly following delivery of written documentation reasonably
substantiating such deficiency, subject to Par having a reasonable period to
verify the accuracy of such figures, and if errors are discovered as a result of
such audit in IntelGenx's favor exceeding the greater of five percent (5%) and
Ten Thousand Dollars ($10,000) for the period audited (which shall be no less
than one (1) year), Par shall reimburse lntelGenx for the reasonable expense of
such audit.

5.5.4    Accounting. The Parties acknowledge that any expenses or costs deducted
in determining Net Sales and Net Profits under this Agreement may be based upon
accruals, which accruals will be compliant with GAAP; provided, however, that
when the actual results become known relative to any accrued amount, any
difference between the actual results and the accrual shall be accounted for in
the subsequent payments due hereunder (subject to customary processing delays).
To the extent that the difference between such accruals and the actual results
has led to an underpayment, Par shall pay IntelGenx the amount of such
underpayment on the next date payment is due to IntelGenx hereunder. To the
extent that the difference between such accruals and the actual results has led
to an overpayment to IntelGenx, Par may at its option set-off such overpayments
against subsequent payments to be made to IntelGenx or issue an invoice for the
overpayment, which shall be paid by lntelGenx within forty-five (45) days after
IntelGenx's receipt thereof. By the date that is forty-five (45) days after the
end of the sixth month following the expiration of the last lot of a Product
and/or AG Product for which a sale was made pursuant to this Agreement, Par
shall reconcile (and give to IntelGenx a report of such reconciliation) all
accrued calculations and deductions used in the calculations of Net Sales of
such Product or AG Product with actual processed credits. If the report shows an
underpayment to IntelGenx, Par shall pay IntelGenx the amount of the
underpayment at the time it gives the report to IntelGenx. If the report shows
an overpayment to IntelGenx, IntelGenx shall pay Par the amount of the
overpayment within thirty (30) days of the receipt of such reconciliation.

ARTICLE 6.      EXCLUSIVITY AND INTELLECTUAL PROPERTY

6.1      Exclusivity. During the Term, neither Party, by itself, its Affiliate
or through any Third Party, shall develop, seek regulatory approval for,
manufacture, import, market, sell, distribute, or otherwise commercialize in the
Territory any Drug Product that is a Therapeutic Equivalent to any Brand Product
or otherwise work on the development of, or supply of any Product, any AG
Product, or any Drug Product that is a Therapeutic Equivalent to any Brand
Product, except for the development and commercialization of any Product or
commercialization of any AG Product pursuant to this Agreement.

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6.2      Right of First Negotiation. In the event lntelGenx successfully
completes a [***] is a Therapeutic Equivalent to a branded pharmaceutical
product (the "[***]"), IntelGenx shall promptly provide Par with written notice
thereof. Par shall have the exclusive right, for a period of forty-five (45)
days after receipt of such notice, to negotiate with IntelGenx to agree upon and
execute a definitive agreement for Par to become the co-marketer, co-distributor
or exclusive marketer and/or distributor in the Territory, as the case may be,
for the [***]. The Parties shall each negotiate in good faith with each other
during such period. If, prior to the end of such forty-five (45) day period (or
such longer period as may be mutually agreed upon by the Parties), a definitive
agreement in respect thereof has not been executed by the Parties, IntelGenx
shall thereafter owe no further obligation to Par with respect to the
commercialization of the [***], and may negotiate and execute a definitive
agreement with a Third Party in respect of the development and/or
commercialization of the [***], but only if the terms and conditions of such
agreement, taken as a whole, are not materially more favorable to such Third
Party than the terms and conditions set forth in the last best written offer
provided to Par by lntelGenx.

6.3      General Ownership. Except as expressly provided in this Agreement, each
Party shall own its own Intellectual Property consistent with United States or
other applicable international patent, trademark, and copyright law.

6.4      Product Intellectual Property.

6.4.1    lntelGenx shall have the exclusive right to enforce Intellectual
Property that is Controlled by IntelGenx covering each Product against Third
Parties that may (or may attempt to) make, have made, use, have used, sell, have
sold, import or have imported, or otherwise market or commercialize any Drug
Product containing the API of such Product and having the same dosage form as
such Product, including the tight to collect damages. Par shall, at IntelGenx's
cost and expense, cooperate with IntelGenx in good faith in connection with the
foregoing, as IntelGenx may reasonably request. In the event that IntelGenx
elects not to enforce such Intellectual Property, Par shall have the right, but
not the obligation, to enforce such Intellectual Property as set forth in this
Section 6.4.1, and IntelGenx shall cooperate with Par in connection therewith.

6.4.2    Intellectual Property that is jointly invented or conceived during the
Term under this Agreement shall be jointly owned by the Parties, unless
otherwise agreed in writing. Employees of lntelGenx, whether serving as advisors
or consultants to Par or serving Par in any other capacity, shall be considered
employees of IntelGenx for the purpose of determining ownership of Intellectual
Property.

6.4.3    For the avoidance of doubt, Intellectual Property covering inventions
or improvements that are created or conceived in the course of developing a
Product shall be owned solely by a Party if only its employees create or
conceive such invention or improvement.

6.5      License Grant.

6.5.1    IntelGenx hereby grants to Par a limited, exclusive (even as to
IntelGenx), irrevocable, perpetual, royalty-free license under the Intellectual
Property that is Controlled by IntelGenx or its Affiliates to manufacture, have
manufactured, use, sell, have sold and import and/or otherwise for the sole
purpose of the commercialization of each Product and/or AG Product in the
Territory (including all components thereof).

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6.5.2    The license granted to Par under Section 6.5.1 is sublicensable (and
further sublicensable), in whole or in part, to Third Parties in arm's-length
transactions, subject to the following terms: (i) Par shall provide IntelGenx
with written notice of any intended sublicense, including the name of the
intended sublicensee and the material terms thereof; and (ii) IntelGenx shall,
within ten (10 business days (or such shorter period as is reasonably specified
by Par to address the exigencies of negotiation of an agreement with such
sublicensee) after delivery of Par's written notice to IntelGenx, provide
written notice to Par indicating whether it approves the sublicense proposed by
Par, such approval not to be unreasonably withheld, delayed or conditioned, it
being acknowledged and agreed by IntelGenx that it shall consider in good faith
the need to sublicense a substitute Third Party manufacturer in the event of any
supply disruption involving the Manufacturer. The failure of lntelGenx to
deliver such written notice to Par within such ten (10) business day period
shall be deemed to be an approval of such proposed sublicense. Any sublicense
approved or deemed approved under this Section 6.5.2 shall be consistent with
the terms of this Agreement, including an obligation for such sublicensee to
comply with obligations similar to those set forth in this Agreement.

6.6      Reserved Rights. Subject to Sections 6.1 and 6.5 hereof, Par
acknowledges and agrees that IntelGenx may, now or in the future and without
obligation to Par, develop, use or employ Intellectual Property that is
Controlled by IntelGenx for other products, including formulation and process,
various analytical methods, stability protocols and other methods, techniques or
information similar to those used in connection with the Product hereunder
(excluding Par's Confidential Information) to pursue other business and product
development activities that are part of lntelGenx' business without obligation
to Par.

6.7      Authorized Generic Product. Par shall be permitted, without requiring
license or approval from IntelGenx, to enter into an agreement with the owner of
any Brand Product under which Par may sell an AG Product (an "AG Agreement"),
and Par may thereafter acquire, use, sell and otherwise market such AG Product
pursuant to such AG Agreement in the Territory. Par shall be allowed to sell
such AG Product in place of, or in addition to, the Product to which such AG
Product relates; provided, however, that in the event that Par enters into an AG
Agreement, Par shall continue to be bound by its royalty obligations to
IntelGenx under Section 5.5.1 during the Term, and will pay the applicable
percentage of Net Profits as set forth in Section 5.5 on the sales of both AG
Product and Product. For purposes of clarification, if Par enters into an AG
Agreement related to a Product, Par shall remain obligated to pay any unpaid
development fees in respect of such Product that were earned by IntelGenx in
accordance with Section 5.1 prior to Par’s entry into such AG Agreement.

6.8      Notification. The Parties shall promptly notify each other of any
allegation that any activity undertaken pursuant to this Agreement that
infringes or may infringe the Intellectual Property rights of any Third Party.
Each Party shall assist and cooperate with the other Party in the defense of any
suit, action, Proceeding or claim relating to a Product (including consenting to
being named as a nominal party thereto).

6.9      Patent and Regulatory Litigation.

6.9.1    Par's legal counsel shall be responsible for managing any litigation
brought by the Parties or by a Third Party seeking a judicial determination of
whether the submission of Par's ANDA or the importation, manufacture, use, sale
or marketing of a Product infringes the patent rights of such Third Party
("Patent Litigation"). Par's legal counsel shall also be responsible for
managing the Parties' participation in any Proceedings and litigation related to
citizen's petitions filed with the FDA regarding a Product or any claims based
on or related to the Parties' or a Third Party's attempt to secure, challenge or
appeal an FDA decision concerning such Product or competitive products
(collectively, "Regulatory Litigation"). Par shall control and manage Patent
Litigation and Regulatory Litigation and any other matters relating to
Intellectual Property rights of a Third Party in its discretion, using counsel
of its choice. In connection with such Patent Litigation, Regulatory Litigation
or such other matters, each Party shall cooperate with each other at its own
expense.

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6.9.2    In connection with any Patent Litigation and/or Regulatory Litigation,
Par's legal counsel shall keep IntelGenx's legal counsel (retained at
IntelGenx's option and expense) reasonably informed with respect to material
events in the progress and settlement of such Proceedings and litigation.
IntelGenx's counsel may provide input relating to the management of Patent
Litigation and Regulatory Litigation, and Par shall consider the suggestions of
lntelGenx' counsel in good faith and take such suggestions into account to the
extent that, in the judgment of Par's in-house counsel, such suggestions do not
adversely affect Par's position in any Intellectual Property and Regulatory
Litigation.

6.9.3    IntelGenx's legal counsel shall be permitted to monitor the progress of
the Intellectual Property and Regulatory Litigation, and Par shall keep
IntelGenx informed of any intended settlement. IntelGenx shall fully cooperate
with Par in connection therewith.

6.9.4    In the event of any patent litigation brought by a Third Party solely
against IntelGenx for inducement to infringe or contributory infringement as a
result of the obligations set forth in this Agreement, IntelGenx shall have the
right to defend such litigation using legal counsel selected by Par, in its sole
discretion ("Appointed Legal Counsel"), and at Par's cost and expense.

(a)      In the event of such litigation and selection by Par, each Party shall
cooperate with each other in connection therewith, including entering into
appropriate joint defense and/or joint privilege agreements. In the event that
Par makes a determination to join a party to such litigation, IntelGenx shall,
at Par's written request, move to implead Par as a party thereto.

(b)      In connection therewith, IntelGenx shall ensure that the Appointed
Legal Counsel shall keep Par informed with respect to the defense of such
litigation (including access to all material documentation with regard thereto)
and shall disclose to Par all material correspondence with the courts and
adverse parties. If lntelGenx wishes to be represented with respect to such
litigation by counsel of its own choosing (which counsel shall act in an
advisory role only and shall not participate in the defense of such litigation),
such representation shall be at IntelGenx's sole cost and expense.

(c)      Par shall, subject to Applicable Laws, make available its employees and
relevant records in its possession or control, as applicable and to the extent
reasonably necessary to assist in the defense of such litigation.

6.10     Settlement and Assertion of Rights. Par shall be entitled to settle or
compromise any claim with respect to Patent Litigation or Regulatory Litigation,
and to enter into any agreement in respect thereof, without the prior written
consent of IntelGenx. IntelGenx shall not enter into any settlement agreement,
other agreement, consent judgment or other voluntary final disposition of any
Proceeding, threatened Proceeding, litigation or threatening litigation relating
to a Product without the prior written consent of Par. Both Parties shall have
the right to assert all Intellectual Property rights related to a Product
against Third Parties, subject to mutual consultation. Notwithstanding the
foregoing or any text to the contrary contained herein, with respect to matters
relating to Intellectual Property rights of any Third Party other than Patent
Litigation or Regulatory Litigation, neither Party shall, without the consent of
the other Party, enter into any settlement or compromise or consent to any
judgment in respect of any claim and/or proceeding related to rights licensed to
Par under this Agreement, unless such settlement, compromise or consent includes
an unconditional release of the other Party from all liability arising out of
the claim, if any, and does not otherwise limit or impair the other Party's
rights.

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ARTICLE 7.      CONFIDENTIALITY AND PUBLIC DISCLOSURE

7.1      Treatment of Confidential Information. A Receiving Party shall retain
in strict confidence, and not disclose, divulge or otherwise communicate to any
other Person, any Confidential Information of the Disclosing Party, whether
received prior to or after the Effective Date, and shall not use any such
Confidential Information for any purpose, except pursuant to the terms of, and
as required to carry out such Receiving Party's obligations, under this
Agreement, except that each Receiving Party may disclose Confidential
Information of the Disclosing 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, (b) will use the Confidential information only for such
limited purposes, and (c) are bound by confidentiality obligations no less
protective than those set forth in this Agreement.

7.1.1    A Receiving Party hereby shall 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
prevent and restrain the unauthorized disclosure of such Confidential
Information by any of its Representatives, but no less than a reasonable
standard of care. The Receiving Party shall be jointly and severally liable for
any breach by any of its Representatives of the restrictions set forth in this
Agreement.

7.1.2    Without limiting the generality of any of the foregoing, the Parties
shall not make any disclosure of Confidential Information that would be
reasonably likely to preclude the Disclosing Party from obtaining U.S. or
foreign patents on any patentable invention or discovery described or otherwise
embodied in such Party's Confidential Information.

7.1.3    The Confidential Information of each Party includes information from
Third Parties subject to confidentiality restrictions and disclosed by one Party
to the other Party.

7.2      Release from Restrictions.

7.2.1    A Receiving Party may disclose Confidential Information to the extent
that such Confidential Information disclosure is made in response to a valid
order or subpoena of a court of competent jurisdiction or other Governmental
Authority of a country or any political subdivision thereof of competent
jurisdiction or otherwise required by law, in the opinion of counsel to the
Receiving Party; provided, however, that, to the extent practicable, the
Receiving Party shall first provide written notice to the Disclosing Party
reasonably in advance under the circumstances in order to give the Disclosing
Party a reasonable opportunity to quash such order or subpoena or to obtain a
protective order requiring that the Confidential Information or documents that
are the subject of such order be held in confidence by such court or
Governmental Authority or, if disclosed, be used only for the purposes for which
the order or subpoena was issued; and provided further that whether a disclosure
order or subpoena is quashed or a protective order is obtained, the Confidential
Information disclosed in response to such court or Governmental Authority order
or subpoena shall be limited to that information that, in the opinion of counsel
to the Receiving Party, is legally required to be disclosed in such response to
such court or governmental order or subpoena. Par may also disclose Confidential
Information to the extent that such disclosure is made to (i) a Governmental
Authority as required in connection with any filing, application or request for
Regulatory Approval with respect to a Product or under the reporting
requirements of any securities exchange on which the securities of Par or its
Affiliates are traded or (ii) a Third Party to which Par has a contractual
obligation related to a Product, but only to the extent such information is
required by such contractual obligation, provided that in each case (clauses (i)
and (ii)) reasonable measures are taken to assure confidential treatment of such
information.

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7.2.2    A Receiving Party may disclose this Agreement to a Third Party in
connection with or in conjunction with a proposed merger, consolidation, sale of
assets that includes those related to this Agreement, a permitted assignment of
this Agreement or loan financing, raising of capital, or sale of securities,
provided that the disclosing Party obtains an agreement for confidential
treatment thereof on terms no less protective than those contained herein.

7.3      No Implied Rights. Except as otherwise expressly set forth in this
Agreement, nothing herein shall be construed as granting any Receiving Party any
right, title, interest in or ownership of the Confidential Information,
proprietary information or Intellectual Property of the Disclosing Party. For
the avoidance of doubt, 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.

7.4      Survival of Confidentiality Obligations. The confidentiality
obligations of the Parties contained in this Article 7 shall remain binding on
both Parties during the Term and for a period of five (5) years after the
expiration of the Term or the termination of this Agreement, regardless of the
cause of such expiration or termination.

7.5      Use of Name and Disclosure of Term. No press release, public
announcement, confirmation or other communication to the public or Third Parties
regarding the existence or terms of this Agreement or related matters shall be
made by either Party without the prior written consent of the other Party,
including with respect to the form, content and timing of such press release,
public announcement, confirmation or other communication to the public or Third
Parties. Notwithstanding the foregoing or any text to the contrary contained
herein, those communications required by applicable law, regulation or
securities exchange rule (including, but not limited to, a public offering
prospectus), disclosures of information for which consent has previously been
obtained, and information of a similar nature to that which has been previously
disclosed publicly with respect to this Agreement, will not require advance
approval, but will be provided to the other Party as soon as practicable after
the release or communication thereof.

7.6      Third Party Information.

7.6.1    IntelGenx shall not (i) violate or misappropriate the trade secrets,
know- how, or confidential information, or knowingly violate or misappropriate
any other proprietary rights, of any Third Party in developing a Product, and
will not communicate any Third Party trade secrets to Par in connection with its
rights and obligations under this Agreement without receiving permission from
such Third Party and informing Par of communication of such trade secrets or
(ii) provide or disclose any documents or information to Par unless IntelGenx is
the owner thereof, or otherwise has the full and legal right to do so.

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7.6.2    Par shall not (i) violate or misappropriate the trade secrets,
know-how, or confidential information, or knowingly violate or misappropriate
any other proprietary rights, of any Third Party in connection with its rights
and obligations under this Agreement, and will not communicate any Third Party
trade secrets to IntelGenx in connection with its rights and obligations under
this Agreement without receiving permission from such Third Party and informing
IntelGenx of communication of such trade secrets or (ii) provide or disclose any
documents or information to IntelGenx unless Par is the owner thereof, or
otherwise has the full and legal right to do so.

7.7      Remedies. Each Party acknowledges and agrees that: (i) it will be too
speculative to measure the damages that would be suffered by the other Party if
such Party fails to comply with the obligations set forth in this Article 7 and
that, in the event of any such failure, the other Party will be irreparably
harmed and will not have an adequate remedy at law; (ii) the other Party shall,
therefore, be entitled, in addition to any other rights and remedies, to obtain
specific performance of such Party's obligations and to obtain immediate
injunctive relief without having to post a bond; and (iii) such Party shall not
assert, as a defense to any proceeding for such specific performance or
injunctive relief, that the other Party will not be irreparably harmed or that
the other Party has an adequate remedy at law.

ARTICLE 8.      REPRESENTATIONS AND WARRANTIES

8.1      By Par. Par hereby represents, warrants and covenants that:

(a)      Par is a company duly organized, validly existing and in good standing
under the laws of the jurisdiction of its formation;

(b)      Par has the power and authority to enter into and be bound by the terms
and conditions of this Agreement and to perform its obligations hereunder and to
execute this Agreement;

(c)      Par has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and this Agreement has been duly
executed and delivered on behalf of Par and constitutes a legal, valid, binding
obligation, enforceable against Par in accordance with its terms;

(d)      Par is subject to no legal, contractual or other restrictions,
limitations or conditions which conflict with its rights and obligations under
this Agreement or which might affect adversely its ability to perform hereunder;

(e)      Par will comply with all Applicable Laws applicable to its activities
under this Agreement;

(f)      Par has and will maintain appropriate skilled personnel and facilities
to carry out its obligations under this Agreement; and

(g)      No Par employees or other Persons performing services on behalf of Par
under this Agreement have been debarred, or the subject of debarment
Proceedings, under Section 306 of the FD&C Act; and if Par becomes aware that a
Person performing on its behalf under this Agreement has been debarred, or has
become the subject of debarment Proceedings, under Section 306 of the FD&C Act,
Par shall promptly notify IntelGenx and shall prohibit such Person from
performing on its behalf under this Agreement.

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8.2      By IntelGenx. IntelGenx hereby represents and warrants that:

(a)      IntelGenx is a company duly organized, validly existing and in good
standing under the laws of the jurisdiction of its formation;

(b)      IntelGenx has the power and authority to enter into and be bound by the
terms and conditions of this Agreement and to perform its obligations hereunder;

(c)      IntelGenx has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and this Agreement has been duly
executed and delivered on behalf of IntelGenx and constitutes a legal, valid,
binding obligation, enforceable against IntelGenx in accordance with its terms;

(d)      IntelGenx is subject to no legal, contractual or other restrictions,
limitations or conditions which conflict with its rights and obligations under
this Agreement or which might affect adversely its ability to perform hereunder;

(e)      IntelGenx has not misappropriated and will not misappropriate trade
secrets of any Third Party in developing the Product, in the provision of
services and the performance of its obligations under this Agreement or
otherwise in connection with the Products;

(f)      IntelGenx will comply with all Applicable Laws applicable to its
activities under this Agreement;

(g)      IntelGenx has and will maintain appropriate skilled personnel and
facilities to carry out its obligations under this Agreement; and

(h)      No IntelGenx employees or other Persons performing services on behalf
of lntelGenx under this Agreement have been debarred, or the subject of
debarment Proceedings, under Section 306 of the FD&C Act; and if IntelGenx
becomes aware that a Person performing on its behalf under this Agreement has
been debarred, or has become the subject of debarment Proceedings, under Section
306 of the FD&C Act, IntelGenx shall promptly notify Par and shall prohibit such
Person from performing on its behalf under this Agreement.

ARTICLE 9.      INDEMNIFICATION

9.1      Indemnification by IntelGenx. Subject to Section 9.3, IntelGenx shall
defend, indemnify and hold harmless each of Par and its Affiliates, and each of
their respective directors, officers and employees (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, "Liabilities") arising, directly or
indirectly, out of or in connection with Third Party claims, suits, actions,
demands or judgments to the extent relating to or arising out of (i) any breach
or alleged breach by IntelGenx of any representation, warranty, undertaking or
covenant under this Agreement or (ii) any alleged negligence, gross negligence
or willful misconduct by IntelGenx or its Affiliates, past or present employees
or agents; except, in each case, for those Liabilities for which Par has an
obligation to indemnify the IntelGenx Indemnitees pursuant to Section 9.2, as to
which Liabilities each Party shall indemnify the other Party to the extent of
its respective liability for such Liabilities.

21

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9.2      Indemnification by Par. Subject to Section 9.3 and 11.4.4, Par shall
defend, indemnify and hold harmless each of IntelGenx and its Affiliates, and
each of their respective directors, officers and employees (each, an "lntelGenx
Indemnitee") from and against any and all Liabilities arising, directly or
indirectly, out of or in connection with Third Party claims, suits, actions,
demands or judgments to the extent relating to or arising out of (i) any breach
or alleged breach by Par of any representation, warranty, undertaking or
covenant under this Agreement, (ii) any alleged negligence, gross negligence or
willful misconduct by Par or its Affiliates, past or present employees or
agents, and (iii) Patent Litigation or Regulatory Litigation; except, in each
case, for those Liabilities for which IntelGenx has an obligation to indemnify
the Par Indemnitees pursuant to Section 9.1, as to which Liabilities each Party
shall indemnify the other Party to the extent of its respective liability for
such Liabilities.

9.3      Notice and Procedures. If an IntelGenx Indemnitee or a Par Indemnitee
(the "Indemnitee") intends to claim indemnification under this Article 9, it
shall promptly notify the other Party (the "Indemnitor") in writing of any such
alleged Liabilities. In the event that the Indemnitor does not assume and pursue
in a timely and diligent manner the defense of any Third Party claim (but in no
event later than thirty (30) days, or such shorter period as required under
Applicable Laws), then the Indemnitor shall be deemed to have ceded control of
such claim and the Indemnitee shall be entitled to appoint counsel of its own
choice for such defense, at the cost and expense of the Indemnitor. The
Indemnitor shall have the right to control the defense thereof with counsel of
its choice, provided 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 Liabilities covered by this
Article 9. The obligations of this Section 9.3 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 (unless the
Indemnitor is deemed to have ceded control of the applicable Third Party claim
under this Section 9.3) . The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any such action,
if prejudicial to its ability to defend such action, shall relieve the
Indemnitor of any obligation to the Indemnitee under this Article 9 to the
extent that the Indemnitor is materially prejudiced by such delay. It is
understood that only IntelGenx or Par may claim indemnity under this Article 9
(on its own behalf or on behalf of its Indemnitees), and other Persons may not
directly claim indemnity hereunder.

9.4      Other Product Liability Claims. To the extent either Party incurs any
Liabilities arising from or in connection with any product liability claim with
respect to a Product to the extent arising from the actions not subject to the
indemnity obligations set forth in Sections 9.1 or 9.2 (a "Product Claim"), each
Party shall be liable for such portion of the Liabilities in accordance with
such Party's allocation of the Net Profits pursuant to Section 5.5.1; provided,
however, that such Liabilities shall be shared initially by offsetting against
the portion of Net Profits otherwise payable or retained pursuant to Section
5.5.1 and in the event of any shortfall thereafter, each Party's share thereof
shall be paid in accordance with such allocation. Par shall have sole control in
addressing, defending, managing and conducting any negotiations, litigation,
threatened litigation or settlement regarding such Product Claim, using counsel
of its choice. In the event that Par does not respond to any Product Claim
against IntelGenx within (a) sixty (60) days following the notice of such claim
or (b) ten (10) days before the time limit, if any, set forth in the appropriate
laws and regulations for the filing of a response to such Product Claim,
whichever comes first, IntelGenx shall have the right to control any such
Product Claim, using counsel of its own choice. In the event of a Product Claim,
IntelGenx shall cooperate fully with Par, including, if a party in such Product
Claim, the furnishing of a power of attorney to defend IntelGenx in such
litigation in IntelGenx name and/or being named as a party for the purposes of
any cross claim or counterclaim, and Par shall keep IntelGenx and/or IntelGenx
designated legal counsel reasonably informed as to the progress of such action.
Neither Party shall enter into any settlement of a Product Claim, without the
prior written consent of the other, such consent not to be unreasonably
withheld, delayed or conditioned.

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9.5      Exclusive Remedy. The rights of the Par Indemnitees and the IntelGenx
Indemnitees under this Article 9 shall be the sole and exclusive remedy of the
Par Indemnitees and the IntelGenx Indemnitees, as the case may be, with respect
to matters covered hereunder.

ARTICLE 10.    LIMITATION OF LIABILITY

NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, EXCEPT WITH RESPECT
TO A BREACH OF ARTICLE 7 HEREOF AND EXCEPT WITH RESPECT TO AMOUNTS PAYABLE ON
LIABILITIES PURSUANT TO THE INDEMNIFICATION OBLIGATIONS SET FORTH IN ARTICLE 9,
NO PARTY SHALL BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL OR
INDIRECT DAMAGES, INCLUDING FOR LOST PROFITS, OR LOSS OF OPPORTUNITY OR USE OF
ANY KIND SUFFERED BY THE A PARTY, WHETHER IN CONTRACT, TORT OR OTHERWISE.

ARTICLE 11.    TERM AND TERMINATION

11.1    Term. Unless earlier terminated pursuant to this Article 11, the term of
this Agreement in respect a Product or AG Product, as applicable, shall continue
in force from the Effective Date until the latter of (a) the end of the
commercial life of such Product or AG Product or (b) the date that is ten (10)
years following the earlier of Commercial Launch of such Product and the first
commercial sale of such AG Product by Par, its Affiliate or a permitted
sublicensee (the "Term").

11.2    Termination for Breach. Either Party may terminate this Agreement, or
suspend performance under this Agreement upon written notice to the other Party
at any time during the Term of this Agreement, if the other Party is in material
breach of this Agreement and such other Party has not cured such material breach
within forty-five (45) days after notice requesting cure of the breach;
provided, however, that if the pertinent breach is not capable of cure within
forty- five (45) days, but is capable of cure, and the breaching Party has
promptly commenced, and is and continues diligently pursuing in good faith the
remedy of any such breach, then such cure period shall be extended for such
period as may be reasonably required to effectuate such cure; provided further,
however, that if such breach is not capable of cure, the non-breaching Party may
terminate this Agreement, or suspend performance under this Agreement
immediately by delivery of written notice thereof to such breaching Party.

11.3    Termination by Par.

11.3.1 Par may terminate this Agreement in respect of a Product upon delivery of
written notice to IntelGenx if:

(a)      the [***] for such Product is deemed unsuccessful in accordance with
Section 2.4.3, and IntelGenx conducts an additional [***] for such Product Study
that is also unsuccessful (as determined in accordance with Section 2.4.3) .

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(b)      the Pivotal Bioequivalence Study for such Product fails to demonstrate
that such Product is bioequivalent to the applicable Brand Product and (i) Par
does not elect to conduct an additional Pivotal Bioequivalence Study for such
Product pursuant to Section 2.4.4 within sixty (60) days after such failure or
(ii) after such election, such additional Pivotal Bioequivalence Study for such
Product fails again to demonstrate that such Product is bioequivalent to the
applicable Brand Product;

(c)      Par is not the sole First Applicant with respect to the Product ANDA
for such Product;

(d)      at any time after the conclusion of Patent Litigation for such Product,
such Product has become economically unviable; or

(e)      following Commercial Launch of such Product, total Net Profits of such
Product reach a level that is equal to or less than fifteen percent (15%) of
Par's (and its Affiliates') Net Sales of such Products and such conditions
persist for a period of two (2) or more consecutive Calendar Quarters;

and, in each case, Par is not, at the time, pursuing the commercial sale of an
AG Product in respect of such Product.

11.4    Effect of Expiration or Termination. Expiration of the Term or
termination of this Agreement for any reason shall be without prejudice to:

11.4.1 IntelGenx's right to receive all payments due and payable from Par as of
the effective date of such termination, if any, pursuant to the terms of this
Agreement;

11.4.2 Par's right to sell, at its option, the Product remaining in its
inventory at the time of termination (in which event, Net Profits on such sales
shall continue to be shared as set forth above in Section 5.5); and

11.4.3 Any other legal, equitable, or administrative remedies as to which either
Party is or may become entitled.

11.4.4 In the event that Par wishes to terminate this Agreement in respect of a
Product pursuant to Section 11.3.1(e), Par's written notice thereof shall be
deemed an offer by Par to transfer its right, title, interest, ownership and/or
control of the Product ANDA for such Product and all Intellectual Property to
the extent solely and exclusively related to such Product to IntelGenx; and
IntelGenx shall have the right, at its sole discretion, to accept such offer by
delivering written notice thereof within twenty (20) business day following
receipt of such Termination Notice. In the event of such acceptance, (i)
IntelGenx shall (x) assume and/or be responsible for, at its own expense, all
activities necessary to continue the commercialization of such Product, as well
as any Liabilities deriving therefrom, including the obligation to defend,
indemnify and hold harmless each Par Indemnitee from any Liabilities asserted
against Par for such commercialization by IntelGenx, and (y) pay Par a royalty
equal to [***] of net amount received by IntelGenx from the sale of such
Product; and (ii) Par shall have no further obligation to indemnify IntelGenx in
respect of such Product pursuant to Section 9.2 or 9.3. Each Party shall
reasonably cooperate with each other in connection herewith, including
negotiating in good faith appropriate documentation addressing the provisions in
this Section 11.4.4.

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11.5    Survival. In addition to specific indications throughout this Agreement
that Articles and Sections of this Agreement shall survive expiration and
termination of this Agreement, Articles 1, 7, 9, 10, 12, 13, Sections 5.5.3,
5.5.4, 6.3, 11.4, this Section 11.5, 11.6], and any other provisions necessary
and proper to give effect to the intention of the Parties as to the effect of
the Agreement after termination shall survive any expiration or termination of
this Agreement. In addition, unless otherwise expressly set forth herein, no
expiration or termination of this Agreement shall have any effect on any
payment, obligation accruing or arising prior to such expiration or termination.

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

ARTICLE 12.    INSURANCE

12.1    Each Party shall obtain and maintain at all times during the Term,
prudent comprehensive general liability coverage appropriate to its activities
with reputable and financially secure insurance carriers to cover its activities
related to this Agreement. Additionally such insurance coverage shall include
product liability coverage of an appropriate amount, not less than five million
US dollars ($5,000,000) per occurrence, for so long as a Product is being sold
pursuant to this Agreement. Notwithstanding the foregoing, if a Party is a the
Manufacturer for a Product, no later than the date of the FDA’s final approval
of the ANDA for such Product, such Party shall, at its own cost and expense,
obtain and maintain in full force and effect at all times during the Term, and
for a period of three (3) years thereafter:

(a)      commercial general liability insurance covering bodily injury and
property damage with limits no less than Two Million Dollars ($2,000,000) per
occurrence and Five Million Dollars ($5,000,000) in the aggregate; and

(b)      products and completed operations liability insurance (including
coverage for all Product used in clinical trials) with limits no less than (i)
Five Million Dollars ($5,000,000) per occurrence and Twenty Million Dollars
($20,000,000) in the aggregate.

12.2    All of the foregoing insurance policies shall be obtained from an
insurance carrier or carriers having a current A.M. Best rating of at least A-
Class VIII.

12.3    Upon execution of this Agreement and annually thereafter upon request,
each Party shall provide to the other Party with a certificate of insurance
evidencing such coverage. Each Party shall provide the other Party with written
notice within thirty (30) days’ of any material change in the terms or coverage
of such insurance policies or their lapse, cancellation or termination.

12.4    All insurance policies obtained by either Party pursuant to this
Agreement shall be primary and not contributing to any other insurance,
self-insurance or captive insurance maintained by the other party to the extent
of such Party’s indemnification obligations hereunder; provided, however, that
notwithstanding the foregoing, the insurance policies required under this
Section 12 shall not be construed to limit either Party’s liability with respect
to its indemnification obligations under this Agreement.

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ARTICLE 13.    MISCELLANEOUS

13.1    Interpretation and Construction. Unless the context of this Agreement
otherwise requires, (i) the terms "include," "includes," or "including" shall be
deemed to be followed by the words "without limitation" unless otherwise
indicated; (ii) words using the singular or plural number also include the
other; (iii) the terms "hereof," "herein," "hereby," and derivative or similar
words refer to this entire Agreement; (iv) the terms "Article," "Section" and
"Exhibit" refer to the specified Article, Section and Exhibit of this Agreement,
and (v) words of any gender include each other gender. Whenever this Agreement
refers to a number of days, unless otherwise specified, such number shall refer
to calendar days. The headings and paragraph captions in this Agreement are for
reference and convenience purposes only and shall not affect the meaning or
interpretation of this Agreement. This Agreement shall not be interpreted or
constructed in favor of or against either Party because of its effort in
preparing it.

13.2    Independent Contractor Status. It is understood and agreed that nothing
in this Agreement nor any agreements related hereto is intended to nor shall
create a partnership between the Parties. The Parties are independent
contractors and are engaged in the operation of their own respective businesses,
and neither Party is to be considered the agent, partner, joint venturer or
employee of the other Party for any purpose whatsoever and neither Party shall
have any authority to enter into any contracts or assume any obligations for the
other Party nor make any warranties or representations on behalf of that other
Party.

13.3    Waiver. The waiver by either Party of a breach of any provision
contained herein shall be in writing and shall in no way be construed as a
waiver of any succeeding breach of such provision or the waiver of the provision
itself.

13.4    Assignment. This Agreement shall be binding upon and inure to the
benefit of each of the Parties and their respective successors and approved
assigns; provided, however, that IntelGenx may not assign this Agreement without
the prior written consent of Par, unless such assignment is in connection with a
merger or acquisition or sale of all or substantially all of the assets of
IntelGenx to which this Agreement relates. Par may assign this agreement at its
sole discretion, subject to Section 3.1.1. Without in anyway limiting the
preceding, each Party shall provide notice of any assignment of this Agreement
to the other Party. Any assignment of this Agreement not in accordance with this
provision shall be null and void.

13.5    Modification. This Agreement may not be changed, modified, amended or
supplemented except by an express written instrument signed by both Parties.

13.6    Severability. If any provision of this Agreement shall be held illegal
or unenforceable, such provision shall be limited or eliminated to the minimum
extent necessary so that this Agreement shall otherwise remain in full force and
effect and enforceable.

13.7    Further Assurances and Litigation Cooperation. Each Party hereto agrees
to execute, acknowledge and deliver such further instruments and documents, and
to do all such other acts, as may be reasonably necessary or appropriate in
order to carry out the purposes and intent of this Agreement. Each Party shall
invoice the other Party for all charges, costs and expenses which are the
responsibility of the other Party, which shall be paid within thirty (30) days
of receipt of such invoice. Each Party hereto agrees to provide all reasonable
cooperation to the other Party, including providing documents and making its
employees (and former employees) and contractors available for discussion and
available for testimony, in connection with any litigation or regulatory
proceedings (including citizens petitions) related to the Products or related
Third Party products (such as competing products).

26

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13.8    Notices. Any notice or other communication to be given under this
Agreement by any Party to any other Party shall be in writing and shall be
either (a) personally delivered, (b) mailed by registered or certified mail,
postage prepaid with return receipt requested, (c) delivered by overnight
express delivery service or same-day local courier service, or (d) delivered by
telex or facsimile transmission (followed by a copy by the preceding (a), (b) or
(c)), to the address of the applicable Party as set forth below, or to such
other address as may be designated by the Parties from time to time in
accordance with this Section 13.8. Notices delivered personally, by overnight
express delivery service or by local courier service shall be deemed given as of
actual receipt. Mailed notices shall be deemed given three (3) business days
after mailing. Notices delivered by telex or facsimile transmission shall be
deemed given upon receipt by the sender of the answerback (in the case of a
telex) or transmission confirmation (in the case of a facsimile transmission) if
transmitted before 5:00p.m. (recipient's local time) on a business day, and
otherwise on the following business day.

If to IntelGenx:
lntelGenx Corp.
6425 Abrams
Ville St-Laurent (Quebec) H4S 1X9
Canada
Attention: President and CEO Facsimile Number: (514) 331-0436

If to Par:
Par Pharmaceutical, Inc.
300 Tice Boulevard
Woodcliff Lake, NJ 07677
Attention: General Counsel
Facsimile Number: (201) 802-4600

13.9    Governing Law and Jurisdiction. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York without regard to
the conflicts of law provisions thereof with the exception of Sections 5-1401
and 5-1402 of the New York General Obligations Law. The Parties irrevocably
agree that the State and Federal Courts located in the State, City, and County
of New York, shall have exclusive jurisdiction to deal with any disputes arising
out of or in connection with this Agreement and that venue is proper in such
Courts. Each Party hereby expressly consents and submits to the personal
jurisdiction of Federal and State Courts in the State, City and County of New
York. The UN Convention on Contracts for the International Sale of Goods shall
not apply to this Agreement.

13.10 Force Majeure. A Party shall not be liable for non performance or delay in
performance to the extent that such non performance or delay in performance is
not due to its negligence and is caused by any event reasonably beyond the
control of such Party, including wars, hostilities, revolutions, riots, civil
commotion, national emergency, unavailability of supplies, epidemics, fire,
flood, earthquake, force of nature, explosion, terrorist act, embargo, or any
other Act of God, or any law, proclamation, regulation, ordinance, or other act
or order of any court, Governmental Authority (each a "Force Majeure Event").

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In the event that either Party is prevented from discharging its obligations
under this Agreement on account of a Force Majeure Event, such Party shall
notify the other forthwith, and shall nevertheless use Commercially Reasonable
Efforts to discharge its said obligations, even if in a partial or compromised
manner. If either Party is unable to perform its obligations hereunder as a
result of a Force Majeure Event for a period of nine (9) months or greater, then
the other Party shall have the right, upon its issuance of notice to the other
Party, to terminate this Agreement.

13.11 Entire Agreement. This Agreement and any Exhibits attached hereto
constitute the entire agreement between Par and IntelGenx with respect to each
Products and AG Product and supersede all prior representations, understandings
and agreements with respect to such Product and AG Product. This Agreement and
any Exhibits attached hereto shall prevail over those of any purchase order,
agreement, or other document or understanding of any kind pertaining to such
sale.

13.12 Counterparts. This Agreement may be executed in one or more counterparts,
including by transmission of facsimile or PDF copies of signature pages, each of
which shall for all purposes are deemed to be an original and all of which shall
constitute on instrument.

13.13 Third Party Beneficiaries. Except as expressly provided herein, nothing in
this Agreement, either express or implied, is intended to or shall confer upon
any Third Party any legal or equitable right, benefit or remedy of any nature
whatsoever under or by reason of this Agreement.

13.14 Cumulative Rights. The rights and remedies of each of the Parties under or
pursuant to this Agreement are cumulative, may be exercised as often as such
Party considers appropriate and are in addition to its rights and remedies under
general law.

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IN WITNESS WHEREOF, the Parties have executed this Development and
Commercialization Agreement to be effective as of the Effective Date.

 

PAR PHARMACEUTICAL, INC.

 

By:  __________________________________
        Paul V. Campanelli, Chief Executive Officer

 

INTELGENX CORP.

 

By:  __________________________________
        Horst Zerbe, Chief Executive Officer

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Exhibit A
Products

[***]

 

 

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Exhibit B

Listing of Activities Associated with the Development of an ANDA

1.

Reference Listed Drug evaluation

  a.

Drug product literature search

  b.

Physico-chemical characterization of RLD

  c.

Perform 3 month elevated temperature stability tests if deemed necessary

  d.

Evaluate innovator container/closure system

  e.

Evaluate RLD impurity, stability profile evaluation (exposure to heat, light,
oxygen, acid and base)

  f.

Define packaging component specifications

2.

Analytical Development

  a.

Develop stability indicating assay methods for active ingredients, and other
specific excipients, where possible

  b.

Author all analytical test procedures for raw materials, packaging components
and finished product

3.

Container/Closure System Evaluation

  a.

Review supplier specifications for all packaging (container/closure, filler,
desiccant) components

  b.

Establish packaging components (container/closure filler, desiccant)
specifications

  c.

Perform container/closure integrity studies and issue final report

  d.

Perform light penetration studies, where applicable, and issue final report

4.

Raw Materials and packaging materials

  a.

Determine level of impurities/degradants allowed for active drug substance

  b.

Establish incoming specifications for raw materials, packaging components, and
labeling

5.

Drug Development

  a.

Develop the formulation composition and process, identifying critical processing
parameters

  b.

Establish master batch process (“Master Formula”), having all elements needed to
assure compliance with cGMPs

  c.

In collaboration with the manufacturer, develop processing narrative with key
aspects for the production process

  d.

Develop product stability criteria and provide justification for all stability
criteria

  e.

Establish developmental and commercial stability protocols

  f.

Perform comparative impurity assessment between innovator and proposed product
if required to justify stability of the product

  g.

Perform a literature based product safety assessment (required when product
impurity profiles exceed or differ from that of the innovator)

  h.

Establish physicochemical equivalence between the product and RLD

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  i.

Provide a comparison of the qualitative/quantitative composition of proposed
product and RLD formulation

  j.

Write Product Development Report explaining the development approach justifying
API grade, excipient, process, process parameters, and batch size.

  k.

Provide assistance during the PAI, if needed.

  l.

Provide technical support as needed during patent litigation.

6.

Bioequivalence Pilot Study

  a.

Evaluate and Recommend bioequivalence pilot study design to improve probability
of success.

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Exhibit C

Technology Transfer Materials

1.

Information about raw materials including quantities and grades

2.

Analytical method validated for finished product in collaboration with Par

3.

Formulation for high and low dose

4.

Ink and packaging identification (to be performed in collaboration with
manufacturer)

5.

Formulation development report

6.

Process flow diagram

7.

Informal stability data

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Exhibit D

Net Profit Report

          Month x     Month y     Month z     X                                
  Units                                                               PRODUCT X
                        $  -                                   Total Units      
$  -   $  -   $  -   $  -                                   Gross Sales        
                                                      PRODUCT X                
        $  -                                   Total Gross Sales       $  -   $
 -   $  -   $  -                                   Accrued Sales Credits        
                                                      Rebates                  
      $  -                                   Admin Fees                        
$  -                                   Trade and Quantity Discounts            
            $  -                                   Chargebacks                  
      $  -                                   Returns                         $
 -                                   Price Adjustments                         $
 -                                   Medicaid                         $  -      
                            Cash Discounts                         $  -        
                          Total Accrued Sales Credits       $  -   $  -   $  -  
$  -                                   Net Sales                                
                              PRODUCT X                         $  -            
                     

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Total Net Sales       $  -   $ -   $ -   $ -                                  
Acquisition Cost                                                              
PRODUCT X $xx.xx                   $ -                                   Total
Cost of Goods Sold       $  -   $ -   $ -   $ -                                
  Less: Marketing Cost Allowance                       $ -                      
            Net Profit       $  -   $ -   $ -   $ -                            
      Profit Split to Partner   xx%   $  -   $ -   $ -   $ -                    
                                                                             
Sales Allowance Roll forward                                                    
          Beginning Balance       $  -   $ -   $ -   $ -                        
          Accrued Sales Credits                       $ -                      
            Processed Credits                       $ -                        
          Ending Balance       $  -   $ -   $ -   $ -  

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Exhibit E

[***]

 

 

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