IntelGEnx Corp.: Exhibit 10.28 - Filed by newsfilecorp.com





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

 




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.

2




"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.

3




"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.

4




"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.

5




"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.

6




"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.

7




"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.

8




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.

9




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.

10




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.

14




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).

15




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.

16




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.

17




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




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.

22




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) .

23




(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.

24




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.

25




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




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").

27




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.

28




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




Exhibit A
Products

[***]

 

 




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








	 	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.







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







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 	 	 	 	 	  	 	 	  	 	 	  	 	$	 - 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 









	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 	 	  	 	$	 - 	 	$	- 	 	$	- 	 	$	- 	 







Exhibit E

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