Exhibit 10.45


 


CERTAIN CONFIDENTIAL
PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT OF 1934.


 


EXCLUSIVE LICENSE AGREEMENT


 


by and between


 


DEPOMED, INC.


 


and


 


SOLVAY PHARMACEUTICALS, INC.


 


dated


 


November 19, 2008


 

















 


EXCLUSIVE LICENSE AGREEMENT


 


This Exclusive
License Agreement (this “Agreement”) is
dated this 19th day of November, 2008 (the “Execution Date”) by and between Solvay Pharmaceuticals, Inc.,
with offices at 901 Sawyer Road, Marietta, GA 30062 (“Solvay”)
and Depomed, Inc., with offices at 1360 O’Brien Drive, Menlo Park, CA
94025 (“Depomed”).  Each of Solvay and Depomed are referred to
individually herein as a “Party” and
collectively as the “Parties.”


 


RECITALS


 


WHEREAS,
Depomed has used its proprietary AcuFormTM gastric retentive technology to
develop an oral dosage form of gabapentin known as Gabapentin GR®, and is
conducting Phase III clinical development of Gabapentin GR®;


 


WHEREAS, Solvay wishes to obtain an exclusive
license under Depomed’s intellectual property rights in and to Gabapentin GR®
to commercialize and clinically develop the Product (as defined below) within
the Field (as defined below) in the Territory (as defined below); and


 


WHEREAS,
Depomed wishes to license to Solvay its intellectual property rights with
respect to the Product within the Field in the Territory.


 


NOW,
THEREFORE, in consideration of the foregoing, the
covenants and promises contained in this Agreement, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
Depomed and Solvay agree as follows:


 


ARTICLE 1

DEFINITIONS


 


The terms in
this Agreement with initial letters capitalized, whether used in the singular
or the plural, shall have the meaning set forth below or, if not listed below,
the meaning designated in places throughout this Agreement.


 


1.1                               “AE
Profile” has
the meaning set forth on Exhibit A.


 


1.2                               “Affiliate”
means any corporation or
other business entity controlled by, controlling, or under common control with
a Party to this Agreement but only for so long as such relationship exists,
with “control” meaning the (a) direct or indirect beneficial ownership of
more than fifty percent (50%) of the voting stock of, or more than a fifty percent
(50%) interest in the income of, such corporation or other business entity, or (b) direct
or indirect ability or power to direct or cause the direction of management
policies of an entity or otherwise direct the affairs of such entity, whether
through ownership of voting securities or otherwise.


 


1.3                               “Applicable
Law” means
all laws, statutes, ordinances, codes, rules, regulations, and other
pronouncements that have been enacted by a Governmental Authority, in each case
to the extent that the same are applicable to the performance by a Party of its
obligations, and/or exercise of its rights, under this Agreement.


 

















 


Confidential Information, indicated by
[***] has been omitted from this filing and filed separately with the
Securities Exchange Commission


 


1.4                               “Business
Day” means
any day that is not a Saturday or a Sunday or a day on which the Nasdaq Stock
Market or New York Stock Exchange is closed.


 


1.5                               “Calendar
Quarter” means
the respective periods of three (3) consecutive calendar months ending on March 31,
June 30, September 30 and December 31; provided, however, that (a) the
first Calendar Quarter of the term of this Agreement shall extend from the
Effective Date to the end of the first full Calendar Quarter thereafter, and (b) the
last Calendar Quarter of the term of this Agreement shall end upon the
expiration or termination of this Agreement.


 


1.6                               “Calendar
Year” means
(a) for the first Calendar Year of the term of this Agreement, the period
beginning on the Effective Date and ending on December 31, 2009, (b) for
each Calendar Year of the term of this Agreement thereafter, each successive
period beginning on January 1 and ending twelve (12) consecutive calendar
months later on December 31, and (c) for the last Calendar Year of
the term of this Agreement, the period beginning on January 1 of the
Calendar Year in which the Agreement expires or terminates and ending on the
effective date of expiration or termination of this Agreement.


 


1.7                               “Commercially
Reasonable Efforts” means
those efforts and resources [***].


 


1.8                               “Controlled”
means, with respect to
any intellectual property right, that the Party (a) owns or (b) has a
license to such intellectual property right and has the ability to grant to the
other Party a sublicense to such intellectual property right as provided for
herein without (i)violating the terms of any agreement or other arrangements
with any Third Party existing at the time such Party would be first required
hereunder to grant the other Party such sublicense, and (ii) incurring
additional payment obligations arising from the grant of such sublicense under
this agreement, subject to Section 2.1(c).


 


1.9                               “Depomed
Inventions” means
any and all Inventions that describe, claim, cover or relate to the Product and
(a) are conceived during the term of this Agreement by one or more
employees of Depomed or persons contractually obligated to assign or license
patent rights covering such Inventions to Depomed and (b) are not Joint
Inventions.


 


1.10                        “Depomed
Know-How” means,
subject to Section 2.1(c), any and all Know-How that (a) is
possessed, as of the Effective Date, by Depomed or by any Affiliate of Depomed
as of the Effective Date, or that is developed or acquired during the term of
this Agreement by (i) Depomed, (ii) any Affiliate of Depomed, or (iii) any
person contractually obligated to assign or license patent rights covering such
Know-How to Depomed, (b) is Controlled by Depomed or its Affiliates, and (c) is
reasonably required or useful for the clinical development, use, registration,
manufacture, packaging, commercialization or sale of the Product including
without limitation any Know-How Controlled by Depomed relating to Formulation
Technology applied to the Product. 
Depomed Know-How excludes Product Data but includes without limitation Depomed
Inventions and Depomed’s interest in Joint Inventions, in each case to the
extent falling within subsections (a) through (c).


 


1.11                        “Depomed
Patents” means,
subject to Section 2.1(c), (a) any and all patent applications that (i) are
Controlled by Depomed and are filed prior to or during the term of this


 


2

















 


Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


Agreement in the
United States or any foreign jurisdiction, including without limitation any
addition, continuation, continuation-in-part, continued prosecution application
or divisional application thereof or any substitute application therefor and (ii) claim
inventions that are reasonably required or useful for the clinical development,
use, registration, manufacturing, packaging, commercialization or sale of the
Product including without limitation those relating to Formulation Technology
applied to the Product; (b) any patent issued from any such patent
application; (c) any reissue, reexamination, extension or patent term
extension of any such patent; and (d) any other U.S. or foreign patent or
inventor’s certificate Controlled by Depomed that claims inventions reasonably
required or useful for the clinical development, use, registration,
manufacturing, packaging, commercialization or sale of the Product.  Depomed Patents include without limitation
those Patent Rights set forth on Exhibit B and Patent Rights Controlled by
Depomed claiming Depomed Inventions and Joint Inventions, in each case to the
extent falling within subsection (a).


 


1.12                        “Depomed
Technology” means
Depomed Know-How and Depomed Patents.


 


1.13                        “Detail”
(and, with correlative
meanings, the terms “Details” and “Detailing”) means, with respect to the
Product, the activity undertaken on a face-to-face basis by a sales
representative with respect to a target physician or other healthcare
professional with prescribing authority involved or potentially involved in
prescribing the Product.


 


1.14                        “Detailing
Costs” means
that amount determined by multiplying the total number of PDEs promoting
Product in a given Calendar Year (a) by [***]
Dollars ($[***]) for
the remainder of 2008, and (b) for subsequent Calendar Years, by an amount
equal to [***] Dollars ($[***]) increased by the cumulative percentage
increase in the United States Consumer Price Index (found at:
http://www.bls.gov/cpi/) between the first Calendar Year of the term of this
Agreement and the relevant Calendar Year.


 


1.15                        “Dollars”
or “$” means
the lawful currency of the United States.


 


1.16                        “Drug
Approval Application” means,
in the United States, an NDA, including an NDA submitted under Section 505(b)(2) of
the Food, Drug and Cosmetic Act, a supplement to an NDA or an Abbreviated New
Drug Application for the Product, or in the OUS Territory, an equivalent
application for regulatory approval required before commercial sale or
commercial use of the Product in a regulatory jurisdiction.


 


1.17                        “Effective
Date” shall
mean the later of:  (a) the
Execution Date; or (b) the HSR Clearance Date.


 


1.18                        “FDA”
means the U.S. Food and
Drug Administration or any successor agency thereto.


 


1.19                        “Field”
means the treatment or
amelioration of pain, including without limitation treatment of post-herpetic
neuralgia (“PHN”), pain associated with diabetic neuropathy (“DPN”), Phantom
Pain and fibromyalgia.


 


3

















 


Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


1.20                        “First
Position Call” means
a Detail made to healthcare professionals employed by or practicing at a given
healthcare facility, in which a sales representative spends at least sixty
percent (60%) of the time during such Detail discussing the Product.


 


1.21                        “Formulation
Technology” means
Depomed’s proprietary gastric retentive drug delivery technology currently
known as AcuFormTM technology used to optimize delivery of a drug
by achieving improved pharmacokinetic and/or pharmacodynamic characteristics of
an oral formulation of such drug when compared to immediate release
formulations of such drug.


 


1.22                        “FTE”
means a full time
equivalent employee of Depomed directly involved in the relevant activity with
respect to the Product, calculated assuming that such employee works one
thousand eight hundred eighty (1880) hours per Calendar Year.


 


1.23                        “FTE
Charges” means the amount of [***]
dollars ($[***]) per
Calendar Year per FTE engaged in the relevant activity, for the remainder of
2008.  For each subsequent Calendar year
thereafter, the foregoing FTE Charge shall be [***]
dollars ($[***]) per
Calendar Year per FTE engaged in the relevant activity increased by the
cumulative percentage increase in the United States Consumer Price Index
between 2008 and the relevant Calendar Year.


 


1.24                        “Generic
Product” means
a pharmaceutical product that is the subject of either (i) an Abbreviated
New Drug Application referencing data contained in an NDA and for which
Regulatory Approval has been granted by the FDA, or (ii) an equivalent
application and equivalent approval by a regulatory authority for such a
pharmaceutical product in the OUS Territory.


 


1.25                        “Governmental
Authority” means
any governmental agency, board or commission or other governmental authority or
other instrumentality of the United States, any state, county, city or other
political subdivision within the United States or any other jurisdiction within
the Territory (including without limitation the FDA).


 


1.26                        “HSR
Act” shall
mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and
the rules and regulations promulgated thereunder.


 


1.27                        “HSR
Clearance Date” shall
mean the earliest date on which the Parties have actual knowledge that all
applicable waiting periods under the HSR Act with respect to the transactions
contemplated hereunder have expired or have been terminated.


 


1.28                        “HSR
Filing” shall
mean filings by the Parties or their respective Affiliates with the United
States Federal Trade Commission and the Antitrust Division of the United States
Department of Justice of a Notification and Report Form for Certain
Mergers and Acquisitions (as that term is defined in the HSR Act) with respect
to the matters set forth in this Agreement, together with all required
documentary attachments thereto.


 


1.29                        “Indicated”
means with respect to a
specific product, that a label has been approved by FDA for such product that
expressly includes the use of such product to treat a specific ailment, disease
or condition.


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


1.30                        “Inventions”
means any and all
inventions (whether or not patentable), that are conceived during the term of
and pursuant to this Agreement by one or more employees of, or persons
contractually obligated to assign or license Patent Rights covering such
inventions to, Depomed or Solvay.


 


1.31                        “Joint
Inventions” means
any and all Inventions that describe, claim, cover or relate to the Product and
are jointly conceived by one or more employees of, or persons contractually
obligated to assign or license patent rights covering such inventions to, each
of Depomed and Solvay.


 


1.32                        “Know-How”
means inventions,
discoveries, trade secrets, information, experience, data, formulas, protocols,
procedures and results, including without limitation biological, chemical or
physical materials, processes, documents, formulations, compositions,
toxicological, pharmacological, preclinical, clinical, and veterinary data,
dosage regimens, control assays and product specifications.


 


1.33                        “Launch”
means the first
commercial sale of the Product to a Third Party in the Field in the Territory.


 


1.34                        “NDA”
means a New Drug
Application requiring approval by FDA before the Product may be introduced or
delivered for introduction into interstate commerce in the United States.


 


1.35                        “Net
Sales” means
the gross invoice price of Product sold or otherwise disposed of for
consideration by Solvay, its Affiliates or sublicensees to Third Parties,
reduced by the following amounts (calculated in accordance with International
Financial Reporting Standards, consistently applied): (a) the amounts
actually allowed as volume, quantity, trade and/or cash discounts, prompt pay
discounts, refunds, credits, rebates, charge-backs or accruals, including
without limitation rebates paid to assistance programs and any other price
reductions required by a Governmental Authority or Applicable Laws; (b) credits
actually given in connection with retroactive price reductions (including,
without limitation, managed care and similar types of rebates), or for returned
or rejected Product (including withdrawals, expired product and recalls); (c) sales,
value added, excise and turnover taxes and customs duties, imposed directly on
and actually paid by Solvay, its Affiliates or sublicensees (including, without
limitation, duties or other governmental charges levied on, absorbed, or
otherwise imposed on the sale of the Product, value added taxes and other
governmental charges otherwise measured by the billing amount, when including
in billing, but not including national, state, and local taxes based on
income); (d) any inventory management fees, wholesaler service fees or
inducements or similar fees paid to wholesalers or distributors in connection
with the Product; and (e) transportation costs, including cost of export
licenses, insurance and shipping, freight, and handling charges and other
similar expenses, to the extent billed separately to customers.


 


If Solvay or
its Affiliates or sublicensees receive non-cash consideration for Product sold
or otherwise transferred to a Third Party, the fair market value of such
non-cash consideration on the date of the transfer will be calculated assuming
that the gross invoice price that Solvay currently charges Third Parties for
units of Product sold or transferred to such Third Party is the fair market value
of such units of Product, with the aggregate such fair market value deemed the


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


Net Sales for
such Product sold or otherwise transferred, reduced by any applicable amounts
in (a)-(e) above.  Any goods or
services provided in exchange of the supply, disposal of the Product for, or
use of the Product, in clinical or preclinical trials, as free samples or as
charitable donations shall not give rise to any Net Sales.


 


If the Product
is sold in a country together with other goods, with or without a separate
price for such Product, then the Net Sales applicable to the quantity of such
Product included in such transaction will be deemed to be the average Net Sales
for such quantity of the Product for all transactions of such Product made in
such country during the last full Calendar Quarter prior to such transaction or
during the current Calendar Quarter if the Product was not commercially
available in such country in the last full Calendar Quarter.


 


1.36                        “OUS
Territory” means
that portion of the Territory that is outside of the United States.


 


1.37                        “Patent
Rights” means
(a) letters patent (or other equivalent legal instrument), including
without limitation utility and design patents, and including without limitation
any extension, substitution, registration, confirmation, reissue,
re-examination or renewal thereof, (b) an application for letters patent,
including without limitation a reissue application, a re-examination
application, a continuation application, a continued prosecution application, a
continuation-in-part application, a divisional application or any equivalent
thereof that is pending at any time during the term of this Agreement before a
government patent agency, and (c) all foreign or international equivalents
of any of the foregoing in any country.


 


1.38                        “PDE”
means primary detail
equivalents and is calculated by adding A + B + C, where “A” is 1.0 times the
number of First Position Calls, “B” is 0.5 times the number of Second Position
Calls, and “C” is 0.1 times the number of Third Position Calls.


 


1.39                        “Phantom Pain” means a sensation of pain from a part of
the body that has been amputated or in which the nerves have been destroyed.


 


1.40                        “Product”
means the product known
as Gabapentin GR® in the formulation and at the dosage being studied in Depomed
Protocol 81-0062, “A Phase 3 Multicenter, Randomized, Double-Blind,
Placebo-Controlled, Flexible-Dose Study of the Safety and Efficacy of
Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with
Postherpetic Neuralgia,” dated the 25th day of January,
2008, and any alternative strengths of such dosage form, or line extensions of
such product for use within the Field.


 


1.41                        “Product
Data” means any and all data generated in the course of the
development of Products for use in the Field that might reasonably be useful to
or included in any Drug Approval Application seeking any marketing
authorization or other permit, license, registration, or approval to
investigate, market, sell, manufacture and distribute the Product in the
Territory.


 


1.42                        “Promotional
Expenditures” means
all expenses determined in accordance with Generally Accepted Accounting
Practices, applied consistently, incurred by or on behalf of Solvay to the
extent attributable to the marketing, advertising or promotion of the Product
in the


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


Field in the
Territory (but excluding Detailing Costs), including without limitation, to the
extent reasonably attributable to the marketing, advertising or promotion of
the Product in the Field in the Territory, the following:


 


(a)                                  Pre-Launch
and Launch expenses;


 


(b)                                  Marketing,
advertising and marketing research expenses (including Detail messaging
audits);


 


(c)                                  Non-personal
promotion and advertising expenses (including agency fees, direct-to-consumer
advertising, direct mail, internet programs, telemarketing, e-marketing,
reminder promotions and journal advertising);


 


(d)                                  Expenses
of exhibit opportunities carried out at medical conventions, professional and
scientific symposia and other similar events;


 


(e)                                  Expenses
of promotional activities associated with key opinion leaders and educational
programs;


 


(f)                                    Expenses
of managed care marketing programs incurred with the aim of promoting the
Product to managed care audiences;


 


(g)                                 Expenses
of data, market research, including all incremental secondary data purchases,
and pharmacoeconomics studies;


 


(h)                                 Costs
of creating, developing, printing and distributing promotional materials and
voucher/co-pay assistance programs; and


 


(i)                                    Amounts
paid to Third Parties in connection with producing training materials for the
Product, including (i) costs of samples and any amounts paid to Third
Parties for (1) warehousing of samples prior to distribution, and (2) the
distribution of samples to Solvay’s distribution centers; (ii) expenses of
promotional and sales meetings and Product management; and (iii) costs of
such other activities reasonably attributable to the marketing, advertising or
promotion of the Product, including funds allocated to regional marketing
managers and/or accounts (including lunch and learns).


 


1.43                        “Regulatory
Approval” means,
with respect to a particular regulatory jurisdiction, the approval of a Drug
Approval Application by the applicable Governmental Authority in such
regulatory jurisdiction.


 


1.44                        “Regulatory
Filings” means
all applications, filings, dossiers and the like submitted to a Governmental
Authority for the purpose of obtaining Regulatory Approval from that
Governmental Authority in the Territory. 
Regulatory Filings shall include, but not be limited to, all Drug
Approval Applications.


 


1.45                        “Second
Position Call” means
a Detail made to healthcare professionals employed by or practicing at a given healthcare
facility, in which a sales representative spends at


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


least thirty
percent (30%) of the time or more but less than sixty percent (60%) of the time
during such Detail discussing the Product.


 


1.46                        “Solvay
Inventions” means
any and all Inventions that describe, claim, cover or relate to the Product and
(a) are conceived during the term of this Agreement by one or more
employees of Solvay or persons contractually obligated to assign or license
patent rights covering such inventions to Solvay and (b) are not Joint
Inventions.


 


1.47                        “Solvay
Know-How” means
any and all Know-How that describes, claims, covers or relates to the Product
that (a) is possessed, as of the Effective Date, by Solvay or by any
Affiliate of Solvay as of the Effective Date, or that is developed or acquired
during the term of this Agreement by (i) Solvay, (ii) any Affiliate
of Solvay, or (iii) any person contractually obligated to assign or
license patent rights covering such Know-How to Solvay, (b) is Controlled
by Solvay or its Affiliates, and (c) is reasonably required or useful for
the clinical development, use, registration, manufacture, packaging,
commercialization or sale of the Product. 
Solvay Know-How includes without limitation Solvay Inventions and Solvay’s
interest in Joint Inventions, in each case to the extent falling within subsections
(a) through (c).  Solvay Know-How
excludes Product Data.


 


1.48                        “Solvay
Patents” means
(a) any and all patent applications that describe, claim, cover or relate
to the Product that (i) are Controlled by Solvay and are filed prior to or
during the term of this Agreement in the United States or any foreign
jurisdiction, including without limitation any addition, application,
continuation, continuation-in-part, continued prosecution application or
division thereof or any substitute application therefore and (ii) claim an
invention that is reasonably required or useful for the clinical development,
use, registration, manufacturing, packaging, commercialization or sale of the
Product; (b) any patent issued from any such patent application, (c) any
reissue, extension, reexamination or patent term extension of any such patent;
and (d) any other U.S. or foreign patent or inventor’s certificate
Controlled by Solvay, that claims inventions reasonably required or useful for
the clinical development, use, registration, manufacturing, packaging,
commercialization or sale of the Product. 
Solvay Patents include without limitation Patent Rights Controlled by
Solvay claiming Solvay Inventions and Joint Inventions, in each case to the
extent falling within subsection (a).


 


1.49                        “Solvay
Technology” means
Solvay Know-How and Solvay Patents.


 


1.50                        “Termination
Event” means
any (a) withdrawal of the Product in the Field from the market in the
Territory, (b) material medical or scientific concerns as to toxicity,
safety and/or efficacy of Product in the Field, (c) written request of any
Governmental Authority or the applicable institutional review board or data
safety monitoring board to stop clinical trials of the Product in the Field, (d) failure
of the Product to meet all primary endpoints in clinical trials conducted prior
to Regulatory Approval of Product in the Field, (e) a Patent Right
controlled by a Third Party is identified that is not included in the Depomed
Patents and that is not otherwise licensed to Solvay, which Patent Right (i) claims
inventions reasonably necessary for the manufacture, use, sale, offer for sale
or import of the Product in the Field in the Territory and (ii) is not
available for licensing or otherwise transferable to Solvay on terms reasonably
acceptable to Solvay, or (f) any of the following events: (i) a
determination that the Product is not approvable by FDA, as evidenced by a
written communication from FDA to Solvay, its Affiliate


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


or sublicensee; (ii) a
Governmental Authority imposing significant restrictions on Solvay’s ability to
promote the Product in a manner consistent with standard practices in the
pharmaceutical industry for products of similar market potential; or (iii) managed
care providers, comprising at least a majority of the managed care environment
in the United States, blocking, materially restricting (including, without
limitation, imposition of step edits or prior authorizations) or declining
coverage and/or reimbursement for the Product.


 


1.51                        “Territory”
means the United States,
Canada and Mexico.


 


1.52                        “Third
Party” means
any person or entity other than Depomed, Solvay, and their respective
Affiliates.


 


1.53                        “Third
Position Call” means
a Detail made to healthcare professionals employed by or practicing at a given
healthcare facility, in which a sales representative spends less than thirty percent
(30%) but no less than ten percent (10%) of the time during such Detail
discussing the Product.


 


1.54                        “United
States” means
the United States of America (including, without limitation, its territories
and possessions and Puerto Rico).


 


1.55                        “VMS
Indication” means
the treatment or amelioration of vasomotor symptoms in a patient including
without limitation hot flashes.


 


1.56                        “Year”
means any consecutive
twelve (12) month period commencing upon a specified date or the occurrence of
a specified event.


 


ARTICLE 2

GRANT OF RIGHTS; EXCLUSIVITY


 


2.1                               Licenses.  


 


(a)                                  Subject
to the terms and conditions of this Agreement, Depomed grants to Solvay under
the Depomed Technology (i) an exclusive (even as to Depomed),
royalty-bearing license to develop, have developed, make, have made, use,
market, have marketed, promote, have promoted, commercialize, have
commercialized, exploit, import, export, sell, have sold and offer to sell the
Product in the Field in the Territory and (ii) a nonexclusive license to
develop, have developed, make, have made, import and export the Product in the
Field outside the Territory.  Such
licenses shall be sublicensable without the prior written consent of
Depomed.  Subject to the terms and
conditions of this Agreement, Depomed grants to Solvay a nonexclusive license
to use the Product Data Controlled by Depomed or its Affiliates in the Field in
the Territory solely in connection with Solvay’s exercise of its rights and
performance of its obligations under this Agreement.  For clarity, the foregoing license does not
include the right to practice, research, develop, make or commercialize the
Formulation Technology independently of the Product.


 


(b)                                  Subject
to the terms and conditions of this Agreement, Solvay grants to Depomed under
the Product Data Controlled by Solvay, its Affiliates or sublicensees a
nonexclusive, fully-paid license to use the same as necessary to sell the
Product outside the Field in the Territory and in all fields outside the
Territory.


 


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Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


(c)                                  Following
the Effective Date, if Depomed obtains a license or other rights to Know-How
and/or Patent Rights that are useful for the clinical development, use,
registration, manufacturing, packaging, commercialization or sale of Product in
the Field in the Territory but that are not Controlled by Depomed as of the
Effective Date solely because Section 1.8(ii) does not apply (i.e.,
Depomed would incur payment obligations to a Third Party were it to grant to
Solvay a sublicense under such technology and intellectual property rights),
Depomed shall so notify Solvay of such Know-How and/or Patent Rights and upon
Solvay’s request, negotiate the terms under which Depomed would grant a
sublicense to Solvay under such Know-How and/or Patent Rights under this
Agreement.  If the Parties enter into an
amendment to this Agreement or a separate agreement with respect to such Know-How
and/or Patent Rights, then such Know-How and/or Patent Rights shall be deemed
to be Controlled by Depomed and shall thereafter be included in the Depomed
Know-How or Depomed Patents, as applicable, and sublicensed to Solvay pursuant
to Section 2.1(a).  Notwithstanding
the foregoing and anything to the contrary, (i) Depomed makes the
representations, warranties and covenants in Section 6.1 of this Agreement
and (ii) if Solvay [***], Depomed will sublicense to Solvay
any rights Depomed licenses from a Third Party in conjunction with such Third
Party Infringement Claim and solely in such case, Solvay shall not be required
to pay Depomed for any such sublicense under this Section 2.1(c) related
to such Third Party Infringement Claim, [***].


 


(d)                  During the term
of this Agreement, Solvay agrees that neither it nor its Affiliates, licensees
or sublicensees will assert against Depomed, its Affiliates, sublicensees,
distributors or independent contractors involved in the development,
manufacture or commercialization of Product or any customer of the foregoing
entities, any claim, or institute any action or proceeding, whether at law or
equity, under (i) any Solvay Patents owned by Solvay as of the Effective
Date that relate to Product and (ii) any Solvay Patents describing,
claiming, covering or relating to Inventions, in each of (i) and (ii),
based on the development, manufacture, use, practice, importation, marketing,
or sale of the Product either outside the Field in the Territory or in any
field outside the Territory by Depomed, its Affiliates, sublicensees,
distributors or independent contractors or any customer of the foregoing
entities.  This covenant shall be binding
upon, and inure to the benefit of, the Parties, their successors, and assigns.


 


2.2                               Exclusivity.  During the term of this Agreement, Depomed will not, nor
will it authorize any Affiliate or Third Party to, market, promote, distribute
or sell any product Indicated for neuropathic pain, including without
limitation DPN, PHN, or fibromyalgia, in the Territory.  During the term of this Agreement, neither
Party will, nor will it authorize any Affiliate or Third Party to, market,
promote, distribute or sell any other product containing gabapentin in the
Territory outside the scope of this Agreement, except that (i) Depomed
shall have the right to develop, manufacture, use, market, promote, distribute
and sell the Product outside the Field in the Territory; and (ii) any
rights granted to any Third Party pursuant to any agreement set forth in Exhibit C
shall continue to apply and shall not be deemed to be in breach of this Section 2.2.  The Parties acknowledge and agree that
Depomed retains all rights to the Product outside of the Field in the Territory
and in all fields outside of the Territory, including without limitation those
rights related to the VMS Indication.


 


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2.3                               Construction.  It is the intention of the Parties that if any of the
restrictions or covenants contained in Article 2 are held impermissible or
unenforceable by Applicable Law or in any way construed to be too broad or to
any extent invalid, such provision shall not be construed to be null, void and
of no effect, but to the extent such provision would be valid or enforceable
under Applicable Law, such provision shall be construed and interpreted or
reformed so as to provide for a covenant having the maximum enforceable
geographic area, time period and other provisions, although not greater than
those contained herein, as shall be valid and enforceable under such Applicable
Law.  Each of the Parties acknowledges,
however, that the terms of this Agreement have been negotiated by the Parties
and that the limitations on activities are reasonable in light of the
circumstances pertaining to the Parties. 
The Parties further acknowledge that each Party’s and its Affiliates’
commitments in Article 2 are a material inducement for the other Party to
have entered into the transactions contemplated by this Agreement.


 


2.4                               Imports Into or Sales Within and Outside the Territory.  Depomed shall use commercially
reasonable efforts to ensure that the Product is not imported into or marketed,
distributed, or sold in the Territory for use in the Field by Depomed, its
Affiliates or any Third Party authorized by Depomed or its Affiliates.  If Depomed learns of any such activities it
shall promptly respond to any report of such activity and shall use
commercially reasonable efforts to take all appropriate measures to halt
it.  Solvay shall use commercially
reasonable efforts to ensure (i) that the Product is not imported into the
Territory, or marketed, distributed, or sold in the Territory for use outside
the Field and (ii) that Product is not exported from, or marketed,
distributed or sold outside, the Territory for any uses, by Solvay, a Solvay
Affiliate or any Third Party authorized by Solvay or its Affiliates.  If Solvay learns of any such activities, it
shall promptly respond to any report of such activity and shall use
commercially reasonable efforts to take all appropriate measures to halt it.


 


2.5                               Restrictions
Within the Territory.


 


Notwithstanding
anything contained in this Agreement to the contrary, the Parties acknowledge
and agree that, for so long as the Product is being developed, marketed,
promoted, and/or commercialized (a) by Solvay in the Territory in the
Field and (b) by Depomed,
an Affiliate of Depomed, a Third Party authorized by Depomed or an Affiliate of
Depomed (hereinafter in this section only, “Depomed”) in the Territory outside
of the Field (including for the VMS Indication), Solvay and Depomed will:


 


(i)                                                                                     use
commercially reasonable efforts to obtain separate and distinct NDC numbers for
its respective Product;


 


(ii)                                                                                  use
a separate and distinct trade name (brand name) for its respective Product;


 


(iii)                                                                               manufacture,
market, promote, commercialize and sell its respective Product using a tablet
color that is substantially different from that used by the other Party for its
Product;


 


(iv)                                                                              use
commercially reasonable efforts to [***];


 


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(v)                                                                                 not
[***];


 


(vi)                                                                              not
[***];


 


(vii)                                                                           not
[***]; and


 


(viii)                                                                        not
[***].


 


In addition,
Solvay agrees not to [***].  Depomed (including any Affiliate of Depomed
and/or a Third Party authorized by Depomed or an Affiliate of Depomed) agrees
not to [***].  Solvay (including any Affiliate of
Solvay and/or a Third Party authorized by Solvay or an Affiliate of Solvay)
agrees not to [***].


 


(a)                                  Both
Parties envision that there will be two separate NDAs (or equivalents thereto)
for the Product developed and commercialized in the Territory within the Field
by Solvay, its Affiliates and sublicensees, and outside the Field by Depomed,
its Affiliates and sublicensees, respectively.


 


(b)                                  Notwithstanding
anything to the contrary contained herein, [***].


 


(c)                                  In
the event [***].


 


(d)                                  In
the event [***].


 


(e)                                  The
Parties acknowledge and agree that in no event [***].


 


2.6                               Trademarks.  Depomed acknowledges and agrees that Solvay has the right
to develop and maintain, in Solvay’s name, any and all trademarks, names and
logos not owned or Controlled by Depomed as of the Effective Date
(collectively, “Trademarks”) to be used for the Product in the Field in the
Territory.


 


2.7                               No
Implied License.  No right or license under any intellectual
property right is granted or shall be granted by Depomed or Solvay by
implication.  All such rights or licenses
are or shall be granted only as expressly provided in this Agreement.  Depomed reserves and retains all rights in
the Depomed Technology other than the rights expressly granted under this
Agreement.  Solvay reserves and retains
all rights in the Solvay Technology other than the rights expressly granted
under this Agreement.  Solvay shall not
practice the Depomed Technology or use the Product Data outside the scope of
its licenses under Section 2.1. 
Depomed shall not practice the Solvay Technology outside the scope of
its licenses under Section 2.1.


 


ARTICLE 3

PAYMENTS


 


3.1                               Fees.  In consideration for the licenses and other rights granted
herein, Solvay will pay to Depomed a nonrefundable, non-creditable license fee
of Ten Million Dollars ($10,000,000). 
Solvay will also pay to Depomed a nonrefundable, non-creditable fee of
Fifteen Million Dollars ($15,000,000) as reimbursement for costs incurred by
Depomed in connection with the research and development of the Product (the
payments described in this Section 3.1 are


 


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hereinafter referred to as the
“Upfront Fee”).  The Upfront Fee will be paid to Depomed
within sixty (60) days following the Effective Date.


 


3.2                               Milestone
Payments.  In consideration for the licenses and
other rights granted under this Agreement, Solvay shall pay to Depomed each
amount set forth on Exhibit A within thirty (30) days after the first
achievement of the corresponding milestone identified therein by Solvay, its
Affiliates or their sublicensees.  Each
such milestone payment shall be payable one time, and shall be nonrefundable
and non-creditable.


 


3.3                               Running
Royalty.  In consideration for the licenses and
other rights granted under this Agreement, Solvay shall pay to Depomed
incremental royalties based on the Net Sales (by Solvay and its Affiliates and
sublicensees), during the term of this Agreement.  The royalty rate shall be tiered based on the
level of aggregate annual Net Sales of the Product in a given Year following
the date upon which Launch of Product in the Field and in the Territory occurs,
or any anniversary of such date, as set forth in the following table:


 




	
  Royalty Rate

  	
   

  	
  Portion of Net Sales in a Year

  
	
   

  	
   

  	
   

  
	
  14

  	
  %

  	
  < $[***]

  
	
   

  	
   

  	
   

  
	
  16

  	
  %

  	
  > $[***] but < $[***]

  
	
   

  	
   

  	
   

  
	
  20

  	
  %

  	
  > $[***]

  






 


Royalties
shall be calculated using the applicable royalty rate or rates set forth in the
table above and shall be determined based on the annual Net Sales for the Year
in question, and shall be paid at the rate applicable to the portion of Net
Sales within each of the above Net Sales tiers during such Year.  The royalty rates determined in accordance
with this Section 3.3 are incremental rates, which apply only for the
respective increment of annual Net Sales described in the “Portion of Net Sales in a Year” column
in the table above.


 


3.4                               Reports
and Payments.  Within twenty-five (25) days after the end
of each Calendar Quarter, Solvay shall submit to Depomed a report setting out
the sales of the Product in the Territory in such quarter in reasonably
sufficient detail, but not including any specific customer data, to
substantiate its calculation of any payments payable under this Agreement with
respect to such Calendar Quarter, including without limitation the gross amount
invoiced for and the Net Sales resulting from sales of the Product sold by
Solvay, its Affiliates and their respective sublicensees during such Calendar
Quarter reporting period and the specific deductions applied in the calculation
of such Net Sales amounts (the “Quarterly Report”).  Solvay shall require its Affiliates and
sublicensees to record information regarding Net Sales of Product that Solvay
is obligated to report under this Section 3.4, and shall provide such
information to Depomed for purposes of confirming payments due to Depomed.  In conjunction with its submission to Depomed
of the Quarterly Report, Solvay shall pay to Depomed the full amount of any
payments due under this Agreement with respect to such Calendar Quarter.


 


3.5                               Right
to Audit.  Solvay shall keep records in sufficient detail
to permit the determination of Net Sales and royalties payable under this Agreement,
as well as Detailing


 


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Costs and
Promotional Expenditures incurred by Solvay under this Agreement.  Solvay shall also keep or cause to be kept
such records as are required to determine the number of sales representatives
used to provide Details in the Territory and to verify the information required
to be provided pursuant to Section 4.6. 
At the request and expense of Depomed, Solvay shall permit an
independent certified public accounting firm of nationally recognized standing
or another mutually acceptable accounting firm, which is subject to a
confidentiality agreement with Solvay, to examine during ordinary business
hours, no more than once in each Calendar Year and upon no less than thirty
(30) days prior written notice, such records of Solvay and its sublicensees and
their respective Affiliates as may be necessary or reasonably useful to verify
the accuracy or completeness of any report or payment made under this Agreement
for any Calendar Year period ending not more than three (3) years prior to
the date of such request.  These rights
with respect to any Calendar Year shall terminate three (3) years after
the end of any such Calendar Year. 
Depomed shall provide Solvay with a copy of such accounting firm’s
written report within thirty (30) days after completion of such report.  If such accounting firm concludes that an
overpayment or underpayment exists, then the owing Party shall pay the amount
due to the other Party within thirty (30) days after the date Depomed delivers
to Solvay such accounting firm’s written report so concluding, provided that
such payment shall include interest determined in accordance with Section 3.8
from the date any such underpayment was originally due, as applicable, until
payment thereof.  Depomed shall bear the
full cost of such audit unless such audit discloses that any underpayment by
Solvay for the audited period is more than five percent (5%) of the amount
actually due for that audited period, in which case Solvay shall pay the
reasonable fees and expenses charged by the accounting firm.


 


3.6                               Manner
of Payment; Exchange Rate.  All payments to be made by Solvay to
Depomed under this Agreement shall be made in Dollars from a Solvay entity
located in the United States and shall be paid by electronic transfer in
immediately available funds to such bank account in the United States
designated in writing by Depomed.  When
calculating the Net Sales, the amount of such sales in foreign currencies shall
be converted into Dollars at the spot rate for buying Dollars published in the
Wall Street Journal as of last day of the applicable measurement or activity
period (e.g., Calendar Quarter, month, etc.). 
Solvay shall provide reasonable documentation of the calculation and
reconciliation of the conversion figures on a country-by-country basis as part
of its report of Net Sales for the period covered under the Quarterly Report.


 


3.7                               Withholding
Taxes.  In the event that any royalties or other payments due to
Depomed are subject to withholding tax required by Applicable Law to be paid by
Solvay to the taxing authority of any foreign country on Depomed’s behalf,
Solvay may deduct the amount of such tax from the applicable royalties or other
payment otherwise payable to Depomed.  In
such event, Solvay shall pay the taxes to the proper taxing authority and shall
send evidence of the obligation together with proof of payment to Depomed
following such payment and shall reasonably cooperate with Depomed in its
efforts to avoid or minimize such withholding obligations and/or to obtain
credit for payment thereof.


 


3.8                               Interest Due.  Solvay shall pay Depomed interest on any
payments that are not paid on or before the date such payments are due under
this Agreement at a rate of one percent (1%) per month, or the maximum
applicable legal rate, if less, calculated based on the total number of days
payment is delinquent.


 


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ARTICLE 4

DEVELOPMENT, PROMOTIONAL AND COMMERCIALIZATION ACTIVITIES


 


4.1                               Development.  Depomed shall be responsible for completing those clinical
development and manufacturing activities for Product in the Field and in the
Territory that are being conducted or are planned as of the Effective Date and
are set forth in Exhibit D, at Depomed’s sole expense (though Depomed will
include Solvay in the performance of these activities).  Solvay shall be responsible, at its sole
expense, for conducting all other development, manufacturing (to the extent not
performed by Depomed pursuant to Section 4.8) and regulatory activities
for Product in the Field and in the Territory.


 


4.2                               Commercially
Reasonable Efforts to Commercialize.  Commencing upon issuance to Solvay of
Regulatory Approval with respect to the Product in a country of the Territory,
Solvay will exercise Commercially Reasonable Efforts to commercialize the
Product in the Field in such country of the Territory.  Without limiting the foregoing, Solvay shall,
itself or through Affiliates or sublicensees, Launch the Product in each
country of the Territory within [***] days after it receives a letter from the
Regulatory Authority in such country stating that the Product is approved in
such country.


 


4.3                               Specific
Activities.  Subject to Section 4.2
and provided that no Generic Product has been approved for commercial sale in
the Field in the United States, and except to the extent limited by
restrictions imposed by any Governmental Authority or Applicable Law, Solvay
agrees to engage in the following specific activities relating to the Product
in the United States:


(a)                                  Creation
of [***];


 


(b)                                  Creation
of [***];


 


(c)                                  [***];


 


(d)                                  [***];


 


(e)                                  [***];


 


(f)                                    [***];


 


(g)                                 [***];


 


(h)                                 [***];


 


(i)                                    [***];


 


(j)                                    [***];


 


(k)                                [***];


 


(l)                                    [***];


 


(m)                              [***];


 


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(n)                                 [***];


 


(o)                                  Creation
of [***];


 


(p)                                  [***]; and


 


(q)                                  Creation
of [***].


 


4.4                               Promotional
Requirements.  Provided that no Generic Product has been
introduced in the Field in the United States, and except to the extent
expressly prohibited or restricted by Governmental Authority or Applicable Law,
Solvay shall, in the United States, perform the activities described in
subsections (a) and (b):


 


(a)                                  conduct
Details with respect to the Product in the Field in the Territory as follows:


 


(i)                                    if
the AE Profile relating to somnolence is [***], then a
minimum of [***]; or


 


(ii)                                if
the AE Profile relating to somnolence is [***], then a
minimum of [***]; and


 


(b)                                  spend
not less than:


 


(iii)                            [***]
Dollars  ($[***])  on Promotional Expenditures in and/or [***];


 


(iv)                               [***]
Dollars  ($[***])  on Promotional Expenditures in [***];


 


(v)                                   in
[***], an amount equal to [***]; and


 


(vi)                               in
[***], an amount equal to [***].


 


4.5                               Compliance
with Applicable Law.


 


(a)                                  Solvay
will comply in all material respects with all Applicable Laws.  Solvay acknowledges and agrees that all of
its sales representatives and other employees and agents are not, and are not
intended to be or be treated as, employees of Depomed or any of its Affiliates,
and that such individuals are not, and are not intended to be, eligible to
participate in any benefits programs or in any “employee benefit plans”, as
such term is defined in Section 1002(3) of the Employee Retirement
Income Security Act of 1974, as amended, that are sponsored by Depomed or any
of its Affiliates or that are offered from time to time by Depomed or its
Affiliates to their own employees. 
Solvay shall be solely responsible and liable for the payment of all
compensation and benefits under any such benefit plans to such sales
representatives and other employees and agents, even if it is subsequently
determined by any court, the Internal Revenue Service or any other governmental
agency that such individual may be deemed a common law employee of Depomed or
any of its Affiliates.


 


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4.6                               Reports. 
Solvay shall record [***].  Such
records shall be maintained for at least three (3) years after the end of
the Calendar Year to which they pertain. 
Within ten (10) days after the end of each Calendar Quarter, Solvay
shall provide a report to Depomed containing [***].  Depomed shall have the right, through a Third
Party subject to a confidentiality agreement with Solvay at its own expense, to
audit Solvay’s records to confirm the accuracy of such report as provided in Section 3.5
and to confirm Solvay’s compliance with this Article 4.


 


4.7                               Product
Pricing.  For the avoidance of doubt, Solvay shall
have the right, in its sole discretion, to establish the prices at which Solvay
will sell the Product in the Field in the Territory.


 


4.8                               Manufacturing
and Supply.


 


(a)                                  Depomed
shall supply Product for use in conducting Depomed’s development activities for
Product in the Field and in the Territory as set forth in Exhibit D.


 


(b)                                  During the four-year period beginning on the
Effective Date (the “Supply Period”), Depomed shall supply and package (or have
supplied and packaged) Product pursuant to this Section 4.8.  Depomed will use commercially reasonable
efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be
freely assignable to Solvay or its Affiliates, successors or assigns at any
time.  In addition, Depomed and Solvay will negotiate and enter
into a Product supply agreement with business terms substantially similar to
the Depomed Supply Agreement concurrently with the execution and delivery by
Depomed and [***] of the Depomed
Supply Agreement (the “Solvay Supply
Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”).  The Supply Agreements will, together, contain
the following provisions (among others mutually agreeable to the Parties):


 


(i)                                    Under the Solvay Supply Agreement, Depomed
will agree to supply Solvay with its requirements of finished, packaged
Product during the Supply Period;


 


(ii)                                All
manufacturing and records will be performed and maintained in accordance with
specifications, cGMP and Applicable Law;


 


(iii)                            Depomed
will provide reasonable assistance to Solvay in the event Solvay wishes to
qualify a backup Product manufacturer;


 


(iv)                               Depomed
shall [***];


 


(v)                                   Solvay
will pay Depomed the following amounts in connection with all activities
performed by or on behalf of Depomed associated with Product manufacture and
supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in
connection with such manufacture and supply of Product to Solvay, and (B) a
labor charge equal to the FTE Charges for all Depomed employees allocated to
the manufacture and supply of Product to Solvay, not to exceed FTE Charges for
an aggregate of [***] during any given calendar
quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE
Charges for which Solvay must pay Depomed hereunder);


 


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(vi)                               Payments
for activities described in subsection (v) will be made to Depomed within
twenty (20) days after Solvay’s receipt of an invoice from Depomed, with the
Solvay Manufacturing Agreement to include provisions specifying the allocation
of costs between the Product for use within and outside the Field as
applicable; and


 


(vii)                           Depomed
and Solvay will establish a CMC committee including quality, regulatory and
manufacturing personnel, which committee will meet on a monthly basis
throughout the Supply Period to coordinate Product manufacturing and supply
activities.


 


(c)                                  The
Parties acknowledge [***].


 


4.9                               Rights
of First Negotiation.


 


(a)                                  If
Solvay develops and obtains Regulatory Approval of Product for a fibromyalgia
indication, Solvay shall and hereby does grant to Depomed a right of first
negotiation to co-promote the Product in the Field in the Territory solely for
the fibromyalgia indication and solely to obstetricians and gynecologists.  Solvay shall notify Depomed in writing no
later than [***] prior to [***].  If Depomed is
interested in negotiating with Solvay the terms under which Depomed would
co-promote the Product for such indication to obstetricians and gynecologists
in the Territory, it shall so notify Solvay in writing within [***] days after Depomed receives such notice from
Solvay.  For [***]
days after Solvay’s receipt of Depomed’s notice of interest, the Parties shall
negotiate in good faith the terms of a co-promotion agreement for such
indication in the Territory with respect to obstetricians and
gynecologists.  If the Parties do not
execute a co-promotion agreement within such [***]
day period of time, Solvay shall be free to promote itself or with or through
Third Parties the Product for such indication to obstetricians and
gynecologists in the Territory; provided, however, that Solvay shall not grant
to any Third Party the right to co-promote Product for such indication to
obstetricians and gynecologists in the Territory [***].


 


(b)                                  If
Depomed desires to offer to Third Parties the opportunity to participate in [***].  Depomed shall
so notify Solvay in writing prior to offering such opportunity to any Third
Party.  If Solvay is interested in
negotiating with Depomed the terms under which Solvay would [***], it shall so notify Depomed in writing within [***] days after it receives such notice from Depomed.  If Solvay so notifies Depomed, the Parties
shall negotiate in good faith during the [***] day period
following Depomed’s receipt of Solvay’s notice of interest the terms under
which Solvay may [***].  If the Parties do not execute an agreement or
[***] within such [***]
day time period, or if Solvay does not provide a notice of interest within such
[***] day time period, then Depomed
shall have no further obligation to Solvay with respect to [***].


 


ARTICLE 5


REGULATORY


 


5.1                               Regulatory Responsibilities in the United States.


 


(a)                                  Solvay
shall be responsible for making all Regulatory Filings and seeking Regulatory
Approvals for the Product in the Field in the United States, including


 


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without limitation submitting
all reports and responses necessary as part of a Drug Approval
Application.  All Regulatory Filings in
the Field in the United States shall be filed in the name of Solvay, and Solvay
shall be responsible for all communications, meetings and other dealings with
the Governmental Authorities relating to the Product in the Field in the United
States, at its expense.


 


(b)                                  Subject
to Section 5.1(a), Depomed shall be primarily responsible, in consultation
with Solvay, for preparing the first Drug Approval Application for the Product
in the Field in the United States, including without limitation preparing all
reports necessary to support such Drug Approval Application.  Depomed shall also be responsible for preparing
responses for review and submission by Solvay to address any deficiencies or
other issue arising in the Drug Approval Application identified by FDA during
the course of review. Solvay shall have the right to provide substantive and
procedural comments on all such Drug Approval Applications and related filings
and documents reasonably in advance of the anticipated filing or performance
dates. Solvay shall have the right to participate in person or via
teleconference (at Solvay’s election) at any internal Depomed meetings related
to such Drug Approval Application.


 


(c)                                  Until
such time as the Product is approved by FDA in the Field in the United States,
Depomed will provide consulting services to Solvay free of charge to enable
Solvay to assume all responsibilities for making Regulatory Filings and
obtaining Regulatory Approval of Product in the Field and in the United States
to facilitate Solvay’s assumptions of its responsibilities under this
Section.  Following FDA approval of the
Product in the Field in the United States, Depomed will provide a reasonable
number of hours of consulting services, not to exceed a total of [***] hours of such services, free of charge.  The Parties will coordinate reasonable times
and places for such services to be provided. 
If Solvay so requests in writing, Depomed shall provide a reasonable
amount of additional consulting services at times, rates and places mutually
acceptable to the Parties.  Solvay shall
reimburse Depomed’s FTE Charges of providing such additional consulting
services within thirty (30) days after receiving an invoice for such services
from Depomed.


 


(d)                                  Solvay
shall provide Depomed with copies of, and Depomed shall have the right to
reference, use and rely on for the purpose of seeking approval of the Product
outside the Field in the Territory and in all fields outside of the Territory,
all information and underlying data contained in or otherwise relating to all
such Drug Approval Applications for Product filed in the United States by
Solvay, its Affiliates and sublicensees. 
Depomed shall reimburse Solvay for incremental out of pocket costs
incurred by Solvay in connection with Depomed’s exercise of its rights pursuant
to the preceding sentence.  Solvay shall
have a right to reference, use and rely upon the information and underlying
data contained in or otherwise relating to the Drug Approval Applications filed
by Depomed for Product outside the Field in the United States.


 


(e)                                  Solvay
agrees to provide Depomed with a copy (in electronic word processing form) of
all Regulatory Filings with respect to the Product in the Field in the United
States promptly upon the making or submission of such Regulatory Filing.  Solvay shall provide Depomed with advance
notice of any meetings with Governmental Authorities relating to Development
and/or a Drug Approval Application in the United States and


 


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Depomed shall have the right to
observe such meetings.  Solvay shall
promptly furnish Depomed with copies of all correspondence, notes,
communication or minutes of meetings with FDA in each case relating to
Development and/or a Drug Approval Application for the Product in the Field in
the United States.  As between the
Parties, Solvay shall be the legal and beneficial owner of all Drug Approval
Applications and related approvals in United States for the Product in the
Field, subject to Section 8.5. 
Depomed agrees to provide Solvay with a copy (in electronic word
processing form) of all Regulatory Filings with respect to the Product for the
VMS Indication in the United States promptly upon the making or submission of
such Regulatory Filing and to promptly furnish Solvay with copies of all
correspondence, notes, communication or minutes of meetings with any
Governmental Authority in each case relating to Development and/or a Drug
Approval Application for the Product outside the Field, provided that Depomed
shall only be obligated to provide Product Data or information that is safety
data, or specific to the Product for use in the Field.


 


(f)                                    Notwithstanding
anything to the contrary in this Agreement, the reporting of all Adverse Events
and other safety issues relating to the Product shall be handled in accordance
with Sections 5.3, 5.5 and 5.6, and the Pharmacovigilance Agreement.


 


(g)                                 In
the event that FDA threatens or initiates any action to remove the Product from
the market in the Field or in any other field in the United States, the Party
that receives a communication relating to such threatened or initiated action
shall notify the other Party of such communication within one (1) Business
Day after receipt.


 


5.2                               Regulatory Responsibilities in the OUS Territory.


 


(a)                                  Solvay
shall be responsible for preparing and filing Regulatory Filings and seeking
Regulatory Approvals for the Product in the Field in such countries within the
OUS Territory in which Solvay desires, including without limitation preparing
all reports necessary as part of a Drug Approval Application.  The Parties intend that all Drug Approval
Applications for the Product in the Field in the OUS Territory will be
comprised of the Drug Approval Application submitted by Solvay to the FDA as
described in Section 5.1(b), plus such additional data and reports not
required to be submitted to the FDA but required to be submitted in the OUS
Territory.


 


(b)                                  All
Regulatory Filings for the Product in the Field in the OUS Territory shall be
filed in the name of Solvay, and Solvay alone shall be responsible for all
communications and other dealings with the Governmental Authorities relating to
the Product in the OUS Territory.  Solvay
shall provide Depomed with advance notice of any meetings with Governmental
Authorities relating to the Product in the OUS Territory and Depomed shall have
the right to observe such meetings. 
Depomed shall have the right of cross reference, and to use and rely on,
all such Drug Approval Applications filed in the OUS Territory by Solvay, its
Affiliates or sublicensees.  Depomed
shall reimburse Solvay for incremental out of pocket costs incurred by Solvay
in connection with Depomed’s exercise of its rights pursuant to the preceding
sentence.  In addition, Solvay shall at
all times have the right to cross reference, use and rely upon any and all
portions of Drug Approval Applications filed by Depomed for the VMS Indication
in the OUS Territory.


 


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(c)                                  Solvay
agrees to provide Depomed with a copy (which may be wholly or partly in
electronic form) of all Regulatory Filings with respect to the Product in the
Field in the OUS Territory that it plans to make hereunder reasonably in
advance of the date it intends to make such filings, and will reasonably
respond to any questions that Depomed may have regarding such Regulatory
Filings.  As between the Parties, Solvay
shall be the legal and beneficial owner of all Drug Approval Applications for
the Product in the Field and related approvals in the OUS Territory.  Depomed agrees to provide Solvay with a copy
(which may be wholly or partly in electronic form) of all Regulatory Filings
with respect to the Product for the VMS Indication in the OUS Territory
promptly upon the making or submission of such Regulatory Filing, provided that
Depomed shall not be obligated to provide any Product Data or information that
is not safety data and that is not specific to Product for use outside the
Field.


 


(d)                                  After
receipt of any Regulatory Approval of a Drug Approval Application for the
Product in the Field in the OUS Territory hereunder, Solvay shall retain
primary responsibility for dealings with any Governmental Authority with
respect thereto, including filing all supplements and other documents with such
agency with respect to such Drug Approval Application.  Notwithstanding the foregoing, the reporting
of all Adverse Events and other safety issues relating to the Product shall be
handled in accordance with Sections 5.3, 5.5 and 5.6, and the Pharmacovigilance
Agreement.


 


(e)                                  In
the event that any Governmental Authority threatens or initiates any action to
remove the Product in the Field or in any other field from the market in the
OUS Territory, the Party that receives a communication relating to such
threatened or initiated action shall notify the other Party of such
communication within one (1) Business Day after receipt.


 


5.3                               Adverse
Event Reporting.  Each Party shall notify the other of all
information coming into its possession concerning any and all Adverse Events
associated with commercial or clinical uses, studies, investigations or tests
with the Product throughout the world, whether or not determined to be
attributable to the Product and whether or not related to the Field (“Adverse
Event Reports”).  The Parties shall each
identify a person to coordinate the exchange of Adverse Event Reports so as to
enable timely reporting of such Adverse Event Reports to appropriate
Governmental Authorities consistent with all Applicable Laws.  Within sixty (60) days following the
Effective Date, the Parties shall agree in writing on formal procedures for
such exchange in a separate pharmacovigilance agreement (the “Pharmacovigilance
Agreement”).


 


5.4                               Copies
of Responses.  Not later than ten (10) Business Days
prior to submission of responses to any Governmental Authority on product
safety issues regarding the Product, a copy of a near final draft response will
be provided to the other Party for review and comment.  Final copies of responses submitted to any
Governmental Authority will be provided to the other Party within five (5) Business
Days after submission of such response to any Governmental Authority.


 


5.5                               Regulatory
Actions.  The Party responsible to interact with a
Governmental Authority on a specific safety issue regarding the Product must
communicate the action requested by the Governmental Authority to the other
Party without delay.  Such actions may


 


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include, for
example, change in label, Dear Doctor letter, trial on hold for clinical safety
reasons and the like.


 


5.6                               Safety
Database.  The Parties shall, within sixty (60) days
after the Effective Date, agree upon procedures by which each Party shall
report safety data. The Parties acknowledge and agree that a worldwide safety
database will be held and maintained by Solvay and that Depomed will transfer
Product safety data Controlled by Depomed as of the Effective Date to Solvay
for inclusion in such database as described in the Pharmacovigilance Agreement.


 


5.7                               Product
Withdrawals and Recalls.  In the event that either Party (a) determines
that an event, incident, or circumstance has occurred which may result in the
need for a recall or other removal of the Product or any lot or lots thereof
from the market in the Field in the Territory; (b) becomes aware that a
Governmental Authority in the Territory is threatening or has initiated an
action to remove the Product from the market; or (c) is required by any
Governmental Authority in the Territory to distribute a “Dear Doctor” letter or
its equivalent, regarding use of the Product, such Party shall promptly advise
the other Party in writing with respect thereto, and shall provide to such
other Party copies of all relevant correspondence, notices, and the like.  Solvay shall be responsible for conducting
any recall of the Product in the Field, whether voluntary or involuntary, or
taking such other remedial action required by Applicable Laws or agreed to by
the Parties.  At Solvay’s request,
Depomed shall assist Solvay with respect to any such recall or remedial action,
and will provide Solvay with all information that Solvay may request in
connection with its dealings with a Governmental Authority in connection with
such recall or remedial action.  If any
recall of the Product is implemented as a result of Depomed’s material breach
of its obligations under this Agreement or its negligence, Depomed shall bear
that portion of all direct expenses incurred by Solvay in connection with such
recall attributable to such material breach or negligence.  For any and all recalls of Product in the
Field in the Territory required due to any other reason, Solvay shall bear all
expenses incurred in connection with such recall.


 


ARTICLE 6

REPRESENTATIONS, WARRANTIES AND COVENANTS


 


6.1                               Representations,
Warranties and Covenants of Depomed.  Depomed hereby represents and warrants to
Solvay as follows:


 


(a)                                  As
of the Effective Date, Depomed owns all right, title and interest in and to all
Depomed Technology;


 


(b)                                  As
of the Effective Date, Depomed is not aware of any Third Party rights or
technology it reasonably believes are necessary to develop, manufacture and
commercialize the Product as it exists as of the Effective Date in the Field in
the Territory;


 


(c)                                  Depomed
possesses all approvals, consents, licenses and permits required for the
performance of its obligations hereunder, and all such approvals, consents,
licenses and permits are in full force and effect;


 


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(d)                                  To
the best of Depomed’s knowledge after reasonable inquiry, the practice of the
Depomed Technology in connection with the development, manufacture, use, sale,
importation or commercialization of the Product as it exists as of the
Effective Date does not misappropriate or infringe the patent rights,
copyrights, trademark rights, know-how, or other intellectual property rights
of any Third Party, and Depomed has no knowledge of any patents or patent
applications owned by a Third Party and not licensed to Depomed that would be
infringed by the development, manufacture, use, sale, importation or
commercialization of Product in the Field in the Territory, nor has Depomed
received any written claims from Third Party with respect to such matters;


 


(e)                                  Depomed
has not utilized and will not utilize, in conducting development or commercialization
of the Product, any person or entities that at such time are debarred by FDA,
or that, at such time, are under investigation by FDA for debarment action
pursuant to the provisions of the Generic Drug Enforcement Act of 1992 (21
U.S.C. § 335);


 


(f)                                    To
the best of Depomed’s knowledge after reasonable inquiry, no claim is pending
or threatened alleging that a Depomed Patent is invalid or unenforceable; and


 


(g)                                 The
Product supplied by or on behalf of Depomed for use in clinical development
activities in the Field and in the Territory shall have been manufactured in
accordance with applicable Product specifications and Applicable Laws in the
Territory.


 


6.2                               Representations,
Warranties and Covenants of Solvay.  Solvay hereby
represents and warrants to Depomed as follows:


 


(a)                                  Solvay
has not utilized and will not utilize, in conducting development or
commercialization of the Product, any person or entities that at such time are
debarred by FDA, or that, at such time, are under investigation by FDA for
debarment action pursuant to the provisions of the Generic Drug Enforcement Act
of 1992 (21 U.S.C. § 335);


 


(b)                                  Solvay
has obtained, and during the term of this Agreement shall maintain, all
licenses, authorizations, and permissions necessary under Applicable Law for
the meeting and performing its obligations under this Agreement and all such
licenses, authorizations, and permissions are in full force and effect;


 


(c)                                  All
Product manufactured and supplied by or on behalf of Solvay shall have been
manufactured in accordance with applicable Product specifications and
Applicable Laws in the Territory; and


 


(d)                                  No
Product sold in the Territory by Solvay, its Affiliates or sublicensees shall
be adulterated within the meaning of Section 501 of the Federal Food, Drug
and Cosmetic Act.


 


6.3                               Mutual
Representations and Warranties.  Each Party represents and warrants to the
other Party that:


 


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(a)                                  in
the conduct of its business and performance of its obligations hereunder, it
will observe and comply in all material respects with all applicable country,
state and local laws, rules and regulations in the Territory;


 


(b)                                  it
has the legal right and power to enter into this Agreement and to perform fully
its obligations hereunder;


 


(c)                                  this
Agreement has been duly authorized and approved by all necessary and proper
action of such Party;


 


(d)                                  this
Agreement has been duly executed and delivered and is a legal, valid and
binding agreement of such Party, enforceable against such Party in accordance
with its terms;


 


(e)                                  it
has obtained all necessary Third Party approvals for the transactions contemplated
hereby, except with respect to HSR Filings provided for in Section 12.7;


 


(f)                                    it
has not made nor will it make any commitments to any Third Party or Affiliate
that are in conflict with or in derogation of such rights of this Agreement;


 


(g)                                 the
execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder will not violate, conflict with or breach the terms of
such Party’s organizational or governing documents or any covenant, agreement
or undertakes that such Party has with any Third Party as of the Execution Date
or any order, ruling decree, judgment, arbitration award or stipulation to
which such Party is subject; and


 


(h)                                 it
has enforceable written agreements with all of its employees, consultants, or
independent contractors who receive Confidential Information under this
Agreement obligating them to keep such information confidential and to use such
information only as permitted in this Agreement, and assigning to such Party
ownership of all intellectual property rights created in the course of their
employment.


 


6.4                               DISCLAIMER.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE
TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY THE PARTIES ARE
PROVIDED “AS IS” AND, EXCEPT AS EXPRESSLY PROVIDED UNDER SECTION 6.1
THROUGH 6.3 AND SECTIONS 11.2 AND 11.3, EACH PARTY EXPRESSLY DISCLAIMS ANY AND
ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF
DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF
THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF
DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.


 


ARTICLE 7

INTELLECTUAL PROPERTY


 


7.1                               Existing
Proprietary Rights.  Each Party agrees and acknowledges that,
except as expressly granted under this Agreement, such Party shall acquire no
rights of any kind


 


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whatsoever with
respect to any intellectual property rights of the other Party existing as of
the Effective Date.


 


7.2                               Further
Information.  From time to time upon written request
from Solvay, Depomed shall provide to Solvay a complete listing of the issued
patents and pending patent applications included in the Depomed Patents,
including the status of any such applications or patents.  Solvay shall promptly disclose to Depomed all
Solvay Inventions and/or Joint Inventions that are necessary or reasonably
useful for the development, manufacture, use or commercialization of Product in
any field.  Depomed shall promptly
disclose to Solvay all Depomed Inventions and/or Joint Inventions that are
necessary or reasonably useful for the development, manufacture, use or
commercialization of Product in the Field.


 


7.3                               New Inventions.


 


(a)                                  Inventorship
of Inventions shall be determined in accordance with U.S. patent laws.  Each Party shall promptly notify the other
Party after it first learns of the conception of any Solvay Invention, Depomed
Invention or Joint Invention, in each case to the extent necessary or useful
for the development, manufacture, use or commercialization of Product, and
provide the other Party with a copy of any patent applications it proposes to
file within the time period provided in Section 7.4.  All Depomed Inventions, and all intellectual
property rights therein, shall be the property of Depomed.  All Solvay Inventions, and all intellectual
property rights therein, shall be the property of Solvay, subject to Section 7.3(b).  All Joint Inventions, and all intellectual
property rights therein, shall be jointly owned by the Parties such that each
Party has an undivided one-half (1/2) interest, without a duty of accounting to
the other Party, in and to such Joint Invention, subject to Section 7.3(b).  In the event that a jurisdiction requires
consent of co-owners for one co-owner to grant license rights under or
otherwise exploit jointly owned intellectual property, each of the Parties
hereby consents to such license grant under or exploitation of such
intellectual property by the other Party without a requirement of accounting.


 


(b)                                  Notwithstanding
Section 7.3(a), as between the Parties, Depomed shall solely own all
right, title, and interest in and to all Inventions that describe, claim, cover
or relate to Formulation Technology and/or the Product or the use, composition,
formulation or method of making products based on the Formulation Technology
and/or the Product, and all Patent Rights claiming the foregoing and all other
intellectual property rights therein including without limitation all rights to
enforce such Patent Rights.  Such
Inventions, Patent Rights and other intellectual property rights shall be
subject to the licenses granted to Solvay pursuant to this Agreement without
further consideration.  Depomed shall be
responsible, at its sole expense and discretion (subject to Section 7.4),
and if necessary with the cooperation of Solvay, for the preparation, filing, prosecution,
and maintenance of Patent Rights claiming such Inventions as set forth in Section 7.4.


 


(c)                                  Without
additional consideration, each Party hereby assigns to the other Party such of
its right, title and interest in and to any Inventions, Patent Rights claiming
them, and all other intellectual property rights therein, and shall require its
sublicensees and Affiliates, and all independent contractors, employees or
agents of such Party, its Affiliates, or its sublicensees, to so assign to the
other Party such of their right, title and interest in and to


 


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the foregoing, as is necessary
to effectuate the allocation of ownership of Inventions as set forth in this Section 7.3.  Each Party shall, and shall cause its
sublicensees and Affiliates, and all independent contractors, employees and
agents of such Party, its Affiliates, and sublicensees, to, cooperate with the
other Party and take all reasonable actions and execute such agreements,
declarations, assignments, legal instruments and documents as may be reasonably
required to perfect the other Party’s right, title and interest in and to
Inventions, Patent Rights and other intellectual property rights as set forth
in this Section 7.3.  Each Party
shall also include provisions in its relevant agreements with Third Parties
that effect the intent of this Section 7.3(c).


 


7.4                               Prosecution.


 


(a)                                  Individual Patent Filings. 
Each Party shall, to the maximum extent practicable, strive to separate
distinct embodiments within any new or pending Patent Applications that
describe and/or relate to distinct Inventions into separate Patent Applications
wherein the Invention, as defined by the claims, may be Inventions owned solely
by Depomed, Inventions owned solely by Solvay, or Joint Inventions.  Each Party shall have sole discretion and
responsibility to prepare, file, prosecute, and maintain Patent Rights claiming
Inventions that it solely owns, and shall be responsible for related reissue,
reexamination, opposition and interference proceedings.  At least thirty (30) days prior to the
contemplated filing date of any patent application claiming its solely-owned
Invention that is necessary or useful for development, manufacture, or use of
the Product, each Party shall submit to the other a substantially completed
draft thereof, confer with the other Party thereon, and make every reasonable
effort to adopt the other Party’s commercially reasonable suggestions regarding
the preparation of such patent application. 
Each Party shall copy the other Party on any official actions from any
government patent office and submissions to any government patent office with
respect to such patent application.  If
the reviewing Party does not provide a timely comment on such application,
official action or submission, it will be deemed to have no comments thereon.  Solvay shall bear all costs incurred pursuant
to this Section 7.4 for Patent Rights claiming Inventions that Solvay
solely owns, and Depomed shall bear all costs incurred pursuant to this Section 7.4
for Patent Rights claiming Inventions that Depomed solely owns.


 


(b)                                  Joint Patent Filings.  With
respect to all Patents and Patent Applications claiming Joint Inventions that
the Parties jointly own (the “Joint Patent Rights”),
Depomed shall have the first right, but not the obligation, to file, prosecute,
maintain, and defend such Joint Patent Rights on behalf of both Parties (the “Responsible Party”). 
At least thirty (30) days prior to the contemplated filing of such Joint
Patent Rights, Depomed shall submit a substantially completed draft of Joint
Patent Rights claiming the Joint Inventions that are owned jointly by the
Parties to Solvay for its approval, which shall not be unreasonably withheld,
delayed, or conditioned.  Except as set
forth in this Section 7.4(b), below, the Parties shall share equally the
costs of the preparation, filing, prosecution, and maintenance of all Joint
Patent Rights, pursuant to a mutually agreed plan for such activities and a
budget therefor (which plan shall include, without limitation, a listing of
countries in which such Joint Patent Rights will be filed, prosecuted, and
maintained).  Each Party’s one half
undivided interest in and to all Joint Patent Rights shall be included in the
Depomed Patents and the Solvay Patents, as applicable.  If Depomed does not wish to file, prosecute,
or


 


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maintain any Joint Patent
Rights or maintain or defend such a patent in a particular country, Depomed
hereby grants Solvay any necessary authority to file, prosecute, and maintain
such Joint Patent Rights or maintain or defend such Joint Patent Rights in the
name of both Parties if Solvay so requests. 
If either Party elects not to pay its portion of any shared costs for
Joint Patent Rights, it shall so notify the other Party, in which case the
other Party may proceed with respect to such Joint Patent Rights in its own
name and at its sole expense.  In such cases,
the Party electing not to pay its share of costs shall assign its entire right,
title, and interest in and to such Joint Patent Rights to the other Party, and
such Invention shall become an Invention solely owned by the other Party.


 


7.5                               Enforcement.


 


(a)                                  Designated Patent Rights.  “Designated
Patent Rights” shall mean (i) the Solvay Patents, and (ii) the
Depomed Patents, in each case claiming Inventions that, in the absence of
ownership thereof or an appropriate license thereto, would be infringed by the
manufacture (including without limitation through use of Formulation Technology
in such manufacture), use, import, offer for sale or sale of a Product in the
Field.


 


(b)                                  Notice.  Each Party
shall notify the other Party in writing of any alleged or threatened
infringement of the Designated Patent Rights and/or Joint Patent Rights of
which it becomes aware within thirty (30) days of the date such Party becomes
aware of such infringement (or, in the case of an action under the Drug Price
Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”),
five (5) days).  The notice shall
set forth the facts of such infringement in reasonable detail.


 


(c)                                  Infringement of Designated Patent Rights Relating to Formulation
Technology and/or Product.  If
a Third Party is infringing, or either Party reasonably believes a Third Party
may be infringing, any Designated Patent Right by reason of the manufacture,
use or sale of the Formulation Technology and/or the Product by such Third
Party, Depomed shall have the first right, but not the obligation, to
institute, prosecute, and control any action or proceeding with respect to such
infringement by counsel of its own selection, at its expense (with Solvay
having the right to participate in such action only if such infringement arises
by reason of the manufacture, use, or sale of products competitive with the
Product in the Field and in the Territory and be represented, if it so desires,
by counsel of its own selection and at its own expense in any such
action).  To the extent required by
Applicable Laws, Solvay agrees to be joined as a party plaintiff (with Solvay
having the right to be represented, if it so desires, by counsel of its own
selection and at its own expense) if necessary for Depomed to bring and
prosecute such action or proceeding, and to give Depomed reasonable assistance
and authority to bring and prosecute such action or proceeding.  If Depomed fails to bring an action or
proceeding within [***] days
after receiving or giving written notice pursuant to Section 7.5(b) (or,
in the case of an action under the Hatch-Waxman Act, [***] days),
then, if such action relates to infringement arising by reason of the
development, manufacture, use, commercialization or sale of products
competitive with the Product in the Field in the Territory, then, Solvay shall
have the right, but not the obligation, to bring and control any such action by
counsel of its own selection, at its expense. 
To the extent required by Applicable Laws, Depomed agrees to be joined as
a party plaintiff (with Depomed having the right to be represented, if it so
desires, by counsel of its


 


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own selection and at its own
expense in any such action) if necessary for Solvay to bring and prosecute such
action or proceeding, and to give Solvay reasonable assistance and authority to
bring and prosecute such action or proceeding. 
Each Party shall share in any recoveries obtained in connection
therewith, in the following proportion:  [***].  No settlement
or consent judgment or other voluntary final disposition of suit under this Section 7.5(c) may
be entered into without the consent of both Parties, which consents shall not
be unreasonably withheld, delayed, or conditioned.  Notwithstanding the foregoing, in the case of
an action under the Hatch-Waxman Act, if Depomed exercises its first right to
institute an action under this Section 7.5, then Depomed shall (i) obtain
Solvay’s consent, not to be unreasonably withheld, regarding counsel to conduct
such action, (ii) consult with Solvay on all reasonably material matters
arising in such action, and (iii) use reasonable efforts to address
concerns raised by Solvay in any such action. 
The immediately preceding sentence will not be deemed to undermine or
detract from Depomed’s first right to institute, prosecute, and control any
action or proceeding relating to the Formulation Technology and/or the Product.


 


(d)                                  Infringement of Joint Patent Rights That Are Not Designated Patent
Rights.  If a Third Party is
infringing, or the Parties reasonably believe a Third Party may be infringing,
any Joint Patent Right that is not a Designated Patent Right, they shall confer
in good faith to determine whether or not to enforce such Joint Patent Right
against such actual or alleged infringer, and which Party (if any) shall
institute, prosecute, and control any action or proceeding with respect to such
infringement (with the other Party having the right to participate in such
action and be represented, if it so desires, by counsel of its own selection
therein).  The costs of any such
infringement action shall be borne by the Parties in a manner they agree upon
at such time, and each Party shall share in any recoveries obtained in
connection therewith, equally or in the proportion they then agree upon.  No settlement or consent judgment or other
voluntary final disposition of suit under this Section 7.5(d) may be
entered into without the consent of both Parties, which consent shall not be
unreasonably withheld, delayed, or conditioned.


 


(e)                                  Infringement of Solely-Owned Patents That Are Not Designated Patent
Rights.  Each Party may, in
its sole discretion, decide whether to pursue an action against any actual or
alleged infringement of its solely-owned Patent Right that is not a Designated
Patent Right at its own expense, and the other Party shall cooperate in such
efforts to the extent such Patent Rights claim Inventions at the owning Party’s
expense and reasonable request.  The
owning Party shall retain any and all recoveries obtained in connection with
such action.


 


(f)                                    Oppositions by Parties.  If either Party desires to bring an
opposition, action for declaratory judgment, nullity action, interference,
reexamination, reissue or other attack upon the validity, title or
enforceability of any Patent Right controlled by a Third Party that covers the
manufacture, use, or sale of any Product in the Field in the Territory, such Party
shall so notify the other Party and the Parties shall promptly confer to
determine whether to bring such action or the manner in which to settle such
action.  The Party not bringing an action
under this Section 7.5(f) shall be entitled to separate representation
in such proceeding by counsel of its own choice and at its own expense, and
shall cooperate fully with the Party bringing such action.  The costs of any such action shall be borne
by the Parties, and each


 


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Party shall share in any
recoveries obtained in connection therewith, as the Parties may then agree.


 


7.6                               Infringement
of Third Party Rights.


 


(a)                                  Notice.  If the
Development, manufacture, use, sale, or commercialization of Product in the
Field and in the Territory pursuant to this Agreement results in a claim,
action, suit, or proceeding that such activity infringes or misappropriates the
Patent Rights or other intellectual property rights of a Third Party (“Third Party Infringement Claim”), the Party to this
Agreement first having notice shall promptly notify the other Party in
writing.  The notice shall set forth the
facts of the Third Party Infringement Claim in reasonable detail.


 


(b)                                  Litigation Related to Formulation Technology.  Depomed shall have the first
right, but not the obligation, to defend, at its expense, against any Third
Party Infringement Claim based on or arising out of an allegation that the
manufacture, use, import, offer for sale, sale, or other commercialization of
the Product in the Field by reason of the practice or incorporation of the
Formulation Technology pursuant to this Agreement (but not of other aspects of
the Product or any other component of the Product) infringes such Third Party’s
patent rights (collectively, “Formulation Technology
Infringement Claims”). 
Depomed shall have full control over the defense and settlement of Formulation
Technology Infringement Claims; provided, however, that any settlement that
could reasonably be deemed to affect Solvay adversely shall require Solvay’s
prior consent, not to be unreasonably withheld, delayed, or conditioned.  Solvay shall cooperate with Depomed, at
Depomed’s expense and reasonable request, in such defense and shall have the
right to be represented by counsel of its own choice, at Solvay’s expense.  If Depomed fails to defend against any
Formulation Technology Infringement Claim within [***]
days after first learning of such Formulation Technology Infringement Claim,
Solvay shall have the right, but not the obligation, to defend against such
Formulation Technology Infringement Claim with counsel of its own selection at
its expense.  To the extent required by
Applicable Laws, Depomed agrees to participate in such action (with Depomed
having the right to be represented, if it so desires, by counsel of its own
selection and expense therein) if necessary for Solvay to defend such action or
proceeding, to give Solvay reasonable assistance in such action or
proceeding.  The Party controlling the
defense of any such Formulation Technology Infringement Claim will initially
bear all associated costs (“Defense Costs”),
subject to the remainder of this Section 7.6(b) and to Article 11.  All Defense Costs incurred by either Party in
connection with a Formulation Technology Infringement Claim shall be [***].  If a Party would be entitled to require the
other Party to [***] seek
indemnification from the other Party pursuant to Section 11.2 or 11.3, as
applicable, in connection with such Formulation Technology Infringement Claim,
then such Party shall only be entitled to exercise its rights pursuant to
either this Section 7.6(b) or pursuant to Section 11.2 or 11.3,
as applicable, but not pursuant to both Section 7.6(b) and Section 11.2
or Section 11.3, as applicable, with respect to such claim.


 


(c)                                  Litigation Related to Product and Unrelated to Formulation Technology.  Solvay shall have the first right, but not
the obligation, to defend, at its expense, against any Third Party Infringement
Claim based on or arising out of an allegation that the manufacture, use,
import, offer for sale, sale, or other commercialization of a Product, or any


 


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component thereof by Solvay,
its Affiliates or sublicensees, infringes such Third Party’s patent rights that
is not a Formulation Technology Infringement Claim (collectively, “Non-Formulation Technology Infringement Claims”).  Solvay shall have full control over the
defense and settlement of such Non-Formulation Technology Infringement Claims;
provided, however, that any settlement that could reasonably be deemed to
affect adversely Depomed shall require Depomed’s prior consent, not to be
unreasonably withheld, delayed, or conditioned. 
Depomed shall cooperate with Solvay, at Solvay’s expense and reasonable
request, in such defense and shall have the right to be represented by counsel
of its own choice, at Depomed’s expense. 
Solvay will initially bear all costs associated with Non-Formulation
Technology Infringement Claims, subject to Article 11.


 


(d)                                  Oppositions by Third Parties.  If any of the Designated Patent Rights become
the subject of any proceeding commenced by a Third Party in connection with an
opposition, reexamination request, action for declaratory judgment, nullity
action, interference, or other attack upon the validity, title, or
enforceability thereof, then the Party Controlling such Designated Patent Right
shall control such defense at its sole cost; provided that if such action
relates to a Joint Patent Right, the Parties shall confer and determine which
Party shall control such action.  The
Controlling Party shall permit the non-Controlling Party to participate in the
proceeding to the extent permissible under Applicable Laws, and to be
represented by its own counsel in such proceeding, at the non-controlling Party’s
expense.  If either Party elects not to
defend against such action within [***] days
after first learning of such action or proceeding, then the other Party shall
have a backup right to assume defense of such Third Party action at its own
expense, provided that Solvay shall, as the other Party, only have such right
to the extent such Designated Patent Right is relevant to the development,
manufacture, packaging, use, sale or commercialization of Product in the Field
in the Territory.  Any awards or amounts
received in bringing any such action shall be first allocated to reimburse the
Parties’ expenses in such action, and any remaining amounts shall be retained
by the Party bringing such action.


 


(e)                                  Reporting. 
Notwithstanding the foregoing provisions of Section 7.6, if any
Third Party Infringement Claim is commenced, the Party responsible for
controlling defense and settlement of such claim shall provide quarterly
updates to the other Party on the status of any such claim during its pendency.


 


7.7                               Patent
Marking.  All Product labeling and/or packaging
inserts associated with the Product commercialized by Solvay, its Affiliates or
sublicensees shall carry, in a conspicuous location, a patent notice, with
appropriate patent numbers or indicia to the extent permitted by Applicable
Laws if such markings or such notice impact recoveries of damages or equitable
remedies available with respect to infringements of patents in the Territory,
in accordance with and when required by the Applicable Laws of the country in
which (a) the Product is sold, and (b) a claim in a patent included
in the Depomed Patents covering the Product exists (including without
limitation, in each case, Joint Patents).


 


7.8                               Orange
Book Listings.  When applicable, Solvay shall promptly notify
Depomed of Solvay’s intent to
list any issued patents
included in the Depomed Patents in the FDA’s “Orange Book” (i.e., the FDA’s
list of Approved Drug Product with therapeutic equivalence evaluations) for the
Product in the Field and in the Territory, in accordance with all Applicable


 


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Laws.  The Parties shall mutually agree upon the
Depomed Patents to be listed in the Orange Book for Product in the Field and in
the Territory, provided, however, that while NDA holder, Solvay shall have the
final decision with regard to any Patent related to the Product in the Field in
the Territory.


 


ARTICLE 8

TERM AND TERMINATION OF AGREEMENT


 


8.1                               Term.  This Agreement shall become effective on the Effective Date
and unless otherwise terminated pursuant to its terms, shall continue until the
longer of (a) expiration of the last Valid Claim; or (b) the
fifteenth (15th) anniversary of the Effective Date.  As used herein, “Valid Claim” shall mean a
claim of any issued and unexpired patent or patent application within the
Depomed Patents that has been pending approval for no more than ten (10) years
after the initial date of filing of such claim and that has not been held
invalid or unenforceable by a final decision of a court or governmental agency
of competent jurisdiction, which decision can no longer be appealed or was not
appealed within the time allowed.


 


8.2                               Termination
by Depomed.  Depomed may terminate this Agreement upon
sixty (60) days written notice to Solvay if Solvay is in material breach of
this Agreement and such breach is not cured within such sixty (60) day period.


 


8.3                               Termination
by Solvay.  Solvay may terminate this Agreement (a) upon
sixty (60) days written notice to Depomed if Depomed is in material breach of
this Agreement, and such breach is not cured within such sixty (60) day period,
or (b) upon thirty (30) days written notice following the occurrence of a
Termination Event.


 


8.4                               Termination
for Bankruptcy.  To the extent permitted under Applicable
Law, this Agreement may be terminated by either Party immediately upon written
notice to the other Party, in the event that the other Party files or has filed
against it a petition under the United States Bankruptcy Code (the “Bankruptcy
Code”), makes an assignment for the benefit of creditors, has a receiver
appointed for it or a substantial part of its assets, or otherwise takes
advantage of any statute or law designed for relief of debtors.  Notwithstanding the foregoing, the Parties
agree that all rights and licenses granted to Solvay hereunder are, for
purposes of Section 365(n) of the Bankruptcy Code, licenses of
intellectual property within the scope of Section 101 of the Bankruptcy
Code, and Depomed acknowledges that Solvay, as a licensee of such rights and
licenses hereunder, will retain and may fully exercise all of its rights and
elections under the Bankruptcy Code. 
Depomed further acknowledges that, without in any way limiting Solvay’s
rights or Depomed’s obligations hereunder, Solvay will be entitled to a
complete duplicate of (and complete access to) any such intellectual property
and all embodiments thereof upon written request of Solvay (a) upon
commencement of a bankruptcy or insolvency proceeding by or against Depomed,
unless Depomed or its representative or trustee elects to continue to perform
all of its obligations hereunder, or (b) if not delivered under clause (a) of
this Section 8.4 upon the rejection of this Agreement by or on behalf of
Depomed.


 


8.5                               Consequences
of Termination.  Upon expiration or termination of this
Agreement, the following shall apply (in each case only upon expiration or
termination of any applicable waiting period under the HSR Act):


 


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(a)                                  All
undisputed, outstanding payments due and payable to Depomed or Solvay shall be
paid.


 


(b)                                  Solvay
will return to Depomed any and all Depomed Technology and Product Data
transferred to it under this Agreement and will cease all use of the Depomed
Technology and Product Data.


 


(c)                                  Each
Party will return to the other Party or, if so directed by the other Party,
destroy any Confidential Information of the other acquired in connection with
this Agreement (except to the extent provided in or necessary for Depomed’s
exercise of its rights under this Section 8.5).


 


(d)                                  The
license set forth in Section 2.1(a), and all other rights granted to
Solvay under this Agreement, will terminate.


 


(e)                                  Solvay
shall and hereby does grant to Depomed, effective as of the effective date of
such expiration or termination, a fully paid-up, irrevocable, worldwide,
exclusive license, with the right to grant sublicenses, under all Patent Rights
Controlled by Solvay or its Affiliates as of the Effective Date to the extent
related to the Product and any Patent Rights describing, claiming, covering or
relating to Inventions then Controlled by Solvay, its Affiliates or
sublicensees to the extent related to or claiming technology reasonably necessary
to develop, manufacture or commercialize Product as the Product exists as of
the date of expiration or termination, and in the form developed or
commercialized by Solvay in the Field, to develop, make, use, sell, offer for
sale, and import such Product in all fields of use.


 


(f)                                    Depomed
shall and hereby does grant to Solvay, effective as of the effective date of
such expiration or termination of this Agreement, a fully paid-up, irrevocable,
worldwide, nonexclusive license, without the right to further sublicense, under
all the Solvay Inventions and Joint Inventions and under Patent Rights
Controlled by Depomed to the extent they claim such Solvay Inventions and Joint
Inventions, in each case that are assigned in whole or in part to Depomed
pursuant to Section 8.5(e), to develop, make, use, sell, offer for sale
and import products other than Product.


 


(g)                                 Upon
Depomed’s written request, Solvay shall execute all documents necessary to
transfer Solvay’s rights under any Third Party licenses obtained by Solvay, its
Affiliates or sublicensees in connection with the manufacture, development, use
or sale of Product in the Territory in the Field, to the extent such licenses
are transferable, and Depomed shall thereafter be responsible for all costs,
expenses and obligations associated with such Third Party licenses. If any such
licenses are not transferable, Solvay shall use reasonable efforts to assist
Depomed in securing access to such rights from the relevant Third Party.


 


(h)                                 Solvay
shall, without additional consideration, assign to Depomed all of its right,
title and interest in and to any Product-specific Trademark filed during the
course of and pursuant to the Agreement. 
Depomed shall bear the full costs and expense of and be solely
responsible for prosecuting, maintaining, enforcing and defending any
Product-specific Trademark so transferred after the effective date of
termination.


 


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Confidential Information, indicated by [***]
has been omitted from this filing and filed separately with the Securities
Exchange Commission


 


(i)       Upon Depomed’s request,
Solvay shall transfer to Depomed, at no cost to Depomed, and Depomed shall have
the right to use, all materials, Product samples, Product supplies, Product
components, results, analyses, reports, websites, marketing materials,
Regulatory Filings, and Regulatory Approvals, in each case that are reasonably
required by Depomed to continue the development, manufacture, use, or
commercialization of Product after termination of this Agreement, in whatever
form developed, and that are controlled or generated as of the effective date
of such termination by or on behalf of Solvay, its Affiliates or sublicensees
with respect to the Product.  Solvay
shall submit to the FDA and other Regulatory Authorities in the Territory in
jurisdictions in which any regulatory filings have been made with respect to
the Product by Solvay, its Affiliates or sublicensees, within thirty (30) days
after the effective date of such termination, a letter (with a copy to Depomed)
notifying the FDA and such other Regulatory Authorities of the transfer of any
regulatory filings for the Product in such jurisdictions from Solvay to
Depomed.  Additionally, Solvay will grant
to Depomed any rights of reference or access to Regulatory Filings made by
Solvay, its Affiliates or sublicensees that are necessary to practice the
rights granted to Depomed under this Section 8.6(i).  All transfers described in this Section 8.6(i) shall
be at Depomed’s expense.


 


(j)       If at the time of
expiration or termination of this Agreement, Solvay is manufacturing Product
for use in development or commercialization in the Field, Solvay shall, at
Depomed’s request and in accordance with a mutually acceptable supply agreement
to be entered into by the Parties, supply Depomed’s or its designee’s
requirements of Product in final packaged form at commercially reasonable
prices until the earlier of Depomed’s qualification of alternate supply sources
for the Field and the Territory, or eighteen (18) months after such expiration
or termination, provided that Depomed will use commercially reasonable efforts
to qualify alternate supply sources as soon as reasonably practicable.


 


(k)     Sections 3.4 and 3.5 (for the
time period specified therein), 7.3, 8.5, 9.1-9.7, 10, 11.2-11.5 (solely as to
activities conducted during the term of the Agreement, 11.6, and 12 shall
survive termination or expiration of this Agreement.


 


(l)       Exercising the remedy of
termination shall not (a) release any Party from any obligation that has
accrued prior to the effective date of such termination (including the
obligation to pay amounts accrued and due under this Agreement prior to the
effective date of such termination but that are unpaid or become payable
thereafter), (b) preclude the terminating Party from exercising any other
of those remedies to which it may be entitled under this Agreement or
Applicable Law, or (c) terminate any right to obtain performance of any
obligation provided for in this Agreement that shall survive termination.


 


8.6          Alternative
Remedies.  For clarity, if a Party materially
breaches this Agreement and the other Party does not terminate the Agreement
under Sections 8.2 or 8.3, such other Party retains all rights to seek remedies
available to it under law or in equity for such material breach by exercising
its rights under Article 9.


 


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ARTICLE 9

DISPUTE RESOLUTION


 


9.1          Exclusive Dispute
Resolution Mechanism.  In the event that the Parties cannot reach
agreement on a matter arising out of or in connection with this Agreement (including without limitation matters relating
to any Party’s rights and/or obligations hereunder and/or regarding the construction, interpretation and
enforceability of such agreements), the procedures set forth in this Article 9
shall be the exclusive mechanism for resolving any dispute, controversy, or
claim (collectively, “Disputes”) between the Parties that may arise from time
to time that cannot be resolved through good faith negotiation between the
Parties.


 


9.2          Resolution by Executive
Officers.  In the event of any Dispute between the
Parties in connection with this Agreement, the construction hereof, or the
rights, duties or liabilities of either Party under this Agreement, the Parties
shall first attempt in good faith to resolve such Dispute by negotiation and
consultation between themselves.  In the
event that such Dispute is not resolved on an informal basis within ten (10) Business
Days after one Party provides notice to the other Party of such Dispute, either
Party may, by written notice to the other Party, refer such Dispute to the
other Party for attempted resolution by good faith negotiation within thirty
(30) days after such notice is received. 
Such Disputes shall be referred to the Executive Officers for attempted
resolution.  In the event that any
Dispute is not resolved under the foregoing provisions, each Party may, at its
sole discretion, seek resolution of such Dispute in accordance with Section 9.3
and, if applicable, Section 9.4.


 


9.3          Mediation.  Any dispute that has not been resolved within sixty (60)
days after being referred to the senior executives pursuant to Section 9.2
shall be referred to mediation before a mediator that is mutually acceptable to
the Parties.  Such mediation shall be conducted
as soon as practicable, but in no event more than sixty (60) days after
referral to mediation.


 


9.4          Arbitration.  Any Dispute that is not resolved pursuant to Section 9.3
shall be exclusively and finally resolved by binding arbitration pursuant to this
Section 9.4.


 


(a)           Any such arbitration shall be conducted in
New York, New York, United States of America, unless otherwise agreed to by the
Parties in writing.  Each and any
arbitration shall be administered by the American Arbitration Association (the “AAA”), and shall be conducted in accordance with the
Commercial Arbitration Rules of the AAA (the “Rules”),
as such Rules may be amended from time to time, or modified by this Section 9.4
or by agreement of the Parties.  The
Parties will be entitled to conduct discovery
as provided in the U.S. Federal Rules of Civil Procedure and the local rules of
the U.S. District Court for the Southern District of New York, provided,
however, that the Parties will conduct all discovery expeditiously within the
time limit set by the arbitrator(s), it being the intent that discovery be
permitted to the extent necessary to introduce all salient facts.  At any
applicable hearing, the Parties may present testimony (either by live
witness or deposition) and documentary evidence and have the right to be
represented by counsel.  The U.S. Federal
Rules of Evidence will apply to any and all matters submitted to final and
binding arbitration under this Agreement.


 


(b)           Within ten (10) days after receipt of an
arbitration notice from a Party, the Parties shall attempt in good faith to
agree on a single neutral arbitrator with relevant industry 


 


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the Securities Exchange Commission


 


experience to conduct such
arbitration.  If the Parties do not agree
on a single neutral arbitrator within ten (10) days after receipt of an
arbitration notice, each Party shall select one (1) arbitrator and the two
(2) Party-selected arbitrators shall select a third arbitrator with
relevant industry experience to constitute a panel of three (3) arbitrators
to conduct the arbitration in accordance with the Rules.  In the event that only one of the Parties
selects an arbitrator, then such arbitrator shall be entitled to act as the
sole arbitrator to resolve the Dispute or any and all unresolved issues subject
to such arbitration.  Each and every
arbitrator of the arbitration panel conducting the arbitration must and shall
agree to render an opinion within thirty (30) days after the final hearing
before the panel.


 


(c)           The decision or award of the arbitrator(s) shall
be final, binding, and incontestable and may be used as a basis for judgment
thereon in any jurisdiction.  The
arbitrator(s) shall, upon the request of any Party, issue a written
opinion of the findings of fact and conclusions of law and shall deliver a copy
to each of the Parties.  Each Party shall
bear its own costs and attorney’s fees, and the Parties shall equally bear the
fees, costs, and expenses of the arbitrator(s) and the arbitration
proceedings; provided, however, that the arbitrator(s) may exercise
discretion to award costs, including attorney’s fees, to the prevailing
Party.  Without limiting any other
remedies that may be available under Applicable Laws, the arbitrator(s) shall
have no authority to award provisional remedies of any nature whatsoever, or
punitive, special, consequential, or any other similar form of damages.


 


9.5          Preliminary
Injunctions.  Notwithstanding anything in this Agreement to
the contrary, a Party may seek a temporary restraining order or a preliminary
injunction or other equitable remedy from any court of competent jurisdiction
in order to prevent immediate and irreparable injury, loss, or damage on a
provisional basis, pending the decision of the arbitrator(s) on the
ultimate merits of any Dispute.


 


9.6          Patent
Disputes.  Notwithstanding anything in this Agreement to
the contrary, any and all issues regarding the scope, construction, validity,
and enforceability of any Patent Rights in a country within the Territory shall
be determined in a court or other Governmental Authority of competent
jurisdiction under the applicable patent laws of such country.


 


9.7          Confidentiality.  All proceedings and
decisions of the arbitrator(s) shall be deemed Confidential Information of
each of the Parties, and shall be subject to Article 10.


 


ARTICLE 10

CONFIDENTIALITY


 


10.1        Confidential
Information Defined.  During the
performance of this Agreement, it is anticipated that each Party will learn of
information that the other regards as confidential or proprietary, including,
but not limited to, commercial, financial, and technical information,
substances, formulations, techniques, methodologies, customer or client lists,
programs, procedures, data, documents, protocols, results of experimentation
and testing, specifications, databases, business plans, trade secrets, budget
forecasts, business arrangements, information regarding specific transactions,
financial information and estimates, long-term plans and goals, information
relating to the Product, know-how (technical or otherwise), processes,
customers, suppliers, pricing programs, and strategies (“Confidential
Information”).


 


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10.2        Obligations.  Except as expressly permitted in this Agreement, each Party
agrees not to use or disclose the other Party’s Confidential Information for
any purpose other than the performance of this Agreement.  Each Party will treat Confidential
Information furnished by the other Party with the same degree of care as if it
were its own confidential information (but under no circumstances less than
reasonable care).  Except as expressly
permitted by this Agreement, a receiving Party will not disclose Confidential
Information to any Third Party, other than the receiving Party’s Affiliates,
employees, agents, contractors, or consultants who have a need to know the
Confidential Information in order to perform the receiving Party’s obligations
under this Agreement.  The receiving
Party will be responsible for the compliance of all Affiliates, employees,
agents, contractors, and consultants that are provided the Confidential
Information of the disclosing Party with the obligations of this Section 10.2.


 


10.3        Exceptions to
Obligations.  The restrictions on the use and disclosure
of Confidential Information as set forth above shall not apply to any
Confidential Information which: (a) was known by the receiving Party as
evidenced by its written records made prior to the time of receipt hereunder; (b) either
before or after the time of disclosure becomes known to the public other than
through a breach by the receiving Party or its Affiliates, employees, agents,
contractors, or consultants of its obligations under this Agreement; (c) was
lawfully disclosed to the receiving Party by a Third Party having the right to
disclose said Confidential Information; or (d) was information developed
by the receiving Party independently from the Confidential Information provided
by the other Party hereto as evidenced by the receiving Party’s written records.


 


10.4        Required
Disclosures.  The receiving Party shall also be entitled
to disclose the other Party’s Confidential Information to the extent such
Confidential Information is required to be disclosed (a) to or by any
Governmental Authority; (b) to comply with Applicable Laws (including,
without limitation, to comply with SEC, NASDAQ or stock exchange disclosure
requirements), (c) to comply with judicial process or an order of any
governmental body or a court of competent jurisdiction, or (d) to defend
or prosecute litigation, or (e) exercise its rights to seek patent
protection or enforce Patent Rights or make Regulatory Filings; provided,
however, that in each case the Party required to disclose such Confidential
Information under subsections (a) through (d) shall use reasonable
efforts to notify the other Party in advance of such disclosure and shall
provide the disclosing Party with reasonable assistance to obtain a protective
order and/or confidential treatment of such Confidential Information, to the
extent available, and thereafter only discloses the minimum Confidential
Information required to be disclosed in order to ensure legal compliance.


 


10.5        Term.  This undertaking to keep information confidential extends
through the term of this Agreement and will survive the expiration or
termination of this Agreement for a period of five (5) years.


 


10.6        Public Disclosures.  Upon the Execution Date, each Party shall have the right to
issue a press release announcing the existence of this Agreement having a form
and substance mutually agreed upon by the Parties.  Except as required by Applicable Laws or rules of
a securities exchange, each Party agrees not to issue any other press release
or make any other public statement or other disclosure disclosing to any Third
Party any information relating to this Agreement or its terms or the
transactions contemplated hereby without the prior written consent 


 


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the Securities Exchange Commission


 


of the other Party, such consent not to be
unreasonably withheld, delayed, or conditioned; provided however that after any
information regarding this Agreement or its terms or the transactions
contemplated hereby is publicly disclosed, it may thereafter be disclosed by
either Party again in the future without the need to obtain the other Party’s
consent.  Notwithstanding the foregoing,
a Party may disclose the terms of this Agreement in confidence to its
Affiliates in connection with the performance of this Agreement and solely on a
need-to-know basis to potential or actual collaborators or licensees (including
potential sublicensees), who prior to disclosure must be agree to bound by
obligations of confidentiality and non-use no less restrictive than the
obligations set forth in this Article 10; and/or in confidence to
potential or actual investment bankers, investors, lenders, acquirors, merger
partners or other potential financial or strategic partners, and their
attorneys and agents); provided, however,
that the Receiving Party shall remain responsible for any failure by any Person
who receives Confidential Information pursuant to this Section 10.6 to
treat such Confidential Information as required under this Article 10.


 


ARTICLE 11

INSURANCE; INDEMNIFICATION; LIMITATION OF LIABILITY


 


11.1        Insurance Coverage.  During the term of this Agreement and for a
period of two (2) years thereafter, each Party shall carry and maintain
product liability coverage of not less than [***] dollars ($[***]) to
cover any liability that may arise under this Agreement or as required by
Applicable Law.  Each Party shall provide
evidence to the other Party that such other Party has been named as an
additional insured under the policies described herein, and such policies shall
be endorsed to provide for thirty (30) days prior written notice to the other
Party by the insurance carrier of cancellation, expiration, or modification of
the policy.


 


11.2        Indemnity by
Depomed.  Depomed agrees to defend, indemnify and
hold free and harmless Solvay, its Affiliates, and its and their directors,
officers, agents, contractors, and employees from Losses (as defined in Section 11.5)
to the extent resulting from or in connection with (a) the development,
manufacture, use, handling, storage, or other disposition of the Product
outside the Field in the Territory, or outside the Territory, by Depomed or its
Affiliates or sublicensees; (b) any breach by Depomed of the
representations, warranties, covenants, and agreements set forth in this
Agreement; or (c) arising from negligent or willful acts and/or omissions
of Depomed.  The indemnity obligation set
forth above shall not apply, however, to the extent any such claims are caused
by gross negligence or willful misconduct of Solvay.


 


11.3        Indemnification by
Solvay.  To the extent Losses are not covered by
Depomed’s indemnification of Solvay pursuant to Section 11.2, Solvay
agrees to defend, indemnify and hold free and harmless Depomed and its
affiliates, directors, officers and employees from Losses to the extent
resulting from or in connection with (a) the development, use,
manufacture, handling, storage, commercialization or other disposition of the
Product in the Field in the Territory by Solvay or its Affiliates or
sublicensees; (b) any breach by Solvay of the representations, warranties,
covenants, and agreements set forth in this Agreement; or (c) arising from
negligent or willful acts and/or omissions of Solvay.


 


11.4        Notification; Assumption
of Defense; Cooperation and Assistance.  In the event that a Party seeks
indemnification hereunder with respect to a Third Party claim (a “Third 


 


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Securities Exchange Commission


 


Party Claim”), the Party seeking
indemnification (the “Indemnified Party”) shall promptly notify the other Party
(the “Indemnifying Party”) of any Third-Party Claim in respect of which it
intends to claim indemnification under this Article 11, provided that any
failure to provide the Indemnifying Party with any such notice will not relieve
the Indemnifying Party from any liability that it may have to the Indemnified
Party under this Article 11 except to the extent that the ability of the
Indemnifying Party to defend such claim is materially prejudiced by the
Indemnified Party’s failure to give such notice.  If the Indemnifying Party assumes such defense,
the Indemnified Party will have the right to participate in the defense thereof
and to employ counsel, at its own expense, separate from the counsel employed
by the Indemnifying Party; provided, that the Indemnified Party will have the
right to employ counsel to represent it at the expense of the Indemnifying
Party if the Indemnified Party has been advised by its counsel that there are
one or more legal defenses available to it that are different from or
additional to those available to the Indemnifying Party or that there is
otherwise a potential conflict between the interests of the Indemnified Party
and the Indemnifying Party, in which event the reasonable fees and expenses of
such separate counsel will be paid by the Indemnifying Party.  If the Indemnifying Party does not assume
control of the defense of a Third-Party Claim within thirty (30) days after the
receipt by the Indemnifying Party of the notice required pursuant to this Section 11.4,
the Indemnified Party will have the right to defend such claim in such manner
as it may deem appropriate at the reasonable cost and expense of the
Indemnifying Party.  The Indemnified
Party shall cooperate as may be reasonably requested in order to ensure the
proper and adequate defense of any action, claim or liability covered by this
indemnification.  The Indemnifying Party
may not settle or otherwise dispose of any Third-Party Claim without the prior
written consent of the Indemnified Party unless such settlement includes only
the payment of monetary damages (which are fully paid by the Indemnifying
Party), does not impose any injunctive or equitable relief upon the Indemnified
Party, does not require any admission or acknowledgment of liability or fault
of the Indemnified Party and contains an unconditional release of the
Indemnified Party in respect of such Third-Party Claim.  The Indemnified Party may not settle or
otherwise dispose of any Third-Party Claim for which the Indemnifying Party may
be liable for damages under this Agreement without the prior written consent of
the Indemnifying Party.


 


11.5        Losses.  For the purposes of this Article 11, “Losses” shall
mean any and all liabilities, obligations, damages, losses, costs, claims,
actions, judgments, attachments, and expenses (including without limitation the
reasonable fees of attorneys and other professionals, other reasonable
litigation expenses, and any reasonable costs and expenses incurred in
connection with the enforcement of this Agreement).


 


11.6        LIMITATION OF
LIABILITY.  NEITHER SOLVAY NOR DEPOMED SHALL BE LIABLE
TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL, OR
PUNITIVE DAMAGES INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF USE,
REVENUE, PROFIT, OPERATING COSTS, FINANCING AND INTEREST COSTS, AND BUSINESS
INTERRUPTION, HOWEVER THE SAME MAY BE CAUSED, ARISING FROM OR RELATING TO
THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, THE FAULT, BREACH OF CONTRACT,
OR TORT (INCLUDING WITHOUT LIMITATION NEGLIGENCE, STRICT LIABILITY OR
OTHERWISE), EVEN IF THE OTHER PARTY IS ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES.  SUCH LIMITATION SHALL 


 


38

















 


Confidential Information,
indicated by [***] has been omitted from this filing and filed separately with
the Securities Exchange Commission


 


NOT LIMIT EITHER PARTY’S INDEMNIFICATION
OBLIGATIONS UNDER SECTIONS 11.1 THROUGH 11.5 AND SHALL NOT APPLY IN CASES OF (A) THE
WILLFUL MISCONDUCT OF EITHER PARTY, (B) DAMAGES CLAIMED BY THIRD PARTIES, (C) A
PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 10.


 


ARTICLE 12

MISCELLANEOUS


 


12.1        Severability.  If and to the extent that any court or other judicial body
determines any provision of this Agreement to be invalid, such determination
shall in no way affect the legality, validity, and enforceability of the other
provisions of this Agreement, which shall remain in full force and effect and
shall be construed as nearly as possible to reflect the general intentions of
the parties as reflected in this Agreement so long as the economic and legal
substance of the transactions contemplated hereby is not affected in any manner
materially adverse to either Party.


 


12.2        Force Majeure.  Except as otherwise expressly set forth in this Agreement,
neither Party shall be deemed to have defaulted under or breach this Agreement
for failure or delay in fulfilling its obligations under this Agreement to the
extent such failure or delay is due, in whole or in part, to intervention of
any governmental authority or acts of regulatory agencies, fires, earthquakes,
acts of God or causes beyond its control (such occurrence being referred to as
an event of “Force Majeure”).  If an
event of Force Majeure occurs, the affected Party shall promptly notify the
other Party, explaining the nature, details, and expected duration
thereof.  Further, the affected Party
shall also notify the other Party from time to time as to when the affected
Party reasonably expects to resume performance in whole or in part of its
obligations hereunder, and notify the other Party of the cessation of any such
event.  In the event a Party’s
performance is delayed by more than one hundred twenty (120) days due to an
event of Force Majeure, then the other Party will have the right to terminate
this Agreement immediately upon written notice to the affected Party.


 


12.3        Notices.  Wherever notice is required or permitted hereunder, it
shall be by personal delivery, first class mail, overnight delivery service, or
sent by facsimile transmission, with electronic confirmation, properly directed
to the Party at its address and contact information listed below.  Said address and contact information may be
changed from time to time by similar written notice.  All notices will be deemed to have been given
on the date delivered if delivered by personal delivery or facsimile
transmission, and on the date received for all other means of the delivery.


 


39














 


Confidential Information,
indicated by [***] has been omitted from this filing and filed separately with
the Securities Exchange Commission


 


	
  If to Solvay:

  	
   

  	
  If to Depomed:

  
	
   

  	
   

  	
   

  
	
  901 Sawyer Road

  	
   

  	
  1360 O’Brien Drive

  
	
  Marietta, Georgia 30062 U.S.A.

  	
   

  	
  Menlo Park, California 94025 
  U.S.A.

  
	
  Attn: President & CEO

  	
   

  	
  Attn:  President

  
	
  Fax: (770) 578-5749

  	
   

  	
  Fax:  (650) 462-9993

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
   

  	
  With a copy to:

  
	
   

  	
   

  	
   

  
	
  General Counsel

  	
   

  	
  Judith Hasko, Esq.

  
	
  901 Sawyer Road

  	
   

  	
  Latham & Watkins LLP

  
	
  Marietta, Georgia 30062 U.S.A.

  	
   

  	
  140 Scott Drive

  
	
  Fax: (770) 578-5749

  	
   

  	
  Menlo Park, CA 94025

  



 


12.4        Waiver.  No failure or omission by either Party to insist upon or
enforce any of the terms of this Agreement shall be deemed a waiver of such
terms; nor will any waiver on the part of either Party of any right, power, or
privilege hereunder operate as a waiver of any other right, power, or
privilege; nor will any single or partial exercise of any right, power, or
privilege hereunder preclude any other or further exercise thereof or the exercise
of any other right, power, or privilege hereunder.


 


12.5        Non-Solicitation.  During the term of this Agreement, neither Party will
directly or indirectly solicit the employment of any employee of the other
Party.  For purposes of the foregoing,
“solicit” shall not be deemed to mean (a) circumstances where an employee
of a Party initiates contact with the other Party or any of its Affiliates with
regard to possible employment, or (b) general solicitations of employment
not specifically targeted at employees of a Party or any of its Affiliates,
including responses to general advertisements.


 


12.6        Further Assurances.  Each Party shall, at any time, and from time to time, at
the reasonable prior request of the other Party, and at such other Party’s
expense, execute and deliver to the other Party such documents that are
reasonably necessary for such other Party to perform any of its obligations or
exercise its rights set forth herein to the extent such Party is not otherwise
obligated to perform such activities under this Agreement; provided that if
conducting such activities will impose a material burden on such other Party,
the requesting Party shall reimburse the other Party’s FTE Charges for such
activities.


 


12.7        HSR Filing.  Each
Party (or its “ultimate parent entity” as that term is defined under the HSR
Act and its implementing regulations) shall, within ten (10) business days
after the Execution Date (or such later time as may be agreed to in writing by
the Parties), file, on an expedited basis (meaning, with a request for early
termination of the waiting period), the filing fee of which shall be borne by
the Parties equally, with the United States Federal Trade Commission (“FTC”)
and the Antitrust Division of the United States Department of Justice (the
“Division”), any HSR Filing required of it under the HSR Act with respect to
the transactions contemplated hereby. 
The Parties shall cooperate with each other to the extent reasonably
necessary in the preparation of any such HSR Filing.  As promptly as is practicable after


 


40

















 


Confidential Information,
indicated by [***] has been omitted from this filing and filed separately with
the Securities Exchange Commission


 


receiving any request from any appropriate Governmental Authority for
information, documents, or other materials in connection with the review of the
HSR Filing, each Party shall use its commercially reasonable efforts to comply
with such request.  Each Party shall each
cooperate reasonably with the other in connection with resolving any inquiry or
investigation by any Governmental Authority relating to the HSR Filing.  Each Party agrees to use its commercially
reasonable efforts to secure termination or expiration of any waiting periods
under any Applicable Laws and/or to obtain the approval of any antitrust
Governmental Authority, as applicable, for the transactions contemplated
hereby.  In furtherance and not in
limitation of the foregoing, each Party shall promptly inform the other Party
of any communication to or from any Governmental Authority regarding the
Agreement and/or the transactions contemplated by the Agreement.  Except as may be prohibited by any
Governmental Authority or by any Applicable Law, the Parties will consult and
cooperate with one another, and will consider in good faith the views of one
another, in connection with preparing any submission or presentation to any
Governmental Authority in connection with any such inquiry.  Except as may be prohibited by any Governmental
Authority or by any Applicable Law, the Parties will permit authorized
representatives of the other Party to be present at any meeting, telephone call
or conference with such Government Authority in connection with any such
inquiry.  Notwithstanding the foregoing,
nothing contained in this Agreement shall require or obligate either Party to,
and either Party shall not without the prior written consent of the other
Party:  (i) agree or otherwise
become subject to any restrictions, conditions, limitations, licensing
requirements, or other understandings required or requested by the FTC or the
Division in connection the FTC’s or Division’s investigation of the
transactions contemplated by the Agreement as part of the HSR process;  or (ii) agree or otherwise be required
to sell or otherwise dispose of, hold separate (through the establishment or a
trust or otherwise), or divest itself of all or any portion of the business,
assets, or operations of such Party. 
Notwithstanding anything to the contrary contained herein, in the event
a Governmental Authority plans to enjoin the transaction contemplated herein,
or if the HSR Clearance Date has not occurred within six (6) months
following the Execution Date, the Parties may each terminate this Agreement
upon written notice to the other Party.


 


12.8        Relationship of the
Parties.  In fulfilling its obligations under this
Agreement, each Party is acting as an independent contractor.  Except as contemplated under this Agreement,
each Party agrees that it does not have the right to, and will not at any time
hereafter without the other Party’s prior written consent, transact any
business in the name of the other Party or obligate it in any manner, character
or description.  This Agreement does not
establish or create a partnership or joint venture among the Parties.


 


12.9        Successors; Assignment.


 


(a)      Successors.  This Agreement is binding upon and will inure
to the benefit of the Parties and their respective permitted assignees or
successors in interest, including without limitation those that may succeed by
assignment, transfer or otherwise to the ownership of either of the Parties or
of the assets necessary to the conduct of the business to which this Agreement
relates.


 


(b)      Assignment.  This Agreement may not be assigned or
otherwise transferred by either Party without the consent of the other Party,
which consent shall not be


 


41

















 


Confidential Information,
indicated by [***] has been omitted from this filing and filed separately with
the Securities Exchange Commission


 


unreasonably withheld, delayed, or
conditioned; provided, however, that either Party may, without such consent,
assign this Agreement together with all of its rights and obligations hereunder
to its Affiliates, or to a successor in interest in connection with the
transfer or sale of all or substantially all of its business to which this
Agreement relates, or in the event of its merger or consolidation or change in
control or similar transaction, subject to the assignee agreeing to be bound by
the terms of this Agreement.  Any
purported assignment in violation of the preceding sentences shall be
void.  Any permitted successor shall
assume and be bound by all obligations of its assignor or predecessor under
this Agreement.


 


12.10      Complete Agreement;
Modification.  This Agreement, along with its exhibits
which are incorporated herein by this reference, constitutes the entire
agreement between the Parties, and cancels and supersedes any and all previous
agreements between the Parties with respect to the subject matter hereof.  All modifications or amendments hereto must
be in writing and signed by all Parties. 
No renewal, termination or cancellation of this Agreement, or
modification or waiver of any of its provisions, or any future representation,
promise or condition in connection with the subject matter hereof, shall be
binding unless it is made in writing, dated and signed by an authorized officer
or employee of each Party.


 


12.11      Headings.  All section headings contained in this Agreement and in any
exhibit referred to herein or attached to this Agreement are for convenience
only, will not be deemed a part of this Agreement and will not affect the
meaning or interpretation of this Agreement.


 


12.12      Counterparts.  This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which together will
constitute a single instrument.


 


12.13      No Third-Party
Rights.  No provision of this Agreement will be deemed or construed
in any way to result in the creation of any right or obligation in any person
or entity not a Party to this Agreement.


 


12.14      Exceptions Upon
Acquisition.  Notwithstanding anything in this Agreement
to the contrary, no Patent Rights or Know-How Controlled by any acquiror of
Depomed or Solvay, or by an entity that is an Affiliate of such an acquiror
immediately prior to the closing of such acquisition of such Party (“Acquiror
Affiliate”), shall be included in the Depomed Technology or Solvay Technology,
respectively, that is licensed to the other Party under this Agreement, other
than those intellectual property rights arising from activities that such
acquiror or Acquiror Affiliate conducts in connection with activities under
this Agreement with respect to Products after the closing of such
acquisition.  Additionally, the
restrictions provided in Section 2.2 shall not apply to restrict any
activities conducted by any such acquiror of a Party or to the Acquiror
Affiliates of such acquiror.


 


[Signature Page Follows]


 


42

















 


Confidential Information, indicated
by [***] has been omitted from this filing and filed separately with the
Securities Exchange Commission


 


IN WITNESS WHEREOF, the Parties have caused
this Agreement to be executed by their duly authorized representatives on the
Execution Date.


 


	
  Solvay Pharmaceuticals, Inc.

  	
   

  	
  Depomed, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
     /s/ Stephen A. Hill

  	
   

  	
  By:

  	
     /s/ Carl A. Pelzel

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
     Stephen A. Hill

  	
   

  	
  Name:

  	
     Carl A. Pelzel

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   President and CEO

  	
   

  	
  Title:

  	
   President and CEO

  



 


 


[Signature Page to Exclusive License
Agreement]


 

















 


Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


Exhibit A


 


Milestone Payments


 


	
  Milestone

  	
   

  	
  Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  FDA Acceptance of NDA for the Product

  	
   

  	
  $

  	
  10,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Regulatory Approval of an NDA for the
  Product

  	
   

  	
  $

  	
  35,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Achievement of Best Case Label for
  the Product

  	
   

  	
  $

  	
  25,000,000

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  First Time Annual Net Sales exceed $[***]

  	
   

  	
  $

  	
  30,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Time Annual Net Sales exceed $[***]

  	
   

  	
  $

  	
  35,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Time Annual Net Sales exceed $[***]

  	
   

  	
  $

  	
  50,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Time Annual Net Sales exceed $[***]

  	
   

  	
  $

  	
  85,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Time Annual Net Sales exceed $[***]

  	
   

  	
  $

  	
  100,000,000

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Total

  	
   

  	
  $

  	
  370,000,000

  	
   

  



 


Those milestones payable with respect to Annual Net Sales are
cumulative such that if more than one of such milestones is achieved in any
given twelve (12) month period, more than one of the foregoing payments shall
be due in such twelve (12) month period. 
For example, if during the first twelve (12) month period after Launch
Annual Net Sales are $[***], and in
the twelve (12) month period commencing upon the first anniversary of Launch
Annual Net Sales are $[***], then
with respect to the second such twelve (12) month period, Solvay shall pay to
Depomed a total of $[***].


 


“Annual Net Sales” as used in the table
above means aggregate Net Sales in the Territory during any twelve (12) month
period during the term of this Agreement.


 


“Best Case Label” as used in the table
above means an adverse events profile (“AE Profile”)
for [***].


 


	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


The Parties [***].


 

















 


Confidential Information, indicated
by [***] has been omitted from this filing and filed separately with the
Securities Exchange Commission


 


Exhibit B


 


Depomed Patents


 


Issued Patents


 


	
  Patent Title

  	
   

  	
  Patent
  No.

  	
   

  	
  Issue
  Date

  	
   

  	
  Country

  
	
  Extending the duration of drug release within the stomach during the
  fed mode

  	
   

  	
  6,340,475

  	
   

  	
  1/22/2002

  	
   

  	
  U.S.

  
	
  Extending the duration of drug release within the stomach during the
  fed mode

  	
   

  	
  6,635,280

  	
   

  	
  10/21/2003

  	
   

  	
  U.S.

  
	
  Optimal polymer mixtures for gastric retentive tablets

  	
   

  	
  6,723,340

  	
   

  	
  4/20/2004

  	
   

  	
  U.S.

  
	
  Tablet shapes to enhance gastric retention of swellable
  controlled-release oral dosage form

  	
   

  	
  6,488,962

  	
   

  	
  12/03/2002

  	
   

  	
  U.S.

  
	
  Methods of Treatment using a Gastric Retained Gabapentin Dosage

  	
   

  	
  7,438,927

  	
   

  	
  10/21/2008

  	
   

  	
  U.S.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pending Patent Applications

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Application Title

  	
   

  	
  App. No.

  	
   

  	
  Filing
  Date

  	
   

  	
  Country

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 

















 


Confidential Information, indicated by [***] has been omitted from this
filing and filed separately with the Securities Exchange Commission


 


Exhibit C


 


Third Party Agreement(s)


 


Settlement and License Agreement, dated as of November 22, 2002,
between Depomed, Inc. and Bristol-Myers Squibb Company.


 

















 


Confidential Information, indicated
by [***] has been omitted from this filing and filed separately with the
Securities Exchange Commission


 


Exhibit D


 


Depomed Development Activities


 


Depomed will perform activities with respect to Product for use in the
Field in the Territory as are reasonably necessary to:


 


Quality Control Activities


 


1.     [***]


 


2.     [***]


 


Color Deboss; PHN Regulatory Batch


 


1.     Manufacture a product
development batch for each of the 300 mg and 600 mg Products having the
following trade dress [***].


 


2.     [***].


 


3.     [***].


 


Process Qualification/Validation


 


1.     [***].


 


2.     [***].


 


3.     [***].


 


4.     [***].


 


Clinical


 


1.     Complete Study #81-0062.