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EXHIBIT 99.1
COLLABORATION, LICENSE AND SUPPLY AGREEMENT
BETWEEN
ATRIX LABORATORIES, INC.
AND
SANOFI-SYNTHELABO INC.
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TABLE OF CONTENTS
SECTION PAGE NO.
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Article I DEFINITIONS.............................................................................................1
Article II COLLABORATION..........................................................................................8
Section 2.01. Objectives........................................................................................8
Section 2.02. Development Program...............................................................................8
Section 2.03. Atrix Obligations.................................................................................9
Section 2.04. Sanofi-Synthelabo Obligations.....................................................................9
Section 2.05. Availability of Resources; Cooperation............................................................9
Article III LICENSE..............................................................................................10
Section 3.01. License Fee......................................................................................10
Section 3.02. License Terms....................................................................................10
Section 3.03. Marks............................................................................................11
Article IV ROYALTY AND MILESTONE PAYMENTS........................................................................11
Section 4.01. Research and Development Expenses................................................................11
Section 4.02. Royalty Payments.................................................................................11
Section 4.03. Milestone Payments...............................................................................11
Section 4.04. Additional Milestone Payments....................................................................11
Section 4.05. Reports..........................................................................................12
Article V NEW PRODUCT............................................................................................13
Section 5.01. New Product......................................................................................13
Section 5.02. Right of First Negotiation.......................................................................13
Article VI COMMERCIALIZATION.....................................................................................14
Section 6.01. Promotion And Marketing Obligations..............................................................14
Article VII MANUFACTURE AND SUPPLY...............................................................................16
Section 7.01. Agreement to Supply Product......................................................................16
Section 7.02. Quality Assurance................................................................................17
Section 7.03. Atrix's Duties...................................................................................17
Section 7.04. Compliance with Applicable Laws..................................................................18
Section 7.05. Second Manufacturing Source......................................................................19
Section 7.06. Failure to Supply................................................................................19
Section 7.07. Allocation.......................................................................................20
Article VIII PURCHASE AND SALE...................................................................................20
Section 8.01. Purchase Price and Payment.......................................................................20
Section 8.02. Adjustment to Purchase Price/Audit...............................................................20
Section 8.03. Labeling.........................................................................................21
Section 8.04. Purchase Forms...................................................................................21
Section 8.05. Confirmation.....................................................................................22
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Section 8.06. Delivery........................................................................................22
Section 8.07. Forecasts and Orders............................................................................22
Section 8.08. Demonstration Samples...........................................................................23
Article IX WARRANTY, REJECTION AND INSPECTIONS...................................................................23
Section 9.01. Atrix Warranty..................................................................................23
Section 9.02. Rejection of Product for Failure to Conform to Specifications...................................24
Section 9.03. Sanofi-Synthelabo Inspections...................................................................24
Article X REGULATORY COMPLIANCE..................................................................................25
Section 10.01. Marketing Authorization Holder..................................................................25
Section 10.02. Maintenance Of Marketing Authorizations.........................................................25
Section 10.03. Interaction with Competent Authorities..........................................................25
Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance..........................................26
Section 10.05. Post - First Commercial Sale Testing And Reporting..............................................27
Section 10.06. Assistance......................................................................................27
Section 10.07. Compliance......................................................................................27
Article XI PATENTS AND TRADEMARKS................................................................................28
Section 11.01. Maintenance of Patents or Marks.................................................................28
Section 11.02. Cooperation.....................................................................................28
Section 11.03. Atrix to Prosecute Infringement.................................................................28
Section 11.04. Infringement Claimed by Third Parties...........................................................29
Article XII CONFIDENTIALITY......................................................................................29
Section 12.01. Confidentiality.................................................................................29
Section 12.02. Disclosure of Agreement.........................................................................29
Article XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES....................................30
Section 13.01. Co-Marketing Rights.............................................................................30
Article XIV REPRESENTATIONS AND WARRANTIES.......................................................................30
Section 14.01. Corporate Power.................................................................................30
Section 14.02. Due Authorization...............................................................................30
Section 14.03. Binding Obligation..............................................................................31
Section 14.04. Ownership of Atrigel(R) Patent Rights............................................................31
Section 14.05. Patent Proceedings..............................................................................31
Section 14.06. Legal Proceedings...............................................................................31
Section 14.07. Atrix's Manufacturing Facility..................................................................31
Section 14.08. Limitation on Warranties........................................................................32
Section 14.09. Limitation of Liability.........................................................................32
Article XV INDEMNIFICATION.......................................................................................32
Section 15.01. Sanofi-Synthelabo Indemnified by Atrix..........................................................32
Section 15.02. Atrix Indemnified by Sanofi-Synthelabo..........................................................32
Section 15.03. Prompt Notice Required..........................................................................33
Section 15.04. Indemnitor May Settle...........................................................................33
Article XVI COVENANTS............................................................................................34
Section 16.01. Covenant Not To Launch Competitive Product......................................................34
Section 16.02. Limitation To The Territory.....................................................................34
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Section 16.03. Access to Books and Records.....................................................................35
Section 16.04. A&S Spending Levels.............................................................................35
Section 16.05. Marketing Expenses..............................................................................35
Section 16.06. Compliance......................................................................................35
Section 16.07. Protection of the Marks.........................................................................35
Section 16.08. Launch Quantities...............................................................................36
Section 16.09. Further Actions.................................................................................36
Article XVII PRODUCT RECALL......................................................................................36
Section 17.01. Product Recalls or Withdrawal...................................................................36
Section 17.02. Recall Costs....................................................................................37
Section 17.03. Notification Of Complaints......................................................................37
Section 17.04. Notification Of Threatened Action...............................................................38
Article XVIII INSURANCE..........................................................................................38
Section 18.01. Insurance.......................................................................................38
Article XIX TERM; DEFAULT AND TERMINATION........................................................................38
Section 19.01. Term............................................................................................38
Section 19.02. Termination by Either Party.....................................................................39
Section 19.03. Termination by Either Party for Cause...........................................................39
Section 19.04. Termination by Atrix............................................................................39
Section 19.05. Termination by Sanofi-Synthelabo................................................................40
Section 19.06. Remedies........................................................................................40
Section 19.07. Effect of Termination...........................................................................40
Article XX MISCELLANEOUS.........................................................................................43
Section 20.01. No-Solicitation.................................................................................43
Section 20.02. Commercially Reasonable Efforts.................................................................43
Section 20.03. Assignment......................................................................................43
Section 20.04. Force Majeure...................................................................................43
Section 20.05. Governing Law...................................................................................44
Section 20.06. Waiver..........................................................................................44
Section 20.07. Severability....................................................................................44
Section 20.08. Notices.........................................................................................44
Section 20.09. Independent Contractors.........................................................................45
Section 20.10. Rules of Construction...........................................................................45
Section 20.11. Publicity.......................................................................................46
Section 20.12. Entire Agreement; Amendment.....................................................................46
Section 20.13. Headings........................................................................................46
Section 20.14. Counterparts....................................................................................46
Exhibit A - Atrigel(R) Patent hts...............................................................................A-1
Exhibit B - Form of Certificate of Compliance...................................................................B-1
Exhibit C - Specifications......................................................................................C-1
Exhibit D - Form of Stock Purchase Agreement....................................................................D-1
Exhibit E - Development Program.................................................................................E-1
Exhibit F - Sanofi-Synthelabo's SOP.............................................................................F-1
Exhibit G - Six Month Product Development Program...............................................................G-1
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COLLABORATION, LICENSE AND SUPPLY AGREEMENT
This Collaboration, License and Supply Agreement (the "Agreement") is
made as of December 8, 2000 by and between Atrix Laboratories, Inc., a Delaware
corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417
("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation having offices at
90 Park Avenue, New York, NY, 10016 ("Sanofi-Synthelabo"). Atrix and
Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties"
or singly as a "Party."
R E C I T A L S
WHEREAS, Atrix possesses proprietary drug delivery systems including
"Atrigel(R)" and has substantial experience and expertise in the discovery,
design and development of products based on these proprietary drug delivery
systems for medical, dental and veterinary applications;
WHEREAS, Sanofi-Synthelabo possesses substantial resources and
expertise in the development, commercialization and marketing of pharmaceutical
products;
WHEREAS, Atrix wishes to grant to Sanofi-Synthelabo, and
Sanofi-Synthelabo wishes to obtain from Atrix, an exclusive license under
Atrix's Atrigel(R) Technology to market, advertise, promote, distribute, offer
for sale, sell and import the Product in the Territory for use in the Field on
the terms and subject to the conditions set forth herein; and
WHEREAS, Sanofi-Synthelabo wishes Atrix to manufacture and Atrix
desires to manufacture each of the Product to be sold in the Territory by
Sanofi-Synthelabo.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual covenants and agreements contained herein, the Parties hereto, intending
to be legally bound, do hereby agree as follows:
AGREEMENT
ARTICLE I
DEFINITIONS
The following terms as used in this Agreement shall, unless the context
clearly indicates to the contrary, have the meaning set forth below:
"Acceptance for Filing" means Atrix's receipt of a letter issued by the
FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section
314.101.
"ADE" has the meaning set forth in Section 10.04.
"Affiliate" means an individual, trust, business trust, joint venture,
partnership, corporation, association or any other entity which owns, is owned
by or is under common ownership with, a Party. For the purposes of this
definition, the term "owns" (including, with
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correlative meanings, the terms "owned by" and "under common ownership with") as
used with respect to any Party, shall mean the possession (directly or
indirectly) of more than 50% of the outstanding voting securities of a
corporation or comparable equity interest in any other type of entity.
"Applicable Laws" means all applicable laws, rules, regulations and
guidelines within or without the Territory that may apply to the development,
marketing, manufacturing, packaging or sale of the Product in the Territory or
the performance of either Party's obligations under this Agreement including
laws, regulations and guidelines governing the import, export, development,
marketing, distribution and sale of the Product in the Territory, to the extent
applicable and relevant, and including all cGMP or Good Clinical Practices
standards or guidelines promulgated by the FDA or the Competent Authorities and
including trade association guidelines, where applicable, as well as United
States' export control laws and the United States' Foreign Corrupt Practices
Act.
"Approval Letter" means a letter issued by the FDA indicating approval
of a product, as defined in 21 CFR Section 314.105, or a similar letter issued
by a Competent Authority in any other country in the Territory.
"A&S" means Sanofi-Synthelabo's advertising and selling expenditures
incurred in and associated with the promotional support of the Product,
including the creation, development and acquisition of advertising and selling
materials, including, but not limited to, expenditures for samples, detailing
materials, journal advertising, in-office waiting room materials, educational
programs, including Web-site programs for physicians and patients, convention
booths, direct mail, consumer support, third party support, managed care
programs, post-marketing Phase IV studies to support existing indications,
market research, market surveys, market analysis and the training and costs of
the pharmaceutical detail force, the medical therapeutic liaisons and the
telesales staff used with regard to support of the Product. The costs of
warehousing and physical distribution, post-marketing Phase IV studies to
support new indications, and discounts given to managed care organizations shall
not be considered to be A&S expenses for purposes of this Agreement.
"Atrigel(R)" means Atrix's proprietary drug delivery system consisting
of flowable compositions (e.g., solutions, gels, pastes and putties) of
biodegradable polymers and biocompatible solvents.
"Atrigel(R) Know-How" means all Know-How related to Atrix's proprietary
Atrigel(R) drug delivery system as of the Effective Date, which is not covered
by the Atrigel(R) Patent Rights, but is necessary or useful to develop,
manufacture and commercialize the Product in the Territory for use in the Field,
and which is under the Control of Atrix as of the Effective Date.
"Atrigel(R) Patent Rights" means all Patent Rights related to Atrix's
proprietary Atrigel(R) drug delivery system as of the Effective Date and at any
time during the Term of this Agreement, which are necessary or appropriate to
develop, manufacture and commercialize the Product in the Territory for use in
the Field, which are under the Control of Atrix as of the Effective Date and
Improvements thereto developed during the Term. The Atrigel(R) Patent Rights as
of the Effective Date are set forth on Exhibit A.
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"Atrigel(R) Technology" means the Atrigel(R) Patent Rights and the
Atrigel(R) Know-How.
"Atrix Manufacturing Cost" means the actual cost of the Manufacture by
Atrix of the Product under a Manufacturing Process, including the related
quality assurance and quality control activities as required by Applicable Laws
(other than the costs set forth in Section 2.03), which actual cost shall be
comprised of the cost of goods produced as determined in accordance with GAAP,
and shall include direct labor, direct material, including raw materials and
packaging materials, and the allocable portion of the manufacturing overhead of
Atrix directly attributable to the Manufacture of the Product. The allocable
portion of the manufacturing overhead shall be determined by taking the total
facility cost for the period, less an adjustment for idle capacity, and
allocating the remaining facility cost by labor usage to each of the products
produced in the facility during the period. For example: If the facility cost
for the period was $1,000,000 and it was operating at 80% capacity, the
allocable facility cost would be $800,000. If the Product represented 30% of
labor usage during the period, the allocable portion of the manufacturing
overhead directly attributable to the Manufacture of the Product would be
$240,000. Atrix Manufacturing Cost shall exclude selling, general and
administrative, research and development, and interest expenses and any and all
debt service payments of Atrix. For a period of twelve (12) months from the date
of First Commercial Sale of each Product the Atrix Manufacturing Cost for each
Product will be set as follows (the "Twelve Month Cost"):
One Month Product - [**]
Three Month Product - [**]
Four Month Product - [**]
"Certificate of Compliance" means the certificate of compliance in the
form attached hereto as Exhibit B.
"cGMP" means current good manufacturing practices as defined in 21 CFR
Section 110 et seq.
"CMC" means chemistry manufacturing and controls.
"Collaboration" means the activities of the Parties carried out in
performance of, and the relationship between the Parties established by, this
Agreement.
"Competent Authorities" means collectively the governmental entities in
each country in the Territory responsible for the regulation of medicinal
products intended for human use.
"Competitive Product" means any leuteinizing hormone releasing hormone
(LHRH) or derivative or analog thereof, whether agonist or antagonist, whether
naturally-occurring or synthetic, used for the treatment of prostate cancer,
endometriosis or uterine fibroids.
"Confidential Information" means any confidential information of a
Party relating to any use, process, method, compound, research project, work in
process, future development, scientific, engineering, manufacturing, marketing,
business plan, financial or personnel matter relating to the disclosing Party,
its present or future products, sales, suppliers, customers,
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employees, investors or business, whether in oral, written, graphic or
electronic form. Confidential Information shall not include any information
which the receiving Party can prove by competent evidence:
is now, or hereafter becomes, through no act or failure to act
on the part of the receiving Party, generally known or available;
is known by the receiving Party at the time of receiving such
information, as evidenced by its written records maintained in the
ordinary course of business;
is hereafter furnished to the receiving Party by a Third
Party, as a matter of right and without restriction on disclosure;
is independently developed by the receiving Party, as
evidenced by its written records, without knowledge of, and without the
aid, application or use of, the disclosing Party's Confidential
Information; or
is the subject of a written permission to disclose provided by
the disclosing Party.
"Consumer Price Index" means the Consumer Price Index for all Urban
Consumers (Consumer Prices - All Urban Consumers, 1982-84 = 100) as published by
the Bureau of Labor Statistics of the Department of Labor of the United States
Department of Commerce.
"Control" means the possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
"Demonstration Samples" means Units, absent leuprolide acetate, used to
demonstrate the manner in which the Product is prepared and used, and labeled
"demonstration samples, for demonstration purposes only, not for human use."
"Development Program" has the meaning set forth in Section 2.02.
"Effective Date" means 3:00 p.m., Eastern Standard Time on the third
business day after any waiting period (and any extension thereof) and/or
approvals applicable to the consummation of the Agreement under the HSR Act
shall have expired, been terminated or obtained, as applicable.
"FDA" means the United States Food and Drug Administration.
"Field" means the primary indication for the palliative treatment of
prostate cancer and the secondary indication for the treatment of endometriosis
and uterine fibroids.
"First Commercial Sale" means (i) with respect to a country in the
Territory, the first sale for use, consumption or resale of each Product by
Sanofi-Synthelabo in such country and (ii) with respect to the Territory, the
First Commercial Sale in any country within the Territory. A sale to an
Affiliate shall not constitute a First Commercial Sale unless the Affiliate is
the end user of the Product.
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"Four Month Product" means the formulation comprised of leuprolide
acetate in an Atrigel(R) delivery system that provides for the sustained release
of leuprolide acetate over a period of about one hundred and twenty (120) days
and not less than one hundred and twelve (112) days with a primary indication
for the palliative treatment of prostate cancer.
"GAAP" means United States generally accepted accounting principles
consistently applied on a basis consistent throughout the periods indicated and
consistent with each other.
"Good Clinical Practices" means good clinical practices as defined in
21 CFR Section 50 et seq. and Section 312 et seq.
"Governmental Approval" means all permits, licenses and authorizations,
including but not limited to, Marketing Authorization and Pricing and
Reimbursement Approvals required by the FDA or any other Competent Authority as
a prerequisite to the manufacturing, packaging, marketing and selling of the
Product or the Units; excluding, however, import permits.
"HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended.
"Improvements" means any and all developments, inventions or
discoveries in the Field relating to the Atrigel(R) Technology developed, or
acquired by Atrix at any time during the Term and shall include, but not be
limited to, developments intended to enhance the safety and/or efficacy of the
Product.
"Know-How" means all know-how, trade secrets, inventions, data,
processes, techniques, procedures, compositions, devices, methods, formulas,
protocols and information, whether or not patentable, which are not generally
publicly known, including, without limitation, all chemical, biochemical,
toxicological, and scientific research information.
"Launch Quantity" means a quantity of Product adequate to meet the
requirements set forth for the first six (6) months in the initial forecast to
be provided by Sanofi-Synthelabo to Atrix as provided in Section 8.07.
"Manufacture" or "Manufacturing Process" means the storage, handling,
production, processing and packaging of a Product or a Demonstration Sample, in
accordance with this Agreement.
"Marketing Authorization" means all necessary and appropriate
regulatory approvals, excluding Pricing and Reimbursement Approvals, where
applicable, to put the Product on the market in a particular country in the
Territory.
"Marks" means "Atrigel(R)" or "Leuprogel(TM)" or any additional
trademarks selected by the Parties pursuant to Section 6.01(b) in either case,
alone or accompanied by any logo or design and any foreign language equivalents
in sound or meaning, whether registered or not.
"NDA" means a New Drug Application, and all amendments and supplements
thereto, filed or to be filed, with the FDA seeking authorization and approval
to manufacture, package, ship and sell a product as more fully defined in 21 CFR
Section 314.5 et seq.
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"Net Sales" means the [**]
Components of Net Sales shall be determined in the ordinary course of
business in accordance with historical practice and using the accrual method of
accounting in accordance with GAAP.
In the event Sanofi-Synthelabo transfers Product to a Third Party in a
bona fide arm's length transaction, for consideration, in whole or in part,
other than cash or to a Third Party in other than a bona fide arm's length
transaction, the Net Sales price for such Product shall be deemed to be the
standard invoice price then being invoiced by Sanofi-Synthelabo in an arms
length transaction with similar customers. In the event that Sanofi-Synthelabo
includes one or more Product as part of a bundle of products, Sanofi-Synthelabo
agrees not to offer or sell any such Product as a loss leader (i.e. sold at less
than the invoice price at which any such Product is sold when not part of a
bundle of products) in determining the price of the bundled products.
"Net Selling Price" means with respect to a given time period and for a
given country, Net Sales with respect to such country divided by the number of
Units sold in such country during such time period.
"New Product" means a product consisting of a combination of leuprolide
acetate in the Atrigel(R) delivery system (other than the Product and
substantially differentiable from the Product on the basis of leuprolide acetate
concentration or duration of action).
"One Month Product" means the formulation comprised of leuprolide
acetate in an Atrigel(R) delivery system that provides for the sustained release
of leuprolide acetate over a period of about thirty (30) days and not less than
twenty-eight (28) days with a primary indication for the palliative treatment of
prostate cancer.
"Packaging Specifications" means the packaging and labeling
specifications for the Unit, as may be mutually determined by Atrix and
Sanofi-Synthelabo, from time to time.
"Patent Rights" means all rights under patents and patent applications,
and any and all patents issuing therefrom (including utility, model and design
patents and certificates of invention), together with any and all substitutions,
extensions (including supplemental protection certificates), registrations,
confirmations, reissues, divisionals, continuations, continuations-in-part,
re-examinations, renewals and foreign counterparts of the foregoing, and all
improvements, supplements, modifications or additions.
"Pricing and Reimbursement Approvals" means any pricing and
reimbursement approvals which must be obtained before placing the Product on the
market in any country in the Territory in which such approval is required.
"Prime Rate of Interest" means the prime rate of interest published
from time to time in the Wall Street Journal as the prime rate; provided,
however that if the Wall Street Journal does not publish the Prime Rate of
Interest, then the term "Prime Rate of Interest" shall mean the rate
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of interest publicly announced by Bank of America, N.A., as its Prime Rate, Base
Rate, Reference Rate or the equivalent of such rate, whether or not such bank
makes loans to customers at, above, or below said rate.
"Product" means collectively the One Month Product, the Three Month
Product, the Four Month Product, and the Six Month Product (should the Parties
agree to develop it) supplied in Unit packages or any formulation of leuprolide
acetate, in any concentration, in the Atrigel(R) delivery system for the
palliative treatment of prostate cancer.
"Royalty" means the royalty to be paid by Sanofi-Synthelabo to Atrix as
set forth in Section 4.02.
"Royalty Term" means the period of time commencing on the First
Commercial Sale of the Product in any country in the Territory and ending on the
expiration of the last to expire of the Atrigel(R) Patent Rights covering the
Product in such country.
"Shipment" means each individual group of Product received by
Sanofi-Synthelabo from Atrix.
"Six Month Product" means the formulation comprised of leuprolide
acetate in an Atrigel(R) delivery system that provides for the sustained release
of leuprolide acetate over a period of about one hundred and eighty (180) days
and not less than one hundred and sixty eight (168) days with a primary
indication for the palliative treatment of prostate cancer.
"Specifications" means the specifications for the Product attached
hereto as Exhibit C, and as may be amended from time to time by the Parties.
"Stock Purchase Agreement" means that certain Stock Purchase Agreement
dated as of the same date as this Agreement between Atrix and Sanofi-Synthelabo
attached hereto as Exhibit D.
"Term" has the meaning set forth in Section 19.01.
"Territory" means the United States and Canada.
"Third Party" means any entity other than: (a) Atrix, (b)
Sanofi-Synthelabo or (c) an Affiliate of Atrix or Sanofi-Synthelabo.
"Three Month Product" means the formulation comprised of leuprolide
acetate in an Atrigel(R) delivery system that provides for the sustained release
of leuprolide acetate over a period of about ninety (90) days and not less than
eighty-four (84) days with a primary indication for the palliative treatment of
prostate cancer.
"Unit" means the Product packaged in a two-part system consisting of
(a) one syringe of Atrigel(R) delivery system and a needle in a moisture proof
pouch and sterilized by gamma irradiation; (b) one syringe containing sufficient
leuprolide acetate for a One Month Product, Three Month Product, Four Month
Product or Six Month Product, aseptically filled and lyophilized in the syringe,
and packaged in a moisture-proof pouch; (c) instructions for use, as
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such trade or sample package may be changed or reformulated by Atrix and
Sanofi-Synthelabo from time to time; and (d) a commercial trade or sample
package.
"United States" means the United States of America, its territories and
possessions, including the Commonwealth of Puerto Rico.
ARTICLE II
COLLABORATION
Section 2.01. OBJECTIVES. Pursuant to the Development Program, Atrix
shall conduct research and development activities using the Atrigel(R)
Technology to develop a Product for the palliative treatment of prostate cancer.
During the Term, Atrix will have primary responsibility for the activities
described in Section 2.03 and Sanofi-Synthelabo will have primary responsibility
for the activities described in Section 2.04.
Section 2.02. DEVELOPMENT PROGRAM. (a) Development Program. Atrix shall
utilize the Atrigel(R) Technology to conduct research and development
of the One Month Product, the Three Month Product and the Four Month
Product, pursuant to a written, development program to which Atrix and
Sanofi-Synthelabo have given their prior written approval (the
"Development Program"), a copy of which is attached hereto as Exhibit
E.
(b) Six Month Product. If Sanofi-Synthelabo elects to have
Atrix develop the Six Month Product in accordance with Exhibit G,
Sanofi-Synthelabo shall be solely responsible for all costs and
expenses incurred (i) in developing the Six Month Product; and (ii) in
obtaining the Marketing Authorizations for the Six Month Product
(collectively the "Six Month Cost"). Sanofi-Synthelabo shall pay such
Six Month Cost within thirty (30) days of receipt of each invoice from
Atrix for such Six Month Cost. If Sanofi-Synthelabo in good faith
disputes the amount of any such invoice for the Six Month Cost, then
Sanofi-Synthelabo shall notify Atrix that it in good faith disputes the
amount of any such invoice for the Six Month Cost and any such dispute
shall be resolved by the Parties within thirty (30) days from the date
of receipt of the disputed invoice; provided however if the dispute
cannot be resolved to the mutual satisfaction of the Parties within
such thirty (30) day period then either Party may request that the
dispute be submitted to the Chief Executive Officers of Atrix and
Sanofi-Synthelabo, respectively, for joint resolution. If the dispute
is not jointly resolved by the Parties' respective Chief Executive
Officers within ten (10) days from submission to the Parties'
respective Chief Executive Officers, then Atrix shall be entitled to
pursue any and all remedies at law available to it. In no event will
the dispute resolution period exceed a maximum of forty (40) days
unless otherwise agreed to in writing by the Parties. Further,
Sanofi-Synthelabo may in its discretion determine to pay any such
disputed amount and in the event amounts are finally determined not to
be due by Sanofi-Synthelabo, Atrix shall repay, with interest paid at a
rate equal to the Prime Rate of Interest, such excess amounts
determined not to be due.
(c) License for Six Month Product. Upon satisfaction of the
provisions of Section 2.02(b) above, Sanofi-Synthelabo shall be deemed
to have an exclusive license to
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the Six Month Product on the same basis, terms and conditions set forth
in this Agreement for the license for each other Product except that
notwithstanding the foregoing, [**] shall be credited against the
additional Six Month Product Milestone as set forth in Section 4.04 of
this Agreement and [**], if any, shall be credited against amounts owed
by Sanofi-Synthelabo to Atrix as set forth in Section 4.04(ii).
(d) Audit of Six Month Cost. Sanofi-Synthelabo shall have the
right to cause an independent, certified public accountant reasonably
acceptable to Atrix to audit those records of Atrix relating to the
calculation of the Six Month Cost for the sole purpose of verifying the
Six Month Cost. Such audits may be exercised during normal business
hours nor more than once in a twelve (12) month period upon at least
ten (10) days prior written notice.
Section 2.03. ATRIX OBLIGATIONS. Pursuant to the time table established
for its doing so in the Development Program, Atrix will, at its own expense,
except as provided in Section 2.02, be responsible for (a) validation,
formulation and development of the Product, (b) animal toxicology studies
required for commercial launch of the Product, (c) scale-up, initial and
on-going stability studies in primary closure package system(s), (d) supporting
commercialization of the final formulation of the Product in accordance with the
Development Program, and (e) except as provided in Section 2.02, Atrix shall
also secure any and all Governmental Approvals and Marketing Authorizations.
Except as otherwise provided in this Agreement, Atrix shall own and maintain all
Governmental Approvals and related information and shall disclose all such
information to Sanofi-Synthelabo, as soon as possible; provided, however, that
information related to Atrigel(R) Technology shall be subject to the
confidentiality provisions of this Agreement in Article XII, below.
Section 2.04. SANOFI-SYNTHELABO OBLIGATIONS. Sanofi-Synthelabo, at its
own expense, will be responsible for (a) all market research related to the
Product; and (b) commercialization of the Product (including all sales and
marketing activities related to the Product). Sanofi-Synthelabo will obtain
import permits and pay all duties, fees, tariffs and similar obligations
required to market the Product in each country in the Territory.
Section 2.05. AVAILABILITY OF RESOURCES; COOPERATION. Each Party shall
maintain laboratories, offices and/or other facilities reasonably necessary to
carry out the activities to be performed by such Party pursuant to the
Development Program. Upon reasonable advance notice, each Party agrees to make
its employees and non-employee consultants reasonably available at their
respective places of employment to consult with the other Party on issues
arising in connection with any request from any regulatory agency, including,
without limitation, regulatory, scientific, technical and clinical testing
issues.
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** Confidential Treatment Requested.
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ARTICLE III
LICENSE
Section 3.01. LICENSE FEE. In partial consideration for the License
granted under Section 3.02(a), Sanofi-Synthelabo shall pay to Atrix an initial
one-time non-refundable license fee equal to Eight Million Dollars ($8,000,000)
on the Effective Date by wire transfer of immediately available funds to an
account to be designated by Atrix to Sanofi-Synthelabo prior to the Effective
Date. On the Effective Date, Sanofi-Synthelabo shall also purchase from Atrix
Fifteen Million Dollars ($15,000,000) of Atrix's common stock, as provided in
the Stock Purchase Agreement.
Section 3.02. LICENSE TERMS. The terms and conditions of the exclusive
license (the "License") granted by Atrix to Sanofi-Synthelabo shall be as
follows:
(a) License Grant. Atrix hereby grants to Sanofi-Synthelabo an
exclusive license under the Atrigel(R) Technology to market, advertise,
promote, distribute, offer for sale, sell and import the Product in the
Territory for use in the Field subject to the terms and conditions
herein. This exclusive license can only be transferred by
Sanofi-Synthelabo on the basis set forth in Section 20.03 of this
Agreement, below.
(b) License Termination.
(i) If Sanofi-Synthelabo has not undertaken
commercially reasonable efforts to begin distribution and
marketing of the One Month Product, the Three Month Product,
the Four Month Product and/or the Six Month Product, if
applicable, in the United States within ninety (90) days
following receipt of written notice from Atrix that
Governmental Approval has been received for each respective
Product for the United States and provided that Atrix has
available Launch Quantities of the respective Product, then
the following shall occur with respect to each Product not
launched within such ninety (90) days: (i) Atrix shall have
the right to grant a license to a Third Party, to market,
advertise, promote, distribute, offer for sale, sell or import
the One Month Product, the Three Month Product, the Four Month
Product and/or the Six Month Product, if applicable,
respectively, in the United States and (ii) the license
granted to Sanofi-Synthelabo pursuant to Sections 3.02(a) and
3.03 shall automatically terminate with respect to the
applicable Product in the United States and the United States
shall no longer be included in the Territory for such Product.
(ii) The Parties will negotiate in good faith the
launch date in Canada for each Product taking into account
market conditions in Canada and the United States and any
reimbursement issues, as they relate to each Product, in
Canada. If the Parties cannot in good faith agree on a launch
date in Canada for each Product the matter shall be submitted
to the Advisory Board for resolution.
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Section 3.03. MARKS. Subject to the terms and conditions of this
Agreement, Atrix hereby grants to Sanofi-Synthelabo an exclusive in the Field,
royalty-free right to use the Marks in connection with the marketing,
advertising, promotion, distribution and sale of the Product.
ARTICLE IV
ROYALTY AND MILESTONE PAYMENTS
Section 4.01. RESEARCH AND DEVELOPMENT EXPENSES. Except as set forth in
Section 2.02, Atrix shall, at its sole expense, be responsible for all research
and development expenses pertaining to the Product.
Section 4.02. ROYALTY PAYMENTS. Sanofi-Synthelabo shall pay to Atrix a
royalty consisting of [**] for a period equal to the Royalty Term for each
Product in each country in the Territory. All royalty payments due to Atrix
under this Agreement shall be paid within thirty (30) days of the end of each
calendar quarter, unless otherwise specifically provided herein.
Section 4.03. MILESTONE PAYMENTS. Sanofi-Synthelabo shall pay to Atrix,
as licensing fees, the following milestone payments within thirty (30) days
after Atrix gives notice to Sanofi-Synthelabo of the occurrence of the specified
milestone event:
(i) [**]
(ii) [**]
(iii) [**]
(iv) [**]
(v) [**]
(vi) [**]
Section 4.04. ADDITIONAL MILESTONE PAYMENTS. Should the Parties agree
to develop the Six Month Product, Sanofi-Synthelabo shall pay to Atrix, as
licensing fees, the following milestone payments within thirty (30) days after
Atrix gives notice to Sanofi-Synthelabo of the occurrence of the specified
milestone event:
(i) [**]
(ii) [**]
provided however, [**] shall be credited against [**] and [**], if any,
shall be credited against amounts owed by Sanofi-Synthelabo to Atrix as set
forth in Section 4.04(ii).
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** Confidential Treatment Requested.
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Section 4.05. REPORTS.
(a) Reports. Sanofi-Synthelabo shall furnish to Atrix a
quarterly written report showing in reasonably specific detail, on a
Product by Product and country by country basis, (a) the calculation of
Net Sales; (b) royalties payable in United States' Dollars, if any,
which shall have accrued hereunder based upon Net Sales; (c)
withholding taxes, if any, required by law to be deducted with respect
to such sales; (d) the dates of the First Commercial Sales of any
Product in any country in the Territory during the reporting period;
and (e) the exchange rates used to determine the amount of United
States' Dollars (the "Royalty Statement"). Reports shall be due as soon
as possible, but in any event no later than thirty (30) days following
the close of each calendar quarter.
(b) Exchange Rate; Manner and Place of Payment. All payments
hereunder shall be payable in United States dollars. With respect to
each quarter, for countries other than the United States, whenever
conversion of payments from any foreign currency shall be required,
such conversion shall be made at the rate of exchange reported in The
Wall Street Journal on the last business day of the applicable calendar
quarter. All payments owed under this Agreement shall be made by wire
transfer to a bank account designated by Atrix, unless otherwise
specified in writing by Atrix.
(c) Late Payments. In the event that any payment, including
contingent payments, due hereunder is not made when due, each such
payment shall accrue interest from the date due at the rate of one and
one half percent (1.50%) per month; provided, however, that in no event
shall such rate exceed the maximum legal annual interest rate. The
payment of such interest shall not limit Atrix from exercising any
other rights it may have under this Agreement as a consequence of the
lateness of any payment.
(d) Records and Audits. During the Term and for a period of
two (2) years thereafter or as otherwise required in order for Atrix to
comply with Applicable Law, Sanofi-Synthelabo shall keep complete and
accurate records in sufficient detail to permit Atrix to confirm the
completeness and accuracy of: (i) the information presented in each
Royalty Statement and all payments due hereunder; (ii) the calculation
of A&S and (iii) the calculation of Net Sales. Sanofi-Synthelabo shall
permit Atrix to inspect those records of Sanofi-Synthelabo (including
but not limited to financial records) that relate to Net Sales, Royalty
Statements and A&S for the sole purpose of verifying the completeness
and accuracy of the Royalty Statements, the calculation of the Net
Selling Price and Net Sales and the calculation of A&S. Such inspection
shall be at Atrix's expense and shall be subject to reasonable advance
notice to Sanofi-Synthelabo, during Sanofi-Synthelabo's usual business
hours. Further, Atrix shall have the right to cause an independent,
certified public accountant reasonably acceptable to Sanofi-Synthelabo
to audit such records to confirm royalty payments and A&S expenditures
for the Product for the preceding year. Such audits may be exercised
during normal business hours no more than once in any twelve (12) month
period upon at least ten (10) days prior written notice by Atrix to
Sanofi-Synthelabo. If such accounting firm concludes that such payments
were underpaid, Sanofi-Synthelabo shall pay Atrix the amount of any
such underpayments, plus interest at a rate equal to the Prime Rate of
Interest, within thirty (30) days of the date Atrix delivers to
Sanofi-Synthelabo such accounting firm's report so concluding that such
payments were underpaid. If such accounting firm concludes that such
payments were overpaid, Atrix shall pay to Sanofi-Synthelabo the amount
of any
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such overpayments, without interest, within thirty (30) days of the
date Atrix delivers to Sanofi-Synthelabo such accounting firm's report
so concluding that such payments were overpaid. Atrix shall bear the
full cost of such audit unless such audit discloses an underpayment by
more than five percent (5%) of the amount due under this Agreement. In
such case, Sanofi-Synthelabo shall bear the full cost of such audit.
(e) Taxes. All taxes levied on account of the payments
accruing to Atrix under this Agreement shall be paid by Atrix for its
own account, including taxes levied thereon as income to Atrix. If
provision is made in law or regulation for withholding, such tax shall
be deducted from the payment made by Sanofi-Synthelabo, paid to the
proper taxing authority and a receipt of payment of the tax secured and
promptly delivered to Atrix. Each Party agrees to assist the other
Party in claiming exemption from such deductions or withholdings under
any double taxation or similar agreement or treaty from time to time in
force.
(f) Prohibited Payments. Notwithstanding any other provision
of this Agreement, if Sanofi-Synthelabo is prevented from paying any
payments by virtue of the statutes, laws, codes or governmental
regulations of the country from which the payment is to be made, then
such payment may be paid by depositing funds in the currency in which
it accrued to Atrix's account in a bank acceptable to Atrix in the
country whose currency is involved.
ARTICLE V
NEW PRODUCT
Section 5.01. NEW PRODUCT. Subject to Sanofi-Synthelabo's right of
first negotiation under Section 5.02 below, Atrix may or, at Sanofi-Synthelabo's
request, will seek to develop and have the FDA approve a New Product.
Section 5.02. RIGHT OF FIRST NEGOTIATION. For a period of thirty (30)
days following the receipt of notice from (i) Atrix of its intention to develop
a New Product or (ii) Sanofi-Synthelabo of its intention to have Atrix develop a
New Product, Sanofi-Synthelabo shall have the first right to negotiate binding
material terms for a definitive license agreement for the New Product. In the
event (a) Sanofi-Synthelabo does not determine within such thirty (30) day
period to pursue a license for the New Product, (b) the Parties are unable to
reach agreement on binding material terms of such a license within such thirty
(30) day period, or (c) if the Parties have reached agreement on binding
material terms of such a license within such thirty (30) day period, but are
unable to enter into a definitive agreement within ninety (90) days following
the written notice from Atrix, Atrix shall have no further obligation to
Sanofi-Synthelabo under this Section 5.02. If Sanofi-Synthelabo and Atrix cannot
agree to the terms of such license, then Atrix may enter into an agreement with
a Third Party, provided that the terms of the agreement are no less favorable to
Atrix, in any material respect (individually or in the aggregate), than those
last proposed in writing by Sanofi-Synthelabo. The rights of Sanofi-Synthelabo
under this Section 5.02 shall only apply to those countries for which
Sanofi-Synthelabo retains a license under Sections 3.02 and 3.03 as of the date
of Atrix's written notice that the FDA has approved a New Product.
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ARTICLE VI
COMMERCIALIZATION
Section 6.01. PROMOTION AND MARKETING OBLIGATIONS.
(a) Marketing Efforts. Sanofi-Synthelabo agrees to use
commercially reasonable efforts to promote the sale, marketing and
distribution of the Product in the Territory, consistent with accepted
business practices devoting the same level of efforts as it devotes to
its own products of comparable market potential. "Comparable market
potential" shall be fairly determined by Sanofi-Synthelabo in good
faith and shall be based upon market size, price, competition and
general marketing parameters. Each Party shall promptly advise the
other Party of any issues that materially and adversely affect its
ability to market the Product in the Territory. In such event, senior
executives of Sanofi-Synthelabo and Atrix shall meet and in good faith
discuss what actions should be taken in light of such issues.
(b) Trademarks. Sanofi-Synthelabo shall be the exclusive
licensee of the Marks in the Territory for use in connection with the
promotion, marketing and sale of the Product, which trademarks shall
remain the sole property of Atrix. If either Sanofi-Synthelabo or Atrix
desires that the Product subsequently be sold under a different name,
or if any Competent Authority requires that Product be sold under a
different name, the following provisions shall apply: (i) the different
name (the "New Trademark") must be acceptable to Atrix, (ii) the New
Trademark must be legally obtainable by Atrix in each jurisdiction
where the New Trademark is sought, (iii) the New Trademark must be
acceptable to the Competent Authority in each jurisdiction where a
variation making the change to the applicable Marketing Authorization
is sought, (iv) all costs (including reasonable attorneys' fees) for
obtaining any change to a Marketing Authorization and for obtaining the
right to use the New Trademark in each jurisdiction will be paid by (A)
Sanofi-Synthelabo if Sanofi-Synthelabo requested the New Trademark, (B)
Atrix if Atrix requested the New Trademark, and (C) one-half by
Sanofi-Synthelabo and one-half by Atrix if a Competent Authority
required the New Trademark, and (v) any New Trademarks obtained or
authorized shall be owned by and be the sole property of Atrix;
provided, however that any New Trademark requested by
Sanofi-Synthelabo, and all costs for which are paid by
Sanofi-Synthelabo, shall be owned by and be the sole property of
Sanofi-Synthelabo.
(c) Packaging. Atrix shall package and label the Product, the
Units and the Demonstration Samples in compliance with the Packaging
Specifications and Applicable Laws. Atrix, in consultation with
Sanofi-Synthelabo, shall be responsible for assuring that such
packaging and labeling conform with all Applicable Laws, if any, of the
FDA for export of the Product and the Demonstration Samples to the
countries in the Territory other than the United States and that the
Units comply with the Packaging Specifications. Atrix, in consultation
with Sanofi-Synthelabo, shall also be responsible for assuring that
packaging and labeling comply with all Applicable Laws where such
Product is to be distributed for sale. All additional incremental costs
resulting from changes to the Packaging Specifications made at the
request of Sanofi-Synthelabo that are not required
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to export the Product to countries in the Territory on a country by
country basis under Applicable Laws shall be borne by
Sanofi-Synthelabo.
(d) Proposed Pricing Of Product. Within thirty (30) days of
Atrix's receipt of the Marketing Authorization in each country in the
Territory, Sanofi-Synthelabo shall provide the Advisory Board (as
defined below) with a detailed copy of the expected selling price
schedule of the Units in such country in the Territory (including any
(i) prompt payment or other trade or quantity discounts which
Sanofi-Synthelabo expects to offer and (ii) commission rates or rebates
which Sanofi-Synthelabo expects to offer to distributors and agents).
(e) Marketing Plans And Reports. Thirty (30) days prior to the
expected date of First Commercial Sale in any country in the Territory
and at the beginning of each calendar year thereafter,
Sanofi-Synthelabo shall submit to the Advisory Board in writing the
annual marketing, sales and distribution plan for each such country
detailing Sanofi-Synthelabo and its Affiliates' proposed marketing,
sales and distribution strategy and tactics for the sale and
distribution of Product during such calendar year, or portion thereof.
In addition, Sanofi-Synthelabo shall submit to the Advisory Board
copies of any market research reports relating to Product sales and
Product competition which Sanofi-Synthelabo or its Affiliates
commission or otherwise obtain to the extent permissible by the agency
preparing the report. To the extent the foregoing information is
contained in plans or reports which contain information about other
products or markets, Sanofi-Synthelabo may submit to the Advisory Board
only those excerpts from such plans or reports which relate to the
Product and Product competition.
(f) Advisory Board. The Parties agree to form an advisory
board (the "Advisory Board") comprised of three (3) representatives
from each of Sanofi-Synthelabo and Atrix. An officer of each Party
shall serve as the co-chairmen of the Advisory Board. Except as set
forth in Section 13.01, the Advisory Board will meet on a quarterly
basis and at such time will be consulted by Sanofi-Synthelabo on all
major decisions in the marketing of the Product in each country in the
Territory, but Sanofi-Synthelabo, alone, will be responsible for making
the final decisions on all sales, marketing, promotion and distribution
issues, regardless of the action or inaction of the Advisory Board,
including, without limitation, the following areas as they relate to
the sales, marketing, promotion and distribution of the Product:
(i) Product positioning in the marketplace;
(ii) quantity of direct selling efforts, including
the number of sales details to be made;
(iii) extent and degree of non-personal selling and
promotional efforts;
(iv) quantity and content of workshops and medical
symposia;
(v) design and implementation of a Phase IV
clinical study program to support the Product;
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(vi) design and implementation of a consumer
awareness program;
(vii) selection of physicians for a medical advisory
board and speakers bureau;
(viii) planning for international regulatory
submissions;
(ix) dispute resolution regarding sales, marketing
and promotional activities related to the Product; and
(x) internet presence.
(g) Co-Promotional Activities of Atrix. Beginning in month
twenty-four (24) following the launch of the first of any Product on a
country-by-country basis within the Territory, Atrix shall have the
right, [**] to participate in the sales, marketing and promotion of the
Product. If Atrix so elects, Atrix will provide additional field sales
representatives (the "Atrix Sales Force") and/or funding to augment the
sales, marketing and promotional activities of the Product by
Sanofi-Synthelabo as the Parties may agree. [**].
ARTICLE VII
MANUFACTURE AND SUPPLY
Section 7.01. AGREEMENT TO SUPPLY PRODUCT. Subject to the terms hereof,
Sanofi-Synthelabo agrees to purchase exclusively from Atrix, and Atrix agrees to
Manufacture for, and sell exclusively to Sanofi-Synthelabo during the Term of
this Agreement, Sanofi-Synthelabo's total requirements for the Product and the
Demonstration Samples in the Territory on the terms and conditions set forth
herein. Subject to Sanofi-Synthelabo's prior written approval, such approval not
to be unreasonably withheld, conditioned or delayed by Sanofi-Synthelabo, Atrix
may subcontract any part of the Manufacturing Process for the Product and the
Demonstration Samples to a Third Party provided: (a) the Product, the
Demonstration Samples and the facilities continue to meet the requirements as
defined in this Agreement and (b) Atrix has obtained all required Governmental
Approvals. If subcontracting is initiated by Atrix, for any Manufacturing
Process, Atrix will bear the cost of validation and necessary stability work, as
well as any other directly related costs.
Section 7.02. QUALITY ASSURANCE. Atrix shall Manufacture the Product in
accordance with the Specifications. Atrix shall consult with Sanofi-Synthelabo
as to any proposed changes in the Specifications, manufacturing processes, or in
Atrix's quality assurance procedures which might render Atrix unable to supply
Product in accordance with the terms of this Agreement, prior to making those
changes, and obtain Sanofi-Synthelabo's prior, written consent thereto, which
consent will not be unreasonably withheld, conditioned or delayed by
Sanofi-Synthelabo. Atrix shall immediately notify Sanofi-Synthelabo in writing
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** Confidential Treatment Requested.
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of any changes required by a Competent Authority in the Specifications or
Atrix's quality assurance procedures that would render Atrix unable to supply
the Product and/or Demonstration Samples in accordance with the terms of this
Agreement. The Parties agree to develop and execute an appropriate action plan
in such situation.
Section 7.03. ATRIX'S DUTIES. Atrix agrees to Manufacture the Product
in accordance with the Specifications, applicable cGMP and NDA requirements and
to furnish to Sanofi-Synthelabo with every shipment a written certificate of
analysis and Certificate of Compliance that confirms conformity of the Product
to the Specifications and cGMP. The Product may be subjected to testing by
Sanofi-Synthelabo at its designated facility in order to verify conformance of
the Product with the Specifications. In addition, Atrix shall:
(a) Provide Sanofi-Synthelabo with a copy of the written
sampling and testing procedures used by Atrix to confirm conformity of
the Product to the Specifications;
(b) Retain a sample of each batch of Product and, upon
request, make it available to Sanofi-Synthelabo for inspection. The
retained sample shall be sufficient in size to allow Sanofi-Synthelabo
and Atrix to perform tests to determine whether or not the Product
conforms to the Specifications. The retained sample shall be kept under
the same conditions as those under which the Product is stored at
Sanofi-Synthelabo's facilities;
(c) Maintain records to ensure Atrix's ability to perform a
complete lot history via lot tracing of the Product; and
(d) Keep on file all manufacturing records and analytical
results pertaining to the manufacture of each batch of Product for a
period expiring not earlier than two (2) years after the expiration
date of the last lot of Sanofi-Synthelabo's Product manufactured with
that batch of Product. Atrix shall make all such records available to
Sanofi-Synthelabo upon request.
(e) Consult closely on an ongoing basis with the Advisory
Board on all aspects of the manufacturing and development of the
Product, including the use of any subcontractors to perform part of the
Manufacturing Process, the obtaining of any and all required
Governmental Approval(s) for the Manufacture of the Product and the
obtaining of any and all required Marketing Authorizations to permit
the marketing, sale and distribution of the Product in the Territory.
In this regard, Atrix will provide monthly reports to the Advisory
Board on the status of the Manufacture and development of the Product
including, without limitation, to the extent applicable, all current
information on: (i) any material issues, problems or developments with
regard to (x) any subcontractors being utilized to perform part of the
Manufacture of the Product, or (y) any customer service issues; (ii)
the current status of all pending applications seeking any Governmental
Approval(s) or Marketing Authorization(s) for the Product from any
Competent Authority; and (iii) as to the status or progress of
obtaining any patent rights pertaining to any aspect of the Product.
(f) Provide to Sanofi-Synthelabo within twenty-four (24) hours
of receipt by Atrix, complete copies of any and all inspection reports
pertaining to the Manufacture
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and development of the Product which Atrix receives from any Competent
Authority, or which is obtained by Atrix from any third party agency,
and promptly provide to Sanofi-Synthelabo any such report which is
internally produced by Atrix's staff or that of any of its Affiliates.
(g) Provide Sanofi-Synthelabo with complete access to all
existing and hereafter produced: (i) batch records of the Product; (ii)
quality inspection reports of the Product, whether internally or
externally generated; (iii) any and all investigation reports of the
Product, whether internally or externally generated; and (iv) packaging
records pertaining to the Product; and
(h) Provide Sanofi-Synthelabo with notice within twenty-four
(24) hours of notification of any scheduled inspection by any Competent
Authority of Atrix's facilities, books or records, or of the
facilities, books or records of any subcontractor being utilized by
Atrix to perform any portion or all of the Manufacture or development
of the Product. Atrix shall inform such Competent Authority that
Sanofi-Synthelabo may desire to be present at such inspection; provided
that Sanofi-Synthelabo's right to be present is subject to approval by
such Competent Authority and subject to Sanofi-Synthelabo being
available at the time and date established by such Competent Authority.
Atrix shall use reasonable efforts to secure a time and date for such
inspection that is reasonably acceptable to Sanofi-Synthelabo; provided
however that Atrix alone has the right to make the final decision on
all such matters.
Section 7.04. COMPLIANCE WITH APPLICABLE LAWS. Sanofi-Synthelabo and
Atrix (if Atrix has exercised its co-promotion and/or co-marketing rights
pursuant to Sections 6.01(g) and 13.01, respectively, of this Agreement) shall
be responsible for compliance with Applicable Laws relating to the promotion,
marketing, sale and distribution of the Product, Units and the Demonstration
Samples, as applicable. Atrix shall be responsible for compliance with
Applicable Laws relating to the Manufacture, design and production of the
Product and the Demonstration Samples, as applicable, and with cGMP relating to
the Manufacture and testing of the Product.
Section 7.05. SECOND MANUFACTURING SOURCE. Atrix, at its own cost and
expense, shall validate, qualify and obtain all Governmental Approvals for a
Third Party as a second source (the "Second Source") to Manufacture the Product.
Atrix will file a supplement to the NDA for each Product with the FDA no later
than six (6) months after the NDA for each Product is approved to seek FDA
approval for such Second Source to Manufacture each such Product. After such
filing, Atrix shall use reasonable efforts to obtain final FDA approval for such
Second Source to Manufacture each such Product including modifying the NDA
supplement if required by the FDA. Upon prior written notice to Atrix,
Sanofi-Synthelabo shall have the right to inspect and audit the Second Source's
facilities used to Manufacture the Product to confirm that such facilities are
in compliance with Applicable Laws and the Governmental Approvals. Atrix, at its
sole cost and expense, may have a representative(s) accompany
Sanofi-Synthelabo's representative(s) on any such inspection or audit.
Section 7.06. FAILURE TO SUPPLY. Atrix shall immediately notify
Sanofi-Synthelabo if Atrix is unable to fill any order placed by
Sanofi-Synthelabo pursuant to Section 8.07. If Atrix is unable to cure such
failure within thirty (30) days after such notice, Atrix shall, upon such
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failure, make arrangements with the Second Source to Manufacture and sell to
Atrix the Product until such time as Atrix is again able to Manufacture the
Product; provided, however, any consequent incremental costs which result by
reason of the use of the Second Source under this Section 7.06 shall be the sole
cost and liability of Atrix.
Subject to the following paragraph, if Atrix is unable (including due
to reasons of Force Majeure) to supply Product to Sanofi-Synthelabo for a period
of ninety (90) days or more or if Atrix notifies Sanofi-Synthelabo that Atrix
will be unable to perform under this Section 7.06 (or that the Second Source
will be unable to perform under Section 7.05), Atrix hereby grants to
Sanofi-Synthelabo a nonexclusive, royalty-free license under the Atrigel(R)
Technology and any other relevant technology necessary to make or have made the
Product, for use solely for sale or distribution in the Territory and solely
until such time as Atrix is again able to Manufacture the Product at which time
Atrix will regain its exclusive right to Manufacture and supply the Product to
Sanofi-Synthelabo. Sanofi-Synthelabo may grant sublicenses under the foregoing
license with the consent of Atrix, such consent not to be unreasonably withheld.
At the request of Sanofi-Synthelabo, Atrix shall provide reasonable technical
assistance in connection with the transfer of manufacturing described in this
Section.
Notwithstanding the foregoing, Atrix shall not be deemed to be unable
to fill any order placed by Sanofi-Synthelabo as follows: (a) if Atrix's
inability to fill any order arises as a result of [**] increase in
Sanofi-Synthelabo's order over Sanofi-Synthelabo's prior forecast; or (b) in the
event that Atrix must purchase additional equipment or construct a new facility
in order to expand its capacity in order to meet purchase orders hereunder,
Atrix will be deemed to have satisfied this paragraph by placing a purchase
order for such equipment or signing a contract for such construction within
sixty (60) days of Atrix's receipt of Sanofi-Synthelabo's purchase order showing
firm quantities in excess of Atrix's capacity; provided that Atrix diligently
pursues and completes within a reasonable time thereafter such purchase or
construction.
Section 7.07. ALLOCATION. If Atrix exercises its rights to co-market
under Article XIII and if Atrix is unable to supply all of the requirements of
the Product, and quantities ordered by Sanofi-Synthelabo in accordance with
Section 8.07, then Atrix shall allocate the resources available to it so that
Sanofi-Synthelabo receives at least its proportional share of available supplies
as determined based on reasonable forecasts (taking into consideration past
sales and sales performance against forecast) of Sanofi-Synthelabo and Atrix.
ARTICLE VIII
PURCHASE AND SALE
Section 8.01. PURCHASE PRICE AND PAYMENT. Atrix shall sell, and
Sanofi-Synthelabo shall purchase, each Product at a price equal to the Atrix
Manufacturing Cost, including any adjustments pursuant to Section 8.02 (the
"Purchase Price"). Atrix shall invoice Sanofi-Synthelabo monthly for all Product
and Demonstration Samples shipped by Atrix to Sanofi-Synthelabo and payment
shall be due thirty (30) days from receipt of the invoice.
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Section 8.02. ADJUSTMENT TO PURCHASE PRICE/AUDIT.
(a) The Atrix Manufacturing Cost will be adjusted on a Product
by Product basis annually commencing with the first day of the first
calendar month twelve (12) months from the date of the First Commercial
Sale of each Product (the "Adjusted Atrix Manufacturing Cost"). [**]:
(i) if Sanofi-Synthelabo in good faith disputes the
amount of the Adjusted Atrix Manufacturing Cost, then
Sanofi-Synthelabo shall notify Atrix of a good faith dispute
and such dispute shall be resolved by the Parties within
thirty (30) days from the date of notice of the Adjusted Atrix
Manufacturing Cost; provided however if the dispute cannot be
resolved to the mutual satisfaction of the Parties within such
thirty (30) day period then either Party may request that the
dispute be submitted to the Chief Executive Officers of Atrix
and Sanofi-Synthelabo, respectively, for joint resolution. If
the dispute is not jointly resolved by the Parties' respective
Chief Executive Officers within ten (10) days from submission
to the Parties' respective Chief Executive Officers then Atrix
shall be entitled to pursue any and all remedies at law
available to it. In no event will the dispute resolution
period exceed a maximum of forty (40) days unless otherwise
agreed in writing by the Parties; and
(ii) Sanofi-Synthelabo shall pay for Product ordered
during the dispute period at the Purchase Price in effect
prior to Atrix's notice of an adjustment of the Atrix
Manufacturing Cost. If upon resolution of any dispute the
Purchase Price is greater than the Purchase Price paid by
Sanofi-Synthelabo during the dispute period, Atrix will
invoice Sanofi-Synthelabo for the difference and
Sanofi-Synthelabo shall pay the same promptly upon receipt of
such invoice.
(b) If at any time following twelve (12) months from the date
of the First Commercial Sale of each Product, on a Product by Product
basis, the Atrix Manufacturing Cost is in excess of the Twelve Month
Cost then Sanofi-Synthelabo may request that the Parties meet to review
and discuss the Atrix Manufacturing Cost. [**] Notwithstanding the
foregoing, in the event that increases [**] result in an increased
Atrix Manufacturing Cost which becomes, in Sanofi-Synthelabo's sole
judgment to be commercially non-viable, Sanofi-Synthelabo may terminate
this Agreement pursuant to Section 19.05.
(c) Commencing twelve (12) months from the date of First
Commercial Sale of each Product Sanofi-Synthelabo shall have the right
to cause an independent, certified public accountant reasonably
acceptable to Atrix to audit those records of Atrix relating to the
calculation of the Atrix Manufacturing Cost for the sole purpose of
verifying the Atrix Manufacturing Cost. Such audits may be exercised
during normal business hours nor more than once in a twelve (12) month
period upon at least ten (10) days prior written notice.
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Section 8.03. LABELING.
(a) After execution of this Agreement, Sanofi-Synthelabo shall
have the right to review and comment upon any proposed changes to the
labeling for the Product and to participate in discussions with the
Competent Authorities concerning any labeling change. Notwithstanding
the above, Atrix shall have the authority to make the final decision
with regard to any labeling revisions.
(b) Both Parties will approve all artwork developed for
inclusion in the Product packaging, including carton labels, package
inserts, etc., which approval will not be unreasonably withheld,
conditioned or delayed by either Party. If Sanofi-Synthelabo wishes to
institute changes in labeling artwork, both Parties will develop a
mutually acceptable implementation schedule. Neither Party shall alter,
change or in any way modify the artwork, which has previously been
approved, for any reason, without prior written authorization from the
other Party which authorization shall not be unreasonably withheld,
conditioned or delayed by either Party, provided that such approved
artwork shall conform to all Applicable Laws.
Section 8.04. PURCHASE FORMS. Purchase orders, purchase order releases,
confirmations, acceptances and similar documents submitted by a Party in
conducting the activities contemplated under this Agreement are for
administrative purposes only and shall not add to or modify the terms of the
Agreement. To the extent of any conflict or inconsistency between this Agreement
and any such document, the terms of this Agreement shall govern.
Section 8.05. CONFIRMATION. Atrix shall confirm each purchase order
within ten (10) business days from the date of receipt of a purchase order and
shall supply the Product within a maximum of sixty (60) days from the date of
acceptance of a purchase order, or later if so specified in the purchase order.
Failure of Atrix to confirm any purchase order shall not relieve Atrix of its
obligation to supply Product ordered by Sanofi-Synthelabo in conformity with
this Agreement.
Section 8.06. DELIVERY. Delivery terms for Product and Demonstration
Samples shall be FOB Atrix's manufacturing facility at Fort Collins, Colorado.
Atrix shall ship Product and Demonstration Samples in accordance with
Sanofi-Synthelabo's purchase order form or as otherwise directed by
Sanofi-Synthelabo in writing. Title to any Product or Demonstration Samples
purchased by Sanofi-Synthelabo shall pass to Sanofi-Synthelabo upon the earlier
of (i) a common carrier accepting possession or control of such Product or
Demonstration Samples, as applicable, or (ii) passage of such Product or
Demonstration Samples, as applicable, from the loading dock of Atrix's
facilities to Sanofi-Synthelabo or its agent.
Section 8.07. FORECASTS AND ORDERS. (a) Not later than six (6) months
following submission of the NDA or other applicable regulatory filing on a
country by country basis, Sanofi-Synthelabo will provide Atrix with a twelve
(12) month forecast of Sanofi-Synthelabo's requirement of Product on a Product
by Product basis, including Demonstration Samples, on a country by country basis
as follows:
(i) For the first twelve (12) months of the forecast,
the forecasts shall be provided quarterly, no less than
forty-five (45) days prior to the beginning
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of each quarter. Said requirements will be based on standard
production planning parameters including but not limited to
sales forecasts, sales demand forecasts, promotional
forecasts, inventory requirements, and the like. The first two
(2) quarters of the twelve (12) month forecast will be stated
in monthly requirements. The second two (2) quarters of the
twelve (12) month forecast will be total requirement by stock
keeping unit and will be stated as quarterly requirements. The
first three (3) months of the twelve (12) month forecast will
be firm orders to purchase. The second three (3) months will
be allowed to be flexed from the previous forecast by plus or
minus twenty-five percent (25%) per month until fixed by the
subsequent forecast; provided that the aggregate adjustment
from the quantity set forth in the previous forecast for such
three (3) month period shall not exceed fifty percent (50%) in
aggregate during that three (3) month period. The last two (2)
quarters' total quantities will be an estimate and not
binding.
(ii) After the first twelve (12) months
Sanofi-Synthelabo will provide to Atrix a rolling twelve (12)
month forecast with the first three (3) months of the rolling
twelve (12) month forecast a firm order to purchase. Each
order in the rolling twelve (12) month forecast shall be
provided monthly, no less than twenty (20) days prior to the
beginning of each month. All orders will be for full batch
quantities.
(b) It is understood that Atrix will not maintain Product or
Demonstration Sample inventory in excess of the forecast, but will
produce Product or Demonstration Sample upon receipt of that portion of
Sanofi-Synthelabo's forecasts that constitute firm orders to purchase.
The above periods whether fixed or flexible will be adjusted based upon
existing lead times at time of start up.
(c) Sanofi-Synthelabo agrees to purchase a sufficient amount
of Product to enable Sanofi-Synthelabo to carry sufficient inventory to
allow for fluctuations in sales demand so as to allow Atrix reasonable
lead time to meet increased demand. Atrix will use commercially
reasonable efforts to meet any increase in demand in excess of the
allowed adjustment, but will not be obligated to do so; provided,
however, notwithstanding anything to the contrary in this Section 8.07,
Atrix shall be obligated to [**]. All forecasts will be made by
Sanofi-Synthelabo to Atrix in good faith based upon standard commercial
parameters. From time to time after the Effective Date, the Parties
shall consider whether, in light of market demand, manufacturing
capacity, inventory levels and other pertinent factors, to revise the
schedule for delivery of forecasts and, if appropriate, negotiate in
good faith to revise such schedule.
(d) The Launch Quantity of the Product when delivered to the
common carrier shall not have an expiration date of less than fifteen
(15) months from the date of such delivery, provided (a) Product other
than the Launch Quantity shall not have an expiration date of less than
twenty four (24) months once real time stability data is
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submitted by Atrix to the FDA, and/or (b) as the Parties may otherwise
agree in writing on a case by case basis.
Section 8.08. DEMONSTRATION SAMPLES. Pursuant to the provisions of
Section 8.07 above, Atrix shall supply to Sanofi-Synthelabo such quantities of
Demonstration Samples as Sanofi-Synthelabo may reasonably request to be used
solely for training purposes (and not for sale), and not for human use, for so
long as Sanofi-Synthelabo retains a License pursuant to Sections 3.02 and 3.03
in the specific country in the Territory. Demonstration Samples shall be sold by
Atrix to Sanofi-Synthelabo at the Atrix Manufacturing Cost for such
Demonstration Samples. Sanofi-Synthelabo shall not use the Demonstration Samples
for any purpose other than as set forth in this Section 8.08.
ARTICLE IX
WARRANTY, REJECTION AND INSPECTIONS
Section 9.01. ATRIX WARRANTY. Atrix represents and warrants to
Sanofi-Synthelabo that (i) the Product delivered pursuant to this Agreement
shall comply with the Specifications; (ii) is not adulterated or misbranded
under Applicable Laws; and (iii) at the time of Manufacture and delivery to
Sanofi-Synthelabo the Product will be, and is, free from any defects, liens and
encumbrances and Sanofi-Synthelabo shall receive good and marketable title to
the Product.
EXCEPT AS OTHERWISE SET FORTH HEREIN, ATRIX MAKES NO OTHER WARRANTIES
OF ANY OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY
OR FITNESS OF THE PRODUCT AND DEMONSTRATION SAMPLES FOR ANY PURPOSE, AND ATRIX
EXPRESSLY DISCLAIMS ANY SUCH OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND
DEMONSTRATION SAMPLES, EITHER EXPRESSED OR IMPLIED.
Section 9.02. REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO
SPECIFICATIONS. Sanofi-Synthelabo shall have thirty (30) days after the receipt
of any Shipment to determine conformity of the Shipment to the Specifications
and/or Applicable Laws. If testing of such Shipment shows a failure of the
Shipment to meet the Specifications and/or Applicable Laws, Sanofi-Synthelabo
may return the entire Shipment, or any portion thereof, to Atrix at Atrix's
expense within a reasonable time following the above described testing, provided
that notice of non-conformity is received by Atrix from Sanofi-Synthelabo within
forty (40) days of Sanofi-Synthelabo's receipt of said Shipment. Atrix shall
have the option to provide to Sanofi-Synthelabo, within thirty (30) days after
such notice is received by it, Product that meets the Specifications and
Applicable Laws or to promptly provide Sanofi-Synthelabo with full credit for
the Purchase Price paid by Sanofi-Synthelabo for the returned Product. In either
case the cost of freight and handling to return or replace the goods shall be at
the expense of Atrix. If Sanofi-Synthelabo does not notify Atrix of the
non-conformity of the Product within forty (40) days of receipt of said
Shipment, the Product shall be deemed to meet the Specifications, the Packaging
Specifications and Applicable Laws. Notwithstanding anything in this Agreement
to the contrary, the Parties may agree to a return of the Product or an
adjustment in the Purchase Price in the event of any failure or defect in the
Product. Should there be a discrepancy between Sanofi-Synthelabo's test results
and the results of testing performed by Atrix, such discrepancies shall be
finally resolved by testing performed by an independent Third Party mutually
agreed upon by Sanofi-Synthelabo and Atrix.
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The costs of such testing shall be borne by the Party against whom the
discrepancy is resolved. In the event Product has been previously returned to
Atrix and an independent Third Party determines that the Product meets the
Specifications, Sanofi-Synthelabo shall be responsible for all costs associated
with the return.
Section 9.03. SANOFI-SYNTHELABO INSPECTIONS. Atrix shall upon
reasonable (but not less than ten (10) days) prior written notice by
Sanofi-Synthelabo and during normal business hours, allow Sanofi-Synthelabo and
cause any sub-contractors and the Second Source to allow Sanofi-Synthelabo, to
inspect and audit Atrix's facilities, the facilities of Atrix's sub-contractors
and the facilities of the Second Source used to Manufacture the Product and the
Demonstration Samples, twice annually, to confirm that the facilities and the
equipment, personnel and operating and testing procedures used by Atrix, Atrix's
subcontractor(s) and the Second Source in the Manufacture, testing, storage and
distribution of the Product are in compliance with Applicable Laws and the
Governmental Approvals; provided that such inspection does not interfere with
Atrix's, Atrix's sub-contractor(s)' and the Second Source's normal operations or
cause Atrix, Atrix's sub-contractor(s) and the Second Source to violate or be in
breach of any confidentiality agreements with any Third Party.
ARTICLE X
REGULATORY COMPLIANCE
Section 10.01. MARKETING AUTHORIZATION HOLDER. Unless otherwise
required by Applicable Laws, Atrix shall be the holder of all Marketing
Authorizations for each country in the Territory; provided, however, that
Sanofi-Synthelabo shall hold the Canadian Marketing Authorization. Atrix will
own and maintain the Marketing Authorizations (other than the Canadian Marketing
Authorization which shall be the responsibility of Sanofi-Synthelabo) during the
term of this Agreement. Each Party agrees that neither it nor its Affiliates
will do anything to adversely affect a Marketing Authorization.
Section 10.02. MAINTENANCE OF MARKETING AUTHORIZATIONS. Atrix agrees to
maintain the Marketing Authorizations throughout the term of this Agreement,
including obtaining any variations or renewals thereof, and Sanofi-Synthelabo
agrees to reimburse Atrix for [**] of all of Atrix's out-of-pocket expenses
incurred in connection with maintaining the Marketing Authorizations within
thirty (30) days after Atrix submits its invoice and appropriate documentation
to Sanofi-Synthelabo for [**] of such expenses.
Section 10.03. INTERACTION WITH COMPETENT AUTHORITIES.
(a) After execution of this Agreement, each Party shall
provide to the other Party a copy of any significant correspondence
regarding the Product in the Territory that it submits to or receives
from Competent Authorities, within ten (10) days of submission or
receipt, as the case may be. Within five (5) days after receipt of an
Approval Letter for the Product in the Territory, Atrix will notify the
appropriate Competent Authorities in
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writing that Sanofi-Synthelabo will be the contact for all
communications with the Competent Authorities concerning the Product in
the Territory, except for those issues relating to CMC.
(b) Within five (5) days after Atrix notifies
Sanofi-Synthelabo of receipt by Atrix of an Approval Letter for the
Product in the Territory, Sanofi-Synthelabo will notify the appropriate
Competent Authorities in writing that Sanofi-Synthelabo is accepting
the transfer from Atrix described in Section 10.03(a), and assuming
responsibility for all communications with the Competent Authorities
concerning the Product in the Territory, except for those issues
relating to CMC. Sanofi-Synthelabo shall provide Atrix with a copy of
any significant correspondence regarding the Product that it submits to
or receives from the Competent Authorities, within ten (10) days prior
to the date of submission or within ten (10) days from receipt, as the
case may be.
Section 10.04. ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE.
(a) Each Party shall advise the other Party, by telephone or
facsimile, within twenty-four (24) hours after a Party becomes aware of
any potentially serious or unexpected adverse event (including adverse
drug experiences, as defined in 21 C.F.R. Section 314.80 or other
applicable Regulations) (an "ADE") involving the Product or the
Demonstration Samples. Such advising Party shall provide the other
Party with a written report delivered by confirmed facsimile of any
adverse reaction, stating the full facts known to such Party, including
but not limited to customer name, address, telephone number, batch, lot
and serial numbers, and other information as required by Applicable
Laws. For so long as Sanofi-Synthelabo has an exclusive license to
market, promote and sell the Product in the Territory for use in the
Field, Sanofi-Synthelabo shall have full responsibility for (i)
monitoring such adverse reactions; and (ii) data collection activities
that occur between Sanofi-Synthelabo and the patient or medical
professional, as appropriate, including any follow-up inquiries which
Sanofi-Synthelabo deems necessary or appropriate. Sanofi-Synthelabo
shall make any necessary reports to the Competent Authorities, with a
complete copy provided to Atrix at the same time the report is made by
Sanofi-Synthelabo to the Competent Authorities.
If Atrix exercises its right to co-market as set forth in
Section 13.01 then upon the occurrence of an ADE the Parties shall
promptly meet, in person or by telephone, as appropriate, to discuss
and determine how to mutually handle and resolve any issues relating to
or arising from any such ADE.
(b) In the event either Party requires information regarding
adverse drug events with respect to reports required to be filed by it
in order to comply with Applicable Laws, including obligations to
report ADEs to the Competent Authorities, each Party agrees to provide
such information to the other on a timely basis.
(c) The Parties agree to follow Sanofi-Synthelabo's standard
operating procedure for reporting and identifying adverse drug
reactions (the "SOP") a copy of which is attached hereto as Exhibit F.
In the event the SOP is modified or amended during the term of this
Agreement, Sanofi-Synthelabo shall provide Atrix with copies of any
such modification or amendment to the SOP for Atrix's prior approval,
which will
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not be unreasonably withheld, conditioned or delayed, at least five (5)
business days prior to such amendment taking effect. Sanofi-Synthelabo
shall designate a qualified person under Applicable Laws to be
responsible for ADE reporting in each country in the Territory. In the
event Atrix requires information regarding adverse drug events with
respect to reports required to be filed by Atrix in order to comply
with Applicable Laws, Sanofi-Synthelabo agrees to provide such
information to Atrix on a basis sufficient to allow Atrix to timely
comply with Applicable Laws.
(d) If the report of an ADE causes a Competent Authority to
request labeling revision as a result of an ADE or that a Phase IV
surveillance program be conducted, then the Parties shall promptly
enter into discussions and shall mutually agree on all of the material
terms and conditions of such labeling revision or Phase IV surveillance
program; provided, however the costs of such labeling revision or Phase
IV surveillance program shall be borne [**]. Atrix shall have the
authority to make the final decision with regard to any labeling
revisions. Atrix agrees that should Applicable Laws require that any
such interim data and results from such Phase IV surveillance programs
be prepared in written form, Atrix shall comply with such requirements
and provide all such information in writing to Sanofi-Synthelabo and
the Competent Authorities in accordance with Applicable Laws. Atrix
further agrees that Sanofi-Synthelabo shall have the right to
incorporate, refer to and cross-reference such results and underlying
data in any regulatory filing or any other filing or requirement
Sanofi-Synthelabo is required to undertake with respect to the Product.
Section 10.05. POST - FIRST COMMERCIAL SALE TESTING AND REPORTING. If,
after the date of First Commercial Sale in any country in the Territory, adverse
events or other issues arise with respect to the safety or efficacy of the
Product which jeopardizes the Product's performance or are deemed by the Parties
to potentially limit its approved indications, the Parties shall consult with
each other with respect to such events or other issues. If the Parties determine
that the situation requires clinical testing after First Commercial Sale in any
country in the Territory, modifications to any Marketing Authorization or other
communication with any Competent Authority or entity, Atrix shall design and the
Parties shall implement any such testing, modifications or communication as
shall be agreed upon by the Parties, and the costs shall be borne [**].
Section 10.06. ASSISTANCE. Each Party shall provide reasonable
assistance to the other at the other's request, in connection with their
obligations pursuant to this Article X, subject to reimbursement of all of its
out-of-pocket costs by the requesting Party.
Section 10.07. COMPLIANCE. Sanofi-Synthelabo and Atrix shall comply
with all Applicable Laws within the Territory as set forth in this Agreement,
including the provision of information by Sanofi-Synthelabo and Atrix to each
other necessary for Atrix and Sanofi-Synthelabo to comply with any applicable
reporting requirements. Each Party shall promptly notify the other Party of any
comments, responses or notices received from, or inspections by, the FDA, or
other applicable Competent Authorities, which relate to or may impact the
Product
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or the Manufacture of the Product or the sales and marketing of the Product, and
shall promptly inform the other Party of any responses to such comments,
responses, notices or inspections and the resolution of any issue raised by the
FDA or other Competent Authorities.
ARTICLE XI
PATENTS AND TRADEMARKS
Section 11.01. MAINTENANCE OF PATENTS OR MARKS. Atrix shall, at Atrix's
expense, maintain and protect the Atrigel(R) Patent Rights and the Marks in all
countries in the Territory; provided however, that upon written request by
Atrix, Sanofi-Synthelabo shall, at no cost or expense to Sanofi-Synthelabo,
provide such assistance as may be necessary to enable Atrix to comply with the
administrative formalities necessary to maintain any Atrigel(R) Patent Rights or
the Marks.
Section 11.02. COOPERATION. Sanofi-Synthelabo shall make available to
Atrix or its authorized attorneys, agents or representatives, its employees,
agents or consultants necessary or appropriate to enable Atrix to file,
prosecute and maintain patent applications for a period of time sufficient for
Atrix to obtain the assistance it needs from such personnel. Where appropriate,
Sanofi-Synthelabo shall sign or cause to have signed all documents relating to
said patent or patent applications at no charge to Atrix.
Section 11.03. ATRIX TO PROSECUTE INFRINGEMENT. During the Term, each
Party shall give prompt notice to the other of any Third Party act which may
infringe the Atrigel(R) Patent Rights or the Marks and shall cooperate with each
other to terminate such infringement without litigation. Atrix shall, at its
sole expense, prosecute the judicial or administrative proceedings against such
Third Party infringement. Sanofi-Synthelabo shall provide such assistance and
cooperation to Atrix as may be necessary to successfully prosecute any action
against Third Party infringement at Atrix's expense and may deduct the expenses
thereof from any amounts payable to Atrix under this Agreement.
In the event Atrix fails to institute proceedings against any Third
Party infringement of the Atrigel(R) Patent Rights and/or the Marks within
ninety (90) days after notice given by either Party to the other of said Third
Party infringement, Sanofi-Synthelabo may take such action as it deems
appropriate, including without limitation, the filing of a lawsuit against such
Third Party. In such event Atrix will provide such assistance and cooperation to
Sanofi-Synthelabo as may be necessary, at Sanofi-Synthelabo's expense, and
Sanofi-Synthelabo may deduct all costs and expenses of such actions against any
amount payable to Atrix under this Agreement and retain all amounts awarded in
such action. Sanofi-Synthelabo may settle any such claim so long as the terms of
such settlement do not impair Atrix's rights hereunder or Atrix's rights in the
Atrigel(R) Technology. In the event that either Party fails to terminate any
Third Party infringement as a consequence of a final determination by a court of
competent jurisdiction that all or any portion of the patent claims covering the
Product are invalid or unenforceable, then if such infringement results in a
Third Party selling a product that competes with the Product, then
Sanofi-Synthelabo's obligation to pay royalties provided for in this Agreement
in respect of Net Sales of the Product in the affected country in the Territory
shall be reduced by the percentage by which sales of the Product by
Sanofi-Synthelabo in the affected country in the Territory decrease as a result
of the Third Party's sales of the competing product in the affected country in
the Territory.
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Section 11.04. INFRINGEMENT CLAIMED BY THIRD PARTIES. In the event a
Third Party commences, or threatens to commence, a judicial or administrative
proceeding against a Party to this Agreement and such proceeding pertains to a
patent or Mark, the Party against whom such proceeding is threatened or
commenced shall give prompt notice to the other Party. Atrix shall, at its sole
cost and expense, defend any and all such claims or proceedings and shall
indemnify and hold harmless Sanofi-Synthelabo from any and all liabilities,
costs and expenses, including, without limitation, attorneys' fees, incurred
with respect to any such claim or proceeding and Sanofi-Synthelabo shall provide
such assistance and cooperation to Atrix as may be necessary to successfully
defend any such claim or proceeding.
ARTICLE XII
CONFIDENTIALITY
Section 12.01. CONFIDENTIALITY. During the Term and for a period of
[**] thereafter, each Party shall maintain all Confidential Information of the
other Party as confidential and shall not disclose any such Confidential
Information to any Third Party or use any such Confidential Information for any
purpose, except (a) as expressly authorized by this Agreement, (b) as required
by law, rule, regulation or court order (provided that the disclosing Party
shall first notify the other Party and shall use commercially reasonable efforts
to obtain confidential treatment of any such information required to be
disclosed), or (c) to its Affiliates, employees, agents, consultants and other
representatives to accomplish the purposes of this Agreement, so long as such
persons are under an obligation of confidentiality no less stringent than as set
forth herein. Each Party may use such Confidential Information only to the
extent required to accomplish the purposes of this Agreement. Each Party shall
use at least the same standard of care as it uses to protect its own
Confidential Information to ensure that its Affiliates, employees, agents,
consultants and other representatives do not disclose or make any unauthorized
use of the other Party's Confidential Information. Each Party shall promptly
notify the other Party upon discovery of any unauthorized use or disclosure of
the other Party's Confidential Information.
Section 12.02. DISCLOSURE OF AGREEMENT. Neither Party shall release to
any Third Party or publish in any way any non-public information with respect to
the terms of this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld, except for the
disclosure by a Party of the terms of this Agreement to lenders, investment
bankers and other financial institutions of its choice solely for purposes of
financing the business operations of such Party; provided such Party uses
reasonable efforts to obtain a signed confidentiality agreement with any such
financial institution with respect to such information on terms substantially
similar to those contained in this Article XII and except as provided in Section
20.11. Nothing contained in this paragraph shall prohibit either Party from
filing this Agreement as required by the rules and regulations of the Securities
and Exchange Commission, national securities exchanges or the Nasdaq Stock
Market; provided the disclosing Party discloses only the minimum information
required to be disclosed in order to comply with such requirements, including
requesting confidential treatment of this Agreement (after consultation with the
other Party) and filing this Agreement in redacted form.
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ARTICLE XIII
ATRIX'S OPTION TO MARKET THE
PRODUCT UNDER CERTAIN CIRCUMSTANCES
Section 13.01. CO-MARKETING RIGHTS. If Sanofi-Synthelabo should fail to
achieve, through no fault of Atrix, at least a [**], then, and in such event
only, Atrix shall have the right and option, exercisable in its sole discretion,
by written notice to that effect delivered by Atrix to Sanofi-Synthelabo within
sixty (60) days after said event occurs, to co-market the Product in the United
States, either by itself, using a Third Party or in conjunction with a Third
Party. If Atrix exercises its right to co-market the Product in the United
States the following shall occur: (i) Sanofi-Synthelabo shall grant Atrix an
exclusive sublicense of its rights under this Agreement (and no other
Sanofi-Synthelabo proprietary or intellectual property rights) with the right to
sub-license, to market, advertise, promote, distribute, offer for sale, sell and
import the Product in the United States; (ii) Atrix will be solely responsible
for its expenses related to marketing the Product in the United States and Atrix
will retain all revenues from Product that it sells in the United States; (iii)
Atrix and/or its sublicensee shall only be entitled to market one additional
brand of the Product and Atrix and/or its sublicensee shall market the Product
using a different trademark than the Mark and (iv) the Advisory Board will be
deemed to be automatically dissolved as of the date Atrix exercises its right to
co-market the Product.
ARTICLE XIV
REPRESENTATIONS AND WARRANTIES
Section 14.01. CORPORATE POWER. As of the date of this Agreement and as
of the Effective Date, each Party hereby represents and warrants that such Party
is duly organized and validly existing under the laws of the state of its
incorporation and has full power and authority to enter into this Agreement and
the transactions contemplated hereby and to carry out the provisions hereof.
Section 14.02. DUE AUTHORIZATION. As of the date of this Agreement and
as of the Effective Date, each Party hereby represents and warrants that such
Party is duly authorized to execute and deliver this Agreement and to perform
its obligations hereunder.
Section 14.03. BINDING OBLIGATION. As of the date of this Agreement and
as of the Effective Date, each Party hereby represents and warrants that this
Agreement is a legal and valid obligation binding upon it and is enforceable in
accordance with its terms, except that the enforcement of the rights and
remedies created hereby is subject to bankruptcy, insolvency, reorganization and
similar laws of general application affecting the rights and remedies of
creditors and that the availability of the remedy of specific performance or of
injunctive relief is subject to the discretion of the court before which any
proceeding therefor may be brought. As of the date of this Agreement and as of
the Effective Date, the execution, delivery and performance of this Agreement by
such Party does not conflict with any
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agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
Section 14.04. OWNERSHIP OF ATRIGEL(R) PATENT RIGHTS. As of the date of
this Agreement and as of the Effective Date, Atrix represents and warrants that
(a) it is the sole owner of all right, title and interest in and to the
Atrigel(R) Patent Rights and the Marks, (b) it has not granted any license under
the Atrigel(R) Patent Rights or the Marks for any Product in the Territory for
use in the Field to any Third Party and is under no obligation to grant any such
license, except to Sanofi-Synthelabo, and (c) there are no outstanding liens,
encumbrances, agreements or understanding of any kind, either written, oral or
implied, regarding either the Atrigel(R) Patent Rights or the Marks which are
inconsistent or in conflict with this Agreement.
Section 14.05. PATENT PROCEEDINGS. As of the date of this Agreement and
as of the Effective Date, Atrix represents and warrants that, to the best of its
knowledge, (a) no patent or patent application within the Atrigel(R) Patent
Rights is the subject of any pending interference, opposition, cancellation or
other protest proceeding, and (b) the Atrigel(R) Technology does not infringe
the published intellectual property rights of any Third Party.
Section 14.06. LEGAL PROCEEDINGS. As of the date of this Agreement and
as the Effective Date, each Party hereby represents and warrants to the other
Party that there is no action, suit or proceeding pending against or affecting,
or, to the knowledge of either Party, threatened against or affecting that
Party, or any of its assets, before any court or arbitrator or any governmental
body, agency or official that would, if decided against either Party, have a
material adverse impact on the business, properties, assets, liabilities or
financial condition of that Party (that are not already reflected in that
Party's respective financial statements) and which would have a material adverse
effect on that Party's ability to consummate the transactions contemplated by
this Agreement.
Section 14.07. ATRIX'S MANUFACTURING FACILITY. As of the date of this
Agreement and as of the Effective Date, Atrix represents and warrants to
Sanofi-Synthelabo that Atrix's manufacturing facility is capable of
manufacturing [**].
Section 14.08. LIMITATION ON WARRANTIES. Except as expressly set forth
in this Agreement, nothing herein shall be construed as a representation or
warranty by Atrix to Sanofi-Synthelabo that the Atrigel(R) Technology is not
infringed by any Third Party, or that the practice of such rights does not
infringe any published intellectual property rights of any Third Party. Neither
Party makes any warranties, express or implied, concerning the success of the
Development Program or the commercial utility of the Product.
Section 14.09. LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE ENTITLED
TO RECOVER FROM THE OTHER PARTY ANY SPECIAL OR PUNITIVE DAMAGES IN CONNECTION
WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.
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ARTICLE XV
INDEMNIFICATION
Section 15.01. SANOFI-SYNTHELABO INDEMNIFIED BY ATRIX. Atrix shall
indemnify and hold Sanofi-Synthelabo, its Affiliates, and their respective
employees, directors and officers, harmless from and against any liabilities or
obligations, damages, losses, claims, encumbrances, costs or expenses (including
attorneys' fees) (any or all of the foregoing herein referred to as "Loss")
insofar as a Loss or actions in respect thereof, whether existing or occurring
prior to, on or subsequent to the Effective Date, arises out of or is based upon
(a) any misrepresentation (or alleged misrepresentation) or breach (or alleged
breach) of any of the warranties, covenants or agreements made by Atrix in this
Agreement; (b) the manufacturing of any Product or Demonstration Samples; (c)
any claims that the Product (as a result of the use of Atrigel(R) Technology
therein) or its Manufacture (as a result of the use of Atrigel(R) Technology
therein), use or sale infringes the patent, trademark or proprietary right of a
Third Party or (d) if Atrix exercises its rights to co-market the Product under
Article XIII, Atrix's, or its sublicensee's, marketing, sale, distribution or
promotion of the Product.
Section 15.02. ATRIX INDEMNIFIED BY SANOFI-SYNTHELABO.
Sanofi-Synthelabo shall indemnify and hold Atrix, its Affiliates, and their
respective employees, directors and officers, harmless from and against any Loss
insofar as such Loss or actions in respect thereof occurs subsequent to the
Effective Date, whether existing or occurring prior to, on or subsequent to the
date hereof, arises out of or is based upon (a) any misrepresentation (or
alleged misrepresentation) or breach (or alleged breach) of any of the
warranties, covenants or agreements made by Sanofi-Synthelabo in this Agreement;
(b) Sanofi-Synthelabo's use of the Marks or the Marketing Authorizations in the
marketing, sale, distribution or promotion of the Product or the Demonstration
Samples; (c) Sanofi-Synthelabo's marketing, sale, distribution or promotion of
the Product or the Demonstration Samples or (d) the use of Sanofi-Synthelabo's
name and trademark in the packaging and labeling of the Product and in the
marketing, sale, distribution or promotion of the Product or the Demonstration
Samples.
Section 15.03. PROMPT NOTICE REQUIRED. No claim for indemnification
hereunder shall be valid unless notice of the matter which may give rise to such
claim is given in writing by the indemnitee (the "Indemnitee") to the persons
against whom indemnification may be sought (the "Indemnitor") as soon as
reasonably practicable after such Indemnitee becomes aware of such claim,
provided that the failure to notify the Indemnitor shall not relieve it from any
liability which it may have to the Indemnitee otherwise than under this Article
XV. Such notice shall state that the Indemnitor is required to indemnify the
Indemnitee for a Loss and shall specify the amount of Loss and relevant details
thereof. The Indemnitor shall notify Indemnitee no later than sixty (60) days
from such notice of its intention to assume the defense of any such claim. In
the event the Indemnitor fails to give such notice within that time the
Indemnitor shall no longer be entitled to assume such defense.
Section 15.04. INDEMNITOR MAY SETTLE. The Indemnitor shall at its
expense, have the right to settle and defend, through counsel reasonably
satisfactory to the Indemnitee, any action which may be brought in connection
with all matters for which indemnification is available. In such event the
Indemnitee of the Loss in question and any successor thereto shall permit the
Indemnitor full and free access to its books and records and otherwise fully
cooperate with the
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Indemnitor in connection with such action; provided that this Indemnitee shall
have the right fully to participate in such defense at its own expense. The
defense by the Indemnitor of any such actions shall not be deemed a waiver by
the Indemnitor of its right to assert a claim with respect to the responsibility
of the Indemnitor with respect to the Loss in question. The Indemnitor shall
have the right to settle or compromise any claim against the Indemnitee without
the consent of the Indemnitee provided that the terms thereof: (a) provide for
the unconditional release of the Indemnitee; (b) require the payment of
compensatory monetary damages by Indemnitor only; and (c) expressly state that
neither the fact of settlement nor the settlement agreement shall constitute, or
be construed or interpreted as, an admission by the Indemnitee of any issue,
fact, allegation or any other aspect of the claim being settled. No Indemnitee
shall pay or voluntarily permit the determination of any liability which is
subject to any such action while the Indemnitor is negotiating the settlement
thereof or contesting the matter, except with the prior written consent of the
Indemnitor, which consent shall not be unreasonably withheld or delayed. If the
Indemnitor fails to give Indemnitee notice of its intention to defend any such
action as provided herein, the Indemnitee involved shall have the right to
assume the defense thereof with counsel of its choice, at the Indemnitor's
expense, and defend, settle or otherwise dispose of such action. With respect to
any such action which the Indemnitor shall fail to promptly defend, the
Indemnitor shall not thereafter question the liability of the Indemnitor
hereunder to the Indemnitee for any Loss (including counsel fees and other
expenses of defense).
ARTICLE XVI
COVENANTS
Section 16.01. COVENANT NOT TO LAUNCH COMPETITIVE PRODUCT.
(a) Sanofi-Synthelabo hereby covenants and shall cause its
Affiliates to agree not to out-license, commercialize, market, sell,
distribute or have marketed, have sold or have distributed any
Competitive Product in any country in the Territory in which
Sanofi-Synthelabo retains a license granted by Atrix under Article III
during the Term. Notwithstanding the foregoing, if Sanofi-Synthelabo or
any Affiliate acquires an entity or all or substantially all of the
assets of an entity and such entity distributes a Competitive Product
or such assets include a Competitive Product, Sanofi-Synthelabo or such
Affiliate shall have one hundred and eighty (180) days in which to
divest itself of such Competitive Product or to otherwise cease
marketing, sales and distribution of such Competitive Product, and
Sanofi-Synthelabo shall not be in breach of this Section 16.01 if it or
the Affiliate, as the case may be, so divests or ceases marketing,
sales and distribution within such one hundred and eighty (180) day
period;
(b) All of the covenants in this Section 16.01 shall be
construed as an agreement independent of any other provision in this
Agreement, and the existence of any claim or cause of action of either
Party, its designee or its Affiliates against the other Party, whether
predicated on this Agreement or otherwise, shall not constitute a
defense to an action by the Party who is not in breach of this Section
16.01 to enforce such covenants against the other Party;
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(c) The Parties hereby agree that the covenants set forth in
this Section 16.01 are a material and substantial part of the
transactions contemplated by this Agreement; and
(d) Because of the difficulty of measuring economic losses to
Atrix as a result of a breach of the restrictive covenants set forth in
this Section 16.01, and because of the immediate and irreparable damage
that would be caused to Atrix for which monetary damages would not be a
sufficient remedy, the Parties agree that Atrix will be entitled to
seek specific performance, temporary and permanent injunctive relief,
and such other equitable remedies to which it may then be entitled
against Sanofi-Synthelabo. This Section 16.01 shall not limit any other
legal or equitable remedies that Atrix may have against
Sanofi-Synthelabo for violation of the restrictions of this Section
16.01. The Parties agree that Atrix shall have the right to seek relief
for any violation or threatened violation of this Section 16.01 by
Sanofi-Synthelabo from any court of competent jurisdiction in any
jurisdiction authorized to grant the relief necessary to prohibit the
violation or threatened violation of this Section 16.01. This Section
shall apply with equal force to Sanofi-Synthelabo's Affiliates, if any
of them is the holder of the Marketing Authorization at the time the
violation or threatened violation of this Section 16.01 takes place.
Section 16.02. LIMITATION TO THE TERRITORY. Sanofi-Synthelabo covenants
and agrees that it will not, nor shall it permit its Affiliates, without the
prior written authorization of Atrix to: (i) promote or actively solicit sale of
the Product or advertise the Product, outside of the Territory; (ii) purchase or
cause to be purchased Product which Sanofi-Synthelabo has represented, directly
or indirectly, as being for the purpose of sale in a specific country in the
Territory for sale in any other country in the Territory; (iii) contact any of
Atrix's suppliers or vendors of the Product or components relating to the
Product; (iv) contact the Competent Authorities or other entity about the
Product, except as required by Applicable Laws or as may be necessary or
appropriate to carry out its obligations hereunder; and (v) knowingly sell or
distribute for resale the Product purchased hereunder to a Third Party who
intends to sell outside of the Territory.
Section 16.03. ACCESS TO BOOKS AND RECORDS. Sanofi-Synthelabo covenants
and agrees that it shall permit Atrix, at Atrix's expense and during normal
business hours, to exercise the inspection rights granted to Atrix by
Sanofi-Synthelabo under Section 4.05(d).
Section 16.04. A&S SPENDING LEVELS. Sanofi-Synthelabo covenants and
agrees that during the first [**] following the first commercial shipment of the
Product [**], Sanofi-Synthelabo's annual A&S spending levels in each country in
the Territory, on a country by country basis, shall be at least [**], not to
exceed [**] in the aggregate. Sanofi-Synthelabo further covenants and agrees
that after such [**] Period, Sanofi-Synthelabo shall maintain annual A&S
spending levels [**].
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Section 16.05. MARKETING EXPENSES. Sanofi-Synthelabo covenants and
agrees that except as provided in Section 6.01(g), Sanofi-Synthelabo shall be
solely responsible for the cost and implementation of all marketing, sales,
promotional and related activities concerning the marketing, sale and promotion
of the Product.
Section 16.06. COMPLIANCE. Sanofi-Synthelabo covenants and agrees that
it will assume all responsibility for selling and distributing the Product and
the Demonstration Samples, as applicable, including obtaining all necessary
permits and licenses, and any other requirements relating to the import, sale
and distribution of the Product and the Demonstration Samples, as applicable,
imposed by Applicable Law, other than Governmental Approvals and Marketing
Authorizations, and Sanofi-Synthelabo shall comply with all Applicable Laws
affecting the use, possession, distribution, advertising and all forms of
promotion in connection with the sale and distribution of the Product and the
Demonstration Samples in the Territory.
Section 16.07. PROTECTION OF THE MARKS. Sanofi-Synthelabo covenants and
agrees that neither Sanofi-Synthelabo nor its Affiliates shall publish, employ
nor cooperate in the publication of, any misleading or deceptive advertising
material with regard to Atrix or the Marks.
Section 16.08. LAUNCH QUANTITIES. Each Party covenants and agrees to
the other as follows:
(a) that Atrix will provide Launch Quantity of the Product;
(b) that Sanofi-Synthelabo will timely provide to Atrix its
forecast of Sanofi-Synthelabo's requirement of Product, on a Product by
Product basis, including Demonstration Samples, in order to enable
Atrix to timely provide Launch Quantity of the Product to
Sanofi-Synthelabo.
Section 16.09. FURTHER ACTIONS. Upon the terms and subject to the
conditions hereof, each of the Parties hereto shall use its commercially
reasonable efforts to (i) take, or cause to be taken, all appropriate action and
do, or cause to be done, all things necessary, proper or advisable under
Applicable Law or otherwise to consummate and make effective the transactions
contemplated by this Agreement, (ii) obtain from Competent Authorities any
consents, licenses, permits, waivers, approvals, authorizations or orders
required to be obtained or made by the Parties in connection with the
authorization, execution and delivery of this Agreement and the consummation of
the transactions contemplated by this Agreement and (iii) make all necessary
filings, and thereafter make any other required submissions, with respect to
this transaction under (A) the Securities Exchange Act of 1934, as amended and
the Securities Act of 1933, as amended, and the rules and regulations thereunder
and any other applicable federal or state securities laws, (B) the HSR Act, and
any other antitrust regulations and (C) any other Applicable Law. The Parties
hereto shall cooperate with each other in connection with the making of all such
filings, including by providing copies of all such documents to the other
Party's counsel (subject to appropriate confidentiality restrictions) prior to
filing and, if requested, by accepting all reasonable additions, deletions or
changes suggested in connection therewith. Without limiting the generality of
the foregoing, each Party shall take or omit to take such action as the other
Party shall reasonably request to cause the Parties to obtain any material
Governmental Approvals and/or the expiration of applicable waiting periods,
provided that the
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foregoing shall not obligate either Party to take or to omit to take any action
(including, without limitation, the expenditure of funds or any holding separate
and agreeing to sell or otherwise dispose of assets, categories of assets or
businesses) as in the good faith opinion of such Party, would cause a material
adverse effect on a Party.
ARTICLE XVII
PRODUCT RECALL
Section 17.01. PRODUCT RECALLS OR WITHDRAWAL. If at any time or from
time to time any Competent Authority of any country in the Territory requests
either Party to recall the Product or if a voluntary recall is contemplated (a
"Recall"), the Party to whom such request is made or the Party contemplating
such Recall, as the case may be, shall immediately notify the other Party.
Neither Party shall carry out a voluntary Recall without the prior written
approval of the other Party which approval shall not be unreasonably withheld,
conditioned or delayed by either Party. Any Recall shall be carried out by
Sanofi-Synthelabo in as expeditious a manner as reasonably possible to preserve
the goodwill and reputation of the Product and the goodwill and reputation of
the Parties. Sanofi-Synthelabo shall in all events be responsible for conducting
any Recalls, market withdrawals or corrections with respect to the Product.
Sanofi-Synthelabo shall maintain records of all sales and distribution of
Product and customers sufficient to adequately administer a Recall, market
withdrawal or correction for the period required by Applicable Law.
Section 17.02. RECALL COSTS. Sanofi-Synthelabo shall be responsible for
conducting any Recall and the cost and expense of a Recall shall be allocated as
follows:
(a) if such Recall is a voluntary Recall or shall be due to
tampering or other cause, other than a manufacturer's defect, but not
due to the negligence or misconduct of the Parties, or the breach by a
Party of its warranties or obligations hereunder, then
Sanofi-Synthelabo and Atrix shall [**] of the costs and expenses
incurred by Sanofi-Synthelabo in connection with such Recall,
including, without limitation, all product credits and returns, freight
and shipping costs and product disposal expenses. In such event, Atrix
agrees to pay Sanofi-Synthelabo within ten (10) days after its receipt
from Sanofi-Synthelabo of any invoice(s) assessing Atrix [**] of these
said costs, as listed above;
(b) if such Recall shall be due to manufacturer's defect or
the negligence or the breach by Atrix of its warranties or obligations
hereunder or the misconduct of Atrix, all such costs and expenses shall
be borne and paid solely by Atrix and Atrix will reimburse
Sanofi-Synthelabo for any such costs and expenses paid by
Sanofi-Synthelabo within ten (10) days of receipt of an invoice for
such costs and expenses from Sanofi-Synthelabo, and if not so paid
Sanofi-Synthelabo shall have the right to offset such amounts against
amounts otherwise due by Sanofi-Synthelabo to Atrix hereunder; and
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(c) if such Recall is due to the negligence or the breach by
Sanofi-Synthelabo of its warranties or obligations hereunder or the
misconduct of Sanofi-Synthelabo, all such costs and expenses shall be
borne and paid solely by Sanofi-Synthelabo and Sanofi-Synthelabo will
reimburse Atrix for any such costs and expenses paid by Atrix within
thirty (30) days of receipt of an invoice and appropriate documentation
for such costs and expenses from Atrix.
Section 17.03. NOTIFICATION OF COMPLAINTS. Each Party agrees that
throughout the Term of this Agreement, and with respect to all Product or
Demonstration Samples supplied and purchased under this Agreement, after the
termination of this Agreement, it will (i) notify the other Party immediately of
all available information concerning any complaint product defect reports, and
similar notices received by either Party with respect to the Product or
Demonstration Samples, whether or not determined to be attributable to the
Product or Demonstration Samples and (ii) with respect to an ADE, comply with
the provisions of Section 10.04. Sanofi-Synthelabo, in consultation with Atrix,
shall define and implement regulatory compliance procedures, including, without
limitation, action plans and an SOP for product defect reporting and will handle
all product complaints in the Territory. In connection with any such product
complaint Atrix shall cooperate as reasonably requested by Sanofi-Synthelabo
including performing any testing and follow-up investigations mutually agreed
upon by the Parties.
Section 17.04. NOTIFICATION OF THREATENED ACTION. Throughout the
duration of this Agreement and with respect to all Product supplied and
purchased under this Agreement, after the termination of this Agreement, each
Party shall immediately notify the other Party of any information it receives
regarding any threatened or pending action, inspection or communication by or
from a concerned Competent Authority which may affect the safety or efficacy
claims of the Product or the continued marketing of the Product. Upon receipt of
such information, the Parties shall consult with each other in an effort to
arrive at a mutually acceptable procedure for taking appropriate action.
ARTICLE XVIII
INSURANCE
Section 18.01. INSURANCE. Each Party shall, at its sole cost and
expense, obtain and keep in force comprehensive general liability insurance,
including any applicable self-insurance coverage, with bodily injury, death and
property damage limits of Five Million and 00/100 Dollars ($5,000,000.00) per
occurrence and Five Million and 00/100 Dollars ($5,000,000.00) in the aggregate,
including contractual liability and product liability coverage. At such time,
each Party shall furnish the other with a certificate of insurance signed by an
authorized representative of such Party's insurance underwriter evidencing the
insurance coverage required by this Agreement, showing that the other Party has
been listed as an additional party insured on such policy, and providing for at
least thirty (30) days prior written notice to the other Party of any
cancellation, termination or reduction of such insurance coverage.
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ARTICLE XIX
TERM; DEFAULT AND TERMINATION
Section 19.01. TERM. This Agreement shall commence as of the Effective
Date and shall expire on a country-by-country basis on the expiration of the
last applicable Atrigel(R) Patent Right, or any other patents obtained by Atrix
with regard to the Product, in such country (the "Term").
Section 19.02. TERMINATION BY EITHER PARTY. This Agreement may be
terminated and the other agreements contemplated hereunder may be terminated at
any time prior to the Effective Date as follows:
(a) by mutual written consent duly authorized by the boards of
directors of each of Atrix and Sanofi-Synthelabo;
(b) by either Atrix or Sanofi-Synthelabo, if the Effective
Date shall not have occurred on or before February 28, 2001 solely as a
result of the failure of the waiting period to have expired or the
failure to obtain termination or approval under the HSR Act; provided
further that the right to terminate shall not be available to any Party
whose failure to fulfill its obligations hereunder shall have been the
cause of, or shall have resulted in, the failure of the Agreement to be
consummated by the applicable date.
Section 19.03. TERMINATION BY EITHER PARTY FOR CAUSE. Either Party may
terminate this Agreement prior to the expiration of the Term upon the occurrence
of any of the following:
(a) Upon or after the cessation of operations of the other
Party or the bankruptcy, insolvency, dissolution or winding up of the
other Party (other than dissolution or winding up for the purposes or
reconstruction or amalgamation); or
(b) Upon or after the breach of any material provision of this
Agreement by the other Party if the breaching Party has not cured such
breach within sixty (60) days after written notice thereof by the
non-breaching Party.
Section 19.04. TERMINATION BY ATRIX. Atrix may terminate this Agreement
prior to the expiration of the Term with respect to any country in the Territory
upon the occurrence of any of the following:
(a) Upon the failure by Sanofi-Synthelabo to pay for fifteen
(15) days from receipt of notice thereof from Atrix, a copy of which
shall be sent to both Sanofi-Synthelabo's Chief Financial Officer and
General Counsel pursuant to the terms of Section 20.08,: (i) any
royalty payment, or portion thereof, pursuant to Section 4.02; (ii) any
milestone payments, or portion thereof, pursuant to Section 4.03 or
Section 4.04; or (iii) the Purchase Price due to Atrix under Section
8.01 of this Agreement; provided, however, that this subsection (a)
shall not apply to any royalty payment, or portion thereof, pursuant to
Section 4.02, which is the subject of a good faith dispute (a "Disputed
Amount") between Sanofi-Synthelabo and Atrix. Further,
Sanofi-Synthelabo shall pay interest on any Disputed Amount at a rate
equal to the Prime Rate of Interest to
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begin accruing on a daily basis from the date such payment was due and
continuing until such payment is received by Atrix. Any Disputed Amount
shall be resolved by the Parties within ninety (90) days from the date
Sanofi-Synthelabo notifies Atrix of a good faith dispute; provided
however if the dispute cannot be resolved to the mutual satisfaction of
the Parties within such ninety (90) day period then either Party may
request that the dispute be submitted to the Chief Executive Officers
of Atrix and Sanofi-Synthelabo, respectively, for joint resolution. If
the dispute is not jointly resolved by the Parties' respective Chief
Executive Officers within ten (10) days from submission to the Parties'
respective Chief Executive Officers then Atrix shall be entitled to
pursue any and all remedies at law available to it. In no event will
the dispute resolution period exceed a maximum of one hundred (100)
days unless otherwise agreed in writing by the Parties. Further,
Sanofi-Synthelabo may in its discretion determine to pay any such
Disputed Amount and in the event amounts are finally determined not to
be due by Sanofi-Synthelabo, Atrix shall repay, without interest, such
excess amounts determined not to be due; or
(b) Upon the occurrence of any material misrepresentation or
omission in any report required to be delivered by Sanofi-Synthelabo to
Atrix by Section 4.05(a), which misrepresentation or omission is caused
by Sanofi-Synthelabo's willful misconduct, gross negligence or bad
faith.
Section 19.05. TERMINATION BY SANOFI-SYNTHELABO. Sanofi-Synthelabo may
terminate this Agreement prior to the expiration of the Term with respect to any
country in the Territory upon an increase in the Atrix Manufacturing Cost over
the Twelve Month Cost and the failure of Sanofi-Synthelabo and Atrix to reach
mutual agreement on the Purchase Price of the Product.
Section 19.06. REMEDIES. All of the non-breaching Party's remedies
shall be cumulative, and the exercise of one remedy hereunder by the
non-defaulting Party shall not be deemed to be an election of remedies.
Section 19.07. EFFECT OF TERMINATION.
(a) In the event of termination of this Agreement pursuant to
Section 19.02, this Agreement shall forthwith become void, there shall
be no liability under this Agreement on the part of Atrix or
Sanofi-Synthelabo or any of their respective Affiliates, employees,
directors and officers, and all rights and obligations of each Party
hereto shall cease; provided, however, that nothing herein shall
relieve any Party from liability for the willful breach of any of its
representations, warranties, covenants or agreements set forth in this
Agreement.
(b) Subject to Section 19.07(d), upon termination of this
Agreement by Atrix pursuant to Sections 19.03 or 19.04, (i)
Sanofi-Synthelabo shall have no right to practice within the
Atrigel(R) Patent Rights or use any of the Atrigel(R) Technology, (ii)
all rights, title or interest in, or other incidents of ownership
under, the Atrigel(R) Technology and the Marks shall revert to and
become the sole property of Atrix, and (iii) Sanofi-Synthelabo shall
reimburse Atrix for costs and expenses reasonably incurred or committed
to by Atrix and for which Sanofi-Synthelabo is otherwise obligated to
reimburse Atrix pursuant to this Agreement in connection with the
activities performed
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by Atrix in accordance with the Development Program prior to the
effective date of such termination.
(c) Upon termination of this Agreement by Sanofi-Synthelabo
pursuant to Section 19.03, the licenses granted under Sections 3.02 and
3.03 shall remain in effect so long as Sanofi-Synthelabo has not
breached its obligations to Atrix under this Agreement as of the date
of such termination.
(d) Upon termination by Atrix under Sections 19.03 or 19.04 or
by Sanofi-Synthelabo under Section 19.05, the following shall occur:
(i) All applicable licenses granted to
Sanofi-Synthelabo shall terminate immediately, including the
rights granted to Sanofi-Synthelabo pursuant to Sections 3.02
and 3.03, and Sanofi-Synthelabo shall have no further rights
to the Product subject to Sanofi-Synthelabo's option to sell
off existing inventory of Product and distribute existing
inventory of Demonstration Samples for six (6) months after
the termination date under subsection (iii) hereof, and
Sanofi-Synthelabo shall not, either directly or indirectly,
use or permit the use of the same or of the documentation
relating to the Product, except to sell off existing inventory
under subsection (ii) hereof;
(ii) Sanofi-Synthelabo, at its option, may sell off
any existing inventory of Product and utilize the
Demonstration Samples during a period not to exceed six (6)
months following such termination. If Sanofi-Synthelabo
chooses this option, Sanofi-Synthelabo shall:
(A) within thirty (30) days of issuance of a
notice of termination by any Party, notify Atrix that
it intends to sell off existing inventory of Product
and utilize the Demonstration Samples as provided in
this Agreement;
(B) continue to comply with its payment
obligations to Atrix under Article IV;
(C) continue to sell off existing inventory
of Product and utilize the Demonstration Samples for
six (6) months after the notice of termination but at
the expiration of the six (6) months, at Atrix's
election, either (1) sell all existing inventory of
Product and Demonstration Samples to Atrix or (2)
destroy all remaining inventory of Product and
Demonstration Samples in accordance with Applicable
Law, providing Atrix with proof of destruction in
writing sufficient to comply with Applicable Laws;
provided that in either case, Atrix shall pay to
Sanofi-Synthelabo, the full amount of the actual cost
paid by Sanofi-Synthelabo to Atrix for such remaining
inventory of Product and Demonstration Samples. If
Sanofi-Synthelabo sells any inventory of Product or
Demonstration Samples to Atrix pursuant to this
subsection, it shall warrant that such inventory of
Product and Demonstration Samples has
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been stored in compliance with all Applicable Laws,
has not been adulterated and has otherwise been
maintained according to the requirements of
Applicable Laws and Marketing Authorizations;
(D) if Sanofi-Synthelabo notifies Atrix that
Sanofi-Synthelabo does not intend to sell off any
existing inventory of Product and utilize the
Demonstration Samples, Sanofi-Synthelabo shall, at
Atrix's election, either (1) sell all existing
inventory of Product and Demonstration Samples to
Atrix or (2) destroy all remaining inventory of
Product and Demonstration Samples in accordance with
Applicable Law, providing Atrix with proof of
destruction in writing sufficient to comply with
Applicable Laws; provided that in either case, Atrix
shall pay to Sanofi-Synthelabo, the full amount of
the actual cost paid by Sanofi-Synthelabo to Atrix,
for such remaining inventory of Product and
Demonstration Samples. If Sanofi-Synthelabo sells any
inventory of Product or Demonstration Samples to
Atrix pursuant to this subsection, it shall warrant
that such inventory of Product and Demonstration
Samples has been stored in compliance with all
Applicable Laws, has not been adulterated and has
otherwise been maintained according to requirements
of Applicable Laws and Competent Authorities; and
(E) any sales of Product or Demonstration
Samples made by Sanofi-Synthelabo to Atrix pursuant
to this Section 19.07 shall be made by
Sanofi-Synthelabo within thirty (30) days of the end
of the time period specified by Section 19.07(d)(ii)
and shall be shipped to Atrix appropriately packaged
and stored. All transportation costs in connection
with such sale, including without limitation,
insurance, freight and duties, shall be shared
equally by Sanofi-Synthelabo and Atrix. Amounts owed
by Atrix to Sanofi-Synthelabo pursuant to this
Section 19.07(d) for the Product or Demonstration
Samples shall be paid by Atrix within ten (10) days
after receipt by Atrix of an appropriately detailed
invoice from Sanofi-Synthelabo for the amount so
owing to it by Atrix under this subsection.
(e) Expiration or termination of this Agreement shall not
relieve the Parties of any obligation accruing prior to such expiration
or termination. Except as set forth below or elsewhere in this
Agreement, the obligations and rights of the Parties under Sections
11.04, 14.07, 14.08 and Articles XII, XV, XVII and XX shall survive
expiration or termination of this Agreement; provided that in the case
of Section 4.05(d), such rights and obligations shall survive for only
one (1) year after termination or expiration.
(f) Within thirty (30) days following the expiration or
termination of this Agreement, each Party shall return to the other
Party, or destroy, upon the written request of the other Party, any and
all Confidential Information of the other Party in its possession and
upon a Party's request, such destruction (or delivery) shall be
confirmed in writing to such Party by a responsible officer of the
other Party.
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ARTICLE XX
MISCELLANEOUS
Section 20.01. NO-SOLICITATION. During the Term of this Agreement,
neither Party nor its Affiliates (collectively, the "Initiating Group") shall,
directly or through its representatives, solicit for employment or hire any
officer, director, employee or consultant of the other Party or its subsidiaries
or controlled Affiliates (collectively, the "Other Group") with whom the
Initiating Group has contact in connection with, or who otherwise is known by
the Initiating Group to participate in, the transactions contemplated by this
Agreement. The Initiating Group shall not be precluded from hiring any such
person who has been terminated by the Other Group prior to commencement of
employment discussions between such person and the Initiating Group or its
representatives. "Solicitation" shall not include any generalized public
advertisement or any other solicitation by the Initiating Group or its
representatives that is not specifically directed toward any such employee of
the Other Group or toward any group of such employees of the Other Group.
Section 20.02. COMMERCIALLY REASONABLE EFFORTS. Each Party shall use
commercially reasonable efforts to perform its responsibilities under this
Agreement. As used herein, the term "commercially reasonable efforts" means,
unless the Parties agree otherwise, those efforts consistent with the exercise
of prudent scientific and business judgment, as applied to other products of
similar scientific and commercial potential within the relevant product lines of
the Parties.
Section 20.03. ASSIGNMENT. Except as expressly provided hereunder,
neither this Agreement nor any rights or obligations hereunder may be assigned
or otherwise transferred by either Party without the prior written consent of
the other Party (which consent shall not be unreasonably withheld); provided,
however, that either Party may assign this Agreement and its rights and
obligations hereunder without the other Party's consent (a) in connection with
the transfer or sale of all or substantially all of the business of such Party
to which this Agreement relates to another Party, whether by merger, sale of
stock, sale of assets or otherwise, or (b) to any Affiliate. Notwithstanding the
foregoing, any such assignment to an Affiliate shall not relieve the assigning
Party of its responsibilities for performance of its obligations under this
Agreement. The rights and obligations of the Parties under this Agreement shall
be binding upon and inure to the benefit of the successors and permitted assigns
of the Parties. Any assignment not in accordance with this Agreement shall be
void.
Section 20.04. FORCE MAJEURE. Neither Party shall be held liable or
responsible to the other Party nor be deemed to have defaulted under or breached
this Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party, including, but not limited to,
fire, floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other Party, or for any other reason which is
completely beyond the control of the Party (collectively a "Force Majeure");
provided that the Party whose performance is delayed or prevented shall continue
to use good faith diligent efforts to mitigate, avoid or end such delay or
failure in performance as soon as practicable.
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Section 20.05. GOVERNING LAW. This Agreement shall be governed by, and
construed and enforced in accordance with, the laws of the State of New York,
except that no conflict of laws provision shall be applied to make the laws of
any other jurisdiction applicable to this Agreement.
Section 20.06. WAIVER. Except as specifically provided for herein, the
waiver from time to time by either of the parties of any of their rights or
their failure to exercise any remedy shall not operate or be construed as a
continuing waiver of same or of any other of such Party's rights or remedies
provided in this Agreement.
Section 20.07. SEVERABILITY. In case any provision of this Agreement
shall be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected or
impaired thereby.
Section 20.08. NOTICES. All notices, requests and other communications
to any party hereunder shall be in writing and shall be deemed to have been
given if delivered personally, mailed by certified mail (return receipt
requested) or sent by cable, telegram or recognized overnight delivery service
to the parties at the following addresses or at such other addresses as,
specified by the parties by like notice:
IF TO ATRIX: Atrix Laboratories, Inc.
2579 Midpoint Drive
Fort Collins, CO 80525
Attn: Charles P. Cox, Ph.D., M.B.A.
Vice President, New Business Development
Telephone: (970) 482-5868
Facsimile: (970) 482-9735
COPIES TO: Morrison & Foerster LLP
5200 Republic Plaza
370 17th Street
Denver, Colorado 80202-5638
Attn: Warren L. Troupe, Esq.
Telephone: (303) 592-2255
Facsimile: (303) 592-1510
IF TO SANOFI-SYNTHELABO: Sanofi-Synthelabo Inc.
90 Park Avenue
New York, NY 10016
Attn: Gregory Irace
Vice President and Chief Financial Officer
Telephone: (212) 551-4000
Facsimile: (212) 551-4905
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COPIES TO: Sanofi-Synthelabo Inc.
90 Park Avenue
New York, NY 10016
Attn: John Spinmato
Senior Vice President and General Counsel
Telephone: (212) 551-4306
Facsimile: (212) 551-4919
Notice so given shall be deemed given and received (i) if by mail on
the fourth (4th) day after posting; (ii) by cable, telegram, telex of personal
delivery on the date of actual transmission or (as the case may be) personal or
other delivery; and (iii) if by overnight courier, on the next business day
following the day such notice is delivered to the courier service.
Section 20.09. INDEPENDENT CONTRACTORS. It is expressly agreed that
Atrix and Sanofi-Synthelabo shall be independent contractors and that the
relationship between the two Parties shall not constitute a partnership or
agency of any kind. Neither Atrix nor Sanofi-Synthelabo shall have the authority
to make any statements, representations or commitments of any kind, or to take
any action, which shall be binding on the other Party, without the prior written
consent of the other Party.
Section 20.10. RULES OF CONSTRUCTION. The Parties hereto agree that
they have been represented by counsel during the negotiation and execution of
this Agreement and, therefore, waive the application of any law, regulation,
holding or rule of construction providing that ambiguities in an agreement or
other document will be construed against the Party drafting such agreement or
document. Whenever the context hereof shall so require, the singular shall
include the plural, the male gender shall include the female gender and neuter,
and vice versa.
Section 20.11. PUBLICITY. Sanofi-Synthelabo and Atrix shall consult
with each other before issuing any press release with respect to this Agreement
or the transactions contemplated hereby and neither shall issue any such press
release or make any such public statement without the prior consent of the
other, which consent shall not be unreasonably withheld; provided, however, (a)
that a Party may, without the prior consent of the other Party, issue such press
release or make such public statement as may upon the advice of counsel be
required by law or the rules and regulations of the NASDAQ or any stock
exchange, or (b) if it has used reasonable efforts to consult with the other
Party prior thereto, (such consent shall be deemed to have been given if the
recipient of the press release or public statement fails to respond to the other
Party within forty-eight (48) hours after the recipient's receipt of such press
release or public statement). No such consent of the other Party shall be
required to release information which has previously been made public.
Section 20.12. ENTIRE AGREEMENT; AMENDMENT. This Agreement (including
the Exhibits attached hereto) sets forth all of the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the parties hereto with respect to the subject matter hereof and supersedes and
terminates all prior agreements and understandings between the Parties. There
are no covenants, promises, agreements, warranties, representations conditions
or understandings, either oral or written, between the parties other than as set
forth herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be
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binding upon the Parties hereto unless reduced to writing and signed by the
respective authorized officers of the Parties.
Section 20.13. HEADINGS. The captions contained in this Agreement are
not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several articles hereof.
Section 20.14. COUNTERPARTS. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized officers as of the date and year
first above written.
ATRIX LABORATORIES, INC., SANOFI-SYNTHELABO INC.
a Delaware corporation a Delaware corporation
By: /s/ David R. Bethune By: /s/ Ed Proctor
--------------------------------- ----------------------------------
Name: David R. Bethune Name: Ed Proctor
Title: Chairman and Chief Title: President and Chief
Executive Officer Executive Officer
By: /s/ Gregory Irace
-----------------------------------
Name: Gregory Irace
Title: Vice President and Chief
Financial Officer
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EXHIBIT A
ATRIGEL(R) PATENT RIGHTS
[**]
- ----------
** Confidential Treatment Requested.
A-1
51
EXHIBIT B
FORM OF CERTIFICATE OF COMPLIANCE
Issue Date:
--------------------------------
CERTIFICATE OF COMPLIANCE
FOR
--------------------------------------------------------------------
CUSTOMER
---------------------------------------------------------------
LOT NUMBER
-----------------------------------------------------
FILL DATE PREP/EX DATE
---------------------------- --------------------
DOSAGE
-----------------------------------------------------------------
QUANTITY OF RELEASABLE VIALS
-------------------------------------------
The batch production record for this product has been reviewed for
accuracy, completeness, and compliance with established written standard
procedures and in accordance with cGMP requirements. Any deviations/abnormal
occurrences from the aforementioned requirements have been appropriately
documented, reviewed, and approved.
Reviewed By:
-----------------------------------------------------------
Batch Record Auditor
Date:
----------------------------
Approved By:
-----------------------------------------------------------
Acting Supervisor Manager, Documentation
Date:
----------------------------
cc: All Customers
B-1
52
EXHIBIT C
SPECIFICATIONS
(see attached)
[**]
- ----------
** Confidential Treatment Requested.
C-1
53
EXHIBIT D
STOCK PURCHASE AGREEMENT
(see Exhibit 99.2 of this Form 8-K)
D-1
54
EXHIBIT E
DEVELOPMENT PROGRAM
(see attached)
[**]
- ----------
** Confidential Treatment Requested.
E-1
55
EXHIBIT F
SANOFI-SYNTHELABO'S SOP
(see attached)
[**]
- ----------
** Confidential Treatment Requested.
F-1
56
EXHIBIT G
SIX MONTH PRODUCT
DEVELOPMENT PROGRAM
(see attached)
[**]
- ----------
** Confidential Treatment Requested.
G-1