EXHIBIT 10.19
CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
COLLABORATION, LICENSE AND SUPPLY AGREEMENT
BETWEEN
ATRIX LABORATORIES, INC.
AND
SANOFI-SYNTHELABO INC.
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........................................................ 11
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.............................................. 16
Section 7.03. Atrix's Duties................................................. 17
Section 7.04. Compliance with Applicable Laws................................ 18
Section 7.05. Second Manufacturing Source.................................... 18
Section 7.06. Failure to Supply.............................................. 18
Section 7.07. Allocation..................................................... 19
Article VIII PURCHASE AND SALE.................................................. 19
Section 8.01. Purchase Price and Payment..................................... 19
Section 8.02. Adjustment to Purchase Price/Audit............................. 20
Section 8.03. Labeling....................................................... 21
Section 8.04. Purchase Forms................................................. 21
Section 8.05. Confirmation................................................... 21
Section 8.06. Delivery....................................................... 21
Section 8.07. Forecasts and Orders........................................... 21
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.. 23
Section 9.03. Sanofi-Synthelabo Inspections.................................. 24
Article X REGULATORY COMPLIANCE................................................. 24
Section 10.01. Marketing Authorization Holder................................. 24
Section 10.02. Maintenance Of Marketing Authorizations........................ 24
Section 10.03. Interaction with Competent Authorities......................... 24
Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance......... 25
Section 10.05. Post - First Commercial Sale Testing And Reporting............. 26
Section 10.06. Assistance..................................................... 26
Section 10.07. Compliance..................................................... 26
Article XI PATENTS AND TRADEMARKS............................................... 27
Section 11.01. Maintenance of Patents or Marks................................ 27
Section 11.02. Cooperation.................................................... 27
Section 11.03. Atrix to Prosecute Infringement................................ 27
Section 11.04. Infringement Claimed by Third Parties.......................... 28
Article XII CONFIDENTIALITY..................................................... 28
Section 12.01. Confidentiality................................................ 28
Section 12.02. Disclosure of Agreement........................................ 28
Article XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES... 29
Section 13.01. Co-Marketing Rights............................................ 29
Article XIV REPRESENTATIONS AND WARRANTIES...................................... 29
Section 14.01. Corporate Power................................................ 29
Section 14.02. Due Authorization.............................................. 29
Section 14.03. Binding Obligation............................................. 29
Section 14.04. Ownership of Atrigel(R) Patent Rights.......................... 30
Section 14.05. Patent Proceedings............................................. 30
Section 14.06. Legal Proceedings.............................................. 30
Section 14.07. Atrix's Manufacturing Facility................................. 30
Section 14.08. Limitation on Warranties....................................... 30
Section 14.09. Limitation of Liability........................................ 30
Article XV INDEMNIFICATION...................................................... 31
Section 15.01. Sanofi-Synthelabo Indemnified by Atrix......................... 31
Section 15.02. Atrix Indemnified by Sanofi-Synthelabo......................... 31
Section 15.03. Prompt Notice Required......................................... 31
Section 15.04. Indemnitor May Settle.......................................... 31
Article XVI COVENANTS........................................................... 32
Section 16.01. Covenant Not To Launch Competitive Product..................... 32
Section 16.02. Limitation To The Territory.................................... 33
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Section 16.03. Access to Books and Records.................................... 33
Section 16.04. A&S Spending Levels............................................ 33
Section 16.05. Marketing Expenses............................................. 34
Section 16.06. Compliance..................................................... 34
Section 16.07. Protection of the Marks........................................ 34
Section 16.08. Launch Quantities.............................................. 34
Section 16.09. Further Actions................................................ 34
Article XVII PRODUCT RECALL..................................................... 35
Section 17.01. Product Recalls or Withdrawal.................................. 35
Section 17.02. Recall Costs................................................... 35
Section 17.03. Notification Of Complaints..................................... 36
Section 17.04. Notification Of Threatened Action.............................. 36
Article XVIII INSURANCE......................................................... 36
Section 18.01. Insurance...................................................... 36
Article XIX TERM; DEFAULT AND TERMINATION....................................... 37
Section 19.01. Term........................................................... 37
Section 19.02. Termination by Either Party.................................... 37
Section 19.03. Termination by Either Party for Cause.......................... 37
Section 19.04. Termination by Atrix........................................... 37
Section 19.05. Termination by Sanofi-Synthelabo............................... 38
Section 19.06. Remedies....................................................... 38
Section 19.07. Effect of Termination.......................................... 38
Article XX MISCELLANEOUS........................................................ 41
Section 20.01. No-Solicitation................................................ 41
Section 20.02. Commercially Reasonable Efforts................................ 41
Section 20.03. Assignment..................................................... 41
Section 20.04. Force Majeure.................................................. 41
Section 20.05. Governing Law.................................................. 42
Section 20.06. Waiver......................................................... 42
Section 20.07. Severability................................................... 42
Section 20.08. Notices........................................................ 42
Section 20.09. Independent Contractors........................................ 43
Section 20.10. Rules of Construction.......................................... 43
Section 20.11. Publicity...................................................... 43
Section 20.12. Entire Agreement; Amendment.................................... 43
Section 20.13. Headings....................................................... 44
Section 20.14. Counterparts................................................... 44
Exhibit A - Atrigel(R) Patent Rights............................................ 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 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, XX, 00000-0000
("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation having offices at
00 Xxxx Xxxxxx, Xxx Xxxx, XX, 00000 ("Sanofi-Synthelabo"). Atrix and
Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties"
or singly as a "Party."
RECITALS
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 Xxxx-Xxxxx-Xxxxxx 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).
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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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).
Section 4.05. REPORTS.
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(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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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 Xxxxxxx, 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 of each
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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 Xxxx, 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 Xxxx 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
39
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.
40
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.
41
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.
0000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxx, XX 00000
Attn: Xxxxxxx X. Xxx, Ph.D., M.B.A.
Vice President, New Business Development
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
COPIES TO: Xxxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx Xxxxx
000 00xx Xxxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attn: Xxxxxx X. Xxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
IF TO SANOFI-SYNTHELABO: Sanofi-Synthelabo Inc.
00 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxxx Xxxxx
Vice President and Chief Financial Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
42
COPIES TO: Sanofi-Synthelabo Inc.
00 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Spinmato
Senior Vice President and General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
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
43
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]
44
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/ Xxxxx X. Xxxxxxx By: /s/ Xx Xxxxxxx
----------------------------------- ----------------------------------
Name: Xxxxx X. Xxxxxxx Name: Xx Xxxxxxx
Title: Chairman and Chief Executive Title: President & CEO
Officer
By: /s/ Xxxxxxx Xxxxx
----------------------------------
Name: Xxxxxxx Xxxxx
Title: Vice President and Chief
Financial Officer
45
EXHIBIT A
ATRIGEL(R) PATENT RIGHTS
[**]
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A-1
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
EXHIBIT C
SPECIFICATIONS
(see attached)
[**]
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C-1
EXHIBIT D
STOCK PURCHASE AGREEMENT
(see Exhibit 99.2 of Form 8-K filed with SEC on February 23, 2001 by Atrix
Laboratories, Inc.)
D-1
EXHIBIT E
DEVELOPMENT PROGRAM
(see attached)
[**]
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E-1
EXHIBIT F
SANOFI-SYNTHELABO'S SOP
(see attached)
[**]
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F-1
EXHIBIT G
SIX MONTH PRODUCT
DEVELOPMENT PROGRAM
(see attached)
[**]
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G-1
CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
FIRST AMENDMENT TO AGREEMENT
This First Amendment to Collaboration, License and Supply agreement (this
"First Amendment"), is made by and between Atrix Laboratories, Inc., a Delaware
corporation having offices at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, XX, 00000-0000
("Atrix"), and Sanofi-Synthelabo Inc., a Delaware corporation having offices at
00 Xxxx Xxxxxx, Xxx Xxxx, XX, 00000 ("Sanofi-Synthelabo") as of this 21st day of
December, 2001. Atrix and Sanofi-Synthelabo are sometimes referred to
collectively herein as the "Parties" or singly as a "Party."
WHEREAS, the Parties entered into that certain Collaboration, License and
Supply Agreement dated as of December 8, 2000 (the "Agreement"); and
WHEREAS, pursuant to Sections 2.02(b) and 4.04 of the Agreement,
Sanofi-Synthelabo desires to engage Atrix to proceed with the development of the
Six Month Product pursuant to the terms set forth in the Agreement as amended by
this First Amendment.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set
forth in the Agreement and as hereinafter set forth, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
1. Section 2.02(b) of the Agreement is hereby amended in its entirety to
read as follows:
"(b) Six Month Product. Sanofi-Synthelabo elects to have Atrix develop
the Six Month Product in accordance with Exhibits G and H.
Sanofi-Synthelabo shall be [**] incurred (A) in developing the Six Month
Product; and (B) in obtaining the Marketing Authorizations for the Six
Month Product (collectively, the "Six Month Cost"), up to the budgeted
amount set forth in Exhibit H (the "Budgeted Six Month Cost"), plus [**]
Sanofi-Synthelabo shall pay such Six Month Cost within [**] of receipt of
each invoice from Atrix for such Six Month Cost. In the event that the Six
Month Cost exceeds the Budgeted Six Month Cost by more than [**],
Sanofi-Synthelabo shall reimburse Atrix for [**] of the amount in excess of
[**] of the Budgeted Six Month Cost. For example, the budgeted Six Month
Cost is [**] and if the actual Six Month Cost is [**], then
Sanofi-Synthelabo would reimburse Atrix for an aggregate amount equal to
[**] plus [**] of the Six Month Cost in [**] of the Budgeted Six Month Cost
[**]. Notwithstanding anything to the contrary contained in the Agreement,
the sum of the Six Month Cost and all amounts actually paid or owed by
Sanofi-Synthelabo (and not creditable) under its milestone obligations set
forth in Section 4.04 shall not exceed [**].
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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) days 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."
2. A new Section 2.02(c) of the Agreement is hereby added to the Agreement
to read as follows, with current Sections 2.02(c) and 2.02(d) renumbered as
Sections 2.02(d) and 2.02(e), respectively:
"(c) Reduction in Six Month Product Milestones. If the NDA for the Six
Month Product has not been filed:
(i) within [**] of the target date set forth in Exhibit H (the
"NDA Target Date"), and such delay was not caused by a Force Majeure or the
actions or inactions of Sanofi-Synthelabo, the milestone payments otherwise
payable by Sanofi-Synthelabo to Atrix under Section 4.04 shall be reduced
by [**]; or
(ii) within [**] of the NDA Target Date, and such delay was not
caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo,
the milestone payments otherwise payable by Sanofi-Synthelabo to Atrix
under Section 4.04 shall be reduced by an aggregate amount of [**] (for
example, the Six Month Product Milestone payable under Section 4.04(i)
would be reduced to [**]; or
(iii) within [**] of the NDA Target Date, and such delay was not
caused by a Force Majeure or the actions or inactions of Sanofi-Synthelabo,
or if the Six Month Cost exceeds the budgeted Six Month Cost by [**] or
more (provided, such increase in the Six Month Cost was not caused by a
Force Majeure or the actions or inactions of Sanofi-Synthelabo),
Sanofi-Synthelabo may, at its sole discretion, terminate its obligations
with respect to development of the Six Month Product, including, but not
limited to, any payment obligations therefore; provided, however,
Sanofi-Synthelabo shall be responsible for those Six Month Costs incurred
by Atrix prior to the date Atrix receives notice from Sanofi-Synthelabo
that it has elected to terminate its obligations with respect
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to the Six Month Product under this Section 2.02(c)(iii), including any
non-cancelable costs incurred or to be incurred by Atrix, but only to the
extent provided in Section 2.02(b) of the Agreement."
3. New Section 2.02(d) of the Agreement (formerly Section 2.02(c)) is
hereby amended in its entirety to read as follows:
"(d) 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 the Six Month Product on the same basis, terms
and conditions set forth in this Agreement for the license for each other
Product. Notwithstanding the foregoing: (i) (A) [**] of the Six Month Cost
up to [**] of the Budgeted Six Month Cost shall be credited against the Six
Month Product Milestone payable to Atrix under Section 4.04(i) of this
Agreement and (B) the balance of [**] of the Six Month Cost up to [**] of
the Budgeted Six Month Cost, if any, shall be credited against amounts owed
by Sanofi-Synthelabo to Atrix under Section 4.04(ii); and (ii) (A) [**] of
the Six Month Cost in excess of [**] of the Budgeted Six Month Cost, if
any, shall be credited against the Six Month Product Milestone payable
under Section 4.04(i) and (B) [**] of the Six Month Cost in excess of [**]
of the Budgeted Six Month Cost, if any, shall be credited against amounts
owed by Sanofi-Synthelabo to Atrix under Section 404(ii)."
4. The last paragraph of Section 4.04 of the Agreement, which begins with
the words "provided, however" is hereby amended in its entirety to read as
follows:
"provided, however, that the milestone payments payable under this
Section 4.04 shall be subject to the terms and provisions of sections
2.02(c) and (d) of this Agreement."
5. A new Exhibit H is hereby added to the Agreement in the form attached to
this First Amendment. The Parties acknowledge and agree that Exhibits G and H
are based on the current knowledge and understanding of the Parties as to the
development work required to commercialize the Six Month Product and that such
Exhibits are subject to reasonable modification at any time due to actions or
inactions taken by the FDA. The Parties further acknowledge and agree that such
actions or inactions by the FDA could result in delays or increase the costs to
develop the Six Month Product, and that any such actions by the FDA shall
constitute a Force Majeure event under the Agreement.
6. This First Amendment and all rights hereunder may not be assigned or
transferred by either Party without the prior written consent of each of the
Parties hereto.
7. All capitalized terms used and not otherwise defined herein shall have
the same meanings as set forth in the Agreement.
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8. Except as expressly modified by the terms hereof, the terms and
provisions of the Agreement shall remain in full force and effect as originally
written.
9. Signatures on this First Amendment may be communicated by facsimile
transmission and shall be binding upon the Parties transmitting the same by
facsimile transmission. If executed in counterparts, this First Amendment will
be as effective as if simultaneously executed.
4
IN WITNESS WHEREOF, the Parties hereto have caused this First Amendment to
be duly executed by their respective authorized officers as of the day and year
first above written.
ATRIX LABORATORIES, INC.
By: /s/ Xxxxxxx X. Xxx
----------------------------------
Name: Xxxxxxx X. Xxx, Ph.D., M.B.A.
Title: Senior Vice President
Corporate Development
SANOFI-SYNTHELABO INC.
By: /s/ Xxxx X. Xxxxxxxx
----------------------------------
Name: Xxxx X. Xxxxxxxx
Title: Senior Vice President, Legal,
and General Counsel, Secretary
By: /s/ Xxxxxx Xxxxx
----------------------------------
Name: Xxxxxx Xxxxx
Title: Director, Financial Control
5
EXHIBIT H
SIX MONTH PRODUCT EXPENSES AND TIMING
[**]
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CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
SECOND AMENDMENT TO AGREEMENT
This Second Amendment to Collaboration, License and Supply Agreement (this
"Second Amendment"), is made by and between Atrix Laboratories, Inc., a Delaware
corporation having offices at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, XX, 00000-0000
("Atrix"), Sanofi-Synthelabo Inc., a Delaware corporation having offices at 00
Xxxx Xxxxxx, Xxx Xxxx, XX, 00000 ("Sanofi-Synthelabo") as of this 7th day of
March, 2002. Atrix and Sanofi-Synthelabo are sometimes referred to collectively
herein as the "Parties" or singly as a "Party."
WHEREAS, the Parties entered into that certain Collaboration, License and
Supply Agreement dated as of December 8, 2000, as subsequently amended by that
certain First Amendment to Collaboration, License and Supply Agreement dated
December 21, 2001 (collectively, the "Agreement"); and
WHEREAS, the Parties desire to further amend the Agreement as set forth
herein.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set
forth in the Agreement and as hereinafter set forth, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
1. The definition of "Marks" as set forth in Article I of the Agreement is
hereby amended in its entirety to read as follows and all references to the
"Marks" in the Agreement are hereby amended to refer to the "Atrix Xxxx,"
unless otherwise set forth in this Second Amendment:
"Atrix Xxxx" means "Atrigel(R)" or any additional trademarks selected
by the Parties pursuant to Section 6.01(b) other than "Eligard(TM)" in
either case, alone or accompanied by any logo or design and any foreign
language equivalents in sound or meaning, whether registered or not."
2. A new definition is hereby added to the Agreement after the definition
"Royalty Term" in Article I to read as follows:
"Sanofi-Synthelabo Xxxx" means "Eligard(TM)", accompanied by any logo
or design and any foreign language equivalents in sound or meaning, whether
registered or not."
3. Section 3.03 of the Agreement is hereby amended in its entirety to read as
follows:
"Section 3.03. ATRIX XXXX. 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 Atrix Xxxx in the Territory in
connection with the marketing, advertising, promotion,
1
distribution and sale of the Product. The Atrix Xxxx shall remain the sole
property of Atrix."
4. Section 6.01(b) of the Agreement is hereby amended in its entirety to read
as follows:
"(b) Trademarks. The Parties agree that the Product will be marketed
under the Sanofi-Synthelabo Xxxx in the Territory. If either
Sanofi-Synthelabo or Atrix desires that the Product subsequently be sold
under a different name other than "Eligard(TM)", or if any Competent
Authority requires that Product be sold under a different name other than
"Eligard(TM)", 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 [**], 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."
5. Section 8.03(b) of the Agreement is hereby amended in its entirety to read
as follows:
"(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. The Parties acknowledge and agree that the Atrix Xxxx will
appear on the syringe A label, the syringe A pouch label, the outer pouch
and carton of each Unit. In addition, the carton of each Unit will contain
the statement "Atrigel(R) is a registered trademark of Atrix Laboratories,
Inc." 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."
6. Clause (iii) of Section 13.01 of the Agreement is hereby amended by
replacing the term "Xxxx" with the term "Sanofi-Synthelabo Xxxx."
7. Section 15.02(d) of the Agreement is hereby amended in its entirety to read
as follows:
"(d) the use of Sanofi-Synthelabo's name and trademark and the
Sanofi-Synthelabo Xxxx in the packaging and labeling of the Product and in
the marketing, sale, distribution or promotion of the Product or the
Demonstration Samples."
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8. Section 19.07(e) of the Agreement is hereby amended in its entirety to read
as follows:
"(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, 14.08, 14.09 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."
9. The first sentence of Section 10.03(a) of the Agreement is hereby amended
in its entirety to read as follows:
"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 the Competent Authorities,
within ten (10) days prior to the date of submission or within five (5)
days from the date of receipt, as the case may be."
10. The last sentence of Section 10.03(b) of the Agreement is hereby amended in
its entirety to read as follows:
"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 five (5) days from the date of receipt, as the case
may be."
11. This Second Amendment and all rights hereunder may not be assigned or
transferred by either Party without the prior written consent of each of
the Parties hereto.
12. All capitalized terms used and not otherwise defined herein shall have the
same meanings as set forth in the Agreement.
13. Except as expressly modified by the terms hereof, the terms and provisions
of the Agreement shall remain in full force and effect as originally
written.
14. Signatures on this Second Amendment may be communicated by facsimile
transmission and shall be binding upon the Parties transmitting the same by
facsimile transmission. If executed in counterparts, this Second Amendment
will be as effective as if simultaneously executed.
3
IN WITNESS WHEREOF, the Parties hereto have caused this Second Amendment to
be duly executed by their respective authorized officers as of the day and year
first above written.
ATRIX LABORATORIES, INC.
By /s/ Xxxxxxx X. Xxx
-----------------------------------
Name: Xxxxxxx X. Xxx, Ph.D., M.B.A.
Title: Senior Vice President
Corporate Development
SANOFI-SYNTHELABO INC.
By /s/ Xxxx X. Xxxxxxxx
-----------------------------------
Name: Xxxx X. Xxxxxxxx
Title: Senior Vice President
General Counsel and Secretary
By /s/ Xxxxxxx Xxxxx
-----------------------------------
Name: Xxxxxxx Xxxxx
Title: Vice President and
Chief Financial Officer
4
CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
[ATRIX LETTERHEAD]
August 22, 2003
Sanofi-Synthelabo Inc.
00 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxxxxxx Xxxxxxx
We refer to the Collaboration, License and Supply Agreement, dated as of
December 8, 2000, by and between Atrix Laboratories, Inc., a Delaware
corporation ("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation
("Sanofi-Synthelabo"), as subsequently amended on each of December 21, 2001 and
March 7, 2002 (collectively, the "Agreement").
The parties hereto have mutually agreed to further amend the Agreement as
follows:
1. Section 4.02 of the Agreement is hereby amended in its entirety to read
as follows:
Section 4.02 ROYALTY PAYMENTS.
(a) Royalty Payments. Except as set forth in Section 4.02 (b),
Sanofi-Synthelabo shall pay to Atrix a royalty consisting of [**]on a
country-by-country and Product-by-Product basis for a period equal to the
Royalty Term for each Product in each country in the Territory.
(i) Royalty [**]
(i) Royalty [**].
(b) Due Dates. 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.
Except for the modification to Section 4.02, this letter agreement does not
amend, modify or supplement the Agreement in any way. Notwithstanding any
provision of this Amendment, nothing herein constitutes or may be deemed to
constitute a representation, warranty or covenant on the part of
Sanofi-Synthelabo that it will achieve any particular level of Net Sales in any
calendar year.
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** Confidential Treatment Requested.
1
Sincerely yours,
ATRIX LABORATORIES, INC.
By: /s/ Xxxx Xxxxxxxx
----------------------------------
Name: Xxxx Xxxxxxxx
Title: Vice President, Business
Development and Counsel
Accepted and Agreed this __ day of August, 2003
SANOFI-SYNTHELABO INC.
By: /s/ Xxxxxxxx Xxxxxxx
----------------------------------
Name: Xxxxxxxx Xxxxxxx
Title: Vice President, Strategy &
Business Operations
By: /s/ Xxxxxxx Xxxxx
----------------------------------
Name: Xxxxxxx Xxxxx
Title: Senior Vice President & CFO
2
CONFIDENTIAL TREATMENT
REQUESTED BY QLT INC.
FOURTH AMENDMENT TO AGREEMENT
This Fourth Amendment to the Collaboration, License and Supply Agreement (this
"AMENDING AGREEMENT"), is entered into as of the 1st day of March, 2005 between
QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a Delaware corporation having
offices at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, Xxxxxxxx, 00000-0000 ("QLT USA"),
and Sanofi-Synthelabo Inc., a Delaware corporation having offices at 00 Xxxx
Xxxxxx, Xxx Xxxx, XX, 00000 ("SANOFI-SYNTHELABO").
WHEREAS:
A. QLT USA and Sanofi-Synthelabo entered into a Collaboration, License and
Supply Agreement dated as of December 8, 2000, as subsequently amended
(collectively, the "COLLABORATION AGREEMENT");
B. As a result of the acquisition of Aventis SA by Sanofi-Synthelabo SA, Aventis
Pharma Inc., a Canadian corporation ("SA CANADA"), became an Affiliate of
Sanofi-Synthelabo;
C. SA Canada markets products under the brand name [**] in the formulations and
for the indications as described in Exhibit A to this Amending Agreement;
D. Section 16.01 of the Collaboration Agreement contains certain restrictions
with respect to the outlicensing, commercialization, marketing, sale or
distribution by Sanofi-Synthelabo and its Affiliates of Competitive Products;
and
E. QLT USA and Sanofi-Synthelabo wish to amend the Collaboration Agreement
regarding the sale of [**] by Sanofi-Synthelabo or any of its Affiliates in
Canada in exchange for [**] made by Sanofi-Synthelabo to QLT USA, all in
accordance with the terms and conditions set forth in this Amending Agreement.
NOW THEREFORE, in consideration of the mutual covenants and agreements set forth
in the Collaboration Agreement and as hereinafter set forth, and other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties agree as follows:
1. ARTICLE I - NEW DEFINITIONS. The following defined terms shall be added
to Article I of the Collaboration Agreement:
"SA CANADA" means Aventis Pharma Inc."
[**]
[**]
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** Confidential Treatment Requested.
1
"[**]" means [**]. Components of the [**]."
[**]
2. SECTION 4.06. A new Section 4.06 of the Collaboration Agreement shall be
added as follows:
"Sanofi-Synthelabo shall [**] as follows:
(a) [**] of the [**] that are made between [**];
(b) [**] of the [**] that are made between [**];
(c) [**] of the [**] that are made between [**]; and
(d) [**] of the [**] that are made on or after [**].
(e) All [**] pursuant to this Section 4.06 shall [**], unless
otherwise specifically provided herein."
3. SECTION 4.05. All references in Section 4.05(a) of the Collaboration
Agreement to "Products" shall be replaced by the words [**]. In addition, all
reporting obligations of Sanofi-Synthelabo and audit and other rights of QLT USA
set forth in Section 4.05(d) of the Collaboration Agreement shall also apply
with respect to the records of Sanofi-Synthelabo and its Affiliates (including
SA Canada) that relate to the [**] and statements of the [**] prepared in
connection with the [**], irrespective of whether sales are made by
Sanofi-Synthelabo and/or its Affiliates.
4. SECTION 6.01. The following shall be added to the end of Section 6.01 of
the Collaboration Agreement:
"For greater certainty, provided that Sanofi-Synthelabo complies with
its obligations under Section 16.01(e)(ii) to (iv), then the mere fact that
Sanofi-Synthelabo continues to sell (including through any of its
Affiliates) the [**] in Canada shall not give rise to a breach of this
Section 6.01."
5. SECTION 11.03. The final two sentences in Section 11.03 of the
Collaboration Agreement are hereby replaced with the following sentences:
"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 make [**] provided for
in this Agreement in the affected country in the Territory shall be reduced
by the percentage by which sales of the Product by Sanofi-Synthelabo or its
Affiliates in the affected country in the
----------
** Confidential Treatment Requested.
2
Territory decrease as a result of the Third Party's sales of the competing
product in the affected country in the Territory."
6. SECTION 16.01. Section 16.01 of the Collaboration Agreement is hereby
amended by adding the following as a new Section 16.01(e):
"(e)
(i) Effective as of [**], the restrictions in Section 16.01(a) of this
Agreement do not apply to the out-licensing, commercialization, marketing,
sale or distribution in Canada by Sanofi-Synthelabo or its Affiliates of
[**]. For greater certainty, nothing in this Section 16.01(e) alters or
limits the restrictions set out in Section 16.01(a) with respect to the
outlicensing, commercialization, marketing, sale and distribution of [**]
in the United States, which restriction shall continue;
(ii) Sanofi-Synthelabo shall, and shall cause its Affiliates,
including SA Canada to use "reasonable commercial efforts" to [**].
(iii) Neither Sanofi-Synthelabo nor any of its Affiliates will license
or sublicense its rights to the [**] in Canada to a Third Party without the
prior written consent of QLT USA, which consent will not be unreasonably
withheld or delayed. To the extent that Sanofi-Synthelabo or any of its
Affiliates licenses or sublicenses rights to the [**] in Canada to a Third
Party, any sales of the [**] in Canada made by such Third Party shall be
deemed to be included in the definition of the [**] and will be subject to
the corresponding [**] and audit and inspection rights set forth herein."
(iv) Following the date of this Amending Agreement, Sanofi-Synthelabo
and its Affiliates, agents, licensees or sublicensees shall not actively
promote and market the [**]:
(a)QLT USA shall have the right to request, not more than once
during any such year, that Sanofi-Synthelabo provide QLT USA with a
report setting forth in reasonable detail the purchases in Canadian
dollars of the [**], if any, made either directly or indirectly
(including through distributors or wholesalers) to [**]. Where
Sanofi-Synthelabo or its Affiliates does not know the amount of [**]
made indirectly to [**], Sanofi-Synthelabo shall have the option of
relying on information obtained from a reputable third-party market
intelligence firm in order to complete the foregoing report,
(b) [**].
(c)QLT USA shall have same rights as set out in Section 4.05(d)
of this Agreement to inspect and audit the records of
Sanofi-Synthelabo or its Affiliates, if any, that relate to any report
furnished by Sanofi-Synthelabo pursuant to 16(e)(iv) solely to
determine the completeness and accuracy of such report. The notice,
costs and results of such audit shall be determined as if it were an
audit being conducted in accordance with Section 4.05(d) of this
Agreement."
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** Confidential Treatment Requested.
3
7. REFERENCES TO ATRIX TO QLT USA. Effective the date hereof, all
references in the Collaboration Agreement to "Atrix" and "Atrix Laboratories,
Inc." shall be deemed to be references to "QLT USA" and "QLT USA, Inc."
8. ASSIGNMENT OF RIGHTS; TERMINATION OF AMENDING AGREEMENT. Prior to [**].
Sanofi-Synthelabo agrees to provide QLT USA with 30 days' prior written notice
of any such sale, transfer or assignment. Upon the completion of such
transaction, except for such rights and obligations as accrued prior to the date
of termination of this Amending Agreement, this Amending Agreement shall
terminate and be of no further force or effect.
9. TERMINATION.
(a) QLT USA may terminate this Amending Agreement prior to the
expiration of the Term upon the occurrence of any of the following:
(i) [**].
(ii) Upon the occurrence of any material misrepresentation or
omission in any report required to be delivered by Sanofi-Synthelabo
to QLT USA by paragraph 3 of this Amending Agreement, which
misrepresentation or omission is caused by Sanofi-Synthelabo's willful
misconduct, gross negligence or bad faith.
(b) Either party may terminate this Amending Agreement prior to the
expiration of the Term upon or after the breach of any material provision
of this Amending 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.
10. ASSIGNMENT. This Amending Agreement and all rights hereunder may not be
assigned or transferred by either Party except in accordance with the terms of
Section 20.03 of the Collaboration Agreement.
11. CAPITALIZED TERMS. All capitalized terms used in this Amending
Agreement and not otherwise defined herein shall have the same meanings as set
forth in the Collaboration Agreement.
12. TERMS OF COLLABORATION AGREEMENT. Except as expressly modified by the
terms of this Amending Agreement, the terms and provisions of the Collaboration
Agreement (as previously amended) shall remain in full force and effect as
originally written.
13. COUNTERPARTS. This Agreement may be executed in one or more
counterparts, and by the different Parties hereto in separate counterparts, each
of which when executed shall be deemed to be an original but all of which taken
together shall constitute one and the same agreement.
----------
** Confidential Treatment Requested.
4
IN WITNESS WHEREOF, the Parties hereto have caused this Amending Agreement to be
duly executed by their respective authorized officers as of the day and year
first above written.
QLT USA, INC.
By: /s/ Xxxxxxx X. Xxxxxx
---------------------------------
Xxxxxxx X. Xxxxxx
President
SANOFI-SYNTHELABO INC.
By: /s/ Xxxxxxx Xxxxx
---------------------------------
Name: Xxxxxxx Xxxxx
Title: Senior Vice President & Chief Financial Officer
By: /s/ Xxxxxxx Xxxxxxxx
---------------------------------
Name: Xxxxxxx Xxxxxxxx
Title: President & CEO
5
EXHIBIT A
[**]
----------
** Confidential Treatment Requested.
CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
--------------------------------------------
AMENDMENT TO AGREEMENT
This Amendment to the Collaboration, License and Supply Agreement (this
"AMENDING AGREEMENT") is entered into as of this 15th day of February (the
"EFFECTIVE DATE") between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a
Delaware corporation having offices at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx,
Xxxxxxxx, 00000-0000 ("QLT USA"), and Sanofi-Synthelabo Inc., a Delaware
corporation having offices at 00 Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxxxx, XX 00000
("SANOFI-SYNTHELABO").
WHEREAS, QLT USA and Sanofi-Synthelabo have previously entered into a
Collaboration, License and Supply Agreement dated as of December 8, 2000, as
subsequently amended (collectively, the "COLLABORATION AGREEMENT"); and
WHEREAS, QLT USA and Sanofi-Synthelabo have entered into that certain Amended
and Restated Contribution Agreement dated February 9, 2007 (the "CONTRIBUTION
Agreement"), under which the parties agreed that this Amending Agreement shall
automatically become effective upon the payment by Sanofi-Synthelabo of the
Sanofi-Synthelabo Contribution in accordance with the terms of the Settlement
Agreement (as such terms are defined in the Contribution Agreement).
NOW THEREFORE, in consideration of the mutual covenants and agreements set forth
in the Contribution Agreement and as hereinafter set forth, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
1. The Collaboration Agreement is hereby amended as follows:
(a) Section 6.01(g) and Article XIII of the Collaboration
Agreement are deleted in their entirety, any previous exercise
of co-marketing rights by QLT USA is null and void as of the
Effective Date;
(b) Section 4.06(d) of the Collaboration Agreement is deleted in
its entirety and Section 4.06(c) of the Collaboration
Agreement is amended and restated in its entirety as follows:
"(c) [**]Net Sales that are made on or after [**]
(c) Sanofi-Synthelabo transferred all of its rights and
obligations under the Collaboration Agreement to its
Affiliate, Sanofi-Aventis U.S. LLC, in accordance with Section
20.03 of the Agreement. All references in the Collaboration
Agreement to "Sanofi-Synthelabo" and "Sanofi-Synthelabo Inc."
shall be deemed to be references to "Sanofi-Aventis U.S." and
"Sanofi-Aventis U.S. LLC," respectively. Notwithstanding the
foregoing, such assignment shall not relieve Sanofi-Synthelabo
of its responsibilities for performance of its obligations
under the Collaboration Agreement.
--------
** Confidential Treatment Requested.
(d) Section 20.03 is amended to include the following:
"Notwithstanding any other provision of this Agreement,
Sanofi-Synthelabo may assign or transfer this Agreement or its
rights or obligations hereunder (collectively the "Rights"),
whether in the aggregate or on a country-by-country basis,
without the prior written consent of QLT USA but on at least
thirty (30) days prior notice; provided, however, that
Sanofi-Synthelabo may not assign or transfer any Rights
without the prior written consent of QLT USA to: [**]or (b) to
a Third Party [**]. If, during the term of this Agreement,
Sanofi-Synthelabo wishes to assign or transfer all or a
portion of the Rights to a Third Party, Sanofi-Synthelabo will
first offer such Rights to QLT USA. QLT USA will have [**]
following the date Sanofi-Synthelabo first presents QLT USA
with such offer to decide whether to purchase such Rights from
Sanofi-Synthelabo. Should QLT USA desire to purchase such
Rights, QLT USA will provide Sanofi-Synthelabo with written
notice thereof within said [**] and the parties shall
thereupon negotiate in good faith exclusively with each other
for a period not to [**] after the date QLT USA gives the
requisite notice to Sanofi-Synthelabo. Should
Sanofi-Synthelabo and QLT USA not enter into an agreement for
the purchase of such Rights during the negotiation period,
Sanofi-Synthelabo shall be [**]. In the event
Sanofi-Synthelabo does not enter into a definitive agreement
with a Third Party within [**] following the termination of
such negotiation period, if any, with QLT USA has ended, the
provisions of this Section shall apply again, and
Sanofi-Synthelabo, prior to selling such Rights, must first
offer such rights to QLT USA. Any agreement transferring the
Rights in violation of this Section 20.3 shall be null and
void ab initio. Sanofi-Synthelabo shall provide QLT USA with
an unredacted copy of the executed agreement between
Sanofi-Synthelabo and any such Third Party promptly upon
execution of the same. Notwithstanding the foregoing, any
assignment or transfer of a portion (rather than all) of such
Rights shall not alter the rights and obligations of
Sanofi-Synthelabo under the Collaboration Agreement with
respect to the Rights it has not assigned.
[**]
2. This Amending Agreement and all rights hereunder may not be assigned or
transferred by either Party except in accordance with the terms of Section 20.03
of the Collaboration Agreement, as herein amended.
3. All capitalized terms used in this Amending Agreement and not otherwise
defined herein shall have the same meanings as set forth in the Collaboration
Agreement.
4. Except as expressly modified by the terms of this Amending Agreement,
the terms and provisions of the Collaboration Agreement (as previously amended)
shall remain in full force and effect as originally written.
5. This Amending Agreement may be executed in one or more counterparts,
and by the different Parties hereto in separate counterparts, each of which when
executed shall be deemed to be an original but all of which taken together shall
constitute one and the same agreement.
--------
** Confidential Treatment Requested.
IN WITNESS WHEREOF, the Parties hereto have caused this Amending Agreement to be
duly executed by their respective authorized officers as of the day and year
first above written.
QLT USA, INC.
By: /s/ Xxxx X. Xxxxxxxx
-------------------------
Xxxx X. Xxxxxxxx
President
SANOFI-SYNTHELABO INC.
By: /s/ Xxxx X. Xxxxxxxx
------------------------
Xxxx X. Xxxxxxxx
Vice President and General Counsel
By: /s/ Laurent Gilhodes
--------------------
Laurent Gilhodes
Vice President and Controller
SANOFI-AVENTIS U.S. LLC
By: /s/ Xxxx X. Xxxxxxxx
------------------------
Xxxx X. Xxxxxxxx
Vice President and General Counsel
By: /s/ Laurent Gilhodes
--------------------------
Laurent Gilhodes
Vice President and Controller