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EXHIBIT 99.1
COLLABORATION, LICENSE AND SUPPLY AGREEMENT
BETWEEN
ATRIX LABORATORIES, INC.
AND
MEDIGENE AKTIENGESELLSCHAFT
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TABLE OF CONTENTS
SECTION PAGE NO.
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ARTICLE I DEFINITIONS ............................................................................................1
ARTICLE II COLLABORATION..........................................................................................9
Section 2.01. Objectives.....................................................................................9
Section 2.02. Prostate Cancer Development Program............................................................9
Section 2.03. Commercialization.............................................................................11
Section 2.04. Availability of Resources; Cooperation........................................................11
ARTICLE III LICENSE .............................................................................................11
Section 3.01. License Fee...................................................................................11
Section 3.02. License Terms.................................................................................11
Section 3.03. Marks.........................................................................................13
Section 3.04. Ownership of Intellectual Property............................................................13
ARTICLE IV ROYALTY AND MILESTONE PAYMENTS........................................................................13
Section 4.01. Research and Development Expenses.............................................................13
Section 4.02. Royalty Payments..............................................................................13
Section 4.03. Milestone Payments............................................................................14
Section 4.04. Sales Milestone Payment.......................................................................14
Section 4.05. Reports.......................................................................................15
ARTICLE V NEW PRODUCT ...........................................................................................16
Section 5.01. New Product...................................................................................16
Section 5.02. Right of First Negotiation....................................................................16
ARTICLE VI COMMERCIALIZATION.....................................................................................17
Section 6.01. Promotion And Marketing Obligations...........................................................17
ARTICLE VII MANUFACTURE AND SUPPLY...............................................................................20
Section 7.01. Agreement to Supply Product...................................................................20
Section 7.02. Quality Assurance.............................................................................20
Section 7.03. Atrix's Duties................................................................................21
Section 7.04. Compliance with Applicable Laws...............................................................22
Section 7.05. Second Manufacturing Source...................................................................22
Section 7.06. Failure to Supply.............................................................................22
Section 7.07. Allocation....................................................................................24
ARTICLE VIII PURCHASE AND SALE...................................................................................24
Section 8.01. Purchase Price and Payment....................................................................24
Section 8.02. Adjustment to Purchase Price/Audit............................................................24
Section 8.03. Labeling and Artwork..........................................................................25
Section 8.04. Purchase Forms................................................................................26
Section 8.05. Confirmation..................................................................................26
Section 8.06. Delivery......................................................................................26
Section 8.07. Forecasts and Orders..........................................................................27
Section 8.08. Demonstration Samples.........................................................................28
ARTICLE IX WARRANTY, REJECTION AND INSPECTIONS...................................................................28
Section 9.01. Atrix Warranty................................................................................28
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Section 9.02. Rejection of Product for Failure to Conform to Specifications.................................29
Section 9.03. MediGene Inspections..........................................................................29
ARTICLE X REGULATORY COMPLIANCE..................................................................................30
Section 10.01. Marketing Authorization Holder...............................................................30
Section 10.02. Maintenance Of Marketing Authorizations......................................................30
Section 10.03. Interaction with Competent Authorities.......................................................30
Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance.......................................30
Section 10.05. Commercial Sale Testing And Reporting........................................................32
Section 10.06. Assistance...................................................................................32
Section 10.07. Compliance...................................................................................32
ARTICLE XI PATENTS AND TRADEMARKS................................................................................32
Section 11.01. Maintenance of Patents or Marks..............................................................32
Section 11.02. Prosecution of Infringement..................................................................33
Section 11.03. Infringement Claimed by Third Parties........................................................34
ARTICLE XII CONFIDENTIALITY......................................................................................34
Section 12.01. Confidentiality..............................................................................34
Section 12.02. Disclosure of Agreement......................................................................35
ARTICLE XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES....................................35
Section 13.01. Co-Marketing Rights..........................................................................35
ARTICLE XIV REPRESENTATIONS AND WARRANTIES.......................................................................36
Section 14.01. Corporate Power..............................................................................36
Section 14.02. Due Authorization............................................................................36
Section 14.03. Binding Obligation...........................................................................36
Section 14.04. Ownership of Atrigel(R) Patent Rights........................................................36
Section 14.05. Patent Proceedings...........................................................................37
Section 14.06. Legal Proceedings............................................................................37
Section 14.07. Compliance With Applicable Laws..............................................................37
Section 14.08. Limitation on Warranties.....................................................................37
Section 14.09. Limitation of Liability......................................................................37
ARTICLE XV INDEMNIFICATION.......................................................................................38
Section 15.01. MediGene Indemnified by Atrix................................................................38
Section 15.02. Atrix Indemnified by MediGene................................................................38
Section 15.03. Prompt Notice Required.......................................................................38
Section 15.04. Indemnitor May Settle........................................................................39
ARTICLE XVI COVENANTS ...........................................................................................39
Section 16.01. Covenant Not To Launch Competitive Product...................................................39
Section 16.02. Limitation To The Territory..................................................................40
Section 16.03. Access to Books and Records..................................................................40
Section 16.04. A&S Spending Levels..........................................................................40
Section 16.05. Marketing Expenses...........................................................................41
Section 16.06. Compliance...................................................................................41
Section 16.07. Reports......................................................................................41
Section 16.08. Protection of the Marks......................................................................41
Section 16.09. Launch Quantities............................................................................41
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Section 16.10. Further Actions..............................................................................41
Section 16.11. Equitable Relief.............................................................................42
ARTICLE XVII PRODUCT RECALL......................................................................................42
Section 17.01. Product Recalls or Withdrawal................................................................42
Section 17.02. Recall Costs.................................................................................43
Section 17.03. Notification Of Complaints...................................................................43
Section 17.04. Notification Of Threatened Action............................................................44
ARTICLE XVIII INSURANCE..........................................................................................44
Section 18.01. Insurance....................................................................................44
ARTICLE XIX TERM; DEFAULT AND TERMINATION........................................................................44
Section 19.01. Term.........................................................................................44
Section 19.02. Termination by Either Party for Cause........................................................44
Section 19.03. Termination by Atrix.........................................................................44
Section 19.04. Termination by MediGene......................................................................45
Section 19.05. Remedies.....................................................................................45
Section 19.06. Effect of Termination........................................................................45
Section 19.07. License Following Expiration.................................................................48
ARTICLE XX MISCELLANEOUS.........................................................................................48
Section 20.01. No-Solicitation..............................................................................48
Section 20.02. Commercially Reasonable Efforts..............................................................48
Section 20.03. Assignment...................................................................................48
Section 20.04. Force Majeure................................................................................49
Section 20.05. Governing Law................................................................................49
Section 20.06. Waiver.......................................................................................49
Section 20.07. Severability.................................................................................49
Section 20.08. Notices......................................................................................49
Section 20.09. Independent Contractors......................................................................50
Section 20.10. Rules of Construction........................................................................50
Section 20.11. Publicity....................................................................................51
Section 20.12. Entire Agreement; Amendment..................................................................51
Section 20.13. Headings.....................................................................................51
Section 20.14. Counterparts.................................................................................51
Exhibit A - Atrigel(R) Patent Rights .......................................................................A-1
Exhibit B - Form of Certificate of Compliance...............................................................B-1
Exhibit C - [**]............................................................................................C-1
Exhibit D - Form of Stock Purchase Agreement................................................................D-1
Exhibit E - [**]............................................................................................E-1
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Exhibit F - MediGene's SOP..................................................................................F-1
Exhibit G - Drug Delivery Competitors.......................................................................G-1
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COLLABORATION, LICENSE AND SUPPLY AGREEMENT
This Collaboration, License and Supply Agreement (the "Agreement") is
made as of April 4, 2001(the "Effective Date") by and between Atrix
Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint
Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and MediGene Aktiengesellschaft,
a German corporation having offices at Lochhamer Strasse 11,
Planegg/Martinsried, Germany ("MediGene"). Atrix and MediGene 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, MediGene possesses substantial resources and expertise in the
research and development of pharmaceutical products and intends to invest
substantial resources for the commercialization and marketing of pharmaceutical
products under this Agreement;
WHEREAS, Atrix wishes to grant to MediGene, and MediGene 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, MediGene wishes Atrix to manufacture and Atrix desires to
manufacture each of the Product to be sold in the Territory by MediGene.
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
(a) The following terms as used in this Agreement shall have
the meaning set forth below:
"Acceptance for Filing" means MediGene's receipt of a letter issued by
the EMEA or other Competent Authority indicating acceptance for filing of a
regulatory dossier pursuant to Applicable Laws in the Territory.
"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 correlative meanings, the terms
"owned by" and "under common ownership with") as used with
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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 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.
"A&S" means MediGene's advertising and selling expenditures incurred in
and associated with the promotional support of the Product in the Territory,
including the respective overhead allocation costs for supporting and
warehousing the Product, physical and logistic distribution expenses, 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, and the telesales staff used with regard to support of the Product.
"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 and which is under the Control of Atrix as of
the Effective Date, or is created during the term of this Agreement including,
but not limited to, data and documentation of clinical trials and useful for
clinical trials created outside the Territory as of the Effective Date and
during the term of this Agreement, 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.
"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.
"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
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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 for the [**] (the "Twelve Month Cost"):
[**] Dosage Forms Cost:
-------------------
[**] One Month Product - [**]
[**] Three Month Product - [**]
[**] Four Month Product - [**]
[**] Six Month Product - [**]
[**]
[**] Dosage Forms Cost:
-------------------
[**] One Month Product - [**]
[**] Three Month Product - [**]
[**] Four Month Product - [**]
[**] Six 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.
"Collaboration" means the activities of the Parties carried out in
performance of, and the relationship between the Parties established by, this
Agreement.
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"Competent Authorities" means collectively the governmental entities in
each country, or recognized regional authorities, in the Territory responsible
for the regulation of medicinal products intended for human use.
"Competitive Product" means any leuteinizing hormone releasing hormone
(LHRH) or a structurally related derivative or structurally related 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 or proprietary
information of a Party, whether in oral, written, graphic or electronic form,
confirmed in writing and marked as confidential within thirty (30) days of the
date of disclosure. Confidential Information shall not include any information
which the receiving Party can prove by competent evidence:
(a) is now, or hereafter becomes, through no act or failure to
act on the part of the receiving Party, generally known or available;
(b) 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;
(c) is hereafter furnished to the receiving Party by a Third
Party, as a matter of right and without restriction on disclosure;
(d) 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
(e) 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."
"EMEA" means the European Medicine Evaluation Agency.
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[**]
[**]
[**]
[**]
[**]
[**]
"FDA" means the United States Food and Drug Administration.
"Field" means the treatment of prostate cancer, 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
MediGene 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.
"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, import permits, Marketing Authorizations required
by any Competent Authority as a prerequisite to the Manufacturing, packaging,
marketing or selling of the Product or the Units.
"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, whether in written, graphic
or video form or any other form or format.
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"Launch Quantity" means a quantity of Product adequate to meet the
requirements set forth for the first six (6) months in the Initial Forecast.
"Major Countries" or "Major Country" means individually or
collectively, as the case may be, the countries of France, Germany, Italy, Spain
and the United Kingdom.
"Manufacture" or "Manufacturing Process" means the storage, handling,
production, processing and packaging of a Product or a Demonstration Sample, in
accordance with this Agreement and Applicable Laws.
"Marketing Authorization" means all necessary and appropriate
regulatory approvals, including but not limited to, variations thereto, and
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 Atrix in either case, alone or accompanied by any logo or
design and any foreign language equivalents in figure, 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 in the United States as more
fully defined in 21 CFR Section 314.5 et seq.
"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 MediGene 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 MediGene in an arms length transaction with similar
customers. In the event that MediGene includes one or more Product as part of a
bundle of products, MediGene 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 on a product by product basis, Net Sales with respect to such
country divided by the number of Units for the [**] sold in such country during
such time period.
"New Product" means a product containing a combination of leuprolide
acetate in the Atrigel(R) delivery system (other than the Product) or any other
product using any leuteinizing hormone releasing hormone (LHRH) or a
structurally related derivative or structurally related
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analog thereof, whether agonist or antagonist, whether naturally-occurring or
synthetic, for use in the Territory, outside of the Field.
"Packaging Specifications" means the packaging specifications and the
labeling specifications for the Unit, as mutually determined by Atrix and
MediGene from time to time, and in compliance with Applicable Laws.
"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.
"Phase IV" means, as applicable, a study or program designed to obtain
additional safety or efficacy data, detect new uses for or abuses of a drug, or
to determine effectiveness for labeled indications under conditions of
widespread usage, which is commenced after regulatory approval of a Product.
"Pricing and Reimbursement Approvals" means any pricing and
reimbursement approvals which must be obtained before placing 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 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 individually and collectively the [**] supplied in Unit
packages [**], supplied in Unit packages, for use in the Field.
"Royalty" means the royalty to be paid by MediGene to Atrix as set
forth in Section 4.02.
"Royalty Term" means the period of time commencing on the First
Commercial Sale of each Product in any country in the Territory and ending on
the expiration of the last to expire of the Atrigel(R) Patent Rights covering
each Product in such country.
"Shipment" means each individual group of Product received by MediGene
from Atrix.
"Specifications" means the specifications for the Product as may be
amended from time to time by the Parties and in compliance with Applicable Laws.
The Specifications for the [**] are attached hereto as Exhibit C.
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"Stock Purchase Agreement" means that certain Stock Purchase Agreement
dated as of the same date as this Agreement between Atrix and MediGene attached
hereto as Exhibit D.
"Territory" means Albania, Andorra, Armenia, Austria, Azerbaijan,
Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta,
Monaco, Netherlands, Norway, Poland, Portugal, Republic of Moldova, Romania,
Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, The former
Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom and Yugoslavia.
"Third Party" means any entity other than: (a) Atrix, (b) MediGene or
(c) an Affiliate of Atrix or MediGene.
"U.C.C." means the Uniform Commercial Code of Colorado.
"Unit" means the Product, currently packaged in a two-part system
containing (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 [**], aseptically filled and
lyophilized in the syringe, and packaged in a moisture-proof pouch; (c)
instructions for use; and (d) a commercial trade or sample package. The trade or
sample package may be changed or reformulated by Atrix and MediGene from time to
time and the term "Unit" shall refer to the Product in such changed or
reformulated package.
"United States" means the United States of America, its territories and
possessions, including the Commonwealth of Puerto Rico.
[**]
[**]
[**]
[**]
[**]
(b) Each of the following terms is defined in the Section set
forth opposite such term below:
ADE.....................................................................Section 10.04(a)
Adjusted Atrix Manufacturing Cost........................................Section 8.02(a)
Advisory Board........................................................Section 6.01(e)(i)
Agreement.......................................................................Preamble
Atrix...........................................................................Preamble
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Atrix Sales Force........................................................Section 6.01(f)
Clinical Documentation...................................................Section 2.02(c)
Disputed Amount.........................................................Section 19.03(a)
Documentation............................................................Section 8.02(b)
Effective Date..................................................................Preamble
[**]
Force Majeure..............................................................Section 20.04
Indemnitee.................................................................Section 15.03
Indemnitor.................................................................Section 15.03
Initial Forecast.........................................................Section 8.07(a)
Initiating Group...........................................................Section 20.01
License.....................................................................Section 3.02
Licensed Territory......................................................Section 16.02(b)
Loss.......................................................................Section 15.01
MediGene........................................................................Preamble
[**]
Other Group................................................................Section 20.01
Parties.........................................................................Preamble
Party...........................................................................Preamble
Program Technology.......................................................Section 3.04(a)
Purchase Price..............................................................Section 8.01
Recall.....................................................................Section 17.01
Results..................................................................Section 2.02(c)
Royalty Statement........................................................Section 3.04(a)
Second Source...............................................................Section 7.05
SOP.....................................................................Section 10.04(c)
Term.......................................................................Section 19.01
[**]
Twelve Month Cost.........................................See "Atrix Manufacturing Cost"
[**]
ARTICLE II
COLLABORATION
Section 2.01. OBJECTIVES. Pursuant to the [**] Development Program
[**], Atrix and MediGene shall conduct research and development activities using
the Atrigel(R) Technology to develop Product for use in the Field.
Section 2.02. PROSTATE CANCER DEVELOPMENT PROGRAM.
(a) U.S. Product. Atrix shall utilize the Atrigel(R)
Technology to conduct research and development of the [**] for the
palliative treatment of prostate cancer for the U.S.
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market at its own cost and expense, pursuant to a written development
program (the [**]), a copy of which is attached hereto as Exhibit E.
[**] MediGene shall reimburse Atrix for all costs and expenses incurred
by Atrix in supporting MediGene's registration of [**] for use in the
Territory, promptly upon receipt of a reasonably detailed invoice
setting forth such costs and expenses in accordance with a budget
mutually agreed to by the Parties and approved by MediGene.
(i) If additional clinical trials or additional tests
are required by Competent Authorities to market [**] the
Product in the Territory then the Parties shall discuss the
design and budget of such clinical trials and tests and
MediGene shall conduct and pay all costs and expenses
associated with such clinical trials and tests. For the
avoidance of any doubt, MediGene shall make the final
determination as to the design of such clinical trials and
tests; provided that MediGene will consider the effect of such
designs on the marketing and sale of the Product outside the
Territory. Atrix shall diligently assist and support MediGene
in such clinical trials and tests and MediGene shall reimburse
Atrix for all costs and expenses incurred by Atrix in
supporting such clinical trials and tests promptly upon
receipt of a reasonably detailed invoice setting forth such
costs and expenses in accordance with the budget mutually
agreed to by the Parties and approved by MediGene. Further,
Atrix shall sell and supply to MediGene [**] necessary for
such additional clinical trials and tests at Atrix's actual
cost of goods, including overhead allocation but excluding any
manufacturing profit.
(ii) If Atrix's U.S. licensee elects not to fund the
development, [**] in the field of endometriosis or uterine
fibrosis and MediGene elects to fund the development of such
Product for sale in the Territory, then the Parties shall
discuss the design and budget of such development and MediGene
shall conduct and pay all costs and expenses associated with
the development of such Product with such indication in the
Territory. For the avoidance of any doubt, MediGene shall make
the final determination as to the design of such development
program; provided that MediGene will consider the effect of
such design on the marketing and sale of the Product outside
the Territory. Atrix shall diligently assist and support
MediGene in such development program and MediGene shall
reimburse Atrix for all costs and expenses incurred by Atrix
in supporting such development program, promptly upon receipt
of a reasonably detailed invoice setting forth such costs and
expenses in accordance with the budget mutually agreed to by
the Parties and approved by MediGene.
(b) [**]
(c) Regulatory and Clinical Documents. Subject to Section
3.02, MediGene will own all documentation, including all notes,
summaries and analyses related thereto, developed in connection with
such clinical trials and regulatory submissions (the
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"Clinical Documentation") and the results of such clinical testing (the
"Results"); provided that MediGene shall provide Atrix with copies of
all the Clinical Documentation and the Results; and further provided,
that MediGene shall provide Atrix with reasonable access to and full
use of the Clinical Documentation and the Results.
(d) Audit of [**] Costs. MediGene 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
those costs and expenses of Atrix for which MediGene is responsible for
under this Section 2.02 for the sole purpose of verifying such costs
and expenses. Such audits may be exercised during normal business hours
no more than once in a twelve (12) month period upon at least ten (10)
days prior written notice.
Section 2.03. COMMERCIALIZATION. MediGene, at its own expense, will be
responsible for (a) conducting all market research related to the Product; and
(b) commercialization of the Product in the Territory (including all sales and
marketing activities related to the Product). MediGene will obtain Governmental
Approvals in the Territory and pay all duties, fees, tariffs and similar
obligations required to market the Product in each country in the Territory.
Section 2.04. 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 [**].
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.
ARTICLE III
LICENSE
Section 3.01. LICENSE FEE. In partial consideration for the License
granted under Section 3.02(a), MediGene shall pay to Atrix an initial one-time
non-refundable license fee equal to Two Million Dollars ($2,000,000) on the
Effective Date by wire transfer of immediately available funds to an account to
be designated by Atrix to MediGene prior to the Effective Date. On the Effective
Date, MediGene shall also purchase from Atrix Four Million Dollars ($4,000,000)
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 MediGene shall be as follows:
(a) License Grant. Subject to the terms of this Agreement,
Atrix hereby grants to MediGene an exclusive license under the
Atrigel(R) Technology to use, develop, market, advertise, promote,
distribute, offer for sale, sell and import, but not Manufacture, the
Product in the Territory for use in the Field, with a right to
sublicense in accordance with
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this Section 3.02, and agrees to transfer the Atrigel(R) Know-How to
MediGene, only to the extent necessary and sufficient for MediGene to
exercise its rights and perform its obligations hereunder. This
exclusive license can only be transferred by MediGene on the basis set
forth in Section 20.03.
(b) Right to Sublicense without Manufacturing. Subject to the
terms of this Agreement, MediGene shall have the right to grant, under
the license granted by Atrix to MediGene under Section 3.02(a) and
without the prior written consent of Atrix, a sublicense to a Third
Party. MediGene will provide a copy of any such sublicense to Atrix
promptly upon the execution of the same. The right to sublicense
granted under this Section 3.02(b) shall be subject to the terms and
conditions of the license itself, and MediGene shall be responsible for
and shall guarantee the performance by the sublicensee of such
obligations.
(c) [**]
(d) License Termination. If MediGene has not undertaken
commercially reasonable efforts to begin distribution and marketing of
[**], if applicable, in (i) each Major Country within ninety (90) days
following receipt of written notice by MediGene that Governmental
Approval has been received for each respective Product for each Major
Country and (ii) each other country in the Territory within one hundred
and eighty (180) days following receipt of written notice by MediGene
that Governmental Approval has been received for each respective
Product for each other country in the Territory and provided that Atrix
has available Launch Quantities of the respective Product, then the
following shall occur with respect to each Product not so distributed
and marketed: (A) in each Major Country within such ninety (90) days
and (B) in each other country in the Territory within such one hundred
and eighty (180) days: (1) Atrix shall have the right to grant a
license to a Third Party, to market, advertise, promote, distribute,
offer for sale, sell or import [**], if applicable, respectively, on a
country-by-country basis in the Major Countries; provided that the
terms of such licenses are no less favorable to Atrix, in any material
respect, than those set forth in this Agreement (excluding milestone
payments and subject to adjustments to the dollar amount of Net Sales
at which a higher royalty rate becomes payable (to reflect the fact
that the licensee under such license will not have the right to market
and sell the Product in the entire Territory)), (2) the licenses
granted to MediGene under this Agreement shall automatically terminate
with respect to that specific Product in that specific country in the
Territory and such country shall no longer be included in the Territory
for such Product and (3) MediGene shall grant to Atrix an irrevocable,
non-exclusive, royalty-free license, with the right to sublicense, to
use the Clinical Documentation, the Results and the Marketing
Authorizations and make any required filings with Competent
Authorities, only to the extent necessary and sufficient for Atrix or
its licensee to market the Product in such country; provided, however,
such rights shall not include any license or other right to use
MediGene's trademarks or tradedress.
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Section 3.03. MARKS. Subject to the terms and conditions of this
Agreement, Atrix hereby grants to MediGene an exclusive, royalty-free right to
use the Marks in the Territory in connection with the use, development,
marketing, advertising, promotion, distribution and sale of the Product in the
Field.
Section 3.04. OWNERSHIP OF INTELLECTUAL PROPERTY.
(a) All right, title and interest in and to any developments,
inventions or discoveries made in connection with any leuteinizing
hormone releasing hormone (LHRH) or a structurally related derivative
or structurally related analog thereof, whether agonist or antagonist,
whether naturally-occurring or synthetic, used for treatments outside
the Field, which do not relate to the Atrigel(R) Technology or the
Product, made or conceived only during and as a direct result of either
Party's work in connection with this Agreement, shall be jointly owned
by the Parties, including any patentable inventions (the "Program
Technology).
For the avoidance of doubt, MediGene shall have no right,
title or interest in or to the Atrigel(R) Technology or the Marks,
except as specifically set forth in this Agreement.
(b) Atrix and MediGene each grants to the other a
nonexclusive, irrevocable, worldwide, royalty-free, perpetual license,
including the right to grant sublicenses to Affiliates, to make and use
the Program Technology for all research purposes (consistent with the
purpose and intent of this Agreement) other than the sale or
manufacture for sale of products or processes; provided that if any
Party desires to make, manufacture, use, market or sell any product
based upon the Program Technology or desires to provide to a Third
Party a sublicense to make, manufacture, use, market or sell any
product based on the Program Technology, then such Party shall grant to
the other Party a right of first negotiation under substantially the
same terms and procedures as MediGene's right of first negotiation as
set forth in Section 5.02 with respect to such 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. MediGene shall pay to Atrix a royalty
based on [**] for a period equal to the Royalty Term for each Product in each
country in the Territory as follows:
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(a) [**]
(i) [**]
(ii) [**]
(iii) [**]
(b) [**]
(i) [**]
(ii) [**]
(iii) [**]
All royalty payments due to Atrix under this Agreement shall be paid
within forty five (45) days of the end of each calendar quarter, unless
otherwise specifically provided herein.
Section 4.03. MILESTONE PAYMENTS. MediGene shall pay to Atrix, as
licensing fees, the following milestone payments within thirty (30) days after
Atrix gives notice to MediGene of the occurrence of the specified milestone
event:
(a) [**]
(b) [**]
(c) [**]
(d) [**]
(e) [**] and
(f) [**]
[**]. For the avoidance of doubt, the milestone payments referred to in this
Section 4.03 shall be paid only once by MediGene.
Section 4.04. SALES MILESTONE PAYMENT. MediGene shall pay to Atrix as a
one-time payment the sum of [**]. For the avoidance of doubt, the milestone
payment referred to in this Section 4.04 shall be paid only once by MediGene.
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Section 4.05. REPORTS.
(a) Reports. MediGene 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 (collectively,
the "Royalty Statement"). Royalty Statements shall be due as soon as
possible, but in any event no later than sixty (60) 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, 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 Prime Rate of
Interest. 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, MediGene 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. MediGene shall permit an
independent, certified public accountant reasonably acceptable to
MediGene to audit and/or inspect those records of MediGene (including
but not limited to financial records) that relate to Net Sales, Royalty
Statements and A&S for the sole purpose of: (A) verifying the
completeness and accuracy of the Royalty Statements; (B) verifying the
calculation of the Net Selling Price, the calculation of Net Sales and
the calculation of A&S and (C) to confirm Royalty payments and A&S
expenditures for the Product for the previous year. Such inspection
shall be conducted during MediGene's normal business hours, no more
than once in any twelve (12) month period and upon at least ten (10)
days prior written notice by Atrix to MediGene. If such accounting firm
concludes that such payments were underpaid for the preceding year,
MediGene shall pay Atrix the amount of any such underpayments for the
preceding year, plus interest at a rate equal to the Prime Rate of
Interest, within thirty (30) days of the date Atrix delivers to
MediGene such accounting firm's report so concluding that such payments
were underpaid for the preceding year. If such accounting firm
concludes that such payments were overpaid for the preceding year,
Atrix shall pay
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to MediGene the amount of any such overpayments for the preceding year,
without interest, within thirty (30) days of the date Atrix delivers to
MediGene such accounting firm's report so concluding that such payments
were overpaid for the preceding year. 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 for the preceding year. In such
case, MediGene 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 MediGene, 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 MediGene 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 MediGene's right of first
negotiation under Section 5.02 below, Atrix may or, at MediGene's request and at
[**] will, seek to develop and have the EMEA or other Competent Authority
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) MediGene of its intention to have Atrix develop a New
Product, MediGene shall have the first right to negotiate binding material terms
for a definitive license agreement for the New Product. In the event (a)
MediGene 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, which period may be extended upon the mutual agreement of the Parties,
Atrix shall have no further obligation to MediGene under this Section 5.02. If
MediGene and Atrix cannot agree to the terms of such license, then Atrix may
enter into an agreement with a Third Party, provided that
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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 MediGene. The rights of MediGene under this Section 5.02 shall be limited to
those countries in the Territory for which MediGene retains a license under
Sections 3.02 and 3.03 as of the date written notice is received under this
Section 5.02 by Atrix or MediGene, as applicable. If Atrix enters into an
agreement with a Third Party under this Section 5.02, Atrix shall notify
MediGene of this fact within four (4) weeks after the date the agreement is
entered into. MediGene shall then have the right to appoint an appropriate
independent person, reasonably acceptable to Atrix, having sufficient experience
in licensing matters, which person shall execute a confidentiality agreement in
such form as is reasonably satisfactory to Atrix, to examine the terms and
conditions of such agreement to determine that the terms thereof are no less
favorable to Atrix, in any material respect (individually or in the aggregate),
than those last proposed in writing by MediGene. Such determination shall be
made within six (6) weeks after the date Atrix provides notice to MediGene that
it has entered into such an agreement with a Third Party.
ARTICLE VI
COMMERCIALIZATION
Section 6.01. PROMOTION AND MARKETING OBLIGATIONS.
(a) Marketing Efforts. MediGene 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 MediGene 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 MediGene and Atrix
shall meet and in good faith discuss what actions should be taken in
light of such issues.
(b) Trademarks. Subject to the terms and conditions of this
Agreement, MediGene shall have the right to use any trademark, logo,
design and/or tradedress for the Product in the Territory, provided
such trademark, logo, design and/or tradedress complies with Applicable
Laws.
(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
MediGene, 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 into the Territory
and that the Units comply with the Packaging Specifications. Atrix, in
consultation with MediGene, shall also be responsible for assuring that
packaging and labeling comply with all Applicable Laws where such
Product is to be distributed for sale in the Territory. All additional
incremental costs resulting from changes to the Packaging
Specifications made at the request of MediGene that are not required to
export or import the Product to countries in
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the Territory on a country by country basis under Applicable Laws shall
be borne by MediGene.
(d) Marketing Plans And Reports. Sixty (60) days prior to the
expected date of First Commercial Sale in any Major Country and at the
beginning of each calendar year thereafter, MediGene shall submit to
the Advisory Board in writing the annual marketing, sales and
distribution plan for each Major Country detailing MediGene's 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, including the expected selling price
schedules for each Product in each Major Country (including any (i)
prompt payment or other trade or quantity discounts which MediGene
expects to offer and (ii) commission rates or rebates which MediGene
expects to offer to distributors and agents). In addition, upon the
request of Atrix, MediGene shall submit to the Advisory Board copies of
any market research reports relating to Product sales and Product
competition which MediGene 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, MediGene may
submit to the Advisory Board only those excerpts from such plans or
reports which relate to the Product and Product competition.
(e) Advisory Board.
(i) Formation and Function. Promptly after the
Effective Date, MediGene and Atrix will each appoint two (2)
senior representatives to a committee (the "Advisory Board")
that shall have oversight for any activity under this
Agreement for the Territory. Atrix will select an individual
to serve as chairman of the Advisory Board for the initial
twelve (12) months. Thereafter, the chairmanship will rotate
between a MediGene member and an Atrix member every twelve
(12) months. Except as set forth in Section 13.01, the
Advisory Board will be consulted by both Parties on all major
decisions in the development and marketing of the Product in
each country in the Territory, including, without limitation,
in the following areas as they relate to the Product:
(A) Product positioning in the marketplace;
(B) quantity of direct selling efforts,
including the number of sales details to be made;
(C) extent and degree of non-personal
selling and promotional efforts;
(D) quantity and content of workshops and
medical symposia;
(E) design and implementation of a Phase IV
clinical study program to support the Product;
(F) design and implementation of a consumer
awareness program;
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(G) selection of physicians for a medical
advisory board and speakers bureau;
(H) planning for international regulatory
submissions;
(I) dispute resolution regarding sales,
marketing and promotional activities related to the
Product; and
(J) internet presence;
(K) design and performance of other clinical
studies in any country of the Territory.
MediGene, alone, will be responsible for making the final
decisions on the development and marketing of the Product
(subject to the provisions of Section 2.02) regardless of the
action or inaction of the Advisory Board. MediGene agrees that
in making such decisions and taking such actions that it will
consider the effect of such decisions and actions on the
marketing and sale of the Product outside the Territory.
Notwithstanding the foregoing, for the avoidance of doubt,
Atrix, alone, shall make the final decision on all matters
concerning the Manufacture of the Product, except (a) Product
labeling, as provided in Section 8.03, and (b) if MediGene
exercises its Manufacturing rights, as provided in Sections
7.06 or 8.02(b).
(ii) Meetings. The Advisory Board will meet every six
(6) months and at such other times as a Party may request,
alternating between Planegg/Martinsried, Germany and Fort
Collins, Colorado and will otherwise communicate regularly by
telephone, facsimile and/or video conference. The chairman of
the Advisory Board shall prepare minutes of all meetings. Each
Party recognizes the importance of the Advisory Board in the
success of the Collaboration and will use diligent efforts to
cause all of its representatives on the Advisory Board to
attend all meetings of the Advisory Board. A Party may change
any of its appointments to the Advisory Board at any time upon
giving written notice to the other Party.
(iii) Working Groups. The Advisory Board may
establish appropriate working groups for the marketing and any
other activities necessary for the development and marketing
of the Product in the Territory. Each working group shall meet
at least once every three (3) months and at such other times
as a Party may request, alternating between
Planegg/Martinsried, Germany and Fort Collins, Colorado and
will otherwise communicate regularly by telephone, facsimile
and/or video conference. All actions of a working group shall
be by unanimous consent of its members and be reported to the
Advisory Board in writing for approval by the Advisory Board.
Any disputes or disagreements within a working group shall be
resolved by the Advisory Board.
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(f) Co-Promotional Activities of Atrix. Beginning [**]
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, [**] and MediGene will take all actions,
including making any required filings with Competent Authorities,
necessary to allow Atrix to use the applicable Marketing Authorizations
in connection with Atrix's participation in such activities, as far as
legally permissible. [**] Difficulties and differences arising from the
co-promotional activities of Atrix, in particular the Atrix Sales
Force, will be discussed within the Advisory Board. If these
differences cannot be settled by the Advisory Board, MediGene is
entitled to request that the Atrix Sales Force or individual members
thereof are withdrawn.
[**]
ARTICLE VII
MANUFACTURE AND SUPPLY
Section 7.01. AGREEMENT TO SUPPLY PRODUCT. Subject to the terms hereof,
MediGene agrees to purchase exclusively from Atrix, and Atrix agrees to
Manufacture for, and sell exclusively to MediGene during the Term of this
Agreement, MediGene's total requirements for the Product and the Demonstration
Samples in the Territory on the terms and conditions set forth herein. Subject
to MediGene's prior written approval, such approval not to be unreasonably
withheld, conditioned or delayed by MediGene, 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, (b)
Atrix has obtained all required Governmental Approvals to subcontract any part
of the Manufacturing Process for the Product to be sold in the Territory and (c)
the Third Party has obtained all required Governmental Approvals for the
Manufacturing Process for the Product to be sold in the Territory. If
subcontracting is initiated by Atrix or requested by the Competent Authorities
for any Manufacturing Process for Product to be sold in the Territory, 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 MediGene as to any
proposed changes in the Specifications, Manufacturing Process, 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 MediGene's prior, written consent thereto, which consent will not be
unreasonably withheld, conditioned or delayed by MediGene. Atrix shall
immediately notify MediGene in writing 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
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Parties agree to develop and execute an appropriate action plan in such
situation. Any additional costs or expenses shall be shared between the Parties
in such proportion as is equal to each Party's relative fault in causing such
change or changes to occur; provided, however, that if the Parties cannot reach
an agreement in good faith as to the relative fault of each Party or if neither
Party is at fault, such additional costs and expenses shall be born equally by
the Parties.
Section 7.03. ATRIX'S DUTIES. Atrix covenants to Manufacture the
Product in accordance with the Specifications and Applicable Laws, and to
furnish to MediGene with every Shipment a written certificate of analysis and
Certificate of Compliance that confirms conformity of the Product to the
Specifications. The Product may be subjected to testing by MediGene at its
designated facility in order to verify conformance of the Product with the
Specifications. In addition, Atrix shall:
(a) provide MediGene 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 for a period
equal to (i) five (5) years or (ii) such period as required by
Applicable Laws or the Competent Authorities. Upon the written request
of MediGene, Atrix shall make such samples available to MediGene for
inspection. The retained sample shall be sufficient in size to allow
MediGene 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 MediGene's facilities;
(c) maintain records to ensure Atrix's ability to perform a
complete lot history via lot tracing of the Product;
(d) keep on file all manufacturing records and analytical
results pertaining to the Manufacture of each batch of Product for a
period equal to (i) five (5) years or (ii) such period as required by
Applicable Laws or the Competent Authorities, with such period
commencing on the expiration date of the last lot of the last batch of
Product Manufactured and shipped to MediGene. Atrix shall make all such
records available to MediGene upon request;
(e) consult 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 and assist MediGene on an ongoing basis to obtain all necessary
Marketing Authorizations, in accordance with Section 2.02;
(f) provide to MediGene within twenty-four (24) hours of
receipt by Atrix, complete copies of any and all inspection reports
pertaining to the Manufacture and development of the Product which
Atrix receives from any Competent Authority and the FDA, or which is
obtained by Atrix from any Third Party agency, and promptly provide to
MediGene any such report which is internally produced by Atrix's staff
or that of any of its Affiliates;
(g) provide MediGene with complete access to all existing and
hereafter produced: (i) batch records of the Product; (ii) quality
inspection reports of the Product,
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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 MediGene with notice within forty-eight (48) 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 MediGene may desire to be
present at such inspection; provided that MediGene's right to be
present is subject to approval by such Competent Authority and subject
to MediGene 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
MediGene; provided, however, that Atrix alone shall have the right to
make the final decision on all such matters.
Section 7.04. COMPLIANCE WITH APPLICABLE LAWS. MediGene and Atrix (if
Atrix has exercised its co-promotion and/or co-marketing rights pursuant to
Sections 6.01(f) and 13.01, respectively, but only in connection with Atrix's
activities thereunder) 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 and label
the Product for sale in the Territory. No later than three (3) months after the
Marketing Authorization for each Product is approved, Atrix shall take all
necessary actions and provide all necessary information to enable MediGene to
file a variation to the Marketing Authorization for each Product in the
Territory with the Competent Authorities to request approval by such Competent
Authorities for such Second Source to Manufacture each such Product for sale in
the Territory. After such filing, MediGene, with the assistance of Atrix, shall
use reasonable efforts to obtain final approval by the Competent Authorities for
such Second Source to Manufacture each such Product including modifying the
variation to the Marketing Authorization if required by a Competent Authority.
Upon prior written notice to Atrix, MediGene shall have the right, at its sole
cost and expense, 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 MediGene's representative(s) on
any such inspection or audit.
Section 7.06. FAILURE TO SUPPLY.
(a) Atrix shall immediately notify MediGene if Atrix is unable
to fill any order placed by MediGene pursuant to Section 8.07. If Atrix
is unable to cure such failure within fifteen (15) business days after
such notice, Atrix shall, within five (5) business
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days after the expiration of such cure period, make arrangements with
the Second Source for the Second Source to take commercially reasonable
steps to commence the Manufacture of the Product and to 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(a) shall be the sole cost and liability of Atrix.
(b) Subject to Section 7.06(c), if Atrix is unable (including
due to reasons of Force Majeure) to supply Product to MediGene for a
period of forty-five (45) business days or more or if Atrix notifies
MediGene that Atrix and the Second Source will be unable to perform
under Section 7.06(a), then upon such event, Atrix shall be deemed to
have granted to MediGene and MediGene shall be deemed to have, without
any further action by either Party, a non-exclusive royalty-free
license under the Atrigel(R) Technology only to the extent necessary
and sufficient to Manufacture the Product for sale or distribution in
the Territory. At such time as Atrix or the Second Source is again able
to Manufacture the Product, such license to MediGene will terminate and
Atrix will regain its exclusive right to Manufacture and supply the
Product to MediGene, subject to the terms and conditions of the
manufacturing agreement between MediGene and a Third Party
manufacturer. Atrix, upon MediGene's written request, shall provide
MediGene or any Third Party manufacturer chosen by MediGene within two
(2) weeks of the date of such request with all Atrigel(R) Know-How
related to the Manufacturing Process, but only to the extent necessary
and sufficient to exercise its rights hereunder. Atrix shall also
provide MediGene with any additional documentation and materials, at
MediGene's expense, reasonably necessary to Manufacture the Product in
the Territory in accordance with the license granted hereunder. If
MediGene, enters into an agreement with a Third Party to Manufacture
the Product, MediGene shall use commercially reasonable efforts to
limit any such agreement to as short of period of time as commercially
reasonable after giving effect to the period of time Atrix or the
Second Source is expected to be unable to supply the Product. Any Third
Party manufacturer shall execute confidentiality agreements with Atrix
in form and substance reasonably satisfactory to Atrix. If necessary,
Atrix will support the implementation of its Atrigel Know-How for the
Manufacture of the Product by providing appropriate employees giving
the required advice at the premises of MediGene or such Third Party.
The cost for these employees will be borne by MediGene.
Except as set forth in this Section 7.06(b), any additional
costs and expenses reasonably incurred by MediGene shall be borne by
Atrix.
(c) Notwithstanding the foregoing, Atrix shall not be deemed
to be unable to fill any order for Products placed by MediGene if
Atrix's inability to fill any order for Products arises as a result of
[**] increase in MediGene's order for Products over MediGene's prior
firm forecast for each such Product. [**]
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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 MediGene in accordance with Section 8.07,
then Atrix shall allocate the resources available to it so that MediGene
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 MediGene and Atrix.
ARTICLE VIII
PURCHASE AND SALE
Section 8.01. PURCHASE PRICE AND PAYMENT. Atrix shall sell, and
MediGene shall purchase, each Product at a price equal to the Atrix
Manufacturing Cost for each such Product, including any adjustments pursuant to
Section 8.02 (the "Purchase Price"). Atrix shall invoice MediGene monthly for
all Product and Demonstration Samples shipped by Atrix to MediGene and payment
shall be due thirty (30) days from receipt of the invoice.
Section 8.02. ADJUSTMENT TO PURCHASE PRICE/AUDIT.
(a) The Atrix Manufacturing Cost will be adjusted on a Product
by Product and country by country 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 MediGene in good faith disputes the amount of
the Adjusted Atrix Manufacturing Cost, then MediGene shall
notify Atrix of this fact and such dispute shall be resolved
by the Parties within thirty (30) days from the date of notice
to MediGene of the Adjusted Atrix Manufacturing Cost. If such
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 MediGene, 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) MediGene shall pay for Product ordered during
the dispute period at the Purchase Price in effect prior to
Atrix's notice of the Adjusted Atrix Manufacturing Cost. If
upon resolution of any dispute the Purchase Price is greater
than the Purchase Price paid by MediGene during the dispute
period, Atrix will invoice MediGene for the difference and
MediGene shall pay the same promptly upon receipt of such
invoice. If upon resolution of any dispute the Purchase Price
is lower than the Purchase Price paid by MediGene during the
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dispute period, Atrix will reimburse MediGene for the
difference paid during the dispute period, [**].
(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 MediGene may request that the Parties meet to review and
discuss the Atrix Manufacturing Cost. [**] Notwithstanding the
foregoing, commencing twelve (12) months from the date of the First
Commercial Sale of each Product, on a Product by Product basis, in the
event that the total increase results in an increased Atrix
Manufacturing Cost which becomes, in MediGene's sole judgment,
commercially non-viable for a given Product in a given country in the
Territory, MediGene shall have the right, in its sole discretion,
to [**]:
(i) [**];
(ii) [**]; and
(iii) [**].
(c) Commencing twelve (12) months from the date of First
Commercial Sale of each Product MediGene shall have the right, at its
sole cost and expense, 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
and/or the Adjusted Atrix Manufacturing Cost for the sole purpose of
verifying the Atrix Manufacturing Cost or the Adjusted Atrix
Manufacturing Cost, respectively. Such audits may be exercised during
normal business hours no more than once in a twelve (12) month period
upon at least ten (10) days prior written notice. MediGene shall pay
all of the costs of such audit unless such audit discloses an
overstatement of the Atrix Manufacturing Cost or the Adjusted Atrix
Manufacturing Cost by more than [**] of the amount claimed or stated as
the Atrix Manufacturing Cost or the Adjusted Atrix Manufacturing Cost,
respectively, for the preceding year. In such case, Atrix shall pay all
of the costs of such audit.
Section 8.03. LABELING AND ARTWORK.
(a) After execution of this Agreement, Atrix shall have the
right to review and comment upon any labeling and proposed changes to
the labeling of the Product and to participate in discussions with the
Competent Authorities concerning any labeling or proposed labeling
change in accordance with Section 8.03(c). Notwithstanding the above,
MediGene shall make the final decision with regard to any labeling or
labeling revisions, provided that MediGene will consider, in making its
decision, the effect such labeling or labeling revision will have on
the marketing and sale of the Product outside the Territory.
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(b) MediGene will approve all artwork developed for inclusion
in the Product packaging, including carton labels, package inserts,
etc. If MediGene wishes to institute changes in labeling artwork, both
Parties will develop a mutually acceptable implementation schedule. The
actual cost of implementing such change will be at MediGene's sole cost
and expense, including any materials made obsolete by MediGene's
changes to the artwork. Atrix shall not alter, change or in any way
modify the artwork, which has previously been approved, for any reason,
without prior written authorization from MediGene, provided that such
approved artwork shall conform to all Applicable Laws. Notwithstanding
the foregoing, MediGene shall have the final say on any change in such
artwork, provided that MediGene will consider, in making its decision,
the effect any such change will have on the marketing and sale of the
Product outside the Territory and provided further that such change is
in compliance with all Applicable Laws in the Territory.
(c) MediGene shall provide Atrix with notice within
forty-eight (48) hours of notification of any scheduled meeting or
conference with any Competent Authority with respect to any labeling or
proposed labeling change. MediGene shall inform such Competent
Authority that Atrix may desire to be present at such meeting or
conference; provided that Atrix's right to be present is subject to
approval by such Competent Authority and subject to Atrix being
available at the time and date established by such Competent Authority.
MediGene shall use reasonable efforts to secure a time and date for
such meeting or conference that is reasonably acceptable to Atrix;
provided, however, that MediGene alone has the right to make the final
decision on all such matters.
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 five (5) 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
during the first twelve months after the First Commercial Sale of the Product.
[**] Failure of Atrix to confirm any purchase order shall not relieve Atrix of
its obligation to supply Product ordered by MediGene in conformity with this
Agreement.
Section 8.06. DELIVERY. Delivery terms for Product and Demonstration
Samples shall be FOB Atrix's manufacturing facility at Fort Collins, Colorado,
or FOB the Second Source's manufacturing facility. Atrix shall ship Product and
Demonstration Samples in accordance with MediGene's purchase order form or as
otherwise directed by MediGene in writing. Title to any Product or Demonstration
Samples purchased by MediGene shall pass to MediGene upon the earlier of (i) a
common carrier accepting possession or control of such Product or Demonstration
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Samples, as applicable, or (ii) passage of such Product or Demonstration
Samples, as applicable, from the loading dock of Atrix's facilities or the
loading dock of the Second Source's facilities, as applicable, to MediGene 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, MediGene will provide Atrix with a twelve (12) month forecast of
MediGene's requirement of each Product, on a Product by Product basis,
including Demonstration Samples, and on a country by country basis as
follows (the "Initial Forecast"):
(i) For the first twelve (12) months of the forecast
for each Product, the forecasts shall be provided quarterly,
no less than forty-five (45) days prior to the beginning of
each quarter. Said requirements will be based on standard
production planning parameters including but not limited to
sales forecasts, sales demand forecasts, promotional
forecasts, inventory requirements, and the like. The first two
(2) quarters of the twelve (12) month forecast will be stated
in monthly requirements. The second two (2) quarters of the
twelve (12) month forecast will be total requirement by stock
keeping unit and will be stated as quarterly requirements. The
first three (3) months of the twelve (12) month forecast will
be firm orders to purchase. The second three (3) months will
be allowed to be flexed from the previous forecast by plus or
minus [**] 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 [**] in aggregate during that three (3) month
period. [**]
(ii) After the first twelve (12) months MediGene will
provide to Atrix a rolling twelve (12) month forecast for each
Product 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 produce Product or
Demonstration Sample upon receipt of that portion of MediGene'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) MediGene agrees to purchase a sufficient amount of Product
to enable MediGene 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
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contrary in this Section 8.07, Atrix shall be obligated to [**]. All
forecasts will be made by MediGene 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 [**] from
the date of such delivery, provided (a) Product other than the Launch
Quantity shall not have an expiration date of less than [**] once real
time stability data is submitted by Atrix to the respective Competent
Authority, and/or (b) as the Parties may otherwise agree in writing on
a case by case basis.
(e) In the event MediGene does not receive a Marketing
Authorization in a specified country in the Territory, but Atrix
nevertheless has Manufactured the Launch Quantity of the Product for
sale in such country in the Territory, the Atrix Manufacturing Cost
attributable to the Manufacture of the Launch Quantity for sale in such
country shall be borne equally by the Parties after deducting the cost
of any Product which MediGene can sell in another country in the
Territory and the cost of direct materials Atrix could otherwise use in
the manufacture of other products.
Section 8.08. DEMONSTRATION SAMPLES. Pursuant to the provisions of
Section 8.07 above, Atrix shall supply to MediGene such quantities of
Demonstration Samples as MediGene may reasonably request to be used solely for
training purposes (and not for sale), and not for human use, for so long as
MediGene retains a license pursuant to Sections 3.02 and 3.03 in the specific
country in the Territory where the Demonstration Samples are to be used for
training purposes. Demonstration Samples shall be sold by Atrix to MediGene at
[**] for such Demonstration Samples. MediGene 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 MediGene
that (i) the Product delivered pursuant to this Agreement shall comply with the
Specifications at the date of delivery; (ii) the Product to be sold in the
Territory is not adulterated or misbranded under Applicable Laws in the
Territory at the date of delivery; (iii) at the time of Manufacture and delivery
to MediGene the Product will be, and is, free from any defects, liens and
encumbrances and MediGene shall receive good and marketable title to the
Product, and (iv) at the date of Manufacture that Atrix has the right, and to
the best of its knowledge each Second Source has the right, to Manufacture and
label the Product, and (v) to its knowledge no restrictions for the
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import of the Product into the Territory exist at the time of Manufacture and
delivery to MediGene.
EXCEPT AS OTHERWISE SET FORTH HEREIN, ATRIX MAKES NO OTHER WARRANTIES
OF ANY OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY
(AS DESCRIBED IN SECTION 4-2-314 OF THE U.C.C.) OR FITNESS OF THE PRODUCT AND
DEMONSTRATION SAMPLES FOR ANY PURPOSE (AS DESCRIBED IN SECTION 4-2-315 OF THE
U.C.C.), AND ATRIX EXPRESSLY DISCLAIMS ANY SUCH OTHER WARRANTIES WITH RESPECT TO
THE PRODUCT AND DEMONSTRATION SAMPLES, EITHER EXPRESS OR IMPLIED.
Section 9.02. REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO
SPECIFICATIONS. MediGene shall have forty-five (45) days after the receipt of
any Shipment to determine conformity of the Shipment to the Specifications
and/or Applicable Laws, except for hidden defects. A "hidden defect" shall mean
a defect in the Product not discovered by MediGene during its testing of the
Product in accordance with generally accepted industry testing procedures and
which would not be a defect normally expected to be discovered in accordance
with such testing. If testing of such Shipment shows a failure of the Shipment
to meet the Specifications and/or Applicable Laws, MediGene 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 MediGene within forty-five (45) days of
MediGene's receipt of said Shipment except for hidden defects. MediGene shall
have the right to request that Atrix provide to MediGene, within thirty (30)
days after such notice is received by it, Product that meets the Specifications
and Applicable Laws or to promptly provide MediGene with full credit for the
Purchase Price paid by MediGene for the returned Product. In case of a hidden
defect, MediGene shall have the right to request that Atrix provide to MediGene,
within thirty (30) days after a notice concerning a hidden defect is received by
it, Product that meets the Specifications and Applicable Laws or to promptly
provide MediGene with full credit for the Purchase Price paid by MediGene for
the returned Product. In either case the cost of freight and handling to return
or replace the returned Product shall be at the expense of Atrix. If MediGene
does not notify Atrix of the non-conformity of the Product within forty-five
(45) days of receipt of said Shipment, the Product shall be deemed to meet the
Specifications, the Packaging Specifications and Applicable Laws, except for
hidden defects. 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 MediGene'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 MediGene and Atrix. 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,
MediGene shall be responsible for all costs associated with the return.
Section 9.03. MEDIGENE INSPECTIONS. Atrix shall upon reasonable (but
not less than five (5) business days) prior written notice by MediGene and
during normal business hours, allow MediGene and cause any sub-contractors and
the Second Source to allow MediGene, to inspect and audit Atrix's facilities,
the facilities of Atrix's sub-contractors and the facilities of the Second
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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 pertaining to other
products.
ARTICLE X
REGULATORY COMPLIANCE
Section 10.01. MARKETING AUTHORIZATION HOLDER. Unless otherwise
required by Applicable Laws and subject to the provisions of Sections 3.02 and
19.06(e), [**] shall be the holder of all Marketing Authorizations for each
country in the Territory. [**] will own and maintain the Marketing
Authorizations during the term of this Agreement. Each Party agrees that neither
it nor its Affiliates and any sublicensee will do anything to adversely affect a
Marketing Authorization.
Section 10.02. MAINTENANCE OF MARKETING AUTHORIZATIONS. [**] agrees, at
its sole cost and expense, to maintain the Marketing Authorizations throughout
the Term of this Agreement, including obtaining any variations or renewals
thereof.
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 and/or the FDA, within ten (10) days of
submission or receipt, as the case may be.
(b) In addition to the requirements set forth in Section
2.02(c), MediGene 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, including its permitted sublicensees, shall
advise the other Party, by telephone or facsimile, immediately but in
no event later than twenty-four (24) hours after a Party, or its
sublicensees, becomes aware of any potentially serious or unexpected
adverse event (including adverse drug experiences, as defined in
Applicable Laws) (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
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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 MediGene has an exclusive license to market,
promote and sell the Product in any country in the Territory for use in
the Field, MediGene shall have full responsibility for (i) monitoring
such adverse reactions; and (ii) data collection activities that occur
between MediGene and the patient or medical professional, as
appropriate, including any follow-up inquiries which MediGene deems
necessary or appropriate.
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 MediGene'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,
MediGene shall provide Atrix with copies of any such modification or
amendment to the SOP for Atrix's prior approval, which will not be
unreasonably withheld, conditioned or delayed, at least five (5)
business days prior to such amendment taking effect. MediGene shall
designate a qualified person under Applicable Laws to be responsible
for ADE reporting in each country in the Territory.
(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 [**]. MediGene shall have the
authority to make the final decision with regard to any labeling
revisions provided that MediGene will consider, in making its decision,
the effect any such labeling revisions will have on the marketing and
sale of the Product outside the Territory. MediGene agrees that should
Applicable Laws require that any such interim data and results from
such Phase IV surveillance programs be prepared in written form,
MediGene shall comply with such requirements and provide all such
information in writing to MediGene and the Competent Authorities in
accordance with Applicable Laws. MediGene further agrees that Atrix
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 Atrix is required to undertake with respect to
the Product.
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Atrix agrees that MediGene 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 MediGene is
required to undertake with respect to the Product in the Territory.
Section 10.05. COMMERCIAL SALE TESTING AND REPORTING. If, after the
date of First Commercial Sale in any country in the Territory, a Competent
Authority requires additional testing, modification or communication related to
approved indications of the Product, then the Parties shall design and MediGene
shall implement any such testing, modification or communication as shall be
mutually 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. MediGene and Atrix shall comply with all
Applicable Laws within the Territory as set forth in this Agreement, including
the provision of information by MediGene and Atrix to each other necessary for
Atrix and MediGene 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 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.
(a) Atrix shall, at Atrix's expense and to the extent
commercially reasonable, 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, MediGene shall, at no cost
or expense to MediGene, provide such assistance as may be necessary to
enable Atrix to comply with the administrative formalities necessary to
maintain the Atrigel(R) Patent Rights and the Marks and to prosecute
and obtain new patents related to the Atrigel(R) Technology. MediGene
shall, at MediGene's expense, maintain and protect any trademark, logo,
design and/or tradedress for the Product in those countries in the
Territory for which MediGene retains a license pursuant to Section 3.02
and to the extent commercially reasonable, other than the Marks.
(b) MediGene, to the extent commercially reasonable, shall
maintain and protect the Program Technology in all countries in the
Territory and Atrix, to the extent
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commercially reasonable, shall maintain and protect the Program
Technology outside the Territory; provided however, that each Party
shall provide such assistance as may be necessary to enable the other
Party to comply with the administrative formalities necessary to
maintain the Program Technology. In the event that a Party responsible
for the filing, prosecution and maintenance of any patent application
or patent within the Program Technology desires to abandon such patent
application or patent, or if such Party later declines responsibility
for such patent application or patent, such Party shall provide
reasonable prior written notice to the other Party of its intention to
abandon or decline responsibility, and the other Party shall have the
right, but not the obligation, to prepare, file, prosecute, and
maintain any such patent application or patent within the Program
Technology. The Parties shall share equally the costs of filing,
prosecuting and maintaining patents or patent applications within the
Program Technology. In addition, each Party shall provide the other
Party the opportunity to review, consult with and assist such Party in
the preparation of filing, prosecuting and maintaining such patents and
patent applications.
Section 11.02. PROSECUTION OF INFRINGEMENT.
(a) 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 in the Territory 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. MediGene 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 forty-five (45) days after notice given by either Party to
the other of said Third Party infringement, MediGene 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 MediGene as may be
necessary, at MediGene's expense, and MediGene 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.
(b) In the event any patent included in the Program Technology
is infringed by a Third Party, the Party responsible for prosecution
and maintenance of the applicable Program Technology under Section
11.01(b) shall have the right to bring and control such action or
proceeding, using counsel reasonably acceptable to the Parties, and the
other Party shall provide such assistance and cooperation to the Party
bringing such action as may be necessary to successfully prosecute any
action against such Third Party. The Parties shall share equally in the
costs with respect thereto.
In the event Atrix or MediGene, as the case may be, fails to
institute proceedings against any Third Party infringement of the
Program Technology within the earlier of (i) the time period required
under Applicable Laws or (ii) forty-five (45) days after notice
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given by either Party to the other of said Third Party infringement,
the other Party may take such action as it deems appropriate, including
without limitation, the filing of a lawsuit against such Third Party.
In such event Atrix or MediGene, as the case may be, will provide such
assistance and cooperation to the other Party as may be necessary, at
the other Party's expense, and such Party may deduct, in the case of
MediGene, or add, in the case of Atrix, all costs and expenses of such
actions against any amount payable to, in the case of MediGene, or
receivable from, in the case of Atrix, the other Party under this
Agreement and retain all amounts awarded in such action.
(c) Neither Atrix nor MediGene may settle an action or
proceeding against an infringer related to the Program Technology, and
MediGene may not settle an action or proceeding against an infringer
related to Atrigel(R) Technology, with respect to an infringement
without the written consent of the other Party. Such consent shall not
be unreasonably withheld or delayed, but may be withheld if such
settlement would materially and adversely affect the interest of such
Party, including Atrix's rights hereunder or Atrix's rights in the
Atrigel(R) Technology.
Section 11.03. 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 the
Atrigel(R) Patent Rights or Marks, 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 MediGene from any and all
liabilities, costs and expenses, including, without limitation, attorneys' fees,
incurred with respect to any such claim or proceeding and MediGene shall provide
such assistance and cooperation to Atrix as may be necessary to successfully
defend any such claim or proceeding. 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 the Program Technology, the
Party responsible for prosecution and maintenance of the applicable Program
Technology under Section 11.01(a) shall have the right to defend any and all
such claims or proceeding, using counsel reasonably acceptable to the Parties,
and the Parties shall share equally the costs with respect thereto; provided,
however, if such Party elects not to defend such claim or fails to use
commercially reasonable efforts to defend such claim, the other Party shall have
the right to control the defense of such claims by counsel of its own choice at
the cost of the Party who initially had the right to defend such claim.
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
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** Confidential Treatment Requested.
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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 (including those located
in countries outside of the United States) 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.
ARTICLE XIII
ATRIX'S OPTION TO MARKET THE
PRODUCT UNDER CERTAIN CIRCUMSTANCES
Section 13.01. CO-MARKETING RIGHTS. Subject to Section 7.07, if
MediGene should fail to achieve (through no fault of Atrix, including an act of
Force Majeure with respect to Atrix) at least a [**], then, and only if either
of such events occur, Atrix shall have the right and option, exercisable in its
sole discretion, by written notice to that effect delivered by Atrix to MediGene
within sixty (60) days after said event occurs, to co-market the Product in each
such country in the Territory that did not obtain a [**], 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 such country in the Territory the following
shall occur, to the extent allowed by Applicable Laws: (i) MediGene shall grant
Atrix an irrevocable, exclusive, royalty free license, except as against
MediGene, with
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** Confidential Treatment Requested.
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the right to sublicense, under the License granted to MediGene under Section
3.02 of this Agreement (and no other MediGene proprietary or intellectual
property rights) to market, advertise, promote, distribute, offer for sale, sell
and import the Product in such country in the Territory; (ii) MediGene shall
grant to Atrix an irrevocable, non-exclusive, royalty-free license, with the
right to sublicense, to use the Clinical Documentation, the Results and the
Marketing Authorizations and make any required filings with the Competent
Authorities, to the extent legally permissible, in connection with such
activities; (iii) Atrix will be solely responsible for its expenses related to
marketing the Product in such country in the Territory and Atrix will retain all
revenues from Product that it or its sublicensees sell in such country in the
Territory; (iv) Atrix and/or its sub-licensee shall only be entitled to market
one additional brand of the Product and Atrix and/or its sub-licensee shall
market the Product using a different mark than the Mark associated with the
Product in that country in the Territory; (v) subject to and in compliance with
all Applicable Laws, Atrix will use commercially reasonable efforts to restrict
the sale of such Product by its sublicensee outside of said country in the
Territory; and (vi) 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 Effective Date, each Party
hereby represents and warrants that such Party is duly organized and validly
existing under the laws of the jurisdiction 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 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 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 Effective Date, the execution, delivery and performance of
this Agreement by such Party does not conflict with any 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
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 MediGene,
and (c) there are no
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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 Effective Date, Atrix
represents and warrants that, (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) to the best of its knowledge,
the Atrigel(R) Technology does not infringe the published intellectual property
rights of any Third Party.
Section 14.06. LEGAL PROCEEDINGS. As of 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 that, with
respect to Atrix, have been filed with the Securities and Exchange Commission
or, with respect to MediGene, have been disclosed to the relevant stock market
supervisory authority and/or the public) and which would have a material adverse
effect on that Party's ability to consummate the transactions contemplated by
this Agreement.
Section 14.07. COMPLIANCE WITH APPLICABLE LAWS. Atrix represents and
warrants that it is in compliance with Applicable Laws with respect to the
development and Manufacture of Product for clinical trials including, without
limitation, that it owns or has access to manufacturing facilities approved by
the FDA and available for the Manufacture of Product for clinical trials and
that, as of the Effective Date, Atrix is not subject to any stop order from the
FDA or any Competent Authority that would effect Atrix's ability to Manufacture
the Product for clinical trials in the Territory. In addition, to its knowledge,
Atrix is not aware of any fact or circumstance that would cause it to become
subject to a stop order or which would prevent it from complying with Applicable
Laws with respect to the development and Manufacture of Product intended for
sale in the Territory at the time of First Commercial Sale.
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 MediGene 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, EXEMPLARY OR PUNITIVE DAMAGES (AS
SUCH TERMS ARE DEFINED IN BLACK'S LAW DICTIONARY, SIXTH
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** Confidential Treatment Requested.
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EDITION) IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.
ARTICLE XV
INDEMNIFICATION
Section 15.01. MEDIGENE INDEMNIFIED BY ATRIX. Atrix shall indemnify and
hold MediGene, 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 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
(Manufactured by Atrix or the Second Source); (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; (d) if Atrix exercises
its rights to co-market the Product under Article XIII, Atrix's, or its
sub-licensee's, marketing, sale, distribution or promotion of the Product or (e)
the Atrix Sales Force, except to the extent such Loss arises out of, or results
from, the negligence or actions of MediGene.
Section 15.02. ATRIX INDEMNIFIED BY MEDIGENE. MediGene 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 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
MediGene in this Agreement; (b) MediGene's or its sublicensee's use of the Marks
or the Marketing Authorizations in the marketing, use, handling, storage, sale,
distribution or promotion of the Product or the Demonstration Samples; (c)
MediGene's or its sublicensee's marketing, use, handling, storage, sale,
distribution or promotion of the Product or the Demonstration Samples; (d) the
Manufacture of any Product or Demonstration Samples by MediGene or its
sublicensee, which Loss was not the result of Atrix's breach of the terms and
provisions of this Agreement; or (e) the use of MediGene'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 the
Indemnitor from any liability except to the extent that such failure to notify
actually adversely impacts the Indemnitor's ability to defend such claim. 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
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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 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. MediGene
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
MediGene retains a license granted by Atrix under Article III during the Term.
Notwithstanding the foregoing, if MediGene 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,
MediGene 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 MediGene 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;
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Section 16.02. LIMITATION TO THE TERRITORY.
(a) MediGene covenants and agrees that it will not, nor shall
it permit its Affiliates, without the prior written authorization of
Atrix, to the extent allowed by Applicable Laws: (i) promote or
actively solicit sale of the Product or advertise the Product, in any
country where MediGene does not have a necessary Marketing
Authorization or in any country that is not part of the Territory; (ii)
purchase or cause to be purchased Product which MediGene 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) with regard to the Product, contact any of Atrix's
suppliers or vendors of the Product or components relating to the
Product, except as necessary to exercise its right to Manufacture the
Product and to conduct audits, each as set forth in this Agreement;
(iv) contact the FDA or Competent Authorities or other entity located
outside the Territory about the Product, except as required by
Applicable Laws or as may be necessary or appropriate to exercise its
Manufacturing rights or carry out its obligations as set forth in this
Agreement; and (v) knowingly sell or distribute for resale the Product
purchased hereunder to a Third Party who intends to sell such Product
in a country where MediGene does not have a Marketing Authorization, if
required, or in any country that is not part of the Territory.
(b) To the extent Atrix exercises its rights to grant a
license to a Third Party in accordance with Section 3.02(e), Atrix
covenants and agrees that it will not, and shall use commercially
reasonable efforts to ensure that such Third Party does not, without
the prior written authorization of MediGene, to the extent allowed by
Applicable Laws: (i) promote or actively solicit sale of the Product or
advertise the Product, in any country where Atrix does not have the
right to grant such license under Section 3.02(e) (the "Licensed
Territory"); (ii) allow a Third Party to purchase or cause to be
purchased Product which the Third Party has represented, directly or
indirectly, as being for the purpose of sale in the Licensed Territory
for sale in the Territory but outside the Licensed Territory; and (iii)
knowingly sell or distribute for resale the Product to a Third Party
who intends to sell such Product in the Territory but outside the
Licensed Territory.
Section 16.03. ACCESS TO BOOKS AND RECORDS. Each Party covenants and
agrees that it shall permit the other Party, at the other Party's expense and
during normal business hours, to exercise such Party's inspection rights as set
forth in this Agreement.
Section 16.04. A&S SPENDING LEVELS. MediGene covenants and agrees that
during the first [**] months following the date of the First Commercial Sale of
the Product in the Territory [**], MediGene's annual A&S spending levels in the
Territory shall be at least [**] in the aggregate. MediGene further covenants
and agrees that after such [**] Period, MediGene shall maintain annual A&S
spending levels in the Territory [**].
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** Confidential Treatment Requested.
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Section 16.05. MARKETING EXPENSES. MediGene covenants and agrees that,
except as otherwise specified in this Agreement, MediGene 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. MediGene covenants and agrees that, except
as otherwise specified in this Agreement, it will assume all responsibility for
selling and distributing the Product and the Demonstration Samples, as
applicable, including obtaining all necessary Governmental Approvals, and any
other requirements relating to the import, sale and distribution of the Product
and the Demonstration Samples, as applicable, imposed by Applicable Law, and
MediGene 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. REPORTS. MediGene covenants and agrees that, except as
otherwise specified in this Agreement, MediGene shall have the obligation and
responsibility for and shall make any and all necessary reports to the Competent
Authorities, including but not limited to reports on an ADE, and shall provide
Atrix with a complete copy of any such report simultaneously with the submission
of the report to the Competent Authorities. Atrix covenants and agrees that it
shall provide MediGene with a complete copy of any and all necessary reports
simultaneously with the submission of such report to the Competent Authorities
including the FDA.
Section 16.08. PROTECTION OF THE MARKS. The Parties covenant and agree
that neither Party nor their Affiliates shall publish, employ nor cooperate in
the publication of, any misleading or deceptive advertising material with regard
to the Parties, or the Marks or MediGene's trademarks for the Product.
Section 16.09. LAUNCH QUANTITIES. Each Party covenants and agrees to
the other as follows:
(a) that Atrix will provide Launch Quantity of the Product;
(b) that MediGene will timely provide to Atrix its forecast of
MediGene's requirement of Product, on a Product by Product and country
by country basis, including Demonstration Samples, in order to enable
Atrix to timely provide Launch Quantity of the Product to MediGene.
Section 16.10. 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
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(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 and (B) 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 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.
Section 16.11. EQUITABLE RELIEF. The Parties understand and agree that
because of the difficulty of measuring economic losses to the non-breaching
Party as a result of a breach of the covenants set forth in this Article XVI,
and because of the immediate and irreparable damage that may be caused to the
non-breaching Party for which monetary damages would not be a sufficient remedy,
the Parties agree that the non-breaching Party 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 the breaching Party. This
Article XVI shall not limit any other legal or equitable remedies that the
non-breaching Party may have against the breaching Party for violation of the
covenants set forth in this Article XVI. The Parties agree that the
non-breaching Party shall have the right to seek relief for any violation or
threatened violation of this Article XVI by the breaching Party from any court
of competent jurisdiction in any jurisdiction authorized to grant the relief
necessary to prohibit the violation or threatened violation of this Article XVI.
This Article XVI shall apply with equal force to the breaching Party's
Affiliates.
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 requests a Party to recall
the Product or if a voluntary recall of the Product is contemplated by either
Party (collectively, a "Recall"), then 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 in the
Territory without the prior written approval of the other Party, which approval
shall not be unreasonably withheld, conditioned or delayed by either Party. Any
Recall in the Territory shall be carried out by MediGene 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. MediGene shall in all
events be responsible for conducting any Recall in the Territory, market
withdrawals or corrections with respect to the Product in the Territory.
MediGene 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. Atrix shall be
responsible, at its sole cost and expense, for conducting any Recall outside of
the Territory and agrees to notify MediGene immediately if a Competent Authority
outside of the Territory has
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requested a Recall or if Atrix is contemplating a voluntary Recall outside of
the Territory; provided, however, that any such voluntary Recall shall be
subject to Atrix's contractual obligations with Third Parties outside the
Territory and, if Atrix is permitted to exercise discretion under such
contractual obligations, Atrix shall consider the effect of such voluntary
recall on the marketing and sale of the Product in the Territory.
Section 17.02. RECALL COSTS. MediGene shall be responsible for
conducting any Recall in the Territory 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 MediGene and
Atrix shall [**] of the costs and expenses incurred by MediGene 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 MediGene within ten (10)
days after its receipt from MediGene 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 MediGene for
any such costs and expenses paid by MediGene within ten (10) days of
receipt of an invoice for such costs and expenses from MediGene, and if
not so paid MediGene shall have the right to offset such amounts
against amounts otherwise due by MediGene to Atrix hereunder; and
(c) if such Recall is due to the negligence or the breach by
MediGene of its warranties or obligations hereunder or the misconduct
of MediGene, all such costs and expenses shall be borne and paid solely
by MediGene and MediGene 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. MediGene, 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
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Atrix shall cooperate as reasonably requested by MediGene 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 sufficient comprehensive general liability
insurance, including any applicable self-insurance coverage, with bodily injury,
death and property damage including contractual liability and product liability
coverage.
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 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; provided, however, if any such breach relates
solely to one or more Products, then the non-breaching Party may only
terminate this Agreement to the extent it applies to such Product or
Products and this Agreement shall remain in effect as it applies to all
other Products.
Section 19.03. 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:
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(a) Upon the failure by MediGene to pay for fifteen (15) days
from receipt of notice thereof from Atrix, 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 MediGene and Atrix. Further,
MediGene shall pay interest on any Disputed Amount at a rate equal to
the Prime Rate of Interest to 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 MediGene notifies Atrix of a good faith
dispute; provided, however, if the Disputed Amount 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 MediGene, respectively, for
joint resolution. If the Disputed Amount 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, MediGene may in its discretion determine to pay any
such Disputed Amount and in the event amounts are finally determined
not to be due by MediGene, 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 Royalty Statement, which misrepresentation or omission
is caused by MediGene's willful misconduct, gross negligence or bad
faith.
Section 19.04. TERMINATION BY MEDIGENE. MediGene may terminate its
license to the Product for a country in the Territory prior to the expiration of
the Term in the event that MediGene determines in good faith that the Purchase
Price for the Product is not commercially viable with respect to such country in
the Territory in accordance with Section 8.02(b).
Section 19.05. 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. These
remedies shall include the non-breaching Party's right to sue for damages for
such breach without terminating this Agreement.
Section 19.06. EFFECT OF TERMINATION.
(a) Subject to Section 19.06(d), upon termination of this
Agreement by Atrix pursuant to Sections 19.02 or 19.03, (i) MediGene
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, (iii) MediGene shall reimburse Atrix for costs and expenses
reasonably incurred or committed to by Atrix prior to the effective
date of such termination and for which MediGene is otherwise
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obligated to reimburse Atrix pursuant to this Agreement in connection
with the activities performed by Atrix prior to the effective date of
such termination consistent with the budget mutually agreed to by the
Parties and approved by MediGene in accordance with Section 2.02,
provided that Atrix shall use commercially reasonable efforts to
minimize the such costs and expenses between the termination notice
date and the date of termination, and (iv) MediGene shall grant to
Atrix an irrevocable, non-exclusive, royalty-free license, with the
right to sublicense, to the Clinical Documentation, the Results and the
Marketing Authorizations and make any required filings with the
Competent Authorities to the extent necessary and sufficient to market
and sell the Product in the Territory.
(b) Upon termination of this Agreement by MediGene pursuant to
Section 19.02(a), MediGene shall receive an irrevocable, non-exclusive,
royalty-free license, with the right to sublicense, to Manufacture,
market, advertise, promote, distribute, offer for sale, sell and import
the Product in the Territory. Upon termination of this Agreement by
MediGene pursuant to Section 19.02(b), the following shall occur: (i)
MediGene shall have no right to practice within the Atrigel(R) Patent
Rights or use any of the Atrigel(R) Technology, and (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.
(c) Upon termination by Atrix under Sections 19.02 or 19.03 or
by MediGene under Sections 19.02(b) or 19.04, the following shall
occur:
(i) Except as otherwise provided in this Agreement,
all applicable licenses granted to MediGene shall terminate
immediately, including the rights granted to MediGene pursuant to
Sections 3.02 and 3.03, and MediGene shall have no further rights to
the Product subject to MediGene'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 (ii)
hereof, and MediGene 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) MediGene, 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 MediGene chooses this option, MediGene 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
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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 MediGene, the full amount of the actual
cost paid by MediGene to Atrix for such remaining
inventory of Product and Demonstration Samples. If
MediGene 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 the requirements of Applicable Laws and
Marketing Authorizations;
(D) if MediGene notifies Atrix that MediGene
does not intend to sell off any existing inventory of
Product and utilize the Demonstration Samples,
MediGene 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 MediGene, the full amount of the
actual cost paid by MediGene to Atrix, for such
remaining inventory of Product and Demonstration
Samples. If MediGene 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 MediGene to Atrix pursuant to this
Section 19.06 shall be made by MediGene within thirty
(30) days of the end of the time period specified by
Section 19.06(c)(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 MediGene and Atrix. Amounts owed by
Atrix to MediGene pursuant to this Section 19.06(c)
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
MediGene for the amount so owing to it by Atrix under
this subsection.
(d) Except as otherwise provided in this Agreement, 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 3.04, 14.08, 14.09 and Articles
XII,
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XV, XVII and XX and this Article IX shall survive expiration or
termination of this Agreement.
(e) Subject to the provision of Section 19.07, 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.
Section 19.07. LICENSE FOLLOWING EXPIRATION. After expiration of the
Royalty Term, and upon request by MediGene, Atrix shall continue to sell the
Product to MediGene upon terms mutually agreeable to the Parties pursuant to a
separate supply agreement to be negotiated in good faith between the Parties.
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 or employee 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. Unless another standard
is indicated in this Agreement, 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
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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.
Section 20.05. GOVERNING LAW. This Agreement shall be governed by, and
construed and enforced in accordance with, the laws of the State of Delaware,
USA, 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. Any provision of this Agreement held invalid or unenforceable
in part or degree will remain in full force and effect to the extent not held
invalid or unenforceable.
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:
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IF TO ATRIX: Atrix Laboratories, Inc.
2579 Midpoint Drive
Fort Collins, CO 80525
Attn: Charles P. Cox, Ph.D., M.B.A.
Vice President, New Business Development
Telephone: (970) 482-5868
Facsimile: (970) 482-9735
COPIES TO: Morrison & Foerster LLP
5200 Republic Plaza
370 17th Street
Denver, Colorado 80202-5638
Attn: Warren L. Troupe, Esq.
Telephone: (303) 592-2255
Facsimile: (303) 592-1510
IF TO MEDIGENE: MediGene Aktiengesellschaft
Lochhamer Strasse 11
D-82152 Planegg/Martinsried
Germany
Attn: Dr. Martin Poehlchen
Vice President of Business Development
Telephone: 011-49-89-8956-320
Facsimile: 011-49-89-8956-3220
Notice so given shall be deemed given and received (i) if by
international mail on the seventh (7th) day after posting; (ii) by cable,
telegram, telex or personal delivery on the date of actual transmission, with
evidence of transmission acceptance, or (as the case may be) personal or other
delivery; and (iii) if by international courier, on the fourth (4th) business
day following the day such notice is delivered to the international courier
service, or such earlier delivery date as may be confirmed to the sender by such
courier service.
Section 20.09. INDEPENDENT CONTRACTORS. It is expressly agreed that
Atrix and MediGene 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 MediGene 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.
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Section 20.11. PUBLICITY. MediGene 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 other 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 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.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized officers as of the Effective
Date.
ATRIX LABORATORIES, INC., MEDIGENE AKTIENGESELLSCHAFT
a Delaware corporation a German corporation
By: /s/ David R. Bethune By: /s/ Peter Heinrich
Name: David R. Bethune Name: Dr. Peter Heinrich
Title: Chairman and Chief Executive Officer Title: Vorstandsvorsitzender
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EXHIBIT A
ATRIGEL(R) PATENT RIGHTS
[**]
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** Confidential Treatment Requested.
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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
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EXHIBIT C
[**]
(see attached)
[**]
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EXHIBIT D
FORM OF STOCK PURCHASE AGREEMENT
(see Exhibit 99.2 of this Form 8-K).
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EXHIBIT E
[**]
(see attached)
[**]
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** Confidential Treatment Requested.
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EXHIBIT F
MEDIGENE'S SOP
(see attached)
[**]
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** Confidential Treatment Requested.
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EXHIBIT G
DRUG DELIVERY COMPETITORS
[**]
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** Confidential Treatment Requested.
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