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EXHIBIT 10.20
CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.
COLLABORATION, LICENSE AND SUPPLY AGREEMENT
BETWEEN
ATRIX LABORATORIES, INC.
AND
MEDIGENE AKTIENGESELLSCHAFT
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TABLE OF CONTENTS
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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............................................ 14
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..................................... 20
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......................................... 23
ARTICLE VIII PURCHASE AND
SALE....................................... 23
Section 8.01. Purchase Price and
Payment......................... 23
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............................... 26
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..................................... 28
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.............. 31
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................................. 36
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........................................... 37
Section 15.01. MediGene Indemnified by
Atrix...................... 37
Section 15.02. Atrix Indemnified by
MediGene...................... 38
Section 15.03. Prompt Notice
Required............................. 38
Section 15.04. Indemnitor May
Settle.............................. 38
ARTICLE XVI
COVENANTS................................................ 39
Section 16.01. Covenant Not To Launch Competitive
Product......... 39
Section 16.02. Limitation To The
Territory........................ 39
Section 16.03. Access to Books and
Records........................ 40
Section 16.04. A&S Spending
Levels................................ 40
Section 16.05. Marketing
Expenses................................. 40
Section 16.06.
Compliance......................................... 40
Section 16.07.
Reports............................................ 40
Section 16.08. Protection of the
Marks............................ 41
Section 16.09. Launch
Quantities.................................. 41
Section 16.10. Further
Actions.................................... 41
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Section 16.11. Equitable
Relief................................... 41
ARTICLE XVII PRODUCT
RECALL.......................................... 42
Section 17.01. Product Recalls or
Withdrawal...................... 42
Section 17.02. Recall
Costs....................................... 42
Section 17.03. Notification Of
Complaints......................... 43
Section 17.04. Notification Of Threatened
Action.................. 43
ARTICLE XVIII
INSURANCE.............................................. 43
Section 18.01.
Insurance.......................................... 43
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....................... 45
ARTICLE XX
MISCELLANEOUS............................................. 47
Section 20.01.
No-Solicitation.................................... 48
Section 20.02. Commercially Reasonable
Efforts.................... 48
Section 20.03.
Assignment......................................... 48
Section 20.04. Force
Majeure...................................... 48
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.......................................... 50
Section 20.12. Entire Agreement;
Amendment........................ 52
Section 20.13.
Headings........................................... 53
Section 20.14.
Counterparts....................................... 53
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
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
1
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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
2
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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:
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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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<TABLE>
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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"
[**]
</TABLE>
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:
(I) [**]
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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.
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
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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 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,
15
<PAGE>
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 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.
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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 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
17
<PAGE>
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;
(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
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<PAGE>
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.
(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.
[**]
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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 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
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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, 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.
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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 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
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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. [**]
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.
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Section 8.02. ADJUSTMENT TO PURCHASE PRICE/AUDIT.
(a) The Atrix Manufacturing Cost will be adjusted on a Product
by
Product 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
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
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(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.
(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
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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
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.
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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
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
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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 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
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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 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.
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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 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.
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** Confidential Treatment Requested.
30
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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. 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
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** Confidential Treatment Requested.
31
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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 o
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