EXHIBIT 10.159
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE
BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE
COMMISSION
Execution Copy
LICENSE AND SUPPLY
AGREEMENT
by and between
INDEVUS PHARMACEUTICALS,
INC.
and
MADAUS GMBH
THIS LICENSE AND SUPPLY AGREEMENT is
effective as of November 3, 2006 (“ Effective
Date ”), by and between INDEVUS PHARMACEUTICALS,
INC. , a corporation organized and existing under the laws of
the State of Delaware and having its principal office at 33 Hayden
Avenue, Lexington, Massachusetts 02421, United States (“
Indevus ”), and MADAUS GmbH , a company with
limited liability organized and existing under the laws of Germany
and having its principal office at Colonia-Allee 15, 51067 Cologne,
Germany (“ Madaus ”). Indevus and Madaus are
collectively referred to herein as the “
Parties” .
W I T N E S S E T
H:
WHEREAS, Madaus is interested in
developing and commercializing Product (as defined below) in the
Madaus Territory (as defined below) and obtaining from Indevus an
exclusive license under the SANCTURA XR Patents and the Indevus
Know-How (each as defined below), and Indevus is willing to grant
such right and license to Madaus, subject to and on the terms and
conditions set forth herein;
WHEREAS, during the Supply Term (as
defined below), Madaus desires to purchase from Indevus, and
Indevus desires to supply to Madaus, Bulk Drug Product (as defined
below) for the Madaus Territory, subject to and on the terms and
conditions set forth herein; and
WHEREAS, the Parties desire to set
forth a procedure to regulate the commercialization of the Product
in the Joint Territory (as defined below);
NOW, THEREFORE, in consideration of
the foregoing premises and the mutual covenants herein contained,
and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
ARTICLE I
DEFINITIONS
Unless specifically set forth to the
contrary herein, the following terms, where used in the singular or
plural, shall have the respective meanings set forth below. To the
extent any defined terms used herein are stated to have the meaning
ascribed to them in any other agreement referred to herein, such
definitions are incorporated by reference herein:
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1.1.
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“
Affiliate ” shall mean (i) any corporation or
business entity of which more than fifty percent (50%) of the
securities or other ownership interests representing the equity,
the voting stock or general partnership interest are owned,
controlled or held, directly or indirectly, by a Party;
(ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds more than fifty percent
(50%) (or the maximum ownership interest permitted by law) of
the securities or other ownership interests representing the
equity, the voting stock or, if applicable, the general partnership
interest, of a Party or (iii) any corporation or business
entity of which a Party has the right to acquire, directly or
indirectly, at least fifty percent (50%) of the securities or
other ownership interests representing the equity, voting stock or
general partnership interests.
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1.2.
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“
Amendment and Agreement ” means the Amendment and
Agreement entered into as of the Effective Date by and between
Madaus and Indevus.
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1.3.
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“
[*] ” means the Supply Agreement dated as of
November 13, 2002 by and between Madaus and
[*]
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1.4.
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“ Bulk
Drug Product ” means encapsulated Product as manufactured
for the Indevus Territory, in the form prior to being in its
finished and packaged form.
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1.5.
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“
Business Day(s) ” means any day that is not a Saturday
or a Sunday or a day on which the New York Stock Exchange is
closed.
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1.6.
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“
Calendar Quarter ” means the respective periods of
three (3) consecutive calendar months ending on
March 31, June 30, September 30 and
December 31.
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1.7.
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“
Calendar Year ” means each successive period of twelve
(12) months commencing on January 1 and ending on
December 31.
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1.8.
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“
Centralized Procedure ” means the European Union
Centralized Procedure for marketing authorization in accordance
with Council Regulation n° 2309/93 of July 22, 1993 or
any successor regulations.
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1.9.
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“
CFR ” means the United States Code of Federal
Regulations.
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1.10.
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“
Competing Product ” means any once-a-day dosage
formulation for the treatment of overactive bladder and/or urinary
incontinence, including a Generic Drug, other than
(i) Product, or (ii) the drugs marketed by Madaus or one
of its Affiliates or sublicensees on the date hereof and listed on
Schedule 1.10.
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1.11.
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“
Compound ” means the chemical compound known as
trospium chloride.
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1.12.
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“
Compound Supply Agreement ” means the agreement
between Madaus and Indevus dated as of the Effective Date relating
to the supply by Madaus to Indevus or its designees of Compound
obtained by Madaus under the [*] .
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1.13.
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“ Current Good Manufacturing Practices
” or “ GMP
” or “ cGMP ” means the current good
manufacturing practice and standards as provided for (and as
amended or updated from time to time) in applicable ICH Harmonised
Tripartite Guidelines.
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1.14.
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“
Development Committee ” shall have the meaning set
forth in Section 4.3.
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1.15.
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“
DMF ” means a Drug Master File as defined in CFR Title
21 part 314, section 420, including all supplements and amendments
thereto.
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1.16.
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“
Effective Date ” means the date first above
written.
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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1.17.
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“
EMEA ” shall mean the European Agency for the
Evaluation of Medicinal Products based in London (UK), as
established by Council Regulation n° 2309/93 of July 22,
1993, as subsequently amended by Commission Regulation 649/98 of
March 23, 1998, and any successor thereto having substantially
the same functions.
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1.18.
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“ EMEA
Authority ” shall mean EMEA or the applicable Regulatory
Authority (as hereinafter defined) in a country which is an EMEA
member at the time in question.
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1.19.
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“
FDA ” means the United States Food and Drug
Administration and any successor agency having substantially the
same functions.
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1.20.
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“
First Commercial Sale ” means the date of the first
commercial sale of Product in the Madaus Territory by Madaus or its
Affiliates, sublicensee(s) or Marketing Distributors.
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1.21.
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“
GAAP ” means generally accepted accounting principles
in the United States.
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1.22.
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“
Generic Competition ” in any particular country shall
commence on the first date on which Generic Drugs achieve a market
share in one Calendar Quarter of [*] or greater of the total
prescriptions for Product in such country (as so shown by IMS (or
IMS-equivalent) data for such prescriptions in that Calendar
Quarter).
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1.23.
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“
Generic Drug(s) ” means any product containing
Compound that is either defined in a particular country in the
Madaus Territory as a generic drug to Product by applicable legal
texts or regulatory authorities in such country or is AB rated or
substitutable by a pharmacist for Product, other than a product
introduced in such country by Madaus, its Affiliates or
sublicensees.
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1.24.
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“
IND ” mean Indevus’ Investigational New Drug
Application [*] , including all supplements and amendments
thereto.
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1.25.
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“
Indevus Know-How ” means all unpatented information
and data, materials, inventions, improvements and know how,
(i) that are necessary or useful for the development and/or
commercialization of Product or Compound, (ii) that are owned
by Indevus at the Effective Date of this Agreement or that are
generated, developed, discovered, invented or made by or on behalf
of Indevus during the Term of this Agreement, (iii) that are
in Indevus’ possession or control, and (iv) as to which
Indevus has the right to license or sublicense in the Indevus
Territory, the Madaus Territory and/or the Joint Territory, as
applicable. Indevus Know-How shall not include data, materials,
inventions, improvements and know how relating to the use of
Compound in (i) a pulmonary inhalation product, or
(ii) an oral liquid formulation intended for pediatric or
elderly use in overactive bladder, incontinence or detrusor
instability.
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1.26.
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“
Indevus’ Manufacturing Costs ” means the costs
incurred by Indevus (including all costs paid to Third Parties) in
connection with or to enable the manufacturing and supply of Bulk
Drug Product, as described on Schedule 1.26.
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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1.27.
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“
Indevus Territory ” means the United States of
America, including the District of Columbia, and its territories
and possessions.
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1.28.
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“
Initial Supply Term ” shall have the meaning set forth
in Section 12.1.
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1.29.
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“
Joint Territory ” means Canada, Japan, Korea and
China.
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1.30.
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“
Joint Territory Agreements ” means those agreements in
effect as of the Effective Date between Madaus and any Third Party
covering the commercialization of Product in any country in the
Joint Territory, as listed on Schedule 1.30 .
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1.31.
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“
Launch ” means the date of the First Commercial Sale
in the applicable country(ies) in the Madaus Territory.
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1.32.
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“
Losses ” means any and all damages, awards,
deficiencies, settlement amounts, defaults, assessments, fines,
dues, penalties (including penalties imposed by any governmental
authority), costs, fees, liabilities, obligations, taxes, liens,
losses, and expenses (including court costs, interest and
reasonable fees of attorneys, accountants and other experts)
awarded or otherwise paid or payable to Third Parties.
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1.33.
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“
MAA ” or “ Marketing Approval Application
” means a marketing authorization application (including or
comparable to an NDA), including all supporting documentation and
data submitted for such application to be accepted for review or
approval, filed with the requisite Regulatory Authority of any
country in the Madaus Territory, and requesting approval for
commercialization of Product in such country.
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1.34.
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“
Madaus Know-How ” means all unpatented information and
data, materials, inventions, improvements and know how,
(i) that are necessary or useful for the development and/or
commercialization of Product, (ii) that are owned by Madaus at
the Effective Date of this Agreement or that are generated,
developed, discovered, invented or made by or on behalf of Madaus
during the Term of this Agreement, (iii) that are in Madaus
possession or control, and (iv) as to which Madaus has the
right to license or sublicense in the Indevus Territory, the Madaus
Territory and/or the Joint Territory, as applicable.
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1.35.
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“
Madaus License ” means the license agreement dated as
of November 26, 1999 by and between Madaus and Indevus, as
amended in Amendment No. 1 thereto dated as of
January 19, 2004, and as further amended in the Amendment and
Agreement.
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1.36.
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“
Manufacturing Payment ” shall have the meaning set
forth in Section 5.4.
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1.37.
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“
Manufacturing Payment Term ” means the period
commencing on the date of the First Commercial Sale and ending on
the later of (a) [*] or (b) the last day of the
Extension Period. For purposes of this calculation, the
“Extension Period” shall be a period equal to the
number of days from (i) the date of the First Commercial Sale
of SANCTURA XR ™ in the Territory (as each of such terms are
defined in the Madaus License, as amended by the Amendment and
Agreement), until (ii) the date of the First Commercial Sale
(as defined in this Agreement) in either the Major European
Countries or the Other Major Countries.
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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1.38.
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“
Madaus Territory ” means worldwide, other than the
Indevus Territory and the Joint Territory, and subject to
adjustments pursuant to Section 12.4.2.
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1.39.
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“
Major European Countries ” means United Kingdom,
Sweden, Germany, Denmark and Spain.
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1.40.
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“
Manufacturing Facility ” means any manufacturing
facility that is identified in the NDA to manufacture Bulk Drug
Product.
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1.41.
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“
Marketing Distributor ” means a Third Party to whom
Madaus or its Affiliate has granted a right to distribute, market,
sell and/or promote Product in the Madaus Territory.
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1.42.
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“
Mutual Recognition Procedure ” shall mean the mutual
recognition procedure for marketing authorization in accordance
with Directive No. 2003/83/EC of November 6, 2001 or any
successor regulations and/or directives.
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1.43.
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“
NDA ” means Indevus’ new drug application
intended to be submitted to the FDA for marketing authorization of
Product in the United States, and any amendments and supplements
thereto.
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1.44.
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“ Net
Sales ” means the actual gross amount invoiced by Madaus,
its Affiliates or its sublicensees for the commercial sale of
Product in the Madaus Territory to a Third Party, commencing upon
the date of First Commercial Sale, after deducting, in accordance
with GAAP, the following:
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(a) trade, cash, quantity or
ordinary discounts;
(b) allowances for product returns,
including allowances or credits for rejected Product, or spoilage
or recalled Product;
(c) rebates and charge
backs;
(d) sales or excise taxes, VAT or
other taxes, and transportation and insurance charges and
additional special transportation, custom duties, and other
governmental charges;
(e) rebates or similar payments paid
in connection with sales of Product to any governmental or
regulatory authority in respect of any state or federal programs
similar to Medicare or Medicaid in the United States in any country
of the Madaus Territory; and
(f) retroactive price reductions and
write-offs or allowances for bad debt, not to exceed two percent
(2%) of Net Sales.
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1.45.
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“
Other Major Countries ” means Australia, Austria,
India and Portugal.
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1.46.
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“
Party ” means Indevus or Madaus.
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1.47.
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“
Product ” means a controlled or extended-release oral
formulation of Compound for the treatment of overactive bladder
and/or urinary incontinence that requires a prescription from a
physician or other health care professional in the Madaus
Territory, that is intended to be administered once a day, and
which (i) but for the license granted herein, cannot be
manufactured, used or sold without infringing a Valid Claim which
is contained in a SANCTURA XR Patent or (ii) utilizes the SLI
Intellectual Property.
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1.48.
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“
Proprietary Information ” means any and all
scientific, clinical, regulatory, marketing, financial and
commercial information or data, whether communicated in writing,
orally or by any other means, which is owned and under the
protection of one Party and provided to the other Party in
connection with this Agreement.
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1.49.
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“
Regulatory Approval ” means (i) in the case of
the Major European Countries, approval of the MAA by the EMEA in
such Major European Countries (and/or the applicable Regulatory
Authorities in any Major European Country not failing to provide or
rejecting such approval), or (ii) in any other country(ies) of
the Madaus Territory, such approvals of the MAA by Regulatory
Authorities as are required to market Product in such country; in
each case including any required pricing and reimbursement
approvals.
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1.50.
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“
Regulatory Authority ” means the FDA and/or any other
governmental regulatory authority, court, arbitrator, agency,
commission, official or other instrumentality of any federal,
state, county, city or other political subdivision, domestic or
foreign, that performs a function for such political subdivision
similar to the function performed by the FDA for the United States
with regard to the approval, licensing, registration or
authorization to develop, test, manufacture, package, market,
distribute, use, store, import, transport or sell Product in the
Madaus Territory or with respect to the approval of pricing or
reimbursement for such product.
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1.51.
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“
Renewal Supply Term ” shall have the meaning set forth
in Section 12.1.
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1.52.
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“
Royalty Year ” means (i) for the year in which
the First Commercial Sale occurs (the “ First Royalty
Year ”), the period commencing with the first day (the
“ Commencement Date ”) of the Calendar Quarter
in which such First Commercial Sale occurs and expiring on the last
day of the twelfth (12th) month following the Commencement
Date; and (ii) for each subsequent year, each successive
twelve (12) month period commencing on the date immediately
following the last day of the First Royalty Year.
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1.53.
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“
Samples ” means units of Product distributed or
provided to health care professionals in the Madaus Territory for
dispensing, in turn, to patients for “trial use” at no
cost to the patient as well as units distributed or provided for
development, testing, clinical trials or as donations (for example,
to non-profit institutions or government agencies for
non-commercial purposes).
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1.54.
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“
SANCTURA XR Patents ” means all patents and patent
applications in any country in the Madaus Territory that, as of the
Effective Date or at any time during the Term of this Agreement
(a) are owned by Indevus or to which Indevus through license
has rights in the Madaus Territory from a Third Party, and
(b) that are necessary for the use or commercialization of
Product or would be infringed by the importing, marketing, offering
for sale or sale of Product in any country in the Madaus Territory,
including (x) all patents that are Development Patents or
Licensed Patents (each as defined in the Supernus Agreement), and
(y) all certificates of invention and applications for
certificates of invention, substitutions, divisions, continuations,
continuations-in-part, patents issuing thereon or reissues or
reexaminations thereof and any and all supplementary protection
certificates or the like of any such patents and current and future
patent applications, including the patents and patent applications
listed on Schedule 1.54 .
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1.55.
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“
SEC ” means the US Securities and Exchange Commission
or any successor agency.
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1.56.
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“ SLI
Intellectual Property ” shall have the meaning ascribed
to such term in the Supernus Agreement.
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1.57.
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“
Specifications ” means the procedures, requirements,
standards, quality assurance and quality release specifications of
the Bulk Drug Product as set forth on Schedule 1.57 , along
with any agreed amendments or modifications thereto. Schedule
1.57 sets forth the Specifications as of the Effective Date,
which are the specifications set forth in the NDA. The
Specifications shall mean the Specifications included in the NDA
that is approved by the FDA. Regardless of the Specifications,
Madaus shall have the option to purchase from Indevus during the
Supply Term, subject to the provisions of Section 5.4.5 and
5.6, either (a) capsules of Bulk Drug Product marked with the
designation “SANCTURA XR”; (b) unmarked capsules
of Bulk Drug Product; or (c) capsules of Bulk Drug Product
marked with another designation selected by Madaus, in each case in
accordance with the terms of this Agreement.
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1.58.
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“
Supernus Agreement ” means the Development and License
Agreement by and between Indevus and Supernus Pharmaceuticals, Inc.
(f/k/a Shire Laboratories Inc.) (“ Supernus ”)
effective as of March 11, 2003, including any amendments
thereto, a copy of which has previously been provided to
Madaus.
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1.59.
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“
Supernus Side Agreement ” means the Side Agreement
dated as of the Effective Date by and among Indevus, Madaus and
Supernus.
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1.60.
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“
Supernus Payments ” means amounts payable by Indevus
to Supernus pursuant to the Supernus Agreement with respect to the
Madaus Territory or the Joint Territory, as applicable.
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1.61.
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“
Supply Price ” shall have the meaning set forth in
Section 5.4.
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1.62.
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“
Supply Term ” means the Initial Supply Term and any
Renewal Supply Term(s).
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1.63.
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“
Third Party(ies) ” means a person or entity who or
which is neither a Party nor an Affiliate of a Party.
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1.64.
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“
Trademark ” means the trademark SANCTURA XR™ and
any related trademark, symbol, logo trade dress and/or trade name
that Indevus may adopt and register for use in the promotion of
Product.
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1.65.
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“
Valid Claim ” means a claim of (i) an issued and
unexpired and not lapsed (unless reinstated) patent included within
the SANCTURA XR Patents, which has not been revoked or held
unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, and which has not
been disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise or (ii) any patent
application which shall not have been abandoned, cancelled,
withdrawn or pending for more than five (5) years from the
earliest priority date claimed for such application.
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Where words and phrases are used
herein in the singular, such usage is intended to include the
plural forms where appropriate to the context, and vice versa. The
words “including”, “includes” and
“such as” are used in their non-limiting sense and have
the same meaning as “including without limitation” and
“including but not limited to”. References to Articles,
Sections, subsections, and clauses are to the same with all their
subparts as they appear in this Agreement. “Herein”
means anywhere in this Agreement. “Hereunder” and
“hereto” means under or pursuant to any provision of
this Agreement.
ARTICLE II
LICENSE;
SUBLICENSES
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2.1.
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License
Grant . Indevus hereby
grants to Madaus an exclusive license under the SANCTURA XR Patents
and the Indevus Know-How to use, develop, import, offer for sale,
sell, or have sold Product, into and throughout the Madaus
Territory; provided, however , that Indevus shall retain
such rights in the Madaus Territory as are reasonably necessary for
Indevus to exercise its rights and perform its obligations as set
forth in this Agreement. If Madaus has the right to use a second
source of Bulk Drug Product pursuant to the terms of this
Agreement, such license shall include also the right to make and
have made Product in the Madaus Territory, pursuant to such
SANCTURA XR Patents and Indevus Know-How.
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2.2.
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Sublicense
under Supernus Agreement . The license granted to Madaus under
Section 2.1 includes a sublicense by Indevus of Indevus’
rights under the Supernus Agreement to the SLI Intellectual
Property, solely to use, develop, import, offer for sale, sell, or
have sold Product into and throughout the Madaus Territory. Madaus
acknowledges that it is a sublicensee under the Supernus Agreement
to the extent stated in the foregoing sentence and agrees that its
rights are limited (and that any sublicensee of Madaus’
rights under this Agreement shall be limited) by the terms and
conditions of the Supernus Agreement, to the same extent as Indevus
is limited by such terms and conditions, as such terms apply to the
sublicense granted to Madaus hereunder, subject
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to the terms of the Supernus Side
Agreement. Notwithstanding anything to the contrary in this
Agreement (except as set forth in the Supernus Side Agreement), the
rights and licenses granted by Indevus to Madaus hereunder are
subject to the terms, conditions and provisions of the Supernus
Agreement such that Madaus shall be subject to any restrictions or
limitations on the rights granted to Indevus under the Supernus
Agreement expressly applicable to sublicensees or sub-sublicensees
(other than the Supernus Payments). The Parties acknowledge and
agree that amounts equal to the amounts of the Supernus Payments
with respect to the Madaus Territory accruing after the date hereof
with respect to such period are required to be paid by Madaus to
Indevus hereunder.
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2.3.
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Sublicenses . Subject to and consistent with the terms and
conditions of this Agreement, Madaus shall have the right to grant
sublicenses of any of the rights granted to Madaus under
Section 2.1 above and Section 3.1.2 below to Affiliates
or any Third Party to develop, use, import, offer for sale, market,
and sell Product in the Madaus Territory provided, however ,
that any sublicensee is bound by all of the terms, conditions,
obligations, restrictions and other covenants of this Agreement
that protect or benefit Indevus’ rights and interests,
including the obligations under the Supernus Agreement, and that
Madaus shall remain responsible for the performance by the
sublicensee of such obligations.
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2.4.
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Limitation . Nothing in this Agreement shall be deemed to
constitute the grant of any license or other right to either Party,
to or in respect of any product, patent, trademark, Proprietary
Information of the other Party, except as expressly set forth
herein.
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ARTICLE III
TRADEMARKS
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3.1.
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Ownership;
License .
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3.1.1 Indevus shall own and, in its
discretion, shall file, register and maintain appropriate
registrations of the Trademark in the Madaus Territory and the
Joint Territory for use on and in connection with the marketing,
sale, advertising and/or promotion of Product in the Madaus
Territory.
3.1.2 Indevus hereby grants to
Madaus an exclusive right and license to use the Trademark solely
in connection with the marketing, sale, advertising and/or
promotion of Product in the Madaus Territory. Madaus may, at its
sole option, use the Trademark on and in connection with the
commercialization of Product in the Madaus Territory provided,
however , that Madaus agrees not to assign or transfer any of
its rights in and to the Trademark and/or any associated
registrations or applications to any Third Party, except in
connection with a permitted assignment of this Agreement as a
whole. The rights to use of the Trademark hereunder are subject to
the laws of the countries in the Madaus Territory.
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3.1.3 Madaus acknowledges that
Indevus owns all rights, title and interests in and to the
Trademark in the Madaus Territory and the Joint Territory and that
nothing in this Agreement grants Madaus or any persons or entity
any rights, title or interest therein, except as specifically set
forth in Section 3.1.2. Except as specifically set forth in
this Agreement, Madaus and its Affiliates shall not, either during
the Term of this Agreement or at any time thereafter, use, attempt
to register, or register, as a trade/service mark, corporate name,
trade name or domain name, or challenge or contest the validity of,
the Trademark or any other trade names/marks and/or logos of
Indevus, or any trademarks confusingly similar to SANCTURA
XR™, or assist any Third Party in doing any of the foregoing.
Madaus acknowledges that any use of the Trademark, and any goodwill
associated with such use, shall vest in and inure to the benefit of
Indevus.
3.1.4 If Madaus uses a trademark
other than the Trademark in connection with the commercialization
of Product in the Madaus Territory, Indevus acknowledges that as
between the Parties, Madaus shall own all rights, title and
interests in and to the trademark (except to the extent it is a
trademark already owned, registered, licensed, or used with a
trademark (™) designation by Indevus) and that nothing
in this Agreement grants Indevus or any persons or entity any
rights, title or interest therein. Except as set forth in the
Madaus License and in the Supply Agreement as of
December 16 th , 2002 between the Parties, Indevus
and its Affiliates shall not, either during the Term of this
Agreement or at any time thereafter, use, attempt to register, or
register, as a trade/service mark, corporate name, trade name or
domain name, or challenge or contest the validity of, any such
trademark used by Madaus or any other trade names/marks and/or
logos of Madaus, or any trademarks confusingly similar to any such
trademark selected by Madaus, or assist any Third Party in doing
any of the foregoing. Indevus acknowledges that any use of that
trademark, and any goodwill associated with such use, shall vest in
and inure to the benefit of Madaus.
3.1.5 If and to the extent Madaus
uses the Trademark, (a) packaging materials, package inserts,
labels and marketing, sales, advertising and promotional materials
relating to Product distributed in the Madaus Territory or the
Joint Territory and bearing the Trademark shall display the
Trademark only in a form and style and with a placement determined
solely by Indevus, and (b) the appearance of the Trademark and
any other Indevus’ trademarks, trade dress, style of
packaging and the like with respect to Product shall be determined
by Indevus, subject to the terms of this Section 3. Regardless
of whether Madaus uses the Trademark, Madaus will include on its
packaging relating to Product a mutually agreed-upon reference to
the SANCTURA XR Patents licensed by Indevus to Madaus
hereunder.
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3.2.
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Trademark
Infringement .
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3.2.1 Madaus shall promptly notify
Indevus of any actual, alleged or threatened infringement of the
Trademark or of any unfair trade practices, passing off of
counterfeit goods, or similar offenses of which it becomes aware.
Indevus reserves the right to determine, in its sole discretion,
whether to and to what extent to institute, prosecute or defend any
actions or proceedings involving or affecting any rights relating
to the Trademark in the Madaus Territory. Upon Indevus’
reasonable request, Madaus shall
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cooperate with
and assist Indevus in any of Indevus’ enforcement efforts
with respect to the Trademark. Money damages so recovered shall be
allocated in the same manner set forth in
Section 11.3.5.
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3.2.2 Indevus shall promptly notify
Madaus of any actual, alleged or threatened infringement of the
trademark Madaus may use in lieu of the Trademark or of any unfair
trade practices, passing off of counterfeit goods, or similar
offenses of which it becomes aware in connection with the Product.
Madaus reserves the right to determine, in its sole discretion,
whether to and to what extent to institute, prosecute or defend any
actions or proceedings involving or affecting any rights relating
to its trademark.
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3.3.
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Competing
Marks . Madaus shall not
market, promote, sell and/or distribute, or authorize or permit
another to market, promote, sell and/or distribute, any product
other than Product under the Trademark or any confusingly similar
trade names/marks and/or logos. Except as provided by
Section 4.7.6, and subject to the other terms and conditions
of this Agreement, Madaus shall, however, be free to market,
promote, sell and/or distribute, and authorize and permit another
to market, promote, sell and/or distribute, any product including
the Product in the Madaus Territory under a trademark other than
the Trademark so long as it is not confusingly similar to the
Trademark.
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ARTICLE IV
DEVELOPMENT AND REGULATORY
MATTERS; COMMERCIALIZATION
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4.1.
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Exchange of
Information . Within ten
(10) Business Days after execution of this Agreement, Indevus
shall disclose to Madaus in English and in writing all Indevus
Know-How not previously available or made available to Madaus.
Within ten (10) Business Days after submission with the FDA of
Indevus’ NDA for Product, Indevus shall provide Madaus with a
copy of such NDA. As Indevus develops further Indevus Know-How, it
shall promptly disclose it to Madaus in English and in
writing.
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4.2.
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Development. To the extent Madaus determines to commercialize
the Product in a country in the Madaus Territory, Madaus will be
responsible for all preclinical development, toxicology and
clinical development required for such commercialization. The
progress and results of such development and regulatory submissions
and review, as well as such other information reasonably requested
by Indevus relating to the progress, goals or performance of such
development, will be reported to Indevus at meetings of the
Development Committee.
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4.3.
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Development
Committee . The Parties
agree to establish a development committee (the “
Development Committee ”) to facilitate the development
and Regulatory Approval of Product in the Madaus Territory and/or
Joint Territory as follows:
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4.3.1 Composition of the
Committee . The Development Committee shall be comprised of two
(2) named representatives of Indevus and two (2) named
representatives of Madaus, all of whom shall be qualified to
appropriately represent such party at the Development Committee
level. The initial representatives for each Party
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hereto shall be
set forth on Schedule 4.3 . Each Party may substitute one or
more of its representatives, in its sole discretion, effective upon
written notice to the other Party of such change. Additional
representatives or consultants may from time to time, by mutual
consent of the Parties, be invited to attend Development Committee
meetings, subject to compliance with Article VIII. The Development
Committee shall use its reasonable efforts in good faith to resolve
by consensus any issue relevant to the development of the Product
in the Madaus Territory and/or Joint Territory.
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4.3.2 Development Committee
Resolution . If the Development Committee is unable to reach
unanimous agreement on any issue relating to the development and/or
Regulatory Approval of Product in the Madaus Territory or the Joint
Territory, notwithstanding the exercise of its reasonable efforts
as provided in Section 4.3.1, then no action shall be taken
with respect to the particular development or Regulatory Approval
issue.
4.3.3 Meetings and Costs .
Either Party shall have the right to call meetings of the
Development Committee upon reasonable advance notice to the other
Party, with the location for such meetings alternating between
Madaus and Indevus facilities (or such other locations as are
determined by the Development Committee), until the expiration of
the earlier of (a) the Initial Supply Term; (b) the last
Launch of Product in the Major European Counties, the Other Major
Countries or the Joint Territory or (c) the fifth anniversary
of the Effective Date (or such other date as to which the Parties
may mutually agree). Alternatively, the Development Committee may
meet by means of conference call or other similar communications
equipment. Any costs incurred by either Party in connection with
meetings of the Development Committee shall be borne by the
respective Party incurring such cost.
4.3.4 Development Committee
Responsibilities . The Development Committee shall be
responsible for overseeing the development and Regulatory Approval
of Product in the Madaus Territory and/or Joint Territory,
including review and approval of all clinical protocols, regulatory
progress and regulatory strategy, drafts of submissions of Product
prescribing information and other regulatory correspondence and
proposed responses thereto.
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4.4.
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Regulatory
Matters . Subject to the
terms of Section 4.3 and 12.4.2, Madaus shall own, control and
retain primary legal and financial responsibility for the
preparation, filing and prosecution and maintenance of all filings
and regulatory applications required to obtain and maintain
authorization to develop, sell and use Product in the Madaus
Territory. Madaus shall notify Indevus within five
(5) Business Days after the submission of any MAAs, the
receipt of any Regulatory Approvals and of the dates of First
Commercial Sale in each country in the Madaus Territory. Subject to
the terms of Section 4.3, Madaus shall be solely responsible
for filing all reports required to be filed in order to maintain
any Regulatory Approvals granted for Product in the Madaus
Territory, for all promotional materials for Product in the Madaus
Territory, and for all interactions with Regulatory Authorities in
the Madaus Territory regarding such Regulatory Approvals and
approval of all such promotional materials. Madaus shall promptly
notify Indevus with respect to any material changes or material
problems that
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may arise in
connection with its MAAs or Regulatory Approvals in any country in
the Madaus Territory. Except as otherwise provided in Article VII
or Section 12.4.2 of this Agreement, Indevus shall have no
ownership rights to such MAAs or Regulatory Approvals, but shall
have the right to reference such MAAs or Regulatory Approvals in
Indevus’ regulatory filings in the Indevus Territory, if
required.
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4.5.
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Adverse Drug
Experiences and Safety Reporting . Each Party shall maintain a safety database
for Product. Indevus and Madaus agree to promptly exchange all
relevant information that relates to the safety of Product,
including all adverse reaction reports. With respect to adverse
drug experiences reports relating to Product, the Parties will
agree, within six (6) months after the Effective Date but in
any event no later than the commencement of any clinical trials in
the Madaus Territory, on operating procedures for the exchange of
safety information between the Parties sufficient to enable each
Party to comply with its legal obligations to report to the
appropriate Regulatory Authorities in the countries in which
Product is being developed or commercialized by such Party, in
accordance with the appropriate laws and regulations of the
relevant countries and authorities. These operating procedures will
(a) include measures necessary for each Party to comply with
such laws and regulations as apply to such Party; (b) define
responsibilities for adverse experience handling for initial,
follow-up and/or periodic submission to government agencies of
significant information on Product from pre clinical laboratory,
animal toxicology and pharmacology studies and Pre-clinical
Development; (c) include arrangements for the exchange of
serious and non-serious cases including formats and timelines,
Periodic Safety Update Reports, Periodic Reports and answers to
safety related queries by Regulatory Authorities; and (d) be
promptly amended as changes in legal obligations require or as
otherwise agreed by the Parties.
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4.6.
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Regulatory
Cooperation . Each Party
shall inform the other Party, within two (2) Business Days, of
its receipt of any information that: (a) raises any material
concern regarding the safety or efficacy of Product;
(b) concerns suspected or actual Product tampering or
contamination or similar problems with respect to Compound or
Product; (c) is reasonably likely to lead to a recall or
market withdrawal of Product; or (d) concerns any ongoing or
potential Regulatory Authority investigation, inspection,
detention, seizure or injunction involving Compound or
Product.
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4.7.1 Madaus shall use reasonable
commercial efforts consistent with normal business practices to
develop and commercialize Product in the Madaus Territory. Where in
this Section 4.7 Madaus is required to use reasonable
commercial efforts consistent with normal business practices, such
level of effort will be consistent with the level of effort used by
Madaus in connection with other products of Madaus of similar
importance which Madaus intends to launch and sell in the Madaus
Territory, or in the absence of any such similar product then such
effort shall be assessed by reference to good business practice in
the light of all the circumstances then in effect.
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4.7.2 In addition to and not in lieu
of the obligations set forth in Section 4.7.1, Madaus
shall:
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(a)
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submit an MAA
under the Centralized Procedure or Mutual Recognition Procedure
with an EMEA Authority within nine (9) months after receipt by
Madaus of the initial NDA submitted by Indevus with the
FDA;
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(b)
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Launch Product
in the Major European Countries within six (6) months after
Regulatory Approval has been obtained in the applicable
jurisdiction;
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(c)
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submit an MAA
in the Other Major Countries within twelve (12) months after
receipt by Madaus of the NDA submitted by Indevus with the
FDA;
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(d)
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Launch Product
in the Other Major Countries within six (6) months after
Regulatory Approval has been obtained in the applicable
jurisdiction;
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(e)
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expend, in
connection with launch of Product, such amounts as are commercially
reasonable in connection with the marketing and promotion of
Product, with the objective of promoting the therapeutic profile
and benefits of Product in the most commercially beneficial
manner;
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(f)
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provide Indevus
with an annual written report and confer with Indevus at least
quarterly to summarize and update the status of Madaus’
regulatory and commercialization efforts and activities with
respect to Product; and
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(g)
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within fifteen
(15) days after the end of each month, provide Indevus with
unaudited monthly sales reports of Net Sales in the Madaus
Territory, including a report as to the number of Samples
distributed during such month.
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4.7.3 In the event that Madaus
determines not to or fails to fulfill any of its obligations set
forth in Section 4.7.2 with respect to any country in the
Madaus Territory, Indevus shall have the right to terminate this
Agreement with respect to such country by providing forty-five
(45) days written notice of such election to Madaus. In such
event, the provisions of Section 4.7.4 and 12.4.2 shall be
applicable. Madaus shall inform Indevus promptly of any
determination not to, or failure to, fulfill its obligations under
Section 4.7.2 with respect to any country in the Madaus
Territory. Such determination or failure by Madaus shall not
constitute a breach of Section 4.7.2 with respect to such
country and, subject to the provisions of Section 4.7.4, no
damage claims or other claims for payment shall be based on such
determination or failure, except to the extent such determination
or failure is associated with or results in a breach of any other
provision of
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this Agreement,
including Section 4.7.1 or any obligation under Article V or
Article VI. The foregoing right to terminate with respect to a
country in the Madaus Territory shall not apply if Madaus’s
determination or failure is due substantially to Indevus’
inability to obtain one or multiple of one batch production, as may
be requested by Madaus, pursuant to the last sentence of
Section 5.6.2. unless a third party is willing and able to
fulfill (and does in fact fulfill) said obligations with respect to
said country on the terms last offered to Madaus.
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4.7.4 Notwithstanding (a) any
determination by Madaus not to meet, or any failure of Madaus to
meet, any of the obligations set forth in Section 4.7.2 with
respect to any country, and/or (b) any election by Indevus to
terminate the Agreement with respect to such country, any milestone
payments otherwise due pursuant to Section 6.1 with respect to
such country (or any jurisdiction that includes such country) shall
nevertheless be paid by Madaus, subject, however to the next
sentence. As to any country as to which Madaus has made such
milestone payment, but determined not to meet, or failed to meet,
any of the obligations set forth in Section 4.7.2 with respect
to such country, Indevus shall reimburse Madaus fifty percent
(50%) of any milestone or similar payments Indevus receives
during the Term from any Third Party with respect to marketing
Product in that country promptly upon receipt thereof.
4.7.5 If Madaus, its Affiliates or
their respective Marketing Distributors sell Product to a customer
who also purchases other products or services from any such entity,
Madaus agrees not to, and to require its Affiliates and their
Marketing Distributors not to, discount or price Product in a
manner that is intended to disadvantage Product in order to benefit
sales or prices of other products offered for sale by Madaus, its
Affiliates or their Marketing Distributors to such
customer.
4.7.6 Subject to the terms of this
Section 4.7.6, Madaus will not (and will ensure that its
Affiliates do not) at any time during the Term of this Agreement,
directly or indirectly, in any country in the Madaus Territory or
the Joint Territory, or in any country as to which this Agreement
has been terminated in accordance with Sections 4.7.3 and 12.4.2,
develop, manufacture, use, market, import/export, offer for sale,
sell or distribute, any Competing Product, nor cause any Competing
Product to be developed, manufactured, distributed, marketed or
sold on its own behalf or on behalf of any Third Party through any
distributor or chain of distribution. Notwithstanding the
foregoing, in the event that Madaus purchases a Third Party or is
purchased by, or takes control of or becomes controlled by a Third
Party, which has developed or commercialized (and is continuing to
sell), a Competing Product (directly or indirectly) in a country in
the Madaus Territory, then Madaus or such Third Party shall, within
six (6) months after such event either (i) cease
marketing, or cause its applicable Affiliate to cease marketing,
the Competing Product in that country; (ii) divest, or cause
its applicable Affiliate to divest, the Competing Product in that
country; or (iii) give up Madaus’ rights with respect to
Product in that country effective automatically at the end of such
six (6) month period, in which case the provisions of
Section 12.4.2 shall be applicable.
15
ARTICLE V
MANUFACTURE AND
SUPPLY
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5.1.
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Manufacturing Responsibility
. Subject to the terms and
conditions of this Agreement, during the Supply Term Indevus or its
designees shall have the exclusive right to, shall be responsible
for, and shall use commercially reasonable efforts to, manufacture
and supply all Bulk Drug Product required for development and
commercialization of Product in the Madaus Territory and the Joint
Territory. Subject to the terms and conditions of this Agreement,
during the Supply Term, Madaus shall purchase all of its
requirements of Bulk Drug Product for use in the Madaus Territory
or the Joint Territory exclusively from Indevus.
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5.2.
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Third Party
Manufacturers . The
obligation set forth in Section 5.1 shall be subject to the
Manufacturing Facility’s being in compliance with cGMP and
all other regulatory requirements including successful regulatory
inspection by the FDA of any such facility. The Parties acknowledge
and agree that Indevus intends to obtain Bulk Drug Product from
Third Party manufacturers, but has not yet entered into agreements
with any Third Party manufacturers with respect to such Bulk Drug
Product.
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5.3.
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Second
Source . Madaus reserves
the right to appoint a second source supplier of Bulk Drug Product
(a) if Indevus fails after reasonable prior written notice
(i) to meet FDA regulatory requirements with respect to
production of Bulk Drug Product or (ii) is unable to deliver
Bulk Drug Product in quantities which satisfy Madaus’
reasonable commercial requirements for Bulk Drug Product, or
(b) pursuant to the provisions of Section 5.4.2. If
Madaus appoints a second source supplier pursuant to the
immediately preceding sentence, Indevus has the right to receive an
adequate royalty, not to exceed 1% of Net Sales, for giving such a
manufacturing license relying on Indevus Know-How, in addition to
any royalties required under the Supernus Agreement.
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5.4.
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Supply
Price . The supply price
for all Bulk Drug Product supplied during the Supply Term by
Indevus under this Agreement (the “ Supply Price
”) shall equal the sum of (a) Indevus’
Manufacturing Costs, plus (b) [*] of Bulk Drug Product
purchased and used for commercial sales of Product (the “
Manufacturing Payment ”), subject to the
following:
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5.4.1 During the Initial Supply
Term, except as otherwise set forth herein, the portion of the
Supply Price allocated to Indevus’ Manufacturing Costs shall
not exceed [*] of Bulk Drug Product (the “
Manufacturing Costs Cap ”).
5.4.2 During any Renewal Supply
Term, the Supply Price shall be calculated as follows:
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(a)
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During any
portion of any Renewal Supply Term that expires on or prior to the
expiration of the Manufacturing Payment Term in which
Indevus’ Manufacturing Costs exceed the Manufacturing Costs
Cap, the Supply Price shall equal the sum of:
(i) Indevus’ Manufacturing Costs (which shall in this
case not be subject to the Manufacturing
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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16
Costs Cap) plus (ii) the
Manufacturing Payment, provided that the Manufacturing Payment
shall be reduced by the amount by which Indevus’
Manufacturing Costs exceed the Manufacturing Costs Cap. If the
Manufacturing Payment would be reduced to zero, Madaus shall have
the right to appoint a second source supplier of Bulk Drug Product,
provided, however , that in such event, Madaus shall
continue to remain liable for any outstanding Binding Portion of a
Forecast or Purchase Order.
If any portion of such Renewal
Supply Term occurs prior to [*] , the provisions of
Section 3.7(b)(ii)(E) of the Madaus License, as amended by the
Amendment and Agreement, shall also be applicable. For example, if
during any portion of any Renewal Supply Term that expires on or
prior to the expiration of the Manufacturing Payment Term,
Indevus’ Manufacturing Costs equal [*] of Bulk Drug
Product, the Manufacturing Payment will be reduced by [*]
and, accordingly, the Supply Price will equal [*]
(Indevus’ Manufacturing Costs of [*] plus the reduced
Manufacturing Payment of [*] If such period is prior to
[*] , then the Additional Payment (as defined in the License
Agreement, as amended by the Amendment and Agreement), shall also
be reduced by [*]
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(b)
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During any
portion of any Renewal Supply Term that commences after the
expiration of the Manufacturing Payment Term, the Supply Price for
all Bulk Drug Product supplied by Indevus under this Agreement
shall equal Indevus’ Manufacturing Costs, and the
Manufacturing Costs Cap shall not be applicable. If Indevus’
Manufacturing Costs exceed [*] of Bulk Drug Product (subject
to adjustment as set forth in the next paragraph), Madaus shall
have the right to appoint a second source supplier of Bulk Drug
Product, provided, however , that in such event, Madaus
shall continue to remain liable for any outstanding Binding Portion
of a Forecast or Purchase Order.
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The adjustment applicable to this
Section 5.4.2(b) shall be calculated based on:
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(i)
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with respect to
[*] the average of: (A) the number obtained by
(i) dividing the consumer price index
(“Verbraucherindex” 2000=100) as available on the
German Federal Statistics Office (“Statistisches Bundesamt
Deutschlands”) website at
http://www.destatis.de/indicators/d/pre110ad.htm (the
“Website”) with respect to the month most recently
reported on the Website on the date of such inflation adjustment by
(ii) the same index with respect to the most recent month
reported on the Website for September 2011,
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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17
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multiplied by
(iii) [*] and (B) the increase in Indevus’
Manufacturing Costs from September 2011 until the date of any
calculation required by this Section 5.4.2(b); and
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(ii)
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with respect to
[*] the average of (A) the number obtained by
(i) dividing the consumer price index
(“Verbraucherindex” 2000=100) as available on the
German Federal Statistics Office (“Statistisches Bundesamt
Deutschlands”) website at
http://www.destatis.de/indicators/d/pre110ad.htm (the
“Website”) with respect to the month most recently
reported on the Website on the date of such inflation adjustment by
(ii) the same index with respect to the most recent month
reported on the Website for [*] , multiplied by (iii)
[*] and (B) the increase in Indevus’
Manufacturing Costs from [*] until the date of any
calculation required by this Section 5.4.2(b).
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(iii)
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The same
adjustment shall be made annually and shall apply as to each new
one-year period during any Renewal Supply Term commencing after the
expiration of the Manufacturing Payment Term. An example of this
adjustment, for illustrative purposes only, is set forth on
Schedule 5.4.2(b).
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5.4.3 Indevus will use commercially
reasonable efforts, consistent with its agreements with Third Party
manufacturers, to achieve production, volume and other efficiencies
in the manufacturing of the Bulk Drug Product which, to the extent
resulting in a reduction in Indevus’ Manufacturing Costs,
shall result in a corresponding reduction in the portion of the
Supply Price allocated to Indevus’ Manufacturing
Costs.
5.4.4 With respect to Bulk Drug
Product used in the Madaus Territory for Samples, such Bulk Drug
Product (a) will not be subject to the Manufacturing Payment,
and (b) will be provided to Madaus for a supply price equal to
Indevus’ Manufacturing Costs; provided, however , that
during each year of the Initial Supply Term, the Manufacturing
Costs Cap shall be applicable to quantities of Bulk Drug Product
used as Samples during that year that are less than ten percent
(10%) of Madaus’ aggregate annual quantities of Bulk
Drug Product purchased for such year hereunder. Any quantities of
Bulk Drug Product used as Samples exceeding such amount shall not
be subject to the Manufacturing Costs Cap.
5.4.5 With respect to Bulk Drug
Product that are, in accordance with Madaus’ forecasts and
Purchase Orders as provided herein, requested to be marked with a
designation other than the SANCTURA XR designation (“
Madaus Marked Capsules ”), Madaus shall, in addition
to the Supply Price (as adjusted in accordance with
Section 5.4.2), be responsible for and shall pay Indevus
within
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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18
thirty (30) days after being
invoiced, (a) the difference between (i) the amount of
Indevus’ Manufacturing Costs that are associated with the
production of Madaus Marked Capsules, and (ii) the amount of
Indevus’ Manufacturing Costs that would have been associated
with the production of Bulk Drug Product capsules marked with the
SANCTURA XR designation, and (b) any additional costs incurred
by Indevus that are not included in Indevus’ Manufacturing
Costs but are associated with the production of Madaus Marked
Capsules, including manufacturing, testing and storing such Madaus
Marked Capsules, as well as any testing or regulatory filings
required by any Regulatory Authority. For example, if at any time
during the Initial Supply Term, Madaus is purchasing Madaus Marked
Capsules under this Agreement, Indevus’ Manufacturing Costs
associated with the production of Madaus Marked Capsules are
[*] and Indevus’ Manufacturing Costs that would have
been associated with the production of the same quantity of Bulk
Drug Product capsules marked with the SANCTURA XR designation are
[*] then, in addition to the Supply Price for such Madaus
Marked Capsules, Madaus shall pay Indevus an additional [*]
of Madaus Marked Capsules.
5.4.6 Sales of Bulk Drug Product
between Madaus and its Affiliates or licensees or sublicensees, or
among such Affiliates and licensees or sublicensees, shall not be
considered sales of Bulk Drug Product for purposes of calculating
the Manufacturing Payment, but in such cases the Manufacturing
Payment shall be calculated on the number of capsules of Product
sold by such Affiliates or licensees or sublicensees to Third
Parties who are not a Madaus licensee or sublicensee.
5.5.1 Forecasts Prior to
Launch . Not later than thirteen (13) months prior to the
estimated Launch of Product in the first country in the Madaus
Territory, Madaus shall provide Indevus a written forecast of its
estimated requirements for Bulk Drug Product for the six
(6) consecutive Calendar Quarters commencing with the Calendar
Quarter in which such Launch is estimated to occur, broken down on
a quarterly basis. Not less than ten (10) months prior to the
estimated Launch of Product in such country, Madaus shall provide
Indevus with an updated forecast (the “ Launch
Forecast ”) of its estimated requirements of Bulk Drug
Product for each such six (6) Calendar Quarters, broken down
on a quarterly basis. Not less than three (3) months prior to
the estimated Launch of Product in such country, Madaus shall
provide Indevus with a forecast of its estimated requirements of
Bulk Drug Product for the six (6) consecutive Calendar
Quarters commencing at the beginning of the Calendar Quarter that
is at least nine (9) months after the date of such forecast,
broken down on a quarterly basis.
5.5.2 Forecasts After Launch
. Within thirty (30) days after the initial Launch of
Prod
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