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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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(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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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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(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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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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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.
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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 Product in the Madaus
Territory and thereafter on a quarterly basis during the Supply
Term, Madaus shall provide Indevus with an updated rolling forecast
of its estimated requirements of Bulk Drug Product, broken down on
a quarterly basis, for six (6) consecutive calendar quarters
(commencing at the beginning of the first complete Calendar Quarter
that commences after at least nine (9) months after the date
of such forecast, broken down on a quarterly basis.
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[*]
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CONFIDENTIAL TREATMENT
REQUESTED
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